Safety catheter with non-removable retractable needle

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

C604S164020

Reexamination Certificate

active

06730062

ABSTRACT:

FIELD OF THE INVENTION
This invention generally relates to intravenous (IV) catheters; and more particularly, the invention relates to a safety catheter with a retractable needle fixed to the catheter.
BACKGROUND OF THE INVENTION
An intravenous (IV) catheter is an instrument that is used to introduce certain fluids such as saline solution directly into the bloodstream of a patient. Typically, a needle or other stylet is first introduced through the cannula portion of the catheter and into the skin of the patient at the desired location such as the back of the patient's hand or a vessel on the inside of the arm. Once insertion is complete, the needle is removed from the cannula portion of the catheter. After removing the needle, a fluid handling device such as a syringe or IV bag is attached to the luer fitting located at the proximal end of the catheter hub. Fluid is then infused directly from the fluid handling device through the catheter into the bloodstream of the patient.
When the needle is removed from the cannula, the health care worker must place the exposed needle tip at a nearby disposal unit while simultaneously addressing the task required to infuse the fluids into the patient. It is at this juncture that the exposed needle tip creates a danger of an accidental needle stick occurring which leaves the health care worker vulnerable to the transmission of various, dangerous blood-borne pathogens such as human immune virus (HIV) and hepatitis. The risk of a contaminated needle stick is not just isolated to the health care worker inserting the intravenous catheter. Careless disposal of used needles can put other health care workers at risk as well. Even others outside the health care profession, for example those involved in the clean-up and final disposal of medical waste can be at risk of an accidental needle stick from a carelessly discarded needle.
The danger to health care workers and others outside the health care profession from accidental needle sticks has yielded the development of catheters with safety mechanisms in which the occurrence of such accidental needle sticks is prevented. An example of a catheter having a safety mechanism is disclosed in U.S. Pat. No. 6,077,244 issued to Botich et al. on Jun. 20, 2000. A catheter insertion device is described in which the needle is retracted within the housing of the device after use to prevent contaminated needle exposure. A needle retainer releasably retains the needle in an extended position against the rearward bias of the biasing element. The needle retainer engages the hub of the catheter so that when the catheter is removed from the insertion device, the needle retainer automatically releases the needle. The biasing element then propels the needle rearwardly into the housing of the device. The housing can then be safely removed from the catheter enabling a fluid handling device to be attached to the catheter hub.
The advancement of such safety mechanisms on catheters have reduced concerns associated with inadvertent needle sticks; however, there is still opportunity for improvement. The catheters in the prior art have safety mechanisms which shield the needle tip during removal from the catheter to prevent inadvertent needle sticks. Even though the needle tip is shielded, there is still a risk of an accidental needle stick to health care workers or others outside the health care profession. For example, a needle might not retract entirely into its shield or housing. After the needle is removed from the catheter, the tip would be exposed creating a risk of an accidental needle stick. In addition, the safety mechanisms on the catheters in the prior art were not developed to eliminate the risk of exposure to bodily fluids. For example, when the health care worker removes the needle from the catheter, the tip even though safety shielded might discharge some bodily fluids on his gloves. The health care worker could then proceed to inadvertently touch his eye while still wearing the gloves creating a risk of infection from the discharged bodily fluid. In addition, safety catheters of the type mentioned above require the health care worker to separately dispose of the needle and the catheter, thereby providing for two instances where the health care worker is at risk.
Therefore, there has been a desire for an improved catheter which reduces the risk of an inadvertent needle stick and bodily fluid exposure.
SUMMARY OF THE INVENTION
In accordance with the present invention there is provided a safety introducer for insertion into a vessel of a patient for infusion of fluids into or withdraw of fluids from the vessel. The introducer includes a catheter assembly with an elongated catheter tube having lumen extending from a distal end to a proximal end. The proximal end of the tube is attached to a distal end of a catheter body. The catheter body has an elongated cavity extending therethrough from the distal end to a proximal end. The cavity is in fluid communication with the catheter tube. The introducer further includes a needle assembly with an elongated needle having a lumen extending from a distal end to a proximal end. The proximal end of the needle is attached to a distal end of a flexible tube. The flexible tube has a lumen extending from the distal end to a proximal end which is in fluid communication with the elongated cavity. The needle assembly being slidably disposed within the elongated cavity such that a proximally directed force exerted on the flexible tube withdraws the needle assembly substantially completely within the elongated cavity.


REFERENCES:
patent: 5137515 (1992-08-01), Hogan
patent: 5665072 (1997-09-01), Yoon
patent: 5685863 (1997-11-01), Botich et al.
patent: 6077244 (2000-06-01), Botich et al.
patent: 6126641 (2000-10-01), Shields
patent: 99/08742 (1999-02-01), None
patent: 99/24092 (1999-05-01), None
patent: 00/06221 (2000-02-01), None
patent: 00/57940 (2000-10-01), None

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