WO2008033141A1 - Ensemble d'administration de fluide sans aiguille et système de prévention d'erreur - Google Patents

Ensemble d'administration de fluide sans aiguille et système de prévention d'erreur Download PDF

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Publication number
WO2008033141A1
WO2008033141A1 PCT/US2006/036191 US2006036191W WO2008033141A1 WO 2008033141 A1 WO2008033141 A1 WO 2008033141A1 US 2006036191 W US2006036191 W US 2006036191W WO 2008033141 A1 WO2008033141 A1 WO 2008033141A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
fluid
delivery assembly
fluid delivery
set forth
Prior art date
Application number
PCT/US2006/036191
Other languages
English (en)
Inventor
Bridget M. O'hare
Ali Y. Farhat
Original Assignee
Wizard Med, Llc
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 Wizard Med, Llc filed Critical Wizard Med, Llc
Priority to PCT/US2006/036191 priority Critical patent/WO2008033141A1/fr
Publication of WO2008033141A1 publication Critical patent/WO2008033141A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6045—General characteristics of the apparatus with identification means having complementary physical shapes for indexing or registration purposes
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6072—Bar codes
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6081—Colour codes
    • 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
    • A61M5/178—Syringes
    • A61M5/1782—Devices aiding filling of syringes in situ
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula

Definitions

  • the invention relates to the delivery of fluids between storage containers. More particularly, the invention relates to a fluid delivery assembly for moving liquids between storage containers wherein the fluid delivery assembly is safe for the health care professional and the patient.
  • a fluid delivery assembly transfers fluid from a first container filled with a fluid to a second fluid container.
  • the fluid delivery assembly includes a tube extending through a tube length between a base end which is fixedly secured to one of the first and second fluid containers and a distal end.
  • the tube has an inner surface defining a tube contour.
  • the fluid delivery assembly also includes a mating yoke fixedly secured to the other of the first and second fluid containers.
  • the mating yoke defines a body periphery correlating to the tube contour such that the mating yoke in the other of the first and second fluid containers is received within the tube and is capable of moving along the tube length until the first and second fluid containers are in fluid communication.
  • Figure 1 is a side view of the invention incorporated into a bottle with a syringe about to enter the invention
  • Figure Ia is a cross-sectional side view of one embodiment of a modified syringe
  • Figure 2 is an exploded, perspective view of the invention and a syringe, partially cut away;
  • Figure 3 is a side view of the bottle and one embodiment of the invention, with the invention shown in cross section;
  • Figure 4 is a side view of a bottle, partially cutaway, and the invention, shown in cross section, with a syringe inserted therein;
  • Figure 5 is an exploded, perspective view of the invention with a different shaped tube and mating yoke;
  • Figure 6 is a top view of a bottle incorporating a second embodiment of the invention
  • Figure 7 is a cross-sectional side view of a third embodiment of the invention with the syringe being engaged on top;
  • Figure 8 is a cross-sectional side view of the third embodiment of the invention with a syringe being inserted therein;
  • Figure 9 is a cross-sectional side view of the third embodiment of the invention with a modified syringe inserted therein;
  • Figures 10 through 13 are exploded, perspective views of several different shapes used in the embodiments of the invention.
  • Figure 14 is a syringe incorporating an alternative embodiment of the force function yoke.
  • a side view of a fluid delivery assembly is generally indicated at 10.
  • the fluid delivery assembly is designed to transfer fluid from a first container 12 to a second container 14.
  • the first container 12 is storing the fluid 16 that is to be transferred to the second container 14.
  • the first container is a medicine bottle containing liquid medicine and the second container 14 is a syringe.
  • the liquid may be any type of liquid that a health care professional may need to use.
  • a non- exhaustive list of liquids include medicines, blood and other bodily fluids, saline solutions, nutritional supplements and the like.
  • the syringe 14 includes a barrel 18 and a plunger 20.
  • a first end 22 of the plunger 20 has a rubber stopper 24 secured thereto.
  • a second end 26 of the plunger 20 is a thumbpress designed to receive a force in one of two directions to force the plunger 20 back out of the barrel 18 to draw medicine therein, and down through the barrel 18 when it is time to remove the fluid 16 from the syringe 14, into a redrawing container or patient.
  • the fluid delivery assembly 10 includes a tube 28 extending through a tube length 30 between a base end 32 and a distal end 34. The base end 32 is fixedly secured to the first container 12 or an extension of the first container 12.
  • the tube 28 defines an inner tube surface 36 that defines a tube contour.
  • the fluid delivery assembly 10 also includes a mating yoke 38.
  • the mating yoke 38 is fixedly secured to the syringe 14.
  • the mating yoke defines a body periphery that is correlated to the tube contour such that the mating yoke 38 and the syringe 14 are received within the tube 28 a sufficient distance such that fluid 16 in the first container 12 may be transferred from the first container 12 to the syringe 14. This happens because the two containers 12, 14 are in fluid communication.
  • the reason why the two containers 12, 14 are in fluid communication is because the body periphery of the mating yoke 38 is correlated to the inner surface 36 of the tube 28. If the two do not match or correlate, the mating yoke 38 will be prevented from entering the tube 28. This will ensure that the proper fluid 16 or medication is taken.
  • the mating yoke 38 and the tube 28 will be different for each category of medicine so that an incorrect medicine is not given. It is contemplated that a minimum of twelve different medicines or categories of medicines will be categorized such that each mating yoke 38 in tube 28 will have their own unique shape preventing a particular syringe 14 from being used improperly. Many shapes are shown in the Figures. It should be obvious to those skilled in the art that any number of shapes can be used with the invention and that those shown herein are exemplary of different possibilities. It is in no way an implication that these are the only shapes contemplated to be associated with the invention.
  • color coding and pre-labeling allow the color coordination of the syringes with particular types of medicine that are to be used.
  • the combination of the tube 28 and mating yoke 38 with the color coded syringe categories further ensures that the proper medication will be given and that a syringe is not pre-filled with a medicine that is not desired or improper to be given to a patient.
  • RFID tagging and bar coding are two additional systems that may be used in augmenting the efficacy of the protocol associated with the invention. Many other systems or protocols may be incorporated without detracting from the invention as disclosed herein.
  • the mating yoke 38 defines a yoke length 40, extending from an upper edge 41 and a lower edge 43, which is less than one quarter of the tube length 30, which is less distance than is needed to reach a position to transfer the medicine.
  • the yoke length 40 be substantially smaller than the tube length 30, the healthcare professional would be required to seek the proper syringe 14 for the proper first container 12. More specifically, the lengths 30, 40 are chosen such that it would be nearly impossible for a mating yoke 38 to be forced through the whole length of the tube 28 when the body periphery does not match the tube contour. To do so would most likely force the syringe off axis preventing the syringe from receiving the medicine 16.
  • FIG. 10 an alternative embodiment of the fluid delivery assembly is generally indicated at 10', wherein all like primed numerals represent similar elements of the first embodiment, discussed above.
  • a hollow needle 42 is fixedly secured to a top surface 44 of the first container 12', which is a bottle.
  • a funnel 46 extends between the needle 42 and the top surface 44 of the bottle 12'. The funnel 46 allows all of the fluid 16 in the bottle 12' to be able to be removed through the needle 42 into a syringe 14' once it is forced down over the needle 42 through the tube 28'.
  • the seal 48 includes an accordion sheath 50 and a rubber cap 52.
  • Cilia 54 extend between an opening 56 and the barrel 18' of the syringe 14'.
  • the cilia 54 helps maintain the inner surface 36' of the tube 28' clear of any debris that might be associated with the entrance of the barrel 18' into the tube 28'.
  • the rubber cap 52 is pierceable by the needle 42 when the syringe 14' is inserted into the tube 28' and forced down over the needle 42.
  • the syringe 14' and the bottle 12' are inverted and the plunger 20 is retracted from the barrel 18 to pull the fluid 16 out of the bottle 12' into the barrel 18' of the syringe 14', as is done with standard medication transfer from a bottle into a syringe.
  • FIG. 5 a perspective view of the second embodiment is shown.
  • a stop 58 extends around the needle 42 to prevent the syringe 14' from moving further into the tube 28' than is necessary.
  • the tube 28' has an outer contour 60 that matches the inner surface 36' of the tube 28'.
  • the outer contour 60 matches in shape to facilitate the tactile features of the invention. Namely, a healthcare professional will be able to better choose the proper bottle 12' if the healthcare professional can feel the outer contour 60 as well as see the outer contour 60.
  • a third embodiment of the invention is generally shown at 10", wherein double primed reference characters refer to similar elements as those in the first two embodiments.
  • the fluid delivery assembly 10 transfers fluid to a fluid receiving container, namely the syringe 14". It should be appreciated that a device other than a syringe 14" may be used with the fluid delivery assembly 10".
  • the fluid delivery assembly 10" is fixedly secured to the fluid holding container, namely the first container 12" or an extension of the first container 12".
  • the fluid holding container 12" defines a reservoir 62 and a top surface 44".
  • the top surface 44" covers the reservoir 62.
  • the tube 28" extends out from the top surface to a neck opening 64.
  • the tube 28" defines an inner tube surface 36" and defines the tube length 30".
  • the fluid delivery assembly 10" includes a shape margin, generally shown at 66, which extends out of the lower edge 43" of the mating yoke 38". The shape margin 66 will be discussed in greater detail subsequently.
  • the fluid delivery assembly 10" also includes a locking surface 68 that extends out from the inner tube surface 36".
  • the locking surface 68 prevents the rubber cap 52" from sliding down the tube 28".
  • the tube 28" defines a distal perimeter 70 at the distal end 34" thereof.
  • the distal perimeter 70 is similar in shape to the base perimeter 72. More specifically, if the distal perimeter 70 is a square, so too is the base perimeter 72. The distal perimeter 70 is, however, larger than the base perimeter 72.
  • the tube 28" includes a transition section 74 wherein the perimeter of the tube 28" decreases between the distal perimeter 70 and the base perimeter 72 where the transition section 74 begins just above the tip of the needle 42.
  • the transition section 74 has a gradual slope so as to not create unnecessarily sharp edges.
  • the locking surface 68 is disposed along the tube 28" generally at the beginning of the transition section 74 of the tube 28".
  • the transition section 74 is a taper between the distal end 34" and the base end 32".
  • the locking surface 68 extends around the entire inner tube surface 36".
  • An extension 76 is disposed adjacent the locking surface 68 and extends down along a portion of the tube length 30".
  • a locking cover 78 is omega-shaped in cross section and defines a locking flange
  • the locking cover 78 includes or extends out from the rubber cap 52". When positioned in the lock position ( Figure 7), the locking flange 82 prevents the shape margin 66 from moving down into the tube 28" because the locking flange 82 abuts against the locking surface 68.
  • the locking cover 78 also includes a channel 84 that extends around the locking cover 78. The channel 84 is disposed adjacent the locking flange 82.
  • the taper section 74 of the tube 28" is designed to force the mating shape margin 66 to move as one piece (when the shape margin 66 is moved up and down the tube 28").
  • the extension 76 extends along the inner tube surface 36" and is used to prevent the locking flange 82 from relocking prior to its movement above the locking surface 68, which is defined as having the rubber cap 52" in a position such that the needle 42" is covered thereby in its locked position due to its engagement of the locking flange 82 with the locking surface 68. This will ensure the rubber cap 52" will be able to move to a position covering the needle 42" after fluid 16 is transferred.
  • the shape margin 66 is generally C-shaped in cross section. Its dimensions conform substantially similar to the locking cover 78 in that the shape margin 66 and the locking cover 78 engage each other through much of their respectively adjoining surfaces.
  • the shape margin 66 includes a lip 86 that is turned inwardly and nested within the channel 84. Therefore, the Hp 86 and the channel 84 are matingly engaged with each other.
  • the shape margin 66 defines an outer periphery 88 that extends along a tube portion thereof. The outer periphery 88 abuts the inner tube surface 36" as well as the extensions 76. By having the outer periphery 88 abut the inner tube surface 36", movement of the shape margin 66 downwardly forces the lip 86 into the channel 84.
  • the tube 28" and the shape margin 66 may be fabricated from plastic impregnated with lubricating oils to facilitate in the reduction of force required to move the syringe 14" into a position where it can receive fluid 16 therefrom. Should it be determined necessary, the tube 28" can include bearings set therewithin to further reduce the force required to move the shape margin 66 with respect to the tube 28".
  • the spacer 92 has a spacer length 94.
  • the spacer 92 is at the first end 22" of the barrel 18".
  • the spacer 92 includes a center hole 96 that allows fluid to move from the needle 42" up into the barrel 18".
  • the spacer 92 prevents fluid 16 from being stored inside the barrel 18" immediately adjacent the dispensing end, i.e., the first end 22".
  • the spacer 92 is put in place to allow a healthcare professional to draw fluid 16 from the bottle 12" while the syringe 14" is partially within the tube 28".
  • the spacer 92 does so by preventing fluid from being drawn into that space of the syringe 14" allowing the healthcare professional to see graduations 98 which are spaced along the barrel 18" starting at a distance away from the dispensing end 22" a distance equal to the spacer length 94' to reflect the volume inside the barrel 18" consumed by the spacer 94", less the stop 58" length.
  • the syringe assembly 14" also includes an attachment portion 100 that is typically threaded to threadedly engage a needle or to subsequently dispense the fluid 16 from the syringe 14".
  • FIG. 10 alternative embodiments of the force fit features of the invention are generally indicated wherein the mating yoke 38 and the tube 28 are shown in different physical configurations. It should be appreciated that there are several different shapes which may be included to distinguish the numerous medication or categories of medication types. The figures shown herein are but a few examples of the many shapes that may be utilized to perform the force fit function.
  • FIG 14. an alternative embodiment of a syringe assembly 14"" is shown wherein quadruple primed numerals represent like elements.
  • the spacer 92"" is disposed at the first end 22"".
  • the yoke 38"" extends along the barrel 18"" at the end of the spacer 92"".
  • the yoke 38"" extends through a width that is equal to a diameter of the barrel 18"". This design is contemplated for smaller syringe assemblies 14"" to help ensure the syringe assembly 14"" does not become to lopsided with much of the weight of the syringe assembly 14"" being at one end thereof.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un ensemble d'administration de fluide qui transfère du fluide d'un premier contenant rempli de fluide à un second contenant rempli de fluide. L'ensemble d'administration de fluide comprend un tube s'étendant à travers une longueur de tube entre une extrémité de base qui est solidement fixée à l'un des premier et second contenants de fluide et une extrémité distale. Le tube a une surface interne définissant un contour de tube. L'ensemble d'administration de fluide comprend également un étrier correspondant fixé aux autres contenants. L'étrier correspondant définit une périphérie de corps corrélée au contour de tube, de telle sorte que l'étrier correspondant dans l'un des conteneurs de fluide est reçu à l'intérieur du tube et est capable de se déplacer le long de la longueur du tube jusqu'à ce que les premier et second contenants de fluide soient en communication fluide. Un autre aspect de cette invention est qu'elle incorpore un contenant qui élimine le besoin d'une aiguille exposée pour tirer le médicament à l'extérieur du contenant.
PCT/US2006/036191 2006-09-15 2006-09-15 Ensemble d'administration de fluide sans aiguille et système de prévention d'erreur WO2008033141A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2006/036191 WO2008033141A1 (fr) 2006-09-15 2006-09-15 Ensemble d'administration de fluide sans aiguille et système de prévention d'erreur

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2006/036191 WO2008033141A1 (fr) 2006-09-15 2006-09-15 Ensemble d'administration de fluide sans aiguille et système de prévention d'erreur

Publications (1)

Publication Number Publication Date
WO2008033141A1 true WO2008033141A1 (fr) 2008-03-20

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011131781A1 (fr) * 2010-04-23 2011-10-27 Sanofi-Aventis Deutschland Gmbh Insert à clavette codé pour une cartouche de médicament
EP2482870A1 (fr) * 2009-09-29 2012-08-08 Admetsys Corporation Système et procédé permettant de différencier des récipients dans l'administration de médicaments
JP2015167626A (ja) * 2014-03-05 2015-09-28 テルモ株式会社 薬液容器
CN110785196A (zh) * 2017-05-05 2020-02-11 赛诺菲 用于剂量感测的药筒

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6253804B1 (en) * 1999-11-05 2001-07-03 Minimed Inc. Needle safe transfer guard
US6706031B2 (en) * 2000-02-15 2004-03-16 Comar, Inc. Needleless access apparatus and system

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6253804B1 (en) * 1999-11-05 2001-07-03 Minimed Inc. Needle safe transfer guard
US6706031B2 (en) * 2000-02-15 2004-03-16 Comar, Inc. Needleless access apparatus and system

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2482870A1 (fr) * 2009-09-29 2012-08-08 Admetsys Corporation Système et procédé permettant de différencier des récipients dans l'administration de médicaments
EP2482870A4 (fr) * 2009-09-29 2013-07-17 Admetsys Corp Système et procédé permettant de différencier des récipients dans l'administration de médicaments
US9242039B2 (en) 2009-09-29 2016-01-26 Admetsys Corporation System and method for differentiating containers in medication delivery
US9717865B2 (en) 2009-09-29 2017-08-01 Admetsys Corporation System and method for differentiating containers in medication delivery
WO2011131781A1 (fr) * 2010-04-23 2011-10-27 Sanofi-Aventis Deutschland Gmbh Insert à clavette codé pour une cartouche de médicament
US9072845B2 (en) 2010-04-23 2015-07-07 Sanofi-Aventis Deutschland Gmbh Coded keying insert for medicament cartridge
JP2015167626A (ja) * 2014-03-05 2015-09-28 テルモ株式会社 薬液容器
CN110785196A (zh) * 2017-05-05 2020-02-11 赛诺菲 用于剂量感测的药筒
CN110785196B (zh) * 2017-05-05 2024-05-14 赛诺菲 用于剂量感测的药筒

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