WO2006049507A1

WO2006049507A1 - Method, device and system for sterile determination of the operability of medical equipment in a sterile zone.

Info

Publication number: WO2006049507A1
Application number: PCT/NO2005/000419
Authority: WO
Inventors: Sverre Grimnes; Tormod Martinsen
Original assignee: Rikshospitalet-Radiumhospitalet Hf
Priority date: 2004-11-05
Filing date: 2005-11-04
Publication date: 2006-05-11
Also published as: NO20044813D0

Abstract

The present invention provides a method, system and device for sterile testing and determining of the operability of surgical equipment and systems, by measuring a physical quantity related to a therapeutically provided effect of said equipment and system inside a sterile zone. According to an example of embodiment of the present invention a sterile sensing device (14) is brought into the sterile zone for sensing said physical quantity and a signal level related to a level of said physical quantity is transferred to an information device (15). The information device provides an indication of said therapeutically provided effect on basis of said transferred signal level.

Description

Method, device and system for sterile determination of the operability of medical equipment in a sterile zone.

The present invention is related to a method, device and system for sensing physical quantities to be used for therapeutic purposes, and more specifically to a method, device and system for sensing prescribed therapeutically provided effect of a physical quantity of surgical equipment and parts of surgical systems utilized in a sterile zone in accordance with the attached independent claims 1, 5 and 19.

Modern operating theaters provide the surgeon with highly sophisticated equipment for the surgical procedure to be performed on a patient. The complexity is enhanced by the requirement of operating in sterile zones.. Usually many types of present surgical tools are divided in a sterile part used on the patient in the sterile zone, and a remote part located in the vicinity of the sterile zone providing power, chemicals, pressurized air, fluids, light or similar quantities to the sterile part of the equipment in use.

The preparation of the operating theater before a surgical procedure comprises schemes for testing and adjusting equipment to provide prescribed therapeutic levels. However, after the equipment has been installed with parts in the sterile zone, there is no known method and device to test and verify operational mode of said equipment or said parts of systems to eliminate any introduced faults or missing adjustments etc. in the preparation phase just before the equipment and systems are to be used by the surgeon.

The surgical procedures require that critical parts of a procedure functions as anticipated, and therefore the surgeon often wants to be sure that equipment to be used, such as for example a suction device, is functioning before the need of said suction device arise at a critical stage of the surgical procedure. The question and problem at hand is to locate and determine errors without compromising the sterile zone. It is an objective of the present invention to provide a method, system and device for verifying operational mode of surgical equipment and parts of surgical systems utilized in a sterile zone without compromising said sterile zone.

One of the main concerns regarding surgical equipment and systems, as viewed from the surgeon's perspective, is whether or not the equipment or system operates at prescribed therapeutic levels. When there is an indication that for example an electrosurgical electrode is not providing sufficient electric power, the problem may be out of range adjustment of the equipment, or in parts of the system inside or outside the sterile zone. It is for example almost impossible to perform a total test of the whole system without compromising the sterile environment. .

The problem with the electrosurgical tip is not only caused by technical problems related to the equipment and system. Missing therapeutically achieved effect may be related to the patient himself, for example the type of tissue the surgeon is working on. Whenever such a situation arises, the surgeon must identify the reason for the situation which may be an error in the system or some situation related to the patient as described above. It is an objective of the present invention to provide a method, system and device that can verify that surgical equipment and systems provides a prescribed therapeutically used level of a physical quantity in said equipment and/or system. According to an aspect of the present invention, the surgeon can eliminate problems, errors and similar operational situations of said equipment and system as a reason for a missing or a minor therapeutically achieved effect.

Electrosurgery is used for coagulation, cutting and homeostasis, and if the coagulation effect for example disappears, quick error tracing of the system may be very important. At present a surgeon sometimes test the electrode by using a wet compress to see if it "sparks and crackles". This is a very unreliable method. Traditional electronic test equipment is not possible to make sterile, and is therefore unsuitable in the sterile zone. Whenever the electrosurgical electrode is brought out of the sterile zone it is no longer sterile. It is an objective of the present invention to provide a method, system and device to measure a level of a physical quantity used for therapeutic purpose. It is an aspect of the present invention to utilize said measurement to evaluate further steps to be taken as part of an error tracing scheme.

Similar situations as described above may arise when using for example infusion devices, ultrasonic knifes, electrosurgical electrodes, lasers etc. However, the problem of measuring physical quantities such as force, pressure, heat, cryo, radiation, light or electricity etc. is well known to a person skilled in the art. Therefore the problem at hand is to be able to perform measurement of such quantities inside a sterile zone. Prior art has no other solution than bringing equipment out of the sterile zone and replacing the equipment with a new sterile device. The procedure of bringing new equipment in to the sterile zone may be difficult and may require many steps to be performed by the medical staff to ensure that the sterile environment survives the exchange of the equipment. Therefore, there is a need for a method, system and device that provides an easy test, sensing and measurement of physical quantities to ensure that medical equipment and systems used in an operating theater functions in prescribed operational mode, and that such said testing, sensing and measuring can be done without impoverishing the sterile zone. According to an example of embodiment of the present invention, a sensing element of a physical quantity is provided inside a sterile housing, enveloping or coating or similar arrangement, or said sensing element is provided as an integral part of a surface of said housing, enveloping or coating etc. wherein said sensing element is linked to an externally located information device receiving information from said sensing element related to a level of said physical quantity, thereby providing the information device means to assess whether or not the physical quantity is inside prescribed limits related to said therapeutically used effect of said physical quantity.

The present invention provides a method for determining in a sterile zone the operability of a powered surgical equipment, as recited in the accompanying independent patent claim 1.

Further advantageous features of the method for determining in a sterile zone the operability of a powered surgical equipment are recited in the accompanying dependent patent claims 2 through 4, and 38 through 41

The present invention provides a method of use of a sterile sensor element in a sterile zone for determining the operability of a powered surgical equipment, as recited in the accompanying independent patent claim 5.

Further advantageous features of the method of use of a sterile sensor element in a sterile zone for determining the operability of a powered surgical equipment are recited in the accompanying dependent patent claims 6 through 8, and 42.

The present invention provides a kit for ensuring in a sterile zone a proper and sterile performance of a therapeutic procedure using a powered surgical equipment, as recited in the accompanying independent patent claim 9.

Further advantageous features of the kit for ensuring in a sterile zone a proper and sterile performance of a therapeutic procedure using a powered surgical equipment are recited in the accompanying dependent patent claim 10. The present invention provides a method being performed in a sterile zone for ensuring a proper sterile performance of a therapeutic procedure, said therapeutic procedure including the use of a powered surgical equipment adapted to deliver energy to a subject to undergo said procedure, as recited in the accompanying independent patent claim 11.

Further advantageous features of the method being performed in a sterile zone for ensuring a proper sterile performance of a therapeutic procedure, said therapeutic procedure including the use of a powered surgical equipment adapted to deliver energy to a subject to undergo said procedure, are recited in the accompanying dependent patent claims 12 through 14.

The present invention provides a method for controlling operational mode of surgical equipment and/or systems utilized in a sterile zone, measuring a physical quantity related to a therapeutically provided effect of said surgical equipment or system, and estimating level of therapeutically provided effect of said surgical equipment or system on basis of said measured physical quantity measured inside said sterile zone, as recited in the accompanying independent patent claim 15.

Further advantageous features of the method for controlling operational mode of surgical equipment and/or systems utilized in a sterile zone, measuring a physical quantity related to a therapeutically provided effect of said surgical equipment or system, and estimating level of therapeutically provided effect of said surgical equipment or system on basis of said measured physical quantity measured inside said sterile zone are recited in the accompanying dependent patent claims 16 through 18.

The present invention provides a system for controlling operational mode of surgical equipment and/or surgical systems utilized in a sterile zone, wherein said controlling system is measuring a physical quantity related to said operational mode, where said controlling system is measuring said physical quantity inside said sterile zone, as recited in the accompanying independent patent claim 19.

Further advantageous features of the system for controlling operational mode of surgical equipment and/or surgical systems utilized in a sterile zone, wherein said controlling system is measuring a physical quantity related to said operational mode, where said controlling system is measuring said physical quantity inside said sterile zone, are recited in the accompanying dependent patent claims 20 through 33. The present invention provides a device for sensing a physical quantity related to a level of therapeutically provided effect of a surgical equipment and/or system for use inside a sterile zone, as recited in the accompanying independent patent claim 33.

Further advantageous features of the device for sensing a physical quantity related to a level of therapeutically provided effect of a surgical equipment and/or system for use inside a sterile zone, are recited in the accompanying dependent patent claims 34 through 37.

According to a further aspect of the present invention, a sterile sensing device comprising said sterile element comprising said external link possibility, together with an information device according to the present invention, provides a system for eliminating errors, wrong adjustments or similar reasons for a missing or minor therapeutically achieved effect of surgical equipment and/or systems. According to another aspect of the present invention, said system may provide an assessment of further steps to be performed as part of an error tracing scheme. According to another embodiment of the present invention, a computer system is provided as said information device, wherein a program module and/or database system etc. may assist in assessing steps in an error tracing scheme.

The present invention will be explained by way of example, by exemplary embodiments, and with reference to the accompanying drawings, wherein;

Figure 1 illustrates an example of embodiment of the present invention in use with monopolar laparoscopy.

Figure 2 illustrates an example of embodiment of the present invention in use with bipolar laparoscopy.

Figure 3 illustrates an example of embodiment of the present invention in use with ultrasonic knife.

Figure 4 illustrates an example of embodiment of the present invention with telemetry.

Figure 5 illustrates a connector box according to an example of embodiment of the present invention. Figure 6 illustrates an example of embodiment of a sensing element according to the present invention, adapted for sensing a physical quantity of power delivered by monopolar equipment, and having an optional sensing provision for power delivered by bipolar equipment.

Figure 7 illustrates a further variant of the example of an assembly embodiment of the a sensing element illustrated in figure 6, having a set of cables for linking the sensing element to a measurement processing or display device, and having a sleeve to indicate a demarcation between a sterile part and a non-sterile part of the assembly.

Figures 1, 2 and 3 depict different scenarios typically found in operating theaters. There is a sterile zone 10 around the patient where sterile equipment is used to perform the procedure. Typically, parts of the surgical equipment or system are located outside the sterile zone. Cables providing pressurized air, liquids, power etc. are connected to related equipment inside the sterile zone 10. In figure 1 and 2, an insufflator 13 and a power supply 11 for monopolar and bipolar laparoscopy, respectively, is located outside the sterile zone. In figure 3 a similar arrangement is depicted when an ultrasonic surgical knife with an externally located supply 12 is used.

An example of a problem experienced in theater scenarios as illustrated in figures 1, 2 and 3, is loss or malfunction of power transfer from a power supply to the associated equipment located inside the sterile zone 10. The probability of loss of power is dependent on the complexity of the energy transfer system, but may be substantial in a practical set-up.

Similar situations may occur regarding the ultrasonic knife used in the operating theater depicted in figure 3. Loss of power typically prevents the ultrasonic knife to function at all. Also, a wrongly adjusted stimuli signal may prevent a transducer in the ultrasonic knife to oscillate at prescribed frequency, and so on.

Infusion devices are necessary to provide correct delivery of drugs etc. to the patient during the operation. It is obvious that loss of power, malfunctioning pumping elements, wrongly adjusted valves etc. may cause a problem for the present surgical procedure.

Similar situations may occur with other types of equipment such as lasers etc. Common for all these situations described above is that a quick assessment of the reason or reasons for the problem is necessary. Preferably, a verification of critical components and their operational mode, operability or condition should be performed when the operating table is prepared for an operation. The verification is preferably made by support personnel, in the sterile zone, while preparing the theatre for the particular procedure to be performed. In figures 1, 2 and 3, a sensing device 14, or a sensor as describe for an example of embodiment of the present invention, is arranged inside the sterile zone 10. In the embodiment examples provided in figures 1 and 2, the sterile device 14 can sense and measure electric power on the electrosurgical tip of the surgical equipment to be used. When using an example of embodiment of the sensing device, the surgeon brings the electrosurgical tip into contact with a contacting pad on the surface of the sterile sensing device 14. In the monopolar example in figure 1, the sensing device being adapted to the surgical equipment, represented by a monopolar electrode, has a single contacting pad arranged in said sensing device 14. In the bipolar example of figure 2, wherein the surgical equipment is represented by a bipolar forceps, two contacting pads are arranged in the sensing device 14. In the example of an ultrasonic knife shown in figure 3, the sterile device 14 may comprise a piezoelectric crystal adapted to measure ultrasonic power delivered by the ultrasonic knife depicted in figure 3.

As depicted in figures 1, 2 and 3, the sterile sensing device 14 is linked to an external information device 15. In an example of embodiment of the present invention, the information device 15 is adapted to display an indication of a level related to the power sensed by the sensing device 14, as one out of three LED lamps. In the present example, one LED is turned on if said level of power is under a predefined power level, a second LED is turned on if said power is at or close to the predefined power level, and a third level is turned on if said power is above the predefined power level. The link between the sterile device 14 and the information device 15 maybe a signal cable. However, in another example of embodiment of the present invention, the link may be achieved by an optical communication port, for example an infrared communication channel as known to a person skilled in the art. For example, if the sensing device 14 is embodied using digital technology, infrared communication according to the IrDA standard can be used. Another example of embodiment of the present invention utilizes RP transmission, for example a wireless channel according to the Bluetooth standard. Figure 4 depicts an embodiment employing a wireless channel between the sterile device 14 and the information device 15. In another example of embodiment of the present invention, the information device comprises a beeper sounding a sound indicating when said signal is indicating that said physical quantity is inside prescribed limits.

In another example of embodiment of the present invention, the information device comprises a computer system and an attached display. As known to a person skilled in the art the computer system may be programmed to analyze measurements transferred from the sterile sensing device 14 thereby providing further tools to provide an assessment to aid in determining why a missing or anomalous therapeutically achieved effect is experienced in the operating theater. According to an aspect of the present invention, the surgeon may utilize an information device as depicted in any one of figures 1, 2, 3 and 4 to determine, possibly by elimination, if the problem at hand is related to the patient or the surgical equipment or related system. The same example of embodiment provides an easy to use tool for staff when preparing an operational theater before an operation is performed.

According to an example of embodiment of the present invention, a system comprising said sterile sensing device 14 and information device 15 may be used to asses further steps to be taken according to an error tracing scheme. A known problem with error tracing, is how to efficiently locate the source of the error at the place and the time when the equipment is to be used. However, a measurement of a physical quantity, such as for example the electric power at the tip of an electrosurgical knife, provides a means to aid in making a selection from a list of logically deduced further steps to be taken in order to identify the source of the problem, just by measuring the level of the electric power. For example, missing power will logically indicate a poor plug connection, a broken power cable, a destroyed insulation in an endoscope part etc. A wrong level of electric power may indicate a wrongly adjustment of the equipment etc. In another example of embodiment the information device 15 comprises a computer system. According to an aspect of the present invention the computer system may comprise a database with a maintenance history of surgical equipment and systems. Whenever an error tracing is performed the measured value of the level of the physical quantity may be transferred to the computer system together with an identification number for said equipment or system. In this manner the computer system may then display the most probable causes for the error.

Figure 5 illustrates an example of embodiment of a sterile sensing device 14 sensing electric power from monopolar and bipolar electrosurgical tips. The sensing device 14 comprises a contacting pad 21 for a monopolar tip, while contacting pads 19 and 20 are for use when testing bipolar equipment. The information device 15 comprises a rectifier section 16, while a LED driver section 17 and three LEDS 18 provide a display means for displaying a level of said electric power as one out of three possible levels as described above. The LED driver section comprises comparator circuitry as known to a person skilled in the art, to detect said one out of three levels.

In the present example of embodiment of a set of a sensing device and information device as depicted in figure 5, the capacitor 22 is part of a capacitive voltage dividing circuitry comprising said capacitor 22 and a capacitor 23 in said information device 15. When the present example of embodiment is used in a monopolar setting in an operating theater, such as in a scenario as depicted in figure 1, the information device typically is connected via a capacitive coupling to the neutral pole of the power supply 11 as known to a person skilled in the art.

In another example of embodiment of the present invention, the sterile sensing device comprises a piezoelectric crystal and circuitry adapted to transfer a signal that is indicative of the level of ultrasonic power delivered by an ultrasonic surgical knife. Depending on the actual level of the signal, the information device may comprise signal circuitry to condition the signal from the sterile sensing device, before the signal is supplied to perform computing and/or displaying an indicator of the ultrasonic power according to the present invention.

According to another aspect of the present invention, the sensing device 14 and the information system 15 constitute a system providing signal conditioning adapted to the need of providing indications of therapeutically provided physical quantities utilized in a sterile zone in an operating theater. The required signal conditioning may be implemented in said sensing device 14 alone, said information device 15 alone, or be located as functions arranged in both devices 14 and 15. Said signal conditioning means may comprise programmable electronic components, ASICS components, computer systems and software etc. as known to a person skilled in the art.

To facilitate a sterile procedure, a kit is provided, wherein the kit includes a sterile surgical equipment to be used for a particular procedure and a sterile sensing device particularly adapted to sense a power quantity delivered by the surgical equipment.

Claims

C l a i m s

1.

A method for determining in a sterile zone the operability of a powered surgical equipment by measuring a physical quantity related to a therapeutic effect provided by said powered surgical equipment, said sterile zones preferably arranged for therapeutic treatment of a subject and said equipment having a sterile part adapted for delivering said therapeutic treatment, the method comprising: bringing into the sterile zone a sterile sensing element for sensing said physical quantity, said sterile sensing element being part of a sterile sensing device, applying in the sterile zone at least the sterile part of the powered surgical equipment to the sensing element to obtain a measurement of the physical quantity, transferring the measurement from the sensing device to a measurement processing device, and processing the measurement to generate an indication of the operability of the surgical equipment on basis of the measurement.

2.

The method of claim 1, further comprising establishing a communication link between the sensing device and the processing means, the communication link being adapted to transfer the measurement of said physical quantity from the sterile sensing device to the processing device.

3. The method of claim 1 or 2, further comprising estimating a performance level of the therapeutic effect on basis of the indication of operability.

4.

The method of claim 1 or 2, further comprising estimating a performance level of therapeutic effect on basis of the measurement.

5.

Use of a sterile sensor element in a sterile zone for determining the operability of a powered surgical equipment by measurement of a physical quantity related to a therapeutic effect provided by said powered surgical equipment, said sterile zones using said powered surgical equipment, said use including, bringing into the sterile zone a sterile sensor element for sensing said physical quantity, said sterile sensor element being a sterile part of a measuring device; applying in the sterile zone a part of said powered surgical equipment to the sensor element to obtain a measurement of the physical quantity; transferring the measurement from the measuring device to a measurement processing device; and processing the measurement to generate an indication of the operability of the powered surgical equipment on basis of the measurement.

6.

The use of a sterile sensor element in a sterile zone according to claim 5, further including establishing a communication link between the sensing device and the processing means, the communication link being adapted to transfer a measurement of said physical quantity from the sterile sensing device to the processing device.

7.

The use of a sterile sensor element in a sterile zone according to claim 5 or 6, further including estimating a performance level of the therapeutic effect on basis of the indication of operability.

8.

The use of a sterile sensor element in a sterile zone according to claim 5 or 6, further including estimating a performance level of therapeutic effect on basis of the measurement.

9.

A kit for ensuring in a sterile zone a proper and sterile performance of a therapeutic procedure using a powered surgical equipment adapted to deliver energy to a subject to undergo said procedure, wherein said kit comprises; a sterile part of the powered surgical equipment; and a sterile sensor element adapted to be sterilized by a commonly available sterilization method and adapted to cooperate in the sterile zone with the sterile part of the powered surgical equipment for obtaining a signal representing a physical quantity related to said energy and delivering the signal at an output, said output being connectable to a measuring device for obtaining from the signal a measurement while maintaining the sterile condition of the sensor and sterile part of the powered surgical equipment, said measurement being communicable to a processing device for generating an indication of the operability of the powered surgical equipment on basis of the measurement.

10. The kit according to claim 9, wherein said energy being at least one of an electrical, thermal, optical, radiant and acoustical energy.

11.

A method being performed in a sterile zone for ensuring a proper sterile performance of a therapeutic procedure, said therapeutic procedure including the use of a powered surgical equipment adapted to deliver energy to a subject to undergo said procedure, wherein said method comprising; bringing into the sterile zone a kit comprising a sterile part of the powered surgical equipment and a sterile sensor element adapted to be sterilized by a commonly available sterilization method, and adapted to cooperate in the sterile zone with the sterile part of the powered surgical equipment for obtaining a signal representing a physical quantity related to said energy; transferring the signal to a measuring device for obtaining from said signal a measurement while maintaining the sterile condition of the sensor and sterile part of the powered surgical equipment; and communicating the measurement to a processing device for generating an indication of the operability of the powered surgical equipment on basis of the measurement.

12. The method of claim 11, wherein said energy being at least one of an electrical, thermal, optical, radiant and acoustical energy.

13.

The method of claim 11 or 12, further comprising estimating a performance level of the therapeutic effect on basis of the indication of operability.

14.

The method of claim 11 or 12, further comprising estimating a performance level of the therapeutic effect on basis of the measurement.

15.

A method for controlling operational mode of surgical equipment and/or systems utilized in a sterile zone, measuring a physical quantity related to a therapeutically provided effect of said surgical equipment or system, and estimating level of therapeutically provided effect of said surgical equipment or system on basis of said measured physical quantity measured inside said sterile zone, comprising the steps of:

providing a sensing element for said physical quantity as an integral part of a sterile sensing device,

providing an information device associated with said sterile sensing device, wherein said measuring is transferred from said sensing element in said sterile sensing device to said information device,

utilizing said information device to control said operational mode of said surgical equipment.

16.

Method according to claim 15, wherein said sensing element is provided as a sterile sensing surface arranged as an integral part of a surface of said sensing device.

17.

Method according to claim 15 or 16, wherein said utilizing of said information device is to eliminate technical errors in any part or subpart of said surgical equipment and/or system as a reason for absent or minor therapeutically provided effect of said surgical equipment or system.

18.

Method according to claim 15, 16 or 17, wherein said utilizing of said information device is to assess a further step in an error tracing scheme.

19.

A system for controlling operational mode of surgical equipment and/or surgical systems utilized in a sterile zone, wherein said controlling system is measuring a physical quantity related to said operational mode, where said controlling system is measuring said physical quantity inside said sterile zone, comprising: a sensing element comprised in a sterile sensing device (14) sensing said physical quantity, providing a signal indicating a level for said sensed physical quantity,

means in said sensing device (14) transferring said signal to an information device (15),

means in said information device (15) providing an indication of said signal in said information device.

20. System according to claim 19, wherein said indication of said signal in said information device (15) is done as a displaying of said indication on a display device attached to said information device.

21. System according to claim 19 or 20, wherein said indication of said signal in said information device (15) is done by a sounding of a beeper attached to said information device.

22. System according to claim 19, 20 or 21, wherein said indication of said signal in said information device (15) is done by lighting at least one lighting device (18).

23.

System according to claim 19, wherein said sensing element is an integral part of a surface of said sterile sensing device (14).

24.

System according to claim 19, wherein said means transferring said signal level is an optical communication port.

25.

System according to claim 24, wherein said optical communication port is an infrared wireless communication port.

26.

System according to claim 19, wherein said means for transferring said signal level is a wireless RP communication port.

27.

System according to claim 26, wherein said wireless RF communication port is a Bluetooth port.

28.

System according to claim 19, wherein said sensing element is sensing electric power.

29. System according to claim 19, wherein said sensing element is sensing ultrasonic power.

30.

System according to claim 19, wherein said sensing element is sensing intensity of light.

31.

System according to claim 19, wherein said sensing element is sensing infrared radiation.

32.

System according to claim 19, wherein said sensing element is sensing at least one of a physical quantity related to force, pressure, heat, cryo, radiation, light or electricity.

33. Device for sensing a physical quantity related to a level of therapeutically provided effect of a surgical equipment and/or system for use inside a sterile zone, comprising:

a sensing element housed in a sterile enveloping comprising means for transferring a signal related to a level of said physical quantity sensed by said sensing element.

34.

Device according to claim 33, wherein said sensing element is an integral part of a surface of said enveloping.

35.

Device according to claim 33, wherein said device is manufactured as a disposable device.

36.

Device according to claim 33, wherein said sensing element comprises a condensator in a serial connection with said means transferring said signal level.

37.

Device according to claim 33, wherein said means for transferring said signal level is a wire.

38.

The method of claim 1, wherein at least one of the sensing element and the processing device is provided as a disposable device.

39. The method of any one of claims 1 , 2, 3, 4 and 38, further comprising providing the indication of operability to a display device.

40.

The method of claim 39, wherein the displaying device is provided as a disposable device.

41.

The method of any one of claims 1, 2, 3, 4, 38, 39 and 40, wherein the sterile zone is comprised of a plurality of sterile areas being arranged for respective parts of a procedure related to the therapeutic procedure.

42.

The method of use of a sterile sensor element in a sterile zone according to any one of claims 5, 6, 7, and 8, wherein the sterile zone is comprised of a plurality of sterile areas being arranged for respective parts of a procedure related to the therapeutic procedure.