WO2001043756A2 - Regenerationshilfsmittel - Google Patents
Regenerationshilfsmittel Download PDFInfo
- Publication number
- WO2001043756A2 WO2001043756A2 PCT/EP2000/012803 EP0012803W WO0143756A2 WO 2001043756 A2 WO2001043756 A2 WO 2001043756A2 EP 0012803 W EP0012803 W EP 0012803W WO 0143756 A2 WO0143756 A2 WO 0143756A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- container
- monovette
- plasma
- centrifuge
- prp
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0272—Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
- A61M2202/0415—Plasma
Definitions
- the invention relates to a regeneration aid for skin and bone defects in living beings and a method and a kit for its production.
- Such regeneration aids are applied to broken bones, insertion of dental implants and the like and accelerate the healing of wounds and defects considerably. This reduces the burden on the patient, for example by temporarily removing metal splints or metal nails that have been temporarily attached, reducing the necessary duration of walking aids, and so on.
- Such regeneration aids consist inter alia of platelet-rich plasma, so-called platelet-rich plasma (PRP).
- PRP platelet-rich plasma
- the platelets contained in large numbers in such a PRP release various growth factors which control the proliferation and activity of target cells such as fibrocytes, macrophages, osteoblasts and osteoclasts in a dose-dependent manner.
- the growth factors can have both a stimulating and an inhibitory function.
- Another component of such regeneration aids is a synthetically produced substitute or building material, usually in powder or granule form or block material. According to the invention, this is a calcium phosphate, in particular a calcium composite, for example a ⁇ -tri-calcium phosphate.
- Such a bone building material is on the market under the trade name "Cerasorb ® ".
- the regeneration aid is produced by mixing the purchased powdered or granular substitute with the liquid PRP until the desired consistency, generally enabling plastic formability, is achieved.
- the PRP should preferably be generated from the blood of the patient to be treated with the regeneration aid, from freshly drawn own blood.
- the manufacturing process is such that the blood is first centrifuged with a centrifugal force that separates the raw plasma including the platelets contained therein in liquid form as a radially inner fraction from larger solids such as erythrocytes and leukocytes, which the radially outer fraction at this first Form centrifugation step.
- the raw plasma lying radially on the inside is again centrifuged - as a rule after being taken over into a second container - but this time with significantly higher centrifugal force, in particular at least twice the centrifugal force compared to the first centrifuging step, in particular at least 1300 g, in particular at least 1800 g.
- This PRP is then, for example, admixed in a mixing vessel as long as the powder or granular-shaped replacement or builder "Cerasorb ®", until the desired consistency is achieved.
- a monovette in particular with these properties, is also used as the second container, into which the raw plasma is withdrawn from the first container, by first placing a cannula on the monovette by means of an adapter, for piercing the sterile closure of the first container, which then - for centrifugation in the second centrifugation step - is removed, just as the piston rod is broken off at the predetermined breaking point.
- two matching containers in the form of a monovette are used, both of which, however, can be placed one after the other in the same centrifuge, which, as usual, can be adjusted in its speed by the different centrifugal force required for the first and second centrifugation step are going to generate.
- a syringe, a monovette equipped with an adapter and a cannula or another of the commercially available tubes used in the medical field are used for withdrawing part of the particle-free plasma from the second container, as well as for removing the shaken-up PRP.
- the volume removed is compensated for by introducing sterile gas, in particular sterile ambient air, the effort required to pull off these partial volumes is very much less, since the piston position in the outlet container can remain unchanged.
- a cannula with a free end is used for this arranged sterile closure used. This air cannula with the sterile closure arranged at the free end is, in addition to the withdrawal cannula, inserted through the sterile closure of the outlet container before the partial volumes are removed from the outlet container.
- the PRP is preferably not instilled out of this second monovette, by means of an adapter and cannula, into the mixing container, since the retaining force of the sterile closure has to be overcome.
- Fig. 1 the first process steps and Fig. 2 shows the second process steps in principle.
- the first monovette 1 On the left side of FIG. 1, the first monovette 1 is shown, which has a sterile closure 3, but which is pierced by the mandrel 5a of an attached adapter 5 acting on the sterile closure from the outside and is thus opened.
- the adapter 5 carries the cannula 6, which is suitable, for example, for taking blood from a patient, and in particular is equipped as a so-called butterfly cannula 16 with a transverse adhesive strip for remaining on the patient.
- This first monovette 1 has in the course of its piston rod 10 a predetermined breaking point 9 by a taper, in such a longitudinal position that the predetermined breaking point 9 is just outside the container part of the monovette 1 when the piston has reached the fully retracted position.
- this monovette 1 it is advisable to design this monovette 1 so that the piston 15 can be locked in its fully retracted position in a latching 19, for example in the form of inwardly projecting into the sliding path of the piston 15, latching lugs 19.
- This makes it possible, after filling the first monovette 1, to remove the adapter 5 and thus also the cannula 6 or 16, and on the other hand to break off and remove the remainder of the piston rod 10 at the predetermined breaking point 9.
- the monovette 1 thus reduced is also sealed at its front end by the sterile closure 3 and is also sterile, since this is no longer penetrated by the mandrel 5a of the adapter 5.
- the preferably completely filled monovette 1 can thus be inserted in the radial direction into a centrifuge 1 and fixed there by means of suitable holders 12 with the sterile closure 3 pointing radially inwards.
- the raw plasma 14 is removed from the first monovette 1 by means of a second monovette 2, which in turn is equipped with an adapter 5 and cannula 6, as far as possible almost completely.
- the cannula 6 of the second monovette 2 in turn pierces the sterile closure 3 of the first monovette 1.
- the cannula 6 is inserted so far that its free end is positioned near the phase boundary, but still within the radially inner fraction 14.
- an additional cannula 6 is preferably also simultaneously inserted through the sterile closure 3 of the first monovette 1, and an air sterile filter 8 is arranged at the rear, otherwise free end thereof is, so that ambient air can flow into the first monovette 1 after passing through the air sterile filter 8 in accordance with the removal of the raw plasma 14.
- the raw plasma 14 now located in the second monovette 2 is - as shown in FIG. 2 - next - since the second monovette 2 is preferably identical in size to the first monovette 1, at least in terms of attachment in the centrifuge 4 - in attached to the same centrifuge 4, again with the sterile closure 3 pointing radially inwards, and centrifuged there in a second centrifugation step.
- the prevailing centrifugal force is, however, significantly higher, in particular twice as high as in the first centrifuging step, so that within the raw plasma the particle-free and thus lighter plasma 14a is positioned radially inward compared to the platelets 14b which form a solid cake and which almost form a solid cake.
- This second monovette 2 is now, after the second centrifugation step, by means of a further tube 20, preferably again one
- the remaining residue 14a 'of the particle-free plasma is again mixed with the concentrated solids of the plasma, in particular the platelets 14b, by shaking, so that again a platelet-rich, ideally saturated, liquid, the PRP, is formed.
- the PRP is not introduced directly from the second monovette 2 into the mixing container 17, but is first removed from the second monovette 2 by means of a withdrawal tube 7, which comprises a cannula, the flow of the in turn again Air is allowed through an air cannula with an air sterile filter at the rear end.
- the sampling tube 7 does not have a sterile closure 3, so that when the PRP 14 'is pressed into the mixing container 17, no greater force can be overcome and can therefore be metered in very finely.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Cell Biology (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Cardiology (AREA)
- Zoology (AREA)
- Physical Education & Sports Medicine (AREA)
- Virology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biotechnology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Dermatology (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- External Artificial Organs (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP00991200A EP1242100A2 (de) | 1999-12-15 | 2000-12-15 | Regenerationshilfsmittel |
CA002394801A CA2394801A1 (en) | 1999-12-15 | 2000-12-15 | Regenerative adjuvant |
AU31596/01A AU3159601A (en) | 1999-12-15 | 2000-12-15 | Regenerative adjuvant |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19960504A DE19960504A1 (de) | 1999-12-15 | 1999-12-15 | Regenerationsmittel |
DE19960504.1 | 1999-12-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2001043756A2 true WO2001043756A2 (de) | 2001-06-21 |
WO2001043756A3 WO2001043756A3 (de) | 2002-03-28 |
Family
ID=7932768
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2000/012803 WO2001043756A2 (de) | 1999-12-15 | 2000-12-15 | Regenerationshilfsmittel |
Country Status (6)
Country | Link |
---|---|
US (1) | US20030175248A1 (de) |
EP (1) | EP1242100A2 (de) |
AU (1) | AU3159601A (de) |
CA (1) | CA2394801A1 (de) |
DE (1) | DE19960504A1 (de) |
WO (1) | WO2001043756A2 (de) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1494535A2 (de) | 2002-04-13 | 2005-01-12 | Allan Mishra | Zusammensetzungen und minimal invasive verfahren zur behandlung von unvollständiger gewebereparation |
US9351999B2 (en) | 2008-10-07 | 2016-05-31 | Bioparadox, Llc | Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities |
US10214727B2 (en) | 2013-06-04 | 2019-02-26 | Allan Mishra | Platelet-rich plasma compositions and methods of preparation |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005021586A (ja) * | 2003-07-02 | 2005-01-27 | Hidemi Akai | 生体組織補填材とその製造方法および生体組織補填体 |
WO2005065269A2 (en) * | 2003-12-29 | 2005-07-21 | Am Biosolutions | Compositions and method for decreasing the appearance of skin wrinkles |
US7365530B2 (en) | 2004-04-08 | 2008-04-29 | Allegro Microsystems, Inc. | Method and apparatus for vibration detection |
US7462268B2 (en) | 2004-08-20 | 2008-12-09 | Allan Mishra | Particle/cell separation device and compositions |
US8440459B2 (en) * | 2008-10-09 | 2013-05-14 | Allan Kumar Mishra | Platelet rich plasma formulations for cardiac treatments |
US8679474B2 (en) | 2010-08-04 | 2014-03-25 | StemBios Technologies, Inc. | Somatic stem cells |
GB2504679A (en) | 2012-08-03 | 2014-02-12 | Nobel Biocare Services Ag | Bone substitute structure and material |
JP6495174B2 (ja) | 2012-12-06 | 2019-04-03 | ステムバイオス テクノロジーズ,インコーポレイテッド | Lgr5+体性幹細胞 |
GR1010152B (el) * | 2013-10-09 | 2022-01-19 | Γεωργιος Γεωργιου Κολιακος | Ενα συνολο (κιτ) απο μερη για την παρασκευη 10 ml πλασματος πλουσιου σε αιμοπεταλια (prp) |
CN109364529B (zh) * | 2018-11-26 | 2021-05-04 | 曲靖市第二人民医院 | 一种治疗压力性损伤用自体富血小板血浆的制备方法及装置 |
US11125590B2 (en) | 2019-05-07 | 2021-09-21 | Allegro Microsystems, Llc | System and method for vibration detection with direction change response immunity using a magnetic field sensor |
US11029176B2 (en) | 2019-05-07 | 2021-06-08 | Allegro Microsystems, Llc | System and method for vibration detection with no loss of position information using a magnetic field sensor |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1984001805A1 (en) * | 1982-11-01 | 1984-05-10 | Allan M Parham | Medical stopcock valve assembly |
WO1996017871A1 (en) * | 1994-12-07 | 1996-06-13 | Plasmaseal Corporation | Plasma concentrate and tissue sealant compositions |
WO1996023039A1 (en) * | 1995-01-23 | 1996-08-01 | The Regents Of The University Of California | Plasma and polymer containing surgical hemostatic adhesives |
WO1996029113A1 (en) * | 1995-03-20 | 1996-09-26 | Medimop Medical Projects Ltd. | Fluid control device |
WO1997015340A1 (en) * | 1995-10-24 | 1997-05-01 | Astra Pharmaceuticals Pty. Ltd. | Tamper evident syringe design |
WO1997040864A1 (en) * | 1996-04-30 | 1997-11-06 | Medtronic, Inc. | Method for making autologous fibrin sealant |
DE19733899A1 (de) * | 1997-08-05 | 1999-02-11 | Ingo Flesch | Verfahren und Vorrichtung zur Herstellung autologer, thrombozytärer Wachstumsfaktoren sowie System als Bestandteil einer Vorrichtung zur Herstellung autologer, thrombozytärer Wachtstumsfaktoren |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE4445030A1 (de) * | 1994-12-16 | 1996-06-27 | Heraeus Instr Gmbh | Zentrifugierbare medizinische Vorrichtung |
US5614206A (en) * | 1995-03-07 | 1997-03-25 | Wright Medical Technology, Inc. | Controlled dissolution pellet containing calcium sulfate |
US5824084A (en) * | 1996-07-03 | 1998-10-20 | The Cleveland Clinic Foundation | Method of preparing a composite bone graft |
US6322785B1 (en) * | 1999-03-02 | 2001-11-27 | Natrex Technologies | Methods and compositions for bone graft implants |
-
1999
- 1999-12-15 DE DE19960504A patent/DE19960504A1/de not_active Withdrawn
-
2000
- 2000-12-15 EP EP00991200A patent/EP1242100A2/de not_active Withdrawn
- 2000-12-15 AU AU31596/01A patent/AU3159601A/en not_active Abandoned
- 2000-12-15 WO PCT/EP2000/012803 patent/WO2001043756A2/de not_active Application Discontinuation
- 2000-12-15 CA CA002394801A patent/CA2394801A1/en not_active Abandoned
- 2000-12-15 US US10/149,989 patent/US20030175248A1/en not_active Abandoned
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1984001805A1 (en) * | 1982-11-01 | 1984-05-10 | Allan M Parham | Medical stopcock valve assembly |
WO1996017871A1 (en) * | 1994-12-07 | 1996-06-13 | Plasmaseal Corporation | Plasma concentrate and tissue sealant compositions |
WO1996023039A1 (en) * | 1995-01-23 | 1996-08-01 | The Regents Of The University Of California | Plasma and polymer containing surgical hemostatic adhesives |
WO1996029113A1 (en) * | 1995-03-20 | 1996-09-26 | Medimop Medical Projects Ltd. | Fluid control device |
WO1997015340A1 (en) * | 1995-10-24 | 1997-05-01 | Astra Pharmaceuticals Pty. Ltd. | Tamper evident syringe design |
WO1997040864A1 (en) * | 1996-04-30 | 1997-11-06 | Medtronic, Inc. | Method for making autologous fibrin sealant |
DE19733899A1 (de) * | 1997-08-05 | 1999-02-11 | Ingo Flesch | Verfahren und Vorrichtung zur Herstellung autologer, thrombozytärer Wachstumsfaktoren sowie System als Bestandteil einer Vorrichtung zur Herstellung autologer, thrombozytärer Wachtstumsfaktoren |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1494535A2 (de) | 2002-04-13 | 2005-01-12 | Allan Mishra | Zusammensetzungen und minimal invasive verfahren zur behandlung von unvollständiger gewebereparation |
US9320762B2 (en) | 2002-04-13 | 2016-04-26 | Allan Mishra | Compositions and minimally invasive methods for treating incomplete tissue repair |
EP1494535B1 (de) * | 2002-04-13 | 2017-01-18 | Allan Mishra | Zusammensetzungen und minimal invasive verfahren zur behandlung von unvollständiger gewebereparation |
US9351999B2 (en) | 2008-10-07 | 2016-05-31 | Bioparadox, Llc | Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities |
US11638548B2 (en) | 2008-10-07 | 2023-05-02 | Blue Engine Biologies, LLC | Use of platelet rich plasma composition in the treatment of cardiac conduction abnormalities |
US10214727B2 (en) | 2013-06-04 | 2019-02-26 | Allan Mishra | Platelet-rich plasma compositions and methods of preparation |
Also Published As
Publication number | Publication date |
---|---|
DE19960504A1 (de) | 2001-08-16 |
EP1242100A2 (de) | 2002-09-25 |
WO2001043756A3 (de) | 2002-03-28 |
AU3159601A (en) | 2001-06-25 |
CA2394801A1 (en) | 2001-06-21 |
US20030175248A1 (en) | 2003-09-18 |
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