VISUALISATION DEVICE TO PROVIDE INFORMATION ON THE DESIRED SHAPE OF A POSTERIOR SPINAL ROD
20250134555 ยท 2025-05-01
Inventors
Cpc classification
A61B17/7013
HUMAN NECESSITIES
A61B17/8863
HUMAN NECESSITIES
A61B2090/0808
HUMAN NECESSITIES
A61B2034/102
HUMAN NECESSITIES
International classification
A61B17/70
HUMAN NECESSITIES
A61B17/88
HUMAN NECESSITIES
Abstract
A rod shape visualisation device (1) is proposed for providing information on the desired shape of a posterior spinal rod during a bending process whilst being arranged in a sterile operation area. The rod shape visualisation device (1) comprises: (a) a sterile case (10) comprising a housing portion (11) including an entrance aperture (12) and a cover (13). sized and shaped to seal the entrance aperture (12). the sterile case (10) further comprising an inner lumen (14) configured to come in contact with non-sterile or sterile objects. and (b) a non-sterile or sterile visualisation template (40) comprising a displaying side providing information on the desired shape of a posterior rod. The rod shape visualisation device (1) defines a first. open state in which the cover (13) is open, and a second. closed state in which the cover (13) is closed. wherein in the closed state. the displaying side of the visualisation template (40) is visibly arranged in the inner lumen (14).
Claims
1. A rod shape visualisation device for providing information on the desired shape of a posterior spinal rod during a bending process whilst being arranged in a sterile operation area, the rod shape visualisation device comprising: a sterile case comprising a housing portion including an entrance aperture and a cover, sized and shaped to seal the entrance aperture, the sterile case further comprising an inner lumen configured to come in contact with non-sterile or sterile objects, a non-sterile or sterile visualisation template comprising a displaying side providing information on the desired shape of a posterior rod, wherein the rod shape visualisation device defines a first, open state in which the cover is open, and a second, closed state in which the cover is closed, and wherein in the closed state the displaying side of the visualisation template is visibly arranged in the inner lumen.
2. The rod shape visualisation device according to claim 1, wherein the visualisation template is a thin single-use object including a graphical image or representation of the desired rod size and shape.
3. The rod shape visualisation device according to claim 1, wherein the visualisation template is made of a medium or material selected from paper, cardboard, foil, plastic, steel, aluminium or any combination thereof.
4. The rod shape visualisation device according to claim 1, wherein the visualisation template is a screen of an electronic device, such as a tablet computer which is configured to display the desired size and shape.
5. The rod shape visualisation device according to claim 1, wherein the length of the inner lumen is at least 60 cm, more preferably at least 70 cm.
6. The rod shape visualisation device according to claim 1, wherein the housing portion comprises sidewalls comprising topsides, the sidewalls defining a periphery of the inner lumen, wherein at least one of the sidewalls and/or the periphery comprises at least one marking or different colour indicating a border of an area in which contact with non-sterile objects or persons is allowed.
7. The rod shape visualisation device according to claim 1, wherein at least one side of the housing portion and/or the cover is transparent.
8. The rod shape visualisation device according to claim 1, wherein at least one side of the housing portion and/or the cover is electrically conductive for operation as a touchscreen.
9. The rod shape visualisation device according to claim 1, wherein the cover is coupled to the housing by a hinge coupling.
10. The rod shape visualisation device according to a claim 1, wherein the housing is shaped as a box.
11. The rod shape visualisation device according to claim 1, wherein the housing and/or the cover has/have at least one handle.
12. The rod shape visualisation device according to claim 1, wherein the visualisation template is captured in a stable shell or covering.
13. The rod shape visualisation device according to claim 12, wherein the shell or covering comprises at least one handhold.
14. The rod shape visualisation device according to claim 1, wherein the covering and/or visualisation template comprises at least one first placement reference which matches a complementarily arranged second placement reference of the sterile case.
15. The rod shape visualisation device according to claim 1, wherein the rod shape visualisation device comprises a rod holder to hold the spinal rod, and wherein the rod holder is placed on the cover and/or on the housing portion.
16. The rod shape visualisation device according to claim 15, wherein the rod holder is releasably attached to the cover and/or to the housing portion, or the rod holder is an integral part of the rod shape visualisation device.
17. The rod shape visualisation device according to claim 1, wherein the rod shape visualisation device comprises a rod holder to hold the spinal rod, and wherein the rod holder is shaped as the sacral bone.
18. The rod shape visualisation device according to claim 1, wherein the rod shape visualisation device comprises a rod holder to hold the spinal rod, wherein the rod holder is shaped as the sacral bone, and wherein the rod holder comprises an abstract representation of a sacral screw and a rod end.
19. The rod shape visualisation device according to claim 1, wherein the rod shape visualisation device comprises a graphical representation of the sacral bone on the cover.
20. The rod shape visualisation device according to claim 1, wherein the visualisation template is built of a plurality of smaller visualisation sub-templates.
21. The rod shape visualisation device according to claim 20, wherein the sub-templates are of a standardised sheet format.
22. A rod shape visualisation kit, comprising the rod shape visualisation device according to claim 1 and scaling software.
23. The rod shape visualisation kit according to claim 22, wherein the scaling software is configured to divide the length of an image over the target number of sheets.
24. A method of visualisation of a spinal rod size and shape in a sterile surgical area, the method comprising the steps of: obtaining a surgical image of the spine; planning a desired rod shape using the image of the spine; visualising the image on a visualisation template of a rod shape visualisation device; placing the visualisation template into a housing portion of a sterile case of the rod shape visualisation device; and closing a cover of the sterile case to reach a closed state of the rod shape visualisation device, wherein in the close state, the visualisation template is visibly arranged in an inner lumen of the sterile case.
25. The method according to claim 24, wherein the visualisation template is made of a medium or material selected from paper, cardboard, foil, plastic, steel, aluminium or any combination thereof.
26. The method according to claim 24, wherein the method further comprises scaling the image to a real size image of the spine prior to visualising the scaled image on the visualisation template.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Other features and advantages of the invention will become apparent from the following description of non-limiting example embodiments, with reference to the appended drawings, in which:
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DETAILED DESCRIPTION OF THE INVENTION
[0027] The embodiments of the present invention will now be described in detail with reference to the attached figures. The embodiments are described in the context of a posterior rod (which is a component of a posterior spinal stabilisation construct) which is to be manually contoured to a desired size and shape, and a rod shape visualisation device comprising a sterile case and a visualisation template which provide the operating surgeon with exact information on the said desired size and shape. Although the invention is specifically described in this context, the teachings of the invention are not limited to this environment. The teachings of the present invention are equally applicable to shape visualisation devices to be used in connection with other bones, bone plates, nails, external, and internal bone fixators, for instance. When the words first and second are used to refer to different elements, it is to be understood that this does not necessarily imply or mean that the first and second elements are somehow structurally substantially different elements or that their dimensions are substantially different unless implicitly or explicitly stated.
[0028] A rod shape visualisation device in this context means a displaying apparatus or unit, which provides information to the operating surgeon on the rod shape and is formed as an outer case, box, container, envelope, pouch, and it holds an exchangeable visualisation template.
[0029] A sterile case in this context means a box, container, envelope, bag, pouch, or similar that is sized and shaped to hold a specific object or specific objects which may be non-sterile. The sterile case has, defines or features an open state and a closed state, where in the said closed state, the case forms a barrier inhibiting the non-sterile object from contaminating the environment around the sterile case, and where in the said open state, access is provided to the interior of the sterile case. The sterile case may be a reusable or single-use object. In one example, the sterile case is configured to be reprocessed by common hospital reprocessing procedures, such as by washing and/or steam-sterilisation.
[0030] A visualisation template in this context means an object displaying or showing information on the desired shape of the rod. The information may be visualised as a realistic or abstract image of the desired rod contour, a graphical image or representation, but it May also be a set of numbers, coordinates, etc. which provide information on the size and shape. A visualisation template may be made of a medium or material such as a sheet of paper, cardboard, foil, plastic, aluminium, steel, or equivalent media, or combinations thereof. Alternatively, a visualisation template can be a screen of an electronic device, such as a tablet computer with for example a touchscreen, which is projecting or displaying the desired size and shape. In one embodiment, the visualisation device may communicate via wireless or wired communication means, e.g. by means of wireless local area network (WLAN) or Bluetooth technologies for real time updates to the template alignment goal within the sterile case. Messages may be received for example from an imaging device, such as a radiographic imaging device, navigational device, robotic device, and/or another surgical planning device.
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[0032] The example rod shape visualisation device 1 comprises a sterile case 10 serving as a sterility barrier, and a visualisation template 40 serving as an information providing means or element. The sterile case 10 comprises a housing (portion) or main body portion 11 with an entrance aperture or opening 12 and a closure lid or cover 13, which is sized and shaped to close the entrance aperture 12. In this example, the housing portion is a box-shaped housing portion having an inner lumen, cavity, or space 14. The boxed-shaped housing portion 11 has a bottom wall and side walls, namely a first sidewall 15a, a second sidewall 15b, a third sidewall 15c, and a fourth sidewall 15d. Each sidewall respectively has an inside surface or wall 17a, 17b, 17c, 17d, a topside 18a, 18b, 18c, 18d, and an outside surface or wall 19a, 19b, 19c, 19d. The first, second, third, and fourth topsides, respectively, have a first, second, third, and fourth thickness T1, T2, T3, T4. The inner lumen has an average first depth D1, an average first width W1 and an average first length L1. In one example, the inner lumen 14 has a first length of at least 60 cm, more preferably at least 70 cm.
[0033] In this example, the cover 13 is connected to the housing at one sidewall by a hinge coupling or mechanism 16. The hinge coupling allows the cover to be rotated into an open position or a closed position, and so it defines the open and closed states of the rod shape visualisation device 1. The hinge coupling is configured as a pin in a knuckle hinge, but it may instead be formed as a compliant flexure mechanism, a taped foil, a nose in a recess coupling, or any form-fit mechanism that allows rotation of the cover in relation to the box-shaped housing portion. It is to be noted that a hinged connection between the housing portion 11 and the cover 13 is not a mandatory feature. A cover can also be placed loosely on top of the housing to close the inner lumen 14.
[0034] To rigidly close the cover 13, and to provide the required sealing characteristics, the sterile box in this example comprises at least one releasable locking mechanism 20. This locking mechanism can be configured in many alternative designs. For example, as depicted, the releasable locking mechanism 20 is configured as a threaded mechanism 21 having a threaded bolt 27 which engages into a complementarily shaped threaded bore or hole 28. Alternatively, other closing mechanisms, such as an automatically engaging and releasable klick finger, a friction-based ball bearing, a magnetic mating of the cover and the housing portion (a magnetic locking mechanism), an adhesive tape, etc., may achieve the same result.
[0035] Advantageously, the cover 13 may be made of a transparent material providing visibility of the visualisation template 40 through the cover.
[0036] As described, the sterile case 10 is configured to hold a non-sterile object, such as the visualisation template 40. In a typical use scenario, the sterile case is placed in the sterile operation area on a sterile table or similar. A first, sterile assistant or surgeon will open the sterile case, allowing the non-sterile visualisation template 40 to be placed in there by a second, non-sterile assistant. After placement, the sterile assistant or surgeon will close and optionally seal the sterile case.
[0037] During this process, any area which either comes in contact with the non-sterile assistant or the non-sterile visualisation template 40, must be considered contaminated. Hence, only certain areas of the sterile case 10, which can safely be sealed off may come in contact with non-sterile objects or persons.
[0038] As shown in
[0039] In this example, the housing portion 11 comprises a sealing rim or ring 29, which is arranged between the topsides 18a, 18b, 18c, 18d and the cover. The sealing ring 29 may be made of a flexible or rubber-like material, which deforms upon compression. By pressing the cover down using the closing mechanism, the non-sterile area is sealed from the surrounding sterile operation area. In one embodiment, the sealing rim 29 defines the border of area A.
[0040] Furthermore, the housing portion 11 and/or the cover 13 may comprise a first, second or third handle 23, 24 facilitating the use of the rod shape visualisation device 1. The first and second handles 23, 24 can be used to carry the rod shape visualisation device 1, or to stabilise the device while opening the cover. The third handle can be used to open and close the cover 13.
[0041] The visualisation template as shown in the figures is a thin medium or element having a first average height H1, an average second width W2, and an average second length L2. The displaying side 41 or information-showing side of the visualisation template 40 comprises a graphical image or representation 42 of the desired contour, shape, and/or size of the posterior rod.
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[0049] To overcome this risk, as shown in
[0050] In this example, the covering 60 and/or the visualisation template 40 further comprise(s) at least one first placement reference 43, 62, which matches a complementarily arranged second placement reference 32 of the sterile case 10.
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[0059] Furthermore, the covering 60 and/or the visualisation template comprise(s) at least one first placement reference 43, 62 which matches a complementarily arranged second placement reference 32 of the sterile case 10. These placement references ensure that the position of the graphical image or representation 42 matches the position of the rod holder 70 and the rod clamping means 71.
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[0070] In this example at least one of the visualisation device elements is manufactured by means of thermoforming. Thermoforming is a process of heating a thermoplastic sheet to its softening point. The sheet is stretched across a single-sided mould and then manipulated. Then, it cools into the desired shape. The most common methods to get the sheet to conform to its final shape are vacuum-forming, pressure-forming, and mechanical forming. The use of sheets of plastic which may be on a roll of raw material allows for a very cost-efficient production of single-use components. Food blister packaging is a typical example of a thermoformed component.
[0071] In accordance with the example as described in connection with
[0072] The sterile case 10 comprises a housing (portion) or main body portion 11 with an entrance aperture or opening 12 and a closure lid or cover 13, which is sized and shaped to close the entrance aperture 12. In this example, the housing portion is a box-shaped housing portion having an inner lumen, cavity or space 14. The boxed-shaped housing portion 11 has a bottom wall and a first sidewall 15a, a second sidewall 15b, a third sidewall 15c, and a fourth sidewall 15d. Each sidewall respectively has an inside surface or wall 17a, 17b, 17c, 17d, a topside 18a, 18b, 18c, 18d, and an outside surface or wall 19a, 19b, 19c, 19d. The first, second, third, and fourth topsides, respectively, have a first, second, third, and fourth thickness T1, T2, T3, T4.
[0073] The inner lumen has an average first depth D1, an average first width W1 and an average first length L1.
[0074] Further, in this example, the cover 13 is connected to the housing at one sidewall by a hinge coupling 16 or a compliant flexure mechanism allowing rotation of the cover in relation to the box-shaped housing portion.
[0075] To rigidly close the cover 13, and to provide the required sealing characteristics, the sterile box in this example comprises at least one releasable or non-releasable locking mechanism 20 configured as an adhesive tape 92 on the inner side 95 of the cover in such a manner that it will come in contact with one of the topside(s) of the housing portion 11. The adhesive tape in this example comprises a protective cover 93 inhibiting adhesive contact before executing the final closing procedure. Alternatively, the adhesive tape may be arranged at least on one of the topsides 18a, 18b, 18c, 18d in such a manner that it will come in contact with the inner side of the cover.
[0076] In this example, the housing is made of a foil-basis material processed by thermoforming. The sidewalls are obliquely directed inwardly towards the bottom wall to facilitate the manufacturing and to allow easy release of the mould-tooling. Advantageously, this converging shape of the inner lumen also provides a self-centring mechanism to place the visualisation template and/or covering.
[0077] In this example, the casing 60 is formed as an inner box 90, optionally with an inner box cover 91. This cover provides sufficient rigidity for a safe transfer. To provide visibility of the visualisation template, at least one side is transparent. The case 60 may comprise at least one grip, handhold or handle portion to facilitate its safe placement.
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[0084] As described, the shape of the rod is typically based upon a pre-operative planning procedure. Based on X-rays, CT scans, MRI scans, or similar of the patient, the operating surgeon plans the desired shape of the rod using software. For this purpose, different software systems or brands exist. Typically, the software output of the planning result is an image of the patient's spine including a graphical representation of the rod. Most often, the size of this output does not represent the actual size in reality due to a scaling factor. As described for one example, the rod visualisation template is printed or reproduced on one or more sheets of paper, plastic foil, etc. Most efficiently, the sheet format is a standardised format (such as DIN A4, US Letter, etc.) and can be processed with standardised office equipment. To be able to translate the planning image to a correctly sized image on a visualisation template, a scaling method may be needed.
[0085] In a preferred embodiment, the scaling to real size is executed automatically by a rod shape visualisation device accompanying scaling software that recognises, converts and adapts any planning image to a real size image. Example adaptation variables to be considered are one or more of the following: correct scaling factor, length of image versus the division over the target number of sheets, printer and sheet border margins, orientation of the spine in relation to the sheet layout, connection or alignment references if for example the graphical representation of the rod is divided over multiple sheets, the size of the template holding means, etc.
[0086] The method of visualisation of a spinal rod size and shape in a sterile surgical area can be summarised with the steps of: [0087] obtaining a surgical image of the spine; [0088] planning a desired rod shape using the image of the spine; [0089] optionally scaling the image to a real size image of the spine; [0090] visualising the (scaled) image on the visualisation template 40 of the rod shape visualisation device 1; [0091] placing the visualisation template into the housing portion 11 of the sterile case 10 of the rod shape visualisation device 1; and. closing the cover 13 of the sterile case 10 to reach the closed state of the rod shape visualisation device 1.
[0092] In the close state, the visualisation template 40 is visibly arranged in the inner lumen 14 of the sterile case 10.
[0093] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive, the invention being not limited to the disclosed designs. Other embodiments and variants are understood, and can be achieved by those skilled in the art when carrying out the claimed invention, based on a study of the drawings, the disclosure and the appended claims. New embodiments or variants may be obtained by combining any of the above teachings.
[0094] In the claims, the word comprising or including does not exclude other elements or steps, and the indefinite article a or an does not exclude a plurality. The mere fact that different features are recited in mutually different dependent claims does not indicate that a combination of these features cannot be advantageously used. Any reference signs in the claims should not be construed as limiting the scope of the invention.