Patent ID: 12257191

DESCRIPTION

Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal-end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal-end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal-end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

Enclosures for Establishing a Sterile Environment

FIG.1illustrates a system100including an enclosure102for establishing a sterile environment in accordance with some embodiments. WhileFIG.1shows a system including the enclosure102for establishing a sterile environment, the enclosure102will be primarily described in this section. Systems for establishing a sterile environment are primarily described in more detail below in the section on such systems.

The enclosure102is configured for establishing a sterile environment over a patient for a medical procedure. The enclosure102can be of any size suitable for the medical procedure.

As shown, the enclosure102includes a barrier formed of an expandable portion104of the barrier and a patient-interfacing portion106of the barrier. The barrier separates the sterile environment inside of the enclosure102from a non-sterile environment outside of the enclosure102. As such, each portion of the expandable portion104and the patient-interfacing portion106of the barrier separates the sterile environment inside of the enclosure102from a non-sterile environment outside of the enclosure102.

The expandable portion104of the barrier is configured to expand from an unexpanded state of the expandable portion104to an expanded state for working within the sterile environment. The expandable portion104can be an inflatable bag of a translucent plastic (e.g., polyethylene, styrene, polycarbonate, etc.) over the patient-interfacing portion106of the barrier or a framed structure including the translucent plastic stretched between frame elements.

With respect to the framed structure, for example, the framed structure can include a pair of framed ends112of the enclosure102configured to support the expandable portion104of the barrier. Each framed end of the pair of framed ends112is configured to lie down on the patient-interfacing portion106of the barrier in the unexpanded state of the barrier. Each framed end of the pair of framed ends112is also configured to extend vertically from the patient-interfacing portion106of the barrier in the expanded state of the barrier. Each framed end of the pair of framed ends can be independently lifted from the patient-interfacing portion106of the barrier in the unexpanded state of the expandable portion104of the barrier to form the expanded state thereof with simultaneous introduction of filtered air commensurate with a rate at which the pair of framed ends are lifted from the patient-interfacing portion106of the barrier. Alternatively, the framed structure is inflated by introduction of the filtered air.

In view of the foregoing, the enclosure102can further include an air inlet114fluidly connected to the inside of the enclosure102. The air inlet114is configured for introducing air (e.g., filtered air) into the inside of the enclosure102for expanding the enclosure102from the unexpanded state of the expandable portion104to the expanded state thereof. For example, the air inlet is configured for equilibrating pressure inside of the enclosure102when expanding the expandable portion104of the framed structure set forth above from the unexpanded state to the expanded state thereof. And, for example, the air inlet is configured for inflating the expandable portion104of the inflatable bag set forth above from the unexpanded state to the expanded state thereof. In addition, the air inlet114is configured for introducing air (e.g., filtered air) into the inside of the enclosure102for maintaining a greater pressure inside of the enclosure102than outside of the enclosure102when needed. The air inlet114can be fluidly connected to a pump for inflating the expandable portion104of the barrier or maintaining the greater pressure inside of the enclosure102than outside of the enclosure102.

It should be understood that whether the expandable portion104of the barrier includes the inflatable bag or the framed structure, the expandable portion104of the barrier can be inflated through the air inlet114. In addition, maintaining a greater pressure inside of the enclosure102than outside of the enclosure102is particularly important in maintaining the structural integrity of the expandable portion104of the barrier when the expandable portion104is the inflatable bag.

To provide filtered air into the inside of the enclosure102, the enclosure can further include an inline HEPA air filter optionally including an antimicrobial coating on a filter medium of the HEPA air filter. The HEPA air filter is configured to prevent microbial contamination of the sterile environment inside of the enclosure102.

The patient-interfacing portion106of the barrier includes a fenestration110configured for placement directly over an area of interest (e.g., surgical area, wound such as an open wound, a previously closed and dressed wound, a burn wound, etc.) of a patient P; however, the patient-interfacing portion106of the barrier is not limited to the fenestration110. Indeed, the patient-interfacing portion106of the barrier can include any number of additional fenestrations to the fenestration110. The fenestration110has a sealed state and an unsealed state for access to the area of interest from within the sterile environment.

The fenestration110includes an outer seal over a patient-interfacing surface (e.g., outer surface) of the patient-interfacing portion106of the barrier in the sealed state of the fenestration110. A perimeter of the patient-interfacing surface around the fenestration110includes an adhesive configured to adhere the patient-interfacing portion106of the barrier to the patient P with the perimeter of the fenestration110around the area of interest subsequent to sterilization thereof. The outer seal of the fenestration110is configured to protect and maintain an integrity of the adhesive prior to use.

The fenestration110also includes an inner seal over an inner surface of the patient-interfacing portion106of the barrier in the sealed state of the fenestration110. The inner seal of the fenestration110is configured to be removed subsequent to adhering the patient-interfacing portion106of the barrier to the patient P. Removing the inner seal subsequent to adhering the patient-interfacing portion106of the barrier to the patient maintains the sterile environment over the patient P by stopping unfiltered air from entering the enclosure102through the fenestration110.

As shown, the enclosure102can further include a support system108coupled to the patient-interfacing portion106of the barrier. When present, the support system108is coupled to the patient-interfacing portion106of the barrier and includes at least a pair of supports flanking the fenestration110. The support system108is configured to support the enclosure102on a surface (e.g., a top of an operating table, a top of a bed, etc.) when placed over an appendage of the patient P or a main body of the patient P such that the supports flank the appendage or main body of the patient P. The patient P can be positioned in any one of a number of anatomical positions (e.g., supine, prone, right lateral recumbent, left lateral recumbent, etc.) on the surface for use with the enclosure102.

The support system108can be immediately ready to be placed over the patient P subsequent to unpackaging the enclosure102or the support system108can be configured to expand from an unexpanded state to an expanded state for use with the patient P. With respect to the former, for example, the supports of support system108can include fiberfill stuffing, thereby making the support system108immediately ready to be placed over the patient subsequent to unpackaging. With respect to the latter, for example, the support system108can be configured to expand from the unexpanded state to the expanded state in concert with the expandable portion104of the barrier. That is, the supports of the support system108can be fluidly connected to the inside of the enclosure102such that when the expandable portion104of the barrier is inflated, the support system108is also inflated. Alternatively, the support system108can be configured to expand from the unexpanded state to the expanded state independent of the expandable portion104of the barrier through one or more inlets exclusive to the support system108. In this way, the supports of the support system108can be expanded from the unexpanded state to the expanded state with a different fluid than the expandable portion104of the barrier. Instead of air, for example, water can be used to expand the support system108from the unexpanded state to the expanded state. Water is advantageous in that it provides more weight to the enclosure102than air and lowers a center of gravity of the enclosure102as well.

The enclosure102can further include one or more pairs of long-sleeved gloves116integrated into the translucent plastic of the expandable portion104of the barrier. The one-or-more pairs of long-sleeved gloves116are configured to be worn by a clinician when performing the medical procedure within the sterile environment of the enclosure102.

The enclosure102can further include one or more closed-ended tubes117integrated into translucent plastic of the expandable portion of the barrier. Instead of being configured with fingertips like the one-or-more long-sleeved gloves, the one-or-more closed-ended tubes117are configured to accept insertion of a probe (e.g., an ultrasound probe) for use during the medical procedure within the sterile environment of the enclosure102.

The enclosure102can further include one or more pockets118integrated into the expandable portion104or the patient-facing portion106of the barrier. When present, the one-or-more pockets118are configured to hold procedural equipment or supplies for the medical procedure. The one-or-more pockets118are also configured to hold the procedural equipment or supplies subsequent to the use thereof during the medical procedure, thereby safely keeping biohazardous waste safely contained in the enclosure102. The one-or-more pockets118can be inside of the enclosure102, outside of the enclosure102, or a combination thereof. Additionally or alternatively, the enclosure102can include loops, clamps, hook-and-loop fasteners, snaps, glue dots, or other fastening devices to hold the procedural equipment or supplies for the medical procedure. The enclosure102can further include one or more rigid trays configured to hold the procedural equipment or supplies for the medical procedure. Such rigid trays can include any of the foregoing fastening devices for holding the procedural equipment, and the enclosure102, in turn, can include any of the foregoing fastening devices for holding the rigid trays.

The enclosure102can further include an introducing means for introducing procedural equipment or supplies into the sterile environment inside of the enclosure102from the non-sterile environment outside of the enclosure.

FIG.2illustrates the system100ofFIG.1including the enclosure102with a barrier-crossing tube120in accordance with some embodiments. While the tube120is shown crossing the barrier of a framed end of the pair of framed ends112of the enclosure102, the tube120can cross any portion of the barrier that separates the sterile environment inside of the enclosure102from a non-sterile environment outside of the enclosure102. The tube120can include a Luer connector122and a cap124configured to maintain a sterility of a lumen of the tube120for introducing supplies into the sterile environment inside of the enclosure102such as a guidewire, saline, a solution including a medicament, or the like.

FIG.3illustrates the system100ofFIG.1including the enclosure102with a door126in accordance with some embodiments. While the door126is shown in the barrier of a framed end of the pair of framed ends112of the enclosure102, the door126can be in any portion of the barrier that separates the sterile environment inside of the enclosure102from a non-sterile environment outside of the enclosure102. The door126can include a knob, hook, or the like on one side or both sides of the door126configured to facilitate opening the door126for introducing the procedural equipment or supplies into the sterile environment inside of the enclosure102and closing the door126thereafter.

FIG.4illustrates the system100ofFIG.1including the enclosure102with a chute128in accordance with some embodiments. While the chute128is shown extending from the barrier of a framed end of the pair of framed ends112of the enclosure102, the chute128can be extend from any portion of the barrier that separates the sterile environment inside of the enclosure102from a non-sterile environment outside of the enclosure102. The chute128can include a fold-top end having one or more flaps130configured to fold over the chute128in a closed state of the chute128. The one-or-more flaps130are configured to open to one or more sides of the chute128for an open state of the chute128for introducing the procedural equipment or supplies into the sterile environment inside of the enclosure102. The one-or-more flaps130can include a sterile side corresponding to an inside of the chute128when in the closed state thereof. Handling the one-or-more flaps130only by a non-sterile side of the one-or-more flaps130opposite the sterile side ensures the procedural equipment or supplies dropped into the chute128do not come into contact with a non-sterile surface such as the non-sterile side of the one-or-more flaps130.

The chute128can be formed from any tube of the one-or-more closed-ended tubes set forth above configured to accept insertion of a probe (e.g., an ultrasound probe) for use during the medical procedure within the sterile environment of the enclosure102. Indeed, such closed-ended tubes can have scores or similar weakened areas that can be broken apart to create the fold-top end having the one-or-more flaps130.

FIG.5illustrates an alternative enclosure502for the system100ofFIG.1in accordance with some embodiments. Like the enclosure102of any ofFIGS.1-4, the enclosure502is configured for establishing a sterile environment over a patient for a medical procedure. The enclosure502is a framed structure like that set forth above for the enclosure102; however, the enclosure502includes a pop-up frame503including the translucent plastic stretched between portions of the pop-up frame503.

The enclosure502is configured with an unexpanded state in which the pop-up frame503is twisted and folded upon itself in one or more revolutions of the pop-up frame503, thereby locking an amount of torsional potential energy into the pop-up frame503in the unexpanded state of the enclosure502. The enclosure502is also configured with an expanded state in which the pop-up frame503is untwisted and unfolded. A transition from the unexpanded state to the expanded state of the enclosure502is effectuated by releasing the torsional potential energy in the pop-up frame503by perturbing an energetic state of the pop-up frame503at a local minimum in the unexpanded state or by unclipping one or more clips that clip together the one-or-more revolutions of the pop-up frame503in the unexpanded state.

While not shown, the enclosure502includes one or more features set forth above for the enclosure102selected from at least the air inlet114, the fenestration110, the one-or-more pairs of long-sleeved gloves116, the one-or-more closed-ended tubes117, the one-or-more pockets118, and the introducing means for introducing procedural equipment or supplies into the sterile environment inside of the enclosure502.

FIG.6illustrates the system ofFIG.1with another alternative enclosure in accordance with some embodiments.

Like the enclosure102of any figure ofFIGS.1-4, the enclosure602is configured for establishing a sterile environment over a patient for a medical procedure. The enclosure602is a framed structure like that set forth above for the enclosure102; however, the enclosure602includes a top frame603including the translucent plastic stretched between portions of the top frame603, as well as translucent plastic hanging from the top frame603. That said, the enclosure602is not limited to the top frame603. Indeed, the enclosure602can further include a bottom frame framing a patient-interfacing portion like that of the enclosure102or even framed ends like the pair of framed ends112of the enclosure102.

The enclosure602is configured with an unexpanded state in which the translucent plastic attached to the top frame603is folded into the enclosure602or bunched up under the top frame603. The enclosure602is also configured with an expanded state in which the translucent plastic attached to the top frame603hangs from the top frame603. A transition from the unexpanded state to the expanded state of the enclosure602is effectuated by hanging the enclosure602on a boom or the like by the top frame603using a cord.

While not shown, the enclosure602includes one or more features set forth above for the enclosure102selected from at least the air inlet114, the fenestration110, the one-or-more pairs of long-sleeved gloves116, the one-or-more closed-ended tubes117, the one-or-more pockets118, and the introducing means for introducing procedural equipment or supplies into the sterile environment inside of the enclosure602.

Systems for Establishing a Sterile Environment

FIG.1illustrates the system100including the enclosure102for establishing a sterile environment in accordance with some embodiments. While the system100set forth below is described with reference to the enclosure102, it should be understood the system100can alternatively include the enclosure502or602.

As shown, the system100includes the enclosure102for placement over the patient P, as well as sterile procedural equipment132or supplies134for the medical procedure in the sterile environment inside of the enclosure102.

The enclosure102is primarily described in the foregoing section.

The procedural equipment132or supplies134for the medical procedure can be selected for any medical procedure of a number of medical procedures such as a medical procedure for placing a central venous catheter (“CVC”), a peripherally inserted central catheter (“PICC”), a medical port, or the like. With respect to the procedural equipment132, the procedural equipment132can include without limitation one or more puncturing devices, one or more guidewires selected from access guidewires, maneuver guidewires, and rail guidewires, one or more catheters (e.g., a CVC, a PICC, etc.), one or more syringes, or a combination thereof. With respect to the supplies134, the supplies134can include without limitation one or more packages of an antiseptic (e.g., iodopovidone), saline, or a medicament, one or more swabs, gauze, or a combination thereof.

The system100can further include packaging such as a bag or pouch, additional supplies such as one or more pairs of gloves or those selected from the supplies134for the medical procedure, instructions for use, manufacturing information, or the like. For example, the enclosure102including the procedural equipment132or supplies134inside the enclosure102can be disposed in the bag or pouch in the unexpanded state of the enclosure102. In addition, the additional supplies such as the one-or-more pairs of gloves, one or more packages of antiseptic, or the like can be disposed in the bag or pouch along with the enclosure102for independently removing the additional supplies to prepare the patient P and the area or interest for the medical procedure before placing the enclosure102and the fenestration110thereof over the area of interest. The bag or pouch can be sterilized with ethylene-oxide gas and sealed with the enclosure102and the additional supplies, thereby forming the system100in accordance with some embodiments. Such a system can be shipped or stored until ready to use.

Advantageously, the system100obviates a need for a clinician performing a medical procedure with the system100to don protective equipment such as a gown or mask or even use one or more drapes to set-up a sterile field. As such, the system100saves time and money, as well decrease the possibility for compromising a sterile field.

Methods

Methods of the system100include methods for establishing a sterile environment over the patient P for a medical procedure.

A method for establishing a sterile environment over the patient P for a medical procedure includes at least a placing step, an expanding step, and a working step in association with the system100as set forth in more detail below.

The placing step includes placing the enclosure102over an appendage of the patient P or the main body of the patient P such that the fenestration110of the patient-interfacing portion106of the barrier is directly over an area of interest of the patient P. When the support system108is coupled to the patient-interfacing portion106of the barrier, the placing step also includes placing the support system108such that the fenestration-flanking supports of the support system108also flank the appendage or main body of the patient P.

The expanding step includes expanding the expandable portion104of the barrier separating the sterile environment inside of the enclosure102from the non-sterile environment outside of the enclosure102from the unexpanded state to the expanded state. The expanding step can be before or after the placing step.

Expanding the expandable portion104of the barrier can include lifting each framed end of the pair of framed ends112of the enclosure102from the patient-interfacing portion106of the barrier in the unexpanded state of the expandable portion104of the barrier to form the expanded state thereof. Simultaneously, filtered air can be introduced into the inside of the enclosure102with the air inlet114fluidly connected to the inside of the enclosure102. Alternatively, such as in embodiments in which the expandable portion104of the barrier is an inflatable bag, but not limited thereto, the expanding step can include merely inflating the expandable portion104of the barrier with the filtered air introduced into the inside of the enclosure102with the air inlet114. During the expanding step, any fenestrations (e.g., the fenestration110) or other openings should remain sealed such that only filtered air is introduced into the inside of the enclosure102.

As set forth above, introducing the filtered air into the inside of the enclosure102with the air inlet114can also introduce the filtered air into the support system108when the supports of the support system108are fluidly connected to the inside of the enclosure102. In such embodiments, introducing the filtered air into the support system108expands the support system from the unexpanded state to the expanded state in concert with the expandable portion104of the barrier. That said, the support system108can be alternatively configured to expand from the unexpanded state to the expanded state independent of the expandable portion104of the barrier through one or more inlets exclusive to the support system108. When the enclosure is so configured, the method can include a second expanding step before or after the foregoing expanding step of expanding the supports of the support system108from the unexpanded state to the expanded state with a same fluid (e.g., filtered air) or a different fluid (e.g., water) than that for the expandable portion104of the barrier.

The working step includes working in the sterile environment to perform the medical procedure.

The method can further include a preparing step of preparing the area of interest with an antiseptic before the placing step.

The method can further include a first removing step followed by an adhering step as set forth in more detail below. The first removing step can be performed at any time relative to the preparing step, but the adhering step is performed after the preparing step in order to maintain sterility.

The first removing step includes removing the outer seal of the fenestration110from the patient-interfacing surface of the patient-interfacing portion106of the barrier. The first removing step exposes the perimeter around the fenestration110having the adhesive on the patient-interfacing surface.

The adhering step includes adhering the patient-interfacing portion106of the barrier to the patient P by way of the adhesive exposed during the first removing step such that the perimeter of the fenestration110is around the area of interest.

The method can further include an inserting step of inserting at least one hand into a glove of the one-or-more pairs of long-sleeved gloves116integrated into the expandable portion104of the barrier followed by a second removing step of removing the inner seal of the fenestration110from the inner surface of the patient-interfacing portion106of the barrier. The second removing step should be after adhering the patient-interfacing portion106of the barrier to the patient to maintain the sterile environment over the patient P.

While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.