A. Field of the Invention The present invention relates to sterile cases for handheld electronic devices, devices for introducing a non-sterile handheld electronic device into a sterile case without compromising the sterility of the sterile case, assemblies comprising said sterile cases and devices, and methods of using the same.
B. Description of Related Art
Handheld electronic devices are becoming popular for both personal use and in professional settings. These devices increasingly incorporate sophisticated components, including computers, touchscreens, WiFi, wireless telephones, Bluetooth, cameras, microphones, gyroscopes, accelerometers, global positioning system equipment, and long-lived batteries. These and other components have made make them powerful tools for gathering and communicating information. However, these devices cannot be easily sterilized, which limits their applicability in fields requiring a sterile environment, such as operating rooms, many types of laboratories, and semiconductor manufacturing facilities.
Some have proposed wrapping handheld electronic devices in sterile bags or drapes. However, these bags and drapes are bulky and difficult to use.
For safe use of a non-sterile handheld electronic device in a sterile environment, a sterile case is desirable. Moreover, a mechanism to transfer (and remove) the ns-HED into the sterile case without breaching its sterility is desirable.
A sterile case is disclosed for containing a non-sterile handheld electronic device in a sterile environment without compromising sterility of the sterile environment, said case comprising: (a) a first surface; (b) a second surface adapted to engage with the first surface defining a cavity for receiving and holding the non-sterile handheld electronic device between the first surface and the second surface; and (c) at least one engagement feature adapted to secure the first surface to the second surface, thereby sealing the handheld electronic device in the cavity between the first surface and the second surface.
A transfer apparatus is disclosed for sealing a non-sterile handheld electronic device in a sterile case without compromising the sterility of the sterile case, said device comprising: (a) a cavity for holding the sterile case; (b) an input port sized to accept the handheld electronic device, and positioned such that the handheld electronic device is insertable into a sterile case disposed in the cavity when the handheld electronic device is passed through the input port, the input port optionally having a closed configuration and an open configuration; (c) a release port for removing the sterile case from transfer apparatus, optionally having a closed configuration and an open configuration; and (d) a closing feature.
An arrangement for inserting a handheld electronic device into a sterile case is provided, said arrangement comprising: (a) a transfer apparatus for sealing a non-sterile handheld electronic device in a sterile case without compromising the sterility of the sterile case; and (b) a sterile case in an open configuration, wherein the sterile case is positioned in a cavity of the transfer apparatus such that: (b1) a handheld electronic device is insertable into the case through an input port without a user directly contacting the sterile case; and (b2) a closing feature of transfer apparatus of (a) is capable of interacting with a surface of the sterile case to move the sterile case from the open configuration to a closed configuration.
A method of inserting a non-sterile handheld electronic device into a sterile case, the method comprising: (a) providing a sterile case in an open configuration disposed in a transfer apparatus for sealing a non-sterile handheld electronic device in a sterile case without compromising the sterility of the sterile case, wherein the sterile case: (a1) is positioned in a cavity of the transfer apparatus such that, when the sterile case is in the open configuration, a handheld electronic device is insertable into the sterile case via an input port of the transfer apparatus without a user directly contacting the sterile case and without compromising sterility of the sterile case; and (a2) a surface of the sterile case is located in a position accessible to interaction with a closing feature of transfer apparatus of (a) such that interaction between the closing feature of transfer apparatus and the surface of the sterile case transfers the sterile case from the open configuration to a closed configuration; (b) inserting a handheld electronic device into the sterile case via the input port; (c) activating the closing feature of transfer apparatus, thereby moving the sterile case into the closed configuration; and (d) removing the sterile case from the cavity of transfer apparatus through the release port.
Devices, arrangements, methods, and uses are provided for introducing a non-sterile handheld electronic device (“ns-HED”) into a sterile case so that the ns-HED can be introduced into, and used in, a sterile environment, including for example the sterile environments encountered in an operating room, laboratory, or semiconductor manufacturing facility.
In principle, the following devices, arrangements, methods and uses are compatible with any handheld electronic device, including but not limited to cellular phones (including multifunctional phones, such as the IPHONE®, BLACKBERRY®, and ANDROID® brand phones), pagers, calculators, portable media players (such as the IPOD®), digital cameras, tablet computers, and e-readers. In an preferred aspect, the ns-HED comprises one or more elements selected from the group consisting of: a touchscreen, a digital camera capable of taking still and/or video images, a keypad, a microphone, a speaker, a cellular communication device.
Sterile Case
In an aspect, a sterile case is provided for encasing the ns-HED. Preferably, the sterile case is capable of being in an open configuration, in which the ns-HED is capable of being inserted into the sterile case, and in a closed configuration, in which the ns-HED is sealed in the sterile case such that it is substantially prevented from contaminate a sterile environment into which it is introduced. Moreover, the sterile case protects the ns-HED from any contamination that the sterile case may have seen, so that the ns-HED may be reused. After use, the sterile case could optionally be discarded, or could be re-sterilized and reused.
In an aspect, the sterile case comprises:
In an aspect, a first edge of the first surface may be joined to a first edge of the second surface in a manner that permits the first and/or second surface to rotate around an axis or rotation. Rotation of the surface can then be used to transfer the sterile case between open and closed configurations. In such an aspect, the first surface and the second surface may be presented as separate pieces joined together, adapted to be joined to one another, or to be reversibly joined to one another. For example, the first edges may be joined by a hinge. Many types of hinges are known in the art, which can be selected by a person of ordinary skill in the art. As another aspect, the first and second surface may be manufactured as a single piece comprising a live hinge separating the first and second surface.
In another aspect, rotating the surface(s) around the axis of rotation transfers the sterile case from an open configuration to a closed configuration. In the open configuration, the cavity for receiving the handheld electronic device is accessible to the ns-HED, such that the ns-HED can be inserted into the sterile case. In the closed configuration, the handheld electronic device is sealed between the first surface and the second surface. In an aspect, the ns-HED is water-tightly sealed in the sterile case when the sterile case is in the closed configuration.
In an aspect, the sterile case comprises at least one engagement feature adapted to secure the first surface to the second surface, thereby sealing the handheld electronic device in the cavity between the first surface and the second surface.
In an aspect, the at least one engagement feature comprises at least a first section disposed at a second edge of the first surface; and at least a second section disposed at the second edge of the second surface. When the sterile case is in the open configuration, the two sections of the engagement feature are not engaged with one another. When the sterile case is in the closed configuration, the two sections are engaged with one another, thereby holding the sterile case in the closed configuration. In one aspect, the engagement feature comprises a separate feature attached to the surfaces. For example, the engagement feature may comprise a hook and loop fastener system (such as VELCRO®), wherein the hook portion is disposed on one surface and the loop system is disposed on the second system; a magnet system, wherein one of the surfaces comprises a magnet and the second surface comprises a material to which the magnet is attracted; a zipper system.
In another aspect, the engagement feature comprises a first mating part on the first surface and the second mating part on the second surface adapted to mate with the first mating part. The first and second mating parts may be integral with the surfaces, or may be attached to the surfaces as separate pieces. For example, the first and second mating parts may define a snap feature.
In a further aspect, at least one surface of the sterile case may comprise an attachment for at least one instrument.
In another aspect, the sterile case may comprise at least one interaction feature that allows a user to interact with the touchscreen as well as any other buttons or ports on the handheld electronic device. For example, thermoforming could be used to vary the wall thickness across the walls to allow touch-based interaction with ns-HED (thin walls) and the surface finish could be varied to keep the display and other access point transparent while making other surfaces translucent or opaque.
Both the sterile case and the transfer apparatus can be made of plastic and may have components made of metal. Each could have several sub-components. In an aspect, the components can be made via plastic injection molding from one or more polymer materials. The polymer materials can include polyurethane materials, poly-olefin materials, polyaryletherketon (PAEK) materials, or a combination thereof. Further, the polyolefin materials can include polypropylene, polyethylene, halogenated polyolefin, fluoropolyolefin, or a combination thereof. The (PAEK) materials can include polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneetherketoneketone (PEKEKK), or a combination thereof. In an aspect, the components can also be made through thermoforming process with medical grade polymeric resins such as copolyesters (PET, PETG, APET), polystyrene (HIPS), polypropylene, polyvinyl chloride (PVC), polycarbonate and other engineering resins, and acrylic multipolymers. However, these can be made through other manufacturing processes as well.
One exemplary embodiment is shown in
One exemplary embodiment is shown in
One exemplary embodiment is shown in
Transfer Apparatus
In an aspect, a transfer apparatus is provided, for inserting and sealing a ns-HED in a sterile case. The transfer apparatus is adapted to hold a sterile case in a configuration such that ns-HED can be inserted into the sterile case without a user or the ns-HED directly touching an outer surface of the sterile case.
In an aspect, the transfer apparatus comprising a cavity for holding the sterile case. The cavity should ideally maintain a sterile environment for the sterile case. In an aspect, the sterile case is inserted into the cavity and the transfer apparatus and the sterile case are sterilized at the same time.
In an aspect, the cavity is accessible via an input port sized to accept the handheld electronic device, and positioned such that the handheld electronic device is insertable into the sterile case without contacting an outer surface of the sterile case. The input port preferably is sealed until use.
In one aspect, the input port consists of a slot in a wall of the transfer apparatus providing direct access to the cavity, through which the ns-HED is inserted. In such an aspect, a user inserts the ns-HED directly through the slot and directly into the sterile case. Optionally, the slot may be sealed with a removable seal made by a sterile material, such as a flashspun high-density polyethylene fibers (such as that sold under the TYVEK® brand), which seal is removed before use. Optionally, the input port may further comprise a door sealing the slot, may be opened before insertion.
In another aspect, the input port comprises a box positioned next to a slot providing direct access to the cavity of the transfer apparatus. The box comprises an opening through which the ns-HED is inserted into the box. The ns-HED is then pushed through the slot and directly into the sterile case. The opening may optionally be sealed with a removable seal made by a sterile material, such as a flashspun high-density polyethylene fibers (such as that sold under the TYVEK® brand), which seal is removed before use. The box may optionally further comprise a door covering the opening, which is opened before insertion.
In an aspect, the transfer apparatus further comprises a release port for removing the sterile case from the transfer apparatus. In an aspect, the release port is an opening in a side of the transfer apparatus. Optionally, the opening may be sealed with a removable seal made by a sterile material, such as a flashspun high-density polyethylene fibers (such as that sold under the TYVEK® brand), which seal may be removed once the ns-HED is sealed in the sterile case. Optionally, the release port may further comprise a door sealing the slot, which is opened once the ns-HED is sealed in the sterile case.
In another aspect, the transfer apparatus comprises a closing feature, which is adapted to close a sterile case inserted into the cavity of the transfer apparatus.
In an aspect, the closing feature comprises a plunger adapted to be advanced into and out of the cavity. Movement of the plunger is preferably adapted to transfer the sterile case from an open configuration to a closed configuration. In an aspect, movement of the plunger applies a force directly to a surface of the sterile case, thereby closing the case. For example, the plunger may be a surface in contact with a surface of the sterile case. When the plunger is moved, it applies a force to the first surface of the sterile case. The force moves the first surface toward the sterile case and causes it to engage with the second surface of the sterile case. For example, sufficient force could be applied such that a snap mechanism or mating features engage, thereby locking the sterile case shut. In another aspect, movement of the plunger releases a force holding the first and second surfaces of the sterile case apart. For example, a sterile case could be provided comprising a mechanism that forces the first and second surface toward one another (such as a spring loaded mechanism or magnetic attraction) or by arranging the sterile case in the transfer apparatus such that gravity would tend to move the surfaces together. The sterile case could be loaded into the transfer apparatus such that one of the surfaces engages with the plunger to counteract the force (such as by interference fit or using a reversible latch), such that the first and second surfaces are held apart. Movement of the plunger releases the engagement of the surface of the sterile case, and the force moves the surfaces together. As another example, the plunger engages another mechanism, which either forces the surfaces together, or releases a force holding the surfaces apart.
The term “plunger” is not intended to imply any particular shape or material, but in principle can be any solid or substantially solid surface. In an aspect, the plunger is form-fitted to a contour of at least one surface of the sterile case. In an aspect, the plunger is fitted to the surface of the sterile case, so as to hold the sterile case in an open configuration.
In another example, action of the plunger may release a mechanism holding the case open. When the mechanism holding the case open is released, the sterile case is shut by action of one or more springs.
In an aspect, the plunger is attached at an advancing end of a rod adapted to be at least partially advanced into the cavity. In another aspect, advancement of the rod into the cavity optionally moves the input port from the open configuration to the closed configuration, and wherein retraction of the rod from the cavity moves the input port from the closed configuration to the open configuration. For example, a mechanism may be operably connected to a door comprised in the input port. Movement of the rod actuates the mechanism, thereby moving the door from a closed position to an closed position when the rod is moved in, and from an open position to a closed position when the rod is moved out.
In an aspect, the rod is a threaded rod, and the closing feature further comprises a knob operably linked to the threaded rod, wherein rotation of the knob advances or retracts the rod into the cavity of transfer apparatus.
In another aspect, the closing feature comprises an element adapted to transform movement of the ns-HED or a push element into the cavity, into movement of the plunger. Mechanisms for transferring substantially horizontal movement of one body into substantially vertical movement of another body (or vice versa) are well-known in the art.
In another aspect, the closing feature comprises a compliant cover. The compliant cover is preferably placed proximal to a surface of the sterile case. When the case is ready to be closed, a force is applied to the compliant cover, which is then transferred to the surface of the sterile case, thereby closing the case. For example, a user could press on the surface of the sterile case using the compliant cover as a sterile barrier between the user's hand and the sterile case. In another aspect, one or more outer walls of the transfer case is made of the compliant cover. For example, the transfer case is made entirely of the compliant material and having openings at one or both ends. When the sterile case is ready to be loaded, one of the ends is opened, and the ns-HED is inserted through the opening and into the sterile case. The user may then press on any portion of the compliant cover to effect closing of the sterile case.
Arrangements for Inserting the ns-HED into the Sterile Case
Arrangements for inserting a handheld electronic device into a sterile case are also enclosed herein, comprising a transfer apparatus as disclosed herein operably linked to a sterile case as disclosed herein.
In one aspect, said arrangement comprises:
In another aspect, an arrangement is provided in which:
In another aspect, an arrangement is provided, wherein a sterile case is used such that:
In another aspect, an arrangement is provided, wherein the first edge of the first surface is attached to the first edge of the second surface by a hinge, such as, for example, a live hinge.
In another aspect, an arrangement is provided, wherein the engagement feature of the sterile case comprises a first mating part on the first surface and the second mating part on the second surface adapted to mate with the first mating part, wherein the first mating part and second mating part optionally define a snap feature.
In another aspect, an arrangement is provided, wherein the sterile case further comprises a water-tight seal when in the closed configuration.
One exemplary embodiment is shown in
In one embodiment, the first surface (1) and a second surface (2) are attached via a spring-loaded hinge (6). When the knob is moved or rotated, the interference fit is released, and the spring loaded hinge (6) snaps the first surface (1) toward the second surface (2) with sufficient force to cause the snap (3a) to engage with the detent (3b).
In a second embodiment, the rod (21) is threaded, such that when the knob (22) is rotated, the rod (21) moves toward or away from the cavity of the transfer apparatus (17) via a screw mechanism. By rotating the knob (22), the plunger presses against the first surface of the sterile case, causing the surface (1) to rotate around the hinge (6) and move toward the snap (3a) toward the detent (3b). When sufficient force is applied to the first surface (1), the snap (3a) engages with the detent (3b). The rotation of the knob (22) is then reversed, thereby releasing the plunger (20) from the first surface (1).
Another exemplary embodiment is shown in
Based on the design, the method of use could vary. Based on a few designs, the following describes general methods for using the device.
In an aspect, the method comprises:
In another aspect, a method is provided wherein:
In another aspect, a method is provided wherein:
In another aspect, a method is provided wherein:
In another aspect, a method is provided wherein insertion of the handheld electronic device into the sterile case activates the closing feature.
In another aspect, a method is provided wherein:
The plunger may optionally be attached at an advancing end of a rod adapted to be at least partially advanced into the cavity and retracted from the cavity, and wherein activation of the closing feature comprises advancing the rod into the cavity, thereby advancing the plunger into the cavity. Advancement of the rod into the cavity may optionally move the input port from the open configuration to the closed configuration, and retraction of the rod from the cavity may optionally move the input port from the closed configuration to the open configuration. The rod may optionally be a threaded rod, and the closing feature further comprises a knob operably linked to the threaded rod, wherein rotation of the knob advances or retracts the rod into the cavity of transfer apparatus. The plunger optionally holds the surface of the sterile case in the open configuration with an interference fit before activation of the closing feature.
In another aspect, a method is provided, wherein the closing feature comprises a compliant cover, and wherein activation of the closing feature comprises application of pressure to the compliant cover.
In another aspect, a method is provided wherein, in the case water-tightly seals the handheld electronic device into the sterile case when the sterile case is transferred from the open to the closed configuration.
In an aspect, the method comprises:
In another aspect, the input port is a slot and the method comprises:
In another aspect, the input port is a cavity and the method comprises:
In another aspect, the input port is a cavity and the closing of sterile case is combined with the insertion step and the method comprises:
Uses
The devices and arrangements disclosed herein are in principle useful in any sterile environment.
In one aspect, the devices and arrangements disclosed herein may be used in surgical applications in the operating room. A surgeon may want to use the ns-HED for many purposes—as a recording device, as a camera, as a phone, as a computer, as a sensor, as a display device, as an input device etc.
In one aspect, the devices and arrangements disclosed herein may be used by EMT personnel on site to protect patients and the ns-HED from contamination.
In one aspect, the devices and arrangements disclosed herein may be used in battle fields where clean/sterile device may be needed near the injured people.
In one aspect, the devices and arrangements disclosed herein may be used in lab environment or semiconductor industry.
Other uses and embodiments of the described devices, arrangements, and methods will be readily apparent to the person of ordinary skill in the art.
This is a PCT Application, which claims priority to U.S. Provisional Application No. 61/671,073, filed Jul. 12, 2012.
Filing Document | Filing Date | Country | Kind |
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PCT/US2013/050308 | 7/12/2013 | WO | 00 |
Number | Date | Country | |
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61671073 | Jul 2012 | US |