SYSTEM AND METHOD FOR GENERATING INTERFERENCE LINES
Patent Information
- Application Number
- DE502020010565
- Authority / Receiving Office
- DE · DE
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2020-07-30
- Publication Date
- 2025-03-27
- Estimated Expiration
- 2040-07-30
Description
Technical area
[0001] The invention relates to a system for providing incision lines for performing a surgical procedure. Furthermore, the invention relates to a method and a computer program for providing incision lines.
[0002] Surgical treatments for the skin are part of the usual treatment spectrum of a physician, especially a dermatologist. One goal of such dermatosurgical treatment is to provide a gentle, appropriate treatment with aesthetic aspects.
[0003] The choice of the optimal excision and reconstruction technique as well as the preparation and marking of surgical incision edges are essential for safe surgical excision of the affected tissue, as well as for minimizing trauma, optimal wound healing and, last but not least, for avoiding scars from an aesthetic point of view.
[0004] For pigmented skin lesions such as dysplastic nevi (atypical moles) and melanomas, as well as for non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma, a so-called elliptical excision of the skin is typically performed.
[0005] In addition, in cases of clinical suspicion of cancer, elliptical excision can also serve as a single-step diagnostic and therapeutic intervention. Samples obtained through elliptical excision allow for histopathological examination of the skin, including the epidermis, dermis, and subcutaneous fat. The procedure allows for the determination of the depth of the skin lesion and the detection of clear margins within the surrounding tissue. Skin lesions also include moles, warts, malignant and benign skin tumors, and other types of skin lesions.
[0006] Typically, a physician, particularly a dermatologist, uses a marker pen to manually mark or shape the excision. A standard design takes into account a length-to-width ratio of 3:1 and an apical angle of less than 30 degrees. This (standard) design is called a fusiform ellipse because of the sharp (not blunt) points at each end, and this fusiform ellipse should be aligned with the relaxed skin tension lines.
[0007] The marked area of planned excision is directly related to a safe separation of the marked fusiform ellipse and the underlying tissue, which is relevant for histology as well as traumatic skin injury and scarring. US 2011 / 184291 A1 relates to an ultrasound diagnostic device, a medical image diagnostic device, an ultrasound image processing device, a medical image processing device, an ultrasound diagnostic system, and a medical image diagnostic system used when a surgical target area or treatment target area is to be marked prior to a surgical operation or treatment.
[0008] However, the choice of the optimal excision technique, the dimensions and morphology of the incision shape, and the marking of the desired incisions on the patient's skin currently depend on the knowledge, routine, and technical skill of the performing physician, surgeon, or dermatologist as medical professionals. The desired incision edges are usually drawn freehand on the skin with a pen. Furthermore, there is no way to simulate reconstruction, suturing technique, and wound healing prior to the procedure. Once applied to the skin, it is difficult to correct the manual marking.
[0009] In other words, there are currently no systems, devices, or procedures available to a healthcare professional that could create cutting lines according to a standardized process and communicate and make them available to a healthcare professional. Summary of the invention
[0010] It is the object of the invention to avoid or at least mitigate the disadvantages of the prior art and in particular to provide a device and a method which can provide cutting lines, in particular a cutting shape, for a surgical procedure, in particular an excision, preferably an elliptical excision, to medical personnel such as a doctor, surgeon or dermatologist, so that a treatment can be supported and in particular can be carried out even more easily and better.
[0011] In particular, a further object of the invention is to provide medical professionals with a simple, easy-to-use, cost-effective, and reliable system and method. The system should also preferably be handy, adaptive, and portable.
[0012] The object is achieved according to the invention with regard to a generic device or a generic system by a system for generating cutting lines having the features of claim 1, with regard to a generic method by the features of the independent method claim 8 and with regard to a computer program by the features of claim 9.
[0013] Specifically, the object of the invention is achieved by a system for generating cutting lines for carrying out a surgical procedure and displaying these predetermined cutting lines on the skin surface of a patient, in particular predetermined cutting lines for a surgical excision, comprising: an (electromagnetic) detection device which is provided and adapted for digitally detecting, preferably optically detecting, an area of the skin surface of a patient with a skin change, furthermore a determination device which is provided and adapted to determine cutting lines, preferably a cutting pattern / cutting shape with surgical cutting lines, for removing the skin change based on the area of the skin with the skin change detected by the detection device, and finally an output device which is provided and adaptedto output the cutting lines determined by the determination device and to enable a representation of the cutting lines on the skin surface, characterized in that the system further comprises a predefined set of prefabricated, uniquely numbered templates, wherein: the determination device is further adapted to determine from the set of numbered templates the template to be used which has the smallest deviations from the determined predefined cutting lines, and the output device is adapted to display the unique number of the template to be used by means of a display. Through this three-part or three-stage system with detection device, determination device, and output device, the system is provided and adapted to initially detect an individual skin change of a patient, internally, in particular via a computing unit or ECU,To analyze this detected area of the skin surface with the corresponding skin lesion and to determine (digital) cutting lines or a (digital) cutting pattern or a cutting shape with surgical cutting lines for the removal of this skin lesion. Finally, to enable a medical professional, such as a physician, dermatologist, or surgeon, to transmit or output these individualized cutting lines, adapted to the area of the patient's main surface with the skin lesion, these determined or calculated, individually adapted cutting lines. The (electromagnetic) detection device is adapted to digitally detect electromagnetic waves, such as light, IR, and / or X-rays, and to transmit them digitally accordingly. The output of the determined cutting lines on the skin surface can be digital, virtual, or physical.
[0014] Accordingly, the present invention provides a system which, with the aid of digital recording, in particular optical recording, of the affected skin area of the respective patient, creates an optimal, personalized incision shape for an excision and can be selected, planned and simulated by a medical professional.
[0015] Furthermore, the system makes it possible to simulate reconstructions, suturing techniques, and possible wound healing processes and to discuss them with the patient prior to potential surgical treatment. Particular attention is paid to the subsequent incision edges. The skin and tissue to be removed can be dimensioned (e.g., area, length, angle, safety margin) using the system according to the invention and subsequently evaluated by the medical staff. In particular, the system can be used to evaluate and select particularly suitable (surgical) incision lines or patterns in advance.
[0016] The system according to the invention provides medical personnel with a device which, based on the appropriately adapted determination unit, provides a type of predetermined process for determining or determining cutting lines.
[0017] Advantageous embodiments are claimed in the subclaims and are explained below.
[0018] The output device can have a projector, and the output device can further be adapted to optically project the specific, predetermined cutting lines indirectly via a transparent pane or directly onto the detected area of the patient's skin. In particular, the output device is adapted to spatially detect the area of skin with the skin change using the detection device itself or another camera, in particular a 3D camera, and to project the specific cutting lines directly onto this area of the skin change relative to it. If the patient moves, the cutting lines move accordingly, so that the cutting lines are always maintained relative to the skin change. A projector is a simple and cost-effective means of graphically displaying the cutting lines.Another advantage is that both the medical personnel and the patient can see the incision lines at the same time. If the incision lines are not optically projected directly onto the skin but indirectly onto a transparent, milky, or semi-transparent screen, it can be ensured that the predetermined plane of the screen is always used as the projection surface, which reduces the complexity of the system. If, for example, a patient is not present, the projector can also project the incision lines onto the screen and the medical personnel can then evaluate these incision lines together. In particular, the projector is adapted to display an overlay of the captured image of the skin area and the incision lines in order to enable a digital or virtual representation of the incision lines on the digitally captured skin surface.
[0019] The projected cutting lines can still be visible, at least temporarily, on the detected area of the patient's skin surface after the projection has ended. The output device is thus adapted to project electromagnetic rays of a defined wavelength, in particular below and / or above the wavelength of visible light, in a defined manner onto an area of the skin surface. In particular, the output device can be adapted to emit rays, such as UV (ultraviolet) rays, in a defined orientation (in the manner of a laser beam or a projection with a defined outline). For example, a radiation-sensitive, in particular UV-sensitive, substance can be applied to the skin of the patient with the skin change, onto which the output device applies the cutting lines in the manner of a radiation-based marking.This radiation-sensitive substance can, for example, change color due to the introduction of radiation, in particular UV radiation, so that, especially in the case of a transparent substance, the cutting lines become visible in color. Alternatively or additionally, a loose substance applied to the skin, for example a powder, can be solidified by the introduction of radiation, so that the solidified area indicates the cutting lines (in the manner of sintering). The dispensing device can have a controllable laser that projects the cutting lines. A type of radiation-sensitive film, in particular a semi-transparent or transparent film, can also be provided, which can be applied to the skin area, wherein the dispensing device is adapted so that the wavelengths of the projected rays correspond to the sensitive wavelength of the radiation-sensitive film.In other words, similar to a photo negative of a photographic film, the specific cutting lines can be temporarily or permanently introduced into the radiation-sensitive film by the output device, in particular by the projector. In this specific form, the system therefore comprises, in addition to the detection device, the determination device, and the output device, the radiation-sensitive film (which can be applied to the skin, in particular, placed on it and fixed) adapted to the output device.
[0020] The output device can have a display and the output device can be adapted to display an overlay of the captured optical digital image of the patient's skin with the skin change and the incision lines determined for this purpose on the display, wherein the display can be an augmented reality (AR) display. In particular, a user interface can also be displayed on the display or the display is adapted to display such a user interface. The display can be a touch display. Such a display can, for example, be a computer display / screen or a display of a handheld device such as a smartphone. In particular, a smartphone can also display an overlay of the patient's skin with the skin change and the determined incision lines on its display by means of a camera, in particular a 3D camera, and augmented reality.
[0021] The output device can comprise a printer, in particular a 3D printer, wherein the output device is adapted to print, by means of the printer, a film with the predefined cutting lines or a customized template of the predefined cutting lines, which can be placed on the detected area of the skin with the skin change and, in particular, can be fixed to the skin area. Because the output device comprises the printer, a graphic representation of the cutting lines can be printed, in particular, on a transparent or semi-transparent adhesive film, preferably with a position and / or orientation marking.
[0022] These films can be applied, in particular, to a correspondingly complementary position and / or location marking on the patient's skin, so that the incision lines lie directly on and aligned with the skin lesion relative to it. In the case of a 3D printer, a customized template can be printed, for example, using rapid prototyping (as additive manufacturing from the 3D printer), which can then be applied to the site of the skin lesion.
[0023] The output device can have a controllable laser, and the output device can be adapted to control the laser such that it cuts a template with the specific cutting lines from a raw object, such as a plastic plate. This embodiment can also be designed to be particularly compact and, in particular, portable. Thus, the system can, in particular, produce a flat or curved plastic plate adapted to a body section as a raw object on-site and quickly, which the medical personnel can subsequently use for a consultation or surgical procedure. Alternatively, a colored, in particular sterile, sheet or an opaque, in particular sterile, film can also be cut out using the laser in such a way that a defined opening remains, representing the defined cutting lines.In other words, a central area of the sheet or film is cut out, which can then be applied to the area of skin with the skin change in the manner of a sterile surgical drape.
[0024] According to the present invention, the system further comprises a predefined set of prefabricated, preferably disinfectable, uniquely numbered templates, wherein: the determination device is further adapted to determine, from the set of numbered templates, the template to be used which has the smallest deviations from the specific, predetermined cutting lines, and the output device is adapted to display the unique number of the template to be used by means of an indicator, in particular by means of a display. This provides a particularly robust and simple system. The predefined set of templates can be kept in doctor's offices, for example, and the system determines from this predefined set a small number of the most suitable or a single, i.e., the most suitable, template for a surgical procedure.
[0025] In particular, the prefabricated, uniquely numbered templates can be placed on the detected area of the skin with the skin lesion and, in particular, can be fixed to the skin area. In particular, the templates can have an adhesive surface, for example an adhesive surface, so that when placed on the patient's skin, they remain firmly fixed in place. Alternatively or additionally, the templates can have a form-fitting fastening device, for example in the form of an elastic rubber band, to fix the templates to the patient's skin.
[0026] According to one embodiment, the system may further comprise an input device, in particular in the form of a keyboard, a graphical pointing device such as a mouse, a touchscreen, and / or a gesture controller, which is adapted to capture further medical parameters of the patient and forward these parameters to the determination device, wherein the determination device takes these parameters into account when determining the incision lines. The input device enables active intervention by the medical personnel. For example, the physician may enter the patient's age, gender, skin type, or pre-existing condition, which will be taken into account accordingly by the system, for example, by selecting a larger safety distance for an older patient.
[0027] Preferably, a particularly portable client, such as a handheld device, can comprise the capture device and / or the output device, and a central server can comprise the determination device. The capture device, the output device, and the determination device are connected to one another via a network for data communication in order to exchange digital data. In particular, they are connected to one another via a wired network, WLAN, and / or Bluetooth network. Further preferably, the server and client are connected to one another via the internet as at least a portion of the network.
[0028] According to one embodiment, the determination device for determining the incision lines can be adapted to apply predefined rules to determine incision lines for removing the skin lesion based on the area of the skin with the skin lesion detected by the detection device. These rules can, in particular, be stored as standard rules and / or entered by the medical personnel.
[0029] For example, a predefined rule can be to detect a width and a perpendicular length of the skin lesion and to provide a fusiform ellipse having a width and height multiplied by a factor S, preferably with a value of the factor S between 1.2 and 2.5, particularly preferably S=1.5. For a predefined width, a length of the fusiform ellipse is preferably selected such that the apical angle of the fusiform ellipse is less than 30°. In particular, a memory of the determination device is adapted to store the predefined rules.
[0030] If a suture or incision line is planned over a convex body part, such as on the extremities, even with optimal elliptical excision planning, the suture ends may become warped. In one embodiment, the determination device can therefore also include, among the predefined rules, the rule that for convex body parts, the determined incision lines have a curved and / or S-shaped incision line (lazy S). The system can thus avoid this problem by additionally planning a curved or S-shaped configuration (lazy S) for the skin suture.
[0031] According to a further aspect of the invention, the stored predefined rules can include a rule that bases the incision lines on a V-shaped excision for a skin lesion detected by the detection device with a substantially triangular outer contour of the skin lesion. This further rule can therefore deviate from the spindle shape for approximately triangular areas with the goal of preserving healthy tissue at the base and preventing the incision from appearing too long. A V-shaped excision is therefore suitable for this purpose, which, after lateral wound edge mobilization, is to be closed in the shape of a Y, which is commonly referred to by those skilled in the art as a VY-plasty.
[0032] According to a further aspect of the invention, the stored predetermined rules can comprise a rule which, in the case of a skin change in the facial area detected by the detection device, uses a complex sliding flap for the incision lines to be determined, in particular a T-plasty and / or U-plasty and / or a rotation plasty and / or a sliding pivot flap and / or a wedge excision and / or a distant flap as the contour of the incision lines.
[0033] In particular, the medical staff can enter via the input unit that the area in question is the face, or the determination device can be adapted to automatically recognize a facial area based on the captured image (face recognition). In the facial area, in addition to the spindle shape, a more complex advanced flap surgery may be necessary to maintain the aesthetic units (T- or U-shaped flap, rotation flaps, advanced flaps, wedge excisions, distant flaps or even the decision for open, i.e. secondary wound healing). This can be performed depending on the anatomy and size of the defect (skin change) and, to date, on the experience of the surgeon. Here, the system can provide individual support in the decision-making process by planning the optimal excision type and simulating various conceivable scar patterns.
[0034] According to a further aspect of the invention, the stored predefined rules can include a rule that automatically uses a so-called double WY shape as the incision pattern for a skin change in the neck and throat area detected by the detection device. Furthermore, other incision shapes are also suitable, particularly in the neck and throat area, such as the double WY plasty, where the tumor is excised with a double, W-shaped incision and a Y-shaped wound closure occurs. Overall, the system is able, thanks to the predefined and stored rules, to appropriately consider all incision shapes known in the prior art and general specialist knowledge and to provide support for such incisions. Further rules can also be added to the predefined, stored rules, so that the system according to the invention can be expanded in line with new research results.
[0035] Preferably, the determination device can have a storage unit in which a predefined database in the form of a table of predefined images of skin changes and respectively associated cutting lines is stored, wherein the determination device compares the captured image of the patient's skin with the skin change with the predefined images and determines the predefined image with the smallest differences to the captured image, whereby, by assigning the cutting line to the predefined image, the determination device determines the associated cutting lines.
[0036] In other words, a database with at least two columns or a two-dimensional field / array, each containing a graphic image and a cutting line associated with the graphic image, can be stored in the storage unit. The determination device is particularly adapted to compare the detected area of skin with the graphic / graphically stored image in individual comparisons and to determine any deviation according to predefined rules.
[0037] These predefined rules can, for example, include a mathematical deviation from the outline (shape of the outline / contour) of the skin change in the graphic image to the outline of the detected skin change. Likewise, the predefined rules stored in the determination device can be such that a length-width ratio and / or an apical angle between the graphic image and the detected area of the patient's skin with the skin change is compared, and a length-width ratio and / or an apical angle with the smallest difference is determined. The at least two-dimensional field with the graphic image for which the smallest deviation was determined according to the predefined rules is selected by the determination device, and the intersection line assigned to the graphic image is determined as the predefined intersection line and forwarded to the output device for output.
[0038] According to a further aspect of the invention, the determination device can, depending on the size of the predefined database, carry out a weighting when taking into account the predefined rules stored in the determination device for determining the cutting lines or the predefined images when determining the cutting lines, in particular wherein, if the size of the predefined database is small, the predefined rules are given greater weight than the predefined images in the predefined database.
[0039] Preferably, the determination device may be adapted to perform a computer-implemented method for training a deep convolutional neural network to classify a first set of images of skin lesions with a second set of training images obtained by enlarging a first set of training images by rotating the first set of images and / or rotating the first set of images in color space to include skin color variations. Preferably, the determination device may be further adapted to apply a weighting with respect to a length-to-width ratio of the skin lesion and / or an apical angle in the deep convolutional network in the training method.
[0040] Preferably, the system may be designed and adapted to perform the steps: Sending digital data of an optical image (capture) of the detection device of an area of a patient's skin with a skin change to the determination device; preferably sending and / or transferring patient data to or through the determination device or loading patient data, in particular through a practice information system, an image processing system (PACS) or the software of a dermatoscope, which are stored in the memory unit of the determination device.is; selecting an excision technique from a plurality of excision techniques stored in the determination device or by requesting manual input from a medical professional; selecting an incision shape with surgical incision lines from a plurality of stored incision shapes (such as a spiral incision shape, elliptical incision shape, circular incision shape, W-incision shape) by the determination device; dimensioning of the incision shape to the skin change of the patient's skin surface by the determination device; preferably dimensioning of the incision shape by the determination device; preferably simulation of the reconstruction and / or the healing process by the determination device; requesting input to approve the surgical planning (the confirmation of the selection of the incision shape); .
[0041] Furthermore, the system is designed and adapted to perform the following step: Output to the output device as a selection aid for a suitable template from a set of pre-made templates.
[0042] In other words, a system is provided that enables the planning and simulation of an excision (incision lines) and transfers the simulation result (incision lines and, if applicable, other surgical information) to the patient's skin, or at least outputs it superimposed. Various output options are available. The simulation result (incision lines) is preferably output and displayed by the determination unit by selecting the appropriate template from a set of various templates and outputting the simulation result (incision lines) accordingly via an output device. In addition, output can also be provided using a computer-aided drawing aid (particularly augmented reality).In other words, a system is provided which makes it possible to individually plan, simulate and optimise a dermatological excision on the basis of an image, using a computer-aided or computer-assisted method, and to transfer this "planning" to the skin and the subsequent surgical field of the patient by means of the device or the method.
[0043] In addition, the invention relates to a method for generating and displaying predetermined incision lines on the skin surface of a patient for performing a surgical procedure, comprising the steps of: sending digital data of an optical image of an area of a patient's skin with a skin change to a determination device; determining / assigning incision lines, in particular a cutting pattern, to the optical image by the determination device;and outputting the determined cutting lines, in particular a specific cutting pattern, by an output device, characterized in that the step of determining / assigning cutting lines comprises determining a template to be used from a predefined set of prefabricated, uniquely numbered templates, wherein the template to be used has the smallest deviations from the specific predetermined cutting lines, and wherein the step of outputting specific cutting lines comprises displaying the unique number of the template to be used by means of a display. This method can provide medical professionals with a standardized and effective process for generating and outputting cutting lines.
[0044] The invention also relates to a computer program comprising instructions which, when the program is executed by a system according to the invention, cause the system to display incision lines for a surgical excision on the skin surface of a patient by carrying out the steps of the method according to the invention. Short description of the characters
[0045] The invention is explained in more detail below using preferred embodiments with the aid of figures. They show: Fig. 1 is a schematic side view of a system for generating and displaying cutting lines according to a first comparative example, in which the system is designed as a portable module. Fig. 2 is a schematic, perspective view of a system for generating and displaying cutting lines according to a second comparative example, in which the system has a client and a server. Fig. 3 is a schematic view of a template matrix of the determination unit, which adapts the selected cutting shape to a skin change and displays it accordingly using the output device. Fig. 4 is a partial view of a system according to a comparative example, in which the output device is adapted to draw cutting lines around a skin change using a marking pen. Fig. 5 is a flowchart of a workflow of a system of a further preferred embodiment.6 shows a schematic representation of a workflow of a system of a further preferred embodiment, in which the system provides a medical professional with an output form and has the cutting lines output accordingly by the output device, Figs. 7 and 8 show a schematic view of a user interface of a system according to a further embodiment, and .
[0046] The figures are schematic in nature and are intended only to aid understanding of the invention. Like elements are designated by the same reference numerals. The features of the various embodiments may be interchanged. Detailed description of preferred embodiments
[0047] Fig. 1shows a schematic view of a system 1 for generating and displaying incision lines 2 for performing a surgical procedure according to a first comparative example. The system 1 is adapted to display these predefined incision lines 2 on a skin surface of a patient P, in particular predefined incision lines 2 for a surgical excision. The term "display" is to be interpreted broadly and is not limited to a display, for example.
[0048] For digitally capturing, in this comparative example, optically capturing, an area of the patient's P skin surface with a skin lesion H, the system comprises an (electromagnetic) detection device 3 with a (digital) camera 6, which can capture images in the visible light range (as electromagnetic radiation). For example, the camera can comprise a conventional CMOS sensor with upstream optics, via which an image of the area of the patient's P skin surface with the skin lesion H is digitally captured.
[0049] The system 1 further comprises a determination device 4. The area of the skin with the skin change H detected by the detection device 3 or the captured image is then (digitally) forwarded to the determination device 4. In this embodiment, the determination device 4 has a storage unit 7 in the form of a conventional memory, for example a hard disk, an SSD, a RAM, or the like, and a computing unit 8 (ECU), for example in the form of a CPU and / or GPU. The determination device 4 is specifically adapted to determine (surgical) incision lines 2, preferably an incision pattern / incision shape with surgical incision lines 2, for removing the skin change H based on the image captured by the detection device 3.
[0050] In order to output the incision lines and display them accordingly, the system 1 further comprises an output device 5, which is adapted to output the incision lines 2 determined by the determination device 4 and to enable a display of the incision lines 2 on the skin surface. In this comparative example, the output device 5 comprises a projector 9 for this purpose. For example, the projector 9 can project the incision lines 2 onto the skin surface of the patient P around the skin alteration H using a transmitted-light projection of a digitally controllable display matrix. The output device 5 is adapted to optically project the incision lines 2 directly around the skin alteration H using the projector 9, so that the incision lines 2 are arranged relative to the skin alteration H exactly as the actual surgical incision is subsequently intended to run.By means of the detection device 3 with the camera 6, the position and location of the skin area of the patient P or of the skin change H is spatially detected and, in accordance with this position and location, the incision lines 2 are projected around the skin change H. To calculate the adjusted position and location, the output device in this comparative example uses the computing unit 8 of the determination device 4. In other words, the area of the patient is detected three-dimensionally by the detection device 3 and the projector 9 is controlled in such a way that the incision lines are displayed (projected) in an adjusted manner relative to the skin change H.
[0051] The detection device 3, the determination device 4, and the output device 5 are all arranged on a stand base 10, so that this system 1 is designed as a portable system or module and can be used as a self-contained unit. This makes it particularly easy to initially position and reposition in doctor's offices or clinics.
[0052] A touch display 11 is arranged on the back or top of the stand base 10, via which a medical professional can enter information such as patient data, as well as display patient data or, alternatively or in addition to the projection, an overlay of the captured image and specific cutting lines 2. The touch display 11 thus handles both the input and output of information.
[0053] On the underside, the stand base 10 has a base 12, which holds the system 1 stable on a surface, for example, a table top. A power unit 13, in particular in the form of a rechargeable battery such as a Li-ion battery, and a communication unit 14 with an antenna (not shown) are integrated into the base 12. The power unit 13 enables the system 1 to be used temporarily in a self-sufficient mobile manner without power. Using the communication unit 14, the system can also exchange data with a computer, such as a personal computer or a handheld device (e.g., a smartphone).
[0054] System 1 can therefore create, output, or display an optimal, personalized incision pattern with incision lines 2 for an excision using digital optical recording of the skin lesion H of the respective patient P. These incision lines 2 can then be confirmed by medical professionals, and a surgical procedure can be planned and simulated. This allows patient P to see the incision pattern with incision lines 2 directly on the affected skin surface, which is advantageous for preoperative consultation. Furthermore, system 1 can simulate reconstructions, suture techniques, and possible wound healing processes, and discuss them with the patient prior to potential surgical treatment.
[0055] The area, length, angle, and safety margin of the skin and tissue to be removed are measured by the system 1 and displayed on the touch display 11. A medical professional can then evaluate the selection of the cutting lines 2.
[0056] If the medical staff is not satisfied with the incision lines 2 specified or determined by the system 1, they can make an input via the touch display 11 on the user interface and, in particular, select a different excision technique and / or a different incision shape. Based on this, the determination device 4 provides the medical staff with another incision pattern with surgical incision lines 2 or a selection of several incision patterns with surgical incision lines 2. The medical staff can confirm the incision pattern or select the most suitable one from among the incision patterns, which is then used for the surgical procedure.In particular, if several cutting patterns with cutting lines 2 are selected on the touch display 11, this can be projected directly onto the skin surface so that the medical staff and also the patient can quickly and easily see the direct representation of the options.
[0057] Figure 2shows a system 1 of a further comparison example. In this comparison example, the system 1, in contrast to the first comparison example, is divided into a handheld 13, which has the capture device 3 and the output device 5 and acts as a client, and a separate server 14, which has the determination device 4. This makes it possible to establish a 1:n relationship between the central server 14 and the determination unit 4, on which in particular data relating to the assignment of images to cutting lines is stored, and a plurality of clients in the form of the handhelds 13, instead of a 1:1 relationship. In particular, if a computer-implemented method is used for training neural networks, the central server 14 can centrally collect the data and use it for training.
[0058] Server 14 and handheld 13 are connected to each other via a network, in this comparison example via a wireless network, in particular a WLAN network, which can be integrated via the Internet, and can both receive and send data.
[0059] Fig. 3shows a schematic diagram of a template matrix 15 stored in a system 1 of a preferred embodiment, which is stored in the memory unit 7 of the determination unit 4, which automatically selects a cutting shape adapted to a skin change based on the skin change or can be manually selected via touch display 11 and displayed by the output device 5. For example, based on a contour of the skin change in the captured image, the system automatically selects a length to width ratio (A, B or C; shape) and a size (1, 2 or 3) and forwards this automatic selection (here B-3) to the output device. Alternatively or additionally, the system can also request the medical personnel to select a combination (letter-number), which is then output accordingly by the output device. In this way, a user can see the various cutting lines orDisplay cutting shapes and, in particular, quickly change them manually.
[0060] Fig. 4 shows a partial perspective view of a system 1 of another comparative example. The system 1 comprises an output device 5 with a marking device 16 with a (marking) pen. The marking device 16 is adapted to be adjustable in the X, Y, and Z directions and, through appropriate control by the output device 5, to draw the incision lines 2 on the patient's skin surface. Fig. 4 an apical angle of less than 30° is also shown.
[0061] Fig. 5shows, in the form of a flowchart, a workflow of the system 1 according to another preferred embodiment. After starting the system 1, patient data and images of the corresponding skin region with skin change H, which was recorded by the recording device 2, are first loaded. Various incision shapes (for example, ellipse, WY-plasty and more) are available for selection, which can be manually selected and modified in size and shape by the determination device 4 of the system 1 itself or by a medical professional. Surgically relevant data (such as size, safety margin, etc.) are permanently displayed, in particular on a screen. After successful verification of the incision shape, the excision and reconstruction, i.e. the incision lines 2, can be simulated and explained and shown to the patient.With the planning result in the form of the cutting lines 2, a suitable template can then be selected from a set and the manual marking of the cutting planning of the cutting lines 2 on the skin can be supported by means of a mobile device (handheld 13) and with the help of augmented reality.
[0062] As soon as the planning has been completed and approved by the future surgeon, the system 1 can, in particular, make specifications for selecting a suitable template (from a set of pre-made templates). After startup, patient data and graphic recordings (captured images) of the corresponding skin region with the skin change are loaded. The system offers a variety of incision shapes (e.g. ellipse, WY, etc.) to choose from, which can be selected and changed in size and shape. Surgically relevant data (e.g. size, safety margin, etc.) is permanently displayed.
[0063] Fig. 6 shows in the form of a flowchart the operation of a system 1 of another preferred embodiment. In Fig. 6the system boundaries of system 1 are also shown. An image of the affected skin region can be taken in advance using a digital dermatoscope, for example. The only thing that is crucial for system 1 is that a captured image, in particular a digital image, of the skin surface of the patient with the skin change is available. In this embodiment, the capture device is adapted to capture and process a provided (digital) image, which was taken, for example, by a doctor a few days ago, and to make corresponding specific incision lines 2 available via the output device 5, here, for example, in the form of a printed template. The actual surgery can then be carried out independently of system 1 and output device 5, in particular only using the provided, individual template.
[0064] Figs. 7 and 8schematically shows a user interface of a system 1 of another preferred embodiment, which is displayed via a display or touchscreen. After loading a specific patient and loading the acquired image or recording of the affected skin area, various excision techniques and incision shapes are displayed on the user interface, which can be selected and modified.
[0065] Fig. 8 schematically illustrates how, after selecting a specific excision technique and incision shape (such as an ellipse), the affected tissue (e.g., a nevus) is outlined and the incision area is measured. In particular, measurements or parameters such as total area and / or length and / or incision angle are permanently displayed, which can be read by medical personnel. List of reference symbols
[0066] 1 System for generating and displaying cutting lines 2 Cutting line 3 Detection device 4 Determination device 5 Output device 6 Camera 7 Storage unit 8 Computing unit 9 Projector 10 Stand base 11 Touch display 12 Stand base 13 Handheld 14 Server 15 Template matrix 16 Marking device P Patient H Skin change
Claims
1. System (1) for generating cutting lines (2) for performing a surgical intervention and displaying these predetermined cutting lines (2) on the skin surface of a patient (P), in particular predetermined cutting lines (2) for a surgical excision, comprising: an electromagnetic detection device (3) for digitally detecting, preferably optically detecting, an area of the skin surface of a patient (P) with a skin alteration (H), a determination device (4) adapted to determine cutting lines (2), preferably a cutting pattern / cutting shape with surgical cutting lines (2), for removing the skin alteration (H) on the basis of the area of the skin with the skin alteration (H) detected by the detection device (3), and an output device (5) adapted to output the cutting lines (2) determined by the determination device (4) and to enable visualisation of the cutting lines (2) on the skin surface, characterised in that the system (1) further comprises a predefined set of prefabricated, distinctly numbered templates, wherein: the determining device (4) is further adapted to identify from the set of numbered templates the template to be used having the least deviations from the determined predetermined cutting lines (2), and the output device is adapted to indicate, by means of a display, the unique number of the template to be used.
2. System (1) according to claim 1, characterised in that the prefabricated, distinctly numbered templates can be placed on the detected area of the skin with the skin alteration and, in particular, can be fixed to the area of the skin.
3. System (1) according to one of the preceding claims, characterised in that the system further comprises an input device (11), in particular in the form of a keyboard, which is adapted to record further medical parameters of the patient, to forward these parameters to the determination device (4), the determination device (4) taking these parameters into account when determining the cutting lines (2).
4. System (1) according to one of the preceding claims, characterised in that a portable client (13) comprises the detection device (3) and / or the output device (5), and a central server (14) comprises the determination device (4), wherein the detection device (3), the output device (5) and the determination device (4) are connected to one another via a network, in particular a LAN or WLAN network or via the internet, in order to exchange digital data.
5. System (1) according to one of the preceding claims, characterised in that the determination device (4) for determining the cutting lines (2) applies predetermined rules in order to determine cutting lines (2) for removing the skin alteration on the basis of the area of the skin with the skin alteration detected by the detection device (3).
6. System (1) according to one of the preceding claims, characterised in that the determination device (4) has a memory unit in which a predefined database is stored in the form of a table of predefined images of skin alterations and associated cutting lines (2), wherein the determination device (4) compares the captured image of the patient's skin showing the skin alteration with the predefined images and determines the predefined image with the smallest differences, whereby the determination device (4) determines the associated cutting lines (2).
7. System (1) according to claim 6, characterised in that the determination device (4), depending on the size of the predefined database, carries out a weighting when taking into account the predefined rules stored in the determination device (4) for determining the cutting lines (2) or the predefined images when determining the cutting lines (2), in particular the predefined rules being weighted more heavily than the predefined images in the predefined database if the predefined database is small.
8. Method for generating and displaying on a patient's skin surface predetermined cutting lines (2) for performing a surgical intervention, comprising the steps of: sending digital data of an optical image of an area of a patient's skin with a skin alteration to a determination device (4), determining / assigning cutting lines (2), in particular a cutting pattern, to the optical image by the determination device (4), and delivering defined cutting lines (2), in particular a defined cutting pattern, by an output device (5), characterised in that the step of determining / assigning cutting lines (2) comprises determining a template to be used from a predefined set of prefabricated, distinctly numbered templates, wherein the template to be used has the smallest deviations from the assigned predetermined cutting lines (2), and wherein the step of delivering defined cutting lines (2) comprises displaying the unique number of the template to be used by means of a display.
9. Computer program comprising instructions which, when the program is executed by a system as defined in any one of claims 1 to 7, cause it to display cutting lines (2) for a surgical excision on the skin surface of a patient (P) by executing the steps as defined in claim 8.