WO1996007357A1

WO1996007357A1 - Hypodermic needle resheathing device

Info

Publication number: WO1996007357A1
Application number: PCT/US1995/011341
Authority: WO
Inventors: Bonnie J. Nicklas
Original assignee: Kliskey Marketing
Priority date: 1994-09-06
Filing date: 1995-09-06
Publication date: 1996-03-14

Abstract

Resheathing device (10) for used hypodermic needles. Disclosed is a resheathing device comprising a top wall (12) having therein a plurality of apertures (16) of different configurations, each of which is particularly adapted to receive a hypodermic needle sheath having the same size and shape as that of the aperture, and sides (14) which slope downwardly and outwardly from said top wall member. The sides or side walls terminate in lower edges which lie in a common plane so as to provide a planar base for supporting the resheathing device on a horizontal supporting surface. A bottom wall (18) is optional. The apertures in the top wall member include one or more circular apertures and one or more apertures in the shape of a regular polygon.

Description

HYPODERMIC NEEDLE RESHEATHING DEVICE

TECHNICAL FIELD This invention relates to a device for resheathing the hypodermic needle on a syringe after use, the device also serving as a container to carry or store medical supplies or waste materials. BACKGROUND OF THE INVENTION

Protection of health care workers from various blood-transmitted diseases, notably AIDS and hepatitis, have become a matter of increasing concern. Probably the most frequent mode of transmission of such disease from an infected patient to a health care worker is by accidental puncture of the health care worker's skin by the hypodermic needle of a hypodermic syringe which has just been used in the treatment of the patient. To prevent such accidental puncture, it is essential to resheath the hypodermic needle on the syringe in such a manner that there is little or no risk to the health care worker. Resheathing of a used hypodermic needle in the conventional manner, i.e., with the health care worker holding the sheath of the hypodermic needle in one hand (typically the left hand) while inserting the hypodermic needle of the syringe into the sheath with the other hand (typically the right hand), poses a high risk to the health care worker. In this two-handed resheathing method, the worker's hand might accidentally slip in the process of resheathing, with the result that the hypodermic needle accidentally stabs and punctures the worker.

A large number of devices have been proposed in patents and other literature for the purpose of resheathing the hypodermic needle after use. Some of these devices permit one-handed resheathing. One-handed resheathing improves considerably the safety factor in resheathing, since the hand not required for resheathing may be safely away from either the hypodermic needle or the sheath of the hypodermic needle. In fact, OSHA (the United States Occupational Health and Safety Administration) has adopted a standard which requires physician's offices, hospitals, medical schools and medical laboratories to use a one-handed resheathing method.

One matter that has received scant attention in knowr. resheathing devices is the fact that the sheaths or caps of commercially available hypodermic needles come in various sizes and shapes. The most common shapes are circular (or round), square and hexagonal, but sizes of the sheaths vary. Typically, a hypodermic needle resheathing device is designed to receive a hypodermic needle sheath of only one size and shape, usually circular.

SUMMARY OF THE INVENTION

An object of this invention is to provide a simple and inexpensive device which is capable of resheathing hypodermic needles wherein the sheaths have various sizes and shapes.

A hypodermic needle resheathing device according to the present invention comprises: (a) a top wall member having a plurality of apertures of different sizes and shapes extending therethrough, each aperture being adapted to hold a hypodermic needle sheath of predetermined size and shape in frictional engagement; and (b) side wall means extending downwardly from the top wall member for supporting the top wall member in a raised position above a supporting surface for the resheathing device. BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a top plan view of the invention according to a first embodiment thereof. Fig. 2 is a vertical sectional view, taken along line 2-2 of Fig. 1.

Fig. 3 is a partial cross-sectional view of the device shown in Figs. 1 and 2, showing a resheathed hypodermic needle and syringe assembly frictionally held in one of the apertures in the top wall of the device.

Figs. 4 and 5 are partial vertical sectional views, taken at right angles to each other, showing a modified form of the invention.

Fig. 6 is a partial cross-sectional view showing a still further modified form of the invention.

BEST MODE FOR CARRYING OUT THE INVENTION

This invention will now be described with particular reference to the accompanying drawings. Representative embodiments including the best mode and preferred embodiment of the invention will be illustrated and described. Referring to Figs. 1 and 2, a hypodermic needle resheathing device 10 according to a preferred embodiment of this invention comprises an essentially planar top wall member 12 and a plurality of side walls 14 (collectively side wall means) extending downwardly from the top wall member 12 to a supporting surface. In the preferred embodiment shown, the top wall 12 has four peripheral edges and is trapezoidal, and the four side walls 14 extend downwardly and preferably slightly outwardly from the peripheral edges of top wall member 12. The slight outward slope of the side walls 14 provides device 10 with a base which is larger in cross-sectional area than the top, resulting in improved stability of the device on a planar supporting surface. The slope angle of side walls 14 is small, e.g., about 3° to about 15° measured from the vertical, and will not exceed 45° in virtually any case.

Resheathing device 10 is preferably made of molded plastic of sheet thickness, but may be made of formed plastic or sheet metal. The device 10 can thus be inexpensively produced in large quantities, particularly if manufactured from molded plastic. Furthermore, a rigid or semi-rigid plastic (polyvinyl chloride, for example) will have sufficient strength to hold a resheathed hypodermic needle, and at the same time will have a slight degree of resiliency, which is an aid in frictionally holding a sheath in place in the device and in resheathing a used hypodermic needle while still attached to a syringe.

Top wall 12 has a plurality or series 16 of apertures, 16a, 16b, 16c, 16d, 16e and 16f of different sizes and shapes extending therethrough. Each of the openings or apertures corresponds to the size and shape of the outside cross-sectional size and shape of the sheaths of a standard commercially available hypodermic needle.

The top wall member 12 is preferably inclined at an angle to the horizontal for ease of use. The angled top surface ergonomically facilitates the one-handed resheathing method by allowing the user to easily see the proper

16 to which a particular hypodermic needle sheath corresponds. The angle of inclination may vary from about 5° to about 20°; an angle of about 15° is preferred. This angle will not exceed 45° in any case.

The openings 16a through 16f are in the shape of commercially available hypodermic needle sheaths of simple geometric figures each having a central axis, i.e., a circle, a square, or a regular hexagon. The openings are preferably arranged in a row or straight line which runs the lengthwise direction of the top wall member 12 from the top edge to the bottom edge of the top wall member. The device 10 in use is oriented so that the top edge is the edge which is farther from the user. The number of apertures 16 shown is merely illustrative. There may be more or fewer apertures. The apertures preferably include at least one circular aperture and at least one aperture in the shape of a regular polygon. Normally, no two apertures will have the same configuration (i.e., the same size and shape), since such redundancy is not usually necessary. Two apertures may have the same shape but different sizes; note for examples circular apertures 16a, 16b and square apertures 16c, 16d and 16f.

The portion of top wall member 12 surrounding an aperture grips a hypodermic needle sheath and holds the same by frictional engagement. A slight degree of resiliency in the material forming device 10 (molded plastic, for example) aids in such gripping. Each of the openings 16 may be surrounded by a sleeve 22 (shown in Fig. 3) extending a short distance downwardly from the underside of the top wall member 12, as an aid in gripping a sheath of a hypodermic needle. The configuration of the apertures 16 are particularly directed to commercial hypodermic needle sheaths so that each aperture 16a-16f provides an exact fit for the sheath. In this way, positioning of the sheath within the aperture can be performed in a secure, stable, and controlled manner. Similarly, the secure positioning of the sheath within an aperture 16 enables controlled recapping of the hypodermic needle as the sheath is positively retained in a secure position to prevent any unwanted motion of the sheath during resheathing of a hypodermic needle.

The bottom edges of all sides 14 forming the side wall means lie in a common plane so that the device 10 will rest in a stable fashion on a horizontal support surface. This horizontal support surface may be, for example, a countertop or tabletop in a physician's office, hospital, or medical laboratory, or may be a night stand or table beside a patient's bed.

In a first preferred embodiment, as shown in Fig. 2, the bottom of the device 10 will be open to allow the device to be flipped for use as a container to carry or store medical supplies or waste materials. In a hospital or similar environment, a nurse or other health care worker handling and using syringes can use the device 10 to carry supplies for administration to a patient or patients. In use, a syringe assembly having a hypodermic needle thereon, may be carried within the device 10 and subsequently removed for use with a particular patient. Upon removal of the medical supplies, the device 10 is positioned on any suitable supporting surface with the top wall 12 exposed to the view of the health care worker. The sheath of the uncontaminated hypodermic needle is removed and placed in the proper aperture 16 to allow subsequent one-handed resheathing of the contaminated hypodermic needle after use. Thereafter, any waste materials, including the resheathed contaminated hypodermic needle and syringe assembly can be placed back into the device 10 used as a container for transport to a proper waste facility.

Alternatively, as shown in ghost in Fig. 2, the device 10 may have a closed bottom comprised of a flat horizontal bottom wall 18, which acts as a closure member. The bottom surface of this flat bottom wall 18 may be co-planar with the bottom edges of the side walls 14. The top wall 12, side walls 14 and bottom wall 18 together enclose an interior space. Bottom wall 18 is adapted to rest on a planar supporting surface. In an embodiment of the device including a bottom wall 18, one of the apertures 16 provided in the top wall 12 may be dimensioned to allow a resheathed contaminated needle on a syringe to be dropped into the enclosed interior space of the device 10 for transport to a proper waste facility.

Printed indicia 20 may be provided on the top face of the top wall member 12 as an aid to the user in placing a hypodermic needle sheath, hypodermic needle and attached syringe after use, in the correct hole. These indicia will typically include, beside each aperture 16a through 16f, information which will aid the user in selecting the correct aperture for a given hypodermic needle sheath and for the hypodermic needle and syringe after use. Such indicia will typically include make and model (or series) numbers of common commercially available syringes which have the sheath size and shape corresponding to the size and shape of the aperture.

The hypodermic needle resheathing device 10 of this invention is intended to be used in conjunction with hypodermic needle sheaths or caps of conventional structure. For purposes of greater understanding, a conventional medical syringe assembly, 30, with a hypodermic needle attached being commonly used in medical practice for administering injections, is shown in Fig. 3. Syringe assembly 30 includes a cylindrical barrel 32, an attachment site for a hub 34 (typically cylindrical) below the barrel, and a hypodermic needle 36 which extends downwardly from the hub 34 along the axis of the syringe 30. Barrel 32, hub 34 and hypodermic needle 36 may form an integral sub-assembly. The conventional hypodermic needle 36 of the syringe assembly 30 further includes a removable cap or sheath 38 which frictionally engages the hub 34 and covers or encases the hypodermic needle 36 when the syringe assembly is not in use. Sheath 38 is elongated, hollow and is open at one end (the upper end as shown in the drawings) and closed at the other end. As earlier stated, common commercial sheaths 38 may come in a variety of cross-sectional sizes and shapes. Common cross-sectional shapes include circular, square and hexagonal (regular hexagon). Also commercially available hypodermic needles 36 may have sheaths 38 of the same cross-sectional shape (circular, for example) but of different sizes or diameters. The sheaths 38 may also have a plurality of ribs and will usually have a collar 39 formed at the bottom outside surface thereof.

Syringe assembly 30 further includes an axially extending plunger 40 which reciprocates in barrel 32. Plunger 40 terminates at its upper end in a plunger top 42 (always outside the barrel 32) for manual activation by the health care worker, and at its lower end in a piston 44 (always inside the barrel). Plunger 40, top 42 and piston 44 form an integral sub-assembly which is reciprocal within barrel 32.

The apertures 16a through 16f in top 12 of the device 10 again have various exact configurations (i.e., different sizes and/or shapes) corresponding to particular conventional sheaths so that virtually any cross-sectional size and shape of sheath 38 used with a commercially available hypodermic needle will exactly fit one of the apertures 16a through 16f. The exact fit of the sheath within aperture 16 prevents unwanted motion of the sheath during the resheathing procedure and provides better stability for properly resheathing a used needle. Various modifications of the device can be made in accordance with this invention. Figs. 4, 5 and 6, illustrate modified forms of the bottom portion of the device of this invention.

It may desirable to use the device 10 (either open or closed bottom) as a temporary storage container for discarded syringes. A closed bottom embodiment may also be suitable for this purpose. In such an embodiment, the device 10 must be large enough to receive a discarded syringe assembly with hypodermic needle attached. Also, means for providing access to the interior space of the device 10 must be provided. A suitable sized aperture within top wall 12 could be provided as earlier stated, or as shown in Figs. 4 and 5, a removable bottom wall 50 could be provided. The bottom wall 50 includes a bottom closure member 52 which slides in guide slots 54 on opposite sides 14 of device 10. A thin layer 60 of a non-skid material, e.g., rubber, may be provided on the bottom surface of bottom wall so that the device will remain in position and will not slip or slide on a supporting surface.

Fig. 6 illustrates an open bottom embodiment. In this embodiment, the bottom edges of the side walls 14 form an annular rim which is planar and common to all sides, and which extends around the entire perimeter of the sidewalls 14 at the lower end of the device. This rim provides a horizontal surface which may rest on a horizontal supporting surface as above described. If desired, a thin layer 62 of a non- skid material, e.g., rubber, may be provided on this rim so that the device 10 will remain in position and will not slip or slide on the supporting surface.

Use of the resheathing device 10 of this invention to resheath a used hypodermic needle 36 attached to a syringe assembly 30 will now be described. Steps in use of the device 10 are as follows:

1.) Prior to use, the sheath 38 is removed from a syringe 30. Normally the hypodermic needle 36 will be sterile and not previously used.

2.) The sheath or hypodermic needle cap 38 is removed from the hypodermic needle 36 on syringe 30 and is placed into the appropriate aperture 16, such as 16a, 16b, 16c, 16d, 16e or 16f, i.e., correlating to the aperture having a size and shape exactly matching that of the sheath in the top wall member 12 of the device 10. The sheath is held frictionally in place in one of the apertures 16a through 16f, i.e., the aperture whose shape and size matches that of the sheath. A boss 39 may be provided on the exterior of the sheath 38; this is common in commercial practice and limits downward movement of the sheath when the hypodermic needle is being resheathed using the device.

3.) The barrel 32 of syringe 30 is filled with an injectable fluid, (e.g., a medication in a suitable solvent or the like), an injection is performed and the hypodermic needle 36 is withdrawn from the tissues of the patient.

4.) The used hypodermic needle 36 on syringe 30 is placed into the open end of the sheath 38 until the hub 34 engages the inside surface of the sheath near its upper end. Only one hand is required for resheathing and at no time is either hand exposed to the threat of an accidental needle stick. The used and recapped hypodermic needle 36 of syringe 30, is withdrawn with one hand as a unit from the aperture in the top plate 12 of device 10 and is then discarded. The used and resheathed hypodermic needle 36 and syringe assembly 30 may be discarded in any medically appropriate manner. The resheathing device 10 according to this invention may serve as a temporary collection receptacle for collection of several used syringes, and may then be discarded along with used syringe assemblies in any appropriate manner if desired. Where there is no base or bottom wall 18, the device 10 is turned over so that the top wall 12 becomes the base of an open top container or receptacle, and used hypodermic needles and attached syringes are placed in the container 10. When a desired number of used hypodermic needles and attached syringes has been so placed, the container 10 and/or the hypodermic needles 36 and syringes 30 therein are discarded in an appropriate manner. In units 10 having a base or bottom wall 18, the bottom wall 18 may be opened, e.g., by sliding as described previously, and then closed. Several syringes may be inserted in this manner if desired before both the device 10 and the hypodermic needles and syringes contained therein are discarded. Or the top plate 12 of the device may be provided with an opening (not shown) large enough to insert a resheathed used hypodermic needle and attached syringe. Several used syringes may be inserted into the interior space of the device 10 in this manner, after which the device 10 and/or the used hypodermic needles and attached syringes contained therein are discarded.

An important advantage of the device of the present invention is that the device provides optimum stability for positioning a sheath therein and subsequently resheathing the used hypodermic needle, such that the person who is resheathing the hypodermic needle 36 after use (typically a health care worker) requires only one hand for resheathing. Since the device 10 itself has a plurality of apertures which exactly match conventional hypodermic needle sheaths, the aperture will positively, frictionally hold the sheath 38 in place while the hypodermic needle 36 is being resheathed. This arrangement allows the user to guide the hypodermic needle 36 and attached syringe 30 into place with only one hand while the other hand is free and remote from either the hypodermic needle 36 or the resheathing device. This virtually eliminates the danger of accidental puncture during resheathing.

The device also permits safe resheathing of used needles while attached to a syringe assembly. In this way, the hypodermic needle and attached syringe, being a contaminated assembly, remains in a safe condition without any exposure of the health care worker to risk of being infected by contaminated blood or other bodily fluids. A further advantage of the present invention is that the sloping or beveled top plate 12 is ergonomically desirable, being sloped at an angle that enables the user to resheath a used syringe by a natural swing of the arm from the elbow, with little or no strain. Further advantages of the device of this invention include low cost, potential for mass production, and ability to serve as a temporary carrier or receptacle for used syringes.

While this invention has been described in detail with particular reference to the best mode and preferred embodiment thereof, it shall be understood that such description is by way of illustration and not limitation.

Claims

WHAT IS CLAIMED IS:

1. A hypodermic needle resheathing device comprising:

(a) a top wall member having a plurality of apertures of different sizes and shapes extending therethrough, each of said apertures being adapted to receive a needle sheath of predetermined size and shape, and

(b) side wall means extending downwardly from said top wall for supporting said top wall member in a raised position above a supporting surface for said resheathing device.

2. A resheathing device according to Claim 1 in which said top wall member is inclined at an angle not exceeding 45° to the horizontal.

3. A resheathing device according to Claim 1 in which said apertures are arranged in a row.

4. A resheathing device according to Claim 3 in which said top wall member is planar and inclined at an angle not greater than 45° to the horizontal and in which said row is straight and extends in the direction of inclination.

5. A resheathing device according to Claim 1 in which said top wall has four edges and said side wall means comprised four sides which extend downwardly from respective edges of said top wall.

6. A resheathing device according to Claim 5 in which said sides have lower edges which lie in a common plane, forming a base for allowing said resheathing device to be supported on a planar supporting surface.

7. A resheathing device according to Claim 6, further including a bottom wall which intersects said side walls, said bottom wall, side walls and top wall member together enclosing an interior space.

8. A resheathing device according to Claim 7 in which said base is removable so as to permit the introduction of used syringes into said interior space.

9. A resheathing device according to Claim 6, said device being open at the bottom so that, when inverted, it forms an open top receptacle.

10. A resheathing device according to Claim 6 in which said sides slope downwardly and outwardly from said top wall member to said lower edges, this slope angle being less than 45° to the vertical.

11. A resheathing device according to Claim 1 wherein said apertures include at least one circular aperture and at least one aperture in the shape of a regular polygon.

12. A resheathing device according to Claim 1 wherein said top wall member has a top surface having, along side each aperture, printed indicia providing the user with information as to at least one make and model of syringe which has a sheath of the same size and shape as that of the aperture.

13. A resheathing device according to Claim 1 wherein each of said plurality of apertures is matched to a predetermined sheath configuration to optimize stability upon resheathing of said hypodermic needle.