EP2229200A1 - Spike having two pins - Google Patents

Spike having two pins

Info

Publication number
EP2229200A1
EP2229200A1 EP08863238A EP08863238A EP2229200A1 EP 2229200 A1 EP2229200 A1 EP 2229200A1 EP 08863238 A EP08863238 A EP 08863238A EP 08863238 A EP08863238 A EP 08863238A EP 2229200 A1 EP2229200 A1 EP 2229200A1
Authority
EP
European Patent Office
Prior art keywords
sectional area
piercing
cross
removal device
channel
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Withdrawn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
EP08863238A
Other languages
German (de)
French (fr)
Inventor
Andreas Kalitzki
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.)
Bayer Intellectual Property GmbH
Original Assignee
Bayer Schering Pharma 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 Bayer Schering Pharma AG filed Critical Bayer Schering Pharma AG
Publication of EP2229200A1 publication Critical patent/EP2229200A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7518General characteristics of the apparatus with filters bacterial
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/75General characteristics of the apparatus with filters
    • A61M2205/7536General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2206/00Characteristics of a physical parameter; associated device therefor
    • A61M2206/10Flow characteristics
    • A61M2206/20Flow characteristics having means for promoting or enhancing the flow, actively or passively

Definitions

  • the invention relates to a removal device of an infusion system with a holding part and at least two with different length from this outstanding piercing, wherein the shortest protruding piercing part comprises a liquid channel and wherein the longest outstanding piercing part comprises at least one air channel.
  • the speed of infusions is limited by the volume flow which flows from the stoppered infusion bottle through the sampling device into the droplet chamber.
  • the dimensions of the components are subject to standards in which a secure puncture of the removal device is ensured by the plug.
  • a removal device comprises two coaxially arranged puncture parts, of which the inner comprises an air duct and the outer one fed from two containers fluid channel.
  • the volume flow of the liquid is limited by the cross section of the outer piercing part, which in turn is determined by the plug geometry.
  • the present invention is based on the problem to develop a sampling device in which a safe piercing of the plug and a large volume flow of the liquid can be achieved while maintaining the standard dimensions.
  • all puncture parts are arranged side by side and parallel to each other. They have a shank with a nominal cross-sectional area.
  • the inner cross-sectional area of the fluid channel is at least 60% of the largest nominal cross-sectional area of the puncture parts.
  • Figure 1 section through an infusion bottle with stopper
  • FIG. 22 top view of the sampling device of Fig. 1;
  • FIG. 3 shows a section through the removal device from FIG. 1;
  • Figure 5 is a plan view of Figure 4; FFiigguurr 66: sampling device with modified stopper;
  • FIG. 8 top view of FIG. 7
  • FIG. 9 Dimetric view of the longest protruding part of FIG. 7.
  • FIG. 1 shows in a longitudinal section as parts of an infusion system (10) an infusion bottle (11) with a stopper (12) inserted therein and with a removal device (31) of an infusion set (21) inserted in the stopper (12).
  • the infusion bottle (11) filled with an active substance-containing liquid is first closed by means of the stopper (12).
  • the stopper (12) is pierced by means of the removal device (31) and the infusion bottle (11) is then fastened downwards in a holder with the stopper (12).
  • the active substance-containing liquid (5) can now, under the action of gravity through the removal device (31), penetrate into the e.g. flow to the removal device (31) connected drop chamber (22) and the infusion hose (23).
  • An embodiment without a drop chamber (22) is also conceivable, in which the active substance-containing liquid (5) is sucked out of the infusion bottle (11), for example, at a flow rate of up to 10 milliliters per second.
  • the infusion bottle (11) shown in Figure 1 is e.g. a glass bottle and corresponds for example to the design described in EN ISO 8536-1, Form A. It has here, for example, a neck of 32 millimeters. The inner diameter at the upper edge is 22.5 millimeters in this embodiment.
  • EN ISO 8536-2 form A. In the unassembled state, for example, it has a outer diameter of 30.8 millimeters and a height of 12.2 millimeters.
  • the diameter of the insertion part (13), with which the plug (12) is inserted into the infusion bottle (11), in the undeformed state is 23.6 millimeters.
  • the plug (12) has on its - the insulating flask (11) facing - top (14) has a recess (15) with a depth of, for example, eight millimeters, whose base has a diameter of 13 millimeters.
  • the removal device (31) comprises in the embodiment shown in Figures 1 and in the plan view of Figure 2, a holding part (32) and two e.g. to the holding part (32) integrally formed Einstechmaschine (41, 51).
  • the puncture parts (41, 51) can also be inserted or formed in the holding part (32).
  • the two puncture parts (41, 51), e.g. Piercing mandrels (41, 51) are arranged parallel to each other next to each other.
  • the piercing spike (41), shown here on the right, hereinafter referred to as a short piercing spike (41) has e.g. an upstanding from the holding part (32) protruding free length of 28 millimeters.
  • the long piercing spike (51) shown on the left protrudes, for example, out of the holding part (32) by 43 millimeters.
  • Both piercing spikes (41, 51) in the exemplary embodiment have a maximum outside diameter of 5.6 millimeters. They protrude respectively with a cylindrical or conical shaft (42, 52) and with a holding part (32) facing away from the holding part (32) tip (43, 53). In the transition to Tip (43, 53), the respective shaft (42, 52) has a circular cross section with a diameter of, for example, 5.2 millimeters.
  • These cross-sectional areas (45, 55) are referred to below as nominal cross-sectional areas (45, 55). They are shown for example in the figure 1 as a dashed line. In FIG. 2, they are delimited, for example, by the circumferential lines of the piercing mandrels (41, 51). The distance of the nominal cross-sectional area (45, 55) to the upper end of the tips (43, 53) is in each case, for example, 13 millimeters,
  • the short piercing spike (41) penetrates the retaining part (32). It has a longitudinal channel (46) which has a constant or a cross-section which widens from top to bottom. With a wall thickness of, for example, 0.5 millimeters, the maximum internal cross section of this liquid channel (46) is 65% of the nominal cross-sectional area (45) of the piercing spike (41).
  • the inlet opening (47) of the liquid channel (46) lying at the top in FIG. 1 is part of the lateral surface (44) and adjoins, for example, the tip (43).
  • the long spike (51) has a longitudinal channel (61), which is deflected in the holding part (32) in the radial direction to the outside.
  • This air channel (61) has, for example in the area of the nominal cross-sectional area (55), the same internal cross-sectional area (66) as the liquid channel (46).
  • the outlet opening (63) of the air channel (61) located at the top in FIG. 1 is part of the lateral surface (54) and adjoins, for example, the tip (53) of the long piercing spike (51).
  • the removal device (31) is first attached to the infusion bottle (11) Plug (12) set.
  • the long piercing spike (51) contacts the piercing region (19) of the stopper (12) delimited by the reinforcing ring (17).
  • the plug (12) cuts and displaces the long piercing mandrel (51) with its tip (53) the material of the plug (12).
  • the short piercing mandrel (41) contacted the Aufstech Buffalo Scheme (19) of the plug (12).
  • the short piercing spike (41) also pierces the
  • the area of the plug (12) penetrated by the nominal cross-sectional areas (45, 55) of the piercing spikes (41, 51) here amounts to 5.6% of the projected area of the underside (16) of the plug (12) or 32 % of the area of the piercing area (19).
  • the inner cross-sectional areas (49, 66) of the liquid (46) and the air channel (61) are thus in the exemplary embodiment in each case 10.5% of the projected area of the piercing area (19).
  • the liquid (5) provided in the infusion bottle (11) flows under the influence of gravity through the liquid channel (46) into the drop chamber (22).
  • air from the environment (1) flows through the air filter (65), the membrane (64) and the air channel (61) into the infusion bottle (11). Due to the large cross section of the liquid channel (46) and a sufficient air supply through the air channel (61) in this case a high volume flow of the liquid (5) is achieved.
  • the Einstechmaschine (41, 51) may also have different nominal cross-sectional areas (45, 55).
  • the piercing part (41) with the liquid channel (46) has a larger nominal diameter than the piercing part (51) with the air channel (61).
  • the inner cross-sectional area (49) of the liquid channel (46) is then at least 60% of the larger nominal cross-sectional area (45; 55) of, for example, two puncturing parts (41, 51).
  • FIGS. 4 and 5 show a further embodiment of a removal device (31) in a section and in a plan view.
  • the short piercing spike (41) is constructed as described in connection with FIGS. 1 to 3.
  • the long piercing spike (51) has both an air channel (61) and a liquid channel (56), both of which are arranged parallel to one another.
  • the inlet opening (57) of the liquid channel (56) is e.g. 14 millimeters below the outlet opening (63) of the air duct (61).
  • This liquid channel (56) penetrates the holding part (32), its lower end is e.g. at the same height as the lower end of the liquid channel (46) of the short piercing spike (41).
  • the air duct (61) in this embodiment has the same length as the air duct (61) shown in FIG.
  • the liquid (56) and the air duct (61) of the long piercing spike (51) have an identical inner cross-sectional area (59, 66) in the embodiment shown in FIGS. 4 and 5. This amounts to, for example, 35% of the nominal cross-sectional area (45, 55) of a piercing part (41, 51).
  • the total cross-sectional area of the fluid channels (46, 56) in this embodiment is 100% of the nominal cross-sectional area (45, 55) of a piercing spike (41, 51). Since the cross section of the air channel (61) is largely uncritical during infusion, a further increased liquid volume flow can be achieved with the removal device (31) shown here in comparison to the variant shown in FIGS. 1 to 3.
  • FIG. 6 shows a section through a removal device (31) shown in FIGS. 4 and 5 and a modified plug (12).
  • the reinforcing ring (17), and thus the piercing region (19) surrounded by it, are of spectacle design.
  • the plug recess (15) may have this shape.
  • the sum of the internal cross-sectional areas (49, 59) of the fluid passages (46, 56) is 22% of the area of the piercing area (19).
  • the sum of the internal cross-sectional areas (49, 59) of the fluid channels (46, 56) is 3% of the projected plug area.
  • the cross-sectional area (59) of the liquid channel (56) is kidney-shaped in this embodiment. It is 42% of the nominal cross-sectional area (45, 55) of an stinging thorns (41, 51).
  • the sum of the inner surface areas (49, 59) of the liquid channels (41, 51) is thus for example 107% of the nominal cross-sectional area (45, 55) of a piercing mandrel (41, 51).
  • the air channel (61) has e.g. a round cross section.
  • the cross-sectional area (66) of the air duct (61) of this extraction device (31) is here 7% of the nominal cross-sectional area (45, 55).
  • FIG. 9 shows a dimetric view of the long piercing spike (51) from FIGS. 7 and 8 without the holding part (32). In this view, the air outlet (63) and the tip (53) partially cover the liquid inlet (57).
  • the longest piercing part (51) can have one air channel (61) and all other piercing parts (41) each have one liquid channel (46).
  • the Einstechmaschine (41, 51) may also be formed so that all have a fluid channel (46, 56).
  • the longest piercing part (51) then additionally comprises an air channel (61).

Abstract

The invention relates to a removal device (31) of an infusion system (10) having a mounting part (32) and at least two penetrating parts (41, 51) having different lengths and protruding therefrom, wherein the shortest protruding penetrating part (41) comprises a fluid channel (46) and wherein the longest protruding penetrating part (51) comprises at least one air channel (61). To this end, all penetrating parts are disposed adjacent and parallel to each other. They have a shaft (42, 52) having a nominal cross-sectional area. The inner cross-sectional area of the fluid channel is further at least 60% of the largest nominal cross-sectional area of the penetrating parts, at least in the region of the shaft. According to the present invention, a removal device is developed wherein a secure penetration of the stopper and a larger volume flow of fluid is achieved while maintaining standard dimensions.

Description

Spike mit zwei Dornen Spike with two thorns
Beschreibung :Description :
Die Erfindung betrifft eine Entnahmevorrichtung eines Infusionssystems mit einem Halteteil und mindestens zwei mit unterschiedlicher Länge aus diesem herausragenden Einstechteilen, wobei das kürzest herausragende Einstechteil einen Flüssigkeitskanal umfasst und wobei das längst herausragende Ein- stechteil zumindest einen Luftkanal umfasst.The invention relates to a removal device of an infusion system with a holding part and at least two with different length from this outstanding piercing, wherein the shortest protruding piercing part comprises a liquid channel and wherein the longest outstanding piercing part comprises at least one air channel.
Die Geschwindigkeit von Infusionen wird begrenzt durch den Volumenstrom, der aus der mittels eines Stopfens geschlossenen Infusionsflasche durch die Entnahmevorrichtung in die Tropfen- kammer fließt. Hierbei unterliegen die Abmessungen der Bauteile Normen, bei denen ein sicheres Durchstechen der Entnahmevorrichtung durch den Stopfen gewährleistet ist.The speed of infusions is limited by the volume flow which flows from the stoppered infusion bottle through the sampling device into the droplet chamber. In this case, the dimensions of the components are subject to standards in which a secure puncture of the removal device is ensured by the plug.
Aus der EP 1 652 544 Al ist eine Entnahmevorrichtung be- kannt . Sie umfasst zwei koaxial zueinander angeordnete Einstechteile, von denen das innere einen Luftkanal und das äußere einen aus zwei Behältern gespeisten Flüssigkeitskanal umfasst. Der Volumenstrom der Flüssigkeit ist durch den Querschnitt des äußeren Einstechteils begrenzt, der wiederum durch die Stopfengeometrie bestimmt wird. Beim Einstecken der Entnahmevorrichtung besteht die Gefahr, dass der Stopfen ausgestochen wird und Stopfenteile in die Infusionsflasche fallen. Der vorliegenden Erfindung liegt die Problemstellung zugrunde, eine Entnahmevorrichtung zu entwickeln, bei der unter Einhaltung der Normabmessungen ein sicheres Aufstechen des Stopfens und ein großer Volumenstrom der Flüssigkeit erreicht werden kann .From EP 1 652 544 A1 a removal device is known. It comprises two coaxially arranged puncture parts, of which the inner comprises an air duct and the outer one fed from two containers fluid channel. The volume flow of the liquid is limited by the cross section of the outer piercing part, which in turn is determined by the plug geometry. When inserting the sampling device, there is a risk that the stopper is gouged out and plug parts fall into the infusion bottle. The present invention is based on the problem to develop a sampling device in which a safe piercing of the plug and a large volume flow of the liquid can be achieved while maintaining the standard dimensions.
Diese Problemstellung wird mit den Merkmalen des Hauptan- spruchs gelöst. Dazu sind alle Einstechteile nebeneinander und parallel zueinander angeordnet. Sie haben einen Schaft mit einer Nenn-Querschnittsflache . Außerdem beträgt zumindest im Bereich des Schaftes die Innenquerschnittsflache des Flüssigkeitskanals mindestens 60% der größten Nenn-Querschnittsflache der Einstechteile.This problem is solved with the features of the main claim. For this purpose, all puncture parts are arranged side by side and parallel to each other. They have a shank with a nominal cross-sectional area. In addition, at least in the region of the shaft, the inner cross-sectional area of the fluid channel is at least 60% of the largest nominal cross-sectional area of the puncture parts.
Weitere Einzelheiten der Erfindung ergeben sich aus den Unteransprüchen und den nachfolgenden Beschreibungen der schema- tisch dargestellten Ausführungsformen.Further details of the invention will become apparent from the subclaims and the following descriptions of the schematically illustrated embodiments.
Figur 1: Schnitt durch eine Infusionsflasche mit Stopfen undFigure 1: section through an infusion bottle with stopper and
Entnahmevorrichtung ; FFiigguurr 22: Draufsicht der Entnahmevorrichtung aus Figur 1;Removal device; Fig. 22: top view of the sampling device of Fig. 1;
Figur 3 Schnitt durch die Entnahmevorrichtung aus Figur 1;FIG. 3 shows a section through the removal device from FIG. 1;
Figur 4 Montierte Entnahmevorrichtung mit zweiFigure 4 mounted removal device with two
Flüssigkeitskanälen und einem Luftkanal;Fluid channels and an air duct;
Figur 5 Draufsicht auf Figur 4 ; FFiigguurr 66: Entnahmevorrichtung mit modifiziertem Stopfen;Figure 5 is a plan view of Figure 4; FFiigguurr 66: sampling device with modified stopper;
Figur 7 Entnahmevorrichtung für hohenFigure 7 removal device for high
Flüssigkeitsvolumenstrom; Figur 8: Draufsicht auf Figur 7; Figur 9: Dimetrische Ansicht des längst herausragenden Einstechteils aus Figur 7.Liquid flow; FIG. 8: top view of FIG. 7; FIG. 9: Dimetric view of the longest protruding part of FIG. 7.
Die Figur 1 zeigt in einem Längsschnitt als Teile eines Infusionssystems (10) eine Infusionsflasche (11) mit einem darin eingesetzten Stopfen (12) und mit einer in den Stopfen (12) eingesteckten Entnahmevorrichtung (31) eines Infusionsbestecks (21) .FIG. 1 shows in a longitudinal section as parts of an infusion system (10) an infusion bottle (11) with a stopper (12) inserted therein and with a removal device (31) of an infusion set (21) inserted in the stopper (12).
Zur Vorbereitung einer Infusion wird die mit einer wirkstoff- haltigen Flüssigkeit befüllte Infusionsflasche (11) zunächst mittels des Stopfens (12) verschlossen. Der Stopfen (12) wird mittels der Entnahmevorrichtung (31) durchstoßen und die Infu- sionsflasche (11) dann mit dem Stopfen (12) nach unten in einem Halter befestigt. Die wirkstoffhaltige Flüssigkeit (5) kann nun unter Einwirkung der Schwerkraft durch die Entnahmevorrichtung (31) hindurch in die z.B. an die Entnahmevorrichtung (31) angeschlossene Tropfenkammer (22) und den Infusions- schlauch (23) fließen. Auch eine Ausführung ohne Tropfenkammer (22) ist denkbar, bei der die wirkstoffhaltige Flüssigkeit (5) beispielsweise mit einem Volumenstrom von bis zu 10 Millilitern pro Sekunde aus der Infusionsflasche (11) abgesaugt wird.To prepare for an infusion, the infusion bottle (11) filled with an active substance-containing liquid is first closed by means of the stopper (12). The stopper (12) is pierced by means of the removal device (31) and the infusion bottle (11) is then fastened downwards in a holder with the stopper (12). The active substance-containing liquid (5) can now, under the action of gravity through the removal device (31), penetrate into the e.g. flow to the removal device (31) connected drop chamber (22) and the infusion hose (23). An embodiment without a drop chamber (22) is also conceivable, in which the active substance-containing liquid (5) is sucked out of the infusion bottle (11), for example, at a flow rate of up to 10 milliliters per second.
Die in der Figur 1 dargestellte Infusionsflasche (11) ist z.B. eine Glasflasche und entspricht beispielsweise der in der EN ISO 8536-1, Form A beschriebenen Bauform. Sie hat hier z.B. eine Halsmündung von 32 Millimetern. Der Innendurchmesser am oberen Rand beträgt in diesem Ausführungsbeispiel 22,5 Millimeter.The infusion bottle (11) shown in Figure 1 is e.g. a glass bottle and corresponds for example to the design described in EN ISO 8536-1, Form A. It has here, for example, a neck of 32 millimeters. The inner diameter at the upper edge is 22.5 millimeters in this embodiment.
Der Stopfen (12) ist beispielsweise ein Gummistopfen nachThe plug (12), for example, a rubber stopper after
EN ISO 8536-2, Form A. Er hat im unmontierten Zustand z.B. ei- nen Außendurchmesser von 30,8 Millimetern und eine Höhe von 12,2 Millimetern. Der Durchmesser des Einsetzteils (13), mit dem der Stopfen (12) in die Infusionsflasche (11) eingesetzt wird, beträgt im unverformten Zustand 23,6 Millimeter. Der Stopfen (12) hat an seiner - der Isolierflasche (11) zugewandten - Oberseite (14) eine Einsenkung (15) mit einer Tiefe von z.B. acht Millimetern, deren Grundfläche einen Durchmesser von 13 Millimetern hat. An der Unterseite (16) des Stopfens (12), vgl. Figur 3, trägt dieser einen unterbrochenen Verstärkungs- ring (17), der die auf die Unterseite (16) projizierte Fläche der Einsenkung (15) umgibt. Weitere Verstärkungsrippen (18) sind radial ausgerichtet außerhalb des Verstärkungsrings (17) angeordnet. Letztere verhindern beim Transport und bei der Lagerung der Stopfen (12) ein Verkleben der Stopfen (12).EN ISO 8536-2, form A. In the unassembled state, for example, it has a outer diameter of 30.8 millimeters and a height of 12.2 millimeters. The diameter of the insertion part (13), with which the plug (12) is inserted into the infusion bottle (11), in the undeformed state is 23.6 millimeters. The plug (12) has on its - the insulating flask (11) facing - top (14) has a recess (15) with a depth of, for example, eight millimeters, whose base has a diameter of 13 millimeters. At the bottom (16) of the plug (12), cf. 3, this carries an interrupted reinforcing ring (17), which surrounds the surface of the depression (15) projected onto the underside (16). Further reinforcing ribs (18) are arranged radially aligned outside of the reinforcing ring (17). The latter prevent during transport and storage of the plug (12) sticking of the plug (12).
Die Entnahmevorrichtung (31) umfasst in dem in den Figuren 1 und in der Draufsicht der Figur 2 dargestellten Ausführungsbeispiel ein Halteteil (32) und zwei z.B. an das Halteteil (32) angeformte Einstechteile (41, 51) . Die Einstech- teile (41, 51) können auch in das Halteteil (32) eingesetzt oder eingeformt sein. Die beiden Einstechteile (41, 51), z.B. Einstechdorne (41, 51), sind parallel zueinander nebeneinander angeordnet. Der hier rechts dargestellte, im Folgenden als kurzer Einstechdorn (41) bezeichnete Einstechdorn (41) hat z.B. eine nach oben aus dem Halteteil (32) herausstehende freie Länge von 28 Millimetern. Der links dargestellte lange Einstechdorn (51) ragt beispielsweise um 43 Millimeter aus dem Halteteil (32) heraus.The removal device (31) comprises in the embodiment shown in Figures 1 and in the plan view of Figure 2, a holding part (32) and two e.g. to the holding part (32) integrally formed Einstechteile (41, 51). The puncture parts (41, 51) can also be inserted or formed in the holding part (32). The two puncture parts (41, 51), e.g. Piercing mandrels (41, 51) are arranged parallel to each other next to each other. The piercing spike (41), shown here on the right, hereinafter referred to as a short piercing spike (41), has e.g. an upstanding from the holding part (32) protruding free length of 28 millimeters. The long piercing spike (51) shown on the left protrudes, for example, out of the holding part (32) by 43 millimeters.
Beide Einstechdorne (41, 51) haben im Ausführungsbeispiel einen maximalen Außendurchmesser von 5,6 Millimetern. Sie ragen jeweils mit einem z.B. zylinderförmigen oder kegelförmigen Schaft (42, 52) und mit einer dem Halteteil (32) abgewandten Spitze (43, 53) aus dem Halteteil (32) heraus. Im Übergang zur Spitze (43, 53) hat der jeweilige Schaft (42, 52) einen kreisförmigen Querschnitt mit einem Durchmesser von z.B. 5,2 Millimetern. Diese Querschnittsflächen (45, 55) werden im Folgenden als Nenn-Querschnittsflachen (45, 55) bezeichnet. Sie sind z.B. in der Figur 1 als gestrichelte Linie dargestellt. In der Figur 2 werden sie beispielsweise durch die Um- fangslinien der Einstechdorne (41, 51) begrenzt. Der Abstand der Nenn-Querschnittsflache (45, 55) zum oberen Ende der Spitzen (43, 53) beträgt jeweils z.B. 13 Millimeter,Both piercing spikes (41, 51) in the exemplary embodiment have a maximum outside diameter of 5.6 millimeters. They protrude respectively with a cylindrical or conical shaft (42, 52) and with a holding part (32) facing away from the holding part (32) tip (43, 53). In the transition to Tip (43, 53), the respective shaft (42, 52) has a circular cross section with a diameter of, for example, 5.2 millimeters. These cross-sectional areas (45, 55) are referred to below as nominal cross-sectional areas (45, 55). They are shown for example in the figure 1 as a dashed line. In FIG. 2, they are delimited, for example, by the circumferential lines of the piercing mandrels (41, 51). The distance of the nominal cross-sectional area (45, 55) to the upper end of the tips (43, 53) is in each case, for example, 13 millimeters,
Der kurze Einstechdorn (41) durchdringt das Halteteil (32) . Er weist einen Längskanal (46) auf, der einen konstanten oder einen sich von oben nach unten aufweitenden Querschnitt hat. Bei einer Wandstärke von beispielsweise 0,5 Millimeter beträgt der maximale Innenquerschnitt dieses Flüssigkeitskanals (46) 65 % der Nenn-Querschnittsflache (45) des Einstechdorns (41) . Die in der Figur 1 oben liegende Eintrittsöffnung (47) des Flüssigkeitskanals (46) ist ein Teil der Mantelfläche (44) und grenzt beispielsweise an die Spitze (43) an.The short piercing spike (41) penetrates the retaining part (32). It has a longitudinal channel (46) which has a constant or a cross-section which widens from top to bottom. With a wall thickness of, for example, 0.5 millimeters, the maximum internal cross section of this liquid channel (46) is 65% of the nominal cross-sectional area (45) of the piercing spike (41). The inlet opening (47) of the liquid channel (46) lying at the top in FIG. 1 is part of the lateral surface (44) and adjoins, for example, the tip (43).
Der lange Einstechdorn (51) hat einen Längskanal (61), der im Halteteil (32) in radialer Richtung nach außen umgelenkt ist. Dieser Luftkanal (61) hat beispielsweise im Bereich der Nenn- Querschnittsflache (55) die gleiche Innenquerschnittsflä- che (66) wie der Flüssigkeitskanal (46) . An seiner halteteil- seitigen Eintrittsöffnung (62) hat er z.B. eine semipermeable Membran (64) und einen bakteriendichten Luftfilter (65) . Die in der Figur 1 oben liegende Austrittsöffnung (63) des Luftkanals (61) ist ein Teil der Mantelfläche (54) und grenzt bei- spielsweise an die Spitze (53) des langen Einstechdorns (51) an.The long spike (51) has a longitudinal channel (61), which is deflected in the holding part (32) in the radial direction to the outside. This air channel (61) has, for example in the area of the nominal cross-sectional area (55), the same internal cross-sectional area (66) as the liquid channel (46). At its holding part-side inlet opening (62) it has e.g. a semi-permeable membrane (64) and a bacteria-proof air filter (65). The outlet opening (63) of the air channel (61) located at the top in FIG. 1 is part of the lateral surface (54) and adjoins, for example, the tip (53) of the long piercing spike (51).
Um das Infusionsbesteck (21) an die Infusionsflasche (11) anzuschließen, wird zunächst die Entnahmevorrichtung (31) an den Stopfen (12) angesetzt. Hierbei kontaktiert zunächst der lange Einstechdorn (51) den vom Verstärkungsring (17) begrenzten Aufstechbereich (19) des Stopfens (12) . Beim Hereindrücken in den Stopfen (12) schneidet und verdrängt der lange Einstech- dorn (51) mit seiner Spitze (53) das Material des Stopfens (12) . Sobald im Ausführungsbeispiel der lange Einstechdorn (51) den Stopfen (12) durchstoßen hat, kontaktiert der kurze Einstechdorn (41) den Aufstechbereich (19) des Stopfens (12) . Beim weiteren Hineindrücken der Entnahmevorrich- tung (31) durchstößt auch der kurze Einstechdorn (41) denIn order to connect the infusion set (21) to the infusion bottle (11), the removal device (31) is first attached to the infusion bottle (11) Plug (12) set. In this case, first of all the long piercing spike (51) contacts the piercing region (19) of the stopper (12) delimited by the reinforcing ring (17). When pushing in the plug (12) cuts and displaces the long piercing mandrel (51) with its tip (53) the material of the plug (12). As soon as in the embodiment of the long piercing spike (51) has pierced the plug (12), the short piercing mandrel (41) contacted the Aufstechbereich (19) of the plug (12). Upon further pushing in of the removal device (31), the short piercing spike (41) also pierces the
Stopfen (12), vgl. Figur 3. Die von den Nenn-Querschnittsflachen (45, 55) der Einstechdorne (41, 51) durchdrungene Fläche des Stopfens (12) beträgt hier 5,6 % der projizierten Fläche der Unterseite (16) des Stopfens (12) bzw. 32 % der Fläche des Aufstechbereichs (19) . Die Innenquerschnittsflachen (49, 66) des Flüssigkeits- (46) und des Luftkanals (61) betragen somit im Ausführungsbeispiel jeweils 10,5 % der projizierten Fläche des Aufstechbereichs (19) .Plug (12), cf. FIG. 3. The area of the plug (12) penetrated by the nominal cross-sectional areas (45, 55) of the piercing spikes (41, 51) here amounts to 5.6% of the projected area of the underside (16) of the plug (12) or 32 % of the area of the piercing area (19). The inner cross-sectional areas (49, 66) of the liquid (46) and the air channel (61) are thus in the exemplary embodiment in each case 10.5% of the projected area of the piercing area (19).
Nach dem Aufhängen der Infusionsflasche (11) steht dieAfter hanging up the infusion bottle (11) is the
Spitze (43) des kurzen Einstechdorns (41) z.B. 24 Millimeter in die Flüssigkeit (5) hinein, während der lange Einstechdorn (51) z.B. 39 Millimeter weit in die Infusionsflasche (11) hineinragt .Tip (43) of the short piercing spike (41), e.g. 24 millimeters into the liquid (5) while the long piercing spike (51) is e.g. 39 millimeters far into the infusion bottle (11) protrudes.
Mit dem Beginn der Infusion fließt die in der Infusionsflasche (11) bereitstehende Flüssigkeit (5) unter dem Einfluss der Schwerkraft durch den Flüssigkeitskanal (46) in die Tropfenkammer (22) . Gleichzeitig strömt Luft aus der Umgebung (1) durch den Luftfilter (65), die Membran (64) und den Luftkanal (61) in die Infusionsflasche (11) . Aufgrund des großen Querschnitts des Flüssigkeitskanals (46) und eine ausreichende Luftzufuhr durch den Luftkanal (61) wird hierbei ein hoher Volumenstrom der Flüssigkeit (5) erreicht. Die Einstechteile (41, 51) können auch unterschiedliche Nenn- Querschnittsflächen (45, 55) aufweisen. Beispielsweise weist das Einstechteil (41) mit dem Flüssigkeitskanal (46) einen größeren Nenn-Durchmesser als das Einstechteil (51) mit dem Luftkanal (61) auf. Zumindest im Bereich des Schaftes (42) beträgt die Innenquerschnittsflache (49) des Flüssigkeitskanals (46) dann mindestens 60% der größeren Nenn-Querschnitts- fläche (45; 55) der z.B. zwei Einstechteile (41, 51) .With the beginning of the infusion, the liquid (5) provided in the infusion bottle (11) flows under the influence of gravity through the liquid channel (46) into the drop chamber (22). At the same time, air from the environment (1) flows through the air filter (65), the membrane (64) and the air channel (61) into the infusion bottle (11). Due to the large cross section of the liquid channel (46) and a sufficient air supply through the air channel (61) in this case a high volume flow of the liquid (5) is achieved. The Einstechteile (41, 51) may also have different nominal cross-sectional areas (45, 55). For example, the piercing part (41) with the liquid channel (46) has a larger nominal diameter than the piercing part (51) with the air channel (61). At least in the region of the shank (42), the inner cross-sectional area (49) of the liquid channel (46) is then at least 60% of the larger nominal cross-sectional area (45; 55) of, for example, two puncturing parts (41, 51).
Die Figuren 4 und 5 zeigen ein weiteres Ausführungsbeispiel einer Entnahmevorrichtung (31) in einem Schnitt und in einer Draufsicht. Der kurze Einstechdorn (41) ist so aufgebaut, wie im Zusammenhang mit den Figuren 1 bis 3 beschrieben. Der lange Einstechdorn (51) hat sowohl einen Luftkanal (61) als auch einen Flüssigkeitskanal (56) , die beide parallel zueinander angeordnet sind. Die Eintrittsöffnung (57) des Flüssigkeitskanals (56) liegt z.B. 14 Millimeter unterhalb der Austrittsöffnung (63) des Luftkanals (61) . Dieser Flüssigkeitskanal (56) durchdringt das Halteteil (32), sein unteres Ende liegt z.B. auf der gleichen Höhe wie das untere Ende des Flüssigkeitskanals (46) des kurzen Einstechdorns (41) . Der Luftkanal (61) hat in diesem Ausführungsbeispiel die gleiche Länge wie der in der Figur 1 dargestellte Luftkanal (61) .Figures 4 and 5 show a further embodiment of a removal device (31) in a section and in a plan view. The short piercing spike (41) is constructed as described in connection with FIGS. 1 to 3. The long piercing spike (51) has both an air channel (61) and a liquid channel (56), both of which are arranged parallel to one another. The inlet opening (57) of the liquid channel (56) is e.g. 14 millimeters below the outlet opening (63) of the air duct (61). This liquid channel (56) penetrates the holding part (32), its lower end is e.g. at the same height as the lower end of the liquid channel (46) of the short piercing spike (41). The air duct (61) in this embodiment has the same length as the air duct (61) shown in FIG.
Der Flüssigkeits- (56) und der Luftkanal (61) des langen Einstechdorns (51) haben in dem in den Figuren 4 und 5 dargestellten Ausführungsbeispiel eine identische Innenquerschnittsflache (59, 66) . Diese beträgt jeweils z.B. 35 % der Nenn-Querschnittsflache (45, 55) eines Einstechteils (41, 51) . Somit beträgt die Gesamtquerschnittsfläche der Flüssigkeitskanäle (46, 56) in diesem Ausführungsbeispiel 100 % der Nenn- Querschnittsflache (45, 55) eines Einstechdorns (41; 51) . Da bei einer Infusion der Querschnitt des Luftkanals (61) weitgehend unkritisch ist, kann mit der hier dargestellten Entnahmevorrichtung (31) gegenüber der in den Figuren 1 bis 3 gezeigten Variante ein weiter erhöhter Flüssigkeitsvolumen- ström erreicht werden.The liquid (56) and the air duct (61) of the long piercing spike (51) have an identical inner cross-sectional area (59, 66) in the embodiment shown in FIGS. 4 and 5. This amounts to, for example, 35% of the nominal cross-sectional area (45, 55) of a piercing part (41, 51). Thus, the total cross-sectional area of the fluid channels (46, 56) in this embodiment is 100% of the nominal cross-sectional area (45, 55) of a piercing spike (41, 51). Since the cross section of the air channel (61) is largely uncritical during infusion, a further increased liquid volume flow can be achieved with the removal device (31) shown here in comparison to the variant shown in FIGS. 1 to 3.
Die Figur 6 zeigt einen Schnitt durch eine in den Figuren 4 und 5 dargestellte Entnahmevorrichtung (31) und einen modifizierten Stopfen (12) . Der Verstärkungsring (17) und damit der von ihm umgebene Aufstechbereich (19) sind brillenförmig ausgebildet. Gegebenenfalls kann auch die Stopfeneinsenkung (15) diese Gestalt aufweisen. Beim Durchstechen dieses Stopfens (12) besteht eine geringere Gefahr des Einreißens des Aufstechbereichs (19) . Mit den Abmessungen der in den Figu- ren 4 und 5 dargestellten Einstechdornen (41, 51) beträgt die Summe der Innenquerschnittsflachen (49, 59) der Flüssigkeitskanäle (46, 56) 22 % der Fläche des Aufstechbereichs (19) . Bezogen auf die projizierte Fläche der Unterseite (16) des Stopfens (12) beträgt die Summe der Innenquerschnittsflachen (49, 59) der Flüssigkeitskanäle (46, 56) 3 % der projizierten Stopfenfläche .FIG. 6 shows a section through a removal device (31) shown in FIGS. 4 and 5 and a modified plug (12). The reinforcing ring (17), and thus the piercing region (19) surrounded by it, are of spectacle design. Optionally, the plug recess (15) may have this shape. When piercing this plug (12) there is less risk of tearing the Aufstechbereichs (19). With the dimensions of the piercing spikes (41, 51) shown in FIGS. 4 and 5, the sum of the internal cross-sectional areas (49, 59) of the fluid passages (46, 56) is 22% of the area of the piercing area (19). Based on the projected area of the underside (16) of the plug (12), the sum of the internal cross-sectional areas (49, 59) of the fluid channels (46, 56) is 3% of the projected plug area.
In den Figuren 7 und 8 ist ein weiteres Beispiel einer Entnahmevorrichtung (31) dargestellt. Der kurze Einstechdorn (41) entspricht den in den Figuren 1 und 4 gezeigten Einstechdornen (41). Die Längenabmessungen des langen Einstechdorns (51) entsprechen den Maßen des in den Figuren 4 und 5 dargestellten langen Einstechdorns (51) . Der lange Einstechdorn (51) verfügt auch in diesem Ausführungsbeispiel über einen Luft- (61) und über einen Flüssigkeitskanal (56) .FIGS. 7 and 8 show a further example of a removal device (31). The short piercing spike (41) corresponds to the piercing spikes (41) shown in FIGS. 1 and 4. The length dimensions of the long piercing spike (51) correspond to the dimensions of the long piercing spike (51) shown in FIGS. 4 and 5. The long piercing spike (51) also has an air (61) and a liquid channel (56) in this embodiment.
Die Querschnittsfläche (59) des Flüssigkeitskanals (56) ist in diesem Ausführungsbeispiel nierenförmig ausgebildet. Sie beträgt 42 % der Nenn-Querschnittsflache (45, 55) eines Ein- stechdorns (41, 51) . Die Summe der Innenqυerschnittsflachen (49, 59) der Flüssigkeitskanäle (41, 51) beträgt damit z.B. 107 % der Nenn-Querschnittsflache (45, 55) eines Ein- stechdorns (41, 51) .The cross-sectional area (59) of the liquid channel (56) is kidney-shaped in this embodiment. It is 42% of the nominal cross-sectional area (45, 55) of an stinging thorns (41, 51). The sum of the inner surface areas (49, 59) of the liquid channels (41, 51) is thus for example 107% of the nominal cross-sectional area (45, 55) of a piercing mandrel (41, 51).
Der Luftkanal (61) hat z.B. einen runden Querschnitt. Die Querschnittsfläche (66) des Luftkanals (61) dieser Entnahmevorrichtung (31) beträgt hier 7 % der Nenn-Querschnittsflache (45, 55) .The air channel (61) has e.g. a round cross section. The cross-sectional area (66) of the air duct (61) of this extraction device (31) is here 7% of the nominal cross-sectional area (45, 55).
Die Figur 9 zeigt eine dimetrische Ansicht des langen Ein- stechdorns (51) aus den Figuren 7 und 8 ohne das Halteteil (32) . Der Luftaustritt (63) und die Spitze (53) verdecken in dieser Ansicht bereichsweise den Flüssigkeitseintritt (57).FIG. 9 shows a dimetric view of the long piercing spike (51) from FIGS. 7 and 8 without the holding part (32). In this view, the air outlet (63) and the tip (53) partially cover the liquid inlet (57).
Um einen noch höheren Flüssigkeitsstrom zu erreichen, ist auch der Einsatz von drei oder mehr Einstechteilen (41; 51) denkbar. Hierbei kann z.B. das längste Einstechteil (51) einen Luftkanal (61) und alle anderen Einstechteile (41) jeweils ei- nen Flüssigkeitskanal (46) aufweisen. Die Einstechteile (41, 51) können jedoch auch so ausgebildet sein, dass alle einen Flüssigkeitskanal (46, 56) aufweisen. Das längste Einstechteil (51) umfasst dann zusätzlich einen Luftkanal (61) . In order to achieve an even higher liquid flow, the use of three or more piercing parts (41, 51) is also conceivable. In this case, for example, the longest piercing part (51) can have one air channel (61) and all other piercing parts (41) each have one liquid channel (46). However, the Einstechteile (41, 51) may also be formed so that all have a fluid channel (46, 56). The longest piercing part (51) then additionally comprises an air channel (61).
Bezugszeichenliste :List of reference numbers:
1 Umgebung1 environment
5 Flüssigkeit5 liquid
10 Infusionssystem10 infusion system
11 Infusionsflasche11 infusion bottle
12 Stopfen12 plugs
13 Einsetzteil13 insert part
14 Oberseite14 top
15 Einsenkung15 depression
16 Unterseite16 bottom
17 Verstärkungsring17 reinforcing ring
18 Verstärkungsrippen18 reinforcing ribs
19 Aufstechbereich19 Aufstechbereich
21 Infusionsbesteck21 infusion sets
22 Tropfenkammer22 drop chamber
23 Infusionsschlauch23 infusion tube
31 Entnahmevorriehtun31 Withdrawal procedure
32 Halteteil32 holding part
41 kürzest herausragendes Einstechteil, kurzes Einstechteil, Einstechdorn41 shortest piercing part, short piercing part, piercing spike
42 Schaft42 shaft
43 Spitze43 tip
44 Mantelfläche 45 Nenn-Querschnittsflache44 lateral surface 45 nominal cross-sectional area
46 Längskanal, Flüssigkeitskanal46 longitudinal channel, liquid channel
47 Eintrittsöffnung47 inlet
48 Austrittsöffnung48 outlet opening
49 Innenquerschnittsflache 51 längst herausragendes Einstechteil, langes Einstechteil, Einstechdorn49 inner cross-sectional area 51 Long outstanding piercing part, long piercing part, piercing spike
52 Schaft 53 Spitze52 shaft 53 tip
54 Mantelfläche54 lateral surface
55 Nenn-Querschnittsflache55 nominal cross-sectional area
56 Längskanal, Flüssigkeitskanal56 longitudinal channel, liquid channel
57 Eintrittsöffnung 58 Austrittsöffnung57 inlet opening 58 outlet opening
59 Innenquerschnittsflache59 inner cross-sectional area
61 Längskanal, Luftkanal61 longitudinal channel, air duct
62 Eintrittsöffnung 63 Austrittsöffnung62 inlet opening 63 outlet opening
64 Membran64 membrane
65 Filter, Luftfilter65 filters, air filter
66 Innenquerschnittsflache 66 inner cross-sectional area

Claims

Patentansprüche : Claims:
1. Entnahmevorrichtung (31) eines Infusionssystems (10) mit einem Halteteil (32) und mindestens zwei mit unterschiedlicher Länge aus diesem herausragenden Einstechteilen (41, 51), wobei das kürzest herausragende Einstechteil (41) einen Flüssigkeitskanal (46) umfasst und wobei das längst herausragende Einstechteil (51) zumindest einen Luftkanal (61) umfasst, dadurch gekennzeichnet,1. extraction device (31) of an infusion system (10) having a holding part (32) and at least two different lengths of this outstanding piercing parts (41, 51), wherein the shortest protruding piercing part (41) comprises a fluid channel (46) and wherein long outstanding piercing part (51) comprises at least one air channel (61), characterized
- dass alle Einstechteile (41, 51) nebeneinander und parallel zueinander angeordnet sind,- That all Einstechteile (41, 51) are arranged side by side and parallel to each other,
- dass alle Einstechteile (41, 51) einen Schaft (42, 52) mit einer Nenn-Querschnittsflache (45, 55) haben und dass zumindest im Bereich des Schaftes (42) die Innenquer- schnittsflache (49) des Flüssigkeitskanals (46) mindestens 60% der größten Nenn-Querschnittsflache (45; 55) der Einstechteile (41, 51) beträgt.- That all Einstechteile (41, 51) have a shaft (42, 52) with a nominal cross-sectional area (45, 55) and that at least in the region of the shaft (42), the inner cross-sectional area (49) of the liquid passage (46) at least 60% of the largest nominal cross-sectional area (45, 55) of the Einstechteile (41, 51).
2. Entnahmevorrichtung (31) nach Anspruch 1, dadurch gekenn- zeichnet, dass die Nenn-Querschnittsflache (45, 55) der Einstechteile (41, 51) zumindest annähernd identisch ist.Second extraction device (31) according to claim 1, characterized in that the nominal cross-sectional area (45, 55) of the Einstechteile (41, 51) is at least approximately identical.
3. Entnahmevorrichtung (31) nach Anspruch 1, dadurch gekenn- zeichnet, dass die Innenquerschnittsflache (49) des Flüssigkeitskanals (46) der Innenquerschnittsflache (66) des Luftkanals (61) entspricht. 3. removal device (31) according to claim 1, characterized in that the inner cross-sectional area (49) of the liquid channel (46) of the inner cross-sectional area (66) of the air channel (61).
4. Entnahmevorrichtung (31) nach Anspruch 1, dadurch gekennzeichnet, dass sie mindestens zwei Flüssigkeitskanäle (46, 56) umfasst, wobei die Summe der Innenquerschnittsflachen (49, 59) größer ist als die Nenn-Querschnittsflache (45; 55) eines Einstechteils (41; 51)4. removal device (31) according to claim 1, characterized in that it comprises at least two fluid channels (46, 56), wherein the sum of the inner cross-sectional areas (49, 59) is greater than the nominal cross-sectional area (45; 55) of a puncture part ( 41; 51)
5. Entnahmevorrichtung (31) nach Anspruch 1, dadurch gekenn- zeichnet, dass das längst herausragende Einstechteil (51) zusätzlich einen Flüssigkeitskanal (56) umfasst.5. removal device (31) according to claim 1, characterized in that the longest protruding piercing part (51) additionally comprises a liquid channel (56).
6. Entnahmevorrichtung (31) nach Anspruch 3 oder 4, dadurch gekennzeichnet, dass die zwei genannten Flüssigkeitskanäle (46, 56) unterschiedliche Längen haben.6. removal device (31) according to claim 3 or 4, characterized in that the two said fluid channels (46, 56) have different lengths.
7. Entnahmevorrichtung (31) nach Anspruch 1, dadurch gekenn- zeichnet, dass der Luftkanal (61) ein Filter (65) aufweist. 7. removal device (31) according to claim 1, characterized in that the air channel (61) has a filter (65).
EP08863238A 2007-12-17 2008-12-04 Spike having two pins Withdrawn EP2229200A1 (en)

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DE102007061346A DE102007061346A1 (en) 2007-12-17 2007-12-17 Spike with two thorns
PCT/EP2008/010278 WO2009077084A1 (en) 2007-12-17 2008-12-04 Spike having two pins

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WO2009077084A1 (en) 2009-06-25
CN101896215A (en) 2010-11-24
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CA2707810A1 (en) 2009-06-25

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