Apparatus for Safe Use, Disposal and Retention of Needles

1. Field of the Invention (Technical Field)

This invention relates, to an apparatus for safely using and disposing of intravenous and hypodermic needles, and for effectively retaining used needles within the apparatus.

2. Description of the Related Art Including Information Disclosed under 37 C.F.R. 6SS1.97-1.99 (Background Art)

The need exists in the art to protect doctors, nurses, other health practitioners, and others who may come into contact with used needles, from being pricked with needles after the needles have been used intravenously. In particular, an apparatus is needed to prevent needle pricks during or directly after use of needles to thereby prevent the transmission of blood-carried diseases or organisms via used needles, such as hepatitis and HIV (the AIDS related virus). The need also exists in the art to safely dispose of needles after they have been used, so that others, such as waste handlers, do not accidentally get pricked with the needles and thereby exposed to blood-carried diseases or organisms.

A common practice in the art is to cut needles so that they can't be reused. However, this practice may even increase the chances of a health practitioner getting pricked with a needle and certainly does not prevent accidental pricks after disposal.

Several devices have been developed in the art which provide a sheath member around the used needle, to prevent needle pricks. The most common device in the art is a needle cap which is removed from the needle before use and placed back on the needle after use for disposal. However, practitioners often stick themselves with needles when they replace this cap. Moreover, the cap can be removed after disposal, thereby potentially exposing others to needle pricks. Mounted devices exist in the art for preventing needle pricks when the cap is replaced; these mounted devices consist of circular holders for holding the cap while the needle is replaced in the cap, so that the practitioner does not need to hold the cap. However, if the cap is not seated correctly within the holder, the practitioner may have to use his or her hand to hold the cap, thereby defeating the purpose of the mounted device. Moreover, these devices are permanently mounted and thus not useful in situations requiring more mobility for the practitioner, such as in a hospital room.

Another practice to prevent needle pricks is to have the practitioner discard uncapped or unsheathed needles into a waste bin. However, this often does not protect waste handlers from being pricked with needles.

Several syringes or blood-drawing devices have been developed in the art to provide a sheath or guard which can be extended or forced over the needle after use. Such devices are represented in U.S. Pat. No. 4,631,057, entitled Shielded Needle, to Mitchell; U.S. Pat. No. 4,643,200, entitled Safety Blood Donor Apparatus, to Jennings, Jr.; U.S. Pat. No. 4,655,751, entitled Liquid Dispensing and Receiving Syringe, to Harbaugh; U.S. Pat. No. 4,664,654, entitled Automatic Protracting and Locking Hypodermic Needle Guard, to Strauss; and U.S. Pat. No. 4,676,783, entitled Retractable Safety Needle, to Jagger, et al. The guards on these devices are not retrofittable with conventional syringes or blood-drawing devices; thus the devices cannot be utilized in all situations with conventional needles. Also, in the '057, '751, '654, and '783 Patents, the open ends of the guards do not prevent fluids from dripping out. Another device is disclosed in U.S. Pat. No. 4,266,543, entitled Hypodermic Needle Protection Means, to Blum, which teaches pushing the needle against a hard surface for allowing the needle to be forced into a housing. This device, however, may cause a practitioner to get pricked with the needle if the hard surface is not adequate. Also, there is no assurance that the needle will go completely into the housing and a careless practitioner may dispose of the needle/housing arrangement with the needle sticking partially out. Furthermore, as with the devices discussed above, this housing cannot be utilized with standard intravenous needles; the needle/housing arrangement must be purchased and used as a single unit.

U.S. Pat. No. 4,778,453, entitled Medical Device, to Lopez; U.S. Pat. No. 4,781,692, entitled Retractable Safety Needles, to Jagger, et al.; U.S. Pat. No. 4,160,450, entitled Outside-the-Needle Catheter Device with Needle Housing, to Doherty; U.S. Pat. No. 3,421,509, entitled Urethral Catheter, to Fiore; U.S. Pat. No. 4,692,154, entitled Catheter Guide, to Singery, et al.; and U.S. Pat. No. 3,592,192, entitled Intravenous Catheter Apparatus with Catheter Telescoped on Outside of Puncturing Cannula, to Harautuneian, teach various needle and catheter devices. Lopez requires manual movement of a needle guard relative to a needle, while Doherty and Jagger, et al., do not disclose entry and closure means at one end of the needle housing. Fiore and Singery, et al., teach catheter structure per se, while Harautuneian teaches a telescoping cannula.

U.S. Pat. No. 4,799,927, entitled Needle Guide and Puncture Protector, to Davis, et al., while teaching a protective needle cover, requires manual manipulation of needle and cover.

Thus, the need exists in the art to provide an apparatus, which can be used with conventional needles, for safely disposing used needles and for preventing needle pricks. An apparatus which also prevents fluids from dripping off the needles and out of associated tubing is also needed. Further, the need exists to assure needle retention in any such apparatus.

Prior U.S. Pat. No. 4,927,415, entitled Apparatus for Safe Use and Disposal of Needles, to Brodsky, issue date May 22, 1990, the teachings of which are incorporated herein by reference, relates to an apparatus for the safe use and disposal of an intravenous needle. The apparatus comprises a needle-safe containment structure comprising a longitudinal body having first and second ends, entry and closure means disposed at the first end for allowing the needle to enter the longitudinal body and for denying exit of the needle therethrough, and an aperture at the second end of the longitudinal body; and discrete needle pulling means attachable to the needle and passed through the entry and closure means and the aperture for drawing the needle into the longitudinal body for safe positioning and disposal of the needle within the needle-safe containment structure after use of the needle. The longitudinal body is preferably generally tubular in shape and comprises a puncture-resistant material, such as plastic, rubber, vinyl, or the like.

The entry and closure means preferably comprises a plurality of overlapping flaps to allow the needle to pass therethrough from outside the longitudinal body into the longitudinal body and deny exit of the needle therethrough. These overlapping flaps fold or collapse inward as the needle passes into the longitudinal body, and then come back together to prevent the needle from exiting the longitudinal body.

The apparatus preferably comprises stopping means to prevent the needle from being pulled from the longitudinal body through the second end thereof. The needle pulling means may comprise these stopping means which engage the longitudinal body during the pulling of the needle through the longitudinal body. Alternatively, stopping means may be disposed at the second end and within the longitudinal body.

The needle pulling means may be removably attachable to the needle. In an alternative embodiment, the apparatus further comprises the needle, and the needle is attached to the needle pulling means. The needle pulling means is preferably hollow tubing, useful for carrying fluids to or from a patient. The needle pulling means or hollow tubing exiting the second end may be attachable to fluid movement devices, such as a syringe or blood-drawing device.

The needle may be a hypodermic needle or a trocar/cannula arrangement. For a trocar/cannula arrangement, when the needle pulling means is pulled, the trocar is drawn into the longitudinal body and the cannula is left in place within a patient.

In accordance with the present invention, there is provided an apparatus for the safe use, retention, and disposal of an intravenous needle. The apparatus comprises a needle-safe containment structure comprising a body having first and second ends, entry and closure means disposed at the first end for allowing the needle to enter the longitudinal body and for denying exit of the needle therethrough, and an aperture at the second end of the longitudinal body; and discrete needle pulling means attachable to the needle and passed through the entry and closure means and the aperture for drawing the needle into the longitudinal body for safe positioning and disposal of the needle within the needle-safe containment structure after use of the needle. Needle retention means are disposed at the second end of the longitudinal body for assuring retention of the needle within the needle-safe containment structure.

In the preferred embodiment, the needle retention means comprises a textured surface of the material comprising the longitudinal body. Alternatively, the needle retention means comprises a textured surface of a material comprising a higher coefficient of friction than the material of the longitudinal body.

The preferred embodiment comprises a textured surface comprising a plurality of annular ribs. An alternative embodiment comprises a textured surface comprising a helical rib. Yet another embodiment of the present invention comprises a textured surface comprising a plurality of protuberances.

Accordingly, it is a primary object of the present invention to provide an apparatus for preventing needle pricks from intravenous needles, assuring needle retention in such apparatus, and for safely disposing of the intravenous needles after use.

It is another object of the present invention to provide an apparatus for preventing needle pricks and assuring needle retention which is easy to manufacture and use.

An advantage of the apparatus of the present invention is that it is easy to use and protects health practitioners, waste handlers, and others from being pricked with needles retained within such apparatus.

Another advantage of the present invention, in addition to needle retention, is that fluids from dripping needles and tubing are also retained.

Additional objects, advantages and novel features of the invention, and further scope of applicability of the present invention, will be set forth in part in the detailed description to follow, taken in conjunction with the accompanying drawings, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.

The accompanying drawings, which are incorporated into and form a part of the specification, illustrate several embodiments of the prior application and the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purposes of illustrating a preferred embodiment of the invention and are not to be construed as limiting the invention. In the drawings:

FIG. 1 is an isometric view of the preferred embodiment of the invention of the prior application, showing a needle outside the longitudinal body;

FIG. 2 is a cutaway view of the embodiment of FIG. 1;

FIG. 3 is a cutaway view of the embodiment of FIG. 1, showing the needle after being drawn into the longitudinal body;

FIG. 4 is a cutaway view of the preferred embodiment of the present invention showing annular ribs;

FIG. 5 is a cutaway view of an alternative embodiment of the present invention showing a helical rib; and

FIG. 6 is a cutaway view of another alternative embodiment of the present invention showing protuberances.

The prior invention, U.S. Pat. No. 4,927,415, and the present invention both relate to an apparatus for the safe use and disposal of intravenous needles. The apparatus of the invention comprises needle-safe containment means comprising a longitudinal body having first and second ends, entry and closure means disposed at the first end for allowing the needle to enter the longitudinal body and for denying exit of the needle therethrough, and aperture means at the second end of the longitudinal body; and discrete needle pulling means attachable to the needle and passed through the entry and closure means and the aperture means for drawing the needle into the longitudinal body for safe positioning and disposal of the needle within the needle-safe containment means after use of the needle.

Reference is now made to FIGS. 1-3 which illustrate the preferred embodiment of the apparatus 10 of the prior application and FIGS. 4-6, which illustrate the preferred embodiment of the apparatus 10 of the present invention. The longitudinal body 12 is generally tubular in shape and preferably comprises a puncture-resistant material, such as plastic, rubber, vinyl, or the like. The longitudinal body 12 has a first end 14 and a second end 16. Pulling means, such as hollow tubing 18 passes through an entry and closure opening 20 at the first end 14 and an aperture 22 at the second end 16 and through the interior 24 of the longitudinal body 12. The hollow tubing 18 at the first end 14 is attachable to a needle 26.

FIGS. 1, 2, and 4 show a needle 26 prior to or just after use. After the needle 26 is used, a user holds the longitudinal body 12 with one hand and pulls on the hollow tubing 18 with another hand which allows the needle 26 to slide through the entry and closure opening 20 and into the interior 24 of the longitudinal body 12. FIGS. 3, 5, and 6 show the needle 26 disposed within the interior 24 of the longitudinal body 12 for disposal. As can be seen, the user does not come into contact with the needle 26 and thus will not be pricked with the needle 26. Likewise, the longitudinal body 12 prevents others, such as waste handlers, from being pricked with the needle 26 after disposal.

The entry and closure opening 20 allows entry of the needle 26 into the interior 24 of the longitudinal body 12, and also prevents the needle 26 from exiting the longitudinal body 12 once it becomes disposed therein. The preferred entry and closure opening, shown in the drawings, comprises a plurality of overlapping flaps (for example, see 28, 28', and 28") which fold inward as the hollow tubing 18 and needle 26 are pulled through the entry and closure opening 20 into the interior 24 of the longitudinal body 12 (see FIGS. 1, 2, and 4) and close back together after the needle 26 has completely passed through the entry and closure opening 20 and is disposed within the interior 24 of the longitudinal body 12 (see FIGS. 3, 5, and 6). Such flaps 28, 28' and 28" would need to be made of a resilient material, such as plastic, vinyl, rubber, or the like, so that they can fold inward and then come back together. As can be appreciated by those skilled in the art, any number of flaps may be utilized and the invention is not limited to the number of flaps depicted in the drawing. For example, two (see FIGS. 4-6), three (see FIGS. 1-3), four (not shown) or more (not shown) flaps may be utilized. Likewise, other entry and closure means can be utilized in accordance with the invention, as long as such entry and closure means allows entry of the needle into the longitudinal body and prevents exit therefrom.

The invention may further comprise stopping means 30 for preventing the needle 26 from passing through the aperture 22 at the second end 16 after the pulling means 18 has drawn the needle 26 into the longitudinal body 12. The stopping means 30 may be slidably attached to the pulling means 18 on the interior 24 of the longitudinal body 12 so that when the needle 26 is pulled into the interior 24 of the longitudinal body 12, the stopping means 30 engages with the longitudinal body 12, thereby stopping any further pulling and preventing the needle 26 from exiting the aperture 22 at the second end 16. In an alternative embodiment, the stopping means 30 may be disposed within the interior 24 of the longitudinal body 12 at the second end 16 to stop the needle 26 from exiting the second end 16.

In one embodiment of the invention, the pulling means 18 is removably attachable to a needle 26. In such an embodiment, the apparatus is usable with conventional needles, available in the art. In an alternative embodiment, the apparatus of the invention includes a needle so that the attachment to a needle is not necessary.

The apparatus of the invention can be used with any type of needle common to the art, such as an intravenous needle, hypodermic needle, a trocar/cannula arrangement, etc. The drawings show only one type of needle, but the invention is not limited to any particular type or types of needles. In a trocar/cannula arrangement, commonly used for introducing intravenous fluids to a patient, the trocar (usually a rigid metal needle), surrounded by the cannula (a pliable hollow sheath), is inserted into the patient's vein. The trocar is then removed, leaving the cannula behind in the patient's vein. Because the cannula is pliable, the patient is more comfortable when the body, containing the cannula, is moved. The apparatus is useful for disposing the trocar portion once it is removed from the patient.

The term "intravenous," used throughout the specification and claims, is intended primarily to mean intravenous use of a needle for a patient, human or animal, however, this term is also intended to include uses of a needle which are potentially dangerous or harmful if a person can be pricked with the needle. For instance, needles may be used in chemical or biochemical applications, in which the user may be harmed by, for example, toxic substances if pricked with the needle.

When fluid needs to be introduced to or taken from a patient or other source, the preferred pulling means, as shown in the drawings, is hollow tubing 18 through which the fluid passes. With the hollow tubing 18 at the first end 14 attached or attachable to a needle 26, the hollow tubing 18 at the second end 16 can be attached to fluid movement means, such as a syringe or blood-drawing device (not shown). The apparatus may comprise fluid movement means, or may be removably attachable to fluid movement means. As can be appreciated by those skilled in the art, if fluid movement is not desired, the pulling means need not be hollow tubing, but can be any type of pulling device, such as a wire or line (not shown).

Reference is now made to FIGS. 4-6 which illustrate the embodiments of the present invention. The interior of second end 16 of longitudinal body 12 may comprise a material 41 having a higher coefficient of friction than the material comprising longitudinal body 12. The purpose of such material 41 is to prevent slippage along second end 16 of needle 18, thus retaining needle 18 within longitudinal body 12. For example, if longitudinal body 12 comprises vinyl, material 41 can comprise rubber or any other material of higher coefficient of friction than vinyl. Other such contrasting compositions will suggest themselves to those skilled in the art. The criterion remains, however, that all such materials comprise puncture-resistant materials.

To further reduce slippage and unwanted egress of needle 26 from second end 16 of longitudinal body 12, the interior of second end 16 may comprise a textured surface. The textured surface may comprise a series of annular ribs 42, such as shown in FIG. 4. Such ribs 42 tend to block passage of needle 26, thereby retaining needle 26 within longitudinal body 12. The number of ribs is immaterial, as any desired number may be used. Further, the height or depth of such ribs 42 is also immaterial, so long as there is no interference with free passage of discrete needle pulling means 18 through longitudinal body 12.

With reference to FIG. 5, an alternative embodiment of the present invention is depicted therein. In this embodiment, the textured surface of the interior of second end 16 of longitudinal body 12 comprises a helical rib 52. Such helical rib 52 also tends to block passage of needle 26, thereby retaining needle 26 within longitudinal body 12. Again, as with the FIG. 4 embodiment, the number of turns of helical rib 52, or its height or depth are of no moment, as aforesaid.

The ribs 42 and 52, illustrated in FIGS. 4 and 5, preferably project or protrude slightly above the interior surface of second end 16. However, in an alternative embodiment, such ribs may be present as grooves in the interior surface of second end 16. The term "ribs," as used throughout the specification and claims, is intended to cover both projected ribs and grooved ribs.

An alternative embodiment of the present invention, shown in FIG. 6, illustrates a textured surface comprising a plurality of protuberances 62. Protuberances 62 likewise serve to deter and block passage of needle 26, thereby retaining needle 26 within longitudinal body 12. The number, spacing, and height or depth of protuberances 62 are of no consequence, so long as free passage of discrete needle pulling means 18 is permitted. Likewise, in an alternative embodiment, such protuberances may be recessed dimples and the term "protuberances," as used throughout the specification and claims, is intended to include both raised and recessed areas.

It will occur to those ordinarily skilled in the art that the various embodiments of textured surfaces may be formed directly upon the interior surface of the material forming second end 16 of longitudinal body 12. Accordingly, such textured surfaces may be impressed thereon by integral molding, adhesive, or ultrasonic bonding, machining, or similar manufacturing processes well known to those ordinarily skilled in the art.

Although the invention has been described with reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents.