Closed Circuit Forced Hot Air Intraoperative Patient Warmer With Improved Sterility

Abstract

A system for a closed circuit forced hot air warmer of patient beds and blankets with improved sterility has a patient mattress or blanket microprocessor controlled warmer that circulates heated air in a closed system without releasing warmed air into the area surrounding the patient or into the operating room. The system helps to avoid the exposure of patients and hospital workers in the operating room to possible infecting microbes carried in unsterile turbulent air currents related to the release of air from non-closed systems. The machinery and flexible hoses of the system are initially sterilized by a microprocessor controlled antimicrobial mist generator. The system does not discharge jets of warmed air due to the closed circuit arrangement. Turbulent air flow previously produced in the vicinity of the patient by high velocity air jets is eliminated. An ambient, quiescent condition accorded by closed circuit heating prevents infection of patients and operating room personnel by microbe migration.

Claims

1-9. (canceled)

10. A system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility, comprising: a) a sterilized blower with microprocessor controlled air heating capability having an input and an output opening, each opening being provided with a high-efficiency particulate air filter; b) said high-efficiency particulate air filters having pore openings less than 0.22 microns capable of filtering microbes and dust particles; c) said output opening of said sterilized blower being appointed to be connected to an input connection of a bed or blanket using a sterilized flexible hose with quick release connector; d) said bed or blanket having an output that is appointed to be connected to the input of said sterilized blower with a second sterilized flexible hose with quick release connector; e) said sterilized blower being appointed to circulate heated air within said bed or blanket, thereby forming a closed circuit without discharging said heated air into the area surrounding a patient or into an operating room; and f) an antimicrobial mist generator already containing or permitting the addition of an antimicrobial liquid for internal sterilization of said sterilized blower and sterilized flexible hoses, said antimicrobial mist generator having an input port and an output port; whereby said system for said closed circuit forced hot air warmer of patient beds and blankets with improved sterility prevents microbial contamination of said patient or of hospital workers by unsterile air currents generated by warm air circulating within the apparatus or released into the operating room.

11. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 10, wherein said internal sterilization of said sterilized blower and said sterilized flexible hoses is carried out by connecting said output of said sterilized blower to said input port of said antimicrobial mist generator, which may be either disposable or reusable, and connecting said output port of said antimicrobial mist generator to said inlet of the sterilized blower, forming a closed circuit running a sterilization cycle for a preselected time period.

12. The system for closed circuit forced hot air warmer of lent beds and blankets with improved sterility as recited by claim 10, wherein said preselected time period is less than 15 minutes.

13. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 11, wherein when said sterilization cycle is complete, an aliquot of sterile distilled water is introduced and any residual disinfectant is taken up into circulated water vapor.

14. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 11, wherein after said sterilization cycle said antimicrobial mist generator is disconnected.

15. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 13, wherein said sterilized blower and said sterilized flexible hoses are cleared of accumulated moisture by running said sterilized blower with said antimicrobial mist generator disconnected so that said accumulated moisture is blown out through said sterilized flexible hose.

16. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 13, wherein said sterilized blower and said sterilized flexible hoses are cleared of accumulated moisture by running said sterilized blower with said antimicrobial mist generator containing a dry sponge or dessicant previously inserted or released into the chamber of the generator, discarding the material or disposing the entire disposable generator when the drying cycle is complete.

17. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 10, wherein said antimicrobial mist generator is sealed with a gasket and filled with an aliquot or capsule of antimicrobial liquid.

18. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 15, wherein said antimicrobial liquid is atomized by flow of warm air from said sterilized blower through said input port of said antimicrobial mist generator and is delivered to said output port of said antimicrobial mist generator for delivery through said sterilized blower and said sterilized flexible hoses.

19. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 11, wherein said antimicrobial mist generator is sealed with a gasket and tilled with an aliquotor capsule of said antimicrobial liquid.

20. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 10, wherein sterilized blower with microprocessor controlled air heating capability controls flow of warm air and therefore atomization in said antimicrobial mist generator.

21. The system far closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 10, wherein said sterilized blower with microprocessor controlled air heating capability controls warm air temperature, warm air flow rate and air pressure.

22. The system for closed circuit forced hot air warmer of patient bed and blankets with improved sterility as recited by claim 1, wherein an interior of said sterilized blower and said flexible hoses are sterilized by connecting to said antimicrobial mist generator for a preselected time prior to connecting and use of said bed or blanket.

23. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 21, wherein said bed or blanket is connected with flexible quick connect hoses to said sterilized blower with microprocessor controlled air heating capability after said antimicrobial mist generator is disconnected and said internal sterilization of said sterilized blower and sterilized flexible hoses is completed, if necessary, thereby preventing the possibility of patients suffering infections from being exposed to unsterile air containing microbes.

24. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 10, wherein said sterilized blower is connected to said antimicrobial mist generator which, in turn, is connected to said bed or blanket, wherein said output of said bed or blanket is connected to said input of said sterilized blower with microprocessor controlled air heating capability.

25. A system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility, comprising: a) a sterilized blower with microprocessor controlled air heating capability having an input and an output opening, each opening being provided with a high-efficiency particulate air filter; b) said high-efficiency particulate air filters having pore openings less than 0.22 microns capable of filtering microbes and dust particles; c) said output opening of said sterilized blower being appointed to be connected to an input connection of a bed or blanket using a sterilized flexible hose with quick release connector; d) said bed or blanket having an output that is appointed to be connected to the input of said sterilized blower with a second sterilized flexible hose with quick release connector; e) said sterilized blower being appointed to circulate heated air within said bed or blanket, thereby forming a closed circuit without discharging said heated air into the area surrounding a patient or into an operating room; and f) a mist generator containing an antimicrobial liquid for internal sterilization of said sterilized blower and sterilized flexible hoses; whereby said system for said closed circuit forced hot air warmer of patient beds and blankets with improved sterility prevents microbial contamination of said patient or of hospital workers by unsterile air currents generated by warm air released into the operating room.

26. The system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility as recited by claim 25, wherein said sterilized blower is connected to said antimicrobial mist generator which, in turn, is connected to said bed or blanket, wherein said output of said bed or blanket is connected to said input of said sterilized blower with microprocessor controlled air heating capability.

27. A system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility, comprising: a) a sterilized blower with microprocessor controlled air heating capability having an input and an output opening, each opening being provided with a high-efficiency particulate air filter; b) said high-efficiency particulate air filters having pore openings less than 0.22 microns capable of filtering microbes and dust particles; c) said output opening of said sterilized blower being appointed to be connected to an input connection of a bed or blanket using a sterilized flexible hose with quick release connector; d) said bed or blanket having an output that is appointed to be connected to the input of said sterilized blower with a second sterilized flexible hose with quick release connector; e) said sterilized blower being appointed to circulate heated air within said bed or blanket, thereby forming a closed circuit without discharging said heated air into the area surrounding a patient or into an operating room; and f) means for adding an antimicrobial liquid for internal sterilization of said sterilized blower and sterilized flexible hoses; whereby said system for said closed circuit forced hot air warmer of patient beds and blankets with improved sterility prevents microbial contamination of said patient or of hospital workers by unsterile air currents generated by warm air released into the operating room.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0030] The invention will be more fully understood and further advantages will become apparent when reference is had to the following detailed description of the preferred embodiments of the invention and the accompanying drawing, in which:

[0031] FIG. 1 illustrates a system for delivering warm air to patient beds and blankets in a closed circulating circuit;

[0032] FIG. 2 illustrates the blower with air warmer machinery and flexible tubes being sterilized by the antimicrobial mist generator;

[0033] FIG. 3 illustrates the details of the microprocessor controlled blower with input port 202 and an output port, both provided with HEPA filters;

[0034] FIG. 4 illustrates the microprocessor controlled antimicrobial mist generator;

[0035] FIG. 5 illustrates the patient mattress or blanket; and

[0036] FIG. 6 illustrates the sterilization process of the patient bed or blanket prior to disposal.

DETAILED DESCRIPTION OF THE INVENTION

[0037] The objective of the invention is to provide warmth to a patient by a warmer that circulates heated air within a patient bed or blanket in a closed system without releasing warmed air into the area surrounding the patient or in the operating room, thereby preventing the possibility of patients suffer infections and hospital workers in the operating room being exposed to infecting microbes.

[0038] Measurements have shown that a patient on a hospital bed loses about 1.6 degrees C. body temperature during the first hour. Such body temperature loss can lead to hypothermia, shivering and may compromise the patient's healing [See http://solutions.3m.com/wps/portal/3M/en_EU/Healthcare-Europe/EU-Home/Products/InfectionPrevention/Patient_Warming/.] Patient warming beds and warming blankets are essential to prevent this onset of patient hypothermia.

[0039] For the past two decades, maintenance of patient body temperature during surgery has largely been achieved with forced hot air warming; this process replaced circulating hot water blankets, which were cumbersome and often ruptured, covering the floor with water. Tent, blanket and mattress designs have also been used. Virtually all of these have been inexpensive and disposable, and have attempted to avoid the problem of difficult and often incomplete cleaning between uses. All of the currently used forced hot air devices have a blanket or pad with multiple holes that emit the warmed air around the patient or an open tent over the patient into which the warm air is blown. Some recent studies have documented that the release or leakage of the forced air causes unwanted air currents that bring up potentially unclean air from near the floor or cause increased numbers of particles and bacteria to circulate over the prepped area of the surgical incision, increasing the risk of operative infection. Examination has also revealed bacteria collecting within the blowers. Another study demonstrated that the air currents interfere with the laminar airflow sometimes used in the operating room to discourage bacterial contamination. The FDA has also recently released an alert, describing their concerns and the need for a regular program of cleaning and maintenance of heater/cooler devices. While the contention that these devices are related to an increase in operative infections has been questioned, it seems reasonable to attempt to avoid air leakage and any possibly undesirable air currents that might increase infection risk. Avoiding the buildup of bacteria within the blower is obviously a reasonable goal. Bacterial contamination related to increased infection has recently been reported in the liquid of water blankets. Staying with a forced hot air system that employs inexpensive, disposable mattresses and blankets that do not need to be cleaned is clearly desirable.

[0040] Recently FDC has issued the following warning located at http://www.medscape.com/viewarticle/852750 which is reproduced below:

[0041] FDA Warns Infection A Risk With Heater-Cooler Devices [0042] Megan Brooks [0043] Disclosures|Oct. 15, 2015

[0044] The use of heater-cooler devices has been associated with nontuberculous mycobacterium (NTM) infections, primarily in patients undergoing cardiothoracic surgeries, the US Food and Drug Administration (FDA) warned today.

[0045] Heater-cooler devices are used during medical and surgical procedures to warm or cool a patient, as appropriate. The devices include water tanks that provide temperature controlled water to external heat exchangers or warming/cooling blankets through closed circuits.

[0046] Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air, via the device's exhaust vent, into the environment and to the patient, the FDA notes in a safety communication posted on its website. Between January 2010 and August 2015, the FDA received 32 reports of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination, with 25 reported this year.

[0047] “Some reports describe NTM infections related to cardiothoracic surgeries, but other reports do not specify the procedure the patient was undergoing,” the FDA notes. Eight reports were related to three events describing patient infections occurring in US healthcare facilities, whereas the other 24 reports involved facilities outside the United States, mostly in Western Europe.

[0048] In some cases, patients presented with infections several months to years after their surgical procedure. The FDA is not aware of NTM infections acquired by hospital staff.

[0049] The FDA says it is “actively” monitoring the situation and will provide updates as appropriate.

[0050] The aim of today's safety communication is to “heighten awareness about infections associated with heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients,” they say.

Recommendations

[0051] In addition to following standard precautions, the FDA recommend that healthcare facilities and staff using heater-cooler devices consider implementing the following measures to reduce risk to patients:

[0052] Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer's device labeling. Ensure you have the most current version of the manufacturers' instructions for use readily available to promote adherence.

[0053] Do not use tap water to rinse, fill, refill or top off water tanks, as this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. When making ice needed for patient cooling during surgical procedures, use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. Deionized water and sterile water created through reverse osmosis is not recommended because it may promote corrosion of the metal components of the system.

[0054] Direct the heater-cooler's vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient.

[0055] Establish regular cleaning, disinfection, and maintenance schedules for heater-coder devices according to the manufacturers' instructions to minimize the risk for bacterial growth and subsequent patient infection.

[0056] Develop and follow a comprehensive quality control program for maintenance, cleaning, and disinfection of heater-cooler devices. Your program may include written procedures for monitoring adherence to the program and documenting set up, cleaning, and disinfection processes before and after use.

[0057] Immediately remove from service heater-cooler devices that show discoloration or cloudiness in the fluid lines/circuits, which may indicate bacterial growth. Consult your hospital infection control officials to perform the appropriate follow-up measures and report events of device contamination to the manufacturer.

[0058] Consider performing environmental, air, and water sampling and monitoring if heater cooler contamination is suspected. Environmental monitoring requires specialized expertise and equipment to collect and process samples, which may not be feasible in all facilities.

[0059] Healthcare facilities should follow their internal procedures for notifying and culturing patients if they suspect infection associated with heater-cooler devices.

[0060] The present invention addresses the aforementioned issues by providing a patient warming bed or blanket that is heated by the circulation of controlled warm air. The warming system circulates all of the warmed air within a closed circuit, so that no warmed air is released outside the closed warm air circulating system. This absence of release of warmed air prevents circulating air currents that may bring microbes to open wounds of a patient.

[0061] The closed circuit of the warming system is sterilized with antimicrobial disinfectant spray or atomized mist. The warm air contained in the closed circulating system is sterile. At the end of use of the bed or blanket, the system can be sterilized with antimicrobial disinfectant atomized mist and the disposable bed or blanket discarded.

[0062] The closed circuit forced hot air warmer consists of a blower connected by flexible conduit using quick connect couplings to a terminal device, which may be a blanket or a mattress that is not an open tent. The air that enters the terminal device passes through a HEPA filter with a pore size less than 0.22 microns to catch any bacteria or particles in the incoming airflow. The warm air passes through a structured chamber, or a folded tube within the chamber, so that the blanket or mattress is filled with warm air that passes slowly through the device to an outflow port and returns back to the blower in a completely closed system. There are no apertures to release warm air and no air leaks from the system, avoiding possible turbulence and air currents in the operating room. The internal chamber structure insures that warm air is not shunted to the outflow port, but rather fills the entire chamber, so that the entire device remains warm, transmitting heat to the patient by direct contact and maintaining body temperature. The return air conduit is detachable from the device, as well. The blanket or mattress, therefore, remains a simple, inexpensive device and is suitable for disposal after use.

[0063] The HEPA filters at the inflow and outflow portals of the blower and the fact that each disposable pad is clean help to avoid bacterial contamination. The unique design of the system makes sterilization of the air channels in the blower and the connecting tubes easy to perform. The detached ends of the flexible inflow and outflow lines are each connected to a small (detachable) chamber containing a well. A measured amount of liquid disinfectant is introduced through a separate port and the blower is turned on. The circulating air will take up the disinfectant, which will be carried through the system as an aerosol. After a brief period, all internal surfaces are disinfected. A second aliquot of STERILE distilled water can be added later to rinse out the system. Following the disinfection step; the two conduits are disconnected. Any aerosol (mostly water) that remains is blown out and the sterilized system is read for use. In addition, a sponge or other trap may be employed to capture the water.

[0064] A filtered port allows ambient air to enter the blower at the beginning of a cycle. When the system has been filled and air begins to return via the outflow conduit, the entry portal is capped and only air from the outflow conduit can enter the blower for recirculation.

[0065] Briefly stated, the closed circuit forced hot air warmer of patient beds and blankets with improved sterility provides hot air for warming a patient bed or blanket, preventing hypothermia of the patient that may significantly increase healing time periods. Warm air is supplied, from a blower the inlet and outlet ports of which are guarded with a HEPA filter having a pore dimension less than 0.22 microns to prevent the entry or microorganisms or dust particles. The temperature of warm air, its pressure and flow rate are controlled by a control panel set by the operator of the device. When used to warm the bed of the patient, the air pressure within the mattress helps to support the patient's body weight. Being a closed system, the pressure can be readily increased according to the weight and size of the patient. The flow rate determines how quickly the warmed air is delivered to the patient and is related to the rotational rate of a blower motor.

[0066] FIG. 1 illustrates at 100 a system for delivering warm air to patient beds and blankets in a closed circulating circuit. The closed circuit warm air delivery system comprises a blower 101 with microprocessor controlled temperature, pressure and flow control that has input and output ports each guarded by HEPA filters. The blower output port is connected to the input port of patient bed or blanket 102 using by flexible tubing with quick release connectors 104. The output port of the patient bed or blanket is connected to the input port of the blower 101 using flexible tubing again with quick release connectors 104. The microprocessor control panel is shown at 105. The microprocessor controls the warm air temperature at 105a warm airflow rate at 105b and warm air pressure at 105c. The warm airflow path is therefore a continuous closed circuit with no warm air escape location. The airflow rate is proportional to the speed of rotation of the blower motor. The pressure in the patient bed, which is capable of supporting the body weight of the patient, is also controlled by the blower fan motor speed. The electrical current supplied to the heating elements controls the warm air temperature.

[0067] FIG. 2 illustrates at 200 the blower with air warmer machinery and flexible tubes used being sterilized by the antimicrobial mist generator. The blower with air warmer machinery is shown at 101 with HEPA filters both at inlet and outlet. The output of the blower is connected to the inlet of the antimicrobial mist generator 103 using a flexible hose provided with quick release couplings. The output of the antimicrobial mist generator 103 is connected to the inlet port of the blower 101 using a flexible hose provided with quick release couplings. The antimicrobial solution in the antimicrobial mist generator is atomized and circulated in this closed path for a preselected time period, which may be as long as 15 minutes, disinfecting circuit sterilizing the blower with air warming machinery 101 and all the flexible hoses in the system. At the end of this disinfecting step, the quick release couplings are disconnected and any moisture present in the blower 101 and flexible hoses is blown out through the outlet hose. Any excess water can be blown into a dry sponge.

[0068] FIG. 3 illustrates at 300 the details of the microprocessor controlled blower with warm air delivery 101. As illustrated, the blower has input port 302 and output port 303 both provided with HEPA filters. The quick release connectors of the flexible hose are shown at 104. The warm air flow bath is indicated by the arrows. The blower with warm air delivery has a blower fan and electrical heating elements with sensors for air temperature, air pressure and air low rate communicating with the microprocessor control as shown in FIG. 1

[0069] FIG. 4 illustrates at 400 the microprocessor controlled antimicrobial mist generator, which is only used to achieve internal sterilization of the blower warm air machinery 101 and all the flexible hoses used. The mist generator is filled with a capsule 402 that has the antimicrobial liquid sealed with gasket 403, which is atomized by the flow of warm air through the input port and is delivered to the output port. The microprocessor according to FIG. 2 turns on the antimicrobial mist spray during initial set up to sterilize the interior surfaces of blower and flexible tubes. When the sterilization operation is complete, an aliquot of sterile distilled water is introduced and any residual disinfectant is removed in the circulated water vapor. Quick release couplings 104 connect the flexible hoses to the inlet and outlet of antimicrobial mist generator 103. The mist generator is disconnected from both flexible hoses and the system dried internally by running the blower. Any excess water can be blown out into a clean sponge.

[0070] FIG. 5 illustrates at 500 the patient bed or blanket 102. The inlet of warm air into the bed or blanket is shown at 501. The patient bed or blanket has a plurality of interconnected airflow paths indicated by arrows shown at 503. The outlet of the patient bed or blanket 102 is shown at 502. The connection of flexible hose to the inlet and outlet is done using quick release couplings 104.

[0071] FIG. 6 illustrates at 600 an optional arrangement for the sterilization process of patient bed or blanket. This is similar to FIG. 1 except that the antimicrobial mist generator 103 is inserted between the blower warm air machinery 101 and the patient bed or blanket 102 and a closed circuit is formed using flexible hoses with quick release connectors 104. When used prior to disposal, the sterilization process is run for about 15 minutes and the sterilized patient bed or blanket is discarded.

[0072] In its preferred embodiment, the system for closed circuit forced hot air warmer of patient beds and blankets with improved sterility of the present invention comprises: [0073] 1) a blower with controlled air heating capability having an input and an output opening, each opening being provided with a HEPA filter; [0074] 2) said HEPA filters having pore openings less than 0.22 microns capable of filtering microbes and dust particles; [0075] 3) said output opening being connected to an input connection of a bed or blanket using a flexible hose with quick release connector; [0076] 4) said patient bed or blanket having an output that connects the exiting warm air to the input of said blower, said connection being made with a flexible hose and quick release connector; [0077] 5) the entire flow path of warmed air being a closed circuit with no discharge of warmed air surrounding the patient within the operating room; [0078] 6) a flexible hose able to connect to an antimicrobial mist generator 8 with a quick release connector; [0079] 7) said antimicrobial mist generator being connectable to the return blower with a quick release connector; [0080] 8) said antimicrobial mist generator being detached during warming of the patient bed or blanket by passage of warm air from said blower; [0081] 9) said antimicrobial mist generator, being reconnected to the blower by the output and return hose, being tuned on as needed for internal cleaning after the safe disposal of said patient bed or blanket;

[0082] whereby said system for said closed circuit forced hot air warmer of patient beds and blankets with improved sterility prevents the microbial contamination of the patient or hospital workers in the operating room.

[0083] Having thus described the invention in rather full detail, it will be understood that such detail need not be strictly adhered to, but that additional changes and modifications may suggest themselves to one skilled in the art, all falling within the scope of the invention as defined by the subjoined claims.