Medical device using a coiled electrode

<u style="single">Field of the invention</u>

0001The present invention concerns the field of surgery, more particularly the field of cancer surgery and is related to a medical device or instrument.

<u style="single">State of the art</u>

0002Most cancer cells first develop in a primary tumor site such as the breast, colon or lung, but then cells from these cancers can spread, or metastasize, to other parts of the body where they may form new tumors.

0003A possible strategy for the treatment of cancer corresponds to a local treatment of the tumor, wherein cancer is attacked at a specific site. Different techniques have been developed on the basis of said strategy. Ablation surgery in order to remove tumors is certainly the most common local treatment used worldwide. However, other local treatment techniques also exist, among which is radiation therapy, wherein radioactive particles, seeds or rods implanted directly into a tumor are used. This type of radiation treatment is called brachytherapy.

0004New local treatment techniques such as radio-frequency (RF) ablation procedure and other similar interventional radiology catheter ablation procedures reveal to be particularly promising for patients whose cancers cannot be treated surgically.

0005The device used in the radiofrequency ablation technique generally comprises a needle which is placed through the skin and into the tumor. The needle is linked to a radiofrequency generator such that when a radiofrequency is sent through the needle, the needle is heated and destroys the tumor. This procedure is performed under conscious sedation and most patients can go home the same day.

0006RF treatment presents several advantages: <ul id="ul0001" list-style="dash" compact="compact"><li>it is a new local treatment option for cancer;</li><li>it is a minimally invasive method;</li><li>its safety has been proven over many years in thousands of people;</li><li>it is less risky and has fewer complications compared to surgery;</li><li>generally, only local anesthesia is required;</li><li>it may be done as an outpatient procedure, or shorten hospital stay;</li><li>most patients can resume normal activities within a few days;</li><li>it can be repeated if necessary;</li><li>and it may be combined with other treatment options, such as chemotherapy.</li></ul>

0007However, the capabilities of RF technique are nowadays limited as there is a real technical difficulty in controlling precisely the region to be destroyed with the existing RF devices. Indeed, the conception of said devices is such that the heating of the tissues tends to propagate beyond the tumour site. In some cases, cell's dehydration stops the heating propagation and then, the treatment's effectiveness. Currently, some cooled devices and expandable electrodes allows bigger regions to be destroyed. Then, increasing the destruction volume is possible, but the precise control of the destruction region becomes to be reached. This is important in some organs where the lesion of neighbour organs and structures, like important vessels, represents a real and still unsolved problem.

0008Among the solutions proposed in the prior art in order to solve this problem, it has been suggested in document <patcit id="pcit0001" dnum="US5507743A"><text>US 5,507,743</text></patcit> to use a RF ablation device comprising a variable pitch helical electrode capable of wrapping the tumor. However, the use of said device presents a serious drawback from a practical point of view, as it is known that increasing the distance between the two poles of the electrode produces two undesirable effects. The first undesirable effect is that the physician must increase the RF generator power, so as to compensate the bigger distance to destroy. However, increasing the power heats the cells closer to the active electrode to temperatures as high as 90 or 100 Celsius degrees, dehydrating these cells and stopping the heating effect (the heating and consequently the destruction effect is propagated through the cell's water). The second undesirable effect is that more distant tissues are easily cooled by surrounding vessels, thereby increasing the risk of non destruction of all tumoral cells. <patcit id="pcit0002" dnum="US20020049439A"><text>US2002/0049439</text></patcit> discloses on RF ablation device with concentric helical electrodes.

0009In other words, there is still a need for a satisfying device which could be used in RF ablation techniques in order to destroy by heating a tumor site inside an organ.

<u style="single">Aims of the invention</u>

0010The present invention aims to provide a medical device or instrument and a process adapted for the ablation (i.e. destruction) by radiofrequency technique of a target volume, such as a tumor, located inside or at an anatomical organ such as prostate, kidney, adrenal glands, breast, lungs and pancreas, an even brain, which would not present the drawbacks of the solutions of the prior art.

0011In particular, the present invention aims to provide a device and a process which would ensure, in operating conditions, a total but specific destruction of a predetermined unsafe tissue volume inside or at said organ, while preserving the surrounding safe tissues.

0012Another aim of the present invention is to provide a device and a process which could be used or carried out both easily and securely.

<u style="single">Summary of the invention</u>

0013The invention is defined in appended claim 1, preferred embodiments are described in the dependent claims.

0014The present invention is related to a medical device adapted for the ablation of a target volume inside an anatomical organ, said device comprising as elements a main body, stabilising means for stabilising the device relatively to the organ and heating means in the form, of a bipolar electrode comprising parts activatable by an external radiofrequency generator for heating said target volume, wherein said bipolar electrode comprises a first element having the form of a central anchoring member, and a second element having the form of at least two concentric helices of different predetermined diameter and of predetermined length, said helices surrounding the central anchoring member.

0015Advantageously, said central anchoring member may take the form of a central needle or of an extremely thin helix.

0016Preferably, said helices are rigid i.e. said helices are not deformable by simple external manual pressure (not deformable by direct manipulation).

0017Preferably, the medical device can adopt at least one rest configuration wherein the bipolar electrode is unactivable and is folded-up inside the stabilising means and the main body, and at least one working configuration wherein the bipolar electrode protrudes outside the stabilisation means so as to deploy both the anchoring member and the helices, said helices thereby forming a cage-like structure around said anchoring member, with an internal face facing the central anchoring member and an external face oriented in an opposite manner (exposed to the environment), and wherein said bipolar electrode is activable so as to have a passive pole and an active pole.

0018It is meant by "activation of the electrode" the circulation inside said electrode of a current of electric or electromagnetic type from one area of said electrode which forms the first pole to another area of said electrode which forms the second pole.

0019According to a configuration not part of the invention, in the working configuration at least one of the helices is activatable independently from the others, only on its internal face, so as to form the first pole of the bipolar electrode, while the second pole of the bipolar electrode can be formed either by the central anchoring member or by the external face of the helix forming the active pole or by the external face of an helix of smaller diameter than the helix forming the active pole.

0020According to the invention, in the working configuration at least one of the helices is activable independently from the others, on both its internal face and its external face, so as to form the first pole of the bipolar electrode, while the second pole of the bipolar electrode can be formed either by the central anchoring member or by a helix of smaller diameter than the helix forming the active pole.

0021In the present invention, the helices of the medical device may be activatable at least on one fraction of their length, and possibly on their full length.

0022Preferably, in the rest configuration, the device according to the invention has the following degrees of freedom in a referential system (O,X,Y,Z) centred at the centre of the main body: <ul id="ul0002" list-style="dash" compact="compact"><li>Rotation around the Z axis;</li><li>Rotation around the Y axis;</li><li>Translation along the X axis;</li><li>Translation along the Y axis;</li><li>Translation along the Z axis.</li></ul>

0023Preferably, in the working configuration, the anchoring member of the bipolar electrode has one degree of freedom in a referential system (O,X,Y,Z) centred at the centre of the main body corresponding to a translation along the X axis, while the helices have two degrees of freedom each, one corresponding to a translation along the X axis, and the other to a rotation around the X axis.

0024Preferably, in the working configuration any translation or rotational movement of the main body and of the stabilising means is blocked.

0025Preferably, the medical device of the invention is conceived such that the positioning of its different elements relatively to the target volume and relatively to each other and the activation state of said parts of the bipolar electrode are able to be controlled by controlling means.

0026Advantageously, said controlling means comprise a robot.

0027The present invention is also related to a surgical assembly comprising the medical device according to any one of the preceding claims, coupled to controlling means.

0028Preferably, said controlling means comprise a robot.

0029Preferably, the surgical assembly further comprises a 3D-navigation system. It is meant by "3D-navigation system any device able to take 3D informations on the position in real time of an object such as a camera or ultrasound measurement device (echographic navigation system).

0030Preferably the controlling means also comprise a computer coupled to the robot via interfacing means such as an A/D converter.

0031Preferably, said assembly is linked to a fixed support such as a surgical table.

0032Also described is a process for the destruction of a target volume inside an anatomical organ by radiofrequency ablation technique using the medical device or the surgical assembly as disclosed above, said process comprising the,following steps: <ul id="ul0003" list-style="dash" compact="compact"><li>determining parameters comprising at least the anatomical features (size, shape, position, ...) of the target volume to be treated;</li><li>on the basis of said parameters, defining at least the number of helices to use in the bipolar electrode, the first and second poles of the bipolar electrode, the sequence of activation of the bipolar electrode, and the intensity and time of activation of said bipolar electrode;</li><li>introducing said medical device inside the patient;</li><li>once the target organ is reached, positioning the medical device relatively to the target volume;</li><li>performing the treatment procedure of the target tumor following the predetermined parameters.</li></ul>

0033The present disclosure also concerns a process for the destruction of a target volume inside an anatomical organ by radiofrequency ablation technique using the medical device or the surgical assembly disclosed hereabove.

0034, Preferably, said process comprises the following steps: <ul id="ul0004" list-style="none" compact="compact"><li>by means of the 3D navigation system, <ul id="ul0005" list-style="dash" compact="compact"><li>establishing a surgical protocol according to different parameters including the anatomical features of the target volume to be treated, said surgical protocol defining namely the sequence and type of movements of the medical device and of its different elements, the number of helices to use in the bipolar electrode, the definition of the first and second poles of the bipolar electrode, the sequence of activation of the bipolar electrode, the intensity and time of activation of said bipolar electrode;</li><li>manually introducing said medical device inside the patient and approximately positioning said device relatively to the target volume;</li><li>starting the automatic operating of the robot so as to perform the surgical procedure under automatic control following the pre-established surgical protocol;</li><li>monitoring the surgical procedure and possibly restoring a manual control on the device, in case of security problems.</li></ul></li></ul>

0035The present disclosure also concerns the use of said medical device or said surgical assembly for the treatment of a target volume inside an anatomical organ selected from the group consisting of kidneys" lungs, liver, breast, prostate and brain.

<u style="single">Short description of the drawings</u>

0036<figref idref="f0001">Fig. 1</figref> represents an overview of the medical device according to the present invention.

0037<figref idref="f0002">Fig. 2</figref> represents said medical device in rest configuration (pre-operative position with the electrode folded-up inside the main body of the device).

0038<figref idref="f0003">Fig. 3a</figref> represents a detailed view of the bipolar electrode comprised in a device according to the invention, and including a needle shaped central pole and two cage-like helical poles.

0039<figref idref="f0004">Fig 3b</figref> represents a front view of said cage-like helical poles.

0040<figref idref="f0005">Fig. 4</figref> represents the main body of a medical device provided with its stabilizing means, and shows the different degrees of freedom for said medical device.

0041<figref idref="f0006">Fig. 5</figref> represents a medical device according to the invention, with its bipolar electrode in a first operating position, wherein the needle-like pole arranged inside a target volume and one helical pole deployed and arranged around said target,volume.

0042<figref idref="f0007">Fig. 6</figref> represents a medical device according to the invention, with its bipolar electrode in a second operating position, wherein two helical poles are deployed around said target volume.

0043<figref idref="f0008">Fig. 7</figref> illustrates an overview of a surgical system comprising the medical device according to the present invention which is linked to a robotic arm and controlling means, and is fixed via the robotic arm to a surgical table or floor.

<u style="single">Detailed description of the invention</u>

0044As illustrated on <figref idref="f0001">Figure 1</figref>, the medical device 1 according to the invention comprises as elements a main body 2, stabilizing means 3, and a bipolar electrode 10.

0045Advantageously but not necessarily, said device 1, as shown on <figref idref="f0008">Figure 7</figref>, is in fact part of an assembly comprising also controlling means. Said controlling means may advantageously comprise a robot supported by a robotic arm 6 and piloted by computerising means 7, for controlling the operating state of the device 1.

0046The main body 2 and the stabilizing means 3 of the device 1 according to the invention have both a distal end, 20 and 30 respectively, and a proximal end 21 and 31 respectively.

0047The main body 2 is attached by its distal end 20 to the proximal end 31 of the stabilizing device 3, while its proximal end 21 can be attached to the robotic arm 6 of a robot.

0048The stabilizing means 3 is configured so as to allow its positioning at the outer surface of a target volume or organ in operating conditions, thereby contributing to the stabilisation of said target relatively to the device. For example, as shown on <figref idref="f0001">Figure 1</figref> and more detailed on <figref idref="f0005">Figure 4</figref>, the stabilising means 3 may have a hollow cylindrical shape, with its walls delimiting an internal cavity 33 and a more external cavity 32.

0049The bipolar electrode 10, as further shown on <figref idref="f0001">Figure 1</figref>, comprises a central needle 5. The needle 5 of the electrode 10 has a distal end 51 in the form of a tip so as to be able to penetrate inside a target tissue volume in operating conditions. Said needle 5 has also a proximal end 52, by which the needle 5 of the electrode 10 may be linked to an external radio-frequency (RF) source or generator so as to constitute a passive pole of the electrode 10 that is to say in operating conditions an electric or electromagnetic current provided by the radiofrequency generator may flow towards it.

0050The bipolar electrode 10 also comprises at least two helical or coiled elements 4' , 4"... which are concentric helices able to surround the needle 5 and to form a cage-like structure around said needle 5, when deployed according to a working configuration (see hereafter). Each of said helices is defined by its diameter D and its length L. Another feature characterizing an helix is its pitch P.

0051Preferably, the diameter D of all the helical elements 4', 4", ... are a multiple of a distance d, d being the diameter of the smallest helix, i.e. the distance between the smallest helical elements 4' and the main axis A of the needle 5.

0052According to the present invention, this distance d can be different depending on the embodiment of the medical device 1 and on the target organ (prostate, kidneys, breast, ...) to be treated and its anatomical features (size and shape, namely).

0053Each of the helical elements 4', 4", ... of the electrode 10 has a distal end 41', 41", ... and a proximal end 42' , 42", .... The proximal ends 42', 42", ... are linked to the external radio frequency (RF) generator, while the distal ends 41', 41", ... are free.

0054As illustrated in <figref idref="f0004">figure 3b</figref>, for each of said helical elements 4' , 4" ..., an internal face 43' , 43", ... arranged towards the central needle 5 and an external face 44', 44", ... arranged towards the outside environment can be defined.

0055According to a first configuration not part of the invention, only the internal faces 43', 43", ... of said helical elements are activatable separately and independently by the controlling means so that the internal face of one of said helices may constitute the first pole of the electrode 10, that is to say in operating conditions, an electric or electromagnetic current flows from it to the area of the bipolar electrode forming the second pole.

0056On the contrary, each of the external faces 44', 44", ... of the helical elements 4' , 4", ... are susceptible to form the second pole of the electrode 10, so that in operating conditions an electric or electromagnetic current may flow from the first pole to the external face of one of the helices forming the second pole.

0057In this first configuration, the second pole of the bipolar electrode 10 may also be formed by the central needle 5.

0058According to the configuration according to the invention, the helices are activable separately and independently by the controlling means on both their internal faces 43', 43", ... and their external faces 44', 44", ... so that one of said helix may constitute the first pole of the electrode 10, that is to say in operating conditions, an electric or electromagnetic current flows from it to the area of the bipolar electrode forming the second pole.

0059In said second embodiment, the second pole may be formed either by another helix of smaller diameter than the helix forming the first pole, or by the central needle 5.

0060It should be noted that the composition of the helices is adapted according to the activation scheme to be achieved. For example, in the invention, wherein the the helices are activable on both faces, the helices are entirely made of an adequate biocompatible and conducting metallic component. Comparatively, in the first configuration not part of the invention, wherein the helices are activable only on their internal face, only said internal face is made of such a metallic conducting component, while the external faces of the helices is made of an adequate biocompatible and isolating polymeric component.

0061It should be noted that in both configurations, the helices are activatable either along their full length or only along at least one fraction of said length. It means that in the case wherein the helices are activatable only on one or more fractions of their length an adequate isolation pattern of the helices has to be provided.

0062According to the invention, the device 1 may adopt at least one rest configuration as shown on <figref idref="f0002">Figure 2</figref>, wherein, the bipolar electrode 10 (needle 5 + helices 4',4", ...) is folded up inside the main body 2 and the stabilising means 3 (bipolar electrode hidden from the outside environment) and wherein the bipolar electrode 10 cannot be activated (is unactivatable).

0063It means that in - said rest configuration, both the ends 41', 41", ... and 42', 42", ... of the helices 4',4", ... are folded up inside the stabilizing device 3 and main body 2.

0064Moreover, in rest configuration, the medical device 1 as a whole presents different degrees of freedom.

0065More precisely, as illustrated on <figref idref="f0005">Figure 4</figref>, in the referential system (O, X, Y, Z) centred at the centre O of the main body 2 of the medical device 1, the following degrees of freedom are associated to the medical device 1: <ul id="ul0006" list-style="dash" compact="compact"><li>rotation around the Z axis;</li><li>rotation around the Y axis;</li><li>translation along the X axis;</li><li>translation along the Y axis;</li><li>translation along the Z axis.</li></ul>

0066According to the invention, the device 1 may also adopt at least one working configuration, wherein the bipolar electrode 10 (needle 5 and at least one helix 4') protrudes outside the stabilising means, beyond the distal end 30 of said stabilising means 3. The distal ends 41', 41", ... of the helical elements 4',4", ... can be deployed out from the stabilizing device 3, while the proximal ends 42', 42", ... of said helical elements remains inside the stabilizing device 3 and main body 2. In addition, in working configuration the bipolar electrode 10 is activatable. It means that the bipolar electrode can be activated or not, depending on its activation state.

0067An example of such a working configuration is represented on <figref idref="f0001">Figure 1</figref>.

0068In said working configuration, the device 1 is such that only the bipolar electrode 10 is able to move, the needle 5 presenting one degree of freedom, which corresponds to a translation along the X axis, while the helices 4', 4", ... of the electrode 10 are able to perform a translation along the X axis and/or rotation around the X axis.

0069Therefore, the working configurations of the medical device 1 differ from each other at least by a different orientation of the bipolar electrode 10 that is to say of the needle 5 and/or of the helices 4',4", ..., relatively to the main body 2 in the referential system mentioned hereabove (see <figref idref="f0007">Figure 6</figref>).

0070It should be noted that the combination of both movements (translation + rotation around X axis) allows in operating conditions the positioning of the helices 4', 4", ... of the electrode 10 around a target volume (target tumor or tumoral target region) with one unique entry point into the organ, following a corkscrew-like movement.

0071It should also be noted that the medical device 1 of the invention is conceived in such a manner that the movements of the main body 2 and of the stabilisation means 3 are locked before the needle 5 and the helices 4', 4" *... of the electrode 10 can move. It means that in working configuration, the main body 2 and the stabilising means 3 cannot move. In addition, it is also possible to lock the robotic arm 6 of the assembly.

0072All these movements of the medical device 1 are done with a near millimeter precision, under the control of the controlling means.

0073Advantageously, all these movements are done via the robotic arm 6 of a robot and by means of different activators and micro-activators.

0074In this case, all the activators or micro-activators necessary for these movements can be placed in the main body 2 of-the device 1, or in the robotic arm 6 or somewhere else in the assembly itself.

0075These activators and micro-activators necessary for the described movements of the medical device 1 can be of several types, including electrostatic, magnetic, piezo-electric, thermic, shape memory allow (SMA), fluidic and electro-rheologic ones

0076An important feature of the present device is the fact that the configuration the device 1, as well as the activation state of the bipolar electrode are contrallable by the controlling means.

0077Furthermore, it should be noted that the composition and dimensions of the different elements of the device 1 i.e. the main body 2, the stabilizing device 3, the needle 5 or other equivalent anchoring member and the helices 4', 4", ... of the electrode 10 are compatible with their technical use (the prostate, kidneys, adrenal glands, lungs, etc...), in particular in terms of biocompatibility, and can be easily adapted from the present description by the man skilled in the art.

0078In practice, the anchoring member (needle 5) and the helices 4',4", ... always work together so as to form the bipolar electrode 10, with the electric or electromagnetic current flowing from the more external pole (the first pole) to the more internal pole (second pole) as defined hereabove.

0079This movement of the current from the periphery to the center of the medical device allows a better control of the region to be destroyed by heating. The present apparatus and associated process thus prevent undesirable heating of the surrounding tissues located immediately outside the active helix.

0080In a first case, as illustrated in <figref idref="f0006">figure 5</figref>, wherein the target volume 100 (target tumor or tumoral region) is sufficiently small, the controlling means and thus possibly the robot, control the different elements of the device in such a manner that in the working configuration the needle 5 and the smallest helix 4' protrude outside the main body and stabilising means 3, the needle 5 penetrating inside the target volume 100 and the helix 4' wrapping said target volume 100, while helix 4" of greater diameter is folded up inside the main body 2 and stabilising means 3. The needle 5 operates as a second pole, while the internal face 43' of the smallest helix 4' operates as the first pole and the external face 44' of said helix 4' remains inactive i.e. is not activated by the RF external generator.

0081In a second case, as illustrated in <figref idref="f0007">figure 6</figref>, the target volume 100 to be destroyed by heating is bigger than the diameter of the smallest helix 4'. Therefore, the controlling means and thus possibly the robot control the device in such a manner that the needle 5 as anchoring member and the helices 4', 4" protrude outside the main body 2 and stabilising means 3, the needle 5 and the helix 4' penetrating inside the' target volume 100 and the helix 4" wrapping said target volume 100. The second pole is the external face 44' of the smallest helix 4' and the first pole is the internal face 43" of the immediately bigger helix 4". (The other faces of the two helices 4' and 4", i.e. the internal face 43' of the smallest helix 4' and the external face 44" of the immediately biggest helix 4" are inactive, i.e. not activated by the external RF generator).

0082Similarly, if necessary, it is possible to destroy even bigger target volumes 100 by deploying and activating through the controlling means other helices 4"', 4""... , of bigger diameter as mentioned previously. So, the technical features of the device 1, and namely the number of helices 4' , 4" , 4"' , , 4"" , ... in the device 1, depend on the conception of said device 1 and can be adapted according to one or more target organs and their anatomical characteristics and specificities.

0083It is thus possible to adapt the diameter of the helix to the volume of the target volume by selecting the appropriate external helix.

0084In practice, the use of the device and assembly according to the invention can be done according to a process comprising the following steps, in the embodiment wherein the controlling means comprise a micro-robot.

0085Before the surgery, the robot orders the 3D navigation system to take informations such as images about the tumor and target organ. Said informations are treated by the robot (controlling means) so as to determine a surgical protocol (sequence in time of movements of the device 1, number of helices to be protruding, definition of the second and first poles, intensity and length of the activation of the electrode, ...) according to parameters including anatomical features (position, shape, size, ...) of the tumor and organ to be treated.

0086During the surgery, the surgeon introduces the medical device in rest configuration inside the patient using the 3D-navigation system which allows the monitoring in real time of the position of both the medical device and the target organ. Once the target organ is reached, the surgeon positions approximately the medical device relatively to the target organ and starts the automatic operating of the robot according to the predefined surgical protocol. The surgeon lets the robot operating but he has the possibility to monitor the whole surgical procedure through the navigation system.

0087Using its robotic arm 6 the robot readjust the position of the device, which is still in rest configuration, relatively to the target organ and namely the precise positionning of the stabilizing means 3 at the outer surface of the target organ so as to align the main axis X of the medical device 1 with the tumoral region 100 to be destroyed by heating.

0088The stabilizing device 3 thus gives to the navigation system an important fixed point and allows an easier penetration of the electrode 10 into the patient's skin or organ's surface.

0089The robot then orders the configuration change of the device into the working configuration, with the deployment of the needle 5 until it reaches the tumor or tumoral region center and the deployment of the smallest helix 4' in such a manner that said helix 4' may wrap the tumor or tumoral region 100 to be destroyed. The actuators responsible for this deployment and the degrees of freedom have been described above.

0090The robot then activates the poles of the electrode 10 as described above in the first case.

0091When the tumor or tumoral region 100 is bigger than the diameter of the smallest helix 4', the robot orders the deployment of one or more additional helices 4"' , 4''', 4"", ... so as to completely wrap the tumoral region to be destroyed by heating. The activation of the helices is done as in the second case described above.

0092The tumoral regions wrapped by the helical cage-like helices 4', 4" , 4"', ... of the electrode 10 are thus destroyed by heating, with no damage to surrounding tissues and only a few penetration points in the patient's skin or on the surface of the organ (the prostate, kidneys, adrenal glands, lungs, etc...). The present device 1 thus requires a minimally invasive intervention.

0093It should be noted that the robot 1 with its robotic arm 6 is provided with securing means activatable in case of abnormalities for interrupting the working of the robotic system so that the surgeon may continue manually the surgical procedure.

0094In this manner, the medical device of the present invention offers all the guarantees of security for the patient.

0095As illustrated hereabove, the medical device 1 according to the present invention thus offer undeniable advantages over the state of the art.