Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/042—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating using additional gas becoming plasma
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/44—Applying ionised fluids

Definitions

• the invention relates to a tool for a medical plasma treatment device.
• Such a tool can be used equally well on a patient (human) or on an experimental model (animal).
• Such a tool can be used in numerous branches of medicine such as, and without limitation, in otorhinolaryngology, in pneumology, in gastroenterology (upper part and lower part of the digestive system and for example esophagus, stomach, pancreas, large intestine , small intestine, duodenum, biliary tree ...), in laparoscopy, in gynecology (including obstetrics), in dermatology, in orthopedics ...
• Such a tool can be used for many medical applications such as, and in a non-limiting way, oncological application (anti-tumor effect for example), decontamination of fluid and/or natural cavity and/or cellular tissues and/or 'organs ..., fight against stenosis (particularly in the bile ducts), fight against atresia, aid in blood coagulation, surface chemical activation, coating, stimulation or regeneration of cellular tissues and/or organs , chemical functionalization, ...
• Such a tool can be implemented to apply a plasma directly to a given area to be treated and/or indirectly via a solution (liquid and/or gaseous) applied to the area to be treated, the solution being or having been previously treated with plasma.
• the invention also relates to a device comprising such a tool.
• Plasma is considered a state of matter in the same way as liquid, solid and gas. This “fourth state” can be obtained by ionization of a gas subjected to an electric field or even brought to high temperature.
• An object of the invention is to propose a tool for a medical treatment device which is totally secure vis-à-vis a patient (or an experimental model) and a practitioner.
• An object of the invention is also to provide a medical treatment device incorporating such a tool.
• the tool comprising at least one instrument.
• the instrument comprises at least from the inside outwards:
• the instrument further comprising at least one counter-electrode arranged externally to the internal dielectric screen.
• the inventors were able to observe that the instrument thus described allowed good insulation of the supply electrode vis-à-vis an external environment, which made it possible to protect a patient (or experimental model) treated by such a tool. as well as a practitioner handling the tool.
• the supply electrode is a metal wire.
• the supply electrode is polarized and the counter-electrode is a grounding electrode.
• the instrument comprises at least one additional layer.
• the additional layer is chosen from:
• the external dielectric screen is said to be “external” as opposed to the other internal dielectric screen which is always arranged closer to the center of the instrument.
• the additional layer is a spacer layer which is arranged on the internal dielectric screen or on the counter-electrode.
• the instrument comprises two additional layers, namely an external dielectric screen and a spacer layer, the spacer layer being arranged between the internal dielectric screen and the sheath.
• the spacer layer is composed of a plurality of spacer rings which are independent of each other.
• the internal dielectric shield covers a distal end of the feed electrode.
• At least one cap arranged at the distal end of the instrument in order to guide a passage of the plasma from the inside of the instrument to the outside of the instrument in service.
• the cap is an integral part of the counter-electrode, thus forming the distal end of said counter-electrode.
• the cap has at least one zone with a hydrophobic surface.
• At least the distal end of the counter-electrode is shaped like a cylinder.
• the tool comprises a needle arranged on a distal part of the tool.
• the tool can thus be used for percutaneous treatment, by directly introducing its distal part provided with a needle into the body of the patient (or experimental model) which - de facto - does not require the use of an endoscope.
• the invention also relates to a medical treatment device comprising an applicator in which at least one duct is formed, the tool as mentioned above being arranged so that at least its instrument extends in said duct.
• the tool can be installed in existing commercial applicators.
• the invention also relates to a method of medical treatment implemented using a tool as mentioned above, comprising the steps of approaching the tool to an area to be treated and of generating a plasma by the tool in order to subjecting said area to be treated to said plasma.
• Figure 1 is a schematic view of a device according to a particular embodiment of the invention.
• FIG. 2a is a perspective view of a medical tool according to a first embodiment of the invention associated with the device shown in FIG. 1,
• Figure 2b is a radial sectional view of the tool shown in Figure 2a,
• Figure 2c is a sectional view, along a section plane parallel to an axial section plane, of the tool shown in Figure 2a,
• FIG. 3 shows possible variants of the tool shown in Figure 2a
• FIG. 4a Figure 4a is a perspective view of a medical tool according to a second embodiment of the invention associated with the device shown in Figure 1
• Figure 4b is a radial sectional view of the tool shown in Figure 4a
• FIG. 5 shows possible variants of the tool shown in Figure 4a
• Figure 6 shows different possibilities of conformations of a dielectric shield of a medical tool associated with the device shown in Figure 1.
• the medical treatment device 1 comprises an applicator which is here an endoscope
• the endoscope 2 comprises at least one main duct called the working duct crossing it right through between a proximal end 2a of the endoscope intended to be arranged outside a body 100 of a patient and a distal end 2b of the endoscope intended to be arranged in the patient's body 100 close to an area to be treated.
• distal end must be understood as being the end arranged on the distal end side 2b of the endoscope and “proximal end” as being the end arranged on the proximal end side 2a of the endoscope.
• the endoscope 2 can be introduced into the patient via a natural or artificial cavity 101 of the patient.
• the endoscope 2 is flexible enough to be able to deform in order to follow, if necessary, the natural path of the cavity 101 or of a channel 102 extending said cavity and in which it circulates (bile duct, digestive tract. ..).
• the endoscope 2 comprises three main ducts and two secondary ducts.
• the device 1 comprises a tool 10 capable of generating a plasma, the tool 10 comprising at least one instrument 11 which is arranged in one of the three main ducts 3 of the endoscope 2.
• Said duct 3 has a diameter for example between 1 and 66 millimeters, and for example between 2 and
• the duct 3 has a diameter of 4.2 millimeters (it being understood that this diameter must necessarily be large enough for the instrument
• the instrument 11 can be introduced therein and therefore necessarily greater than the external diameter of the instrument 11 - which will be that of the sheath or of the external dielectric screen of the instrument 11 in the embodiments described below).
• the instrument 11 is not attached (in any case not continuously over its entire length) to the duct 3.
• the tool 10 here comprises a single instrument 11.
• the tool 10 is here composed solely of said instrument 11.
• Instrument 11 extends coaxially with duct 3 of endoscope 2 in which it is arranged when endoscope 2 (and therefore instrument 11) extends in a straight direction.
• the instrument 11 is also flexible enough to be able to deform to follow the movement of the associated endoscope 2.
• Instrument 11 is a tubular instrument.
• the instrument 11 also extends axially in a general direction X.
• the instrument 11 extends more particularly here so that at least one of its axial ends protrudes from the endoscope 2.
• the tubular instrument 11 extends more particularly here so that its two axial ends protrude from endoscope 2.
• the distal end 11b of the instrument 11 thus extends out of the endoscope 2 (distal end 2b side of the endoscope 2) and the proximal end 11a of the instrument 11 extends out of the endoscope (proximal end side 2a of the endoscope 2).
• the device 1 also comprises a system for generating a plasma which comprises at least one gas supply source 4 and at least one electrical energy supply source 5, each of said sources being connected to the tool 10.
• the gas supply source 4 has for example the following parameters:
• a carrier gas chosen from helium, air, argon, neon, etc., and/or
• a carrier gas at a flow rate of between 0 and 10 liters per minute (according to standard temperature and pressure conditions taken at 25 degrees Celsius and 1 bar - CSTP) and preferably between 0.01 and 1 liter per minute and which is preferably 0.1 liter per minute, and/or
• the electrical energy supply source 5 has for example the following parameters:
• DC square, sinusoidal, triangular, sawtooth, etc.
• AC square, sinusoidal, triangular, sawtooth, etc.
• pulsed etc.
• a frequency voltage between 0 (not included) and 27.12 Megahertz and preferably between 100 Hertz and 10 kilohertz and which is preferably 1 kilohertz.
• the device 1 also comprises a system for evacuating the residual gas 6 not transformed into plasma and/or the generated plasma present in the tool 10 and/or the instrument 11, the residual gas evacuating system also being connected to tool 10.
• the device 1 can of course comprise one or more other additional elements such as for example a second electrical energy supply source 7 this time connected to the endoscope 2 or even a device for microfluidic control of the flow rate of the carrier gas and/or or secondary injected into the instrument 11.
• a second electrical energy supply source 7 this time connected to the endoscope 2 or even a device for microfluidic control of the flow rate of the carrier gas and/or or secondary injected into the instrument 11.
• the device 1 is advantageously designed to be able to operate according to several modes.
• a gas is injected into the instrument 11: the plasma generated in the instrument 11 then tends to propagate beyond the distal end 11b of the instrument 11 in the form of a feather ( "feather" in English) whose dimensions can be adapted by modifying, for example, the flow rate of the carrier gas and/or the distance between the distal end of the instrument and the area to be treated.
• a liquid and/or vapor solution for example a physiological medium, a pharmacological drug, etc.
• the solution is thus activated and/or treated by the plasma generated in the instrument 11 throughout the progression of the liquid solution in the instrument 11 before reaching the area to be treated.
• the instrument 11 of said tool 10 comprises at least from the inside outwards at least four layers:
• the supply electrode 12 is therefore a polarized electrode.
• the supply electrode 12 is made of an electrically conductive material and for example of a metal and for example based on or copper and/or aluminum.
• feed electrode 12 is a single wire.
• the supply electrode 12 is thus very simple in structure.
• the external diameter of supply electrode 12 is for example between 0.01 and 10 millimeters and preferably between 0.01 and 5 millimeters, and for example between 0.05 and 0.35 millimeters and for example between 0.1 and 0.3 millimeters.
• the supply electrode 12 is directly connected to the electrical energy supply source 4. Consequently, its electrical potential is not floating and depends only on the electrical characteristics of the electrical energy supply source. 4 which are otherwise known and perfectly controlled. Consequently, the supply electrode 12 is an electrode whose value is always known (and therefore not floating).
• the internal dielectric screen 13 is for example:
• the coating then also covering the axial ends of the supply electrode 12 (the internal dielectric screen 13 then having no specific shape as long as it does not is not affixed to the supply electrode 12).
• the supply electrode 12 is entirely arranged inside the internal dielectric screen 13: the plasma cannot therefore come into contact with said supply electrode 12 as well as the zone to be treated or the immediate environment of said zone (tissue, biological fluid, etc.). This limits the risk of the plasma transiting towards a thermal arc regime.
• the internal dielectric screen 13 is of course made of a dielectric material.
• the internal dielectric screen 13 is for example made of a natural or artificial rubber.
• the internal dielectric screen 13 is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.).
• the external diameter of the internal dielectric screen 13 is for example between 0.01 and 20 millimeters, and for example between 0.5 and 3 millimeters and for example between 1.0 and 1.1 millimeters (it being understood that this diameter is moreover necessarily greater than that of feed electrode 12).
• the sheath 16 is shaped like a tube open at its two axial ends.
• sheath 16 forms a support structure for the instrument 11.
• Sheath 16 is preferably made of a dielectric material.
• the sheath 16 is for example made of a natural or artificial rubber.
• the sheath 16 is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.).
• the outer diameter of the sheath 16 is for example between 0.4 and 46 millimeters, and for example between 1.2 and 4 millimeters and for example between 2.0 and 2.5 millimeters (it being understood that this diameter is necessarily greater than that of the lower layer which is directly adjacent).
• Counter electrode 14 is preferably a ground electrode.
• the counter-electrode 14 is a floating electrode.
• the counter-electrode 14 is for example made of metal.
• the counter-electrode 14 is optionally based on or made of copper and/or aluminum.
• the external diameter of the counter-electrode 14 is for example between 0.6 and 56 millimeters, and for example between 1.3 and 6 millimeters and for example between 2.2 and 2.7 millimeters (it being understood that this diameter is moreover necessarily greater than that of the lower layer directly adjacent to it).
• the instrument 11 comprises at least one additional layer arranged above the internal dielectric screen 13.
• the additional layer is for example chosen from:
• the instrument 11 comprises the two aforementioned additional layers.
• the spacer layer 17 is here arranged between the internal dielectric screen 13 and the sheath 16.
• the spacer layer 17 is for example shaped so that the radial distance separating the internal dielectric screen 13 from the sheath 16 is preferably between 10 micrometers and 10 millimeters and is preferably between 0.1 and 1 millimeters and is preferably between between 0.4 and 0.6 millimeters and is for example 0.5 or 0.45 millimeters.
• the external diameter of the spacer layer 17 is for example between 0.3 and 40 millimeters, and for example between 1 and 3.5 millimeters and for example between 1.6 and 1.9 millimeters (it being understood that this diameter is moreover greater than that of the lower layer which is directly adjacent to it).
• the spacer layer 17 is here composed of a plurality of spacer rings 18 which are independent of each other. Nevertheless, each of these rings 18 allows the same spacing between the internal dielectric screen 13 and the sheath 16 so that they jointly form a general spacer layer.
• Figure 2c makes it possible to better visualize said spacer layer 17.
• rings 18 are arranged at regular intervals around internal dielectric screen 13 in direction X.
• the distance (in direction X) separating two consecutive rings 18 is therefore the same between two pairs of different rings.
• the distance separating two consecutive rings 18 is for example less than 15 centimeters and preferably less than 10 centimeters.
• At least one of the rings 18 is made of a dielectric material.
• At least one of the rings 18 is for example made of a natural or artificial rubber.
• At least one of the rings 18 is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.).
• plastic material polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.
• the different rings 18 are identical to each other so that the following description of one of the rings 18 is also applicable to the other rings 18.
• the ring 18 is here composed of at least two independent elements from one another.
• the ring 18 is composed of four elements independent of each other.
• the ring 18 is generally shaped like a ring, each element forming a segment 19 of this ring.
• the four elements are preferably distributed circumferentially in a regular manner around the internal dielectric screen 13. Each element is arranged substantially at 90 degrees from each of the two elements of the same ring 18 framing it.
• each ring 18 is oriented in the same way with respect to the internal dielectric screen 13. Consequently, a segment of a ring 18 is necessarily aligned (in the direction X) with another segment of each of the other rings 18.
• the length of segment 19 (in direction X) is preferably between 0.2 millimeters and 100 millimeters, and preferably between 2 and 20 millimeters and preferably between 3 and 6 millimeters and is preferably 5 millimeters.
• the thickness of segment 19 is preferably between 10 micrometers and 10 millimeters and preferably between 0.1 and 1 millimeter and is preferably 0.5 millimeter.
• Each segment 19 can extend so as to have an outer periphery forming a sector with an angle of between 35 and 50 degrees and for example be 45 degrees.
• the external dielectric screen 15 is for example shaped like a tube which is open at its two axial ends or corresponds to a coating layer directly affixed to the counter-electrode 14 preferably covering the axial ends of said counter- electrode 14 (the external dielectric screen 15 then having no proper shape as long as it is not affixed to the counter-electrode 14).
• the outer dielectric screen 15 is of course made of a dielectric material.
• the outer dielectric screen 15 is for example made of a natural or artificial rubber.
• the external dielectric screen 15 is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.).
• the outer dielectric screen 15 is preferably transparent.
• the external diameter of the external dielectric screen 15 is for example between 0.8 and 66 millimeters, and for example between 2 and 10 millimeters and for example between 3.2 and 4 millimeters (it being understood that this diameter is moreover necessarily greater than that of counter electrode 14).
• the distance L1 along the direction X separating the distal face of the supply electrode 12 from that of the internal dielectric screen 13 is between 0 (the value 0 being excluded from the interval) and 20 millimeters, and preferably is between 0.5 and 5 millimeters, and preferably between 0.8 and 3 millimeters, and is for example 1 millimeter or 2.5 millimeters, and/or
• the distance L2 along the direction X separating the distal face of the internal dielectric screen 13 from the distal end of the sheath 16 is between 0 millimeters and 1 meter, and preferably is between 2 and 10 millimeters, and preferably between 4 and 7 millimeters, and is for example 5 millimeters.
• the distance L2 along the direction X separating the distal face of the internal dielectric screen 13 from that of the sheath 16 can be equal to zero for example and in a non-limiting manner for dermatological applications.
• the "supply electrode 12 and internal dielectric screen 13" assembly not being integral in the present case with the counter-electrode 14 and the sheath 16, the distance L2 can easily be modified during an intervention by the practitioner as needed.
• the counter-electrode 14 is shaped as a tube which is open at its two axial ends or else corresponds to a coating layer directly affixed to one of the layers which is immediately adjacent to it, in this case here the sheath 16.
• the distal end of the counter-electrode 14 is entirely arranged inside the external dielectric screen 15.
• the distance in the direction X separating the distal face of the counter-electrode 14 from that of the sheath 16 is between 0.01 and 100 millimeters , and for example between 1 and 20 millimeters and is for example 5 millimeters.
• the instrument 11 thus comprises, from the inside outwards, the following successive layers:
• the instrument 11 here only comprises these six layers.
• the different layers all extend coaxially with each other and in the X direction.
• the internal dielectric screen 13 extends coaxially to the supply electrode 12 directly around the latter.
• the spacer layer 17 extends coaxially with the internal dielectric screen 13 and directly around the latter.
• Sheath 16 extends coaxially with spacer layer 17 and directly around the latter.
• Counter-electrode 14 extends coaxially to sheath 16 directly around the latter.
• the outer dielectric screen 15 extends coaxially to the counter-electrode 14 directly around the latter.
• supply electrode 12 and the internal dielectric screen 13 are integral with each other.
• sheath 16, the counter-electrode 14 and the external dielectric screen 15 are integral with each other.
• the assembly formed by the supply electrode 12 and the internal dielectric screen 13 can however slide along the assembly formed by the sheath 16, the counter-electrode 14 and the external dielectric screen 15.
• the distal faces of the sheath 16 and of the external dielectric screen 15 are at the same level (in the direction X), and/or - the distal faces of the external dielectric screen 15 and of the counter-electrode 14 are not at the same level because the length of the counter-electrode 14 is preferably less than that of the external dielectric screen 15 (in the direction X ), and or
• the distal faces of the sheath 16 and of the counter-electrode 14 are not at the same level because the length of the counter-electrode 14 is preferably less than that of the sheath 16 (in the direction X).
• the supply electrode 12 is arranged inside the internal dielectric screen 13 whose distal end is itself closed and itself arranged inside the sheath 16 and/or the counter-electrode 14 and/or the external dielectric screen 15. distal faces of the sheath 16 and of the external dielectric screen 15; the latter two being preferably in the same plane.
• the supply electrode 12 is arranged inside the internal dielectric screen 13 whose proximal end is itself closed and itself arranged inside the sheath 16 and/or the counter-electrode 14 and/or the external dielectric screen 15. It is also noted that the proximal faces of at least the sheath 16, the counter- electrode 14 and the external dielectric screen 15 are preferably all at the same level. Consequently, the outer dielectric screen 15 and the sheath 16 here have the same length (in the direction X).
• the total length of the sheath 16 and/or of the counter-electrode 14 and/or of the external dielectric screen 15 is here between 0.05 millimeters and 5 meters, and preferably between 1 and 3 meters and preferably between 1.5 and 2.5 meters and is preferably 2 meters.
• the sheath 16 and the external dielectric screen 15 have the same length (in the direction X) ⁇
• the tool 10 and/or the associated device 1 comprises at least one guide wire 20 of the tool 10.
• Such a guide wire 20 facilitates the movement of the tool 10 in the body 100 of the patient, in particular if it is a question of passing the tool 10 in cavities of very small diameter.
• the guide wire 20 extends here through the entire instrument 11 so as to emerge outside the two ends of the instrument 11.
• the guide wire 20 extends in the instrument 11 in the space delimited between the internal dielectric screen 13 and the sheath 16. If the spacer layer 17 is present, then the guide cable passes through the interstices of this spacer layer 17.
• the guide cable 20 passes for example between two consecutive segments 19 of a same ring 18 and this for all the rings 18 of the spacer layer 17.
• gas supply source 4 like the gas evacuation system 6 are also connected in a delimited area between the internal dielectric screen 13 and the sheath 16.
• this space is very large (for example by going up to a radial distance between the internal dielectric screen 13 and the sheath 16 of 10 millimeters) it is possible to pass other elements than the cable guide 20 in the space delimited by the spacer layer 17 such as for example an endoprosthesis (or "stent" in English).
• an electric current is passed through the supply electrode 12 which will cause, by potential difference between the supply electrode 12 and the counter-electrode 14, the generation of a plasma at the inside the instrument 11 and/or outside the instrument 11 depending on the operating mode of the chosen device.
• the area to be treated is exposed to plasma for a time interval of between 0.01 second and 2 hours and preferably between 10 seconds and 30 minutes and preferably between 1 and 10 minutes.
• the first deviation which corresponds to the distance L1 has already been dealt with previously.
• the second deviation is for its part comprised between for example a few hundred microns and several centimeters.
• the plasma generated is advantageously a "cold plasma", that is to say a plasma out of thermodynamic equilibrium where the temperature of the electrons is much higher than that of the ions, itself higher than those of the neutral species. (atoms and molecules).
• the temperature of this cold plasma is in line with the patient's body.
• This plasma is generated at atmospheric pressure and therefore does not require any particular enclosure (for example vacuum). The inventors have thus been able to develop a prototype generating a plasma whose gas temperature is less than 40 degrees Celsius, thus facilitating its direct application to the human body.
• the device 1 and in particular the tool 10 thus described has electrical insulation making its use very safe for both the user and the patient. L. Finally, the tool 10 has little or no impact on the tissues surrounding the area to be treated.
• the plasma generated is said to be “volumic” because it can extend into the volume separating the internal dielectric screen 13 from the sheath 16, volume defined by the spacer layer 17. that the plasma generated is entirely contained in this volume (as far as the instrument is concerned), the plasma also being able to propagate out of the instrument 11 towards the zone to be treated.
• the tool 10 and/or the device 1 comprises at least one cap arranged at the distal end of the instrument 11. Referring to Figure 2a, without cap, the plasma spreads globally in the axial extension of the distal end 11b of the instrument 1.
• Figure 3 illustrates different possible cap shapes.
• the cap is preferably made of metal and for example copper and/or aluminum.
• the cap is physically in contact with the counter-electrode 14.
• the electric potential of the cap corresponds to that of the counter-electrode and can therefore be at ground potential or at a floating potential.
• the cap can be arranged at the level of the distal end 11b of the instrument or on the contrary extend the latter. In this case, the cap extends coaxially to the instrument 11 and therefore to the X direction.
• the distal end of the cap may have a flat or rounded distal face.
• the distal face is rounded.
• the distal face is shaped like a dome and especially like a half-dome.
• the distal face is optionally shaped into a geodesic dome.
• the cap may include at least one mesh area and/or at least one solid area (i.e. without a hole or orifice other than this possibly present to allow the guide wire to pass).
• the mesh area has a regular mesh.
• the grid can be a network in one dimension (for example formed only of rings or only of branches) or in two dimensions (the grid then being formed of an intersection between rings and branches).
• the rings are preferably coaxial with the X direction.
• the branches are preferably coaxial with the X direction.
• the rings preferably extend at regular intervals from each other and/or coaxially to each other and/or are identical to each other.
• the branches preferably extend at regular intervals from each other and/or parallel to each other and/or are identical to each other.
• the distance separating two consecutive branches is for example between 1 micrometer and 5 millimeters and preferably between 50 and 750 micrometers and is preferably 250 micrometers.
• the distance separating two consecutive rings is for example between 1 micrometer and 5 millimeters and preferably between 50 micrometers and 750 micrometers and for example 250 micrometers.
• the cap it is thus possible to adapt the shape of the plasma pen to the type of intended application. It is in particular possible to project the plasma radially to directly treat the internal wall of the channel 102 and/or that of the cavity 101 into which the endoscope 2 is introduced.
• the cap 21a is simply arranged at the level of the distal end 11b of the instrument 11. At least the portion of the cap 21a outside the instrument 11 is screened and is moreover shaped like a dome.
• the cap 21b is arranged to extend the distal end 11b of the instrument 11.
• the portion of the cap 21b outside the instrument 11 comprises a solid cylindrical section which is extended by a completely meshed distal end and moreover shaped like a dome.
• the cap 21c is arranged to extend the distal end 11b of the instrument 11.
• the portion of the cap 21c outside the instrument 11 comprises a meshed cylindrical section which is extended by a solid distal end and otherwise shaped like a dome.
• the cap 21d is arranged to extend the distal end 11b of the instrument 11.
• the portion of the cap 21d outside the instrument 11 comprises a meshed cylindrical section which is extended by a meshed distal end and is also shaped like a dome.
• the instrument 11 of said tool 10 comprises at least from the inside outwards at least four layers:
• the supply electrode 12 is therefore a polarized electrode.
• the supply electrode 12 is made of an electrically conductive material and for example of a metal and for example based on or copper and/or aluminum.
• feed electrode 12 is a single wire.
• the supply electrode 12 is thus very simple in structure.
• the external diameter of the supply electrode 12 is for example between 2 micrometers and 10 millimeters and for example between 2 micrometers and 2 millimeters, and for example between 50 and 350 micrometers and for example between 100 and 150 micrometers and is example of 100 micrometers.
• the supply electrode 12 is directly connected to the electrical energy supply source 4. Consequently, its electrical potential is not floating and depends only on the electrical characteristics of the electrical energy supply source. 4 which are also known and perfectly controlled. Consequently, the supply electrode 12 is an electrode whose value is always known (and therefore not floating).
• the internal dielectric screen 13 is for example:
• the coating corresponds to a coating directly affixed to the supply electrode 12, the coating then also covering the axial ends of the supply electrode 12 (the internal dielectric screen 13 then having no specific shape as long as it is not affixed to the supply electrode 12).
• the supply electrode 12 is entirely arranged inside the internal dielectric screen 13: the plasma cannot therefore come into contact with said supply electrode 12 as well as the zone to be treated or the immediate environment of said zone (tissue, biological fluid, etc.). This makes the instrument very safe to use for both practitioner and patient.
• the distance along the direction X separating the distal face of the supply electrode 12 from that of the internal dielectric screen 13 is between 0 (the value 0 being excluded from the interval) and 20 millimeters, and preferably is between 0.5 and 5 millimeters, and preferably between 0.8 and 3 millimeters, and is for example 1 millimeter or 2.5 millimeters, and/or
• the distance along the X direction separating the distal face of the internal dielectric screen 13 from the distal end of the sheath 16 is between 0 millimeters and 1 meter, and preferably is between 2 and 10 millimeters, and preferably between 4 and 7 millimeters, and is for example 5 millimeters.
• the distance along the direction X separating the distal face of the internal dielectric screen 13 from that of the sheath 16 can be equal to zero for example and in a non-limiting manner for dermatological applications.
• the "supply electrode 12 and internal dielectric screen 13" assembly not being integral in the present case with the counter-electrode 14 and the sheath 16, the distance separating them can easily be modified during an intervention. by the practitioner as needed.
• the internal dielectric screen 13 is of course made of a dielectric material.
• the internal dielectric screen 13 is for example made of a natural or artificial rubber.
• the dielectric screen internal 13 is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.).
• the external diameter of the internal dielectric screen 13 is for example between 0.01 and 30 millimeters, and for example between 2 and 3.6 millimeters and for example between 2.5 and 3 millimeters and is for example 2.8 millimeters (it being understood that this diameter is moreover necessarily greater than that of the supply electrode 12).
• Counter electrode 14 is preferably a ground electrode. As a variant, the counter-electrode 14 is a floating electrode.
• the counter-electrode 14 is for example made of metal.
• the counter-electrode 14 is optionally based on or made of copper and/or aluminum.
• the counter-electrode 14 is shaped like a tube which is open at its two axial ends or else corresponds to a coating layer directly affixed to one of the layers which is immediately adjacent to it, in this case the internal dielectric screen 13 without covering the distal ends of said layer (the counter-electrode 14 then having no specific shape as long as it is not affixed to said lower layer).
• the external diameter of the counter-electrode 14 is for example between 0.3 and 36 millimeters, and for example between 1.4 and 3.6 millimeters and for example between 2.5 and 3.5 millimeters and is for example 3 millimeters (it being understood that this diameter is elsewhere necessarily higher than that of the lower layer which is directly adjacent to it).
• the distal end of the counter-electrode 14 can however be shaped differently in order to modify this propagation as can be seen in FIG. 5.
• the distal end of counter-electrode 14 may have a flat or rounded distal face.
• the distal face is rounded.
• the distal face is shaped like a dome and especially like a half-dome.
• the distal face is optionally shaped into a geodesic dome.
• the distal end of the counter-electrode 14 may comprise at least one gridded area and/or at least one solid area (i.e. without a hole or orifice other than this possibly present to allow a guide wire 20 to pass which will be described later ).
• the mesh area has a regular mesh.
• the mesh can be a one-dimensional network, formed for example of branches, or two-dimensional (the mesh then being formed of an intersection between rings and branches).
• the rings are preferably coaxial with the X direction.
• the branches are preferably coaxial with the X direction.
• the rings preferably extend at regular intervals from each other and/or coaxially to each other and/or are identical to each other.
• the branches preferably extend at regular intervals from each other and/or parallel to each other and/or are identical to each other.
• the distance separating two consecutive branches is for example between 1 micrometer and 5 millimeters and preferably between 50 and 750 micrometers and is preferably 250 micrometers.
• the distance separating two consecutive rings is for example between 1 micrometer and 5 millimeters and preferably between 50 micrometers and 750 micrometers and for example 250 micrometer.
• the distal end of the counter-electrode 14 it is thus possible to adapt the shape of the plasma pen to the type of intended application. It is in particular possible to project the plasma radially to directly treat the internal wall of the channel 102 and/or those of the cavity 101 into which the endoscope 2 is introduced.
• the distal end of the counter-electrode 14 has a gridded zone whose length (in the direction X) is preferably between 1 millimeter and 2 meters and preferably between 1 and 10 centimeters and is preferably 5 centimeters .
• the mesh zone begins here at the level of the distal face.
• the length of counter-electrode 14 (in direction X) outside said gridded zone is preferably between 0.1 meter and 50 meters, and is preferably between 1.5 and 2 meters and is preferably 1.95 meters.
• the distal face is domed.
• the entire distal end is screened in a two-dimensional screen.
• the distal face is domed. The entire distal end is meshed according to a two-dimensional mesh apart from the distal face which is solid.
• the distal face is flat. The entire distal end is meshed according to a two-dimensional mesh apart from the distal face which is solid.
• the distal face is domed.
• the entire distal end is screened in a one-dimensional screen.
• the distal face is flat.
• the entire distal end is screened in a one-dimensional screen apart from the distal face which is solid.
• the distal face is flat.
• the entire distal end is meshed according to a one-dimensional mesh including the distal face.
• the sheath 16 is for example shaped as a tube which is open at its two axial ends.
• sheath 16 forms a supporting structure for the instrument.
• the sheath 16 is preferably made of a dielectric material.
• the sheath 16 is for example made of a natural or artificial rubber.
• the sheath 16 is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.).
• Sheath 16 is preferably transparent.
• the sheath 16 is for example between 0.9 and 56 millimeters, and for example between 1.9 and 8 millimeters and for example between 3.5 and 4.5 millimeters and is for example 4 millimeters (it being understood that this diameter is moreover necessarily greater than that of counter electrode 14).
• the instrument 11 comprises at least one additional layer arranged between the internal dielectric screen 13 and the sheath 16.
• the additional layer is for example a spacer layer 17.
• the spacer layer 17 is here arranged between the counter-electrode 14 and the sheath 16
• the outer diameter of the spacer layer 17 is for example between 0.8 and 46 millimeters, and for example between 1.6 and 7 millimeters and for example between 0.3 and 0.4 millimeters and is for example 3.8 millimeters (it being understood that this diameter is also higher than that of the lower layer which is directly adjacent to it).
• the spacer layer 17 is here composed of a plurality of spacer rings which are independent of each other. Nevertheless, each of these rings allows the same spacing between the counter-electrode 14 and the sheath 16 so that they jointly form a general spacer layer 17 .
• the rings are arranged at regular intervals around counter-electrode 14 in direction X.
• the distance (in direction X) separating two consecutive rings is therefore the same between two pairs of different rings.
• the distance separating two consecutive rings is for example less than 15 centimeters and preferably less than 10 centimeters.
• At least one of the rings is made of a dielectric material. At least one of the rings is for example made of a natural or artificial rubber. At least one of the rings is for example made of plastic material (polyvinylidene fluoride, polytetrafluoroethylene, perfluoroalkoxy, etc.). Preferably the different rings are identical to each other so that the following description of one of the rings is also applicable to the other rings.
• the ring is here composed of at least two independent elements from one another.
• the ring is made up of four elements independent of each other.
• the ring is generally shaped like a ring, each element forming a segment of this ring.
• the four elements are preferably distributed circumferentially in a regular manner around the counter-electrode 14.
• Each element is arranged substantially at 90 degrees from each of the two elements of the same ring framing it.
• each ring is oriented in the same way with respect to the counter-electrode 14. Consequently, a segment of a ring is necessarily aligned (in the direction X) with another segment of each of the other rings.
• the length of the segment (in the X direction) is preferably between 0.2 millimeters and 100 millimeters, and preferably between 2 and 20 millimeters and preferably between 3 and 6 millimeters and is preferably 5 millimeters.
• the thickness of the segment is preferably between 10 micrometers and 10 millimeters and preferably between 0.1 and 1 millimeter and is preferably 0.5 millimeter.
• Each segment can extend so as to have an outer periphery forming a sector with an angle of between 35 and 50 degrees and for example be 45 degrees.
• the instrument 11 thus comprises, from the inside outwards, the following successive layers:
• the instrument 11 here comprises only these five layers.
• the different layers all extend coaxially with each other and in the X direction.
• the internal dielectric screen 13 extends coaxially to the supply electrode 12 directly around the latter.
• the counter-electrode 14 extends coaxially with the internal dielectric screen 13 while being attached to the latter.
• the spacer layer 17 extends coaxially to the counter-electrode 14 while being attached to the latter.
• Sheath 16 extends coaxially with spacer layer 17 directly around the latter.
• supply electrode 12 and the first dielectric screen 13 and the counter-electrode 14 are integral with each other.
• the supply electrode 12 is arranged inside the internal dielectric screen 13 whose distal end is closed and itself arranged inside of the sheath 16 and/or of the counter-electrode 14.
• the distal faces of the sheath 16 and of the counter-electrode 14 are not preferentially not at the same level (in direction X) and open (preferably counter-electrode 14 is in fact arranged inside sheath 16).
• proximal faces of at least the sheath 16 and the counter-electrode 14 are preferably not at the same level, preferably the counter-electrode 14 is indeed arranged inside the sheath 16. Consequently these two layers do not have the same length (along the X direction).
• the total length of the sheath 16 and/or of the counter-electrode 14 (in the direction X) is here between 0.05 millimeters and 5 meters, and preferably between 1 and 3 meters and preferably between 1.5 and 2.5 meters and is preferably 2 meters. In the present case, the sheath 16 and the counter-electrode 14 do not have the same length (in the direction X).
• the tool 10 and/or the associated device 1 comprises at least one guide wire 20 of the tool 10.
• Such a guide wire 20 facilitates the movement of the tool 10 in the body 100 of the patient, in particular if it is a question of passing the tool 10 in cavities of very small diameter.
• the guide wire 20 extends here through the entire instrument 11 so as to emerge outside the two ends of the instrument 11.
• the guide wire 20 extends in the instrument 11 in the space delimited between the counter-electrode 14 and the sheath 16. If the spacer layer 17 is present, then the guide wire passes through the interstices of this spacer layer 17.
• gas supply source 4 like the gas evacuation system 6 are also connected in the space delimited between the counter-electrode 14 and the sheath 16.
• an electric current is passed through the supply electrode 12 which will cause, by potential difference between the supply electrode 12 and the counter-electrode 14, the generation of a plasma at the inside the instrument 11 and/or outside the instrument 11 depending on the mode of operation of the device 1 chosen.
• the area to be treated is exposed to plasma for a time interval of between 0.01 second and 2 hours and preferably between 10 seconds and 30 minutes and preferably between 1 and 10 minutes.
• the first discrepancy has already been dealt with previously.
• the second deviation is for its part comprised between for example a few hundred microns and several centimeters.
• the device 1 and in particular the tool 10 thus described allows a targeted application of a plasma on a patient.
• the plasma generated is advantageously a "cold plasma", that is to say a plasma out of thermodynamic equilibrium where the temperature of the electrons is much higher than that of the ions, itself higher than those of the neutral species. (atoms and molecules).
• the temperature of this cold plasma is in line with the patient's body.
• This plasma is generated at atmospheric pressure and therefore does not require any particular enclosure (for example vacuum). The inventors were thus able to develop a prototype generating a plasma whose gas temperature is less than 40 degrees Celsius, thus facilitating its direct application to the human body.
• the device 1 and in particular the tool 10 thus described has electrical insulation making its use very safe for both the user and the patient. L. Finally, the tool 10 has little or no impact on the tissues surrounding the area to be treated.
• the plasma generated is said to be “surface” because it can extend into the space separating the supply electrode 12 from the counter-electrode 14, a space of small dimensions because the counter-electrode 14 is attached directly to the internal dielectric screen 13 itself attached directly to the supply electrode 12.
• the plasma propagates generally only along the counter-electrode 14. It is noted that the generated plasma is entirely contained in this space (as far as the instrument is concerned), the plasma being able moreover to propagate out of the instrument 11 towards the zone to be treat.
• At least one of the layers may have at least one distal end shaped other than as a straight cylinder (when at least the distal end of the instrument extends in the direction X).
• the internal dielectric screen 13 is always shaped like a right cylinder.
• the internal dielectric screen 13 can however be shaped differently.
• the distal end 13b of the internal dielectric screen 13 is rounded.
• the distal end 13b of the internal dielectric screen 13 thus substantially forms a dome at least at its distal face.
• the rest of the internal dielectric screen 13 is shaped like a straight cylinder.
• the internal dielectric screen 13 has successively from its proximal end to its distal end:
• proximal section including the proximal end, shaped like a straight cylinder
• connection section 30 between the proximal section and the rounded distal end, the connection section 30 forming a clearance.
• the internal dielectric screen 13 thus locally has a section narrowing between the proximal section and the distal end 13b at the level of its connection section 30.
• This narrowing is formed by a rounding provided in the internal dielectric screen 13.
• the narrowing is thus shaped into a groove of considerable length (in the direction X).
• the maximum diameter of the distal end 13b is substantially equal to that of the proximal section.
• the internal dielectric screen 13 has successively from its proximal end to its distal end 13b:
• proximal section including the proximal end, shaped like a straight cylinder
• a rounded distal end 13b (for example substantially forming a dome at least at its distal face),
• the internal dielectric screen 13 thus locally has a section narrowing between the proximal section and the distal end 13b at the level of the connection section 31.
• the narrowing 30 is formed at its two longitudinal ends (in the direction X) by two straight connectors, one with the proximal section, the other with the end distal 13b rounded.
• the narrowing is thus shaped into a groove of significant length (in the X direction)
• the maximum diameter of the distal end 13b is substantially equal to that of the proximal section.
• the distal end 13b is shaped here in a half-dome whose base is attached to the connecting section 30.
• the internal dielectric screen 13 has successively from its proximal end to its distal end:
• proximal section including the proximal end, shaped like a straight cylinder
• a rounded distal end 13b (for example substantially forming a dome at least at its distal face),
• connection section 31 between the proximal section and the rounded distal end 13b, the connection section 31 comprising a succession of grooves and/or grooves along the direction X.
• the grooves and/or the grooves are of small dimensions but are more numerous.
• the grooves and/or the grooves are preferably all identical to one another and/or arranged at regular intervals along the direction X.
• the internal dielectric screen 13 has successively from its proximal end to its distal end 13b:
• proximal section including the proximal end, shaped like a straight cylinder, - a rounded distal end 13b (for example substantially forming a dome at least at its distal face),
• connection section between the proximal section and the rounded distal end, the connection section being shaped like a thread and therefore being externally threaded.
• the device may include other elements than what has been indicated, such as one or more other tools inserted into the applicator (biopsy tool, camera-type observation tool, illumination tool, etc.). in addition to the tool described dedicated to the generation of a plasma.
• tools inserted into the applicator biopsy tool, camera-type observation tool, illumination tool, etc.
• the spacer layer may be different from what has been indicated.
• the spacer layer may be in one piece or may be formed from a different number of elements than what has been indicated.
• the spacer layer may comprise at least two spacer rings which are different from one another and/or spaced apart differently from another pair of spacer rings. At least one of the rings may be in one piece or may be formed from a different number of elements from what has been indicated.
• the ring may thus be formed of two elements interconnected, for example by a ring with a diameter smaller than that of the outer elements.
• the cap It is also possible to protect the distal end of the instrument, for example by covering said end at least in part with a tip made of a hydrophobic material in order to limit the risk of penetration of a fluid inside the instrument.
• the cap and/or the distal end of the counter-electrode could directly form this tip by being made of a hydrophobic material. If there is a tip and a cap, it is possible to place one outside the other. Of course, in the event of the existence of a tip and a cap, care will be taken to ensure that the tip always allows the plasma to pass to the outside.
• each of the layers described may be formed by depositing a coating on the immediately adjacent lower and/or upper layer or by a tube of the pipe type, at least one of said layers may be formed otherwise.
• at least one of the layers could be formed by winding a wire around the immediately adjacent lower layer. The wire will of course be wound very tightly in order to limit the space between the turns as much as possible and thus form a uniform layer.
• the counter-electrode could be formed in this way (for the two embodiments described) by winding a metal wire.
• the distal end of the counter-electrode of the first embodiment may be shaped as in the second embodiment and/or the instrument of the second embodiment may comprise a cap as in the first embodiment. If a distal face is not planar, the distance taken between said face and another point will be considered implicitly as being taken at the most distal point of said face and the other point.
• the tool is shaped to be able to be used with an endoscope, the tool could be shaped otherwise.
• the tool will include at least one needle.
• the needle will have an outer diameter between 1 and 5 mm and an inner diameter between 20 ⁇ m and 3 mm.
• the needle will be made of metal.
• the needle will then be connected to a distal end of the tool.
• the needle can thus be connected to the counter-electrode 14 and in particular to its distal end. This needle will make it possible to use the tool no longer according to the endoscopic approach as previously described but according to the percutaneous approach.
• This needle will be shaped to allow the plasma to reach the area to be treated.
• the needle will be hollow.

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• 2021
  • 2021-04-28 EP EP21728271.4A patent/EP4329653A1/de active Pending
  • 2021-04-28 US US18/287,328 patent/US20240198121A1/en active Pending
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