Terminal detection system
Patent Information
- Application Number
- DE602022021366
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-12-28
- Filing Date
- 2022-12-28
- Publication Date
- 2025-09-10
- Estimated Expiration
- 2042-12-28
AI Technical Summary
Current methods for connecting implanted ultrasound devices to a control unit are hindered by the difficulty in detecting the connection terminal due to factors like edema and thick scalp, leading to prolonged connection times and patient discomfort.
An implantable medical device with a positioning mark comprising light sources or electromagnetic resonant circuits to facilitate the detection of the connection terminal, allowing for precise localization using optical or electromagnetic methods.
Reduces the time required for treatment sessions by enhancing the accuracy and speed of connecting the device to the control unit, minimizing patient discomfort and reducing the need for multiple insertion attempts.
Description
[0001] The project leading to the submission of this application has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 960141. FIELD OF THE INVENTION
[0002] The present invention relates to the general technical field of treatment devices (in particular ultrasound) - for example intracorporeal or implantable devices - intended to be electrically connected to a remote control unit.
[0003] Such devices can be implanted in humans and mammals to treat a pathology, such as glioblastoma, using ultrasound. BACKGROUND OF THE INVENTION
[0004] Document WO 2018 / 007500 discloses a device for treating brain disorders.
[0005] In reference to the figure 1 , such a device consists of: of an ultrasonic device 1 made of non-ferromagnetic material, of a control unit 2 remote from the ultrasonic device 1, and of connection means 3 between the ultrasonic device 1 and the control unit 2.
[0006] The ultrasonic device 1 is intended to be positioned in a burr hole made in a patient's skull. It comprises: a support, one (or more) transducer(s) 12 for generating ultrasonic waves for treating a brain condition, one (or more) electrical connection terminal(s) 13 intended to cooperate with the connection means 3.
[0007] The control unit 2 is intended to supply electrical energy to the ultrasonic device 1, and to adjust its operating parameters.
[0008] The connection means 3 are intended to electrically connect the ultrasonic device 1 to the control unit 2. They generally comprise: one (or more) electrical connection cable(s) 31, one end of which is connected to the control unit, and one (or more) transdermal needle(s) 32 connected to the other end of the cable 31.
[0009] The operating principle of this device is as follows. Once the ultrasound device 1 is implanted in the patient's skull, a series of treatment sessions are provided to treat the pathology affecting him. At each new treatment session, the ultrasound device 1 is connected to the control unit 2 via the connection means 3.
[0010] A healthcare worker connects cable 31 to control unit 2 and then inserts needle 32 through the patient's skin to terminal 13 of the ultrasound device.
[0011] Once the end of the needle 32 is connected to terminal 13, the control unit 2 can be activated to supply the ultrasonic device 1 with electrical energy.
[0012] Currently, terminal 13 of the ultrasound device 1 is detected by palpation through the patient's scalp, as the latter has been sutured in place by the surgeon after implantation.
[0013] However, in some patients, detection of terminal 13 may be difficult due to various factors (edema, significant thickness of the scalp, etc.). This increases the time required to electrically connect needle 32 to terminal 13c (over two minutes). In addition, several insertion attempts may be necessary, which increases discomfort for the patient.
[0014] An aim of the present invention is to provide a method and a system allowing healthcare personnel to facilitate the detection of the position of a connection terminal of an implanted ultrasound device. BRIEF DESCRIPTION OF THE INVENTION
[0015] The invention is defined by claim 1. Other embodiments of the invention are defined in the dependent claims.
[0016] To this end, the invention proposes an apparatus for treating a pathology comprising: an implantable device at an opening in a patient's skull, the implantable device comprising a processing unit having upper and lower faces and including an electrical connection terminal extending on the upper face, a remote control unit for determining and controlling operating parameters of the implantable device, and delivering electricity to it, electrical connection means for electrically connecting the processing unit to the remote control unit via the electrical connection terminal, remarkable in that the implantable device comprises a positioning mark to facilitate detection of the position of the electrical connection terminal, said positioning mark comprising at least two light sources, such as light-emitting diodes, each capable of emitting light radiation towards the outside of the upper face, the electrical connection terminal extending between said light-emitting diodes.
[0017] Preferred but non-limiting aspects of the present invention include: the wavelength of the light radiation emitted by each light-emitting diode may be between 600 and 1600 nanometers, preferably between 850 and 1250 nanometers, and even more preferably between 950 and 1100 nanometers, in particular of the order of 1050 nanometers; the distance between the light-emitting diodes may be between 15 and 60 millimeters, preferably between 20 and 40 millimeters, in particular of the order of 25 millimeters; the distance between each light-emitting diode and the connection terminal may be between 9 and 35 millimeters, preferably between 12 and 25 millimeters, in particular of the order of 15 millimeters; each light-emitting diode may be configured to emit light radiation having a respective wavelength different from the wavelengths of the other light-emitting diodes;each light-emitting diode may be configured to emit light radiation having a respective intensity different from the intensities of the other light-emitting diodes; the positioning marker may further comprise at least one passive resonant electrical circuit; said at least one passive resonant electrical circuit may be configured to interact with an active resonant electrical circuit integrated into a location unit, said interaction making it possible to supply the implantable medical device with electrical energy by induction; said at least one passive resonant electrical circuit may comprise a coil operatively coupled to a capacitor, said coil extending around the electrical connection terminal; said at least one passive resonant electrical circuit may be configured such that the resonance frequency of said at least one passive resonant electrical circuit is between 10 MHz and 50 MHz;the implantable device may comprise: ∘ a support plate including first and second opposite faces, the processing unit being intended to be mounted on the first face of the support plate, ∘ a fixing part intended to be positioned on the second face of the support plate and being configured to press the processing unit against the first face of the support plate when the processing unit, the support plate and the fixing part are assembled, the fixing part including the positioning mark;advantageously: ∘ the support plate may comprise a through-hole, ∘ the electrical connection terminal may comprise a pin extending projecting towards the outside of the processing unit, the pin being intended to be positioned in the through-hole of the support plate, ∘ the fixing part may comprise: ▪ a conduit adapted to receive at least a portion of the pin, and ▪ a peripheral collar extending perpendicular to a longitudinal axis of the conduit, the collar being intended to be positioned on the second face of the support plate, the peripheral collar including the positioning mark.; BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Other advantages and characteristics of the method and system according to the invention will emerge more clearly from the following description of several variant embodiments, given as non-limiting examples, from the attached drawings in which: there figure 1schematically illustrates an example of a device for treating a brain condition including an ultrasound device electrically connected to a remote control unit by means of connection means (transdermal needle + cable), the figure 2 is a schematic cross-sectional representation of a treatment apparatus according to the invention, the figure 3 is a schematic perspective representation of an implantable medical device, the figure 4 is a schematic representation of an ultrasound unit of the implantable medical device, the Figure 5 is a schematic representation of a support plate of the implantable medical device, the figure 6 is a schematic perspective representation of a fixing part of the implantable medical device, the figure 7 is an image representing a light radiation emitted through a phantom simulating the behavior of a scalp, the figure 8is an image of three light rays emitted through the phantom simulating the behavior of the scalp, the figure 9 is a curve illustrating the light intensity of radiation emitted through the phantom simulating the behavior of the scalp as a function of the thickness of said phantom, the figure 10 is a schematic representation of electronic circuits integrated in a localization unit on the one hand and in the implantable medical device (and more precisely in a collar of the implantable medical device). DETAILED DESCRIPTION OF THE INVENTION
[0019] We will now describe different examples of the system and method according to the invention with reference to the figures. In these different figures, equivalent elements are designated by the same numerical reference. 1. General information
[0020] In reference to the figure 2 , the treatment device includes: an implantable medical device 1 in a patient 4, a remote control unit 2 for determining and controlling operating parameters of the implantable device 1, and delivering electricity to it, electrical connection means 3 for electrically connecting the implantable device 1 to the remote control unit 2, a unit for locating the implantable device 1.
[0021] The medical device 1 is capable of being implanted in a cranial bone 41 of the patient 4 to allow treatment and / or imaging of a brain area of interest 42. To do this, the practitioner performs a craniectomy. An incision is made in the scalp 43, then the skin (and muscles if applicable) is lifted (are lifted) in order to expose the skull 41. The skull 41 is then cut to form a bone flap. The cranial bone flap is removed to leave a cranial opening in which the implantable medical device 1 can be positioned. Once the implantable medical device 1 is correctly positioned, it is fixed on the periphery of the cranial opening by any means known to those skilled in the art (anchoring screws, gluing, etc.), then the scalp 43 (skin and muscles) is replaced to cover the implantable medical device 1.
[0022] At each new treatment / imaging session, a healthcare worker electrically connects the implantable medical device 1 to the remote control unit 2 using the connection means 3.
[0023] As illustrated in the figure 1 , these connection means 3 include in particular: an electrically conductive cable 31, a needle 32 mounted at one end of the cable 31, the needle 32 being able to be inserted into a connection terminal 113 of the ultrasound unit 11, and a connecting socket (not shown) at the other end of the cable 31, the connecting socket being able to be connected to a complementary socket of the control unit 2.
[0024] Specifically, the caregiver connects the connecting jack to the remote control unit 2. The caregiver then inserts the needle 32 into the scalp 43 of the patient 4, and inserts the end of the needle into a connection terminal 113 (illustrated in figure 3 ) so as to finalize the electrical connection of the implantable medical device 1 to the remote control unit 2.
[0025] It may be difficult for the healthcare personnel to identify by palpation the position of the connection terminal 113 once the medical device 1 has been implanted, the latter being covered by the scalp 43 (skin and muscles) of the patient's skull 4. However, knowledge of the precise position of the connection terminal 113 is necessary to ensure adequate positioning of the transdermal needle 32.
[0026] To facilitate detection of the connection terminal 113 through the scalp 43 of the patient 4, the implantable medical device 1 comprises a positioning mark. This positioning mark is configured to interact with the location unit.
[0027] This location unit allows the precise position of the connection terminal 113 to be detected.
[0028] Advantageously, the localization unit can be contained in a handpiece, or be integrated into the connection means 3. 2. Implantable medical device 2.1. General presentation
[0029] In reference to the figure 3 , the implantable medical device 1 comprises: an ultrasound unit 11 for emitting ultrasound waves for imaging or treatment, a support plate 12 on which the ultrasound unit 11 is mounted, and a fixing piece 13 for locking the ultrasound unit 11 against the support plate 12.
[0030] The ultrasound unit 11, the support plate 12, and the fixing piece 13 are separate elements intended to be assembled to form the implantable medical device 1. More precisely, to form the implantable medical device 1, these different elements are assembled so that the support plate 12 extends between the ultrasound unit 11 and the fixing piece 13.
[0031] When the implantable medical device 1 is positioned in the cranial opening, the ultrasound unit 11 extends opposite the brain area of interest 42. Thus, once implanted, the ultrasound unit 11 faces the brain area of interest 42, while the attachment part 13 extends opposite the scalp 43 of the patient 4.
[0032] The positioning marker makes it easier for the healthcare personnel to detect the position of the connection terminal 113 in order to facilitate the insertion of the needle 32 into said connection terminal 113.
[0033] To do this, the positioning mark comprises one (or more) marker(s) surrounding the connection terminal 113. This (or these) marker(s) may be of the optical marker and / or electromagnetic resonance marker type, as will be described in more detail below.
[0034] The use of a positioning marker makes it possible to reduce the time required to implement an imaging and / or treatment session of brain area 42, particularly compared to a solution based on the use of a neuro-navigation set.
[0035] Indeed, to use a neuro-navigation set, it may be necessary to move the patient 4, which: is time-consuming, increases the risk of infection, and can cause additional stress in the patient. 2.2. Ultrasound unit
[0036] In reference to the figure 4 , the ultrasound unit 11 comprises: one (or more) electronic card(s) 111 adapted to exchange electrical power and control signals with the remote control unit 2, one (or more) ultrasound transducer(s) 112 - for example circular with a diameter of 10 millimeters (each) - adapted to generate ultrasound waves for treatment (or imaging) of the brain area of interest 42, and an electrical connection terminal 113 for connecting the ultrasound unit 11 to the remote control unit 2.
[0037] The electronic card(s) 111 and the transducer(s) 112 are positioned on a first face of the support plate 12 when the implantable medical device 1 is assembled. Since the electronic card 111 and the transducers 112 are known to those skilled in the art, they will not be described in more detail below.
[0038] The electrical connection terminal 113 makes it possible to connect the implantable medical device 1 to the external control unit 2 which supplies the transducers 112 with electrical energy and regulates their operating parameters.
[0039] The connection terminal 113 comprises a pin 1131 extending outwardly from an upper face of the ultrasonic unit 11. The upper wall 1132 of the pin 1131 comprises a blind hole 1133 into which the end of the needle 32 is intended to be introduced to electrically connect the ultrasonic unit 11 to the electrical connection means 3. Advantageously, the connection terminal 113 may comprise a conical flare (or countersink) 1134 provided at the entrance to the blind hole 1133. This makes it possible to guide the needle 32 towards the blind hole 1133 to facilitate the introduction of the end of the needle into the blind hole 1133.
[0040] The side wall of the pin 1131 may comprise a thread 1135. This thread 1135 is intended to cooperate by screwing with a corresponding thread provided on the internal face of a conduit of the fixing part 13. This makes it possible to ensure the securing of the ultrasound unit 11, the support plate 12 and the fixing part 13 during the assembly of the medical device 1. The fact that the ultrasound unit 11 cooperates by screwing with the fixing part 13 makes it possible, during the phase of connecting the intracranial device to the control unit, to distribute the force applied by the needle to the connection terminal over an entire surface of the support plate 12. 2.3. Support plate
[0041] In reference to the Figure 5 , an example of a support plate 12 is illustrated. The support plate 12 is generally rectangular, but may have any shape, such as a circular, triangular or square shape.
[0042] The material constituting the support plate 12 may be a metal, such as titanium or any other metal known to those skilled in the art (possibly coated with parylene or equivalent if the metal used is not biocompatible in itself).
[0043] The support plate 12 comprises a through hole 121 for the passage of the connection terminal 113. The edge 122 of the through hole 121 may be covered with a layer of polymer material, such as silicone. This layer of polymer material makes it possible to limit the risks of loosening between the connection terminal 113 and the fixing part 13. 2.4. Fixing part
[0044] In reference to the figure 6 , the fixing part 13 comprises: a conduit 131 capable of receiving the pin 1131, and a peripheral collar 132.
[0045] The conduit 131 is intended to cooperate with the connection terminal 113 so as to block the support plate 12 between the ultrasonic unit 11 and the fixing part 13. More precisely, the conduit 131 consists of a nut whose threaded hole is intended to cooperate by screwing with the thread 1135 of the side wall of the pin 1131. In other words, the internal face of the conduit 131 comprises a thread complementary to the thread 1135 of the side wall of the pin 1131.
[0046] The collar 132 extends at the base of the conduit 131, perpendicular to the axis of revolution of the conduit 131. It is intended to come into contact with a second face of the support plate 12 opposite the first face opposite the upper face of the ultrasound unit 11. The collar 132 makes it possible to press the support plate 12 against the ultrasound unit 11 when the implantable medical device 1 is assembled.
[0047] Preferably, the collar 132 is circular in shape. This allows for better distribution of the force applied by the needle when it is inserted into the blind hole 1143 of the connection terminal 114.
[0048] The assembly principle of the implantable device 1 is as follows. An operator inserts the pin 1131 of the connection terminal 113 through the through-hole 122 of the support plate 12. Once the ultrasound unit 11 is in position on the first face of the support plate 12, the operator then places the fixing part 13 on the connection terminal 113. The fixing part 13 is installed on the pin 1141 so that the base of the conduit 131 (at the level of which the collar 132 extends) is opposite the second face of the support plate 12 (opposite the first face). The operator then screws the fixing part 13 onto the pin 1131, which causes the collar 132 to be pressed against the support plate 12: the ultrasound unit 11, the support plate 12 and the fixing part are then secured. This gives the implantable medial device 1 illustrated in figure 2 .
[0049] Advantageously, and as illustrated in the figure 6, the collar 132 may include the positioning mark making it easier for medical personnel to detect the connection terminal 113. The fact that the positioning mark is integrated into the fixing part 13 makes it possible to limit the modifications to be made to the device described in WO 2018 / 007500 to facilitate the detection of the connection terminal 113.
[0050] We will now describe in more detail various characteristics associated with the positioning marker according to the invention. 2.5. Positioning marker
[0051] Different solutions have been proposed for the positioning reference, including: an optical solution in which the positioning mark comprises two (or more) light sources - such as light-emitting diodes (LEDs) - surrounding the connection terminal, and / or an electromagnetic solution in which the positioning mark comprises one (or more) passive resonant electrical circuit(s) surrounding the connection terminal.
[0052] In any case, the location unit comprises one (or more) sensor(s) adapted to interact with the positioning reference. This (or these) sensor(s) may consist of: a light detector - such as a camera - when the positioning mark comprises optical markers, and / or a resonant circuit when the positioning mark comprises one (or more) active resonant electrical circuit(s).
[0053] The advantages associated with each of the solutions considered (optical / electromagnetic) for the positioning reference will now be presented with reference to the figures. 2.5.1. Optical solution 2.5.1.1. Principle
[0054] The optical solution uses the detection of light radiation emitted by light sources (such as LEDs) through the patient's scalp to detect the position of the connection terminal.
[0055] One (or more) light detector(s) - such as one (or more) camera(s) - is (are) located in the location unit (which may or may not be integrated into the connection means) and receives (receive) the light emitted by the light sources.
[0056] Due to diffusion through the scalp tissues, the light radiation emitted by each LED light source appears as “ stain » 5 on the detector(s), as shown in figure 7 .
[0057] The center of each spot 5 corresponds to the position of the light source having generated the light radiation associated with said spot.
[0058] To determine the position of the connection terminal 113 in the case of a positioning reference including three light sources each located at an equal distance from said connection terminal 113, the principle is as follows.
[0059] An operator moves the localization unit over the patient's scalp. The detector(s) acquire(s) one (or more) image(s) of the light radiation emitted by the light sources. This (or these images) can be displayed on display means such as a screen. Such an image is shown in figure 8 .
[0060] The center of each spot 51, 52, 53 is calculated - by a calculator which may be integrated (or not) into the localization unit - to estimate the position of each light source. Indeed, as indicated previously, the center of each spot is representative of the position of the light source having produced the spot. The centers thus calculated can be displayed on the image (or images) displayed on the display means.
[0061] The barycenter 54 of the centers of spots 51-53 is then calculated by the calculator to estimate the position of the connection terminal. More precisely, the barycenter of the centers of spots 51-53 is representative of the position of the connection terminal 113.
[0062] Using 3 LEDs, each making wide, separable spots, allows for precision far superior to the resolution of each spot.
[0063] While monitoring the camera, the operator moves the needle of the connection means to the center of the connection terminal, and inserts it into the patient's scalp to electrically connect the medical device 1 to the control unit 2. 2.5.1.2. Experimentation and results
[0064] An experiment was carried out to study: the influence of scalp thickness, and the effect of the wavelength of light radiation emitted by each light source.
[0065] For this experiment, a light-emitting diode was inserted into an agar phantom mimicking the optical behavior of the scalp. This agar phantom was composed of: one liter of water, 20g of powdered agar, 1.67g of titanium dioxide (TiO2), 0.19ml of India ink, and 1g of benzoic acid.
[0066] A Raspberry Pi PiNoIR camera (emulating the behavior of the localization unit) was used to capture the light that passed through the agar phantom. The results of this experiment are illustrated in figure 9 which represents a spot diameter at 50% light intensity as a function of the agar phantom thickness for light-emitting diodes (LEDs) of different wavelengths.
[0067] As the reader will appreciate on the figure 9 , the spot diameter increases with phantom thickness, suggesting a decrease in the position accuracy of the LED light source.
[0068] The combination of a light-emitting diode (LED) emitting light radiation at a wavelength of 1050nm and a phantom with a thickness of 16.16mm gives a spot with a diameter small enough (19.40mm) to distinguish three spots in the case of an implantable medical device 1 comprising three light-emitting diodes distributed at an equal distance from the connection terminal 113 and separated from each other by a distance of 25 millimeters).
[0069] For information purposes, tests were carried out with an implantable medical device 1 including a positioning marker comprising three light-emitting diodes (LEDs): emitting light radiation at a wavelength of 1050 nm (infrared), separated from each other by a distance of 25 millimeters, distributed at an equal distance from the connection terminal.
[0070] The location unit was able to locate the position of connection terminal 113: with an accuracy of 2.4 mm in 87% of cases, and with an accuracy of 3.2 mm in 100% of cases, for 30 tests carried out with two flat phantoms of thicknesses 9 mm and 14 mm and a non-flat phantom with a variable thickness between 6 mm and 13 mm.
[0071] Of course, the reader will appreciate that light sources emitting light radiation at longer wavelengths can be used to minimize the phenomenon of diffusion through the patient's scalp.
[0072] Furthermore, the reader will appreciate that light sources emitting light radiation at different wavelengths from each other can be used in the positioning reference frame. This makes it possible to detect the center of each spot (and therefore the position of each light source), even in the case of overlapping spots produced by different light sources. 2.5.2. Electromagnetic resonance solution
[0073] To detect the position of the connection terminal 113, the electromagnetic solution uses an impedance variation when two resonant circuits interfere.
[0074] For the implementation of the electromagnetic solution, several resonant electrical circuits are arranged in the localization unit and in the implantable medical device 1.
[0075] More precisely : the positioning marker of the implantable medical device comprises: ∘ a passive resonant electrical circuit including a coil surrounding the connection terminal 113, or ∘ several passive resonant electrical circuits each including one (or more) respective coil(s), said coils being distributed around the connection terminal 113 at an equal distance therefrom, the location unit comprises one (or more) active resonant electrical circuit(s) each including one (or more) coil(s) arranged (distributed) on a surface intended to come into contact with the patient's scalp.
[0076] The fact that the positioning marker comprises a resonant electrical circuit including a coil - rather than a permanent magnet - makes the treatment apparatus according to the invention compatible with magnetic resonance imaging (MRI) techniques.
[0077] If the optical solution makes it possible to detect the position of the connection terminal with great precision (±1.6mm), the electromagnetic solution makes it possible to have information concerning the orientation of the connection terminal, which further facilitates the operator's action to insert the end of the transdermal needle 32 into the connection terminal113. 2.5.2.1. Principle
[0078] The electromagnetic solution uses impedance variation when two resonant circuits are close enough to interfere, or when the impedance of a circuit including a coil is changed by the presence of a metal or a magnet.
[0079] The principle of the electromagnetic solution is to use the variation caused by electromagnetic induction when moving the localization unit above the implantable medical device to locate the position of the connection terminal 113.
[0080] Specifically, a primary coil (contained in the localization unit) induces an electromagnetic field directed toward a secondary coil (contained in the implantable medical device). When the primary and secondary coils are brought together, the power transmission to the secondary coil causes a loss in the resonant electrical circuit including the primary coil. By detecting the corresponding variation in the primary circuit, the location of the connection terminal can be deduced.
[0081] The principle of the electromagnetic solution is well known and has been described in numerous documents, such as US 5,697,377. 2.5.2.2. Experimentation and results
[0082] An experiment was carried out to study the accuracy in detecting the connection terminal using the electromagnetic solution.
[0083] The implantable medical device included a resonant electrical circuit comprising: a 5-turn coil having a diameter of 2.5 cm integrated into the collar 132 of the fixing part 13, a capacitor mounted in parallel whose value was chosen to obtain a resonant circuit having a resonant frequency of 16.5 MHz.
[0084] This implantable medical device was inserted into an agar phantom mimicking the behavior of the scalp. This agar phantom was composed of: 80 cl of water, 20 g of glycine, 0.6 g of sodium chloride (NaCl), and 1.6 g of agar powder.
[0085] Two types of localization units were tested: the first localization unit comprised a coil identical to that contained in the resonant circuit of the implantable medical device and a capacitor connected in parallel and whose value was chosen to obtain a resonant circuit having a resonant frequency of 16.5 MHz (resonant frequency identical to the resonant frequency of the resonant circuit contained in the implantable medical device), the second localization unit comprised a spiral coil (interesting shape for energy transmission) of 18 turns and an external diameter approximately equal to 3 cm, and a capacitance adjusted to have a resonant frequency equal to 16.5 MHz (resonant frequency of the resonant circuit contained in the implantable medical device).
[0086] The fact that the coils (contained in the implantable medical device and in the localization unit) are respectively associated with capacities made it possible to obtain resonant circuits at the same frequency in the medical device on the one hand and in the localization unit on the other hand.
[0087] The inventors have in fact discovered that the use of resonant circuits allowed: to improve the efficiency of the coupling between the medical device and the localization unit, and to improve the detection capacity of this coupling, compared to solutions based on the use of a coil and a magnet for example.
[0088] The accuracy in detecting the position of the connection terminal was lower than that obtained with the optical solution.
[0089] However, the inventors discovered that the combination of the two solutions made it possible to facilitate the connection of the transdermal needle to the connection terminal 113, in particular by providing precise information on the position of the connection terminal (optical solution) and on its orientation (electromagnetic solution).
[0090] Furthermore, the use of resonant circuits as proposed with the electromagnetic solution makes it possible to electrically power the implantable medical device by induction. It is therefore no longer necessary for batteries to be integrated into it for the implementation of the optical solution. 3. Location unit
[0091] As previously indicated, the location unit may be integrated into the connection means or separated from them. In particular, the location unit may be integrated: to the connection means, or to a tool intended to be fixed to the connection means, or to an intermediate tool totally independent of the connection means and allowing the operator to locate the implant.
[0092] In an alternative embodiment, the location unit is integrated into a tool including a preemption handle and the location unit comprising proximity sensors capable of interfering with the positioning marker contained in the implantable medical device.
[0093] Proximity sensors assess the alignment of the handle with the medical device, in order to detect the position of the connection terminal and thus facilitate the insertion of the transdermal needle into it.
[0094] In operation, the operator can mark the needle insertion location on the skin with a felt-tip pen, then remove the intermediate tool and puncture the skin at the mark. 4. Example of implementation
[0095] In reference to the figure 10 an example of implementation of the treatment apparatus has been illustrated. More specifically, examples of electronic circuits integrated in the medical device 1 on the one hand, and in the localization unit 6 on the other hand have been illustrated.
[0096] The medical device comprises an LC resonant circuit (including a 3.7µH coil L2 mounted in parallel with a capacitance C2 of 6.8nF), and three LED-type light sources D1, D2, D3 each mounted in parallel with the LC resonant circuit. This electronic circuit is integrated into the fixing part, in particular in the collar.
[0097] The localization unit 6 comprises a camera (not shown), a generator B, a resistor R gene connected in series with the generator B, and an LC resonant circuit (including a coil L1 of 3.7µH connected in parallel with a capacitance C1 of 6.8nF) connected to the generator B. 5. Principle operating
[0098] The operating principle of the treatment device described above is as follows.
[0099] At each new treatment session, an operator moves the localization unit close to the patient's head.
[0100] For better detection or to limit the energy to be supplied to the resonant circuit, it is possible to slide the localization unit over the patient's scalp. Indeed, to supply electrical energy to light sources by induction, it is preferable to limit the distance between the resonant circuit of the localization unit and the resonant circuit contained in the medical device.
[0101] To prevent contamination, the localization unit may be covered with a sterile envelope, such as a " Ultrasound Probe Cover » developed by the company CIVCO.
[0102] The localization unit is moved over the patient's head. When a maximum impedance disturbance is detected at the localization unit, it emits a signal (visual or audible, etc.) to warn the operator of the position of the connection terminal. The electromagnetic energy transmitted by the resonant circuit of the localization unit is used to inductively power the light sources of the positioning marker.
[0103] The detector of the localization unit acquires an image of the light spots produced by the light sources contained in the medical device. The calculator of the localization unit calculates the centers of the spots (representative of the positions of the light sources), and estimates the position of the barycenter of the centers of the spots (representative of the position of the connection terminal). This various information can be displayed on the display means.
[0104] The operator can then take a marker (such as a felt-tip pen) and mark the position of the barycenter which corresponds to the position of the point to be punctured with the transdermal needle.
[0105] The reader will have understood that many modifications can be made to the treatment device described above without departing from the teachings presented here.
[0106] For example, even if the device was presented with reference to an implantable medical device allowing the treatment and / or imaging of a brain area of interest by ultrasound, it is quite obvious that: The implantable medical device may be configured for the treatment and / or imaging of another tissue of interest in the human or animal body. The implantable medical device may include a treatment unit based on a technology other than ultrasound.
[0107] Furthermore, the various components enabling the implementation of the optical and electromagnetic solutions presented above can be reversed in the implantable medical device and in the localization unit. In particular, the implantable medical device can integrate a camera and an active resonant electrical circuit, while the localization unit integrates light sources and a passive resonant circuit.
Claims
1. An apparatus for treating a pathology comprising: - a device (1) implantable at an opening made in the cranium of a patient, the implantable device (1) including a treatment unit (11) having upper and lower faces and including an electrical connection terminal (114) extending on the upper face, - a remote-control unit (2) for determining and controlling operating parameters of the implantable device (1), and delivering electricity thereto, - electrical connection means (3) for electrically connecting the treatment unit (11) to the remote-control unit via the electrical connection terminal (114), characterised in that the implantable device comprises a positioning indicator in order to facilitate detection of the position of the electrical connection terminal (114), said positioning indicator comprising at least two light sources, such as light-emitting diodes, each capable of emitting light radiation towards the outside of the upper face, the electrical connection terminal (114) extending between said light-emitting diodes.
2. The apparatus according to claim 1, wherein the wavelength of the light radiation emitted by each light-emitting diode is comprised between 600 and 1600 nanometres, preferably comprised between 850 and 1250 nanometres, and even more preferably comprised between 950 and 1100 nanometres, in particular of the order of 1050 nanometres.
3. The apparatus according to any one of claims 1 or 2, wherein the distance between the light-emitting diodes is comprised between 15 and 60 millimetres, preferably comprised between 20 and 40 millimetres, in particular of the order of 25 millimetres.
4. The apparatus according to any one of claims 1 to 3, wherein the distance between each light-emitting diode and the connection terminal is comprised between 9 and 35 millimetres, preferably comprised between 12 and 25 millimetres, in particular of the order of 15 millimetres.
5. The apparatus according to any one of claims 1 to 4, wherein each light-emitting diode is configured to emit light radiation having a respective wavelength different from the wavelengths of the other light-emitting diodes.
6. The apparatus according to any one of claims 1 to 5, wherein each light-emitting diode is configured to emit light radiation having a respective intensity different from the intensities of the other light-emitting diodes.
7. The apparatus according to any one of claims 1 to 6, wherein the positioning indicator further comprises at least one resonant passive electrical circuit.
8. The apparatus according to claim 7, wherein said and at least one resonant passive electrical circuit is configured to interact with a resonant active electrical circuit integrated into a location unit, said interaction allowing to supply the implantable medical device with electrical energy by induction.
9. The apparatus according to claim 8, wherein said and at least one resonant passive electrical circuit comprises a coil functionally coupled to a capacitor, said coil extending around the electrical connection terminal (114).
10. The apparatus according to any one of claims 7 to 9, wherein said and at least one resonant passive electric circuit is configured so that the resonance frequency of said and at least one resonant passive electric circuit is comprised between 10 MHz and 50 MHz.
11. The apparatus according to any one of claims 1 to 10, wherein the implantable device (1) comprises: - a support plate including first and second opposite faces, the treatment unit (11) being intended to be mounted on the first face of the support plate (12), - a fixing part (13) intended to be positioned on the second face of the support plate (12) and being configured to press the treatment unit (11) against the first face of the support plate (12) when the treatment unit (11), the support plate (12) and the fixing part (13) are assembled, and wherein said fixing part includes the positioning indicator.
12. The apparatus according to claim 11, wherein: - the support plate (12) comprises a through orifice (122), - the electrical connection terminal (114) comprises a pin (1141) projecting outwards from the treatment unit, the pin being intended to be positioned in the through orifice of the support plate, - the fixing part (13) comprises: ∘ a conduit (131) adapted to receive at least a portion of the pin (1141), and ∘ a peripheral flange (132) extending perpendicular to a longitudinal axis of the conduit (131), the flange (132) being intended to be positioned on the second face of the support plate (12), and wherein said peripheral flange includes the positioning indicator.