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AU2011101361A4 - A prefilled syringe for administering buffered lignocaine - Google Patents

A prefilled syringe for administering buffered lignocaine Download PDF

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Publication number
AU2011101361A4
AU2011101361A4 AU2011101361A AU2011101361A AU2011101361A4 AU 2011101361 A4 AU2011101361 A4 AU 2011101361A4 AU 2011101361 A AU2011101361 A AU 2011101361A AU 2011101361 A AU2011101361 A AU 2011101361A AU 2011101361 A4 AU2011101361 A4 AU 2011101361A4
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Australia
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chamber
chambers
lignocaine
plunger
contents
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AU2011101361A
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Andrew Lumsden
Kylie Lumsden
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A PREFILLED SYRINGE FOR ADMINISTERING BUFFERED LIGNOCAINE 5 A prefilled syringe for administering buffered lignocaine comprises a first and second chamber filled with lignocaine and buffer respectively wherein in use by pressing a plunger into the chambers the contents of the chambers are completely mixed before being expelled and wherein the first chamber has a volume ten times the volume of the second chamber to combine the lignocaine and buffer in a ratio of 10:1.

Description

I A PREFILLED SYRINGE FOR ADMINISTERING BUFFERED LIGNOCAINE FIELD OF THE INVENTION 5 This invention relates to prefilled syringes for administering buffered lignocaine. BACKGROUND OF THE INVENTION Lignocaine (also known as lidocaine) is a common local anesthetic which many 10 general practitioners and dentists use in their surgeries on a daily basis. Lignocaine is locally injected into a patient before minor surgery. However during administration of lignocaine patients often experience an unpleasant stinging or burning sensation at the application site. 15 The stinging sensation associated with lignocaine injections has been attributed to its low pH and increasing its pH by buffering lignocaine with sodium bicarbonate has been shown to reduce this undesirable feeling. However, use of buffered lignocaine, particularly in Australia, is uncommon due to the difficulties associated with its preparation, storage and application. 20 Lignocaine and sodium bicarbonate when stored separately, have a shelf life of approximately 2 and 3 years respectively. However, once sodium bicarbonate and lignocaine are mixed together the shelf life is reduced to between 1-7 days if stored at room temperature or a maximum of 3 weeks if refrigerated. 25 Practitioners have been known to prepare a large vial of pre-mixed buffered lignocaine from which they draw out a dosage for each patient. However, given the short shelf life of the pre-mixed solution, vials need to be prepared frequently and much of the mixture is thrown away. This is both labour intensive and results in 30 significant wastage. Further, there is a risk of contaminating the mixture during manual preparation and each time a needle enters the vial the risk of cross 2 contamination increases. It is these problems that prevent practitioners from using buffered lignocaine. A two-chambered vial has been developed which contains lignocaine and a buffer in 5 separate chambers and the wall between the two chambers is broken to mix the two solutions when required by bending or twisting the vial. The vial has a stopper for the insertion of a syringe for extraction of the mixture for administration. However, the outside of such vials is not sterile which is problematic for practitioners 10 who tend to wear sterile gloves to perform injections and in order to maintain sterility of their gloves must either extract mixture without touching the vial or have a second person hold the vial for them. Further, if the stopper has been touched or contaminated and is not cleaned properly then there is a risk of contamination of the needle during insertion into the stopper. This two chambered vial is difficult and time 15 consuming to use. Reference also may be made to US Patent 5137528 which discloses an ampoule having a stopper slidably mounted to one end and a rubber diaphragm secured at the other end. An aperture barrier is provided in the ampoule between each end and has 20 an aperture sealed by a plug. Sterile acidified liquid local anesthetic is contained in a compartment adjacent the stopper and sterile alkaline neutralizing reagent is contained in a compartment defined by the barrier and the rubber diaphragm. In use the ampoule is placed in the barrel of a hypodermic syringe to perforate the rubber diaphragm and communicate with the compartment located adjacent the stopper. 25 The hypodermic needle is then inserted into the oral tissues of the patient. Thereafter the plunger of the syringe is advanced against the stopper to advance the stopper in the ampoule thereby to pressurize the local anesthetic to dislodge the plug and to force the acidified local anesthetic into the alkaline neutralizing reagent and hence immediately into the tissues of the patient. 30 However it was to be appreciated that the above arrangement was extremely complicated especially in regard to use of the ampoule which could lead to 3 contamination when the ampoule is placed in the barrel of the syringe. Also use of the ampoule was time consuming and labour intensive. This reference however described suitable dosages for the anesthetic solution such that 0.18ml of anesthetic solution such as 2% lidocaine hydrochloride (1/10 the volume of a 1.8ml ampoule) 5 were replaced with 0.18ml of 8.4% sodium bicarbonate. Reference may also be made to US Patent 5209724 which describes a syringe suitable for mixing 0.3-2.0% by weight of the composition and which also has sufficient sodium bicarbonate to maintain a pH between 7.0-7.6. This composition 10 also includes from about 0.0004 moles of dissolved carbon dioxide per ml of composition up to the satisfaction level of dissolved carbon dioxide at a C02 head pressure of up to about 2.5 atmospheres. However in relation to this particular reference it was considered necessary to add 15 carbon dioxide such as by addition or bubbling through the sodium carbonate solution. It has been shown that in a lot of cases this is not necessary and complicates use of the composition which is administered to a patient through a prefilled syringe having separate chambers wherein the contents of each container are mixed during administration to a patient. 20 It is also controversial whether the addition of C02 has any improvement on the action of local anesthetic. Curatolo et al. (Anesthesia and Analgesia 86 1998, p. 341) observed no effect on analgesia with the addition of C02 to lignocaine. 25 Many studies have been conducted on the efficacy of lignocaine combined with sodium bicarbonate, none of which added extra C02 for the purpose of their trials, indicating that additional C02 is not a requirement for effective analgesia of buffered lignocaine. 30 Adding C02 to a prefilled dual chamber syringe of lignocaine and sodium bicarbonate buffer would incur significant extra financial costs and labour in the manufacture of 4 the product. Since this step is not necessary and has not been conclusively shown to add any value, its use is extremely questionable Therefore, there is a need for an improved device for administering buffered 5 lignocaine. OBJECT OF THE INVENTION It is therefore an object of the present invention to provide an improved device for 10 administering buffered lignocaine or at least to provide an alternative to the prior art. STATEMENT OF THE INVENTION According to the present invention there is provided a prefilled syringe for 15 administering buffered lignocaine comprising a first chamber filled with lignocaine, and a second chamber filled with sodium bicarbonate buffer wherein said lignocaine and buffer do not have any added carbon dioxide wherein in use by pressing a plunger into the chambers the contents of both chambers are completely mixed within the syringe before being expelled through the needle tip, and where the first said 20 chamber has a volume 5-15 times the volume of the second chamber. It is highly desirable that the contents of both chambers are able to completely mix within the syringe prior to any liquid being expelled out of the tip to enable the neutralizing action for the lignocaine and buffer to take full effect. 25 In one form the chambers are the same length and are located side by side and the syringe has a compartment which can receive a needle tip and encloses one end of the chambers and wherein in use, pressing a plunger into each chamber simultaneously expels the contents of each chamber into the compartment where the contents completely mix before being expelled through the needle tip. 30 In another form the chambers have substantially the same diameter and are located end to end and are separated by a wall wherein in use, pressing a plunger into the 5 second chamber ruptures the wall separating the two chambers allowing the contents of both chambers to be completely mixed and then expelled. In yet another form the chambers have substantially the same diameter and are located end to end and are separated by a rubber stopper and the first chamber has 5 an enlarged portion wherein in use, pressing a plunger into the second chamber moves the rubber stopper separating the two chambers into the enlarged portion of the first chamber leaving a space around the plunger through which the contents of the two chambers can be completely mixed before being expelled. 10 BRIEF DESCRIPTION OF THE DRAWINGS An embodiment of the invention is now described by way of example only with reference to the accompanying drawings in which: 15 Fig 1 is a cross section view of a prefilled syringe according to one embodiment of the present invention. Fig 2 is a cross section view of a prefilled syringe according to another embodiment of the present invention. 20 DETAILED DESCRIPTION OF THE INVENTION A prefilled syringe for administering buffered lignocaine comprises a first chamber 1 filled with lignocaine and a second chamber 2 filled with buffer said first chamber 1 preferably having a volume ten times the volume of second chamber 2 and wherein in 25 use by pressing a plunger 3 into chambers 1 and 2 the contents of the chambers are completely mixed before being expelled. In one form, shown in Fig 1, chambers 1 and 2 are located side by side and a compartment 4 encloses one end of the chambers and has an opening which 30 receives a needle tip 5. Chambers 1 and 2 are hollow cylinders of the same length however, chamber 1 has a volume ten times the volume of chamber 2. Therefore the 6 cross section of chamber 1 has an area ten times the area of the cross section of chamber 2. Since chambers 1 and 2 are of the same length, plungers 3a and 3b can be pressed 5 into each chamber simultaneously to expel the contents of each chamber into compartment 4 where the contents mix completely before being expelled through the opening in compartment 4 and through needle tip 5 into the patient. The plunger for each chamber has a rubber stopper 6a and 6b at one end which are sized to sealably fit within its corresponding chamber. The two plungers 3a and 3b are joined at the 10 opposite end to allow simultaneous insertion of the plungers into chambers 1 and 2. Chambers 1 and 2 each have a wall 7 which seals the contents within the chamber and prevents them from mixing during storage. When plungers 6a and 6b are pressed into the chambers the pressure created ruptures wall 7 allowing the contents to mix in compartment 4 before being expelled. Compartment 4 can be sufficiently 15 large to enable the contents to completely combine therein before being expelled. In another form, shown in Fig 2, chambers 1 and 2 are located end to end with a rubber stopper 8 separating the two chambers. Chamber 2 is sealed with another rubber stopper 9 at the end of a plunger 3 and chamber 1 has an opening which 20 receives a needle tip 5. Chambers 1 and 2 are hollow cylinders of substantially the same diameter, however chamber 1 has an enlarged portion 11 of greater diameter. Chamber 1 also has a substantial air pocket such that when plunger 3 is pressed into chamber 2 the air in chamber 1 is expelled until plunger 8, separating the two chambers, reaches enlarged portion 11 leaving a space around plunger 8 through 25 which the contents of the two chambers can mix completely. Plunger 3 can then be pressed into the chambers to expel the buffered lignocaine from needle tip 5 into the patient. The air pocket in chamber 1 also forms an air lock to prevent leakage of the contents from the syringe during storage. 30 In yet another form plunger 8 separating the two chambers can be replaced with a wall (not shown). An air lock at the tip of the syringe prevents the liquid in chamber 2 from leaking from the syringe during storage. When a plunger is pressed into the 7 second chamber the wall between the two chambers is ruptured due to the pressure build up allowing the contents of the two chambers to mix. Some of the air in the tip of the syringe is expelled which ensures that no solution is accidentally expelled. The plunger can then be pressed into the syringe to expel the buffered lignocaine from the 5 needle into the patient. In this embodiment chamber 1 may have an enlarged portion 11 or may have a constant diameter. Furthermore, in this embodiment, the location of the first and second chambers can be switched such that the plunger is pressed into the first chamber. 10 Each of the syringes described above can be sold with a needle tip already attached to the syringe, or alternatively can have a cap sealing the opening which is removed before use and a needle tip attached. Each syringe will contain 5mIs of lignocaine in the first chamber and 0.5mls of buffer 15 in the second chamber. The buffer is preferably 8.4% sodium bicarbonate solution however an equivalent amount of sodium bicarbonate powder would also be used. In an alternative embodiment, adrenaline or another suitable adrenoceptor agonist such as epinephrine is combined with the lignocaine in the first chamber of the 20 syringe to reduce bleeding during minor surgical procedures. The syringe can be filled with different concentrations of lignocaine with or without adrenaline and the most frequently used strengths will be 1% lignocaine without adrenaline or combined with 50 micrograms of adrenaline and 2% lignocaine without adrenaline or combined with 62.6 micrograms of adrenaline. 25 The shelf life of sodium bicarbonate and lignocaine when stored separately in the devices described above is approximately 2 years. ADVANTAGES 30 The present invention provides a prefilled syringe for administering buffered lignocaine which significantly reduces the risk of contamination of the product. The 8 present invention provides a syringe that is easy to use and which allows the solutions to be mixed in a single step in a sterile environment. This device also significantly reduces the time it takes for a practitioner to prepare 5 buffered lignocaine as they do not have to manually measure and mix the two solutions. The separation of the buffer and the lignocaine significantly increase the shelf life of the product which reduces wastage. This increased shelf life also means the product can be mass produced and transported. 10 While US Patent 5209724 disclosed the use of prefilled syringes for administration of buffered lignocaine, in the present invention it has been found that there is no need for addition of carbon dioxide so that the prefilled syringes of the present invention clearly distinguish over this reference. 15 In regard to US Patent 5137128 it is considered that use of prefilled syringes for use of buffered lignocaine is a far simpler procedure than use of the ampoule described in this reference.
9 VARIATIONS It will be realized that the foregoing has been given by way of illustrative example only and that all other modifications and variations as would be apparent to persons skilled 5 in the art are deemed to fall within the broad scope and ambit of the invention as herein set forth. Throughout the description and claims of this specification the words "comprise" and variations of that word such as "comprises" and "comprising" are not intended to 10 exclude other additives components integers or steps.

Claims (4)

1. A prefilled syringe for administering buffered lignocaine comprising a first chamber filled with lignocaine, and a second chamber filled with sodium bicarbonate 5 buffer wherein said lignocaine and buffer do not have any added carbon dioxide wherein in use by pressing a plunger into the chambers the contents of both chambers are completely mixed within the syringe before being expelled through the needle tip, and where the first said chamber has a volume 5-15 times the volume of the second chamber. 10
2. The prefilled syringe of claim 1 wherein the chambers are the same length and are located side by side and a compartment which can receive a needle tip encloses one end of the chambers and wherein in use pressing a plunger into each chamber simultaneously expels the contents of each chamber into the compartment 15 where the contents are completely mixed before being expelled through the needle tip.
3. The prefilled syringe of claim 1 wherein the chambers have substantially the same diameter and are located end to end and are separated by a wall wherein in 20 use, pressing a plunger into the second chamber ruptures the wall separating the two chambers allowing the contents of both chambers to be completely mixed prior to being expelled.
4. The prefilled syringe of claim 1 wherein the chambers have substantially the 25 same diameter and are located end to end and are separated by a rubber stopper and the first chamber has an enlarged portion wherein in use pressing a plunger into the second chamber moves the rubber stopper separating the two chambers into the enlarged portion of the first chamber leaving a space around the plunger through which the contents of the two chambers can combine and be completely 30 mixed within the syringe prior to being expelled.
AU2011101361A 2010-11-15 2011-10-24 A prefilled syringe for administering buffered lignocaine Ceased AU2011101361A4 (en)

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AU2010101255 2010-11-15
AU2011101361A AU2011101361A4 (en) 2010-11-15 2011-10-24 A prefilled syringe for administering buffered lignocaine

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD750768S1 (en) 2014-06-06 2016-03-01 Anutra Medical, Inc. Fluid administration syringe
US9387151B2 (en) 2013-08-20 2016-07-12 Anutra Medical, Inc. Syringe fill system and method
USD763433S1 (en) 2014-06-06 2016-08-09 Anutra Medical, Inc. Delivery system cassette
USD774182S1 (en) 2014-06-06 2016-12-13 Anutra Medical, Inc. Anesthetic delivery device
CN111417420A (en) * 2017-11-17 2020-07-14 瑞典孤儿比奥维特鲁姆有限公司 Syringe assembly with ion exchange material
US11633353B2 (en) 2017-06-05 2023-04-25 Dizlin Pharmaceuticals Ab Levodopa infusion solution

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9387151B2 (en) 2013-08-20 2016-07-12 Anutra Medical, Inc. Syringe fill system and method
US9393177B2 (en) 2013-08-20 2016-07-19 Anutra Medical, Inc. Cassette assembly for syringe fill system
US9579257B2 (en) 2013-08-20 2017-02-28 Anutra Medical, Inc. Haptic feedback and audible output syringe
US10010483B2 (en) 2013-08-20 2018-07-03 Anutra Medical, Inc. Cassette assembly for syringe fill system
US10010482B2 (en) 2013-08-20 2018-07-03 Anutra Medical, Inc. Syringe fill system and method
USD750768S1 (en) 2014-06-06 2016-03-01 Anutra Medical, Inc. Fluid administration syringe
USD763433S1 (en) 2014-06-06 2016-08-09 Anutra Medical, Inc. Delivery system cassette
USD774182S1 (en) 2014-06-06 2016-12-13 Anutra Medical, Inc. Anesthetic delivery device
US11633353B2 (en) 2017-06-05 2023-04-25 Dizlin Pharmaceuticals Ab Levodopa infusion solution
US12048764B2 (en) 2017-06-05 2024-07-30 Dizlin Pharmaceuticals Ab Levodopa infusion solution
CN111417420A (en) * 2017-11-17 2020-07-14 瑞典孤儿比奥维特鲁姆有限公司 Syringe assembly with ion exchange material
CN111417420B (en) * 2017-11-17 2024-02-02 瑞典孤儿比奥维特鲁姆有限公司 Injector assembly with ion exchange material

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