US 3561918 A
Description (OCR text may contain errors)
Feb. 9, 1971 c, Y
GAS STERILIZATION MEDICAL CASE 2 SheetsShee 1 Filed Feb. 28. 1968 Feb. 9, 1971 c. D. RAY
GAS STERILIZATION MEDICAL CASE 2 Sheets-Sheet 2 Filed Feb. 28. 1968 United States Patent US. Cl. 21-84 6 (Ilaims 10 ABSTRACT OF THE DISCLOSURE A portable apparatus for housing and sterilizing medical implements, having a separable two-piece but gastight container comprising a mechanism communicating with the container interior for applying a sterilizing gas thereto, the container conforming to the size of the implement for which it is intended to house, and further adapted to receive such implement by means of spring clip or other suitable means secured to the inner surface(s) of the container. A window is provided at the top of the container for visually inspecting an indicating device temporarily secured within the container and under the window to determine if a suitable concentration of gas has been provided for sterilization. A relief valve is 9 provided for bleeding off gas within the housing prior to use of the implement therein. Additional provisions adapt the device for use with a disposable gas cartridge should a source of gas not be readily at hand.
The present invention relates to sterilization apparatus and more particularly to devices utilized for gaseous sterilization of various types of equipment employed in the field of medicine.
With the advancement of instrumentation for utilization in surgicial, diagnostic and other medical procedures, the present trend has been for the instrument to be more complex and include a number of intricate parts whereas the over-all size of the instruments has, for the most part, decreased. Such intricate parts might include such items as electrodes, fittings, probes, catheters, operating microscope heads, fiberoptic scopes, etc., for a wide variety of instruments, for example, heart valves, pacemakers, microsurgical tools, anesthesia equipment, and the like, which instruments, in most instances, are extremely expensive. Quite often, handling of such instruments leads to loss of or damage to critical pieces. Unfortunately, a small critical part inadvertently dropped into the sink or lost in the swaddling wrappings of surgical linens can terminate the utility of an entire surgical machine and perhaps cause an entire surgical procedure to be procrastinated. To prevent the for the want of a nail situation from cropping up in the surgical schedule, much effort is expended to provide detailed procedural techniques or checking systems for ensuring the presence of all critical parts and for minimizing damage. However, as a result of the increasing number of instruments becoming available and being frequently used by those in the medical profession, such procedural technique are often overlooked or abandoned as nurses and ice doctors become more burdened with the care of such instruments, the complexity of which places immoderate demands on their time and/or training.
In attempts to lessen those problems discussed above, containers are provided, in many instances, to carry and store instruments of the type heretofore referred to in order to prevent damage to or loss of critical parts. However, such containers have not proved to entirely solve the problems noted above as such instruments must normally be sterilized prior to being employed in any surgical or diagnostic procedure. For this reason, handling of instruments by one or more persons may readily result in damage or destruction thereto. Furthermore, considering that such instruments are most always placed in a relatively larger sterilization chamber, absorbent materials are employed to wrap the instruments prior to placement therein. With all present-day sterilization equipment utilizing gas, cloth or plastic wrappers are most always used about the instrumentation and such use delays the penetration and dissipation of gas to and from, respectively, the instruments, therefore prolonging the sterilization time and leading to the need for drawing out the gas at the conclusion of the sterilization procedure.
SUMMARY OF THE INVENTION It is the purpose of the present invention to obviate or markedly reduce the problems noted above. The latter is accomplished, in part, by provisions of a reliable, portable and inexpensive container which not only serves as a carrier for a particular medical instrument to house and protect the same, but in addition, to doubly serve as a sterilizing unit inaugurating the one-instrument, one sterilizer concept. Several other significant advantages are provided for in the present invention over the prior art. One such advantage is inherent in the fact that the sterilization unit is predesigned to simultaneously function as the instrument container and the container is made sufficiently small, yet large enough to accommodate the instrument which it is to house; thus, a minimum amount of gas is necessary to provide suitable gas concentration for proper sterilization. Further advantages are that minimum handling of instruments is incurred and the portability of the sterilization unit enables the sterilization period to be eifected at any time, such as, for example, while a physician is traveling to a medical station. With such a latter benefit, complex instruments so housed could easily become part of the itinerant physicians equipment that he carries from one hospital to another. An additional provision calls for clamping devices or like members permanently secured within the container to provide a place for each of several parts comprising an instrument, enabling inventory to be exact and simple and simultaneously to eliminate the need for Wrapping and other procedures such as those normally undertaken on the part of an instrument nurse prior to a sterilizing procedure. In addition, other provisions in the present invention provide for tell-tale indicating rneans enabling one to determine when the proper sterilizing conditions have been met to ascertain whether sterilization of an instrument within the container has been accomplished.
Other objects, advantages, and capabilities of the present invention will become apparent from the following description, taken in conjunction with the accompanying '3 CD drawings illustrating a preferred embodiment of the invention.
DETAILED DESCRIPTION In the drawings:
FIG. 1 is a perspective view of the present invention showing a reliable, inexpensive, portable gas sterilizing and carrying container.
FIG. 2 is a top plan view of the lower container portion 13 shown in FIG. 1 with the cartridge receiving unit 27 shown in section.
FIG. 3 is a bottom plan view of the upper container portion 12 shown in FIG. 1.
FIG. 4 is a sectional view of the window unit 18 taken across the lines 4-4 of FIG. 3.
Referring now in more detail to the drawings, there is shown in FIGS. 1, 2 and 3 a two-piece gas-tight case or container 11, preferably constructed of stainless steel, aluminum, magnesium, or suitable plastic material, and including upper and lower portions 12 and 13, respectively, these portions having mating surfaces for providing optimum alignment of the two portions of the container when mated to one another and including a gasket 14 of silicone rubber, neoprene or similar substance permitting maximum sealing for forming a gastight closure.
Located at and secured to the top of the container portion 12, by suitable means, is a handle 15, the particular type of handle used being designed to accommodate the container size and mass. At the front and rear of the container side walls are attached a pair of container fasteners or latches 16 of the spring loaded type adapted to maintain the upper and lower portions of the container in a tight embracing relation and secure the container integrity in those instances when positive pressures are introduced within the container for sterilization purposes. Mounted at the top of container portion i12 is a sealing-venting port 17 including a manually controllable relief valve enabling the space within the container to be readily opened or closed to the atmosphere as will be described hereinafter. The construction of such manually controllable relief valves are wellknown in the art. Adjacent relief valve 17 there is seated in upper container portion 12 a hexagonal unit 18 comprising a pressure-tight sight-glass window which may best be described with reference to FIG. 4 wherein there is shown a hexagonal bolt 19 having a centrally located cylindrical aperture 21 extending completely therethrough, whereby at each end of aperture 21 is fixedly secured a transparent medium 22 which might be of lens configuration. A nut 23 is employed to secure bolt 19 to the top of upper container section 12 and an O-ring 24 is positioned between the bolt and the container top surface to serve as a gasket. Intermediate nut 23- and container top surface 12 is a holding device 25, which might be a spring clip, designed to hold an indicator strip 26 under the window.
There is illustrated with reference to FIG. 2 a receptacle unit generally designated as 27 for receiving a gas cartridge, comprising a tubing member 28 situated to extend into the container. Tubing member 28 is capped at its inwardly extending end by a piercing assembly 29 constructed of hardened steel and including a hollow piercing pin 31 open to the otherwise enclosed container. Positioned within tubing member 28 and concentrically about piercing pin 31 is a coiled spring 32 and an O- ring 33, the latter adapted to provide a gas-tight seal when a disposable gas cartridge 34 is urged against spring 32 to be punctured by the piercing pin. The outwardly extending end of tubing member 28 is fitted within a bushing 35 which is integrally connected, as by brazing, to an end wall of the lower container portion '13. A threaded cap 36 is provided to threadably engage the outwardly extending end of bushing member 35, the inner surface of the cap having a washer '37 of silicone rubber, neoprene or Teflon material upon which a hard cylindrical member 38 is mounted and fastened to the cap by conventional screw means, cylindrical member 38 being of an outer diameter which is less than that of the bushing inner diameter. Positioned intermediate cylindrical member 38 and bushing 35 is an O-ring 39 frictionally engaging a circular groove extending about member 38, so that when cap 36 is tightly screwed onto bushing 35, washer 37 and O-ring 39 aid to further ensure a gas-tight connection.
As may be readily observed from viewing FIGS. 2 and 3, anchored to the inner surfaces of container 11 are a plurality of clips or snaps 41. Each of these clips 41 is specifically designed to accommodate one article or intricate part of the particular medical implement 42 for which the container has been specifically designed; thus, each separate part of the medical implement is provided with a home within the container. If desired, each area about a clip 41 can be provided with indicia means such as a design outline of the article or written data 40 to denote which particular article or part which that clip 41 has been designed to accommodate. Accordingly, inventory of a multipart medical implement within the container could be virtually made at any time prior to closure of the container. Further, since the container doubly serves as a sterilization device, the intricate parts of the implement 42 supported by clips 41 clearly need not be wrapped by an absorptive material prior to a sterilization procedure, allowing the sterilizing gas to have full access to all surfaces of a medical implement, thereby increasing the over-all effectiveness of such a procedure. It might also be expedient to provide a removable freestanding tray adapted to snugly fit the lower container portion 13, in which case the tray itself would contain support members for holding parts of the medical implement. An advantage of the latter feature is that the tray would enable the medical implement, in its unassembled state, to be brought intact to the immediate disposal of a physician at an operating or diagnosing station.
An alternate embodiment of the present invention might comprise a valve 43 shown in dotted lines in FIG. 1. Such a valve could be utilized as a substitute for or in combination with cartridge receiving unit 27 and/or relief valve 17: for example, valve 43 might be utilized for injection of the container with a sterilizing gas from a separate main and/0r portable source of supply by way of flexible tubing or the like; valve 43 mightalso be used for bleeding the sterilizing gas from the container once the sterilizing procedure has been completed; or valve 43 could be employed in combination with relief valve 17 where air under pressure could be introduced within the container by way of valve 43 to eject the sterilizing gas from the container through relief valve 17, if desired. Similarly, through valve 43 a negative pressure, or vacuum, might be applied to the inner aspect of the container prior to gas introduction to promote better gas concentration or to remove the gas after sterilization. It is readily evident that in those cases where the medical implement and therefore the container are of extremely small size, valve 43 may be an expedient alternative to cartridge receiving unit 27.
In the instant embodiment, the preferred operation of the invention will be described with implementation of ethylene oxide gas as the sterilization agent since this gas has obtained general acceptance in the field. However, other types of accepted gaseous sterilizing agents might be employed. Ethylene oxide is widely used as a bactericidal agent for the reason that it has been proved to be quite effective for sterilization purposes at room temperature and humidity. Not only does ethylene oxide act as an agent on both bacterial and vegetable molds, but, in addition, it will also destroy all forms of insect life and viral agents. However, in consideration of its explosive and toxic properties, it is conventionally used,
as in the present invention, in mixtures with Freon which not only dilutes the toxic gas but additionally serves as a flame-retardant agent.
Indicator strip 26, heretofore referred to, is used within the chamber formed by the container so that the sterilization point of a given sterilizing gas may be routinely determined. The strip used as an indicator for ethylene oxide gas is commercially made available by a company known under the tradename ATI. Other indicators might be suitably adapted for other sterilizing gases. The indicator strip or portion thereof will turn color to visually indicate that a required concentration of ethylene oxide has been applied for the necessary time to insure sterilization of the medical implement subjected to the gas within the treating container. In brief then, an effective sterilization range can be indicated by a color change in the test strip.
In operation of the present invention, with the medical implement to be sterilized stored intact within the container, a fresh indicator strip 26 is placed under spring clip to be visible through the window or transparent medium 22; then, all latches 16 are fastened and relief valve 17 is placed in a closed position. A disposable gas cartridge 34 containing a mixture of ethylene oxide and Freon is inserted within the cartridge receiving unit 27. Cap 36 is screwed onto bushing 35, simultaneously forcing cartridge 34 against the coil spring 32 causing the leading edge of the cartridge to be punctured by piercing pin 31 allowing the mixture within the cartridge to be introduced to the gas-tight chamber defined by container 11, whereby a pressure in excess of atmospheric pressure may be developed within the container.
When indicator strip 26 has changed color to indicate that the sterilizing conditions have been met, assuring proper sterilization of the medical implement, then should it be desirable to remove the implement, relief valve 17 is opened. With some of the ethylene oxide gas having been released via the relief valve, latches 16 are unfastened, top portion 12 of the container is removed and the medical implement is allowed to aerate for a short period of time to evaporate any of the ethylene oxide which may have condensed on the implement. The physician will then be ready to remove said implement and to assemble the same for its intended use. After such use, all implement parts are cleaned, rinsed or wiped at the table at the conclusion of the medical procedure and immediately returned to the container for future use. A designated area in the container is provided for each separable part of the medical implement, if separable. Inventory may be readily made at the termination of the medical procedure and prior to storage of the instrument to determine whether any one part of the implement is missing.
In those instances when the implement and thus the container are of relatively small magnitude, it may, of course, prove to be impractical to employ latches of the type shown in FIG. 1. Accordingly, in such cases it may be expedient to have a pair of mating container halves provided with overlapping flanged portions or other similar arrangements including suitable gasket means to allow for a gas-tight fit between the container halves when joined together. Examples of such small implements might include an electrode, pacemaker, etc.
As the container might be unfastened prior to opening the relief valve, it is conceivable that suflicient pressure might be built up so that in some instances the container top would pop off and perhaps cause some damage. With the above in mind, it might be desirable to add a camming feature to the fastener to prevent the latches from being unlocked while excessive pressures are existing within the container. Such safety fasteners are well known in the art. 1
It is, of course, realized that while the present embodiment has been discussed with reference to medical implements, it is understood that the invention may also be used for scientific implements such as those used for laboratory purposes where a sterilizing procedure is required. I
While I have particularly shown and described a preferred embodiment of the invention, it is distinctly understood that the invention is not limited thereto but that modifications may be made within the scope of the invention and such variations as are covered by the scope of the appended claims.
1. A sterilizing apparatus adapted for transportably housing a medical implement which consists of two or more separable parts, comprising a two-section container adapted to provide a gas-tight connection defining a closed chamber, means providing communication from said chamber to the exterior thereof, said communication means adapted to be connected with a source for supplying a sterilizing gas to said chamber, fastening means secured in fixed relation to said chamber for removably receiving each of said parts generally exposing said implement to the space defined by the chamber, window means for viewing an area of said chamber from without, indicator means for indicating a proper concentration of said gas for sterilization purposes, and holding means for removably receiving said indicator means within the housing enabling the indicator means to be visually observed through said window means.
2. Apparatus according to claim 1 including a valve mounted in said container and adapted to permit a gas flow from said chamber to the exterior thereof.
3. Apparatus according to claim 2 whereby said communication means comprises receptacle means disposed for receiving a disposable cartridge, said receptacle means including means for puncturing said cartridge to introduce a medium in said cartridge directly to said chamber, and means enclosing said receptacle means for urging said cartridge against said puncturing means.
4. Apparatus according to claim 3 whereby said valve is further adapted to also permit a gas to be introduced to said chamber from the exterior thereof.
5. A sterilizing apparatus adapted for transportably housing a medical implement which consists of two or more separable parts, comprising a two-section container adapted to provide a gas-tight connection defining a closed chamber, means providing communication from said chamber to the exterior thereof, said communication means adapted to be connected with a source for supplying a sterilizing gas to said chamber, support means secured in fixed relation to said chamber for removably receiving each of said parts generally exposing said implement to the space defined by the chamber, window means for viewing an area of said chamber from without, indicator means for indicating a proper concentration of said gas for sterilization purposes, and means for holding said indicator means within the housing enabling the indicator means to be visually observed through said window means, including indicia means associated with said support means to indicate which of said parts each support means is to accommodate.
6. A sterilizing apparatus adapted for transportably housing a medical implement which consists of two or more separable parts, comprising a two-section container adapted to provide a gas-tight connection defining a closed chamber, means providing communication from said chamber to the exterior thereof, said communication means adapted to be connected with a source for supplying a sterilizing gas to said chamber, support means secured in fixed relation to said chamber for removably receiving each of said parts generally exposing said implement to the space defined by the chamber, window means for viewing an area of said chamber from without, indicator means for indicating a proper concentration of said gas for sterilization purposes, and means for holding said indicator means within the housing enabling the indicator means to be visually observed through said window means, including a free-standing tray and where said 8 support means are secured to said container by way of 3,093,242 6/1963 Huyck 2158UX the free-standing tray which is adapted to be tightly fitted 3,114,599 12/ 1963 Fanning 21-5 8X in one of said container sections. 3,261,660 7/ 1966 Wilkinson 21-105 3,436,173 4/1969 Power 2158X References Cited UNITED STATES PATENTS 5 JOSEPH SCOVRONEK, Primary Examiner V D. G. MILLMAN, Assistant Examiner 1,872,917 8/1932 Epstein 21-105X 2,472,028 5/1949 Son 21 105 2,965,936 12/1960 Kaye 2158X 3,013,656 12/1961 Murphy 2'1-105UX 10 21-58, 91, 105; 20616