Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-09-30
2004-04-06
Sykes, Angela D. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S187000, C604S272000, C606S131000
Reexamination Certificate
active
06716192
ABSTRACT:
BACKGROUND
The present invention is a medical needle such as an arterial blood gas sampling needle extending from a syringe, having its tip or distal end visibly marked for increased safety of patients and healthcare persons, as well as for improved economics in the care of patients.
In a fair number of incidents a needle intended to be inserted into an artery by a healthcare technician does not hit the mark. In such cases the needle is required to be withdrawn and reinserted, but in the process the original needle upon complete withdrawal from the patient, sanitary practice dictates that the needle not be used over again and must be discarded as waste. In such instances if the needle is withdrawn only in part, and not completely from the area of insertion, it can be guided under the patient's skin to reach the artery successfully.
Such a technique of movement under the skin for arterial puncture must be done carefully and does not allow a large margin of error. Redirectioning of the needle below the skin must be done gently if an initial attempt fails to enter the artery. The needle must be withdrawn almost to the skin surface before redirecting it to avoid tearing of underlying tissue.
A problem arises, however, that while the needle is being withdrawn it is very difficult to determine how close the tip is to the surface in the underlying tissue. The result is that the needle is usually completely withdrawn from the skin and a new needle kit be opened for use. This requires additional time to place pressure on the puncture site until bleeding ceases and re-prep of skin at a new puncture site for reinsertion of the needle. This develops a possible additional chance for infection at the new puncture site as well as causing additional pain to the patient. To reduce such possibilities the needle is retained below the skin surface by withdrawing it up to near the surface of the skin as far as possible without actually withdrawing it from the skin.
Therefore an object of the invention is to provide means indicating when an inserted needle is near the surface of the skin during withdrawal to avoid undesired complete withdrawal from the skin.
Also in the use of such needles their tips are frequently difficult to see and accidental needle sticks occur not too infrequently to both the patient and caretaker technician because of the poor visibility of the metallic body of the needle, and especially the tip.
Another object of the invention therefore is to make the needle tips more visible to reduce the chances of accidental sticks in users, patients and other persons.
In acupuncture practice as another area of healthcare, it is important to know how deep needles are in treatment sites. Further, it can be said generally that the invention is useful in any procedure in which a needle is inserted in a patient.
BRIEF SUMMARY OF THE INVENTION
According to the disclosed invention, the tip of the needle is provided with a highly visible marking such as a black tip or can be pigmented with an esthetic non-threatening bright color, such as orange, yellow or green, so that the tip is more visible than its usual stainless steel body and sharply pointed patient insertion end. In this regard it is also conceived that the entire body of the needle can be colored in contrast to the normal color of flesh of patients. Even in such cases, however, dependent upon use, it would likely be desired that the tip be provided a different color than the body to indicate the zone to be avoided against accidental sticks.
Regardless of the color of the body of the needle, according to the present invention, the tip is provided a contrasting color extending for a distance,for example of three to four millimeters up the shaft, so that as it is pulled back after insertion into the skin of a patient, the color near the tip becomes visible before emergence from the skin. The technician or caretaker is thus alerted as to how close the tip of the needle is to the surface. Complete pullback or withdrawal of the needle from the skin thus becomes unnecessary allowing safe redirection and avoiding cutting of tissue, and eliminating the costly need for use of another needle kit.
The invention also embodies the concept of a needle with two colors at its tip, one at the extreme tip with contrasting color to prevent accident finger sticks and another color just above the extreme end to indicate the length of the tip remaining between the skin. The colors can be provided on the needle in the form such as a ring or a band to indicate upon withdrawal or pull out that the extreme or distal end is near and that further withdrawal can be halted if desired. The mark can also be in the form of a series of visible circumferential bands or grooves in the needle near its tip to provide a graduated indication of the distance to the tip.
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Becton Dickenson Product Catalog, 1993, p. F-2, Mar. 30, 1993.
Blanco Patricia
Schroeder Charles F.
Sykes Angela D.
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