DE102023128996A1 - Method for determining destructive tearing of eye tissue based on a point migration model, computer program, ophthalmic analysis device and ophthalmic surgical system - Google Patents

Abstract

One aspect of the invention relates to a method, in particular a computer-implemented method, for determining a destructive tear of a real tissue of a real eye (2), comprising the following steps:
a) providing at least one piece of information characterising the real tissue of the eye (2) and/or the living being having the eye (2) to an evaluation unit (26);
b) generating a patient-adapted digital tissue model for the real tissue by parameterizing a predetermined and provided digital tissue base model depending on the information from step a) with a model adaptation unit (26a);
c) to determine a destructive tear of real tissue of a real eye (2), modeling at least one tear line section (38, 45) of a tear line (34) of the tissue, which occurs when a surgical instrument (32) is applied to the eye (2) in a manner that constitutes a destructive tear, depending on a movement model with which at least this movement of the tear line section (38, 45) and/or a movement of the instrument (32) is modeled as a point migration. The invention also relates to an analysis device (24), a computer program, and a system (1).

Description

Technical field

One aspect of the invention relates to a method for simulating the determination of destructive tearing of real tissue of a real eye. Another aspect of the invention relates to a computer program. Furthermore, one aspect of the invention relates to an ophthalmic analysis device. Furthermore, one aspect of the invention relates to an ophthalmic surgical system.

State of the art

During ophthalmic surgical procedures, such as the removal of a natural lens from the eye and its replacement with an implanted intraocular lens, the natural lens is removed from the capsular bag. This requires opening the capsular bag. It is common practice in this context to create an opening in the anterior wall of the capsular bag to remove the natural lens.

It is known to open the capsular bag at its anterior capsular bag wall, for example by exposure to laser radiation, thereby creating a hole in this anterior capsular bag wall.

In contrast to such procedures, mechanical tearing tools such as needles or forceps are known. These tools are inserted into the anterior chamber of the eye through an incision in the cornea previously created with a surgical knife. These mechanical tearing tools tear the anterior capsular bag wall open by directly impacting it. This creates a corresponding opening in the anterior capsular bag wall, allowing the natural lens to be removed from the capsular bag. Removal of the natural lens can be performed, for example, using phacoemulsification.

These mechanical cracking tools are more widely used than non-mechanical cracking tools, such as lasers, particularly for cost reasons.

However, even with these mechanical tearing tools, inaccuracies in the formation of tears are possible. This can result from the surgeon's handling of the mechanical tearing tool, which creates an inaccurate rhexis on the anterior capsular bag wall, particularly with regard to the tear geometry and the tear position relative to the capsular bag. This can result in inaccurate and undesirable directions of the rhexis and/or undesirably large or undesirably narrow shapes of the openings on the anterior capsular bag wall. If such disadvantages occur and rhexis sections result that extend to the peripheral edge of the anterior capsular bag wall, a disadvantage can arise in that the intraocular lens to be implanted subsequently can no longer be held securely and reliably, i.e. in particular not symmetrically and centered, in the capsular bag. In isolated cases (typically ~1%), it can even happen that the anterior capsular bag tears, particularly due to mechanical influences, to such an extent that an intraocular lens can no longer be secured there, resulting in additional surgical effort and a higher risk of further complications. Above all, these alternatives generally result in a less than optimal refractive outcome for the patient. Although these disadvantages occur with mechanical tearing tools, these tools are widely used in medical procedures due to their low cost and relatively rapid creation of an opening in the anterior capsular bag wall. In particular, a mechanical tearing tool allows for better integration into the surgical workflow compared to a laser, making the overall procedure faster.

Today's surgical procedures are typically performed manually by medical personnel. However, telemanipulated robots are also already known to be used in surgery. The degree of automation in surgical procedures is also increasing, and the support provided by such telemanipulated robots is also increasing.

In general, the properties of the tissue to be treated vary from patient to patient. Therefore, it is a significant advantage today for surgical staff to have a high level of expertise in order to select the right procedure and to perform the surgical intervention in a way that corresponds to the properties of the tissue to be operated on. This also applies to telemanipulated robot-assisted procedures, in which surgical staff guide the robot through the various steps of the procedure. In this context, automated surgery is highly dependent on a thorough understanding of the properties and behavior of the tissue, especially in the eye. This is so that it is possible to distinguish between intentional and unintentional changes to the tissue during the automatically performed operation and its planning.

From the US 2023 / 015 7872 A1 is a microsurgical robotic system for ophthalmology.

Description of the invention

It is an object of the present invention to provide a method, a computer program, an ophthalmic analysis device and an ophthalmic surgical system in which the understanding of an individual real tissue is increased and the repeatability of a surgical procedure for different tissues is thereby improved and more individually adapted.

This task is solved by a method, a computer program, an ophthalmic analysis device and an ophthalmic surgical system.

1. a) Insbesondere Bereitstellen zumindest einer Information, die das reale Gewebe des Auges und/oder das Lebewesen, welches das Auge aufweist, charakterisiert, insbesondere an eine Auswerteeinheit;
2. b) Insbesondere Erzeugen eines patientenangepassten digitalen Gewebemodells für das reale Gewebe durch Parametrieren eines vorgegebenen und bereitgestellten, digitalen Gewebebasismodells abhängig von den Informationen aus Schritt a), insbesondere mit einer Modellanpassungseinheit;
3. c) Insbesondere zum Bestimmen eines zerstörenden Reißens eines realen Gewebes eines realen Auges Modellieren zumindest eines Risslinienabschnitts eines Risses des Gewebes, der bei einem als zerstörendes Reißen erfolgendes Einwirken auf das Auge mit einem chirurgischen Instrument auftritt, abhängig von einem Bewegungsmodell, mit welchem zumindest diese Bewegung des Risslinienabschnitts als Punktwanderung modelliert wird und/oder eine Bewegung des Instruments als Punktwanderung modelliert wird, insbesondere mit der Auswerteeinheit.

One aspect of the invention relates to a method, in particular a computer-implemented method, for simulatively determining a destructive tear of a real tissue of a real eye, preferably comprising the following steps:

1. a) In particular, providing at least one piece of information characterising the real tissue of the eye and/or the living being having the eye, in particular to an evaluation unit;
2. b) In particular, generating a patient-adapted digital tissue model for the real tissue by parameterizing a predetermined and provided digital tissue base model depending on the information from step a), in particular with a model adaptation unit;
3. c) In particular for determining a destructive tearing of a real tissue of a real eye, modeling at least one tear line section of a tear in the tissue which occurs when the eye is affected as a destructive tearing with a surgical instrument, depending on a movement model with which at least this movement of the tear line section is modeled as point migration and/or a movement of the instrument is modeled as point migration, in particular with the evaluation unit.

Such a method now makes it possible to provide real information about an eye to be treated, in particular, to an electronic analysis system with at least one evaluation unit. A particularly advantageous feature of the method is that this analysis system can, based on the information provided concerning the eye to be treated, also simulate, for example, an intentional and necessary destructive tearing of a tissue, for example an anterior wall of a capsular bag. Destructive tearing means, in particular, that the tissue is not torn from an edge, which is easier to control. It means, in particular, that the tearing begins at a starting point remote from an edge of the tissue. In the case of a capsular bag wall, which is an example of a tissue, the edge can be the area where the capsular bag is connected to the zonular fibers. The tearing therefore preferably begins at a hole or opening created in the tissue. The hole can be an elongated line created, for example, by cutting, i.e., severing, the tissue. In particular, the tearing begins at one end, especially a radially outer end, of this linear dividing line in the tissue. During cutting, the tissue is separated using a cutting tool, so that the tool always starts where the tissue has not yet been separated. The further cutting separation therefore always occurs directly where the tool acts directly on the tissue. This is different with tearing. During tearing, the tissue is grasped at a gripping point with a tool or instrument and then the tissue is torn open. Since the gripping point does not change during a tearing process, the gripping point moves further and further away from the front tear point, where the transition between the tear line and the tissue that has not yet been torn open is located. This is precisely what makes it difficult to tear the tear line precisely. This is precisely why the method proposed above is particularly advantageous. This procedure is intended especially for tearing open the capsular bag, in particular an anterior wall of the capsular bag.

Modeling based on point migration enables a simpler yet accurate approach to simulate and predict a crack line section and/or instrument movement.

Point migration specifically means that a line segment is determined based on at least two specific points whose positions in the tissue are known and/or estimated or predicted. In particular, a line model, for example, as a linear or non-linear line, is created between the two points, preferably as the starting point and the end point.

Preferably, the tissue model is created as only a two-dimensional surface, especially as a plane.

In particular, at least the motion model is preferably used for real-time path planning of the tear line in a robotic context. In particular, at least the motion model is capable of predicting the next movements, for example, of a cystotome attached to a robot in order to create a desired tear line in the capsular bag, in particular an anterior wall of the capsular bag. In a real-time application, a tear line can be created interactively with robotic instrument guidance and path planning.

In particular, based on a current state (e.g., current position of the instrument used for tearing, position of the tear, etc.) and a desired position of the instrument or a desired position and a course of the tear line based, for example, on relationships observed in experiments, an emerging crack position, in particular a crack line (forward model) or a necessary instrument position (backward model) is calculated to generate the desired input. The finer the step size selected, the more precise the result of the trajectory generated, for example, along which the instrument, in particular the tip of the instrument that directly contacts the tissue, is to be moved.

The unique feature of this method is its simple parameterization – instead of requiring numerous physical variables such as Young's modulus, the entire model can be adapted to different tissue behaviors using just two (or four) parameters. Since capturing all beneficial tissue properties is very difficult, this model allows for easy adaptation to the patient's actual tissue.

In particular, the tissue to be modeled is only two-dimensional. This allows for a precise prediction of how the tissue will behave with a reasonable level of effort, especially computational effort. In particular, dynamic processes can be simulated quickly and accurately.

In particular, the model is adapted as an eye-specific digital tissue model using the model adaptation unit. This means, in particular, that the basic tissue model is not used across the board for different eyes, but that this basic tissue model is first created and adapted as precisely as possible to the eye to be observed and analyzed, i.e. the entire eye or a specific part of it that is relevant for the procedure. This tissue model can therefore also be adapted during the analysis itself, in particular again. This tissue model can therefore also be adapted during a surgical procedure using the model adaptation unit. For example, the differentiation of the location of a specific tissue, due to variations in tissue thickness or previous damage, for example, can be taken into account in the analysis if this is advantageous for the procedure.

Such an eye-specific digital tissue model can therefore vary from eye to eye, particularly with regard to the number and/or type of parameters that describe the tissue model.

The tissue can be a single tissue or a tissue system composed of several, particularly different, tissues of the eye. In particular, it is a capsular bag of an eye.

The tearing can be intentional and necessary for the surgical procedure. But it can also be unintentional and avoidable.

It is also possible for the evaluation unit to provide the specific tear line section and/or the specific movement of the instrument as output information. It is also possible for the evaluation unit to generate control signals based on the simulated information, with which at least one surgical instrument and/or a display unit can be controlled, particularly during a surgical procedure on this real eye.

In particular, it is also possible that the at least one specific potential tear line is provided as auxiliary information during a surgical procedure on the eye, in particular to a surgical system.

• c1) Bereitstellen von, insbesondere zumindest aktuellen, Instrumenteninformationen, die zumindest einen Punkt, insbesondere auch eine Position des Punkts, eines realen chirurgischen Instruments während eines chirurgischen Eingriffs am Auge charakterisieren, mit welchem zum Reißen auf das Gewebe eingewirkt wird, an die Auswerteeinheit;
• c2) Bereitstellen von, insbesondere zumindest aktuellen, Rissinformationen, die zumindest einen Punkt, insbesondere auch eine Position des Punkts, eines vorliegenden, realen Risslinienabschnitts, der während des chirurgischen Eingriffs am Auge am Gewebe durch das Einwirken mit dem chirurgischen Instrument aufgetreten ist, charakterisieren, an die Auswerteeinheit;
• c3) Modellieren einer Bewegung zumindest eines durch die Instrumenteninformation in Schritt c1) charakterisierten Punkts des Instruments an einen potenzielle zukünftigen Punkt, insbesondere auch eine Position des Punkts, in dem Gewebemodell auf Basis eines bereitgestellten Bewegungsmodells, mit welchem zumindest diese Bewegung als Punktwanderung mit der Auswerteeinheit modelliert wird;
• c4) Bestimmen eines modellierten weiteren Risslinienabschnitts in dem Gewebe, der auf den vorliegenden realen Risslinienabschnitt folgt, zumindest abhängig von den modellierten Informationen in Schritt c3) mit der Auswerteeinheit.

In one embodiment, the following steps are carried out for step c):

• c1) providing, in particular at least current, instrument information characterising at least one point, in particular also a position of the point, of a real surgical instrument during a surgical procedure on the eye, with which the tissue is acted upon in order to tear, to the evaluation unit;
• c2) providing, in particular at least current, tear information to the evaluation unit, which characterises at least one point, in particular also a position of the point, of an existing, real tear line section which has occurred on the tissue during the surgical procedure on the eye as a result of the action of the surgical instrument;
• c3) modeling a movement of at least one point of the instrument characterized by the instrument information in step c1) to a potential future point, in particular also a position of the point, in the tissue model on the basis of a provided movement model with which at least this movement is modeled as a point migration with the evaluation unit;
• c4) Determining a modeled further tear line section in the fabric following the existing real tear line section, at least depending on the modeled information in step c3) with the evaluation unit.

• c1') Bereitstellen von Risslinieninformationen, die zumindest einen zukünftig gewünschten, aktuell noch nicht erfolgten Risslinienabschnitt der Risslinie charakterisieren, insbesondere an die Auswerteeinheit;
• c2') Modellieren einer Bewegung einer Position des Instruments an einen potenzielle zukünftigen Punkt, insbesondere auch eine Position des Punkts, in dem Gewebemodell auf Basis eines bereitgestellten Bewegungsmodells, mit welchem zumindest diese Bewegung als Punktwanderung modelliert wird, wobei die Bewegung so modelliert wird, dass zumindest der in Schritt c1') gewünschte Risslinienabschnitt erzeugt wird, insbesondere mit der Auswerteeinheit.

In addition to or instead of steps c1 to c4), it is possible that the following steps are carried out for step c):

• c1') Providing crack line information characterising at least one crack line section of the crack line that is desired in the future and has not yet been created, in particular to the evaluation unit;
• c2') Modeling a movement of a position of the instrument to a potential future point, in particular also a position of the point, in the tissue model on the basis of a provided movement model with which at least this movement is modeled as a point migration, wherein the movement is modeled in such a way that at least the crack line section desired in step c1') is generated, in particular with the evaluation unit.

Point migration offers advantages for these processes in particular, allowing for accurate yet rapid information acquisition. This is particularly advantageous for real-time requirements. Therefore, this method can deliver the required information on demand and very quickly, even during eye surgery.

When considering the point hike, preferably more than five points, especially more than ten points, especially more than twenty points, are considered. In particular, fewer than one hundred points are considered.

It is possible for the point migration to occur as a linearized point migration. This model models a distance between two points as a linear segment. This allows for a simple procedure for determining the distance between the points. This is particularly advantageous when the points are very close to each other. Despite the linearization, it still allows for a very precise statement about at least one simulated crack line segment and/or at least one simulated instrument movement.

However, it is also possible for the point migration to occur as a non-linearized point migration. This means that the distances between two neighboring points can also be non-linear, for example, curved.

In one embodiment, in step c3), an at least two-dimensional direction vector is modeled for a movement characterized as a point migration of at least one point characterized by the tear information in step c2) to the potential future point of the surgical instrument in the tissue model. Depending on the direction vector and/or previously performed tear movements, the further tear line section is modeled in step c4).

This allows the course of a crack line section and/or an instrument trajectory to be determined, in particular predicted, based on simple existing point information and/or potential future point information. Point information can be point positions. Point information can also be the type of point, whether it relates to the crack or the instrument.

If, for example, a new point position of the instrument, in particular in the eye area, is provided to the method, in one embodiment a straight-line movement from the old previous point to the new point can be assumed and this can be used as a basis for modeling.

In one embodiment, the direction between a point characterizing a previous leading end of a crack as the leading crack position and a point characterizing a new position of the instrument can be determined by simulation. A characterizing direction vector is preferably generated. Such a direction vector is advantageous for performing further determination steps more precisely.

Preferably, this direction vector can be scaled. It is possible that the sca lation is carried out in such a way that the direction vector has half the length measured between a point that characterizes a previous position of the instrument and a point that characterizes a new position of the instrument. In particular, these analyses are also carried out in two dimensions. This also means that the tissue is modeled in a plane, so that the points resulting in this plane are also viewed in two dimensions. This results in precise but simpler modeling. Such specific scaling ensures that for each section of movement of the instrument the tear or the tear line is only adjusted by half of this section. In particular, this occurs due to the folding over of an already torn tissue flap, in particular a wall flap of the anterior wall of the capsular bag.

In one embodiment, the direction vector is decomposed using the motion model into a first vector component and a second vector component. The first vector component describes a shear component of a shear force acting on the tissue that occurs when the instrument impacts the tissue. The second vector component describes a tear component of a tear force acting on the tissue that occurs when the instrument impacts the tissue. The tear force is or characterizes, in particular, the tensile stress. In particular, these vector components are determined using the adapted tissue model. Preferably, the vector components are perpendicular to one another. In particular, the first vector component is oriented in the direction of the previously observed crack line direction. In particular, a movement average is formed from several, in particular three, previous directions of previous sections of the crack lines. The decomposition thus occurs in the direction of the previously observed crack movement direction. This can either be the last crack direction directly or a weighted average window of the last three directions. The second vector component is preferably formed orthogonally to this averaged direction of the orientations of the crack line sections.

The number of directions considered may depend, for example, on their availability. If, for example, there are not enough observations available during the simulation and therefore not enough information is provided to the evaluation unit, fewer directions will be considered.

Averaging the directions also counteracts fast and/or angular crack line sections, thus reducing inaccurate predictions. Since human tissue, especially in the eye, exhibits a certain degree of elasticity, hard edges rarely develop in cracks. If a sharp change in direction is performed in the instrument, the crack in the eye reacts with only a slight delay and significantly more smoothly than the sharp change in direction of the instrument. This is taken into account by the averaged window.

The window size can be adjusted to the simulation resolution. This means that if more, but smaller, movements are simulated, a larger window may be required to achieve the same effect as with fewer steps and a smaller window size. The window size refers to the observation intervals and/or observation time windows.

• - Insbesondere Bereitstellen eines Schwellwerts für einen mechanischen Widerstand des realen Gewebes und eines Schwellwerts für eine Zugfestigkeit des realen Gewebes, insbesondere an die Auswerteeinheit;
• - Insbesondere Vergleichen der Werte der Vektorkomponenten mit den Schwellwerten, insbesondere mit der Auswerteeinheit.

In one embodiment, the following steps are carried out:

• - In particular, providing a threshold value for a mechanical resistance of the real tissue and a threshold value for a tensile strength of the real tissue, in particular to the evaluation unit;
• - In particular, comparing the values of the vector components with the threshold values, in particular with the evaluation unit.

• - Insbesondere Bestimmen einer Rissrichtung und/oder einer Risskraft durch Summation der beiden Vektorkomponenten, insbesondere mit der Auswerteeinheit;
• - Insbesondere Reduktion der entstehenden Risskraft, insbesondere Abziehen einer konstanten Kraft, die der Geweberesistenz und Zugkraft des realen Auges entspricht, insbesondere mit der Auswerteeinheit.

In particular, the tear line is preferably propagated further only if the vector components, i.e., the forces they model, exceed the threshold. The thresholds for a phantom eye, which is a model, are preferably set to zero. This means that a tear is simulated with each step. In one embodiment, these thresholds can also be individually adapted to the patient's specific tissue properties.

• - In particular, determining a crack direction and/or a crack force by summing the two vector components, in particular with the evaluation unit;
• - In particular, reduction of the resulting tear force, in particular subtraction of a constant force that corresponds to the tissue resistance and tensile force of the real eye, in particular with the evaluation unit.

The tensile force is directional. This means it acts more strongly in certain directions, for example, radially outward than orthogonally. Therefore, if a tear is made toward the center of the eye or from the center of the eye outward, tissue resistance must be overcome or additional forces are applied.

In one embodiment, this force can be set to zero for the modeled phantom eye. This means that the previously determined direction from the two vector components is no longer changed.

These thresholds are calculated for human tissue. They can be adjusted, particularly during a training phase of the procedure.

• - Insbesondere Bestimmen einer modellierten zukünftigen Rissposition abhängig von dem Vergleichen, insbesondere mit der Auswerteeinheit;
• - Insbesondere Bestimmen des modellierten weiteren Risslinienabschnitts in dem Gewebe abhängig von dem Richtungsvektor und dieser modellierten zukünftigen Rissposition, insbesondere mit der Auswerteeinheit.

In one embodiment, the fabric resistance is modeled as a constant that is subtracted independently of the resulting crack direction.

• - In particular, determining a modeled future crack position depending on the comparison, in particular with the evaluation unit;
• - In particular, determining the modeled further crack line section in the fabric depending on the direction vector and this modeled future crack position, in particular with the evaluation unit.

In one embodiment, the vector components are scaled, in particular by the evaluation unit. Preferably, the values of the scaled vector components are then compared with the threshold values. In particular, the scaled vector components are then summed to determine the crack direction and/or crack force.

The scaling can be linear. The scaling can be determined experimentally for the modeled phantom eye. Here, too, it can be planned that these values are adjusted at the beginning of the procedure. They can, for example, be approximated to the actual tissue parameters for an average human and/or during the test tears in the eye center. A scaling factor for the first vector component can be between 0.8 and 1.0, in particular 1.0. A scaling factor for the second vector component can be between 0.10 and 0.20, in particular 0.15.

In one embodiment, the threshold values are determined using test functions and/or based on stored correlations in reference tissues. Thus, in one example, these threshold values are determined. It is also possible to determine the scaling factors of the vector components in addition to or instead of this.

In one embodiment, the relationships are determined based on recorded and evaluated real robot-assisted movements of a surgical instrument during tearing of the real tissue or a comparison tissue representing reference tissue, in particular, movements of the instrument and associated tear lines are determined as relationships. This also allows automated movements to be taken into account.

Correlations can also be determined between recorded and evaluated, real and predefined, particularly two-dimensional, reference movements of a surgical instrument during tearing of real tissue or a reference tissue representing reference tissue, in particular, movements of the instrument and associated tear lines can be determined as correlations. In particular, movements performed manually by a person with the instrument, particularly specific manual reference movements, can thus also be taken into account.

In one embodiment, a spiral movement of the instrument is used as the reference movement, and the associated crack line is recorded and assigned to this movement as a context. In one embodiment, a test circle with a radius smaller than a target circle of the instrument is used as the reference movement, and the associated crack line is recorded and assigned to this movement as a context. A curved line is also generally possible as the reference movement. For example, a segment of an arc or a segment of a circle that is not completely circumferential.

In one embodiment, the two-dimensionally determined further tear line section is projected onto a three-dimensional model shape of the fabric, so that a three-dimensional further tear line section is modeled.

The preferably two-dimensional determination of at least one crack line section, in particular of an entire crack line, can be projected three-dimensionally using cosine functions, for example. This is a simple method for obtaining three-dimensional information from the two-dimensional information available. All determinations during point migration can therefore initially be performed more easily in two dimensions. Each vector of the 2D model then corresponds to the cosine projection of the same vector on the 3D surface. The model implementation then only needs to be adjusted so that each vector is shorter by the corresponding cosine projection factor.

In one embodiment, in step a), real information about the eye tissue acquired during a surgical procedure is provided as characterizing information, and/or real information about the eye tissue acquired during a preliminary examination, in particular immediately before the surgical procedure, is provided as characterizing information. This can be determined, for example, using test functions and/or experiments at non-critical locations of the real tissue.

In one embodiment, for step a), for example, preoperatively determined information, which preferably also characterizes a real reaction of the real tissue of the eye, is also provided, and/or preferably intraoperatively determined information, which preferably also characterizes a real reaction of the real tissue of the eye, is also provided.

Furthermore, characteristic information can also be, for example, the type and/or severity of a tissue defect, in particular a defect that is to be at least improved by the surgical intervention. In particular, (bio)mechanical properties can also be taken into account. Furthermore, geometric information about at least partial elements of the real tissue can also be used as a basis. Partial elements in this context can be, for example, the cornea, the capsular bag, zonular fibers, the natural lens, the pupil, etc., or partial regions thereof. Geometric parameters can be, for example, a thickness, a diameter, a length, a distance, or the like.

In addition to or instead of this, organism-specific information about the organism to which the eye belongs and/or phenotypic information and/or geometric information about the eye can be provided to the evaluation unit as characterizing information, and/or biomechanical parameters and/or the mass and/or elasticity of the eye, in particular of the actual tissue of the eye, can be provided as characterizing information. This allows the degree of eye-specific generation of the tissue model and/or the individual level of detail of at least partial areas of the tissue to be modeled to be specified in a variety of ways.

In particular, as already explained above, it is possible for the information provided in step a) to be determined through test functions. These test functions are preferably carried out on the patient's individual tissue. Tissue properties include, in particular, mechanical and biomechanical properties. These include, for example, elasticity and strength, such as tensile strength, flexural strength, and torsional strength. However, tissue properties can also be thermal and thermomechanical properties. Biological and optical properties are also examples of tissue properties. Some of the properties can also be geometry-dependent and/or direction-dependent.

In addition, additional patient data such as age, gender, race, metabolism, metabolic factors such as diabetes or blood pressure, or known diseases, medications such as blood thinners or cortisone, and/or disorders can be used as provided information. These can then also be taken into account in the generation of the digital tissue response model and/or for the prediction of a potential response of the real tissue by the analysis system. Standard surgical instruments or special test instruments can be used to perform the test functions. In addition, sensor systems such as a surgical microscope or an intraoperative OCT (optical coherence tomography) system can be used to read the reactions of the tissue and/or the tool to the applied test functions. A sensor integrated into the tool can also be used.

Age, in particular, influences both the geometry or curvature of the capsular bag and its elasticity. Although the patient's age can be (easily) determined, variations due to various patient pathologies should also be taken into account. These variations can be measured, for example, by observing the spiral tear formation mentioned above, particularly from the center of the capsular bag.

An eye-specific generation of a tissue model means, in particular, that a blanket standard model of a tissue is not used as a basis, which is defined in a blanket manner by specific parameters, and only parameter values then enable a certain individualization of the tissue. Rather, in the context of the application, an eye-specific generation means, in particular, that the number of parameters that describe the tissue and are to be used as a basis for the generation of the tissue model are selected individually and depending on the situation, in particular by the analysis system itself. In addition to this, or instead of this, it can then also be provided that, in particular by the analysis system itself, the number and/or type of sub-elements of a tissue or tissue system that are to be used as a basis for the digital tissue model to be generated are individually selected. are to be selected. This allows for significantly greater flexibility with regard to the generation of a digital tissue model, at least with regard to the underlying parameters and/or the underlying sub-elements of a tissue. In another exemplary embodiment, it is also possible for functional links between the selected parameters and/or links between the selected sub-elements to be used as a basis for the eye-specific generation of a tissue model, in particular also by the analysis system itself. This means that the individual sub-elements of the tissue model to be generated and/or the parameters to be taken into account are also individually linked.

In one embodiment, this analysis system can also generate such an eye-specific tissue model, for example, based on artificial intelligence. In this context, this analysis system can also comprise a neural network. This also enables the analysis system to continuously train itself and improve accordingly. In particular, the complexity of generating such an eye-specific digital tissue model can also be improved on the basis of a neural network. This is because individual action-reaction sequences based on correspondingly selected parameters and/or selected sub-elements for the tissue model to be generated can then be further improved and adapted to the situation of the real tissue.

The individualization and needs-based creation of a digital tissue model that is as close to reality as possible is thereby improved or increased.

Another key aspect is that the analysis system also generates predictive information through simulated modeling. This means that a prediction result for a tear line in the tissue, in particular on the anterior wall of a capsular bag, is carried out using this evaluation unit, in particular the analysis system, based on the model. This prediction or prediction result then preferably represents an example of auxiliary information provided by the analysis system. This enables a very precise and individual model-based analysis of a specific tissue to be treated during a surgical procedure. This procedure and the prediction result as auxiliary information enable both medical professionals and an automated surgical system to perform this surgical procedure more accurately and safely (with lower complication rates).

In one embodiment, providing the result of the prediction as auxiliary information can involve displaying this auxiliary information on a display device, in particular of an ophthalmic surgical system. However, it is also possible for this provision to be made to a control unit of an ophthalmic surgical system in order for the control unit to control at least one surgical instrument based on this auxiliary information. This is particularly advantageous when the ophthalmic surgical system is a telemanipulated robot-assisted system or a semi- or fully autonomous robotic system. The control unit can be an evaluation unit or have such an evaluation unit.

When providing the information in step a), it is possible for these real reactions to be elicited or provoked through test functions. This can be performed, in particular, on a real eye prior to the surgical procedure. In another embodiment, it is also possible for such test functions to be performed additionally or instead during a surgical procedure, and then for real reactions of the real tissue to be provoked during the surgical procedure. These test functions can be performed either on the tissue that is being removed or on tissue that remains untouched.

This makes it possible for the auxiliary information to be generated in one embodiment before the surgical procedure, and in particular for it to be completed then. In another embodiment, it is possible for the auxiliary information to be generated in addition to or instead of during a surgical procedure. It is also possible for such test functions to be performed on dummy eyes or test eyes. These can also be provided as real, physical models. It is also possible for such a test function to be generated simulatively on a simulatively generated digital eye, and for a digital reaction to then occur.

It is therefore particularly advantageous to be able to predict how the actual tissue will react based on this auxiliary information. This allows the surgical procedure to be tailored much more individually. In particular, unwanted tissue reactions or the surprise of medical personnel or a surgical robot during the surgical procedure can be better avoided. By raising awareness among medical personnel and/or the ophthalmic surgical system through the information provided, they can anticipate and respond better to potentially anticipated tissue reactions, and the surgical procedure can be better adapted accordingly. This also improves the surgical outcome.

A tissue of an eye can be, for example, the cornea, the capsular bag, zonular fibers, the natural lens, the pupil, etc. In particular, it is an anterior wall of the capsular bag. A tissue can also be a membrane on the retina.

Tearing can be intentional and necessary for the surgical procedure. But it can also be unintentional and avoidable.

In one embodiment, additional auxiliary information that differs from the auxiliary information is generated by the evaluation unit. This allows the information base generated and provided by the analysis system to be expanded.

In one embodiment, a type of use of a surgical instrument to be performed for the ophthalmic surgical procedure, in particular a movement guide, is generated as additional auxiliary information. In addition or instead of this, a surgical instrument to be used for the ophthalmic surgical procedure can be selected or suggested as additional auxiliary information. In addition or instead of this, a type of implant intended for implantation in the eye can be generated as additional auxiliary information. Such an implant can be, for example, an intraocular lens. Thus, such first additional auxiliary information is in particular information that does not directly relate to information about the tissue or information or action for the surgical procedure that is dependent or derived therefrom, but rather represents information about which objects are advantageous for the surgical procedure.

In one embodiment, a location on the eye for positioning and/or inserting a surgical instrument and/or a sequence plan for performing an ophthalmic surgical procedure and/or a warning is generated as further, in particular second, additional auxiliary information. This is also additional advantageous information that is beneficial to medical personnel or even in an at least partially automated surgical procedure. This is because it also allows more needs-based surgical procedures to be performed for different eyes and thus different tissues and resulting tear lines, so that complications or adverse surgical outcomes can be significantly reduced. For example, a surgical robot system could perform a procedure based on the prediction, analyze the simulated tear line, and adapt the further procedure based on the additional auxiliary information generated from it.

In one embodiment, additional auxiliary information is generated by the evaluation unit depending on the auxiliary information. This results in a cascaded, automated generation of information useful for preparing for a surgical procedure and/or for performing a surgical procedure. Thus, the at least one evaluation unit can intelligently generate an information tree as needed. This allows the number and/or type of auxiliary information to be designed more flexibly and variable. Thus, here too, the generation of the type and/or quantity of helpful information can be tailored to the eye being treated.

In one embodiment, the auxiliary information can be output on an output unit. The output unit can be part of the ophthalmic surgical system. This means that the auxiliary information and/or the additional auxiliary information can also be presented to and perceived by medical personnel. An output unit can be a display. However, it is also possible for the output unit to be part of a surgical microscope. This means that the auxiliary information and/or the additional auxiliary information can also be displayed in the field of view of medical personnel when they are working with the surgical microscope. The output can also be provided as an acoustic signal, for example as a voice signal, or as a haptic signal in addition to or instead of an acoustic signal.

A further aspect of the invention relates to a computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method according to the above-mentioned aspect or an advantageous embodiment thereof. In this context, the computer can be a computing unit or evaluation unit. This can be a component of an ophthalmic surgical system. The computing unit can be designed separately from a control unit. However, it can also be a component of the control unit.

A further aspect of the invention relates to an ophthalmic analysis device. This device has at least one evaluation unit. It can also have at least one memory. This analysis The analysis device or the analysis system is designed to perform a method according to the above-mentioned aspect or an advantageous embodiment thereof. In particular, the method is performed using the ophthalmic analysis device. This ophthalmic analysis device can be a component of an ophthalmic surgical system.

A further aspect of the invention relates to an ophthalmic surgical system having at least one surgical instrument. The system is designed to perform, in particular to plan and/or adapt, a surgical procedure, preferably at least depending on the tear line determined and provided by the method according to the above-mentioned aspect or an advantageous embodiment thereof. The system can, in addition to or instead of this, be designed to offer and/or select a first surgical method or a different second surgical method, preferably at least depending on a tear line determined by the method according to an above-mentioned aspect or an advantageous embodiment thereof. It is also possible to issue a recommendation, in particular for medical personnel. It is also possible to offer or select a decision in this regard both binary and parametrically. The ophthalmic surgical system can be designed for phacoemulsification. In addition to or instead of this, it can be designed, in particular, to perform a capsulorhexis on an eye. Removing a membrane from the retina is also possible.

• - Insbesondere Bereitstellen zumindest einer durch das Verfahren gemäß dem oben genannten Aspekt oder einem vorteilhaften Ausführungsbeispiel davon erzeugten Hilfsinformation, insbesondere aufweisend einen Risslinienabschnitt;
• - Insbesondere Betreiben zumindest einer Systemeinheit, wie beispielweise zumindest eines chirurgischen Instruments und/oder einer Ausgabeeinheit und/oder eines Operationsbeobachtungsgeräts, wie eines Operationsmikroskops und/oder eines OCT-Systems, des Systems abhängig von der bereitgestellten Hilfsinformation, insbesondere aufweisend den Risslinienabschnitt, insbesondere während eines chirurgischen Eingriffs an einem Auge.

A further independent aspect relates to a method for operating an ophthalmic surgical system, comprising the following steps:

• - In particular, providing at least one piece of auxiliary information generated by the method according to the above-mentioned aspect or an advantageous embodiment thereof, in particular comprising a crack line section;
• - In particular, operating at least one system unit, such as at least one surgical instrument and/or an output unit and/or a surgical observation device, such as a surgical microscope and/or an OCT system, of the system depending on the provided auxiliary information, in particular comprising the tear line section, in particular during a surgical procedure on an eye.

A surgical observation device can be a surgical microscope or an OCT system. The OCT (optical coherence tomography) system can also have sensors that view a surgical area from a distance.

In particular, the operation of the system unit or functional unit may be a selection and/or setting of operating parameters and/or a movement, such as a robot-assisted movement or guided movement, of the system unit.

In particular, the system unit can be controlled, preferably during the surgical procedure. This also enables greater automation and a high level of safety during the surgical procedure.

In particular, in addition to or instead of this, surgical methods can be suggested and/or selected depending on the auxiliary information, in particular the determined fracture line, and/or a surgical procedure can be planned, in particular by the system. For this purpose, for example, the type and/or number of system units that are or could be required can also be determined.

In particular, the proposed method, computer program, ophthalmic analysis device, and ophthalmic surgical system can increase the repeatability of surgical procedures by building on a better understanding of patient-specific tissue properties. This also helps medical personnel, such as surgeons, select the most appropriate surgical procedure for the individual patient and their tissue properties. Furthermore, medical personnel can be supported in performing the surgical procedure through a better understanding of tissue properties. In particular, medical personnel can be supported by assistance functions, such as warning systems or trajectory recommendations for guiding a surgical tool. However, the method is also particularly advantageous for at least semi-autonomous, and in particular fully autonomous, robot-assisted surgical procedures. The determined tear line can then be used as an input parameter, for example, for trajectory planning algorithms or other algorithms that influence the behavior of the robot system. In this context, the ophthalmic surgical system, as mentioned above, can also be at least a semi-autonomous surgical robot system.

The auxiliary information already mentioned above can, as already explained above, be issued be used. In one embodiment, further interpretation can be left to the medical personnel. In another embodiment, the auxiliary information can be processed by the system, in particular by algorithms and/or reference data. This allows for improved processing, which is then made available to the medical personnel, thus enabling easier interpretation. For example, a traffic light system for the auxiliary information and/or a measure of the reliability of the auxiliary information can also be used in this context.

Furthermore, it is possible that the auxiliary information can be processed using algorithms and/or reference data, in particular to provide assistance functions to medical personnel. Assistance functions in this context can be force warnings or surgical instructions. Furthermore, it is possible that the auxiliary information can be processed by algorithms and/or reference data to provide inputs for trajectory planning for the trajectory guidance of a surgical instrument. This can also be done for at least semi-autonomous robot subtasks and corresponding trajectory planning algorithms. The auxiliary information can also be further processed by algorithms and/or reference data to provide recommendations for the most suitable access for a surgical instrument on the real eye and/or to select and/or recommend the most suitable tools or surgical instruments and/or implants.

The combination of the provided information, which characterizes a real reaction of the actual tissue of the eye, with preoperative data provides advantageous basic information for the system-based generation of the individual eye tissue model. This also enables highly customized model design and, based on this model, highly individualized generation of a prediction, particularly of a tear line, and/or the resulting generation of auxiliary information. This enables particularly precise validation and adaptation of the surgical procedure.

In particular, the concept can also be intended for a body part in general, not just an eye. A body part of a living being is, in particular, a body part that is elastically deformable upon impact. It can be an internal body part and thus lie entirely within the body of a living being. However, it can also be a body part that is visible from the outside. The body part can be located on or in the head.

The analysis device can then generally be a medical analysis device. The system can then generally be a surgical system.

Further features of the invention emerge from the claims, the figures and the description of the figures. The features and combinations of features mentioned above in the description, as well as the features and combinations of features mentioned below in the description of the figures and/or shown alone in the figures can be used not only in the respective combination specified, but also in other combinations without departing from the scope of the invention. Thus, embodiments are to be regarded as encompassed and disclosed by the invention that are not explicitly shown and explained in the figures, but which emerge and can be generated through separate combinations of features from the explained embodiments. Embodiments and combinations of features are also to be regarded as disclosed that therefore do not have all the features of an originally formulated independent claim. Furthermore, embodiments and combinations of features are to be regarded as disclosed, in particular through the embodiments presented above, which go beyond or deviate from the combinations of features presented in the backreferences to the claims.

The concrete values of parameters and information on ratios of parameters or parameter values for defining embodiments of the device given in the documents are to be regarded as being included in the scope of the invention, even in the case of deviations, for example due to measurement errors, system errors, DIN tolerances, etc., which also includes explanations that refer to essentially corresponding values and information.

Short description of the drawings

• 1 eine schematische Darstellung eines Ausführungsbeispiels eines ophthalmochirurgischen Systems mit einem Ausführungsbeispiel einer augenmedizinischen Analysevorrichtung;
• 2 eine Darstellung eines aufgerissenen Gewebes, insbesondere einer vorderen Wand eines Kapselsacks;
• 3 eine Darstellung eines modellierten Gewebes mit spezifischen Punkten, die eine Rissposition und Instrumentenpositionen bei der Simulation charakterisieren;
• 4 eine Darstellung gemäß 3, in welcher eine beim Simulieren auf die Darstellung gemäß 3 folgende Situation gezeigt ist; und
• 5 eine Darstellung gemäß 3 und 4, in welcher eine beim Simulieren auf die Darstellung gemäß 4 folgende Situation gezeigt ist.

Embodiments of the invention are explained in more detail below with reference to schematic drawings. They show:

• 1 a schematic representation of an embodiment of an ophthalmic surgical system with an embodiment of an ophthalmic analysis device;
• 2 a representation of a torn tissue, in particular an anterior wall of a capsular bag;
• 3 a representation of a modeled tissue with specific points characterizing a crack position and instrument positions in the simulation;
• 4 a representation according to 3 , in which a simulation based on the representation according to 3 the following situation is shown; and
• 5 a representation according to 3 and 4 , in which a simulation based on the representation according to 4 the following situation is shown.

Preferred embodiments of the invention

In the figures, identical or functionally identical elements are provided with the same reference symbols.

In 1 is a schematic representation of an ophthalmic microsurgical system or an ophthalmic surgical system 1 at least for phaco-surgery on one eye 2. The representation according to 1 shows symbolically some components of System 1 for the simplified explanation of the general principle of operation of System 1. System 1 can also be used to peel off a membrane on a retina.

The system 1 preferably comprises a device unit 3, which may, for example, be a trolley or the like. An operating unit 4 is preferably arranged in or on the device unit 3. This operating unit 4 can, for example, comprise a user interface, an input unit such as a keyboard or the like, and a display unit such as a monitor or a display. Furthermore, a fluidic system 5 is preferably arranged in the device unit 3, which has a pump and a control unit for controlling the pump and connected components. The fluidic system 5 has an irrigation device 6 with an irrigation branch and an aspiration device 7 with an aspiration branch. The irrigation device 6 has a container 8 for rinsing fluid, for example a BSS solution, which is an irrigation fluid, which is directed to a phaco handpiece. The phaco handpiece is an ophthalmic surgical handpiece 9. It is, in particular, a component of the ophthalmic surgical system 1. The aspiration device 7 is also connected to the ophthalmic surgical handpiece 9. The handpiece 9 is an example of a surgical instrument. The system 1 preferably comprises further surgical instruments. A tool for tearing open the capsular bag of an eye may also be provided for this purpose. A surgical instrument for polishing the capsular bag may also be provided and be a component of the system 1. These examples are not intended to be exhaustive.

In an alternative embodiment, it can be provided that the ophthalmic surgical system 1 has a tank 8' ( 1 ). In such an embodiment, the cooling fluid intended for cooling the incision is provided separately from the irrigation device 6 and separately from the container 8. The tank 8' can be arranged separately from the handpiece 9 and connected to the handpiece 9, for example, via a line, such as a hose connection.

In a further embodiment, it can be provided that the separate tank 8' is arranged in the handpiece 9. It can be arranged in the handpiece 9 in a non-destructively detachable or non-destructively detachable manner. It can also be provided that a first separate tank 8' is arranged in the handpiece 9 and a further separate tank 8' is arranged externally to the handpiece 9. This further tank 8' external to the handpiece 9 can be fluidically connected to the tank 8' arranged in the handpiece 9.

Furthermore, the device unit 3 comprises, in particular, an ultrasound unit 10, which is designed to excite the oscillation of a piezoelectric element 11 in the ophthalmic surgical handpiece 9, by means of which a hollow needle 12 of the ophthalmic surgical handpiece 9 is excited to oscillate. The device unit 3 further comprises, in particular, a control unit 13. The control unit 13 can also be designed to control a vitrectomy handpiece 14, which can in particular be a component of the ophthalmic surgical system 1. The vitrectomy handpiece 14 is an example of a surgical instrument. The vitrectomy handpiece 14 is preferably also connected to the fluidic system 5, in particular via an aspiration line 15. In addition, a further control unit 16 can be provided, which controls a preferably present further surgical instrument 17, for example for diathermy. Furthermore, the system 1, and in particular the device unit 3, can comprise further modules and control units as well as systems, which are symbolically represented by the unit 18. This also includes further internal units and peripheral devices. The ophthalmic surgical system 1 preferably further comprises a foot control panel 19, which is connected to the device unit 3, in particular to communication devices and control units of the device unit 3.

Another surgical instrument 30 may be a cutting tool for cutting open a capsular bag of the eye 2.

Another surgical instrument 32 can be a tearing tool for tearing open a capsular bag of the eye 2. In particular, if this, in particular an anterior wall of the capsular bag, is locally is cut open, so that the wall is further torn there.

The eye 2 can be a real, living eye. It has a natural lens 20 arranged in a capsular bag 21. The capsular bag 21 has an anterior capsular bag wall 22 and a posterior capsular bag wall 23. The eye 2 can be a real eye of a human or an animal. However, it can also be a dummy eye. In this embodiment, it can be taken from a dead living being and be a dummy eye made of biological material. However, the dummy eye can also be artificially produced, for example, and be formed at least partially from plastic, for example. However, it can also be an eye only simulated on a screen. In this embodiment, the eye 2 can be displayed 2-dimensionally or 3-dimensionally. The dummy eyes or the simulated eye also have the usual components, in particular a lens 20 and a capsular bag 21.

In 1 An embodiment of an ophthalmic surgical device, which is in particular an ophthalmic analysis device 24, is also shown. The ophthalmic analysis device 24 can be a component of the ophthalmic surgical system 1. However, the ophthalmic analysis device 24 can also be a separate device. It can be used during an actual surgical procedure on a real eye 2, as well as for training or educational purposes for medical personnel, for example. The ophthalmic analysis device 24 can also be used as a separate unit without the system 1, in particular for training or educational purposes. It can be an analysis system.

The ophthalmic analysis device 24 preferably has at least one input unit 25. This can be a keyboard. However, it can also be a touch-sensitive input field. However, the input unit 25 can also be configured for voice input in addition to or instead of voice input.

The ophthalmic analysis device 24 preferably has at least one evaluation unit 26. The evaluation unit 26 is also designed, in particular, to evaluate the information input via the input unit 25. The ophthalmic analysis device 24 preferably has an optical display unit 27. This optical display unit 27 can be a separate screen. However, the optical display unit 27 can also be, for example, a component of a surgical microscope 28. The display unit 27 is an example of an output unit.

The ophthalmic analysis device 24 preferably has at least one detection device 29. The detection device 29 can, for example, be an image generation unit, such as a camera. In particular, this image generation unit is sensitive in the spectral range visible to humans.

The ophthalmic analysis device 24 can also be designed purely as an ophthalmic analysis system, in addition to or instead of the aforementioned applications. With such a design, surgical results from an already completed real operation can also be subsequently evaluated and analyzed. For example, a surgical microscope (stereo cameras) with or without an OCT (optical coherence tomography) system for 3D imaging can be provided. For example, a Brillon microscope, with which tensions in the tissue can be visualized, can also be provided in addition to or instead of this.

The ophthalmic analysis device 24 can also be designed purely as an ophthalmic analysis system, in addition to or instead of the aforementioned applications. With such a design, surgical results from an already completed real operation can also be subsequently evaluated and analyzed.

In 2 A schematic representation of the anterior capsular bag wall 22 is shown in a partial area. This anterior capsular bag wall 22 is shown here already partially torn open. The anterior capsular bag wall 22 has a limiting edge 22a. As in 2 As can be seen, the tearing does not begin from this edge 22a. Rather, when tearing open the capsular bag 21, in particular this anterior capsular bag wall 22, the tearing begins at a distance from this edge 22a. In particular, a surgical instrument 30 is used to pierce this not yet destroyed capsular bag 21, in particular the not yet destroyed anterior capsular bag wall 22, away from this edge 22a. This piercing with the instrument 30 causes a cutting severance, so that an elongated severance or an elongated hole 31 is formed in the anterior capsular bag wall 22. This dividing line created by cutting is, as in also in 2 rectilinear or essentially rectilinear. This dividing line has a radially inner end 31a and a radially outer end 31b. Starting from this achieved state, In contrast to the previously performed cutting of the capsular bag wall 22, a tearing can then take place. For this purpose, for example and preferably with the symbolically represented instrument 32, the tissue is attacked, in particular in the radially outer end 31b, at a contact point, in particular a gripping point 33. By moving this instrument 32, the tissue, here the anterior capsular bag wall 22 of the capsular bag 21, is torn open, so that a tear line 34 is created, of which a tear line section is shown here. As in this 2 In the intermediate state shown, in which the front capsular bag wall 22 is not yet completely torn open, the gripping point 33 remains the same during a tearing process, so that during a continuous tearing process, this gripping point 33 moves further and further away from a front and further moving end 35 of the continuously enlarging tear line 34. A torn tissue flap 22b of the capsular bag wall 22 is shown.

In particular, the tissue to be torn open in this example is generally considered to be a very thin wall. It is inherently dimensionally unstable. This means that, viewed on its own, it cannot be set up or maintained in a stable shape. Especially with such tissues, the described procedure for tearing is unstable, making the course of the tear line 34 very difficult to predict. In particular, due to a wide variety of influencing parameters, the tear line 34 can degenerate very quickly along its course. This has disadvantages, since inaccurate or undesired tearing and thus an undesired course of the tear line 34 can make the subsequent implantation of the intraocular lens into the remaining capsular bag 21 more difficult. It is therefore particularly important to be able to create the tear line 34 as precisely as possible.

The ophthalmic analysis device 24 can be used to perform a method for generating auxiliary information for an ophthalmic surgical procedure on a real eye.

1. a) Bereitstellen zumindest einer Information, die das reale Gewebe des Auges 2 und/oder das Lebewesen, welches das Auge 2 aufweist, charakterisiert, insbesondere an die Auswerteeinheit 26;
2. b) Erzeugen eines patientenangepassten digitalen Gewebemodells 36 (2) für das reale Gewebe, insbesondere durch Parametrieren eines vorgegebenen und bereitgestellten, digitalen Gewebebasismodells abhängig von den Informationen aus Schritt a) mit einer Modellanpassungseinheit 26a (1);
3. c) zum Bestimmen eines zerstörenden Reißens eines realen Gewebes, insbesondere der vorderen Wand 22 des Kapselsacks 21, des realen Auges 2 Modellieren zumindest eines Risslinienabschnitts 38 (4) eines Risses beziehungsweise einer Risslinie 39 (4) des Gewebes, der bei einem als zerstörendes Reißen erfolgendes Einwirken auf das Auge 2 mit einem chirurgischen Instrument 30, 32 auftritt, abhängig von einem Bewegungsmodell 37, mit welchem zumindest diese Bewegung des Risslinienabschnitts 38 und/oder eine Bewegung 40 (3) des Instruments 30, 32 als Punktwanderung modelliert wird.

With the ophthalmic analysis device 24, a method, in particular a computer-implemented method, for simulatively determining a destructive tear of a real tissue of a real eye, preferably comprising the following steps, can be carried out:

1. a) Providing at least one piece of information characterizing the real tissue of the eye 2 and/or the living being having the eye 2, in particular to the evaluation unit 26;
2. b) Creating a patient-adapted digital tissue model 36 ( 2 ) for the real tissue, in particular by parameterizing a predetermined and provided digital tissue base model depending on the information from step a) with a model adaptation unit 26a ( 1 );
3. c) for determining a destructive tearing of a real tissue, in particular of the anterior wall 22 of the capsular bag 21, of the real eye 2, modeling at least one tear line section 38 ( 4 ) of a crack or a crack line 39 ( 4 ) of the tissue, which occurs when the eye 2 is affected by a destructive tearing with a surgical instrument 30, 32, depending on a movement model 37, with which at least this movement of the tear line section 38 and/or a movement 40 ( 3 ) of the instrument 30, 32 is modeled as point migration.

The model adaptation unit 26a can be a separate unit from the evaluation unit 26. However, it can also be a component of the evaluation unit 26.

• Insbesondere wird dazu auf 3 verwiesen.
• c1) Bereitstellen von, insbesondere aktuellen, Instrumenteninformationen des Instruments 30, 32, die zumindest einen von einem Rand 36a entfernten Punkt 41, insbesondere mit dessen Position, eines realen chirurgischen Instruments 30, 32, insbesondere einer auf das Gewebe direkt einwirkenden Spitze des Instruments 30, 32, während eines chirurgischen Eingriffs am Auge 2 aktuell charakterisieren, mit welchem zum Reißen auf das Gewebe eingewirkt wird, an die Auswerteeinheit 26;
• c2) Bereitstellen von, insbesondere aktuellen, Rissinformationen, die zumindest einen Punkt 42, insbesondere mit einer Position, eines vorliegenden, realen Risslinienabschnitts, der während des chirurgischen Eingriffs am Auge 2 aktuell am Gewebe durch das Einwirken mit dem chirurgischen Instrument 30, 32 aufgetreten ist, charakterisieren, an die Auswerteeinheit 26;
• c3) Modellieren einer Bewegung zumindest des durch die Instrumenteninformation in Schritt c1) charakterisierten Punkts 41, insbesondere einer Position des Punkts 41, des Instruments 30, 32 an eine potenzielle Zukunftsposition gemäß einem zukünftigen Punkt 43 in dem Gewebemodell 36 auf Basis eines bereitgestellten Bewegungsmodells 37, mit welchem zumindest diese Bewegung als Punktwanderung 44 modelliert wird;
• c4) Insbesondere Bestimmen eines modellierten weiteren Risslinienabschnitts 38 ( 4) in dem Gewebe, insbesondere der auf einen bereits vorliegenden realen Risslinienabschnitt 45 folgt, zumindest abhängig von den modellierten Informationen der Punkte 41, 42, 43 in Schritt c3) mit der Auswerteeinheit 26.

Preferably, the following steps will be carried out for step c):

• In particular, 3 referred to.
• c1) Providing, in particular current, instrument information of the instrument 30, 32, which currently characterizes at least one point 41 remote from an edge 36a, in particular with its position, of a real surgical instrument 30, 32, in particular a tip of the instrument 30, 32 acting directly on the tissue, during a surgical procedure on the eye 2, with which the tissue is acted upon to tear, to the evaluation unit 26;
• c2) Providing, in particular current, tear information to the evaluation unit 26, which characterizes at least one point 42, in particular with a position, of an existing, real tear line section that has currently occurred on the tissue during the surgical procedure on the eye 2 as a result of the action of the surgical instrument 30, 32;
• c3) modeling a movement of at least the point 41 characterized by the instrument information in step c1), in particular a position of the point 41, of the instrument 30, 32 to a potential future position according to a future point 43 in the tissue model 36 on the basis of a provided movement model 37, with which at least this movement is modeled as a point migration 44;
• c4) In particular, determining a modeled further crack line section 38 ( 4 ) in the fabric, in particular which follows an already existing real tear line section 45, at least depending on the modelled information of the points 41, 42, 43 in step c3) with the evaluation unit 26.

• c1'') Bereitstellen von Risslinieninformationen, die zumindest einen zukünftig gewünschten, aktuell noch nicht erfolgten Risslinienabschnitt der Risslinie charakterisieren;
• c2') Modellieren einer Bewegung einer Position des Instruments 30, 32 an eine potenzielle Zukunftsposition gemäß einem zukünftigen Punkt 43 in dem Gewebemodell 36 auf Basis eines bereitgestellten Bewegungsmodells 37, mit welchem zumindest diese Bewegung als Punktwanderung 44 modelliert wird, wobei die Bewegung so modelliert wird, dass zumindest der in Schritt c1') gewünschte Risslinienabschnitt 38 erzeugt wird.

It is also possible that the following steps are carried out:

• c1'') Providing crack line information which characterises at least one crack line section of the crack line which is desired in the future and has not yet been completed;
• c2') Modeling a movement of a position of the instrument 30, 32 to a potential future position according to a future point 43 in the tissue model 36 on the basis of a provided movement model 37, with which at least this movement is modeled as a point migration 44, wherein the movement is modeled such that at least the tear line section 38 desired in step c1') is generated.

Preferably, in step c3) as shown in 4 then also an at least two-dimensional direction vector 46 is modeled in the tissue model 36. The direction vector is represented in particular only by its two vector components 46a and 46b. The direction vector 46 is represented here, for example, as a linearized point migration 47 ( 5 ) characterized movement of at least one point 42 characterized by the crack information in step c2) to the potential future position according to the future point 43 of the surgical instrument 30, 32 is determined.

Depending on the direction vector 46 and/or previously performed crack movements, the further crack line section 38 is modeled in step c4). Preferably, the direction vector 46 is scaled depending on the path length between points 41 and 43 of the instrument 30, 32. Preferably, it is scaled to half the length of the path between points 41 and 43.

As furthermore in 4 As shown, the direction vector 46 is decomposed by the motion model 37 into a first vector component 46a and a second vector component 46b. The first vector component 46a describes a shear component of a shear force acting on the tissue, which occurs when the instrument 30, 32 acts on the tissue. This decomposition is also determined using the tissue model 36. The second vector component 46b describes a tear component of a tear force acting on the tissue, which occurs when the instrument 30, 32 acts on the tissue. The vector components 46a and 46b are perpendicular to one another in the plane of the modeled tissue.

In one embodiment, at least one threshold value for a mechanical resistance of the real tissue is provided, in particular to the evaluation unit 26. In one embodiment, at least one threshold value for a tensile strength of the real tissue is provided, in particular to the evaluation unit 26.

Preferably, the vector components 46a and 46b are also scaled linearly. Preferably, this scaling can be performed at least as a function of at least one piece of information that characterizes the actual tissue of the eye 2 and/or the living being that has the eye 2. Preferably, the first vector component 46a is scaled with a scaling factor of one. Preferably, the second vector component 46b is scaled with a scaling factor of 0.15. In particular, these values can be determined experimentally and used as a basis.

Preferably, these vector components 46a and 46b are compared with the threshold values for mechanical resistance.

Preferably, a determination of a crack direction and/or a crack force is carried out by summing the two vector components 46a and 46b.

Preferably, the resulting tear force is reduced, in particular by subtracting a constant force corresponding to the tissue resistance and tensile force of the real eye. The tensile force is preferably directed. Thus, when a tear is performed toward the center of the eye or from the center of the eye outward, resistance is overcome or additional forces are applied.

In particular, the fabric resistance is modeled as a constant that is subtracted independently of the resulting crack direction.

A modeled future crack position is then determined by determining a future point 47, as shown in 5 shown. In particular, this occurs at least depending on the comparisons mentioned above.

In particular, at least a partial area of the modeled further tear line section 38 in the fabric is determined at least as a function of the direction vector 46 and this modeled future point 47.

If necessary, the procedure can be repeated, for example to determine and predict another crack line section based on the model.

Preferably, a surgical procedure with a surgical, in particular ophthalmic, system 1 on the eye 2 is planned depending on at least one tear line section 38 determined by the method explained above. For example, a trajectory along which a surgical instrument, for example the surgical instrument 32, is guided during the surgical procedure on or in the eye 2, can also be planned.

In particular, the system 1 is designed to carry out a surgical intervention depending on at least one tear line section 38 of the real tissue determined by the method explained above, in particular to plan and/or adapt it, and/or
the system 1 is designed to offer and/or select a first surgical method or a different second surgical method depending on at least one tear line section 38 of the real tissue determined by the method explained above,
and/or
the system 1 is designed to control, in particular robotically control, at least one system unit of the system 1 depending on at least one tear line section 38 of the real tissue determined by the method explained above,
and/or.
the system 1 is designed to display the tear line section 38 of the real tissue determined by the method explained above in a surgical microscope of the system 1, in particular three-dimensionally, in particular as an overlay on a current real image of the eye 1.

QUOTES CONTAINED IN THE DESCRIPTION

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Cited patent literature

• US 2023 / 015 7872 A1 [0009]

Claims (13)

A method, in particular a computer-implemented method, for determining destructive tearing of real tissue of a real eye (2), comprising the following steps: a) Providing at least one piece of information characterizing the real tissue of the eye (2) and/or the living being having the eye (2) to an evaluation unit (26); b) Generating a patient-adapted digital tissue model for the real tissue by parameterizing a predetermined and provided digital tissue base model depending on the information from step a) using a model adaptation unit (26a); c) to determine a destructive tearing of a real tissue of a real eye (2), modeling at least one tear line section (38, 45) of a tear line (34) of the tissue, which occurs when the eye (2) is affected as a destructive tearing with a surgical instrument (32), depending on a movement model with which at least this movement of the tear line section (38, 45) and/or a movement of the instrument (32) is modeled as a point migration. Procedure according to Claim 1 , wherein the following steps are carried out for step c): c1) providing instrument information which characterizes at least one point (41), in particular also a position of the point (41), of a real surgical instrument (32) during a surgical procedure on the eye (2), with which the tissue is acted upon to tear, to the evaluation unit (26); c2) providing tear information which characterizes at least one point (42), in particular also a position of the point (42), of an existing, real tear line section (45) which has occurred on the tissue during the surgical procedure on the eye (2) as a result of the action of the surgical instrument (32), to the evaluation unit (26); c3) Modeling a movement of at least one point (41) of the instrument (32) characterized by the instrument information in step c1) to a potential future point (43), in particular also a position of the point (43), in the tissue model (36) on the basis of a provided movement model (37), with which at least this movement is modeled as a point migration with the evaluation unit (26); c4) Determining a modeled further tear line section (38) in the tissue that follows the existing real tear line section (45), at least depending on the modeled information in step c3) with the evaluation unit (26), and/or wherein for step c), instead of and/or in addition to steps c1) to c4), the following steps are carried out: c1') Providing tear line information that characterizes at least one future desired, currently not yet realized tear line section (38) of the tear line (39); c2') Modeling a movement of a position of the instrument (32) to a potential future point (43), in particular also a position of the point (43), in the tissue model (36) on the basis of a provided movement model (37), with which at least this movement is modeled as a point migration (44), wherein the movement is modeled such that at least the tear line section (38) desired in step c1') is generated. Procedure according to Claim 2 , wherein in step c3) an at least two-dimensional direction vector (46) for a movement characterized as point migration of at least one point (42) characterized by the tear information in step c2) to the potential future point (43) of the surgical instrument (32) in the tissue model (36) is modeled, wherein the further tear line section (38) is modeled in step c4) depending on the direction vector (46) and/or previously performed tear movements. Procedure according to Claim 3 , wherein the direction vector (46) is broken down by the movement model (37) into a first vector component (46a) and a second vector component (46b), wherein the first vector component (46a) describes a shear component of a shear force acting on the tissue which occurs when the instrument (32) acts on the tissue, and the second vector component (46b) describes a tear component of a tear force acting on the tissue which occurs when the instrument (32) acts on the tissue. Procedure according to Claim 4 , wherein the following steps are carried out: - Providing a threshold value for a mechanical resistance of the real tissue and a threshold value for a tensile strength of the real tissue; - Comparing the values of the vector components (46a, 46b) with the threshold values; - Determining a tear direction and/or tear force by summing the two vector components (46a, 46b); - Reducing the resulting tear force, in particular deducting a constant force that corresponds to the tissue resistance and tensile force of the real eye (2); - Determining a modeled future point (47) depending on the comparison; - and determining the modeled further tear line section (38) in the tissue depending on the direction vector (46) and this modeled future point (47). Procedure according to Claim 5 , whereby the threshold values are determined by test functions and/or based on stored correlations in reference tissues. Procedure according to Claim 6 , wherein the relationships are determined based on recorded and evaluated, real robot-assisted movements of a surgical instrument (32) during tearing of the real tissue or of a comparison tissue, which represent reference tissue, in particular movements of the instrument (32) and the associated tear lines are determined as relationships, and/or the relationships are determined based on recorded and evaluated, real and predetermined, in particular two-dimensional, reference movements of a surgical instrument (32) during tearing of the real tissue or of a comparison tissue, which represent reference tissue, in particular movements of the instrument (32) and the associated tear lines are determined as relationships. Procedure according to Claim 7 , wherein a spiral movement of the instrument (32) is used as the reference movement and the associated crack line is detected and assigned to this movement as a connection and/or a test circle with a radius smaller than a target circle of the instrument (32) is used as the reference movement and the associated crack line is detected and assigned to this movement as a connection. Method according to one of the preceding Claims 2 until 8 , wherein the two-dimensionally determined further tear line section (38) is projected onto a three-dimensional model shape of the fabric, so that a three-dimensional further tear line section (38) is modeled and produced. Method for planning a surgical intervention with a surgical, in particular ophthalmic, system (1) on an eye (2), in which a trajectory along which a surgical instrument (30, 32) is guided during the surgical intervention on or in the eye (2) is determined as a function of at least one according to a method according to one of the preceding Claims 1 until 9 a tear line (34, 39) of the real tissue of the real eye (2) is planned, in particular with an evaluation unit (26), and/or in which a surgical intervention is carried out depending on at least one tear line determined according to a method according to one of the preceding Claims 1 until 9 simulatively determined tear line (34, 39) of the real tissue of the real eye (2), and/or in which depending on at least one according to a method according to one of the preceding Claims 1 until 9 simulatively determined tear line (34, 39) of the real tissue of the real eye (2), a first surgical method or a second surgical method different therefrom is selected, in particular is offered and/or selected by the system (1) itself, and/or in which the at least one according to a method according to one of the preceding Claims 1 until 9 a simulated tear line (34, 39) of the real tissue of the real eye (2) is output to an output unit (26). Computer program, comprising instructions which, when executed by a computer, cause the computer to carry out the method according to one of the preceding Claims 1 until 10 to execute. Ophthalmic analysis device (24) with at least one evaluation unit (26), wherein the analysis device (24) is designed to carry out a method according to one of the preceding Claims 1 until 10 is trained, in particular with the aid of a computer program according to Claim 11 . Ophthalmic surgical system (1), comprising at least one surgical instrument (30, 32), wherein the system (1) is designed to carry out a surgical procedure depending on at least one of the methods according to one of the preceding Claims 1 until 9 specific tear line (34, 39) of the fabric, in particular to plan and/or adapt it, and/or wherein the system (1) is designed to be dependent on at least one tear line (34, 39) carried out by the method according to one of the preceding Claims 1 until 9 a specific tear line (34, 39) of the tissue, a first surgical method or a second surgical method different therefrom, and/or wherein the system (1) is designed to offer and/or select at least one system unit of the system (1) depending on at least one method carried out by the method according to one of the preceding Claims 1 until 9 to control a specific tear line (34, 39) of the tissue, in particular to control it robotically, and/or. wherein the system (1) is designed to process the data obtained by the method according to one of the preceding Claims 1 until 9 to display a specific tear line (34, 39) of the tissue in a surgical microscope of the system (1), in particular three-dimensionally, in particular as an overlay to a current real image of the eye (2).

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