WO2013188931A1 - Container filled with a local anaesthetic and method for preparing a mixture of a local anaesthetic and a second liquid - Google Patents

Container filled with a local anaesthetic and method for preparing a mixture of a local anaesthetic and a second liquid Download PDF

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Publication number
WO2013188931A1
WO2013188931A1 PCT/BE2013/000028 BE2013000028W WO2013188931A1 WO 2013188931 A1 WO2013188931 A1 WO 2013188931A1 BE 2013000028 W BE2013000028 W BE 2013000028W WO 2013188931 A1 WO2013188931 A1 WO 2013188931A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid
container
chambers
mixture
local anaesthetic
Prior art date
Application number
PCT/BE2013/000028
Other languages
English (en)
French (fr)
Inventor
Jan Gustaaf M. VERMEYLEN
Original Assignee
Vermeylen Jan Gustaaf 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 Vermeylen Jan Gustaaf M filed Critical Vermeylen Jan Gustaaf M
Publication of WO2013188931A1 publication Critical patent/WO2013188931A1/en

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
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3294Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles comprising means for injection of two or more media, e.g. by mixing

Definitions

  • Container filled with a local anaesthetic and method for preparing a mixture of a local anaesthetic and a second liquid.
  • the present invention relates to a container filled with a local anaesthetic and a method for producing a mixture of a local anaesthetic and a second liquid. It is known that when administering a local anaesthetic, for example lidocaine, mixed with adrenalin or otherwise, pain can be experienced by the patient.
  • a local anaesthetic for example lidocaine, mixed with adrenalin or otherwise
  • the pierceable seal, for example a rubber stopper, of the containers is pierced a number of times because the containers contain a number of doses, which may give rise to sterility problems.
  • the purpose of the present invention is to provide a solution to at least one of the aforementioned and other disadvantages, by providing a container that is intended to store a first and a second liquid separately in separate chambers and is intended to let the liquids flow simultaneously out of the container, that is filled with a first and second liquid in the separate chambers, whereby the first liquid is a solution of a local anaesthetic and the second liquid is an agent to adjust the pH of the first liquid.
  • the second liquid is a sodium bicarbonate solution in water, which preferably has a concentration of 8.4%.
  • the local anaesthetic is lidocaine .
  • the container is arranged such that the first liquid and the second liquid can be mixed while they are in the container.
  • the container is arranged such that the first liquid and the second liquid, when they are mixed while in the container, form a mixture with a pH between 7 and 7.5. More preferably this pH is between 7.2 and 7.4. In this way the sensation of pain is reduced.
  • the container can be arranged by designing the volumes of the chambers and/or the anticipated relative outflow rates, in combination with the nature and concentration of the liquids, such that that the desired pH is reached.
  • the container is arranged such that the first liquid and the second liquid can be mixed while they are in the container, because the container is provided with a joint outlet channel that connects to both chambers and because the container is designed to allow the first and second liquid to flow simultaneously with a constant ratio of their outflow rates from their chambers to the joint outlet channel, whereby the mixing takes place in the joint outlet channel.
  • a static mixer is preferably present in the joint outlet channel.
  • a practical embodiment of a container according to the invention is a syringe with two chambers, that can comprise an injection needle or otherwise, of which one chamber is filled with the first liquid and the other chamber is filled with the second liquid, whereby each chamber has a separate plunger, and the plungers of the chambers can be operated by a joint control.
  • Such syringes with two chambers, or two lumens are known.
  • Such a syringe can, even without an injection needle, be provided with a joint outlet channel, to which an injection needle that is fitted will connect.
  • Such a syringe can also be constructed such that an adapted needle is affixed over separate outlets of the chambers, whereby the cavity in the needle forms the joint outlet channel .
  • the container is arranged such that the first liquid and the second liquid can be mixed while they are in the container, because the container is provided with a partition between the chambers that is breakable or removable.
  • this container can be constructed as a syringe, or it can be a separate container, from which the mixture can be extracted after mixing by a conventional syringe with one chamber in order to then be injected.
  • the invention further concerns the use of a container that is intended to store a first and a second liquid separately in separate chambers and is intended to let the liquids flow out simultaneously, whereby the first liquid is a solution a local anaesthetic and the second liquid is an agent to adjust the pH of the first liquid.
  • the invention also concerns a method for making a mixture of a first liquid and a second liquid to be injected, whereby the first liquid is a solution of a local anaesthetic and whereby the second liquid is an agent to adjust the pH of the first liquid, characterised in that the first liquid and the second liquid are brought together from separate chambers that form part of a joint container for the liquids, and are simultaneously forced out of the container .
  • the invention also concerns a method for administering a local anaesthetic to a patient, whereby a mixture of a first liquid and a second liquid is injected, whereby the first liquid is a solution of a local anaesthetic and whereby the second liquid is an agent to adjust the pH of the first liquid, characterised in that the mixture is made according to a method described above.
  • the mixture to be injected is injected from the container immediately after the mixing, or first a quantity of mixture is made that is then put in a conventional syringe and injected by means of that.
  • the term ⁇ agent' in the expression A agent to adjust the pH of the first liquid' means a chemical compound in pure form, dissolved form, or diluted form, or a mixture of such chemical compounds.
  • Figure 1 schematically shows a perspective view of a container according to the invention
  • figure 2 shows a cross-section of the container of figure 1 according to line II-II;
  • figure 3 shows a cross-section of the container of figure 1 according to figure 2, in an earlier state of use .
  • the container 1 shown in the drawings consists of a syringe 2 and an injection needle 3, that are connected together by means of a screw thread.
  • the container 1 is shown in figures 1 and 2 in a situation that is ready to administer an injection.
  • the container 1 has a first chamber 4 for liquid and a second chamber 5 for liquid.
  • the chambers 4 and 5 are, in this example but not necessarily, cylindrical and have a round cross-section.
  • the diameter Dl of the first chamber 4 in this example is 1.4 cm and the diameter D2 of the second chamber in this example is 0.5 cm.
  • the areas of the cross-sections of the chambers 4 and 5 thus have a ratio of 8.
  • the chambers 4 and 5 each have a plunger 6, 7 that can move in the channel concerned.
  • the two plungers 6 and 7 are each connected to a joint control 8 in the form of a shaft with a pushbutton.
  • Chambers 4 and 5 each have an outlet channel 9 and 10.
  • the outlet channels 9, 10 come together in a joint outlet channel 11 that has a part 11A located in the syringe 2 and a part 11B in the injection needle 3.
  • h section 12 with a spiral form is affixed on the inside wall in the joint outlet channel 11.
  • the first chamber 4 is filled with a solution 13 of 1% lidocaine and 5 ppm adrenalin.
  • the second chamber 5 is filled with a solution 14 of 8.4% sodium bicarbonate, NaHCC>3 . Both solutions 13 and 14 are liquids.
  • Air bubbles are removed from the syringe 2 and injection needle 3 in the usual way. Then the injection needle is inserted into the body of the patient at the site where a local anaesthetic is needed.
  • lidocaine solution 13 As a result eight times more lidocaine solution 13 than sodium bicarbonate solution 14 is injected, irrespective of the absolute speed of injection.
  • the section 12 with spiral form can also be affixed in the syringe 2 instead of the injection needle 3.
  • a means other than a stopper 15 for closing the chambers 4,5, would have to be provided in the period that the solutions 13, 14 are not yet used.
  • the containers 1 according to the invention are intended for single use.
  • the areas of the cross-sections of the chambers 4 and 5 in this specific example have a ratio of 8. However this ratio can be different in different cases, and is related to the nature and concentration of the liquids to be used.

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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/BE2013/000028 2012-06-20 2013-06-07 Container filled with a local anaesthetic and method for preparing a mixture of a local anaesthetic and a second liquid WO2013188931A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BE201200421A BE1020761A3 (nl) 2012-06-20 2012-06-20 Houder gevuld met een lokaal anestheticum en werkwijze om een mengsel van een lokaal anestheticum met een tweede vloeistof aan te maken.
BE2012/0421 2012-06-20

Publications (1)

Publication Number Publication Date
WO2013188931A1 true WO2013188931A1 (en) 2013-12-27

Family

ID=48747869

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BE2013/000028 WO2013188931A1 (en) 2012-06-20 2013-06-07 Container filled with a local anaesthetic and method for preparing a mixture of a local anaesthetic and a second liquid

Country Status (2)

Country Link
BE (1) BE1020761A3 (nl)
WO (1) WO2013188931A1 (nl)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111417420A (zh) * 2017-11-17 2020-07-14 瑞典孤儿比奥维特鲁姆有限公司 带有离子交换材料的注射器组件
US20210162175A1 (en) * 2019-12-03 2021-06-03 Boston Scientific Scimed, Inc. Agent delivery devices

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5137528A (en) * 1990-11-26 1992-08-11 Crose Virginia W Ampoule for administering a liquid local anaesthetic
WO2005016170A2 (en) * 2003-08-14 2005-02-24 3M Espe Ag Unit-dose syringe for a multi-component material
US20070225645A1 (en) * 2006-03-27 2007-09-27 Danyel Tarinelli Dual air regulated spray applicator
WO2008001221A2 (en) * 2006-06-21 2008-01-03 Novartis Ag Concurrent delivery device for multiple vaccines
WO2008051925A2 (en) * 2006-10-23 2008-05-02 Sibbitt Wilmer L Jr Reciprocating mixing syringes
AU2010101255A4 (en) * 2010-11-15 2010-12-23 Lumsden, Andrew A prefilled syringe for administering buffered lignocaine

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5137528A (en) * 1990-11-26 1992-08-11 Crose Virginia W Ampoule for administering a liquid local anaesthetic
WO2005016170A2 (en) * 2003-08-14 2005-02-24 3M Espe Ag Unit-dose syringe for a multi-component material
US20070225645A1 (en) * 2006-03-27 2007-09-27 Danyel Tarinelli Dual air regulated spray applicator
WO2008001221A2 (en) * 2006-06-21 2008-01-03 Novartis Ag Concurrent delivery device for multiple vaccines
WO2008051925A2 (en) * 2006-10-23 2008-05-02 Sibbitt Wilmer L Jr Reciprocating mixing syringes
AU2010101255A4 (en) * 2010-11-15 2010-12-23 Lumsden, Andrew A prefilled syringe for administering buffered lignocaine

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CLIFFORD R WHEELESS: "Local Anesthetic properties for Lidocaine", 16 December 2011 (2011-12-16), XP055051631, Retrieved from the Internet <URL:http://www.wheelessonline.com/ortho/local_anesthetic_properties_for_lidocaine> [retrieved on 20130129] *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111417420A (zh) * 2017-11-17 2020-07-14 瑞典孤儿比奥维特鲁姆有限公司 带有离子交换材料的注射器组件
JP2021503322A (ja) * 2017-11-17 2021-02-12 スウェーディッシュ オーファン バイオヴィトルム エービー(ピーユービーエル) イオン交換材料を有するシリンジアセンブリ
JP7227971B2 (ja) 2017-11-17 2023-02-22 スウェディッシュ オーファン バイオビトラム アクティエボラーグ (ペーウーベーエル) イオン交換材料を有するシリンジアセンブリ
CN111417420B (zh) * 2017-11-17 2024-02-02 瑞典孤儿比奥维特鲁姆有限公司 带有离子交换材料的注射器组件
US20210162175A1 (en) * 2019-12-03 2021-06-03 Boston Scientific Scimed, Inc. Agent delivery devices

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Publication number Publication date
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