Patent ID: 12220264

The foregoing and other features of the present disclosure will become apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are, therefore, not to be considered limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings.

DETAILED DESCRIPTION OF THE INVENTION

While various embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed.

As used herein, and unless otherwise specified, the term “about” or “approximately” means an acceptable error for a particular value as determined by one of ordinary skill in the art, which depends in part on how the value is measured or determined. In certain embodiments, the term “about” or “approximately” means within 1, 2, 3, or 4 standard deviations. In certain embodiments, the term “about” or “approximately” means within 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05% of a given value or range. In certain embodiments, the term “about” or “approximately” means within 40.0 mm, 30.0 mm, 20.0 mm, 10.0 mm 5.0 mm 1.0 mm, 0.9 mm, 0.8 mm, 0.7 mm, 0.6 mm, 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm or 0.1 mm of a given value or range. In certain embodiments, the term “about” or “approximately” means within 5.0 kg, 2.5 kg, 1.0 kg, 0.9 kg, 0.8 kg, 0.7 kg, 0.6 kg, 0.5 kg, 0.4 kg, 0.3 kg, 0.2 kg or 0.1 kg of a given value or range, including increments therein. In certain embodiments, the term “about” or “approximately” means within 1 hour, within 45 minutes, within 30 minutes, within 25 minutes, within 20 minutes, within 15 minutes, within 10 minutes, within 5 minutes, within 4 minutes, within 3 minutes within 2 minutes, or within 1 minute. In certain embodiments, the term “about” or “approximately” means within 20.0 degrees, 15.0 degrees, 10.0 degrees, 9.0 degrees, 8.0 degrees, 7.0 degrees, 6.0 degrees, 5.0 degrees, 4.0 degrees, 3.0 degrees, 2.0 degrees, 1.0 degrees, 0.9 degrees, 0.8 degrees, 0.7 degrees, 0.6 degrees, 0.5 degrees, 0.4 degrees, 0.3 degrees, 0.2 degrees, 0.1 degrees, 0.09 degrees. 0.08 degrees, 0.07 degrees, 0.06 degrees, 0.05 degrees, 0.04 degrees, 0.03 degrees, 0.02 degrees or 0.01 degrees of a given value or range, including increments therein.

As used herein, and unless otherwise specified, the term “plurality”, and like terms, refers to a number (of things) comprising at least one (thing), or greater than one (thing), as in “two or more” (things), “three or more” (things), “four or more” (things), etc.

As used herein, the terms “connected”, “operationally connected”, “coupled”, “operationally coupled”, “operationally linked”, “operably connected”, “operably coupled”, “operably linked,” and like terms, refer to a relationship (mechanical, linkage, coupling, etc.) between elements whereby operation of one element results in a corresponding, following, or simultaneous operation or actuation of a second element. It is noted that in using said terms to describe inventive embodiments, specific structures or mechanisms that link or couple the elements are typically described. However, unless otherwise specifically stated, when one of said terms is used, the term indicates that the actual linkage or coupling may take a variety of forms, which in certain instances will be readily apparent to a person of ordinary skill in the relevant technology.

As used herein, the terms “comprises”. “comprising”, or any other variation thereof, are intended to cover a nonexclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

As used herein, whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

As used herein, whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

As used herein, the terms “user”, “end user” or “end-user” are interchangeably used. As used herein, and unless otherwise specified, these terms refer to a person or customer who ultimately uses or is intended to ultimately use a product. End users may or may not be “customers” in the usual sense-they are commonly employees of the customer. For example, if a large retail corporation buys a software package for its employees to use, even though the large retail corporation was the “customer” which purchased the software, the end users are the employees of the company, who will use the software at work. In an alternate example, hospitals which purchase power tools and medical devices for its employees (doctors and nurses) to use, even though the hospital was the “customer” which purchased the power tools and medical devices, the end users are the employees of the hospital, who will use the power tools and medical devices in surgery.

As used herein, the terms “subject” or “patient” are used interchangeably. As used herein, the terms “subject” and “subjects” refers to an animal (e.g., birds, reptiles, and mammals), preferably a mammal including a primate (e.g., a monkey, chimpanzee, and a human) (and a non-primate (e.g., a camel, donkey, zebra, cow, pig, horse, cat, dog, rat, and mouse). In some embodiments, the mammal is 0 to 6 months old, 6 to 12 months old, 1 to 5 years old, 5 to 10 years old, 10 to 15 years old, 15 to 20 years old, 20 to 25 years old, 25 to 30 years old, 30 to 35 years old. 35 to 40 years old. 40 to 45 years old, 45 to 50 years old, 50 to 55 years old, 55 to 60 years old, 60 to 65 years old, 65 to 70 years old, 70 to 75 years old, 75 to 80 years old, 80 to 85 years old, 85 to 90 years old. 90 to 95 years old, 95 to 100 years old or over 100 years old. In a preferred embodiment, the subject or patient is a human. In certain embodiments, the human is 0 to 6 months old, 6 to 12 months (1 year) old, 1 to 10 years old, 10 to 20 years old, 20 to 30 years old, 30 to 40 years old. 40 to 50 years old. 50 to 60 years old, 60 to 70 years old, 70 to 80 years old, 80 to 90 years old, or 90 to 100 years old, 100 to 110 years old, etc., etc. The upper limit of the natural lifespan or maximum lifespan of a human is generally accepted to be about 125 years but is not intended herein to be an upper limit of the age of a patient.

As used herein, and unless otherwise specified, the term “anterior” refers to human anatomy and means the front surface of the body; often used to indicate the position of one structure relative to another, that is, situated nearer the front part of the body. Alternately, it may also refer in a similar fashion to an apparatus or structure.

As used herein, and unless otherwise specified, the term “posterior” refers to human anatomy and means the back surface of the body; Often used to indicate the position of one structure relative to another, that is, nearer the back of the body. Alternately, it may also refer in a similar fashion to an apparatus or structure.

As used herein, and unless otherwise specified, the term “superior” refers to human anatomy and means situated nearer the vertex of the head in relation to a specific reference point; opposite of inferior. It may also mean situated above or directed upward. Alternately, it may also refer in a similar fashion to an apparatus or structure.

As used herein, and unless otherwise specified, the term “inferior” refers to human anatomy and means situated nearer the soles of the feet in relation to a specific reference point; opposite of superior. It may also mean situated below or directed downward. Alternately, it may also refer in a similar fashion to an apparatus or structure.

As used herein, and unless otherwise specified, the term “medial” refers to human anatomy and means situated toward the median plane or midline of the body. Alternately, it may also refer in a similar fashion to an apparatus or structure.

As used herein, and unless otherwise specified, the term “lateral” refers to human anatomy and means denoting a position farther from the median plane or midline of the body or a structure. It may also mean “pertaining to a side”. Alternately, it may also refer in a similar fashion to an apparatus or structure.

As used herein, the term “proximity” means nearness in space or relationship, but not excluding the potential to be touching. Proximity is also alternatively meant to mean that one thing may be so close to another thing as to be “in direct or nearly direct contact” (in proximity) with another thing along some point. To “place something in proximity” is also meant to mean that items are “paired” or “mated together” either in their paired function or at some point of contact.

As used herein, and unless otherwise specified, the term “translucent” means allowing some, but not all, light to pass through a thing. Being of a nature that allows for the partial transmission of light bat causing sufficient diffusion to prevent perception of distinct images therethrough. Alternatively, translucent may also mean allowing light to pass through only partially or diffusely; being semi-transparent. In some embodiments, it may be advantageous to modify the meaning of transparent wherein an alternative meaning may include translucent or shaded to mean that the clarity remains only slightly altered or dulled, but the “brightness”, “tone”, “luminance”, “luminosity”, and or “lightness” may be altered, allowing filtered light to pass through such as for example may occur with packaging.

As used herein, and unless otherwise specified, the term “vertical”, “vertically oriented” and similar terms mean; generally perpendicular to, at, or near, right angles to a horizontal plane; in a direction or having an alignment such that the top of a thing is above the bottom. In certain embodiments, the term “vertically oriented” means within ±20.0 degrees, ±15.0 degrees, ±10.0 degrees, ±9.0 degrees, ±8.0 degrees, ±7.0 degrees, ±6.0 degrees, ±5.0 degrees, ±4.0 degrees, ±3.0 degrees, ±2.0 degrees, ±1.0 degrees, ±0.9 degrees, ±0.8 degrees, ±0.7 degrees, ±0.6 degrees, ±0.5 degrees, ±0.4 degrees, ±0.3 degrees, ±0.2 degrees or ±0.1 degrees of a given value or range, including increments therein.

As used herein, and unless otherwise specified, the term “horizontally oriented” and similar terms mean; generally perpendicular to, at, or near, right angles to a vertical plane; in a direction, or having an alignment such that the top of a thing is generally on, or near the same plane as the bottom, both being parallel or near parallel to the horizon. In certain embodiments, the term “horizontally oriented” means within ±20.0 degrees, ±15.0 degrees, ±10.0 degrees, ±9.0 degrees, ±8.0 degrees, ±7.0 degrees, ±6.0 degrees, ±5.0 degrees, ±4.0 degrees, ±3.0 degrees, ±2.0 degrees, ±1.0 degrees, ±0.9 degrees, ±0.8 degrees, ±0.7 degrees, ±0.6 degrees, ±0.5 degrees, ±0.4 degrees, ±0.3 degrees, ±0.2 degrees or ±0.1 degrees of a given value or range, including increments therein.

As used herein, and unless otherwise specified, the term “substantially perpendicular” and similar terms mean generally at or near 90 degrees to a given line, or surface or to the ground. In certain embodiments, the term “substantially perpendicular” means within ±20.0 degrees, ±15.0 degrees, ±10.0 degrees, ±9.0 degrees, ±8.0 degrees, ±7.0 degrees, ±6.0 degrees, ±5.0 degrees, ±4.0 degrees, ±3.0 degrees, ±2.0 degrees, ±1.0 degrees, ±0.9 degrees, ±0.8 degrees, ±0.7 degrees, ±0.6 degrees, ±0.5 degrees, ±0.4 degrees, ±0.3 degrees, ±0.2 degrees or ±0.1 degrees of a given value or range, including increments therein.

As used herein, and unless otherwise specified, the term “power tool”, and similar terms refers to any type of battery-powered instrument commonly found in a hospital surgical setting. These may include, but are not limited to saws, drills, reamers, burring tools, cautery instruments, illuminating instruments, surgical robots and robotic tool accessories. This is not intended to be an exhaustive list, but merely an illustrative listing for the potential applications of this device and methods.

As used herein, and unless otherwise specified, combinations such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, C, or any combination thereof” include any combination of A, B, and/or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as “at least one of A, B, or C,” “one or more of A, B, or C,” “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, C, or any combination thereof” may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, where any such combinations may contain one or more member or members of A, B, or C.

As used herein, and unless otherwise specified, the terms “battery cover”, “battery door”, “battery housing cover”, “battery compartment cover” or “battery cover (door)” and like terms refer to the same item and have the same meaning. The battery cover is a moveable feature, usually hinged, that functions to enclose the battery within the sterile battery housing compartment of the device.

As used herein, and unless otherwise specified, the terms “Controlled Sterile and Non-Sterile Zones” refer to sterile zones within the packaging assembly, and specifically within the tray assembly within the packaging assembly. In particular “Controlled Sterile Zones” are protected sterile zones within the tray assembly that are sterile when removed from the packaging assembly and remain sterile when transferred to the surgical field. “Controlled Non-Sterile Zones” are also protected sterile zones within the tray assembly that are sterile when removed from the packaging assembly but become non-sterile after insertion of a non-sterile battery into the product while it is still in the tray assembly. For example, the interior battery compartment is a “controlled non-sterile zone”, wherein it is initially sterile within the tray assembly, but becomes non-sterile after a sterility barrier shield is retracted and a non-sterile battery is inserted into the interior battery compartment. The entire tool remains sterile, however, since the sterile exterior battery cover which is in the “controlled sterile zone”, is subsequently closed over the interior battery compartment and non-sterile battery, thus maintaining overall sterility of the (exterior) tool.

A medical device packaging tray assembly100is illustrated inFIG.1, as it would appear following removal from an outer sterile shield “bag”130, (not shown) and includes sterile zones101and non-sterile zones102integrated within the assembly. A sterile battery powered medical instrument device200is securely positioned within the proximal sterile zones101, the instrument200comprising a device body and handle201, a proximal battery housing202and battery housing cover (door)203in an opened position.

FIG.2illustrates the inferior side of the medical device packaging assembly100, positioned in a vertically oriented position, as it would be held by a sterile user in a sterile surgical field, prior to inserting a non-sterile battery209. In the vertical orientation as shown, a releasable sterility barrier shield104with a cautionary label119is visible to a non-sterile observer, who would presumably be delivering the non-sterile battery209to the device, for insertion into the exposed internal battery compartment207of the battery housing202, which is exposed via an opening123in the inferior side of the packaging tray assembly100, which constitutes a non-sterile zone102once the tray assembly and instrument are removed from the outer sterile shield “bag”130, (not shown).

Further, as seen inFIG.2, the releasable sterility barrier shield104comprises a pull tab112on one end and a plurality of optional retaining features120, which are captured in an equal number of retaining captures121on the inferior surface122of the tray assembly.

Alternately, as seen inFIGS.7A,7B &8, the releasable sterility barrier shield104may comprise a pull tab112on one end and a plurality of optional retaining features120, which are captured in an equal number of retaining captures121on the inferior surface122of the tray assembly.

Further, as seen inFIG.2, a non-sterile battery209is illustrated as it would be oriented for delivery into the exposed internal battery compartment207of the battery housing202, exposed via the non-sterile zone102opening123in the inferior side of the packaging tray assembly100. A sterile end-user would present the vertically oriented device in the packaging tray while a presumably non-sterile support person would proceed to properly orient and insert the non-sterile battery209into the exposed internal battery compartment207of the battery housing202until the battery contacts208and battery latching mechanism212are engaged to secure the battery in the battery housing.

FIG.3illustrates the inferior side of the medical device packaging assembly100, positioned in a vertical orientation, as it would be held by a sterile user in a sterile surgical field, following insertion of a non-sterile battery209, and removal or release of the releasable sterility barrier shield104with a cautionary label119. It should be noted at this point that no sterility compromise of the exterior surfaces of the medical device could occur at this point since only the internal compartment207of the battery housing has been exposed to the non-sterile battery209while the remainder of the entire device has been behind the sterility barrier shield104and within the sterile zone101of the medical device packaging assembly100. Also shown in this figure are the interior of the battery housing cover210and the battery housing compression pads211, used to secure the battery snugly within the battery housing and dampen any potential vibration that may occur between the battery and the housing when the device is running

FIG. [4]4A illustrates a key component of the device and method, wherein the vertical orientation positioning of the medical device, as it would be held by a sterile person when next removing the battery laden device200from the packaging tray assembly100. As illustrated herein, a sterile end-user would proceed to remove the battery laden device200from the packaging tray by, releasing the capture feature118(shown inFIGS.6A &6B) and the battery housing male locking latch204retaining the battery housing cover203and the device200within the superior and inferior slide captures114/116within the sterile zone101and sliding the device vertically upward (proximally) toward the inferior tray opening124and back toward the end-user, out of the tray, leading with the open battery housing cover (door)203. Capture features, as described herein may comprise various forms of snaps and snap retainers, magnets, tape, releasable adhesive (glue), or serrated material (tear away) strips. In the preferred embodiment, snap features interfacing between the releasable components of the tray are used.

Once free of the packaging tray, the sterile end-user can easily push the exterior cover surface (203a) of the battery housing cover (door)203, to pivot the cover about the battery housing hinge206and engage the battery hosing locking latch204on the cover with the battery housing latch receiver205in the external battery housing202.

FIG.5illustrates an embodiment of a typical medical device assembly200as illustrated inFIG.1, as it would appear following insertion of a non-sterile battery, closure of the battery housing cover and removal from the packaging tray assembly. A sterile battery powered medical instrument device200is at this point fully prepped and ready for use.

FIG.6Aillustrates an embodiment of a translucent or clear packaging tray assembly100, in a top ISO view, without a device. As illustrated herein, the proximal, sterile zones101, comprise capture features,114/116,118for securely retaining the medical device proximal to the inferior non-sterile zone102, beneath the device. Further, as shown inFIG.6B, in an opposite side, top IOS view, the representative battery powered tool is nested within the superior and inferior slide captures114/116, and the battery housing male locking latch is captured on the capture lip118of the packaging tray, within the sterile zone101, above the sterile barrier shield104.

As noted above,FIGS.7A &7Billustrate at least one possible alternative configuration of the releasable sterility barrier shield104which may comprises a pull tab112on one end, a plurality of optional retaining features120, which are captured in an equal number of retaining captures121on the inferior surface122of the tray assembly100and a releasable sterility barrier shield hinge feature108, configured for attachment to one end of the inferior surface122of the tray assembly, opposite the pull tab112. Further, as seen in these figures, pull tab feature112is configured to be positioned and grasped within a clearance feature, such as110, in the tray assembly100. Alternatively, the sterility barrier shield hinge feature108may also comprise a tape-like hinge versus a flexible plastic hinge. This feature, would potentially prevent the releasable sterility barrier shield104from accidentally dropping into the sterile field when it is released and contaminating the field.

FIG.8is an illustrative view ofFIG.7Awith a device, nested in the packaging tray with a hinged sterile barrier shield, following insertion of the battery, before removal of the tool in an upward and backward fashion relative to the tray, maintaining the battery housing cover203in the sterile zone, behind the sterile shield104, prior to closure of the battery housing cover.

FIG.9illustrates a typical entire sterile battery powered medical device packaging system150with the tool200, the packaging tray assembly100and an illustrative sterile shield outer transport “bag”130. One of skill in the art would recognize that such sterile shield outer transport containers can frequently comprise one or more boxes, one or more plastic bags, or a combination of both, as deemed necessary by the manufacturer to guarantee sterile shipping and delivery to the end-user.

In some embodiments of the medical device packaging system, the tray assembly is configured from injection molded materials. In some embodiments, the exterior outer shield or transport packaging may be configured from injection molded materials.

In some embodiments of the medical device packaging system the tray assembly is configured from vacuum formed materials. In some embodiments, the exterior outer shield or transport packaging may be configured from vacuum formed materials.

In some embodiments, the exterior outer shield or transport packaging may be configured from polyethylene or similar plastic packaging materials.

In some embodiments of the medical device packaging system the tray assembly is configured from die cut materials.

In some embodiments, the exterior outer shield or transport packaging may be configured from die cut materials.

Provided herein is a method of sterile transfer of a non-sterile component to a sterile device in a sterile field comprising: providing a medical device packaging system comprising a packaging tray assembly having both sterile and non-sterile zones; providing a sterile medical device releasably secured within a sterile zone of the packaging tray assembly; wherein said medical device comprises a sterile receiver housing and sterile receiver housing cover; providing a non-sterile component configured for assembly to the sterile medical device within the sterile field; inserting said non-sterile component internally into a receiver housing opening of the sterile receiver housing through a non-sterile zone opening in the packaging tray assembly; closing the open receiver housing opening with the sterile receiver housing cover; and removing the sterile tool comprising the internally inserted non-sterile component from the packaging tray assembly in the sterile field.

Provided herein is a method of sterile transfer of a non-sterile component to a sterile device in a sterile field comprising: providing a medical device packaging system comprising a packaging tray assembly having both sterile and non-sterile zones; providing a sterile medical device releasably secured within a sterile zone of the packaging tray assembly; wherein said medical device comprises a sterile receiver housing and sterile receiver housing cover; providing a non-sterile component configured for assembly to the sterile medical device within the sterile field; inserting said non-sterile component internally into a receiver housing opening of the sterile receiver housing through a non-sterile zone opening in the packaging tray assembly; removing the sterile tool comprising the internally inserted non-sterile component from the packaging tray assembly in the sterile field; and closing the open receiver housing opening with the sterile receiver housing cover.

In some embodiments of the method, the non-sterile component is a battery.

In some embodiments of the method, said battery comprises: a disposable battery; a single use battery; a limited use battery; a rechargeable battery; or a recyclable battery.

In some embodiments of the method, the medical device comprises: a reusable power tool; a disposable power tool; a single use power tool or limited use power tool.

In some embodiments of the method, the packaging tray assembly having both sterile and non-sterile zones further comprises providing at least one sterile barrier shield, wherein said barrier shield is: releasable; removeable; hinged; or a combination thereof.

In some embodiments of the method, said sterile barrier shield provides an access port to a non-sterile zone in the packaging tray assembly.

In some embodiments of the method, the packaging tray assembly having both sterile and non-sterile zones further comprises providing at least one sterile barrier shield, wherein said barrier shield is non-releasable; or non-removeable.

In some embodiments of the method, the packaging tray assembly having both sterile and non-sterile zones further comprises providing retaining features within the sterile zone to releasably secure the sterile medical device during the insertion of said non-sterile component internally into the receiver housing opening of the sterile receiver housing.

While various embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.