Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-08-04
2003-05-06
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06558354
ABSTRACT:
BACKGROUND OF THE INVENTION
The subject invention relates to an adapter for releasably connecting an introducer needle assembly to a catheter introducer. More specifically, this adapter allows an introducer needle assembly designed for use with a standard intravascular (IV) catheter to be used with a catheter introducer.
Catheters, particularly IV catheters, are used for infusing fluid, such as normal saline solution, various medicaments and total parenteral nutrition, into a patient, withdrawing blood from a patient or monitoring various parameters of the patient's vascular system. Typical peripheral IV catheters tend to be relatively short, and usually are on the order of about two inches or less in length. The most common type of IV catheter is an over the needle peripheral IV catheter. As its name implies, an over the needle catheter is mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle assembly is inserted at a shallow angle through the patient's skin into a blood vessel. Thereafter, the catheter is threaded over the needle and inserted completely into the blood vessel. Once proper placement of the catheter into the blood vessel is confirmed, the clinician withdraws the introducer needle, leaving the catheter in place, and attaches an appropriate device to the catheter. Such a device can include a fluid delivery device, a PRN, a deadender cap or a blood pressure monitoring probe.
In order to attach such devices to a catheter, the catheter includes a hub having a female luer portion at its proximal end. As such, the introducer needle assembly includes a male luer portion at its distal end that extends into and engages the female luer portion of the catheter hub. The male luer portion of the introducer needle assembly thus supports the catheter hub and holds it in the proper orientation to facilitate the insertion of the catheter into a patient.
In contrast to typical peripheral IV catheters, catheter introducers are typically used in conjunction with peripherally inserted central catheters (PICC), or other relatively long, thin and flexible medical devices, to facilitate insertion and placement of the catheter or other medical device into the patient's vasculature. A typical catheter introducer includes a splittable cannula and a hub with a pair of wings fixed to the proximal end of the cannula. An introducer needle assembly is used to place the catheter introducer into the patient. Similar to a typical peripheral IV catheter, the introducer needle is located Within the catheter introducer and both are inserted into a patient in the same general manner as a typical peripheral IV catheter. However, after the clinician withdraws the introducer needle, the clinician inserts the PICC or other relatively long, thin and flexible medical device into the proximal opening of the catheter introducer until the PICC or other medical device is properly placed in the patient's vasculature. After placement of the PICC or other medical device, the clinician grasps the wings and pulls them apart to split the catheter introducer. In this way, the splittable introducer can be removed from the patient over any hub located on the proximal end of the PICC or other medical device.
Since the catheter introducer is not typically connected to another medical device, the hub on the catheter introducer is not configured as a female luer. Instead, the proximal end of the hub has an opening large enough only for the introducer needle to pass therethrough. As such, introducer needle assemblies for use with catheter introducers have a distal portion that is configured to engage the exterior of the hub of the catheter introducer to hold the catheter introducer in the proper orientation on the introducer needle assembly. In addition these introducer needle assemblies must prevent rotation of the catheter introducer with respect to the introducer needle assembly so the wings on the hub are properly aligned with the introducer needle bevel to facilitate proper insertion of the catheter introducer into the patient.
Because of the different configurations of the hub for a typical peripheral IV catheter and a typical catheter introducer, different configurations for the introducer needle assemblies are needed for these different products. The introducer needle assembly used for a typical peripheral IV catheter must have a distal portion that includes a male luer portion that is inserted into and engages the female luer portion of the catheter hub and holds the catheter in an appropriate orientation with the introducer needle. The introducer needle assembly used for a typical catheter introducer must have a distal portion that does not extend into the hub but still holds the catheter introducer in an appropriate orientation with respect to the introducer needle. Specifically, the distal portion of the introducer needle assembly must hold the catheter introducer such that: (a) the distal tip of the catheter introducer is the appropriate distance proximal of the bevel defining the sharp distal tip of the introducer needle; and (b) there is no relative rotation between the catheter introducer and the introducer needle.
However, the need for different introducer needle assemblies for a peripheral IV catheter and a catheter introducer is expensive. Thus, it would be desirable to have an adapter that would allow a single introducer needle assembly having a male luer portion at its distal end to be used with a device having a female luer portion at its proximal end, such as a peripheral IV catheter, and a device without a female luer portion, such as a catheter introducer, and which provides stabilization between the device and the introducer needle assembly and properly axially locates the device with respect to the introducer needle.
SUMMARY OF THE INVENTION
It is therefore an object of this invention to provide an adapter that would allow a single introducer needle assembly having a male luer portion at its distal end to be used with a device having a female luer portion at its proximal end, such as a peripheral IV catheter, and a device without such a female luer portion, such as a catheter introducer and which provides stabilization between the device and the introducer needle assembly and properly axially locates the device with respect to the introducer needle.
The adapter of this invention includes a hollow main body portion with an axial dimension at least about as long as the length of a standard male luer. When the catheter introducer is engaged with the adapter, the distal tip of the catheter introducer is located an appropriate distance proximal of the bevel defining the sharp distal tip of the introducer needle. A flange extends longitudinally from the distal end of the main body portion to engage the proximal end of the catheter introducer. This distally directed flange stabilizes the catheter introducer with respect to the introducer needle. In addition, and if desired, one or more flanges extend longitudinally from the proximal end of the main body portion to engage the distal end of the introducer needle assembly. These proximally directed flanges hold the main body portion of the adapter to the introducer needle assembly. Alternatively, the adapter could dispense with the proximally directed flanges and could be connected to the introducer needle assembly by an adhesive.
The adapter of this invention may be used with any introducer needle assembly typically used with an IV catheter to allow a catheter introducer to be used therewith. For example, it may be used with an introducer needle assembly having spring activated needle retraction mechanism such as shown in U.S. Pat. No. 4,747,831. In addition, the adapter of this invention may be used with other types of shielded introducer needle assemblies, such as shown in U.S. Pat. Nos. 4,762,516; 5,000,740; and 6,004,294, as well as non-shielded introducer needle assemblies.
REFERENCES:
patent: 4333455 (1982-06-01), Bodicky
patent: 4613329 (1986-09-01), Bodicky
patent: 4747831 (1988-05-01
Becton Dickinson and Company
Murtha James J.
Robinson Daniel
Walberg Teresa
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