Abstract:
A collapsible containment apparatus ( 36 ) with a first hub ( 21 ), a second hub ( 22 ), a plurality of articulated arms ( 23, 25 ) coupled to the first hub ( 21 ), a plurality of support arms ( 24 ) coupled to both the second hub ( 22 ) and the articulated arms ( 23 ), and a flexible canopy ( 73 ) carried by the articulated arms ( 23 ). The apparatus ( 36 ) is collapsed by relative movement of the two hubs ( 21, 22 ) away from one another, and deployed by relative movement of the hubs ( 21, 22 ) toward one another. When the apparatus ( 36 ) is deployed the canopy ( 73 ) creates a closed interior environment, which may be sterile.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of and claims priority of PCT/US2014/038698, with an International Filing Date of 20 May 2014, the disclosure of which is incorporated herein by reference. 
     
    
     FIELD 
       [0002]    The present invention relates to a portable designated work station. 
       BACKGROUND 
       [0003]    Containment of an isolated sterile environment and controlled processes within the environment are central ideas behind having a deployable compact surgical and biological apparatus and methods of use. One application for the apparatus is to perform surgical, medical and non-medical procedures with post-operation capability. Current systems spaces have limitations; they are large, not collapsible, limited in number, stationary, and must contain the patient&#39;s entire body, even in mobile medical units. In addition to these limitations, and in spite of these sterile precautions, nosocomial infections due to cross-contamination and exposure to exogenous or endogenous airborne contaminants are still very high. There is a need for a sterile controlled microenvironment. In larger scale emergencies, battlefields, and areas of conflict, mobile field treatment units and other disaster response surgical field units are widely used in spite of their limitations of number, locations, size, cost and time of deployment and limitation of functions. After initial treatment there is a need for post-surgical care facilities for large wounds, amputations and burns. More often, specific wound treatment and healing, such as skin grafting treatment, may require specific procedures and highly specialized facilities for treatment and containment, one of which is hyperbaric oxygen therapy (HBOT). HBOT chambers are large, complex to use, expensive to manufacture and assemble, and require specific medical facilities. These chambers are often used for limited time periods for diabetic wounds and persistent wound infection treatment. All of these treatments require the placement of the patient entirely within a controlled space with limited access for direct treatment, and an expensive hospitalization with the presence of an aseptic environment; which are limited and hard to maintain. Such contained spaces are not always available, are limited in numbers and are expensive. 
         [0004]    An immediate step is wound control, preparation and treatment, while post-care and healing comprise a longer term step. During these processes, medical dressings are not able to contain the wound while keeping it directly accessible for monitoring to the care provider. Bandages and liquid dressings may trap foreign contaminants in the wound, and may not prevent further contamination. Therefore, there is a critical need for site accessibility for treatment methods of wound and burn triage, along with containment to help prevent further complications that can lead to undesirable outcomes. 
         [0005]    In a wide range of laboratory and industrial settings for biological, chemical, electronic or other special processing needs, there is the need to perform the work in a sterile, aseptic or isolated and contained environment. Special requirements are sometimes overwhelming and costly to achieve. 
       SUMMARY 
       [0006]    Presently there is no solution for an expandable, portable, small, light-weight, inexpensive and optionally sterile microenvironment. The invention solves this problem. 
         [0007]    The deployable compact surgical and biological apparatus and methods of use can provide a full or partial solution. The apparatus is an expandable, reversible controlled microenvironment system; it is light and portable, and fits many applications. It meets the individual and diverse tasks in medical, laboratory, and industrial fields. The present invention provides an isolated space or volume which may expand longitudinally to enclose a controlled environment; allows visual observations; allows manipulation, insertion, and/or removal of items within the interior space through one or more particular sleeves; while maintaining an isolated and sealed environment. The device provides either full or partial containment of objects which are contained within, or interface with, the controlled microenvironment. 
         [0008]    This invention fulfills the need for a sterile expandable, controllable, small, deployable, portable and practical solution to properly contain and support surgical sites, treatment and healing of wounds, and application of medication and analgesics. In addition the invention will facilitate skin grafting and in-vivo tissue and cell culture, without the loss of wound containment integrity and its surrounding environment sterility. Fully or partially containing the subject for wound treatment within a collapsible apparatus will address the immediate needs of the patient while being easily carried by the medical personnel in their pack. This need is not only required in the secondary care unit but as a primary triage measure to contain the wound as soon as it happens to prevent loss of vital tissues, tissue functions and costly infections. This invention meets these needs, and also can provide a controlled microenvironment to conduct otherwise complex and costly procedures. 
         [0009]    In addition, the invention meets the requirements of incubators for various applications. These applications can include neonatal incubators, tissue and cell culture incubators and general biological incubators. Acting as an incubator, the invention can also sterilely isolate, and allow independent manipulation of different contained items internally without cross-contamination. Each internal compartment can have its own independently controlled microenvironment. The invention meets the requirements of isolated and controlled environments. 
         [0010]    The invention can incorporate fluid delivery ports, air-locked bi-directional sleeves and sealing features. It is capable of introducing gases and/or other fluids into the enclosed work space, and can include components and features that control the nature, purity, temperature, humidity, light and/or sterility of gases or other fluids introduced into the enclosed space. These components and features can include pumps, filters, ultraviolet, ozonizer sterilizers, conduits, couplings, canisters, valves, similar fluid control devices, electrical controls, direct and indirect lights (white, ultraviolet, blue or infrared light, etc.) and wiring. The invention can accommodate sealed entry of a variety of devices and device extensions which can be employed to treat wounds, minimize pain, maintain a sterile environment, and other non-medical functions. 
         [0011]    One application of the apparatus is to create a contained surgical site in order to provide the means to conduct a surgery. The device is capable of sealing around the perimeter of a partially or fully introduced object. Such contained microenvironment can be achieved through an internal or an external source of sterilization, such as ultraviolet germicidal irradiation or ozonizer that circulates treated air within the microenvironment. 
         [0012]    This apparatus consists of an expandable and collapsible containment structure that provides a controlled environment, sized and configured by a plurality of ribs to define a closed contained space and to extend in at least one direction, generally outwardly, with connections and access sleeves for manipulation and handling. 
         [0013]    The apparatus may accomplish a reversible expandable microenvironment system comprised of an expandable and collapsible containment frame and membrane (canopy), which is sized and configured to support the contained space, to define this closed space (alternately called contained space, containment space, contained volume, or containment volume). It extends in at least one direction generally outwardly from the space to house a work field of full or partial subject containment. The space is sized to define an operating or containment field, which consists of a combination of a plurality of ribs each comprising a lower portion, and upper portion, and a pivot connector interconnecting the lower and upper portions which makes the containment structure. There can be a variety of mechanisms used to achieve this type of expandable containment space structure, for use in the desired applications. It can be expanded longitudinally to fully enclose longer and/or larger objects. 
         [0014]    One aspect may be a collapsible containment apparatus comprising a first hub, a second hub, a plurality of articulated arms coupled to the first hub, a plurality of support arms coupled to both the second hub and the articulated arms, and a flexible canopy carried by the articulated arms. The apparatus is collapsed by relative movement of the two hubs away from one another, and deployed by relative movement of the hubs toward one another. When the apparatus is deployed the canopy creates a closed interior environment. 
         [0015]    The apparatus may include a shaft connecting the first and second hubs, where one or both of the hubs are movable along the shaft. The articulated arms may be pivotably coupled to the first hub, and the support arms may be pivotably coupled to both the second hub and the articulated arms. The canopy may be at least in part transparent. The canopy may be made at least in part of a polymeric material. The canopy may include a base that forms the bottom of the interior environment. The base may comprise an outer layer that is impervious to fluids, and at least one layer inside of the outer layer that is constructed and arranged to absorb fluids. There may be an adhesive on the outside of the base, to allow the base to be adhered to an object. 
         [0016]    The apparatus may include a light source that provides light to the interior environment. The apparatus may further comprise an ultraviolet (UV) light source that is located so as to expose air in the interior environment to UV light. The UV light source may be located outside of the canopy in a volume that is fluidly coupled to the interior environment. The apparatus may include one or more sleeves coupled to the canopy and extending into the interior, the sleeves sized and shaped to accept the lower end of an arm of a person. The sleeves may comprise an elastic cuff that fits tightly over the lower end of the arm. The apparatus may include an air-lock sleeve coupled to the canopy. The air-lock sleeve may include mechanisms at each end that allow the sleeve to be selectively opened and closed at both ends of the sleeve. 
         [0017]    The apparatus may further include a releasable locking device that is engaged when the hubs are moved together. The apparatus may further include a source of heating or cooling fluid that can be passed through a base of the canopy when the apparatus is deployed. The apparatus may further include a pair of flap drapes coupled to the canopy and that can be wrapped around an object. The canopy may include a base that forms the bottom of the interior environment, where the drapes are coupled to this base. The apparatus may comprise two sets of hubs and arms, connected together by hinged struts that allow the two sets of hubs and arms to be pulled apart longitudinally while still supporting the canopy. The apparatus may further include a reinforcement structure for the canopy that is either on or in the canopy. The canopy may have an outer layer that is impervious to fluids. The apparatus may further include one or more tubes that pass through the canopy. The tubes may be for delivery of gas, liquid or mist into the interior environment or into a base of the canopy. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1 : Collapsible rib frame 
           [0019]      FIG. 2 : Partially erected rib frame 
           [0020]      FIG. 3 : Central shaft with upper and lower clevis (hubs) 
           [0021]      FIG. 4 : General detailed view of the apparatus 
           [0022]      FIG. 5 : General view of the bottom of the base of the apparatus 
           [0023]      FIG. 6 : Different layers of the bottom of the apparatus 
           [0024]      FIG. 7 : Enlarged view of the positioning of the flap drapes to the tubular channels and the stabilizing rod. 
           [0025]      FIGS. 8A and 8B : Detailed cross-section of the base of the apparatus 
           [0026]      FIG. 9 : Engaged lower and upper hubs other after containment structure deployment. 
           [0027]      FIG. 10 : Deployment of the apparatus 
           [0028]      FIG. 11 : Full subject containment use of apparatus 
           [0029]      FIG. 12 : Partial subject containment use of the apparatus 
           [0030]      FIG. 13 : Longitudinal cross-section of the dome base 
           [0031]      FIG. 14 : Example of accordion-like longitudinal expansion configuration 
           [0032]      FIG. 15 : Non-deployed longitudinal configuration 
           [0033]      FIG. 16 : Coiled configuration 
           [0034]      FIG. 17 : Partial containment of subject&#39;s head through the base of the apparatus 
           [0035]      FIG. 18 : Partial containment of subject&#39;s limb through a sleeve of the apparatus 
           [0036]      FIG. 19 : Full exposure of the surgery field through the base of an injury site 
       
    
    
     DETAILED DESCRIPTION 
       [0037]    An object of the present invention is to fulfill the need for a deployable compact surgical and biological apparatus and methods of use. In accordance with the principles of the present invention, this objective is obtained by providing a versatile, portable, expandable, surgical/medical and non-medical contained work space. It includes at least one collapsible container defining a generally geometric-shaped configuration in a sterile sealed package. The package is sized for a portable kit that is easy to carry by individuals. It is constructed and arranged to be expandable from a cylindrical ( FIG. 10 ), longitudinal ( FIG. 14 ,  15 ) or flat ( FIG. 16 ), configuration to a closed space (volume), or custom contoured operative configuration defining a contained (closed) space sufficient to house and conduct any given operation with the ability to have its own microenvironment. 
         [0038]    Generally, the apparatus  36  is an expandable and collapsible closed system, transparent, air and liquid impermeable space; an expandable and collapsible contained apparatus adapted to be erected in the field or where needed from a collapsed compacted form into an expanded form for handling, treating or processing an object or performing a task; or isolating, transporting and treating a person or an object. The apparatus extends into at least one direction generally outwardly from a collapsible packaged space to house a work field of full  62  or partial  63 ,  64 ,  65 ,  56  subject or field containment. One configuration example of this invention includes a contained miniature space ( FIG. 4 ), and comprises a collapsible frame ( FIG. 1 ,  14 ,  15 ), including a plurality of ribs pivoted at their upper ends to an upper hub or clevis member  21  providing a given final structure shape. At points spaced downwardly from their upper ends, each arm has pivoted thereto a radial stay member extending inwardly of the dome  24  to be pivoted to a lower hub or clevis  22 . The upper clevis includes a central opening  51  to slide upwardly a central shaft  26 , which is connected to the lower clevis  22 . The lower clevis has fixed thereto the central shaft or rod  26  which protrudes upwardly and passes through upper clevis  21 . The central shaft is pulled upwardly manually or mechanically to deploy and erect the collapsed containment structure outwardly ( FIG. 2 ). The upper clevis will stop the upward movement of the lower clevis ( FIG. 9 ), and locks  27  into each other by the passing of the central shaft  26  through the upper clevis  21 . Spring-lock mechanism  27  is fixed toward the lower part of the central shaft  26 . It latches when the lower clevis reaches the upper clevis and the latches  27  pass the upper clevis and expand outwardly and sit on the upper surface of the upper clevis  21 . Latches  27  can be pushed inward to allow the hubs to be pushed apart to collapse the apparatus. 
         [0039]    The containment device general construction may be comprised of a metal or polymeric rib structure ( FIG. 2 ). Each rib is comprised of an elongated lower section  25 , which can be relatively flexible. The upper end of the lower section is pivotably connected at joint  41  to an upper section  23 , which is pivoted to the upper clevis  21 , and is relatively flexible and resilient so that the upper portions of the ribs conform to the shape of the canopy material forming the overall containment volume shape  36 . An accordion-like embodiment may expand longitudinally to house larger objects. See  FIGS. 15 and 16 . In this case two spaced collapsible frames form the ends of the structure. They are connected together by hinged ribs  61  that form the top of the expanded structure. This example is deployed by pulling up on the two rings while also pulling them apart. The containment space (a dome), consists of an at least partially transparent (see through) polymeric canopy  73  of high transparency and strength and covers the ribbed containment space structure ( FIG. 2 ) tightly to form a contained field. The contained field may or may not be sterile. Canopy  73  may consist of liquid, fog and glare repellent polymeric surface material. The collapsible structure may comprise a canopy made of transparent polymeric material with an integrated reinforcing fiber-based net  66 , or may be reinforced by spaced fibers permanently attached to or within the transparent containment material  36 . The canopy covers tightly when erected the containment volume frame from all directions ( FIG. 4 ). The canopy material advantageously can include a complete floor portion base  50 , which can be connected to the sidewalls of the canopy through connecting edge or seam  39 . Advantageously, the ribs and stays of the frame are of extruded polymeric tubing or rods, or metal tubing or rods. The clevis members are molded from polymeric material or are metal, as are all of the pivotal connector members of the frame. 
         [0040]    The invention may include one or more gloved-sleeves  29  connected outwardly to openings in the side of the canopy, with sealing elastic cuffs  43  to form a tight closure around the operator&#39;s arms. Inwardly, the other free ends of the sleeves terminate with gloved formation  49 . A completely sealed and loosely connected inner diaphragm can be positioned at a wrist elastic region  52 . The sleeves are tubular and openly connect outwardly to the surface of the canopy  44 , with an elastic edged-curtain  43  to form a tight closure around the upper part of the operator arms or any other object. These polymeric sleeves may be modified and used to handle and manipulate partially an object  72  ( FIG. 18 ) inside the apparatus without having direct physical contact between the operator&#39;s hands and the inner surfaces, objects or space of the apparatus. 
         [0041]    One or more two-sided opening delivery (pass through) air-lock sleeves  45  can be connected to the surface of the canopy; with ends consisting of a closing zipper, Velcro® (hook and loop fastening materials) or other types of interlocking and sealing mechanisms  30 , to close both ends of the sleeve outwardly and inwardly. Thus the sleeves act as air-locks. These sleeves are used to have controlled access to the inside and the outside of the apparatus. Sleeves with smaller ports are used to deliver or provide an access path for entry of devices such as scopes  57 . 
         [0042]    On one side of the canopy surface (typically the outside) there can be controlled flow mechanisms  54  (e.g., valves) for access tubes  31  passing through the canopy for fluid, mist  67 , filtered or sterilized air, electrical cords  71  and other such supply or device needs  70 , with couplings  55  providing connections between the outside and the inside of the apparatus. One tube can have a small bidirectional air flow filter  70  connected to a tube to inflate the containment volume or to suction air out or to provide certain gases. 
         [0043]    By opening/cutting through the base  50  of the apparatus, a full access to the operated on field  63  can be achieved with partial subject containment and full field containment  63 . The apparatus base  50  can have a continuous base surface connected to the downward end of the canopy surfaces  39 , which will provide a closed system. Base  50  can be made of double polymeric sheet or layers of surgical absorbent drape materials  35 ,  46 ,  47 ,  50 . Double polymeric sheets  46 ,  47  are sealed completely around the edges  39  and can enclose zigzag tubes  68  for circulating air or fluid to create a temperature controlled mattress with two simple in and out valves  48 ,  53 . This removable air or fluid filled mattress will create a cushion to support the use of the apparatus for subjects placed inside the apparatus and can provide heat insulation. In addition, there can be an air filter  28  (e.g., a HEPA filter) fixed on the side of one of the canopy surfaces to provide filtered air to the dome if needed. 
         [0044]    On the bottom of apparatus base  50  there can be surgical grade gel adhesive  37  to fix and seal the apparatus against the operated field or an object (e.g., a body part)  56 . Parallel to two opposing sides of the adhesive  37 , there may be two tubular tunnels  34  to house two apparatus-base stabilizer polymeric or metal rods  33  passing through the two tubular channels. The two tubular tunnels can also have two pair of ties  32 . Each pair of ties may be fixed apart to each tubular tunnel and around the bars  33 . Ties  32  will stabilize the base of the apparatus around the serviced object  56  by wrapping two flap drapes  38  around the serviced object  56 , to contain and protect the integrity of the worked-on surface adhered to the bottom of the base  50  of the containment volume. The functions of the ties may also be accomplished with hook and loop type fasteners (e.g. Velcro® hook and loop fastening materials) or other mechanical fasteners. 
         [0045]    At the bottom of the lower clevis  22 , a light source  40  of any wave length can be configured with inner or outer source of power  71 , to illuminate the inner field or to provide ultraviolet (UV), blue or infrared light within the unit. The light source may be connected to the bottom of the lower clevis, facing the inner space of the containment volume. Light source  40 , such as UV, may have a removable shield  59  placed in front of it to prevent direct exposure of the patient or object to the light, but it will allow direct contact and circulation of the contained air within the space of the embodiment. A small fan  60  can be added to circulate the air within the interior space. On the other hand, an external sterilizer (UV, Ozonizer) may be added externally  70  to achieve the same purpose, with air circulated from the contained volume past the sterilizer and back into the contained volume. A fan may be used to aid in circulation of the air. 
         [0046]    This invention can be adapted for various applications, including but not limited to the following: 
         [0047]    Partial Containment ( FIGS. 17-19 ): 
         [0048]    The apparatus can be used to conduct a wide array of procedures, surgeries or operations for human and non-human use, by placing the operator&#39;s hand into the apparatus gloves to get access to the worked-on (operated-on) site, and by opening/cutting through the base of the apparatus to reach the patient. Alternatively, partial parts of the patient (such as limbs) may be introduced into the interior of the apparatus (controlled space) through the air-lock sleeves. The operator&#39;s hands are isolated from, and do not directly contact, items within the contained and controlled space. This apparatus can be used in situations where no conventional medical establishment is available, such as in ambulatory and emergency services, third world countries, in areas of conflicts, rural areas, or in a regular clinical setting. This apparatus can also be applied for arthroscopy, endoscopy, and other procedures in an office setting instead of the use of a surgery room. In addition, the apparatus can be used for the treatment of burn victims and wounds or situations mandating a special contained environment and care. Examples of other situations include treatment and healing of skin graft donor sites, diabetic foot ulcers, amputation wounds, and other severe or chronic wounds. The device allows the introduction of various substances and/or control of the contained environment. The apparatus allows for the non-conventional approach of having the serviced subject (patient) and the operator outside the actual operating field, which negates the need for an aseptic room and operator&#39;s preparation, but it will give the operated-on site a high degree of containment and maintain a sterilized/aseptic field. The operator will reach the operated-on site through the gloved sleeves without direct contact. There will be very minimal or no effect or contact of the surrounding environment on the operation site when instruments or objects are delivered through the side sealable sleeves. In addition to the sterilizers, there can be positive air pressure maintained through a pressurized air-canister connected to the controlled flow access tubes, or negative pressure using a vacuum device. This apparatus can also be used to contain and clean any spills of any chemicals or biohazard materials, or for other situations were containment is required. 
         [0049]    Full Containment ( FIG. 11 ): 
         [0050]    The apparatus can also be used as a fully contained space for a wide variety of uses, in-vivo or in-vitro. The device may provide a sterilized/aseptic area for handling, testing and manipulating human subjects, other objects, biohazard agents, and chemicals placed within the contained space of the apparatus. In general, the agents are delivered through the sealable air-locked sleeves. To deliver any object inside the apparatus, unseal and open the outside portion of the sleeve, deliver the object to the inside of the sleeve, reseal the outside sleeve portion, then from inside the apparatus and by using the gloved sleeves unseal and open the inner sleeve portion and bring the object into the inner space of the apparatus. Positive air pressure from the air source can be maintained at all times to prevent contamination, in addition to the use of a sterilizer if desired. 
         [0051]    The apparatus can be used in the field of preterm born infants or for small animals as an incubator or treatment station with minor changes to the basic platform; that is, like the addition of light, heat, humidity, oxygen, etc. One sleeve can be made large enough to deliver thereto large objects, with air-lock capability. The apparatus can be used for disposable or longer term use. This contained and sealed system will provide the operator and the surrounding environment complete protection and vice versa, and safe disposal of biological, medical, and/or other potentially hazardous materials with significantly lower cost than current methods. 
         [0052]    The apparatus can be used as a portable clean room in many other industries, such as delicate assembly or handling of electronics, among other uses whenever clean, aseptic or sterile environment is needed. 
         [0053]    The apparatus can be used when and wherever a skilled operator is available, but there is lack of availability of the appropriate physical setting and space. It is flexible and versatile by the simplicity of adding useful features like a sterilizer, light, suction, fluid delivery, oxygen/air, etc. The apparatus is small, light weight, cost effective, dramatically reduces procedural costs, increases patient safety, and saves time. 
       APPENDIX 
     List of Numbered Parts in the Drawings 
       [0000]    
       
           21  Upper clevis (upper hub) 
           22  Lower clevis (lower hub) 
           23  Upper radial member of the canopy frame ribs structure 
           24  Short arm connected the lower clevis (hub) and the upper rib radial member of the canopy frame 
           25  Lower radial member of the canopy frame ribs structure 
           26  Central shaft 
           27  Mechanism to lock lower and upper clevis (hub) 
           28  HEPA and such filter 
           29  Gloved sleeve 
           30  Sleeve interlocking/sealing mechanism 
           31  Tube with controlled access between the interior and exterior environment 
           32  Base ties 
           33  Base tubular tunnel bar 
           34  Base tubular tunnel 
           35  Base absorbent layer material 
           36  The apparatus, contained environment, canopy, dome 
           37  Base adhesive 
           38  Base flap drape 
           39  Connecting edge between the canopy and the lower section floor (base) 
           40  Light source 
           41  Folding joint mechanism between the upper ( 23 ) and lower ( 25 ) 
           43  Outer elastic cuff of the sleeve 
           44  Outward sleeve and canopy connection 
           45  Air-lock sleeve 
           46  Base non-absorbent layer material 
           47  Base non-absorbent layer material 
           48  Base valve 
           49  Glove of the lower sleeve portion 
           50  The base of the apparatus 
           51  Central opening of the upper clevis (hub) for sliding in the central shaft 
           52  Diaphragm to, and wrist elastic of, the lower portion of the sleeve 
           53  Base valve 
           54  Controlled access valve between the exterior and interior contained environment 
           55  Tube coupling 
           56  Partial subject containment with full field containment 
           57  Sleeve port for endoscopes and such 
           59  Light removable shield 
           60  Circulating air fan 
           61  Accordion-like mechanism bare members 
           62  Full subject containment 
           63  Partial subject containment with full field containment 
           64  Partial subject containment with full field containment 
           65  Partial subject containment with full field containment 
           66  Canopy reinforcing net 
           67  Introduced fluids 
           68  Base zigzag heating/cooling system (tubes) 
           70  Exterior supply devices (gases, sterility, suction, etc.) 
           71  Supply cords 
           72  Air-locked sleeves for partial subject containment 
           73  Canopy