Patent Application
20180318032
The present disclosure relates to cases, in particular to carrying cases for storing and transporting sterile objects.
Bags with partitions are often used by medical device sales representatives, such as orthopedic device sales representatives, to carry, maintain inventory, and deliver boxed and sterile packages, implants or devices for use at the point of care during surgery. These bags are typically soft bags made of fabric material with dividers made of plastic supported by foam.
These bags are sometimes moved into operating rooms, creating a risk of contamination of the bags' contents as well as the environment due to the nature of the fabric material and polymers used in their manufacture. In addition, these materials may not be able to be cleaned effectively and the materials themselves may not be safe for use in the operating room.
Therefore, often times, the carrying bags of the prior art are prohibited from entering into a sterile environment such as a hospital operating room. Instead, the contents therein are handled separately from the bag and independently transported into the sterile environment. Such a process is not only time-consuming but also requires additional work to track the contents.
In addition, the task at hand within the sterile environment is delayed when a need arises for a part that is not present in the sterile environment. For example, a surgeon may need a part of a different size during surgery. If that particular part is not already in the operating room, one must leave the operating room, locate the part, ensure that the part meets the sterilization requirements and transport the part into the operating room.
Therefore, a need exists for a case capable of transporting sterile objects, including transporting entire cases or trays of the sterile objects into a sterile environment, while minimizing the risk of contamination of the sterile environment.
The following presents a simplified summary of some embodiments of the invention in order to provide a basic understanding of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in a simplified form as a prelude to the more detailed description that is presented later.
The case of the present invention solves the problems of the prior art and provides additional advantages.
The case of the present invention comprises: (i) an outer container, having at least one lid and at least one base; (ii) a optional tamper-proof seal coupled to said lid; (iii) a removable inner tray made of thermoplastic polymer; and (iv) a handle coupled to said inner tray. The tray in the present invention is made from wipeable foam dividers wrapped in a foam tub which drastically improves cleanability/wipeability. The wipeable foam dividers may be composed of polypropylene foam, either with or without a foam wrap.
In one embodiment, the outer container is constructed of a polymeric material capable of being wiped and/or sanitized. Thus, the outer container is sanitized and transported in its entirety into a sterile environment. Therefore, a user is provided with a greater selection of items since the user could have access to the entire contents of the case.
The present invention also provides a method for preparing the case comprising the steps of: (i) cleaning the tray and the inside of the outer container; (ii) placing the tray in the container; (iii) placing objects in the tray; (iv) securing the lid to the outer container; and (v) applying a tamper-proof seal.
The present invention also provides a method for using the case comprising the steps of: (i) removing an optional tamper-proof seal; (ii) opening the lid; (iii) removing the tray; and (iv) transporting the tray to the final destination. The method of the present invention includes taking the case into the operating room (OR) environment, with the case containing the tray with the dividers and the implants into the OR after cleaning the case and its contents.
The material and design of the case with the removable tray make it lightweight, enable easy and effective cleaning, and minimize the risk of contamination. In an operating room environment, where speed and cleanliness are crucial, this provides faster access to required medical equipment while minimizing the risk to patients. The case would also be valuable in research and forensic laboratory environments where contamination is a major concern.
In one embodiment, the present invention is a carrying case comprising: an outer container having an outer lid; a first tamper-proof seal coupled to the outer lid; a removable inner tray having a compartment for holding an object; and an inner handle coupled to the inner tray. The outer container is composed of a material selected from a polymeric material, fabric coated with a polymeric material, metal, and/or a composite material. The polymeric material is selected from silicone, plastic, and vinyl. The metal includes aluminum and stainless steel. The outer container may have a waterproof wipeable interior surface. The carrying case optionally includes an outer handle coupled to an outer surface of the outer container. The carrying case optionally includes a carrying strap coupled to an outer surface of the outer container. The carrying case optionally includes a roller coupled to an outer surface of the outer container. The optional tamper-proof seal is selected from an adhesive tape and an airtight zipper. The removable inner tray includes: a bottom surface; and a plurality of side walls coupled to the bottom surface. The carrying case optionally includes a divider forming a plurality of compartments for respectively storing a plurality of objects. Each compartment includes an inner lid coupled to a second tamper-proof seal. The removable inner tray is composed of material selected from a polypropylene foam, a thermoplastic polymer, a metal, or silicone.
In another embodiment, the present invention is a method comprising: providing a case with an outer container, a tray, an outer lid, and an optional first tamper-proof seal; cleaning the tray and inside of the outer container; placing the tray in the outer container; placing an object in the tray; securing the outer lid to the outer container; and may include applying the first tamper-proof seal to the lid. The method optionally includes forming a plurality of compartments for respectively storing a plurality of objects using a divider, providing an inner lid for each compartment, and sealing the inner lid with an optional second tamper-proof seal.
In an alternative embodiment, the present invention is method comprising: providing a case with an outer container, a tray, an outer lid, and a first tamper-proof seal, wherein the tray holds an object; removing the first tamper-proof seal from the outer lid; opening the outer lid; removing the tray with the object; and transporting the tray with the object to a destination. The method optionally includes forming a plurality of compartments for respectively storing a plurality of objects using a divider; and removing a selected object from a respective compartment, as well as providing an inner lid for each compartment; and unsealing a selected inner lid with a second tamper-proof seal to remove the selected object.
The foregoing summary, as well as the following detailed description of presently preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.
In the drawings:
To facilitate an understanding of the invention, identical reference numerals have been used, when appropriate, to designate the same or similar elements that are common to the figures. Further, unless stated otherwise, the features shown in the figures are not drawn to scale, but are shown for illustrative purposes only.
Certain terminology is used in the following description for convenience only and is not limiting. The article “a” is intended to include one or more items, and where only one item is intended the term “one” or similar language is used. Additionally, to assist in the description of the present invention, words such as top, bottom, side, upper, lower, front, rear, inner, outer, right and left are used to describe the accompanying figures. The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import.
Referring to
In the exemplar embodiment, the outer container 102 is made of a polymeric material such as silicone or plastic, with a waterproof interior surface that can be cleaned. The polymeric material enables the container 102 to be lightweight, comfortable to carry, easy to clean, and allows for a lid 104 without a separate hinge component. In other embodiments, the outer container 102 is made of metal or metal alloy such as stainless steel, or a composite material.
In the exemplar embodiment, an outer handle 106 is coupled to the outer container 102 as well as a carrying strap 108 to facilitate transport. Optionally, rollers could be operably coupled to the outer container 102 on an outer surface thereof to further assist a user for transport.
The optional tamper-proof seal (not shown) can be used to secure the lid 104 of the outer container 102 in a closed position (not shown) and would provide a visual indication of whether the lid 104 has been opened. The tamper-proof seal may be an adhesive tape that must be removed or severed to open the lid 104. This ensures that the contents of the container 102 are not exposed to the outside environment prior to its intended use.
Alternatively, the optional tamper-proof seal could be an airtight zipper having means for securing the zipper closed. For example, the zipper could include one or more pull tabs having holes so that a lock, e.g., combination lock, key lock or zip tie, could be secured to holes of adjacent pull tabs or between one pull tab and another engagement on the outer portion of the outer container 102.
Referring to
Referring to
In another embodiment, each compartment comprises a lid coupled to a tamper-proof seal. This enables individual objects to be removed from the compartments without the risk of contaminating the other objects.
Alternatively, the case 1 could be provided with multiple inner trays. For example, the case 1 could include inner trays stacked on top of each other to accommodate for quantity or size of the content within the case 1. As a further alternative, the case 1 could be provided with multiple compartments, with each compartment having its own inner tray. For example, an upper compartment could be separated from a lower compartment with an intermediate floor between the compartments while each compartment is accessed by a separate tamper-proof seal.
In the exemplar embodiment, the removable inner tray 202 is made of polypropylene foam. The material is lightweight, safe for operating room use, easily cleaned, and does not have any stray fibers that can enter the sterile field. In other embodiments, the removable inner tray 202 is made of silicone, a thermoplastic polymer, or metal.
Referring to the method for preparing the case, the method comprises the steps of: (i) cleaning the tray and the inside of the outer container; (ii) placing the tray in the container; (iii) placing objects in the tray; (iv) closing the lid; and (v) optionally applying a tamper-proof seal.
In the exemplar embodiment, the inside of the outer container 102 and the removable inner tray 202 are cleaned by hand or machine and the tray 202 is placed in the container 102. Sterile objects, such as medical implants, are placed in the tray 202. The lid 104 of the container 102 is closed and a tamper-proof seal is applied to hold the lid 104 closed. The container 102 can then be transported or stored to maintain inventory.
Referring to the method for using the case 1, the method comprises the steps of: (i) removing the tamper-proof seal; (ii) opening the lid 104; (iii) removing the tray 202; and (iv) transporting the tray 202 to the final destination.
At the point of use, the optional tamper-proof seal if used is broken, the lid 104 of the outer container 102 is opened, the removable inner tray 202 is removed, and the tray 202 is transported to the final destination, such as an operating room. This ensures that only the tray 202 and its contents are transported and not the container 102, which had been exposed to the outside environment and possibly contaminated.
In another embodiment, the outer container 102 is made of material that can be easily and effectively cleaned. The outer container 102 is cleaned prior to transport into a sterile environment. Thus, the entire case 1 and its contents therein are available in the sterile environment.
The case 1 is cleaned and sanitized by methods known in the art. These methods include the methods specified in the Guideline for Disinfection and Sterilization in Healthcare Facilities published by the Center for Disease Control of the U.S. Department of Health and Human Services, which is incorporated herein by reference.
In an alternative embodiment, shown in
At least one tray 310, 312 is provided which is shaped and dimensioned to fit inside the outer container 302. Each tray 310, 312 may optionally include at least one handle 314, 316, respectively, for manipulating and inserting or removing the trays 310, 312 into or out of the outer container 302. Each tray 310, 312 may be a corrugated box composed of plastic or other materials. Furthermore, at least one insert 318, 320 is provided which is shaped and dimensioned to fit inside a tray 310, 312, respectively. Each insert 318, 320 may be composed of polyethylene (PE) foam or other known materials, and each insert 318, 320 may include at least one compartment 322-330, respectively, which are shaped and dimensioned for receiving sterilized objects.
In addition, each of the compartments 322-330 may be shaped and dimensioned to receive dividers 332-348, respectively, which may be composed of polypropylene (PP) foam or other known materials, for further subdividing respective compartments 322-330 laterally and/or longitudinally into subcompartments for individually receiving sterilized objects.
As such, the case of the present invention provides a solution for transporting sterile objects, including transporting entire cases or trays of the sterile objects into a sterile environment, while minimizing the risk of contamination of a sterile environment. The case of the present invention could be used in a variety of applications, including, but not limited to, hospitals, research centers and forensic laboratories.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention will be, therefore, indicated by claims rather than by the foregoing description. All changes, which come within the meaning and range of equivalency of the claims, are to be embraced within their scope.
This application claims priority to U.S. Provisional Application No. 62/500,606, filed on May 3, 2017, which is incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62500606 | May 2017 | US |
