WO2006031227A1 - Systeme d'avertissement pour administration de medicaments - Google Patents

Systeme d'avertissement pour administration de medicaments Download PDF

Info

Publication number
WO2006031227A1
WO2006031227A1 PCT/US2004/029825 US2004029825W WO2006031227A1 WO 2006031227 A1 WO2006031227 A1 WO 2006031227A1 US 2004029825 W US2004029825 W US 2004029825W WO 2006031227 A1 WO2006031227 A1 WO 2006031227A1
Authority
WO
WIPO (PCT)
Prior art keywords
recited
plunger
drug delivery
syringe
medicament
Prior art date
Application number
PCT/US2004/029825
Other languages
English (en)
Inventor
James M. Sumka
Original Assignee
Sumka James M
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 Sumka James M filed Critical Sumka James M
Priority to PCT/US2004/029825 priority Critical patent/WO2006031227A1/fr
Publication of WO2006031227A1 publication Critical patent/WO2006031227A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • 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
    • 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
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M5/50—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 preventing re-use, or for indicating if defective, used, tampered with or unsterile

Definitions

  • the present invention relates to a drug delivery warning system; and more specifically to a warning system that comprises a drug delivery article and a recognition article operative to warn the user that the medicament within the drug delivery article should not be administered intrathecally.
  • Medication errors are an important cause of patient morbidity and mortality.
  • One common cause of medication error involves administration of the wrong drug. In some cases this is the result of a caregiver grabbing the wrong syringe.
  • the ability to quickly and accurately identify which syringe is delivering which medicament is extremely important when various medicaments are being delivered simultaneously, particularly in emergency or surgical situations.
  • the ability to distinguish various syringes even in the environment of an emergency response situation is very important.
  • Syringe swaps where a caregiver picks up the wrong syringe and administers the medicament into the wrong site on the patient, continue to occur even when the syringes are labeled.
  • vincristine One drug that has been linked to fatalities due to its accidental administration in the wrong location is vincristine. This vinca alkaloid is used extensively in chemotherapy because of its anti-tumor activity and lack of myelosyuppression at dosages commonly used in combination with other chemotherapeutic agents. Vincristine is safe when administered intravenously but potentially fatal when given intrathecally. In many instances, vincristine is administered with other medicaments on the same day. There have been several incidences where intrathecal administration of vincristine resulted in the death of a patient. There is a strong need in the art for an accurate, inexpensive system that would reliably warn an administrator of this medicament that the medicament should not be given intrathecally.
  • the invention provides a drug delivery warning system that especially suited for use in the medical field to prevent the inadvertent, potentially fatal injection of a pharmaceutical solution into the wrong site of a patient.
  • the system has a prominent recognition article for warning the caregiver that medicament within the syringe must not be administered intrathecally. It can also convey a warning that medicament within the drug delivery article must be administered with utmost caution; that administration of the medicament to the wrong body site may be extremely harmful to the patient. Further, the recognition article can convey a warning that that injection of the medicament is restricted solely to a preselected site of a patient.
  • the drug delivery warning system comprises a drug delivery article and a recognition article.
  • the recognition article warns users that the medicament within the drug delivery article must not be administered intrathecally. Depending on the medicament, the recognition article may also warn users against administration of the medicament at other body sites that may be adversely affected thereby.
  • the drug delivery article is preferably a syringe; and the recognition article comprises a red colored marking on the syringe.
  • This drug warning system is correlated with an industry recognized standard within a medical community, which conveys a warning that the contents of the drug delivery article are hazardous, and that caution must be undertaken to prevent the potentially fatal injection of an incorrect pharmaceutical solution into a patient.
  • the drug warning system is easy to implement by a medical community, owing to its relative simplicity and low operating cost. Due to its simplicity, the drug warning system is readily implemented by a medical community as an industry standard, providing clear recognition that medicament within the syringe must be administered with caution.
  • a medical community that is cost-conscious would welcome an inexpensive system especially suited to help prevent syringe swaps ⁇ a problem frequently associated with the fatal intrathecal injection of vincristine into a patient.
  • Fig. Ia is a perspective view of a syringe depicting the recognition article as a red strip running longitudinally down the syringe;
  • Fig. Ib is a perspective view of a Syringe depicting the recognition article as comprising a red colored plunger
  • Fig. Ic is a perspective view of the Syringe depicting the recognition article as comprising a red colored entire syringe;
  • Fig. 2 is a perspective partial cut-out view of the Syringe depicting the recognition article as comprising a red colored plunger;
  • Fig. 3a is a perspective view of the Syringe depicting the recognition article as comprising a red colored plunger and flange; and Fig. 3b is a perspective view of the Syringe depicting the recognition article as comprising a red colored finger press.
  • the term drug delivery article means a vehicle for administering a pharmacological agent to a patient including syringes, needles used in the intravenous delivery of pharmacologic agents and other such articles.
  • industry standard means an accepted standard within the medical establishment within a particular community. This community may be local (for example a particular hospital), regional, s nationwide, or nationwide.
  • prominent means easily visible upon a quick glance.
  • the recognition article must be easily visible to the user to ensure that the user can quickly determine (i) that the medicament within a drug delivery article must not be given intrathecally, or (ii) that the medicament within the drug delivery article must be administered with the utmost caution to the patient in that administration of the medicament to the wrong body site may be exceedingly harmful to the patient.
  • the term "recognition article” means a prominently displayed marking on the syringe that correlates with an industry standard within a medical community denoting (i) that the medicament within the drug delivery article must not be administered intrathecally, or (ii) that the medicament within the drug delivery article must be administered with the utmost caution to the patient in that the administration of the medicament within the drug delivery article to the wrong body site may be fatal to the patient.
  • the present invention provides a drug delivery system aimed at preventing the potentially fatal administration of medicaments to a patient due to the administration of the medicament to the wrong body site.
  • a prominent recognition article on the drug delivery system would warn users not to administer the medicament intrathecally or to take extra precautions before administering the drug.
  • the recognition article can comprise a prominent marking, such as a colored part of the syringe or specifically colored labels. Red colored markings on the syringe are preferred; when used, such red colored markings denote "warning, use caution when administering the medicament within this syringe".
  • the recognition article is correlated with a recognized industry standard, which conveys a warning that (i) the contents of the drug delivery system are hazardous; and (ii) caution must be undertaken to prevent the potentially fatal injection of a medicament into the wrong site in a patient.
  • the recognition article could be a colored marking on the drug delivery article that comprises the entire drug delivery article, one or more components of the drug delivery article or even one section of one of the components of the drug delivery article.
  • the recognition article can be layered onto the drug delivery article or embedded within the material making up the drug delivery article.
  • the preferred colored marking would be red, a color that symbolizes "danger”.
  • a medical community could easily adopt an industry standard that represents that a syringe bearing a red marking signifies that the medicament within the syringe should not be administered intrathecally.
  • the preferred drug delivery article would be a syringe.
  • the syringe may be composed of thermoplastic resins, glass or any material that is commonly used in the production of syringes.
  • the syringe would preferably comprise a barrel for containing a fluid medicament and a plunger. Index markings to allow the user to determine the amount of medicament within the syringe may be placed on either the plunger or barrel.
  • the drug delivery article is a syringe 10.
  • the syringe 10 comprises a barrel 20, having a proximal end 22 and a distal end 24 along a central longitudinal axis.
  • the barrel 20 acts as a reservoir for fluid inside the syringe.
  • the distal end of the barrel 24 has an aperture for permitting fluid exchange with the interior reservoir of the barrel.
  • a tapered frusto-conical shaped tip 28 on the distal end of the barrel is adapted to accept a cannula or needle 40.
  • the proximal end 22 of the barrel is open to receive a plunger 30.
  • a flange 26 at the proximal end of the barrel facilitates handling and positioning the syringe barrel.
  • the distal end of the plunger 38 fits into the proximal end of the barrel 22.
  • the plunger 30 includes a finger press 34 on the proximal end of the plunger 36 and a seal member 39 at the distal end of the plunger 38.
  • the plunger includes index markings 32.
  • the recognition article comprises a red marking 12 running longitudinally down the barrel.
  • Fig. Ib and Fig. 2 Another embodiment of the drug warning system is depicted in Fig. Ib and Fig. 2, in which the recognition article includes a red marking 12 on the plunger 30. In this embodiment the entire plunger is composed of the red marking 12. It will be understood by those skilled in the art that variations of this embodiment may be used, wherein only a portion of the plunger is composed of the red marking.
  • Fig. Ic depicts another embodiment of the syringe in which the entire syringe 10 is composed of the red marking 12.
  • a syringe 110 in which the index markings 132 are on the barrel 120, is depicted by Figure 3a and Fig. 3b.
  • the entire plunger 130 and flange 126 are composed of the red marking 112.
  • the finger press 134 is composed of the red marking 112.
  • the red marking may comprise a surface coating composed of a red material, which is placed on the syringe or a component part thereof; or it may comprise a red colored dye embedded into the material of which the syringe is composed or a component part thereof. It is important that the red marking be readily apparent to the user when the syringe is placed on a nearby surface, so that a user can distinguish the red marked syringe of the present invention with other syringes nearby, which are not similarly marked.
  • the red marking is applied so that index markings on the syringe are not concealed thereby.
  • application of the red marking would preferably not be operative to prevent a user from observing the fluid level within the syringe barrel.
  • index markings are typically applied to the syringe using an ink printing process.
  • index markings there are numerous other ways to apply the index markings, including embossed application or molding of the index markings onto the syringe, which are thereafter printed or altered by color applications to effect high contrast volume index markings on the syringe.
  • embossed application or molding of the index markings onto the syringe which are thereafter printed or altered by color applications to effect high contrast volume index markings on the syringe.
  • Such various marking means for application of index markings onto the syringe are contemplated as falling within the scope of the appended claims.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (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 système de délivrance de médicament comprenant un article permettant d'administrer un médicament à un patient. Ce système est associé à un article de reconnaissance corrélé à une norme reconnue par l'industrie, permettant de signaler à un membre du personnel soignant que des précautions doivent être prises avant d'administrer un médicament au patient. Ce système permet ainsi de fournir un impératif hautement visible permettant de mettre en garde le personnel contre l'administration par inadvertance d'un agent pharmaceutique dans un site erroné du patient. Ce système comprend de préférence une seringue (10) portant un marquage (12) rouge signalant au personnel soignant que l'injection intrathécale du médicament contenu dans la seringue soit être évitée. Un signal activé par le marquage rouge peut avertir additionnellement que le contenu de l'article de délivrance de médicament est dangereux et que des précautions doivent être prises pour éviter l'injection potentiellement létale d'une solution pharmaceutique inadéquate à un patient.
PCT/US2004/029825 2004-09-14 2004-09-14 Systeme d'avertissement pour administration de medicaments WO2006031227A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2004/029825 WO2006031227A1 (fr) 2004-09-14 2004-09-14 Systeme d'avertissement pour administration de medicaments

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2004/029825 WO2006031227A1 (fr) 2004-09-14 2004-09-14 Systeme d'avertissement pour administration de medicaments

Publications (1)

Publication Number Publication Date
WO2006031227A1 true WO2006031227A1 (fr) 2006-03-23

Family

ID=36060337

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/029825 WO2006031227A1 (fr) 2004-09-14 2004-09-14 Systeme d'avertissement pour administration de medicaments

Country Status (1)

Country Link
WO (1) WO2006031227A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013061039A1 (fr) * 2011-10-24 2013-05-02 Owen Mumford Limited Seringue multi-dose à graduation configurable
JP2018019946A (ja) * 2016-08-04 2018-02-08 ニプロ株式会社 シリンジおよびプレフィルドシリンジ

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US5692640A (en) * 1995-12-05 1997-12-02 Caulfield; Patricia E. Syringe content identification system
US20040024368A1 (en) * 2002-08-02 2004-02-05 Broselow James B. Color-coded medical dosing container
US20040186437A1 (en) * 2003-03-20 2004-09-23 Frenette Claude E. Content-coded medical syringe, syringe set and syringe content identification method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US5692640A (en) * 1995-12-05 1997-12-02 Caulfield; Patricia E. Syringe content identification system
US20040024368A1 (en) * 2002-08-02 2004-02-05 Broselow James B. Color-coded medical dosing container
US20040186437A1 (en) * 2003-03-20 2004-09-23 Frenette Claude E. Content-coded medical syringe, syringe set and syringe content identification method

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013061039A1 (fr) * 2011-10-24 2013-05-02 Owen Mumford Limited Seringue multi-dose à graduation configurable
JP2018019946A (ja) * 2016-08-04 2018-02-08 ニプロ株式会社 シリンジおよびプレフィルドシリンジ

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