WO2022171315A1 - Screening device to support a clinical diagnosis, in particular a diagnosis of cystic fibrosis - Google Patents
Screening device to support a clinical diagnosis, in particular a diagnosis of cystic fibrosis Download PDFInfo
- Publication number
- WO2022171315A1 WO2022171315A1 PCT/EP2021/061862 EP2021061862W WO2022171315A1 WO 2022171315 A1 WO2022171315 A1 WO 2022171315A1 EP 2021061862 W EP2021061862 W EP 2021061862W WO 2022171315 A1 WO2022171315 A1 WO 2022171315A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sweat
- screening device
- diagnosis
- sensor
- meq
- Prior art date
Links
- 238000003745 diagnosis Methods 0.000 title claims abstract description 15
- 238000012216 screening Methods 0.000 title claims abstract description 13
- 201000003883 Cystic fibrosis Diseases 0.000 title claims abstract description 11
- 238000003759 clinical diagnosis Methods 0.000 title description 2
- 210000004243 sweat Anatomy 0.000 claims abstract description 29
- 150000003839 salts Chemical class 0.000 claims abstract description 4
- 238000002405 diagnostic procedure Methods 0.000 claims abstract description 3
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims description 11
- 239000000460 chlorine Substances 0.000 claims description 11
- 229910052801 chlorine Inorganic materials 0.000 claims description 11
- QCHFTSOMWOSFHM-WPRPVWTQSA-N (+)-Pilocarpine Chemical compound C1OC(=O)[C@@H](CC)[C@H]1CC1=CN=CN1C QCHFTSOMWOSFHM-WPRPVWTQSA-N 0.000 claims description 7
- QCHFTSOMWOSFHM-UHFFFAOYSA-N SJ000285536 Natural products C1OC(=O)C(CC)C1CC1=CN=CN1C QCHFTSOMWOSFHM-UHFFFAOYSA-N 0.000 claims description 7
- 229960001416 pilocarpine Drugs 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 4
- 230000009471 action Effects 0.000 claims description 3
- 230000008569 process Effects 0.000 claims description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- 230000028327 secretion Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000003097 mucus Anatomy 0.000 description 2
- 230000004936 stimulating effect Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000032258 transport Effects 0.000 description 2
- 108010062745 Chloride Channels Proteins 0.000 description 1
- 102000011045 Chloride Channels Human genes 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 208000026350 Inborn Genetic disease Diseases 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 208000035415 Reinfection Diseases 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 208000010668 atopic eczema Diseases 0.000 description 1
- 210000000621 bronchi Anatomy 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 210000000245 forearm Anatomy 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 208000016361 genetic disease Diseases 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000035772 mutation Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
- A61B5/14517—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat
- A61B5/14521—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat using means for promoting sweat production, e.g. heating the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
Definitions
- the present invention relates to a screening device to support clinical diagnoses, in particular the diagnosis of cystic fibrosis.
- the screening test of the present invention is a small/medium-sized, transportable and practical instrument, and is designed to take the amount of salinity in sweat, necessary in clinical practice to help support some diagnoses, especially for the diagnosis of cystic fibrosis.
- the present description will therefore focus on the diagnosis of cystic fibrosis, even if the described device can also be used for other clinical diagnoses.
- Cystic fibrosis is an autosomal recessive genetic disorder caused by a mutation in the CF gene that codes for a protein that acts as a chlorine channel, called CFTR.
- the alteration of this gene causes the production of excessively thick mucus, which causes various problems, including: recurrent infections; closure of the bronchi; and also involves an anomaly in the transport of salts and determines the production of more dehydrated secretions.
- sweat is rich in sodium and chlorine, releasing and producing thicker and viscous mucus, which tends to clog the ducts in which it is found.
- this disease among the symptoms that can be found: excessive salinity in the sweat of the subject affected by this disease.
- the first step consists of stimulating sweat, through the application, on the legs or forearms, of two electrodes on which two gels containing pilocarpine are placed.
- the low-voltage electric current which comes from a battery-powered generator, promotes the transport of pilocarpine to the superficial layers of the skin, stimulating the production of sweat.
- the second step involves the analysis of the patient's sweat.
- test can be performed only and exclusively by expert personnel and in specialized structures
- the time required is approximately 30 minutes
- the device must be sent to a specialized laboratory, where the reporting time can be 1 or 2 working days. Furthermore, a single laboratory result is not sufficient to confirm or exclude the diagnosis of CF.
- Object of the present invention is solving the aforementioned prior art problems, by providing a screening device to support clinical diagnoses, in particular the diagnosis of cystic fibrosis, which replaces the technique indicated above, which requires a healthcare professional to be carried out and suitable tools.
- test device of the present invention comprises:
- At least one salinity detector 2 connected to the buffer 1 and able to measure the quantity of salts present on the tissue to be analyzed;
- At least one sensor/actuator 3 connected to the salinity detector 2, which sensor/actuator 3, depending on the concentrations, signals the values that can be found for a probable diagnosis.
- the subject Upon a secretion of sweat, the subject can put the device under the armpits for a few minutes (preferably, about 5 minutes), which is the time necessary for the pad 1 to absorb the sweat.
- concentrations on which detector 2 will have to be based are the following: a concentration of chlorine in sweat: ⁇ 40 mEq/L corresponds to a normal situation
- a concentration of chlorine in sweat of an intermediate level between 40 and 60 mEq/L is a suggestive value, but not sufficient for a diagnosis of CF: it could be signaled by sensor 3, for example, with the color yellow
- a concentration of chlorine in sweat equal to or greater than 60 mEq/L supports the diagnosis of cystic fibrosis.
- the sensor 3 can be connected to at least one display (not shown) to show the user the result calculated by sensor 3 using detector 4.
- concentration of chlorine in the sweat is intermediate, between 40 and 60 mEq/L, then a yellow light may turn on.
- concentration of chlorine in sweat is equal to or greater than 60 mEq/L, then a red light may turn on.
- the inventive device it is possible to associate at least one patch 4, connected to the salinity detector 3, this patch 4 operating as a transdermal release element containing pilocarpine.
- an external power supply (not shown) or an internal battery (not shown) can be used to speed up the process/action of pilocarpine to release sweat, through the patch 4.
- an internal battery (not shown)
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Biomedical Technology (AREA)
- Medical Informatics (AREA)
- Biophysics (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Optics & Photonics (AREA)
- Dermatology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
A screening device is described to support clinical diagnoses, in particular the diagnosis of cystic fibrosis; this device comprises: a pad (1) absorbing the amount of sweat necessary for the purpose of a diagnostic test; a salinity detector (2) connected to the buffer (1) and able to measure the quantity of salts present on a tissue to be analyzed; a sensor/actuator (3) connected to the salinity detector (2), this sensor/actuator (3) being designed, according to the concentrations, to signal the values found for a diagnosis.
Description
SCREENING DEVICE TO SUPPORT A CLINICAL DIAGNOSIS IN PARTICULAR A DIAGNOSIS OF CYSTIC FIBROSIS
The present invention relates to a screening device to support clinical diagnoses, in particular the diagnosis of cystic fibrosis. The screening test of the present invention is a small/medium-sized, transportable and practical instrument, and is designed to take the amount of salinity in sweat, necessary in clinical practice to help support some diagnoses, especially for the diagnosis of cystic fibrosis. The present description will therefore focus on the diagnosis of cystic fibrosis, even if the described device can also be used for other clinical diagnoses.
Cystic fibrosis is an autosomal recessive genetic disorder caused by a mutation in the CF gene that codes for a protein that acts as a chlorine channel, called CFTR. The alteration of this gene causes the production of excessively thick mucus, which causes various problems, including: recurrent infections; closure of the
bronchi; and also involves an anomaly in the transport of salts and determines the production of more dehydrated secretions.
Therefore, sweat is rich in sodium and chlorine, releasing and producing thicker and viscous mucus, which tends to clog the ducts in which it is found. In this disease, among the symptoms that can be found: excessive salinity in the sweat of the subject affected by this disease.
For this reason, the sweat test was created in 1959, by Gibson and Cooke. This known test involves two steps:
1. The first step consists of stimulating sweat, through the application, on the legs or forearms, of two electrodes on which two gels containing pilocarpine are placed. The low-voltage electric current, which comes from a battery-powered generator, promotes the transport of pilocarpine to the superficial layers of the skin, stimulating the production of sweat.
2. The second step, on the other hand, involves the analysis of the patient's sweat.
The known art has the following disadvantages: the test can be performed only and exclusively by expert personnel and in specialized
structures
- it can cause pain or feel itchy with the appearance of eczema in the area where sweat has been stimulated
- for the phase in which the absorbent paper must be applied, in order to perform the test correctly, the time required is approximately 30 minutes
- risk of burns, albeit in rare cases (in the order of one case out of 50,000) and increases in the event of lack of operator experience or obsolete/antiquated equipment
- for sweat analysis, the device must be sent to a specialized laboratory, where the reporting time can be 1 or 2 working days. Furthermore, a single laboratory result is not sufficient to confirm or exclude the diagnosis of CF.
Object of the present invention is solving the aforementioned prior art problems, by providing a screening device to support clinical diagnoses, in particular the diagnosis of cystic fibrosis, which replaces the technique indicated above, which requires a healthcare professional to be carried out and suitable tools.
The above and other objects and advantages of
the invention, as will emerge from the following description, are achieved with a screening device for supporting clinical diagnoses, in particular the diagnosis of cystic fibrosis, such as that described in claim 1. Preferred embodiments and non-trivial variants of the present invention form the subject of the dependent claims.
It is understood that all the attached claims form an integral part of the present description.
The present invention will be better described by some preferred embodiments, provided by way of non-limiting example, with reference to the attached drawings, in which the only Figure 1 is a schematic view of a preferred embodiment of the device according to the present invention.
With reference to the Figure, a preferred embodiment of the device of the present invention is illustrated and described. It will be immediately obvious that innumerable variations and modifications (for example relating to shape, dimensions, arrangements and parts with equivalent functionality) can be made to what is described without departing from the scope of the invention as appears from the attached claims.
With reference to Figure 1, the test device of
the present invention comprises:
- at least one pad 1 absorbing the amount of sweat necessary for the purpose of a diagnostic test;
- at least one salinity detector 2 connected to the buffer 1 and able to measure the quantity of salts present on the tissue to be analyzed;
- at least one sensor/actuator 3 connected to the salinity detector 2, which sensor/actuator 3, depending on the concentrations, signals the values that can be found for a probable diagnosis.
Upon a secretion of sweat, the subject can put the device under the armpits for a few minutes (preferably, about 5 minutes), which is the time necessary for the pad 1 to absorb the sweat.
The amounts of sweat that pad 1 must collect must be:
- more than 75 mg
- less than 400/500 mg so that these quantities are sufficient to carry out the test correctly, as is already known to a person skilled in the art.
Furthermore, the concentrations on which detector 2 will have to be based are the following: a concentration of chlorine in sweat: < 40
mEq/L corresponds to a normal situation
- a concentration of chlorine in sweat of an intermediate level, between 40 and 60 mEq/L is a suggestive value, but not sufficient for a diagnosis of CF: it could be signaled by sensor 3, for example, with the color yellow
- a concentration of chlorine in sweat equal to or greater than 60 mEq/L supports the diagnosis of cystic fibrosis.
Up to 6 months of age, the normal concentration of chlorine in sweat drops to 30 mEq/L.
The sensor 3 can be connected to at least one display (not shown) to show the user the result calculated by sensor 3 using detector 4.
For example, if the concentration of chlorine in sweat: < 40 mEq/L for adults or 30 mEq/L for children, then a green light might turn on.
If the concentration of chlorine in the sweat is intermediate, between 40 and 60 mEq/L, then a yellow light may turn on.
If the concentration of chlorine in sweat is equal to or greater than 60 mEq/L, then a red light may turn on.
The advantages offered by this test, unlike
the known art, are: it does not require the assistance of experienced or specialized personnel
- delivers results in minutes
- can be run anywhere you want, given the size of the device does not cause irritation or other consequences to the subject under examination
- avoids the phase of sending to a laboratory in order to analyze the sample, which is replaced in the innovative device by component 3, which is able to quickly examine the value necessary for the purposes of the test.
At an end part of the inventive device, it is possible to associate at least one patch 4, connected to the salinity detector 3, this patch 4 operating as a transdermal release element containing pilocarpine.
Preferably, an external power supply (not shown) or an internal battery (not shown) can be used to speed up the process/action of pilocarpine to release sweat, through the patch 4. Alone a patch 4, according to the art, note can take from 48 to 72 hours to release the substance, and have desired effects, while the purpose of the battery
or power supply is to reduce the release time of the substance to allow the secretion of sweat.
Some preferred embodiments of the present invention have been illustrated and described above: obviously, numerous variants and modifications, functionally equivalent to the previous ones, which fall within the scope of the invention as highlighted in the attached claims, will be immediately apparent to those skilled in the art.
Claims
1. A screening device to support clinical diagnoses, in particular a diagnosis of cystic fibrosis, said device comprising:
- at least one tampon (1) absorbing the amount of sweat necessary for the purpose of a diagnostic test;
- at least one salinity detector (2) connected to the buffer (1) and able to measure the quantity of salts present on a tissue to be analyzed;
- at least one sensor/actuator (3) connected to the salinity detector (2), said sensor/actuator (3) being designed, according to the concentrations, to signal values found for a diagnosis.
2. Screening device according to claim 1, characterized in that it further comprises at least one display, connected to the sensor (3) and designed to show a user the result calculated by the sensor (3) by means of the detector (4).
3. Screening device according to claim 2, characterized in that:
- if the concentration of chlorine in sweat: < 40 mEq/L for adults or 30 mEq/L for children, a green light comes on on the display; if the concentration of chlorine in the sweat is
intermediate, between 40 and 60 mEq/L, a yellow indicator lights up on the display;
- if the concentration of chlorine in the sweat is equal to or greater than 60 mEq/L, a red indicator lights up on the display.
4. Screening device according to claim 1, 2 or 3, characterized in that it further comprises a patch (4), connected to the salinity detector (3), said patch (4) operating as a transdermal release element containing pilocarpine.
5. Screening device according to claim 4, characterized in that it further comprises an external power supply to speed up the process/action of pilocarpine in releasing sweat, through the patch (4).
6. Screening device according to claim 4, characterized in that it further comprises an internal battery to speed up the process/action of pilocarpine in releasing sweat, through the patch (4).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102021000002924 | 2021-02-11 | ||
| IT102021000002924A IT202100002924A1 (en) | 2021-02-11 | 2021-02-11 | SCREENING DEVICE TO SUPPORT CLINICAL DIAGNOSIS, PARTICULARLY THE DIAGNOSIS OF CYSTIC FIBROSIS |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022171315A1 true WO2022171315A1 (en) | 2022-08-18 |
Family
ID=75904905
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2021/061862 WO2022171315A1 (en) | 2021-02-11 | 2021-05-05 | Screening device to support a clinical diagnosis, in particular a diagnosis of cystic fibrosis |
Country Status (2)
| Country | Link |
|---|---|
| IT (1) | IT202100002924A1 (en) |
| WO (1) | WO2022171315A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150112165A1 (en) * | 2013-10-18 | 2015-04-23 | University Of Cincinnati | Sweat sensing with chronological assurance |
| WO2020061460A1 (en) * | 2018-09-21 | 2020-03-26 | University Of Cincinnati | Devices for integrated, repeated, prolonged, and/or reliable sweat stimulation and biosensing and for removing excess water during sweat stimulation |
| EP3643236A1 (en) * | 2018-10-24 | 2020-04-29 | Nokia Technologies Oy | An apparatus for sensing biometric parameters |
-
2021
- 2021-02-11 IT IT102021000002924A patent/IT202100002924A1/en unknown
- 2021-05-05 WO PCT/EP2021/061862 patent/WO2022171315A1/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150112165A1 (en) * | 2013-10-18 | 2015-04-23 | University Of Cincinnati | Sweat sensing with chronological assurance |
| WO2020061460A1 (en) * | 2018-09-21 | 2020-03-26 | University Of Cincinnati | Devices for integrated, repeated, prolonged, and/or reliable sweat stimulation and biosensing and for removing excess water during sweat stimulation |
| EP3643236A1 (en) * | 2018-10-24 | 2020-04-29 | Nokia Technologies Oy | An apparatus for sensing biometric parameters |
Non-Patent Citations (1)
| Title |
|---|
| SAMUEL M MOSKOWITZ ET AL: "Clinical practice and genetic counseling for cystic fibrosis and CFTR-related disorders", GENETICS IN MEDICINE, vol. 10, no. 12, 1 December 2008 (2008-12-01), US, pages 851 - 868, XP055413096, ISSN: 1098-3600, DOI: 10.1097/GIM.0b013e31818e55a2 * |
Also Published As
| Publication number | Publication date |
|---|---|
| IT202100002924A1 (en) | 2022-08-11 |
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