DE102017120569A1 - Device for sterilization-parameter-dependent mechanical actuation or activation of functional units - Google Patents

Abstract

The present invention relates to a device (1) for sterilization-parameter-dependent mechanical actuation or activation of functional units (2) with an actuating element or actuator (3) which can be converted from a basic state into an actuated state in order to carry out an actuating movement and at least one functional unit (2) cooperating with the actuator (3) so as to be actuated or activated by the actuating movement of the actuator (3) and / or by the actuator (3) staying in the operating state.
According to the invention, the adjusting element (3) is designed to change from the ground state to the operating state only within a predefined pressure and temperature state region and to return to the ground state outside the predefined pressure and temperature range.

Description

The present invention relates to a device for sterilization parameter-dependent mechanical actuation or activation of functional units with an actuating element, which is convertible from a ground state into an operating state to perform an actuation or triggering movement and at least one functional unit which interacts with the actuator in such a way that the actuating or triggering movement of the actuating element is actuated or triggered.

Background of the invention

In hospitals, clinics, laboratories or similar facilities, it is often necessary to subject various containers, goods or equipment to sterilization. For quality assurance, these can be equipped with sterilization parameter-dependent functional units, such as indicator elements for indicating a sterile condition, counters for counting sterilization processes or valves for venting containers or devices. These sterilization-parameter-dependent functional units are generally designed so that they make use of the ambient conditions prevailing during sterilization and switch depending on a sterilization parameter and / or make use of the energy released during the sterilization process.

State of the art

Since common steam sterilization uses high temperatures and pressures to kill (pathogenic) microorganisms, temperature- or pressure-dependent actuators are typically used in corresponding devices to actuate / activate the functional unit in a particular pressure range or temperature range , Thus, the prior art temperature-dependent control elements for activating functional units are known, for example, based on bimetallic or shape memory metals. Further, the prior art pressure-dependent actuators for activating functional units are known, such as, membranes or pressure relief valves.

However, it has been found that such a switching behavior (such a tripping characteristic), which is based on a singular sterilization parameter, is very error-prone. A pure pressure detection is particularly disadvantageous in that during a sterilization cycle several phases are passed through with fluctuating pressure conditions, so that there is a risk of unwanted multiple actuation / activation. On the other hand, purely temperature-dependent actuators respond not only in the sterilization phase but also, for example, during drying, during cleaning or during an additional residence time in the sterilizer. In addition, the high inertia of such systems often does not reveal a clear switching point, so that, in particular, the high temperature of sterile containers directly after sterilization does not allow certain systems to safely jump to their ground state.

Against this background, the object of the present invention is to provide a device with which a functional unit can be actuated or activated simply, safely, without error and automatically as a function of specific sterilization parameters.

Brief description of the invention

This object is achieved according to the present invention by a device having the features of claim 1. Subordinate claims relate to advantageous developments of the invention. Claims 11 and 12 relate to a sterile product container or a medical device with a device according to one of claims 1 to 10.

The term sterilization-relevant functional unit of a medical device is intended to include in the context of this application all functional units which are in a functional relationship with a sterilization process (eg valves, closures, sterilization counters, sterile displays) and on a medical device (eg sterile goods containers, surgical instruments, implants , Sterilizers) are arranged or intended to be arranged on such a device.

A device according to the invention basically has at least one active and / or passive sterilization-relevant functional unit of a medical device and an actuator / actuator for actuating / activating / triggering / switching over said functional unit (s). For this purpose, the actuator is from a ground state in an operating state in which the actuator / actuator (or at least a portion or a sub-component thereof) has a different shape (geometry) and / or position than in the ground state, transferable, so as an actuating movement to execute or to allow. The at least one functional unit cooperates with the actuating element in such a way that it is actuated / actuated or activated / activatable by the actuating movement of the actuating element / actuator and / or by a lingering of the actuating element / actuator in the actuation state and / or remains. According to the actuator / actuator is designed exclusively within a predefined pressure and Change temperature state range from the ground state in the actuation state and / or dwell in this and return outside the predefined pressure and temperature range in its ground state. The term pressure and temperature state area is defined as a subspace of a two-dimensional topological space of pressure and temperature values. It may also be a non-contiguous subspace, ie there may be several separate pressure and temperature state areas in which the actuator / actuator performs the actuating movement. In other words, the device according to the invention reacts only to one or more specific combination (s) of heat and pressure, wherein the response parameters can be set or adjusted constructively exactly to the application. In this way, functional units can be reliably and independently actuated / activated depending on sterilization parameters.

In summary, therefore, the invention essentially relates to a device with a functional unit and an actuator / actuator for autonomous and mechanical actuation / activation or release for actuation / activation of the functional unit at certain pressure and temperature environmental conditions at a specific time (or several specific times ) during a sterilization process.

Preferably, the actuator / actuator can be designed such that it is under normal pressure conditions (eg, the atmospheric pressure at sea level) at an elevated temperature after sterilization in the normal / normal state. In particular, the actuator can therefore be at an exemplary pressure of about 1 bar at temperatures less than or equal to 50 ° C, in particular less than 90 ° C, in the basic / normal state. In this way, an unwanted actuation / activation of the functional unit by the actuator / actuator due to residual heat can be prevented.

According to one embodiment, the actuating element / actuator may be designed, at high pressures and high temperatures, in particular at temperatures between 110 ° and 140 ° in combination with pressures greater than or equal to 2 bar, preferably also pressures greater than or equal to 1.5 bar, to remain in the ground state and at a combination of low pressures (less than 0.5 bar, preferably less than 0.2 bar, more preferably less than or equal to 0.1 bar) with moderate temperatures (higher than 40 ° C) to carry out the actuation movement.

According to a preferred embodiment, the actuator / actuator may have at least one fluid-tight chamber, which is filled with an actuator filling and whose volume is defined by a chamber wall, which in turn has at least one movable actuator portion which due to a change in volume of Aktorfüllung relative to the remaining wall sections of Chamber is movable to perform an actuation or release movement. In such an embodiment, therefore, an expansion of the actuator filling forced by one or more sterilization parameters drives the actuation or release movement of the actuator section of the actuator / actuator.

According to a further aspect, the actuating element / actuator, the chamber, the actuator filling and the Aktorabschnitt can be designed such that the Aktorabschnitt the actuation or release movement exclusively due to a phase transition of at least a portion of Aktorfüllung, preferably a phase transition from a liquid into a gaseous phase, performs. Since such a phase transition always depends on the ambient pressure and the ambient temperature, an actuator / actuator can be implemented with simple means that reacts only to certain combinations of heat and pressure. A control element / actuator designed in this way additionally has the advantage that it does not need an internal power supply but instead draws its energy from the environment (ie indirectly from sterilizer / autoclave) required for the actuation or release movement.

According to an advantageous embodiment, the actuator filling may consist essentially of a biocompatible liquid, in particular of water or a hydrocarbon. In general, however, a design with other liquids is just as conceivable. By selecting the Aktorfüllung the tripping characteristic of the actuator / actuator can be adjusted. Biofeed actor satisfaction reduces risks that could arise from the withdrawal of actor fulfillment. By using water as actuator filling, it is possible to achieve that the actuator / actuator actuates / activates the functional unit or releases it for actuation in the event of a combination of higher temperatures and lower pressures. An exemplary field of application would therefore be a functional unit which triggers independently and reliably only in the drying phase of a sterilization cycle (with low hysteresis reacting to a combination of heat and vacuum).

Likewise, a mixture of different liquids or a mixture of a liquid and air or a liquid and another gas / gas mixture can be used as Aktorfüllung to the tripping characteristic of the actuator / Actors even more accurate or set for other applications.

According to a further preferred aspect, the fluid-tight chamber may advantageously be permanently sealed in a fluid-tight manner. In other words, the actuator / actuator according to the invention can advantageously be a closed system. In other words, in a preferred embodiment, the chamber can only be opened by destroying the chamber or seal. This prevents inadvertent opening of the chamber and an associated unintentional leakage of Aktorfüllung.

According to a preferred embodiment, the actuator portion of the chamber wall may be formed as a piston, in particular as a lifting or plunger, whose piston housing forms the remaining chamber wall. In other words, in such an embodiment, the chamber wall may be rigid and the wall section formed by the piston may be mounted axially movable relative to the remaining wall sections in order to carry out the actuating movement as a result of a volume change of the actuator filling.

According to a further preferred aspect, the actuator section of the chamber wall or another wall section can be formed as a flexible wall section, which reversibly expands and / or bends as a result of a volume change of the actuator filling and thus effects the actuating movement.

According to a further embodiment, the chamber may be formed by a radially expandable / bendable but in the longitudinal direction tensile rigid substantially tubular membrane. By means of such a chamber, an increase in volume of the actuator filling can be converted into a pulling movement.

According to a preferred embodiment, the device according to the invention may have a biasing element for applying a biasing pressure to the actuator filling. In other words, regardless of the ambient pressure, a certain biasing pressure can be applied to the actuator filling. In this way, the tripping characteristic of the actuator / actuator can be more accurately, for example. Set to a specific point during steam sterilization. More preferably, as such biasing elements, temperature, humidity or pressure sensitive components (e.g., NiTi shape memory devices or bimetal parts) may be used to further refine the tripping characteristic of the actuator / actuator.

According to a further preferred aspect, only the actuator section of the chamber can be exposed to the ambient pressure state, while the remaining sections of the chamber wall are structurally decoupled from the ambient pressure state. Preferably, this decoupling is achieved by a pressure-stable housing. In this way, the predictability of the tripping characteristic of the actuator / actuator can be improved.

Another optionally independently claimable aspect of the invention relates to a sterile container or sterilization basket with a device according to the invention described above.

Another optionally independently claimable aspect of the invention relates to a medical device, preferably a surgical device or a sterilizer with a device according to the invention described above.

list of figures

The invention will be explained below with reference to preferred embodiments with reference to the accompanying figures.

• 1a bis 1c: Skizzen zum physikalischen Hintergrund der vorliegenden Erfindung;
• 2a und 2b: Skizzen einer kolbenartigen Ausführungsform eines Stellelements in einem Grundzustand und in einem Betätigungszustand;
• 3a bis 3d: Skizzen verschiedener Ausführungsform zur Versiegelung bzw. Einkapselung einer Aktorfüllung in einem Stellelement gemäß der vorliegenden Erfindung;
• 4: eine Detailansicht der kolbenartigen Ausführungsform des Stellelements gemäß der vorliegenden Erfindung;
• 5: eine Detailansicht der Dichtung der kolbenartigen Ausführungsform des Stellelements gemäß der vorliegenden Erfindung;
• 6a bis 6f: Skizzen verschiedener Ausführungsformen der Erfindung bei denen die Funktionseinheit als Ventil ausgebildet ist;
• 7 eine schlauchartige Ausführungsform der vorliegenden Erfindung;
• 8 die schlauchartige Ausführungsform der vorliegenden Erfindung im Grundzustand und im Betätigungszustand; und
• 9a und 9b eine bevorzugte Lagerung für eine schlauchartige Ausführungsform der vorliegenden Erfindung im Grundzustand und im Betätigungszustand.

Show it

• 1a to 1c : Sketches of the physical background of the present invention;
• 2a and 2 B : Sketches of a piston-like embodiment of an actuating element in a ground state and in an operating state;
• 3a to 3d : Sketches of various embodiments for sealing or encapsulating an actuator filling in an actuator according to the present invention;
• 4 a detail view of the piston-like embodiment of the actuating element according to the present invention;
• 5 a detail view of the seal of the piston-like embodiment of the actuating element according to the present invention;
• 6a to 6f : Sketches of various embodiments of the invention in which the functional unit is designed as a valve;
• 7 a hose-like embodiment of the present invention;
• 8th the tubular embodiment of the present invention in the ground state and in the operating state; and
• 9a and 9b a preferred storage for a hose-like embodiment of the present invention in the ground state and in the operating state.

Various medical or medical-technical articles, such as, for example, sterile containers, baskets, sterilizers or surgical instruments, are provided with functional units 2 equipped to perform an action or change state depending on certain sterilization parameters. Examples of these are sterilization cycle counters, sterile displays, valves or closures, which respectively count, open, close or the like under certain ambient conditions and therefore at certain times during a sterilization process. The actuation or activation of these functional units (or the activation for their actuation) usually takes place by means of an actuating element / actuator 3 , which is an actor section 33 having, with it with a corresponding functional unit 2 (mechanical) is coupled to the functional unit 2 to press, to activate or to switch its state. Usually solves the functional unit in such systems 2 independently depending on external parameters such as ambient pressure, temperature or humidity, which does not require manual operation. Previously known systems are dependent on a single environmental parameter. Due to the numerous and complex environmental conditions during a sterilization process and due to hysteresis behavior, such systems are often unreliable and tend to trip in the wrong place during the sterilization process.

Therefore, it is the object of the present invention to provide a device 1 with a functional unit 2 and an actuator / actuator 3 which reacts to a combination of different parameters (ie to more than one parameter) with low hysteresis and thus an accurate and safe triggering / activating of the functional unit 2 guaranteed at the right time during the sterilization process. More specifically, such a device according to the invention 1 only react to predetermined pressure and temperature combinations. According to a preferred embodiment, this can be implemented particularly easily by an actuating element / actuator 3 is used, which only then activates / activates the functional unit, if a certain proportion of Aktorfüllung F is vaporized (is in a gaseous / vaporized state). Such an actuator / actuator 3 is through him or his actor fulfillment F own material properties per se designed to trigger only at certain pressure and temperature combinations and thus solves the task in an elegant way.

The 1a to 1c are sketches of the physical principle of a preferred embodiment of the present invention. Accordingly, there is an actuator / actuator 3 according to the preferred embodiment, a chamber 31 (Pad / pillow / capsule) with a basic volume (volume in the ground state) on. Said chamber 31 is on the one hand with an actor filling F filled and on the other hand designed such that at least one section 33 (hereinafter actor section 33 called) the chamber wall to the rest of the chamber wall is relatively movable or deformable. In this way causes a change in volume of actuator filling F a movement of the movable or deformable Aktorabschnitts 33 the chamber wall 32 , The 1a to 1c show an exemplary chamber 31 with flexible / deformable walls in different states. Increases the volume of actor filling F , For example, because of a thermal expansion or a phase transition of at least a portion of the actuator filling F in a gaseous phase G , the flexible walls of the chamber bulge 31 to the outside, whereby a movement with relatively high energy density is triggered / aktuiert. The 2a and 2 B show an alternative embodiment of such a chamber 31 in the manner of a (stroke) piston 33 , The chamber wall is in this case by a piston with a piston end face 331 trained actuator section 33 and a piston housing 32 Are defined. All chamber wall sections 32 are rigid in such an embodiment and the piston 33 is concerning his housing 32 axially guided relatively movable, causing it due to a change in volume of Aktorfüllung F sets in motion. In contrast to the prior art piston with piston housing, no fluid exchange takes place in a control element designed in this way. Instead, that's with the actor filling F filled chamber 31 permanently sealed to a loss of actor filling F and is operated solely on the basis of the volume change of the actuator filling F due to the environmental conditions.

• - (voreingestellter) Druck in der Kammer 31;
• - Menge an Aktorfüllung F in der Kammer 31;
• - andere/zusätzliche Medien im Stellelement/Aktor 3 bzw. der Kammer 3 (z.B. Luft),
• - äußerer Druck;
• - äußere Temperatur;
• - (mechanischer) Widerstand der Kammer 31 gegenüber einer Volumenänderung; und
• - zur Betätigung/Arbeitsverrichtung benötigte Kraft.

Basically, the absolute volume increase in the chamber 31 of the actuating element 3 essentially influenced by the following variables:

• - (preset) pressure in the chamber 31 ;
• - Quantity of actuator filling F in the chamber 31 ;
• - Other / additional media in the actuator / actuator 3 or the chamber 3 (eg air),
• - external pressure;
• - external temperature;
• - (mechanical) resistance of the chamber 31 against a volume change; and
• - For the operation / Arbeitsverrichtung required force.

In the design of an actuating element / actuator according to the invention 3 Therefore, all these parameters must be adapted constructively to the respective application.

The 3a to 3d show several examples of fluid-tight chambers 31 (Pads / Pillows / Capsules), each with an actuator filling F , In addition to the above-described piston-like design ( 3c) are two embodiments with flexible / deformable walls 32 shown. Such chambers 31 with flexible / deformable wall 32 can, for example, from silicone (see. 3b) or thin sheet metal (cf. 3a) be educated. Preferably, such chambers 31 with flexible / deformable wall 32 a corrugation / corrugation / folding 37 have a deformation or a movement of a Wandungsabschnitts 32 supported in a preferred direction. More specifically, a flexible / deformable wall section 33 with a corrugation / corrugation / folding 37 be formed, the wave troughs and mountains (minima and maxima) extend substantially in the direction of the preferred direction to the actuator section 33 train. In a further preferred embodiment, the corrugation 37 of the flexible / deformable wall section 33 also be aligned transversely to the preferred direction (see. 3d) , You could be such a constructive designed actuator / actuator 3 also as bellows or accordion-like describe.

According to the preferred embodiment shown, the actuator filling F with the remaining components of the control element be designed so constructive that it only performs an actuating movement when at least a certain proportion of Aktorfüllung F merges into a gaseous state. Specifically, water or certain hydrocarbons can be used as Aktorfüllung F, which additionally bring the advantage of being biocompatible.

For example, a water-based actuator charge F would begin to boil at about 100 ° C at an atmospheric pressure equal to atmospheric pressure at sea level. The temperature and pressure conditions used in a steam sterilization are usually 134 ° C at 3 bar or 121 ° C at 2 bar. Accordingly, a control element filled with water would not change to the operating state under these ambient conditions, since there is no or hardly any evaporation due to the high prevailing pressures. In the drying phase of a sterilization cycle, on the other hand, strong negative pressures prevail, down to 0.1 bar. In an exemplary temperature and pressure state during such a drying phase of 45.8 ° C at 0.1 bar would result in a vapor content of 15.5% with an executed as water Aktorfüllung F, whereby sufficient energy is provided to, for example Open valve. The example described above shows that a device according to the invention 1 In a simple way constructive can be adjusted so that it comes in a sterilization cycle only in the drying phase to an actuator, since the actuator / actuator 3 only in a defined temperature and pressure state range with elevated temperatures in combination with relatively low pressures triggers.

4 shows a more detailed representation of a piston-like embodiment of an actuator / actuator 3 , The piston end face 331 forms in interaction with the piston housing 32 the chamber 31 , which is filled with the actuator filling F, in this example water. The piston 33 is over a lid 332 with a guide bush 333 perpendicular to the piston end face 331 mounted translationally displaceable. The lid 332 is detachable on the piston housing 32 attached. In the example shown, the releasable attachment is as a thread 334 implemented. The entire actuator / actuator 3 is in the example shown rotationally symmetrical, so it is basically a sealed and with an actuator filling F filled cylinder pistons. The actuating movement is performed in the example shown in the axial direction of the axis of rotation. Circumferentially distributed circumferentially and outside the usual working range of the piston are several security holes 335 arranged, which is a deformation / damage of the actuator 3 with an excessively high volume increase of actuator filling F prevent. The chamber 31 of the actuating element / actuator 3 forms a closed system in normal operation, so it is sealed fluid-tight, to escape the Aktorfüllung F to prevent. As in 5 illustrated, the seal in the piston-like embodiment, preferably by sealing elements 336 on the side surface of the piston 33 be executed. In particular, two axially offset piston seals on the side surface of the piston 33 or between pistons 33 and housing inner surface may be arranged.

According to a preferred embodiment, the functional unit 2 the device according to the invention a valve 21 and it is therefore a device 1 for the sterilization parameter-dependent opening and closing of a valve 21 , In the 6a to 6f Various exemplary arrangements are shown, such as an actuator / actuator 3 with a valve 21 interact or per se as a valve 21 could act to such a device 1 to build.

The 6a and 6b show an embodiment in which a sealing cap 22 is used to one or more valve openings 23 to close. Preferably, the sealing cap 22 be biased in a closed state (see. 6b) , These can be preloading elements 25 be provided, which is the sealing cap 22 against a wall section / valve seat 24 Pretension. In the actuation state, the actuating element / actuator generates 3 in such a device a Ausfahrhub, the sealing cap 22 against the Biasing direction lifts and thus the valve 21 opens (cf. 6a) ,

The 6c and 6d show embodiments with poppet valves. This is a sealing plate 26 on a valve seat 24 pressed to a valve opening 23 seal. Again, it is advantageous if the sealing plate 26 against the valve seat 24 (spring) is biased. The actuator / actuator 3 can in such a valve, for example. Via an actuating bolt 27 perform the actuating movement to the sealing plate from the valve seat 24 withdraw. In a preferred embodiment, the actuator / actuator 3 arranged on the outside of a Sterilgutbehälterwandung while the sealing plate 26 is arranged on the inside of a Sterilgutbehälterwandung. The actuating bolt 27 is in such an embodiment through the valve seat 24 or the valve opening 23 and thus passed through the Sterilgutbehälterwandung. Of course, in such an embodiment, a corresponding counter bearing 28 needed, which is the actuator / actuator 3 determines to make it a movement of the sealing plate 26 can obtain.

While in the embodiments described above, the valve 21 is closed in the ground state and by the actuating movement of the actuator / actuator 3 opened, it is just as conceivable that the valve 21 is open in the basic state and is closed in the operating state. In a preferred embodiment, the enlarged dimensions of the actuator in the operating state per se cause the valve to close. At the in 6e illustrated embodiment is, for example, the actuator in a vent passage 29 with an access 291 and an exit 292 arranged. While in the illustrated ground state, a medium through the vent passage 29 can happen, the actuator is so constructive in such an embodiment to the dimensions of the vent passage 29 adjusted so that it increases in the operating state so that the vent passage 29 is blocked fluid-tight. Similarly, the works in 6f illustrated embodiment in which the actuator / actuator 3 in the ground state on a valve seat 24 is arranged and on the valve opening 23 rests so that the actuator / actuator 3 at a certain pressure from the valve seat 24 lifts off and a fluid can pass. In the operating state, the volume of the actuating element / actuator increases 3 so that this enters into a positive connection with the wall sections surrounding the vent opening and thus lifting the actuating element / actuator 3 from the valve seat 24 prevented.

According to a further preferred embodiment according to the 7 to 9 , Can an inventive actuator 3 or its chamber 31 be constructed substantially tubular or a tubular membrane 4 have, at the two axial ends sleeve-shaped end pieces / connecting pieces 33 . 41 are arranged. The fluid-tight connection between membrane 4 and the connecting pieces 33 . 41 can by clamping sections or clamping sleeves 42 respectively. The membrane 4 is preferably radially elastic but at the same time axially tensile / zugstarr, so with an increase in volume in the hose 4 located actuator filling F this widens in the radial direction, but at the same time contracts in the axial direction. This is achieved, for example, in that an elastic hose 4 with a (not shown) scrim of tensile fibers / yarns, for example. Aramid yarns combined. By such a tubular actuator / actuator 3 can be (as in 8th such as 9a and 9b shown) a contraction movement due to an increase in volume of Aktorfüllung F achieve. The chamber 31 is permanently sealed fluid-tight at the actuator shown. In this way, analogous to the above-described piston-like embodiment, only at a phase transition at least a portion of the Aktorfüllung F a sufficiently large volume change of the actuator filling F inside the chamber 31 achieved in order to effect an effective actuating movement (contraction). The actuator / actuator 3 remains in the operating state (contracted state) until the actor filling F is no longer in the predefined pressure and temperature range, ie until the actuator filling has largely returned to the liquid phase.

As in 9a and 9b such a hose-like actuator / actuator can be represented 3 preferably with an end portion or with a connecting piece 41 about a camp 44 be fixed, while the opposing end portion arranged connection piece the Aktorabschnitt 33 represents and about a floating bearing 43 slidably guided. Preferably, the entire actuator / actuator 3 from a housing or cladding tube 36 surround that tube-like chamber 31 decoupled from the ambient temperature and / or the ambient pressure at least partially. In such an embodiment, for example, only the actuator section 33 (Here, the movable by means of movable bearing connection piece) be exposed to the ambient pressure. In this way, the behavior of the actuator filling is closer to the theoretical values of the corresponding TS diagram and more independent of external influences.

The 10a to 10c show various medical devices 5 that with a device according to the invention 1 for sterilization parameter-dependent mechanical actuation; Activation and / or actuation release of sterilization-relevant functional units 2 are equipped.

10a shows an example of a sterile container 5 , with a functional unit designed as a valve 2 , which in the actuation state of the actuating element 3 opened and / or released for opening.

10b shows an example of a surgical instrument 5 equipped with a functional unit designed as a sterilization cycle counter 2 is equipped, which by the actuating movement of the actuating element 3 is counted up or unlocked for counting up.

10c shows an example of a sterilizer 5 comprising a functional unit designed as a sterilization cycle counter 2 is equipped, which by the actuating movement of the actuating element 3 is counted up or unlocked for counting up.

LIST OF REFERENCE NUMBERS

1 Contraption; 2 functional unit 21 Valve; 22 Sealing cap; 23 Valve opening; 24 Wall portion / valve seat; 25 Biasing member; 26 Sealing plate; 27 Actuating pin; 28 Thrust bearing; 29 Vent passage; 291 Entrance; 292 Output; 3 Actuator / actuator; 31 chamber 32 chamber wall; 33 actuator section; 331 Piston face; 332 Cover; 333 Guide bushing; 334 Thread; 335 Security holes; 336 Sealing elements; 34 Piston housing; 35 Biasing member; 36 pressure stable housing; 37 Fluting / curl / folding; 4 tubular membrane; 41 Connection pieces; 42 Clamping portion / clamping sleeve; 43 floating bearing; 44 Bearing; and 5 Medical device.

Claims (11)

Device (1) for sterilization parameter-dependent mechanical actuation; Activating and / or actuating release of sterilization-relevant functional units (2) of medical devices (5) with an actuating element (3) which can be converted from a basic state into an actuated state in order to carry out an actuating movement; and at least one functional unit (2) which cooperates with the actuating element (3) in such a way that it is actuated and / or activated by the actuating movement of the actuating element (3) and / or by the actuating element (3) remaining in the operating state, characterized in that the control element (3) is adapted to change only within a predefined pressure and temperature state range from the ground state to the actuation state and / or dwell in this and return outside the predefined pressure and temperature range in the ground state. Device (1) according to Claim 1 , characterized in that the adjusting element (3) has a fluid-tight chamber (31) which is filled with an actuator filling (F) and whose volume is defined by a chamber wall (32), which in turn has at least one movable actuator section (33), which is movable and / or deformable due to a change in volume of the actuator filling (F) relative to the remaining wall sections of the chamber (31) in order to carry out the actuating movement. Device (1) according to Claim 2 , characterized in that the adjusting element (3), the chamber (31), the Aktorfüllung (F) and the Aktorabschnitt (33) are designed in such a constructive manner that the Aktorabschnitt (33) the actuating movement exclusively due to a phase transition of at least a portion of Actuator filling (F), in particular a phase transition from a liquid to a gaseous phase performs. Device according to Claim 2 or 3 , characterized in that the actuator filling (F) consists essentially of at least one biocompatible Material, in particular at least one biocompatible liquid, particularly preferably from water or a hydrocarbon exists. Device (1) according to one of the Claims 2 to 4 , characterized in that the fluid-tight chamber (31) is permanently sealed fluid-tight. Device (1) according to one of the Claims 2 to 5 , characterized in that the Aktorabschnitt (33) of the chamber wall as a piston, in particular as a lifting or plunger, is formed, the piston housing (34) through the remaining chamber wall (32) is formed. Device (1) according to Claim 1 or 2 , characterized in that the actuator portion (33) of the chamber wall is formed as a flexible wall portion which reversibly expands and / or curves due to a change in volume of the actuator filling (F). Device (1) according to one of the preceding claims, characterized by a biasing element (25, 35) for applying a biasing pressure to the actuator filling (F). Device (1) according to one of the preceding claims, characterized in that only the Aktorabschnitt (33) of the chamber (31) is exposed to the ambient pressure state, while the remaining portions of the chamber wall (32) are structurally decoupled from the ambient pressure state, in particular by a pressure-stable housing (36) are decoupled. Device (1) according to one of the preceding claims, characterized in that the at least one functional unit is designed as a valve (21) or Sterilisationszyklenzähler or sterile display or closure. Medical device (5) characterized by a device (1) according to one of Claims 1 to 8th ,

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