WO2022238427A1

WO2022238427A1 - Device and method for optically supported landmarking

Info

Publication number: WO2022238427A1
Application number: PCT/EP2022/062677
Authority: WO
Inventors: Theodoros THEODORIDIS
Original assignee: Theodoridis Theodoros
Priority date: 2021-05-11
Filing date: 2022-05-10
Publication date: 2022-11-17
Also published as: EP4337130A1; DE102021112230A1

Abstract

The invention relates to a method for visual support of landmark-supported interventions, comprising the provision of image data of the region of interest, which is established by means of imaging methods; the determination of the data essential for the intervention; the implementation of the data essential for the intervention into the image data for projection, and the true-to-scale projection of the image data onto the region of interest. The invention further relates to a projection device for carrying out the method. The method according to the invention and the device according to the invention allow a significantly improved orientation of the treated person during a landmark-supported intervention without additional exposure to radiation.

Description

The invention relates to a method and a device for the optical support of landmark-supported interventions.

A wide variety of interventions are known in medicine in which liquids or tissue samples are taken from a patient or substances are fed into the body using special instruments such as syringes, cannulas or needles. Such interventions include, for example, punctures, injections or biopsies.

In many cases, the interventions mentioned require a high degree of precision and skill on the part of the person treating the patient, so that the respective instrument is inserted so precisely that the removal or injections take place at the desired locations, i.e. the desired tissue is removed or the desired structures are supplied with an active substance will. It is also crucial not to damage any sensitive tissue, organs, vessels or nerves during the procedure.

The correct selection of the puncture site, the puncture angle and the puncture depth are essential for the success of such an intervention. The treating person usually determines these parameters before carrying out the intervention using images that were created using imaging methods, for example using X-ray images, computed tomography images (CT), magnetic resonance images (MRT) or ultrasound images (US). 2

In order to determine the correct puncture site when inserting the instrument, the treating person can then orientate himself using so-called landmarks of the patient's body. In this context, one speaks of landmark-based interventions. Landmark-based interventions are therefore interventions in which the person treating the patient orients himself to palpatory anatomical points on the patient's body during the intervention and does not use any additional imaging methods to control the puncture site, the puncture angle and the puncture depth. Using the example of interventional injection therapy on the spine, this means that the cannula is placed and advanced solely on the basis of anatomical landmarks and the experience of the treating person. When placing and inserting the injection needle, the practitioner orients himself, for example, on the spinous processes of the vertebrae or the position of the pelvic bones in order to determine the ideal puncture position for the respective treatment.

A disadvantage of this known method of landmark-supported intervention is that the treating person must have a great deal of experience in order to actually be able to carry out the best possible intervention based solely on the anatomical landmarks. Accordingly, imaging methods are used in whole or in part in a large number of such interventions. X-ray image converters and computed tomography (CT) are preferred imaging methods. Both methods are associated with a high level of radiation exposure for the patient, at least cumulatively over the required treatment time, which requires repeated treatments.

In individual cases, the additional radiation exposure during therapy can be 10 to 100 times the radiation exposure of the diagnosis, depending on the repetition and frequency of the treatments. Such high radiation exposure applies wherever possible due to the high health risks for the patient 3 without jeopardizing patient safety during the intervention to be carried out.

There are hardly any low-radiation alternatives to landmark-based interventions. In the meantime, various computer-based devices are available that calculate the puncture site, the puncture angle and the puncture depth for a corresponding intervention from an existing image data set and can display them to the treating person in real time during the intervention, for example by means of a laser trajectory, but such devices are both expensive and also expansive and therefore not suitable for large-scale use outside of clinics.

It is therefore the object of the invention to provide a device and a method which enable visual support in landmark-assisted interventions without leading to increased radiation exposure of the patient. This object is achieved by a method having the features of claim 1 and a device having the features of claim 6. Advantageous configurations are the subject matter of the dependent claims. It should be pointed out that the features listed individually in the claims can also be combined with one another in any technologically meaningful manner and thus show further refinements of the invention.

According to the invention, the region of interest (ROI) is understood to mean the part of the body that includes the structure to be treated and at which the intervention is to be carried out accordingly. The invention is based on the idea that an image of the ROI obtained by means of imaging methods, in particular by X-ray, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound (US), is projected onto the corresponding part of the patient's body during the intervention. The projection of the image supports the practitioner in the landmark-supported intervention. 4

In a development of the invention, the image data mentioned can also be supplemented by additional light image data. The light image data also relates to the ROI and facilitates the positioning of the image projection. The image data obtained by means of imaging methods are superimposed congruently with the light image data in order to enable an improved adaptation of the projection to the anatomy of the ROI.

The projected image includes additional information that simplifies the intervention for the practitioner. This includes, for example, information about the puncture site, the puncture angle and the puncture depth. Specifically, the additional information includes, for example, a marking of the puncture site; also an indication of the angle, a graphic marking or a numerical value for the puncture angle and/or a numerical indication of the length of the puncture depth.

In order to achieve a true-to-scale projection of the image onto the patient, a scale is preferably depicted on the image, by means of which the projection of the image can be adapted to the real size. If a scale of 10 cm, for example, is given on the image, this scale must also measure 10 cm in the projection.

A projection device for projecting the image onto the patient's body is required to carry out the method according to the invention.

A projection device according to the invention comprises a projection unit for light projection of image files and a data memory for storing image files in particular. The exchange or the transmission of data between an external device, for example a computer, a tablet or another storage unit for providing data, and the projection device can take place wirelessly or with a cable by appropriate means. 5

The projection device preferably also comprises a distance sensor which is suitable for measuring the distance or the path between the projection device and the projection surface. The projection surface is understood to be the part of the patient's body onto which the image data is projected. The distance data can be useful in calculating a true-to-scale projection of the image data onto the patient.

Furthermore, the projection device preferably includes a microprocessor which is suitable for calculating a realistic projection of the image data onto the projection surface from the information on the size and resolution of the image data and the distance between the projection device and the projection surface determined by the distance sensor. A realistic projection of the image data means that the image data is projected onto the patient in the true-to-scale size, so that the projection and the real anatomy of the patient are congruent at least to the extent that they correspond in size. The projection device then carries out a corresponding size adjustment automatically, for example by means of a digital zoom or a lens zoom. The projection device otherwise corresponds in structure to

Essential known projectors. Preferably, the

Projection device Opportunities for oblique projection through appropriately implemented devices to correct any trapezoidal distortion that occurs, such as lens shift or digital keystone correction. An oblique projection of the images is advantageous so that the treating person covers the projected image as little as possible during the intervention.

Preferably, the projection unit also includes the option of short-distance projection through the implementation of special lens and/or mirror systems such as aspheric lenses. Such a short-distance projection is advantageous so that the device can also be used in a space-saving manner in smaller treatment rooms. 6

The invention also includes a method for image-supported intervention with landmarks.

A method according to the invention for image-supported intervention with landmarks comprises at least the following steps:

(A) providing image data of the region of interest obtained by means of imaging methods;

(B) determining the data essential to the intervention;

(C) implementing the data essential for the intervention in the image data for projection;

(D) Projecting the image data to scale onto the region of interest.

The image data are preferably X-ray image data, CT image data, MRT image data or also US image data. The image data can be two- or three-dimensional.

In a development of the invention, the image data mentioned can also be supplemented by additional light image data. The light image data also relates to the region of interest and is used to facilitate the alignment of the later projection. For this purpose, the image data are superimposed congruently with the light image data in order to enable an improved adaptation of the projection to the anatomy of the region of interest.

After successful alignment, the light image data can preferably be hidden from the projection in order to prevent distraction by this image data, which is unimportant for the actual intervention. Likewise, after successful alignment, further data that is not essential 7 are for intervention, to be hidden. For example, it is conceivable that after successful alignment and satisfactory projection, ultimately only the data on the puncture site, puncture angle and puncture depth are projected. Accordingly, the procedure for image support of landmark-based interventions can also include the following steps:

(A1) providing region-of-interest image data and superimposing said region-of-interest image data on said light image data; and (D1) hiding the light image data and optionally further data from the projection, step (A1) preferably taking place after step (A) and step (D1) taking place after step (D).

The data essential for the intervention are noted in the image files or in the image data in such a way that they can be read by the treating person in a later projection. The data essential for the intervention include, for example, a scale for the true-to-scale projection of the image data, a marking of the puncture site, and information on the puncture angle, the puncture direction, and the puncture depth.

With the help of the scale, it is possible in the simplest way to adapt the image file to the region of interest when projecting the image data by enlarging or reducing the projection of the image data in such a way that the scale has the correct size. The size or the length of the ruler can easily be measured manually on the projection. 8th

Alternatively, as described above, the projection device includes a corresponding automated option for image size correction and carries out this size calibration in an automated manner.

The device according to the invention has the advantage over the prior art that it is extremely space-saving and inexpensive. It is easy to operate and can be used in practically every medical practice, even outside of a larger clinic.

The method according to the invention has the advantage over the prior art that, in contrast to known image-assisted interventions that use imaging methods with a high radiation exposure, it does not entail any additional radiation exposure. This also applies if a large number of interventions have to be carried out as part of a therapy, because the procedure itself does not involve any additional radiation exposure, since the necessary images have already been taken as part of the diagnosis or a check-up.

Furthermore, the method according to the invention has the advantage over the known landmark-supported intervention that the supportive projection of the image and intervention data means that appropriate interventions can also be carried out safely by relatively inexperienced practitioners. As a result, a large number of patients can be treated without additional radiation exposure.

The invention and the technical environment are explained in more detail below with reference to the figures. It should be pointed out that the figures show a particularly preferred embodiment variant of the invention. However, the invention is not limited to the embodiment variant shown. In particular, the invention includes any combination of the technical features that are listed in the claims or described as relevant to the invention in the description, insofar as this is technically reasonable.

Show it: 9

1 shows a processed image file;

FIG. 2 shows the processed image file according to FIG. 1 supplemented by a scale and information on the image resolution;

3 shows an exemplary arrangement of the projection device for projecting the image file onto the patient;

4 shows the image file according to FIG. 2 projected onto a patient. FIG. 1 shows an X-ray image 1 of an ROI in the region of the lumbar spine, prepared according to the invention, with the marked vertebrae L3 to L5. The puncture site, the puncture angle and the puncture depth are marked as additional data for orientation for the treating person when carrying out the intervention. Anatomical data 2 such as the course of the iliac crest, the median line and the lumbar vertebrae L3 to L5 are marked as an additional orientation aid for later alignment of the projection on the patient's body. These lines help with alignment for congruent projection of the X-ray image 1 onto the patient's body. FIG. 2 shows the X-ray image 1 according to FIG. 1 supplemented by data on the resolution of the image 4 and by a scale 5. The scale 5 helps with the correct size adjustment of the projection on the patient's body. As soon as the scale 5 is shown true to scale on the patient's body, ie in the present case has an actual length of 10 cm in the projection, the projection corresponds to the actual scale of the x-ray image. For alignment that is congruent, the treating person can use the anatomical data 2, FIG. 1) for orientation, such as the course of the iliac crest or the position of the lumbar vertebrae, which he can see or feel on the patient. Figure 3 shows a possible arrangement of the projection device 6 for projecting an image file on the body of a patient P, present on the 10

Back of the patient P. The projection 7 is true to scale. Using specific markings on the image file, the treating person A aligns the projection 7 on the body. The projection device 6 can be provided in a mobile manner, for example as a desktop device or mounted on a stand. Stationary attachment is also conceivable, for example to permanently equip different treatment rooms with such a projection device 6 .

FIG. 4 shows the projection 7 of the image file 1 according to FIG. 2 onto the region of interest, in this case the back of the patient P. It is easy to see how helpful the projection 7 of the image prepared according to the invention with the aid of the projection device according to the invention is for the treating person A. In addition to the well-known landmarks, the treating person A receives a comprehensive insight into the internal anatomy of the patient (2, Fig. 1). Together with the additional data on the intervention (3, FIG. 1) such as puncture site, puncture angle and puncture depth, this enables the treating person A to carry out a much more precise treatment with better treatment success and fewer risks for the patient.

As soon as the projection 7 has been aligned to scale and anatomically correct, the data not required for the further intervention, for example the anatomical data (2, Fig. 1) can optionally be hidden from the projection 7 so that, for example, only the data for the intervention (3, Fig. 1) such as the puncture site, puncture angle and puncture depth are projected. Here the treating person A himself decides which data are needed for the intervention and should be part of this reduced projection 7 .

11

reference list

1 X-ray image (digitized image file)

2 anatomical data (position of the iliac crest, the lumbar vertebrae) 3 data on the intervention (puncture site, puncture angle and puncture depth)

4 image data

5 scale

6 projection device

7 Projection A treating person

B patient

Claims

12 patent claims

1. Procedure for image support of landmark-based interventions comprising the following steps:

(A) providing image data of the region of interest created using imaging methods;

(B) determining the data essential to the intervention;

(C) implementing the data essential for the intervention into the image data for projection;

(D) Projecting the image data to scale onto the region of interest.

2. Method for image support of landmark-based interventions according to claim 1 further comprising the following steps:

(A1) providing region-of-interest image data and superimposing said region-of-interest image data on said light image data; and

(D1) masking out the light image data and optionally further data from the projection, step (A1) taking place after step (A) and step (D1) taking place after step (D). 13

3. Methods for image support of landmark-based

Interventions according to one of claims 1 or 2, characterized in that the image data are preferably X-ray image data, CT image data, MRT image data or US image data and are present in two or three dimensions.

4. Methods for image support of landmark-based

Interventions according to one of the preceding claims, characterized in that the essential data for the intervention are selected from the scale for the true-to-scale projection of the image data, the marking of the puncture site, the information on the puncture angle, the puncture direction and the puncture depth.

5. Methods for image support of landmark-based

Interventions according to one of the preceding claims, characterized in that the imaging methods are X-ray, CT, MRT or US.

6. Projection device for the optical support of landmark-supported interventions according to the method according to claims 1 to 5, with a projection unit for projecting image data; a data memory for storing image data; a microprocessor for processing and calculating image data.

7. Projection device for the optical support of landmark-supported interventions according to claim 6 comprising means for short-distance projection.

8. projection device for the optical support of landmark-based interventions according to one of claims 6 or 7 with 14 a distance sensor for determining the distance between

Projection unit and projection surface.

9. Projection device for the optical support of landmark-based interventions according to one of claims 6 to 8 with means for compensating for trapezoidal distortion.

10. Projection device for the optical support of landmark-supported interventions according to one of claims 6 to 9 with a memory for storing data and means for wireless or wired data exchange.