Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-07-26
2003-07-01
Denion, Thomas (Department: 3748)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S192000, C604S198000
Reexamination Certificate
active
06585703
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to peripherally inserted central and/or midline catheters lines and, more specifically, to a dividable catheter line introducer device that is fitted with a simple, very reliable and effective needle guard. The needle guard positively prevents hazardous needle sticks when the introducer needle has been retracted from the introducer catheter. After removal of the needle guard, a peripherally inserted central and/or midline catheter line is inserted through the catheter introducer into the patient, and the introducer catheter is divided into two halves that are removable from the line and patient.
BACKGROUND OF THE INVENTION
Intravenous catheters for the infusion of fluids into the veins of a patient are typically one of two general types. One type is the “through-the-needle” catheter wherein the catheter is threaded through the needle and into the vein of a patient. In the through-the-needle type catheter, the needle is not withdrawn from the patient upon placement of the catheter. The second type of catheter is the “over-the-needle” type. Upon insertion of the introducer catheter into a patient, the insertion needle is withdrawn leaving the catheter in the body.
Needle guards are known in the art, but are generally limited for use with short peripheral catheters. The introducer needle is mounted in the needle guard so that when the needle is removed from the catheter it is received into the needle guard. It is also known in the art to use positive-lock needle guards that positively lock the needle in the guard.
Short peripheral catheters are distinguishable from peripherally inserted central catheter (“PICC”) lines in that PICC lines are inserted into the vascular system of the patient whereas short peripheral catheters are inserted into a vein of the patient. Not surprisingly, these different applications require different catheter structures and correspondingly different restrictions to the use of a needle guard on the introducer catheter.
In the use of a PICC line, a flexible catheter is introduced into the vascular system of a patient and subsequently manipulated to move the catheter through the vascular system of a patient to a desired location. Because the catheter must be moved upwardly through the vascular system, the catheter must be formed from a soft, biocompatible, pliable, and flexible material which is capable of winding through and extending through substantial lengths of the vascular system. It is not unusual for such catheters to extend from two to thirty inches or more through the vascular system of a patient. The insertion of the PICC line must also occur without causing trauma to the vascular system.
Because of the need to insert the PICC line catheter such long distances into the vascular system of a patient, the prior art devices tended to use through-the-needle catheter systems. In these through-the-needle catheter systems, after venous insertion, the needle or cannula is retained within the patient and the desired length of catheter is inserted through the cannula and into the vein of the patient. As will be apparent to those of ordinary skill in the art, in such applications, blood leakage is commonplace which exposes administrating personnel to substantial health risks, such as that associated with the AIDS virus, hepatitis, and other infectious diseases.
In view of these concerns, over-the-needle catheter systems have been recently introduced specifically adapted for PICC line applications. The use of over-the-needle catheter systems has made the use of needle guard that much more difficult.
In one prior art device, the insertion of a limited length (i.e., finite length) of catheter into a patient's vein is facilitated while permitting the needle to be withdrawn after the initial insertion via a stylet extending through the catheter and then stowed within a protective sheath to prevent accidental puncture and/or exposure. However, this prior art device is limited to the length of the catheter provided, necessitating the correct initial selection of catheter length. Further, this device has a relatively complex construction, is relatively costly to fabricate, increases the patient's cost, and is relatively complicated to use, requiring a significant amount of training and manipulative skill.
The short peripheral catheter, on the other hand, poses fewer barriers to the incorporation of a needle guard on the introducer catheter. The short peripheral catheter, like the syringe, employs only a needle stick to introduce a catheter that remains external to the patient's body. Therefore, the problems encountered where a catheter is inserted into the vascular system of a patient do not arise with the use of a short peripheral catheter. As such, the short peripheral catheter introducer relatively easily allows incorporation of a needle guard.
Today, PICC line introducers typically are “over-the-needle” catheters. Typically, the introducer needle used with PICC lines is not used with a needle guard assembly. The introducer needle is therefore exposed when removed from the body. The exposed introducer needle, after withdrawal from the catheter, exposes healthcare workers to the possibility of accidental needle sticks and all the associated risks of exposure to bloodborne pathogens during the subsequent handling and disposal process.
In an effort to overcome these problems, several devices have been disclosed in the prior art that attempt to provide some means of closing off, blocking, containing or otherwise preventing the needle tip in a syringe, catheter, or similar device from being exposed after withdrawal from a patient.
One such prior art system is disclosed in U.S. Pat. No. 5,000,740 to Ducharme et al. A catheter device is described with a safety needle guard that covers and protects the needle after use of the device. The device includes a semi-tubular needle housing containing a flash chamber with a hollow needle extending from the distal end of the flash chamber. A tubular needle guard concentrically fits and slides within the needle housing. The needle guard has a longitudinal slot through which the mounting base of the flash chamber passes as the guard slides within the housing. The top of the semi-tubular housing is open so that a user may access the top of the tubular needle guard with a finger to urge the needle guard to an extended position from the distal end of the housing and in a surrounding position about the needle. As the needle guard attains its fully extended position about the needle, it locks in place in the needle housing.
Another prior art system is disclosed in U.S. Pat. No. 5,000,736 to Kaufhold, Jr. et al. A medicinal syringe including a tubular plunger from which air has been evacuated and a seal member releasably attached on the distal end of the plunger. Upon application of a predetermined longitudinal axial force to the seal member, the attachment between the seal member and the plunger will rupture, releasing the seal member for movement within the plunger. The seal member when released will be forced by the differential pressure between the vacuum and the ambient air into the interior of the tubular plunger. The plunger is slidably disposed in a tubular barrel. A needle is disposed in a hub releasably attached within the distal end of the barrel. Upon application of a predetermined longitudinal axial force to the hub, the attachment between the hub and the barrel will rupture, releasing the hub for movement within the barrel. The hub when released will be forced by the pressure differential, along with the distal plunger seal member, into the interior of the tubular plunger, carrying the needle with it. The attachment between the hub and barrel is adapted to rupture prior to that between the seal member and plunger. Once drawn into the tubular plunger, the needle and hub will remain there indefinitely, thus eliminating accidental puncturing by the needle of a person in the vicinity of the syringe.
Bonaldo, U.S. Pat. No. 4,917,669, discloses a catheter inserter has
Godfrey Mark
Kassel Michael
Wells Scott
Denion Thomas
Gardner Carton & Douglas LLC
Span-America Medical Systems, Inc.
Trieu Theresa
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