WO2019057061A1

WO2019057061A1 - Infection control package

Info

Publication number: WO2019057061A1
Application number: PCT/CN2018/106442
Authority: WO
Inventors: Tze Chuen NG
Original assignee: The University Of Hong Kong
Priority date: 2017-09-20
Filing date: 2018-09-19
Publication date: 2019-03-28
Also published as: CN111655111A

Abstract

An infection control package (29) is made from an ultra-thin and translucent foldable plastic sheet (31) and a collapsible frame formed from rods (35). The rods (35) and sheet (31) can be in a compact package (29) that can be assembled into a surgical tent (30). A cross circle (32) located in the plastic sheet (31) at a bottom portion thereof is provided with an adhesive (40) under a cover sheet (42) so that the cross circle (32) can be adhered to the skin of a surgical patient at the site of the proposed surgery, thus reducing at least the bottom area of the tent (30).

Description

INFECTION CONTROL PACKAGE

TECHNICAL FIELD

The present invention is generally directed to a sterile operating chamber, and more particularly to a small portable package that can be converted into a sterile operating chamber.

BACKGROUND OF THE INVENTION

When surgical procedures are carried out it is important that the procedures take place in a sterile environment in order to prevent infections. In modern facilities this typically involves a very clean surgical room, which may be equipped with a positive air flow to reduce airborne transmission of germs, bacteria and viruses. In addition the instruments are sterilized. Operating room personnel wash their hands and dress in surgical gowns, caps and masks. The patient will have sterile drapes placed over their body and the area of the operation is swabbed with alcohol.

These preparations for surgery in a sterile environment are expensive and time consuming. In less modern facilities, many of these features are unavailable. When operating in the field, especially in war and during natural disasters, hardly any of them will be available.

In the article, Teodorescu et al., “An Ultraportable Device Platform for Aseptic Surgery in Field Settings, ” Journal of Medical Devices, June 2016, Vol. 10, it is proposed that the paradigm be changed so that rather than creating a large sterile room in which the surgery takes place, that the space that matters is the surgical incision itself. This results in shrinking the challenge of providing a sterile space from over 5 000 ft ³ to a space of under 10 ft ³. A design according to the proposal is called SurgiBox and a schematic is shown in Fig. 1.

The prior art design of Fig. 1 is an ultraportable platform 10 for aseptic surgery on a patient 12 in field settings. The platform includes a reusable, nonsterile component and a sterilizable, disposable, patient-specific component. The reusable component includes a rigid, collapsible fame 11, e.g., made of rigid PVC tubing connected with standard fittings, as well as a system for regulating the environment enclosed by the frame 11, which is connected through an opening 23. A clear plastic film 13 is attached to the preassembled frame so as to form the enclosed environment. The platform 10 can have two modules, module 15 located over the body of the patient 12 in proximity to the site for the proposed surgical incision. As illustrated in Fig. 1, this is over the upper torso 12a of the patient, who is lying on a table 19 that also supports the platform. The first module also may not extend to the table so that the patient’s arms 12c and head 12d are outside the environment. The second module 17 is located over the legs 12b of the patient, and may not extend to the support table 19, i.e., the legs 12b are not within the regulated environment. This second module can be used for the dedicated instrument tray. These modules can be connected to form a continuous sterile field, but can also be used independently.

It should be noted that with the SurgiBox, the sterile environment for the surgery is within the platform and particularly in the module 15 over the incision site. Thus, instead of having to sterilize an entire operating room, only the interior of the SurgiBox needs to be sterilized. This makes it particularly useful in combat zones, disaster areas and even local surgical rooms in third world countries.

The top plastic surface of the platform, at least over the surgical site in module 15, is under enough tension to provide a clear view of the surgical field. However, the sides may remain tension-free. At least one slit materials port 20 is provided on each of the two longer opposite sides of the environment. They permit items to be taken in and out of the surgical field. One pair of arm ports 22 is located next to each material port.

The system for regulating the environment enclosed by the frame includes a battery that powers a motor of an air fan that injects air into the enclosure through a HEPA filter and rubber tubing that is inserted into the modules.

While the SurgiBox provides an improvement in providing sterilized zones at remote unclean environments, it would be beneficial if such a device could be provided an even more reduced zone for sterilization.

SUMMARY OF THE INVENTION

The present invention is directed to a small translucent plastic package that can be erected into a sterile operating chamber located above a surgical incision site. The lower portion is adhered to the skin of the patient about the site, thus reducing to a minimum the amount of space that needs to be kept sterile.

In order to achieve this result the material of the package is an ultra-thin and translucent plastic and includes tightening belts. The bottom is provided with a translucent cross circle sign for locating the perimeter of surgical circle zone. This circle is provided with an adhesive under a cover sheet. Once the surgical site is identified the patient’s skin in that area is swabbed with Iodine disinfectant. Then when the cross circle is located over the incision site the cover sheet is peeled off and the cross circle is adhered to the patient’s skin surface.

The package also includes a frame made of rods that support the translucent plastic material and form a tent. Once the cross circle is affixed, rods are assembled to form the frame. The rods have male and female joints that are manually assembled to establish the frame with a firm base. Belts are located at the four corners of the frame that can be tightened against the edge of the operating table (OT) for firm anchorage stability.

An air filter and pump are provided to inflate the tent and to flush out existing gas media inside. This helps to establish a germ free environment inside the tent because the filtered air is flowing in one direction and leaves the tent through a safety window with one way valve. The tent can be connected to a Sterilization Chamber with sterilized instruments. In order to make use of these a seal is peeled off the Sterilization Chamber and a cord is tightened against the Chamber’s ring to create a seal. All the hand tools are sterilized within reach by the nurse. Also, the cover for the Tethered Instrumental Tools e.g. drill with electrical cable, suction tubing, can also be accessed. Long sleeves are provided with cords to tighten the handle of a tool, thus exposing the functional head.

A surgeon wearing spectacles or goggles must fasten them to the ultra-thin translucent plastic on a side surface of the tent to create direct vision. The goggles are secured about the head of the surgeon by a head band that fastens at back. Concave curvature above and below the eye level are provided to give free space for the protruding forehead of the surgeon, as wells as the nose and mouth of the surgeon for breathing.

Arm or glove ports are provided in the tent for the surgeon, and perhaps a nurse. The surgeon may wear interspace gloves before inserting the hands into the prepared larger size gloves ports through the tent. An extra pair of prepared gloves may be stowed below the tent ready just in case of accidental leakage.

A portable LED lighting system is provided for the top surface of the small tent. This OT Light has a handle that can be inserted within a plastic ring in the top surface of the tent so as to adhere on the surface of a light circle by surface tension.

With the small surgical tent of the present invention the bottom surface can be reduced in size to that of the incision area, thus easing the burden of sterilization. It is easy to assemble and can utilize simple environmental control apparatus. Thus, in some embodiments it can be very portable.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages of the present invention will become more apparent upon reference to the following detailed description and annexed drawings in which like designations denote like elements in the various views, and wherein:

Fig. 1 is a schematic diagram of a prior art portable platform for performing aseptic surgery;

Fig. 2A is a cross-sectional view of the package of the present invention in its fully assembled condition and connected to substantial environmental equipment, and Fig. 2B is an enlarged view of the end of the tent where the external support equipment is connected;

Fig. 3 is a front perspective view of the package of the present invention in its assembled state;

Fig. 4A is a side view and Fig. 4B is a bottom view of the package of the present invention in collapsed form showing the adhesive cross circle, and Fig. 4C showing the male and female joints at the ends of the frame rods that can be connected to assemble the frame;

Fig. 5A is a cross-sectional view of a portion of the tent according to the present invention with surgeon’s googles adhered to the tent, Fig. 5B is an alternative design in which the goggles are a mask, and Fig. 5C shows a small tube extending into the tent which is sized to accept a finger covered by a smooth fitting glove;

Fig. 6A shows the space or astronaut version of the package of the present invention, Fig. 6B shows a top plan and elevational view of the astronaut package during processes of positioning the package over the patient, Fig. 6C shows the astronaut package during erection of the tent, Fig. 6 D shows the connection of external support apparatus to the package; assembly; Fig. 6E shows the package in use during an operation and Fig. 6F shows the sterilized zone when the package is assembled and being used;

Fig. 7 shows and end view of the package according to the space or astronaut version with external support equipment connected thereto;

Fig. 8 illustrates a war zone version of the package of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Fig. 2A is a cross section of the package 29 of the present invention in its fully assembled and inflated condition so as to form a tent 30. The tent is comprised of a sheet of ultra-thin and translucent foldable plastic 31 that can be supported by a collapsible frame formed from rods 35. A distinguishing feature of this package is the cross circle 32, which is adhesively attached to the body of the patient at the proposed site of the surgical incision. In a prior art design, the bottom of the tent would at least extend to the chest of the patient as shown in dotted line in Fig. 2A. It also could extend under the patient. As a result of the use of the cross circle 32 to size of the tent at its bottom, the effort needed to sterilize it are greatly reduced.

A collapsed version of the package 29 is shown in Fig. 4A. From Fig. 4A it can be seen that in the collapsed version the rods 35 and the sheet 31 fold on top of each other. This package is completely sterilized and stored in a seal pouch (not shown) . The plastic package is leak proof, both in the collapsed and inflated state. At the bottom of the package as shown in Fig. 4B there is the cross circle 32. It has a clear center, but the periphery has an adhesive 40 with a cover 42 over it. In the collapsed condition the user can look down through the package and see the skin surface of the patient. Once the surgical site is identified the patient’s skin in that area is swabbed with Iodine disinfectant. Then the cross circle is located over the incision site and the cover sheet 42 is peeled off exposing the adhesive strip 40. Then the cross circle is adhered to the patient’s skin surface.

Typically the patient 12 is lying on an operating table 50. Once the package is adhered to the patient’s skin as shown in Fig. 2, it is expanded to form the tent 30 by connecting the female and

male joints

34, 35 at the ends of the rods as shown in Fig. 4C. These rods can be fit together easily so that erection of the tent can be accomplished within one minute. They may be made from a single plastic casting or molding. Further, the tent 30 is inflated by air pressure that is used to flush out existing gas media inside the tent, which helps to establish a germ free environment inside the tent. In one embodiment this air supply is provided by a battery, an air fan powered by the battery, a tube 52 leading from the fan to the interior of the tent 30, a filter 53 located in the tube and a safety window in the tent with a one way valve to allow air to leave the tent. The filter may be a 99.99%filter because near zero particle influx means near zero infection. In the embodiment shown in Fig. 2A, instead of blowing air into the tent 30 from a fan, compressed air from a cylinder or canister 55 is provided through the tube 52. In either case the air or gas is used to inflate the tent and to flush out existing gas media inside. This helps to establish a germ free environment inside the tent because the filtered air is flowing in one direction and leaves the tent on the other side through the safety window 85, which has a one way valve in the form of three plastic leaflets.

In Fig. 2A the gas canister is supported by a mobile support unit 60 with wheels 62. The mobile unit is connected by a conduit 65 to support equipment. The conduit carries functional connections. Also attached to mobile unit 60 are a sterilization chamber 66 and a functional connection chamber 68. Long sleeves 61 may extend from the chamber 68 into the interior of the tent as shown in Fig. 2B. These sleeves are molded into the plastic material 31 of the tent 30. Sterilization chamber 66 may surgery hand tools on a tray. In addition the mobile unit may be used for handing materials ancillary to an operation, e.g., a bag of saline solution 67. In a version of the system for remote operation, rather than a mobile unit with compressed air, simple available structures would be used.

A lighting system 70 is provided for the top surface of the tent 30. One feature of the present invention is that it can be used in a modern operating theater to reduce the sterilization burden. Thus, it is not only for use in remote and harsh environment. When used in a conventional operating theater, the lighting system 70 may be that conventionally found in such a facility. When used in a remote harsh environment, this OT light may use LEDs powered by batteries. In either case, the lighting system 70 is adapted to have a handle 72 that can be inserted within a plastic ring in the top surface of the tent so as to adhere on the surface of a light circle by surface tension. This light illuminates the surgical site well because it is in contact with the plastic material and thus minimizes reflections.

Fig. 3 shows the various connections to the tent 30. These include arm or

glove ports

80, 81 for the surgeon, and perhaps a nurse. The surgeon may wear interspace gloves 89 (see Fig. 5A) before inserting his or her hands into the prepared larger

size glove ports

80, 81 through the tent 30. An extra pair of prepared gloves may be stowed below the tent ready just in case of accidental leakage. At one side there are

ports

82, 83 for the sterilization chamber docketing and functional connections docketing. These ports allow for the introduction of tools and/or organs into the tent. On the other side of the tent there is the previously-mentioned safety window port 85 with a one-way valve in the form of leaflets for allowing purging air to escape and for entering unexpected tools or removing tissue samples (e.g., biopsy) . Rods 35 that form the frame are also visible in Fig. 3.

A surgeon wearing spectacles or goggles 85 must fasten them to the ultra-thin translucent plastic material 31 on a side surface of the tent 30 to create direct vision as shown in Fig. 5A. The goggles are secured about the head of the surgeon by a head band 87 that fastens at the back. At the location of the goggles the plastic 31 is made thicker and is given a concave curvature 86a above and 86b below the eye level to provide free space for the protruding forehead of the surgeon, as well as the nose and mouth of the surgeon for breathing. Fig. 5B is an alternative design in which the goggles are a mask.

Fig. 5C shows a small tube extending into the tent 30 which is sized to accept a finger covered by a smooth fitting glove. This can be used during a surgical procedure where the whole hand is not needed, e.g., where some instrument, tissue or thread needs to be held in place or perhaps the patient’s pulse needs to be measured.

The design as disclosed above can be modified to serve in different environments with different patients. For example, a European model may be made larger than an Asian model to accommodate different patent sizes. Further, there can be a model designed for a war zone and a model design for space, where it could be used for surgery on an astronaut. All four of these basic designs are compact package sizes.

Fig. 6A shows the space or astronaut versions. Since the patient will be weightless in space, the patient is fixed on the table 50 by means of belts 84 that are connected to brackets on the table as shown in Fig. 6A. The belts may drape about the body of the patient or they may be fastened to the cross circle 32. The space unit has the usual glove ports 80 and goggles 85.

Figs. 6B –6E shows the various states of use of the space version. In particular, Fig. 6B shows a top plan and elevational view of the astronaut package during processes of positioning the package over the patient so the cross circle 32 can be applied appropriately. Fig. 6C shows the space or astronaut package during erection of the tent. During this process the rods 35 are snapped together and purging gas is entered into the tent. Fig. 6 D is the part of the process when the external support apparatus is to be connected to the tent.

In Fig. 6E the package in use during surgery. This is represented by four people wearing goggles and observing and/or performing the surgery. Also, at least two hands in the glove ports are shown performing the surgery. It should be noted that in this version and the others, the ultra-flexible plastic 31 allows the operators to reach the desired depth within the surgical site. The sterilized zone is shown in Fig. 6F. Since the surgical site is completely sealed, theoretically the surgeons do not need to wear the typical gloves, face masks or gowns. Once the surgery is complete, the entire package can be disposed of in a safe way. Thus, there is no cross contamination between the surgeon and the patient.

Auxiliary equipment for supporting the surgical package is shown in Fig. 7. In Fig. 7 the tent 30 is to the left. The functional connections 68 discussed above can have a carousel 97 located in it. As indicated the carousel may have provisions for saline tubing, sterilized gauze, anesthetic injections, blood transfusions, sedation injections and hemostatic dressings. The sterilization chamber 66 previously discussed is shown in Fig. 7 has having a carousel 96 with provisions for scissors, forceps, sutures, scalpels, tweezers and retractors.

In the arrangement of Fig. 7 the frame has a hanger 91 for a blood bag 92 that is connected by a tube to a needle 98 for providing the patient with a transfusion. Further a foot pump 94 is provided to establish operation of the equipment by foot power. It can provide suction through a rigid tube 99 in the tent to a flexible tube that leads to the pump 94. Any fluid in the line is collected in reservoir 95. Air from pump 94 passes through tube 52 and filter 53 back into the tent.

If used in space, the compact sterilized package, which can be made of PVC, not only protects the patient from infection, but also because of its sealed box design it prevents blood contamination of the space craft cabin under zero gravity and prevents unknown particles from another planet, to which the body has no defense, from entering the open wound.

Fig. 8 shows a war zone version of the invention. Basically its tent is smaller in size, but still has glove ports 80, window 85, sterilized instrument box 66 and gas inlet 52. This version is designed for a single surgeon. This portable unit uses battery powered LEDs for lighting system 70. Because of its low vertical height, the goggles adhered to the tent can be replaced with a surgical vision scope 93 on the top surface. Nevertheless, googles can also be used with or without the scope. Also, no gloving is necessary to save time in treating battlefield emergencies.

The present invention has a number of beneficial aspects. It can be used in both indoor and outdoor applications. It can be adapted for complicated, minor, space or war zone surgeries. It is especially useful for long duration complex surgeries in the operating theatre (e.g. open heart and transplants surgeries) .

The tent can be erected with a high ceiling so as to cater to all surgeries, especially where vertical instrumentation is required. Further, it provides direct real time vision by direct adhesion of the goggles to the plastic of the tent. If necessary the tent can be anchored to the operating theater table for stability.

There is only one outlet through a safety window with a one way valve made of leaflets. In addition a filter can be located in the window. The safety window can also be used as an emergency communication channel between the outside and inside of the infection control package. There is direct connection to a sterilization chamber with full surgical implements for specific operations.

The system uses sterilized protection sleeves for functional tools, e.g., a drill with a tether and suction with tubing. The long protection sleeves may be part of one cast molding plastic package. Dual protection is provided by the infection control package, i.e., against particles dropping down into an open wound and against fluids being ejected up toward the surgeon.

Specific features of the invention are shown in one or more of the drawings for convenience only, as each feature may be combined with other features in accordance with the invention. Alternative embodiments will be recognized by those skilled in the art and are intended to be included within the scope of the claims. Accordingly, the above description should be construed as illustrating and not limiting the scope of the invention. All such obvious changes and modifications are within the patented scope of the appended claims.

Claims

An infection control package comprising:

an ultra-thin and translucent foldable plastic sheet;

a collapsible frame formed from rods, which with the sheet can be assembled into a surgical tent; and

a cross circle located in the plastic sheet at a bottom portion thereof, said circle is provided with an adhesive under a cover sheet so that the cross circle can be adhered to the skin of a surgical patient at the site of the proposed surgery.
The infection control package of claim 1 further including belts at locations representing the four corners of the tent formed with the rods and plastic sheet, which belts are used to tighten the frame to a surgical table on which the package is located and without undue pressure on a patient on the table.
The infection control package of claim 1 wherein the rods have male and female joints that are manually assembled to establish the frame as a tent with a firm base.
The infection control package of claim 1 further including goggles or spectacles for the surgeon that are adhered to a side surface of the tent to create direct vision of the surgical site.
The infection control package of claim 1 further including glove ports in a side surface of the tent for the surgeon.
The infection control package of claim 1 in combination with a lighting system for the top surface of the tent, said lighting system having a handle that can be inserted within a plastic ring in the top surface of the tent so as to adhere on the surface of a light circle by surface tension.
The infection control package of claim 1 in combination with an air fan, a tube leading from the fan to the interior of the tent, a filter located in the tube and a safety window with a one way valve on the tent to allow air to leave the tent, whereby the air inserted flushes out existing gas media inside the tent to establish a germ free environment inside the tent.
The infection control package of claim 1 in combination with a battery, an air fan powered by the battery, a tube leading from the fan to the interior of the tent, a filter located in the tube and a safety window with a one way valve on the tent to allow air to leave the tent, whereby the air inserted flushes out existing gas media inside the tent to establish a germ free environment inside the tent.
The infection control package of claim 1 in combination with a manually operated pump that creates air flow, a tube directing the pump air flow to the interior of the tent, a filter located in the tube and a safety window with a one way valve on the tent to allow air to leave the tent, whereby the air inserted flushes out existing gas media inside the tent to establish a germ free environment inside the tent.