WO2025181180A1

WO2025181180A1 - A method and apparatus for monitoring a surgical intervention device

Info

Publication number: WO2025181180A1
Application number: PCT/EP2025/055237
Authority: WO
Inventors: Daniel Fossum BRATBAK; Thomas James ETHERIDGE; Michael James HERD
Original assignee: St Olavs Hospital Trondheim University Hospital; Norwegian University of Science and Technology NTNU
Current assignee: St Olavs Hospital Trondheim University Hospital; Norwegian University of Science and Technology NTNU
Priority date: 2024-02-26
Filing date: 2025-02-26
Publication date: 2025-09-04
Anticipated expiration: 2026-08-26
Also published as: GB2638678A; GB202402703D0

Abstract

The present disclosure relates to a method for monitoring a manually- actuated surgical intervention device, which in a particular embodiment is a cryogenic surgical intervention device (1). The method comprises: using a detection system (100) to contactlessly detect a state (7) of an element (3) of a medical device (1), determining an actuation status of the medical device (1) based on the contactlessly detected state (7) of the element (3), and calculating a duration of actuation of the medical device and/or a degree of actuation of the medical device (1) based on the determined actuation status to estimate an effect of the medical device (1). Other statuses of the medical device (1) may additionally or alternatively be determined based on the contactlessly detected state (7) of the element (3).

Description

A METHOD AND APPARATUS FOR MONITORING A SURGICAL INTERVENTION DEVICE

The present invention relates to a method and apparatus for determining a status of a surgical intervention device.

Cryogenic intervention devices are commonly employed to cryoneurolyse a nerve in the head, neck or back of the patient for generally treating conditions afflicting nerves, such as trigeminal neuralgia.

Cryoneurolysis is a technique where nerves are frozen, e.g. with a probe or needle, causing Wallerian degeneration of the nerve. Wallerian degeneration results in the destruction of the axons of the nerve and the encasing myelin sheath; however the surrounding endoneurium tubes, perineurium and epineurium remain intact during Wallerian degeneration. Given that these structures remain intact after freezing, the axons and myelin are able to regenerate and thereby permit the nerve to regain function. Cryoneurolysis thus provides a reversible block to the functioning of the nerve since the nerve will eventually regenerate. As such, conditions (e.g. pain conditions) of nerves can be blocked, albeit reversibly using cryoneurolysis.

When applying cryoneurolysis, it is helpful for the operator of the cryogenic surgical intervention device (referred to herein after as “interventionist”) to be able to understand how much cryogenic fluid has been delivered to cool the target as well as to understand how much regions surrounding the target have been undesirably cooled to avoid their degeneration.

In order to monitor the status of such devices today, they incorporate various electronic sensors providing sensor readings that enable monitoring of the status of the device. They are also often tethered to a base station to transmit sensor data to a monitoring device.

Such electronics increase the cost and complexity involved in manufacturing the medical device, increase the number of safety regulations which the device must comply with, and increase a size and/or weight of the device. Additionally, the physical tether restricts how the device can be used, and can impede or complicate use of the device.

Furthermore, in use, cryogenic surgical intervention devices can cause frost and/or condensation to form. Water from this frost and/or condensation can damage the electronics and/or reduce the accuracy of electronic sensor readings. The object of this invention therefore is to improve the monitoring of a status of a surgical intervention device.

According to a first aspect, there is provided a method comprising: using a detection system: contactlessly detecting a state of an element of a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; and determining a status of the medical device based on the contactlessly detected state of the element, wherein the status of the medical device comprises an actuation status of the medical device; and calculating a duration of actuation of the medical device and/or a degree of actuation of the medical device.

The invention of the first aspect is advantageous since it uses a detection system separate to the medical device in order to contactlessly determine and track a status of the medical device. It does not require the medical device to comprise an internal electronic sensor in order to monitor this status, thereby addressing the above-mentioned issues by reducing electronics within the medical device itself whilst still monitoring the status of the medical device. In particular, the method may comprise contactlessly detecting the state of the element of the medical device by the detection system, and may comprise determining the status of the medical device by the detection system. Thus, such a detection system avoids the need for a person, such as the interventionist, to perform this contactless detection and subsequent determination themselves (e.g. by the user performing visual observation of the state of the element and making the subsequent determination themselves). Contactlessly detecting a state of an element of a medical device may not comprise visual observation by a user. Determining a status of the medical device may not comprise a determination made by a user.

The method of the first aspect does not involve any surgical or therapeutic intervention on a patient. Whilst the method may be used adjacent to a surgical or therapeutic intervention performed on a patient, referred to hereinafter as a procedure, no functional relationship exists between determining and tracking a status of the medical device and the procedure. For example, the method may be used to train a user of the medical device when practicing on non-living human beings or animals, or artificial targets. A state of the medical device as used herein may refer to a measurable property of the medical device that varies in use and affects the function of the medical device. The state may be discrete and/or continuous in itself but also discrete and/or continuous in how it is detected.

A status of the medical device as used herein may refer to a property of the medical device relevant to the procedure in which it is intended for use. The status of the medical device does not comprise the position and/or orientation of the medical device.

The method of the first aspect may comprise, in addition to determining the status, using the detection system to determine a position of the medical device and/or an orientation of the medical device.

The method according to the first aspect may comprise using the detection system to monitor the state of the element over a period of time. The status of the medical device may be determined based on the state of the element over the period of time. The status of the medical device may be performed in real-time, for example such that the determined and tracked status of the medical device is constantly up to date.

Whilst the method according to the first aspect recites the medical device as being one of a cryogenic surgical intervention device, a cryogenic surgical intervention device comprising a nerve stimulator, a radiofrequency ablation device, or a surgical intervention device comprising a medical balloon, the method according to the first aspect may be performed with other medical devices. For example, the medical device may be any surgical intervention device configured for manual actuation by an interventionist.

The medical device may be console independent and/or may be handheld device. That is, the medical device may be entirely independently contained and may not rely on an external source of fluid, electricity or control. This may be made possible through use of a storage vessel containing a fluid for use in the procedure, such as a cannister.

A console independent, handheld device is particularly advantageous in an outpatient scenario. Alternatively, in other embodiments, the medical device may be connected to a console, e.g., via suitable cabling and/or conduits. The console may comprise a source of a fluid for use in the procedure.

Thus, the medical device may be a handheld device, which may be console independent or connected to a console (i.e. console dependent). The medical device may comprise a marker configured such that an appearance of the marker changes depending upon the state of the element, or wherein the element of the medical device is a marker configured to change its appearance. The state of the element is then detected based on the appearance of the marker.

The medical device may comprise a plurality of markers. The teachings below, whilst described in respect to the singular marker, apply likewise to the plurality of markers. Where a plurality of markers are used, the state of the element may be detected depending upon the relative appearances the plurality of markers. This may be useful for accounting for environmental changes. Where a plurality of markers are used, the combined appearances of the plurality of markers may indicate a code.

The appearance of the marker may vary proportionally to the state of the element. This may not be directly proportional and/or may only be within a range of the state of the element.

The use of the marker improves the detection of the physical property by providing distinct element(s) which the detector may be more easily adapted to detect.

The marker may be an optically detectable sphere attached to the medical device, or a static marker on a surface of the medical device. The static marker may be a circle, square, zig-zag, a dot matrix, bar code, QR code. The static marker may be reflective.

The detection system may be based on light (e.g. infrared), sound waves or magnetic fields. That is to say, the step of contactlessly detecting the state of the element of the medical device, which is optionally done through the use of one or more markers, may comprise detecting with light (e.g. infrared), sound waves or magnetic fields that are emitted and/or reflected from the one or more markers and/or the medical device. As such, the detector may be a light detector (e.g. an optical or infrared camera), a sound detector or a detector of magnetic fields.

The detection system may comprise a plurality of detectors. The detectors may be positioned at different positions in space so as to permit the most accurate, reliably and precise detection of the medical device and, optionally, the one or more markers. The selection of the detector may depend upon the marker used and or the state of the element being detected. As noted above, the step of detecting the position of the medical device and/or the optional step of detecting the reference marker may comprise detecting with light (e.g. infrared), sound waves or magnetic fields that are emitted and/or reflected from the medical device and/or the optional one or more markers.

The element may be a movable element and the state of the element may be a position of the movable element.

The movable element may be configured to only move in a pre-determined manner, which may be determined by a connection between the movable element and a body of the medical device. The pre-determined manner may be a rotation about a pivot point, wherein the marker may be offset from the pivot point; or may be a linear movement of the movable element where the marker moves linearly with the movable element; or any other detectable movement of the movable element.

The appearance of the marker may change based on coverage of the marker by a covering element, the position of the movable element determining the coverage of the marker. The coverage may include a fully covered state and/or a fully uncovered state, optionally including one or more partially covered states.

The movable element may comprise the marker and a second element of the medical device may comprise the covering element. Alternatively, the movable element may comprise the covering element and a second element of the medical device may comprise the marker. The second element may be a body of the medical device or a second movable element of the medical device.

The coverage of the marker may be determined by one or more of: a shape/form of the appearance of the marker; and a colour of the appearance of the marker. Different shapes/forms and or colours may be used to indicate an extent of partial coverage.

Partial coverage of a marker may be preferential, since it still enables the detection system to detect the marker as opposed to entire coverage of the marker. This improves robustness, as it enables the detection system to still track the marker and avoid scenarios where the marker is obscured for reasons unrelated to a change in the physical parameter. For example, when the medical device is outside of a region detectable by the detector of the detection system.

The movable element may comprise the marker and the appearance of the marker may be a position of the marker relative to a second element of the medical device, optionally wherein the second element comprises a second marker. The second element may be a body of the medical device or a second movable element of the medical device.

The movable element may be one of: a trigger, a slider, a covering element, a removable needle, a valve, a piston.

The covering or uncovering of the marker may be by the setup of the medical device. The medical device may comprise a connection feature by which a component is attached, wherein the connection feature comprises the covering element or the marker. For example, in a cryogenic surgical intervention device a cannister may be attached. The attachment of the cannister may obscure or partially obscure the marker, such that the detection system may detect the physical property that the cannister is connected. The cryogenic surgical intervention device may require a needle to be attached in a corresponding manner. The attachment of the cannister may further require the attaching of a cap over the cannister to the medical device. In addition or alternatively to the cannister obscuring or partially obscuring the marker, the attachment of the cap may obscure or partially obscure the same marker or a different one.

The movable element may be a rotating element driven by a gas flow of the medical device. This gas flow may be an exhaust gas flow. Alternatively, this gas flow may be an intake gas flow, the intake gas flow being pulled by a gas flow within the device through a venturi injector. The rotating element may be configured to spin, wherein the state of the element is a rotational speed. The rotating element may be configured such that the rotational speed is proportional to the flowrate of the gas flow, thereby enabling an estimation of the flowrate.

The position of the movable element may be contactlessly detected by a detector of the detection system, and wherein the detector of the detection system comprises one or more of: an optical camera, and an infrared camera, and an electromagnetic detector. The optical camera may include types of cameras sensitive to the visible spectrum, such as RGB cameras.

The state of the element may be a temperature of the element. The temperature may be contactlessly detected by a detector of the detection system, and wherein the detector of the detection system comprises an infrared detector. Alternatively or additionally, where the medical device comprises a marker, the marker may be a temperature reactive marker. The temperature reactive marker may comprise a thermochromatic paint or film. As the temperature of the thermochromatic paint or film changes it changes between opaque, which covers the marker, and transparent, which makes the marker visible.

The temperature of the element therefore may be detected through the appearance of the temperature reactive marker, wherein the detector of the detection system comprises a camera such as an optical camera.

Where the state of the element is a temperature of the element, the element may comprise one or more of: an external surface of the medical device exposed to exhaust gases, a lumen of the medical device, a cannister of the medical device, and a needle of the medical device.

The state of the element may be its exposure to a predetermined gas, wherein the element is the marker. The marker may comprise a chromatic membrane sensitive to the presence of the predetermined gas and the detector of the detection system may comprise a camera, such as an optical camera.

The marker may be positioned at an external surface of the medical device exposed to exhaust gases.

The predetermined gas may be one or more of carbon dioxide (CO2), argon, helium, and nitrogen dioxide (NO2), with a corresponding chromatic membrane. In particular, the predetermined gas may be carbon dioxide (CO2) and the chromatic membrane may be a chromatic CO2 indicator. Such chromatic membranes may change between transparent and visible when exposed to the predetermined gas.

The state of the element may be a sound generated by the element, which may include an intensity of the sound and/or a frequency of the sound. The detector of the detection system comprises an audio detector, such as a microphone.

The sound may be generated mechanically by a flow of a gas through or adjacent the element. The intensity and/or frequency of the sound may depend upon the flowrate of the flow of gas, thereby enabling an estimation of the flowrate.

The element of the medical device may be a whistle configured to be driven by a flow of a gas in the medical device, optionally wherein the whistle is driven by the flow of an exhaust gas in the medical device.

The sound wave may be outside the human hearing range. By outside the human hearing range, it should be understood that the sound is not noticeably perceptible to humans. The sound wave may be a frequency above the human hearing range. Whilst the human hearing range is generally considered to be 20 Hz to 20 kHz, there is a considerable variation in sensitivity based on frequency and with age, as the upper limit in adults is often closer to 15-17 kHz. Therefore, by a frequency above the human hearing range may be above a frequency at which a typical human’s sensitivity drops off.

The element may comprise an elastic membrane, wherein a pressure within the medical device acts on a first side of the elastic membrane, and wherein the elastic membrane is configured to expand with increasing pressure. The elastic membrane may comprise the marker, such that the appearance of the marker that changes as the elastic membrane expands/contracts may be one or more of a size, a colour, and a reflectiveness.

The element may be the marker and the appearance of the marker may be changes based on coverage of the marker by a user of the medical device. The user may selectively cover/uncover the marker to communicate a change in the physical property. The marker may be positioned on the medical device such that correct use of the device requires the user to cover the marker.

The method may comprise detecting a plurality of states for example at different times, e.g. periodically, and determining and tracking a status of the medical device based on the plurality of states. Using a plurality of states can improve accuracy of the status being determined and tracked, as well as enabling a more complex status to be determined and tracked. In this regard, the actuation status may be determined based on one or more of the position of the movable element, the temperature of the element, the exposure of an element to a predetermined gas, the sound generated by the element, the state of the elastic membrane, and the coverage of a marker by the user.

For example, a cryogenic surgical intervention device may comprise a trigger, connected to a valve element for variably controlling the release of a cryogenic gas. The movable element may be either of the valve element or the trigger, the position of which can be used to determine the actuation status of the cryogenic surgical intervention device.

The cryogenic surgical intervention device may comprise a sprung piston which is acted on by a pressure within the device, the sprung piston being the movable element. Alternatively or additionally, the cryogenic surgical intervention device may comprise two elements movable due to a Venturi effect created in a tube with gas flow causing a pressure differential between two positions in a tube. The position(s) of the movable elements may be used to determine a pressure within the cryogenic surgical intervention device, which may be used in turn to determine whether the device is being actuated.

Additionally or alternatively to the movable elements, cryogenic surgical intervention device may comprise the elastic membrane which is acted on the by the pressure within the device.

The cryogenic surgical intervention device may comprise the temperature reactive marker indicator, the appearance of which changes depending upon the temperature of an external surface of the cryogenic surgical intervention device exposed to exhaust gases. The actuation of the cryogenic surgical intervention device causes exhaust gases to flow, which cause the external surface to drop in temperature thereby enabling the determination of actuation.

The cryogenic surgical intervention device may comprise the marker comprising a chromatic membrane sensitive to the presence of the predetermined gas, which may be placed on an external surface exposed to exhaust gases, the exhaust gases comprising the predetermined gas. The actuation of the cryogenic surgical intervention device causes exhaust gases to flow, which cause appearance of the marker to change and thereby enabling the determination of actuation.

The cryogenic surgical intervention device may comprise an element, which may be a whistle, that generates sound, the sound being generated mechanically by the flow of gas through or adjacent the element. The actuation of the cryogenic surgical intervention device causes gases to flow and generates sound, thereby enabling determination of actuation.

The actuation status may include details regarding the actuation of particular functions of the medical device. For example, when the medical device is a cryogenic surgical intervention device comprising a nerve stimulator, this may be whether the nerve stimulator is active and/or whether a cryogenic gas is being released.

The method may further comprise comparing the duration of actuation to a desired duration and/or the degree of actuation to a desired degree. The actuation status may comprise the duration of actuation and/or the degree of actuation. The duration of actuation may be a cumulative duration and/or a number of use cycles. The desired duration may be based on a particular procedure the medical device is intended for use in, for example taking into account different requirements of a treatment site based on an understanding of a patient’s physiology. The medical device may comprise a cannister and the method may further comprise estimating an amount of fluid remaining in the cannister based on the actuation status. The status of the medical device may comprise the amount of fluid remaining in the cannister and/or a remaining duration of fluid use, which may be in addition to the actuation status. For example, when the medical device is a cryogenic surgical intervention device, the medical device may comprise a cannister containing a cryogenic gas. This cryogenic gas may be stored in the cannister as liquid gas and the status may be the amount of liquid gas remaining in the cannister.

The method may comprise estimating an effect of the medical device based on the actuation status. The effect of the medical device may be updated as the actuation status, and any other stat changes over a period of time.

For example, in a cryogenic surgical intervention device the effect may be a cooled volume, referred to hereinafter as a “cryo volume”. The cryo volume may include a location, size/shape, and/or temperature. The cryo volume may be determined based on the actuation of the cryogenic surgical intervention device, which may be based on one or more of the position of a trigger, the temperature of exhaust gases, a position of a sprung piston which is acted on by a pressure within the device, etc.

The estimated effect may be used to determine whether a cooldown period is required which the medical device may be used again.

The detection system may display the estimated effect, optionally wherein the estimated effect is displayed visually overlaying a medical image. An extent of an effect may be visualised with different colours. This may include a comparison to one or more desired effects, which may be determined based on a particular procedure the medical device is intended for use in, for example taking into account different requirements of a treatment site based on an understanding of a patient’s physiology. The one or more desired effects may take into account any inaccuracies associated with a procedure, such as those associated with producing the estimated effect, and adjusted accordingly. Other inaccuracies may be associated with a determined position of the medical device, which may be determined using a surgical navigation system which may be combined with the detection system.

For example, in the cryogenic surgical intervention device a desired cryo volume may be displayed, the size of which may be increased to account for disparities between the cooled volume and the estimated effect. The estimated effect may use different colours to visualise different temperatures.

The cryo volume may be estimated as a cumulative effect. As the actuation status of the cryogenic surgical intervention device changes, the cryo volume may be updated and subsequently displayed on the detection system. The updated cryo volume then may be compared to the one or more desired effects, which may guide the next actuation of the cryogenic surgical intervention device by the interventionist. In this regard, performing several separate actuations of cryogenic surgical intervention device may be preferred, since this can achieve a cryo volume closer to the one or more desired effects,

According to a second aspect, there is provided a method comprising using a detection system: contactlessly detecting a state of an element of a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; determining a status of the medical device based on the contactlessly detected state of the element, wherein the status of the medical device comprises a configuration of the medical device; and generating an alert responsive to determining that: a) the configuration of the medical device corresponds to a predetermined incorrect configuration, and/or b) the configuration of the medical device does not correspond to a predetermined correct configuration.

The configuration status may be whether the medical device has been assembled correctly. For example, when the medical device is the cryogenic surgical intervention device, the status may be whether a cannister has been correctly attached to the cryogenic surgical intervention device.

The method according to the second aspect may incorporate the method according to the first aspect, such that the method may comprise determining an actuation status of the medical device in addition to determining the configuration status of the medical device.

The alert may be in the form of a visual warning and/or guidance. The alert may be visually displayed by the detection system and/or an audible alert by a speaker of the detection system. The determination which the alert is generated in response to may be based on a plurality of states. For example, in a cryogenic surgical intervention device it may be detected that the device is being actuated through a marker on a movable element, such as a marker on a trigger, but no sound is generated by a whistle which indicates that no cryogenic gas is flowing. In this case, cryogenic surgical intervention device is not operated correctly and an alert is generated. The plurality of states may further indicate the specific issue and a specific alert may be generated accordingly. For example, it could be that there is no supply of cryogenic gas in the cannister or that there is a blockage in the cryogenic surgical intervention device.

The status may be information data of the medical device, such as a serial number, calibration information, a capacity of a storage vessel, or an expiry date.

The method may comprise determining and tracking a plurality of these statuses.

According to a third aspect, there is provided a method comprising: using a detection system: contactlessly detecting one or more markers on a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; determining coverage and/or non-coverage of each marker on the medical device by the interventionist; and generating an alert responsive to determining coverage or non-coverage of a marker indicative of incorrect operation of the medical device.

The markers may be configured to be non-covered or covered, respectively, by a hand of the interventionalist during correct operation of the medical device.

The alert may be audible or visual.

The method according to the third aspect may perform the optional steps described above in relation to the first aspect, including any non-method features presented optionally.

According to a fourth aspect, there is provided a computer program product comprising instructions that when executed on a processor of a detection system will configure the detection system to perform the method of the first aspect. The computer program product may further configure the detection system to carry out any of the (optional) functionality described above in relation to the first aspect of the invention.

According to a fifth aspect, there is provided a detection system comprising: a detector configured to contactlessly detecting a state of an element of a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; and a controller comprising a memory module and a processor, wherein the controller is configured to carry out the method according to the first aspect.

The controller may be further configured to carry out any of the (optional) functionality described above in relation to the first aspect of the invention.

As described above in relation to the first aspect, the detection system may comprise a light detector (e.g. an optical camera or an infrared camera), a sound detector or a detector of magnetic fields. The optical camera may include types of cameras sensitive to the visible spectrum, such as RGB cameras.

The detection system may comprise a plurality of these detectors. The detectors may be positioned at different positions in space so as to permit detection of the medical device from different angles. This helps achieve the most accurate, reliably and precise detection of the medical device and, optionally, the one or more markers. The selection of the detector may depend upon the marker used and or the state of the element being detected.

According to a sixth aspect, there is provided a system comprising the detection system of the fifth aspect, optionally including any of the optional features described thereof; as a medical device, wherein the medical device is a surgical intervention device configured for manual actuation by the interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon.

The medical device in the sixth aspect may comprise a marker configured such that an appearance of the marker changes depending upon the state of the element, or the element of the medical device is a marker configured to change its appearance depending upon the state; and wherein the state of the element is contactlessly detected based on the appearance of the marker.

According to a seventh aspect, there is provided a surgical intervention device configured for manual actuation by an interventionist, wherein the device comprises a marker configured such that an appearance of the marker changes depending upon a state of an element of the device, wherein the appearance of the marker is contactlessly detectable, and wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon.

In relation to the device of the seventh aspect, the contactlessly detectable appearance may be used to contactlessly detect the state of the element of the device, which may be used to determine a status of the medical device based on the contactlessly detected state of the element. The status of the medical device may comprise an actuation status of the medical device.

As described above in relation to the first aspect, the medical device in the sixth aspect or the surgical intervention device in the seventh aspect may comprise a plurality of markers. The teachings below, whilst described in respect to the singular marker, apply likewise to any or all of the plurality of markers. Where a plurality of markers are used, the state of the element may be detected depending upon the relative appearances the plurality of markers. This may be useful for accounting for environmental changes. Where a plurality of markers are used, the combined appearances of the plurality of markers may indicate a code.

The use of the marker improves the detection of the physical property by providing distinct element(s) which the detection system may be more easily adapted to detect.

The marker may be an optically detectable sphere attached to the medical device, or a static marker on a surface of the medical device. The static marker bay be a circle, square, zig-zag, a dot matrix, bar code, QR code. The static marker may be reflective.

The detection system may be based on light (e.g. infrared), sound waves or magnetic fields. That is to say, the step of contactlessly detecting the state of the element of the medical device, which is optionally done through the use of one or more markers, may comprise detecting with light (e.g. infrared), sound waves or magnetic fields that are emitted and/or reflected from the one or more markers and/or the medical device.

Certain embodiments of the invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:

Figure 1 shows a cryogenic surgical intervention device for manual actuation by an interventionist on a patient;

Figure 2 shows the cryogenic surgical intervention device of Figure 1 , further comprising a plurality of markers that are optically reflective spheres;

Figure 3 shows the cryogenic surgical intervention device of Figure 1 , further comprising a plurality of markers that are optically reflective spheres;

Figures 4A-4C show the operation of an opacity marker in the cryogenic surgical intervention device of Figure 3;

Figures 5A-5C show the operation of an optically reflective spheres in the cryogenic surgical intervention device of Figure 2;

Figures 6A-6C show the operation of a coverage marker in the cryogenic surgical intervention device of Figure 3;

Figure 7 shows a coverage marker of the cryogenic surgical intervention device of Figure 3;

Figure 8 shows the cryogenic surgical intervention device of Figure 2 with a cannister improperly attached;

Figure 9 shows the cryogenic surgical intervention device of Figure 3 with a cannister improperly attached; and

Figure 10 shows a detection system with the cryogenic surgical intervention device of Figure 2.

Figure 1 shows a surgical intervention device for manual actuation by an interventionist on a patient, in particular a cryogenic surgical intervention device 1. The cryogenic surgical intervention device comprises a body 2, a trigger 3, a surgical element 4, a cannister 5, and a handle 6. The surgical element 4 is a cryogenic needle (sometimes termed ‘cryoneedle’) or a cryogenic probe (sometimes termed a ‘cryoprobe’) configured to contact and cryoneurolyse a nerve, which may be located in the head, neck, or back of a patient.

The cryogenic surgical intervention device 1 is a console independent, handheld device. That is, the cryogenic surgical intervention device 1 is entirely independently contained and does not rely on a tether to supply it with cryogenic gas or for a system to determine a status of the cryogenic surgical intervention device 1. The handle 6 is any part of the cryogenic surgical intervention device 1 for holding by an interventionist.

A detection system contactlessly detects a state of an element of the cryogenic surgical intervention device 1, which is then used to determine a status of the cryogenic surgical intervention device 1. The status includes an actuation status of the cryogenic surgical intervention device 1 , from which it is possible to determine an amount of fluid left in the cannister 5, and an effect of actuation of the cryogenic surgical intervention device 1, amongst other features relevant to the use of the cryogenic surgical intervention device 1. This detection system then goes on to visually display the status or information derived therefrom to the interventionist.

In use, the cryogenic surgical intervention device 1 allows the interventionist to target and cryoneurolyse a nerve in the head, neck or back of a patient in order to treat an underlying condition. For example, the cryogenic surgical intervention device 1 can be used to target and cryoneurolyse a trigeminal nerve of the patient in order to treat trigeminal neuralgia. Alternatively, the cryogenic surgical intervention device 1 can be used to target and cryoneurolyse an occipital nerve of the patient in order to treat occipital neuralgia. These nerves and conditions are merely exemplary, and very many other nerves and/or conditions are treatable using the cryogenic surgical intervention device 1.

Cryoneurolysis involves freezing a target nerve, using the cryogenic surgical intervention device 1. The freezing is achieved by release of a pressurized cryogenic gas from the cannister 5, which subsequently flows through the surgical element 4 to cause a distal end of the surgical element 4 to reach cryogenic temperatures. The cryogenic fluid may be any fluid suitable for cryoneurolysis, but Carbon Dioxide is contemplated here. The distal end of the surgical element 4 is then to be placed in contact with the nerve to thereby cryoneurolyse it.

To reach cryogenic temperatures, the surgical element 4 comprises an aperture at the distal end which causes rapid expansion of the pressurized cryogenic gas as it passes therethrough. This rapid expansion of the pressurized cryogenic gas, under the Joule Thomson effect, causes a rapid decrease in temperature of the distal end to cryogenic temperatures. In addition or alternatively to the above, pressurized cryogenic gas is stored in liquified form in the cannister 5, which undergoes a phase change in the surgical element 4. The cryogenic temperature reached depends upon: a duration of actuation, a pressure drop of the cryogenic gas, and/or a flowrate of the flowing cryogenic gas. These are determined, respectively, by a duration of actuation of the trigger 3, and a degree of actuation of the trigger 3.

Figure 2 shows a cryogenic surgical intervention device 1 similar to the cryogenic surgical intervention device 1 in Figure 1 , wherein the cryogenic surgical intervention device 1 further comprises a plurality of markers that are optically reflective spheres 7.

The trigger 3 comprises an optically reflective sphere 7 affixed to it, such that a relative position of the optically reflective sphere 7 of the trigger 3 to the cryogenic surgical intervention device 1 indicates a degree of actuation of the trigger 3. This degree of actuation of the trigger can been seen in Figures 5A-5C.

The cannister 5 comprises an optically reflective sphere 7 affixed to it, such that the position of the optically reflective sphere 7 of the cannister 5 to the cryogenic surgical intervention device 1 indicates whether the cannister 5 has been attached such that the cryogenic surgical intervention device 1 is properly configured. The detection of improper attachment of the cannister 5 can been seen in Figure 8.

The body 2 comprises a plurality of optically reflective spheres 7 attached to an array 8, such that their relative arrangement is fixed with respect to each other in a known irregular configuration. That is to say, the markers are not in a rotationally symmetrical configuration. This enables the absolute position and orientation of the cryogenic surgical intervention device 1 to be determined by the detection system, which may be used to subsequently determine the relative position of the other optically reflective spheres 7 of the cryogenic surgical intervention device 1.

The optically reflective spheres 7 are adapted to reflect infrared light. An infrared detector therefore may contactlessly detect the markers by their reflection of infrared light, which can be bolstered by the detector being a combined infrared emitter and detector that emits infrared light and subsequently detects any reflected infrared light by the optically reflective spheres 7. However, it will be appreciated that other means of detection may be used, for example using a visible-light camera and image analysis.

Figure 3 shows another cryogenic surgical intervention device 1 similar to the cryogenic surgical intervention device 1 in Figure 1 , wherein the cryogenic surgical intervention device 1 comprises a plurality of markers. The illustrated markers include coverage markers 9, movable markers 10, alignment markers 11, and opacity markers 12. It will be appreciated that the cryogenic surgical intervention device 1 may use only some and not all of these markers.

An optical detector of the detection system is able to track the plurality of markers to contactlessly detecting a state of an element of cryogenic surgical intervention device 1.

The coverage markers 9 are located on the trigger 3, on the handle 6 and on the body 2 of the cryogenic surgical intervention device 1.

The coverage marker 9 on the handle 6 will be covered by the interventionist when holding the cryogenic surgical intervention device 1, such that its coverage indicates whether the interventionist is holding the cryogenic surgical intervention device 1 properly. The coverage marker 9 on the body 2 can be selectively covered by the interventionist when using the cryogenic surgical intervention device 1 , such that the interventionist can selectively communicate with detection system to indicate a state of an element of the medical device that they have detected themselves. For example, the interventionist might wish to communicate that the target being cryoneurolysed has changed.

The movable marker 10 has its position determined by a pressure or a flowrate of the cryogenic gas within the cryogenic surgical intervention device 1. In the former case, the movable marker may be a sprung piston element that is acted upon the pressure of the cryogenic gas, wherein the spring rate of the sprung piston is known such that the pressure acting on the sprung piston can be determined. To account for atmospheric pressure changes, the sprung piston may be a venturi meter. In the latter case, the position of the movable marker 10 may depend upon a degree of opening of a valve by the trigger 3, wherein the correlation between the degree of opening of the valve and the flowrate through it is known.

Figures 4A-C shows how the opacity marker 12 in Figure 3 operates.

An opacity of the opacity marker 12 changes depending upon the state of an element of the cryogenic surgical intervention device 1. In this case, the state of the element is the temperature of the cannister 5, and the opacity marker 12 comprises a thermochromatic paint or film. The thermochromatic paint or film changes between opaque, as seen in Figure 4A, translucent, as seen in Figure 4B, and transparent, as seen in Figure 4C, as the temperature of the cannister 5 changes. Therefore, an optical detector of the detection system may contactlessly detect the temperature of the cannister and determine the status of the cryogenic surgical intervention device 1 based on this.

Whilst the above opacity marker 12 is described in relation to a temperature of the cannister, other elements and states are contemplated by the present invention. For instance, the opacity marker 12 may be positioned such that exhaust gases of the cryogenic surgical intervention device 1 impinge upon it. In such an arrangement, a thermochromatic paint or film could be used to contactlessly detect a temperature of the exhaust gases. Additionally or alternatively, an opacity marker 12 impinged by exhaust gases may comprise a chromatic membrane sensitive to the presence of a predetermined gas, such as Carbon Dioxide, which is used to contactlessly detect the presence of the predetermined gas.

Figures 5A-C shows how the optically reflective sphere 7 affixed to the trigger 3 in the embodiment of Figure 2 operates, with the other markers being omitted to more clearly illustrate this operation.

As the trigger 3 is actuated by the interventionist, the position of the optically reflective sphere 7 relative to the cryogenic surgical intervention device 1 changes. The relative position changes from unactuated, as seen in Figure 5A, to partially actuated, as seen in Figure 5B, and then to fully actuated, as seen in Figure 5C. Therefore, an optical detector of the detection system may contactlessly detect a degree of actuation of the trigger 3 and determine the actuation status of the cryogenic surgical intervention device 1 based on the position of the optically reflective sphere 7 relative to the cryogenic surgical intervention device 1.

Figures 6A-C shows how the coverage marker 9 on the trigger 3 in the embodiment of Figure 3 operates, with the other markers being omitted to more clearly illustrate this operation.

As the trigger 3 is actuated by the interventionist, a coverage of the coverage marker 9 by a covering element of the cryogenic surgical intervention device 1 changes. The actuation changes the coverage from uncovered, as seen in Figure 6A, to partially covered, as seen in Figure 6B, and then to fully covered, as seen in Figure 6C. Therefore, an optical detector of the detection system may contactlessly detect a degree of actuation of the trigger 3 and determine the actuation status of the cryogenic surgical intervention device 1 based on the degree of coverage of the coverage marker 9. Figure 7 shows the cryogenic surgical intervention device 1 of Figure 3, where the surgical element 4 is detached from the body 2, with some of the markers being omitted to more clearly illustrate this.

The surgical element 4 of a cryogenic surgical intervention device 1 is often removable so that the other parts of the cryogenic surgical intervention device 1 can be re-used. To facilitate this, the surgical element 4 and the body 2 will have corresponding connectors 13. To ensure proper connection of the surgical element 4, its connector 13 (or the connector 13 of the body 2) comprises a coverage marker 9 arranged such that it is obscured by the other connector 13 when the surgical element 4 and the body 2 are properly connected.

Figure 8 shows the cryogenic surgical intervention device 1 in the embodiment of Figure 2, wherein the cannister 5 is improperly attached, with some of the markers being omitted to more clearly illustrate this.

As the cryogenic surgical intervention device 1 is used, the fluid within the cannister 5 will be depleted and the replacement of the cannister 5 will be required. This replacement can be facilitated, for example, through a screw connection between the cannister 5 and the body 2.

Typically, these cannisters 5 comprise a seal which needs puncturing in order for the cryogenic fluid contained therein to be released. To do this, the cryogenic surgical intervention device 1 comprises a puncturing element, which is arranged such that when the cannister 5 is properly attached, e.g. sufficiently screwed, to the cryogenic surgical intervention device 1 the puncturing element will pierce the seal.

To detect this proper attachment of the cannister 5, the cryogenic surgical intervention device 1 comprises optically reflective spheres 7 affixed to both the body 2 via an array 8 and the cannister 5. The relative position of these markers can be contactlessly detected with an optical detector in order to determine whether the cannister 5 is properly attached.

Figure 9 shows the cryogenic surgical intervention device 1 in the embodiment of Figure 3, wherein the cannister 5 is improperly attached, with some of the markers being omitted to more clearly illustrate this.

To detect this proper attachment of the cannister 5, the cryogenic surgical intervention device 1 comprises alignment markers 11 on the cannister 5 and the body 2. The relative position of these markers can be contactlessly detected with an optical detector in order to determine whether the cannister 5 is properly attached.

Figure 10 shows a detection system 100 and a cryogenic surgical intervention device 1.

The cryogenic surgical intervention device 1 shown and described below is that of the embodiment of Figure 2, but the detection system 100 equally may be used with the cryogenic surgical intervention device 1 of the embodiment of Figure 3 or other surgical intervention devices. The patient 130 in this case may be a live, human patient, or may be a non-living human being or animal, or an artificial target to permit training an interventionist in the use of the cryogenic surgical intervention device 1.

The detection system 100 comprises a display 120, and a controller (not shown) comprising a memory module and a processor that are both embedded in the same unit comprising the display 120. The detection system further comprises a detector assembly 110 which is a combined emitter and detector. The detector assembly 110 is capable of detecting the position of the optically reflective spheres 7, or other markers, of the cryogenic surgical intervention device 1.

Also shown is an array 140 which is fixed to the head of the patient 130 such that it is fixed relative to the anatomy of the patient 130. The array 140 comprises three optically reflective spheres 150, such that their relative arrangement is fixed with respect to each other in a known irregular configuration. The optically reflective spheres 150 are adapted to reflect infrared light, and may be the same or different to the optically reflective spheres 7 of the cryogenic surgical intervention device 1. It will be appreciated that the detection system 100 can be used to monitor the cryogenic surgical intervention device 1 in the absence of array 140.

The controller, in addition to controlling the combined detector assembly 110, is (as above) arranged to receive information about the reflected infrared light received at the combined detector and to process this information in order to determine the origin/origins of any reflected infrared light detected.

More specifically, the controller is arranged to control the combined detector assembly 110 to carry out emission of infrared light via the emitter and detection of the emitted infrared light that has been reflected back to the detector. The controller then uses the detection of infrared light, which was initially emitted from the emitter and subsequently reflected from the optically reflective spheres 7, 150 to the detector, to determine the positions optically reflective spheres 7 of the cryogenic surgical intervention device 1 and optically reflective spheres 150 of the array 140. This determination is enabled by the detection of infrared light,

The controller then determines the relative positions of the optically detectable spheres 7 of the cryogenic surgical intervention device 1 in order to contactlessly determine a relative position of the trigger 3. Additionally or alternatively, the controller can contaclessly detect other states of elements of cryogenic surgical intervention device 1 in order to determine other statuses as described throughout the description.

The controller uses the relative position of the trigger 3 to determine an actuation status of the cryogenic surgical intervention device 1 and may, if appropriate, calculate a degree of actuation of the trigger 3. This determination uses a known relationship between the two, which may be pre-determined through testing of the device or through knowledge of the cryogenic surgical intervention device’s 1 structure.

The controller is able to track the relative position of the trigger 3 during its use by the interventionist to determine the actuation status of the trigger 3 over a period, such that a duration of actuation of the trigger 3 may be calculated. This is achieved through continued emission/detection of reflected infrared right using the detector assembly 110 and continued processing of the information associated with the detected, reflected infrared light.

The controller is further configured to reconcile an MRI image 170 of the patient 130 showing a nerve in the head, neck or back of the patient with the patient’s 130 actual anatomy that has been determined through detection of the position of the array 140 in a similar manner though its optically reflective spheres 150. The MRI image 170, which is stored in the memory of the controller, is communicated to the processor, and the processor then reconciles the MRI image 170 with the anatomy of the patient by mapping/superimposing the MRI image 170 of the patient 130 over the determined anatomy of the patient 130.

With the information received at the controller, the controller determines the relative position between the patient 130 and the cryogenic surgical intervention device 1. This is then communicated to the display 120, which the position of the cryogenic surgical intervention device 1 (and in particular a working end of the surgical intervention device 1) relative to the nerve in the MRI image 170 of the patient 130. In that way, the interventionist is able to view the relative position between the cryogenic surgical intervention device 1 and the position of anatomical features of the patient 130 as depicted in the MRI image 170, most notably the position of a nerve in the head, neck or back of the patient 130 that is to be targeted for subsequent cryoneurolysis.

Any movement of the optically reflective spheres 150 (such as resulting from movement of the patient 130) and/or the optically reflective spheres 7 (such as resulting from movement of the cryogenic surgical intervention device 1 by the interventionist) can then be determined and tracked by the controller, optionally in real-time, which can communicate these changed positions to the display 120 to thereby permit the interventionist to visualise how the relative position between the surgical intervention device 1 and the anatomy of the patient 130, and more specifically the nerve in the head, neck or back of the patient 130, has changed.

The controller uses the actuation status to estimate an effect of the cryogenic surgical intervention device 1, which we refer to as a cryo volume. This determined cryo volume includes a location, size, shape, and temperature of a volume cooled by the cryogenic surgical intervention device 1 , all of which are determined by the controller in response to the actuation status. The controller may use the position of the cryogenic surgical intervention device 1 relative to the patient 130 to refine this estimated effect by knowledge of the thermal properties of the space surrounding the cryogenic surgical intervention device.

The effect of the cryogenic surgical intervention device 1 is then communicated, by the controller, to the display 120 to be displayed overlaid on the MRI image 170 of the patient 130, such that the interventionist can visualize the extent which the cryogenic surgical intervention device 1 has cryoneurolysed the target nerve of the patient 130. The temperature of the cryo volume is visualized through use of a colour gradient, contour lines, or some other suitable visual means.

The interventionist may input into the controller a desired effect to be achieved on the target nerve. The desired effect is then communicated, by the controller, to the display 120 to be displayed overlaid on the MRI image 170 of the patient 130 in a similar manner as the estimated effect. The interventionist then can visualize the extent to which the desired effect is achieved, by looking at how the estimated effect visually compares on the display 120. In displaying the desired effect on the display 120, the controller may take into account known inaccuracies in its estimation of the effect of the cryogenic surgical intervention device 1 as well as position tracking by the detector 110 to add a buffer to the visualisation of desired effect. The buffer improves the similarity of the underlying effect achieved by the cryogenic surgical intervention device to the desired effect.

Whilst visualization of the cryo volume on an MRI is one exemplary, visual output, the status data may be indicated in other manners too. In one example, based on the degree of actuation of the trigger 3 and the duration of actuation of the trigger 3, the controller may estimate a quantity of cryogenic fluid that has been dispensed from a canister of the cryogenic surgical intervention device 1. The display 170 may then comprise a visual depiction or a numerical indication of the remaining cryogenic fluid in the cannister of the cryogenic surgical intervention device 1.

Additionally or alternatively, as discussed above, the markers 7, 9-12 of the cryogenic surgical intervention device 1 may be suitable for indication of the configuration of the cryogenic surgical intervention device 1. The controller may be configured to compare the detected state of the markers to a predetermined arrangement that is indicative of an incorrect configuration, and/or to a predetermined arrangement that is indicative of a correct configuration. The detection system 100 may then be further configured to generating an alert, which may be visible and/or auditory, responsive to determining that the configuration of the cryogenic surgical intervention device either corresponds to the predetermined incorrect configuration, or does not correspond to the predetermined correct configuration.

Whilst the markers are described above being detected by the detection system, they may also be detected by a surgical navigation system, which may be part of the same system as the detection system. The surgical navigation system is used to detect the position of the cryogenic surgical intervention device 1 to perform guided cryogenic surgical intervention on the patient in parallel with the detection system determining a status of the medical device, with both systems displaying their relevant information on the same display. Such a surgical navigation system and its interaction with the present markers 7, 9-12 is described in PCT/EP2023/073379, wherein the present markers 7, 9-12 correspond to the reference markers disclosed therein, the disclosure of which is incorporated by reference in its entirety. In particular, the plurality of optically reflective spheres 7 attached to an array 8 in the embodiment of Figure 2 is particularly suited for the position tracking in this system due to their relative arrangement being fixed with respect to each other and their position/orientation relative to a working end of the cryogenic surgical intervention device 1 being known as well.

It should therefore be understood that a cryogenic surgical intervention device in accordance with the embodiment of Figure 1 may use a combination of the markers from the embodiment of Figure 2 and the markers from the embodiment of Figure 3. Their separate illustration is not based on any incompatibilities between these different types of markers, which serve to detect the same state of an element of the cryogenic surgical intervention device 1 in some cases.

Whilst the above embodiments are primarily discussed in relation to markers, they are not necessary for the present invention. For instance, where the detection system comprises an infrared detector, this may be used to contactlessly detect a temperature of an element, such as the cannister 5 or a surface impinged upon by exhaust gases, of the cryogenic surgical intervention device 1, without requiring a marker comprising a thermochromatic paint or film. Another instance would be where the cryogenic surgical intervention device 1 comprises a whistling element driven by the flow of cryogenic gas and the detection system comprises a microphone to detect the produced sound.

Whilst the above embodiments are also primarily discussed in relation to a cryogenic surgical intervention device 1 , the present invention is also not limited to this particular type of surgical intervention device. Rather, the skilled person would appreciate the application of the above teachings in relation to other surgical intervention device configured for manual actuation by an interventionist, such as radiofrequency ablation devices, devices comprising medical balloons, etc. For instance, the surgical element 4 could easily be replaced with a medical balloon.

Claims

1. A method comprising: using a detection system: contactlessly detecting a state of an element of a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; and determining a status of the medical device based on the contactlessly detected state of the element, wherein the status of the medical device comprises an actuation status of the medical device; and calculating a duration of actuation of the medical device and/or a degree of actuation of the medical device.

2. A method according to claim 1 , further comprising, using the detection system: determining a position of the medical device and/or an orientation of the medical device.

3. A method according to claim 1 or 2, further comprising: displaying, using a visual display of the detection system, information indicative of the calculated duration of actuation relative to a target duration of actuation and/or the calculated degree of actuation relative to a target degree of actuation.

4. A method according to claim 1 , 2 or 3, wherein the method further comprises: estimating an effect of actuation of the medical device based on the duration of actuation of the medical device and/or the degree of actuation of the medical device; and displaying, using a visual display of the detection system, the estimated effect of actuation of the medical device.

5. A method according to claim 4, wherein the estimated effect of actuation of the medical device is displayed visually as an area of effect overlaying a medical image.

6. A method according to any of claims 1 to 5, wherein the medical device comprises a cannister, and the method further comprises: estimating an amount of fluid remaining in the cannister based on the duration of actuation of the medical device and/or a degree of actuation of the medical device.

7. A method according to any preceding claim, wherein the element is a movable element of the medical device, and wherein the state of the element is a relative position of the movable element.

8. A method according to claim 7, wherein the movable element is a trigger or slider of the medical device, and wherein the trigger or slider is configured for manual actuation by the interventionist.

9. A method according to claim 7, wherein the movable element is a valve or a piston of the medical device, and wherein the valve or piston is configured to move in response to manual actuation of the medical device by the interventionist.

10. A method according to claim 7, 8 or 9, wherein: the movable element comprises a first marker, the medical device comprises at least one identifiable part that does not move with actuation of the movable element, the relative position of the movable element is contactlessly detected based on a position of the first marker relative to the position of the at least one identifiable part.

11. A method according to claim 7, 8 or 9, wherein: the medical device comprises a marker arranged such that an appearance of the marker changes based on coverage of the marker by a covering element, the relative position of the movable element determining coverage of the marker; and the relative position of the movable element is contactlessly detected based on a determined coverage of the marker.

12. A method according to any of claims 1 to 5, wherein: the medical device comprises a marker configured such that an appearance of the marker changes depending upon the state of the element, or the element of the medical device is a marker configured to change its appearance depending upon the state; and wherein the state of the element is contactlessly detected based on the appearance of the marker.

13. A method according to claim 12, wherein the state of the element is a temperature of the element and/or exposure of the element to a predetermined gas.

14. A method according to any preceding claim, wherein the state of the element is contactlessly detected by a detector of the detection system, and wherein the detector of the detection system comprises one or more of: an optical camera, an infrared camera, and an electromagnetic detector.

15. A method according to any of claims 1 to 5, wherein the state of the element is a flow of a gas through or adjacent the element, wherein the medical device is configured such that a sound is generated responsive to the flow of a gas through or adjacent the element, and wherein the state of the element is contactlessly detected by an audio detector of the detection system.

16. A method according to claim 15, wherein the sound is generated at a frequency outside of human hearing range.

17. A method according to any of claims 1 to 5, wherein the state of the element is a temperature of the element, and wherein the temperature of the element is contactlessly detected by an infrared detector of the detection system.

18. A method comprising: using a detection system: contactlessly detecting a state of an element of a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; determining a status of the medical device based on the contactlessly detected state of the element, wherein the status of the medical device comprises a configuration of the medical device; and generating an alert responsive to determining that: a) the configuration of the medical device corresponds to a predetermined incorrect configuration, and/or b) the configuration of the medical device does not correspond to a predetermined correct configuration.

19. A method comprising: using a detection system: contactlessly detecting one or more markers on a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; determining coverage and/or non-coverage of each marker on the medical device by the interventionist; and generating an alert responsive to determining coverage or noncoverage of a marker indicative of incorrect operation of the medical device.

20. A computer program product comprising instructions that when executed on a processor of a detection system will configure the detection system to perform the method of any preceding claim.

21. A detection system comprising: a detector configured to contactlessly detecting a state of an element of a medical device, the medical device being a surgical intervention device configured for manual actuation by an interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon; and a controller comprising a memory module and a processor, wherein the controller is configured to carry out the method of any of claims 1 to 19.

22. A system comprising: the detection system according to claim 21 ; and a medical device, wherein the medical device is a surgical intervention device configured for manual actuation by the interventionist, wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon;

23. A system according to claim 22, wherein the medical device comprises a marker configured such that an appearance of the marker changes depending upon the state of the element, or the element of the medical device is a marker configured to change its appearance depending upon the state; and wherein the state of the element is contactlessly detected based on the appearance of the marker.

24. A surgical intervention device configured for manual actuation by an interventionist, wherein the device comprises a marker configured such that an appearance of the marker changes depending upon a state of an element of the device, wherein the appearance of the marker is contactlessly detectable, and wherein the medical device is one of: a cryogenic surgical intervention device, optionally comprising a nerve stimulator; a radiofrequency ablation device; or a surgical intervention device comprising a medical balloon.