WO1999044655A2 - Medication infusion set - Google Patents
Medication infusion set Download PDFInfo
- Publication number
- WO1999044655A2 WO1999044655A2 PCT/US1999/004757 US9904757W WO9944655A2 WO 1999044655 A2 WO1999044655 A2 WO 1999044655A2 US 9904757 W US9904757 W US 9904757W WO 9944655 A2 WO9944655 A2 WO 9944655A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- cannula
- needle
- infusion
- medication
- housing
- Prior art date
Links
- 238000001802 infusion Methods 0.000 title claims abstract description 191
- 229940079593 drug Drugs 0.000 title claims abstract description 87
- 239000003814 drug Substances 0.000 title claims abstract description 87
- 238000003780 insertion Methods 0.000 claims abstract description 63
- 230000037431 insertion Effects 0.000 claims abstract description 63
- 238000007789 sealing Methods 0.000 claims abstract description 11
- 230000001681 protective effect Effects 0.000 claims abstract description 10
- 238000011144 upstream manufacturing Methods 0.000 claims abstract description 10
- 230000008878 coupling Effects 0.000 claims abstract description 9
- 238000010168 coupling process Methods 0.000 claims abstract description 9
- 238000005859 coupling reaction Methods 0.000 claims abstract description 9
- 239000012790 adhesive layer Substances 0.000 claims description 11
- 239000000853 adhesive Substances 0.000 claims description 9
- 230000001070 adhesive effect Effects 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 7
- 239000002184 metal Substances 0.000 claims description 3
- 238000010276 construction Methods 0.000 claims description 2
- 238000000926 separation method Methods 0.000 abstract description 9
- 230000000737 periodic effect Effects 0.000 abstract description 2
- 238000007920 subcutaneous administration Methods 0.000 description 7
- 239000002991 molded plastic Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 4
- 208000012266 Needlestick injury Diseases 0.000 description 3
- 230000000386 athletic effect Effects 0.000 description 3
- 238000003287 bathing Methods 0.000 description 3
- 238000005452 bending Methods 0.000 description 3
- 230000009182 swimming Effects 0.000 description 3
- 102000004877 Insulin Human genes 0.000 description 2
- 108090001061 Insulin Proteins 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 229940125396 insulin Drugs 0.000 description 2
- 230000013011 mating Effects 0.000 description 2
- 238000010137 moulding (plastic) Methods 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 230000000717 retained effect Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 206010069803 Injury associated with device Diseases 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 230000000774 hypoallergenic effect Effects 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 231100000344 non-irritating Toxicity 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
-
- 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
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
- A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
-
- 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
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
Definitions
- This invention relates generally to devices and methods for delivering a selected medication or other therapeutic fluid to a patient at a subcutaneous infusion site. More particularly, this invention relates to an improved medication infusion set of the type having a soft or flexible cannula adapted for subcutaneous placement, in combination with an infusion needle associated with a protective shroud plate to minimize risk of patient contact therewith while providing a high strength and unidirectional releasible coupling with the cannula.
- the selected medication is then coupled to the cannula, typically by means of a length of infusion tubing connected to a medication source, to deliver the medication through the cannula to the patient.
- the infusion tubing is connected to the cannula housing at a location downstream from the septum as shown, for example, in U.S. Patents 4,755,173; 5,176,662; and 5,257,980.
- the infusion tubing is coupled to the cannula housing by means of an infusion needle passed through the septum as shown, for example, in U.S. Patent 5,522,803.
- Subcutaneous infusion sets of the above-described type are used extensively to administer medication to a patient over an extended period of time.
- such infusion sets are used with medication infusion pumps of the type described in U.S. Patents 4,562,751 ; 4,685,903; 5,080,653; and 5,097,122 for delivering a long-term medication such as insulin in a continuous or programmable dosage to the patient.
- medication infusion pumps of the type described in U.S. Patents 4,562,751 ; 4,685,903; 5,080,653; and 5,097,122 for delivering a long-term medication such as insulin in a continuous or programmable dosage to the patient.
- the medication source must be periodically disconnected from the cannula.
- the infusion set should be replaced every few days, whereby it is necessary for the patient to uncouple the medication source from an in situ cannula upon removal thereof from the patient, and to recouple the infusion tubing with a second, newly placed cannula.
- some patients may briefly disconnect the medication source and related infusion tubing from the cannula to facilitate certain activities, such as swimming or bathing, or participation in certain athletic activities, etc.
- an optimal medication infusion set is adapted for low profile and inobtrusive placement on the patient, while permitting quick and safe periodic disconnection from and reconnection to the medication source.
- use of an infusion needle adapted for coupling through the self-sealing septum provides a quick and easy structure for connecting and disconnecting the medication source from the cannula, but also subjects the patient to undesirable needle sticks from exposure to the infusion needle.
- this arrangement requires a strong and reliable mechanical interlock between the cannula housing and the infusion needle to insure consistent and proper interengagement without inadvertent component separation, while permitting quick and easy and repeated disconnection when desired. All of these features are desirably provided in an infusion set constructed from relatively simple and preferably disposable components which can be manufactured in a cost-efficient manner from medical grade plastic or the like.
- the present invention provides an improved medication infusion set designed to meet these features and advantages, by including an infusion needle associated with a protective shroud plate.
- the shroud plate closely overlies and substantially encases the infusion needle in a manner minimizing risk of patient contact therewith, while additionally providing a strong guide structure for keyed or one-way interconnection with a cannula housing.
- an improved medication infusion set for use in delivering medication through a soft cannula to a selected subcutaneous infusion site on a patient.
- the soft cannula is supported by a compact and low profile cannula housing which includes a self-sealing septum disposed at a proximal or upstream end of the cannula.
- An infusion hub is provided with latch means for releasible assembly with the cannula housing, and includes a short infusion needle coupled via infusion tubing or the like to a source of the selected medication.
- the infusion hub includes a protective shroud plate which closely overlies and substantially encases the infusion needle to reduce risk of inadvertent patient contact therewith.
- the protective shroud plate is configured for unidirectional or one-way reception into a matingly shaped slot formed in the cannula housing upon assembly of the components to provide a high strength connection.
- the cannula housing comprises a compact plastic molding defining an internal bore for seated reception of a proximal end of the soft cannula.
- a generally cylindrical needle guide is also seated within the cannula housing and has a downstream end press-fitted into the cannula proximal end.
- the needle guide defines a flared upstream end, and a ball-shaped resilient and self- sealing septum is retained therein by a retainer clip adapted for snap-fit mounting onto the cannula housing.
- the cannula housing is initially assembled with an insertion hub which may also be formed from a molded plastic and includes at least one and preferably a pair of resilient latch arms for snap-fit reception into aligned latch ports formed in a proximal face of the cannula housing.
- the insertion hub carries an elongated insertion needle passed through the septum and needle guide, and further through the soft cannula terminating in a pointed tip end disposed a short distance beyond the distal or downstream end of the cannula.
- the insertion needle is utilized to pierce the patient's skin at a selected medication infusion site, to transcutaneously place the soft cannula, after which the insertion hub is separated from the cannula housing to withdraw the insertion needle from the cannula.
- the shroud plate is configured for slide-fit reception into a matingly shaped slot formed in the proximal face of the cannula housing, with a one-way fit, for accurate guided reception of the infusion needle through the septum to extend partially into the needle guide.
- At least one and preferably a pair of resilient latch arms on the infusion hub are provided for snap-fit reception into the latch ports on the cannula housing to releasibly interlock the components.
- the infusion hub is securely coupled with the cannula housing with a high strength interconnection resistant to bending or twisting forces that could otherwise contribute to inadvertent component separation.
- the infusion hub can be quickly and easily disconnected from the cannula housing when desired, for example, when the cannula is replaced or during patient activities requiring temporary disconnection of the medication source.
- the infusion hub is adapted for quick and easy reconnection to the existing or to a replacement cannula housing, with a simple one-way snap-fit connection, and with the infusion needle substantially concealed from patient contact at all times.
- FIGURE 1 is an exploded perspective view illustrating a medication infusion set formed in accordance with the novel features of the invention, to include a cannula housing assembled with an insertion hub, shown in exploded relation with a needle guard;
- FIGURE 5 is an exploded perspective view illustrating assembly of the cannula housing
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/623,287 US6520938B1 (en) | 1998-03-04 | 1999-03-03 | Medication infusion set |
DK99912273T DK1223997T3 (en) | 1998-03-04 | 1999-03-03 | Medical infusion set |
AU30685/99A AU3068599A (en) | 1998-03-04 | 1999-03-03 | Medication infusion set |
DE69940222T DE69940222D1 (en) | 1998-03-04 | 1999-03-03 | MEDICAL INFUSION DEVICE |
EP99912273A EP1223997B1 (en) | 1998-03-04 | 1999-03-03 | Medication infusion set |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/034,626 US6056718A (en) | 1998-03-04 | 1998-03-04 | Medication infusion set |
US09/034,626 | 1998-03-04 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1999044655A2 true WO1999044655A2 (en) | 1999-09-10 |
WO1999044655A3 WO1999044655A3 (en) | 1999-10-28 |
Family
ID=21877584
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/004757 WO1999044655A2 (en) | 1998-03-04 | 1999-03-03 | Medication infusion set |
Country Status (6)
Country | Link |
---|---|
US (2) | US6056718A (en) |
EP (1) | EP1223997B1 (en) |
AU (1) | AU3068599A (en) |
DE (1) | DE69940222D1 (en) |
DK (1) | DK1223997T3 (en) |
WO (1) | WO1999044655A2 (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2001052617A2 (en) * | 2000-01-18 | 2001-07-26 | Sterling Medivations, Inc. | Subcutaneous injection set for use with a reservoir that has a septum |
WO2002094352A2 (en) * | 2001-05-18 | 2002-11-28 | Deka Products Limited Partnership | Infusion set for a fluid pump |
EP1368080A2 (en) * | 2001-03-04 | 2003-12-10 | Sterling Medivations, Inc. | Infusion hub assembly and fluid line disconnect system |
EP1839699A1 (en) * | 2004-12-22 | 2007-10-03 | Terumo Kabushiki Kaisha | Connector, tube assembly, infusion tube set, and container for medical use |
US7306578B2 (en) | 2002-01-04 | 2007-12-11 | Deka Products Limited Partnership | Loading mechanism for infusion pump |
GB2450781A (en) * | 2007-07-06 | 2009-01-07 | Applied Medical Technology Ltd | Connector with shielded needle for connecting a tube to an infusion device |
US7517335B2 (en) | 2002-02-18 | 2009-04-14 | Cequr Aps | Device for administering of medication in fluid form |
WO2011112331A1 (en) * | 2010-03-10 | 2011-09-15 | Becton, Dickinson And Company | Catheter device with hooding feature |
US9180245B2 (en) | 2008-10-10 | 2015-11-10 | Deka Products Limited Partnership | System and method for administering an infusible fluid |
WO2017211493A1 (en) * | 2016-06-10 | 2017-12-14 | Fresenius Kabi Deutschland Gmbh | Cannulation device |
WO2018186964A3 (en) * | 2017-04-07 | 2019-01-17 | Becton, Dickinson And Company | Low-profile extension for a catheter assembly |
EP4137175A1 (en) * | 2021-08-18 | 2023-02-22 | Medtronic MiniMed, Inc. | Infusion set with rotatable hub and process |
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US7885697B2 (en) | 2004-07-13 | 2011-02-08 | Dexcom, Inc. | Transcutaneous analyte sensor |
DK2201969T3 (en) | 1997-12-31 | 2011-07-18 | Medtronic Minimed Inc | Insertion kit for an insertion kit |
US8465425B2 (en) | 1998-04-30 | 2013-06-18 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US8480580B2 (en) | 1998-04-30 | 2013-07-09 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US6949816B2 (en) | 2003-04-21 | 2005-09-27 | Motorola, Inc. | Semiconductor component having first surface area for electrically coupling to a semiconductor chip and second surface area for electrically coupling to a substrate, and method of manufacturing same |
US8688188B2 (en) | 1998-04-30 | 2014-04-01 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US8346337B2 (en) | 1998-04-30 | 2013-01-01 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US9066695B2 (en) | 1998-04-30 | 2015-06-30 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US6175752B1 (en) | 1998-04-30 | 2001-01-16 | Therasense, Inc. | Analyte monitoring device and methods of use |
US8974386B2 (en) | 1998-04-30 | 2015-03-10 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US6949084B2 (en) * | 1998-05-14 | 2005-09-27 | Disetronic Licensing Ag | Catheter head for subcutaneous administration of an active substance |
US6355021B1 (en) * | 1998-07-14 | 2002-03-12 | Maersk Medical A/S | Medical puncturing device |
US6391007B2 (en) | 1998-12-23 | 2002-05-21 | Joseph Jawshin Chang | Solid blunt for a needle assembly |
US20020120231A1 (en) * | 2000-01-18 | 2002-08-29 | Douglas Joel S. | Subcutaneous injection set with secondary injection septum |
US6572586B1 (en) * | 2000-07-25 | 2003-06-03 | Animas Corporation | Low profile infusion set |
WO2002032287A2 (en) * | 2000-10-17 | 2002-04-25 | Schneider Patricia G | Emergency medical dispensing card |
US6673440B2 (en) | 2000-11-06 | 2004-01-06 | Sterling Medivations, Inc. | Subcutaneous injection set tubing with solvent bonding |
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US7083597B2 (en) | 2001-01-05 | 2006-08-01 | Applied Diabetes Research, Inc. | Pivoting joint infusion system with seal |
US6579267B2 (en) * | 2001-01-05 | 2003-06-17 | Applied Diabetes Research, Inc. | Pivoting joint infusion assembly |
US8343115B2 (en) * | 2001-01-05 | 2013-01-01 | Applied Diabetes Research, Inc. | Low profile pivoting joint infusion assembly |
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US8066639B2 (en) | 2003-06-10 | 2011-11-29 | Abbott Diabetes Care Inc. | Glucose measuring device for use in personal area network |
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WO2017211493A1 (en) * | 2016-06-10 | 2017-12-14 | Fresenius Kabi Deutschland Gmbh | Cannulation device |
US10945760B2 (en) | 2016-06-10 | 2021-03-16 | Fresenius Kabi Deutschland Gmbh | Cannulation device |
WO2018186964A3 (en) * | 2017-04-07 | 2019-01-17 | Becton, Dickinson And Company | Low-profile extension for a catheter assembly |
US11116936B2 (en) | 2017-04-07 | 2021-09-14 | Becton, Dickinson And Company | Low-profile extension for a catheter assembly |
EP4137175A1 (en) * | 2021-08-18 | 2023-02-22 | Medtronic MiniMed, Inc. | Infusion set with rotatable hub and process |
Also Published As
Publication number | Publication date |
---|---|
US6056718A (en) | 2000-05-02 |
US6520938B1 (en) | 2003-02-18 |
DE69940222D1 (en) | 2009-02-12 |
DK1223997T3 (en) | 2009-03-30 |
EP1223997B1 (en) | 2008-12-31 |
EP1223997A2 (en) | 2002-07-24 |
WO1999044655A3 (en) | 1999-10-28 |
AU3068599A (en) | 1999-09-20 |
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