Enclosure for establishing a sterile field for a medical procedure, system and method thereof

Abstract

Enclosures for establishing a sterile environment over a patient for a medical procedure, and systems and methods thereof, are disclosed. The enclosures can include an expandable portion of a barrier that separates a sterile environment inside the enclosure from a non-sterile environment outside the enclosure, and a patient interface connection portion of the barrier. In some embodiments, the enclosures can also include a support system coupled to the patient interface connection portion of the barrier. The patient interface connection portion of the barrier can include one or more fenestrations for direct placement over one or more areas of interest of the patient, and access to the areas of interest from within the sterile environment. When present, the support system can flank the fenestrations. The support system is configured to support the enclosure on a surface when placed over an appendage of the patient or a body of the patient.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 992,062, filed March 19, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to enclosures, systems, and methods for establishing a sterile environment for medical procedures. Background Technology

[0004] Medical procedures, such as surgical procedures, require certain precautions to ensure that the immediate environment in which the procedure is performed is sterile. Ensuring such a sterile environment protects the patient from infection when the patient's natural protective barrier (i.e., their skin) is compromised during the procedure.

[0005] This article discloses a shell for creating a sterile environment above a patient for medical procedures, as well as the system and method thereof. Summary of the Invention

[0006] This document discloses a housing for establishing a sterile environment above a patient for medical procedures. In some embodiments, the housing includes an expandable portion of a barrier and a patient-interfacing portion of the barrier. The expandable portion of the barrier separates the sterile environment inside the housing from the non-sterile environment outside the housing. The expandable portion of the barrier is configured to expand from a non-expanded state to an expanded state for operation within the sterile environment. The patient-interfacing portion of the barrier includes a fenestration configured to be placed directly above the patient's area of ​​concern. The fenestration has a sealed state and an unsealed state to allow access to the area of ​​concern from within the sterile environment.

[0007] In some embodiments, the housing further includes a support system coupled to a patient interface connection portion of the barrier in the flanking section. The support system is configured to support the housing on the surface when placed over the patient's appendage or main body. The patient can be positioned in any of a number of anatomical locations on the surface.

[0008] In some implementations, the support system is configured to expand from a non-expanded state to an expanded state in accordance with the expandable portion of the barrier.

[0009] In some implementations, the support system is configured as a scalable portion that expands from a non-expanded state to an expanded state, independent of the barrier.

[0010] In some embodiments, the housing further includes a pair of framed ends of the housing configured to support an expandable portion of the barrier. Each of the pair of framed ends is configured to lie down on the patient interface connection portion of the barrier in the unexpanded state. Each of the pair of framed ends is also configured to extend vertically from the patient interface connection portion of the barrier in the expanded state.

[0011] In some embodiments, the housing further includes an air inlet fluidly connected to the inside of the housing. The air inlet is configured to introduce filtered air into the inside of the housing so that the expandable portion of the barrier expands from a non-expanded state to an expanded state or maintains a greater pressure inside the housing relative to the outside of the housing.

[0012] In some embodiments, the housing further includes an in-line high-efficiency particulate air (“HEPA”) filter, which optionally includes an antimicrobial coating on the filter media of the HEPA air filter. The HEPA air filter is configured to prevent microbial contamination of the sterile environment inside the housing.

[0013] In some implementations, the opening includes an outer seal above the patient interface connection surface of the patient interface connection portion of the barrier in the sealed state of the opening.

[0014] In some implementations, the periphery of the patient interface connection surface of the barrier's patient interface connection portion around the vent includes an adhesive. The adhesive is configured to adhere the patient interface connection portion of the barrier to the patient after sterilization, wherein the periphery of the vent surrounds the area of ​​concern. An external seal for the vent is configured to protect and maintain the integrity of the adhesive prior to use.

[0015] In some implementations, the fenestration includes an inner seal above the inner surface of the patient interface connection portion of the barrier in a sealed state. The inner seal of the fenestration is configured to be removed after the patient interface connection portion of the barrier has been adhered to the patient. Removing the inner seal after the patient interface connection portion of the barrier has been adhered to the patient maintains a sterile environment above the patient.

[0016] In some implementations, the housing further includes one or more pairs of long-sleeved gloves integrated into an expandable portion of the barrier. The long-sleeved gloves are configured to be worn by clinicians when performing medical procedures in a sterile environment.

[0017] In some embodiments, the housing further includes one or more closed-ended tubes integrated into an expandable portion of the barrier. The one or more closed-ended tubes are configured to receive probe insertion for use in a sterile environment during medical procedures.

[0018] In some embodiments, the housing further includes one or more pockets integrated into an expandable portion of the barrier. The one or more pockets are configured to hold surgical equipment or supplies used in medical procedures. The one or more pockets are located inside the housing, outside the housing, or a combination thereof.

[0019] In some embodiments, the housing further includes introducing means for introducing additional surgical equipment or supplies from a non-sterile environment outside the housing into a sterile environment inside the housing.

[0020] This document also discloses a system for establishing a sterile environment above a patient for a medical procedure. In some embodiments, the system includes: a housing for placement above the patient; and surgical instruments or supplies for the medical procedure within the sterile environment inside the housing. In some embodiments, the housing includes an expandable portion of a barrier and a patient interface connection portion of the barrier. The expandable portion of the barrier separates the sterile environment inside the housing from a non-sterile environment outside the housing. The expandable portion of the barrier is configured to expand from a non-expanded state to an expanded state for operation within the sterile environment. The patient interface connection portion of the barrier includes an opening configured for placement directly above the patient's area of ​​concern. The opening has a sealed state and an unsealed state to allow access to the area of ​​concern from within the sterile environment.

[0021] In some embodiments, the housing further includes a support system coupled to a patient interface connection portion of the barrier on the fenestrated flank. The support system is configured to support the housing on a surface when placed over the patient's appendages or the patient's body. The patient can be positioned in any of a number of anatomical locations on the surface.

[0022] In some implementations, the opening includes an outer seal on the patient interface connection surface of the patient interface connection portion of the barrier in the sealed state of the opening.

[0023] In some implementations, the periphery of the patient interface connection surface of the barrier's patient interface connection portion around the vent includes an adhesive. The adhesive is configured to adhere the patient interface connection portion of the barrier to the patient after sterilization, wherein the periphery of the vent surrounds the area of ​​concern. An external seal for the vent is configured to protect and maintain the integrity of the adhesive prior to use.

[0024] In some implementations, the fenestration includes an inner seal above the inner surface of the patient interface connection portion of the barrier in a sealed state. The inner seal of the fenestration is configured to be removed after the patient interface connection portion of the barrier has been adhered to the patient. Removing the inner seal after the patient interface connection portion of the barrier has been adhered to the patient maintains a sterile environment above the patient.

[0025] In some embodiments, the surgical apparatus includes one or more puncture devices selected from one or more guidewires for accessing guidewires, manipulating guidewires, and orbiting guidewires, one or more catheters, one or more syringes, or combinations thereof.

[0026] In some implementations, the supplies include one or more packets of disinfectant, saline or medicine, one or more swabs, gauze, one or more drapes or combinations thereof.

[0027] This document also discloses a method for establishing a sterile environment above a patient for a medical procedure. In some embodiments, the method includes a placement step, an expansion step, and an operating step. The placement step includes placing the housing above the patient's appendage or the patient body such that an opening in the patient interface connection portion of the housing's barrier is directly above the patient's area of ​​concern. The expansion step includes expanding an expandable portion of the barrier from a non-expanded state to an expanded state, which separates the sterile environment inside the housing from the non-sterile environment outside the housing. The operating step includes operating within the sterile environment to perform the medical procedure.

[0028] In some implementations, the expansion step includes lifting each of a pair of frame ends of the housing from the patient interface connection portion of the barrier in its unexpanded state to form its expanded state.

[0029] In some implementations, the extended step includes introducing filtered air into the inside of the housing via an air inlet fluidly connected to the inside of the housing.

[0030] In some implementations, filtered air is introduced into the interior of the housing via an air inlet, and also into a support system that is coupled to a patient interface connection portion of the barrier on either the vent or the patient's appendage or body. Introducing filtered air into the support system allows the support system to expand into an expanded state consistent with the expandable portion of the barrier, moving it from a non-expanded state to an expanded state.

[0031] In some embodiments, the method further includes a first removal step and an adhesion step. The first removal step includes removing the outer seal of the window from the patient interface connection surface of the barrier's patient interface connection portion. The first removal step exposes the periphery around the window on the patient interface connection surface where adhesive is present. The adhesion step includes adhering the patient interface connection portion of the barrier to the patient with respect to the periphery of the window around the area of ​​concern.

[0032] In some embodiments, the method further includes a second removal step: after the patient interface connection portion of the barrier is adhered to the patient, the inner seal of the vent is removed from the inner surface of the patient interface connection portion of the barrier. The second removal step maintains a sterile environment above the patient.

[0033] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of such concepts in more detail. Attached Figure Description

[0034] Figure 1 A system including a housing for establishing a sterile environment is shown according to some embodiments.

[0035] Figure 2 The illustration shows a housing including a barrier-crossing tube according to some embodiments. Figure 1 The system.

[0036] Figure 3 The following are illustrations, according to some embodiments, including a housing with a door. Figure 1 The system.

[0037] Figure 4 The illustration shows a housing including a chute according to some embodiments. Figure 1 The system.

[0038] Figure 5 The following are illustrated according to some implementation schemes. Figure 1 An alternative shell for the system.

[0039] Figure 6 The following are illustrated according to some implementation schemes. Figure 1 Another alternative shell for the system. Detailed Implementation

[0040] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and may optionally be combined with or substituted for features of any of the many other embodiments disclosed herein.

[0041] Regarding the terminology used herein, it should be understood that the terminology is for the purpose of describing certain specific embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as “left,” “right,” “up,” “down,” “front,” and “back” are for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include the plural forms.

[0042] The terms "proximal," "proximal portion," or "proximal portion" for catheters, as disclosed herein, include a portion of the catheter intended to be close to the clinician when used on a patient. Similarly, for example, the term "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when used on a patient. For example, the term "proximal end" of a catheter includes one end of the catheter intended to be close to the clinician when used on a patient. A proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, a proximal portion, proximal portion, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise requires, a proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0043] For example, the term "distal," "distal portion," or "distal part" of a catheter disclosed herein includes a portion of the catheter intended to be proximate to or located within the patient when used on a patient. Similarly, the term "distal length" of a catheter includes the length of the catheter intended to be proximate to or located within the patient when used on a patient. For example, the term "distal end" of a catheter includes one end of the catheter intended to be proximate to or located within the patient when used on a patient. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0044] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0045] Shell used to create a sterile environment

[0046] Figure 1 A system 100, including a housing 102 for establishing a sterile environment, is shown according to some embodiments. Although Figure 1 A system including a housing 102 for establishing a sterile environment is shown, but the housing 102 will be described primarily in this subsection. Systems for establishing sterile environments will be described in more detail in the following subsections concerning such systems.

[0047] The housing 102 is configured to establish a sterile environment above the patient for medical procedures. The housing 102 can be of any size suitable for medical procedures.

[0048] As shown in the figure, the housing 102 includes a barrier formed by an expandable portion 104 of the barrier and a patient interface connection portion 106 of the barrier. The barrier separates the sterile environment inside the housing 102 from the non-sterile environment outside the housing 102. Thus, each portion of the expandable portion 104 and the patient interface connection portion 106 of the barrier separates the sterile environment inside the housing 102 from the non-sterile environment outside the housing 102.

[0049] The expandable portion 104 of the barrier is configured to expand from an unexpanded state to an expanded state for operation in a sterile environment. The expandable portion 104 may be an expandable bag of translucent plastic (e.g., polyethylene, styrene, polycarbonate, etc.) above the patient interface connection portion 106 of the barrier, or a frame structure comprising translucent plastic stretched between frame elements.

[0050] Regarding the frame structure, for example, the frame structure may include paired frame ends 112 of the housing 102 configured to support an expandable portion 104 of the barrier. Each of the paired frame ends 112 is configured to lie prone on the patient interface connection portion 106 of the barrier in the unexpanded state. Each of the paired frame ends 112 is also configured to extend vertically from the patient interface connection portion 106 of the barrier in the expanded state. Each of the paired frame ends can be independently lifted from the patient interface connection portion 106 of the barrier in the unexpanded state of the expandable portion 104 of the barrier to form its expanded state, while introducing filtered air in an amount proportional to the rate at which the paired frame ends are lifted from the patient interface connection portion 106 of the barrier. Alternatively, the frame structure can be expanded by introducing filtered air.

[0051] In view of the foregoing, housing 102 may further include an air inlet 114 fluidly connected to the interior of housing 102. Air inlet 114 is configured to introduce air (e.g., filtered air) into the interior of housing 102 to expand housing 102 from its unexpanded state to its expanded state. For example, air inlet is configured to balance the pressure inside housing 102 when the expandable portion 104 of the aforementioned frame structure is expanded from its unexpanded state to its expanded state. And, for example, air inlet is configured to inflate the expandable portion 104 of the aforementioned expandable bag from its unexpanded state to its expanded state. Additionally, air inlet 114 is configured to introduce air (e.g., filtered air) into the interior of housing 102 to maintain a higher pressure inside housing 102 than outside housing 102 when needed. Air inlet 114 may be fluidly connected to a pump to inflate the expandable portion 104 of the barrier or to maintain a higher pressure inside housing 102 than outside housing 102.

[0052] It should be understood that regardless of whether the expandable portion 104 of the barrier comprises an inflatable bag or a frame structure, the expandable portion 104 of the barrier can be inflated through the air inlet 114. Furthermore, when the expandable portion 104 is an inflatable bag, maintaining a greater pressure inside the outer shell 102 than outside the outer shell 102 is particularly important in maintaining the structural integrity of the expandable portion 104 of the barrier.

[0053] To provide filtered air into the interior of housing 102, the housing may further include an inline HEPA air filter, which optionally includes an antimicrobial coating on the filter media of the HEPA air filter. The HEPA air filter is configured to prevent microbial contamination of the sterile environment inside housing 102.

[0054] The patient interface connection portion 106 of the barrier includes a window 110 configured to be placed directly over the area of ​​concern of patient P (e.g., surgical area, wound such as an open wound, a previously closed and dressed wound, burns, etc.); however, the patient interface connection portion 106 of the barrier is not limited to the window 110. In fact, the patient interface connection portion 106 of the barrier may include any number of additional windows besides the window 110. The window 110 has a sealed state and an unsealed state to allow access to the area of ​​concern from a sterile environment.

[0055] The opening 110 includes an outer seal above the patient interface connection surface (e.g., outer surface) of the patient interface connection portion 106 of the barrier in a sealed state. The periphery of the patient interface connection surface surrounding the opening 110 includes an adhesive configured to adhere the patient interface connection portion 106 of the barrier to the patient P after sterilization, wherein the periphery of the opening 110 surrounds the area of ​​concern. The outer seal of the opening 110 is configured to protect and maintain the integrity of the adhesive prior to use.

[0056] The window 110 also includes an inner seal above the inner surface of the patient interface connection portion 106 of the barrier in the sealed state. The inner seal of the window 110 is configured to be removed after the patient interface connection portion 106 of the barrier has been adhered to the patient P. Removing the inner seal after the patient interface connection portion 106 of the barrier has been adhered to the patient maintains a sterile environment above the patient P by preventing unfiltered air from entering the housing 102 through the window 110.

[0057] As shown, the housing 102 may further include a support system 108 coupled to the patient interface connection portion 106 of the barrier. When present, the support system 108 is coupled to the patient interface connection portion 106 of the barrier and includes at least a pair of supports on the flanks of the opening 110. The support system 108 is configured such that when placed over the appendages or body of the patient P, the supports are on the flanks of the appendages or body of the patient P, thereby supporting the housing 102 on a surface (e.g., the top of an operating table, the top of a bed, etc.). The patient P can be positioned in any of a plurality of anatomical positions on the surface used with the housing 102 (e.g., supine, prone, lateral recumbent, left lateral recumbent, etc.).

[0058] After removing the packaging of the outer shell 102, the support system 108 can be immediately ready to be placed over the patient P, or the support system 108 can be configured to expand from a non-expanded state to an expanded state for use with the patient P. Regarding the former, for example, the support member of the support system 108 may include fiberfill stuffing, thereby making the support system 108 immediately ready to be placed over the patient after removing the packaging. Regarding the latter, for example, the support system 108 can be configured to expand from a non-expanded state to an expanded state in accordance with the expandable portion 104 of the barrier. That is, the support member of the support system 108 can be fluidly connected to the inside of the outer shell 102 such that when the expandable portion 104 of the barrier expands, the support system 108 also expands. Alternatively, the support system 108 can be configured to expand from a non-expanded state to an expanded state independently of the expandable portion 104 of the barrier via one or more dedicated inlets for the support system 108. In this way, the support member of the support system 108 can expand from a non-expanded state to an expanded state using a different fluid than the expandable portion 104 of the barrier. For example, instead of air, water can be used to extend the support system 108 from a non-extended state to an extended state. Water is advantageous because, compared to air, it provides greater weight to the housing 102 and also lowers the center of gravity of the housing 102.

[0059] The housing 102 may further include one or more pairs of long-sleeved gloves 116 of translucent plastic integrated into an expandable portion 104 of the barrier. The one or more pairs of long-sleeved gloves 116 are configured to be worn by clinicians when performing medical procedures within the sterile environment of the housing 102.

[0060] The housing 102 may further include one or more end-closure tubes 117 integrated into a translucent plastic portion of an expandable barrier. Instead of being configured with fingertips like one or more long-sleeved gloves, the one or more end-closure tubes 117 are configured to receive the insertion of a probe (e.g., an ultrasound probe) for use within a sterile environment of the housing 102 during medical procedures.

[0061] The housing 102 may further include one or more pockets 118 integrated into an expandable portion 104 of the barrier or a patient-facing portion 106. When present, the one or more pockets 118 are configured to hold surgical instruments or supplies for a medical procedure. The one or more pockets 118 are also configured to retain the surgical instruments or supplies after their use during the medical procedure, thereby safely containing biohazardous waste within the housing 102. The one or more pockets 118 may be inside the housing 102, outside the housing 102, or a combination thereof. Additionally or alternatively, the housing 102 may include rings, clips, hook-and-loop fasteners, snaps, glue dots, or other fastening devices to hold surgical instruments or supplies for a medical procedure. The housing 102 may further include one or more rigid trays configured to hold surgical instruments or supplies for a medical procedure. Such rigid trays may include any of the aforementioned fastening devices for holding surgical instruments, and the housing 102 may further include any of the aforementioned fastening devices for holding rigid trays.

[0062] The housing 102 may further include a guiding device for introducing surgical instruments or supplies from a non-sterile environment outside the housing into a sterile environment inside the housing 102.

[0063] Figure 2 The illustration shows a housing 102 including a barrier crossing tube 120 according to some embodiments. Figure 1 System 100. Although tube 120 is shown as a barrier across the frame ends 112 of the paired frame ends 112 of housing 102, tube 120 may extend across any portion of the barrier separating the sterile environment inside housing 102 from the non-sterile environment outside housing 102. Tube 120 may include a Luer connector 122 and a cap 124 configured to maintain the sterility of the lumen of tube 120 for introducing supplies, such as guidewires, saline, solutions including medications, etc., into the sterile environment inside housing 102.

[0064] Figure 3 The following is shown according to some embodiments: a housing 102 including a door 126. Figure 1 System 100. Although door 126 is shown in the barrier at the frame ends of the paired frame ends 112 of housing 102, door 126 may be in any part of the barrier that separates the sterile environment inside housing 102 from the non-sterile environment outside housing 102. Door 126 may include knobs, hooks, etc. on one or both sides of door 126, configured to facilitate opening door 126 to introduce surgical equipment or supplies into the sterile environment inside housing 102 and then closing door 126.

[0065] Figure 4The illustration shows a housing 102 including a groove 128 according to some embodiments. Figure 1 System 100. Although a chute 128 is shown extending from a barrier at one of the frame ends 112 of a pair of frame ends 112 of the housing 102, the chute 128 may extend from any portion of the barrier that separates the sterile environment inside the housing 102 from the non-sterile environment of the housing 102. The chute 128 may include a fold-top end having one or more flaps 130 configured to fold over the chute 128 in a closed state. The one or more flaps 130 are configured to open to one or more sides of the chute 128 to allow the chute 128 to be in an open state for introducing surgical instruments or supplies into the sterile environment inside the housing 102. The one or more flaps 130 may include a sterile side corresponding to the inside of the chute 128 when in its closed state. One or more flaps 130 are manipulated only by means of the non-sterile side of the flaps 130 opposite to the sterile side to ensure that surgical equipment or supplies falling into the chute 128 do not come into contact with non-sterile surfaces (such as the non-sterile side of one or more flaps 130).

[0066] The groove 128 can be formed from any of the tubes described above, one or more end-sealed tubes configured to receive the insertion of a probe (e.g., an ultrasound probe) for use in the sterile environment of the housing 102 during medical procedures. In practice, such end-sealed tubes may have notched or similarly weakened areas that can be separated to create a folded tip with one or more flaps 130.

[0067] Figure 5 The following are examples of implementation schemes for use with respect to some embodiments. Figure 1 The alternative housing 502 for system 100. Like Figure 1-4 Like any of the housings 102, housing 502 is configured to establish a sterile environment above the patient for medical procedures. Housing 502 is a frame structure similar to that described above for housing 102; however, housing 502 includes a pop-up frame 503 comprising a translucent plastic stretched between portions of the pop-up frame 503.

[0068] The outer shell 502 is configured in an unexpanded state, wherein the pop-out frame 503 is twisted and folded by itself during one or more revolutions, thereby locking a certain amount of torsional potential energy into the pop-out frame 503 in the unexpanded state of the outer shell 502. The outer shell 502 is also configured in an expanded state, wherein the pop-out frame 503 is untwisted and unfolded. The transition from the unexpanded state to the expanded state of the outer shell 502 is achieved by: releasing the torsional potential energy in the pop-out frame 503 by perturbing the energy state of the pop-out frame 503 to a local minimum in the unexpanded state, or by removing one or more clips that hold the pop-out frame 503 together after one or more revolutions in the unexpanded state.

[0069] Although not shown, housing 502 includes one or more features described above for housing 102, which are at least selected from air inlet 114, window 110, one or more pairs of long-sleeved gloves 116, one or more end-closure tubes 117, one or more pockets 118, and guiding devices for introducing surgical equipment or supplies into the sterile environment inside housing 502.

[0070] Figure 6 An alternative housing is shown according to some embodiments. Figure 1 The system.

[0071] as Figure 1-4 Like any of the housings 102, housing 602 is configured to establish a sterile environment above the patient for medical procedures. Housing 602 is a frame structure similar to that described above for housing 102; however, housing 602 includes a top frame 603 comprising translucent plastic stretched between portions of the top frame 603 and translucent plastic hanging from the top frame 603. That is, housing 602 is not limited to the top frame 603. In fact, housing 602 may further include a bottom frame that frames the patient interface connection portion such as a portion of housing 102, or even frames the frame ends of the paired frame ends 112 of housing 102.

[0072] The housing 602 is configured in an unextended state, wherein the translucent plastic attached to the top frame 603 is folded into the housing 602 or bundled below the top frame 603. The housing 602 is also configured in an extended state, wherein the translucent plastic attached to the top frame 603 hangs down from the top frame 603. The transition from the unextended state to the extended state of the housing 602 is achieved by suspending the housing 602 from the top frame 603 onto a boom or similar device using ropes.

[0073] Although not shown, housing 602 includes one or more features described above for housing 102, which are at least selected from air inlet 114, window 110, one or more pairs of long-sleeved gloves 116, one or more end-closure tubes 117, one or more pockets 118, and guiding devices for introducing surgical equipment or supplies into the sterile environment inside housing 602.

[0074] Systems for establishing a sterile environment

[0075] Figure 1 A system 100 including a housing 102 for establishing a sterile environment is shown according to some embodiments. Although the system 100 is described below with reference to housing 102, it should be understood that the system 100 may alternatively include housing 502 or 602.

[0076] As shown in the figure, system 100 includes a housing 102 for placement above patient P, and sterile surgical equipment 132 or supplies 134 for medical procedures in a sterile environment inside the housing 102.

[0077] The foregoing section mainly describes the outer casing 102.

[0078] Surgical equipment 132 or supplies 134 can be selected for any medical procedure in many medical procedures (such as procedures for placing a central venous catheter (“CVC”), a peripherally inserted central catheter (“PICC”), a medical port, etc.). Regarding surgical equipment 132, surgical equipment 132 may include, but is not limited to, one or more puncture devices, one or more guidewires (selected from entry guidewires, manipulation guidewires, and track guidewires), one or more catheters (e.g., CVC, PICC), one or more syringes, or combinations thereof. Regarding supplies 134, supplies 134 may include, but are not limited to, one or more packets of disinfectant (e.g., povidone-iodine), saline or medication, one or more swabs, gauze, or combinations thereof.

[0079] System 100 may further include packaging such as bags or pouches, additional supplies such as one or more pairs of gloves or those selected from supplies 134 for medical procedures, instructions for use, manufacturing information, etc. For example, in its unexpanded state, the housing 102, including surgical equipment 132 or supplies 134, may be arranged in a bag or pouch. Furthermore, additional supplies such as one or more pairs of gloves, one or more packets of disinfectant, etc., may be arranged together with the housing 102 in a bag or pouch so that the additional supplies can be removed independently before placing the housing 102 and its opening 110 over the area of ​​concern, in preparation for the patient P and the area of ​​concern for the medical procedure. The bags or pouches can be sterilized with ethylene oxide gas and sealed using the housing 102 and the additional supplies, thus forming system 100 according to some embodiments. Such systems can be transported or stored until ready for use.

[0080] Advantageously, System 100 eliminates the need for clinicians using System 100 to perform medical procedures to wear protective equipment such as gowns or masks, or even to set up sterile areas using one or more drapes. In this way, System 100 saves time and money and reduces the possibility of damaging sterile areas.

[0081] method

[0082] The method of system 100 includes a method for establishing a sterile environment for a medical procedure above the patient P.

[0083] A method for establishing a sterile environment above a patient P during a medical procedure includes at least placement steps, extension steps, and operating steps associated with system 100, as described in more detail below.

[0084] The placement step includes placing the housing 102 over the appendage or body of the patient P such that the opening 110 of the patient interface connection portion 106 of the barrier is directly above the area of ​​concern of the patient P. When the support system 108 is coupled to the patient interface connection portion 106 of the barrier, the placement step also includes placing the support system 108 such that the supports of the support system 108 on the flanks of the opening are also on the flanks of the patient P's appendage or body.

[0085] The expansion step includes expanding the expandable portion 104 of the barrier, which, from an unexpanded state to an expanded state, separates the sterile environment inside the housing 102 from the non-sterile environment outside the housing 102. The expansion step can be performed before or after the placement step.

[0086] The expandable portion 104 of the extended barrier may include lifting each of the paired frame ends 112 of the housing 102 from the patient interface connection portion 106 of the barrier in its unextended state to form its extended state. Simultaneously, filtered air may be introduced into the interior of the housing 102 via an air inlet 114 fluidly connected to it. Alternatively, such as in embodiments where the expandable portion 104 of the barrier is an inflatable bag (but not limited thereto), the expansion step may include inflating the expandable portion 104 of the barrier only with filtered air introduced into the interior of the housing 102 via the air inlet 114. During the expansion step, any windows (e.g., window 110) or other openings should remain sealed such that only filtered air is introduced into the interior of the housing 102.

[0087] As described above, when the support member of the support system 108 is fluidly connected to the inside of the support system 108, filtered air can also be introduced into the support system 108 by means of air inlet 114 to introduce filtered air into the inside of the housing 102. In such an embodiment, introducing filtered air into the support system 108 extends the support system and the expandable portion 104 of the barrier from a non-expanded state to an expanded state in accordance with each other. That is, the support system 108 can be alternatively configured to extend from a non-expanded state to an expanded state independently of the expandable portion 104 of the barrier via one or more inlets dedicated to the support system 108. When the housing is configured in this way, the method may include a second expansion step before or after the above-described expansion step: extending the support member of the support system 108 from a non-expanded state to an expanded state with the same fluid (e.g., filtered air) or a different fluid (e.g., water) as the expandable portion 104 of the barrier.

[0088] The work procedures involve working in a sterile environment to perform medical procedures.

[0089] The method may further include a preparation step: preparing the area of ​​concern with a disinfectant before the placement step.

[0090] The method may further include a first removal step, followed by an adhesion step, as described in more detail below. The first removal step can be performed at any time relative to the preparation step, but in order to maintain sterility, the adhesion step is performed after the preparation step.

[0091] The first removal step includes removing the outer seal of the window 110 from the patient interface connection surface of the patient interface connection portion 106 of the barrier. The first removal step exposes the periphery (with adhesive on the patient interface connection surface) around the window 110.

[0092] The adhesion step includes adhering the patient interface connection portion 106 of the barrier to the patient P by means of the adhesive exposed during the first removal step, such that the periphery of the opening 110 is around the area of ​​concern.

[0093] The method may further include an insertion step: inserting at least one hand into one or more pairs of long-sleeved gloves 116 integrated into the expandable portion 104 of the barrier; followed by a second removal step: removing the inner seal of the vent 110 from the inner surface of the patient interface connection portion 106 of the barrier. The second removal step should be performed after the patient interface connection portion 106 of the barrier has been adhered to the patient to maintain a sterile environment above the patient P.

[0094] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, they are not intended to limit the scope of the concepts provided herein. Additional changes and / or modifications will be readily apparent to those skilled in the art, and are included in a broader sense as well. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A housing for creating a sterile environment above a patient for a medical procedure, comprising: The barrier has an expandable portion that separates the sterile environment inside the housing from the non-sterile environment outside the housing. The expandable portion of the barrier is configured to expand from a non-expanded state to an expanded state so as to operate within the sterile environment. The patient interface connection portion of the barrier includes a window configured to be placed directly above the patient’s area of ​​concern, the window having a sealed state and an unsealed state to allow access to the area of ​​concern from within the sterile environment; and A support system, coupled to the patient interface connection portion of the barrier on the vent side wing, the support system being configured to support the housing on the surface when placed over the patient's appendages or the patient's body in any of a plurality of anatomical positions on the surface.

2. The housing of claim 1, wherein the support system is configured to extend from a non-extended state to an extended state in accordance with the extendable portion of the barrier.

3. The housing of claim 1, wherein the support system is configured to extend from a non-extended state to an extended state independently of the extendable portion of the barrier.

4. The housing of claim 1, further comprising a pair of frame ends of the housing configured to support an expandable portion of the barrier, each of the pair of frame ends being configured to lie prone on the patient interface connection portion of the barrier in an unexpanded state and to extend vertically from the patient interface connection portion of the barrier in an expanded state.

5. The housing of claim 1, further comprising an air inlet fluidly connected to the inner side of the housing, the air inlet being configured to introduce filtered air therein so that an expandable portion of the barrier expands from the unexpanded state to the expanded state, or maintains a greater pressure on the inner side of the housing than on the outer side of the housing.

6. The housing of claim 5, further comprising an online high-efficiency particulate air filter including an optional antimicrobial coating on the filter medium of the high-efficiency particulate air filter, the high-efficiency particulate air filter being configured to prevent microbial contamination of the sterile environment inside the housing.

7. The housing according to claim 1, wherein the opening includes an outer seal above the patient interface connection surface of the patient interface connection portion of the barrier in the sealed state of the opening.

8. The housing of claim 7, wherein the periphery of the patient interface connection surface of the patient interface connection portion of the barrier surrounding the window includes an adhesive configured to adhere the patient interface connection portion of the barrier to the patient after sterilization, wherein the periphery of the window surrounds the area of ​​concern, and the outer seal of the window is configured to protect and maintain the integrity of the adhesive before use.

9. The housing of claim 7, wherein the window includes an inner seal above the inner surface of the patient interface connection portion of the barrier in the sealed state of the window, the inner seal of the window being configured to be removed after the patient interface connection portion of the barrier is adhered to the patient, thereby maintaining the sterile environment above the patient.

10. The housing of claim 1, further comprising one or more pairs of long-sleeved gloves integrated into an expandable portion of the barrier, the one or more pairs of long-sleeved gloves being configured to be worn by a clinician when the medical procedure is performed in the sterile environment.

11. The housing of claim 1, further comprising one or more end-sealing tubes integrated into an expandable portion of the barrier, the one or more end-sealing tubes being configured to receive insertion of a probe for use in the sterile environment during the medical procedure.

12. The housing of claim 1, further comprising one or more pockets integrated into an expandable portion of the barrier, the one or more pockets configured to hold surgical equipment or supplies for the medical procedure, the one or more pockets being inside the housing, outside the housing, or a combination thereof.

13. The housing of claim 1, further comprising a guiding device for introducing additional surgical equipment or supplies from the non-sterile environment outside the housing into the sterile environment inside the housing.

14. A system for establishing a sterile environment above a patient for a medical procedure, comprising: A housing for placement above a patient, the housing comprising: The barrier has an expandable portion that separates the sterile environment inside the housing from the non-sterile environment outside the housing. The expandable portion of the barrier is configured to expand from a non-expanded state to an expanded state so as to operate within the sterile environment. The patient interface connection portion of the barrier includes a window configured to be placed directly above the patient's area of ​​concern, the window having a sealed state and an unsealed state to allow access to the area of ​​concern from within the sterile environment; and A support system, coupled to the patient interface connection portion of the barrier on the vent flank, is configured to support the housing on the surface when placed over the patient's appendage or the patient's body in any of a plurality of anatomical positions on the surface; and Surgical equipment or supplies for use in the medical procedure within the sterile environment inside the housing.

15. The system of claim 14, wherein the window opening includes an outer seal above the patient interface connection surface of the patient interface connection portion of the barrier in the sealed state of the window opening.

16. The system of claim 15, wherein the periphery of the patient interface connection surface of the patient interface connection portion of the barrier surrounding the window includes an adhesive configured to adhere the patient interface connection portion of the barrier to the patient after sterilization, wherein the periphery of the window surrounds the area of ​​concern, and the outer seal of the window is configured to protect and maintain the integrity of the adhesive before use.

17. The system of claim 15, wherein the opening includes an inner seal above the inner surface of the patient interface connection portion of the barrier in the sealed state of the opening, the inner seal of the opening being configured to be removed after the patient interface connection portion of the barrier is adhered to the patient, thereby maintaining the sterile environment above the patient.

18. The system of claim 14, wherein the surgical apparatus comprises one or more puncture devices selected from one or more guidewires, one or more catheters, one or more syringes, or combinations thereof, from an entry guidewire, a manipulating guidewire, and a track guidewire.

19. The system of claim 14, wherein the supply comprises one or more packets of disinfectant, saline or medicine, one or more swabs, gauze, one or more drapes or combinations thereof.

20. A method for establishing a sterile environment above a patient for a medical procedure, comprising: The shell is placed above the patient's appendage or the patient's body such that the opening of the patient interface connection portion of the shell's barrier is directly above the patient's area of ​​concern. The expandable portion of the barrier extends from a non-expanded state to an expanded state, separating the sterile environment inside the housing from the non-sterile environment outside the housing; and The medical procedure is performed in a sterile environment. Extending the expandable portion of the barrier includes introducing filtered air into the interior of the housing via an air inlet fluidly connected to the interior of the housing. The filtered air is introduced into the inner side of the housing via an air inlet, and the filtered air is also introduced into a support system that is connected to the patient interface connection portion of the barrier on both the flank of the window and the patient's appendage or body, so that the support system is extended from a non-extended state to an extended state in accordance with the extendable portion of the barrier.

21. The method of claim 20, wherein extending the expandable portion of the barrier comprises lifting each of a pair of frame ends of the housing from the patient interface connection portion of the barrier in the unextended state of the expandable portion of the barrier to form the extended state of the expandable portion of the barrier.

22. The method of claim 20, further comprising: Remove the outer seal of the opening from the patient interface connection surface of the patient interface connection portion of the barrier, thereby exposing the periphery around the opening where the adhesive is present on the patient interface connection surface. and With the periphery of the window surrounding the area of ​​concern, the patient interface connection portion of the barrier is adhered to the patient.

23. The method of claim 22, further comprising, after adhering the patient interface connection portion of the barrier to the patient, removing the inner seal of the window from the inner surface of the patient interface connection portion of the barrier, thereby maintaining the sterile environment above the patient.

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