- BACKGROUND OF THE INVENTION
The invention relates to an improved design for a container which is a health care safety product designed to help protect against accidental injury during the passage of sharp instruments; i.e., suture needles and scalpels within the performance of any surgical procedure. It does not involve direct patient contact.
There are approximately 500,000 to 800,000 needle stick injuries reported each year regarding healthcare professionals in the United States. Other than in the patient's room, these accidents occur most often in the operating room. As a result of this significant health hazard, health device manufacturers have developed various products designed to protect healthcare professionals. These items include retractable syringes, “sharps” containers, syringe covers, syringe guards, etc. While needle sticks associated with syringes account for an estimated 75% of the problem, IT IS estimated that most of the remaining 25% are the result of sticks associated with suturing during surgical procedures or during the unprotected passing of these sharps. It is this niche which has not been adequately adressed by suture manufacturers who have left it up to the discretion of the end user to provide their own protection.
The Occupational Safety & Health Administration (OSHA) in directive #CPL2-2.44D, issued Nov. 5, 1999 mandated a change in the Federal Blood Borne Pathogens Act. They called for a shift in work practice controls and issued a call for engineering solutions for use when sharps are passed from one individual to another. The Act states, “The employer must use engineering and work practice controls to eliminate occupational exposure or reduce it to the lowest feasible extent.” Further, they specifically called for the elimination of “hand-to-hand” or direct passing of all sharps. The overall goal is to reduce the risk of accidental needle or scalpel injuries during this process. Additionally, they issued four engineering design requirements which include:
(1) A thick safety feature that provides a barrier between the hands and needle after use. The safety feature should allow or require the worker's hands to remain behind the needle at all times;
(2) The safety feature is an integral part of the device and not an accessory;
(3) The safety feature is in effect before disassembly and remains in effect after disposal to protect users and trash handlers; and
(4) The safety feature is as simple as possible, requiring little or no training to use effectively.
The apparatus of the present invention is designed to meet all of OSHA's design requirements while remaining user friendly and without the incorporation of new hand movements during an operation. It is compact, hand-held, and functions for both suture needles of all sizes as well as scalpels. Additionally, it functions as a safe return device (i.e., passing of sharps occurs in two directions). Moreover, it acts as a counting device for needles and also functions as a temporary storage and/or disposable container for used suture needles and scalpels. Known efforts to date have been focused on prevention of syringe needle sticks with retractable syringes. Simple guard type devices are also available for some scalpels. No other multi-functional yet simple device for use with suture needles and scalpels that also satisfies the new OSHA requirements is known.
- SUMMARY OF THE INVENTION
The Prior Art fails to recognize the value in coupling slots for use with sharp implements which effectively immobilize the sharp implement for transfer purposes, coupled with a magnetically enhanced disposal compartment for easy counting and disposal. By using the novel design of the present invention, coupled with the new system arrangement of the essential elements of the invention, a more flexible configuration is shown which overcomes the inherent limitations of the teachings of the Prior Art as well as permitting a wider range of applications, not permitted with the presently available systems.
The invention eliminates many of the inherent limitations of the Prior Art by designing an apparatus which is composed of a rectangular box of clear plastic with approximately half of the box top open. Magnets are embedded within to secure the needle mounted in a special slot. A sliding door on the top half holds sharps (i.e. used suture needles and scalpel blades). The scalpel anchors are similarly embedded and designed to cover the scalpel itself while exposing only the handle. In a preferred embodiment, it is designed for single use, although reusable versions are contemplated.
It is an object of this invention to provide an apparatus which is designed to meet all of OSHA's new regulations, be hand-held and compact, with dual functions for both suture needles as well as scalpels.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other objects of this invention will be evident when viewed in light of the drawings, detailed description, and appended claims.
The invention may take physical form in certain parts and arrangements of parts, a preferred embodiment of which will be described in detail in the specification and illustrated in the accompanying drawings which form a part hereof, and wherein:
FIG. 1 is a top view of the apparatus comprising this invention showing a sliding door in a partially open position;
FIG. 2 is a side elevational view of the apparatus shown in FIG. 1;
FIG. 3 is a cross-sectional view as may be taken at the line 3-3 in FIG. 2;
FIG. 4 is a top view of the sliding door;
FIG. 5 is an enlarged cross-sectional view of the door shown in FIG. 4 as taken at the line 5-5 thereof; and
DETAILED DESCRIPTION OF THE INVENTION
FIG. 6 is a cross-sectional view taken at the line 6-6 in FIG. 2 and showing an alternative configuration for a wall which divides the two compartments of the apparatus.
Referring now to the drawings wherein the showings are for purposes of illustrating the preferred embodiment of the invention only and not for purposes of limiting the same, the Figures show the apparatus for sharp implement transfer, counting and temporary disposal or storage of the present invention.
This device is hand-held and at least partially constructed of clear plastic with embedded magnets. The chosen material of construction must be capable of withstanding a sterilization environment, although in one embodiment, it will only be used once. Traditionally, suture needles, scalpels and other sharps are passed “hand-to-hand” or directly from assistant to surgeon. As an example, in the course of an operation, the passing of sharps occurs in the following steps. The assistant removes the needle from the sterile package and mounts the needle on a needle holder. The needle is exposed. The assistant then “passes” the needle and holder to the surgeon using direct, hand-to-hand technique. The surgeon, when completed, then passes the needle back to the assistant. Again, the needle/scalpel remains exposed at all times during this process.
The needle escort provides protection during each step of the above procedures. First, the assistant uses a needle holder to mount the needle within the protective escort device. Secondly, the needle escort device is passed with the hands behind the needle, as specified in OSHA requirements. The only way for the surgeon to access the needle is with a needle holder, not with the use of hands or fingers. When complete, the surgeon disposes the needle in the top retractably sealable box where the used needle remains until the end of the case, at which time all needles are easily counted and the entire device is properly disposed of, in a permanent fashion, in an appropriate permanent sharps disposal container. The needle escort is unique in that it incorporates protection without being cumbersome. It is lightweight and disposable. It is designed for both forward and backward passing of instruments and eliminates direct hand-to-hand passing and exposure during the above process.
As seen in FIGS. 1 and 2, the apparatus 10 comprises a two-compartment system in which sterilized sharp implements are removably positionable for suturing use in exposed holding and handling receptacle 12 and sharp implements for either storage or subsequent disposal are placed in sealable disposal and storage compartment 14. The apparatus has a pair of longitudinal side walls 16, a pair of end walls 34,36, a floor 50, and in a preferred embodiment, an inner wall 18 which separates the holding and handling receptacle 12 from the disposal and storage compartment 14.
As illustrated in FIGS. 1 and 3, the holding and handling receptacle 12 comprises a pair of longitudinal side walls 16, floor 50, inner wall 18, which in a preferred embodiment is shared with adjacent disposal and storage compartment 14, and exterior receptacle end wall 36. In one embodiment of the invention end wall 36 is discontinuous at three locations, although this number could be increased or decreased, and optionally, eliminated. As evidenced in FIG. 1, a pair of slots 44 are shown in spaced apart relationship to each other and positioned toward longitudinal side walls 16. These openings are available for scalpel insertion and holding when passed from a physician's assistant to a physician. In a preferred embodiment, a third opening 52 is present which in cooperation with V-shaped notch 24 in floor 50 facilitates linkage with suture material, i.e., thread which is held in engagement with the apparatus 10 through suture card (not shown) which is secured via opposed rails 26.
As illustrated in FIGS. 1 and 6, the sealable disposal and storage compartment 14 comprises a pair of longitudinal side walls 16, a floor 50, an inner wall 18, which in a preferred embodiment is shared with adjacent holding and handling receptacle 12, and exterior compartment end wall 34. The end wall is slightly lowered in comparison to side walls 16 to accommodate sliding engagement of a securely fastenable covering device 20, which for safety purposes, prevents the sharp implement from falling out of the apparatus when it is positioned in a manner other than laying flat on a horizontal surface. In a preferred embodiment, this covering device 20 will be slidably positionable via grooves 22 inside exterior walls 16 of disposal and storage compartment 14 and commonly shared interior wall 18. The longitudinal side walls 16 preferably have an indentation 28 contained at approximately the mid-point along the length to accommodate holding the apparatus between a thumb and a finger of a user.
In order to securely position the sharp implements and/or needles, a pair of magnets 46 are securely positioned on floor 50 adjacent end wall 36 of holding and handling receptacle 12. For disposal, at least one magnet 38 is positioned in disposal and storage compartment 14 for securing the sharp implements prior to closing of the receptacle by cover member 20. Optionally, as best illustrated in FIG. 4, the covering device will have a pair of laterally extending hooks 30 for stop positioning of the cover member 20 against longitudinal side walls 16 and a protruding lip 40 along two longitudinal sides and one interior side of the cover member for insertion into grooves 22 on the interior of longitudinal side walls 16 of disposal and holding compartment 14. For ease of movement, a plurality of grooves 32 are either molded as raised edges or cut into cover member 20. In a preferred embodiment, a first raised ridge 42 a as best seen in FIG. 5, is molded into cover member 20 on the under side for ensuring secure engagement with an interior side of lowered end wall 34 of the disposal and holding compartment 14 of cover member 20. Additionally, a second raised ridge 42 b is shown positioned interiorly of first raised ridge 42 a to minimize the possibility of cover member 20 falling to the floor upon lateral peripheral movement by a user effected to opening the cover member.
As seen in FIG. 3, a pair of openings 44 in exterior receptacle end wall 36 permit insertion of scalpel blades with associated grooved handles, said handle grooves typically being normal to the longitudinal axis of the scalpel and dimensioned so as to frictionally fit into openings 44 in end wall 36. In one embodiment of this invention, foam or flexible inserts 48 are positioned within opening 44 so as to accommodate differently sized scalpel handles.
When the device is being used in association with suture materials (not shown), typically provided in sterile elongated packaging dimensioned so as to be frictionally positionable within inwardly directed legs 26 after removal of the packing material, the sterilized needle with suture material threadably attached, is positioned using a needle holder onto magnets 46 with suture material passing through notch 24 in floor 50. After the threaded needle has been positioned onto magnets 46, the needle holder is disengaged from the needle and apparatus 10 held in a forward facing position exposed to the physician or suture technician. After passing, the needle is reattached to the needle holder for use by the physician or suture technician to effect the skin closure. Upon completion of the closure, the needle is deposited onto magnet 38 in the disposal and holding compartment 14 after opening of securedly refastenable lid 20, followed by disengagement of the needle holder and closure of lid 20.
While securedly refastenable lid 20 has been described so far as a slidably repositionable device with a ridge which is guided by a groove in the disposal and holding compartment 14, there is no need to limit it to such. One of the key considerations is the degree of integrity of the closure coupled with the magnet which is positioned along at least a portion of the bottom of the compartment. Alternative lid configurations could include, a hinged arrangement with frictional snap fit characteristics. Yet further embodiments, include encasing the magnet into either the floor of the compartments or in separable plastic inserts dimensioned so as to be positionable within either one or both of the compartments. This is anticipated to be helpful when the device is intended for multiple uses, and sterilized multiple times.
In light of the sterilization requirement, it is important that any plastic which is employed to manufacture the apparatus be capable of withstanding sterilization environments. Typical of sterilizable polymers would include the following non-limiting examples: poly(meth)acrylics, e.g., poly(meth)acrylic acids and esters thereof, e.g., poly(meth)acrylates, polyamides such as nylon, polyesters and polyolefins such as polyethylene, including ultra high molecular weight polyethylene and crosslinked polyethylenes or polypropylene, polyetherimides, acetal copolymers, polyethersulfones, polyarylethersulfones, polysulfones, PPO (polyphenylene oxide & styrene), polystyrenes, polycarbonates, and ABS (acrylonitrile butadiene styrene).
In order to implement the OSHA directives, it is important that cover member 20 be transparent or translucent so as to enable counting of the sharps contained within disposal and holding compartment 14. Other structural members of the apparatus need not have either the transparent or translucent characteristic.
This invention has been described in detail with reference to specific embodiments thereof, including the respective best modes for carrying out each embodiment. It shall be understood that these illustrations are by way of example and not by way of limitation.