A thermoablation device

Abstract

The thermoablation device comprises at least one energy source, at least two connectors for respective applicators, sensors adapted to detect the presence of an applicator connected to each connector, and a control unit. The latter is configured to allow to deliver energy through the applicators only if at least two respective applicators are connected to the connectors.

Description

A THERMOABLATION DEVICEDESCRIPTIONTECHNICAL FIELD

[0001] The present invention relates to medical devices for thermo-ablative treatment, in particular for example for thermo-ablative treatment of benign or malignant tumors. Embodiments described herein relate to multi-source medical devices, that is comprising two or more sources for the simultaneous treatment of tumors or the like, with two or more applicators.BACKGROUND ART

[0002] Energy sources are known to be used for thermo-ablative treatments of cancer lesions, i.e., for the destruction of cancer cells, through controlled and localized application of appropriate amounts of heat energy.

[0003] There are a number of such devices that differ first and foremost in the type of source used. Most common today are laser devices that deliver laser energy, generated by one or more sources, through an applicator, typically comprising an optical guide, such as an optical fiber. Other thermo-ablative devices use other forms of energy, such as radio frequency or micro-waves.

[0004] Especially in the field of equipment and devices using laser sources as energy sources, the use of multi-source configurations, that is devices with two or more energy sources, for example laser sources, each combined with an applicator, has been particularly advantageous.

[0005] One of the main advantages of using multiple delivery sources (laser sources with respective optical fibers, for example) lies in the fact that applicators can be optimally arranged to define a form of ablation generally compatible with the form of the lesion to be treated, whether benign or malignant.

[0006] In addition, there are devices and models that allow the simulation of thermal damage and thus treatment effects by taking into account the coalescing effect of using several appropriately arranged applicators simultaneously in addition to providing aneedle guidance system. Said systems could actually provide useful information to determine the parameters, including the number of applicators, for a given treatment. See WO-A-2019053614

[0007] This is particularly useful in the case of laser sources using optical fibers which are introduced into the tissue to be treated by means of suitable sharp needles. In the transverse plane with respect to the insertion direction of the applicators there can be obtained elliptical-like, triangular or quadrangular shapes by changing the number of applicators, i.e., optical fibers. In the longitudinal direction, multiple forms of ablation depending on the mutual positioning of the tips of the optical fibers can be obtained.

[0008] Another advantage of multi-source devices with multiple applicators lies in the option of splitting power (and therefore energy) at different points. This is advantageous from the point of view of treatment effectiveness, compared to having a single applicator positioned in the center of the cancer lesion to be removed, or laterally with respect thereto.

[0009] The use of multiple applicators, typically multiple optical fibers, allows to achieve a better synergistic action and to obtain confluent thermal lesions in a single ablation volume that has the characteristics required by the specific clinical case. This is known as volume amplification, given that the volume treated is many times larger than what would be treated with a single applicator multiplied by the number of applicators used. Fig.1 shows that the overall ablation volume varies depending on the mutual distance of two or four parallel optical fibers of a multiple laser source device. There is obtained an amplification of the treated volume around 12-15 mm of mutual distance between the tips of the fibers of the applicator, with an overall volume that is five times that of a single fiber, in the case of two fibers applied simultaneously, and a maximum of a whole fifteen times in the case of four fibers. If the fibers are further spaced apart, the overall volume decreases dramatically, given that separate thermal lesions are obtained asymptotically.

[0010] Furthermore, the treatment with multiple applicators is more homogeneous than the treatment with a single applicator, given that this allows to avoid hot-spots with better energy distribution in the treated volume, that is less energy is needed toperform ablation. The efficiency of the treatment is therefore improved, meaning that the same volume of tissue is treated with less total energy delivered than with a single applicator (single fiber and single source).

[0011] Despite the many advantages offered by multiple applicator devices, many users, for economic reasons, prefer to use a single optical fiber and reposition it several times so as to cover the entire target lesion, although simultaneous use is recommended for the treatment. In this manner, only one applicator, typically one optical fiber, is used for each procedure, with lower cost for consumables, considering that applicators are single-use.

[0012] This practice, which derives from other ablative techniques (micro-wave and radio frequency) where the technology currently only provides one applicator (electrode or antenna), does not allow to exploit the full potential of the multi-applicator technique. US 2019 / 175270 discloses a radio frequency ablation system, in which a single radio frequency source delivers energy through a cable and divider to two antenna applicators. The two antennas then deliver the same energy.

[0013] As noted above, repeated application at different points with the same applicator is much less effective than treatment with multiple applicators at these sites simultaneously. Although used sequentially in different positions during the same procedure on the same patient, the use of a single applicator often turns into an under-treatment and therefore results in poor effectiveness in cytoreduction, and sometimes in incomplete ablation with local relapse in malignant oncological forms.

[0014] The object of the present invention is to provide a multiple applicator thermoablation device that tends to reduce or prevent the misuse of a single applicator with repeated repositioning during the treatment.SUMMARY

[0015] According to an aspect, disclosed herein is a thermoablation device, comprising: at least one laser energy source; at least two connectors for respective applicators; and sensors adapted to detect the presence of an applicator connected to each connector. The device further comprises a control unit configured to allow to deliver energy through the applicators only if at least two respective applicators, each of whichcomprises a respective optical fiber, are connected to said at least two connectors.

[0016] In some embodiments, the number of sources is preferably greater than one and the number of connectors is greater than one, so that each source has at least one connector associated with it. In this manner, the energy output from each source can be modulated in a different way and independently of that emitted from the other sources. This is useful for adapting the volume impacted by the emitted energy to the shape of the lesion. The use of multiple independent sources, each provided with one or more connectors, is particularly advantageous in the case of laser sources. However, the same multi-source approach can also be used with other energy sources, for example radio frequency.

[0017] Although preferable, the number of connectors does not need to be equal to the number of sources. For example, there can be one or more sources associated with two or more connectors. This still allows to deliver different energies (from different sources) towards different applicators, with the possibility that each applicator can deliver metered energy independently from all other applicators (if the number of sources is at least equal to the number of connectors), or at least two applicators can independently deliver metered energies if there are at least two sources each associated, that is connected, that is interfaced with at least one connector.

[0018] Embodiments described herein prevent the possibility of the operator performing procedures using a single applicator, typically a single optical fiber, in the case of laser devices, and allow the simultaneous use of at least two applicators. From a clinical evaluation, the use of two applicators is a good compromise between cost and effectiveness of treatment. Obviously, even a greater number can be used until the maximum number of applicators allowed in the individual device is reached. Should a cancer lesion be of a size compatible with the use of only one fiber, the additional fiber will not be used and the system will prevent the use of the additional fiber on the next patient (for example, using the multiple insertion technique). To establish the number of applicators to be used for the treatment, there are also available support systems which allow to simulate the insertion of multiple applicators so as to find the optimal position and number, besides the treatment parameters.

[0019] According to another aspect, disclosed herein is a method for controlling athermoablation device, comprising: at least one laser energy source; a plurality of connectors for respective applicators; a system for detecting the presence of a plurality of optical fiber applicators connected to the respective connectors; a control unit. The method comprises the following steps: receiving, in said control unit, a command to delivery energy towards a plurality of applicators connected to the connectors of the device; verifying, through the control unit, whether respective applicators are connected to at least two of said connectors; enabling the delivery of energy only if respective applicators are connected to the at least two connectors.

[0020] Further features and embodiments are defined in the attached dependent claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The invention will be clearer from the description and the attached drawings, which illustrate an embodiment provided by way of non-limiting example of the invention. More particularly, in the drawings:Fig. l shows a diagram illustrating the increased effectiveness of multiple applicator ablative treatments compared to single-applicator treatments;Fig.2 shows a diagram of a multi-source and multi-applicator device; and Figs. 3, 4, 5, 6A and 6B show flow charts explaining the operation of a thermoablation device in various embodiments.DETAILED DESCRIPTION

[0022] In the following description, specific reference will be made to a thermoablation device that uses laser sources for power generation and optical fibers as applicators. This embodiment is particularly useful, given that the delivery of laser energy through multiple applicators simultaneously at multiple points of the tissues to be treated provides an advantageous synergistic effect, described above with reference to Fig. l.

[0023] In the following description a number of sources is provided which is equal to the maximum number of applicators that can be used, assuming that each applicator, i.e., in this case each optical fiber, is supplied with energy from its own dedicated source. This solution is particularly advantageous because it allows to control andmodulate the energy for each applicator. However, the option is not ruled out, of connecting a plurality of applicators to a single source, i.e., providing two or more connectors, with which respective applicators can be interfaced, and which can receive energy from a common source.

[0024] Fig.2 shows a diagram of a thermoablation device 1 comprising a plurality of laser sources 3.1, 3.2. Although in the diagram of Fig.2 only two laser sources are provided, as will be clear from the following description, the number of sources may be greater, for example three or four, with a corresponding larger number of applicators that can be used combined and simultaneously.

[0025] Each laser source 3.1 and 3.2 is associated with a respective connector 5.1, 5.2, to enable the coupling of an applicator, consisting of (or comprising) an optical fiber 7.1, 7.2 to each connector 5.1, 5.2.

[0026] In some embodiments, each applicator 7.1, 7.2 may comprise a data medium9.1, 9.2, configured to interact with a reading and writing interface 11.1, 11.2, with which each connector 5.1, 5.2, may be provided with for the purposes described in greater detail below.

[0027] In some embodiments, each connector 5.1, 5.2 may be provided with a presence sensor 13.1, 13.2, to detect the presence of an applicator 7.1, 7.2 correctly connected with the respective connector 5.1, 5.2.

[0028] The thermoablation device 1 further comprises a control unit 15. The control unit may in turn consist of a number of single units linked together in appropriate hierarchical relationships.

[0029] The control unit 15 can be functionally connected to each laser source 3.1,3.2, to each presence sensor 13.1, 13.2 and to each reading and writing interface 11.1 and 11.2.

[0030] A human-machine interface or group of human-machine interfaces, with which an operator may interact with the thermoablation device 1, is indicated with 17. In order to interact with the thermoablation device 1, a member is also provided for activating the energy emission by the laser sources 3.1, 3.2. In the diagram of Fig.2, the activation member is shown in the form of a control pedal 19, which allows theoperator to control the delivery of energy while leaving the hands free.

[0031] The device may further comprise a simulation functional block 16, which could be integrated in the block 15. The simulation block 16 is adapted to perform a pre-treatment simulation and therefore planning the procedure, identifying the most appropriate parameters to be used in ablative treatment, in particular based on the tissue to be treated. The parameters identified by the simulation may comprise, in particular, the number and type of applicators to be used simultaneously and, where appropriate, their position. A functional block of this type may be configured as disclosed in WO2019053614.

[0032] In a simplified embodiment, the thermoablation device 1 may be without reading and writing interfaces 11.1, 11.2 and applicators 7.1, 7.2 may be without data media 9.1, 9.2.

[0033] In a particularly simple possible embodiment, the thermoablation device 1 is configured to operate with the simple use of presence sensors 13.1, 13.2. In this case the thermoablation device 1 can operate by performing a procedure summarized in the flow diagram of Fig.3. At start-up, after the applicators 7.1, 7.2 have been connected to the thermoablation device 1 through the connectors 5.1, 5.2 and placed in the desired positions in or on the patient, the control unit 15 remains in standby waiting for a command through the pedal 19 or another actuation member. When the command signal is received, before the device starts to deliver energy generated from the sources 3.1, 3.2 to the applicators 7.1, 7.2, a check is carried out to verify the successful connection of the applicators to the connectors 5.1, 5.2. This check is performed by means of the presence sensors, 13.1, 13.2. If the check is successful, that is if both connectors are interfaced with a corresponding applicator 7.1, 7.2, the thermoablation device starts to deliver energy. Otherwise, no energy is emitted and therefore the thermoablation cycle cannot take place.

[0034] Already in this simplified embodiment, the important technical result lying is obtained that the device prevents the operator from performing a thermoablation cycle with a single applicator, since both applicators must be placed in the operating position in order for the thermoablation device 1 to start delivering energy.

[0035] In the embodiment described with reference to Fig.3, the applicators 7.1, 7.2may be without data medium 9.1, 9.2 and the connectors 5.1, 5.2 may not be combined with data reading and writing interfaces 11.1, 11.2.

[0036] In embodiments in which the thermoablation device 1 comprises more than two sources and / or more than two connectors for as many applicators, it may be provided for that the energy supply be enabled when the control unit 15 detects the presence of at least two applicators. This ensures that the operator cannot carry out procedures with a single applicator (a single fiber), but without forcing to simultaneously use the maximum number of applicators that device 1 can accept. In general, therefore, it may be provided for that the thermoablation device 1 comprises more than one connector (at least two) and that the energy delivery can be activated when at least two applicators are connected to at least two (or more) connectors.

[0037] In a more developed embodiment, the thermoablation device 1 uses the reading and writing interfaces 11.1, 11.2 and data media 9.1, 9.2 with which applicators 7.1, 7.2 are provided. The operation in this case is configured so that, when energy has been delivered through an applicator for patient treatment, the applicator becomes unusable for subsequent use, as it is marked as “expired”. This operation can be carried out by the control unit 15 which detects the energy dose delivered through each applicator 7.1, 7.2 and writes on the respective data medium 9.1, 9.2 an indication that the applicator has been used. This data remains stored in the data medium 9.1, 9.2 of the applicator and prevents further use thereof. To this end, in this embodiment it is provided for that upon activation of the energy delivery cycle through the pedal 19, or other suitable actuation member, the control unit 15 performs a double check: besides checking whether both connectors 5.1, 5.2 of the thermoablation device 1 have been correctly provided with the respective applicators 7.1, 7.2, the control unit 15 also checks whether any of the two applicators interfaced to the connectors has expired. If at least one of the two applicators has expired, i.e., has been marked in a previous use as used or exhausted by writing a corresponding datum on the data medium 9.1, 9.2, the energy delivering cycle is not started until the expired applicator is replaced.

[0038] This operating mode is summarized in the flowchart in Fig.4, where the step of writing the datum relating to the use of the applicator 7.1, 7.2 on the respective data medium 9.1, 9.2 is not explicitly shown. This step can be performed for example at the start of the treatment or at the end of the treatment. When performed at the end of thetreatment, the data stored on the chip contained in, or constituting, the data medium 9.1, 9.2 may contain information about the total energy delivered.

[0039] In a further embodiment, it can be provided that, in a preliminary stage of the energy delivering cycle, the control unit 15 stores, in data medium 9.1, 9.2 of each applicator 7.1, 7.2 connected to the thermal ablation device, a code that associates with each other, i.e., mutually pairs the applicators to each other. This allows to prevent the possibility that the operator uses only one applicator 7.1, 7.2 for each procedure, in order to save on consumables, thus bypassing the checks that the control unit 15 performs in order to force the operator to carry out treatments using a multiple applicator.

[0040] This embodiment performs a check during the use of the thermoablation device, which is summarized in the flowchart in Fig.5. The two checks described above are performed here, i.e., it is checked whether there are as many applicators 7.1, 7.2 as there are connectors 5.1, 5.2, or whether there are at least two connected applicators, and it is further checked whether there has been no previous use of the applicators in any other procedure (i.e. it is checked that the applicators have not expired). The third check is aimed at checking whether the two applicators have the same identification code, or association code, or pairing code, that is they are associated, i.e. paired, to each other. The identification code, i.e., the mutual association code, i.e., the mutual pairing of the plurality of applicators to be used simultaneously, is stored by the control unit 15 in the respective data media 9.1, 9.2 by means of the reading and writing interfaces 11.1, 11.2 at an appropriate pre-treatment step, which is not shown in the flowchart of Fig.5. For example, this code can be stored when the applicators 7.1, 7.2 are engaged, i.e., connected to the connectors 5.1, 5.2, or even after checking the presence of applicators and checking whether they have expired. As will be clarified with reference to a further embodiment described below, mutual pairing, i.e., the mutual association of applicators, may be postponed to a stage where the correct functioning of the applicators has been checked beforehand, in order to avoid having to replace both applicators in the event of a single faulty applicator which has to be replaced.

[0041] The identification code, i.e., the association or mutual pairing code of the applicators can be the same code for all applicators 7.1, 7.2 connected to the thermoablation device 1 in preparation for a procedure. However, this is not essential. As a matter of fact, it is also possible to associate with each applicator 7.1, 7.2 a specificidentification code, different for the two (or more) applicators, and then generate an association, i.e., a pairing between the two or more codes by means of the control unit 15. For example, the control unit can assign to the two applicators 7.1, 7.2 the two codes XX00001 and XX00002 and store in an appropriate memory a record of the fact that these two unique codes identify two applicators paired with each other.

[0042] In this sense, instead of storing identification codes, i.e. pairing or association codes, in the two data media (equal or different but paired), it would also be possible to read through the reading and writing interfaces 11.1, 11.2 two unique codes prestored in the data media of the two applicators 7.1, 7.2, for example at the time of their production. The two unique codes are then paired with each other by the control unit 15, which stores the record thereof and is therefore capable of granting or denying consent to deliver energy, after verifying that applicators with the unique codes that the control unit 15 has preliminarily associated, i.e., matched, with each other, are interfaced to the device.

[0043] The use of unique codes pre-stored in the applicator data media may also be useful should one desire to use different kinds of applicators and it is useful to have them recognized by the equipment with which they are connected.

[0044] A more elaborate method of operating the thermoablation device 1 is described below with specific reference to the flow chart of Figs.6A, 6B. In this embodiment, each applicator or optical fiber 7.1, 7.2 can take one of three possible conditions: new, used and expired (“EXP”). Each condition is identified by information stored in a data medium, for example a chip with which the applicator is provided.

[0045] The condition of the specific applicator is changed through interaction with the reading and writing interface 11.1, 11.2 associated with connector 5.1, 5.2 to which the applicator 7.1, 7.2 is connected. The operating mode, described below with reference to Figs.6A, 6B, requires that the energy dose delivered through each applicator or optical fiber 7.1, 7.2 is detected by the control unit in particular at an early stage of a treatment cycle. For the correct use and handling of the applicators 7.1, 7.2 two threshold values of the delivered energy dose are set. These threshold values are labeled Thl and Th2 in the flow chart of Figs.6A, 6B. DoseA and DoseB indicate the energy doses delivered through the two optical fibers or applicators 7.1, 7.2. Thethreshold values Thl, Th2 are chosen low enough to have no significant therapeutic effect.

[0046] As will be clear from the following description, these two threshold values are used to manage the preliminary stages of the use cycle of the thermoablation device 1, before actual therapeutic treatment, and they have the function of correctly managing the two optical fibers 7.1, 7.2, to ensure that they are always used in combination, and that it is not possible to carry out treatment with one optical fiber and a subsequent treatment with the other. Basically, as will be clear from the following detailed description, the method summarized in the flowchart of Figs.6A, 6B prevents the operator from circumventing the restriction of always operating with multiple applicators. More precisely, the constraint can be circumvented, but without this allowing the operator to use the second fiber in a subsequent treatment cycle on another patient. In this sense, the method of managing and controlling the device makes it actually useless to circumvent the multi-fiber treatment restriction, since circumventing this restriction does not bring any cost-saving benefits.

[0047] Using again the nomenclature used in the flow chart of Figs.6A, 6B, the expression “PairCode” is used to indicate the identification code, or pairing code, also known as the association code, which mutually associates two applicators 7.1, 7.2 connected and used together and simultaneously for a given treatment.

[0048] In the flowchart of Figs.6A, 6B, it is assumed that two applicators or optical fibers are used. However, it must be understood that the method described below (as well as the other simpler methods described above) can be expanded to a situation where the number of applicators to be used simultaneously is greater than two, for example three or four.

[0049] The treatment of the patient requires a preliminary step of setting the thermoablation device 1. This preliminary step requires that the operator to connect an applicator 7.1, 7.2 to each connector 5.1, 5.2. The operator shall then adjust the delivery parameters (in the case of lasers: emission parameters) for each energy source 3.1, 3.2. Basically, these parameters can be the same or different for the two sources.

[0050] As mentioned above, the procedure can also be carried out on a thermoablation device 1 which has more than two sources and / or more than two connectors, usinga number of applicators equal to or less than the number of connectors available (but always at least two). Furthermore, as mentioned above, it cannot be ruled out that a source be functionally connected to several connectors and thus configured to supply energy to multiple applicators, although the bi-unique pairing of one source to each connector is preferable, given that it allows easier handling and allows the energy delivered through each applicator to be modulated independently of the other (or the others, if more than two are provided for).

[0051] In the light of the above, with reference to the block diagram of Fig.2 and the flow chart of Fig.6A, 6B, the thermoablation device 1 is controlled as follows. After connecting applicators or fiber optics 7.1, 7.2 to the connectors 5.1, 5.2, after applying the applicators to the patient, and after setting the thermoablation device 1 to carry out the treatment cycle on the patient, the operator starts the thermoablation device 1 (block 201). This can be a new start or a resumption of activity of the thermoablation device 1, for example after a standby period. For example, a standby period may occur if, for whatever reason, a treatment that has already started must be stopped before it can be resumed on the same patient.

[0052] As a first operation (block 202), the control unit 15 checks the applicators 7.1, 7.2 to verify whether they are present and that their status is consistent with their use in the application cycle just started (or resumed after a standby period). Basically, in this step the control unit 15 checks for the presence of applicators 7.1, 7.2 connected to both connectors 5.1, 5.2 and reads, via the reading and writing interfaces 11.1, 11.2, the data contained in data medium 9.1, 9.2 of each applicator 7.1 and 7.2. These data contain the applicator status, which cannot be expired, i.e, the applicator cannot be marked “EXP” at the start of treatment. If one or both applicators are absent, or marked as expired, a corresponding warning (block 203) is emitted through the human machine interface 17, for example including a display or a monitor. If only one is marked “EXP” but the other is marked “USED” and they are used twinned, that is, they are paired to each other, that is associated with each other, then the treatment can be performed using only the applicator marked “USED”, as clarified hereinafter, see below.

[0053] The conditions that may occur and the resulting behaviors of the thermoablation device 1 are summarized in Table 1 below, where the symbol “-“indicates no applicator, the symbol “[^’indicates the presence of a new applicator, the indication[EXP] means that the connected applicator has expired, and lastly the indication [USED] means that the applicator has been used.TABLE 1

[0054] Therefore, in the illustrated embodiment, if one of the two connectors is without an applicator, the thermoablation device 1 does not proceed any further and requires the connection of the missing applicator (7.1 or 7.2). These two conditions correspond to the first two rows of Table 1. If one of the applicators has expired and the other is new (rows three and four of Table 1), the replacement of the expired applicator is required. In this manner, the device prevents the operator (in order to carry out treatments with only one applicator) from trying to circumvent the multi-applicator treatment restriction by simply always keeping the same applicator (7.1 or 7.2), which remains inactive, connected to one of the two connectors 5.1, 5.2. In the conditions of rows three and four, should the thermoablation device 1 not block the delivery, requiring the replacement of the expired applicator, it would be easy to use the thermoablation device 1 always with only one applicator, while keeping the other applicator always connected but disabled.

[0055] Vice versa, should one of the two applicators be expired and the other be used, or should both be used, the thermoablation device 1 can proceed with the treatment. These conditions mean that at block 201 an activity is resumed after a standby step, onthe same patient (therefore using applicators already previously connected, then marked as used). As a matter of fact, in the case of row six or seven, one of the two applicators is marked as expired (EXP) and has therefore been previously connected, paired with the other, but not used. This condition may occur in rare clinical cases where treatment has to be performed with only one applicator. In this case, the first time the thermoablation device 1 is used with the new patient, the operator will be required to connect two applicators, even if one of the applicators is not used. This restriction is due to the fact that the device to which only one applicator is connected does not deliver energy (conditions of rows 1 and 2 of Table 1).

[0056] It should be noted that, should a treatment with a new patient be started at block 201 (instead of resuming a treatment kept in standby), the used applicator condition will never occur, given that the operator must always use new applicators for each new patient. This means that when the thermoablation device 1 is started at block201 to start treating a new patient, the only conditions that can occur are those of rows 1, 2, 3, 4, 5, and 9.

[0057] Thus said, returning to the diagram of Figs.6A, 6B, should the check of block202 be positive (that is should one of the conditions in rows 6 to 9 of the table be met), in block 204 the control unit checks, for each applicator 7.1, 7.2, whether it is marked, i.e., whether both applicators have already been provided with an identification code, i.e., an association code, or pairing code, indicated as “PairCode”. This occurs for any applicator that has already been applied and has already undergone the check steps described below, for example before a standby period of the thermoablation device 1. Applicators with an identification code, i.e., an association code, or pairing code are “paired” and can only work together, that is both must be connected to the thermoablation device 1.

[0058] Should the check referred to in block 204 be successful, that is should the applicators contain, stored in their data medium, an identification, association, or pairing code (“PairCode”), the check switches to the last block 219, where the thermal ablation device 1 performs the treatment until it is terminated or until a subsequent standby period (block 220). Clearly, the treatment takes place after the pedal 19 is activated by the operator.

[0059] Should the check referred to in block 204 be negative, i.e., should it be found that the applicators 7.1 , 7.2 are not paired with each other by a respective identification, or pairing or association code, “PairCode”, stored in the respective data media, the check switches to block 205, allowing to start the treatment, but also carrying out the step of marking the applicators, so that the operator cannot “save” one applicator by circumventing the obligation to connect two of them simultaneously, for each treatment, thus always changing all applicators when the patient changes. Should the block 204 be negative because the two applicators have already been paired but do not appear paired to each other, i.e., they were paired to different applicators, then the system will not allow to proceed and will require to replace both applicators.

[0060] At block 205, the thermoablation device 1 may start to deliver energy according to parameters previously set by the operator. For example, the emission is started and stopped using the control through the pedal 19.

[0061] In summary, the following can happen in the steps described above. Should the check of block 202 show that one of the applicators is not connected, at block 203 the operator is prompted to connect the missing applicator. Should the check of block 202 show that one of the applicators has expired (that is marked “EXP”), but not connected together with its “twin”, it is required to be replaced at block 203. On the other hand, as mentioned above, should the applicator marked “USED” be paired with the applicator marked “EXP”, the device can carry out the treatment using only the applicator marked “USED”:

[0062] Should the check of block 204 show that both applicators 7.1, 7.2 are admissible and have already been paired, the checking procedure switches to block 219, skipping the intermediate blocks. On the other hand, should the applicators not yet have been paired by marking with the “PairCode”, that is they are two new applicators, the intermediate steps described below are carried out, which have the function of: allowing to check the correct functioning of both applicators (i.e., to check whether they are not faulty but emitting correctly), and subsequently associating the applicators with each other with the PairCode, to prevent a subsequent single use of only one of them, paired with a third applicator.

[0063] Going back to the diagram of Figs.6A, 6B, should the two applicators 7.1, 7.2not be paired with each other, the checking procedure switches from block 204 to block 205. The operator initiates the treatment by pressing the pedal 19 (or another control member). This allows to check for the correct operation of the two applicators. For example, should the applicators comprise optical fibers, the operator can check whether they emit laser radiation at their distal end. In some embodiments, the thermoablation device 1 may be provided with a photodiode or other device sensitive to laser radiation, in front of which there may be placed the distal end of the optical fibers of one and then the other of the optical fibers 7.1, 7.2. Through the control unit 15, the thermoablation device 1 will check whether, upon pressing the pedal 19 and with the distal end of the fiber arranged facing the detector, the latter detects the actual set laser radiation emission.

[0064] Depending on the type of applicator used, there cannot be ruled out the possibility that it has an integrated sensor or detector.

[0065] Regardless of how the wholeness and correct functioning of each applicator 7.1, 7.2 is checked, the thermoablation device 1, and more precisely its control unit 15, is programmed so that the combination, that is the association, or pairing, of the two applicators occurs after the operator has been given the opportunity to check the correct operation of the applicators. This is enabled by the fact that, before storing the PairCode in the data media of each applicator 7.1, 7.2, a certain dose of energy must have been delivered to at least one of the two applicators, in whose absence the pairing is not carried out. Should the energy dose, below which pairing does not occur, be low enough not to substantially imply any clinical effect, this allows to test for the correct functioning of the applicators before they are paired and pair them before they have interacted with the patient in a clinically significant manner.

[0066] In the diagram in Figs.6A, 6B, it was assumed that the thermoablation device 1 cannot control the energy dose delivered to each applicator 7.1, 7.2 during delivery, but that it is necessary to stop delivery to carry out the check on the dose delivered and subsequent determination of the status of the applicator. This limitation can actually be overcome with different management systems, for example with two CPUs, or multicore CPUs, which allow parallel processes during the delivery step and for which it is possible, for example, that the check on the delivered dose as well as writing the status of the applicator (the status is actually decided based on the check on the dose)are carried out during delivery and not as simplified in Figs.6A, 6B, where the delivered dose is calculated in the non-emission condition.

[0067] In Figs.6A, 6B, the block 206 checks when the operator releases the pedal 19 thus stopping delivery. When this happens, the system switches to block 207, where the energy dose delivered towards each applicator 7.1, 7.2 is calculated. If the applicators include optical fibers, and each is associated with its own laser source, in this step the control unit 15 calculates the dose emitted by each source 5.1, 5.2. Should the system allow checking and writing simultaneously with delivery, the block 206 may be bypassed and the block 207 may be parallel to block 205. In this case, block 205 and block 219 are merged and the flow of blocks 206 to 218 is simultaneous and parallel to block 205.

[0068] After calculating the dose delivered by each source, the checking procedure switches to block 208, to check whether and which of the two applicators 7.1, 7.2 received a dose equal to or greater than the first threshold Thl. The check procedure remains on this loop until block 208 shows that at least one of the two applicators 7.1, 7.2 has reached or exceeded the threshold Thl. In this case the check procedure switches to block 209, which provides for writing the identification, i.e., pairing, or association code, PairCode, in the two data media 9.1, 9.2 of the two applicators 7.1, 7.2. Block 210 shows the condition that the identification, pairing, or association code has been written in the two data media 9.1, 9.2. From this point forward, the two applicators 7.1, 7.2 may only be used in combination and never independently of each other and possibly combined with another applicator.

[0069] Besides the identification, association, or pairing code, PairCode, in each of the two data media data 9.1, 9.2 there may be possibly stored a datum which identifies the connector 5.1, 5.2 (and therefore the source 3.1, 3.2) to which each applicator has been connected, in order to avoid a reversal of the positions of the two applicators.

[0070] The subsequent steps of the method shown in Figs.6A, 6B have the function of marking as “USED” the or each emitter 7.1, 7.2 which delivered a dose equal to or close to the threshold Thl and marking as “EXP” any applicator that did not receive energy or that received significantly less energy than the one that reached the dose Thl. This procedure allows, on the one hand, to carry out (if requested) a treatmentwith a single applicator and, on the other hand, to prevent the reuse of the applicator that was paired with the other but not used.

[0071] To this end, a second energy threshold Th2 is provided, that is substantially lowre than Thl . In the case of applicators comprising optical fibers, the thresholds Thl and Th2 may be respectively equal to approximately 500 Joules and approximately 200 Joules, where these values being provided by way of non-limiting example.

[0072] Therefore, going back to the diagram of Fig.6A, 6B, the method starting from block 210 is as follows. Firstly, it should be borne in mind that block 210 is only reached when at least one of the two emitters 7.1 and 7.2 has emitted a dose of energy greater than Thl. At block 211, the control unit 15 checks whether the first applicator 7.1 has emitted a dose of energy greater than Thl, that is whether the DoseA dose is equal to or greater than Thl. Should the answer be affirmative, then there arises the need to check whether the second applicator has also emitted a dose greater than Thl, this check being carried out in block 212. Should the outcome be positive in this case too, i.e., if both applicators 7.1 and 7.2 have delivered a dose greater than the threshold Thl, they are both marked as “USED”. This marking is stored in the respective data media 9.1, 9.2 together with the already stored pairing, or identification, i.e., association code, PairCode, as schematically shown in block 213.

[0073] Should the outcome of the check at block 212 be negative, the checking procedure switches to block 214, where it is checked whether the applicator 7.2 emitted much less than the applicator 7.1. This is done by comparing the absolute value of the difference between the DoseA and DoseB doses delivered by 7.1 and 7.2 respectively with the second threshold value Th2.

[0074] Should the check carried out at block 214 indicate that the absolute value of the difference of the two doses emitted is less than the threshold Th2, then the second applicator 7.2 is also marked as “USED”, block 213. On the other hand, should the absolute value of this difference be higher than the threshold Th2, it means that the second emitter has not emitted energy or has emitted energy that is significantly lower than the first emitter. This can happen if the emission parameters set are such that they operate with only one emitter. When this happens (positive outcome of the check block 214), the second emitter 7.2 is marked as “EXP” and therefore not usable (anymore),while emitter 7.1 is marked as “USED”, see block 215.

[0075] On the other hand, should the checking procedure have reached block 210 because the second emitter 7.2 has exceeded the emission threshold Thl (that is DoseB>Thl), the outcome of the check at block 211 is negative and the checking procedure switches to block 216, to check whether the emitter 7.1 delivers a dose not markedly lower than Thl, using the same approach described above based on the threshold value Th2. Should the absolute value of the difference in DoseA and DoseB doses be lower than the second threshold Th2, then both applicators are marked as “USED” in block 217. Otherwise, this means that the applicator 7.1 emitted much less than applicator 7.2 and therefore applicator 7.1 will be marked as expired “EXP”, while applicator 7.2 will be marked as “USED”, see block 218.

[0076] From each block 213, 215, 217 and 218 the checking procedure switches to block 219 to continue the treatment until it is completed (block 220).

[0077] Basically, the result of this complex method is that the applicators 7.1, 7.2 are marked as “USED” if energy is actually delivered for therapeutic purposes through them. If one of them is not receiving or receives significantly less energy, it is marked as “EXP”. In any case, the two applicators are paired, i.e., combined or associated, through the PairCode. As a result, as long as they remain connected to the thermoablation device 1, the latter can operate based on Table 1 discussed above, delivering energy through the applicator as “USED”.

[0078] At the end of the single patient treatment, the applicators are removed and replaced with new sterile applicators. If one of the applicators has not been used, in an attempt to avoid the consumption of two applicators for a single treatment and then reuse the applicator, which has not been used in the just completed treatment, for another patient, this is prevented by the fact that the applicator is however marked as “EXP”, see Table 1.

[0079] It should be noted that the procedure described above from block 204 to block 220 can take place at the moment the operator releases pedal 19, regardless of which treatment step had been reached at that moment. The operator may release pedal 19 immediately after checking the correct operation of the applicators, before resuming the actual treatment. In this case, the method for pairing, i.e., associating and writingthe “used” or “expired” applicator conditions is actually performed prior to the actual clinical treatment. But this is not necessary. As a matter of fact, the operator can also complete the entire treatment without ever releasing pedal 19 after the first start of the thermoablation device 1. In this case, the marking and mutual pairing, or mutual association, of the fibers shall be carried out immediately after the end of the treatment, with the same effect. That is, even in this case, the applicators will be associated with each other, each one characterized by the “used” or “expired” status and each possibly uniquely paired to one or the other of the two sources.

[0080] The distinction between the two “EXP” and “USED” conditions allows, on the one hand, to prevent the multiple use of an applicator that is connected to the thermoablation device with the sole purpose of “deceiving” the check that requires the use of two applicators. The marking of the connected but not used applicator as “expired” ensures that the applicator is still unusable. On the other hand, it is still possible to use a single applicator. This dual function would not be possible if the system were not able to distinguish between the two conditions.

[0081] The method described with reference to Figs.6A, 6B with two applicators can be extended to the use of a higher number of applicators. For example, using three or four applicators, the system behaves as described above, checking the dose delivered through each applicator and noting when the first applicator reaches the dose Thl . The applicator that reaches the threshold Thl becomes the one that controls all the others. A check is then carried out between the master applicator and each of the other applicators. If the applicator has reached the threshold Thl, it is marked as USED and paired to the master applicator. If the threshold Thl has not been reached, the difference between the doses delivered by the master applicator and the checked applicator is checked. If the absolute difference between the two doses is equal to or greater than the threshold Th2, the second applicator is marked “EXP”. If the absolute difference between the two doses is less than the threshold Th2, the second applicator is marked “USED”.

[0082] While the invention has been described in terms of specific various embodiments, the persons skilled in the art will understand that many modifications, changes and omissions may be carried out, without departing from the scope of the invention, as described in the claims below.

[0083] The following also forms an object of the present invention:Clause 1. A thermoablation device, comprising: at least one energy source; at least two connectors for respective applicators; sensors adapted to detect the presence of an applicator connected to each connector; a control unit configured to enable energy delivery by the applicators only if at least two respective applicators are connected to said at least two connectors.Clause 2. The device of clause 1, preferably comprising at least two sources and preferably an energy source for each connector.Clause 3. The device of clause 1 or 2, wherein the source or sources are laser sources and wherein the applicators comprise optical fibers.Clause 4. The device of any one of the preceding clauses, wherein each connector is combined with a presence sensor, interfaced with the control unit and configured to detect the presence of an applicator connected to the respective connector.Clause 5. The device of any of the preceding clauses, wherein each connector comprises an interface for reading and writing data in a data medium integrated in each applicator; each interface being functionally connected to the control unit.Clause 6. The device of clause 5, wherein the control unit is configured to write, in the data medium of each applicator connected to one of the connectors of the device, through the respective reading and writing interface, an information which prevents a subsequent reuse of the applicator after said applicator has been connected to the connector of the device.Clause 7. The device of clause 5 or 6, wherein the control unit is configured to check, for each applicator connected to one of the connectors of the devicebefore delivering energy and through data stored in the data medium of the applicator, whether the applicator has expired and therefore needs to be replaced.Clause 8. The device of clause 5 or 6, wherein the control unit is configured to check, for each applicator connected to a respective connector, before delivering energy and through data stored in a data medium of the applicator, whether the applicator is correct for the chosen application, depending on the behavior parameters set on the device.Clause 9. The device of clause 8, wherein the behavior of the control unit is defined at the time of manufacture, by the service menu, or in remote mode; and wherein the control unit can be configured to change the behavior of the device depending on the data stored in the data medium of the applicator.Clause 10. The device of clause 9, comprising a simulation or planning block adapted to carry out a pretreatment simulation so as to establish the most appropriate parameters depending on the tissue to be treated, in particular one or more of the following: the number of applicators, the type of applicators, the position of the applicators.Clause 11. The device of any one of clauses 5 to 10, wherein the control unit is configured to write, on the data medium of each applicator connected to one of the connectors of the device, an identification code which mutually associates the applicators simultaneously connected with the device; and wherein the control unit is configured to enable energy delivery through at least one of the applicators only if the applicators connected to the device have, stored in the respective data media, identification codes which mutually associate the applicators connected to the device.Clause 12. The device of any one of the preceding clauses, wherein the control unit is configured to: identify the presence of applicators connected to the connectors; prevent the use of the device if an insufficient number of applicators are connected to the connectors; check the status of the connected applicators, identifying whether each applicator is new, used or expired; mutually associate the applicators simultaneously connected to the device; enable to perform a treatment using the deviceif all the following conditions are met:- a sufficient number of applicators are connected to the device;- the applicators are mutually associated; and- at least one of the applicators is used, or all applicators are new.Clause 13. The device of clause 12, wherein the control unit is configured to deliver a first dose of energy through the applicators connected to the connectors before mutually associating the applicators.Clause 14. The device of clause 13, wherein the control unit is configured to: mark as used a first applicator connected to the device, through which in a step prior to the mutual association of the applicators, a dose of energy greater than a first threshold was delivered; and mark as expired a second applicator, associated with the first applicator and through which in said step prior to the mutual association a dose of energy smaller than a second threshold was delivered therethrough, or mark said second applicator as used if a dose of energy greater than the second threshold was delivered therethrough..Clause 15. A method for controlling a thermoablation device, comprising: at least one energy source; a plurality of connectors for respective applicators; a system for detecting the presence of a plurality of applicators connected to the respective connectors; a control unit; wherein the method comprises the following steps: receiving, in said control unit, a command for delivering energy to a plurality of applicators connected to the connectors of the device; verifying, through the control unit, whether respective applicators are connected to at least two of said connectors; delivering energy only if respective applicators are connected to at least two connectors.Clause 16. The method of clause 15, further comprising the following step: through the control unit and a reading and writing interface combined to eachconnector, store in a data medium combined with each applicator a connected to a respective connector of the device, an information adapted to prevent a subsequent reuse of the applicator.Clause 17. The method of clause 16, further comprising the step of verifying, through the control unit and the reading and writing interface, whether each applicator connected to the connectors is enabled to be used, before delivering energy through the applicators.Clause 18. The method of clause 15, 16 or 17, further comprising the step of mutually associating the applicators simultaneously connected with the respective connectors by storing mutually associated identification codes on the data media of the applicators through the reading and writing interfaces.Clause 19. The method of clause 18, comprising the steps of: verifying whether all applicators connected to the connectors have mutually associated identification codes; and enabling the energy delivery through the applicators only if the applicators are mutually associated by the respective identification codes.Clause 20. The method of any one of clauses 15 to 19, comprising the following steps: detecting the presence of applicators connected to the connectors; preventing the use of the device if an insufficient number of applicators is connected to the connectors; verifying the status of the connected applicators, detecting if each applicator is new, used or expired; mutually associating the applicators connected simultaneously to the device; allowing to perform a treatment through the device if all the following conditions are met: a sufficient number of applicators are connected to the device; the applicators are mutually associated; andat least one of the applicators is used, or all applicators are new.Clause 21. The method of clause 20, further comprising the step of delivering a first dose of energy through the applicators connected to the connectors before mutually associating the applicators. Clause 22. The method of clause 21, comprising the following steps:- marking as used a first applicator connected to the device, through which in a step prior to the mutual association of the applicators, a dose of energy greater than a first threshold was delivered; and- marking as expired a second applicator, associated with the first applicator and through which in said step prior to the mutual association a dose of energy smaller than a second threshold was delivered, or mark said second applicator as used if a dose of energy greater than the second threshold was delivered therethrough.

Claims

CLAIMS1. A thermoablation device, comprising: at least one laser energy source; at least two connectors for respective applicators; sensors adapted to detect the presence of an applicator connected to each connector; a control unit configured to allow to deliver energy through the applicators only if at least two respective applicators are connected to said at least two connectors, said applicators each comprising a respective optical fiber.

2. The device of claim 1, comprising a laser energy source for each connector.

3. The device of claim 1 or 2, comprising at least two laser energy sources and at least one respective connector associated with each of said at least two laser sources.

4. The device of any one of the preceding claims, wherein each connector is combined with a presence sensor, interfaced with the control unit and configured to detect the presence of an applicator connected to the respective connector.

5. The device of any of the preceding claims, wherein each connector comprises an interface for reading and writing data in a data medium integrated in each applicator; each interface being functionally connected to the control unit.

6. The device of claim 5, wherein the control unit is configured to write, in the data medium of each applicator connected to one of the connectors of the device, through the respective reading and writing interface, an information which prevents a subsequent reuse of the applicator after said applicator has been connected to the connector of the device.

7. The device of claim 5 or 6, wherein the control unit is configured to check, for each applicator connected to one of the connectors of the device beforedelivering energy and through data stored in the data medium of the applicator, whether the applicator has expired and therefore needs to be replaced.

8. The device of claim 5 or 6, wherein the control unit is configured to check, for each applicator connected to a respective connector, before delivering energy and through data stored in a data medium of the applicator, whether the applicator is correct for the chosen application, depending on the behavior parameters set on the device.

9. The device of claim 8, wherein the behavior of the control unit is defined at the time of manufacture, by the service menu, or in remote mode; and wherein the control unit is adapted to be configured to change the behavior of the device depending on the data stored in the data medium of the applicator.

10. The device of claim 9, comprising a simulation or planning block adapted to carry out a pretreatment simulation so as to establish the most appropriate parameters depending on the tissue to be treated, in particular one or more of the following: the number of applicators, the type of applicators, the position of the applicators.

11. The device of any one of claims 5 to 10, wherein the control unit is configured to write, on the data medium of each applicator connected to one of the connectors of the device, an identification code which mutually associates the applicators simultaneously connected with the device; and wherein the control unit is configured to allow the delivery of energy through at least one of the applicators only if the applicators connected to the device have, stored in the respective data media, identification codes which mutually associate the applicators connected to the device.

12. The device of any one of the preceding claims, wherein the control unit is configured to: identify the presence of applicators connected to the connectors; prevent the use of the device if an insufficient number of applicators are connected to the connectors; verify the status of the connected applicators, identifying whether each applicator is new, used or expired; mutually associate the applicators connected simultaneously to the device; allow to perform a treatment using the device if all thefollowing conditions are met:- a sufficient number of applicators re connected to the device;- the applicators are mutually associated; and- at least one of the applicators is used, or all applicators are new.

13. The device of claim 12, wherein the control unit is configured to deliver a first dose of energy through the applicators connected to the connectors before mutually associating the applicators.

14. The device of claim 13, wherein the control unit is configured to: mark as used a first applicator connected to the device, through which in a step prior to the mutual association of the applicators, a dose of energy greater than a first threshold was delivered; and mark as expired a second applicator, associated with the first applicator and through which in said step prior to the mutual association a dose of energy smaller than a second threshold was delivered therethrough, or mark said second applicator as used if a dose of energy greater than the second threshold was delivered therethrough..

15. A method for controlling a thermoablation device, comprising: at least one laser energy source; a plurality of connectors for respective optical fiber applicators; a system for detecting the presence of a plurality of applicators connected to the respective connectors; wherein the method comprises the following steps: receiving, in said control unit, a command for delivering energy to a plurality of applicators connected to the connectors of the device; verifying, through the control unit, whether respective applicators are connected to at least two of said connectors; enabling the delivery of energy only if respective applicators are connected to the at least two connectors.

16. The method of claim 15, further comprising the following step: through the control unit and a reading and writing interface combined to each connector, store in a data medium combined with each applicator a connected toa respective connector of the device, an information adapted to prevent a subsequent reuse of the applicator.

17. The method of claim 16, further comprising the step of verifying - through the control unit and the reading and writing interface, whether each applicator connected to the connectors is enabled to be used, before delivering energy through the applicators.

18. The method of claim 15, 16 or 17, further comprising the step of mutually associating the applicators simultaneously connected with the respective connectors by storing mutually associated identification codes on the data media of the applicators through the reading and writing interfaces.

19. The method of claim 18, comprising the steps of: verifying whether all applicators connected to the connectors have mutually associated identification codes; and enabling the energy delivery through the applicators only if the applicators are mutually associated by the respective identification codes.

20. The method of any of claims 15 to 19, comprising the following steps: detecting the presence of applicators connected to the connectors; preventing the use of the device if an insufficient number of applicators is connected to the connectors; verifying the status of the connected applicators, detecting if each applicator is new, used or expired; mutually associating the applicators connected simultaneously to the device; allowing to perform a treatment through the device if all the following conditions are met: a sufficient number of applicators are connected to the device; the applicators are mutually associated; and at least one of the applicators is used, or all applicators are new.

21. The method of claim 20, further comprising the step of delivering a first dose of energy through the applicators connected to the connectors before mutually associating the applicators.

22. The method of claim 21, further comprising the following steps: - marking as used a first applicator connected to the device, through which in a step prior to the mutual association of the applicators, a dose of energy greater than a first threshold was delivered; and- marking as expired a second applicator, associated with the first applicator and through which in said step prior to the mutual association a dose of energy smaller than a second threshold was delivered, or mark said second applicator as used if a dose of energy greater than the second threshold was delivered therethrough.

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