US20160303791A1 - System and Method for Sterilization of Medical Instruments within a Hydrogen Peroxide Sterilization Process - Google Patents

Abstract

A system and method of sterilization for medical instruments within a hydrogen peroxide sterilization process is provided. A medical instrument is housed in a sterilization tray, wherein the sterilization tray is formed from polypropylene and a glass material. The medical instrument and sterilization tray are subjected to a hydrogen peroxide sterilant.

Description

CROSS REFERENCE TO RELATED APPLICATION
• This application claims benefit of U.S. Provisional Application Ser. No. 62/149,032, entitled, “System and Method for Sterilization of Medical Instruments Within a Hydrogen Peroxide Sterilization Process” filed Apr. 17, 2015 and U.S. Provisional Application Ser. No. 62/166,994, entitled, “System and Method for Sterilization of Medical Instruments Within a Hydrogen Peroxide Sterilization Process” filed May 27, 2015, the entire disclosure of which is incorporated herein by reference.
FIELD OF THE DISCLOSURE
• The present disclosure is generally related to sterilization of medical instruments and more particularly is related to a system and method for sterilization of medical instruments within a hydrogen peroxide sterilization process.
BACKGROUND OF THE DISCLOSURE
• The sterilization of medical instruments and tools before, after, and sometimes during medical procedures is a foundation of modern health care, as it is imperative in preventing the spread of harmful contaminants. Commonly, medical instruments are held within sterilization trays which are then processed through a sterilization operation. The sterilization operation can include sterilization within an autoclave, which is a pressure chamber that subjects the medical instruments to high pressure saturated steam at approximately 250° F.-270° F. for a period of time. Other sterilization processes include the use of chemical sterilant or light-based sterilizing devices.
• Sterilization trays used within the medical industry are commonly manufactured from polyphenylsulfone (PPSU) often known by the brand name RADEL®. The PPSU utilizes an extrusion process combined with a thermoforming process or is injection molded from resin. These PPSU have proven successful in many types of sterilization processes, such as within steam autoclave, but they have points of failure in low temperature sterilization processes. For example, low-temperature chemical sterilizing using hydrogen peroxide has become more commonplace when sterilizing medical instruments that cannot tolerate steam sterilization. When the PPSU is subjected to hydrogen peroxide sterilization, however, the hydrogen peroxide is absorbed and causes the PPSU to discolor and become brittle over time, which leads to tray failure, or worse, ineffective sterilization due to a drop in the concentration level of hydrogen peroxide in the sterilization chamber.
• Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies.
SUMMARY OF THE DISCLOSURE
• Embodiments of the present disclosure provide a system and method for sterilization of medical instruments within a hydrogen peroxide sterilization process. Briefly described, in architecture, one embodiment of the method, among others, can be broadly summarized by the following steps: housing a medical instrument on a sterilization tray, wherein the sterilization tray is formed from polypropylene and a glass material; and subjecting the medical instrument and sterilization tray to a hydrogen peroxide sterilant. The sterilization tray may be formed from polypropylene and the glass material by first injection molding the polypropylene and the glass material into a sheet form and then thermoforming the sheet form of the polypropylene and the glass material into a tray form. In one of many alternatives, the sterilization tray may be formed from polypropylene and the glass material by injection molding the polypropylene and the glass material into a tray form.
• The present disclosure can also be viewed as providing methods of manufacturing and using a sterilization tray. In this regard, one embodiment of such a method, among others, can be broadly summarized by the following steps: combining a quantity of polypropylene with a glass material; injecting the combined quantity of polypropylene with glass material into a sheet form; thermoforming the sheet form of the combined quantity of polypropylene with glass material into a tray form, thereby providing a sterilization tray; and subjecting the sterilization tray to a hydrogen peroxide sterilant.
• Other systems, methods, features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, be within the scope of the present disclosure, and be protected by the accompanying claims.
BRIEF DESCRIPTION OF THE DRAWINGS
• Many aspects of the disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.
• FIG. 1 is a schematic illustration of a method of sterilizing medical instruments within a hydrogen peroxide sterilization process, in accordance with a first exemplary embodiment of the present disclosure.
• FIG. 2 is a schematic illustration of a method of manufacturing and using a sterilization tray, in accordance with a second exemplary embodiment of the present disclosure.
• FIG. 3 is a schematic illustration of a method of manufacturing and using a sterilization tray, in accordance with the second exemplary embodiment of the present disclosure.
DETAILED DESCRIPTION
• FIG. 1 is a schematic illustration of a method of sterilizing medical instruments within a hydrogenperoxide sterilization process10, in accordance with a first exemplary embodiment of the present disclosure. The method of sterilizing medical instruments within a hydrogenperoxide sterilization process10, which may be referred to herein simply as ‘method10’ includes housing amedical instrument20 in asterilization tray30, wherein the sterilization tray is formed from polypropylene and a glass material. Themedical instrument20 andsterilization tray30 are subjected to ahydrogen peroxide sterilant40 within a hydrogenperoxide sterilization process50.
• Unlike a hydrogen peroxide sterilization process used with conventional PPSU sterilization trays, which are prone to degrading after being subjected to hydrogen peroxide, it has been found that trays formed from polypropylene (PP) and a glass material, such as glass fibers, glass spheres, or a combination thereof, can prove to be successful in hydrogen peroxide sterilization. The combination of PP and the glass material resists penetration of the hydrogen peroxide into the surface of the tray, since the PP and glass material provide for a less porous surface than conventional PPSU and glass trays. Thus, while PPSU absorbs hydrogen peroxide in low-temperature, PP with glass does not. Accordingly, PP and glass material formed trays may be capable of long term, successful use with hydrogen peroxide sterilization. Further, the process described herein may, in some situations, be used with ethylene oxide or other chemical sterilants.
• FIG. 2 is a schematic illustration of a method of manufacturing and using asterilization tray110, in accordance with a second exemplary embodiment of the present disclosure. The method of manufacturing and using asterilization tray110, which may be referred to herein simply as ‘method110’ includes forming themedical sterilization tray130 by injection molding a polypropylene (PP)120 and aglass material122 into a tray form. ThePP120 and theglass material122 may be provided to aninlet162 of aninjection molding device160. ThePP120 andglass material122 may be pre-mixed into aresin126, without the addition of copolymers, prior to being fed into theinlet162 of theinjection molding device160. Inside theinjection molding device160, the combined resin may be injected into a mold having a tray-form shape, which may include any type of shape to house medical instruments. The resultingtray130 may then be used to sterilize medical instruments within a low-temperature hydrogenperoxide sterilization device150. Thesterilization device150 receives an input ofhydrogen peroxide140 which is applied to thetray130 and the medical instruments thereon, and effectively sterilizes the instruments, as is known in the art. Alternatively, or in addition, thesterilization device150 may receive an input ofsteam144 for use in sterilization, and/or the sterilization device may receive an input of a chemical sterilant including, but not limited to an ethylene-oxide basedsterilant142.
• In comparison to PPSU which is commonly used in medical sterilization trays, PP has a higher melt flow rate than PPSU and therefore PP is often more successfully used in injection molding. It is noted that theglass material122 may include a variety of types of glass fillers and other materials. Commonly, glass fibers, glass spheres, or a combination of glass fibers and spheres may be used with the PP. Theglass filling material122 may provide rigidity to theeventual tray130, such that it can support medical instruments properly. Up to 30% of the sterilization tray material may be glass fiber and/or glass spheres. While other materials and fillers may be included, the use of EVAL®, EVOH resin and film (ethylene vinyl alcohol copolymer) may be restricted or fully omitted from the combined resin and the resultingtray130.
• FIG. 3 is a schematic illustration of a method of manufacturing and using asterilization tray110, in accordance with the second exemplary embodiment of the present disclosure. Similar toFIG. 2, themethod110 includes forming themedical sterilization tray130 by injection molding aPP120 and aglass material122. However, the method ofFIG. 3 includes further injection molding thePP120 and theglass material122 into asheet form124, first, and then thermoforming thesheet form124 of thePP120 and theglass material122 into a tray form.
• In this process, thePP120 and theglass material122 may be provided to aninlet162 of aninjection molding device160. ThePP120 andglass material122 may be pre-mixed into a resin, without the addition of copolymers, prior to being fed into theinlet162 of theinjection molding device160. Inside theinjection molding device160, the combined resin may be injected into a mold having a sheet form, e.g., a substantially planar sheet that is sized for thermoforming. Once cooled fully, the sheet form of the combined resin may be placed in athermoforming device180. Within thethermoforming device180, the sheet form of the combined resin is heated to a pliable forming temperature and formed to a tray-shape in a mold, which may include any type of shape to house medical instruments. The tray-shape is trimmed to create a finalmedical sterilization tray130, which may then be used to sterilize medical instruments within a low-temperature hydrogenperoxide sterilization device150. Thesterilization device150 receives an input ofhydrogen peroxide140 which is applied to thetray130 and the medical instruments thereon, and effectively sterilizes the instruments, as is known in the art.
• It has been found that thermoforming PP materials alone may result in non-usable products, since the PP is often incapable of withstanding the thermoforming process. Theglass filling materials122 may be used to properly thermoform the sheet-form of the combined resin by helping the sheet-form of the combined resin maintain uniformity in shape. In one example, it has been found that the combined use of glass fibers and glass spheres may provide substantial benefits in maintaining uniformity during the cool down process after thermoforming.
• It should be noted that any process descriptions or blocks in flow charts should be understood as representing modules, segments, or steps that include one or more instructions for implementing specific logical functions in the process, and alternate implementations are included within the scope of the present disclosure in which functions may be executed out of order from that shown or discussed, including substantially concurrently or in reverse order, depending on the functionality involved, as would be understood by those reasonably skilled in the art of the present disclosure.
• It should be emphasized that the above-described embodiments of the present disclosure, particularly, any “preferred” embodiments, are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) of the disclosure without departing substantially from the spirit and principles of the disclosure. All such modifications and variations are intended to be included herein within the scope of this disclosure and the present disclosure and protected by the following claims.

Claims (20)

What is claimed is:

1. A method of sterilization for medical instruments within a hydrogen peroxide sterilization process, the method comprising:

housing a medical instrument in a sterilization tray, wherein the sterilization tray is formed from polypropylene and a glass material; and

subjecting the medical instrument and sterilization tray to a hydrogen peroxide sterilant.

2. The method ofclaim 1, wherein the sterilization tray is formed from polypropylene and the glass material by:

injection molding the polypropylene and the glass material into a sheet form; and

thermoforming the sheet form of the polypropylene and the glass material into a tray form.

3. The method ofclaim 2, further comprising:

premixing the polypropylene and the glass material into a resin without the addition of copolymers prior to the injection molding.

4. The method ofclaim 1, wherein the sterilization tray is formed from polypropylene and the glass material by injection molding the polypropylene and the glass material into a tray form.

5. The method ofclaim 1, wherein the glass material includes one of glass fibers and glass spheres.

6. The method ofclaim 1, wherein the sterilization tray includes up to 30% glass material.

7. The method ofclaim 1, further comprising:

subjecting the medical instrument and sterilization tray to a steam sterilization.

8. A method of manufacturing and using a sterilization tray comprising:

combining a quantity of polypropylene with a glass material;

injecting the combined quantity of polypropylene with glass material into a sheet form;

thermoforming the sheet form of the combined quantity of polypropylene with glass material into a tray form, thereby providing a sterilization tray; and

subjecting the sterilization tray to a hydrogen peroxide sterilant.

9. The method ofclaim 8, further comprising:

premixing the polypropylene and the glass material into a resin without the addition of copolymers prior to the injection molding.

10. The method ofclaim 8, wherein the sterilization tray is formed from polypropylene and the glass material by injection molding the polypropylene and the glass material into a tray form.

11. The method ofclaim 8, wherein the glass material includes one of glass fibers and glass spheres.

12. The method ofclaim 8, wherein the sterilization tray includes up to 30% glass material.

13. The method ofclaim 8, further comprising:

subjecting the medical instrument and sterilization tray to a steam sterilization.

14. A method of sterilization for medical instruments within a chemical sterilization process, the method comprising:

housing a medical instrument on a sterilization tray, wherein the sterilization tray is formed from polypropylene and a glass material; and

subjecting the medical instrument and sterilization tray to at least one chemical sterilant.

15. The method ofclaim 14, wherein the subjecting of the medical instrument and sterilization tray to a chemical sterilant includes subjecting the medical instrument and sterilization tray to an ethylene oxide-based sterilant.

16. The method ofclaim 14, wherein the sterilization tray is formed from polypropylene and the glass material by:

injection molding the polypropylene and the glass material into a sheet form; and

thermoforming the sheet form of the polypropylene and the glass material into a tray form.

17. The method ofclaim 16, further comprising:

premixing the polypropylene and the glass material into a resin without the addition of copolymers prior to the injection molding.

18. The method ofclaim 14, wherein the sterilization tray is formed from polypropylene and the glass material by injection molding the polypropylene and the glass material into a tray form.

19. The method ofclaim 14, wherein the glass material includes one of glass fibers and glass spheres, and wherein the sterilization tray includes up to 30% glass material.

20. The method ofclaim 14, further comprising:

subjecting the medical instrument and sterilization tray to a steam sterilization.

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