DE102021006553A1 - A method of providing a tissue for laboratory testing, and using an extracted volume of a cornea in a laboratory testing - Google Patents

Abstract

The invention relates to a method for providing a tissue for a laboratory examination, comprising: Determining ametropia data of an eye (16) of a specified human or animal patient, the ametropia data describing a degree of ametropia of the eye (16) (S1) based on the ascertained Ametropia data: determining a target geometry of a correction area of a cornea (17) of the eye (16), the determined target geometry fulfilling a specified ametropia reduction criterion which specifies suitability for reducing the degree of ametropia (S3), determining interfaces (20, 22) of a volume body (18) within the correction area, the extraction of which converts the correction area from an actual geometry to the determined target geometry (S4), and providing (S5) the volume body (18 ) for a laboratory test (S6). The method also includes determining health information of the given patient (S7); and providing the ascertained health data for the laboratory examination, and/or taking into account the ascertained health data (S9) in the laboratory examination (S6).

Description

The invention relates to a method for preparing a tissue or a tissue sample for a laboratory examination, and the use of an extracted volume body of a cornea in a laboratory examination. The tissue provided or the tissue sample provided is a volume body of the cornea.

A volume body or lenticule is understood to mean a portion of the cornea, for example a slice of tissue. The boundary surfaces of the lenticle or volume can form a biconvex, biconcave, plano-convex or plano-concave volume, for example. The lenticule or solid can optionally be lenticular or bean-shaped. The lenticule or solid can be symmetrically or asymmetrically shaped.

The use of donor corneas as an implant is, for example, from U.S. 2019/038399 A1 , U.S. 2019/175333 A1 , US 2020/0046559 A1 and WO 2019/084557 A1 known. Human donor eyes or donor corneas, as well as animal in-vivo or ex-vivo eyes or corneas, or synthetic materials are also currently used for laboratory tests, medical studies and equivalence tests.

The disadvantage here is that when synthetic materials or donor corneas are used in laboratory tests, little or no statement can be made about the extent to which the results are influenced by a specific pathology of the synthetic material or the donor cornea. This means that if a test is repeated, there will be a discrepancy in the results, which is caused by discrepancies between the materials used.

Even with a modification of a volume body from a donor cornea, as for example in the US 2009/143 858 A1 described, solid-specific factors can influence the laboratory test. This is due to an individual physiology of the donor cornea, which can vary between different donor corneas.

Another problem is that the use of donor organs is subject to strict regulations and is therefore complicated to regulate and can often be very expensive. This is also often true for animal organs, especially in vivo tissue.

An object underlying the invention is to improve a quality of laboratory tests on corneal tissue.

The stated object is achieved by the method according to the invention, the use according to the invention and the volume body according to the invention in accordance with the independent claims. Advantageous developments are given by the dependent claims.

The invention is based on the idea of providing extracted human corneal lenticules for a laboratory application instead of donor eyes or donor corneas and/or animal in vivo/ex vivo eyes or corneas and/or synthetic materials and optionally using them in the laboratory application . In other words, a lenticle or solid is used which is already specifically cut, i.e. the shape of the lenticle is known, as well as the medical history of the patient from whom the lenticle was taken. While in the methods of the prior art this data can no longer be collected later or is associated with considerable costs, the extracted lenticules are precisely defined in terms of their physiology and their dimensions. Instead of disposing unused, as in the prior art, of lenticules or volume bodies which are extracted from the human cornea during refractive treatments, such a lenticule or volume body is provided according to the invention, for example preserved for laboratory examination. The provision can include, for example, preserving and/or cooling in a nutrient solution.

The use of extracted lenticules, in particular extracted human lenticules, which would otherwise have been disposed of, on the one hand obsolete ethical restrictions, on the other hand the equivalence for the later target application in the human eye is given directly, in contrast to animal organs or synthetic materials. The advantages of using animal lenticules for studies on animal solids or corneas are analogous.

The method can optionally be referred to as a method of providing a tissue for use in a laboratory study. The specified human or animal patient is a defined patient whose defective vision data are assigned in the provided volume body. Specifying the human or animal patient may include designating the patient from whom the lenticle is to be provided.

The method according to the invention for providing a tissue for a laboratory test comprises the following steps.

Ametropia data of an eye of a specified human or animal patient is determined, the ametropia data describing a degree of ametropia of the eye, preferably of a human patient. In particular, ametropia data can be determined for at least one eye-specific parameter, the eye-specific parameters describing an ametropia and/or a geometry of the human or animal eye that causes the ametropia. The ametropia data can describe, for example, ametropia, ie a deviation in the refractive power of an eyeball or a cornea from the ideal value, for example nearsightedness, farsightedness or astigmatism. The determined ametropia data can, for example, describe a value of a refractive power, ie an indication in dioptre, or, for example, a deviation of a corneal curvature from a normal value. The ametropia data can be determined, for example, by retrieving the ametropia data from a data store or data server, or can be recorded, for example, by a measuring device that takes measurements of the cornea and/or determines an ametropia. The ametropia data can preferably be determined by a control device, ie a device, a device component or a device group that is set up to receive and evaluate signals and to provide, for example generate, control data. The control device can be designed, for example, as a control check, computer program, computer program product or control program.

A target geometry of a correction region of a cornea of the eye is determined on the basis of the determined ametropia data, the determined target geometry fulfilling a specified ametropia reduction criterion which specifies suitability for reducing the degree of ametropia. The determination of the target geometry can preferably also be carried out by the control device. To determine the target geometry, a lenticle geometry can be determined, for example, which can describe the dimensions of a lenticle and its position in the cornea. In other words, the determined target geometry, ie the desired shape of the lenticle and its position in the cornea, can describe, in particular, the desired shape of the lenticle.

In other words, the specified ametropia reduction criterion is the specification that the identified ametropia is reduced or even completely eliminated by the target geometry. Optionally, the specified ametropia reduction criterion can, for example, specify a minimum value of such a reduction, or a minimum probability with which the ametropia is reduced. The criterion for reducing ametropia can be stored in a memory of the control device, for example.

The method also includes determining boundary surfaces of a volume body within the correction area, the extraction of which converts the correction area from an actual geometry to the determined target geometry of the correction area. The actual geometry is the current geometry of the cornea before a lenticle extraction, and the determined target geometry is the corrected geometry that results from the extraction of the lenticle. To convert the actual geometry into the target geometry, the method includes determining boundary surfaces of a volume body or lenticle within the correction area, the extraction of which converts the correction area from an actual geometry into the determined target geometry. This is in particular an anterior boundary surface and a posterior boundary surface of the lenticle as cutting surfaces for forming or shaping the lenticle.

The volume body extracted from the cornea is then made available for a laboratory examination. Providing the extracted volume body can, for example, include storing the extracted volume body in a nutrient solution and/or extracting the lenticle per se. In particular, the provision of the lenticle can include the provision of the lenticle of the specified human or animal patient, the determined ametropia data being assigned to the extracted volume body.

A laboratory test is understood to be an ex vivo procedure that includes one or more physiological tests on the removed tissue.

The advantages mentioned above result.

Ideally, the volume body extracted from the cornea can be provided for a laboratory examination to collect patient-specific data of that given human or animal patient from whose cornea the volume body originates. In other words, the laboratory test can include one or more patient-specific tests. For example, the laboratory test may include an analysis of whether the corneal tissue of the given patient from which the lenticle originates, has tolerance or intolerance to a predetermined substance. This embodiment of the method according to the invention enables a particularly well-tailored analysis for the individual patient.

In a further embodiment of the method according to the invention, providing the volume body can include storing the volume body under at least one predetermined storage condition. The specified storage condition can preferably prescribe a storage temperature and/or a nutrient medium in which the volume body is stored and/or a storage period. Such a linking of patient-specific ametropia data under storage conditions enables an even more precise interpretation of the results of the subsequent laboratory examination.

The method can preferably include ascertaining health data of the specified patient from whom the provided volume body originates. This ascertained health data can preferably describe a corneal pathology of the specified patient and/or a medical history of the specified patient. According to this embodiment, the determined health data can additionally be provided for the laboratory examination and/or the determined health data can be taken into account in the laboratory examination. On the one hand, the laboratory examination can be carried out much more precisely because it is known what has to be taken into account during the laboratory examination, for example, or what can be examined. Furthermore, the results of the laboratory test can be interpreted even more precisely.

Ideally, the method may include using the provided solid in the laboratory investigation. In other words, the method can include the laboratory test itself. This increases the advantages already mentioned above.

The laboratory examination can preferably be a medical test procedure. In particular, this can be a screening method which can include bringing the provided volume body into contact with an active substance to be screened. Alternatively or additionally, the medical test method can include at least one tolerance test. For a particularly large and insightful study, the laboratory test may be a test or series of tests from a clinical trial.

In a further advantageous embodiment of the method according to the invention, the volume body can be extracted from the cornea by means of a laser device of an ophthalmic surgical treatment device, the laser device being set up to emit laser pulses in the ranges specified below: in a wavelength range between 300 nanometers (nm) and 1400 nanometers, preferably between 700 nanometers and 1200 nanometers; with a respective pulse duration between one femtosecond (fs) and one nanosecond (ns), preferably between 10 femtoseconds and 10 picoseconds (ps); and a repetition rate greater than 10 kilohertz (KHz), preferably between 100 kilohertz and 100 megahertz.

Alternatively, the control device can provide control data which cause the laser device to emit laser pulses in a wavelength range between 300 nanometers (nm) and 1,400 nanometers, preferably between 700 nanometers and 1,200 nanometers; with a respective pulse duration between one femtosecond (fs) and one nanosecond (ns), preferably between 10 femtoseconds and 10 picoseconds (ps); and a repetition rate greater than 10 kilohertz (KHz), preferably between 100 kilohertz and 100 megahertz.

A laser device is understood to mean a device for controlling photoablative ophthalmological lasers. For this purpose, for example, a shortened laser and a beam focusing device can be designed in such a way that the laser beam pulses cause a photodisruption in a focus located within the organic material. Femtosecond systems are used in corneal surgery to perform, for example, deep anterior lamilar keratoplastic (DALK) and/or penetrating keratoplasty (PKP). Such laser devices can also be used for laser in situ keratomileusis (LASIK), i.e. a short incision lenticle extraction (“small incision lentical extraction, SMILE”), i.e. a method of refractory surgery in which a lenticle of the cornea is inserted through a peripheral cut is removed.

A femtosecond laser is particularly well suited to producing volumetric bodies within the cornea. The use of photodisruptive lasers in the method according to the invention also has the advantage that the cornea does not have to be irradiated in a wavelength range below 300 nanometers. In laser technology, this range is subsumed under the term "deep ultraviolet". This advantageously prevents unintentional damage from being caused by these very short-wavelength and high-energy rays tion of the cornea takes place. Photodisruptive lasers of the type used here usually introduce pulsed laser radiation with a pulse duration between one femtosecond and one nanosecond into the cornea tissue. As a result, the power density of the respective laser pulse, which is necessary for the optical breakthrough, can be spatially limited so that a high level of cutting accuracy is made possible when producing the interfaces. A laser device is understood to mean that component of the laser device which emits the bundled light, ie the laser.

The object set above is achieved by a volume body, which can also be referred to as a lenticle, for use in a laboratory examination, in particular in a medical test method, the volume body being provided from a method of one of the above-described embodiments of the method according to the invention. Such a volume body has the advantage that patient data and ametropia data can be assigned to it without a very high organizational or monetary effort being associated with it.

The object set out above is achieved by using a volume body extracted from a cornea of a given human or animal patient in a laboratory examination, in particular in a medical test method. The advantages mentioned above result.

The volume body can preferably be used in a laboratory examination to collect patient-specific data of that given patient from whose cornea the volume body originates. The advantages have already been discussed above.

The use of the volume body can optionally include storing the volume body, preferably storing the volume body under a predetermined storage condition, in particular under one of the storage conditions already mentioned above. Here, too, the advantages already discussed arise.

Preferably, the use may include a screening method as a laboratory test. The advantages mentioned above result.

Optionally, the use can include using determined health data of the specified human or animal patient to analyze the test results, in particular taking into account this determined health data of the specified human or animal patient. Ideally, the determined health data can describe a corneal pathology of the given patient and/or a medical history of the given human or animal patient. The advantages have already been discussed above.

The use can preferably include using a volume body that is provided by an embodiment of the method according to the invention. The advantages already mentioned result.

• 1 eine schematische Darstellung einer Behandlungsvorrichtung;
• 2 eine schematische Darstellung einer Variante der Bereitstellung eines Volumenkörpers, insbesondere einer Bereitstellung oder Erzeugung des Volumenkörpers gemäß einem Ausführungsbeispiel des erfindungsgemäßen Verfahrens; und
• 3 eine schematische Darstellung einer weiteren Ausführungsform des erfindungsgemäßen Verfahrens.

Further features of the invention result 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 combination specified in each case, but also in other combinations, without going beyond the scope of the invention leaving. The invention is therefore also to be considered to include and disclose embodiments that are not explicitly shown and explained in the figures, but that result from the explained embodiments and can be generated by separate combinations of features. Versions and combinations of features are also to be regarded as disclosed which therefore do not have all the features of an originally formulated independent claim. Furthermore, embodiments and combinations of features, in particular through the embodiments presented above, are to be regarded as disclosed which go beyond or deviate from the combinations of features presented in the back references of the claims. It shows:

• 1 a schematic representation of a treatment device;
• 2 a schematic representation of a variant of the provision of a volume body, in particular a provision or generation of the volume body according to an embodiment of the method according to the invention; and
• 3 a schematic representation of a further embodiment of the method according to the invention.

Elements that are the same or have the same function are provided with the same reference symbols in the figures.

the 1 shows a schematic representation of a treatment device 10 with an ophthalmic surgical laser of a laser device 12 for the separation of a predefined corneal volume/cornea volume of a cornea 14 of a human or animal eye 16, ie a volume body 18, which can also be referred to as a lenticule, with predefined boundary surfaces 20, 22, preferably by means of photodisruption. It can be seen that, in addition to the laser device 12, a control device 24 can be configured for the laser device 12, so that it emits pulsed laser pulses in a predefined pattern into the cornea 14, for example, with the determined boundary surfaces 20, 22 of the volume body 18 to be formed being defined by, for example, a predefined pattern can be generated by photodisruption. Alternatively, the control device 24 can be a control device 24 that is external to the treatment device 10 .

The boundary surfaces 20, 22 determined form a volume body 18 in the exemplary embodiment shown, with the position of the volume body 18 being selected in this exemplary embodiment such that it can lie within a stroma 26 of the cornea 14, for example. Furthermore, it is off 1 recognizable that between the stroma 26 and an epithelium 28 the so-called Bowman's membrane 30 can be formed.

Furthermore, the 1 and the 2 that the laser beam 32 generated by the laser device 12 is deflected in the direction of a surface 36 of the cornea by means of a beam deflection device 34, such as a rotary scanner. The beam deflection device 34 is also controlled by the control device 24 in order to generate the determined boundary surfaces 20, 22, preferably also incisions or cuts 38, along predetermined incision courses.

The laser device 12 shown can preferably be a laser device 12 with a photodisruptive laser that is designed to emit laser pulses in a wavelength range between 300 nanometers (nm) and 1400 nm, preferably between 700 nm and 1200 nm, with a respective pulse duration between 1 femtosecond (fs) and 1 nanosecond (ns), preferably between 10 fs and 10 picoseconds (ps), and a repetition rate greater than 10 kilohertz (KHz), preferably between 100 KHz and 100 megahertz (MHz). The control device 24 can optionally also have a storage device (not shown) for at least temporarily storing at least one control data record, the control data record(s) comprising control data for positioning and/or for focusing individual laser pulses in the cornea 14. The position data and/or focusing data of the individual laser pulses can be generated within the stroma 26 of the eye 16, for example, based on a previously measured topography and/or pachymetry and/or the morphology of the cornea or the optical ametropia correction to be generated, preferably based on a determined actual -Geometry of the cornea 14 and preferably based on an analysis of how the volume body 18 should be designed to correct the ametropia.

the 2 shows a schematic representation of the creation of the volume body 18 as an example of the provision S5 of the volume body 18 according to an embodiment of the present method. It can be seen that the determined boundary surfaces 20, 22 are generated by means of the pulsed laser beam 32, which is directed via the beam deflection device 34 in the direction of the cornea 14 or in the direction of the surface 36 of the cornea 14. The determined boundary surfaces 20, 22 can form a volume body 18 in this case. Furthermore, in the exemplary embodiment shown, the laser device 12 produces further cuts 38, each along an incision course 46, 48, which in each case intersects the volume body 18 at a predefined angle and with a predefined geometry and is formed up to the surface 36 of the cornea 14. The volume body 18 defined by the boundary surfaces 20, 22 can then be extracted from the cornea 14 via the respective incision 38.

To determine ametropia data (method step S1, cf 1 ), which can indicate a value in dioptres, for example, or other suitable data for describing the ametropia, for example the control device 24 can receive the corresponding data from a data server, for example, or the ametropia data can be determined as data input or already existing data. Optionally, an actual geometry of an area to be corrected, i.e. a geometry of the area before an intervention that causes the ametropia, can be determined (S2), for example by measuring the area to be corrected using means known to the person skilled in the art from the prior art and these measurement data are used as ametropia data for determining the actual geometry. Optionally, the determined ametropia data can already describe the actual geometry. The actual geometry can be, for example, a thickness of a portion of the cornea 14 and/or a curvature of the cornea 14.

A three-dimensional, preferably digital model of the cornea 14 and/or the area to be corrected can optionally be provided on the basis of the determined ametropia data and/or the optionally determined actual geometry. For example, the target geometry of an area to be corrected can be determined using such a model (S3). The target geometry can optionally meet a predetermined ametropia reduction criterion, ie the specification that the ametropia determined is reduced or even completely eliminated by the target geometry. Optionally, the ametropia reduction criterion can, for example, specify a minimum value of such a reduction, or a minimum probability with which the ametropia is reduced. The ametropia reduction criterion can be stored in the memory device, for example. Based on the target geometry, which can also describe the position of the volume body 18 in the cornea 14, the boundary surfaces 20, 22 of the volume body 18, ie the cut surfaces, can be determined (S4).

If, for example, there is an ametropia of five dioptres, a correction can be provided, for example by removing a volume 18 at a depth of six millimeters from the optical zone.

The extraction of the volume body 18 is shown as an example for the provision S5 of the volume body 18 . Alternatively or additionally, the provision S5 of the volume body can include that the volume body 18 includes storing the volume body 18, for example under one or more predetermined storage conditions such as a storage temperature and a storage duration. The additional or alternative storage condition can preferably also be a nutrient medium in which the volume body 18 is stored. For example, the volume body 18 can be preserved and cooled in a commercially available nutrient solution. Suitable mixtures are known to those skilled in the art from the prior art.

the 3 illustrates the principle of the method according to the invention again by a further scheme. The method steps S1, S3 and S4 have already been to the 1 and the 2 described. The use of the provided volume body 18 includes the use of the volume body 18 in a laboratory test S6, which can be used in particular to collect patient-specific data for the human or animal patient from whom the volume body 18 originates. This can preferably be a medical test method, preferably a screening method in which, for example, it can be tested which substances have a predetermined effect on the lenticule tissue. This can be done, for example, as part of a clinical study.

Ideally, health data of the specified patient can be determined (S7), preferably before the laboratory examination S6, which describes, for example, the patient's corneal pathology and/or a medical history, such as blood values or previous illnesses. These are then made available (S8) for the laboratory examination S6 and preferably taken into account (S9).

Overall, the examples show how lenticules can be provided for laboratory testing, as well as using extracted human corneal lenticules instead of donor eyes or corneas and/or animal in vivo/ex vivo eyes and/or synthetic materials.

According to a further example, lenticules or volumes 18 extracted from the human cornea in refractive treatments, which would otherwise have been discarded unused, can be preserved, for example by cooling in a nutrient solution, for further use in a laboratory examination.

1. 1. Verfahren zum Bereitstellen eines Gewebes für eine Laboruntersuchung, gekennzeichnet durch die Schritte:
   • - Feststellen von Fehlsichtigkeitsdaten eines Auges (16) eines vorgegebenen menschlichen oder tierischen Patienten, wobei die Fehlsichtigkeitsdaten einen Grad einer Fehlsichtigkeit des Auges (16) beschreiben (S1),
   • - anhand der festgestellten Fehlsichtigkeitsdaten: Ermitteln einer Soll-Geometrie eines Korrekturbereichs einer Kornea (17) des Auges (16), wobei die ermittelte Soll-Geometrie ein vorgegebenes Fehlsichtigkeitsreduktions-Kriterium erfüllt, welches eine Eignung zur Reduktion des Grads der Fehlsichtigkeit vorgibt (S3),
   • - Ermitteln von Grenzflächen (20, 22) eines Volumenkörpers (18) innerhalb des Korrekturbereichs, dessen Extraktion den Korrekturbereich von einer Ist-Geometrie in die ermittelte Soll-Geometrie überführt (S4), und
   • - Bereitstellen (S5) des aus der Kornea (17) extrahierten Volumenkörpers (18) für eine Laboruntersuchung (S6).
2. 2. Verfahren nach Ausführungsform 1, dadurch gekennzeichnet, dass das Bereitstellen des aus der Kornea (17) extrahierten Volumenkörpers (18) für eine Laboruntersuchung zum Erheben von patientenspezifischen Daten desjenigen vorgegebenen menschlichen oder tierischen Patienten erfolgt, aus dessen Kornea (17) der Volumenkörper (18) stammt.
3. 3. Verfahren nach einer der Ausführungsformen 1 oder 2, dadurch gekennzeichnet, dass das Bereitstellen (S5) des Volumenkörpers (18) das Lagern des Volumenkörpers (18) unter mindestens einer vorgegebenen Lagerbedingung umfasst; vorzugsweise wobei die vorgegebene Lagerbedingung vorschreibt: eine Lagertemperatur; und/oder ein Nährmedium, in dem der Volumenkörper (18) gelagert wird; und/oder eine Lagerdauer.
4. 4. Verfahren nach einer der Ausführungsformen 1 bis 3, gekennzeichnet durch:
   • - Feststellen von Gesundheitsdaten des vorgegebenen Patienten, von dem der bereitgestellte Volumenkörper (18) stammt (S7); vorzugsweise wobei die festgestellten Gesundheitsdaten eine Kornea-Pathologie des vorgegebenen Patienten und/oder eine Kranken-Historie des vorgegebenen Patienten beschreiben; und
   • - Bereitstellen der festgestellten Gesundheitsdaten für die Laboruntersuchung, und/oder Berücksichtigen der festgestellten Gesundheitsdaten (S9) bei der Laboruntersuchung (S6).
5. 5. Verfahren nach einer der Ausführungsformen 1 bis 4, gekennzeichnet durch
   • - Verwenden des bereitgestellten Volumenkörpers (18) in der Laboruntersuchung (S6).
6. 6. Verfahren nach einer der Ausführungsformen 1 bis 5, dadurch gekennzeichnet, dass die Laboruntersuchung (S6) ein medizinisches Testverfahren ist; vorzugsweise:
   • - ein Screening-Verfahren umfassend ein Inkontaktbringen des bereitgestellten Volumenkörpers (18) mit einem zu screenenden Wirkstoff; und/oder
   • - ein Verträglichkeitstest.
7. 7. Verfahren nach einer der Ausführungsformen 1 bis 6, dadurch gekennzeichnet, das:
   • - die Laboruntersuchung (S6) ein Test oder eine Testserie einer klinischen Studie ist.
8. 8. Verfahren nach einer der Ausführungsformen 1 bis 7, gekennzeichnet durch:
   • - Extrahieren des Volumenkörpers (18) aus der Kornea (17); vorzugsweise mittels einer Lasereinrichtung (12), die dazu ausgelegt ist, Laserpulse in einem Wellenlängenbereich zwischen 300 nm und 1400 nm, vorzugsweise zwischen 700 nm und 1200 nm, bei einer jeweiligen Pulsdauer zwischen 1 fs und 1 ns, vorzugsweise zwischen 10 fs und 10 ps, und einer Wiederholungsfrequenz größer 10 KHz, vorzugsweise zwischen 100 KHz und 100 MHz, abzugeben.
9. 9. Volumenkörper (18) zur Anwendung in einer Laboruntersuchung (S6), insbesondere in einem medizinischen Testverfahren, wobei der Volumenkörper (18) aus einem Verfahren nach einer der Ausführungsformen 1 bis 8 bereitgestellt ist.
10. 10. Verwendung eines aus einer Kornea (17) eines vorgegebenen Patienten extrahierten Volumenkörpers (18) in einer Laboruntersuchung (S6), insbesondere in einem medizinischen Testverfahren.
11. 11. Verwendung nach Ausführungsform 10 in einer Laboruntersuchung (S6) zum Erheben von patientenspezifischen Daten desjenigen vorgegebenen Patienten, aus dessen Kornea (17) der Volumenkörper (18) stammt.
12. 12. Verwendung nach Ausführungsform 10 oder 11, umfassend das Lagern des Volumenkörpers (18), vorzugsweise das Lagern des Volumenkörpers (18) unter einer vorgegebenen Lagerbedingung.
13. 13. Verwendung nach einer der Ausführungsformen 10 bis 12, umfassend ein Screening-Verfahren als Laboruntersuchung (S6).
14. 14. Verwendung nach einer der Ausführungsformen 10 bis 13, gekennzeichnet durch:
    • - Verwenden, insbesondere Berücksichtigen, von festgestellten Gesundheitsdaten des vorgegebenen Patienten zur Analyse der Testergebnisse; vorzugsweise wobei die festgestellten Gesundheitsdaten eine Kornea-Pathologie des vorgegebenen Patienten und/oder eine Kranken-Historie des vorgegebenen Patienten beschreiben.
15. 15. Verwendung nach einer der Ausführungsformen 10 bis 14, dadurch gekennzeichnet, dass der Volumenkörper (18) durch ein Verfahren nach einem der Ansprüche 1 bis 8 bereitgestellt ist.

The invention further includes the following embodiments:

1. 1. A method for providing a tissue for laboratory testing, characterized by the steps:
   • - determining ametropia data of an eye (16) of a specified human or animal patient, the ametropia data describing a degree of ametropia of the eye (16) (S1),
   • - based on the determined ametropia data: determining a target geometry of a correction area of a cornea (17) of the eye (16), the determined target geometry fulfilling a specified ametropia reduction criterion which specifies suitability for reducing the degree of ametropia (S3) ,
   • - determining boundary surfaces (20, 22) of a volume body (18) within the correction area, the extraction of which converts the correction area from an actual geometry into the determined target geometry (S4), and
   • - Providing (S5) the volume body (18) extracted from the cornea (17) for a laboratory examination (S6).
2. 2. Method according to embodiment 1, characterized in that the volume body (18) extracted from the cornea (17) is made available for a laboratory examination to collect patient-specific data of that given human or animal patient from whose cornea (17) the volume body ( 18) originates.
3. 3. The method according to any one of embodiments 1 or 2, characterized in that the provision (S5) of the volume body (18) comprises storing the volume body (18) under at least one predetermined storage condition; preferably wherein the predetermined storage condition dictates: a storage temperature; and/or a nutrient medium in which the volume body (18) is stored; and/or a storage period.
4. 4. The method according to any one of embodiments 1 to 3, characterized by:
   • - Determining health data of the specified patient from whom the provided volume body (18) originates (S7); preferably wherein the ascertained health data describes a corneal pathology of the specified patient and/or a medical history of the specified patient; and
   • - Providing the established health data for the laboratory examination, and/or taking into account the established health data (S9) in the laboratory examination (S6).
5. 5. The method according to any one of embodiments 1 to 4, characterized by
   • - Using the provided solid (18) in the laboratory investigation (S6).
6. 6. Method according to one of embodiments 1 to 5, characterized in that the laboratory examination (S6) is a medical test method; preferably:
   • - A screening method comprising bringing the provided volume body (18) into contact with an active ingredient to be screened; and or
   • - a tolerance test.
7. 7. The method according to any one of embodiments 1 to 6, characterized in that:
   • - the laboratory test (S6) is a test or series of tests from a clinical study.
8. 8. The method according to any one of embodiments 1 to 7, characterized by:
   • - extracting the volume body (18) from the cornea (17); preferably by means of a laser device (12), which is designed to generate laser pulses in a wavelength range between 300 nm and 1400 nm, preferably between 700 nm and 1200 nm, with a respective pulse duration between 1 fs and 1 ns, preferably between 10 fs and 10 ps , And a repetition frequency greater than 10 KHz, preferably between 100 KHz and 100 MHz to deliver.
9. 9. Volume body (18) for use in a laboratory test (S6), in particular in a medical test method, the volume body (18) being provided from a method according to one of embodiments 1 to 8.
10. 10. Use of a volume body (18) extracted from a cornea (17) of a specified patient in a laboratory examination (S6), in particular in a medical test method.
11. 11. Use according to embodiment 10 in a laboratory examination (S6) for collecting patient-specific data of that given patient from whose cornea (17) the volume body (18) originates.
12. 12. Use according to embodiment 10 or 11, comprising storing the solid (18), preferably storing the solid (18) under a predetermined storage condition.
13. 13. Use according to any one of embodiments 10 to 12, comprising a screening method as a laboratory test (S6).
14. 14. Use according to one of embodiments 10 to 13, characterized by:
    • - Using, in particular taking into account, ascertained health data of the specified patient for analysis of the test results; preferably wherein the ascertained health data describe a corneal pathology of the specified patient and/or a medical history of the specified patient.
15. 15. Use according to any one of embodiments 10 to 14, characterized in that the volume body (18) is provided by a method according to any one of claims 1 to 8.

QUOTES INCLUDED IN DESCRIPTION

This list of documents cited by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent Literature Cited

• US2019038399A1 [0003]
• US2019175333A1 [0003]
• US 2020/0046559 A1 [0003]
• WO 2019/084557 A1 [0003]
• US2009143858A1 [0005]

Claims (14)

Method for providing a tissue for a laboratory examination, characterized by : - determining ametropia data of an eye (16) of a specified human or animal patient, the ametropia data describing a degree of ametropia of the eye (16) (S1), - using the ascertained ametropia data : Determining a target geometry of a correction area of a cornea (17) of the eye (16), the determined target geometry fulfilling a predetermined ametropia reduction criterion which specifies suitability for reducing the degree of ametropia (S3), - determining boundary surfaces (20, 22) of a volume body (18) within the correction area, the extraction of which converts the correction area from an actual geometry to the determined target geometry (S4), - providing (S5) the volume body (18 ) for a laboratory examination (S6), - Determination of health data of the specified patient ient from which the provided volume body (18) originates (S7); preferably wherein the ascertained health data describes a corneal pathology of the specified patient and/or a medical history of the specified patient; and - providing the ascertained health data for the laboratory examination, and/or taking into account the ascertained health data (S9) in the laboratory examination (S6). procedure after claim 1 , characterized in that the volume body (18) extracted from the cornea (17) is provided for a laboratory examination to collect patient-specific data of that specified human or animal patient from whose cornea (17) the volume body (18) originates. Method according to one of the preceding claims, characterized in that the provision (S5) of the volume body (18) comprises the storage of the volume body (18) under at least one predetermined storage condition; preferably wherein the predetermined storage condition dictates: a storage temperature; and/or a nutrient medium in which the volume body (18) is stored; and/or a storage period. Method according to one of the preceding claims, characterized by - using the provided volume body (18) in the laboratory test (S6). Method according to one of the preceding claims, characterized in that the laboratory test (S6) is a medical test method; preferably: - a screening method comprising bringing the provided volume body (18) into contact with an active substance to be screened; and/or - a tolerance test. Method according to one of the preceding claims, characterized in that - the laboratory examination (S6) is a test or a test series of a clinical study. Method according to one of the preceding claims, characterized by - extracting the volume body (18) from the cornea (17); preferably by means of a laser device (12), which is designed to generate laser pulses in a wavelength range between 300 nm and 1400 nm, preferably between 700 nm and 1200 nm, with a respective pulse duration between 1 fs and 1 ns, preferably between 10 fs and 10 ps , And a repetition frequency greater than 10 KHz, preferably between 100 KHz and 100 MHz to deliver. Volume body (18) for use in a laboratory test (S6), in particular in a medical test method, the volume body (18) from a method according to one of Claims 1 until 7 is provided. Use of a volume body (18) extracted from a cornea (17) of a given patient in a laboratory examination (S6), in particular in a medical test method,. use after claim 9 in a laboratory examination (S6) for collecting patient-specific data of that specified patient from whose cornea (17) the volume body (18) originates, including using, in particular taking into account, ascertained health data of the specified patient to analyze the test results. use after claim 9 or 10 , comprising storing the solid body (18), preferably storing the solid body (18) under a predetermined storage condition. Use after one of claims 9 until 10 , comprising a screening method as a laboratory test (S6). Use after one of claims 9 until 12 , wherein the ascertained health data describe a corneal pathology of the specified patient and/or a medical history of the specified patient. Use after one of claims 9 until 13 , characterized in that the volume body (18) by a method according to any one of Claims 1 until 7 is provided.

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