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
  • A61B18/18—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
  • A61B18/22—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
• • 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
  • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
  • A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
  • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
  • A61B5/6864—Burr holes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/40—Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0526—Head electrodes
  • A61N1/0529—Electrodes for brain stimulation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00017—Electrical control of surgical instruments
  • A61B2017/00022—Sensing or detecting at the treatment site
  • A61B2017/00039—Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• • 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
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00434—Neural system
• • 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
  • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
  • A61B2018/00434—Neural system
  • A61B2018/00446—Brain

Definitions

• the invention relates to an intracerebral probe implantable in a human or animal brain, a treatment device comprising such a probe, for the treatment of areas of the brain subject to dysfunctions.
• Such a probe is temporarily implanted in the brain to locally treat a dysfunctional brain zone. It is used, in particular, to treat the metabolic or electrophysiological dysfunctions of the brain causing neurological or psychiatric symptoms or diseases, such as, for example, epilepsy, Parkinson's disease, obsessive-compulsive disorders, depression, etc. .
• the invention relates solely to the latter two types of processing means, namely laser and cryogenics. Indeed, compared to other means of treatment, the laser and cryogenics have, in particular, the following advantages:
• Laser or cryogenic processing probes are well known and are used in the following manner.
• a finer registration is carried out using a so-called detection probe, carrying on its intracerebral portion several detectors capable of detecting a dysfunction in the cerebral zones which surround them.
• US 2003/0009207 discloses a detection probe with a plurality of electrodes distributed over its intracerebral portion. Each electrode makes it possible to record electroencephalogram-type signals, denoted EEG, representative of the electrical activity of the cerebral area surrounding this electrode. From this signal it is possible to identify a cerebral dysfunction at one of the electrodes.
• EEG electroencephalogram-type signals
• Laser or cryogenics treatment probes have only a therapeutic function and have no diagnostic function. It is therefore necessary to insert and then remove a detection probe before inserting the laser or cryogenics treatment probe instead.
• the subject of the invention is an intracerebral probe comprising a first part (or internal part) with means for laser treatment or cryogenics, characterized in that it comprises: a second hollow part (or external part) surrounding the first part, the first part sliding inside the second part along the longitudinal axis of the latter; and a plurality of detectors distributed along a portion of the second portion so as to locate a dysfunctional brain zone along the longitudinal axis of the second portion (referred to hereinafter as axial registration).
• said detectors are electrodes, each electrode being capable of detecting the electrical activity of the surrounding cerebral zone. Cerebral electrical activity is a good indicator of neurological dysfunction.
• the electrodes make it possible to perform precise tracking along the longitudinal axis of the second part. Finally, these electrodes make it possible to perform electrophysiological monitoring during the treatment by ensuring a continuous electrical recording at the treated area.
• the detectors are distributed circumferentially on the second part, around the longitudinal axis of the latter, or are segmented circumferentially so as to be able to detect angularly, about said longitudinal axis, a cerebral zone of dysfunction.
• the second part can carry (at a determined axial position) four detectors or a detector annulus segmented into four segments, these detectors or segments being distributed angularly at 0, 90, 180 and 270 ° around the probe. It is thus possible to make an angular registration, in addition to the aforementioned axial registration.
• the laser or cryogenic processing means have by default a 360 ° action around the laser emission source or cold (located on the first part of the probe).
• the second part of the probe has at least one side treatment window for directing the action of the processing means, that is, directing the transmission laser radiation, or cold in a certain direction.
• the emission zone of the laser or cryogenic processing means is thus determined by the position, the shape and the size of this window.
• this treatment window extends less than 360 ° around the second part of the probe, the action of the processing means is oriented angularly. For example, if the treatment window extends to 180 °, it becomes possible to treat an area of the brain located on one side of the probe, without treating the area on the opposite side.
• the probe comprises laser processing means and said lateral treatment window is a window transparent to the laser radiation emitted by these processing means.
• said lateral treatment window is extended along the longitudinal axis of the second part and / or circumferentially around this axis.
• the laser processing means can be moved inside this window.
• the circumferential width of said lateral treatment window varies along the longitudinal axis of the second part.
• the processing window is in the form of T (or +), a branch of this T (or of this +) extending circumferentially and the other branch of this T (or of this +) extending axially.
• the processing window is V-shaped. These T-shaped, + or V-shaped can also be obtained by juxtaposing several small windows. Thus, by moving the processing means (ie the first part of the probe) along the longitudinal axis of the second part, the angular extent of the emission zone of the processing means is varied.
• the probe is implanted in a part of the brain in which a malfunction is likely to occur.
• This part of the brain is "squared" or rather divided into several detection zones delimited by the detectors.
• the detectors being distributed along the longitudinal axis of the second part, or even circumferentially around this axis, the detection zones follow one another along this axis, or even around it.
• the probe and its detectors can then be left in a fixed position for a few hours or days, waiting for a sufficient collection of data.
• This latter embodiment has, in addition, an advantage for the detection of dysfunctions that occur only occasionally, such as those at the origin of epileptic seizures.
• it can be caused by stimulating the part of the brain concerned, for example, by passing an electric current between two electrodes. It may be either additional electrodes fixed on the intracerebral portion of the second part of the probe and specially dedicated to stimulation, or existing electrodes used as detectors, which is operated differently.
• the detectors of said probe are intended to detect electrophysiological, magnetic or metabolic changes in the tissue (modification of the electrical activity of the patient). base, spectrum modification, etc.) with respect to a normal activity known to the healthy subject for the detection zone.
• the detectors used can be of different types and thus be able to detect various parameters such as electrical activity, the magnetic activity and / or the local metabolism of the brain tissues that surround them.
• these detectors are distributed in the vicinity of the intracranial end of the second part of the probe.
• the electrical activity detected by means of these electrodes may correspond to the potential difference between two of these electrodes (called bi-polar recording) or to the potential difference between one of these electrodes. and an extracranial reference electrode (called monopolar recording).
• the subject of the invention is also a kit comprising a probe according to the invention, a guide for guiding the second part of the probe during its implantation in the brain, and a fixation system for fixing this second part and the guide in a relative position determined.
• this kit comprises a plastic sheath extending between said guide and the extracranial end of the first part of the probe, so as to maintain a sterile environment at the junctions between the guide and the second part of the probe. the probe, and between the first and the second part of the probe.
• the invention also relates to a processing device comprising, in addition to the probe according to the invention, control means for controlling the operation of said laser treatment means or cryogenics, these control means being connected to the detectors of the invention. the probe so as to be able to receive information from these detectors during processing and to modulate the operation of said processing means as a function of the information received.
• the processing device further comprises a connection system for connecting said control means to an MRI apparatus so as to be able to receive information from the MRI apparatus during processing and to modulate the operation of said MRI apparatus. according to the information received.
• a connection system for connecting said control means to an MRI apparatus so as to be able to receive information from the MRI apparatus during processing and to modulate the operation of said MRI apparatus. according to the information received.
• FIG. 1 represents a first example of a probe according to the invention
• FIG. 2 is a sectional view of a second example of a probe according to the invention.
• FIG. 3 is a perspective view of the external part of a third example of a probe according to the invention.
• FIG. 4 represents an exemplary device according to the invention.
• the probe comprises an inner part 5 with laser processing means and a hollow outer part 2 surrounding the inner part 5.
• the inner part 5 is slidably mounted inside the outer part 2 following the longitudinal axis of the latter.
• detectors 6 are distributed along a portion of the outer portion 2, located near its intracranial end.
• the probe 1 is long and thin and extends along a main axis A, which is also the longitudinal axis of the outer portion 2 of the probe.
• the outer portion 2 of the probe has an intracerebral portion 2A introduced into the brain C and an extra-cerebral portion 2B.
• the external part 2 alone does not have sufficient rigidity to be able to be inserted into the brain without deforming, use is made of means for rigidifying the latter (not shown). It may be, for example, a tubular guide slid outside the probe to increase its rigidity.
• a cooling system for example a reciprocating coolant system (not shown), is provided in the inner part of the probe in order to control (limit) brain warming C.
• the inner portion 20 is constituted by a glass fiber 15. This fiber 15 is, if necessary, surrounded by a protective sheath. Laser radiation may be conducted by this glass fiber 15 and be emitted at the end of the inner portion.
• the inner portion 20 is a cryogenic probe. According to a well-known example of cryogenic probe, it comprises three long tubes (inner, intermediate and outer) concentric. The inner tube is used as a conduit for the transport of liquid nitrogen. The space between the inner tube and the intermediate tube is used as a conduit for the transport of the nitrogen after it has passed into a gaseous state in a chamber at the intracranial end of the inner portion 20.
• gripping means 33 In the example, it is a wheel attached to the extracranial end of the portion 20.
• the inner portion 20 is graduated at its clamping zone, which makes it possible to know the relative position of the inner and outer parts 20 and 22 and / or to manually adjust this position with reference to the graduations.
• Such a probe 11 is used as follows: first we slide the outer portion 22 of the probe 20 in the guide 26 and it sinks into the patient's brain to reach the desired position.
• the outer portion 22 may be depressed alone or with the inner portion 20. If the portion 22 alone or with the portion 20 does not have sufficient rigidity to be able to drive the probe, a mandrel is used slid inside the probe for increase its rigidity.
• the outer portion 22 is open at both ends (it is recessed from one end to the other). During implantation, it must be ensured that the inner part 20 or the optional mandrel obstructs the opening of the intracranial end of the external part 22 to prevent material from entering through this opening.
• the electrical activity of the surrounding cerebral environment is detected by means of the detectors 16. If a neurological dysfunction occurs, the cerebral zone where this dysfunction occurs is identified. Then, the end 25 of the inner part 20 is moved to this zone (If the inner part 20 has not yet been inserted inside the outer part 22, it is then that it ballast). Once the end 25 is in the right place, the outer portion 22 is pulled so as to expose (strip) the end 25 so that the laser or cryogenic treatment can reach the malfunction zone and treat it. The treatment phase is usually started only after the endpoint has been discovered. According to this embodiment, the outer portion 22 thus forms a protective envelope around the laser treatment means or by cryogenics until they are stripped by removing said outer portion 22. Once the treatment is done, it is possible to cover the processing means by pushing said outer portion 22. Such a configuration makes it possible to have on the outer portion 22 the maximum number of detectors.
• a sterile plastic protector 32 is fixed on one side around the guide 26 and on the other around the extracranial end 20, in front of the wheel 33 so that this wheel is external to protection 32.
• This protection 32 surrounds almost all of the extra-cerebral portion of the probe 11, and keeps its internal environment sterile. It is flexible and transparent so that it can manipulate the clamping screws 23, 29, and read the graduations present on the inner and outer parts 20, 22.
• This third example of a probe according to the invention differs from that of FIG. 2 only with respect to the outer part of the probe and therefore only this outer portion 122 is described.
• Figure 3 shows in perspective the outer portion 122 and, more specifically, the distal end portion of this outer portion.
• the outer portion 122 is closed at its distal end and has first 131, second 132 and third 133 small side windows, juxtaposed along the longitudinal axis A of the outer portion 122, and thus forming a (large) side treatment window 130
• the circumferential width of this window 130 varies along the longitudinal axis A of the outer portion 122 in the following manner: as one moves away from the distal end of the outer portion 122, this circumferential width increases.
• the first window 131 has an opening angle of 90 ° about the longitudinal axis A (its circumferential width corresponds to a quarter of the circumference of the outer portion 122); the second window 132 has an opening angle of 180 ° about the longitudinal axis A (its circumferential width corresponds to half the circumference of the outer portion 122); and the third window 133 has an opening angle of 360 ° about the longitudinal axis A (its circumferential width corresponds to therefore at the circumference of the outer part 122).
• These three windows are aligned so that their mediating planes, containing the axis A, are merged.
• window 130 makes it possible to treat complex geometry zones of the brain, since by moving the processing means (ie the first part of the probe) along the longitudinal axis A of the outer part 122, and by rotating ( if necessary) this outer portion 122 about its axis A, it is possible to perform a treatment in a particular angular direction, with an opening angle (or therapeutic arc) complete 360 °, or partial 90 ° or 180 ° .
• the detectors 116 are distributed axially and circumferentially around the axis A and, more particularly, around the small windows 131, 132, 133, as well as upstream and downstream of them.
• said lateral treatment window 130 is a window transparent to the laser radiation emitted by the processing means.
• said lateral treatment window 130 is an area of increased thermal conductivity with respect to the remainder of the outer portion 122 (the rest of the outer portion being preferably made of a good material). thermal insulator).
• this method of treatment consists of:
• the area of aforementioned brain dysfunction is identified by detecting the electrical activity in different areas of the brain by means of detection electrodes.
• the probe is implanted by stereotaxis or by a robotized neuronavigation system under local or general anesthesia.
• measurements are made simultaneously in several adjacent zones, located in the same region of the brain, using a probe according to the invention carrying a plurality of detectors.
• processing information is recovered from the detectors located in the treated area and the operation of said processing means is modulated according to the information retrieved.
• the probe is not implanted at random in the brain. Pre-spotting by MRI of particular regions of the brain in which neurological dysfunctions appear to appear, for example, during an epileptic seizure. Then, the coordinates and implantation trajectories of the probe are calculated by stereotaxis.
• a stereotactic frame is preferably used. This frame is an extracranial guide to practice in the skull the trephine hole through which we will pass the probe.
• the probe can also be implanted using a robotic neuronavigation system. The probe is introduced into the brain until the carrier portion of the sensing electrodes reaches the localized area during pre-screening. We can follow and measure the movements of the probe (or parts of it) by MRI.
• this guide When a guide 26 of the type shown in FIG. 2 is used, this guide is screwed into the bit hole made and the probe is passed through this guide.
• FIG. 4 An example of a device according to the invention making it possible to implement a treatment method of the type previously described, is shown schematically in FIG. 4.
• This device comprises a probe 1, 11, according to the invention of the type of that of FIG. 1 or 2, a signal analysis unit 50 connected to the detectors 6, 16 of the probes 1, 11, via the electrical wires 7, 17.
• a multiplexer 51 is provided between the wires 7, 17 and the unit 50.
• the signal analysis unit 50 receives for example from each pair of detectors an EEG type signal. It treats this signal so as to identify therein abnormalities reflecting a tissue dysfunction. Once the anomaly is detected, it transmits to the computing and control unit 52 to which it is connected, the information that an anomaly has been detected by such detector (s). The computing and control unit 52 can then calculate the position in the brain of the malfunctioning brain zone.

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• 2005
  • 2005-08-18 FR FR0508595A patent/FR2889813B1/fr active Active
• 2006
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