CN116531674A - Intracavity photodynamic therapy equipment - Google Patents

Intracavity photodynamic therapy equipment Download PDF

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Publication number
CN116531674A
CN116531674A CN202310705870.8A CN202310705870A CN116531674A CN 116531674 A CN116531674 A CN 116531674A CN 202310705870 A CN202310705870 A CN 202310705870A CN 116531674 A CN116531674 A CN 116531674A
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CN
China
Prior art keywords
light
light guide
photodynamic therapy
endoluminal
layer
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Pending
Application number
CN202310705870.8A
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Chinese (zh)
Inventor
胡晓明
罗恋梅
张军
熊基源
金腾
王旭
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Beijing Institute of Technology BIT
Beijing Anzhen Hospital
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Beijing Institute of Technology BIT
Beijing Anzhen Hospital
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Application filed by Beijing Institute of Technology BIT, Beijing Anzhen Hospital filed Critical Beijing Institute of Technology BIT
Priority to CN202310705870.8A priority Critical patent/CN116531674A/en
Publication of CN116531674A publication Critical patent/CN116531674A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • A61N5/0603Apparatus for use inside the body for treatment of body cavities
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/067Radiation therapy using light using laser light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0601Apparatus for use inside the body
    • A61N5/0603Apparatus for use inside the body for treatment of body cavities
    • A61N2005/0611Vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0632Constructional aspects of the apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/065Light sources therefor
    • A61N2005/0651Diodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/065Light sources therefor
    • A61N2005/0651Diodes
    • A61N2005/0652Arrays of diodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0664Details

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  • Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

The invention discloses an intracavity photodynamic therapy device, which relates to the technical field of medical appliances and comprises: the device comprises a luminous light source, a light guide and a light homogenizing device, wherein the luminous light source and the light homogenizing device are respectively arranged at two ends of the light guide, the light homogenizing device can be arranged at a treatment position in a cavity, and treatment light emitted by the luminous light source can be conducted to the treatment position in the cavity through the light guide and the light homogenizing device; the light homogenizer comprises a light guide layer and a scattering layer, wherein the scattering layer covers the outer side of the light guide layer, and the light power ratio of illumination energy of the therapeutic light in side illumination and axial transmission can be adjusted by changing the shape of the interface section of the light guide layer and the scattering layer. The invention can improve the uniformity of illumination, thereby ensuring the effect of photodynamic therapy.

Description

Intracavity photodynamic therapy equipment
Technical Field
The invention relates to the technical field of medical equipment, in particular to intracavity photodynamic therapy equipment.
Background
Photodynamic therapy uses the selective uptake and retention of photosensitizers by pathological cells, remains in pathological tissues for a certain period of time, irradiates focal sites with laser light of specific wavelength, induces strong photochemical reaction under the participation of molecular oxygen in biological tissues to generate very active singlet oxygen and other chemically active products, thereby achieving the aim of damaging targeted cells or tissues, and has been widely applied to tumors, skin diseases, inflammations, ophthalmic diseases, infectious diseases and the like. Photosensitizers, light and oxygen are three essential elements of photodynamic therapy.
At present, laser, light emitting diode and the like are often used as excitation light sources for photodynamic therapy in clinic, for example, patent CN105749427B discloses a photodynamic therapy light guide system which can be used for a human body cavity, and the photodynamic therapy light guide system consists of columnar optical fibers or point-shaped LED lamps, a temperature control sleeve, a photosensitizer conveying sleeve and an oxygen conveying sleeve so as to solve the problems of loss of photosensitizer and oxygen, temperature control and the like in photodynamic therapy.
However, the treatment light guide system has poor treatment effect on narrow parts such as vaginal fornix and the like in the body cavity; specifically, as shown in fig. 1, the vaginal fornix 401 is located in the female pelvis, and is a circular shadow pit between the female cervix 402 and the vagina, and the inner side surfaces of the cervix 402, the vaginal fornix 401 and the vaginal wall 403 need to be simultaneously irradiated with high-uniformity light during photodynamic therapy, while the conventional columnar optical fiber, the flat-top optical fiber and the like are difficult to guide therapeutic light into the vaginal fornix 401 during illumination, so that the photodynamic therapy effect is affected.
Disclosure of Invention
The invention aims to provide an intracavity photodynamic therapy device which solves the problems in the prior art and can improve the uniformity of illumination so as to ensure the photodynamic therapy effect.
In order to achieve the above object, the present invention provides the following solutions:
the present invention provides an endoluminal photodynamic therapy device comprising: the device comprises a luminous light source, a light guide and a light homogenizing device, wherein the luminous light source and the light homogenizing device are respectively arranged at two ends of the light guide, the light homogenizing device can be arranged at a treatment position in a cavity, and treatment light emitted by the luminous light source can be conducted to the treatment position in the cavity through the light guide and the light homogenizing device; the light homogenizer comprises a light guide layer and a scattering layer, wherein the scattering layer covers the outer side of the light guide layer, and the light power ratio of illumination energy of the therapeutic light in side illumination and axial transmission can be adjusted by changing the shape of the interface section of the light guide layer and the scattering layer.
Preferably, the interface section of the light guide layer and the scattering layer is conical, and the distance from the vertex of the interface section to the vertex of the scattering layer is higher than 1 times of the equivalent light scattering path.
Preferably, the section of the light homogenizing device far away from the light guide is of a W-shaped structure.
Preferably, the light guide layer is made of transparent silica gel or organic plastic, and the scattering layer is made of silica gel, organic glass or soluble biocompatible material.
Preferably, the light guide is of a barrel-shaped structure, the length of the light guide is 80-300 mm, a central through hole is axially formed in the light guide, and the light homogenizing device is of an annular structure and is circumferentially arranged at the end part of the light guide, which is far away from the luminous light source.
Preferably, the light homogenizer comprises a plurality of arc blocks, all of which are distributed along the circumference to enclose the light homogenizer.
Preferably, a radiating fin is further arranged at one end of the light guide, where the luminous light source is arranged, the luminous light source is located between the radiating fin and the light guide, a central opening is arranged on the radiating fin, and the central opening is communicated with a central through hole on the light guide.
Preferably, the light emitting source is a light emitting diode or a laser light source.
Preferably, the light guide and the light homogenizer are integrally formed.
Preferably, the light guide and the light homogenizer are of split type structure, the light guide is made of hard light guide material, and the light homogenizer is made of flexible material.
Compared with the prior art, the invention has the following technical effects:
the light homogenizing device can be placed in narrow cavity treatment parts such as vaginal fornix and the like for illumination, comprises the light guide layer and the scattering layer to form a sandwich structure, and can adjust the light power ratio of illumination energy of treatment light in lateral illumination and axial transmission by changing the shape of the interface section of the light guide layer and the scattering layer, so that irradiance uniformity in a lateral treatment surface can be improved, and the effect of photodynamic treatment is ensured.
In addition, the therapeutic light emitted by the luminous light source is conducted to the treatment part in the cavity through the light guide and the light homogenizing device, the luminous light source is far away from the treatment part in the cavity, the excessive temperature rise caused by the thermal effect of the luminous light source is reduced, and the thermal damage of normal tissues is avoided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is an anatomic view of the cervical fornix;
FIG. 2 is a schematic exploded cross-sectional view of the operation of an intracavity photodynamic therapy device (the dome may be illuminated alone) in accordance with an embodiment of the present invention;
FIG. 3 is a cross-sectional view of a homogenizer portion according to an embodiment of the present invention;
in fig. 4, the solid line is the light intensity distribution curve with angle at the interface of the light guide and the light homogenizer, and the dotted line is a typical shape of the interface profile of the light guide layer and the scattering layer;
FIG. 5 is a graph of contrast in illuminance for an endoluminal photodynamic therapy device according to an embodiment of the present invention formed on a surface of a vaginal vault, wherein reference a indicates a normalized illuminance distribution for a typical vaginal vault surface formed of a single scattering material, and reference b indicates a normalized illuminance distribution for a typical vaginal vault surface formed of an endoluminal photodynamic therapy device according to an embodiment of the present invention;
FIG. 6 is a schematic cross-sectional view of a connecting section of the light homogenizer and the light guide when the endoluminal photodynamic therapy device according to the embodiment of the present invention treats both the vaginal fornix and the cervix;
FIG. 7 is a schematic diagram of an exemplary method of calculating an interface profile for the endoluminal photodynamic therapy device of FIG. 6.
In the figure: 401 is the vaginal fornix, 402 is the cervix uteri, 403 is the vaginal wall, 404 is the external orifice of the cervix uteri, 101 is the heat sink, 201 is the light source of the light emission, 301 is the light guide, 301a is the interface of the light guide and the light homogenizer, 302 is the light homogenizer, 302a is the light guide layer, 302b is the scattering layer, 302c is the interface profile of the light guide layer and the scattering layer.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The invention aims to provide an intracavity photodynamic therapy device which solves the problems in the prior art and can improve the uniformity of illumination so as to ensure the photodynamic therapy effect.
In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description.
Example 1
As shown in fig. 2-7, the present embodiment provides an intracavity photodynamic therapy device, which is mainly suitable for photodynamic therapy in narrow space areas such as a vaginal fornix 401 in a human body cavity; wherein, the intracavity photodynamic therapy device mainly comprises: the device comprises a luminous light source 201, a light guide 301 and a light homogenizer 302, wherein the luminous light source 201 and the light homogenizer 302 are respectively arranged at two ends of the light guide 301, the light homogenizer 302 can be placed in an intracavity treatment position, and treatment light emitted by the luminous light source 201 can be conducted to the intracavity treatment position through the light guide 301 and the light homogenizer 302; the light homogenizer 302 includes a light guiding layer 302a and a scattering layer 302b, the scattering layer 302b covers the outer side of the light guiding layer 302a to form a sandwich structure, and the light power ratio of the illumination energy of the therapeutic light in lateral illumination and axial transmission can be adjusted by changing the shape of the interface section 302c of the light guiding layer 302a and the scattering layer 302b, so that irradiance uniformity in a lateral treatment surface can be improved, and the effect of photodynamic therapy is ensured.
In this embodiment, the light guide 301 is preferably a hollow barrel-shaped structure, in which a central through hole is axially disposed, the length of the light guide 301 is 80 mm-300 mm, the outer diameter is 20 mm-40 mm, the wall thickness is 2 mm-6 mm, and the light homogenizer 302 is a ring-shaped structure and is circumferentially disposed at an end of the light guide 301 far from the light-emitting source 201.
In the embodiment, the light guide 301 is used for realizing long-distance transmission of therapeutic light from the vulva to the vicinity of the cervix 402, so that the light-emitting source 201 is far away from the treatment part in the cavity, the excessive temperature rise caused by the thermal effect of the light-emitting source 201 is reduced, and the thermal damage of normal tissues is avoided; meanwhile, the central through hole not only can facilitate the operation of doctors, but also can be used for monitoring the temperature, blood oxygen saturation and other conditions of the surface of the cervical 402, and can also be used for air cooling and heat dissipation.
In this embodiment, the light guide 301 and the light homogenizer 302 are integrally formed or split, preferably split; the light guide 301 is made of a hard light guide material, such as optical plastic or organic glass, preferably high refractive index organic glass, and the light guide layer 302a of the light homogenizer 302 is made of transparent silica gel, organic plastic, and the light scattering layer 302b is made of silica gel doped with 0.01-10% of silica, organic nano-beads, organic glass mixed with organic nano-beads, and soluble biocompatible material such as sodium hyaluronate mixed with photosensitizer.
As a preferred embodiment, the light homogenizer 302 is entirely made of a flexible material such as silica gel, at this time, the light guide layer 302a is made of a transparent silica gel material, the scattering layer 302b is made of a semitransparent silica gel material, the shape of the end of the light homogenizer 302 far away from the light guide 301 is matched with the shape of the treatment site in the cavity, and can better contact with the surface to be illuminated of the treatment site in the cavity, as shown in fig. 2 and 3, when only the vaginal fornix 401 is subjected to photodynamic therapy, the whole light homogenizer 302 can be tapered; the light guide 301 is made of a hard light guide material; the connection ends of the light homogenizer 302 and the light guide 301 may be detachably connected by a snap connection or other connection means.
As a preferred embodiment, in this embodiment, to facilitate the placement of the light homogenizer 302 into the vaginal fornix 401, the light homogenizer 302 is configured to include a plurality of arc-shaped blocks with different radians, and all of the arc-shaped blocks are circumferentially distributed to enclose the light homogenizer 302.
In this embodiment, the light emitting source 201 is preferably a plurality of light emitting diodes, more preferably, the light emitting diodes are all arranged in a circumferential array, specifically, the power of the light emitting diodes is more than 1W, and the light emitting diodes are uniformly arranged at intervals of 10-30 ° on the circumference; alternatively, the light-emitting source 201 may be formed by a circular scanning method or wave guide shaping using a laser source.
In this embodiment, the light guide 301 is further provided with a heat sink 101 at one end of the light source 201, the light source 201 is located between the heat sink 101 and the light guide 301, a plurality of heat dissipation fins are disposed at a side of the heat sink 101 away from the light source 201, a central opening is disposed on the heat sink 101, and the central opening is communicated with a central through hole on the light guide 301, so that treatment, cooling, observation and the like can be facilitated.
In this embodiment, as shown in fig. 3, the interface section 302c between the light guiding layer 302a and the scattering layer 302b is conical, and the outer surface is covered with the scattering layer 302b made of light scattering material, wherein the height of the top of the light guiding layer of the light homogenizer from the bottom is L h The height of the vertex of the light guide layer of the light homogenizer from the light scattering layer is L b W is the radial thickness of the interface between the light guide layer of the light homogenizer and the light guide when contacting, and the distance L from the vertex of the interface section 302c of the light guide layer 302a and the scattering layer 302b to the vertex of the scattering layer 302b b More than 1 time of the equivalent path of light scattering (mean free path of light scattering), i.e. u T =u a +u s Wherein u is a U is the absorption coefficient s For the scattering coefficient, the mean free path of light scattering mfp=1/u T
Alternatively, when the light intensity distribution curve of the light guide 301 formed at the interface 301a between the light guide and the light homogenizer is shown as a solid line in fig. 4, if the full angle of half intensity is α, the curve of the interface 302c between the light guide layer 302a and the scattering layer 302b is a conic curve, three points in the conic curve are respectively overlapped with the vertex of the conic curve and two points at the outermost width of the decomposition surface 301a between the light guide and the light homogenizer, and the height from the vertex is 0.1×l h When it is at a radial distance Ta from the scattering layer 302b of the homogenizer 302 of not less than 1 times the light scattering equivalent path.
Briefly, a straight line may be used instead of the interface profile 302c curve of the light guiding layer and the scattering layer, such that
Optionally, the normalized curve of intensity of light with angular distribution at the interface 301a of the light guide and light homogenizer (solid line in fig. 4) is scaled, i.e. the longitudinal height is enlarged to the extent that the dashed lines' y and L h The radial thickness W of the interface is equal to the radial thickness W of the interface when the light guide layer of the light homogenizer is contacted with the light guide by transversely stretching beta, and the two curves and the X-axis are kept to form the same area;
optionally, the interface profile 302c curve of the light guiding layer 302a and the scattering layer 302b is made to satisfy:
where n=1 to 10, and x is the distance from the central axis.
As shown in fig. 5, the illuminance contrast chart formed on the surface of the vaginal vault 401 in this embodiment is shown, where the symbol a represents the normalized illuminance distribution of the surface of the typical vaginal vault 401 formed by the single scattering material, and b represents the normalized illuminance distribution of the surface of the typical vaginal vault 401 formed by the endoluminal photodynamic therapy device in this embodiment.
For treating the vaginal fornix 401 and the cervical part 402 at the same time, fig. 6 shows a schematic cross-sectional view of a connecting section of the light homogenizer 302 and the light guide 301, wherein the light homogenizer 302 is made of silica gel, and a distal end (an end far away from the light-emitting source 201) of the light homogenizer is in a W-shaped structure and is matched with the cervical part 402 and the vaginal fornix 401 in shape; typically, the angle between the side of the proximal end (near the end of the luminescent light source 201) and the axis is equal to the half-intensity divergence angle of the light at the end face of the light guiding section, and the curve of the interface section 302c of the light guiding layer 302a and the scattering layer 302b can be drawn as follows:
as shown in figure 7 of the drawings,
1) Selecting n characteristic points on the surfaces of the vaginal fornix 401 and the cervix 402, and enabling the fitting curves of the characteristic points to be matched with the surfaces of the vaginal fornix 401 and the cervix 402;
2) Calculating the distance d from the center o point of the circular side wall of the light guide 301 to each characteristic point and the included angle alpha between the connecting line and the axis, and recording the maximum value of the distance square and the included angle cosine of the parameters:
T=max(d 2 cos(α)) (3)
and let the connection line between the feature point and the center o point pass through the thickness d of the scattering layer 302b s And d s Is 1-3 times of light scattering equivalent path.
3) The thickness of the other feature points corresponding to the passing scattering layer 302b is:
wherein i=1 to (n-1).
4) Fitting the end points of the line segments to form the curves of the interface sections 302c of the light guide layer 302a and the scattering layer 302 b.
The principles and embodiments of the present invention have been described in detail with reference to specific examples, which are provided to facilitate understanding of the method and core ideas of the present invention; also, it is within the scope of the present invention to be modified by those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the invention.

Claims (10)

1. An endoluminal photodynamic therapy device, characterized by: comprising the following steps: the device comprises a luminous light source, a light guide and a light homogenizing device, wherein the luminous light source and the light homogenizing device are respectively arranged at two ends of the light guide, the light homogenizing device can be arranged at a treatment position in a cavity, and treatment light emitted by the luminous light source can be conducted to the treatment position in the cavity through the light guide and the light homogenizing device; the light homogenizer comprises a light guide layer and a scattering layer, wherein the scattering layer covers the outer side of the light guide layer, and the light power ratio of illumination energy of the therapeutic light in side illumination and axial transmission can be adjusted by changing the shape of the interface section of the light guide layer and the scattering layer.
2. An endoluminal photodynamic therapy device according to claim 1, wherein: the cross section of the light homogenizer is of a conical structure, the cross section of the interface between the light guide layer and the scattering layer is conical, and the distance from the vertex of the cross section of the interface to the vertex of the scattering layer is higher than 1 times of the equivalent light scattering path.
3. An endoluminal photodynamic therapy device according to claim 1, wherein: the section of the light homogenizing device is far away from one end of the light guide device and is of a W-shaped structure.
4. An endoluminal photodynamic therapy device according to any one of claims 1-3 wherein: the light guide layer is made of transparent silica gel or organic plastic, and the scattering layer is made of silica gel, organic glass or soluble biocompatible material.
5. An endoluminal photodynamic therapy device according to claim 1, wherein: the light guide is of a barrel-shaped structure, the length of the light guide is 80-300 mm, a central through hole is axially formed in the light guide, and the light homogenizing device is of an annular structure and is arranged at the end part of the light guide, which is far away from the luminous light source, in a surrounding mode.
6. The endoluminal photodynamic therapy device according to claim 5, wherein: the light homogenizing device comprises a plurality of arc-shaped blocks, all the arc-shaped blocks are distributed along the circumference and enclose the light homogenizing device.
7. The endoluminal photodynamic therapy device according to claim 5, wherein: the light guide is characterized in that a radiating fin is further arranged at one end of the light-emitting light source arranged on the light guide, the light-emitting light source is located between the radiating fin and the light guide, a central opening is formed in the radiating fin, and the central opening is communicated with a central through hole in the light guide.
8. The endoluminal photodynamic therapy device according to claim 1 or 7, wherein: the luminous light source is a light emitting diode or a laser light source.
9. The endoluminal photodynamic therapy device according to claim 1 or 5, wherein: the light guide and the light homogenizing device are of an integrally formed structure.
10. The endoluminal photodynamic therapy device according to claim 1 or 5, wherein: the light guide and the light homogenizing device are of split type structures, the light guide is made of hard light guide materials, and the light homogenizing device is made of flexible materials.
CN202310705870.8A 2023-06-14 2023-06-14 Intracavity photodynamic therapy equipment Pending CN116531674A (en)

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CN202310705870.8A CN116531674A (en) 2023-06-14 2023-06-14 Intracavity photodynamic therapy equipment

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310705870.8A CN116531674A (en) 2023-06-14 2023-06-14 Intracavity photodynamic therapy equipment

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CN116531674A true CN116531674A (en) 2023-08-04

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