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United States Patent m

Vanderhoof

[11] Patent Number: [45] Date of Patent:

4,846,811 Jul. 11,1989

[54] SLIDING SHEATH FOR MEDICAL NEEDLES

[75] Inventor: Merton J. Vanderhoof, Balboa Island, Calif.

[73] Assignee: International Medical Innovators, Inc., San Clemente, Calif.

[21] Appl. No.: 8,308

[22] Filed: Jan. 29,1987

[51] Int. Q.* A61M5/00

[52] U.S. CI 604/263; 604/198

[58] Field of Search 604/110, 162, 192, 198,

604/263

[56] References Cited

U.S. PATENT DOCUMENTS

2,571,653 10/1951 Bastien 128/218

2,592,744 6/1986 Jagger et al 604/192

2.847.995 8/1958 Adams 128/214

2.847.996 8/1958 Cohen 128/218

2,888,923 6/1959 Da Cunha Reis 128/218

3.306.290 2/1967 Weltman 128/218

3.306.291 2/1967 Burke 128/218

3,356,089 12/1967 Francis 128/221

3,485,239 12/1969 Vanderbeck 128/218

3,536,073 10/1970 Farb 604/162

3,780,734 12/1973 Wulff 128/218

3,884,230 5/1920 Wulff 128/221

3,890,971 6/1975 Leeson 128/218

4,139,009 2/1979 Alvarez 128/218

4,170,993 10/1979 Alvarez 604/263 X

4.266.543 5/1981 Blum 128/218

4.266.544 5/1981 Wardlaw 128/218

4,273,123 6/1981 Lemelson 128/218

4,356,822 12/1982 Winstead-Hall 128/215

4,373,526 2/1983 Kling 128/215

4,392,859 7/1983 Dent 604/198

4,425,120 1/1984 Sampson et al 604/263 X

4,425,120 1/1984 Sampson et al 604/198

4,430,080 2/1984 Pasquini et al 604/263 X

4,507,117 3/1985 Vining et al 604/196

4,573,976 3/1986 Sampson et al 604/198

4,631,057 12/1986 Mitchell 604/198

4,643,199 2/1987 Jennings, Jr 128/763

4,659,330 4/1987 Nelson et al 604/192

4,664,259 5/1987 Landis 206/365

4,675,005 6/1987 Deluccia 604/110

4,676,783 6/1987 Jagger et al 604/162 X

4,676,783 6/1987 Jagger et al 604/171

4,681,567 7/1987 Masters et al 604/198

Primary Examiner—Dalton L. Truluck
Attorney, Agent, or Firm—Stetina and Brunda

[57] ABSTRACT

Apparatus and methods of utilizing the same to prevent accidental medical needle sticks are disclosed, characterized by use of a raised locking member coaxially mounted upon the needle approximately midway between a body member mounting the needle and the needle tip which presents an exterior contour to engage complementary features within the interior channel of a tubular sleeve which slides coaxially along the needle. The slidable sleeve is held at a first position proximate the body member and exposing the needle tip by a mechanical detent formed from frictional engagement of complementary surfaces upon the sleeve and the locking member and/or the body member. After medical use, the spent and contaminated needle is sheathed by sliding the tubular sleeve to a second position wherein it is securely held by a detent resultant from engagement with the locking member. The sheathing guards against accidental needle sticks transmitting disease. An optional end cap may be affixed including frangible affixation by engagement with the locking member, slidable sleeve, or body member. All components may be readily retrofitted upon preexisting needles.

30 Claims, 2 Drawing Sheets

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SLIDING SHEATH FOR MEDICAL NEEDLES

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention concerns the prevention of disease transmission occurring from accidental sharp, or needle sticks with spent or contaminated medical needles.

2. Description of Relevant Art
Accidental needle stick injuries are common amongst

health care workers such as doctors, nurses, laboratory
personnel, and housekeeping personnel. Accidental
needle sticks with contaminated needles can result in
the transmission of diseases including Acquired Im-
mune Deficiency Syndrome (AIDS), Hepatitis B, Non-
A-Non-B Hepatitis, and other diseases transmissable
through the blood. The severe health hazards and con-
sequences associated with these diseases have resulted
in well-thought-out protocols for handling medical
needles and a near universal use of needle and syringe
disposal containers.

Notwithstanding the care taken with contaminated medical needles, it is estimated in the publication BioMedical International, Vol. IX. 23-24 for December, 1986 that "an estimated 800,000 sharp or needle sticks occur each year in the U.S.". It is further estimated that "primary treatment (glamma globulin, hepatitis B immune globulin, tetanus) and subsequent blood analysis and care costs ... $600-$ 1,000 per incident". This figure may be compared with a similar report that "each needle stick injury costs a hospital more than $200.00" in U.S. Pat. No. 4,592,744 filed Aug. 14,1985. Whatsoever the actual prevalence and actual cost of an accidental needle stick injury, it is indisputable that each such 35 injury is psychologically disconcerting to the health care worker receiving the injury.

Accidental needle sticks may often occur when a drawer of blood, or any administrator injecting a patient, attempts to recap or dispose of a needle, syringe, or vacuum tube phlebotomy system after use. Although modern health care protocols seldon allow for any prolonged exposure of a contaminated needle upon a work surface, in some instances a contaminated needle is set upon a work surface by one person, normally the administrator, and subsequently removed for disposal by another person, normally an assistant or nurse. During the course of this handling and interchange accidental self-sticks and sticks of other persons occasionally occur.

In order to reduce the numbers of accidental needle sticks during necessary handling, a number of needle sheathing systems have been developed within the prior art. These systems generally show a sheathing or a resheathing of a needle by dealing with the entire injection apparatus, or syringe, to which the needle is connected. In many instances the needle will be withdrawn within a syringe, or the entire syringe will be covered by sliding covers.

The present invention will be seen to be distinguished from such prior art in one aspect by dealing with the sheathing of a needle directly at and along the length of the needle itself, as opposed to sheathing any syringe or ampoule to which the needle is connected. Particularly, the needle sheating scheme in accordance with the 65 present invention exhibits in a first general embodiment a localized locking member, i.e. a bead or protuberance, rigidly positioned along the length of the needle. The

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locking member is cooperatively interactive with a sliding tubular sleeve coaxially positioned along the length of the needle in order to selectively retain this sleeve in a position sheathing the end of the needle. Although such a sheathing scheme needs to be given a broad interpretation, and although the means of engaging and retaining a sliding tubular sleeve need not appear exactly as a locking bead or protuberance which is positioned directly upon the needle, the present invention does involve a sleeve which slides along the needle in order to sheath the needle, and a retaining or locking mechanism for such slidable sleeve which retaining mechanism is in a fixed relationship to the needle. This should be contrasted to a prior art sheathing devices which either (i) slide along a syringe, or are (ii) replaceably removable from the needle. By such differences and other differences, the present invention may be observed to comprise a significant unobvious departure from the prior art.

In particular, the following is a list of U.S. Patents which exemplify the current state of art: U.S. Pat. Nos. 4,592,744; 4,507,117; 4,392,859; 4,373,526; 4,273,123 4,266,544; 4,139,009; 3,890,971; 3,485,239; 3,356,089 3,306,291; 3,306,290; 2,925,083; 2,888,923; 2,847,966: 2,847,995.

U.S. Pat. No. 4,592,744 shows a syringe which is self-resheathing within a case when the needle is withdrawn.

U.S. Pat. No. 4,507,117 shows a syringe with a needle retractable into the barrel of the syringe.

U.S. Pat. No. 4,392,859 shows an automatic injecting device having a spring-biased retracting needle.

U.S. Pat. No. 4,373,526 shows a protective closure for a hypodermic needle which may receive and retain the needle after it is removed from, or broken off, the end of the syringe.

U.S. Pat. No. 4,266,544 shows a device on the end of a syringe apparatus which renders a needle inoperable subsequent to being used.

U.S. Pat. No. 4,139,009 shows a retractable cover means for a hypodermic.

U.S. Pat. No. 3,890,971 shows a safety feature for syringes which, subsequent to being used, locks the plunger and needle such that it is incapable of being reused.

U.S. Pat. No. 3,485,239 shows a self-contained syringe wherein the hypodermic needle is initially situated within a barrel.

U.S. Pat. No. 3,356,089 shows a needle sheath and guide, particularly for selectable penetration control.

U.S. Pat. No. 3,306,291 shows the use of frangible connections in combination with syringes and the like.

U.S. Pat. No. 3,306,290 shows the use of a springbiased retractable syringe.

U.S. Pat. No. 2,925,083 shows a hypodermic syringe with a hood for guarding the needle.

U.S. Pat. No. 2,888,293 shows a syringe within a coaxial protective tube.

U.S. Pat. No. 2,847,996 shows the use of a hypodermic having two barrel-like compartments.

U.S. Pat. No. 2,847,995 shows the use of retractable needle within a rubber sheath.

As a further point of comparison of the prior art to the present invention, it should be additionally observed that the referenced patents show unique apparatus constructions which are generally incompatible to be assimilated with or retrofitted upon any pre-existing standard

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