WO2020007948A1 - Guide device for inserting an instrument through a wall - Google Patents

Guide device for inserting an instrument through a wall Download PDF

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Publication number
WO2020007948A1
WO2020007948A1 PCT/EP2019/067915 EP2019067915W WO2020007948A1 WO 2020007948 A1 WO2020007948 A1 WO 2020007948A1 EP 2019067915 W EP2019067915 W EP 2019067915W WO 2020007948 A1 WO2020007948 A1 WO 2020007948A1
Authority
WO
WIPO (PCT)
Prior art keywords
guide
instrument
guide device
tubular guide
tubular
Prior art date
Application number
PCT/EP2019/067915
Other languages
French (fr)
Inventor
Ludovic BENICHOU
Jérémy ADAM
Original Assignee
Bone 3D
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bone 3D filed Critical Bone 3D
Priority to EP19734816.2A priority Critical patent/EP3817674A1/en
Publication of WO2020007948A1 publication Critical patent/WO2020007948A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8605—Heads, i.e. proximal ends projecting from bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8685—Pins or screws or threaded wires; nuts therefor comprising multiple separate parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3407—Needle locating or guiding means using mechanical guide means including a base for support on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B2090/103—Cranial plugs for access to brain

Definitions

  • the invention relates to the technical field of guide devices for the insertion of an instrument through a wall, for example a bone wall, to reach an area of interest located inside or behind this wall.
  • stereotactic frames are often used. Such frames are fixed around the area of interest and allow precise guidance of an instrument for piercing a bone or removing a tissue.
  • frames are impractical to use because they are heavy, and in addition they require a complex installation procedure.
  • the positioning procedure of the instrument to be inserted requires several successive images to be taken, these images often being x-rays, which implies preparation time before inserting the instrument into the body of a very long subject.
  • a surgical guide helmet made to measure for a subject.
  • This helmet includes a curved portion disposed on the subject's head, the curved portion being provided with a guide tube.
  • This guide tube receives a depth control element, which is slidably attached in the guide tube, and whose position relative to the guide tube is adjustable in order to vary the entry depth of a needle biopsy or surgical tool.
  • This guide helmet therefore does not require the use of usual, impractical stereotaxic frames, nor the production of a multitude of images of the subject's body before insertion of the instrument.
  • the invention particularly aims to provide a guide device for the insertion of an instrument through a wall, allowing to be installed quickly and precisely on the application area.
  • the invention particularly relates to a guide device for the insertion of an instrument through a wall, configured to be applied to an area application and to guide the instrument to a predetermined position relative to the wall, comprising
  • tubular guide defining an insertion axis, configured to allow insertion and guiding, in the tubular guide, of the instrument, the guiding being exerted along the insertion axis, from an upstream end of the tubular guide towards the application zone, the tubular guide forming an axial stop configured to cooperate directly with the instrument and to impose a predetermined depth of insertion of the instrument, and the tubular guide having come integrally with the fixing arm.
  • a tubular guide which, at the same time, came integrally with the fixing arms of the device and directly ensures the axial positioning of the instrument.
  • This instrument is, for example, a trocar used to biopsy an area of interest, or a drill used to pierce a bone of a subject, such as the skull, a pelvis bone or a long bone.
  • an intermediate piece such as an element of depth control of the instrument, source of inaccuracy or time to spend adjusting a depth, in medical consultation or operating room.
  • the safer use brought by the direct positioning of the instrument in the tubular guide avoids risks of adjustment errors at this stage.
  • tubular guide means an elongated hollow body, the section of which can be of any shape and whose function is to guide the instrument.
  • the tubular guide is of polygonal or circular section, it could also be of square section or take other forms still.
  • the axial stop is configured to cooperate directly with the instrument, that is to say without an intermediate positioning part.
  • the device is preferably made to measure, and in particular achievable by additive manufacturing, which is particularly comfortable for the user who must insert the instrument through the wall, because no adjustment is necessary at the time of fixing.
  • the term “subject” means a living being such as a vertebrate animal, such as a mammal, and in particular a human being.
  • the term “application zone” generally means a part of the subject's body against which the guide device is configured to be applied, for example a part of the scalp.
  • the term “zone of interest” is also generally understood to mean an area arranged inside the subject's body, in which an intervention requiring the insertion of an instrument into the subject's body must be carried out, for example a sample or an ablation, or the injection of a substance.
  • the zone of interest is generally distinct from the zone of application and is located at a certain depth with respect to this zone of application.
  • the wall through which the instrument is inserted is generally a rigid wall, that is to say little or not deformable, which is distinguished from a flexible fabric and whose rigidity is comparable to rigidity of a bone wall.
  • the so-called rigid wall is to be understood as a slightly deformable wall in comparison with a deformable fabric.
  • the wall is preferably a bone wall.
  • the guide device is preferably applied to the application area temporarily, and that the insertion of the instrument is also temporary.
  • the fixing means are removable, the guide device and the instrument being subsequently removed from the wall.
  • the guide device for inserting an instrument through a wall may further include one or more of the following characteristics, taken alone or in combination.
  • the guide device comprises a single, two, or even three, fixing arms configured to be fixed on the application area by removable fixing means and each being made integrally with the tubular guide, preferably two fixing arms, preferably still a single fixing arm.
  • the number of fixing arms used is particularly interesting because it corresponds to the number of incisions required in the application area. Being able to limit the number of incisions is a particularly advantageous aspect. If the material of the guide device is particularly rigid, having no plastic or elastic deformation in the force levels that can be developed by a user of the guide, having for example a rigidity close to that of titanium, it is conceivable to produce a guide device having only one fixing arm. _The presence of two or three fixing arms ensures a particularly stable and precise positioning of the guide device on the application area. Having two instead of three is particularly interesting.
  • the at least one fixing arm comprises polarizing means configured to impose a predetermined angular position of the fixing arm relative to the removable fixing means.
  • polarizing means comprise an asymmetrical shape of an orifice in the fixing arm, so that a single angular position of the fixing arm relative to the fixing means is possible.
  • the removable fixing means are intraosseous fixing means, for example self-drilling screws.
  • the guide is positioned on a rigid structure, making it possible to serve as a fixed support and limiting any deformation of the support, therefore the risks of unwanted displacement during use.
  • the guide device further comprises at least one positioning arm, configured to be supported on the application area.
  • the guide device is fixed on at least one point, which is a fixing arm, and is further supported on a second or even a third point which are positioning arms, ensuring good stability, without having to unnecessarily place additional removable fastening means, that is to say in certain cases without having to unnecessarily drill an additional hole in the application area.
  • the tubular guide has a tubular shape having an upper surface extending substantially radially and the axial stop is formed by this upper surface.
  • the axial stop has a support surface suitable for stable and precise support of the instrument when it is inserted in its final position of use.
  • the axial stop is configured to cooperate directly with a drilling bit in the wall, allowing to reach the desired drilling depth.
  • the axial stop is configured to cooperate directly with a trocar, allowing the user to precisely position the trocar in the area of interest to be biopsied.
  • the axial stop is configured to cooperate directly with a syringe, an electrode or even a probe.
  • the tubular guide is configured to receive an additional tubular guide, this tubular guide being configured to guide another instrument intended to be inserted through the wall.
  • the tubular guide configured to directly receive an instrument intended to be inserted into the skull, having a certain diameter, but in addition it can receive an additional tubular guide capable of forming a liner around another instrument having a smaller diameter, so that it can also guide this other instrument.
  • the tubular guide is configured to directly receive a drilling drill, making it possible to pierce the skull to access the interior, and also to receive an additional tubular guide, capable of receiving a trocar to perform the biopsy, the trocar having in this case a smaller diameter than the drill bit.
  • the guide device may further comprise a stiffening rib of the tubular guide, preferably carried by the at least one fixing arm.
  • the device has a high rigidity, allowing it to be made of a relatively flexible material, while being light and ensuring optimal guidance. .
  • the guide device for inserting an instrument into the body of a subject is a guide device for intracranial biopsy.
  • the invention also relates to a set of a guide device as presented above and an instrument received directly in the tubular guide to be inserted through the wall, such as a drill bit or a trocar. It is understood that the guide device can also be a guide device for inserting a syringe, an electrode or even a probe through the wall.
  • Another object of the invention is a method of manufacturing a guide device as described above, comprising the following steps:
  • a tailor-made guide device by defining a digital model directly from the three-dimensional image illustrating the application area provided with at least one fixing point.
  • Step b) of the above process can include, in particular, the determination by numerical calculation:
  • the orientation of the tubular guide is preferably coincident with a straight line passing through a biopsy area and a central point of the guide device
  • step b) of the above method can advantageously include the determination by numerical calculation of other parameters.
  • the height of the guide device can also be determined if necessary, advantageously taking into account a thickness of a fabric disposed between the application area and the rigid wall, such as the thickness of the subject's scalp.
  • the method of manufacturing the guide device can comprise, in parallel with step b), or before or after step b), the definition of a digital model of an additional tubular guide configured to be received by the guide device and to guide another instrument intended to be inserted through the wall.
  • the step of defining the digital model of the additional tubular guide may include in particular, the determination by numerical calculation of the outside diameter, the inside diameter and / or the length of the additional tubular guide.
  • Figure 1 is a side perspective view of a guide device for the insertion of an instrument through a wall.
  • the wall here is the skull of a subject.
  • FIG. 2 is a perspective view from above of the guide device of FIG. 1.
  • FIG. 3 is a bottom perspective view of the device of FIG. 1.
  • FIG. 4 is a view of an additional tubular guide which can be attached to the guide device of FIG. 1.
  • FIGS. 5a, 5b, 5c are perspective views, respectively assembled side, before assembly and disassembled side of a removable fixing means usable with the guide device of FIG. 1.
  • FIG. 6 is a representation of the guide device of FIG. 1 in position on the skull of a subject and provided with an additional tubular guide according to an alternative embodiment of that illustrated in FIG. 4.
  • Figure 7 is a representation of the guide device of Figure 6 in position on the skull of a subject, with the instrument inserted and positioned in the area of interest.
  • FIG. 8 is a side perspective view of a guide device comprising a single fixing arm, with a polarizing means
  • FIG. 9 is a side perspective view of a removable fixing means with a polarizing device, intended to cooperate with the guide device of FIG. 8.
  • Figure 10 is a representation of the guide device of Figure 8 in position on a wall in which is fixed the removable fixing means of Figure 9, with the instrument inserted.
  • the guide device 1 for the insertion of an instrument through a wall comprises a tubular guide 2 defining an insertion axis X, and configured to allow insertion and the guide of the instrument intended to be inserted through the wall.
  • the guidance is exerted along the insertion axis X, from an upstream end of the tubular guide 2 towards the application area.
  • the guide device also comprises, in this particular example, three fixing arms 3, configured to be fixed to the application area by removable fixing means, connected to the tubular guide 2.
  • the tubular guide 2 came integrally with the fixing arms 3.
  • the guide device 1 is configured to be fixed on the body of a subject, and more particularly on his skull, and the instrument is in particular a drilling forest intended for be inserted into the subject's body.
  • the area of application is the subject's scalp and the area of interest is part of the brain. To be able to act on this area of interest, the skull is pierced with the piercing drill.
  • the tubular guide 2 forms in its upstream part an axial stop 4, shown in Figures 1 and 2, configured to cooperate directly with the instrument to be inserted and impose a predetermined depth of insertion of the instrument.
  • the axial stop 4 is formed by the upper surface of the tubular guide 2, here of annular shape, which extends substantially radially.
  • the guide device does not require the use of means for adjusting the depth of the instrument to be inserted.
  • the guide device 1 is preferably manufactured by additive manufacturing. It can be made of polymeric material or metal.
  • the polymeric materials are, for example, photopolymerizable resin such as the resin manufactured under the brand Formlabs and under the reference Résiné Dental LT
  • the metal is, for example, titanium.
  • Rigidification or reinforcement ribs 5, carried by the fixing arms 3 and visible in FIG. 1, can be provided to give sufficient rigidity to the guide device 1, so that the instrument is inserted precisely at the desired location in an identified area of interest.
  • These ribs 5 are more particularly useful when the guide is made of a relatively flexible material, because they confer improved rigidity to the tubular guide 2 allowing precise guidance.
  • the fixing arms 3 comprise, at their external ends, i.e. opposite to the tubular guide 2, end parts 6 intended to cooperate with the removable fixing means.
  • the removable fixing means can be a screw assembly 40, shown in Figure 5, comprising a first screw 41 provided with a self-tapping thread 42, and a tapped head 43 provided to receive a second screw 44.
  • the end parts 6 of the fixing arms 3 comprise an orifice 8 through which the rod of the screw 44 passes.
  • the end parts 6 of the fixing arms 3 comprise a surface 7 " lower "intended to be positioned on the head 43 of the self-drilling screw 41, and a surface 9" upper "intended to receive the screw 44, the fixing of the guide device 1 on the fixing means being thus obtained by tightening the screw 44 in the head of the screw 43.
  • the guide device 1 comprises a single fixing arm 3.
  • the part of end 6 of the fixing arm 2 and the removable fixing means 40 can be provided with respective polarizing means 60, 45, cooperating with each other so as to ensure that the guide device 1 is positioned on the area of application of the subject's body relative to the removable fixing means 40 at an angle allowing the insertion of the instrument at the desired location in the area of interest.
  • the polarizing means 45 of the removable fixing means 40 is shown in FIG. 9. It is understood that the shape of the respective polarizing means is not limited to what is shown in FIGS. 8 and 9.
  • the guide device 2 further comprises a positioning arm, configured to be supported on the subject's application area. This positioning arm being only supported on the subject's body, it is not necessary for it to cooperate with a removable fixing means.
  • the tubular guide 2 of the guide device 1 may also be provided to receive an additional tubular guide 10 shown in FIG. 4.
  • the additional tubular guide 10 has an external dimension, more precisely here an external diameter, substantially equal to or slightly smaller than the internal dimension, or diameter inside, of the tubular guide 2 into which it is intended to be inserted.
  • the additional tubular guide 10 also has an internal diameter of dimension adapted to the insertion of another instrument, in particular a trocar.
  • the additional guide 10 is configured so that its assembly position relative to the guide device is predetermined, preferably fixed, not adjustable. This is achieved, for example, by virtue of an upper part having a collar, with an outside diameter wider than the lower part inserted in the tubular guide 2, and having a lower end 12 forming a stop capable of cooperating with the stop 4 of the tubular guide. 2.
  • the upper surface of the additional tubular guide 10, of annular shape here also extends substantially radially and forms an axial stop 11 configured to cooperate directly with the instrument to be inserted and to impose a predetermined depth of insertion of the other instrument.
  • the additional guide 10 therefore has the same advantages as those described for the tubular guide 2, namely great ease and great safety in use.
  • FIG. 6 illustrates a guide device 1 for intracranial biopsy, in place on a mannequin simulating a skull 20 of a subject.
  • An additional tubular guide 10 is in the insertion position in the tubular guide 2 of the guide device.
  • the removable fixing means 40 are in place in the subject's skull, and the end parts 6 are in position on the removable fixing means 40.
  • FIG. 7 illustrates an assembly of a guide device 1 as described in FIG. 6, and of an instrument 50, the assembly being in position on the skull 20 of a subject.
  • the instrument 50 is here a trocar, the end of which is positioned in the area of interest 21.
  • FIG. 10 illustrates an assembly of a guide device 1 as described in FIG. 8, and of an instrument 50, the assembly being in position on the rigid wall 20.
  • the guide device 1 comprises a single fixing arm 3, the end of which 6 is fixed to the removable fixing means 40 by cooperation of the respective polarizing means 60 and 45.
  • screws or other removable fixing means 40 are put in place on the intended application area on the subject's body.
  • a three-dimensional image on which the removable fixing means 40 in place are visible, as well as the area of interest 21 (for example a biopsy area) is produced.
  • This three-dimensional image can be obtained for example by a three-dimensional scanner.
  • the three-dimensional image obtained above is displayed, the image illustrating, as indicated above, part of the subject's body 20 and comprising at least one point of attachment of the guide device 1 to the application area 22, the attachment point being represented by the removable attachment means 40 in place, the image also illustrates the area of interest 21.
  • the three-dimensional image serves as the basis for the creation of a digital model of the guide device 1, comprising the at least one fixing arm 3 and the tubular guide 2.
  • the model is created tailor-made for each guide device 1, depending, in particular but not limited to,
  • removable fastening means such as self-tapping screws with tapped head, their number and their position on the application area
  • this position being able to be defined by a distance and an angular position, the dimensions of the instrument or instruments to be inserted 50.
  • this second step may include the determination by digital calculation of the dimensions of the fixing arms 3 and, optionally, of a positioning arm, of the orientation of the guide tubular 2, the axis X of which is preferably coincident with a straight line passing through an area of interest 21 and a central point of the guide device 1, and of the dimensions of the tubular guide 2.
  • This second step also includes, where appropriate , determining by calculation of the shape and dimension of the second tubular guide 10.
  • the dimensions of the tubular guide 2 that is to say its length, its inside diameter, its outside diameter are a function of the subject, the area of interest targeted and the surgeon's equipment. Other characteristics of the guide device are also determined if necessary, such as the clearance between the skull and the top of the tubular guide, which depends on the thickness of the subject's scalp.
  • the guide device 1 is manufactured by computer-aided manufacturing using the digital model defined in the second step above.
  • additive manufacturing is used to manufacture the guide device 1.
  • the manufacture of the guide device 1 is simple and quick. It does not require the use of expensive and complex machines, and can be easily automated, at least in part, which makes it accessible to many users.
  • the step of the above method may include the determination by numerical calculation of other parameters, such as the internal diameter of the tubular guide 2.
  • the method of manufacturing the guide device 1 may include , in parallel with the second step, or before or after this second step, the definition of a digital model of the additional tubular guide 10 configured to be received by the guide device 1.
  • the step of defining the model numerical measurement of the additional tubular guide 10 includes, in particular, the determination by numerical calculation of the outside diameter, the inside diameter and / or the length of the additional tubular guide 10.
  • the guide device 1 has been described essentially with reference to an intracranial biopsy of a subject, which may be a mammal, including a human being.
  • the instruments 50 used are generally a drill for piercing the skull, and a trocar for the biopsy of the area of interest 21.
  • the drill After positioning of the guide device 1 on the area of application of the body of the subject, which is here a part of the skull, the drill is inserted into the tubular guide 2, and the skull is pierced, the drill reaching the desired depth thanks to the stop 4 of the tubular guide 2.
  • the drill is then removed, and the additional tubular guide 10 is placed in the tubular guide 2.
  • the trocar is then inserted into the additional guide 10 to perform the biopsy of the biopsy area, and precisely reaches the biopsy area 21 by cooperating with the stop 11.
  • the guide device for the insertion of an instrument through a wall can be used to be applied to a living subject, to a dead subject for example for autopsies, or even to an inanimate object , for example a mannequin for teaching manipulations to students.
  • the guide device for inserting an instrument through a wall can also be used on other parts of the body of a subject than a skull, such as long bones, pelvic bone or spine, in combination with instruments such as injection needles, or surgical instruments.
  • the guide device can be used on human beings or animals, in particular on horses for interventions in the dorsal region, or on subjects for bone marrow samples.

Abstract

The invention relates to a guide device (1) for inserting an instrument (50) through a wall, said device being configured to be applied to an application area and to guide the instrument according to a predetermined position with respect to the wall, comprising: - at least one attachment arm (3) which is configured to be attached to the application area by removable attachment means, - a tubular guide (2) which defines an insertion axis (X) and is configured such that the instrument can be inserted and guided in the tubular guide (2), the guiding being done along the insertion axis (X), from an upstream end of the tubular guide (2) to the application area, the tubular guide (2) forming an axial abutment configured to cooperate directly with the instrument and to impose a predetermined insertion depth of the instrument, and the tubular guide (2) being made of the same material as the attachment arm (3).

Description

Dispositif de guide pour l’insertion d’un instrument à travers une paroi  Guide device for inserting an instrument through a wall
[0001] L’invention concerne le domaine technique des dispositifs de guide pour l’insertion d’un instrument à travers une paroi, par exemple une paroi osseuse, pour atteindre une zone d’intérêt située à l’intérieur ou derrière cette paroi. The invention relates to the technical field of guide devices for the insertion of an instrument through a wall, for example a bone wall, to reach an area of interest located inside or behind this wall.
[0002] Pour réaliser des biopsies intracrâniennes, on utilise souvent des cadres de stéréotaxie. De tels cadres sont fixés autour de la zone d’intérêt et permettent de guider avec précision un instrument pour le perçage d’un os ou le prélèvement d’un tissu. Néanmoins, de tels cadres sont peu pratiques d’utilisation car ils sont lourds, et de surcroît ils nécessitent une procédure d’installation complexe. Dans d’autres cas où il est nécessaire d’insérer un instrument dans le corps d’un sujet, tels que l’intervention sur des colonnes vertébrales de chevaux, ou des ponctions de moelle dans des os longs de mammifères, la procédure de positionnement de l’instrument à insérer nécessite d’effectuer plusieurs images successives, ces images étant souvent des radiographies, ce qui implique un temps de préparation préalablement l’insertion de l’instrument dans le corps d’un sujet très long.  To perform intracranial biopsies, stereotactic frames are often used. Such frames are fixed around the area of interest and allow precise guidance of an instrument for piercing a bone or removing a tissue. However, such frames are impractical to use because they are heavy, and in addition they require a complex installation procedure. In other cases where it is necessary to insert an instrument into the body of a subject, such as intervention on the spines of horses, or bone marrow punctures in long bones of mammals, the positioning procedure of the instrument to be inserted requires several successive images to be taken, these images often being x-rays, which implies preparation time before inserting the instrument into the body of a very long subject.
[0003] Il a déjà été proposé, dans la demande US 2013/274778 A, un casque de guidage chirurgical, réalisé sur mesure pour un sujet. Ce casque comprend une portion courbe disposée sur la tête du sujet, la portion courbe étant munie d’un tube de guidage. Ce tube de guidage reçoit un élément de contrôle de la profondeur, qui est rapporté de façon coulissante dans le tube de guidage, et dont la position par rapport au tube de guidage est réglable afin de faire varier la profondeur d’entrée d’une aiguille de biopsie ou d’un outil chirurgical. Ce casque de guidage ne nécessite donc pas l’utilisation de cadres de stéréotaxie habituels, peu pratiques, ni la réalisation d’une multitude d’images du corps du sujet avant insertion de l’instrument.  It has already been proposed, in US application 2013/274778 A, a surgical guide helmet, made to measure for a subject. This helmet includes a curved portion disposed on the subject's head, the curved portion being provided with a guide tube. This guide tube receives a depth control element, which is slidably attached in the guide tube, and whose position relative to the guide tube is adjustable in order to vary the entry depth of a needle biopsy or surgical tool. This guide helmet therefore does not require the use of usual, impractical stereotaxic frames, nor the production of a multitude of images of the subject's body before insertion of the instrument.
[0004] Cependant, avec un tel casque de guidage chirurgical, lorsqu’il doit procéder à une insertion d’un instrument dans le corps du sujet, un utilisateur du casque doit régler la position axiale de l’élément de contrôle de la profondeur par rapport au tube de guidage, par exemple grâce à des marques visuelles. Ce contrôle de profondeur prend du temps à l’utilisateur et peut constituer un risque d’imprécision.  However, with such a surgical guide helmet, when he has to insert an instrument into the subject's body, a user of the helmet must adjust the axial position of the depth control element by relative to the guide tube, for example by means of visual marks. This depth check takes time for the user and can be a risk of inaccuracy.
[0005] L'invention a notamment pour but de fournir un dispositif de guide pour l’insertion d’un instrument à travers une paroi, permettant d’être installé de façon rapide et précise sur la zone d’application.  The invention particularly aims to provide a guide device for the insertion of an instrument through a wall, allowing to be installed quickly and precisely on the application area.
[0006] A cet effet, l’invention a notamment pour objet un dispositif de guide pour l’insertion d’un instrument à travers une paroi, configuré pour être appliqué sur une zone d’application et pour guider l’instrument selon une position prédéterminée par rapport à la paroi, comportant To this end, the invention particularly relates to a guide device for the insertion of an instrument through a wall, configured to be applied to an area application and to guide the instrument to a predetermined position relative to the wall, comprising
- au moins un bras de fixation, configuré pour être fixé sur la zone d’application par des moyens de fixation amovibles, et  - at least one fixing arm, configured to be fixed on the application area by removable fixing means, and
- un guide tubulaire définissant un axe d'insertion, configuré pour permettre l'insertion et le guidage, dans le guide tubulaire, de l’instrument, le guidage étant exercé selon l'axe d'insertion, depuis une extrémité amont du guide tubulaire vers la zone d’application, le guide tubulaire formant une butée axiale configurée pour coopérer directement avec l'instrument et imposer une profondeur prédéterminée d'insertion de l'instrument, et le guide tubulaire étant venu de matière avec le bras de fixation.  - a tubular guide defining an insertion axis, configured to allow insertion and guiding, in the tubular guide, of the instrument, the guiding being exerted along the insertion axis, from an upstream end of the tubular guide towards the application zone, the tubular guide forming an axial stop configured to cooperate directly with the instrument and to impose a predetermined depth of insertion of the instrument, and the tubular guide having come integrally with the fixing arm.
[0007] Ainsi, on propose d’utiliser un guide tubulaire qui, à la fois, est venu de matière avec les bras de fixation du dispositif et assure directement le positionnement axial de l’instrument. Cet instrument est, par exemple, un trocart utilisé pour biopsier une zone d’intérêt, ou un foret utilisé pour percer un os d’un sujet, tel que le crâne, un os du bassin ou un os long. Il en résulte que l’on dispose d’une unique pièce directement prête pour assurer le positionnement de l’instrument, et qu’il n’est donc pas nécessaire de régler une partie ou rapporter de pièce intermédiaire, telle qu’un élément de contrôle de profondeur de l’instrument, source d’imprécision ou de temps à passer à régler une profondeur, en consultation médicale ou en bloc opératoire. Par ailleurs, outre la facilité d’utilisation apportée par l’installation rapide du dispositif sur la zone d’application sur le corps du sujet, et l’utilisation plus sûre apportée par le positionnement direct de l’instrument dans le guide tubulaire, on évite des risques d’erreur de réglage à ce stade.  Thus, it is proposed to use a tubular guide which, at the same time, came integrally with the fixing arms of the device and directly ensures the axial positioning of the instrument. This instrument is, for example, a trocar used to biopsy an area of interest, or a drill used to pierce a bone of a subject, such as the skull, a pelvis bone or a long bone. As a result, there is a single piece directly ready to ensure the positioning of the instrument, and it is therefore not necessary to adjust a part or add an intermediate piece, such as an element of depth control of the instrument, source of inaccuracy or time to spend adjusting a depth, in medical consultation or operating room. Furthermore, in addition to the ease of use provided by the rapid installation of the device on the application area on the subject's body, and the safer use brought by the direct positioning of the instrument in the tubular guide, avoids risks of adjustment errors at this stage.
[0008] On entend par « guide tubulaire » un corps creux allongé, dont la section peut être de forme quelconque et ayant pour fonction de guider l’instrument. Par exemple, le guide tubulaire est de section polygonale ou circulaire, il pourrait également être de section carrée ou prendre d’autres formes encore.  The term "tubular guide" means an elongated hollow body, the section of which can be of any shape and whose function is to guide the instrument. For example, the tubular guide is of polygonal or circular section, it could also be of square section or take other forms still.
[0009] On comprend que la butée axiale est configurée pour coopérer directement avec l'instrument, c’est-à-dire sans pièce intermédiaire de positionnement.  It is understood that the axial stop is configured to cooperate directly with the instrument, that is to say without an intermediate positioning part.
[00010] On comprend par ailleurs que le dispositif est réalisé de préférence sur mesure, et notamment réalisable par fabrication additive, ce qui est particulièrement confortable pour l’utilisateur qui doit insérer l’instrument à travers la paroi, car aucun réglage n’est nécessaire au moment de la fixation.  We also understand that the device is preferably made to measure, and in particular achievable by additive manufacturing, which is particularly comfortable for the user who must insert the instrument through the wall, because no adjustment is necessary at the time of fixing.
[0001 1 ] On entend généralement par « sujet », un être vivant comme par exemple un animal vertébré, tel qu’un mammifère, et notamment un être humain. [00012] On entend par ailleurs généralement par « zone d’application » une partie du corps du sujet contre laquelle le dispositif de guide est configuré pour être appliqué, par exemple une partie du cuir chevelu. On entend en outre généralement par « zone d’intérêt » une zone disposée à l’intérieur du corps du sujet, dans laquelle une intervention nécessitant l’insertion d’un instrument dans le corps du sujet doit être réalisée, par exemple un prélèvement ou une ablation, ou encore l’injection d’une substance. La zone d’intérêt est généralement distincte de la zone d’application et se trouve à une certaine profondeur par rapport à cette zone d’application. D’autre part, la paroi à travers laquelle l’instrument est inséré est généralement une paroi rigide, c’est-à- dire peu ou pas déformable, qui se distingue d’un tissu souple et dont la rigidité est comparable à la rigidité d’une paroi osseuse. En d’autres termes, la paroi dite rigide est à entendre comme une paroi peu déformable en comparaison avec un tissu déformable. La paroi est de préférence une paroi osseuse. Generally, the term "subject" means a living being such as a vertebrate animal, such as a mammal, and in particular a human being. [00012] Furthermore, the term “application zone” generally means a part of the subject's body against which the guide device is configured to be applied, for example a part of the scalp. The term “zone of interest” is also generally understood to mean an area arranged inside the subject's body, in which an intervention requiring the insertion of an instrument into the subject's body must be carried out, for example a sample or an ablation, or the injection of a substance. The zone of interest is generally distinct from the zone of application and is located at a certain depth with respect to this zone of application. On the other hand, the wall through which the instrument is inserted is generally a rigid wall, that is to say little or not deformable, which is distinguished from a flexible fabric and whose rigidity is comparable to rigidity of a bone wall. In other words, the so-called rigid wall is to be understood as a slightly deformable wall in comparison with a deformable fabric. The wall is preferably a bone wall.
[00013] On comprend par ailleurs que le dispositif de guide est de préférence appliqué sur la zone d’application de manière temporaire, et que l’insertion de l’instrument est également temporaire. En d’autres termes, les moyens de fixation sont amovibles, le dispositif de guide et l’instrument étant par la suite retirés de la paroi.  It is also understood that the guide device is preferably applied to the application area temporarily, and that the insertion of the instrument is also temporary. In other words, the fixing means are removable, the guide device and the instrument being subsequently removed from the wall.
[00014] Le dispositif de guide pour l’insertion d’un instrument à travers une paroi peut en outre comporter l’une ou plusieurs des caractéristiques suivantes, prises seules ou en combinaison.  The guide device for inserting an instrument through a wall may further include one or more of the following characteristics, taken alone or in combination.
[00015] - Le dispositif de guide comprend un seul, deux, ou encore trois, bras de fixation configurés pour être fixés sur la zone d’application par des moyens de fixation amovibles et étant chacun venu de matière avec le guide tubulaire, de préférence deux bras de fixation, de préférence encore un seul bras de fixation. Le nombre de bras de fixation utilisés est particulièrement intéressant car il correspond au nombre d’incisions nécessaires dans la zone d’application. Pouvoir limiter le nombre d’incisions est un aspect particulièrement avantageux. Si le matériau du dispositif de guide est particulièrement rigide, ne présentant pas de déformation plastique ou élastique dans les niveaux de force pouvant être développés par un utilisateur du guide, présentant par exemple une rigidité proche de celle du titane, il est envisageable de réaliser un dispositif de guide ne possédant qu’un unique bras de fixation. _La présence de deux ou trois bras de fixation assure un positionnement particulièrement stable et précis du dispositif de guide sur la zone d’application. Le fait d’en prévoir deux au lieu de trois est particulièrement intéressant.  - The guide device comprises a single, two, or even three, fixing arms configured to be fixed on the application area by removable fixing means and each being made integrally with the tubular guide, preferably two fixing arms, preferably still a single fixing arm. The number of fixing arms used is particularly interesting because it corresponds to the number of incisions required in the application area. Being able to limit the number of incisions is a particularly advantageous aspect. If the material of the guide device is particularly rigid, having no plastic or elastic deformation in the force levels that can be developed by a user of the guide, having for example a rigidity close to that of titanium, it is conceivable to produce a guide device having only one fixing arm. _The presence of two or three fixing arms ensures a particularly stable and precise positioning of the guide device on the application area. Having two instead of three is particularly interesting.
[00016] - Le au moins un bras de fixation comprend des moyens détrompeurs configurés pour imposer une position angulaire prédéterminée du bras de fixation par rapport au moyen de fixation amovible. Ainsi, un bras de fixation unique pourrait être suffisant pour assurer le positionnement correct et précis du dispositif de guide sur la zone d’application, évitant de placer inutilement des moyens de fixation amovibles supplémentaires. Par exemple, des moyens détrompeurs comprennent une forme asymétrique d’un orifice du bras de fixation, de sorte qu’une unique position angulaire du bras de fixation par rapport au moyen de fixation est possible. - The at least one fixing arm comprises polarizing means configured to impose a predetermined angular position of the fixing arm relative to the removable fixing means. Thus, a single fixing arm could be sufficient to ensure the correct and precise positioning of the guide device on the application area, avoiding unnecessarily placing additional removable fixing means. For example, polarizing means comprise an asymmetrical shape of an orifice in the fixing arm, so that a single angular position of the fixing arm relative to the fixing means is possible.
[00017] - Les moyens de fixation amovibles sont des moyens de fixation intra-osseux, par exemple des vis auto-foreuses. Ainsi, le guide est positionné sur une structure rigide, permettant de servir de support fixe et limitant toute déformation du support, donc des risques de déplacement non souhaité lors de l’utilisation.  - The removable fixing means are intraosseous fixing means, for example self-drilling screws. Thus, the guide is positioned on a rigid structure, making it possible to serve as a fixed support and limiting any deformation of the support, therefore the risks of unwanted displacement during use.
[00018] - Le dispositif de guide comprend en outre au moins un bras de positionnement, configuré pour être en appui sur la zone d’application. Ainsi, le dispositif de guide est fixé sur au moins un point, qui est un bras de fixation, et s’appuie en outre sur un deuxième, voire un troisième point qui sont des bras de positionnement, assurant une bonne stabilité, sans avoir à placer inutilement des moyens de fixation amovibles supplémentaires, c’est-à-dire dans certains cas sans avoir à percer inutilement un trou supplémentaire dans la zone d’application.  - The guide device further comprises at least one positioning arm, configured to be supported on the application area. Thus, the guide device is fixed on at least one point, which is a fixing arm, and is further supported on a second or even a third point which are positioning arms, ensuring good stability, without having to unnecessarily place additional removable fastening means, that is to say in certain cases without having to unnecessarily drill an additional hole in the application area.
[00019] - Le guide tubulaire présente une forme tubulaire ayant une surface supérieure s’étendant sensiblement radialement et la butée axiale est formée par cette surface supérieure. Ainsi la butée axiale présente une surface d’appui adaptée pour un appui stable et précis de l’instrument lorsqu’il est inséré dans sa position finale d’utilisation.  - The tubular guide has a tubular shape having an upper surface extending substantially radially and the axial stop is formed by this upper surface. Thus, the axial stop has a support surface suitable for stable and precise support of the instrument when it is inserted in its final position of use.
[00020] - La butée axiale est configurée pour coopérer directement avec un foret de perçage dans la paroi, permettant d’atteindre la profondeur de perçage souhaitée.  - The axial stop is configured to cooperate directly with a drilling bit in the wall, allowing to reach the desired drilling depth.
[00021 ] - La butée axiale est configurée pour coopérer directement avec un trocart, permettant à l’utilisateur de positionner précisément le trocart dans la zone d’intérêt à biopsier.  - The axial stop is configured to cooperate directly with a trocar, allowing the user to precisely position the trocar in the area of interest to be biopsied.
[00022] - La butée axiale est configurée pour coopérer directement avec une seringue, une électrode ou encore une sonde.  - The axial stop is configured to cooperate directly with a syringe, an electrode or even a probe.
[00023] - Le guide tubulaire est configuré pour recevoir un guide tubulaire additionnel, ce guide tubulaire étant configuré pour guider un autre instrument destiné à être inséré à travers la paroi. Ainsi, non seulement le guide tubulaire est configuré pour recevoir directement un instrument destiné à être inséré dans le crâne, présentant un certain diamètre, mais en outre il peut recevoir un guide tubulaire additionnel capable de former un chemisage autour d’un autre instrument ayant un diamètre plus petit, de façon à pouvoir guider, également, cet autre instrument. Par exemple, le guide tubulaire est configuré pour recevoir directement un foret de perçage, permettant de percer le crâne pour accéder à l’intérieur, et également pour recevoir un guide tubulaire additionnel, capable de recevoir un trocart pour réaliser la biopsie, le trocart ayant dans ce cas un diamètre plus petit que le foret de perçage. - The tubular guide is configured to receive an additional tubular guide, this tubular guide being configured to guide another instrument intended to be inserted through the wall. Thus, not only is the tubular guide configured to directly receive an instrument intended to be inserted into the skull, having a certain diameter, but in addition it can receive an additional tubular guide capable of forming a liner around another instrument having a smaller diameter, so that it can also guide this other instrument. For example, the tubular guide is configured to directly receive a drilling drill, making it possible to pierce the skull to access the interior, and also to receive an additional tubular guide, capable of receiving a trocar to perform the biopsy, the trocar having in this case a smaller diameter than the drill bit.
[00024] - Le dispositif de guide peut comprendre en outre une nervure de rigidification du guide tubulaire, portée de préférence par le au moins un bras de fixation. Ainsi, le dispositif possède une grande rigidité, permettant qu’il soit fabriqué en un matériau relativement souple, tout en étant léger et en assurant un guidage optimal. .  - The guide device may further comprise a stiffening rib of the tubular guide, preferably carried by the at least one fixing arm. Thus, the device has a high rigidity, allowing it to be made of a relatively flexible material, while being light and ensuring optimal guidance. .
[00025] - Le dispositif de guide pour l’insertion d’un instrument dans le corps d’un sujet est un dispositif de guide pour biopsie intracrânienne.  - The guide device for inserting an instrument into the body of a subject is a guide device for intracranial biopsy.
[00026] L’invention a également pour objet un ensemble d’un dispositif de guide tel que présenté ci-dessus et d’un instrument reçu directement dans le guide tubulaire pour être inséré à travers la paroi, tel qu’un foret de perçage ou un trocart. On comprend que le dispositif de guide peut également être un dispositif de guide pour l’insertion d’une seringue, d’une électrode ou encore d’une sonde à travers la paroi.  The invention also relates to a set of a guide device as presented above and an instrument received directly in the tubular guide to be inserted through the wall, such as a drill bit or a trocar. It is understood that the guide device can also be a guide device for inserting a syringe, an electrode or even a probe through the wall.
[00027] Un autre objet de l’invention est un procédé de fabrication d’un dispositif de guide tel que décrit ci-dessus, comprenant les étapes suivantes :  Another object of the invention is a method of manufacturing a guide device as described above, comprising the following steps:
a) affichage d'une image tridimensionnelle illustrant la zone d’application et au moins un point de fixation sur la zone d’application,  a) display of a three-dimensional image illustrating the application area and at least one attachment point on the application area,
b) définition d'un modèle numérique du dispositif de guide, comprenant le au moins un bras de fixation et le guide tubulaire, et éventuellement définition d'un modèle numérique du guide additionnel, et  b) definition of a digital model of the guide device, comprising the at least one fixing arm and the tubular guide, and optionally definition of a digital model of the additional guide, and
c) fabrication assistée par ordinateur du dispositif de guide, en utilisant le modèle numérique, de préférence par fabrication additive.  c) computer-aided manufacturing of the guide device, using the digital model, preferably by additive manufacturing.
[00028] Ainsi, on propose ici de fabriquer un dispositif de guide sur mesure, en définissant un modèle numérique directement à partir de l’image tridimensionnelle illustrant la zone d’application munie d’au moins un point de fixation.  Thus, it is proposed here to manufacture a tailor-made guide device, by defining a digital model directly from the three-dimensional image illustrating the application area provided with at least one fixing point.
[00029] L’étape b) du procédé ci-dessus peut comprendre, notamment, la détermination par calcul numérique:  Step b) of the above process can include, in particular, the determination by numerical calculation:
- d’une dimension du au moins un bras de fixation et éventuellement d’un bras de positionnement,  - of a dimension of at least one fixing arm and possibly of a positioning arm,
- de l’orientation du guide tubulaire, dont l’axe est de préférence confondu avec une droite passant par une zone à biopsier et un point central du dispositif de guide,- the orientation of the tubular guide, the axis of which is preferably coincident with a straight line passing through a biopsy area and a central point of the guide device,
- d’une dimension du guide tubulaire, et éventuellement d’une dimension du guide tubulaire additionnel. - one dimension of the tubular guide, and possibly one dimension of the additional tubular guide.
[00030] On comprend que le calcul d’une dimension du guide tubulaire, ou encore du guide tubulaire additionnel, peut comprendre le calcul de sa longueur, de son diamètre intérieur et/ou de son diamètre extérieur. De tels paramètres peuvent en effet être fonction du sujet, de la zone d’intérêt visée et de l’équipement du chirurgien. On comprend par ailleurs que l’étape b) du procédé ci-dessus peut comprendre avantageusement la détermination par calcul numérique d’autres paramètres. Par exemple, on peut également déterminer si besoin la hauteur du dispositif de guide, en tenant compte avantageusement d’une épaisseur d’un tissu disposé entre la zone d’application et la paroi rigide, telle que l’épaisseur du scalp du sujet.  It is understood that the calculation of a dimension of the tubular guide, or even of the additional tubular guide, can include the calculation of its length, its inside diameter and / or its outside diameter. Such parameters may indeed depend on the subject, the area of interest and the equipment of the surgeon. It is also understood that step b) of the above method can advantageously include the determination by numerical calculation of other parameters. For example, the height of the guide device can also be determined if necessary, advantageously taking into account a thickness of a fabric disposed between the application area and the rigid wall, such as the thickness of the subject's scalp.
[00031 ] Par ailleurs, le procédé de fabrication du dispositif de guide peut comprendre, en parallèle de l’étape b), ou avant ou après l’étape b), la définition d’un modèle numérique d’un guide tubulaire additionnel configuré pour être reçu par le dispositif de guide et pour guider un autre instrument destiné à être inséré à travers la paroi. Dans ce cas, l’étape de définition du modèle numérique du guide tubulaire additionnel peut comprendre notamment, la détermination par calcul numérique du diamètre extérieur, du diamètre intérieur et/ou de la longueur du guide tubulaire additionnel.  Furthermore, the method of manufacturing the guide device can comprise, in parallel with step b), or before or after step b), the definition of a digital model of an additional tubular guide configured to be received by the guide device and to guide another instrument intended to be inserted through the wall. In this case, the step of defining the digital model of the additional tubular guide may include in particular, the determination by numerical calculation of the outside diameter, the inside diameter and / or the length of the additional tubular guide.
[00032] Nous allons maintenant présenter un mode de réalisation de l’invention donné à titre d’exemple non limitatif et à l’appui des figures annexées dans lesquelles : la figure 1 est une vue en perspective latérale d’un dispositif de guide pour l’insertion d’un instrument à travers une paroi. La paroi est ici le crâne d’un sujet. We will now present an embodiment of the invention given by way of non-limiting example and in support of the appended figures in which: Figure 1 is a side perspective view of a guide device for the insertion of an instrument through a wall. The wall here is the skull of a subject.
La figure 2 est une vue de dessus en perspective du dispositif de guide de la figure 1. FIG. 2 is a perspective view from above of the guide device of FIG. 1.
La figure 3 est une vue de dessous en perspective du dispositif de de la figure 1. FIG. 3 is a bottom perspective view of the device of FIG. 1.
La figure 4 est une vue d’un guide tubulaire additionnel pouvant être rapporté sur le dispositif de guide de la figure 1 . FIG. 4 is a view of an additional tubular guide which can be attached to the guide device of FIG. 1.
Les figures 5a, 5b, 5c sont des vues en perspective respectivement latérale assemblée, avant assemblage et latérale démontée d’un moyen de fixation amovible utilisable avec le dispositif de guide de la figure 1.  FIGS. 5a, 5b, 5c are perspective views, respectively assembled side, before assembly and disassembled side of a removable fixing means usable with the guide device of FIG. 1.
La figure 6 est une représentation du dispositif de guide de la figure 1 en position sur le crâne d’un sujet et muni d’un guide tubulaire additionnel selon une variante de réalisation de celui illustré sur la figure 4. La figure 7 est une représentation du dispositif de guide de la figure 6 en position sur le crâne d’un sujet, avec l’instrument inséré et positionné dans la zone d’intérêt.FIG. 6 is a representation of the guide device of FIG. 1 in position on the skull of a subject and provided with an additional tubular guide according to an alternative embodiment of that illustrated in FIG. 4. Figure 7 is a representation of the guide device of Figure 6 in position on the skull of a subject, with the instrument inserted and positioned in the area of interest.
La figure 8 est une vue en perspective latérale d’un dispositif de guide comportant un seul bras de fixation, avec un moyen détrompeur, FIG. 8 is a side perspective view of a guide device comprising a single fixing arm, with a polarizing means,
La figure 9 est une vue en perspective latérale d’un moyen de fixation amovible avec détrompeur, destiné à coopérer avec le dispositif de guide de la figure 8. FIG. 9 is a side perspective view of a removable fixing means with a polarizing device, intended to cooperate with the guide device of FIG. 8.
La figure 10 est une représentation du dispositif de guide de la figure 8 en position sur une paroi dans laquelle est fixé le moyen de fixation amovible de la figure 9, avec l’instrument inséré. Figure 10 is a representation of the guide device of Figure 8 in position on a wall in which is fixed the removable fixing means of Figure 9, with the instrument inserted.
[00033] Comme illustré sur les figures 1 à 3, le dispositif de guide 1 pour l’insertion d’un instrument à travers une paroi comprend un guide tubulaire 2 définissant un axe d’insertion X, et configuré pour permettre l’insertion et le guidage de l’instrument destiné à être inséré à travers la paroi. Le guidage est exercé selon l’axe d’insertion X, depuis une extrémité amont du guide tubulaire 2 vers la zone d’application. Le dispositif de guide comprend également, dans cet exemple particulier, trois bras de fixation 3, configurés pour être fixés sur la zone d’application par des moyens de fixation amovibles, reliés au guide tubulaire 2. Le guide tubulaire 2 est venu de matière avec les bras de fixation 3.  As illustrated in Figures 1 to 3, the guide device 1 for the insertion of an instrument through a wall comprises a tubular guide 2 defining an insertion axis X, and configured to allow insertion and the guide of the instrument intended to be inserted through the wall. The guidance is exerted along the insertion axis X, from an upstream end of the tubular guide 2 towards the application area. The guide device also comprises, in this particular example, three fixing arms 3, configured to be fixed to the application area by removable fixing means, connected to the tubular guide 2. The tubular guide 2 came integrally with the fixing arms 3.
[00034] Dans le cas illustré ici par les figures, le dispositif de guide 1 est configuré pour être fixé sur le corps d’un sujet, et plus particulièrement sur son crâne, et l’instrument est en particulier un forêt de perçage destiné à être inséré dans le corps du sujet. Ainsi dans l’exemple, la zone d’application est le cuir chevelu du sujet et la zone d’intérêt est une partie du cerveau. Pour pouvoir agir sur cette zone d’intérêt, on perce le crâne grâce au foret de perçage.  In the case illustrated here by the figures, the guide device 1 is configured to be fixed on the body of a subject, and more particularly on his skull, and the instrument is in particular a drilling forest intended for be inserted into the subject's body. So in the example, the area of application is the subject's scalp and the area of interest is part of the brain. To be able to act on this area of interest, the skull is pierced with the piercing drill.
[00035] Le guide tubulaire 2 forme dans sa partie amont une butée axiale 4, représentée sur les figures 1 et 2, configurée pour coopérer directement avec l'instrument à insérer et imposer une profondeur prédéterminée d'insertion de l'instrument. La butée axiale 4 est formée par la surface supérieure du guide tubulaire 2, de forme ici annulaire, qui s’étend sensiblement radialement. Ainsi, le dispositif de guide ne nécessite pas l’utilisation de moyens de réglage de profondeur de l’instrument à insérer.  The tubular guide 2 forms in its upstream part an axial stop 4, shown in Figures 1 and 2, configured to cooperate directly with the instrument to be inserted and impose a predetermined depth of insertion of the instrument. The axial stop 4 is formed by the upper surface of the tubular guide 2, here of annular shape, which extends substantially radially. Thus, the guide device does not require the use of means for adjusting the depth of the instrument to be inserted.
[00036] Le dispositif de guide 1 est fabriqué de préférence par fabrication additive. Il peut être fabriqué en matériau polymère ou en métal. Les matériaux polymères sont par exemple de la résine photo-polymérisable telle que la résine fabriquée sous la marque Formlabs et sous la référence Résiné Dental LT Le métal est, par exemple, du titane.  The guide device 1 is preferably manufactured by additive manufacturing. It can be made of polymeric material or metal. The polymeric materials are, for example, photopolymerizable resin such as the resin manufactured under the brand Formlabs and under the reference Résiné Dental LT The metal is, for example, titanium.
[00037] Des nervures de rigidification ou de renfort 5, portées par les bras de fixation 3 et visibles sur la figure 1 , peuvent être prévues pour donner une rigidité suffisante au dispositif de guide 1 , afin que l’instrument soit inséré précisément à l’endroit voulu d’une zone d’intérêt identifiée. Ces nervures 5 sont plus particulièrement utiles lorsque le guide est fabriqué en un matériau relativement souple, car elles confèrent une rigidité améliorée au guide tubulaire 2 permettant un guidage précis. Rigidification or reinforcement ribs 5, carried by the fixing arms 3 and visible in FIG. 1, can be provided to give sufficient rigidity to the guide device 1, so that the instrument is inserted precisely at the desired location in an identified area of interest. These ribs 5 are more particularly useful when the guide is made of a relatively flexible material, because they confer improved rigidity to the tubular guide 2 allowing precise guidance.
[00038] Les bras de fixation 3 comportent, à leurs extrémités externes, i.e. opposées au guide tubulaire 2, des parties d’extrémité 6 destinées à coopérer avec les moyens de fixation amovibles.  The fixing arms 3 comprise, at their external ends, i.e. opposite to the tubular guide 2, end parts 6 intended to cooperate with the removable fixing means.
[00039] De manière non limitative, les moyens de fixation amovibles peuvent être un assemblage de vis 40, représenté à la figure 5, comprenant une première vis 41 pourvue d’un filetage auto-taraudant 42, et d’une tête taraudée 43 prévue pour recevoir une seconde vis 44. Les parties d’extrémité 6 des bras de fixation 3 comprennent un orifice 8 dans lequel passe la tige de la vis 44. Ainsi, les parties d’extrémité 6 des bras de fixation 3 comprennent une surface 7 « inférieure » destinée à être positionnée sur la tête 43 de la vis auto-foreuse 41 , et une surface 9 « supérieures » destinée à recevoir la vis 44, la fixation du dispositif de guide 1 sur le moyen de fixation étant ainsi obtenue par serrage de la vis 44 dans la tête de la vis 43.  Without limitation, the removable fixing means can be a screw assembly 40, shown in Figure 5, comprising a first screw 41 provided with a self-tapping thread 42, and a tapped head 43 provided to receive a second screw 44. The end parts 6 of the fixing arms 3 comprise an orifice 8 through which the rod of the screw 44 passes. Thus, the end parts 6 of the fixing arms 3 comprise a surface 7 " lower "intended to be positioned on the head 43 of the self-drilling screw 41, and a surface 9" upper "intended to receive the screw 44, the fixing of the guide device 1 on the fixing means being thus obtained by tightening the screw 44 in the head of the screw 43.
[00040] Dans un autre mode de réalisation, représenté à la figure 8, le dispositif de guide 1 comporte un seul bras de fixation 3. Dans ce mode de réalisation en particulier, mais également dans celui de la figure 1 , la partie d’extrémité 6 du bras de fixation 2 et le moyen de fixation amovible 40 peuvent être pourvus de moyens détrompeurs respectifs 60, 45, coopérant entre eux de manière à assurer que le dispositif de guide 1 est positionné sur la zone d’application du corps du sujet par rapport au moyen de fixation amovible 40 selon un angle permettant l’insertion de l’instrument à l’endroit souhaité de la zone d’intérêt. Le moyen détrompeur 45 du moyen de fixation amovible 40 est représenté à la figure 9. Il est bien entendu que la forme des moyens détrompeurs respectifs n’est pas limitée à ce qui est représenté sur les figures 8 et 9.  In another embodiment, shown in Figure 8, the guide device 1 comprises a single fixing arm 3. In this embodiment in particular, but also in that of Figure 1, the part of end 6 of the fixing arm 2 and the removable fixing means 40 can be provided with respective polarizing means 60, 45, cooperating with each other so as to ensure that the guide device 1 is positioned on the area of application of the subject's body relative to the removable fixing means 40 at an angle allowing the insertion of the instrument at the desired location in the area of interest. The polarizing means 45 of the removable fixing means 40 is shown in FIG. 9. It is understood that the shape of the respective polarizing means is not limited to what is shown in FIGS. 8 and 9.
[00041 ] Dans encore un autre mode de réalisation, le dispositif de guide 2 comprend en outre un bras de positionnement, configuré pour être en appui sur la zone d’application du sujet. Ce bras de positionnement étant seulement appuyé sur le corps du sujet, il n’est pas nécessaire qu’il coopère avec un moyen de fixation amovible.  In yet another embodiment, the guide device 2 further comprises a positioning arm, configured to be supported on the subject's application area. This positioning arm being only supported on the subject's body, it is not necessary for it to cooperate with a removable fixing means.
[00042] Le guide tubulaire 2 du dispositif de guide 1 peut en outre être prévu pour recevoir un guide tubulaire additionnel 10 représenté sur la figure 4. Le guide tubulaire additionnel 10 a une dimension extérieure, plus précisément ici un diamètre extérieur, sensiblement égal ou légèrement inférieur à la dimension intérieure, ou diamètre intérieur, du guide tubulaire 2 dans lequel il est destiné à être inséré. Le guide tubulaire additionnel 10 a par ailleurs un diamètre intérieur de dimension adaptée à l’insertion d’un autre instrument, notamment d’un trocart. The tubular guide 2 of the guide device 1 may also be provided to receive an additional tubular guide 10 shown in FIG. 4. The additional tubular guide 10 has an external dimension, more precisely here an external diameter, substantially equal to or slightly smaller than the internal dimension, or diameter inside, of the tubular guide 2 into which it is intended to be inserted. The additional tubular guide 10 also has an internal diameter of dimension adapted to the insertion of another instrument, in particular a trocar.
[00043] Le guide additionnel 10 est configuré de manière à ce que sa position d’assemblage par rapport au dispositif de guide soit prédéterminée, de préférence fixe non réglable. Cela est réalisé, par exemple, grâce à une partie supérieure ayant une collerette, de diamètre extérieur plus large que la partie inférieure insérée dans le guide tubulaire 2, et possédant un extrémité inférieure 12 formant butée apte à coopérer avec la butée 4 du guide tubulaire 2. D’autre part, la surface supérieure du guide tubulaire additionnel 10, de forme annulaire ici, s’étend également sensiblement radialement et forme une butée axiale 11 configurée pour coopérer directement avec l'instrument à insérer et imposer une profondeur prédéterminée d'insertion de l’autre instrument. Le guide additionnel 10 présente par conséquent les mêmes avantages que ceux décrit pour le guide tubulaire 2, à savoir une grande facilité et une grande sûreté d’utilisation.  The additional guide 10 is configured so that its assembly position relative to the guide device is predetermined, preferably fixed, not adjustable. This is achieved, for example, by virtue of an upper part having a collar, with an outside diameter wider than the lower part inserted in the tubular guide 2, and having a lower end 12 forming a stop capable of cooperating with the stop 4 of the tubular guide. 2. On the other hand, the upper surface of the additional tubular guide 10, of annular shape here, also extends substantially radially and forms an axial stop 11 configured to cooperate directly with the instrument to be inserted and to impose a predetermined depth of insertion of the other instrument. The additional guide 10 therefore has the same advantages as those described for the tubular guide 2, namely great ease and great safety in use.
[00044] La figure 6 illustre un dispositif de guide 1 pour biopsie intracrânienne, en place sur un mannequin simulant un crâne 20 d’un sujet. Un guide tubulaire additionnel 10 est en position d’insertion dans le guide tubulaire 2 du dispositif de guide. Les moyens de fixation amovibles 40 sont en place dans le crâne du sujet, et les parties d’extrémité 6 sont en position sur les moyens de fixation amovibles 40.  FIG. 6 illustrates a guide device 1 for intracranial biopsy, in place on a mannequin simulating a skull 20 of a subject. An additional tubular guide 10 is in the insertion position in the tubular guide 2 of the guide device. The removable fixing means 40 are in place in the subject's skull, and the end parts 6 are in position on the removable fixing means 40.
[00045] La figure 7 illustre un ensemble d’un dispositif de guide 1 tel que décrit à la figure 6, et d’un instrument 50, l’ensemble étant en position sur le crâne 20 d’un sujet. L’instrument 50 est ici un trocart, dont l’extrémité est positionnée dans la zone d’intérêt 21 .  FIG. 7 illustrates an assembly of a guide device 1 as described in FIG. 6, and of an instrument 50, the assembly being in position on the skull 20 of a subject. The instrument 50 is here a trocar, the end of which is positioned in the area of interest 21.
[00046] La figure 10 illustre un ensemble d’un dispositif de guide 1 tel que décrit à la figure 8, et d’un instrument 50, l’ensemble étant en position sur la paroi rigide 20. Le dispositif de guide 1 comprend un unique bras de fixation 3, dont l’extrémité 6 est fixé au moyen de fixation amovible 40 par coopération des moyens détrompeurs respectifs 60 et 45.  FIG. 10 illustrates an assembly of a guide device 1 as described in FIG. 8, and of an instrument 50, the assembly being in position on the rigid wall 20. The guide device 1 comprises a single fixing arm 3, the end of which 6 is fixed to the removable fixing means 40 by cooperation of the respective polarizing means 60 and 45.
[00047] Nous allons à présent décrire un exemple non limitatif de procédé de fabrication du dispositif de guide 1 .  We will now describe a non-limiting example of the method for manufacturing the guide device 1.
[00048] Préalablement à la fabrication du guide 1 , des vis ou autres moyens de fixation amovibles 40 sont mis en place sur la zone d’application envisagée sur le corps du sujet. Ensuite, une image tridimensionnelle sur laquelle sont visibles les moyens de fixation amovibles 40 en place, ainsi que la zone d’intérêt 21 (par exemple une zone à biopsier) est réalisée. Cette image tridimensionnelle peut être obtenue par exemple par un scanner tridimensionnel. Prior to the manufacture of the guide 1, screws or other removable fixing means 40 are put in place on the intended application area on the subject's body. Next, a three-dimensional image on which the removable fixing means 40 in place are visible, as well as the area of interest 21 (for example a biopsy area) is produced. This three-dimensional image can be obtained for example by a three-dimensional scanner.
[00049] Dans une première étape du procédé de réalisation du dispositif de guide 1 , on procède à l’affichage de l’image tridimensionnelle obtenue ci-dessus, l’image illustrant, comme indiqué ci-dessus, une partie du corps du sujet 20 et comprenant au moins un point de fixation du dispositif de guide 1 sur la zone d’application 22, le point de fixation étant représenté par le moyen de fixation amovible 40 en place, l’image illustre également la zone d’intérêt 21.  In a first step of the method for producing the guide device 1, the three-dimensional image obtained above is displayed, the image illustrating, as indicated above, part of the subject's body 20 and comprising at least one point of attachment of the guide device 1 to the application area 22, the attachment point being represented by the removable attachment means 40 in place, the image also illustrates the area of interest 21.
[00050] Dans une seconde étape du procédé, l’image tridimensionnelle sert de base à la création d'un modèle numérique du dispositif de guide 1 , comprenant le au moins un bras de fixation 3 et le guide tubulaire 2. Le modèle est créé sur mesure pour chaque dispositif de guide 1 , en fonction, en particulier mais de manière non limitative,  In a second step of the method, the three-dimensional image serves as the basis for the creation of a digital model of the guide device 1, comprising the at least one fixing arm 3 and the tubular guide 2. The model is created tailor-made for each guide device 1, depending, in particular but not limited to,
du type des moyens de fixation amovibles, comme par exemple des vis auto- foreuses à tête taraudée, de leur nombre, et de leur position sur la zone d’application,  the type of removable fastening means, such as self-tapping screws with tapped head, their number and their position on the application area,
- de la position de la zone d’intérêt 21 par rapport aux moyens de fixation amovibles - the position of the area of interest 21 relative to the removable fixing means
40, cette position pouvant être définie par une distance et une position angulaire, des dimensions du ou des instruments à insérer 50. 40, this position being able to be defined by a distance and an angular position, the dimensions of the instrument or instruments to be inserted 50.
[00051] Ainsi, de manière non limitative, dans un mode de réalisation, cette seconde étape peut comprendre la détermination par calcul numérique des dimensions des bras de fixation 3 et, éventuellement, d’un bras de positionnement, de l’orientation du guide tubulaire 2, dont l’axe X est de préférence confondu avec une droite passant par une zone d’intérêt 21 et un point central du dispositif de guide 1 , et des dimensions du guide tubulaire 2. Cette seconde étape comprend également, le cas échéant, la détermination par calcul de la forme et de la dimension du second guide tubulaire 10.  Thus, without limitation, in one embodiment, this second step may include the determination by digital calculation of the dimensions of the fixing arms 3 and, optionally, of a positioning arm, of the orientation of the guide tubular 2, the axis X of which is preferably coincident with a straight line passing through an area of interest 21 and a central point of the guide device 1, and of the dimensions of the tubular guide 2. This second step also includes, where appropriate , determining by calculation of the shape and dimension of the second tubular guide 10.
[00052] Les dimensions du guide tubulaire 2, c’est-à-dire sa longueur, son diamètre intérieur, son diamètre extérieur sont fonction du sujet, de la zone d’intérêt visée et de l’équipement du chirurgien. D’autres caractéristiques du dispositif de guide sont également déterminées si besoin, telles que la taille de jeu entre la boite crânienne et le haut du guide tubulaire, qui dépend de l’épaisseur du scalp du sujet.  The dimensions of the tubular guide 2, that is to say its length, its inside diameter, its outside diameter are a function of the subject, the area of interest targeted and the surgeon's equipment. Other characteristics of the guide device are also determined if necessary, such as the clearance between the skull and the top of the tubular guide, which depends on the thickness of the subject's scalp.
[00053] Dans une troisième étape du procédé, on fabrique le dispositif de guide 1 par fabrication assistée par ordinateur en utilisant le modèle numérique défini à la deuxième étape ci-dessus. De préférence, on utilise la fabrication additive pour fabriquer le dispositif de guide 1.  In a third step of the method, the guide device 1 is manufactured by computer-aided manufacturing using the digital model defined in the second step above. Preferably, additive manufacturing is used to manufacture the guide device 1.
[00054] Ainsi, la fabrication du dispositif de guide 1 est simple et rapide. Elle ne nécessite pas l’emploi de machines onéreuses et d’utilisation complexe, et peut être facilement automatisée, au moins en partie, ce qui la rend accessible à de nombreux utilisateurs. Thus, the manufacture of the guide device 1 is simple and quick. It does not require the use of expensive and complex machines, and can be easily automated, at least in part, which makes it accessible to many users.
[00055] On comprend que l’étape du procédé ci-dessus peut comprendre la détermination par calcul numérique d’autres paramètres, tels que le diamètre intérieur du guide tubulaire 2. Par ailleurs, le procédé de fabrication du dispositif de guide 1 peut comprendre, en parallèle de la seconde étape, ou avant ou après cette seconde étape, la définition d’un modèle numérique du guide tubulaire additionnel 10 configuré pour être reçu par le dispositif de guide 1. Dans ce cas, l’étape de définition du modèle numérique du guide tubulaire additionnel 10 comprend notamment, la détermination par calcul numérique du diamètre extérieur, du diamètre intérieur et/ou de la longueur du guide tubulaire additionnel 10.  It is understood that the step of the above method may include the determination by numerical calculation of other parameters, such as the internal diameter of the tubular guide 2. Furthermore, the method of manufacturing the guide device 1 may include , in parallel with the second step, or before or after this second step, the definition of a digital model of the additional tubular guide 10 configured to be received by the guide device 1. In this case, the step of defining the model numerical measurement of the additional tubular guide 10 includes, in particular, the determination by numerical calculation of the outside diameter, the inside diameter and / or the length of the additional tubular guide 10.
[00056] Dans l’exemple illustratif ci-dessus, le dispositif de guide 1 a été décrit essentiellement en référence à une biopsie intracrânienne d’un sujet, qui peut être un mammifère, y compris un être humain. Dans ce cas, les instruments 50 utilisés sont généralement un foret pour le perçage du crâne, et un trocart pour la biopsie de la zone d’intérêt 21. Après mise en place du dispositif de guide 1 sur la zone d’application du corps du sujet, qui est ici une partie du crâne, le foret est inséré dans le guide tubulaire 2, et le crâne est percé, le foret atteignant la profondeur voulue grâce à la butée 4 du guide tubulaire 2. Le foret est ensuite retiré, et le guide tubulaire additionnel 10 est mis en place dans le guide tubulaire 2. Le trocart est ensuite inséré dans le guide additionnel 10 pour réaliser la biopsie de la zone à biopsier, et atteint précisément la zone à biopsier 21 en coopérant avec la butée 11 .  In the above illustrative example, the guide device 1 has been described essentially with reference to an intracranial biopsy of a subject, which may be a mammal, including a human being. In this case, the instruments 50 used are generally a drill for piercing the skull, and a trocar for the biopsy of the area of interest 21. After positioning of the guide device 1 on the area of application of the body of the subject, which is here a part of the skull, the drill is inserted into the tubular guide 2, and the skull is pierced, the drill reaching the desired depth thanks to the stop 4 of the tubular guide 2. The drill is then removed, and the additional tubular guide 10 is placed in the tubular guide 2. The trocar is then inserted into the additional guide 10 to perform the biopsy of the biopsy area, and precisely reaches the biopsy area 21 by cooperating with the stop 11.
[00057] Il est entendu que le dispositif de guide pour l’insertion d’un instrument à travers une paroi peut être utilisé pour être appliqué sur un sujet vivant, sur un sujet mort par exemple pour des autopsies, ou encore sur un objet inanimé, par exemple un mannequin pour l’enseignement de manipulations à des étudiants.  It is understood that the guide device for the insertion of an instrument through a wall can be used to be applied to a living subject, to a dead subject for example for autopsies, or even to an inanimate object , for example a mannequin for teaching manipulations to students.
[00058] Il est également entendu que le dispositif de guide pour l’insertion d’un instrument à travers une paroi est également utilisable sur d’autres parties du corps d’un sujet qu’un crâne, telles que les os longs, les os du bassin ou la colonne vertébrale, en association avec des instruments tels que des aiguilles d’injection, ou des instruments chirurgicaux. Le dispositif de guide peut être utilisé sur des êtres humains ou des animaux, en particulier sur des chevaux pour des interventions dans la région dorsale, ou sur des sujets pour des prélèvements de moelle osseuse. On peut encore, selon un autre exemple, envisager d’utiliser le dispositif de guide pour insérer un instrument à travers une carapace.  It is also understood that the guide device for inserting an instrument through a wall can also be used on other parts of the body of a subject than a skull, such as long bones, pelvic bone or spine, in combination with instruments such as injection needles, or surgical instruments. The guide device can be used on human beings or animals, in particular on horses for interventions in the dorsal region, or on subjects for bone marrow samples. We can also, according to another example, consider using the guide device to insert an instrument through a shell.

Claims

Revendications claims
1. Ensemble d’un dispositif de guide (1 ) pour l’insertion d’un instrument (50) à travers une paroi et d’un instrument (50) reçu directement dans le guide tubulaire (2) pour être inséré à travers la paroi, le dispositif de guide (1 ), étant configuré pour être appliqué sur une zone d’application et pour guider l’instrument (50) selon une position prédéterminée par rapport à la paroi, et étant caractérisé en ce qu'il comporte : 1. Assembly of a guide device (1) for the insertion of an instrument (50) through a wall and of an instrument (50) received directly in the tubular guide (2) to be inserted through the wall, the guide device (1) being configured to be applied to an application area and to guide the instrument (50) to a predetermined position relative to the wall, and being characterized in that it comprises:
- au moins un bras de fixation (3), configuré pour être fixé sur la zone d’application par des moyens de fixation amovibles (40),  - at least one fixing arm (3), configured to be fixed on the application area by removable fixing means (40),
- un guide tubulaire (2) définissant un axe d'insertion (X), configuré pour permettre l'insertion et le guidage, dans le guide tubulaire (2), de l’instrument (50), le guidage étant exercé selon l'axe d'insertion (X), depuis une extrémité amont du guide tubulaire (2) vers la zone d’application,  - a tubular guide (2) defining an insertion axis (X), configured to allow insertion and guiding, in the tubular guide (2), of the instrument (50), the guiding being exerted according to the insertion axis (X), from an upstream end of the tubular guide (2) towards the application area,
. le guide tubulaire (2) formant une butée axiale configurée pour coopérer directement avec l'instrument et imposer une profondeur prédéterminée d'insertion de l'instrument (50),  . the tubular guide (2) forming an axial stop configured to cooperate directly with the instrument and to impose a predetermined insertion depth of the instrument (50),
. et le guide tubulaire (2) étant venu de matière avec le bras de fixation (3).  . and the tubular guide (2) having come integrally with the fixing arm (3).
2. Ensemble selon la revendication précédente, dans lequel le dispositif de guide (1 ) comprend un seul, deux, ou encore trois, bras de fixation (3) configurés pour être fixés sur la zone d’application par des moyens de fixation amovibles (40) et étant chacun venu de matière avec le guide tubulaire (2), de préférence deux bras de fixation, de préférence encore un seul bras de fixation. 2. Assembly according to the preceding claim, in which the guide device (1) comprises a single, two, or even three, fixing arms (3) configured to be fixed to the application area by removable fixing means ( 40) and each being made in one piece with the tubular guide (2), preferably two fixing arms, more preferably only one fixing arm.
3. Ensemble selon l’une quelconque des revendications précédentes, dans lequel le au moins un bras de fixation (3) du dispositif de guide (1 ) comprend des moyens détrompeurs (60) configurés pour imposer une position angulaire prédéterminée du bras de fixation (3) par rapport aux moyens de fixation amovibles (40). 3. Assembly according to any one of the preceding claims, in which the at least one fixing arm (3) of the guide device (1) comprises polarizing means (60) configured to impose a predetermined angular position of the fixing arm ( 3) relative to the removable fixing means (40).
4. Ensemble selon l’une quelconque des revendications précédentes, dans lequel les moyens de fixation amovibles (40) sont des moyens de fixation intra-osseux, par exemple une vis auto-foreuse. 4. Assembly according to any one of the preceding claims, in which the removable fixing means (40) are intraosseous fixing means, for example a self-drilling screw.
5. Ensemble selon l’une quelconque des revendications précédentes, dans lequel le dispositif de guide (1 ) comprend en outre au moins un bras de positionnement, configuré pour être en appui sur la zone d’application. 5. Assembly according to any one of the preceding claims, in which the guide device (1) further comprises at least one positioning arm, configured to be supported on the application area.
6. Ensemble selon l’une quelconque des revendications précédentes, dans lequel le guide tubulaire (2) du dispositif de guide (1 ) présente une forme tubulaire ayant une surface supérieure s’étendant sensiblement radialement et la butée axiale (4) est formée par cette surface supérieure. 6. Assembly according to any one of the preceding claims, in which the tubular guide (2) of the guide device (1) has a tubular shape having an upper surface extending substantially radially and the axial stop (4) is formed by this upper surface.
7. Ensemble selon l’une quelconque des revendications précédentes, dans lequel la butée axiale (4) du guide tubulaire (2) est configurée pour coopérer directement avec un foret de perçage de la paroi. 7. Assembly according to any one of the preceding claims, in which the axial stop (4) of the tubular guide (2) is configured to cooperate directly with a drill for drilling the wall.
8. Ensemble selon l’une quelconque des revendications précédentes, dans lequel la butée axiale (4) du guide tubulaire (2) est configurée pour coopérer directement avec un trocart. 8. Assembly according to any one of the preceding claims, in which the axial stop (4) of the tubular guide (2) is configured to cooperate directly with a trocar.
9. Ensemble selon l’une quelconque des revendications précédentes, dans lequel le guide tubulaire (2) est configuré pour recevoir un guide tubulaire additionnel (10), configuré pour guider un autre instrument destiné à être inséré à travers la paroi. 9. Assembly according to any one of the preceding claims, in which the tubular guide (2) is configured to receive an additional tubular guide (10), configured to guide another instrument intended to be inserted through the wall.
10. Ensemble selon l’une quelconque des revendications précédentes, dans lequel le dispositif de guide (1 ) comprend une nervure de rigidification (5) du guide tubulaire10. Assembly according to any one of the preceding claims, in which the guide device (1) comprises a stiffening rib (5) of the tubular guide
(2), portée de préférence par le au moins un bras de fixation (3). (2), preferably carried by the at least one fixing arm (3).
1 1. Ensemble selon l’une quelconque des revendications précédentes dans lequel le dispositif de guide (1 ) est un dispositif de guide pour l’insertion d’un instrument (50) à travers une paroi osseuse, en particulier dispositif de guide pour biopsie intracrânienne. 1 1. An assembly according to any preceding claim wherein the guide device (1) is a guide device for the insertion of an instrument (50) through a bone wall, in particular guide device for biopsy intracranial.
12. Ensemble selon l’une quelconque des revendications précédentes, dans lequel l’instrument est un foret de perçage ou un trocart. 12. Assembly according to any one of the preceding claims, in which the instrument is a drill bit or a trocar.
13. Procédé de fabrication d’un dispositif de guide (1) d’un ensemble selon l’une quelconque des revendications 1 à 12 comprenant les étapes suivantes : 13. Method for manufacturing a guide device (1) of an assembly according to any one of claims 1 to 12 comprising the following steps:
a) affichage d'une image tridimensionnelle illustrant la zone d’application et au moins un point de fixation sur la zone d’application,  a) display of a three-dimensional image illustrating the application area and at least one attachment point on the application area,
b) définition d'un modèle numérique du dispositif de guide (1 ), comprenant le au moins un bras de fixation (3) et le guide tubulaire (2), et éventuellement un guide additionnel (10), et c) fabrication assistée par ordinateur du dispositif de guide, en utilisant le modèle numérique, de préférence par fabrication additive. b) definition of a digital model of the guide device (1), comprising the at least one fixing arm (3) and the tubular guide (2), and optionally an additional guide (10), and c) computer-aided manufacturing of the guide device, using the digital model, preferably by additive manufacturing.
14. Procédé selon la revendication précédente dans lequel l’étape b) comprend la détermination par calcul numérique de : 14. Method according to the preceding claim in which step b) comprises the determination by numerical calculation of:
d’une dimension du au moins un bras de fixation (3) et éventuellement d’un bras de positionnement,  of a dimension of at least one fixing arm (3) and possibly of a positioning arm,
l’orientation du guide tubulaire (2), dont l’axe (X) est de préférence confondu avec une droite passant par une zone d’intérêt et un point central du dispositif de guide (1 ),  the orientation of the tubular guide (2), the axis (X) of which is preferably coincident with a straight line passing through an area of interest and a central point of the guide device (1),
d’une dimension du guide tubulaire (2), et éventuellement d’une dimension du guide additionnel (10).  one dimension of the tubular guide (2), and possibly one dimension of the additional guide (10).
PCT/EP2019/067915 2018-07-04 2019-07-03 Guide device for inserting an instrument through a wall WO2020007948A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP19734816.2A EP3817674A1 (en) 2018-07-04 2019-07-03 Guide device for inserting an instrument through a wall

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR1856144A FR3083438A1 (en) 2018-07-04 2018-07-04 GUIDE DEVICE FOR INSERTING AN INSTRUMENT THROUGH A WALL
FR18/56144 2018-07-04

Publications (1)

Publication Number Publication Date
WO2020007948A1 true WO2020007948A1 (en) 2020-01-09

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PCT/EP2019/067915 WO2020007948A1 (en) 2018-07-04 2019-07-03 Guide device for inserting an instrument through a wall

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FR (1) FR3083438A1 (en)
WO (1) WO2020007948A1 (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1094760A1 (en) * 1998-07-06 2001-05-02 Neutar, LLC Customized surgical fixture
US20080027463A1 (en) * 2006-07-24 2008-01-31 Vanderbilt University Adjustable surgical platform and surgical instrument using same
US20100082035A1 (en) * 2008-09-30 2010-04-01 Ryan Keefer Customized patient-specific acetabular orthopaedic surgical instrument and method of use and fabrication
US20130274778A1 (en) 2012-04-16 2013-10-17 Orthosoft Inc. Patient specific surgical guide

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1094760A1 (en) * 1998-07-06 2001-05-02 Neutar, LLC Customized surgical fixture
US20080027463A1 (en) * 2006-07-24 2008-01-31 Vanderbilt University Adjustable surgical platform and surgical instrument using same
US20100082035A1 (en) * 2008-09-30 2010-04-01 Ryan Keefer Customized patient-specific acetabular orthopaedic surgical instrument and method of use and fabrication
US20130274778A1 (en) 2012-04-16 2013-10-17 Orthosoft Inc. Patient specific surgical guide

Also Published As

Publication number Publication date
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