CA2311316C - Device for simulating implants located under the skin - Google Patents

Device for simulating implants located under the skin Download PDF

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Publication number
CA2311316C
CA2311316C CA002311316A CA2311316A CA2311316C CA 2311316 C CA2311316 C CA 2311316C CA 002311316 A CA002311316 A CA 002311316A CA 2311316 A CA2311316 A CA 2311316A CA 2311316 C CA2311316 C CA 2311316C
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Canada
Prior art keywords
implants
fixation
extension pins
orientation
implant
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CA002311316A
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French (fr)
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CA2311316A1 (en
Inventor
Doris Traxel
Urs Weber
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AO Technology AG
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Synthes USA LLC
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Publication of CA2311316A1 publication Critical patent/CA2311316A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8872Instruments for putting said fixation devices against or away from the bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7083Tools for guidance or insertion of tethers, rod-to-anchor connectors, rod-to-rod connectors, or longitudinal elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8863Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/061Measuring instruments not otherwise provided for for measuring dimensions, e.g. length

Abstract

A device and method used for simulating the position and orientation of a plurality of implants constituting a fixation system is provided. This device includes a base plate that comprises longitudinal parallel tracks and crossbars which are capable of displacement in the plane of the base plate and which can be fixed in any position using tightening screws. The crossbars include integrated spherical pairs into which the implants can be screwed together with the same extension pins as in the in-situ fixation system so that the height of said implants can be adjusted. The device further includes a mechanical positioning unit whose operation is based on electromagnetic or acoustic signal exchange. This unit is used for positioning the implants into the device so that they have the same position and orientation relative to each other as the implants mounted in situ on the fixation system.

Description

DEVICE FOR SIMULATING IMPLANTS LOCATED UNDER THE SKIN
This invention concerns a device for simulating the position and orientation of several implants belonging to a fixation system according to the definition of the species of Patent Claim 1 and a method of prebending a longitudinal rod according to independent Patent Claim 16.
In surgery, an implant system is implanted to reposition and/or stabilize the spinal cord or other fractured bones by mostly exposing the spinal cord or the bones, which thus results in massive damage to the soft tissue and especially the muscles. This damage leads to weakening in the muscular area and thus to weakening in the retaining system for the spinal cord or other extremities and also entails the risk of scarring, which can lead to postoperative problems in patients, especially involving the spine.
This is the situation to be remedied by the present invention. The object of the present invention is to create a device where the implant can be implanted through and/or beneath the skin and/or muscles, leaving the posterior back muscles largely intact. To this end, pedicle screws or other implants are placed through the skin, preferably with the help of a computer assisted surgery system (CAS) such as that described, for example, in U.S. Patent No. 5,383,454 by Buchholz.
The pedicle screws and/or other implants are provided with extension pins which make it possible to implant the pedicle screws and/or other implants through the skin deep in the spinal cord or bones. The ends of these extension pins project out of the skin. After positioning the implant, the extension pins can be removed. An essential problem is that the position of the pedicle screws and/or other implants on/in the bone is not visible and so far it has not been possible to model the longitudinal rod with a trial rod or a bending template as in the past. The longitudinal rod is now adjusted with the help of the device according to the present invention, where primarily the same implants and the same extension pins are used in the device according to this invention as are attached to the fixation system in situ and they are brought into the same position and orientation relative to one another as on the fixation system. If the position and orientation of the entire implant in the device according to this invention is identical to that in situ, a trial rod or a bending template is positioned in the openings in the implant provided for this purpose in the device according to this invention and adjusted there. The longitudinal rod is then adjusted mechanically or electronically as in the conventional method.
The surgeon also has the option of prebending the rod according to a desired contour. Due to the fact that the cross rod of the device according to this invention has a certain flexibility, it is then possible to simulate how the anatomy will change when the rod is bent with slight changes in comparison with the shape determined by the implants in situ.
Accordingly, in one aspect, the invention provides a device for simulating the position and orientation of several implants belonging to one fixation system, and thus the shape of a longitudinal rod which serves to connect these implants within the fixation system wherein the device comprises a base plate with longitudinal splints mounted in parallel and cross rods that can be moved on these longitudinal splints as well as ball joints integrated into these cross rods, the cross rods can be moved in both dimensions of the plane of the base plate and can be secured in any desired position by means of locking screws, the same implants can be screwed into these ball joints with the same extension pins as in the fixation system, so the height of the implants relative to one another can be adjusted, and the ball joints guarantee free rotation and thus the angular adjustment of the implants, and a positioning device is provided with which the extension pins and the implants can be positioned in the device so that they assume the same position and orientation relative to one another as those mounted on the fixation system.
In another aspect, the invention provides a method of pretending a longitudinal rod adapted to connect several implants within a fixation system, wherein extension pins are mounted on the implants in situ, transferring by means of a positioning device the position and orientation of these implants and extension pins relative to one another, which detemvnes the shape of the longitudinal rod, to identical implants and extension pins secured in a device, thus simulating the position and orientation of the implants which determines the shape of the longitudinal rod, and the longitudinal rod is adapted to the implants there or the position of the implants relative to one another is deternvned electronically and the longitudinal rod is prebent mechanically.
An advantageous embodiment of the device according to this invention consists of the fact that the device according to this invention comprises a base plate with parallel longitudinal splints, displaceable cross rods with integrated ball joints and a positioning device.
The cross rods can be moved in the two dimensions of the plane of the base plate and can be secured in any desired position by locking screws. Then the same implants are screwed into the device according to this invention with the same device for simulating the position and orientation of several implants belonging to a fixation system as in the fixation system in situ. A
positioning device belonging to the simulation device includes light emitting diodes (LEDs) attached to the extension pins plus several sensors that detect these emitted electromagnetic waves in space and an analyzing unit.
By computer assisted processing of interference patterns, the analyzing unit makes it possible to position the extension pins and the implants in the device according to this invention so that they assume the same position and orientation with respect to one another as those mounted on the fixation system. Then if the position of the implants and the extension pins in the device according to this invention is identical to that in situ, a tiial rod or a bending template is placed in the openings provided for this purpose on the heads of the implants in the device according to this invention and adjusted there, or the position of the implants relative to one another is determined electronically and the longitudinal rod is bent mechanically.
2a Another advantageous embodiment of the device according to this invention consists of the fact that the positioning device belonging to the device according to this invention comprises electromagnetic wave reflecting means mounted on the extension pins, at least one means for emitting electromagnetic waves in space, several sensors detecting the reflected waves in space and an analyzing unit. Processing of the detected signals by the analyzing unit is then performed as in the embodiment of the device according to this invention described above.
Another advantageous embodiment of the device according to this invention consists of the fact that the positioning device belonging to the device according to this invention comprises Hall sensors mounted on the extension pins, at least one coil that produces a magnetic field in space and one analyzing unit. Processing of detected signals by the analyzing unit is then performed as described for the embodiment of the device according to this invention presented above.
Another advantageous embodiment of the device according to this invention consists of the fact that the positioning device belonging to the device according to this invention comprises magnetic field generating coils mounted on the extension pins, Hall sensors for detecting the magnetic field in space and an analyzing unit. Processing of detected signals by the analyzing unit is then performed as described above for the embodiment of the device according to this invention presented previously.
Yet another advantageous embodiment of the device according to this invention consists of the fact that the sensors of the positioning device are cameras. The electromagnetic waves emitted by the transmitters mounted on the extension pins can be recorded with the help of these cameras. The respective analyzing unit makes it possible to process the images recorded by the cameras so that the extension pins and implants used in the device according to this invention can be brought into the same relative position and orientation relative to one another as the implants and extension pins belonging to the fixation system in situ. Then if the position of the implants and the extension pins in the device according to this invention is the same as that in situ, a trial rod or a bending template is placed in the openings provided for this purpose on the heads of the implants in the device according to this invention and adjusted there, or the position of the implants relative to one another is determined electronically and the longitudinal rod is bent mechanically.
Yet another advantageous embodiment of the device according to this invention consists of the fact that the positioning device belonging to the device according to this invention comprises sensors that detect ultrasonic waves and are mounted on the extension pins, at least one transmitter emitting ultrasonic waves in space and an analyzing unit. By processing interference patterns, the analyzing unit makes it possible for the extension pins and the implants to be positioned in the device according to this invention in such a way that they assume the same position and orientation relative to one another as those mounted on the fixation system. Then if the position of the implants and the extension pins in the device according to this invention is identical to that in situ, a trial rod or a bending template is placed in the openings provided for this purpose on the heads of the implants in the device according to this invention and adjusted there or the position of the implants relative to one another is-determined electronically and the longitudinal rod is bent mechanically.
Yet another advantageous embodiment of the device according to this invention consists of the fact that the positioning device belonging to the device according to this invention includes transmitters that emit ultrasonic waves and are mounted on the extension pins, at least two sensors that detect ultrasonic waves in space and an analyzing unit.
Processing of detected signals by the analyzing unit is then performed by analogy with the embodiments of the device according to this invention described above.
Another advantageous embodiment of the device according to this invention consists, of the fact that the positioning device belonging to the simulation device is part of a computer assisted surgery system (CAS) which makes it possible to measure the position and orientation of objects in space; the implants can be positioned in the device according to this invention so that they assume the same position and orientation relative to one another as those mounted on the fixation system. If the position of the implants and the extension pins in the device according to this invention is then identical to that in situ, a trial rod or a bending template is then placed in the openings provided for this purpose in the heads of the implants in the device according to this invention and adjusted there or the position of the implants relative to one another is measured electronically and the longitudinal rod is bent mechanically.
Another advantageous embodiment of the device according to the present invention consists of the fact that the positioning device belonging to the simulation device operates mechanically according to the principle of a pantograph and makes it possible for the implants to be positioned in the device according to this invention so that they assume the same position and orientation relative to one another as on the fixation system in vivo. Once the position of the implants and extension pins in the device according to this invention is identical to that in situ, a trial rod or bending template is then placed in the openings provided for this purpose in the implants in the device according to this invention and they are adjusted there, or the position of the implants relative to one another is measured electronically and the longitudinal rod is bent mechanically.
Another advantageous embodiment of the device according to this invention consists of the fact that the positioning device belonging to the device according to this invention comprises a mechanical scanning device. This mechanical scanning device makes it possible for the extension pins and the implants to be positioned in the device according to this invention so that they assume the same position and orientation relative to one another as those mounted on the fixation system. Then when the position of the implants and the extension pins in the device according to this invention is identical to that in situ, a trial rod or a bending template is inserted into the openings provided for this purpose in the implants in the device according to this invention and is adjusted there, or the position of the implants relative to one another is measured electronically and the longitudinal rod is bent mechanically.
Another advantageous embodiment of the device according to this invention consists of the fact that a mechanically adjustable transfer device makes it possible for the implants and extension pins to be adjusted by means of positioning pins and sleeves through adaptation to the implants and extension pins of the fixation system so that by shifting the transfer device to~the extension pins and implants inserted into the device, the latter can be brought into the same position and orientation relative to one another as the implants and extension pins belonging to the fixation system. Then when the position of the implants and extension pins in the device according to this invention is identical to that in situ, a trial rod or bending template is inserted into the openings provided for this purpose in the implants in the device according to this invention and adjusted there, or the position of the implants relative to one another is measured electronically and the longitudinal rod is bent mechanically.
Another advantageous embodiment of the device according to this invention consists of the fact that it also includes a clamping device having a length display that can be adjusted to the length of the longitudinal rod, making it possible to push the prebent longitudinal rod beneath the skin or the muscles and insert it in the openings provided for this purpose in the implants. The longitudinal display on the clamping device runs over the skin parallel to the prebent longitudinal rod and thus serves as an orientation aid.
In an advantageous embodiment of the method according to this invention for prebending a longitudinal rod which connects several implants within a fixation system, extension pins are attached to the implants in situ. The position and orientation of these implants and extension pins relative to one another, which determines the shape of the longitudinal rod, is transmitted by means of a positioning device to identical implants and extension pins, thus simulating the position and orientation of the implants which determine the shape of the longitudinal rod. The longitudinal rod is adapted to the implants there and then is implanted.
Another advantageous embodiment of the method according to this invention consists of the fact that the position and orientation of the implants and extension pins that are attached to the fixation system and determine the shape of the longitudinal rod are transmitted by means of a positioning device to identical implants and extension pins secured in a device. This device also makes it possible to simulate how the anatomy changes when the longitudinal rod is bent with minor changes in comparison with the shape predetermined by the implants in situ. It is also possible to simulate changes in anatomy achieved by altering the position of the implants.
According to an aspect of the present invention there is provided an implant simulating device for simulating position and orientation of an elongated element with respect to a plurality of fixation elements of a fixation system, the implant simulating device comprising a base plate having a plane with a first and second dimension, first and second splints extending from the base plate, at least two cross members, each cross member configured and dimensioned for slidingly engaging the first and second splints and having a locking element for fixing the position of the cross member, a fixation element simulator associated with each of the at least two cross members and capable of angular positioning with respect to the cross members, and a correlation system for correlating at least two fixation element simulators to at least two fixation elements of the fixation system, wherein coupling of an elongated element in the at least two fixation element simulators after correlation by the correlating system allows the elongated element to be configured and dimensioned for coupling to the fixation elements prior to implantation.
According to another aspect of the present invention there is provided a method of preparing a longitudinal rod of a fixation system including at least two fixation elements for connecting an elongated element to bone, the method comprising the steps of mounting an elongated inserter on each of at least two of the fixation elements, the fixation elements collectively defining a desired shape transferring position and orientation of at least two of the fixation elements to at least two fixation element simulators to thereby mimic the desired shape, and bending the elongated element to have a configuration that matches the desired shape.
The advantages achieved through this invention include substantially the fact that:
A) The soft tissue need not be opened to determine the contour of the required longitudinal rod.
B) The trial rod or bending template is not introduced deep into the implant and removed again with any hindrance by the soft tissue, so there is no risk of the trial rod or the bending template being deformed. The trial rod or the bending template can be simply inserted into the device according to this invention and removed again as needed without being deformed.
C) The device according to this invention also facilitates checking on whether the longitudinal rod has been prebent correctly.
D) Any correction that might be necessary can be simulated by bending the longitudinal rod itself.
This invention and refinements of this invention are described in greater detail below on the basis of the partially schematic diagrams of several embodiments. The figures show:
Figure 1: a view from above of a portion of the spinal cord with an implanted longitudinal rod and a view from above of an embodiment of the device according to this invention;
Figure 2: a cross section through an embodiment of the device according to this invention;
Figure 3: a perspective view of one embodiment of the device according to this invention;
Figure 4: a perspective view of another embodiment of the device according to this invention;
Figure 5: a clamping device with a position and orientation display for inserting the longitudinal rod beneath the skin or the muscles; and Figure 6: a view of the transfer device according to this invention.
Figure 1 shows a portion of a spinal cord with a spinal cord implant 1 having multiple implants 3 and a longitudinal rod 2, and it also illustrates one variant of the device 4.
Device 4 is adjusted so 7a that longitudinal rod 2 secured there assumes the shame shape as that in the spinal cord implant 1 shown beside it. The variant of device 4 illustrated here shows how the implants 3 assume the same positions relative to one another in the plane visible from above, one on the spinal cord implant 1 and one in the device 4. Displacement of implants 3 in device 4 is achieved by displacement of cross rods 6 of the device according to this invention. Cross rods 6 can be moved in both dimensions of the plane of base plate 27 and can be secured in any desired position by locking screws 7. Ball joints 10 are integrated into cross rods 6.
The same implants 3 as in the fixation system can be screwed into these ball joints 10. The fact that the implants can be screwed in permits movement of the implant 3 in the third dimension normal to the plane of the frame, while ball joints 10 permit free rotation and thus an angular position of implants 3.
Figures 2 and 3 show another advantageous embodiment of the device according to this invention. Device 4 includes a base plate 27 with longitudinal splints 5 mounted in parallel, cross rods 6 and a positioning device 14. A center piece 25 with an integrated ball joint 10 and a bottom plate 15 are attached to cross rods 6. The cross rods 6 can be moved in the two dimensions of the plane of the base plate and can be secured in any desired position by locking screws 7. Then the same implants 3 are screwed into device 4 with the same extension pins 8 as in the fixation system 1 in situ. A positioning device 14 belonging to device 4 includes light emitting diodes (LEDs) 11 mounted on the extension pins 8, several sensors 12 detecting these emitted electromagnetic waves and an analyzing unit 13. By processing interference patterns, analyzing unit 13 makes it possible for the extension pins 8 and implants 3 to be positioned in the device 4 so that they assume the same position and orientation relative to one another as the implants and extension pins attached to the fixation system 1. Then if the position of implants 3 and extension pins 8 in the device 4 according to this invention is the same as that in fixation system l, a trial rod or a bending template is placed in the openings 9 provided for this purpose in the heads 16 in the implants 3 in device 4 and adjusted there, or the position of implants 3 relative to one another is determined electronically and the longitudinal rod 2 is prebent mechanically.

Figure 4 shows another advantageous embodiment of the device according to this invention.
Device 4 comprises a base plate 27 with parallel mounted longitudinal splints 5, cross rods 6 and a positioning device 14. A center piece 25 with an integrated ball joint 10 and a bottom plate 15 are attached to the cross rods 6. The cross rods 6 can be moved in both dimensions in the plane of the base plate and secured by locking screws 7 in any desired position.
Then the same implants 3 with the same extension pins 8 are screwed into the device 4 as in the fixation system 1 in situ. A mechanically adjustable transfer device 20 comprising positioning pins 29, sleeves 30, clamping elements 34 and a connecting rod 31, making it possible for the positioning pins 29 and sleeves 30 to be adjusted by adaptation to the implants 3 and extension pins 8 of the fixation system 1 in such a way that by shifting the transfer device 20 to the implants 3 and extension pins 8 secured in device 4, they can be brought into the same position and orientation relative to one another as the implants 3 and extension pins 8 belonging to fixation system 1. The positioning pins 29 can be rotated freely in space by means of the clamping elements 34 and can be secured in a selected position on connecting rod 31. Due to the fact that the sleeves 30 can be pushed axially over the extension pins 8 on the implants 3 to some extent, sleeves 30 make it possible for the positioning pins 29 to form the axial extension of the extension pins 8, with the rear end faces 17 of the extension pins 8 and the front end faces 18 of the positioning pins 29 coming to lie precisely in contact with one another.
Figure 5 shows a clamping device 40 with the help of which the longitudinal rod 2 can be inserted into the implants beneath the skin or muscles. Clamping device 40 comprises a handle 41, a holder 43 with a recess 47 for the longitudinal rod 2, a locking pin 42 and a position and orientation display 44 with a length scale 45. The rod-shaped holder 43 is fixedly secured in the handle 41 and has a recess 47 on one end such that when the longitudinal rod 2 is inserted, it assumes a certain orientation with respect to its longitudinal axis. The length of the holder 43 is such that the longitudinal rod 2 can be inserted beneath the skin or muscles while the handle 41 remains outside the body. The longitudinal rod 2 inserted into recess 47 is secured by means of a locking pin 42 which can be displaced axially in the holder 43 and can be secured by a screw thread. In parallel with the longitudinal rod 2 secured in the recess 47, a rod-shaped position and orientation display 44 which can be displaced in parallel to the longitudinal rod 2 is mounted in the handle 41. With the help of this position and orientation display 44, it is possible to detect the position and orientation of longitudinal rod 2 to be inserted when longitudinal rod 2 is beneath the skin or muscles for adaptation or implantation. Longitudinal rod 2 can be aligned parallel to the position and orientation display 44 by loosening the nut 48. The length of the position and orientation display 44 can be aligned by loosening the screw 49.
Figure 6 shows an embodiment of the mechanically adjustable transfer device 20 with the help of which the mutual positions and orientation of the implants 3 and extension pins 8 of the fixation system 1 shown in Figure 1 can be transferred to device 4 which is also shown in Figure 1.
Transfer device 20 includes positioning pins 29, sleeves 30 which can be pushed partially over positioning pins 29, clamping elements 34 and a connecting rod 31 which is composed of two rods here. By means of clamping elements 34, which can be displaced axially on the connecting rod 3 l and can be rotated about the longitudinal axis of the connecting rod 31, it is possible to displace the positioning pins 29 in two directions axially and to rotate them about two axes of rotation normal to one other. The positioning pins 29 and sleeves 30 are adjusted on fixation system 1 with regard to their position and orientation. The sleeves 30 make it possible far the positioning pins 29 to form the axial extension of the extension pins 8 due to the fact that they can be pushed partially in the axial direction over the extension pins 8 on implants 3, with the rear end faces 17 of the extension pins 8 and the front end faces 18 of the positioning pins 29 coming to lie precisely in contact with one another.

Claims (35)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A device for simulating the position and orientation of several implants belonging to one fixation system, and thus the shape of a longitudinal rod which serves to connect these implants within the fixation system, wherein:
the device comprises a base plate with longitudinal splints mounted in parallel and cross rods that can be moved on these longitudinal splints as well as ball joints integrated into these cross rods;
the cross rods can be moved in both dimensions of the plane of the base plate and can be secured in any desired position by means of locking screws;
the same implants can be screwed into these ball joints with the same extension pins as in the fixation system, so the height of the implants relative to one another can be adjusted, and the ball joints guarantee free rotation and thus the angular adjustment of the implants; and a positioning device is provided with which the extension pins and the implants can be positioned in the device so that they assume the same position and orientation relative to one another as those mounted on the fixation system.
2. The device of claim 1, wherein the positioning device operates with the help of reflective means or means that emit electromagnetic or acoustic waves and are mounted on the implants or on the extension pins and with a sensor system to receive these waves.
3. The device of claim 1, wherein the positioning device operates with the help of means that deliver acoustic or electromagnetic waves in space and sensors mounted on the implants or extension pins to receive these waves.
4. The device of claim 1, wherein the positioning device permits a transfer of the position and orientation of the implants and the extension pins between the fixation system and the device or vice versa by mechanical means.
5. The device of claim 4, wherein the mechanical means comprise a pantograph or a scanning device or a transporter or combinations of these devices.
6. The device of any one of claims 1 to 5, wherein the positioning device comprises transmitters that emit electromagnetic waves and are mounted on the extension pins, at least two sensors which detect the interference patterns of these electromagnetic waves and an analyzing unit, and the analyzing unit makes it possible to represent the signals detected by the sensors that the extension pins and implants secured in the device can be brought into the same position and orientation relative to one another as the implants and extension pins belonging to the fixation system.
7. The device of any one of claims 1 to 5, wherein the positioning device comprises transmitters which are mounted on the extension pins and emit electromagnetic waves;
the sensor system of the positioning device has cameras; the electromagnetic waves emitted by the transmitters can be recorded with the help of these cameras, and the analyzing unit makes it possible by means of a video analysis method to represent the images recorded by the cameras in such a way that the implants and extension pins secured in the device can be brought into the same position and orientation relative to one another as the implants and extension pins belonging to the fixation system or vice versa.
8. The device of claim 7, wherein the cameras are digital cameras.
9. The device of any one of claims 1 to 5, wherein the positioning device comprises transmitters which are mounted on the extension pins and emit sound waves, at least two sensors which detect the interference patterns of these sound waves and an analyzing unit, and the analyzing unit makes it possible to represent the signals detected by the sensors in such a way that the implants and extension pins secured in the device can be brought into the same position and orientation relative to one another as the implants and extension pins belonging to the fixation system or vice versa.
10. The device of any one of claims 1 to 5, wherein the positioning device comprises at least two transmitters that emit sound waves in space, at least two sensors that detect the interference patterns of these sound waves and are mounted on the extension pins, and an analyzing unit, representing the signals detected by the sensors so that the implants and extension pins secured in the device can be brought into the same position and orientation relative to one another as the implants and extension pins belonging to the fixation system or vice versa.
11. The device of any one of claims 1 to 10, wherein the transmitters are optical light sources.
12. The device of any one of claims 1 to 10, wherein the transmitters are light emitting diodes.
13. The device of any one of claims 1 to 12, wherein the positioning device is part of a device for measuring the position and orientation and belongs to an image processing computer assisted surgery system.
14. The device of any one of claims 1 to 13, wherein with the help of a mechanically adjustable transfer device which comprises positioning pins, sleeves, clamping elements and a connecting rod, and the positioning pins which can rotate freely in space by means of the clamping elements and can be secured in a selected position on the connecting rod, and due to the fact that the sleeves can be pushed in the axial direction partially over the extension pins on the implants, they make it possible for the positioning pins to form the axial extension of the extension pins, where the rear end faces of the extension pins and the front end faces of the positioning pins come to lie precisely in contact with one another, so that the implants and extension pins secured in the device can be brought into the same position and orientation relative to one another as the implants and extension pins belonging to the fixation system or vice versa.
15. The device of any one of claims 1 to 14, wherein it also includes a clamping device which has a position and orientation display that can be adjusted to the length of the longitudinal rod and makes it possible for the prebent longitudinal rod to be inserted beneath the skin or the muscles and brought into the openings provided for this purpose in the implants while the position and orientation display remains above the skin and is thus visible.
16. A method of prebending a longitudinal rod which connects several implants within a fixation system, wherein extension pins are mounted on the implants in situ, transferring by means of a positioning device the position and orientation of these implants and extension pins relative to one another, which determines the shape of the longitudinal rod, to representative implants and extension pins secured in a representative device, thus simulating the position and orientation of the in-situ implants which determines the shape of the longitudinal rod, and the longitudinal rod is adapted to the implants there or the position of the implants relative to one another is determined electronically and the longitudinal rod is prebent mechanically.
17. The method of claim 16, wherein the position and orientation of the implants and extension pins mounted on the fixation system, which determines the shape of the longitudinal rod, is transferred by means of a positioning device to identical implants and extension pins or vice versa, and the longitudinal rod is adapted to the implants there or the position of the implants relative to one another is determined electronically and the longitudinal rod is prebent mechanically.
18. The method of claim 16, wherein the device simulates how the anatomy changes or can be changed when the longitudinal rod is bent with changes in comparison with the shape predetermined by the implants in situ.
19. The method of claim 16, wherein the device simulates how the anatomy changes or can be changed when the position of an implant is changed.
20. An implant simulating device for simulating position and orientation of an elongated element with respect to a plurality of fixation elements of a fixation system, the implant simulating device comprising:
a base plate having a plane with a first and second dimension;
first and second splints extending from the base plate;
at least two cross members, each cross member configured and dimensioned for slidingly engaging the first and second splints and having a locking element for fixing the position of the cross member;

a fixation element simulator associated with each of the at least two cross members and capable of angular positioning with respect to the cross members; and a correlation system for correlating at least two fixation element simulators to at least two fixation elements of the fixation system, wherein coupling of an elongated element in the at least two fixation element simulators after correlation by the correlating system allows the elongated element to be configured and dimensioned for coupling to the fixation elements prior to implantation.
21. The implant simulating device of claim 20 wherein each cross member includes a ball joint for receiving and positioning the fixation element simulator.
22. The implant simulating device of claim 21 wherein each cross member comprises a rod, a bottom plate and a center piece located therebetween and wherein the ball joint is located in the center piece and wherein the bottom plate slides along the first and second splints so that each cross member is movable in the first and second dimension of the plane of the base plate.
23. The implant simulating device of claim 21 wherein the fixation element simulator is designed and configures to be screwed into a ball joint to enable movement of the fixation element simulator in a third dimension which is normal to the plane of the base plate.
24. The implant simulating device of any one of claims 20 to 23 wherein the elongated element is bent to conform to the fixation element simulators and each cross member is flexible to simulate changes in anatomy when the bent elongated element is deformed.
25. The implant simulating device of any one of claims 20 to 23 wherein the elongated element is used as a bending template.
26. The implant simulating device of any one of claims 20 to 25 wherein the correlation system is a position detecting system comprising:
at least one signal transmitter;

at least one sensor for detecting the signal(s); and an analyzing unit for processing the signal(s) to determine position and orientation of at least some of the fixation element simulators.
27. The implant simulating device of claim 26 wherein a signal transmitter is associated with each fixation element simulator.
28. The implant simulating device of claim 27 wherein each transmitter is located on an elongated inserter which is associated with a fixation element simulator.
29. The implant simulating device of claim 28 wherein the elongated inserter is configured and dimensioned to mate with a fixation element simulator.
30. The implant simulating device of claim 27 wherein each signal transmitter comprises at least one light emitting diode (LED) and the sensor comprises a digital camera.
31. The implant simulating device of claim 26 wherein the signal comprises an electromagnetic or acoustic wave.
32. The implant simulating device of any one of claims 20 to 25 wherein the correlation system comprises a pantograph, a scanning device, or a combination thereof.
33. The implant simulating device of any one of claims 20 to 25 wherein the correlation system is a translation device for transferring position and orientation of at least some of the plurality of fixation elements, the translation device comprising at least two translators and a connecting rod linking the at least two translators, each of the at least two translators comprising:
a positioning pin having first and second ends;
a sleeve having first and second ends, the first end configured and dimensioned for receiving the first end of the positioning pin and the second end configured and dimensioned for receiving at least a portion of an elongated inserter coupled to a fixation element; and a clamp having a first portion coupled to the connecting rod and a second portion coupled to the second end of the positioning pin, the first portion rotatable with respect to the second portion for adjusting position and orientation of the positioning pin to align the translator with one of the plurality of fixation elements, wherein transferring each of the at least two translators to one of the at least two fixation element simulators results in the implant simulating device mimicking at least a portion of the fixation system.
34. The implant simulating device of any one of claims 20 to 33 further comprising an elongated element inserter comprising:
a handle;
an elongated holder extending from the handle and having a recess on a distal end for receiving a portion of the elongated element;
a locking pin insertable in the elongated holder for securing the elongated element in the recess; and a position and orientation display extending from the handle and having a length scale, wherein the position and orientation display is parallel to the portion of the elongated element.
35. A method of preparing a longitudinal rod of a fixation system including at least two fixation elements for connecting an elongated element to bone, the method comprising the steps of mounting an elongated inserter on each of at least two of the fixation elements, the fixation elements collectively defining a desired shape:
transferring position and orientation of at least two of the fixation elements to at least two fixation element simulators to thereby mimic the desired shape; and bending the elongated element to have a configuration that matches the desired shape.
CA002311316A 1997-11-21 1997-11-21 Device for simulating implants located under the skin Expired - Lifetime CA2311316C (en)

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WO1999026548A1 (en) 1999-06-03
JP4191380B2 (en) 2008-12-03
ATE260607T1 (en) 2004-03-15
JP2001523514A (en) 2001-11-27
EP1032320B1 (en) 2004-03-03
HK1027952A1 (en) 2001-02-02
US6332780B1 (en) 2001-12-25
DE59711387D1 (en) 2004-04-08
CA2311316A1 (en) 1999-06-03

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