Instrument, robotic otological surgery installation and method for the intracochlear insertion of a cochlear implant electrode

Abstract

This otological surgical instrument (66), for inserting an intracochlear electrode into a patient's inner ear, comprises a main body (68) with a proximal portion (68B) for attachment to a robotic arm and a distal portion (68A) for holding a support device (38) to which the intracochlear electrode is attached by a sliding connection during insertion. The proximal attachment portion (68B) has a hole (74) for the passage of a robotic sliding rod of the robotic arm. The instrument (66) further comprises a sliding element (70) within the main body (68). This sliding element (70) has a proximal portion configured and arranged within the proximal attachment portion (68B) so as to be driven longitudinally by the robotic sliding rod, and a distal portion (70A) configured and arranged so as to drive the intracochlear electrode longitudinally along the axis of its sliding connection.Figure for the abridged version: Fig. 8.

Description

Title of the invention: Instrument, robotic installation for otological surgery and method for the intracochlear insertion of a cochlear implant electrode

[0001] The present invention relates to an otological surgical instrument for inserting an intracochlear electrode of a cochlear implant into the inner ear of a patient. It also relates to a robotic system with an articulated arm carrying such a surgical instrument and a method for inserting an intracochlear electrode into an operating area using such a robotic system.

[0002] A cochlear implant comprises an external part and an internal part, both made up of several elements. The external part, intended to be worn on the ear and against the skin of the patient's skull, generally includes at least one microphone that captures ambient sound and converts it into an electrical signal, a processor that filters the received information, notably to prioritize the processing of speech, and an electromagnetic induction transmitter. The internal part comprises a receiver placed under the skin opposite the transmitter, electrically connected to an intracochlear electrode intended to be placed in the spirally coiled scala tympani of the patient's cochlea using a carrier device to which it is attached by a sliding connection during insertion.The intracochlear electrode is a soft and elastic element, usually integrated into a cylindrical silicone sheath with a pre-formed spiral distal end, which is then difficult to insert into the inner ear during the surgical procedure required to install the internal part of the implant in the patient, even with the help of the carrier device usually provided with the implant.

[0003] The intracochlear electrode is also called an "electrode holder" because it has at its distal end a plurality of conductive terminations, or "electrodes," encased in silicone. However, in the context of the present invention, and to avoid confusion with the support device used to temporarily hold it in place during insertion to facilitate the surgical procedure, the term "electrode holder" will not be used.

[0004] An example of an otological surgical instrument for inserting a cochlear implant electrode into a patient's inner ear is described, for example, in patent document EP 3 513 834 AL II. It has, in its distal part, a cannula into which the cochlear electrode is directly installed by means of a sliding connection before the procedure, and a piston allowing it to be pushed during the procedure for its extraction from the cannula and its insertion into the cochlea. patient. It also features a cylindrical proximal portion for gripping that can be directly grasped by a surgeon. Alternatively, this cylindrical proximal portion can be hooked onto a robotic arm, although it is not specifically designed for this purpose. The instrument itself is quite complex to manufacture, and the manipulation required to push the distal end of the electrode into the cochlea remains subject to the inherent uncertainties of the surgical procedure. Furthermore, this instrument does not allow for the use of the carrier device usually supplied with the intracochlear electrode, as it replaces it.

[0005] Another example of a robotic setup for inserting a cochlear implant electrode into a patient's cochlea is described in US patent document 8,594,799 B2. The setup is illustrated in this document, but the instrument for holding the intracochlear electrode is not detailed. It is stated that a conventional insertion instrument can be used, without specifying which one and without actually explaining how. In this example, too, it does not appear that the instrument allows for the advantageous use of the holder device generally supplied with the intracochlear electrode.

[0006] The invention thus applies more particularly to an otological surgery instrument comprising a main body with a proximal portion for fixing to an articulated robot arm and a distal portion for holding a carrier device to which the intracochlear electrode is fixed in a sliding connection during insertion.

[0007] An example of such an ingeniously simple instrument is described in patent document WO 2021 / 079058 AL II. It has the advantage of freeing the surgical procedure from a first constraint by automating the holding and movement of the instrument, as well as from a second constraint by maintaining the device holding the intracochlear electrode. Of course, it also has the advantage of taking advantage of the device itself, which provides real assistance in inserting the electrode into the patient's cochlea. On the other hand, the actual insertion of the intracochlear electrode into the scala tympani by sliding it out of the device remains a very precise and delicate surgical procedure subject to certain risks.

[0008] It may then be desirable to provide an otological surgical instrument which makes it possible to overcome at least some of the aforementioned problems and constraints.

[0009] An otological surgical instrument is therefore proposed for the insertion of an intracochlear electrode into the inner ear of a patient, comprising a main body with a proximal portion for attachment to an articulated robotic arm and a distal portion for retaining a carrier device to which the intracochlear electrode is attached by a sliding connection during insertion, wherein the proximal attachment portion has a hole for the passage of a robotic sliding rod of the articulated arm. robot, the instrument further comprising a sliding element within the main body and featuring: - a proximal portion configured and arranged within the proximal attachment portion of the main body so that it can be driven longitudinally by the robotic sliding rod of the articulated robot arm to which the proximal attachment portion of the main body is intended to be fixed; and - a distal portion configured and arranged so as to be able to longitudinally drive the intracochlear electrode along the axis of its sliding connection when the electrode is fixed to the carrier device and the latter is held by the distal portion of the main body.

[0010] Thus, the insertion of the intracochlear electrode into the scala tympani of the patient's inner ear can be fully automated without any risk of surgical intervention and by fully utilizing the provided delivery device. Nevertheless, delicate manual actions for capturing and releasing the delivery device remain necessary before and after the operation. However, these two actions can tolerate some minor errors without endangering the patient: capture because it can be performed remotely from the surgical area, and release because it can be performed when the intracochlear electrode is completely removed from its delivery device. Furthermore, these actions are facilitated by the fact that the proximal portion of the instrument remains held by a robotic arm, thus freeing both of the surgeon's hands.

[0011] Optionally: - the proximal portion of the sliding organ is more precisely positioned so that it can be pushed by the robotic sliding rod; and - the distal portion of the sliding organ is more precisely configured and arranged to come against a proximal end of the intracochlear electrode.

[0012] Optionally also, the proximal portion of the sliding organ is a cylindrical rod disposed in a main axis of the proximal fixing portion of the main body, this axis also being a thrust axis of the robotic sliding rod of the articulated robot arm to which the proximal fixing portion of the main body is intended to be fixed.

[0013] Optionally also, the distal portion of the sliding organ is straight and parallel offset from the main axis of the proximal fixing portion of the main body to pass over the distal holding portion of the main body, a deviated median portion connecting the proximal and distal portions of the sliding organ.

[0014] Optionally also, the distal portion of the sliding organ is in the form of a distal end gutter intended to come against the proximal end of the intracochlear electrode, in particular against a marking ring of the intracochlear electrode.

[0015] Optionally also, two curved lateral walls extend locally from edges of the groove formed by the distal portion of the sliding organ, locally extending its section in an arc of a circle, for pinching a distal end of an electrical connection of the intracochlear electrode.

[0016] Optionally also, the proximal fixing portion of the main body comprises a cylindrical sleeve having a locking groove of semi-circular cross-section hollowed longitudinally in its external face and ending in a partially spherical cavity of greater depth.

[0017] Optionally also, the distal portion for retaining the main body has a gutter shape and includes a gripping element for gripping the carrier device, in particular a gripping element which takes the form of a fork with two fixed and rigid teeth obtained by the gutter shape of the distal portion for retaining and by drilling a slot in the bottom of this gutter.

[0018] A robotic surgical intervention system is also proposed, comprising: - a robot equipped with an articulated arm that can be moved electronically and a robotic sliding rod within the articulated arm, also movable electronically; and - an otological surgery instrument according to the invention; in which the articulated arm of the robot has complementary fixing means capable of cooperating with the fixing means of the otological surgery instrument.

[0019] A method for inserting an intracochlear electrode into an operating area is also proposed, using a robotic installation according to the invention, comprising the following steps: - installation of the intracochlear electrode by fixing in a sliding connection and in a retracted configuration in a corresponding carrier device, maintaining the carrier device in the distal portion of the main body of the otological surgery instrument and fixing the latter by the proximal portion of its main body to the articulated arm of the robot; - electronic and / or software control of the robotic installation to approach a distal end of the device carrying an operating area according to a predetermined alignment; - electronic and / or software control of the robotic installation to insert the distal end of the carrier device into the operating area along the predetermined alignment; - deployment of a distal end of the intracochlear electrode into the operative area by sliding drive using the electronically and / or software-controlled robotic sliding rod; - longitudinal withdrawal of the carrier device over a predetermined distance until it is completely detached from the intra-cochlear electrode by coordinated displacement of the intra-cochlear electrode over this distance, by electronically and / or software controlled drive using the robotic sliding rod, and of the carrier device over this same distance but in the opposite direction, by electronically and / or software controlled withdrawal of the articulated arm.

[0020] The invention will be better understood with the aid of the following description, given solely by way of example and made with reference to the accompanying drawings in which: - Figure [1] illustrates an example of the internal part of a cochlear implant, - Figure 2 illustrates the detail of an intracochlear electrode of the part internal cochlear implant of the [Fig.1], - Figure 3 illustrates the intracochlear electrode of Figure 2 when it is fixed via a sliding connection within a corresponding carrier device for insertion into the inner ear of a patient, in a first retracted configuration, - Figure [Fig. 4] illustrates the intracochlear electrode and the carrier device in the configuration of Figure [Fig. 3] when correctly inserted into the patient's inner ear, - Figure 5 illustrates the intracochlear electrode and the device carrying the [Fig.3], in a second deployed configuration of the electrode, - Figure 6 illustrates the intracochlear electrode and the carrier device in the configuration of [Fig. 5] when correctly inserted into the patient's inner ear, - Figure 7 schematically and in perspective represents the general structure of an otological surgical instrument according to a first embodiment of the invention, when it holds an intracochlear electrode and its carrying device in the deployed configuration of the electrode, - Figure 8 schematically represents, in perspective, the structure general of an otological surgical instrument according to a second embodiment of the invention, when it maintains the device carrying an intracochlear electrode, - Fig. 9 schematically represents, in lateral view, the general structure of a sliding organ of the otological surgical instrument of Fig. 8; - Fig. 10 schematically represents, in lateral view, the sliding organ of Fig. 9 mounted on a distal support of a main body of the otological surgical instrument of Fig. 8. - [Fig. 11] schematically represents, in lateral view, the sliding organ and the distal support of [Fig. 10] fitted into a proximal portion of the main body of the otological surgical instrument of [Fig. 8], - [Fig.12] is a transparent representation of [Fig.11], - [Fig. 13] is a lateral view of the otological surgical instrument of the [Fig.8] - [Fig. 14] is a longitudinal section of the otological surgical instrument from [Fig. 8], - Figure 15 schematically represents in cross-section the general structure of a free end of an articulated surgical robot arm, equipped with a robotic sliding rod, - Figure 16 schematically represents in perspective the general structure of a robotic surgical intervention system, according to one embodiment of the invention, and - [Fig. 17] illustrates the successive steps of a procedure for inserting an intracochlear electrode into a patient's ear, using the robotic installation of [Fig. 16].

[0021] The internal part 20 of the cochlear implant illustrated in [Fig. 1] comprises an electromagnetic receiver 22 with a coil 24 connected to an intracochlear electrode 26 by means of an electrical connection 28. The electromagnetic receiver 22 and its coil 24 are intended to be placed under the skin of a patient opposite the transmitter of the external part not shown. The intracochlear electrode 26 is intended to be placed in the scala tympani of the patient's cochlea. Various models of internal parts of cochlear implants are available on the market. The one illustrated in [Fig. 1], marketed under the reference CI632 by Cochlear (registered trademark), also features a second reference electrode 30, which is also electrically connected to the electromagnetic receiver 22.

[0022] The intracochlear electrode 26 is enlarged and illustrated more precisely in [Fig. 2]. It extends with a slight lateral offset but parallel to the free end of the electrical connection 28. The latter comprises a twisted conducting wire, sheathed in a cylindrical silicone casing, which extends linearly, following the slight lateral offset, into the intracochlear electrode 26, itself sheathed in a cylindrical silicone casing molded with that of the electrical connection 28. A thinner silicone envelope Z zone ensures and materializes the aforementioned lateral offset between the free end of the electrical connection 28 and the intracochlear electrode 26.

[0023] The intracochlear electrode 26 is flexible and elastic, with a spirally preformed distal end 26A and a proximal end 26B extending along a common length with the distal end 28A of the electrical connection 28 along the thinner Z-zone. The distal end 26A has a plurality of openings or "windows" 32 aligned in the spirally preformed silicone sheath to form as many electrical contacts, or elementary "electrodes," for interacting with the patient's cochlear nerve. The proximal end 26B has two contact areas against which the intracochlear electrode 26 can be pushed linearly to the right (according to the orientation of [Fig. 2]). A first potential contact area consists of a marking ring 34 surrounding the distal end 28A of the electrical connection 28.A second potential contact zone is formed by the rounded frontal face 36 of the proximal end 26B of the intracochlear electrode 26 itself. Of course, other contact zones against which it is possible to come into contact can be considered depending on the model of intracochlear electrode chosen, which is not necessarily the CI632 model of Figures 1 and 2 illustrated as a non-limiting example.

[0024] Figure 3 illustrates the intracochlear electrode 26 when it is fixed by a sliding connection and integrated into a corresponding carrier device 38 for insertion into the patient's inner ear. This carrier device 38 essentially consists of a longitudinally split tube 40, into which the intracochlear electrode 26 can be fully inserted by sliding, and a grasping fin 42 facilitating its handling. The longitudinal split of the tube 40 is sufficiently wide to allow passage of the thinner silicone sheath Z zone, so that the intracochlear electrode 26 can be fully extended inside the tube 40, in particular its distal end 26A, which temporarily loses its spiral shape, while maintaining the electrical connection 28 outside, in particular its distal end 28A surrounded by the marking ring 34.

[0025] The carrier device 38 also has a marking ring 44. In In the illustration of [Fig. 3], where the intracochlear electrode 26 is retracted into the tube 40, the marking ring 34 is set back to the left relative to the marking ring 44. The carrier device 38 further has a second marking 46, located at a predetermined distance from its distal end 38A, indicating how far it can be inserted into the patient's cochlea for deployment. subsequent to the intracochlear electrode 26. The grasping fin 42 is preferably located at the proximal end 38B of the carrier device 38.

[0026] Figure 4 illustrates the intracochlear electrode 26, more specifically its distal end 26A, and the carrier device 38, more specifically its distal end 38A, in the configuration of Figure 3 when correctly inserted into the patient's inner ear. Figure 4 more precisely illustrates a model of the spiral cochlea 48 and tympanic ramp 50 in which the distal end 38A of the carrier device 38 is inserted until its second marking 46 reaches the base of the tympanic ramp 50.

[0027] Figure 5 still illustrates the intracochlear electrode 26 when it is fixed in a sliding connection and integrated into the carrier device 38. But unlike Figure 3, in this figure the intracochlear electrode 26 has been pushed to the right by sliding in the carrier device 38 until its marking ring 34 reaches the marking ring 44 of the carrier device 38. In this deployed configuration of the intracochlear electrode 26, its distal end 26A extends outside the distal end 38A of the carrier device 38 so as to be able to resume its spiral shape.

[0028] Fig. 6 illustrates the intracochlear electrode 26, more specifically its distal end 26A, and the carrier device 38, more specifically its distal end 38A, in the configuration of Fig. 5 when properly inserted into the patient's inner ear. Figure 6 more precisely illustrates the spiral cochlea 48 and tympanic ramp 50 model into which the distal end 38A of the carrier device 38 is inserted until its second marking 46 reaches the base of the tympanic ramp 50. By comparison with Figure 4, it can be seen that the distal end 26A of the intracochlear electrode 26 was able to be progressively released, resuming its spiral shape within the corresponding spiral shape of the base of the tympanic ramp 50. It can also be seen that the distal end 38A of the carrier device has maintained its position almost unchanged within the patient's cochlea 48.

[0029] The operation of inserting the carrier device 38 into the patient's cochlea until the second marking 46 reaches the base of the tympanic ramp 50, while the intracochlear electrode 26 is fixed there in a sliding connection and in a retracted configuration (see [Fig. 4]), then progressively deploying the distal end 26A of the intracochlear electrode 26 out of the carrier device 38 by sliding push until the marking ring 34 reaches the marking ring 44, thus indicating that the distal end 26A of the intracochlear electrode 26 has reached the bottom of the tympanic ramp 50 (see [Fig. 6]), then withdrawing the carrier device 38 while maintaining the intracochlear electrode in the patient's cochlea, is known when performed manually or using the instrument of patent document WO 2021 / 079058 Al, but delicate and risky.

[0030] The otological surgical instrument 52, schematically represented in [Fig. 7], according to a first embodiment of the present invention, facilitates this operation by cleverly automating it. It comprises, for this purpose, a main body 54 with a distal portion 54A for retaining the carrier device 38 to which the intracochlear electrode 26 is attached by a sliding connection during insertion, a proximal portion 54B for attachment to an articulated robot arm, and a medial portion 54C for retaining a sliding component 56.

[0031] The proximal fixation portion 54B, in the form of a cylindrical sleeve, comprises specific means 58 for achieving this fixation, for example materialized by a simple locking groove 58 of semi-circular cross-section hollowed longitudinally in its external face and terminating in a partially spherical cavity of greater depth in accordance with the teaching of patent document WO 2014 / 080113 AL

[0032] The cylindrical sleeve 54B further has a cylindrical through hole 60, for example of square cross-section in the non-limiting example of [Fig.7], formed along a longitudinal direction extending around a principal axis D of the main body 54. This through hole 60 is intended to allow the passage of a robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 54B is intended to be fixed, along a principal axis of translation which is the axis of revolution of its cylindrical shape and which also corresponds to the principal axis D of the main body 54.

[0033] The central portion 54C, which retains the sliding member 56, is primarily gutter-shaped, centered on the main axis D, and has a smaller diameter than the cylindrical sleeve 54B. This gutter is extended by the distal portion 54A, which closes the gutter into a cylinder. At its distal end, this cylinder opens into a gripping member 62 for clamping the carrier device 38. More precisely, this gripping member 62 is forked with two fixed and rigid prongs formed by the distal gutter opening of the distal portion 54A and by drilling a slot in the bottom of this gutter. The carrier device 38 is held in this slot by its gripping fin 42, while its proximal end 38B, with an outer diameter corresponding to the inner diameter of the distal gutter, fits into the latter.

[0034] The sliding member 56, for its part, has: - a proximal portion 56B configured and disposed at least partially in the cylindrical sleeve 54B for fixing the main body so as to be able to be driven longitudinally by the robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 54B of the main body is intended to be attached, and - a distal portion 56A configured and arranged so as to be able to longitudinally drive the intra-cochlear electrode 26 along the axis of its sliding connection when the electrode is fixed to the carrier device 38 and the latter is held by the distal portion 54A of the main body 54.

[0035] In the more precise but non-limiting example of [Fig.7], the proximal portion 56B of the sliding organ 56 is more precisely arranged so that it can be pushed by the robotic sliding rod along the axis D into the cylindrical sleeve 54B.

[0036] In the more precise but not limiting example of [Fig. 7] also, the sliding member 56 has three deviated portions. The proximal portion 56B is a straight cylindrical rod in the axis D, which is also that of the groove formed by the median portion 54C of the main body 54. The distal portion 56A is straight and parallel to the axis D to pass over the distal portion 54A of the main body 54. A deviated median portion 56C connects the two aforementioned portions 56A and 56C.

[0037] The distal end of the distal portion 56A of the sliding organ 56 has a grasping element 64 for gripping the distal end 28A of the electrical connection 28 of the intracochlear electrode 26. More precisely, it is a grooved element 64, i.e., a hollow cylindrical shape with a longitudinal opening along its entire length, this groove being laterally positioned against the free end of the distal portion 56A. This allows the distal end 28A of the electrical connection 28 to be captured and held within the internal volume of the hollow, open cylinder formed by the groove 64. The longitudinal opening is wide enough to easily capture the distal end 28A of the electrical connection 28 but also narrow enough to hold it during the insertion of the intracochlear electrode into the patient's inner ear.In other words, the edges of the gutter 64 are advantageously folded towards each other to form in section an arc of a circle slightly larger than the semicircle. It can also come to rest against the marking ring 34.

[0038] Thanks to the surgical instrument 52, the insertion of the carrier device 38 into the patient's cochlea until the second marking 46 reaches the base of the tympanic ramp 50, while the intracochlear electrode 26 is fixed there in a sliding connection and in a retracted configuration (see [Fig. 4]), can be carried out robotically and safely by attaching the cylindrical sleeve 54B to an articulated robot arm and then actuating the articulated arm. The operation of progressively deploying the distal end 26A of the intracochlear electrode 26 out of the carrier device 38 By sliding the electrode 56 until the marking ring 34 reaches the marking ring 44, thus indicating that the distal end 26A of the intracochlear electrode 26 has reached the bottom of the scala tympani 50 (see [Fig. 6]), the removal can also be carried out robotically and safely by longitudinally pushing the sliding element 56, and therefore the intracochlear electrode 26, using the robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 54B is intended to be attached. Finally, the removal of the carrier device 38 while maintaining the intracochlear electrode 26 in the patient's cochlea can also be carried out robotically and safely by a combined action of additional longitudinal pushing of the sliding element 56 using the robotic sliding rod of the articulated robot arm, and corresponding longitudinal retraction of the articulated arm itself.

[0039] The otological surgical instrument 66, schematically represented in [Fig. 8], according to a second embodiment of the present invention, also facilitates the three aforementioned operations. It comprises, for this purpose, a main body 68 with a distal portion 68A for retaining the support device 38, to which the intracochlear electrode 26 (not shown in [Fig. 8]) is attached by a sliding connection during insertion, a proximal portion 68B for attachment to an articulated robot arm, and a median portion 68C for retaining a sliding organ 70.

[0040] The proximal fixation portion 68B, in the form of a cylindrical sleeve, includes specific means 72 for achieving this fixation, for example identical to the corresponding means 58 of the first embodiment of [Fig.7].

[0041] The cylindrical sleeve 68B further has a cylindrical through hole 74, for example of circular cross-section in the non-limiting example of [Fig.8], formed along a longitudinal direction extending around a principal axis D' of the main body 68. This through hole 74 is intended to allow the passage of a robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 68B is intended to be fixed, along a principal axis of translation which is the axis of revolution of its cylindrical shape and which also corresponds to the principal axis D' of the main body 68.

[0042] The central portion 68C for retaining the sliding member 70 is primarily gutter-shaped, centered on the main axis D', with a smaller diameter than the cylindrical sleeve 68B. This gutter is extended by the distal portion 68A, which extends to its distal end into a gripping member 76 for clamping the carrier device 38. This gripping member 76 is more precisely shaped like a fork with two fixed and rigid prongs, obtained by the distal gutter shape of the distal portion 68A and by drilling a slot in the bottom of this gutter. The carrier device 38 is held in this slot by clamping its gripping fin 42, while its proximal end 38B, with an outer diameter corresponding to the inner diameter of the distal gutter, is housed in the latter. The gutter formed by the median 68C and distal 68A portions of the main body 68 is furthermore of a section whose diameter decreases slowly from its proximal end to its distal end, thus giving it a slightly hemitronical profile.

[0043] The sliding member 70, for its part, is shown alone in a side view in [Fig. 9]. It features: - a proximal portion 70B configured and disposed at least partially in the cylindrical sleeve 68B for fixing the main body 68 so as to be able to be driven longitudinally by the robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 68B of the main body is intended to be fixed, and - a distal portion 70A configured and arranged so as to be able to longitudinally drive the intra-cochlear electrode 26 along the axis of its sliding connection when the electrode is fixed to the carrier device 38 and the latter is held by the distal portion 68A of the main body 68.

[0044] In the more precise but non-limiting example of figures 8 to 14, the proximal portion 70B of the sliding member 70 is more precisely a cylindrical rod arranged in the extension of the robotic sliding rod along the axis D' in the cylindrical sleeve 70B, so as to be able to be pushed by the latter.

[0045] In the more precise but not limiting example of Figures 8 to 14 also, the distal portion 70A of the sliding organ 70 is in the form of a gutter, also ending for example in a fork by the drilling of a slot at the bottom of this gutter, slot in which for example the thinner Z zone of the intracochlear electrode 26 is housed so that the two teeth of the fork thus formed come against the marking ring 34. Two curved lateral walls 78 can in addition extend locally from the edges of the gutter formed by the distal portion 70A, locally extending its cross-section in an arc of a circle, for a retention by pinching of the distal end 28A of the electrical connection 28 of the intracochlear electrode 26.

[0046] As illustrated in [Fig.9] in a non-limiting manner, the distal portion 70A of the sliding organ 70 can be brought against its proximal portion 70B over a certain length L by fixing with pins 80.

[0047] Fig. 10 also represents, in lateral view, the sliding organ 70 when mounted in the groove formed by the median 68C and distal 68A portions of the main body 68. It is necessary to check at this stage of the assembly of the surgical instrument 66 that the cylindrical rod forming the proximal portion 70B of the sliding organ 70 slides correctly in the median portion 68C of the main body 68 and without coming out of the main axis D'.

[0048] Fig. 11 also represents, in lateral view, the sliding organ 70 when mounted in the groove formed by the median 68C and distal 68A portions of the main body 68 and when the whole is fitted into the cylindrical sleeve 68B to form the surgical instrument 66.

[0049] The transparent view of [Fig. 12] shows that a piston 82 can be mounted to slide inside the cylindrical sleeve 68B, which is fixed to the cylindrical rod 70B, and returned to a default position at the proximal end of the cylindrical sleeve 68B by means of return means such as a spring 84 extending in a bore of the cylindrical sleeve 68B around the cylindrical rod 70B. It is this piston 82 that is specifically intended to be pushed by the robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 68B of the main body 68 is intended to be attached.

[0050] After inserting the gripping fin 42 of the carrier device 38 between the two teeth of the forked distal end 76 of the distal portion 68A of the main body 68, the device is obtained which [Fig. 13] illustrates in lateral view and which [Fig. 14] illustrates in longitudinal section. It can be seen that the carrier device 38 is correctly positioned and held in the axis D' of the surgical instrument 66, that is to say, in the thrust axis of the robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 68B is intended to be attached.

[0051] Thanks to the surgical instrument 66, the insertion of the carrier device 38 into the patient's cochlea 48 until the second marking 46 reaches the base of the tympanic ramp 50, while the intracochlear electrode 26 is fixed there in a sliding connection and in a retracted configuration (see [Fig. 4]), can be carried out robotically and safely by attaching the cylindrical sleeve 68B to an articulated robot arm and then actuating the articulated arm. The progressive deployment of the distal end 26A of the intracochlear electrode 26 out of the carrier device 38 by sliding push until the marking ring 34 reaches the marking ring 44, thus indicating that the distal end 26A of the intracochlear electrode 26 has reached the bottom of the tympanic ramp 50 (see [Fig. 4]).6]), can also be performed robotically and safely by longitudinally pushing the sliding element 70, and therefore the intracochlear electrode 26, using the robotic sliding rod of the articulated robot arm to which the cylindrical sleeve 68B is intended to be attached. Finally, the operation of removing the carrier device 38 while maintaining the intracochlear electrode 26 in the patient's cochlea can also be performed robotically and safely by a combined action of additional longitudinal pushing of the sliding element 70 using the robotic sliding rod of the articulated robot arm, and corresponding longitudinal withdrawal of the articulated arm itself.

[0052] The free end 86 of an articulated arm 88 of a surgical robot, to which the surgical instrument 52 of [Fig. 7] or the surgical instrument 66 of [Fig. 8] can be attached, is shown schematically in cross-section in [Fig. 15]. It is provided with a robotic sliding rod 90 mounted freely in translation inside a sleeve 92. The rotational actuation of the robotic sliding rod 90 about an axis D” is achieved by means of a first rotation motor 94 which drives, in a manner known per se, the sleeve 92 and the robotic sliding rod 90. The translational actuation of the robotic sliding rod 90 is achieved by means of a second translational motor 96 which drives, also in a manner known per se, a threaded rod 98 which pushes the robotic sliding rod 90 along the axis D”.

[0053] The free end 86 of the articulated arm 88 is further provided with additional fixing means 100 cooperating with the fixing means 58 or 72 of the free end of the proximal portion 54B or 68B of the main body 54 or 68 of the surgical instrument 52 or 66, so as to fix the latter on the free end 86 of the articulated arm 88 while engaging the translation axis D” of the robotic sliding rod 90 in the through hole 60 or 74 of the proximal portion 54B or 68B.

[0054] These additional fixation means 100, intermediate between the free end 86 of the articulated arm 88 and the surgical instrument 52 or 66, comprise, for example, a hollow cylinder device provided with two clamping rings 102 and 104, one 102 for fixing to the free end 86, the other 104 for fixing to the cylindrical sleeve 54B or 68B. They are hollow to allow the robotic sliding rod 90 to pass in translation. The locking groove 58 or 72 formed in the cylindrical sleeve 54B or 68B makes it possible to accompany and guide angularly the insertion of the surgical instrument 52 or 66 into the additional fixation means 100, as taught in patent document WO 2014 / 080113 AL. More generally, all known fixation means compatible with the articulated arm configuration 88 illustrated in [Fig.15] are conceivable, including all means of fixing the surgical instrument 52 or 66 in such a way that its main axis of translation D or D' coincides with the axis of intervention D” of the articulated arm 88. .

[0055] More generally, the robotic surgical intervention installation 106 schematically represented in perspective on [Fig. 16] comprises a robot 108 itself comprising at least one articulated arm, the articulated arm 88 of [Fig. 15], which can be moved on electronic control and is provided with the free end 86 fitted with the robotic sliding rod 90. The surgical instrument 66 is shown mounted on the free end 86 using the complementary fixing means 100 so that the axes D' and D” coincide.

[0056] Thus, the robotic sliding rod 90 can come, directly or indirectly, into contact with the proximal portion 70B of the sliding organ 70 of the surgical instrument 66. The latter and the carrier device 38 which is fixed to its distal end are therefore fixed with respect to the reference frame of the free end 86 of the articulated arm 88. It follows that the intracochlear electrode 26, when correctly installed in the carrier device 38 and on the surgical instrument 66, can be driven longitudinally along the axis of its sliding connection, selectively independently of or in coordination with any robotic movement of the surgical instrument 66 itself.

[0057] Furthermore, the main body 68 of the surgical instrument 66, the carrier device 38 and its distal end 38A are fixed relative to the reference frame of the free end 86 of the articulated arm 88. As a result, the distal end 38A can form a pivot point of the robotic installation 106, that is to say, a point which can remain fixed in the reference frame of the robot 108 when the latter moves the articulated arm 88 along three different axes of rotation.

[0058] In particular, in otological surgery, such a configuration of the surgical instrument 66 (or 52) is very advantageous for an intervention during which the surgical gesture requires great precision.

[0059] A method for inserting the intracochlear electrode 26 into a patient's inner ear, using the robotic installation 106 of [Fig.16], will now be detailed with reference to [Fig. 17].

[0060] During a first installation step 200, the intracochlear electrode 26 is fixed by sliding connection and in a retracted configuration within its support device 38, the latter being arranged to be held in the distal portion 68A of the main body 68 of the surgical instrument 66, the latter being in turn fixed by its proximal cylindrical sleeve 68B to the articulated arm 88 of the robot 108 (not visible in [Fig. 17]). During this installation, which can be carried out remotely from the operative area, the end 28A of the electrical connection 28 can also be held in the groove formed by the distal portion 70A of the sliding organ 70 by pinching between the two curved lateral walls 78.

[0061] Then, during an approach step 202, the robotic installation 106 is electronically and / or software-controlled in translation and rotation to bring the distal end 38A of the carrying device 38 close to the surgical area, namely the base of the tympanic ramp of a patient's cochlea, with proper alignment of the surgical instrument 66, the carrying device 38, and the entry point of the base of the tympanic ramp. During this step, the teachings of patent document WO 2021 / 079058 A1 can be used, both from the point of view of the selection of the robot 108 and its electronic and / or software control, to guide the end distal 38A of the carrier device 38 in the right place by exploiting its pivot point property if necessary.

[0062] During a subsequent insertion step 204, maintaining the correct alignment obtained at the end of the approach step 202, the carrier device 38 is inserted into the patient's cochlea until its second marking 46 reaches the base of the tympanic ramp (identified by the reference axis B in [Fig. 17]; see [Fig. 4]). During this step, the teachings of patent document WO 2021 / 058899 A1 can be used, both from the point of view of the choice of the robot 108 and its electronic and / or software control, to perform this insertion by electronically and / or software-controlled movement commands to lock the alignment axis. A specific axis-locking function can be provided and selected in the robotic system 106.

[0063] During a subsequent deployment step 206, maintaining the correct alignment obtained at the end of the approach step 202 and the correct positioning obtained at the end of the insertion step 204, the distal end 26A of the intracochlear electrode 26 is progressively deployed out of the carrier device 38 by sliding push using the robotic sliding rod 90 until the marking ring 34 reaches the marking ring 44, thus indicating that the distal end 26A of the intracochlear electrode 26 has reached the bottom of the patient's tympanic ramp (cf. [Fig.6]) and that the positioning of the intracochlear electrode 26 in the cochlea is correct. This progressive deployment can be programmed at a controlled and possibly constant speed VI of the robotic sliding rod 90 to travel the distance DI which initially separates the marking ring 34 from the marking ring 44.

[0064] During a subsequent withdrawal step 208, maintaining the correct alignment obtained at the end of the approach step 202 and the correct positioning of the intracochlear electrode 26 obtained at the end of the deployment step 206, the carrier device 38 is withdrawn longitudinally until it is completely detached from the intracochlear electrode 26, while keeping the intracochlear electrode 26 in the correct position within the patient's cochlea. A specific electrode locking function can be provided and selected in the robotic installation 106, designed to maintain the correct positioning of the marking ring 34 of the intracochlear electrode 26 obtained at the end of step 206 during the withdrawal of the carrier device 38.

[0065] This operation can be carried out by programming a coordinated, i.e. simultaneous and synchronous, speed V2: - of the intracochlear electrode 26 allowing its marking ring 34 to be moved to a distance D2 from the marking ring 44 of the carrier device 38, by controlled push using the robotic sliding rod 90; and - of the carrier device 38 allowing to compensate for this distance of the two marking rings 34 and 44, by controlled withdrawal of the articulated arm 88 and therefore of the surgical instrument 66 and of the carrier device 38 of the same distance D2 and at the same speed V2 but in the opposite direction.

[0066] It should be noted that, for safety reasons, the robotic installation 106 can be programmed to only allow the activation of the electrode locking function if the axis locking function is also already activated.

[0067] Following this removal step 208, all that remains is to release the distal end 28A of the electrical connection 28 from the two curved lateral walls 78. The surgeon can perform this final operation very simply and safely since both hands are free of any other constraints. The intracochlear electrode 26 is then still correctly positioned in the patient's cochlea. The surgical instrument 66 and the carrier device 38 can be moved away from the operating area by command of the robotic system 106 without any risk either.

[0068] It should be noted that steps 200 to 208 remain unchanged if the surgical instrument 66 is replaced by the instrument 52 or any other embodiment of a surgical instrument conforming to the general principles of the present invention.

[0069] It is clear that an otological surgical instrument such as one of those described above allows for the complete automation of the procedure for inserting an intracochlear electrode into the scala tympani of the cochlea in the inner ear of a patient. It is also clear that a method for inserting an intracochlear electrode into a patient's inner ear such as the one described above makes the surgical procedure completely safe.

[0070] It should also be noted that the invention is not limited to the embodiments described above.

[0071] In particular, the otological surgery instruments and the insertion method described above were considered for an intracochlear electrode and a corresponding carrier device conforming to the reference cochlear implant CI632, but they are also applicable to any other set of intracochlear electrode and corresponding carrier device, subject to possible adaptations of shape depending on the models used.

[0072] It will more generally be apparent to those skilled in the art that various modifications can be made to the embodiments described above, in light of the teaching that has just been disclosed to them. In the detailed presentation of the invention given above, the terms used should not be interpreted as limiting the invention to the embodiments set forth in this description, but should be interpreted to include all equivalents. whose prediction is within the reach of the expert by applying his general knowledge to the implementation of the teaching that has just been disclosed to him.

Claims

1.

2. Demands Otological surgical instrument (52; 66) for inserting an intracochlear electrode (26) into a patient's inner ear, comprising a main body (54; 68) with a proximal portion (54B; 68B) for attachment to an articulated arm (88) of a robot (108) and a distal portion (54A; 68A) for retaining a support device (38) to which the intracochlear electrode (26) is attached by a sliding connection during insertion, characterized in that the proximal attachment portion (54B; 68B) has a hole (60; 74) for the passage of a robotic sliding rod (90) of the articulated arm (88) of the robot (108), and in that the instrument (52; 66) further comprises a sliding element (56; 70) within the main body (54; 68) and having: - a proximal portion (56B; 70B) configured and arranged in the proximal fixing portion (54B; 68B) of the main body (54; 68) so as to be able to be driven longitudinally by the robotic sliding rod (90) of the articulated arm (88) of the robot (108) to which the proximal fixing portion (54B; 68B) of the main body (54; 68) is intended to be fixed; and - a distal portion (56A; 70A) configured and arranged so as to be able to longitudinally drive the intra-cochlear electrode (26) along the axis of its sliding connection when the electrode (26) is fixed to the carrier device (38) and the latter is held by the distal portion (54A; 68A) of the main body (54; 68). Otological surgical instrument (52; 66) according to claim 1, wherein: - the proximal portion (56B; 70B) of the sliding organ (56; 70) is more precisely arranged so that it can be pushed by the robotic sliding rod (90); and - the distal portion (56A; 70A) of the sliding organ (56; 70) is more precisely configured and arranged to come against a proximal end (34; 36) of the intracochlear electrode (26).

3. Otological surgical instrument (52; 66) according to claim 1 or 2, wherein the proximal portion (56B; 70B) of the sliding organ (56; 70) is a cylindrical rod disposed in a principal axis (D; D') of the proximal fixing portion (54B; 68B) of the main body (54; 68), this axis (D; D') also being a thrust axis of the robotic sliding rod (90) of the articulated arm (88) of robot (108) to which the proximal fixing portion (54B; 68B) of the main body (54; 68) is intended to be fixed.

4. Otological surgical instrument (52) according to claim 3, wherein the distal portion (56A) of the sliding organ (56) is straight and parallel offset from the main axis (D) of the proximal fixing portion (54B) of the main body (54) to pass over the distal holding portion (54A) of the main body (54), a deviated median portion (56C) connecting the proximal (56B) and distal (56A) portions of the sliding organ (56).

5. Otological surgical instrument (66) according to claim 3, wherein the distal portion (70A) of the sliding organ (70) is in the form of a distal end gutter intended to come into contact with the proximal end (34) of the intracochlear electrode (26), in particular with a marking ring (34) of the intracochlear electrode (26).

6. Otological surgical instrument (66) according to claim 5, in which two curved side walls (78) extend locally from edges of the groove formed by the distal portion (70A) of the sliding organ (70), locally extending its arc-shaped section, for pinching a distal end (28A) of an electrical connection (28) of the intracochlear electrode (26).

7. Otological surgical instrument (52; 66) according to any one of claims 1 to 6, wherein the proximal fixing portion (54B; 68B) of the main body (54; 68) comprises a cylindrical sleeve having a locking groove (58; 72) of semi-circular cross-section hollowed longitudinally in its external face and ending in a partially spherical cavity of greater depth.

8. Otological surgical instrument (52; 66) according to any one of claims 1 to 7, wherein the distal retaining portion (54A; 68A) of the main body (54; 68) has a shape of gutter and includes a gripping organ (62; 76) by clamping the carrier device (38), in particular a gripping organ which takes the form of a fork with two fixed and rigid teeth obtained by the gutter shape of the distal retaining portion (54A; 68A) and by drilling a slot in the bottom of this gutter.

9. Robotic surgical intervention installation (106) comprising: - a robot (108) equipped with an articulated arm (88) movable by electronic control and a robotic sliding rod (90) in the articulated arm (88) also movable by electronic control; and - an otological surgical instrument (52; 66) according to any one of claims 1 to 8; in which the articulated arm (88) of the robot (108) has complementary fixation means (100) capable of cooperating with the fixation means (58; 72) of the otological surgery instrument (52; 66).

10. A method for inserting an intracochlear electrode (26) into an operating area, using a robotic installation (106) according to claim 9, comprising the following steps: - installation (200) of the intracochlear electrode (26) by fixing in a sliding connection and in a retracted configuration in a corresponding carrier device (38), maintaining the carrier device (38) in the distal portion (54A; 68A) of the main body (54; 68) of the otological surgery instrument (52; 66) and fixing the latter by the proximal portion (54B; 68B) its main body (54; 68) to the articulated arm (88) of the robot (108); - electronic and / or software control (202) of the robotic installation (106) to approach a distal end (38A) of the carrier device (38) to an operating area according to a predetermined alignment; - electronic and / or software control (204) of the robotic installation (106) to insert the distal end (38A) of the carrier device (38) into the operating area along the predetermined alignment; - deployment (206) of a distal end (26A) of the intracochlear electrode (26) in the operative zone by sliding drive using the robotic sliding rod (90) controlled electronically and / or software; longitudinal withdrawal (208) of the carrier device (38) over a predetermined distance (D2) until it is completely detached from the intra-cochlear electrode (26) by coordinated displacement of the intra-cochlear electrode (26) over this distance (D2), by electronically and / or software-controlled drive using the robotic sliding rod (90), and of the carrier device (38) over this same distance (D2) but in the opposite direction, by electronically and / or software-controlled withdrawal of the articulated arm (88).

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