Device to improve accuracy and image stabilisation of ar / VR / mr devices for precise projection of anatomical information onto the stent graft surface

Abstract

The subject of the invention is a device for increasing the accuracy and image stabilization for AR / VR / MR devices for precise superimposition of anatomical information on the stent graft, consisting of a stand (1) with a central groove (2) in which the stent graft (9) is placed, from the stand (1) is equipped with arms (4) on which there is an attachment (5) for AR / VR / MR devices (6), located at a predefined distance from the stamd (1), arms (4) with pivot axes allow rotation of the AR / VR / MR device around the axis of the stentgraft, alternatively arms (4) without pivot axes are equipped with a stentgraft pivot module (7) or a stand pivot module with stentgraft groove (8). The operator observing the stent graft via the AR / VR / MR device sees the actual image with anatomical information superimposed.

Description

[0001] Device to improve accuracy and image stabilisation of AR / VR / MR devices for precise projection of anatomical information onto the stent graft surface

[0002] The object of the invention is a device for increasing the accuracy and image stabilisation of augmented, virtual and mixed reality devices (AR / VR / MR devices) in order to precisely superimpose anatomical information on the surface of a vascular prosthesis, a so-called stent graft.

[0003] A stent graft is a type of vascular prosthesis that is used to treat aortic diseases such as aneurysm or dissection. A stent graft consists of a metal mesh that supports the vessel wall and a synthetic fabric that prevents blood leakage. The stent graft is inserted into the blood vessel through a small incision in the groin or thigh and advanced to the target site under X-ray guidance.

[0004] In some cases, the stent graft must be adapted to the patient's anatomy to ensure the proper blood supply to the organs supplied from the aortic collateral vessels such as the renal arteries, superior mesenteric artery, visceral trunk and the vessels of the aortic arch such as the subclavian artery, left common carotid artery, brachiocephalic trunk. For this purpose, holes, called fenestrations, are created on the stent graft, which correspond to the position of the outlets of these vessels. The fenestrations allow blood to flow from the stent graft into the collateral vessels of the aorta.

[0005] From patent description PL242758, a computer-implemented method for manufacturing and fitting endovascular prostheses using a virtual aortic template is known. The geometric position of key anatomical points, such as the outlets of the aortic collateral vessels, is obtained in advance using medical imaging and diagnostic techniques such as CT or MRL Then, this information is transferred to the stent graft using AR / VR / MR devices, which allow the image with the key anatomical information to be superimposed on the stent graft. In this way, the surgeon can accurately produce a fenestrated stent graft that is anatomically compatible with the specific patient.

[0006] However, existing AR / VR / MR devices have some limitations and drawbacks that affect the quality and precision of the superimposition of anatomical information on the stent graft. AR / VR / MR devices worn on the head or held in the hand are susceptible to natural small movements of the human body, which cause distortion or blurring of the image. In addition, the computational algorithms themselves must determine and continuously recalculate the changing distance relative to the stent graft, which can introduce errors or delays. An error in the position of the fenestration can have serious clinical implications, such as difficulty cannulating the aortic collateral vessels during the procedure or compromised patency of these vessels in postoperative follow-up.

[0007] The invention aims to provide a device to increase the accuracy and image stabilisation for AR / VR / MR devices in order to accurately superimpose anatomical information onto a stent graft, while removing or reducing the drawbacks and limitations of existing devices and other technical solutions. The essence of the invention is an image stabilization device for AR / VR / MR devices for precise superimposition of anatomical information on a stent graft comprising a stand with a central groove in which the stent graft is placed characterized in that the stand is provided with arms, on which an attachment for AR / VR / MR devices is located at a predefined distance from the stand, the arms with pivot axes allowing rotation of the AR / VR / MR device around the axis of the stentgraft positioned in the central groove of the stand, delivering through the stentgraft delivery system, Alternatively, arms without a pivot axis are equipped with a stent graft pivot module or a stand pivot module with a stent graft pivot module.

[0008] Advantageously, the position of the AR / VR / MR device from the stand is at a distance of 5 - 150 cm. Advantageously, the device is made of sterilisable material, preferably metal or plastic.

[0009] The device provides image stabilisation and greater precision in displaying key anatomical information. This is done through defined distances and known possible angles between the stent graft and the AR / VR / MR device, as well as device position stability. Image stabilisation for AR / VR / MR devices is realised, for example, by changing the value of the transformation matrix, thus offsetting image distortions introduced by the physical camera. By reading and transmitting the precise value of the rotation in real time (of the AR / VR / MR device mount, or stent graft pivot module stand, or stent graft, depending on the configuration), greater calculation precision and image stabilisation of the displayed anatomical information is achieved. This is achieved by reducing the calculation delay of mathematical transformations and making the determined values more accurate based on precise measurement. In the case of a tablet or smartphone placed in the mount, the values for the distance of the camera from the stent graft are also known which, in combination with the known angle of rotation of the camera in relation to the stent graft, enables very precise calculations. Precision is key, as it impinges on the accuracy of the fenestration position on the stent graft and therefore has a bearing on the fit of the stent graft to the individual patient. The device is integral to a specific AR / VR / MR device, whose calculation algorithms take into account the known distance and angles to the stent graft. This results in a more precise and stable overlay of the image with key anatomical information onto the stent graft. The device is made of a material that allows sterilisation, such as metal or plastic. The mount for the AR / VR / MR device allows for the placement of a non-sterile AR / VR / MR device. The distances between the components allow handling without contamination of the operating field. Control of the AR / VR / MR device is non-contact, e.g. using hand gesture detection or voice commands. Alternatively, an additional attachment is used to install an attachment for controlling and controlling the AR / VR / MR device.

[0010] The device consists of a stand with a central groove into which the stent graft is placed. The groove centres the position of the stent graft. Arms run from the stand, on which there is a holder with an attachment for AR / VR / MR devices, e.g. for mobile devices with screens such as tablets and smartphones, glasses or goggles worn on the head. Alternatively, it is acceptable to locate a device in the holder that performs light projection (e.g. using a laser or projector) onto the surface of the stent graft. The position of the AR / VR / MR device is at a defined distance to the stand between 5-150 cm. The arms contain axes of rotation around the stent graft, allowing the projection of anatomical information on the lateral parts of the stent graft. Alternatively, the stand with the stentgraft can rotate relative to the AR / VR / MR device or the stentgraft itself can be rotated on the stand with the device determining its rotation angle. When the operator observes the stent graft through the AR / VR / MR device, he or she sees the actual image with anatomical information superimposed. The anatomical information as digital content is superimposed on the lateral parts of the stent graft as a real-world object. In the case of portable devices with screens like tablets and smartphones, the digital visualisation is placed on the screen based on the reading from the device's camera. In the case of glasses or goggles worn on the head, on the other hand, it is taken into account as additional information displayed in transparent lenses or on displays. The space in the invention between the AR / VR / MR device and the surface of the stent graft allows the displayed anatomical information to be marked and transferred.

[0011] The object of the invention is shown in an example of the implementation in the drawing, where fig. 1 shows a general view of the components involved in the implementation of the invention (including the axes of rotation), fig. 2 shows the device in side view, fig. 3 shows the device in top view, fig. 4 shows the device in front view, fig. 5 shows a general view of the components involved in the invention including the stent graft rotation module, fig. 6 shows the device in front view, fig. 7 shows the device in side view, fig. 8 shows the device in plan view, fig. 9 shows a general view of the components (i.e. stent graft positioned in the central groove of the stand; stent graft delivery system), fig. 10 shows the device in frontal view, fig. 11 shows a general view of the components involved in the invention including the rotating module of the stent graft rotation module stand, fig. 12 shows the device in side view, fig. 13 shows the device in frontal view.

[0012] The markings on the figure indicate sequentially: 1 - stand, 2 - central groove, 3 - stent graft site, 4 - arms, 5 - attachment for AR / VR / MR devices, 6 - site for AR / VR / MR devices, 7 - stent graft rotation module, 8 - stand rotation module with stent graft groove, 9 - stent graft positioned in the central groove of the stand; 10 - stent graft delivery system.

[0013] Example 1

[0014] The image stabilisation device for AR / VR / MR devices according to the invention is used for precise superimposition of anatomical information on the stent graft. The device consists of a stand 1 with a central groove 2, in which the stent graft 3 is placed. From the stand 1 run arms 4, on which there is an attachment 5 for AR / VR / MR devices 6, e.g. for a tablet. The position of the AR / VR / MR device 6 is at a defined distance to the stand 1 between 5-150 cm. The arms 4 contain pivot axes that allow the AR / VR / MR device to rotate around the long axis of the stent graft. In this configuration, the stand 1 together with the stent graft 9 remains stationary, and only the position of the AR / VR / MR device attachment 5 relative to them is changed by incomplete rotation either clockwise or counterclockwise. Alternatively, the arms 4 may not include a rotation axis, in which case, in such an embodiment, the invention is provided with a rotation module 7 of the stentgraft 9. The rotation module 7 of the stentgraft 9 is realised by rotating the stentgraft 9 holding system, where the controller transmits this value to the central unit of the AR / VR / MR device. In this configuration, the stentgraft 9 can be rotated clockwise or counterclockwise and the position of the stand 1 does not change. The position of the AR / VR / MR device also remains unchanged, and the information transmitted to the AR / VR / MR device allows the anatomical information to be changed when projected onto the surface of the stent graft 9. Alternatively, the invention comprises a rotation module of the stent graft rotation module stand 8. In such a configuration, the stent graft 9 is placed stationary on the rotation module stand 1, the transverse plane of which can be rotated by pivoting in a clockwise or anti-clockwise direction. By being placed stationary, stentgraft 9 does not change its relative position and the displayed anatomical information changes on projection due to the knowledge of the angle of rotation.

[0015] By knowing the precise value of the rotation of the attachment 5, the projection of the anatomical information can be adjusted to the current pivot or, alternatively, the angle is calculated from a corresponding graphic of known dimensions placed on the stand 1. The angle of rotation of the stentgraft 9 is then taken into account when projecting the anatomical information onto the stentgraft 9. For this purpose, the end of the delivery system 10 of the stentgraft 9 is routed through this module 7. By knowing the precise value of the angle of rotation (in practice, the angular deviation from the initial position), it is possible to take it into account in the rotation of the digital representation of the information (e.g. rotation of the cylinder around the long axis of rotation) so that it corresponds to the actual position of the stentgraft 9.

[0016] The device according to the invention has the advantage of improved precision in the superimposition of the anatomical information on the stent graft 9, due to the predefined distance of the AR / VR / MR device to the stand 1 with the stent graft 9. This facilitates the calculations in the analysis module of these devices, reduces the processor time required for the calculations and eliminates delays in the image projection. As a result, the image is accurate in terms of size and spatial positioning, allowing the fenestration to be precisely aligned with the aortic collateral vessel orifices. The individualised approach to the patient's anatomy increases the safety and effectiveness of the procedure and reduces the risk of clinical complications. In addition, image stabilisation facilitates the surgeon's work by affecting better visibility and control of the stent graft and fenestrations. This enhances comfort and ergonomics, as the surgeon does not have to wear an AR / VR / MR device over his head or hold an AR / VR / MR device, which can be heavy, uncomfortable or limit the field of view. In addition, the separation of the non-sterile AR / VR / MR device from the surgeon's hands, which remains sterile in the operating theatre during stent graft modification for fenestration, utilises the principles of / embodies the principles of aseptics and antisepsis.

[0017] The following should be regarded as beneficial effects of the invention:

[0018] • Improved precision in superimposing anatomical information on the stent graft, thanks to the predefined distance of the AR / VR / MR device to the stent graft stand. This facilitates calculations in the analysis module of these devices, reduces CPU usage and eliminates delays in image projection. As a result, the image is accurate in terms of size and spatial positioning, allowing the fenestration to be precisely aligned with the aortic collateral vessel orifices.

[0019] • Increase the safety and effectiveness of the procedure by better adapting the stent graft to the patient's individual anatomy. This reduces the risk of clinical complications, such as difficulty in cannulating the aortic collateral vessels or compromised patency of these vessels.

[0020] • Facilitating the surgeon's workflow, thanks to image stabilisation. This allows better visibility and control of the stent graft and fenestrations, reducing the time and difficulty of modifications. This also increases the comfort and ergonomics of the surgeon's work, as he or she does not have to wear an AR / VR / MR device over the head or hold an AR / VR / MR device, which can be heavy, uncomfortable or limit the field of view.

[0021] • Separation of the non-sterile AR / VR / MR device from the surgeon's hands in the operating theatre during stent graft modification for fenestration remains sterile using the principles of aseptics and antisepsis. The standard approach with hand manipulation of such a device is not possible for microbiological reasons.

[0022] • The use of a stand with a groove and indentations for the stent graft delivery system, allow the stent graft to be positioned at a fixed position and distance from the AR / VR / MR device. This eliminates the need to measure distance using image analysis or distance measurement systems such as LIDAR, which are subject to errors and delays. This also prevents image distortion or blurring caused by minimal involuntary movements of the human body.

[0023] • The use of arms with pivot axes that allow the AR / VR / MR device to be rotated around the stent graft to obtain a complete projection of the anatomical information on each part of the vascular prosthesis. This allows the fenestration to be better aligned with the aortic collateral vessel orifices, even if they are located on the lateral walls of the stent graft. This also facilitates access to the stent graft and fenestration from different angles and perspectives.

[0024] • The use of alternative rotation methods, such as rotating the stent graft stand or a standalone stent graft on the stand to adjust the viewing angle, allows the image to be tailored to the surgeon's preferences and needs, which can improve comfort and efficiency. It also provides greater flexibility and versatility for the device, as it can work with different models and manufacturers of AR / VR / MR devices.

[0025] • The use of device integrity with a specific AR / VR / MR device, whose calculation algorithms take into account a known distance to the stent graft, improves the accuracy and stability of the image overlay, as there is no need to recalculate the distance every time the position of the AR / VR / MR device changes. This also improves computational efficiency and speed, as there is no need for additional sensors or measurement systems.

Claims

AMENDED CLAIMS received by the International Bureau on October 22, 2025 (22.10.2025)1. An image stabilization device for AR / VR / MR devices for precise superimposition of anatomical information on a stent graft, consisting of a stand (1) with a central groove (2) in which the stent graft (9) is placed, characterised in that the stand (1) is equipped with arms (4), on which there is an attachment (5) for AR / VR / MR devices (6), located at a distance of 5-150 cm from the stand (1), arms (4) either have rotation axes allowing rotation of the AR / VR / MR device around an axis of the stent graft (9) located in the central groove (2) of the stand (1), delivering through a system (10) the delivery of the stent graft (9), or arms (4) are equipped with a stent graft rotation module (7) or a module for rotation of stand with stent graft groove (8).

2. The devices for precise superimposition of anatomical information on a stent graft according to claim 1, characterised in that it is made of sterilisable material, preferably metal or plastic.

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