Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-08-14
2002-11-26
Tanner, Harry B. (Department: 3744)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06485473
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
The risk of needle stick during the insertion of a peripheral catheter into a patient is well known. Such catheters generally utilize an internal needle which projects beyond the tip of the catheter for insertion into a vein. A variety of safety devices have been developed which retract the needle from the catheter into an enclosed container, thereby preventing needle stick after the catheter has been inserted. However, such catheters after insertion can still pose a risk of blood exposure to the nurse inserting the device because the end of the catheter is open or will need to be opened if luer access is desired so that blood can drip from the hub of the catheter after the catheter has been inserted and the needle has been withdrawn. This represents a serious problem and requires meticulous technique to prevent significant blood exposure. Nurses often try to occlude the vein adjacent the tip of the catheter so as to prevent blood from refluxing back into the catheter and out the hub during the engagement of a luer fitting to the catheter. The open hub is generally attached to a heparin well (also called a saline well or prn adapter). Alternatively, an IV tubing may be connected directly to the catheter hub. In both these situations the connection needs to be made quickly to keep blood from refluxing out the open hub. Another technique is to hold the finger or thumb over the tip of the hub while preparing the heparin well for attachment to the hub.
Another problem is that direct luer access to a patient's vascular system generally requires the attachment of a secondary device, such as a heparin well, which comprises a chamber connected to a luer receiving valve. These secondary devices are expensive and cumbersome to attach when blood is leaking out the hub. Indeed blood, leaking out of the hub often is caught in the threads of the saline well where it forms a potential source for bacterial colonization. In addition, such heparin wells can become disconnected, exposing the patient's vascular system to the introduction of air or microorganisms and can result in silent death due to bleeding out the hub when the disconnection is unnoticed as during sleep.
The present invention comprises a catheter having a hub. The hub includes a luer-receiving valve, which can be for example of the types described in my U.S. Pat. No. 6,171,287, the entire disclosure of which is incorporated by reference as if completely disclosed herein. The closed luer access system further includes a needle sized and configured to project through the luer-receiving valve and into the lumen of the catheter so that the sharp point of the needle projects beyond the tip of the catheter. The needle preferable includes the hub, which projects proximally away from the face of the luer receiving valve. The hub preferably includes a lumen, which is enclosed and vented to the atmosphere so that blood can reflux through the needle and into the hub when the catheter containing the needle is inserted into the vein.
The present invention comprises a closed luer vascular access system, which can allow for the safe withdrawal of the needle from the catheter hub while still preventing reflux of blood out the hub before and during any future luer access of the hub after the catheter has been inserted.
The present invention comprises a catheter having a hub. The hub includes a luer-receiving valve, which can be for example of the types described in my U.S. patent application Ser. No. 09/322,037, filed May 28, 1999, the entire disclosure of which is incorporated by reference as if completely disclosed herein. The closed luer access system further includes a needle sized and configured to project through the luer-receiving valve and into the lumen of the catheter so that the sharp point of the needle projects beyond the tip of the catheter. The needle preferable includes the hub, which projects proximally away from the face of the luer receiving valve. The hub preferably includes a lumen, which is enclosed and vented to the atmosphere so that blood can reflux through the needle and into the hub when the catheter containing the needle is inserted into the vein.
The luer-receiving valve, which is interposed between the catheter and the needle hub, preferably, surrounds and is attached to the proximal end of the projecting plastic catheter thereby comprising the hub of the projecting catheter. The one preferred embodiment includes the plastic catheter defining a distal end and a proximal end and a lumen there through. The proximal end of the catheter is connected with a hub. The hub includes a lumen and a proximal end and an elastomeric sealing member occluding the proximal end. The sealing member has a perforation sized and configured to receive a luer male end. The hub and the elastomeric sealing member are sized and configured to be received within a luer lock end of a conventional IV connection terminal or syringe. The closed luer access system further includes a needle having a sharp distal end and a proximal end and a hub connected to the proximal end. The needle defines a lumen extending from the sharp distal end to the hub. The hub defines a lumen which is preferably vented to the outside atmosphere so that blood which enters the lumen of the needle through the tip upon insertion of the needle into the vein can reflux through the needle into the hub so that entry into the vein can be identified by the nurse through the visualization of the blood refluxing back into the lumen of the needle hub. In one preferred embodiment the needle hub includes an open proximal end and a filter which is permeable to air but not to blood occluding the open proximal end. In a presently preferred embodiment, the closed luer access system further includes a retractor for retracting the needle out of the catheter and out of the luer receiving valve hub after the catheter has been inserted into the vein. The retractor can include a spring, which can be held in a compressed state prior to the insertion of the catheter and then released by a trigger to engage the needle hub and thereby retract the needle hub out of the catheter. In operation, the nurse preps the patient's skin and inserts the catheter into the vein. Once the reflux of blood is identified within the needle hub the nurse advances the catheter over the needle into the vein and once he or she is sure that he catheter is in adequate position the trigger is pressed which releases a spring so that it expands and pulls the needle out of the catheter and out of the luer receiving valve catheter hub and into a receptacle wherein it is safely contained. At this point, the enclosed catheter is immediately ready for use and for closed luer access and there is no need for the attachment of a heparin well, saline well or other luer access based catheter-closing device.
It is the purpose of the present invention to provide a closed luer access system which includes an integral luer receiving valve hub configured to mitigate the negative pressure associated with withdrawal of the luer tip from the valve so that the attachment of a saline well is no longer required.
It is further the purpose of the present invention to provide a closed luer access system having a luer receiving valve hub and a retractor for retracting the needle throughout the luer receiving valve hub out of the closed luer access system.
It is further the purpose of the present invention to provide a closed luer access system having a luer receiving valve hub connected to a needle-receiving receptacle so that the needle can be retracted from the catheter into the needle-receiving receptacle.
It is further the purpose of the present invention to provide an automatic retractor such as a spring adjacent the needle so that the needle can be automatically retracted out of the luer receiving valve hub.
It is further the purpose of the invention to provide a catheter having an integral luer receiving valve hub so that upon inadvertent disconnection of the catheter from an attached IV t
Nixon & Vanderhye PC
Tanner Harry B.
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