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WO2022269631A1 - Seringue jetable non réutilisable à protection chimique - Google Patents

Seringue jetable non réutilisable à protection chimique Download PDF

Info

Publication number
WO2022269631A1
WO2022269631A1 PCT/IN2022/050563 IN2022050563W WO2022269631A1 WO 2022269631 A1 WO2022269631 A1 WO 2022269631A1 IN 2022050563 W IN2022050563 W IN 2022050563W WO 2022269631 A1 WO2022269631 A1 WO 2022269631A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
syringes
film
medical device
curing
Prior art date
Application number
PCT/IN2022/050563
Other languages
English (en)
Inventor
Atulkumar Kanaiyalal Shah
Original Assignee
Shah, Nila
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 Shah, Nila filed Critical Shah, Nila
Publication of WO2022269631A1 publication Critical patent/WO2022269631A1/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
    • 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
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0227—Materials having sensing or indicating function, e.g. indicating a pressure increase
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer

Definitions

  • the present invention relates to medical engineering and, more specifically to disposable syringes applied for pharmaceutical injections.
  • the present invention further relates to a disposable, limited or restricted use injectable pharmaceutical syringe that can transmit contaminants, and disease to a person or cause infection if reused.
  • the present invention more particularly relates to barrel part comprising colour changing material composition outside the barrel which changes colour after its first use.
  • Some disposable syringes for injections known to be in widespread use nowadays comprise a cylindrical housing, a piston with a rod accommodated in said housing, and a needle fixing device (cf., e.g., disposable syringes available from Trumo Europe Co., Belgium).
  • a needle fixing device cf., e.g., disposable syringes available from Trumo Europe Co., Belgium.
  • the syringes in question differ very little from disposable syringes now in extensive use in modem medical practice, the sole exception residing in that they are made of a cheaper material (i.e., polymer) and therefore are not subject to sterilization.
  • a syringe which can be rendered inoperable after use presents a viable solution to these issues.
  • Various syringes have been proposed and are commercially available that can be disabled by the user by taking active steps to disable the syringe.
  • Single-use syringes that do not require the user to actively disable the syringe are also thought to offer a solution. It would be desirable to provide syringes that are automatically or passively disabled from reuse and can be manufactured in a cost effective manner by, for example, utilizing fewer parts.
  • the syringe under discussion features its needle fixed in a washer situated in the front portion of the syringe housing and capable of reciprocating lengthwise the axis of the housing.
  • the piston disposed past the washer in the syringe housing and rigidly coupled to the rod is not engaged with the washer but has catches adapted for the piston to engage the washer when both of them interact with each other through their end faces.
  • Yet another object of this invention is to provide such a disposable and non-reusable syringe, which is made of plastic materials and may be used with premeasured doses of medicine.
  • the primary object of the present invention is to provide a process for the development of preparation of an embedded test film to indicate prior use of medical device.
  • the further object of the present invention is to provide various components for the said process for preparation of an embedded test film including preparation of curing solution and preparation of base solution Tetrabutylammonium hydroxide (TBAH) solution.
  • TBAH Tetrabutylammonium hydroxide
  • barrel portion of the syringe of the present invention is applied with curing solution followed by activation through ultra violet radiation (U. V.).
  • the object of the present invention further involves a process of preparation of HPMC film to be applied over outer portion of barrel of the syringe-comprising indicator in preparation of film and said film is applied over outer portion of the syringe. Further, on said film base solution is added which changes the colour of the film.
  • the above objects are accomplished by providing a disposable syringe, which indicate colour change for expiration indication, loss of sterility and restricted reuse of the disposable syringe.
  • a syringe which includes a barrel, an elongate plunger rod and stopper having respective structures and assembly thereof.
  • particularly uses a barrel with specific composition material used for manufacturing shows colour change after first use.
  • a colour changeable composition is disposed directly on an inner portion of the barrel, the chemical composition used thereof having a first colour upon exposure to medicine solution in the parenteral formulation or any fluid filled in it.
  • the barrel portion of the syringe changing colour after the predetermined time to provide a warning indication that the apparatus should no longer be used.
  • Present invention ensures sterility of the medicine even at the purchase point by a patient from medical shop.
  • During storage of syringes in cupboards and drawers in medical stores there are chances that packing of the syringe may have got punctured or perforated while movement of syringes from cupboards and drawers every now and then for taking syringes out and putting them in with every new customer. So, there are chances that such punctured packing loses its sterility of the syringe. Therefore, present invention also relates to that additional benefit it offers to ensure sterility of the syringe while stored in a medical shop at sale point.
  • Figure III Illustrates (a) Yellow colour before Curing (b) Yellow colour after Curing. (c) Red colour after addition of TBAH (d) Yellow colour within 10 minutes after adding
  • a syringe is a simple reciprocating pump consisting of a plunger (though in modern syringes, it is actually a piston) that fits tightly within a cylindrical tube called a barrel.
  • the plunger can be linearly pulled and pushed along the inside of the tube, allowing the syringe to take in and expel liquid or gas through a discharge orifice at the front (open) end of the tube.
  • the open end of the syringe may be fitted with a hypodermic needle, a nozzle or tubing to direct the flow into and out of the barrel.
  • Syringes are frequently used in clinical medicine to administer injections, infuse intravenous therapy into the bloodstream, apply compounds such as glue or lubricant, and draw/measure liquids.
  • Medical syringe Sectors in the syringe and needle market include disposable and safety syringes, injection pens, needleless injectors, insulin pumps, and specialty needles.
  • Hypodermic syringes are used with hypodermic needles to inject liquid or gases into body tissues, or to remove from the body. Injecting of air into a blood vessel is hazardous, as it may cause an air embolism; preventing embolisms by removing air from the syringe is one of the reasons for the familiar image of holding a hypodermic syringe pointing upward, tapping it, and expelling a small amount of liquid before an injection into the bloodstream.
  • S solution which is prepared with sufficient number of syringes, must be clear and colourless.
  • Syringes must have finger grips which prevent rotation more than 180 degrees when syringes are placed horizontally at flat which is angled 10 degree with horizontal plane.
  • finger grips must be in appropriate shape, measure and resistance and they must not have sharp edge or bulge.
  • the dry syringe is weighted and filled with water, discharged, syringe’s outer surface is dried and it is reweighted.
  • the void volume is calculated from the weight of the residual water. This finding is in accordance with the value mentioned in the standards.
  • Bioburden count and prevalence of spore forms in the product should be known. This method can be used when sterilizing agent and sterilization cycle conditions don’t affect the quality of product (United States Pharmacopeia, 2006). Parenteral formulations
  • injectable formulations are also called injectable formulations and are used with intravenous, subcutaneous, intramuscular, and intra-articular administration.
  • the drug is stored in liquid or if unstable, lyophilized form.
  • parenteral means outside the intestines and it includes routes of administration except oral route.
  • Various routes of parenteral administration are: i) Intracutaneous or intradermal - injected into the skin ii) Subcutaneous or hypodermic - under the skin iii) Intramuscular - into a muscle iv) Intravenous - into a vein
  • Some less commonly used routes are: i) Intraarterial - into a artery ii) Intracardiac - into the heart iii) Intraarticular - in the joint iv) Intrasynovial - in a joint fluid area v) Intrathecal - into spinal fluid vi) Intraspinal - in the spinal column
  • Parenteral route of administration is used for the following purposes: a) When rapid action of drug is required e.g.
  • Intravenously administered medicines must be in aqueous solution and they must mix with the blood. Volume of the solution may vary from a few millilitres to litres that can be given by parenteral route. But only the intravenous route is suitable for very large volumes.
  • liquid formulations combine the drug product with a variety of compounds to ensure a stable active medication following storage. These include solubilizers, stabilizers, buffers, tonicity modifiers, bulking agents, viscosity enhancers/reducers, surfactants, chelating agents, and adjuvants. If concentrated by evaporation, the drug may be diluted before administration. For IV administration, the drug may be transferred from a vial to an IV bag and mixed with other materials.
  • Needle Adapter (shown as "E” in figure): It holds the needle.
  • the syringe body including barrel portion for the present invention is made up of Polypropylene.
  • UV curing method The barrel of the syringe under present invention is surface modified using U.V. [Ultra Violet] curing technique, and conjugated with the colour-changing film applied over the barrel surface acting as a sensor.
  • the present invention works on the principle of absorbing carbon dioxide (CO2) from atmosphere and altering the pH of the surface, which results in the change in colour of the film.
  • CO2 carbon dioxide
  • the film which is sticked on the outer surface of the barrel changes its colour as it comes in contact with the atmospheric C02 (carbon dioxide) in air. This indicates the status of the syringe whether it is used or fresh.
  • the process for the present invention comprises the steps of as follow:
  • Curing is a process during which a chemical reaction (such as polymerization) or physical action (such as evaporation) takes place, resulting in a harder, tougher or more stable linkage (such as an adhesive bond) or substance (such as concrete).
  • a chemical reaction such as polymerization
  • physical action such as evaporation
  • a harder, tougher or more stable linkage such as an adhesive bond
  • substance such as concrete.
  • Table 1 Composition of Curing Solution: The process for the preparation of the curing solution involves preparing a uniform admixture of all the ingredients depicted in table 1 of the composition.
  • Base solution for the present invention is an organic base, Tetrabutylammonium hydroxide is used. It is prepared in methanol solvent. Here, Tetrabutylammonium hydroxide (TBAH) solution of pH 14 in Methanol.
  • TBAH Tetrabutylammonium hydroxide

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 une seringue jetable non réutilisable à protection chimique. Plus particulièrement, la présente invention concerne un film sur la partie cylindrique d'une seringue jetable, qui présente un changement de couleur lors de l'exposition à du dioxyde de carbone atmosphérique. La présente invention concerne en outre tous les composants du film de test et leur procédé de préparation. Le présent procédé concerne la préparation d'une solution de durcissement, d'une solution de base et l'application d'un film sur la partie cylindrique de la seringue indiquant le changement de couleur.
PCT/IN2022/050563 2021-06-20 2022-06-20 Seringue jetable non réutilisable à protection chimique WO2022269631A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202121002629 2021-06-20
IN202121002629 2021-06-20

Publications (1)

Publication Number Publication Date
WO2022269631A1 true WO2022269631A1 (fr) 2022-12-29

Family

ID=84544242

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2022/050563 WO2022269631A1 (fr) 2021-06-20 2022-06-20 Seringue jetable non réutilisable à protection chimique

Country Status (1)

Country Link
WO (1) WO2022269631A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104897663A (zh) * 2015-05-21 2015-09-09 北京大学深圳研究生院 一种用于二氧化碳检测的薄膜传感器及其应用
US20190292421A1 (en) * 2018-03-23 2019-09-26 Sensor International, Llc Color changeable adhesives and methods of making such adhesives

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104897663A (zh) * 2015-05-21 2015-09-09 北京大学深圳研究生院 一种用于二氧化碳检测的薄膜传感器及其应用
US20190292421A1 (en) * 2018-03-23 2019-09-26 Sensor International, Llc Color changeable adhesives and methods of making such adhesives

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