Ultra-portable system for in-operation isolation and conditioning of the surgical site environment

Abstract

A portable surgical system is disclosed that includes a transparent and flexible plastic housing (1). The housing is reversibly attached to the patient's body around the surgical site so as to isolate and regulate the immediate environment of the surgical site and reduce splashing of bodily fluids from the surgical site to the surgical provider. The housing is inflated with filtered air. An arm port (8) is integrated into the housing to allow the provider's arm or an augmented instrument (such as a laparoscope or robot) that replaces the arm to enter the interior of the housing. A material port (10) maintains the integrity of the housing environment but allows anatomical specimens, instruments, and other materials to enter and exit the housing (1) during the procedure. The portable surgical system is lightweight and can be used in a conventional operating room to improve sterility, or in other environments where no operating room is available (such as a field hospital).

Description

[0001] Related Applications

[0002] This application is a divisional application of Chinese patent application No. 201780055697.4. This application claims priority and the benefit of U.S. Provisional Patent Application No. 62 / 362,893, filed on July 15, 2016, entitled “Modular Surgical Suite”, which is hereby incorporated by reference for all purposes as if fully set forth herein. Background of the Invention

[0003] I. Field of the Invention

[0004] Exemplary embodiments of the present invention are directed to portable surgical systems for regulating an intraoperative environment at a surgical site; and to methods of implementing and using the same.

[0005] II. Background Discussion

[0006] More than 25% of the global disease burden requires surgical treatment, which can prevent more than 18 million deaths each year. These range from obstetric complications to trauma, to infection, to cancer and beyond. However, 2 billion people do not have access to safe surgical care, and another 2-3 billion people can only receive unsterile surgery in a contaminated environment, resulting in a disproportionate rate of surgical infections. Innovations in this field are generally focused on making operating rooms and operating room ventilation systems more mobile, such as in the form of tents. However, the purchase and maintenance costs of such systems remain high. In addition, such systems are difficult to transport quickly to remote areas. At the same time, more than 85,000 healthcare providers are infected by patient body fluids each year, of which 90% of infected providers worldwide are exposed while working in resource-poor environments. Although personal protective equipment reduces these risks to some extent, there is a clear trade-off between the level of protection and cost and user comfort, which is well documented to correspond to user compliance.

[0007] Exemplary embodiments of the present invention are intended to address the challenges of exposure to infection risks in patient and provider procedures by implementing an ultra-portable, self-contained, passive and active double-sided barrier to contaminant exchange between an incision and the larger surgical field.

[0008] The above information disclosed in the Background section is only for enhancement of understanding of the background of the invention and therefore it may contain information that does not constitute any part of the prior art. SUMMARY OF THE INVENTION

[0009] Exemplary embodiments of the present invention provide a portable surgical system for regulating an intraoperative environment at a surgical site.

[0010] The surgical system includes a transparent soft plastic shell, which is directly attached to the patient's body around the planned surgical site reversibly. The shell is integrated with an arm port to allow the provider's arm or an augmented instrument (such as a laparoscope or robot) to enter the shell interior instead of the arm. The material port that can be repeatedly opened and closed is used to maintain the environmental integrity of the shell, but allows anatomical samples, instruments and other materials to enter and exit the shell during the procedure. Such shells can incorporate one or more parts into a sterile area specific to a given procedure to support an instrument tray. The shell can be filled with air from an environmental control system by an inlet, valve and manifold system integrated into the shell. Environmental control systems can enact such preselected controls required for a given procedure, such as HEPA filtration, humidity regulation, heating or cooling, or the exchange of gas components. The surgical system is lightweight, and can be used in a conventional operating room to improve sterility or be used in other environments (such as field hospitals) where no operating room is available.

[0011] Additional features of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention.

[0012] Exemplary embodiments of the present invention disclose a portable surgical system for regulating an in-operation environment at a surgical site. The surgical system may include a disposable component including a housing having a patient interface and a reusable component including an environmental control system and an optional external support frame.

[0013] The disposable component may include an operating portion and an instrument portion separated from the operating portion. The environmental control component is connected to the housing to control the environment inside the housing. The external support frame may be configured to be connected to the disposable component to provide mechanical support to the disposable component.

[0014] An exemplary embodiment of the present invention also discloses a method of using a portable surgical system, the method comprising the following steps: placing a patient on top of an operating table; placing an instrument tray support on the patient's legs; performing a skin disinfection procedure; placing a disposable component over the surgical site with the operating portion cranial and the instrument portion caudal; for each planned user, placing a pair of surgical gloves inside the housing at the arm opening corresponding to the user's expected position; placing the instrument tray into the instrument portion through the material opening; engaging the environmental control system; attaching an external frame to the instrument tray support; pulling a tether out of the external top of the housing and securing it to the frame in the top clip; placing the arm inside the housing and applying gloves.

[0015] As non-limiting examples, the present application provides the following embodiments:

[0016] 1. A portable surgical system comprising:

[0017] (a) A flexible housing that separates a surgical environment inside the housing from a user environment outside the housing, the housing comprising:

[0018] a surgical drape configured to be disposed over or around a surgical site on a patient's body and to expose the surgical site; and

[0019] one or more areas of high optical clarity for viewing the interior of the housing;

[0020] wherein, when the surgical system is deployed in use, only the surgical site is contained within the surgical housing and the remainder of the patient's body is substantially excluded from the surgical environment within the housing;

[0021] (b) an environmental control system configured to supply air to the housing so as to create substantially sterile conditions within the housing; and

[0022] (c). One or more ports for accessing the surgical site.

[0023] 2. A portable surgical system as described in embodiment 1, wherein the housing further includes at least one instrument portion, and the at least one instrument portion is configured to accommodate an instrument tray inside the housing.

[0024] 3. A portable surgical system as described in embodiment 1, wherein the system further includes a frame configured to support the housing, wherein the frame is disposed outside the housing.

[0025] 4. The portable surgical system of embodiment 1, further comprising one or more arm ports disposed in a side of the housing, wherein each arm port is configured such that the arm port allows a user's arm to access the surgical site without substantially allowing external air to contaminate the surgical site inwardly or contaminants emitted from the patient's body to contaminate the provider outwardly; and

[0026] At least some of the arm openings are configured to enable operating instruments to access the surgical site.

[0027] 5. The portable surgical system as described in Embodiment 1 further comprises one or more material ports disposed in the side of the housing, wherein the material ports are configured to allow material to be brought into and out of the housing without substantially allowing external air to contaminate the surgical site internally or contaminants emitted from the patient's body to contaminate the provider externally.

[0028] 6. A portable surgical system as described in embodiment 1, wherein the housing further includes a flexible tube that receives air from the environmental control system and is configured to produce a substantially uniform airflow over the surgical site.

[0029] 7. A portable surgical system as described in embodiment 6, wherein the flexible tube comprises in whole or in part a retractable tube, the retractable tube being configured to assume an open state when airflow through the retractable tube applies a radially outward pressure sufficient to overcome the radially inward pressure of the housing, and to assume a retracted closed state when airflow through the retractable tube is low such that the pressure applied by the airflow is less than the radially inward pressure of the housing; and

[0030] The open or closed state of the retractable tube serves as an indication of the state of airflow to the housing.

[0031] 8. A portable surgical system as described in embodiment 6, wherein the flexible tube comprises in whole or in part a plurality of perforations linearly arranged along the flexible tube.

[0032] 9. A portable surgical system as described in embodiment 8, wherein the distribution of the perforations along the flexible tube substantially follows the inverse of an elliptical function.

[0033] 10. The portable surgical system as described in embodiment 8, wherein the perforations are located along the flexible tube (x1, x2, x3, x4, ... x k ) follows the following specific set of mathematical expressions described in the specification: x1 = Φ1(V, d, D, ρ, k, L); x2 = Φ2(V, d, D, ρ, k, L); x3 = Φ3(V, d, D, ρ, k, L); ...x k =Φ k (V,d,D,ρ,k,L).

[0034] 11. The portable surgical system of embodiment 8, wherein the location of the perforation along the flexible tube is determined by a calculation comprising a plurality of iterations, the iterations further comprising:

[0035] In the first step, a set of outlet flow velocities is assigned to each perforation;

[0036] a second step, wherein the set of outlet velocities assigned in the first step is used to calculate a set of longitudinal flow velocities in the flexible pipe;

[0037] a third step, wherein the set of longitudinal flow velocities calculated in the second step are used to calculate a set of pressures corresponding to each perforation;

[0038] a fourth step, wherein the Bernoulli equation and the set of pressures calculated in said third step are used to calculate an updated set of exit velocities corresponding to each perforation;

[0039] a fifth step, wherein the updated set of exit velocities determined in said fourth step are scaled to satisfy mass conservation, thereby obtaining a set of estimated velocities corresponding to each perforation; and

[0040] The set of estimated speeds determined in said fifth step of an iteration is used as input for the next iteration.

[0041] 12. A portable surgical system as described in embodiment 11, wherein a set of outlet flow velocities assigned to each perforation in the first step of the first iteration follows a linearly increasing distribution.

[0042] 13. A portable surgical system as described in embodiment 11, wherein the calculation includes N iterations, so that after running each of the N iterations, the N sets of estimated outlet velocities determined tend to a stable distribution of outlet velocities (v F1 、v F2 、v F3 ,…v Fk ).

[0043] 14. The portable surgical system of embodiment 11, wherein the calculation further comprises:

[0044] The outlet velocity (v) as a stable distribution is determined by solving the following system of equations F1 、v F2 、v F3 、v F4 …v Fk ) is a function of a set of puncture locations (x1, x2, x3, x4, … x k ):

[0045] (where 1≤j≤k);

[0046] where α is calculated by setting the distance between the first and last punctures to the desired length: (x k -x1)=L to determine.

[0047] 15. A portable surgical system comprising:

[0048] a flexible housing that separates a surgical environment inside the housing from a user environment outside the housing, the housing including a flexible tube configured to receive air from an environmental control system;

[0049] wherein the flexible tube comprises in whole or in part a plurality of perforations arranged linearly along the flexible tube;

[0050] The positions (x1, x2, x3, x4, ... x5) of the perforations along the flexible tube k ) follows the following specific set of mathematical expressions described in the specification: x1 = Φ1(V, d, D, ρ, k, L); x2 = Φ2(V, d, D, ρ, k, L); x3 = Φ3(V, d, D, ρ, k, L); ...x k =Φ k (V,d,D,ρ,k,L).

[0051] 16. A method of configuring the portable surgical system of embodiment 1 for performing a surgical procedure on a patient, the method comprising:

[0052] Perform standard skin disinfection;

[0053] Apply the cut drape component over the patient;

[0054] placing required materials into the housing;

[0055] applying and securing a frame relative to the patient and the housing top;

[0056] engaging the environmental control system;

[0057] entering the housing through the arm opening; and

[0058] The surgical procedure is initiated by making an incision through the slit drape.

[0059] 17. A method of configuring the portable surgical system of embodiment 1 for performing a surgical procedure on a patient, the method comprising:

[0060] Perform standard skin disinfection;

[0061] placing the patient on the longer free flap of the housing;

[0062] securing the housing relative to the patient's torso with a strap;

[0063] forming a wall of the housing by connecting the long free flaps and the short free flaps of the housing;

[0064] placing required materials into the housing;

[0065] applying and securing a frame relative to the patient and the housing top;

[0066] engaging the environmental control system;

[0067] entering the housing through the arm opening; and

[0068] The surgical procedure was initiated.

[0069] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.

[0070] BRIEF DESCRIPTION OF THE DRAWINGS

[0071] The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention.

[0072] Figure 1 A side view of an inflated portable surgical housing adhered to a surgical site on a patient's torso via a cut surgical drape with air flowing from an air supply on the side of the housing closest to the patient's feet, directed in a cephalad longitudinal direction over the surgical site of the patient.

[0073] Figure 2 For Figure 1 A top view of an expanded portable surgical housing with two users working through an arm port in the operating portion over a torso surgical site and two users working through an arm port in the instrument portion.

[0074] Figure 3 is a side view of an alternative embodiment of a surgical shell utilizing a central frame and angled tethers in the cranial and caudal directions to help support the shell.

[0075] Figure 4 is perpendicular to Figure 3 An axial view of the view shown in , which shows the shape of the center frame and tethers that support it. The patient, instrument tray, and port are excluded from the illustration.

[0076] Figure 5 is a side view of an additional alternative embodiment utilizing two vertical frames at each of the cranial and caudal ends of the housing and tethers to support the surgical housing.

[0077] Figure 6 is perpendicular to Figure 5 An axial view of the view shown in , which shows one of the two identical frames and the shape of the tether supporting the housing.

[0078] Figure 7 for Figure 5 and Figure 6 , which shows how the frame and tethers prevent the housing from collapsing over the surgical site in the event of a sudden loss of pressure.

[0079] Figure 8 is perpendicular to Figure 7 Axial view of the view shown in .

[0080] Fig. 9 is a side view of an alternative embodiment of a surgical housing and frame, wherein a rigid frame fully supports the housing, the frame being attached to each side defining a top portion of the housing. The housing extends circumferentially around the patient's torso.

[0081] Fig.10 Shows Fig. 9 An oblique perspective view of the frame and plastic housing shown in FIG.

[0082] Fig.11 Schematic diagram of part of the air supply system outside the housing.

[0083] Fig.12 An alternative embodiment of the air supply system includes a backup hand pump.

[0084] Fig.13 An axial view showing the overhead inlet tube valve in the housing opening during active air inflow, signaling adequate flow.

[0085] Fig.14 Shows the positive pressure from the housing squeezing the system closed, thus sealing the system and preventing backflow. Fig.13 Axial view of the tube valve.

[0086] Fig.15 An exemplary embodiment of a material port is shown.

[0087] Fig.16 Alternative embodiments of material ports having different port sizes are shown.

[0088] Fig.17 An alternative embodiment of the material ports is shown where there is a small port on each set of sleeves and a larger port in the middle.

[0089] Fig.18 Alternative embodiments of material ports are shown, wherein the dual mode port may be fully open or only partially open as desired.

[0090] Fig.19 It is a side view at armhole level showing the user sleeve and glove in the inflated housing being squeezed together by the positive pressure in the surgical housing before their use.

[0091] Fig. 20 Schematic diagram of airflow inside the housing as it continuously passes through the valve system into and through the manifold system, where the perforation density varies along the manifold to produce a uniform flow.

[0092] Fig.21 To produce Fig. 20 Schematic diagram of the manufacturing process of an embodiment.

[0093] Fig. 22 For those involving Fig. 20 A graph of manifold perforation density and air outlet velocity for an embodiment of the invention.

[0094] Fig.23 Schematic diagram of airflow inside the housing as it continuously passes through the valve system into and through the manifold system, where the diameter of the perforations varies along the manifold to produce a uniform flow.

[0095] Fig.24 for Figure 3 and 4 Schematic sample setup workflow diagram for an implementation of the framework described in .

[0096] Fig.25 for Fig. 9 Schematic sample setup workflow diagram for an implementation of the framework described in .

[0097] Fig.26 Shown is a graph of particle concentration inside the housing as a function of environmental parameters obtained from testing on a prototype portable surgical system.

[0098] Detailed Description of Exemplary Embodiments

[0099] The present invention is more fully described hereinafter with reference to the accompanying drawings showing embodiments of the present invention. However, the present invention can be presented in many different forms and should not be construed as being limited to the embodiments set forth herein. On the contrary, these embodiments are provided so that the present disclosure is thorough and the scope of the present invention will be fully communicated to those skilled in the art. In the accompanying drawings, for clarity, the size and relative size of the layers and regions may be enlarged. The same reference numerals in the accompanying drawings represent the same elements.

[0100] It should be understood that when an element or layer refers to being "on" or "connected to" another element or layer, it may be directly on the other element or layer, or directly connected to the other element or layer, or there may be an intervening element or layer. In contrast, when an element or layer refers to being "directly on" or "directly connected to" another element or layer, there are no intervening elements or layers. It should be understood that for the purposes of this disclosure, "at least one of X, Y, and Z" may be interpreted as only X, only Y, only Z, or any combination of two or more of X, Y, and Z (e.g., XYZ, XY, YY, YZ, ZZ).

[0101] Figure 1FIG. 1 shows a preferred embodiment of a portable surgical system. The portable surgical system comprises a flexible plastic housing 1 which is configured to be supplied with air under positive pressure via an environmental control system 5. The housing 1 may be controlled via a control system such as Figure 1 The incision drape 11 shown in the figure is adhered to the surgical site of the patient 7. The incision drape can be a flexible plastic surgical drape and can include a removable skin adhesive on one side, with or without an antimicrobial impregnation. The portable surgical system can be configured so that filtered air is blown in or through a longitudinal tubular valve 2 having a wall of a flexible, shrinkable plastic (such as polyethylene), and through a manifold having perforations 3. Filtered air can be blown in to create a substantially uniform laminar air flow over the surgical site and through the housing.

[0102] Portable surgical systems may contain multiple ports, e.g. Figure 1 and 2 The arm opening 8 and material opening 10 shown in FIG. In an exemplary embodiment, the portable surgical system may include 4 pairs of integrated cuffed sleeves in the arm opening 8. Figure 2 As shown in the figure, the port 8 provides a user with access to the interior of the housing. The material port 10 can be used to move the surgical tray 9 to the interior of the housing 1 before the surgical procedure. The portable surgical system can also include an instrument tray holder 6, which can be placed around the legs of the patient 7. The tray 9 can be set on top of the instrument tray holder 6.

[0103] exist Figure 1 In the preferred embodiment shown in FIG, the density of perforations 3 defining the manifold outlet in the top tube decreases along the remainder of the manifold above the operative portion, so that the airflow over the cutting surgical drape 11 is substantially constant. If the environmental control system 5 is turned off, the flexible top tube 2 is squeezed closed, thereby sealing the housing 1 and preventing backflow to the fan and filter 5.

[0104] The portable surgical system may include a surgical housing, a frame, and an environmental control system.

[0105] A. Structure of surgical shell

[0106] In an exemplary embodiment, the surgical housing may be disposable, such as Figure 1 The housing 1 shown in FIG. 1 is a schematic diagram of a surgical housing 1. In an exemplary embodiment, the surgical housing can be supplied folded like a surgical gown. When configured, the surgical housing can include one or more top view panels 1a of optically transparent plastic (e.g., polyvinyl chloride). The remainder of the sides of the surgical housing can include a flexible, impermeable plastic, such as low-density polyethylene. The sides of the instrument portion can be shorter than those of the operating portion to fit over an instrument tray support. Figure 1In the preferred embodiment shown in , the bottom of the housing is continuous along the sides.

[0107] like Figure 1 As shown in , the panel of the incision drape 11 can be embedded in the bottom of the operating part. The incision drape acts as an interface with the patient's body. The size and shape of the incision drape 11 can be configured to cover the surgical site on the patient's body while substantially excluding the body surface from the outside of the surgical site. Figure 1 As seen in the figure, only the surgical site of the patient's body (i.e., the area covered by the cutting drape 11) is included in the interior of the surgical shell, while the rest of the patient's body is excluded from the sterile field. By excluding unnecessary body surfaces from the surgical shell, the effectiveness of the system is significantly improved, because the patient's body surfaces contribute to environmental contamination inside the shell. In particular, excluding highly contaminated areas (such as the oropharynx or genitals) may significantly improve the effectiveness of the system. The surgical shell 1 can include cutting drapes 11 of different shapes and sizes, and the cutting drapes 11 can be set at different positions on the surgical shell to suit the needs of different types of medical procedures. The bottom corners of the surgical shell can include straps for fixing the shell to the patient, or to the operating table for additional stability.

[0108] Fig. 9 and 10 A side view and a perspective view of a second preferred embodiment of a portable surgical system are shown, respectively. In a second preferred embodiment, the portable surgical system comprises a surgical shell 1 without a cut surgical drape, wherein the operating part of the patient is placed inside the shell, and wherein the bottom of the shell remains continuous along the side at the level of the instrument part. In the operating part of the shell, one side of the shell can be extended so that it can be inserted under the patient's body, thereby removing the continuous bottom panel. After passing under the patient's body, the remaining length of the extended side can be fixed to the shell side on the opposite side along the free edge of the extended side. The head end of the operating part 18 and the interface with the instrument part 18 can be fixed relative to the patient via an integrated strap.

[0109] Embodiments of the invention are described herein with reference to the accompanying drawings and illustrations, which are schematic illustrations of idealized embodiments (and intermediate structures) of the invention. Thus, variations in the shapes of the illustrations due to, for example, manufacturing techniques and / or tolerances are to be expected. Therefore, embodiments of the invention should not be construed as limited to the particular shapes of the regions shown herein, but rather are to include differences in shapes due to, for example, manufacturing.

[0110] The portable surgical system disclosed herein may include alternative or additional parts that may be added based on procedural needs to accommodate additional instrument trays or users. The above embodiments presented in this disclosure are intended only as exemplary embodiments, and it will be apparent to those skilled in the art that various modifications and variations may be made in the present invention without departing from the spirit or scope of the invention.

[0111] B. Structure of the Framework

[0112] exist Figure 3 and 4 In the exemplary embodiment shown in FIG. 1 , the portable surgical system may include a central frame 13 and tethers 14 that are intended to support the housing 1 in the event of a sudden loss of pressure. The central frame 13 may be lightweight and / or foldable for easy transportation. The frame may be made of rigid materials such as plastic, rigid polyethylene tubing, aluminum tubing, and other materials familiar to those skilled in the art. Figure 4 When viewed axially in the middle, the frame can include four inclined tubes that are reversibly secured to the instrument tray support or operating table so that the instrument tray support or operating table forms the base of a pentagon. One or more of these parts can be connected to each other via custom connectors or hinges configured to maintain the pentagon in the same plane. The highest vertex of the frame can be reversibly attached to the top of the disposable component, such as via a plastic slot formed in the disposable component or simply via a tether 14. The tether 14 can directly support the top of the disposable component, such as the disposable component. Figure 4 The plastic housing 1 is shown below the frame 13 and longitudinally above the cutting surgical drape 11 and the instrument tray support 6. The frame 13 and tethers 14 are configured to provide support to the housing 1 in the event of a sudden loss of pressure. Various other tether arrangements can be utilized depending on the needs of the system to optimize support from the central frame.

[0113] In another exemplary embodiment, the portable surgical system may include Figure 5-8 Frame 15 and tether 14 are shown in FIG. Frame 15 and tether 14 are configured to provide support to housing 1 in the event of a sudden loss of pressure. Instead of supporting the surgical housing in the center, frame 15 includes two vertical sections disposed at the head and tail ends of the housing. Figure 5 A side view of the frame 15 and tether 14 is provided, and Figure 6 A front view of the same system is provided. Figure 7 and 8 It is shown how the frame 15 and tether 14 support the deflated housing 1 b in the event of a sudden loss of pressure due to, for example, opening 10a.

[0114] In an exemplary embodiment, the portable surgical system may include a foldable rigid frame 16 and a Fig. 9 and10 The flexible plastic housing 1 shown in and described in paragraph 3 of the section "Structure of the Surgical Housing" is provided, wherein the surgical housing 1 surrounds the torso of the patient 7. The portable surgical system according to this embodiment does not require a separate instrument tray support. The housing 1 is reversibly sealed in the suprapubic region and underarms of the patient via adjustable openings 18. The structural reliance of this embodiment on positive pressure is not as great as Figure 1-8 The frame may comprise six vertical parts forming two connected sides of a partial cube which can be reversibly attached to the patient or under the operating table. Fig. 9 and 10 As seen in FIG. 1 , the frame may include two parts at the head end, two parts at the tail end, and two parts at the connection between the operating portion and the instrument portion. These parts may include telescopic features to accommodate different sagittal abdominal diameters of the patient's body. These vertical parts may be as shown in FIG. Fig. 9 , where three parts are located horizontally at the top, and two additional horizontal parts define the instrument tray portion; these latter two parts are located at the level required for the instrument tray support above the patient. The frame may also include two longitudinal parts (which are perpendicular to the two above-mentioned types, forming the operating part); and two additional longitudinal parts (which form the instrument part). One or more of all these parts may be connected via hinges or custom connections. The housing may be reversibly connected to the frame 17 in such a way that a uniform outward tension is placed on the top view panel.

[0115] C. Mouth

[0116] Various embodiments of the portable surgical system may have a surgical housing that includes multiple ports. The housing may include two main types of ports. The first type of port on the housing is such as Figure 1 , 2 , 3, 5, 7 and 9, which allow the provider's arm or an augmented instrument (such as a laparoscope or robot) to enter the interior of the housing.

[0117] The number of arms depends on the program requirements. Figure 1 , 2 The preferred embodiment shown in Figures 1, 3, 5, 7 and 9 includes four pairs of arm ports 8, two pairs on each side of the housing 1. The arm ports can take three main forms depending on the use scenario. The first form of arm port is a simple opening in the side of the housing that is reversibly sealed against the user's arm. The second form of arm port is a Figure 2The sleeve shown in 8 is a hollow cylinder or a frustrated cone of impermeable plastic that tapers gradually away from the wall toward the inside of the shell. The length of the sleeve is sufficient to allow ergonomic transfer of instruments between the ports at the opposite ends of the system. The material of the sleeve can be the same as that used for the sides of the shell, or it can be a different material (such as that used in surgical gown sleeves). The sleeve end can be free or can contain a cuff of elastic material to fit the user's wrist. A third form of arm port is the same as the second form, but terminates in a glove. Fig.19 A side view at armhole level is shown showing the user sleeve and gloves in the expanded housing. The user sleeve and gloves are compressed together by the positive pressure in the surgical housing before their use.

[0118] The second type of port on the housing is as follows Figure 1 , 3 , 5, 7 and 9, which allows the instrument tray 9 and instruments to be moved into the housing 1 before the procedure. In addition, the port allows materials to be moved in and out of the housing during the entire surgical procedure. In the case of a caesarean section, it is necessary to be able to quickly and ergonomically transfer the newborn child out of the housing so that it can receive care.

[0119] Figure 15-17 Various possible configurations of the ports are shown, although other embodiments are considered consistent with the nature of the claims. In an exemplary embodiment, the housing 1 may include Fig.15 The large opening 10b shown in Fig.16 and 17 The small opening 10c shown in FIG. 1 or the small opening 10c shown in FIG. Fig.16 and 17 The large opening 10b and the small opening 10c are shown in the figure. The small opening 10c is configured so that small items can be transferred into or out of the enclosure without a significant relative loss of enclosure volume or pressure, regardless of frame availability, because the environmental control system (e.g., a fan) can increase the gas inflow to match the outflow. The large opening 10b allows large items (such as instrument trays, newborns, etc.) to be moved into and out of the enclosure. Fig.18Shown is an exemplary embodiment of a mouth, wherein a connector 29 divides the mouth into two halves, allowing it to be used as a small mouth or a large mouth. This dual-mode mouth 10d ensures that any user can enter the small mouth and the large mouth. In addition to occasionally approaching large items, the mouth can also provide continuous access to lines, pipes, wires and discharges that need to approach external resources. Connector 29 can be a zipper head that slides on the zipper teeth row to adjust the size of the mouth. Alternatively, it can be a material (such as hooks and loops or magnets) that provides rapid reversible attachment. Material mouths can be realized in many ways. They must be easy to open and close repeatedly, as can be realized by using magnetic strips, hooks and loops, plastic zippers, flexible expandable tubes compressed to each other, or other methods.

[0120] D. Environmental control system

[0121] The portable surgical system includes an environmental control system. In a preferred embodiment, Fig.11 An environmental control system is shown in which can include a HEPA filter 19 connected to the housing via a sterile flexible tube 23, a fan (motor blower) 21, a filter-blower adapter 20, a battery 24 and a control part 25. These external components (i.e., components 19, 20, 21, 23, 24 and 25) are collectively referred to as an air supply system. The battery 24 can be disposable or rechargeable, and the system can also cut off the power grid 22 if the procedure occurs in an environment where this is possible. The air supply system can be connected to the flexible top tube 2 of the surgical housing with a flexible tube so that the inlet height of the top airflow tube 2 can be adjusted based on the expansion level of the housing 1. The HEPA filter immediately downstream of the air inflow can be changeable and customizable so that it provides one or more other controls based on the needs of the procedure, such as a humidity regulator filter, the gas content of the supplied medical gas, or a temperature regulator with a heating / cooling water tank.

[0122] In an alternative exemplary embodiment, the air supply system comprises Fig.12 21 and a hand pump 27. The hand pump 27 provides redundancy and can be used when there is no available power supply, or provides a higher flow rate without consuming electricity. The hand pump can be implemented in any number of mechanical settings familiar to those skilled in the art, including but not limited to via a manual or pedal-type bellows pump or other common positive displacement pumps, or a manual or pedal-type rotary pump. The air supply system can also include one or more one-way valves 26, which allow air from only the electric fan 21 or only the hand pump 27 to flow to the plastic housing. The filter 19 is located downstream of the electric and manual air supply.

[0123] An external air supply system is connected to the housing. In an exemplary embodiment, air is supplied through the inlet and thus blows through the entire housing from the head side to the tail side. The expansion time of the surgical housing 1 or by Fig. 9 The adequacy of airflow can be checked by the rise of the windsock in the housing embodiment shown in FIG. The windsock can include a short flexible plastic tube of the same material as the housing side. In another exemplary embodiment, the inlet is connected to a horizontal manifold extending from side to side over the patient. The manifold can include additional folds of housing side plastic that are sealed together into a tubular structure and perforations 3 to produce a parallel, uniform, laminar air outflow stream into the housing.

[0124] In a preferred exemplary embodiment, the inlet is connected to a flexible tube (such as Figure 1 and 2 The flexible tube 2 is connected to the top flexible tube 2 shown in FIG. The flexible tube 2 may include a plurality of perforations 3 acting as a manifold. The flexible tube may extend from one side to the other, or along the shell. The flexible tube may be formed by sealing the folded portion of the shell into a tubular structure. The flexible tube may be a foldable tube that opens when air is blown into the shell and closes when the air is moved out of the shell so that the transmural pressure from the shell facilitates the tube to contract.

[0125] In a preferred exemplary embodiment, the flexible tube may include a plurality of perforations 3 arranged so as to produce parallel, uniform, laminar air outflow flows into the housing. Figure 20-22 As described in detail in the design and manufacturing implementation described in , in our preferred embodiment uniform airflow is achieved by varying the density of perforations in the retractable tube, wherein the density of the perforations is higher at the end of the tube closer to the air 31 supply and the density of the perforations decreases as the distance from the supply increases until the density reaches its lowest value at 37.

[0126] The inventors of the present application have recognized that a nearly uniform air flow can be achieved when the density of perforations along the tube is reduced according to the inverse of an elliptic function. Starting from the observation that the pressure in an inviscid flow will rise along streamlines if the velocity of the air flow decreases, the inventors of the present application have found that in a tube with perforations of constant cross-sectional area, the velocity in the tube will decrease as the air flows through the perforations from which the flow emanates, as long as the flow has a nearly constant density, which is the case for air flows well below the speed of sound. Furthermore, the inventors have recognized that the pressure in the perforated tube rises as the distance from the source increases, and therefore, assuming that the perforations have a constant cross-sectional area, the velocity of the flow from each perforation rises with the distance from the source. As Fig. 20 As shown in FIG. 3 , the velocity is low 35 at a location close to the source 31, and is high 36 at a location far from the source 31. If the density of the perforations is uniform, the air flow rate is too large at a location far from the source, and too small at a location closer to the source.

[0127] An exemplary embodiment of the present invention discloses a flexible pipe 2 (such as Figure 1 , 2 , 11 and 20), which includes being arranged at such positions (x1, x2, x3, x4, ... x along the tube k ) to create multiple perforations for uniform air flow. Fig. 20 The exemplary embodiment in Figure 1 shows a tube that includes a plurality of perforations arranged in a uniaxial row along the tube. The tube may include a plurality of axial rows of perforations arranged on the circumference of the tube so as to cover the entire surface of the tube, or only a certain desired area (such as an area toward the surgical site). The plurality of axial rows may be substantially parallel to each other and to the tube axis.

[0128] The perforations are arranged along the flexible tube so that the axial positions of the perforations along the flexible tube can follow a mathematical relationship (x1, x2, x3, x4, ... x k ) = Φ(V, d, D, ρ, k, L), where V is the air velocity from the source, D is the diameter of the tube, d is the diameter of the perforations, and ρ is the air density, L is the length of the perforated portion, and k is the number of perforations in the row. The mathematical relationship Φ(V, d, D, ρ, k, L) is determined as explained below.

[0129] The location of the perforations along the flexible pipe can be represented by the following multiple mathematical expressions: x1 = Φ1 (V, d, D, ρ, k, L); x2 = Φ2 (V, d, D, ρ, k, L); x3 = Φ3 (V, d, D, ρ, k, L); ... x k =Φ k (V, d, D, ρ, k, L); where V is the air velocity from the source, D is the diameter of the tube; d is the diameter of the perforation, and ρ is the air density. Mathematical expressions Φ1(V, d, D, ρ, k, L), Φ2(V, d, D, ρ, k, L)…Φ k (V, d, D, ρ, k, L) is determined as explained below and may be an expression in the form of a closed solution to (V, d, D, ρ, k, L).

[0130] The perforation density required for a particular pattern for uniform air flow can be determined by iterative calculation.

[0131] Iterative calculation may include multiple iterations, where each iteration includes Fig.21 In the CPU 38, it starts with an assumed form of outlet velocity 39 (e.g., a linearly increasing distribution). These assumed outlet velocities will be denoted as v j , each of the plurality of wells numbered j=1 to k uses a unique subscript (ie, Fig. 20 The speeds v1, v2, v3, ...v shown ink Corresponding to perforations 1, 2, 3...k).

[0132] In the first step of the first iteration (see Fig.21 40), it assumes the form of the outlet velocity 39. The assumed outlet velocities (i.e., v1, v2, v3, ... v k ) can be distributed in a linearly increasing manner (e.g. ) where V is the axial air velocity at the source, D is the diameter of the tube, d is the diameter of the perforation, k is the number of perforations, and j is the perforation or hole index.

[0133] In the second step of the first iteration (see Fig.21 41), the estimated exit velocities (v1, v2, v3, ...v k ) is used to calculate the estimated velocity v_tube 41 in the tube (ie, v_tube 1; v_tube 2; v_tube 3; ...; v_tube k ). Speed ​​v_tube n is the axial velocity in the portion of the tube between perforation "n" and perforation "n+1". Conservation of mass requires that for any number of holes n in a tube of diameter D with perforations of diameter d, the following equation is satisfied:

[0134]

[0135]

[0136] where ρ is the air density, d is the diameter of the perforation, and D is the diameter of the tube. The above equation provides the velocity inside the tube (i.e., v_tube1; v_tube2; v_tube3; ...; v_tube k ).

[0137] In the third step of the first iteration (see Fig.21 42), as explained below, the velocity within the tube is used to calculate a set of pressures (p1, p2, p3, ... p k ). The axial flow in the interior of the tube can be modeled as an inviscid flow. The Bernoulli equation can be used to provide a prediction of the pressure in the tube as a function of the velocity inside the tube calculated in the previous step (i.e., v_tube1; v_tube2; v_tube3; ...; v_tube k ). Assume that the velocity in the tube near the end cap is 0, the velocity at the source is V, and the air density is constant ρ. The pressure at the end of the tube farthest from the source is given by:

[0138]

[0139] This value of pressure P is then used to estimate the pressure 42 inside the tube at each of a number of holes numbered j=1 to k as follows:

[0140]

[0141] These pressures are calculated at each hole and expressed as vectors (p1, p2, p3, ... k )storage.

[0142] In the fourth step of the first iteration (see Fig.21 43), the pressure (p1, p2, p3…p k ) is used to calculate a new estimate of the exit velocity. The flow from the interior of the tube to the exit orifice can be simulated as an inviscid flow. The Bernoulli equation can be used to provide a predicted value for the exit velocity, as shown below:

[0143]

[0144] The above relationship can be used k times (for each number of holes from 1 to K) to calculate the exit velocity estimate at each perforation or hole (i.e., v_u1, v_u2, v_u3 ... v_u k ). Updated exit velocity estimate v_u j Different from the initially assumed distribution (i.e., v1, v2, v3, …v k ).

[0145] By conservation of mass, the sum of the exit velocities must obey the following relationship:

[0146]

[0147] In the fifth step of the first iteration, the exit velocity estimate calculated in the fourth step is used to calculate a set of velocities (v 2-1 、v 2-2 、v 2-3 、v 2-4 ,…v 2-k ). Calculate this set of speeds as follows:

[0148]

[0149] This group of speed v 2-j The calculated exit velocity v_u is retained j , but by scaling each value their magnitudes are adjusted to satisfy mass conservation. and multiply it by the known mass flow supply VρπD 2 / 4 to zoom.

[0150] The outlet velocity distribution (v 2-1 、v 2-2 、v 2-3 、v 2-4 ,…v 2-k ) is used as the updated estimate for the second iteration. For the second iteration, repeat steps 2 to 5 ( Fig.21 41 to 43 in ), thereby obtaining a velocity distribution to be used as an updated estimate for the third iteration. The process is iterated until it converges to a stable distribution of exit velocities (i.e., v F1 、v F2 、v F3 、v F4 …v Fk ). If the total area of ​​the perforations is not small compared to the cross-sectional area of ​​the tube, then the outlet velocity distribution obtained can be approximately elliptical.

[0151] The density of the perforations 44 is determined by making it proportional to the inverse of the exit velocity. In the exemplary embodiment, the position coordinates of the k perforations along the tube are denoted as x1, x2, x3, x4, ... x k , where x k is the distance between perforation k and a reference point on the tube between the air source and the first perforation. The position x can be calculated from a set of equations: j (where j is 1 to k):

[0152] (where 1≤j≤k)

[0153] where α is set by setting the distance between the first and last punctures to the desired length: (x k -x1)=L to determine.

[0154] The above equations allow the technician to derive the mathematical expressions x1 = Φ1(V, d, D, ρ, k, L); x2 = Φ2(V, d, D, ρ, k, L); x3 = Φ3(V, d, D, ρ, k, L); ... x k =Φ k (V, d, D, ρ, k, L), thus providing the location and density of perforations as a function of the parameters (V, d, D, ρ, k, L). The function Φ can be expressed in closed form by the expression n (V,d,D,ρ,k,L).

[0155] Alternatively, the set of parameters can be associated with the resulting position determined by the above algorithm, (V, d, D, ρ, k, L) → (x1, x2, x3, x4, ... x k ), thus forming the function (x1,x2,x3,x4,…x k)=Φ(V,d,D,ρ,k,L). The function Φ(V,d,D,ρ,k,L) can be expressed by an expression in the form of a closed-form solution.

[0156] Depending on the desired perforation location / density (i.e., x1, x2, x3, x4, ... x k ), the position and density of the perforations calculated in the CPU 38 are implemented by the punching die 45 at a position above the transparent plastic tube. The resulting perforation distribution will essentially follow the inverse of the elliptical function. By making the density of the perforations the inverse of the elliptical function, the resulting air distribution in the surgical area is uniform throughout, providing advantages in the quality of the surgical results.

[0157] In an exemplary embodiment of the present invention, a method for manufacturing a portable surgical system may include: (1) running the above-mentioned iterative calculation on a CPU; (2) receiving from the CPU, at a machine for cutting perforations into a tube material, positions (x1, x2, x3, x4, ... x5) corresponding to the perforations. k ); (3) at the position (x1, x2, x3, x4, ... x) received from the CPU k ) at which a perforation is cut into the tube material.

[0158] As an illustration, in Fig. 22 The resulting velocity distribution and perforation density distribution are depicted in a graphical form in FIG. This description is for a case where there are 10 perforations in a collapsible flexible tube, and it will be appreciated that the method can be extended to other numbers of perforations. The number of holes is on the x-axis, and the exit velocity 46 and the perforation density 47 (normalized so that the maximum values ​​are consistent) are represented on the y-axis.

[0159] In another exemplary embodiment, it is also possible to Fig.23 An alternative arrangement of perforations in the flexible tube shown in is used to achieve the above uniform air distribution. In this arrangement, the perforations are equidistant (in Fig.23 The middle distance is denoted as x), while the diameter of the perforation varies (i.e., d1, d2, d3, ... d k ) so that the air flow through each perforation is the same and a 1 / k ratio of the total flow through the manifold. The goal in this case is to uniformly distribute the air flow through each perforation x. i The total area of ​​the perforation is integrated. The die system can be used to form the holes at points x1, x2, x2, ..., x k Cut the correct hole diameter at the

[0160] In contrast, another alternative embodiment of the air handling system within the housing runs the airflow longitudinally along the top center from caudal to cranial.

[0161] As about Fig.13 and14 As described, the portable surgical system may include a flexible tube 2 (eg, Figure 1 , 2 , 11 and 20) to prevent air from flowing back from the surgical housing into the fan and filter. Fig.13 and 14 A cross section through a portion of the surgical housing 1 and a flexible tube 2 attached to or integrated into the surgical housing 1 is shown. Fig.13 The flexible tube is shown in an expanded state when air is blown into the surgical housing from the air supply system 5 . Fig.13 An axial view showing the overhead inlet tube valve in the housing opening during active air inflow, signaling adequate flow. Fig.14 Shows Fig.13 The positive pressure of the housing squeezes the valve closed, sealing the system and preventing backflow. Fig.13 Axial view of the tube valve. Fig.14 The flexible tube is shown in a collapsed state when the air pressure within the housing pushes air from the housing to the outside of the housing. The collapsed tube 2 prevents air from leaving the housing.

[0162] The retractable tube may be made of a flexible material so as to switch from an open state to a closed state, and vice versa, based on air flow. Air flow from the air supply system first passes through an inlet tube valve 2 comprising a sealed tube of retractable plastic. When there is a net positive flow through the tube to the manifold in this configuration, the transmural pressure is positive relative to the shell and the tube is forced open. When there is no air flow or there is reverse air flow, the transmural pressure drops relative to the shell, resulting in longitudinal contraction of the tube. The tube valve reduces additional flow in an over-pressurized environment of the shell when positive shell pressure creates a transmural pressure that favors valve contraction; prevents backflow when positive shell pressure seals air out through the valve; and also serves as an indicator of adequate air flow by virtue of its expansion. Air flow is then allowed to enter the manifold 3 as implemented above in the horizontal manifold system. The relative lengths of the valve and manifold are determined by pressure and air flow program requirements; but the manifold should preferably extend at least the entire length of the operating portion.

[0163] E. Methods for setting up the surgical enclosure with respect to standard surgical workflow

[0164] An exemplary embodiment of the present invention also discloses a method of using the ultra-portable surgical system, the method comprising: Fig.24Steps described in the flow chart. The sterile area corresponding to the surgical drape area in the standard procedure setting includes the entire closed area and sleeve. This method is applicable to all embodiments that utilize a cut surgical drape interface. The user first disinfects the patient's skin 48 using any standard skin antiseptic according to the usual protocol, as long as the standard skin antiseptic provided is allowed to dry completely before applying the cut surgical drape. The user then determines the direction of the surgical shell and cut surgical drape over the planned surgical site 49, extends the instrument portion caudally, sets the shell 50, and adds the required instrument tray and gloves 51 through the material port. Since the entire system is pre-sterilized in the package, the air inside is sterile until the sterile instrument tray is placed. The shell is then connected to the frame 52, which is then stabilized on the instrument tray support, strapped down relative to the patient or operating table for additional stabilization 53, and the environmental control system is turned on 54. The inlet tube valve is expanded as an indication of sufficient airflow through the environmental system. Therefore, the first expansion is also an initial cleanup of any contamination introduced in this step. When the system is fully inflated or the indicator is activated, the environmental system is switched to maintenance mode 55. At this point, the user can place the arm through the arm port in standard protocol, apply gloves or overgolves 56, and begin the procedure 57. Maintenance mode is a program option where the air exchanges are scheduled to be different from those used for initial inflation or options that recirculate air through the exhaust system to extend filter life, but maintenance mode can also be unchanged from existing modes. For use of the arm port, it is recommended that the provider wear a pair of sterile inner gloves (undergolves) and then don a second pair of gloves inside the outer shell in standard double gloving procedures to seal the sleeve port embodiment of the arm port.

[0165] At the end of the procedure following any appropriate skin closure and dressing application, the user removes the tray and any items from inside the housing, cleans any blood or body fluids from inside the housing, removes gloves, then removes the arm from the arm port, turns off the environmental control system, removes the air supply tubing from the air handling inlet, pulls the housing off the frame and away from the patient, and discards the housing, and disposes of the housing.

[0166] For implementation systems that do not use cutting surgical drapes, Fig.25The setup method is described in . In this case, the user places the patient directly on the bottom flap of the operating part 58, places the instrument and gloves into the planned housing 60, connects the bottom flap to the sides of the housing 60, nails the housing from the cranial to the caudal side relative to the patient 61, and then assembles the frame while connected to the housing 62. The environmental control system is engaged 63 and the windsock at the air inlet is monitored to check for adequate flow. When the housing is sufficiently filled with clean air as shown by the indicator (based on air exchange), the environmental system is switched to maintenance mode 64. At this point, the user can place the arm through the arm port in the standard protocol, apply the glove or outer glove 65, and start the procedure 66.

[0167] Although only a few embodiments have been described in detail above, those skilled in the art will appreciate that many changes can be made to the described embodiments without departing from the spirit of the invention.

[0168] F. Supportive Research

[0169] The inventors have implemented various embodiments, such as those described herein in particular, by manufacturing and testing fully self-contained portable surgical systems. In Teodorescu et al. (2016), the inventors have demonstrated an early proof of concept showing that the housing provides 100% protection against external active particle contamination even without an environmental control system engaged ( Fig.26 ). The inventors also demonstrated that even when enclosure contamination reached levels found in a machine shop utilizing charcoal combustion, an air exchange of 2.25 was sufficient to consistently bring contamination particle levels to 0 particles per cubic centimeter. Subsequent systems reduced sensitivity to enclosure contamination and increased setup speeds via the above scheme (e.g., as described in Teodorescu et al. 2017).

[0170] The features of the invention disclosed herein, as specified by the actual surgical end user, distinguish it from the prior art by enhancing usability, ergonomics, independence from external resources, and reliability in field conditions. The inclusion of only the surgical site within the enclosure (excluding the remainder of the patient's body from the sterile field, particularly high contamination areas such as the oropharynx or genitals) increases the effectiveness of the system. The ability of the invention to isolate contamination from surgical wounds (such as blood and body fluids) and contain these contaminants during the product's life cycle is also a key feature.

[0171] It will be apparent to those skilled in the art that various modifications and variations may be made to the present invention without departing from the spirit or scope of the present invention. Therefore, the present invention is intended to cover modifications and variations of the present invention as long as they are within the scope of the appended claims and their equivalents.

[0172] G. References

[0173] The following documents cited in this article are not admitted to be prior art. The following documents cited in this article are hereby incorporated by reference: [1] WO / 2014 / 145032, (GNANASHANMUGAM), March 15, 2013; [2] WO2011041665A2, (HENDERSON), October 1, 2009; [3] WO2005092229, (KRIEK), March 24, 2004; [4] US20070102005 A1, (BONUTTI), August 28, 2001; [5] US6199551B1, (KUSLICH), December 8, 1998; [6] US5299582A, (POTTS), September 16, 1991; [7] WO860 6272, (SCOTT), April 23, 1985; [8] US4367728A, (MUTKE), September 7, 1979; [9] US4275719A, (MAYER), March 30, 1979;

[10] US3051164 A,(TREXLER), August 17, 1959;

[11] American Society of Heating, Refrigeration and Air-Conditioning Engineers(2011).Health Care Facilities(IP).In ASHRAE 2011Handbook-HVAC Application. Atlanta: ASHRAE.;

[12] Allegranzi, B., Bagheri Nejad, S., Combescure, C., Graafmans, W., Attar, H., Donaldson, L., and Pittet, D. (2011). Burden of endemic health-care-associated infection in developing countries: a systematic review and meta-analysis.Lancet.377(9761):228-41.;

[13] Edmiston, CE, Seabrook, GR, Cambria, RA, et al. (2005). Molecular epidemiology of microbial contamination in the operating room environment: is there a risk for infection. Surgery.138(4):573-582.

[14] Sehulster,L.and Chinn,R.Y.W.,2003,“Guidelines for Environmental Infection Control in Health-Care,”. www.cdc.gov / mmwr / preview / mmwrhtml / rr5210a1.htm .

[15] Selcen Kilinc,F.(2015).A review of isolation gowns in healthcare:fabric and gown properties.J Eng Fiber Fabr.10(3):180-190.;

[16] Teodorescu DL,Miller SA,Jonnalagedda S.SurgiBox:An ultraportable system to improve surgical safety for patients and providers in austere settings.IEEE Xplore GHTC 2017(accepted,awaiting publication).;

[17] Teodorescu DL,Nagle D,Hickman M,King DR.An ultraportable device platform for aseptic surgery in field settings.ASME J Medical Devices.J.Med.Devices 10(2),020924(May 12,2016);

[18] Whyte,W.,Hodgson,R.,and Tinkler,J.(1982).The importance of airborne bacterial contamination of wounds.Journal of Hospital Infection.3:123-135。

Claims

1. A portable surgical system comprising: (a) a flexible housing that separates a surgical environment inside the housing from a user environment outside the housing, the housing comprising: a cutting drape embedded in a bottom portion of the operating portion of the housing and configured to be disposed over or around a surgical site on a patient's body and to expose the surgical site, wherein the cutting drape is sized and shaped to cover the surgical site on the patient's body; a flexible tube attached to the interior of the flexible housing and disposed over the surgical site; a plurality of perforations arranged in an axial direction of the flexible tube according to determined diameters and positions to support a substantially uniform laminar air flow in the flexible tube such that the air flow rate through each perforation is the same; one or more areas of high optical clarity for viewing the interior of the housing; wherein when the surgical system is deployed in use, only the surgical site covered by the cut surgical drape is contained within the surgical housing, and the remainder of the patient's body is substantially excluded from the surgical environment within the housing; (b) an environmental control system connected to the flexible tube and configured to supply air to the housing to create substantially sterile conditions inside the housing; as well as (c) one or more ports for accessing the surgical site.

2. The portable surgical system of claim 1, wherein the environmental control system is configured to provide a positive pressure to the housing and increase an inflow of gas into the housing to match an outflow.

3. The portable surgical system of claim 1 , wherein the one or more ports for accessing the surgical site are configured to allow augmented instruments that replace arms to enter the interior of the housing, and wherein the augmented instruments include a laparoscope or a robot. 4 . The portable surgical system of claim 1 , wherein the portable surgical system further comprises a frame attached to the housing and configured to provide support for the housing in the event of a sudden loss of pressure within the housing.

5. The portable surgical system of claim 1 , wherein the one or more ports for accessing the surgical site include a dual-mode port configured to allow a user to adjust the size of the dual-mode port via a zipper, fasteners, or a magnetic strip.

6. The portable surgical system of claim 1 , wherein the flexible tube is configured to receive air from the environmental control system, the flexible tube comprising in whole or in part a retractable tube configured to function as a valve system, wherein the retractable tube is configured to assume an open state when air flows from an air supply system outside the housing through the retractable tube into the housing; and The retractable tube is configured to assume a closed, retracted state when air pressure within the housing pushes air from the housing to the outside of the housing, thereby preventing air from leaving the housing.

7. The portable surgical system of claim 1, wherein the surgical system comprises a disposable component including the housing and a reusable component including the environmental control system.

8. The portable surgical system of claim 1, wherein the surgical system is lightweight and configured to be provided folded like a surgical gown.

9. The portable surgical system of claim 1 , wherein the incision drape is a flexible plastic surgical drape comprising a removable skin adhesive on one side, wherein the housing is configured to adhere to a surgical site of a patient through the incision drape.

10. The portable surgical system of claim 1 , wherein the flexible tube is configured to receive air from the environmental control system and configured to supply the received air to the housing, wherein the flexible tube comprises, in whole or in part, one or more rows of axial perforations, the one or more rows of axial perforations being substantially parallel to each other and to an axis of the flexible tube.

11. A portable surgical system comprising: (a) a flexible housing that separates a surgical environment inside the housing from a user environment outside the housing, the housing comprising: One or more ports for access to the surgical site, a flexible tube attached to the interior of the flexible housing and disposed over the surgical site; a plurality of perforations arranged in an axial direction of the flexible tube according to determined diameters and positions to support a substantially uniform laminar air flow in the flexible tube such that the air flow rate through each perforation is the same; one or more areas of high optical clarity for viewing the interior of the housing, wherein when the surgical system is deployed in use, the housing is configured to surround a torso of a patient such that the torso is located inside the housing, wherein the housing is reversibly sealed to the patient's torso through one or more adjustable openings; (b) an environmental control system connected to the flexible tube and configured to supply air to the housing to create substantially sterile conditions inside the housing.

12. The portable surgical system of claim 11, wherein the housing does not include a cutting drape and is a drape-less housing.

13. The portable surgical system of claim 11, wherein the portable surgical system further comprises a foldable rigid frame configured to be attached to the housing via a hinge or connector, wherein the frame provides support for the housing in the event of a sudden loss of pressure.

14. The portable surgical system of claim 13, wherein the frame includes one or more parts or components that include telescoping functionality to accommodate different body sizes.

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