METHOD FOR MANUFACTURING A CONNECTING ROD FOR ATTACHMENT ELEMENTS SECURED TO THE BODY OF A PATIENT, DEVICE AND CONNECTING ROD FOR CARRYING OUT THE METHOD

20230347400 · 2023-11-02

    Inventors

    Cpc classification

    International classification

    Abstract

    Disclosed is a method for manufacturing a connecting rod between attachment elements secured to the spine of a patient, the method including:—planning the manufacturing of a first virtual rod based on the patient's anatomical data,—positioning and securing the attachment elements on the patient's body,—intraoperatively acquiring the position of the attachment elements for the purpose of creating a second virtual rod,—analyzing the first and second virtual rods for the purpose of creating a third virtual rod,—intraoperatively manufacturing a real rod from the third virtual rod by a bending device. Also disclosed are the device and the connecting rod allowing the method to be carried out.

    Claims

    1. A method for manufacturing a rod for connecting attachment elements secured to the spine of a patient, the method comprising: planning the manufacturing of a first virtual rod based on patient's anatomical data, positioning and securing the attachment elements on the patient's body, intraoperatively acquiring the position of the attachment elements for the purpose of creating a second virtual rod, analyzing the first and the second virtual rods for the purpose of creating a third virtual rod, intraoperative manufacturing an actual rod from the third virtual rod, by the use of a bending device.

    2. The method according to claim 1, further comprising a correcting operation for correcting the third virtual rod for the purpose of creating a fourth virtual rod to be manufactured.

    3. The method according to claim 1, wherein the analysis phase consists in superimposing the second virtual rod on the first virtual rod.

    4. The method according to claim 1, wherein the acquisition is carried out with an instrument and at least one optical or infrared or depth camera.

    5. The method according to claim 1, wherein the acquisition is carried out by a scanner or a mobile camera.

    6. The method according to claim 5, further comprising a positioning operation for positioning markers near or on the attachment elements for acquisition purposes.

    7. A bending device for bending a rod for connecting attachment elements secured to the body of a patient implementing the method according to claim 1, further comprising a sterilizable part equipped with at least driving and bending means for driving and bending the rod and a non-sterilized part equipped with the motorization of said means or with the battery powering the motorization of said means.

    8. The device according to claim 7, wherein the sterilizable part is connected to the motor shafts projecting from the non-sterilized part.

    9. The device according to claim 8, wherein sealing gaskets arranged between the sterilized part and the non-sterilized part implement sealing.

    10. The device according to claim 7, wherein the device is equipped with a drive mandrel ensuring rotation of the rod around the rod's longitudinal axis and translation of this rod along this longitudinal axis so as to make bending in three dimensions possible.

    11. A rod for connecting attachment elements, enabling performing method according to claim 1, wherein the rod is packaged/encapsulated in a flexible container adapted to at least a sterilization method and resistant to the stresses resulting from the bending of the rod.

    12. The connecting rod according to claim 11, wherein at least one end of the rod is pre-formed with an indexing geometric profile.

    13. The connecting rod according to claim 11, wherein said container is peelable.

    14. The method according to claim 2, wherein the acquisition is carried out with an instrument and at least one optical or infrared or depth camera.

    15. The method according to claim 3, wherein the acquisition is carried out with an instrument and at least one optical or infrared or depth camera.

    16. A bending device for bending a rod for connecting attachment elements secured to the body of a patient implementing the method according to claim 2, further comprising a sterilizable part equipped with at least driving and bending means for driving and bending the rod and a non-sterilized part equipped with the motorization of said means or with the battery powering the motorization of said means.

    17. A bending device for bending a rod for connecting attachment elements secured to the body of a patient implementing the method according to claim 3, further comprising a sterilizable part equipped with at least driving and bending means for driving and bending the rod and a non-sterilized part equipped with the motorization of said means or with the battery powering the motorization of said means.

    18. A bending device for bending a rod for connecting attachment elements secured to the body of a patient implementing the method according to claim 4, further comprising a sterilizable part equipped with at least driving and bending means for driving and bending the rod and a non-sterilized part equipped with the motorization of said means or with the battery powering the motorization of said means.

    19. A bending device for bending a rod for connecting attachment elements secured to the body of a patient implementing the method according to claim 5, further comprising a sterilizable part equipped with at least driving and bending means for driving and bending the rod and a non-sterilized part equipped with the motorization of said means or with the battery powering the motorization of said means.

    20. A bending device for bending a rod for connecting attachment elements secured to the body of a patient implementing the method according to claim 6, further comprising a sterilizable part equipped with at least driving and bending means for driving and bending the rod and a non-sterilized part equipped with the motorization of said means or with the battery powering the motorization of said means.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0066] FIG. 1 is a schematic drawing of a sagittal view of a portion of the spine with the desired correction corresponding to the equivalent of an x-ray image revised so as to be corrected;

    [0067] FIG. 2 is a schematic drawing of the portion of the spine with the first modelized virtual rod;

    [0068] FIG. 3 is a schematic drawing of the portion of the spine to be corrected with the attachment elements attached to it;

    [0069] FIG. 4 is a schematic drawing showing in mutual correspondence the sagittal view of a portion of the spine with the attachment elements attached to it, the first virtual rod, the second virtual rod and the resulting rod whose manufacture will be ordered;

    [0070] FIG. 5 is a perspective view of one embodiment of a bender according to the invention;

    [0071] FIG. 6 is an exploded perspective view of said bender;

    [0072] FIG. 7 is a drawing of one embodiment of a packaged sterile rod.

    DESCRIPTION OF A PREFERRED EMBODIMENT

    [0073] The drawing in FIG. 3 schematically shows a portion of a patient's spine PC1, which spine requiring correction by means of attachment elements connected by a connecting rod.

    [0074] In accordance with the invention, in order to manufacture this connecting rod, the practitioner will carry out a planning operation for the manufacture of a first virtual rod.

    [0075] To do this, on the basis of anatomical data (such as one or more x-rays) shown in a simplified way by FIG. 3, the practitioner will imagine a corrected portion of spine PC2 as shown in FIG. 1.

    [0076] In order to implement this correction, a first virtual rod TV1 is defined as shown in FIG. 2.

    [0077] Attachment elements 100 are then attached to the portion of the patient's spine PC1 to be corrected, as shown in FIG. 3.

    [0078] Still as shown in this figure, the position of the attachment element 100 is acquired by means of an instrument 200. The instrument makes it possible to locate the receiving spaces provided by the attachment elements for receiving the rod and to acquire, by means of software, a point at the center of the receiving spaces. Then, the software means connects the points to make a spline representative of the second virtual rod which takes into account the intraoperative conditions. Indeed, this acquisition makes it possible to take account of the actual attachment points of the rod on the portion of spine PC1 and leads to defining a second virtual rod TV2.

    [0079] As shown in FIG. 4, the analysis of the first virtual rod TV1 and the second virtual rod TV2 leads to the creation of a third virtual rod TV3.

    [0080] The intraoperative manufacturing of an actual TR4 rod from this third virtual TV3 rod (itself corrected or not by means of a software solution) by a bending device can then be performed.

    [0081] An embodiment of a bending device D is shown by FIGS. 5 and 6. As shown, this bending device D making it possible to manufacture the actual rod TR4 (shown during manufacture in FIG. 5) is remarkable in that it comprises at least one sterilizable part 300 equipped with driving and bending means for driving and bending the rod TR4 and a non-sterilized part 400 equipped with the motorization of said means and/or the battery to power the motorization of said means.

    [0082] The sterilizable part 300 covers here and is connected to the motor shafts 410 projecting from the non-sterilized part 400.

    [0083] This sterilizable part 300 comprises two pairs of rollers 301, 302 and 303, 304 for driving the rod TR4 in translation along its longitudinal axis to pass it through a bending tool 310 consisting of a disc on which are positioned, diametrically opposite one with respect to the other, two cylindrical lugs 311 and 312. Driven by the rollers, the rod TR4 is positioned between the two lugs 311 and 312 whose rotation ensures the deformation. According to an embodiment not shown, the device comprises a single pair of rollers.

    [0084] According to a feature not shown, device D is also equipped with a mandrel ensuring the rotation of the rod TR4 around its longitudinal axis so as to make the bending possible in three dimensions.

    [0085] Another solution envisaged for keeping a bent rod sterile consists, as shown in FIG. 7, in packing it while it's straight so as to comply with the constraints related to sterilization despite the fact that the connecting rod must undergo a bending operation. Thus, the rod TR5 to be bent is packaged in a flexible container 500 suitable for at least one method of sterilization and resistant to the stresses resulting from the bending of the rod.

    [0086] In order to facilitate gripping by the mandrel (not shown) but also to avoid displacement of the packaging/encapsulation 500 during bending, at least one end of the TR5 rod is pre-formed with an indexing profile.

    [0087] According to a preferred embodiment, this indexing is implemented by a hexagonal profile or by a hexalobular profile such as that known under the trademark “Torx”.

    [0088] It is to be understood that the method, the device and the rod which have just been described and represented above, were described for the purpose of disclosure rather than limitation. Of course, various arrangements, modifications and improvements may be made to the above example, without departing from the scope of the invention.