Patent Publication Number: US-2019167078-A1

Title: Sterilization package

Description:
FIELD 
     The subject matter disclosed herein relates to sterilizing endoscopes. 
     BACKGROUND 
     Endoscopes are reusable medical devices. An endoscope should be reprocessed, i.e., decontaminated, between medical procedures in which it is used to avoid causing infection or illness in a subject. Endoscopes are difficult to decontaminate as has been documented in various news stories. See, e.g., Chad Terhune, “Superbug outbreak: UCLA will test new scope-cleaning machine,” LA Times, Jul. 22, 2015, http://www.latimes.com/business/la-fi-ucla-superbug-scope-testing-20150722-story.html (last visited Oct. 30, 2017). Typically, endoscope reprocessing is performed by a disinfection procedure that includes at least the following steps: removing foreign material from the endoscope, cleaning the endoscope, and disinfecting the endoscope by submerging it in a disinfectant capable of substantially killing microorganisms thereon, e.g., infection causing bacteria. One exemplary disinfectant is CIDEX® OPA Solution, manufactured and distributed by Applicant, Advanced Sterilization Products, Division of Ethicon US, LLC, a Johnson &amp; Johnson company (“ASP”). 
     Many healthcare facilities including hospitals decontaminate medical devices by sterilization procedures. Various sterilization techniques may be employed, such as steam, hydrogen peroxide, and vapor phase sterilization, either with or without a gas plasma and ethylene oxide (EtO). Each of these methods depends to a certain extent on the diffusion rates of the sterilization fluids, typically gases, upon the medical devices to be sterilized. Certain sterilization techniques are conducted at pressures other than ambient pressure or atmospheric pressure. For example the STERRAD® System, STERRAD® NX System or STERRAD® 100NX System of ASP, are examples of sterilization systems that vaporize hydrogen peroxide and operate at low pressures, e.g., less than 200 millitorr. 
     Sterilization procedures are generally regarded as being more effective than disinfection procedures at killing microorganisms. However, sterilizing endoscopes effectively has various shortcomings. These shortcomings have to date minimized the likelihood that a healthcare facility, such as hospital, will opt to sterilize endoscopes instead of disinfect endoscopes. 
     One such shortcoming arises when an endoscope must be coiled to fit into a sterilization chamber. Endoscopes used on human subjects may be over approximately 10 to 12 feet long, whereas a vacuum chamber in a sterilizer—into which the endoscope must fit—may be much shorter. For example, a vacuum chamber of the STERRAD® 100 NX System has dimensions of approximately 2 feet×1.5 feet×0.5 feet and the STERRAD® NX System has dimensions of approximately 2 feet×1 ft×0.5 feet. Accordingly, an endoscope that is about 10 feet long likely would need to be configured into a coil having about five convolutions to fit into the vacuum chambers. Those portions of the endoscope that touch other portions of the endoscope or other materials within the sterilization chamber (e.g., a sterilization tray in which it is placed, a wall of the chamber, impermeable portions of a sterilization pouch) may be referred to as “mated surfaces.” Mated surfaces are difficult to sterilize relative to exposed, i.e., non-mated surfaces because an adequate amount of sterilant to kill the bacteria on the mated surfaces may not reach those mated surfaces within a reasonable amount of time. Endoscopes are typically fabricated from polyurethane, which is vapor absorptive, such that it may absorb a gaseous sterilant, including hydrogen peroxide, before the sterilant can penetrate through the endoscope to the mated surfaces. Thus, the mated surfaces may not be sufficiently exposed to the sterilant to effectively kill the bacteria. 
     SUMMARY 
     A sterilization package is described herein. The sterilization package is suited to disposing an endoscope therein. The sterilization package may include a first leg, a second leg connected to the first leg, an opening, and a flap disposed proximate the opening and configured to cover the opening. The package, and particularly the first leg, the second leg, and the flap may be fabricated from a vapor permeable material. The package may be at least 95% by weight of the material. The first leg may have a first length, the second leg may have a second length, and the first length plus the second length may equal at least approximately six feet. The vapor-permeable material may include a non-woven fabric, including melt flow, spun-bonded or flashspun materials, e.g., flashspun high-density polyethylene fibers and/or non-woven polypropylene fabric. 
     An adhesive may be disposed upon the flap. The adhesive may be adapted to seal the flap about the opening. The opening may be a single opening disposed in the first leg proximate the second leg. The package may lack any other openings. 
     Also disclosed herein is a method for sterilizing an endoscope in a sterilization package, such as the sterilization package described above. The method may be used to sterilize endoscopes that are at least six feet long. The endoscope may be placed into the package. The flap may be sealed over the opening of the package. The package, with the endoscope disposed therein, may be placed into a vacuum chamber of a sterilization system. The package, with the endoscope disposed therein, may be coiled before, during, or after placing the package in the vacuum chamber. The coiled package and endo scope may be checked to confirm that no portion of the endoscope contacts another portion of the endoscope. The coiled package and endoscope may be placed in the vacuum chamber without placing a sterilization tray in the vacuum chamber. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       While the specification concludes with claims which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: 
         FIG. 1A  depicts an endoscope; 
         FIG. 1B  depicts the endoscope of  FIG. 1A  in a coiled configuration; 
         FIG. 2  depicts a sterilization package; and 
         FIG. 3  depicts the endoscope of  FIG. 1A , coiled inside the sterilization package of  FIG. 2 . 
     
    
    
     DETAILED DESCRIPTION 
     The following description sets forth certain illustrative examples of the claimed subject matter. Other examples, features, aspects, embodiments, and advantages of the technology should become apparent to those skilled in the art from the following description. Accordingly, the drawings and descriptions should be regarded as illustrative in nature. 
       FIG. 1A  shows an exemplary endoscope  10 . An endoscope typically comprises an insertion tube or first tube  12  and a second tube  14 , both connected to a body  16 . Although endoscopes come in many lengths, as measured from first end  18  of first tube  12  to second end  20  of second tube  14 , the present disclosure focuses on endoscopes that are at least six feet long, because endoscopes that are at least six feet long likely must be coiled to fit into a sterilization chamber, thus creating the mated-surfaces problem described above.  FIG. 1B  shows endoscope  10  in a coiled configuration. Significant portions of endoscope  10  are covered by other portions of endoscope  10 , creating mated surfaces. 
     Uncoiled, endoscope  10  is difficult to fit inside the vacuum chamber of a sterilization system that a hospital is likely to own and use, e.g., the STERRAD® 100 NX System or the STERRAD® NX System. Coiled, the endoscope may fit therein, but a sterilization cycle may fail to sterilize the endoscope because the sterilant may not reach the mated surfaces or penetrate through the endoscope material in the vicinity of the mated surfaces. 
       FIG. 2  shows a sterilization package  100  that helps prevent an endoscope from contacting itself when coiled. Package  100  may be used to increase the likelihood that an endoscope may be sterilized. Sterilization pack  100  includes a first leg  112 , a second leg  114 , a flap  116 , and an opening  118  disposed thorough first leg  112  and proximate flap  116 . Flap  116  may be brought into contact with first leg  112 , such that edge  120  of flap  116  may contact edge  122  of opening  118 . An adhesive or sealant  124  may be disposed on edge  120  and/or edge  122  such that flap  116  seals opening  118  upon contact between edge  120  and edge  122 . Sterilization package  100  has a shape similar to endoscope  10  such that endoscope may be inserted therein, likely via opening  118 , and such that first leg  112  conforms closely to first tube  12  and second leg  114  conforms closely to second leg  14 . In some embodiments, a portion  126  of first leg  112  may be larger than other portions of first leg  112  to facilitate placement of body  16  therein. Opening  118  may be disposed through larger portion  126  and flap  116  may be disposed proximate thereto to further facilitate inserting endoscope  10  into package  100  and to facilitate sealing opening  118  with flap  116 . 
     First leg and second leg may be sealed or unsealed at their respective ends  128  and  130 . The ends may be sealed during manufacturing, or sealed by healthcare personnel before or after endoscope  10  is inserted into package  100 . Healthcare personnel may find it easier to place endoscope  10  into package  100  if ends  128  and  130  are not sealed by the manufacturer. Irrespective of whether ends  128  and  130  are unsealed or sealed by the manufacturer, opening  118  should always be sealed using flap  116  by healthcare personnel after endoscope  10  is placed fully into package  100 . When ends  128  and  130  are sealed by the manufacturer, package  100  has opening  118  is the only opening in package  100 . Package  100  should comprise a vapor permeable material. Suitable materials include, e.g., flashspun high-density polyethylene fibers, including DuPont™ Tyvek®, and non-woven polypropylene fabric, including KIMBERLY-CLARK* KIMGUARD* Sterilization Wrap. Ideally, Package  100  should minimize use of vapor-impermeable materials, including the impermeable polymer materials that are often included in, e.g., breathable sterilization tear pouches, e.g., Qosina P/N 91200. Such materials include, e.g., polyesters and low-density polyethylene films. 
     By maximizing the amount of vapor permeable material and minimizing the amount of vapor impermeable material of which package  100  is comprised, package  100  enables sterilant to reach an endoscope&#39;s surfaces by helping to remove mated surfaces. In some embodiments, package  100  is comprised entirely of vapor permeable material or materials. In some embodiments, package  100  is comprised of at least 95% vapor permeable material by weight and/or volume. Vapor impermeable materials may be included in small quantities to assist with sealing package  100  or to view endoscope  10  within package  100  when sealed. However, vapor impermeable materials should be minimized, particularly near to polyurethane portions of the endoscope, to avoid introduction of mated surfaces between the endoscope and impermeable portions of the package. As shown in  FIG. 3 , endoscope  10  may be disposed within package  100 , flap  116  may seal opening  118 , and the combination of endoscope  10  and package  100  may be placed into a coiled configuration. In the coiled configuration, endoscope  10  may fit within a vacuum chamber of a sterilization system. So coiled, two layers of package  100  are disposed any portions of endoscope  10  that would otherwise contact to form a mated surface. Thus, no portion of endoscope  10  contacts any other portions the endoscope, few or no portions of endoscope  10  touch a vapor impermeable portion of sterilization package  10 , and no portion of endoscope  10  will touch a sterilization tray or a wall of a vacuum chamber. Two layers of package  100  provides sufficient separation about endoscope  10  to allow a sterilant to reach those surfaces that would otherwise be mated with vapor impermeable or vapor absorptive surfaces. 
     The inventor has discovered an additional benefit of using package  100 , i.e., that use of package  100  results in improved removal of residual moisture upon or within the endoscope, that might otherwise inhibit sterilization of the endoscope. Typically, instruments to be sterilized are placed into a sterilization tray, which is then wrapped with a sterilization wrap. The tray and the wrap are of substantial mass that they inhibit conduction of energy from walls or shelving of the vacuum chamber to the endoscope. Accordingly, this energy cannot assist vaporization of residual moisture. Package  100  removes the need to use a wrapped sterilization tray, it is lightweight, and a poor insulator. For those reasons, endoscope  10  may be sterilized in package  100  but not in a sterilization tray such that endoscope  10  within package  100  may be placed into a vacuum chamber of a sterilization system without a sterilization tray. This may enable greater conduction of energy to the endoscope and improved removal of residual moisture. 
     In light of the foregoing, package  100  may be used according to the following exemplary steps. First, package  100  and endoscope  10  are provided. Second, first tube  12  is positioned inserted through opening  118  and into first leg  112 . Third, second tube  14  is inserted through opening  118  and into second leg  114 . Fourth, body  16  is disposed through opening  118  and into portion  126 . Fifth, opening  118  is sealed by adhering flap  116  over it. In those instances where ends  128  and  130  of first leg and second leg are unsealed, healthcare personnel may seal them. Sixth, endoscope  10  along with package  100  are together coiled. Seventh, endoscope  10  along with package  100  are placed, in a coiled configuration, into a vacuum chamber of a sterilization system. This step may be performed with endoscope  10  in a sterilization tray. Alternatively, this step may be performed without a sterilization tray. That is, endoscope  10  in package  100  may be placed directly into the vacuum chamber without using a sterilization tray. 
     It should be understood that any of the examples and/or embodiments described herein may include various other features in addition to or in lieu of those described above. The teachings, expressions, embodiments, examples, etc. described herein should not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined should be readily apparent to those of ordinary skill in the art in view of the teachings herein. 
     Having shown and described exemplary embodiments of the subject matter contained herein, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications without departing from the scope of the claims. Some such modifications should be apparent to those skilled in the art. For instance, the examples, embodiments, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative. Accordingly, the claims should not be limited to the specific details of structure and operation set forth in the written description and drawings.