EP2341862A1 - Appareil et procede de traitement d'une partie de corps humain ou animal mettant en oeuvre des moyens de delivrance de doses de traitement et des moyens de contrôle de dosimetrie - Google Patents
Appareil et procede de traitement d'une partie de corps humain ou animal mettant en oeuvre des moyens de delivrance de doses de traitement et des moyens de contrôle de dosimetrieInfo
- Publication number
- EP2341862A1 EP2341862A1 EP09814145A EP09814145A EP2341862A1 EP 2341862 A1 EP2341862 A1 EP 2341862A1 EP 09814145 A EP09814145 A EP 09814145A EP 09814145 A EP09814145 A EP 09814145A EP 2341862 A1 EP2341862 A1 EP 2341862A1
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- EP
- European Patent Office
- Prior art keywords
- treatment
- instrument
- doses
- human
- during
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
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- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
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- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/203—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
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- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
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- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
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Definitions
- the present invention relates to the field of treatment of the human or animal body by means of an instrument which makes it possible to locally deliver treatment doses to a part of a human or animal body.
- the invention relates more particularly, but not exclusively, to the field of the treatment of a part of the human or animal body by cutaneous, subcutaneous or intra-cutaneous irradiation using electromagnetic radiation, the doses of corresponding treatment in this case the energies of said electromagnetic radiation delivered to different positions of the instrument in the area or volume treated.
- the treatment may be a therapeutic, prophylactic or cosmetic treatment of non-invasive type, or be an invasive therapeutic, prophylactic or cosmetic treatment, for example subcutaneous or intra-cutaneous, such as for example adipocytolysis, lipolysis, endovenous treatments, remodeling, scarring of the skin by heating collagen present in the dermis, liposuction.
- a treatment dose is locally delivered to a human or animal body part, for cosmetic, therapeutic or prophylactic purposes of said human or animal body part, and using a specific medical instrument, still commonly referred to as "handpiece", and adapted in particular to the nature of the doses of treatment to be delivered.
- the treatment dose may be for example a dose of electromagnetic radiation; in this case, the dose delivered corresponds to the energy of the electromagnetic radiation applied to a given position of the instrument in a zone or volume of treatment.
- the treatment dose may be for example a dose of a substance or chemical administered locally to said human or animal body part; in this case, the dose delivered corresponds to the quantity of substance or chemical administered at each position of the instrument.
- the electromagnetic radiation is introduced into the dermis or under the dermis, to the zone or volume to be treated, for example by means of a hollow needle or a cannula, in which is introduced an optical fiber connected to a suitable source of electromagnetic radiation, for example a laser.
- the treatment is then carried out continuously or discontinuously on the cannula / optical fiber or needle / optical fiber assembly, and by actuating the laser source, so as to fire lasers at different positions of the laser. distal end of emission of the optical fiber during the continuous or discontinuous movement of removal of the assembly cannula / optical fiber or needle / optical fiber.
- adipocytolysis and lipolysis which consist in treating, in particular by thermal effects, the fat cells present.
- adipocytolysis and lipolysis which consist in treating, in particular by thermal effects, the fat cells present.
- the hypodermis by introducing into the hypodermis, at different depths, the distal end of the optical fiber through which the electromagnetic radiation emerges.
- Lipolysis allows destruction of adipocytes under the effect of electromagnetic radiation. This destruction results in a liquefaction of the fat in the areas near the passage of the optical fiber, where the temperature is mounted sufficiently high (50-70 0 C) to destroy the membranes of adipocytes and release the triglycerides.
- adipocytolysis is used to describe the medium and long-term effect of temperature rise on adipocytes. Indeed in areas further from the passage of the optical fiber, the temperature rise is lower (40-50 0 C). However, these temperatures induce a thermal stress in the adipocytes which will trigger apoptosis of the adipocytes in the months following the treatment. This progressive cell death thus causes a loss of volume in the treated fatty tissue which reaches its maximum 6 to 8 months after the intervention. In this particular type of invasive treatment, adipocytolysis is the major effect of electromagnetic radiation and lipolysis is only a small contribution to the reduction of fat volume.
- invasive treatments there may also be mentioned treatments for obtaining a tissue retraction by delivering doses of electromagnetic radiation under the dermis.
- non-invasive type of treatments all the therapeutic, prophylactic or cosmetic treatments involving external irradiation of a part of the human or animal body by electromagnetic radiation, for example by means of an exo-laser, are known in particular.
- electromagnetic radiation for example by means of an exo-laser
- all thermal treatments of the skin of the non-invasive type are concerned.
- the therapeutic, prophylactic, or cosmetic effect depends on the doses of treatment that are actually delivered to the human or animal body part, but also on the location and distribution of these doses. These treatments are so called dose-dependent. Underdosing may make the therapeutic, prophylactic, or cosmetic treatment less effective or even ineffective. Conversely, an overdose can lead to irreversible damage in the treated area and for example cause irreversible and damaging destruction of certain healthy tissues or healthy cells. Overdose or under dosing does not depend solely on the dose delivered at each position of the instrument, but depends on also the location and distribution of these doses. The location and distribution of doses depends on how the practitioner handles the instrument being treated.
- a major difficulty of the treatments by local electromagnetic irradiation (external or internal) of a part of human or animal body is related to the risks of irreversible destruction by thermal effect of non-targeted cells in the treated area, or even in a zone contiguous to the treated area.
- This risk depends not only on the power and the wavelength of the electromagnetic radiation, but also and especially on the speed at which the electromagnetic irradiation spot is displaced in the area to be treated.
- this last speed of movement parameter is most often dependent on a manual human action implemented by the practitioner carrying out the treatment, and is therefore an important source of risk.
- a laser lipolysis solution in which the laser beam is introduced into the hypoderm by means of a cannula / optical fiber assembly.
- An objective in this publication is to protect the dermis against the destructive thermal effects of the laser beam by ensuring that the distal end of the optical fiber, when fired, is not located in the dermis, but is located in the hypodermis far enough away of the dermis.
- we control the depth of the laser shot by detecting by means of an external optical sensor the intensity of the light energy of the shot, which passes through the different layers (hypoderm, dermis, epidermis), and which is visible by the sensor from the outside. The higher the intensity, the lower the depth of laser fire.
- This solution does not allow a location of the area actually treated in a frame linked to the human or animal body, and does not allow to know the distribution of energy doses in the area actually treated.
- a handpiece comprising an optical fiber which is connected to a laser source, and which allows a treatment with electromagnetic irradiation of an external part of a human body.
- This handpiece is further equipped with optical detection means for detecting the absolute position of the handpiece or for detecting variations in certain positioning parameters of the handpiece, such as variations in position, variations inclination or variations in the speed of movement of the handpiece. This information is used for example for an automatic control of the power of the laser.
- the information on the absolute position of the handpiece or on the variations of the positioning parameters of the handpiece does not make it possible to locate the zone actually treated in a reference frame related to the human or animal body, and therefore can not be used to control that the area or volume that was to be treated was actually treated with the correct doses of treatment.
- Such visual control of the positioning of the handpiece is possible in the case of a non-invasive treatment, but is not suitable for a treatment implemented by means of an invasive instrument.
- the practitioner can not easily visually control the position at each moment during treatment of his instrument in the area or volume treated. It is therefore impossible for him visually to reliably control the location of the different doses that are delivered. There is therefore a need for a technical solution to guide the practitioner's gesture during an invasive treatment so that he can ensure that he delivers the treatment doses to the right place in the area where in the volume to be treated.
- One solution for guiding the practitioner's gesture during an invasive treatment could be to practice the gesture by controlling it with an MRI-type medical imaging system.
- this type of solution requires the use of a medical imaging device very expensive and bulky, which limits its deployment.
- An object of the invention is to propose a new technical solution which makes it possible to facilitate and improve the control of the treatment doses which are delivered to a part of a human or animal body, and which can be implemented with any type of treatment.
- means for delivering treatment doses used in a dose-dependent treatment that is to say both with means for delivering invasive or non-invasive type of treatment doses.
- the subject of the invention is thus an apparatus for treating a human or animal body part having the technical features referred to in claim 1.
- This treatment apparatus comprises:
- locating means which make it possible to identify and delimit spatially in a predefined reference frame (Rt) and in the form of registration data (Pi), a zone or volume of the human or animal body to be processed,
- locating means which make it possible to locate, in the form of location data (P '), the instantaneous position, in said reference frame (Rt), of the output of the treatment dose-delivering means,
- the treatment may consist in treating the human or animal body part with electromagnetic waves, electric waves, or mechanical waves, and more particularly acoustic waves, and in this case the treatment dose is energy of the treatment wave which is delivered at a given position of the treatment dose delivery means.
- the treatment may also consist in the administration of a substance or a chemical product in said part of the human or animal body; in this case, the treatment dose is the quantity of substance or chemical administered at each position of the treatment dose-delivering means.
- Another object of the invention is a method of treatment as defined in any of the appended process claims.
- the subject of the invention is also the use of the abovementioned apparatus or the aforementioned method for carrying out a treatment chosen from the following group: subcutaneous or intracutaneous treatment, endovenous treatment, destruction of adipose cells, lipolysis treatment, treatment of adipocytolysis, heating of collagen in the dermis, cosmetic treatment of remodeling or scarring of the skin by heating collagen present in the dermis.
- a treatment chosen from the following group: subcutaneous or intracutaneous treatment, endovenous treatment, destruction of adipose cells, lipolysis treatment, treatment of adipocytolysis, heating of collagen in the dermis, cosmetic treatment of remodeling or scarring of the skin by heating collagen present in the dermis.
- FIG. 1 is a diagrammatic representation of an exemplary medical device of the invention allowing an invasive laser treatment of a part of a human body
- FIG. 2 represents an example of a medical instrument comprising a handpiece allowing the manipulation of a cannula / optical fiber assembly
- FIG. 3 is an example of a block diagram of the main electronic components of the processing apparatus of FIG. 1.
- FIGS. 4 and 5 represent algorithms illustrating the main operating steps of the apparatus of FIG. 1.
- FIG. an example of displaying the area to be treated, which has been identified, before a first dose of treatment is delivered,
- FIG. 7 represents an example of a display of the area to be treated, which has been identified, and of the mapping of the doses which are delivered during a treatment.
- FIG. 1 shows schematically an example of a medical device, which is in accordance with the invention, and which allows the treatment of a part of a human body C.
- the treatment apparatus allows the implementation of different types of invasive laser treatment of the human body.
- these treatments non-exhaustive mention may be made of laser adipocytolysis, laser lipolysis, endovenous laser treatments, laser remodeling of the skin and scarring of the skin by heating the collagen present in the dermis and / or by thermal stimulation using a fibroblast laser to accelerate the production of collagen in the dermis.
- This treatment apparatus comprises means for delivering the treatment doses comprising an instrument 1, which can be manipulated by hand, and which has, for example, the particular structure of FIG. 2, and an electromagnetic radiation source 13b.
- the instrument 1 comprises, for example, a handpiece 10 on which is fixed a cannula 11, and an optical fiber 12 which is threaded into the handpiece 10 and into the cannula 11 and which is immobilized relative to said cannula.
- the distal end 12a of the optical fiber constitutes the output of the instrument 1 by which the electromagnetic irradiation doses are delivered.
- the distal end 12a of the optical fiber 12 is flush with the distal opening 11a of the cannula.
- the distal end 12a of the optical fiber 12 could be located outside the cannula 11, but in the immediate vicinity of the distal opening 11a of the cannula 11.
- the handpiece 10 allows hand manipulation of the cannula 11 / optical fiber assembly 12, and is a non-invasive part of the instrument 1.
- the portion of the cannula11 / optical fiber assembly 12, which is referenced "INV" in Figure 2, which is external to the handpiece 10, and which extends from the distal end 10a of the handpiece 10, is an invasive part of the instrument 1 to be introduced partially or totally in the part of the human body C to be treated.
- the optical fiber 12 is connected at its other end to the source of electromagnetic radiation (FIG. 3 - laser source 13b) which is integrated in a device 13 also comprising a screen 13a for the visualization of the laser treatment.
- the transmission frequency of the source 13b will be chosen in a manner known per se by those skilled in the art, and may, depending on the type of treatment, be in the visible, infrared, microwave or radio frequency range.
- the transmission frequency and / or the power of the electromagnetic radiation source are preferably adjustable.
- the instrument 1 delivers at its distal emitting end 12a electromagnetic radiation that can be applied to a portion of the body C to be treated.
- the treatment apparatus also comprises:
- the locating means 2 comprise a magnetic field emitter 20, a sensor 21 which is fixed to the instrument 1, at a position different from the position of the output 12a of the optical fiber 12, and electronic calculation means 22.
- the senor 21 is housed inside the handpiece 10.
- an electric cord CO is shown which is connected to the sensor 21. and which contains, on the one hand, the electrical wires supplying the sensor and, on the other hand, the electrical wires carrying the electrical signals 21a delivered by the sensor 21.
- the transmitter 20 is fixed and positioned near the body C and emits a magnetic field which is received by the sensor 21.
- the sensor 21 is sensitive to the magnetic field produced by the transmitter 20 and delivers electrical signals 21a which are characteristic of its instantaneous absolute position and its instantaneous absolute inclination in said magnetic field.
- These electrical signals 21a are received and processed by first electronic calculation means 22a which are able to calculate in real time data P [x (t), y (t), z (t)]) coding the instantaneous absolute position 3D said sensor and data A [ ⁇ (t), ⁇ (t), ⁇ (t)] coding the 3D instantaneous absolute inclination of said sensor in a predefined three-dimensional coordinate system (X, Y, Z).
- the predefined three-dimensional coordinate system (X, Y, Z) constitutes the reference frame (Rt) of the magnetic field emitter 20.
- the body C is placed in the magnetic field emitted by this emitter 20, and the part of treated body C is preferably immobile in the reference (X, Y, Z) during the treatment period.
- the reference frame (Rt) could be linked to the human or animal body part, for example by fixing the magnetic field emitter 20 on the human or animal body part to be treated. In this case, once the zone or the volume to be treated has been located in the reference frame (Rt), it is not necessary to redo the marking in case of movement of the human or animal body part.
- the data P [x (t), y (t), z (t)] on the instantaneous absolute position 3D of the sensor 21 and the data A [ ⁇ (t), ⁇ (t), ⁇ (t)] on the instantaneous absolute inclination 3D of the sensor 21 are processed in real time by second electronic calculation means 22b , which are parameterized with the relative position Pc (dx, dy, dz) of the sensor 21 with respect to the output 12a of the optical fiber 12.
- This relative position Pc of the sensor 21 is fixed in time, whatever the position and the inclination of the instrument 1, and is information, preferably modifiable, which is for example stored in a memory of the second electronic calculation means 22b.
- the second electronic calculation means 22b are designed so as to calculate in real time data P '[x' (t), y '(t), z' (t)] coding the instantaneous absolute position 3D of the output 12a of the optical fiber 12 of the instrument 1 in the three-dimensional coordinate system (X 1 Y 1 Z), from said data encoding the instantaneous absolute position 3D P [X (t), Y (t), Z (t)] and the instantaneous absolute inclination 3D A [ ⁇ (t), ⁇ (t), ⁇ (t)] of the sensor 21, and from the relative position Pc (dx, dy, dz) of the sensor 21.
- the first electronic calculating means 22a are integrated in an external casing distinct from the aforementioned device 13 and the second electronic calculating means 22b are integrated with said device 13 and communicate locally with the first means electronic computing 22a by a link 22c ( Figure 1) which can indifferently be wired or wireless type.
- the transmitter 20, the sensor 21 and the first electronic calculation means 22a are known means, and may for example, and without limitation to the invention, be constituted by the components of a magnetic location device marketed by Ascension Technology Corporation under the brand name "Flock of Birds®".
- the second electronic calculation means 22b may be constituted by any programmable processing unit, for example using a microprocessor or microcontroller capable of executing a processor.
- the second electronic calculation means 22b could be integrated in the same housing as the first electronic calculation means 22a.
- the first 22a and second 22b electronic calculation means could be implemented using the same calculation processor.
- the electronic means 3 may be implemented in the form of any type of programmable electronic processing unit including in particular a microprocessor or microcontroller capable of automatically executing a program stored in a memory and specific to the invention.
- the electronic means 3 receive as input at least data P '[x' (t), y '(t), z' (t)] coding the instantaneous absolute position 3D of the output 12a of the optical fiber 12, and also in the particular example illustrated two signals 13c and 13d delivered by the laser source 13b.
- the signal 13c allows the electronic means 3 to be informed if a laser shot is in progress or not.
- This signal 13c is for example a binary type electrical signal which can take two levels up and down, and which is for example in the high state when a shot is in progress (laser source activated) and in the low state 0 on the other hand.
- the signal 13c is a signal encoding the instantaneous power PUI (t) of the laser source 13b.
- the electronic dosimetry control means 3 also output two control signals 3a, 3b enabling them to automatically control the laser source 13b ( means of delivering treatment doses).
- the signal 3a is a signal for adjusting the power of the laser source 13b.
- the signal 3b is a signal for controlling the stopping of the laser source 13b, in case of detection of an overdose.
- the locating means 2 After starting the locating means 2, the electronic control means 3 and the laser source 13b, the locating means 2 implement a first calibration step 401 (FIG. 4).
- This calibration step consists in setting the relative position Pc (dx, dy, dz) of the sensor 21 with respect to the output 12a of the optical fiber 12, so that the second calculation means 22b can automatically calculate the instantaneous position 3D P '[x' (t), y '(t), z' (t)] of the output 12a of the optical fiber 12, from the data provided by the first electronic calculation means 22a and coding the instantaneous absolute position 3D P [X (t), Y (t), Z (t)] and the instantaneous absolute inclination 3D A [ ⁇ (t), ⁇ (t), ⁇ (t)] of the sensor 21.
- the dosimetry control means 3 execute a program for locating the treatment zone (FIG. 4, step 402).
- the practitioner traces on the skin of the patient, for example by means of a felt, the contour C ( Figure 1) of each area to be treated.
- the zone to be treated is for example constituted by the part of the human body situated inside the contour C, and no dose of energy must be delivered in the parts of the human body located at the outside of this contour C. Then, the practitioner decontaminates the area to be treated by basting a sanitizing product on the skin of the patient.
- the tracking program ( Figure 4 / Step 405) consists of enter by the practitioner several locating points Pj of the contour C, using the instrument 1 without delivering a treatment dose, in order to locate and delimit the treatment zone in the reference frame Rt (reference (X 1 Y 1 Z)).
- the practitioner positions the outlet 12a of the instrument in contact with the skin of the patient on a point of the contour C, and moves the instrument 1 in contact with the skin of the patient, and following the contour C.
- the locating means 2 supply the electronic means 3 with the instantaneous absolute position in the reference frame Rt of the output 12a of the instrument 1, and the electronic means 3 record in the form of tracking data Pj (Xj, yi , Zj) several of these instantaneous absolute positions of the output 12a of the instrument 1.
- the electronic means 3 use these registration points P 1 (X 1 , y 2, Z 1) in particular to represent on the screen 13 a the contour C of the zone to be treated (FIG. 6) corresponding to the contour C traced on the patient, as and as the practitioner moves the instrument over contour C.
- This step of locating the area to be treated in the reference frame Rt is important because it makes it possible, by means of the registration points Pj, to link the reference frame Rt to the part of the body of the patient to be treated.
- the identification could be made in three dimensions and invasively by means of the instrument 1, and the control means could be programmed to display on the screen 3, no longer a treatment zone in a plane delimited by a contour C, but to represent in three dimensions a volume of treatment.
- the identification could be carried out, not by means of the processing instrument 1, but by means, for example, of a specific tool dedicated solely to tracking, and allowing acquisition by the electronic means 3 Pi locating points of the zone or the volume to be treated in the reference frame Rt.
- This tracking tool may for example be a specific pointing device, which is different from the processing instrument 1, and which is suitable to be used to point points of P 1 location on the zone or in the volume to be treated of the human or animal body.
- the treatment apparatus is ready for use by the practitioner.
- the practitioner performs, using the instrument 1, the appropriate subcutaneous or intracutaneous laser treatment in a manner known per se, according to a treatment protocol that he has previously determined.
- the practitioner uses one or more incisions in the skin around the area by means of a scalpel and then begins the treatment by introducing, through one of the incisions made, the end of the cannula assembly 11 / fiber optic 12 in the dermal plane or in the dermis (depending on the type of treatment) in the treatment area that has been identified.
- the practitioner performs in a manner known per se treatment by performing a series of laser shots and moving the assembly cannula 11 / optical fiber 12 in the treatment area. The practitioner reiterates these operations until the entire area to be treated has been scanned by laser fire.
- the electronic means 3 are programmed to, during processing, automatically detect in real time whether the instrument 1 is correctly positioned within the area to be treated, and to automatically calculate in real time three dosimetry control parameters.
- step 403 the speed of displacement of the output 12a of the optical fiber 12, which is equivalent in this particular example of instrument 1 to the speed of displacement of the cannula 11; mapping the laser energy doses delivered into the tissue, i.e. the laser energy doses delivered at each point in the area that was actually treated; at least one processing instruction (FIGS. 4 and 5: "TREATMENT SETPOINT" for manual or automatic regulation of the treatment.
- FIG. 5 shows a more detailed algorithm for the implementation of step 403. Detection of the positioning of the instrument
- the electronic means 3 use the location data of the output 12a of the instrument 1 supplied by the locating means 2 to display in real time on the screen 13a a cursor at the position P 'detected in the reference frame Rt.
- this cursor is represented in the form of a cross and is referenced L.
- the locating means 2 make it possible to locate the output 12a of the treatment instrument, independently of the delivery or not by the instrument 1 of a treatment dose.
- the slider L may advantageously be displayed for the practitioner on the screen 13a, before the practitioner delivers a treatment dose.
- the practitioner can thus firstly visually check if the cursor L is correctly positioned in the zone which has been marked and which is displayed on the screen 13a (contour C), and can, if necessary, correct the position of the exit 12a. of the instrument 1.
- the practitioner actuates the laser source 13b to deliver a dose of treatment at this position.
- the electronic means 3 automatically compare the instantaneous position P 'of the output 12a of the instrument 1, located in real time in the reference frame Rt by the location means 2, with the locating points Pj of the area to be treated, and automatically detect whether this position P 'is located inside or outside the treatment zone which has been located.
- the electronic means 3 When the electronic means 3 detect that this position P 'is located outside the treatment zone which has been identified, they inform the practitioner (step 403c), by triggering for example an audible or visual alarm, so that the practitioner if necessary correct the position of the instrument.
- the electronic means 3 can also be designed to control automatically stopping the means for delivering the doses (laser source 13b), when they detect that this position P 'is located outside the treatment zone which has been identified.
- this automatic detection of the correct positioning of the instrument is performed before a laser shot is made.
- this mapping consists of associating, in a 3D array, with each instantaneous absolute position 3D P '[X' (t), Y '(t), Z' (t)] of the output 12a of the optical fiber the dose of electromagnetic radiation delivered at this position, ie the sum of the energies delivered at this position (summation of the calculated values of the "Delta E" parameter of FIG. 5 for each position P '[X' (t) , Y '(t), Z' (t)]).
- this mapping of laser energy doses is calculated from the following information:
- the electronic means 3 calculate the cumulative treatment dose ("Delta E") for this position.
- the treatment dose (“Delta E ") calculated is for example displayed on the screen 13a ( Figure 7 / parameter designated" Energy (Joules) ").
- the electronic means 3 are also programmed to display on the screen 13a, in real time during the treatment, the mapping of the treatment doses delivered at each point, and where appropriate accumulated at each point, in relation with the contour C of the area that has been identified ( Figure 7).
- the treatment dose delivered at each point, and if necessary the cumulative treatment dose delivered at each point, is for example coded by a color depending on the dose level.
- the practitioner can advantageously, by looking only at the screen 13a, visually control the location of the doses delivered in relation to the area to be treated, and adapt his gesture so as not to leave the area that is delimited on the screen 13a by the outline C.
- This display thus allows a guide of the practitioner's gesture, which is particularly useful in the case an invasive treatment during which the practitioner can not see the position of the output 12a of the instrument 1 dose delivery.
- this display allows the practitioner to control the distribution of the treatment doses in the marked area, and in particular to ensure that all the points of the zone inside the contour C have been treated with the right dose, and if not, re-fire the untreated points or points where the dose is not sufficient.
- the mapping of the laser energy doses delivered in the tissue is a 2D mapping (summation of the energy doses - parameter "Delta E" in FIG. 5) in a predefined plane (for example the X plane 1 Y).
- the mapping of the energy doses can be 3D mapping or 1D mapping (summation of the energy doses - "Delta E" parameter in FIG. 5). following a predefined axis (for example the X axis).
- dose mapping could be established by recording only the successive positions of the doses delivered (parameter P '[x' (t), y '(t), z' (t)]) without calculation. of energy ("Delta E" parameter). Actual movement speed of the instrument
- the calculation of the real movement speed of the instrument being processed is performed from the instantaneous 3D positions P '[x' (t), y '(t), z' (t)] of the output 12a of the optical fiber 12 which are successively calculated at each iteration.
- the speed of displacement of the output 12a of the dose delivery instrument 1 is for example displayed in real time on a screen 13a of the device 13 (FIG. 4 or 5 / step 404), which enables the practitioner to control real time during the treatment the speed of movement of the instrument 1 and to manually adjust his gesture so as to respect a minimum speed of movement that he has predefined, and reduce the risk of overdose related to a speed of travel too slow.
- the speed can be displayed in digital form or coded for example by means of a bar graph scale.
- the electronic control means 3 are programmed to calculate in real time, during a treatment, at least one treatment instruction from the registration data (Pj) of the area to be treated, location data (P ') of the output 12a of the instrument 1, and a map, called "treatment map".
- This treatment map is previously established by the practitioner, by associating at each point of the area to be treated which has been located (inside the contour C) a predefined value of a treatment parameter, said treatment parameter being for example the dose of treatment, the speed of movement of the instrument 1, the power of the means 13b for delivering doses.
- This treatment map is recorded in the electronic means 3, prior to the start of the treatment.
- this processing map defines a single value of the identical processing parameter for the entire zone to be treated that has been located.
- this map can define different values of the treatment parameter (dose, speed or power) for different points of the zone to be treated which has been identified.
- the setpoint which is calculated may be a treatment dose (energy) setpoint to be delivered, a travel speed setpoint of the instrument, a power set of the dose delivery means (laser source 13b) or more generally a setpoint relating to any setting parameter of the dose delivery means.
- the processing instruction is calculated by automatically selecting, in the processing map, the value of the processing parameter associated with the instantaneous position P 'of the processing instrument 1, which is detected in the reference frame Rt by the location means 2 Regulation of the treatment parameter
- the treatment instruction can advantageously be displayed in real time on the screen 13a in relation to the actual value of the measured treatment parameter (dose, speed or power), so as to enable the practitioner to manually regulate this processing parameter (for example modification of the speed of movement of the instrument, manual adjustment of the power of the laser source 13b, manual stop of the laser shot in progress) in order to respect the treatment setpoint displayed on the screen 13a.
- dose dose, speed or power
- this processing parameter for example modification of the speed of movement of the instrument, manual adjustment of the power of the laser source 13b, manual stop of the laser shot in progress
- the electronic means 3 can advantageously be designed to automatically control the means 13b for delivering the treatment doses, so as to automatically regulate, during the treatment, the operation of the means 13b for delivering the treatment doses, so as to automatically comply with the treatment instruction which has been calculated (FIG. step 405).
- the dosimetry control means 3 may advantageously be designed (FIG. 4 or 5 / step 406):
- the dosimetry control means 3 can advantageously be designed:
- the treatment can be performed by the practitioner with greater security.
- mapping of doses delivered in relation to the treatment area which has been identified may be recorded, and possibly used by the practitioner for a follow-up in the time of treatment protocols of a patient.
- the invention is not limited to an apparatus for implementing an intra-cutaneous or subcutaneous electromagnetic irradiation treatment (visible, infra-red, microwave or radio frequency), but may also be implemented to control the doses of energy delivered by means of an apparatus comprising an instrument adapted for the implementation of an endovenous treatment, or comprising an exo-laser-type instrument adapted for the implementation of an external non-invasive laser treatment applied on the surface of the skin.
- an apparatus comprising an instrument adapted for the implementation of an endovenous treatment, or comprising an exo-laser-type instrument adapted for the implementation of an external non-invasive laser treatment applied on the surface of the skin.
- the energy source 13b is not necessarily a source of electromagnetic radiation, but may for example be a source of acoustic energy, the instrument being in this case designed to deliver the acoustic energy produced by said source.
- the invention is also not limited to a laser treatment apparatus, but may more generally be implemented to control any type of treatment doses delivered by means of any known type of medical instrument, the doses being able to example be a chemical or drug administered to a part of a human or animal body.
- invasive-type treatments such as, for example, liposuction
- an invasive instrument is used to aspirate a given quantity of cells or tissues in a part of the human or animal body, such as, for example, a cannula for aspirate the fat cells in the special case of liposuction.
- This type of treatment poses the same problems as the aforementioned dose-giving treatments, and it is important for the efficacy and the safety of the treatment to be able to control not only the quantities of cells or tissues removed but also what was the location and distribution, in a frame linked to the human body or treated animal, quantities of cells or tissues that have been removed.
- the invention can thus also be implemented for invasive type treatments, such as, for example, liposuction, in which an invasive instrument is used to aspirate a given quantity of cells or tissues in a part of the human or animal body, such as for example a cannula for aspirating fat cells in the particular case of liposuction.
- invasive type treatments such as, for example, liposuction
- an invasive instrument is used to aspirate a given quantity of cells or tissues in a part of the human or animal body, such as for example a cannula for aspirating fat cells in the particular case of liposuction.
- the electronic location means make it possible to automatically locate the instantaneous position of the input of the instrument in a predefined reference frame Rt, and the calculation of the doses by the electronic dosimetry control means 3 corresponds to the quantity of cells or tissues that have been removed at one position of the instrument.
- the invention can also be applied to a treatment apparatus which both makes it possible to deliver treatment doses via an output 12a of an instrument and makes it possible to aspirate treatment doses via an input of an instrument (same instrument or instrument different from that delivering the doses).
- the locating means preferably make it possible to locate in the reference frame Rt the instantaneous position of the output of the instrument delivering the doses and the instantaneous position of the input of the instrument drawing the doses, and are thus suitable. to deliver location data P 'coding the instantaneous position in the reference frame Rt of the output of the instrument delivering the doses, and location data P' coding the instantaneous position in the reference frame Rt of the input of the instrument sucking the doses.
- the location of the instantaneous position P 'in a reference frame Rt of the output 12a of the treatment dose delivery means is not necessarily of the 3D type, but can also be a 2D or a 1-D location.
- the locating means 2 which have been described can be replaced by any technical means for locating, in the form of data of location (P '), the instantaneous position, in a predefined reference frame (Rt), of the output 12a of the means for delivering the treatment doses.
- the invention is thus not limited to the particular structure of the locating means 2 which have been described by way of non-limiting example only.
- these locating means 2 may be based on an optical detection, if necessary through the skin, of the treatment dose delivered, and for example the light spot corresponding to the laser shot.
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- Engineering & Computer Science (AREA)
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- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
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Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP09814145A EP2341862A1 (fr) | 2008-09-16 | 2009-03-04 | Appareil et procede de traitement d'une partie de corps humain ou animal mettant en oeuvre des moyens de delivrance de doses de traitement et des moyens de contrôle de dosimetrie |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP08370019A EP2163218A1 (fr) | 2008-09-16 | 2008-09-16 | Appareil de traitement d'une partie de corps humain ou animal, comportant un instrument permettant de délivrer et/ou un instrument permettant d'aspirer localement des doses de traitement et des moyens de controle de dosimétrie |
US14529909P | 2009-01-16 | 2009-01-16 | |
PCT/FR2009/000228 WO2010031908A1 (fr) | 2008-09-16 | 2009-03-04 | Appareil et procede de traitement d'une partie de corps humain ou animal mettant en oeuvre des moyens de delivrance de doses de traitement et des moyens de contrôle de dosimetrie |
EP09814145A EP2341862A1 (fr) | 2008-09-16 | 2009-03-04 | Appareil et procede de traitement d'une partie de corps humain ou animal mettant en oeuvre des moyens de delivrance de doses de traitement et des moyens de contrôle de dosimetrie |
Publications (1)
Publication Number | Publication Date |
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EP2341862A1 true EP2341862A1 (fr) | 2011-07-13 |
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ID=40011011
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Application Number | Title | Priority Date | Filing Date |
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EP08370019A Withdrawn EP2163218A1 (fr) | 2008-09-16 | 2008-09-16 | Appareil de traitement d'une partie de corps humain ou animal, comportant un instrument permettant de délivrer et/ou un instrument permettant d'aspirer localement des doses de traitement et des moyens de controle de dosimétrie |
EP09814145A Withdrawn EP2341862A1 (fr) | 2008-09-16 | 2009-03-04 | Appareil et procede de traitement d'une partie de corps humain ou animal mettant en oeuvre des moyens de delivrance de doses de traitement et des moyens de contrôle de dosimetrie |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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EP08370019A Withdrawn EP2163218A1 (fr) | 2008-09-16 | 2008-09-16 | Appareil de traitement d'une partie de corps humain ou animal, comportant un instrument permettant de délivrer et/ou un instrument permettant d'aspirer localement des doses de traitement et des moyens de controle de dosimétrie |
Country Status (5)
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US (1) | US20100069895A1 (fr) |
EP (2) | EP2163218A1 (fr) |
JP (1) | JP2012502714A (fr) |
CN (1) | CN102196781A (fr) |
WO (1) | WO2010031908A1 (fr) |
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Publication number | Publication date |
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WO2010031908A1 (fr) | 2010-03-25 |
JP2012502714A (ja) | 2012-02-02 |
US20100069895A1 (en) | 2010-03-18 |
EP2163218A1 (fr) | 2010-03-17 |
CN102196781A (zh) | 2011-09-21 |
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