DESC:AN AUTO DISABLE SYRINGE FOR PREVENTION OF REUSE OF THE SYRINGE

FIELD OF INVENTION:

[001] This invention is related to an auto disable Syringe for prevention of Reuse of the Syringe. The invention in particular is directed to single use Syringe, which ensures safety of users.

[002] The sterile hypodermic auto-disable syringe for single use with needle having hub and Auto Disable function of syringe for fixed dose immunization is intended to be used for the medical purpose to inject vaccine into body.

BACKGROUND/PRIOR ART OF THE INVENTION:

[003] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[004] Plastic disposable Syringes are in market since last more than 45 years, which has been used in medical field with an intention of single use.

[005] Currently available disposable syringe(s) can be re-used and therefore miss-used. The disposable syringes are re used or re sold without Sterilization may/may not be with Switched Needles. This results in spreading of infectious diseases.

[006] Thus, it causes harmful effects not only to the patients but also to the healthcare workers. Hence, an improved single use syringe is required to be devised.
[007] For reuse prevention of Syringe, Auto disable syringes are introduced by the proposed application.

[008] Now, reference may be made to the Patent US 8287491. The same is discussed herein below:

[009] A single-use auto-disable syringe device of reduced size utilizes a locking element to prevent re-use of the syringe by locking the plunger rod with respect to the barrel upon completion of an injection stroke. The plunger rod includes a plurality of teeth comprising distally facing shoulders provided on a majority of the length of an elongate portion of the plunger rod and a breakable section configured to break upon the application of excessive axial or torsional force. The breakable section is preferably provided at a distal end of the plunger rod so that a proximal end of the locking element engages the syringe barrel and plunger rod at a position more proximal than the breakable section. In this way, the locking element resists some of the force that would otherwise be applied to the breakable section if the plunger rod were twisted. The plunger rod also includes an intermediate tooth provided on a distal-most tooth to prevent the user from repeatedly drawing in doses too small to activate the safety mechanism.

[0010] The aforesaid known art is complicated in design rendering the same expensive. Hence, the present invention has been introduced which is simple in construction and effectively serves the purpose.

OBJECTS OF THE INVENTION:

[0011] It is therefore the object of the present disclosure to overcome the aforementioned and other drawbacks in prior arts.

[0012] It is an object of the present disclosure to provide an Auto Disable Syringe for prevention of Reuse of the Syringe.

[0013] It is a primary object of the present disclosure to provide an Auto Disable Syringe for prevention of Reuse of the Syringe, which is simple in construction.

[0014] It is another object of the present disclosure to provide an Auto Disable Syringe for prevention of Reuse of the Syringe, which serves the purpose efficiently.

[0015] It is yet another object of the present disclosure to provide an Auto Disable Syringe for prevention of Reuse of the Syringe, which uses accurate dosage of medicine avoiding wastage thereof.

[0016] It is still another object of the present disclosure to provide an Auto Disable Syringe for prevention of Reuse of the Syringe, which avoids spreading of infectious diseases owing to single use.

[0017] These and other objects and advantages of the present invention will be apparent to those skilled in the art after a consideration of the following detailed description taken in conjunction with the accompanying drawings in which a preferred form of the present invention is illustrated.

SUMMARY OF THE INVENTION:

[0018] One or more drawbacks of conventional systems and process are overcome, and additional advantages are provided through the apparatus/composition and a method as claimed in the present disclosure. Additional features and advantages are realized through the technicalities of the present disclosure. Other embodiments and aspects of the disclosure are described in detail herein and are considered to be part of the claimed disclosure.

[0019] Auto Disable syringe uses specialized plunger lock and break system in order to auto disable after injection to prevent re-use or re-sell.

[0020] According to the invention, there is provided an auto disable Syringe for prevention of Reuse of the Syringe (100) comprising of Plunger (101) accommodated in Barrel (102) with Gasket (103), wherein the Plunger (101) is provided with arrow type tip (104) with wings (105) for locking with said gasket (103) inside the barrel (102), in which the plunger (101) is having hinge at its lower portion for detaching the plunger while retracting back to avoid reuse thereof.

[0021] The Gasket (103) of Auto Disable Syringe is having profile substantially same as that of the barrel inner profile in transverse direction, in which said Gasket (103) of Auto Disable Syringe (100) is having O ring shape that it is used with the arrow type plunger (101).

[0022] The Hinge is provided that once the tip is locked on barrel wings, said plunger is broken into pieces when it is pulled backward.

[0023] The plunger is having the arrow type tip with a gasket there below in barrel to be incorporated inside barrel luer nozzle after use.

[0024] The plunger is divided into two parts and connects two parts of the plunger with two hinge for easy breaking off when plunger is pulled back for re-use after injection.

[0025] The syringe attains the following positions during operation thereof:-
- Initial Position (Figure 4A)— This position defines initial position of plunger in barrel when medicine in taken in syringe barrel;
- Second Position (Figure 4B)– This position defines once medicine in injected and arrow type plunger is locked while injecting the medicine;
- Third Position (Figure 4C) – Once Plunger is locked in barrel, while pulling the plunger backward it is detached and broken to prevent the re-use of syringe.

[0026] The Syringes Barrel and plunger are made up of food grade polypropylene, the Gasket is made of material including Natural Rubber and Needle is made of Stainless Steel tube.

[0027] Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

[0028] It is to be understood that the aspects and embodiments of the disclosure described above may be used in any combination with each other. Several of the aspects and embodiments may be combined to form a further embodiment of the disclosure.

[0029] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

[0030] The illustrated embodiments of the subject matter will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. The following description is intended only by way of example, and simply illustrates certain selected embodiments of devices, systems, and processes that are consistent with the subject matter as claimed herein, wherein:-
Figure 1 shows: Components of an auto disable Syringe for prevention of Reuse of the Syringe according to the present invention.
Figure 2 shows: Plunger of the auto disable Syringe of the present invention.
Figure 3 shows: Gasket of the auto disable Syringe of the present invention.
Figure 4a, 4b and 4c shows: Initial, second and third position of the syringe during operation.
Figure 5 shows: Test Result of the invention.

[0031] The figures depict embodiments of the disclosure for purposes of illustration only. One skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the disclosure described herein.

DETAIL DESCRIPTION OF THE INVENTION WITH REFERENCE TO THE ACCOMPNAYING DRAWINGS:

[0032] While the embodiments of the disclosure are subject to various modifications and alternative forms, specific embodiment thereof have been shown by way of example in the figures and will be described below. It should be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternative falling within the scope of the disclosure.

[0033] The present invention makes a disclosure regarding a technology pertaining to invention directing to an Auto Disable Syringe for prevention of Reuse of the Syringe.

[0034] Now, reference may be made to figure 1-3.

[0035] The Auto Disable Syringe (100) comprises Plunger (101) accommodated in Barrel (102) with Gasket (103).

[0036] The Plunger (101) is specially designed with a tip member (104) for locking mechanism. The tip (104) is locked at wing (105) inside the barrel after completion of an injection stroke. Further, the plunger is provided with hinge at its intermediate portion, so that the plunger breaks into two pieces by getting its lower portion detached from its upper portion. The Hinge is provided so that once the tip is locked on barrel wings, said plunger is broken when it is pulled backward. As a result, the syringe can't be re used.

[0037] Barrel is provided with gasket inside so that once the tip of plunger moves inside luer nozzle of the barrel, the plunger gets locked at its wing with the gasket. This prevents the plunger to move backward.

[0038] Thus, the Plunger (101) is specially designed with arrow type tip (104) for locking mechanism and with hinge provided at lower portion of plunger. The hinge causes the plunger (101) to get detached so that it can’t be re-used.

[0039] The Plunger is specially designed with arrow type tip (104) with wings (105) for locking mechanism. So that once arrow type plunger moves inside Luer nozzle it will break the plunger. The plunger gets locked inside the barrel, that prevents the plunger to move backward. While pulling the plunger backward the plunger is broken into pieces at the hinge so that it can’t be re-used.

[0040] The Gasket of Auto Disable Syringe is having profile substantially same as that of the barrel inner profile in transverse direction. Gasket of Auto Disable Syringe (100) is designed in O ring shape as shown in figure-3 so that it can be used with the design of arrow type plunger (101).

[0041] This syringe attains the following positions during operation thereof:-

- Initial Position (Figure 4A)— This position defines initial position of plunger in barrel when medicine in taken in syringe barrel.
- Second Position (Figure 4B)– This position defines once medicine in injected and arrow type plunger is locked while injecting the medicine. (Due to design of plunger tip and barrel wings this locking mechanism will work)
- Third Position (Figure 4C) – Once Plunger is locked in barrel, while pulling the plunger backward it is detached and broken to prevent the re-use of syringe.
[0042] The syringe is designed for fixed dosage of medicine.
For Example: 0.5 ml without restricting scope of the invention to the same. Thus, various other dosage of medicine can be accommodated in the Syringe of the instant invention.

Function: The Auto-disable syringe that passively gets activated upon delivering injection of the nominal fixed dose to prevent subsequent reuse of the syringe and the needle. The Auto-disable syringe has a built-in mechanism designed to give dose after which the syringe is permanently disabled.
The barrels of syringes are marked with the following information:
a) Appropriate graduated scale
b) Total graduated capacity in milliliter

PURPOSE:

Auto disable Mechanism is introduced with the following purposes:
1.1 Prevention of syringe to be re -used
1.2 Wastage and inaccuracy dosage of medicine while taking medicine
1.3 Prevention of re use or re sell of Disposable syringes without Sterilization
1.4 Prevention of re use or re sell of Disposable syringes with Switched Needles
1.5 Avoids spreading of infectious diseases and ensures proper accurate dosage of medicine

Material:
Auto-disable syringes comprising of 4 components which are Barrel, Plunger, Gasket and Needle. Syringes Barrel and plunger can be made up of food grade polypropylene. Gasket is made of material including Natural Rubber and Needle can be made of Stainless Steel tube.
The above is given as example without restricting scope of the invention to the same. Thus, other materials readily apparent to a person skilled in the art are understood to be within purview of the invention.

Application:
This product is designed and invented keeping techno commercial aspect of Auto Disable function of syringe, which can be easier and helpful in case of mass immunization programs.

Sr No. Components 3 Part -Disposable Syringe 3 Part -Auto Disable Syringe
1 Plunger The plunger is located at the end of the syringe and is made of plastic. Its purpose is to fill or empty the barrel. The plunger is pulled back to fill the barrel and is pushed forward for emptying. The plunger is specially designed with arrow type tip for the locking mechanism and with a hinge provided at the lower portion of the plunger to get detached so that it can’t be re-used.
2 Barrel The barrel is the part of the syringe that contains the fluid, whether it is a medication, blood or a solution drawn from the body. The barrel is designed with wings so that once arrow type plunger moves inside Luer nozzle, it will get locked and prevents the plunger to move backward.
3 Gasket The gasket to be used for a medical syringe, the gasket comprising: a main body made of an elastic material; and a film provided on a surface of the main body; the gasket having a circumferential surface portion to be brought into contact with an inner peripheral surface of a barrel of the syringe; the gasket further comprising a projection provided on a surface portion of the film present in the circumferential surface portion as extending circumferentially of the gasket.
The gasket of Auto Disable Syringe is designed in O ring shape so that it can be used with the design of arrow type plunger.
4 Instruction to Use Easy to use Easy to use and requires trainee for usage
5 Infection Transmission Need to worry about your physical condition as Chances of infection is high. Don’t have any mechanism to protect medical specialists and patients from thetransmission of blood pathogens like HIV (Human Immunodeficiency Virus). Do not need to worry about your physical condition as it minimizes the threat of any infections. The syringe protects the medical specialists and patients from the transmission of blood pathogens like HIV (Human Immunodeficiency Virus). It guarantees the least risk of reuse.
6 Needle Fitment Luer Slip/Lock design- dead space is high The fixed-needle design ensures the removal of the dead space within the syringe.
7 Re-Use The possibility of Reuse is high Possibility of Reuse is ZERO, as Plunger gets detached so that It can’t be reused.
8 Medicine Wastage As dead space is high, medicine wastage is higher.
As dead space will be less, wastage of medicine is low.

Working Models:

Auto-disable syringe:0.5 ml
Ref: ISO 7886-3 2020

Parameter TOLERENCE Nominal capacity-0.5 ml
Dead Space ±5% 0.475-0.525
Needle Gauge Sizes
- 16 18 21 22 23 24 25 26 27 29 30
Needle OD in mm ± 0.05 1.65 1.25 0.82 0.71 0.62 0.55 0.52 0.40 0.41 0.3 0.32
Needle Material - Stainless steel
Effective length ss needle in mm ± 0.3 mm 25.40 for 1”
Bond between hub and cannula - 3.500-4.500 kgf

· Sterile, Non-Pyrogenic.
· Sterilized by ethylene oxide
· Shelf life of 5 years from the date of Mfg. / Sterilization

TEST RESULT
Batch No. Dead space O.D OF Needle Effective Length of needle (in mm) Bond between hub and Cannula (KGF)
220103 0.04 0.6 24.92 3.5
220203 0.05 0.61 24.85 3.6
221303 0.04 0.63 24.95 3.5
221403 0.03 0.61 25 3.7
221903 0.04 0.63 24.9 3.5

[0043] Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases, it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.

[0044] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0045] It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particulars claim containing such introduced claim recitation to inventions containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and/or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogues to “at least one of A, B and C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). In those instances where a convention analogous to “at least one of A, B, or C, etc.” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (e.g., “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, etc.). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B”.

[0046] The above description does not provide specific details of manufacture or design of the various components. Those of skill in the art are familiar with such details, and unless departures from those techniques are set out, techniques, known, related art or later developed designs and materials should be employed. Those in the art are capable of choosing suitable manufacturing and design details.

[0047] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. It will be appreciated that several of the above-disclosed and other features and functions, or alternatives thereof, may be combined into other systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may subsequently be made by those skilled in the art without departing from the scope of the present disclosure as encompassed by the following claims.

[0048] The claims, as originally presented and as they may be amended, encompass variations, alternatives, modifications, improvements, equivalents, and substantial equivalents of the embodiments and teachings disclosed herein, including those that are presently unforeseen or unappreciated, and that, for example, may arise from applicants/patentees and others.

[0049] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.
,CLAIMS:WE CLAIM
1. An auto disable Syringe for prevention of Reuse of the Syringe (100) comprising of Plunger (101) accommodated in Barrel (102) with Gasket (103), wherein the Plunger (101) is provided with arrow type tip (104) with wings (105) for locking with said gasket (103) inside the barrel (102), in which the plunger (101) is having hinge at its lower portion for detaching the plunger while retracting back to avoid reuse thereof.

2. The auto disable Syringe for prevention of Reuse of the Syringe (100) as claimed in claim 1, wherein the Gasket (103) of Auto Disable Syringe is having profile substantially same as that of the barrel inner profile in transverse direction, in which said Gasket (103) of Auto Disable Syringe (100) is having O ring shape that it is used with the arrow type plunger (101).

3. The auto disable Syringe for prevention of Reuse of the Syringe (100) as claimed in claim 1 or 2, wherein the Hinge is provided that once the tip is locked on barrel wings, said plunger is broken into pieces when it is pulled backward.

4. The auto disable Syringe for prevention of Reuse of the Syringe (100) as claimed in claims 1-3, wherein the plunger is having the arrow type tip with a gasket there below in barrel to be incorporated inside barrel luer nozzle after use.

5. The auto disable Syringe for prevention of Reuse of the Syringe (100) as claimed in claims 1-4, wherein said plunger is divided into two parts and connects two parts of the plunger with two hinge for easy breaking off when plunger is pulled back for re-use after injection.

6. The auto disable Syringe for prevention of Reuse of the Syringe (100) as claimed in claims 1-5, wherein the syringe attains the following positions during operation thereof:-
- Initial Position (Figure 4A)— This position defines initial position of plunger in barrel when medicine in taken in syringe barrel;
- Second Position (Figure 4B)– This position defines once medicine in injected and arrow type plunger is locked while injecting the medicine;
- Third Position (Figure 4C) – Once Plunger is locked in barrel, while pulling the plunger backward it is detached and broken to prevent the re-use of syringe.

7. The auto disable Syringe for prevention of Reuse of the Syringe (100) as claimed in claims 1-6, wherein the Syringes Barrel and plunger are made up of food grade polypropylene, the Gasket is made of material including Natural Rubber and Needle is made of Stainless Steel tube.