METHOD AND APPARATUS FOR STERILIZING MEDICAL INSTRUMENTS
20230129864 · 2023-04-27
Inventors
- Franciscus Maria VERHOEVEN (Amsterdam, NL)
- Theo Alex Eduard VAN DER LEIJ (Moergestel, NL)
- Mirte PEETERS (Dongen, NL)
- Thijs DE JONG (de Bilt, NL)
Cpc classification
A61L2202/14
HUMAN NECESSITIES
A61L2/24
HUMAN NECESSITIES
F24F2006/008
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61L2202/24
HUMAN NECESSITIES
F24F6/00
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61L2202/15
HUMAN NECESSITIES
International classification
Abstract
A method and apparatus for sterilizing medical instruments, including a device for controlling specific humidity, SH, of flow of a gas or gas mixture. The device includes a tank for storing a volume of water. The tank has an inflow port for receiving the gas or gas mixture, and an outflow port for allowing humidified gas or gas mixture at the required SH to exit the tank. The temperature of the water and/or the pressure of the supplied gas or gas mixture are controlled for the required SH.
Claims
1. A sterilization apparatus for sterilizing medical instruments, including: a device for controlling specific humidity, SH, of flow of a gas or gas mixture, including a tank for storing a volume of water, wherein the tank has an inflow port for receiving the gas or gas mixture; wherein a temperature of the water and/or a pressure of the received gas or gas mixture are controlled for a required SH; and wherein the tank has an outflow port for allowing humidified gas or gas mixture at the required SH to exit the tank.
2. The apparatus of claim 1, wherein the inflow port is arranged to have the gas or gas mixture enter the volume of water below a water surface thereof.
3. The apparatus of claim 1, wherein the outflow port is in communication with a gas head inside the tank.
4. The apparatus of claim 1, including a processor arranged for retrieving a desired SH value and for determining values for a required temperature and/or required pressure on the basis of the desired SH value.
5. The apparatus of claim 1, including a temperature sensor, and temperature controller for maintaining the water at a controlled temperature.
6. The apparatus of claim 4, wherein the processor is arranged for receiving a controlled temperature value as input, and for determining the required pressure on the basis of the desired SH and the controlled temperature value.
7. The apparatus of claim 1, including a pressure regulator for maintaining a pressure in the tank at a controlled pressure.
8. The apparatus of claim 4, wherein the processor is arranged for receiving a controlled pressure value as input, and for determining the required temperature on the basis of the desired SH and the controlled pressure value.
9. The apparatus of claim 4, wherein the processor is arranged for controlling the temperature and/or pressure in the tank on the basis of the required temperature and/or required pressure.
10. The apparatus of claim 4, wherein the processor is arranged for receiving an indication representative of desired sterilization parameter and determining the desired SH value on the basis thereof.
11. The apparatus of claim 1, including a water supply port for maintaining a water level of the volume of water within a predetermined interval.
12. The apparatus of claim 1, including a plasma source having an ionization chamber in communication with the device for controlling specific humidity.
13. The apparatus of claim 12, wherein the outflow port of the device is connected to a gas input of the ionization chamber via a choke.
14. The apparatus of claim 12, including one or more of: a RH sensor, temperature sensor, pressure sensor, and flow sensor, in a connection from the outflow port of the device to a gas input of the ionization chamber.
15. The apparatus according to claim 1, including: a chamber arranged for placing a medical instrument therein; and a temperature control unit arranged for controlling a temperature of the medical instrument and/or the chamber such that the temperature of the medical instrument is below the temperature of chamber for allowing a sterilizing agent to at least partially condense onto the medical instrument.
16. A method for sterilizing a medical instrument, including: placing the medical instrument in a chamber; supplying a humidified gas stream to the medical instrument, wherein the humidified gas stream has a controlled specific humidity and is obtained by: providing a gas stream into a tank storing a volume of water, controlling a temperature of the water and/or a gas pressure of the supplied humidified gas stream for a required specific humidity, flowing the humidified gas stream having the controlled specific humidity from the tank.
17. The method of claim 16, including having the humidified gas stream enter the tank below a water surface of the volume of water.
18. The method of claim 16, including flowing the humidified gas stream having the controlled specific humidity from a gas head inside the tank.
19. The method of claim 16, including using a processor for retrieving a desired SH value and for determining values for a required temperature and/or required pressure on the basis of the desired SH value.
20. The method of claim 16, including using a temperature sensor, and using temperature controller for maintaining the water at the controlled temperature.
21. The method of claim 19, including the processor receiving a controlled temperature value as input, and determining a required pressure on the basis of the desired SH and the controlled temperature value.
22. The method of claim 16, including controlling the gas pressure using a pressure regulator for maintaining a pressure in the tank at a controlled pressure.
23. The method of claim 19, including the processor receiving a controlled pressure value as input, and determining a required temperature on the basis of the desired SH and the controlled pressure value.
24. The method of claim 19, including the processor controlling the temperature and/or a pressure in the tank on the basis of the required temperature and/or required pressure.
25. The method of claim 19, including the processor receiving an indication representative of desired sterilization parameter and determining the desired SH value on the basis thereof.
26. The method of claim 16, including automatically maintaining a water level of the volume of water in the tank within a predetermined interval.
27. The method of claim 16, including at least partly ionizing the humidified gas stream having the controlled specific humidity using a plasma source prior to supplying the humidified gas stream to the medical instrument.
28. The method of claim 27, including flowing the humidified gas stream having the controlled specific humidity from the tank to the plasma source via a choke.
29. The method of claim 27, including measuring one or more of: relative humidity, temperature, pressure, and flow, in a connection from the tank to the plasma source.
30. The method according to claim 16, including controlling a temperature of the medical instrument and/or the chamber such that the temperature of the medical instrument is below the temperature of chamber for allowing a sterilizing agent to at least partially condense onto the medical instrument.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] Embodiments of the present invention will now be described in detail with reference to the accompanying drawings in which:
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
DETAILED DESCRIPTION
[0038]
[0039] The apparatus 1 includes a sterilizing agent source 16. The sterilizing agent source 16 is arranged for providing a sterilizing agent. In this example, the sterilizing agent includes at least partially recombined ionized humidified air. In this example, the sterilizing agent source 16 includes a plasma source 20. The plasma source 20 includes an output port 28 in communication with the sterilizing agent supply port 12 of the chamber 4.
[0040] A first duct 30 extends between the plasma source 20 output port 28 and the sterilizing agent supply port 12 of the chamber 4. The first duct 30 includes a choke 32. In this example, the first duct 30 further includes a first valve 34. The first valve 34 is arranged for selectively opening and closing the first duct 30. Here the first valve 34 is positioned upstream of the choke 32. It will be clear that alternatively the first valve 34 may be positioned downstream of the choke 32.
[0041] The choke 32 is arranged for causing choked flow of the sterilizing agent from the plasma source 20 to the chamber 4 when the chamber is at the reduced pressure. The choked flow is a fluid dynamic condition associated with the Venturi effect. When a gas stream at a given pressure and temperature passes through a choke, also referred to as restriction or constriction, into a lower pressure environment the gas velocity increases. At initially subsonic upstream conditions, the conservation of mass principle requires the gas velocity to increase as it flows through the smaller cross-sectional area of the choke. At the same time, the Venturi effect causes the static pressure, and therefore the density, to decrease at the choke. Choked flow is a limiting condition where the mass flow will not increase with a further decrease in the downstream pressure for a fixed upstream pressure and temperature. The physical point at which the choking occurs for adiabatic conditions is when the velocity at the exit of the choke is at sonic conditions; i.e., at a Mach number of 1. Hence, thanks to the choke 32 the pressure in the plasma source 20 does not decrease below a predetermined threshold pressure when the pressure in the chamber 4 is reduced further below such predetermined threshold pressure.
[0042] Steady-state choked flow occurs when the pressure downstream of the choke falls below a critical value relative to the pressure upstream of the choke. The critical pressure value p* can be calculated from the following equation.
[0043] Herein p.sub.0 is the absolute upstream pressure and γ the heat capacity ratio c.sub.p/c.sub.v of the gas or gas mixture. For air the heat capacity ratio γ is about 1.4. Thus for air p*=0.528p.sub.0.
[0044] When the gas velocity is choked, the equation for the mass flow rate is as follows.
[0045] Herein {dot over (m)} is the mass flow rate in kg/m2, C.sub.d the discharge coefficient (dimensionless), A the cross-sectional area of the hole in m.sup.2, ρ.sub.0 the real gas density at total pressure p.sub.0 and temperature T.sub.0 in kg/m.sup.3, and T.sub.0 the absolute upstream temperature of the gas in K. The discharge coefficient C.sub.d is the ratio of the actual discharge to the theoretical discharge, i.e. the ratio of the mass flow rate at the discharge end of the nozzle to that of an ideal nozzle which expands an identical working fluid from the same initial conditions to the same exit pressures. The discharge coefficient C.sub.d is generally in the range of 0.5-1. The Discharge coefficient can e.g. be on the order of 0.6 (e.g. sharp edged orifice) to 0.8 (e.g. longer hole). The discharge coefficient for a specific choke can easily be determined by comparing a measured mass flow rate to the theoretical mass flow rate (C.sub.d=1).
[0046] Hence, by properly designing the flow restriction properties of the choke 32 it is possible to prevent the pressure in the plasma source 20 to decrease below the threshold pressure, while the sterilizing chamber 4 is evacuated. Thus, the plasma source 20 can be operated continuously at nearly constant pressure, e.g. at near-ambient pressure. Hence, composition of the at least partially recombined gas mixture from the plasma source 20 can remain constant, or at least nearly constant, i.e. sufficiently constant, despite reducing the pressure in the sterilizing chamber 4.
[0047] In the example of
[0048] In the example of
[0049] In this example, a pump 46 is connected to a pumping port 48 of the chamber 4. The apparatus 1 in this example includes a temperature control unit 49. In this example, the temperature control unit 49 includes a cooling unit 50. The cooling unit 50 is arranged for cooling the medical instruments 2. In
[0050] The plasma source 20 includes an input port 22 for feeding a humidified air stream into the plasma source 20. In
[0051]
[0052] By flowing, e.g. bubbling, the gas through the water, the relative humidity, RH, of the gas will be at, or near, 100%. Also, by flowing the gas through the water, the temperature of the gas will be equal to, or close to, the temperature of the water. It will be appreciated that a person of skill in the art can easily determine, e.g. on the basis of some simple experiments, a volume of liquid required for ensuring that in the gas head of the tank the relative humidity, RH, of the gas will be at 100%, and that the temperature of the gas will be equal to the temperature of the water.
[0053] In the example of
[0054] In the example of
[0055] The specific humidity, SH, of the gas in the gas head in the tank 54 is dependent on the relative humidity, RH, of the gas, the pressure and the temperature. As described above, the RH can be set to 100% in the tank. The temperature of the gas can be set by setting the temperature of the water in the tank, e.g. using the temperature controller 64. The pressure of the gas in the gas head can be set by setting the feed pressure using the pressure regulator 60. For example, for a desired specific humidity of 10 grams of water vapor per kilogram of gas, and a water temperature of 40° C., using equation EQ1 the required pressure can be calculated to be P.sub.tot(40, 10)=4.623 bar(a). Thus, by setting the pressure regulator 60 to 4.623 bar(a) and setting the temperature controller 64 to 40° C., gas flow having a specific humidity of 10 g/kg can be obtained.
[0056] In the example of
[0057] In this example, the processor is arranged for receiving an indication representative of a desired sterilization parameter. The desired sterilization parameter can e.g. be a desired reactive component content of the plasma. The indication representative of the desired sterilization parameter can e.g. be one of a set of predetermined settings of the sterilization apparatus. The predetermined settings can e.g. relate to different instruments to be sterilized, different grades of contamination of the instruments to be sterilized, different levels of sterilization, or the like. The processor in this example determines the desired SH value on the basis of the indication representative of the desired sterilization parameter. The processor can e.g. look up the desired SH value corresponding to the desired sterilization parameter in a database or memory. In the example of
[0058] In this example, a connection from the outflow port 58 of the humidifier 26 to the input port 22 of the plasma source 20 includes one or more of a RH sensor 73A, a temperature sensor 73B, a pressure sensor 73C, and a flow sensor 73D. These sensors can be used for verifying a mass flow towards the plasma source and/or for verifying the SH of the gas flowing to the plasma source 20. The SH can be calculated from the measured RH, temperature and pressure, on the basis of equation EQ1.
[0059] In this example, the SH value determined from the readings of the sensors 73A, 73B, 73C is used for verification only. In this example, there is no data connection between the sensors 73A, 73B, 73C and the processor 65 or controller 64. It will be appreciated that it is also possible to use the determined SH value for adjusting the pressure and or temperature in the tank 54 for controlling the SH.
[0060] The apparatus as described in relation to
[0061] The gas having the predetermined SH value is fed 112 from the outflow port 58 of the humidifier 26, towards the plasma source 20. Here, the pressure of the gas stream is reduced 114 by the further pressure regulator 70 and the second choke 72. The air stream entering the plasma source 20 has the predetermined SH value. The specific humidity of the air entering the plasma source 20 can e.g. be 10±1 g/kg (grams of water per kg of air).
[0062] According to a second method 200, see
[0063] The medical instruments 2 to be sterilized are placed inside the chamber 4. Then, the pressure in the chamber 4 is reduced 208 by the pump 36. In this example the pressure is reduced to approximately 50 mbar
[0064] In this example, with the first valve opened, the flow of the ionized humidified air from the plasma source 20, at least partly, recombines while flowing into the chamber 4. The sterilizing agent formed by the at least partly recombined ionized humidified air then contacts 212 the medical instruments 2 to be sterilized. Optionally, if the medical instruments 2 are, or have been, cooled, the sterilizing agent, at least partially, condenses 214 onto the medical instruments 2 and sterilizes the medical instruments 2. If the walls 6 of the chamber 4 are not cooled, less cooled than the medical instruments, or even heated, condensation of the sterilizing agent onto the walls 6 can be prevented.
[0065] In this example, as an option, the second valve 38 is opened 216 at moment 216a when the pressure in the chamber 4 rises to about 850 mbar, i.e. when the pressure in the chamber exceeds a predetermined threshold opening pressure of, here, 850 mbar. The opening of the second valve causes sterilizing agent to rush into the chamber 4 via the second duct 36, i.e. bypassing the choke 32. When the second valve 38 is open, the first valve 34 may be closed if desired. Hence, when the pressure in the chamber 4 is not too low, i.e. here not below the predetermined threshold opening pressure of in this example 850 mbar, the second valve 38 can be opened to allow a greater mass flow of sterilizing mixture than is achievable through the choke 32. As the pressure in the chamber 34 is above the threshold opening pressure at that time, the pressure in the plasma source cannot drop below the threshold opening pressure.
[0066] The medical instruments 2 may be taken from the chamber 218 immediately or may remain in the chamber 4 for some time for additional exposure to the sterilizing agent. The sterilizing agent may be fed to the destructor 42 via the exhaust port 14.
[0067]
[0068]
[0069] Herein, the invention is described with reference to specific examples of embodiments of the invention. It will, however, be evident that various modifications and changes may be made therein, without departing from the essence of the invention. For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, alternative embodiments having combinations of all or some of the features described in these separate embodiments are also envisaged.
[0070] In the example of
[0071] It will be appreciated that the humidifier as described herein can also be used in alternative sterilizing apparatus than described in view of
[0072] In the example of
[0073] It is possible that the apparatus further includes a washing unit arranged for washing and/or rinsing the medical instruments prior to sterilization. Preferably, the medical instruments are dried prior to sterilization. The cooling gas stream, optionally including the atomized water, can be supplied to the washed medical instruments for drying and cooling the medical instruments.
[0074] However, other modifications, variations, and alternatives are also possible. The specifications, drawings and examples are, accordingly, to be regarded in an illustrative sense rather than in a restrictive sense.
[0075] For the purpose of clarity and a concise description features are described herein as part of the same or separate embodiments, however, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described.
In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word ‘comprising’ does not exclude the presence of other features or steps than those listed in a claim. Furthermore, the words ‘a’ and ‘an’ shall not be construed as limited to ‘only one’, but instead are used to mean ‘at least one’, and do not exclude a plurality. The mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to an advantage.