WO2023126983A1 - Clean room assembly for patient treatment and general surgical procedures - Google Patents

Abstract

A clean room assembly for patient treatment and general surgical procedures, said assembly comprising: an enclosure (1A) mounted on to a bed (11); transparent segments of rolling curtains (12); doors (1) to open like a wing, on either side of said enclosure (1A); ports (9), in said enclosure (1A), to allow passage of cables and / or tubes into said enclosure (1A), each of said port consisting, essentially, of: a flexible disc (22) to receive cables and / or tubes; a circumferential ring (25), being a flexible circular slotted frame (25), configured to receive said flexible disc (22); and waist cuffs (4Q, 4P) adapted to be flexed around a user's body to limit air infiltration to said enclosure (1A).

Description

CLEAN ROOM ASSEMBLY FOR PATIENT TREATMENT AND

GENERAL SURGICAL PROCEDURES

FIELD OF THE INVENTION:

This invention relates to the field of biomedical engineering.

Particularly, this invention relates to a clean room assembly for patient treatment and general surgical procedures.

BACKGROUND OF THE INVENTION:

In India, around 7 million people suffer from burn injuries each year with 1.4 lakh deaths and 2.4 lakh people suffer with disability (National Health Portal). Burns are also a leading cause of morbidity; millions who survive suffer from lifelong disability and disfigurements with resulting emotional trauma and stigma. The treatment of bums is very expensive and, more often than not, results in deformity, disfigurement, and disability and takes form of a pressing social issue. It is beyond the reach of a common man who actually needs it. It has the potential of wrecking any stable family.

For millions of bum victims, in India, there are 1,339 beds at 67 centres (hospitals with dedicated burn-care units), according to data compiled in 2016 by the National Academy of Bums-India (NABI); this is one of the most comprehensive assessments of the state of burn-care management in India by the academy, which counts 1,200 burn-care professionals as its members. Of the 1,339 beds, 297 are in intensive care units (ICUs) meant exclusively for patients with critical bum injuries. Of the 67 centres, 37 —or more than half— are privately operated. So, it is obvious that there is a wide gap between the number of patients sustaining bums every year (7 million) and requiring treatment (7 lakhs) and versus number of beds available for treatment.

The data suggest that a large number of bum-care patients are likely to be treated in general wards, as opposed to special bum-care units in hospitals. More than 65% Indians do not use government health facilities because they are too far, are inadequately staffed, and offer poor quality of services. Global market is expected to reach USD 2.33 Billion by 2021 from USD 1.68 Billion in 2016, at a CAGR of 6.8% from 2016 to 2021. And it’s estimated the global burn care market size is expected to reach USD 3.4 billion by 2027.

There is a need for an assembly which can be used as an alternative for portable positive pressure units for the treatment of burns.

There is a need for an assembly which can be used as an alternative for emergency general surgery units, containing patients with immunodeficiency issues, for post- surgical patient care,

According to prior art citation EP0619108A, there is disclosure of a device for isolating a patient mainly for isolating the patient during treatment in a room type setting. The doctor need to enter to the unit for accessing the patient. However, this citation consumes more floor space and flow rate and chances of infiltration of air are also much higher.

According to prior art citation CN210767995U, there is disclosure of a portable isolation ward for high infectivity patient room type design where a person needs to enter the room to access the patient. The equipment also needs to be positioned inside the unit, according to this citation. However, there is a need for an assembly, having a design, such that access to the enclosure is easier and consumes relatively lesser floor space and such that equipment can be positioned outside the assembly.

According to prior art citation JP2018140262A, there is disclosure of a self- contained sterile surgical environment; which is very specific for a body part and an entire patient cannot be contained. The design, of this citation, uses an enclosure capsule which is pressurized and gloves are provided to access the body part. However, there is a need for an assembly, having a design, such that the entire body of a patient can be accessed with ease and equipment etc. can be easily integrated.

According to prior art citation WO2016122435A1, there is disclosure of a portable and quickly deployable pre- sterilized isolation unit mounted on a bed enclosing a patient. In this citation, an enclosure is positioned on a bed by a supporting frame and access to the patient is by attached gloves. The hand cuff design restricts the movement of the user which is sought to be overcome.

Therefore, there is a need to alleviate all these prior art related problems and provide a new and improved solution.

OBJECTS OF THE INVENTION:

An object of the invention is to prevent cross infection during patient treatment in hospitals.

Another object of the invention is to provide an assembly provisioning an isolation room for patient treatment and for conducting general surgical procedures

Yet another object of the invention is to provide an assembly, having a design, such that access to the enclosure /assembly is easier and also consumes less floor space.

Still another object of the invention is to provide an assembly, having a design, such that equipment, required, can be positioned outside the assembly.

An additional object of the invention is to provide an assembly, having a design, such that an entire body of a patient can be accessed with ease while equipment, tools, and the like can be easily integrated.

SUMMARY OF THE INVENTION:

According to the invention, there is provided a clean room assembly for patient treatment and general surgical procedures, said assembly comprising:

- an enclosure mounted on to a bed;

- transparent segments of rolling curtains, placed on relatively longer sides of said bed, ends of said curtains overlapping each other;

- one or more doors configured to open like a wing, on either side of said enclosure, said either side corresponding with said longer sides of said bed;

- one or more ports, in said enclosure, to allow passage of cables and / or tubes into said enclosure, each of said port consisting, essentially, of: o a flexible disc having one or more holes, on its planar surface, of one or more diameters, said flexible disc having a first splice across the disc, said flexible disc having a second splice cutting across each of said one or more holes, said holes being configured to receive cables and / or tubes; o a circumferential ring, being a flexible circular slotted frame, configured to receive said flexible disc such that an external circumference of said flexible disc corresponds to an internal circumference of said circumferential ring such that said circumferential ring, circumferentially ensconces, said flexible disc; and

- one or more waist cuffs consisting, essentially, of: o at least one flexible member positioned linearly with respect to at least one side of said bed, and adapted to be flexed around a user’ s body to limit air infiltration to said enclosure.

In at least an embodiment, said assembly comprises one or more two-way openable material transfer boxes attached at relatively shorter front end of said enclosure to allow transfer or items in and out of said enclosure.

In at least an embodiment said assembly comprises an instrument transfer box, being a two-way box, attached on to an operative rear end of said enclosure, said box being configured to be opened from inside as well as from outside.

In at least an embodiment, said enclosure is connected to a pressurised air purifier configured to maintain a pressure, selected from a positive pressure or a negative pressure, inside said enclosure.

In at least an embodiment, said enclosure comprises exhaust ports to exhaust air outside said enclosure. In at least an embodiment, said assembly comprises wing-shaped top hinged doors being part of said enclosure, said hinged doors being hinged laterally with respect to said enclosure and said bed in said enclosure.

In at least an embodiment, said assembly comprises a zipper, on a wall of said enclosure, in connection with said circumferential ring.

In at least an embodiment, said circumferential ring comprises plugs configured to plug unused holes from said one or more holes.

In at least an embodiment, said more waist cuffs consists, essentially, of an air tight seal, said air tight seal being made by using a ‘Reuleaux trianglular’ shaped flexible member, in that, a geometric member being attached to an enclosure frame with split air lock design having:

- a first air seal attached with said enclosure frame; and

- a second air seal fixed on a door of said enclosure frame.

In at least an embodiment, one or more waist cuffs consists, essentially, of:

- a first fabric partially overlapping a second fabric (4Q); in a lengthwise manner, forming a gap therebetween when a user enters through a seam formed by said partial overlap.

In at least an embodiment, one or more waist cuffs consists, essentially, of:

- a hinged rigid / flexible rod configured to flex and allow a user to move sideways, in said enclosure, to a next segment.

In at least an embodiment, said enclosure is a flexible enclosure, in that, - a frame, of said enclosure, being made with highly flexible material;

- conduits, being provided, on said enclosure;

- a foldable canopy extending outward from said enclosure;

- a flap type structure added on to said foldable canopy; and

- a stretchable fabric being attached on to said foldable canopy.

In at least an embodiment, said enclosure is a flexible enclosure, in that,

- a frame, of said enclosure, being made with highly flexible material;

- a hole, in said enclosure, with a resilient, hinged, unidirectional flap lid such that it opens upon entering and close upon exiting.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The invention will now be described in relation to the accompanying drawings, in which:

FIGURE 1 illustrates a view enclosure, being a clean room assembly for patient treatment and general surgical procedures, of this invention;

FIGURE 2 illustrates another view enclosure, being a clean room assembly for patient treatment and general surgical procedures, of this invention;

FIGURE 3 illustrates another view enclosure, being a clean room assembly for patient treatment and general surgical procedures, of this invention;

FIGURE 4 illustrates another view enclosure, being a clean room assembly for patient treatment and general surgical procedures, of this invention;

FIGURE 5 illustrates various cable / tube entry ports;

FIGURE 6 illustrates a circular slotted frame for the various cable / tube entry ports of FIGURE 5;

FIGURE 7 illustrates various tubes being inserted through holes on a disc;

FIGURE 8 illustrates various cable / tube entry ports of a flexible disc with holes of various diameters;

FIGURE 9 illustrates various cable / tube entry ports of a flexible disc with holes of various diameters;

FIGURE 10 illustrates another embodiment, of this invention, achieved using two stretchable sheets

FIGURE 11 illustrates a type of waist cuff designed to minimize air infiltration;

FIGURE 12 illustrates a type of waist cuff designed to minimize air infiltration;

FIGURE 13 illustrates a type of waist cuff designed to minimize air infiltration

FIGURE 14 illustrates a type of waist cuff designed to minimize air infiltration

FIGURE 15 illustrates an air seal using a flexible member;

FIGURE 16 illustrates a type of waist cuff designed to minimize air infiltration;

FIGURE 17 illustrates a stretchable air seal fabric;

FIGURE 18 illustrates a type of waist cuff designed to minimize air infiltration;

FIGURE 19 illustrates one, of various, type/s of opening/s on the sides of enclosure of FIGURE 1;

FIGURE 20 illustrates one, of various, type/s of opening/s on the sides of enclosure of FIGURE 1;

FIGURE 21 illustrates one, of various, type/s of opening/s on the sides of enclosure of FIGURE 1;

FIGURE 22 illustrates one, of various, type/s of opening/s on the sides of enclosure of FIGURE 1;

FIGURE 23 illustrates the embodiment of FIGURE 1 made with a flexible enclosure;

FIGURE 24 illustrates the embodiment of FIGURE 1 made with a flexible enclosure;

FIGURE 25 illustrates the embodiment of FIGURE 1 made with a flexible enclosure; FIGURE 26 illustrates a patient on a bed in the enclosure of FIGURE 1 ;

FIGURE 27 illustrates a tray, for keeping instruments, in the enclosure of FIGURE 1;

FIGURE 28 illustrates flexible transparent curtains overlapped with respect to each other in the enclosure of FIGURE 1 ;

FIGURE 29 illustrates wing- shaped top hinged doors designed as a part of the main enclosure; and

FIGURE 30 illustrates a user, in the enclosure of FIGURE 1.

DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

According to the invention, there is provided a clean room assembly for patient treatment and general surgical procedures.

In at least an embodiment, the assembly, of this invention, comprises an enclosure (1A) which is mounted on to a bed (11 A) or on a similar structure enclosing the bed (11) and its occupant (33) (patient). The base of the assembly (1A) is also covered with a fabric or a plastic sheet type material and the bed (11 A) can be put over or under the fabric or a plastic sheet type material; this makes the assembly sealed from all sides. At the longer sides of the bed (11), in order to access the patient, transparent segments of rolling curtains (12) are placed. The ends of these curtains overlap (19) each other so as to minimize air infiltration through the gaps. If these curtains (12) are rolled up, corresponding area of bed (11 A) can be accessed. If all the curtains (12), at one side, are rolled up, the entire bed (11 A) can be accessed. The curtains (12) can be raised/ rolled up according to the height of a nursing staff / doctor (3) (user), entering the assembly (1A). Traditional curtain rolling and ratchet based / friction based locking mechanisms are ideal for positioning the curtains (12) in place. Through this opening, the patient (33) can be moved out, as well, if required.

In at least an embodiment, the assembly, of this invention, comprises additional doors (1) (Wing door) which opens like a wing to either side of the assembly / enclosure (1A) which can be used to get control of air infiltration while curtains (12) are opened. The wing door type design ensures sideways mobility of user along with controlling infiltration.

In at least an embodiment, the assembly, of this invention, comprises a two-way openable material transfer boxes (34) attached at shorter front (1C) end of the enclosure such that medicines / food / instruments / other materials can be transferred in and out of the enclosure (1A) through the same.

The instruments, equipment, cables, or tubes, which need to be attached to the patient, is inserted through special cable/tube entry ports at the rear end (IB) of the enclosure. The various features and components of the unit are explained below.

In at least an embodiment, of this invention, the unit consists of an enclosure (1A, Fig (1)) which is connected to an air purifier (5), the air purifier (5) maintains a positive pressure (or negative pressure if necessary) operation. The entire unit is assembled over a bed (11 A); thus, enclosing the patient (16). This maintains the patient in a clean positive pressure environment thus eliminating infiltration of contaminated outside air. The inside air will be exhausted out of the unit through exhaust ports (18) enabled with fine air filters eliminating microbes and foul order, if any.

In at least an embodiment, of this invention, the equipment tubing and wiring, and the like, are routed in to the enclosure through a specially designed cable / tube entry ports (9). These ports (9) permit cable / tube to enter in to the enclosure (1A) without air infiltration since the unit positively pressurized by the air purifier possibility of air infiltrating in will be less. The cable / tube entry ports (9, Fig (5)) consist of a flexible disc (22) with holes of various diameters (28). The cable / tubes can be inserted through holes on the disc (22) by twisting edge (22A) of the flexible disc (22). Typically, the flexible disc (22) has a first (radial) splice (22A) across the disc. Typically, the flexible disc (22) has a second (circular) splice (22B) cutting across each of the holes. These splices allow the flexible disc (22A) to open up at a particular hole, from the plurality of holes, in order to receive a cable / tube. Once cables are inserted to the flexible disc (22), it is placed in a flexible circular slotted frame (25). The unused holes are plugged with flexible plugs (20) attached on to a slotted frame (25). If the cable consists of large size units, at the ends (e.g. oxygen face mask), zippers (23) are opened and the cable is inserted and the zipper is closed. During operation, the cable / tube entry unit is be similar to what is shown in Fig (5). The cable / tube entry unit (26) is attached with the main enclosure (1A) by stitching, welding, or by common textile / sheet joining methods. The main enclosure (1A) can be made using woven / non-woven fabrics, plastic flexible / rigid sheets etc.

In at least an embodiment, of this invention, the front end (IB), of the assembly / enclosure, has provision for cable / tube entry ports (26), Air purifier duct inlet (10), and the like, are connected.

In at least an embodiment, of this invention, at the rear end (1C) of the enclosure, instrument transfer box (14), air exhaust ports (18), and the like can be attached. The instrument transfer box (14) is a two-way box which is attached on to the main enclosure rear end (1C). This can be opened from inside as well as from outside; this enables to transfer any material or instruments during patient treatment. This helps in transfer of material or instrument without contaminated air infiltration. The instrument transfer boxes are attached on to the enclosure by adhesive tapes or it can be permanently fixed on to the enclosure as well. The inner door (34) of the instrument tray can be used as a tray for keeping the instruments if required (Fig (27)).

In at least an embodiment, of this invention, left (ID) and right (IE) sides, of the main enclosure, consist of flexible transparent curtains (12) which are overlapped with respect to each other (Fig (28)). These curtains can be rolled to corresponding top rollers (17) to access the patient. Since the curtains are rolled to the top, it does not hinder patient (16) movement in and out of bed. The overlapping (19) of curtains is ensured in order to minimize air seepage in between the curtains since there is no direct connection between each curtains. C-type channels / overlaps are provided on the edges of the main unit where the curtain is engaged with the main unit. Initially the curtain is lifted to the operative top by holding and lifting its handles (12A). This action makes the curtains to roll to the top by a standard spring-loaded curtain rolling mechanism. Or, if the curtain (12) itself is made with material having resilience that itself will make the curtain roll to the operative top rollers. This can be either fully rolled to the top or partially rolled (Fig (28)) as per ergonomic comfort or need of the user. After treating the patient, the user closes the curtains by holding on the handles (12A). The openings or closing of curtains can be made automatic as well, so the physical contact on handles can be avoided.

If curtain on both the sides are open, that creates heavy load on the air purifier and chances of infiltration will be higher. To eliminate this issue, in at least an embodiment, of this invention, wing-shaped top hinged doors (1) are designed as a part of the main enclosure (1 A), (Fig (29)). The user needs to get closer to the bed of the patient; this stretches the base stretchable fabric and creates a space for the user (Fig (30)). Then, the door (1) needs to be closed. The boot strut (2) / similar mechanisms at the sides smoothens the closing of door and keeps them in place. Then the curtains will be rolled to top and patient can be accessed. Being, in this position, the user can simply move sideways if required.

In at least an embodiment, of this invention, in order to minimize air infiltration, a special type of waist cuff (4Q, 4P) is designed (Fig 16, 18). One way of achieving this is by using a hinged rigid / flexible rod (13) flexes and allows the user to move sideways to a next segment. Once the user is moved after the hinged rigid / flexible rod (13) regains its initial position stretching the fabric (4). Instead of the hinged rigid / flexible member, the air seal fabric can be stretched using spring or elastic rope (4J) or a combination of both (13 & 4J) can be used to achieve the same effect. This ensures a tight seal between the user and the enclosure so that there is minimum possibility of air infiltration. The air purifier (5) pumps extra volume of air to ensure occupants comfort and to ensure positive pressure.

Fig (10) represents the same effect is achieved using two stretchable sheets fig (10), (4Q, 4P). In at least an embodiment, of this invention, one stretchable fabric (4P) is attached on to the main enclosure and other (4Q) on to the wing (1) door it can be placed at an angle (Fig (13,14)) for better ergonomics.

In at least an embodiment, of this invention, another design, for air seal, is obtained by using a ‘Reuleaux trianglular’ shaped flexible member (4A), (Fig (16)). In this design, a geometric member is attached to an enclosure frame (4K) and in split air lock design Fig: (15 & 16) design air seal design a first air seal (4D) is attached with the enclosure frame (4K) and a second air seal (4E) is fixed on a door (1) at a door frame (4L) of the enclosure frame (4K).

In at least an embodiment, of this invention, a bed top (11 A) is designed with an option for patient bathing, in cases where it is difficult to move the patient outside. The bed top, typically, can be attached with a liquid containing sheet (29 A). The ends of the sheet can be attached to the extending legs (11) of the bed, by a concentric shaft type rigid member (11B). The top portion of the rigid member (11B) contains a projection for attachment of a ring (29) which is attached permanently on to the sheet (29 A). This contains liquids or body spills from the patient during treatment. Also, it can be easily removed after use.

In at least an embodiment, of this invention, on the top frame (31 A), of the enclosure, hooks (31) can be placed holding limbs (33) of the patient. The hooks (31) attached on to frame can be used to mount mechanisms assisting physiotherapy of the patient can also be included on to the main frame.

As shown in Fig 23, Fig 24, and Fig 25, in at least an embodiment, of this invention, the unit can be made with a flexible enclosure; here, the enclosure can be made similar to a collapsible mosquito net type design. In this design, the frame (38 A), of the enclosure, is made with highly flexible material like spring steel. Conduits are made, on the enclosure fabric, and the frame is inserted on to this. Up on folding the frame, on a specific way, the entire enclosure can be collapsed to small size pouch. In such design openings on the sides of enclosure are made and a foldable canopy (36) is made as in Fig 19, Fig 20, Fig 21, and Fig 22. In at least an embodiment, a flap type structure (37) is added on the foldable canopy (36). In order to minimize the gap between user and enclosure opening, a stretchable fabric (40, 40A) will be attached on to the side opening structure

(36). The user enters in to the unit through the gap (39); since that region is stretchable, it will wrap around the user. This leaves minimum gap; hence, infiltration is minimum. Since a positive pressure is maintained, these gaps act as exhaust ports during usage.

As shown in Fig 20, in at least an embodiment, of this invention, instead of two stretchable fabrics a single stretchable fabric with a hole (39, Fig (20)), at centre, is provided with a unidirectional flap lid (41). This opens if someone is entering through it and closes automatically during exit. To ensure that it remains closed, a spring or an elastic member (42) or a resilient element is added to the lid to keep it shut on exit of user. This flap lid is hinged (41 A) on to the entry port

(37).

TECHNICAL ADVANTAGES:

• No additional floor space is consumed other than what a regular hospital bed is utilized while using the unit. Also the unit can be retrofitted to existing hospital beds on demand.

• In this invention’s design, equipment and medicines such as IV fluids etc. are place outside the enclosure unit (sterile zone) the interaction with those does not affect cleanliness of the enclosure. Due to the same reason the equipment can be transferred / swapped / moved without affecting enclosure environment.

• Since the unit is an enclosed space, it makes it easy to integrate climate control module along with the air purifier.

• Quick access to patient by the doctor or nursing staff, no special ergonomic constrains affecting the interaction with patient.

• The nursing staff or doctor could access the patient as if treating them in normal bed; ergonomic restrictions are minimum in the current invention’s design.

• Provision for transfer of equipment’s, instruments etc. are provided using material transfer boxes attached on to the enclosure.

• Visibility of patient is not hindered at unacceptable levels since all the side front and back side of the unit can be made transparent as per requirement. Also this helps the patient not to feel claustrophobic.

It is to be noted that even if even if positive pressure cleanrooms are common the invention focuses on maintaining cleanliness of the enclosure with efficient accessibility to the enclosure; the structure, the construction, the working, the functioning related to ‘access’ contributes to the INVENTIVE STEP of this invention.

The construction, which teaches, accessing a patient, minimizing possibility of infiltration, provisioning for cable and tube entry to the enclosure, enabling sideways movement of the user while accessing the patient without having infiltration, and the like; all also contributes to the INVENTIVE STEP of this invention.

Furthermore, prior arts are plagues with providing an effective mechanism in order to contain positive pressure whilst, simultaneously, providing accessibility. Access provided for the positive pressure units, of prior arts, are prone to contamination if multiple people are using the unit and is time consuming to enter in and out. The structure of the assembly / enclosure, of this invention, solves this problem which is what contributes to the INVENTIVE STEP of this invention.

Additionally, most of prior art designs do not permit movement of a user sideways so as to access a patient which limits a user’s motion to access the patient. The structure of the assembly / enclosure, of this invention, solves this problem which is what contributes to the INVENTIVE STEP of this invention.

Additionally, cable or tube entry, of prior art designs, are not easy to use and, in most cases, there is no specific way to fit tubes of various sizes. The structure of the assembly / enclosure, of this invention, solves this problem which is what contributes to the INVENTIVE STEP of this invention. In the current invention’s design provision for inserting facemask is also provided which is also what contributes to the INVENTIVE STEP of this invention.

The TECHNICAL ADVANCEMENT, of the current invention, lies in at least the following aspects:

• Curtain type design which acts as an air lock and with provides provision accessing patients.

• The ‘waist cuff’ design along with ‘wing door’ which provides easy accessibility for user to the patient.

• Cable or tube entry design especially entry of nonstandard large sized objects.

The assembly, of this invention, consists of a portable and quickly deployable pre sterilized isolation unit (Sterile Enclosure) which can be mounted on to each bed. This can convert any general ward/ICU in to an isolation ward/ICU, provision for dressing the patient is also provided in the unit. Special ports are designed on either sides of enclosure for medical personnel entry, through that they can access the patients for treatment as well as doing patient’s mundane activities. The transfer box attached on one of its sides helps in transfer of sterile/contaminated materials in and out of the enclosure. The assembly provides a clean environment for keeping the patients and doing their mundane activities. It’s also designed to function as a sterile space for dressing and conducting minor surgical procedures for such patients as well.

While this detailed description has disclosed certain specific embodiments for illustrative purposes, various modifications will be apparent to those skilled in the art which do not constitute departures from the spirit and scope of the invention as defined in the following claims, and it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Claims

CLAIMS,

1. A clean room assembly for patient treatment and general surgical procedures, said assembly comprising:

- an enclosure (1A) mounted on to a bed (11);

- transparent segments of rolling curtains (12), placed on relatively longer sides of said bed (11), ends of said curtains (12) overlapping (19) each other;

- one or more doors (1) configured to open like a wing, on either side of said enclosure (1A), said either side corresponding with said longer sides of said bed (11);

- one or more ports (9), in said enclosure (1A), to allow passage of cables and / or tubes into said enclosure (1A), each of said port consisting, essentially, of: o a flexible disc (22) having one or more holes (28), on its planar surface, of one or more diameters, said flexible disc (22) having a first splice (22A) across the disc, said flexible disc (22) having a second splice (22B) cutting across each of said one or more holes, said holes (28) being configured to receive cables and / or tubes; o a circumferential ring (25), being a flexible circular slotted frame (25), configured to receive said flexible disc (22) such that an external circumference of said flexible disc (22) corresponds to an internal circumference of said circumferential ring (25) such that said circumferential ring (25), circumferentially ensconces, said flexible disc (22); and

- one or more waist cuffs (4Q, 4P) consisting, essentially, of: o at least one flexible member (4A) positioned linearly with respect to at least one side of said bed (11), and adapted to be flexed around a user’s body to limit air infiltration to said enclosure (1A). The assembly as claimed in claim 1 wherein, said assembly comprising one or more two-way openable material transfer boxes (34) attached at relatively shorter front (1C) end of said enclosure (1A) to allow transfer or items in and out of said enclosure (1 A). The assembly as claimed in claim 1 wherein, said assembly comprising an instrument transfer box (14), being a two-way box, attached on to an operative rear end (1C) of said enclosure, said box (14) being configured to be opened from inside as well as from outside. The assembly as claimed in claim 1 wherein, said enclosure (1A) being connected to a pressurised air purifier (5) configured to maintain a pressure, selected from a positive pressure or a negative pressure, inside said enclosure (1A). The assembly as claimed in claim 1 wherein, said enclosure (1A) comprising exhaust ports (18) to exhaust air outside said enclosure (1A). The assembly as claimed in claim 1 wherein, said assembly comprising wing-shaped top hinged doors (1) being part of said enclosure (1A), said hinged doors being hinged laterally with respect to said enclosure (1A) and said bed in said enclosure. The assembly as claimed in claim 1 wherein, said assembly comprising a zipper (23), on a wall of said enclosure, in connection with said circumferential ring (25). The assembly as claimed in claim 1 wherein, said circumferential ring (25) comprising plugs (20) configured to plug unused holes from said one or more holes. The assembly as claimed in claim 1 wherein, said more waist cuffs (4Q, 4P consisting, essentially, of an air tight seal, said air tight seal being made by using a ‘Reuleaux trianglular’ shaped flexible member (4A), in that, a geometric member being attached to an enclosure frame (4K) with split air lock design having:

- a first air seal (4D) attached with said enclosure frame (4K); and

- a second air seal (4E) fixed on a door (1) of said enclosure frame (4K). The assembly as claimed in claim 1 wherein, one or more waist cuffs (4Q, 4P) consisting, essentially, of:

- a first fabric (4P) partially overlapping a second fabric (4Q); in a lengthwise manner, forming a gap therebetween when a user enters through a seam formed by said partial overlap. The assembly as claimed in claim 1 wherein, one or more waist cuffs (4Q, 4P) consisting, essentially, of:

- a hinged rigid / flexible rod (13) configured to flex and allow a user to move sideways, in said enclosure, to a next segment. The assembly as claimed in claim 1 wherein, said enclosure (1A) being a flexible enclosure, in that,

- a frame (38 A), of said enclosure (1A), being made with highly flexible material;

- conduits, being provided, on said enclosure;

- a foldable canopy (36) extending outward from said enclosure;

- a flap type structure (37) added on to said foldable canopy (36); and

- a stretchable fabric (40, 40A) being attached on to said foldable canopy (36). The assembly as claimed in claim 1 wherein, said enclosure (1A) being a flexible enclosure, in that,

- a frame (38A), of said enclosure (1A), being made with highly flexible material;

- a hole (39), in said enclosure (1A), with a resilient, hinged, unidirectional flap lid (41) such that it opens upon entering and close upon exiting.

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