Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-06-18
2004-04-27
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S110000, C604S164120, C604S188000, C604S198000
Reexamination Certificate
active
06726658
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention pertains to a device used to establish an IV catheter in a patient. More particularly, the invention pertains to a safety infusion device that includes a handpiece used to store and to selectively extend the IV catheter so that it can be introduced into the patient, the handpiece being constructed and arranged to insure that the IV catheter and the so-called underlying needle can be retracted into the barrel at will to protect clinicians from accidental needlesticks.
2. Description of the Prior Art
IV infusion is one of the most widely used procedures performed in hospitals and other healthcare provider sites. These infusions involve continuously injecting one or more liquids into the veins of a patient to achieve various results. Simple infusion systems may consist of a catheter inserted into the vein and secured to the patient, a pole holding a bottle or bag used as the source of the liquid, a flexible tube feeding the liquid to the catheter either directly, or though some kind of fluid control device. More complex devices include fusion pumps that can deliver fluids to the patient at carefully metered rates using specific profiles.
However, independent of which infusion system is used, the IV catheter must first be established. Many different devices are used to perform this step. A popular system consists of a cylindrical receptacle. A hollow steel needle is attached co-axially to one end of the receptacle. A hollow catheter is mounted on the steel needle in a coaxial arrangement. The hollow catheter has a shaft, preferably made of a plastic material and terminating in a standard connector, such as a male Luer lock. A spring is disposed in the receptacle so that when a latch mounted on the receptacle is activated, the steel needle separates from the catheter and is snapped into the receptacle. Once the steel needle is snapped into the receptacle, it is locked in place so that it cannot be extended and reused. Since the needle and the catheter are normally exposed, a protective cap is generally provided over the needle.
Using this type of system a catheter is established as follows. First, the clinician finds and preps a proper site on the skin. Next, the system is removed from a sealed enclosure, and its protective cap is removed. The needle and the catheter mounted thereon are inserted through the skin until the tip of the needle and the catheter reaches a predetermined site. The catheter is then secured with the forefinger of one hand and the latch is activated to cause the needle to snap into the receptacle before a needlestick. The receptacle with the captured needle is then disposed. Systems of this kind are available from Becton Dickinson of Franklin Lakes, N.J.; Johnson & Johnson Medical, Inc. of Arlington, Tex., and described in the following patents, incorporated herein by reference:
5,688,249
5,520,654
5,304,136
5,700,250
5,141,497
5,683,365
5,755,709
D378,405
5,348,544
5,749,857
5,755,709
5,411,486
5,792,122
5,795,339
5,676,658
D381,418
5,690,619
However, these systems are not satisfactory for several reasons. As is well known in the art, the catheter has to extend into a vein and must be oriented properly in order for it to be effective. However, very often clinicians cannot find the proper vein or the proper infusion site on their first try. Therefore, after the needle and catheter have been inserted, the whole system becomes contaminated. Often, before the system can be reinserted, a new site has to be found and prepared.
The clinician, especially if she is alone, cannot select and prepare a new site while holding the contaminated system and therefore must make a decision on what to do with it. At least one manufacturer suggests that the system should be discarded. However, obviously, this is a wasteful step.
The clinician can also decide to recap the needle and then place it on a horizontal position. However, this process requires two hands and is exactly the situation that subjects people to inadvertent needlesticks.
Another disadvantage of existing systems is that they normally require a linear or translational motion of the needle during insertion. This is disadvantageous because it causes the needle to bend thereby causing pain to the patient. Moreover, if the needle bends during insertion, it will miss the vein and the process has to be repeated.
Commonly assigned application Ser. No. 09/506,484 filed Feb. 17, 2000, entitled HAND-PIECE FOR INJECTION DEVICE WITH A RETRACTABLE AND ROTATING NEEDLE, now U.S. Pat. No. 6,428,517 and incorporated herein by reference, discloses an injection device with a barrel from which a needle is selectively extended and retracted using a translational and rotational motion for dispensing an anesthetic to a patient.
Commonly assigned patent application Ser. No. 09/745,751 filed Dec. 21, 2000, entitled METHOD OF PERFORMING AN INJECTION USING A BI-DIRECTIONAL ROTATIONAL INSERTION TECHNIQUE, and incorporated herein by reference discloses the advantages of using a bi-directional rotational technique for dispensing anesthetics.
OBJECTIVES AND SUMMARY OF THE INVENTION
An objective of the present invention is to provide a system for establishing a catheter which overcomes the above-mentioned disadvantages.
A further objective is to provide a system that can be used easily by clinicians.
Other objectives and advantages will become apparent from the following description.
Briefly, the subject application pertains to a device for establishing an IV catheter by a clinician. The device includes a housing sized and shaped to fit in the hand of the clinician; a catheter assembly including a catheter member with a front portion adapted to be inserted into the vein of a patient; and a control member adapted to reciprocate the catheter assembly within said housing between a retracted position in which said catheter assembly is completely contained in said housing and an extended position in which said catheter member extends outwardly of said housing. A catheter member can be removably attached to the catheter assembly so that it can be removed in the extended position.
The catheter assembly includes a needle member with a needle extending outwardly of the housing when the catheter member is in the extended position. The needle is arranged and constructed for insertion in the vein with the catheter member being telescopically associated with the needle member. The catheter member is removably attached to the needle member.
In one embodiment the catheter member and the housing cooperate to rotate the catheter assembly about a longitudinal axis as the catheter assembly is reciprocated by said control member.
The device also can include locking means for locking the catheter assembly or the needle after the catheter replacement with respect to the housing. These locking means can be adapted to lock the catheter assembly in either the retracted position or the extended position. In addition, the control member can be disabled by the use of the same, or a different locking means so that after the catheter element is properly established, the needle used to establish the catheter cannot be reused.
REFERENCES:
patent: 5141497 (1992-08-01), Erskine
patent: 5304136 (1994-04-01), Erskine et al.
patent: 5348544 (1994-09-01), Sweeney et al.
patent: 5411486 (1995-05-01), Zadini et al.
patent: 5423766 (1995-06-01), Di Cesare
patent: 5501675 (1996-03-01), Erskine
patent: 5520654 (1996-05-01), Wahlberg
patent: D378405 (1997-03-01), Musgrave et al.
patent: D381418 (1997-07-01), Erskine et al.
patent: 5676658 (1997-10-01), Erskine
patent: 5683365 (1997-11-01), Brown et al.
patent: 5688249 (1997-11-01), Chang et al.
patent: 5690619 (1997-11-01), Erskine et al.
patent: 5700250 (1997-12-01), Erskine et al.
patent: 5749857 (1998-05-01), Cuppy
patent: 5755709 (1998-05-01), Cuppy
patent: 5792122 (1998-08-01), Brimhall et al.
patent: 5795339 (1998-08-01), Erskine
patent: 6325781 (2001-12-01), Takagi et al.
Casler Brian L.
Gottleib, Rackman & Reisman, P.C.
MIlestone Scientific, Inc.
Williams Catherine S.
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