Instrument and robotic system for otologic surgery for receiving and holding an electrode holder of a cochlear implant

Description

[0001] The present invention relates to an otological surgery instrument for inserting a cochlear implant electrode holder into a patient's inner ear. It also relates to a robotic installation comprising such an instrument.

[0002] The invention applies more particularly to an otological surgery instrument of this type, comprising a proximal gripping end and a functional distal end for capturing and holding a portion of the electrode holder during insertion.

[0003] A cochlear implant consists of 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 individual's skull, generally includes at least one microphone that captures a sound environment and transforms the sound into an electrical signal, a processor that filters the information received, in particular to process the voice as a priority, and a transmitter by electromagnetic induction. The internal part includes a receiver placed under the skin opposite the transmitter, electrically connected to an electrode holder intended to be placed in the scala tympani of the individual's cochlea. The electrode holder is a flexible and elastic element, generally made of silicone, which is difficult to insert into the inner ear during the surgical procedure necessary to install the internal part of the implant in a patient.

[0004] An example of an otological surgery instrument for inserting a cochlear implant electrode holder into a patient's inner ear is, for example, described in patent application EP 3 513 834 A1. It has a distal part with a cannula in which the electrode holder is installed before surgery and a piston for pushing the electrode holder during surgery to extract it from the cannula and insert it into the patient's cochlea. It also has a proximal cylindrical gripping portion that can be directly held by a surgeon. Alternatively, this proximal cylindrical portion can be caught in the hook of a robot arm, although it is not specifically designed for this purpose. The instrument itself is quite complex to manufacture.

[0005] Another example of a robotic installation for inserting a cochlear implant electrode holder is described in US patent 8,594,799 B2. The installation is illustrated in this document, but the instrument for capturing and holding the electrode holder is not detailed. It is indicated that a usual insertion instrument can be used, without indicating which one and without really explaining how. Documents US 2018 / 050196, FR 3 066 378 and WO 2013 / 166293 describe other known systems.

[0006] An example of a common instrument is a micro-forceps articulated at the distal end of a rod whose proximal part is designed to be held by hand. To free the surgeon's other hand, it is then necessary for the opening and closing actuation of the micro-forceps to be controlled by the hand holding the instrument. This again results in a complex instrument to manufacture. And for such an instrument to be carried by the articulated arm of a robot, the latter must be sufficiently sophisticated to not only hold the instrument but also to actuate its micro-forceps in opening and closing.

[0007] It may thus be desirable to provide an otological surgery instrument for inserting a cochlear implant electrode holder into a patient's inner ear which makes it possible to overcome at least some of the aforementioned problems and constraints.

[0008] An instrument of this type is therefore proposed comprising a proximal gripping end and a functional distal end for capturing and holding a portion of the electrode holder during insertion, in which: the proximal end comprises means for attachment to an articulated robot arm; and the distal end comprises a fixed member for gripping by gripping the portion of the electrode holder.

[0009] By presenting a proximal end specifically provided with means for attachment to an articulated robot arm, it is possible to free oneself from a constraint in terms of availability of the surgeon's hands and to provide a functional distal end for capture and holding that is much simpler than those envisaged in the prior art. Thus, a fixed member for gripping by clamping, including in particular the fact that it is not articulated, is cleverly proposed in combination with the means for attachment to a robot arm to form a simple and inexpensive instrument to manufacture. It requires manual action by the surgeon to capture or release the desired electrode holder portion since it is fixed and in particular not articulated, but this is no longer a problem given its proximal end specifically intended to be held by a robot arm.

[0010] Optionally, the fixed gripping member is also rigid, the gripping of the portion of the electrode holder being achieved by the elasticity of the latter.

[0011] In this case, the otological surgery instrument can be made of surgical stainless steel, in particular type 304L or 316L according to the AISI standard.

[0012] Also optionally, the fixed gripping member is a two-pronged fork extending in the extension of a distal portion of the instrument, for capturing and holding the electrode holder portion between these two prongs.

[0013] In this case, the otological surgery instrument may have several deflected portions all extending in the same plane parallel to a main plane of the two teeth of the fork.

[0014] In this case also, the otological surgery instrument may have several deflected portions all extending in the same plane perpendicular to a principal plane of the two teeth of the fork.

[0015] Also optionally, each tooth of the fork is rectangular in section.

[0016] Also optionally, the fixed gripping member is a groove attached laterally against the free end of a distal portion of the instrument, for capturing and holding the electrode holder portion in the interior volume of the groove.

[0017] Also optionally, the means of attachment to the articulated robot arm comprise a locking groove hollowed longitudinally in the external face of the proximal end of the instrument.

[0018] A robotic surgical intervention facility is also proposed, comprising: a robot provided with an articulated arm movable under electronic control; and an otological surgery instrument (30; 30') according to any one of claims 1 to 9; 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] The invention will be better understood with the aid of the following description, given solely by way of example and with reference to the appended drawings in which: [ Fig.1 ] there figure 1 schematically represents the general structure of an example of an internal part of a cochlear implant with its electrode holder, [ Fig.2 ] there figure 2 represents schematically and in longitudinal view the general structure of an otological surgery instrument for the insertion of an electrode holder such as that of the figure 1 , according to a first embodiment of the invention, [ Fig.3 ] there figure 3 illustrates the instrument of the figure 2 in perspective, [ Fig.4 ] there figure 4 illustrates a variant of the instrument of the figure 2 in perspective, [ Fig.5 ] there figure 5 represents schematically and in perspective the general structure of an otological surgery instrument for the insertion of an electrode holder such as that of the figure 1 , according to a second embodiment of the invention, [ Fig.6 ] there figure 6 is a set of two side and front views of a functional distal end of the instrument of the figure 5 , [ Fig.7 ] there figure 7 is a set of two side and front views of a variant for the functional distal end of the instrument of the figure 5 , [ Fig.8 ] there figure 8 schematically and partially represents the general structure of a robotic surgical intervention installation including the instrument of the figure 2 , And [ Fig.9 ] there figure 9 illustrates the successive stages of a surgical intervention procedure using the robotic installation of the figure 8 .

[0020] The internal part 10 of the cochlear implant illustrated in the figure 1 comprises a receiver 12 connected to an electrode holder 14 using an electrical connection 16. The receiver 12 is intended to be placed under the skin of an individual opposite the transmitter of the external part not shown. The electrode holder 14 is intended to be placed in the scala tympani of the individual's cochlea.

[0021] There are different types of electrode holders on the market. The one shown in the figure 1 has a main body 18 forming a support for a plurality of electrodes 20 as well as a proximal fin 22 facilitating its grip. The main body 18 is flexible and elastic, generally made of silicone, of essentially cylindrical shape with a circular section. The proximal fin 22 is optional, flexible, elastic and generally made of silicone like the main body 18, and extends the latter according to a rectangular flat section.

[0022] The otological surgery instrument 30 shown schematically on the figure 2 is suitable for inserting the electrode holder of the figure 1 into the inner ear of a patient by grasping it by its proximal fin 22. According to an advantageous but optional embodiment, it has several deflected portions allowing the surgeon's line of sight to be freed. Alternatively, it could be rectilinear.

[0023] It thus comprises a first holding or fixing portion 32, extending around a first rectilinear axis A1 and having a proximal gripping end 34 around this first rectilinear axis A1. The proximal gripping end 34 comprises means 36 for fixing to an articulated robot arm, for example embodied by a simple locking groove of semi-circular section hollowed longitudinally in its external face and ending in a partially spherical cavity of greater depth in accordance with the teaching of patent FR 2 998 344 B1.

[0024] The otological surgery instrument 30 further comprises a second deflection portion 38, integral with the first portion 32, extending without any degree of freedom from the first portion 32 in the main direction of a second rectilinear axis A2 moving it away from the first rectilinear axis A1. The angle between the axes A1 and A2 is for example between 2 and 10 degrees, preferably between 2 and 4 degrees, to give a very elongated shape to the instrument 30 with minimal lateral bulk.

[0025] The otological surgery instrument 30 further comprises a third functional support portion 40, integral with the second portion 38, extending without any degree of freedom from a distal end 42 of the second portion 38 around a third rectilinear axis A3 different from the second rectilinear axis A2 and bringing it closer to the first rectilinear axis A1. This third portion 40 has a functional distal end 44 which, in accordance with the present invention, comprises a fixed member for gripping by gripping a desired portion of the electrode holder 14. The angle between the axes A1 and A3 is for example between 2 and 10 degrees, preferably between 2 and 4 degrees. It must be sufficient to clear the field of vision of a user and facilitate the surgical procedure, while limiting the lateral bulk of the surgical instrument 30.Advantageously but optionally, in accordance with the general principles of patent application FR 3 066 378 A1, the third portion 40 is shaped, by its length and by the orientation of the third rectilinear axis A3, in such a way that the first rectilinear axis A1 around which the first portion 32 extends passes through the functional distal end 44 - and more precisely through the fixed gripping member by clamping - of the third portion 40 at a pivot point P.

[0026] The three portions 32, 38 and 40 of the otological surgery instrument 30 may be made, with the possible exception of the proximal gripping end 34 and the functional distal end 44, of a single rod (simple cylindrical rod of circular, square or rectangular section, or linkage) having two bends: the first bend at the junction of the first and second portions 32, 38; the second bend at the junction of the second and third portions 38, 40, that is to say at the distal end 42 of the second portion 38. Furthermore, all the constituent elements of the instrument 30 described above may be designed in plastic, metal, stainless steel, titanium or other rigid materials or combinations of biocompatible rigid materials suitable for surgical application in otorhinolaryngology.An example of a material particularly recommended in otological surgery is surgical stainless steel type 304L or 316L according to the AISI (American Iron and Steel Institute) standard, which can constitute the entire instrument. In this case, the fixed gripping member forming the functional distal end 44 can be made in one piece with the rest of the rod forming the three deflected portions 32, 38 and 40. The advantage of having a fixed gripping member that is rigid like the rest of the instrument is the simplicity of manufacturing the assembly and its compliance with surgical requirements. The gripping of the desired portion of the electrode holder 14 can in any case be achieved thanks to the elasticity of the latter.

[0027] When the proximal gripping end 34 is an attachment to the aforementioned shaft, it may consist of a substantially cylindrical sleeve including a bore along the axis A1 for receiving the proximal end of the shaft. Similarly, when the functional distal end 44 is an attachment to the aforementioned shaft, it may include a cylindrical projection for receipt in a bore along the axis A3 distally of the shaft. The advantage of a functional distal end 44 being designed as an attachment is that the remainder of the instrument 30 may be manufactured in a standard manner, as a “universal” instrument, and provided with a set of removable distal ends for different surgical functions other than that a minima gripping by gripping a portion of the electrode holder 14.

[0028] In terms of dimensions and conformations, the instrument 30 must generally have a total length (between the proximal end and the pivot point P) of between 10 and 20 cm, preferably between 10 and 15 cm, for use in otological surgery. For example, when this length is close to 14 cm with an angle between the axes A1 and A3 of approximately 3.2 degrees, this makes it possible to offset the lateral observation distance by 1 cm, when the user's eye is 18 cm from the pivot point P, i.e. approximately 4 cm longitudinal distance from the proximal end of the instrument 30 along the axis A1. This configuration proves satisfactory in use. Furthermore, a cylindrical rod diameter of between 1 and 2 mm is also suitable. It should be noted, however, that these values are given for information purposes only and that they could in particular be smaller or larger depending on the intended applications and contexts.

[0029] Depending on the method of implementation of the figure 2 , the fixed gripping member by clamping is more precisely a fork with two teeth 46 and 48 extending in the extension of the third portion 40 of the instrument 30, for capturing and holding the proximal fin 22 of the electrode holder 14 between these two teeth. The shape and dimensions of the two teeth 46, 48 are to be defined according to the shape and dimensions of the proximal fin 22 or of any other portion of the electrode holder 14 that it is desired to grip and hold. In particular, in the case of a proximal fin of rectangular flat section like that of the figure 1 , parallel teeth of rectangular sections spaced with a negative clearance depending on the thickness of the fin are suitable. Alternatively, they could be of sections other than rectangular, in particular round, oval, etc.

[0030] The perspective view of the figure 3 shows that the otological surgery instrument 30, including its three deflected portions 32, 38, 40, extends in a plane P1 which is parallel to the main plane in which the two teeth 46 and 48 extend. It is even the same plane.

[0031] Alternatively, the perspective view of the figure 4 shows that the otological surgery instrument 30, including its three deflected portions 32, 38, 40, extends in a plane P1 which can be perpendicular to the main plane P2 in which the two teeth 46 and 48 extend in parallel. Other variants are also possible and depend mainly on the shape of the electrode holder to be captured and held as well as on the way in which it is desired to insert it into the patient's inner ear.

[0032] The 30' otological surgery instrument illustrated on the figure 5 differs from those of figures 2 à 4 by its functional distal end 44' whose fixed gripping member by clamping is no longer a fork but a gutter 50, that is to say a hollow cylindrical element with a longitudinal opening 52 over its entire length, this gutter 50 being attached laterally against the free end of the third rectilinear portion of the instrument 30'. This allows capture and maintenance of the cylindrical main body 18 of the electrode holder 14 in the interior volume of the hollow and open cylinder formed by the gutter 50. This is in particular a preferred embodiment in the case where the electrode holder 14 does not have a proximal fin 22. The longitudinal opening is sufficiently wide to easily capture the electrode holder 14 but also sufficiently narrow to maintain it during its insertion into the patient's inner ear.In other words, the edges of the gutter 50 are advantageously folded towards each other to form in section an arc of a circle slightly greater than the semicircle.

[0033] Side and front views of the figure 6 show that the longitudinal opening 52 is opposite the third portion of rod against which the gutter 50 is fixed.

[0034] Side and front views of the figure 7 show a variant in which the longitudinal opening 52 is angularly offset by approximately 90 degrees to be positioned laterally relative to the third rod portion. Other variants are also possible and depend mainly on the shape of the electrode holder to be captured and held as well as the way in which it is desired to insert it into the patient's inner ear.

[0035] A robotic surgical intervention installation using the otological surgery instrument 30 is illustrated very schematically in the figure 8 . It comprises a robot 60 equipped with a carrying arm 62 movable on electronic control. An example of a robot compatible with an installation according to the invention is given in the article by Miroir et al, entitled “RobOtol: from design to evaluation of a robot for middle ear surgery”, published on the occasion of the IEEE / RSJ International Conference on Intelligent Robots and Systems which was held from October 18 to 22, 2010 in Taipei (TW). It has an architecture and kinematics particularly well adapted to otological surgical interventions of the middle or inner ear of patients, in particular those concerning the insertion of the internal part of a cochlear implant.

[0036] The installation illustrated on the figure 8 further includes: the otological surgery instrument 30 whose proximal gripping end 34 is provided with fixing means 36 with a locking groove, and complementary means for fixing the proximal gripping end 34 of the instrument 30 to the carrying arm 62 of the robot 60.

[0037] These complementary fixing means comprise, for example, a clamping ring 64 arranged at the free distal end of the carrier arm 62 of the robot 60, this carrier arm 62 itself being intended to receive by insertion the proximal gripping end 34. The locking groove 36 makes it possible to accompany and angularly guide the insertion of the instrument 30 into the carrier arm 62 of the robot 60, as taught in patent FR 2 998 344 B1. More generally, all known fixing means compatible with the configuration of the installation illustrated in the figure 9 are conceivable, in particular any means making it possible to fix the otological surgery instrument 30 in such a way that its main axis A1 corresponds with the intervention axis of the robot 60.

[0038] Of course, instrument 30 can be replaced by instrument 30' of the figure 5 .

[0039] There figure 9 illustrates the successive steps of a surgical intervention method for the insertion by a surgeon of the electrode holder 14 into the cochlea of a patient using the robotic installation of the figure 8 .

[0040] During a first step 100, the surgeon fixes the otological surgical instrument 30 or 30' to the free end of the articulated arm 62 of the robot 60.

[0041] During a following step 102, it grasps the electrode holder 14 and grips the desired portion, proximal fin 22 or main body 18, in the fixed gripping member 44, 46 or 50.

[0042] During a step 104 of inserting the electrode holder 14 into the patient's inner ear, the surgeon precisely directs the electrode holder 14 towards the inside of the cochlea by moving the functional distal end 44 or 44' of the otological surgery instrument 30 or 30' carried by the articulated arm 62 of the robot 60 using a control peripheral (not shown). The surgical procedure is thus very precise and controlled.

[0043] When the electrode holder 14 is correctly installed in the cochlea, the surgeon manually releases its portion enclosed in the fixed gripping member 44, 46 or 50 during a step 106.

[0044] Finally, during a last step 108, the surgeon removes the otological surgery instrument 30 or 30' from the operating area by precisely controlling its movement using the control peripheral.

[0045] It is clear that a robotic installation such as that described above makes it possible to facilitate and secure a surgical procedure for inserting a cochlear implant electrode holder into the inner ear of a patient using an instrument that is simple to design, manufacture and use. The known gestures can be reproduced by eliminating tremors and involuntary movements and ensuring reproducibility of the surgical procedure.

[0046] The invention is defined by the following claims.

Claims

1. An otologic surgery instrument (30; 30') for inserting a cochlear implant (10) electrode holder (14) into a patient's inner ear, comprising a gripping proximal end (34) and a functional distal end (44; 44') for capturing and holding a portion (22; 18) of the electrode holder (14) during insertion, wherein: - the proximal end (34) comprises means (36) for fastening to an articulated arm (62) of a robot (60); and - the distal end (44; 44') comprises a member (46, 48; 50) for gripping the portion (22; 18) of the electrode holder (14) by clamping; characterized in that the member for gripping by clamping is fixed, including in particular the fact in that it is not articulated.

2. The otologic surgery instrument (30; 30') as claimed in claim 1, wherein the fixed gripping member (46, 48; 50) is furthermore rigid, the gripping of the portion (22; 18) of the electrode holder (14) being done by elasticity of the latter.

3. The otologic surgery instrument (30; 30') as claimed in claim 2, made of surgical stainless steel, in particular of 304L or 316L type according to AISI standard.

4. The otologic surgery instrument (30) as claimed in any one of claims 1 to 3, wherein the fixed gripping member by clamping is a two-pronged fork (46, 48) extending along a distal portion (40) of the instrument (30), for capturing and holding the portion (22) of electrode holder (14) between these two prongs (46, 48).

5. The otologic surgery instrument (30) as claimed in claim 4, comprising several deviated portions (32, 38, 40) all extending in one and the same plane (P1) parallel to a main plane (P1) of the two prongs (46, 48) of the fork.

6. The otologic surgery instrument (30) as claimed in claim 4, comprising several deviated portions (32, 38, 40) all extending in one and the same plane (P1) perpendicular to a main plane (P2) of the two prongs (46, 48) of the fork.

7. The otologic surgery instrument (30) as claimed in any one of claims 4 to 6, wherein each prong (46, 48) of the fork has a rectangular cross section.

8. The otologic surgery instrument (30') as claimed in any one of claims 1 to 3, wherein the fixed gripping member by clamping is a gutter (50) attached laterally to the free end (44') of a distal portion (40) of the instrument (30'), for capturing and holding the portion (18) of electrode holder (14) within the interior volume of the gutter (50).

9. The otologic surgery instrument (30; 30') as claimed in any one of claims 1 to 8, wherein the means (36) for fastening to the articulated arm (62) of the robot (60) comprise a locking groove hollowed longitudinally in the outer face of its proximal end (34).

10. A robotic surgical intervention installation comprising: - a robot (60) with an articulated arm (62) that can be moved under electronic control; and - an otologic surgery instrument (30; 30') as claimed in any of claims 1 to 9; wherein the articulated arm (62) of the robot (60) has complementary fastening means (64) adapted to cooperate with the fastening means (36) of the otologic surgery instrument (30; 30'