Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-12-12
2003-04-08
Yuen, Henry C. (Department: 3754)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S164010, C604S164020, C604S164060
Reexamination Certificate
active
06544239
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to self-blunting medical needles and, in particular, to needle assemblies that can lock in a blunted configuration.
2. Related Art
Many accidental needle-stick wounds are sustained by healthcare workers each day. The problem is aggravated by the trend of moving treatment out of hospitals and into doctors' offices and neighborhood clinics as part of programs to reduce healthcare costs. This trend increases the number and dispersion of healthcare workers who administer injections and draw blood samples, while reducing the frequency of such injections per individual healthcare worker. As a consequence, a larger number of less experienced people are administering injections and/or taking blood samples. Although in the past an occasional serious illness such as that caused by the hepatitis B virus was sustained as a result of an accidental needle-stick wound, the problem was not considered to be a serious one until the advent of human immunodeficiency virus (HIV) and the knowledge that this virus is transmissible to healthcare workers through needle-stick wounds from a contaminated needle. HIV causes acquired immune deficiency syndrome (AIDS), a disease, which, insofar as is presently known, is invariably fatal, and which has already killed millions and infected millions more. HIV is often referred to simply as “the AIDS virus” and the Surgeon General of the United States of America noted in a published (September, 1987) interview that there is no better way to become infected with the AIDS virus than to take blood from an AIDS patient and accidentally inflict a needle-stick wound with the contaminated needle.
This situation has stimulated activity to develop devices which reduce or eliminate the possibility of accidental needle-stick wounds without excessively increasing the unit cost of needles.
U.S. Pat. No. 5,176,655 to McCormick et al, dated Jan. 5, 1993 and entitled “DISPOSABLE MEDICAL NEEDLE AND CATHETER PLACEMENT ASSEMBLY HAVING FULL SAFETY ENCLOSURE MEANS”, discloses a winged set in which a needle is movably and concentrically disposed within a tubular member to which the wings are attached. The needle is connected to the wings via straps (
42
). A guard device (
50
) is carried on the tubular member by a pair of clip legs (
56
). During use, the needle protrudes through the tubular member and the blocking plate bears on the side of the needle under the force of the spring. After the device has been used, the needle is withdrawn into the tubular member and the blocking plate springs down over the end of the tubular member to permanently prevent the sharp tip of the needle from exiting the tubular member (see column 3, lines 23-29, and column 6, lines 28-36). The tubular member is not adapted for engagement with any other device and no method or mechanism for re-sharpening the winged set is disclosed. Neither the needle nor the blunting member are fully enclosed one within the other.
U.S. Pat. No. 4,627,841, issued to Dorr on Dec. 9, 1986 and entitled “INFUSION NEEDLE”, discloses a winged venipuncture set in which a needle is movably mounted within a catheter. A spring biases the catheter forward so that it protrudes beyond the tip of the needle and the device is configured so that when grasped for use, the catheter is withdrawn against the bias of the spring to sharpen the needle until the device is released. No locking mechanism for keeping the catheter in one position or the other is shown.
U.S. Pat. No. 5,743,882, issued to Luther on Apr. 28, 1998 and entitled “NEEDLE BLUNTING ASSEMBLY FOR USE WITH INTRAVASCULAR INTRODUCERS”, discloses a non-automatic manual needle blunting assembly which features a blunting member disposed telescopically within the passageway of a needle or cannula and manually axially movable from a “non-blunting” position to a “blunting” position. In alternative embodiments, the blunting member is held in place by screw threads or elastomeric fins within a chamber defined by the needle member. The referenced needle is neither automatic in operation nor lockable, the user manually advances or retreats the blunting assembly and the positioning can be altered by an accidental bump.
U.S. Pat. No. 5,374,252 to Banks et al, dated Dec. 20, 1994 and entitled “LOCKING PNEUMONEEDLE”, discloses a pneumoneedle used for introducing an insufflating gas into the abdominal cavity of a patient via the fluid conduit. The device comprises a cannula (
20
) (
FIG. 1
) mounted in a housing (
12
). The housing (
12
) also contains a tubular protector (or “blunting member”) (
31
) disposed within the cannula and movable between a retracted position in which the sharp tip of the cannula is exposed and a deployed position in which the blunt end (
32
) of the protector extends beyond the sharp tip of the cannula. The protector (
31
) is tubular and has a distal aperture (
36
) that is exposed when the protector is moved to the deployed position. There is also a proximal aperture (
35
) that opens to an internal fluid passageway portion of the housing (
12
). A fluid conduit (
8
) (
FIG. 2
) in the housing communicates with fluid passageway portion (
18
) and extends at an angle relative to the longitudinal axis of the needle cannula.
In the medical field, pneumoneedles such as those disclosed by Banks et al are considered to serve a function that is disparate from that of intravenous fluid flow devices and the knowledge in the art pertaining to pneumoneedles is not seen as analogous or pertinent to intravenous needles.
U.S. Pat. No. 5,250,036, issued to Farivar on Oct. 5, 1993 and entitled “INTRAVENOUS CATHETER PLACEMENT SYSTEM”, teaches an intravenous catheter placement system having an external insertion guard tool assembly and a flexible catheter with an attachment at one end. Farivar does not teach a releasable locking mechanism.
U.S. Pat. No. 5,462,533, issued to Daugherty on Oct. 31, 1995 and entitled “SELF CONTAINED NEEDLE AND SHIELD”, teaches a design having a cannula made up of two concentric tubes. First tube (
12
) comprises the puncture tip of the cannula, second tube (
14
) is mounted co-axially around first tube (
12
), and the two may be axially adjusted so as to withdraw the puncture tip of first tube (
12
) within second tube (
14
). The design allows latching of the cannula in the blunted position after use. Latching member (
34
) comprises spring (
44
) having spring end (
54
) which engages with step (
56
) upon retraction of the puncture tip into the blunted position. However, no means is disclosed for disengaging spring end (
54
) from step (
56
) and thus releasing the needle from the blunted position back into a sharpened position. The mechanism is located within the apparatus, so access during use is impossible. It would be advantageous to allow the healthcare worker to re-use the self-blunting needle under certain circumstances. For example, despite the presence of a flash chamber to aid in locating a vein, occasionally the first puncture of the patient does not hit a vein and the needle must be re-inserted. During “intermittent administration,” the user will use the same syringe to withdraw doses from a supply vial and administer them, several times.
It would also be advantageous to provide self-blunting needles which efficiently utilize the needle itself for fluid flow and which do not combine the function of blunting apparatus and catheter.
It would be advantageous to remove the possibility of accidental bumps or jostles changing the blunt or non-blunt configuration of the needle. It would also be advantageous to provide automatically self-blunting apparatus.
SUMMARY OF THE INVENTION
The present invention provides a needle assembly comprising a needle member comprising a needle cannula mounted in a housing, the needle cannula comprising a puncture tip and comprising a needle passageway extending substantially lengthwise through the needle cannula, and a blunting member comprising a blunting probe, the blunting probe comprising a blunt end, the blunting probe
Hauri Marius Walter
Holdaway Richard G.
Kinsey P. Spencer
Polidoro John M.
Bio-Plexus Delaware, Inc.
Fristoe John
Libert & Associates
Spaeth Frederick A.
Yuen Henry C.
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