EP2800597A1 - Unité cylindre-piston comportant une canule courte - Google Patents

Unité cylindre-piston comportant une canule courte

Info

Publication number
EP2800597A1
EP2800597A1 EP12797780.9A EP12797780A EP2800597A1 EP 2800597 A1 EP2800597 A1 EP 2800597A1 EP 12797780 A EP12797780 A EP 12797780A EP 2800597 A1 EP2800597 A1 EP 2800597A1
Authority
EP
European Patent Office
Prior art keywords
cylinder
piston unit
cannula
short cannula
short
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP12797780.9A
Other languages
German (de)
English (en)
Inventor
Rudolf Matusch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
LTS Lohmann Therapie Systeme AG
Original Assignee
LTS Lohmann Therapie Systeme AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by LTS Lohmann Therapie Systeme AG filed Critical LTS Lohmann Therapie Systeme AG
Publication of EP2800597A1 publication Critical patent/EP2800597A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J1/00—Pistons; Trunk pistons; Plungers
    • F16J1/005—Pistons; Trunk pistons; Plungers obtained by assembling several pieces
    • 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
    • A61M5/46—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 having means for controlling depth of insertion

Definitions

  • the invention relates to a cylinder-piston unit with at least one
  • Injection solution receiving cylinder with outlet and at least one piston.
  • the present invention is therefore based on the problem of developing a cylinder-piston unit for a disposable injector, which u.a. for a virtually painless penetration of the human skin. for the application highly viscous
  • the cylinder or a cylinder upstream component has an end face, from the intended emptying of the cylinder-piston unit protrudes a short cannula, which has an outlet opening at its free end.
  • Outlet opening has an area whose border has a ground-level point or ⁇ edge near the ground.
  • the ground-level point or the ground-level edge is 0.1 mm away from the face or its foremost point or edge.
  • the disposable injector supports, in addition to the cylinder-piston unit, a drive installed in an injector housing and acting on a piston-actuating ram.
  • Spring drives gas drives with open gas cartridges or pyrotechnic drives can be used as possible drives.
  • Known spring energy storage use prestressed mechanical or pneumatic springs or spring systems. If a spring energy store is used as the drive, the piston actuating ram is held in a form-fitting manner by at least one support rod or towing hook arranged on or in the injector housing for pretensioning and holding this spring energy store.
  • the one or more support rods or towing hooks are locked by means of one or more triggering elements until the disposable injector in its locked position.
  • a short short cannula which penetrates after placing the injector on the skin of the patient during subsequent application of the injection solution only a few tenths of a millimeter into the skin of the patient.
  • the penetration depth is mechanically limited by the front end face of the injector.
  • Monoclonal antibodies are administered easily and virtually painlessly.
  • the front end of the injector can also be the front end of a - the short-tubule during storage of the injector occlusive - elastomer or
  • Adhesive disc which is slidably mounted in the direction of the longitudinal extent of the injector on the cylinder.
  • Cylinder-piston unit with short cannula protective housing
  • FIG. 1 shows a cylinder-piston unit (10) of a disposable injector.
  • the cylinder-piston unit (10) consists of a cylinder (20) and an example two-piece piston (80).
  • Adhesive disc (110) carries sealed and protected short cannula (61)
  • a protective housing 150
  • a protective housing 150
  • the lower part of a piston actuating punch (7) is shown, which belongs to the disposable injector, not shown here.
  • the cylinder (20) is fastened to the injector by means of its external thread (22) present in the rear region or by means of slots (23).
  • an adhesive disk (110) is additionally arranged in the cylinder bottom area.
  • the e.g. one-piece cylinder (20) consists of a housing adapter (21), a
  • the housing adapter (21) fixes the cylinder (20) in an injector housing (not shown).
  • the housing adapter (21) fixes the cylinder (20) in an injector housing (not shown).
  • the slots (23) have e.g. a depth of 2 mm. They are located at the end of the thread in the immediate vicinity of the pipe section (28).
  • the width of the slots (23) is e.g. 0.6 mm.
  • Stop ridge (24) whose outside diameter is e.g. identical to the
  • Thread outside diameter can be. The outside diameter of the thread
  • Pipe section (28) is more than twice the diameter of the
  • the cylinder wall (29) along the pipe section length for example, a constant wall thickness of 3.25 mm.
  • the bottom section (33) comprises an outwardly flat bottom plate (34), which corresponds to the average wall thickness of the cylinder wall (29) in the region of the pipe section (28).
  • a cylindrical tube-shaped annular web (51) is integrally formed in the outer region of the bottom plate (34).
  • Adhesive disk receiving space (53) spans, for example, as high as the wall thickness of the bottom plate (34).
  • the height is e.g. 3 mm.
  • the wall thickness of the annular web (51) is about one third of the wall thickness of the cylinder wall (29) of the pipe section (28).
  • the cylinder inner wall (31) is cylindrical at least in the pipe section (28). It has there, e.g. an inner diameter of 5.5 mm. In the region of the housing adapter (21), the cylinder inner wall (31) widens.
  • the cone angle of this expansion (25) is e.g. 50 degrees.
  • the length of the widening (25) corresponds to approximately one third of the length of the housing adapter (21).
  • the cylinder inner wall (31) terminates in a cylinder bottom (45) whose cone angle is e.g. 160 degrees is.
  • a short cannula (61) is arranged in the center of the bottom portion (33) . Its center line runs e.g. congruent to the center line (5) of the cylinder-piston unit (10).
  • the short cannula (61) extends in the bottom portion (33) e.g. between the cylinder bottom (45) and the flat end face (46). It is either inserted during the injection process of the cylinder (20) in its injection mold for mounting or it is subsequently pressed or glued into the finished cylinder (20).
  • the short cannula (61) is, for example, a thin-walled tube (62), which is produced, for example, from a stainless steel. It has, for example, an outer diameter of 0.5 mm.
  • the wall thickness is usually 0.05 mm, 0.06 mm or 0.07 mm, cf. DIN 13097-4, appendix A, issue August 2009.
  • the cannula (62) has at its free, front End including a single cut, a facet cut or a
  • the respective main grinding angle is between 9 and 18 degrees, cf. DIN 13097-4, appendix B, issue August 2009.
  • the angle is 45 degrees.
  • the cannula tip (64) is dependent on the wall thickness and elasticity of the adhesive disc (110) used - e.g. 1 to 1, 5 mm over the ring web (51) over.
  • an adhesive disc (110) is arranged in the front region of the adhesive disc receiving space (53). It has a material thickness at least 0.4 mm larger than the depth of the
  • Adhesive Disk Storage Room (53).
  • the adhesive disc (110) is attached to the short cannula (61) in such a way that it does not penetrate the front third of the adhesive disc (110).
  • a sealing area (117) closing the short cannula (61) at the front.
  • the substantially cylindrical outer wall of the adhesive disk (110) is guided on the cylindrical inner wall (52) of the annular web (51).
  • the adhesive disk (110) has a radial, for example, in the upper area of its outer wall. 0.5 mm, protruding circumferential web (123), via which it rests elastically on the front inner edge (59) of the annular web (51).
  • the latter can also have a radially inwardly projecting web formed in the front region of the annular web (51) and inserted in a corresponding annular groove
  • Adhesive disc (110) protrudes elastically.
  • the adhesive disk (110), for example made of rubber or another elastomer, is provided with an adhesive layer (121) consisting of a pressure-sensitive adhesive, for example, on its flat front end face.
  • the remaining surface areas have a good lubricity, since the adhesive disk (110) is treated or teflonized at least partially with silicone oil.
  • the adhesive of the adhesive disc (121) is designed so that its adhesive force to the adhesive disc (110) is greater by at least 50% compared to a disinfected skin surface (201).
  • the adhesive disk (110) laterally has at least one notch oriented parallel to the center line (5) which, upon insertion of the sliding disk (110) into it
  • Adhesive disc receiving space (53) allows the existing air easily displace.
  • the air can also be connected to the ring bridge (51) near the
  • Figures 2 and 3 show a short cannula (61) having a wall thickness of 0.05 mm with an outer diameter of 0.5 mm and which has a single cut with a bevel angle of e.g. 45 degrees.
  • the needle tip (64) is just in the adhesive disc (110) during the pressing of the injector onto the patient skin (200).
  • the short cannula (61) has reached its application depth.
  • the adhesive disc (110) on the skin surface (201)
  • the short cannula (61) has penetrated so deeply that its outlet opening (71), cf.
  • the outlet opening (71) has an elliptical border (72) in the single cut.
  • the border (72) has passed through the horny layer (203).
  • the foremost point (73) is positioned in the dermis (205) according to FIG.
  • the area centroid (77) of the area (71) enclosed by the border (72) is only at the transition of the epidermis (202) to the dermis (205) by way of example. This is the ground level point (74) of the End face (113) of the adhesive disc (1 0) in the range of 0.15 0.3 mm away.
  • the distance dimension (0.15-0.3 mm), instead of a flat surface (113), is related to the edge corresponding to the penetration curve of the short cannula (61) and the cylinder end face.
  • the front (73) and the rear point (74) by a near-ground (76) and a front edge (75) is replaced.
  • FIG. 7 shows a short cannula (61) whose front end has a cannula taper (63) shortly before the cut (65) or in front of the outlet opening (71).
  • the diameter is e.g. 0.1 mm smaller than in the rear needle area.
  • the front generated, for example, by material diving
  • Needle section has a minimum length which is in the range of half to twice the needle diameter.
  • a pot-shaped protective housing (150), a sterile closure surrounds according to Figure 1, the pipe section (28) and the bottom portion (33) with the inserted
  • the protective housing (150) is made, for example, from the plastic cycloolefin copolymer (COC) due to its shape. This material has a particularly low Gas and water vapor permeability.
  • the protective housing (150) can be made of glass.
  • Protective housing (150) e.g. 1, 5 mm.
  • the axial distance between the bottom (152) of the protective housing (150) and the adhesive disk (110) is according to FIG. 1 e.g. 1 mm.
  • the protective housing (150) is releasably fixed in two places.
  • the first point is at the transition between the pipe section (28) and the stop web (24) of the cylinder (20).
  • a conventional O-ring (161) instead of a conventional O-ring (161), a quadring, a profile ring or the like can be used.
  • the sealing ring (161) is clamped during assembly between the protective housing (150) and the cylinder (20), so that it can easily take over a centering and holding function in addition to the sealing function. Possibly. the sealing ring (161) can also be replaced by a sealing, viscous adhesive.
  • the second point for supporting the protective housing (150) on the cylinder (20) is located in the bottom (152) of the protective housing (150).
  • the protective housing (150) comprises e.g. five radially oriented support ribs (159). This am
  • Circumference of the shell (51) equidistantly distributed support ribs (159) are formed, for example, on the bottom (152) and on the jacket (151).
  • the support ribs (159) have radial inner surfaces, with which they on the cylindrical outer surface (119) of the
  • Adhesive disc (110) abut.
  • For axial support of the adhesive disc (110) is also on the bottom (152) a
  • annular support web (153) arranged, which rests with its upper, circular edge on the adhesive disk (110), in the central region thereof.
  • the edge is in this case so narrow that it develops only a slight adhesive force with respect to the adhesive disk (110).
  • the cylinder (20) is filled with an injection solution (1).
  • Liquid level (2) of the injection solution (1) is located in the transition region between the housing adapter (21) and the pipe section (28). On the
  • Liquid level (2) is bubble-free and sterile disc-shaped sealing body (100) placed on the sealing under a radial clamping action on the
  • Cylinder inner wall (31) is applied. Behind the sealing body (100) a cup-shaped drive body (81) is arranged. The propellant body (81) partially rests on the sealing body (100) or it is at a distance of e.g. 0.2 to 0.5 mm.
  • the sealing body (100) is here a disc whose undeformed diameter e.g. twice as big as its slice thickness.
  • the disc (100) has a groove profile (107), e.g. has two grooves (108).
  • Grooved profile (107) is here, for example, designed so that the sealing body (100) in cross-section on both sides as a sectional profile has a wavy line with two, the grooves (108) forming troughs.
  • the wavy line here is circular arcs
  • the sealing body (100) is an elastomer body, the wave crests of the set sealing disc are flattened, cf. FIGS. 1 and 4.
  • the pot-shaped drive body (81) whose length corresponds, for example, its outer diameter, consists of a disk-shaped impact plate (83) and a molded apron (90), the thickness of the impact plate (83) is slightly larger than the length of the skirt (90), see.
  • FIG. 1 The pot-shaped drive body (81) whose length corresponds, for example, its outer diameter, consists of a disk-shaped impact plate (83) and a molded apron (90), the thickness of the impact plate (83) is slightly larger than the length of the skirt (90), see.
  • FIG. 1 The pot-shaped drive body (81) whose length corresponds, for example, its outer diameter, consists of a disk-shaped impact plate (83) and a molded apron (90), the thickness of the impact plate (83) is slightly larger than the length of the skirt (90), see.
  • FIG. 1 The pot-shaped drive body (81) whose length corresponds, for example, its outer diameter, consists of a disk-shaped impact plate (83) and a molded
  • Piston actuation punch (7) hits, has at least one e.g. central
  • Cylinder space areas (11, 12) with each other with minimal throttle effect connects.
  • the bore (97) whose minimum diameter is between 1 and 2 mm ends according to the embodiments at the rear end face (85) of the drive body (81), e.g. in a channel cross (88) of two channels intersecting in the area of the bore (97).
  • the channels of the channel cross (88) each have a semicircular cross section, the diameter of the cross sections being e.g. corresponds to the diameter of the bore.
  • the skirt formed as an elastic sealing lip (90) connects.
  • the wall of the skirt (90) tapers, starting from the end face (84), towards the front, outer sealing edge (91), which bears elastically against the cylinder inner wall (31) in each operating state of the injector.
  • the latter essentially has the shape of a truncated cone whose cone angle is e.g. Measures 20 degrees.
  • Piston (80) allows a simple bubble-free filling and a sterile closing of the cylinder-piston unit (10) in conjunction with a
  • the injector with the adhesive disk (110) is placed in advance on the skin surface (201) of the patient.
  • the adhesive disc (110) which is still in its installed position (111), adheres via its adhesive layer (121) to the skin surface (201).
  • the adhesive disk (110) is loaded, with overcoming the blocking effect of the circumferential web (123) and with a piercing of the adhesive disc (110) - along the short cannula (61) in the direction of the bottom portion (33) slips to with its rear end face (115) on the end face (46) of the bottom portion (33) to apply.
  • the adhesive disk (110) is now in its application position (112). She now fills the
  • Adhesive disc receiving space (53) completely made. For example, she stands in front 0.5 mm over the annular web (51). In the Anpressvorgang is by increasing the
  • the injector is triggered by pressing on the skin (200).
  • Piston actuation plunger (7) abruptly loads the two-part piston (80) in order to introduce the injection solution (1) via the short cannula into the upper layers of the skin (200) of the patient, cf. FIG. 4.
  • Subcutaneous tissue (206). In the fatty tissue rich in capillaries
  • This pressurized injection solution pool (210) will at least substantially empty itself via the inflow passage (211) as the injector is lifted off the skin (200) with all its parts.
  • the adhesive disk (110) remains behind due to its adhesive layer (21) until it is removed separately.
  • the opening of the elastomeric body (110) initially punctured by the short cannula (61) closes completely immediately after the removal of the injector.
  • the patient removes the adhesive disc (110) - including the adherent
  • Adhesive layer (121) only when the injection-related curvature of the
  • Front side front; Face, flat surface
  • Circular bar Protection uss sheath, tubular

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Combustion & Propulsion (AREA)
  • Chemical & Material Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une unité cylindre-piston comportant au moins un cylindre contenant une solution d'injection, pourvu d'une ouverture de sortie, et au moins un piston. Le cylindre ou un composant placé en amont du cylindre présente une face frontale à partir de laquelle fait saillie une canule courte lors du vidage conforme de l'unité cylindre-piston, la canule présentant une ouverture de sortie sur son extrémité libre. L'ouverture de sortie présente une face dont le bord possède un point proche de la base ou une arête proche de la base. Le point proche de la base ou l'arête proche de la base se situe à une distance de 0,15 - 0,3 mm de la face frontale ou de son point ou arête situé le plus en avant. L'unité cylindre-piston selon l'invention destinée à un élément d'injection à usage unique permet une pénétration quasiment sans douleur dans la peau humaine, notamment pour l'administration de solutions d'injection très visqueuses.
EP12797780.9A 2011-11-16 2012-11-16 Unité cylindre-piston comportant une canule courte Withdrawn EP2800597A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102011119203A DE102011119203A1 (de) 2011-11-16 2011-11-16 Zylinder-Kolben-Einheit mit Kurzkanüle
PCT/EP2012/072821 WO2013072455A1 (fr) 2011-11-16 2012-11-16 Unité cylindre-piston comportant une canule courte

Publications (1)

Publication Number Publication Date
EP2800597A1 true EP2800597A1 (fr) 2014-11-12

Family

ID=47297154

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12797780.9A Withdrawn EP2800597A1 (fr) 2011-11-16 2012-11-16 Unité cylindre-piston comportant une canule courte

Country Status (5)

Country Link
US (1) US9599220B2 (fr)
EP (1) EP2800597A1 (fr)
JP (1) JP6175066B2 (fr)
DE (1) DE102011119203A1 (fr)
WO (1) WO2013072455A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015107774A1 (fr) 2014-01-16 2015-07-23 テルモ株式会社 Seringue pour injection de solution de médicament dans une couche de peau supérieure
WO2016117164A1 (fr) * 2015-01-20 2016-07-28 テルモ株式会社 Ensemble aiguille à injection et injecteur équipé de celui-ci pour l'injection d'une solution médicamenteuse dans la couche supérieure de la peau
CN110638555A (zh) * 2019-09-30 2020-01-03 晨建熙望(广州)畜牧设备有限公司 一种感应式电动无针注射器系统及其装置

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EP0749758A1 (fr) * 1995-06-22 1996-12-27 Pharmacia AB Améliorations d'injections
WO2000009184A1 (fr) * 1998-08-13 2000-02-24 Imprint Pharmaceuticals Limited Appareil d'apport d'une substance pourvu d'une ou de plusieurs aiguilles entrainees a grande vitesse
US20020193740A1 (en) * 1999-10-14 2002-12-19 Alchas Paul G. Method of intradermally injecting substances
WO2007071485A1 (fr) * 2005-12-20 2007-06-28 Novo Nordisk A/S Appareil de rétention cutanée pour une unité médicale d’injection sans aiguille
US20090157041A1 (en) * 2001-09-12 2009-06-18 Pettis Ronald J Microneedel-based pen device for drug delivery and method for using same
WO2010038879A1 (fr) * 2008-09-30 2010-04-08 Terumo Kabushiki Kaisha Aiguille d'injection et dispositif d'injection de médicament
DE102008052749A1 (de) * 2008-10-22 2010-05-27 Hahn-Schickard-Gesellschaft für angewandte Forschung e.V. Nadel, Nadelanordnung, Spritzgussform und Verfahren zum Herstellen

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US6224567B1 (en) * 1999-09-08 2001-05-01 Cambridge Biostability Limited Modified disposable injector device
FR2805749B1 (fr) 2000-03-01 2002-05-17 Poudres & Explosifs Ste Nale Seringue sans aiguille a deux niveaux de vitesse d'injection
WO2003074102A2 (fr) * 2002-03-04 2003-09-12 Nano Pass Technologies Ltd. Dispositifs et procedes permettant le transport d'un fluide a travers une barriere biologique
US7252651B2 (en) * 2003-01-07 2007-08-07 Becton, Dickinson And Company Disposable injection device
AU2004298717A1 (en) 2003-12-18 2005-06-30 Novo Nordisk A/S Nozzle device with skin stretching means
US7645264B2 (en) * 2005-04-11 2010-01-12 Becton, Dickinson And Company Injection device with secondary reservoir
DE102005054600A1 (de) 2005-11-14 2007-05-24 Lts Lohmann Therapie-Systeme Ag Zylinderkolbeneinheit mit einer nichtzylindrischen Kammer
JP5036730B2 (ja) 2006-01-31 2012-09-26 ノボ・ノルデイスク・エー／エス 事前充填式医療用ジェット注射装置のシール
JP5118533B2 (ja) * 2008-03-28 2013-01-16 テルモ株式会社 注射針セット
WO2009119787A1 (fr) * 2008-03-28 2009-10-01 テルモ株式会社 Injecteur
CN102369034A (zh) * 2009-03-30 2012-03-07 泰尔茂株式会社 注射针组合体及药剂注射装置
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EP0749758A1 (fr) * 1995-06-22 1996-12-27 Pharmacia AB Améliorations d'injections
WO2000009184A1 (fr) * 1998-08-13 2000-02-24 Imprint Pharmaceuticals Limited Appareil d'apport d'une substance pourvu d'une ou de plusieurs aiguilles entrainees a grande vitesse
US20020193740A1 (en) * 1999-10-14 2002-12-19 Alchas Paul G. Method of intradermally injecting substances
US20090157041A1 (en) * 2001-09-12 2009-06-18 Pettis Ronald J Microneedel-based pen device for drug delivery and method for using same
WO2007071485A1 (fr) * 2005-12-20 2007-06-28 Novo Nordisk A/S Appareil de rétention cutanée pour une unité médicale d’injection sans aiguille
WO2010038879A1 (fr) * 2008-09-30 2010-04-08 Terumo Kabushiki Kaisha Aiguille d'injection et dispositif d'injection de médicament
DE102008052749A1 (de) * 2008-10-22 2010-05-27 Hahn-Schickard-Gesellschaft für angewandte Forschung e.V. Nadel, Nadelanordnung, Spritzgussform und Verfahren zum Herstellen

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Title
See also references of WO2013072455A1 *
VON PING M. WANG: "Precise Microinjection into Skin Using Hollow Microneedies", JOURNAL OF INVESTIGATIVE DERMATOLOGY, vol. 126, 2006 *

Also Published As

Publication number Publication date
JP6175066B2 (ja) 2017-08-02
US9599220B2 (en) 2017-03-21
WO2013072455A1 (fr) 2013-05-23
DE102011119203A1 (de) 2013-05-16
JP2015501676A (ja) 2015-01-19
US20140245882A1 (en) 2014-09-04

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