Positive engagement-disengagement catheter sleeve

Details Positive engagement-disengagement catheter sleeve Positive engagement-disengagement catheter sleeve

1998-12-28

2001-05-22

Bockelman, Mark (Department: 3734)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S165020

Reexamination Certificate

active

06235005

ABSTRACT:

BAGKGROUND
(1) Field of the Invention
The invention relates to catheters. More specifically, the invention relates to a sleeve that positively engages an introducer to reduce the risk of unintentional needle sticks.
(2) Background
Catheters and sleeves therefor have been ubiquitous in the medical supplies market for some time. A typical catheter assembly arrives in sterile packaging and comprises a catheter, the introducer, and a sleeve. The purpose of the sleeve is to protect the needle tip during shipping and to prevent unintentional needle sticks as the catheter and introducer are removed from the sterile packaging. To that end, the sleeve needs to have sufficient retention force that it does not unintentionally become disengaged from the introducer as the sterile packaging is removed. However, if the retention force is too great, the incidence of needle pricks in the course of removing the sleeve actually increases. By way of example, a user typically grabs the sleeve in one hand and the introducer in the other, then pulling the sleeve in one direction and the introducer in the opposite direction, when the introducer snaps free, the arms of the user recoil, causing the user to inadvertently stick themself. This has been an area of substantial concern.
One common way of retaining the sleeve on the introducer is to mold three detents into the sleeve to engage an annular flange on the introducer. This works adequately for certain types of catheters. However, catheters have been developed that have wings that permit the catheter to be more easily secured to a patient after introduction. These wings necessitate grooves in the sleeve to accommodate the wings while the catheter is sleeved. With the introduction of the grooves, the structural integrity of the sleeve is such that disengagement from the detents is highly likely, as only a very loose hold is possible. Attempts to accommodate this problem by increasing the size of the detent between the grooves has resulted in cases of both an unreliable hold and too strong a hold, both resulting in increased risk for unintentional needle sticks.
BRIEF SUMMARY OF THE INVENTION
A positive engagement/disengagement catheter sleeve to reduce risks of needle sticks is disclosed. The sleeve has a base and a body which define a pair of grooves. The grooves define a deformable region of the sleeve therebetween. At least one detent is provided inside the base within the deformable region. A mechanism is provided to cause the detent to disengage when the mechanism is actuated.


REFERENCES:
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patent: 4790827 (1988-12-01), Haber et al.
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patent: 5219339 (1993-06-01), Saito
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patent: 2 733 916 A1 (1996-11-01), None
patent: WO 97/25082 (1997-07-01), None

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