An aseptic syringe for collection of samples

Abstract

An aseptic syringe (100) for collection of samples include a cylinder (102), a piston (104), an operating part (106) extending from a proximal end (104-1) of the piston (104) and a barrier (108) configured between a proximal end (102-1) of the cylinder (102) and the operating part (106) such that that the barrier (108) remains outside of the inner hollow of the cylinder (102) thereby foreclosing any possibility of the barrier (108) getting damaged by getting stuck between the cylinder (102) and the piston (104). The syringe (100) includes a barrier cover (114) that protects the barrier (108) as well as supports and guides the operating part (106) during pushing-pulling of the piston (104). A locking mechanism (128) slidablly configured over the barrier cover (114) enables collection of precise volumes of the sample.

Description

AN ASEPTIC SYRINGE FOR COLLECTING SAMPLESTECHNICAL FIELD

[0001] The present disclosure relates generally to the technical field of devices for collecting samples, In particular, it pertains to a single use syringe for collecting samples in an aseptic manner.BACKGROUND

[0002] 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.

[0003] The conventional methods of collection of samples for analysis, where the sample is to be collected in an aseptic manner, pose a greater risk of contamination of the collected sample. It is essential to ensure that the devices or apparatus used to collect samples are sterile to avoid contamination of the sample. During the process, it is also routinely required to collect a small (<= 20mL) but precise volume of the sample, to minimize product loss while ensuring sufficient sample size for analysis purposes. For such applications, in the interest of minimizing inventory holding, it is desirable that a single device design can collect precise volumes of different values rather than having a separate apparatus for each volume to be collected.

[0004] Moreover, single-use systems are very common in biochemical engineering, where the apparatus used for the bioprocess is discarded after one use. The single-use systems offer numerous advantages such as lower manual labor, quicker set-up time, reduced chance of contamination, greater flexibility, etc. Thus, it is desirable to provide the above solution in the form of a disposable, single-use device. However, as the Bioprocesses need to be done in a very clean and controlled environment, and the materials used should not adversely affect the quality or quantity of the yield, the solution should not introduce any materials in contact with the bioprocess that could negatively affect the yield or quality e.g. leachable, extractables, endotoxins, etc.

[0005] To address the above limitations, various approaches have been investigated. For instance, Patent document US7597683B2 discloses a syringe for a fluid, comprising a cylinder, a piston portion arranged in the cylinder and slidable on its inside, and an operating meansconnected to the piston portion for sliding thereof. The operating means projects from the first end of the cylinder and the cylinder has at a second end an inlet and outlet part for said fluid. Moreover, a sealing means is connected in a contamination-free manner to the cylinder in the area of the first end thereof and extends into the cylinder to isolate, sealed against contamination, the inside of the cylinder from the environment. However, the device of the cited reference has limitation in that the sealing may get stuck between the cylinder and piston, making it harder to operate. Besides, damage to the sealing may cause contamination to pass through. Moreover, when the piston is pulled back, the sealing collects in the cylinder, which creates an opposing force on the plunger thereby making it hard for the operator to extract a precise volume of fluid.

[0006] Patent document US20030065291A1 discloses a syringe equipped with a flexible barrier that is connected between the syringe body and the plunger, operable to prevent contaminants from entering the injection fluid housed within the syringe body through the rear opening. However, this disclosure has limitation in that the barrier remains uncovered. There exists a high probability of the barrier sustaining damage during use, which compromises both efficacy and operator safety. Furthermore, since the barrier is intended to slide between the cylinder and piston, there is a risk of it getting stuck there between, potentially impeding the device's operation. Consequently, there is a considerable likelihood of contaminants infiltrating the collected sample.

[0007] There is, therefore, a requirement in the art to overcome the above-mentioned problems by providing a simple, compact, and efficient aseptic syringe for collecting samples.OBJECTS OF THE DISCLOSURE

[0008] A general object of the present disclosure is to overcome drawbacks of the known devices for sample collection.

[0009] Another object of the present disclosure is to provide a syringe for sample collection that can collect a precise volume of the sample.

[0010] Another object of the present disclosure is to provide a syringe with a barrier that does not get stuck between the cylinder and piston.

[0011] Yet another object of the present disclosure is to provide a syringe with a barrier where the barrier is well protected against damage.SUMMARY

[0012] Aspects of the present disclosure relate generally to the technical field of single-use syringes, In particular, it pertains to an improved aseptic syringe for collecting samples that overcomes drawbacks of known aseptic syringes.

[0013] In an aspect, the disclosed syringe for collecting a sample includes a cylinder, a piston, an operating part and a barrier. The cylinder has a distal end with a nozzle and an open proximal end with an inner hollow extending between the distal end and the proximal end, where the nozzle provides fluidic connectivity between the inner hollow and outside of the cylinder,

[0014] The piston is configured within the inner hollow of the cylinder for linear motion between a collapsed position in which an inner end of the piston moves close to the distal end of the cylinder, and an extended position, in which the inner end of the piston moves close to the proximal end of the cylinder.

[0015] The operating part is coupled to the piston at an outer end of the piston to facilitate linear movement of the piston by pulling and pushing of the operating part by a user.

[0016] In an aspect, a distal end of the barrier is coupled to the proximal end of the cylinder and a proximal end of the barrier is coupled to the operating part such that the barrier remains outside of the inner hollow of the cylinder.

[0017] In an embodiment, the syringe may include a plunger coupled to the piston at an inner end of the piston for sliding movement within the inner hollow of the cylinder along with the piston.

[0018] In an embodiment, the operating part may be integral to the piston and projects out of the inner hollow of the cylinder, even in the collapsed position of the piston.

[0019] In an embodiment, the syringe may include a connection portion located between the piston and the operating part. The connection portion may be configured for coupling the proximal end of the barrier to the operating part.

[0020] In an embodiment, the barrier may be configured to provide a seal between the inner hollow of the cylinder and the outside of the cylinder. The seal extends between the proximal end of the cylinder and the connection portion between the piston and the operating part, to prevent contaminants from entering the cylinder.

[0021] In an embodiment, the barrier may be of a cylindrical bellows shape. The barrier may be made of an elastomeric material.

[0022] In an embodiment, the syringe may include a first overlapping ring for coupling a proximal end of the barrier to the operating part, and a second overlapping ring for coupling of a distal end of the barrier to the proximal end of the cylinder.

[0023] In an embodiment, the syringe may include a barrier cover extending beyond the proximal end of the cylinder such that the barrier is located within the barrier cover for protection.

[0024] In an embodiment, the operating part may be guided by the barrier cover during the pushing and pulling of the operating part by the user.

[0025] In an embodiment, the syringe may include a locking mechanism to enable collection of a precise volume of the sample. The locking mechanism may be adjustably configured on the barrier cover such that it functions as a stopper during pulling operation of the piston, thereby defining a limit to which the piston is pulled, limiting the maximum volume of the sample that is dawn through the nozzle.

[0026] The locking mechanism may be slidablly configured over the barrier cover and may include one or more extensions that project inwards through one or more apertures provided on the barrier cover. The inward projecting one or more extensions engage with the connection portion to limit pulling operation of the piston.

[0027] In an embodiment, the one or more extensions can be a retractable locking pin that can be pulled and then inserted through a selected aperture in the barrier cover after the locking mechanism has been repositioned after sliding.

[0028] In an embodiment, the barrier cover may include measurement markings to guide positioning of the locking mechanism for collection of different precise volumes of the sample.

[0029] In an embodiment, the barrier cover may include a plurality of measurement markings to guide positioning of the locking mechanism for collection of different precise volumes of the sample.

[0030] In an embodiment, the cylinder may include markings indicative of volume of sample collected within the syringe to facilitate extraction of precise volumes.

[0031] In an embodiment, the syringe may be pre-sterilized by gamma irradiation or x-ray irradiation or any other known means.

[0032] In an embodiment, the cylinder may be configured such that pulling the operating part for moving the piston from the collapsed position to the extended position results in intake of a predefined quantity of the sample into the cylinder.

[0033] 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.BRIEF DESCRIPTION OF DRAWINGS

[0034] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.

[0035] FIG. 1 illustrates an exemplary front view of the proposed aseptic syringe, in accordance with embodiments of the present invention.

[0036] FIG. 2 illustrates an exemplary cross-sectional view of the proposed aseptic syringe, in accordance with embodiments of the present invention.

[0037] FIG. 3 illustrates an exemplary view of a piston and an operating part of the proposed aseptic syringe, in accordance with embodiments of the present invention.DETAILED DESCRIPTION

[0038] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0039] In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details.

[0040] If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0041] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0042] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

[0043] The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0044] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure).

[0045] Embodiments explained herein relate to a simple, compact, and efficient aseptic syringe. Specifically, the aseptic syringe of the present disclosure overcomes drawbacks of the known aseptic syringes that have a barrier located such that the barrier gets located between acylinder and a piston of the syringe, which makes it prone to damage on account of getting entangled between the two, affecting sealing as well as operational efficiency. In an aspect, the barrier of the disclosed aseptic syringe is entirely located outside of the cylinder fixed between a proximal open end of the cylinder and an operating part that extends towards proximal side from the piston. Additionally a barrier cover is provided to protect the barrier. The barrier may also be used to guide the operating part during linear movement of the operating part along with the piston when the operating part is pulled and pushed to move the piston between a collapsed position and an extended position during operation of the syringe for collection and discharge of a sample.

[0046] Referring now to FIGs. 1 to 3, in an aspect, the proposed syringe (collectively designated as 100, herein) for collecting samples can in the main, include a cylinder 102, a piston 104, a plunger 110, a barrier 108 (also referred to as a bellow 108, herein), an operating part 106 with an operating end 112, a barrier cover 114, a locking mechanism 128 slidablly configured on the barrier cover 114, and a plurality of measurement markings 130 provided on the barrier cover 114.

[0047] In an embodiment, the cylinder 102 can be a hollow cylinder with a nozzle 122 located at a distal end 102-2 (the lower end in FIGs. 1 and 2) in providing a fluidic communication between the inner hollow of the cylinder 102 and outside of the syringe 100 for receiving and discharging a sample from the syringe 100. The cylinder 102 can have an open proximal end 102-1 (the upper end in FIGs. 1 and 2) for receiving the piston 104 there within. The cylinder 102 together with the piston 104 can be the operative portion of the syringe 100 facilitating suction and discharge of the sample within / from the cylinder 102 when the piston 104 is moved up, away from the distal end 102-2 towards the proximal end 102-1, by pulling the operative part 106 using the operating end 112, or when the piston 104 is moved down towards the proximal end 102-1 by pushing the operative part 106 using the operating end 112. The syringe 100 can be configured to be held by the user from the barrier cover 114.

[0048] In an embodiment, the piston 104 can include a proximal end 104-1 and a distal end 104-2. The operating part 106 can extend towards the proximal side (top side in FIGs, 1 and 2) of the syringe 100. Operating part 106 can be a separate part fixed to the piston 104 by any suitable means, or it can be integral to the piston 104. The plunger 110 can be fixed to the distalend 104-2 of the piston 104 that ensures suction action by a close sliding fit with inner circumference of the cylinder 102.

[0049] In an embodiment, the plunger 110 may be coupled to the distal end 104-2 of the piston 104. The plunger 110 upon push-pull action on the piston 104 can slide within the cylinder 102. The sliding of the plunder 108 can create and release vacuum within the cylinder 102 between the plunger 110 and the nozzle 122. The plunger 110 can be in configured for close sliding fit with an inner circumference of the cylinder 102 to enable suction and discharge of the sample.

[0050] In an embodiment, the barrier 108 can be positioned between the proximal end 102-1 of the cylinder 102 and the operating part 106, such as a connection portion 126 of the operating part 106 that joins the operating part 106 to the proximal end 104-1 of the piston 104. Specifically, a proximal end 108-1 of the barrier 108 can be fixed to the operating part 106 and a distal end 108-2 of the barrier 108 can be fixed to the proximal end 102-1 of the cylinder 102. As the connection portion 126 located at junction of the piston 104 and the operating part 106 is sized bigger than inner hollow of the cylinder 102, the operating part 106 remains outside of the cylinder 102, foreclosing any possibility of the barrier 108 getting stuck between the cylinder 102 and the piston 104.

[0051] In an embodiment, the barrier 108 fitted in the manner as described above and shown in FIG. 2, provides a seal between the inner hollow of the cylinder 102 and the outside of the cylinder 102. The seal extends between the proximal end 102-1 of the cylinder 102 and the connection portion 126 between the piston 104 and the operating part 106, to prevent contaminants from entering the cylinder 102.

[0052] In an embodiment, the a proximal end 108-1 of the barrier 108 can be fixed to the operating part 106 through a first ring 116 (also referred to as first overlapping ring 116, herein) and the distal end 108-2 of the barrier 108 can be fixed to the proximal end 102-1 of the cylinder 102 by a second ring 118 (also referred to as second overlapping ring 118, herein), as shown in the sectional view of FIG. 2. Specifically, the proximal end 102-1 of the cylinder 102 can include a flange 120 to facilitate fixing of the second ring 118, while the first ring 116 is fixed at the connection portion 126, which also has a flange like structure.

[0053] In an embodiment, the barrier 108 can be cylindrical bellow shaped such that when the operating part 106 is pushed and pulled, the barrier 108 undergoes expansion andcompression. A barrier cover 114 is provided that extends beyond the proximal end 102-1 of the cylinder 102 such that the barrier 108 is located within the barrier cover 114 for protection, In another embodiment, the barrier cover 114 can incorporate inner axial ribs to support the operating part 106 and guide the operating part 106 during the pushing and pulling of the operating part by the user

[0054] In an embodiment, configuration of the barrier cover 114, the cylinder 102, the piston 104, and the operating part 106 can be such that during the pulling movement of the piston 104, the piston 104 undergoes linear movement of a pre-defined distance that controls the precise amount of sample that can be sucked in by the syringe 100. Additionally, the cylinder 102 can include markings, such as markings shown in FIG. 1, indicating volume of the sample collected within the syringe 100. This can be used to extract precise volumes as desired with the same device design, when the requirement is to collect a volume that is less than the maximum amount that can be accommodated in the syringe 100.

[0055] In an embodiment, a locking mechanism 128 may be adjustably configured on the barrier cover 114 which can define the extent to which the piston 104 can be pulled during the pulling operation of the operating part 106 / the piston 104. Limiting the pulling of the operating part 106 / piston 104 can limit the maximum volume of the sample that can be dawn through the nozzle 122. The user can slide the locking mechanism 128 linearly along the barrier cover 114.

[0056] In an embodiment, the locking mechanism 128 may be slidablly configured over the barrier cover 114 and may include one or more extensions, such as extensions 128-1, that project inwards through one or apertures 130 provided on the barrier cover 114. The inward projecting one or more extensions 128-1 can engage with the connection portion 126 to limit pulling operation of the piston 104.

[0057] In an embodiment, the one or more extensions 128-1 can be a retractable locking pin that can be pulled and then inserted through a selected aperture 130 in the barrier cover 114 after the locking mechanism has been repositioned after sliding.

[0058] In an embodiment, the cylinder 104 and the barrier cover 114 may include a plurality of measurement markings 132 such that the measurement markings 132 on the cylinder 104 can be indicative of volume of sample collected within the syringe 100 to facilitate extraction of precise volumes and the measurement markings 132 on the barrier cover 114 can guidepositioning of the locking mechanism 128 for collection of different precise volumes of the sample.

[0059] In an exemplary embodiment, the syringe 100 can include a cap 124. The cap 124 may be configured on the nozzle 122 of the syringe to keep the nozzle 122 sterile. The cap 124 can act as a preventive measure against potential contamination. Additionally, the cap 124 can be fixed with the cylinder 102 by breakable locks such that when the cap 124 is removed for use of the syringe 100, the locks break indicating that the syringe has been used or tampered with, thus preventing possibility of reuse or use of a tempered syringe 100.

[0060] In an exemplary embodiment, the syringe 100 can be assembled and then sterilized, such as by gamma irradiation or x-ray irradiation. Alternatively or additionally, different parts, such as the cylinder 102, the piston 104 along with the operating part 106, the plunger 110, the barrier 108, the first ring 116, the second ring 118, the barrier cover 114, and the cap 124 may be pre-sterilized before assembling the syringe 100.

[0061] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.ADVANTAGES OF THE DISCLOSURE

[0062] The present disclosure provides an aseptic syringe that overcomes drawbacks of the known devices for sample collection.

[0063] The present disclosure provides a syringe for sample collection that can collect a precise volume of the sample.

[0064] The present disclosure provides a syringe with a barrier that does not get stuck between the cylinder and piston.

[0065] The present disclosure provides a syringe with a barrier where the barrier is well protected against damage.

Claims

We Claim:

1. A syringe for collecting a sample, the syringe (100) comprising: a cylinder (102) having a distal end (102-2) with a nozzle (122) and an open proximal end (102-1) with an inner hollow extending therebetween, the nozzle (122) providing fluidic connectivity between the inner hollow and outside of the cylinder (102); a piston (104) configured within the inner hollow of the cylinder (102) for linear motion between a collapsed position in which an inner end of the piston (104) moves close to the distal end (102-2) of the cylinder (102), and an extended position, in which the inner end of the piston (104) moves close to the proximal end (102-1) of the cylinder (102); an operating part (106) coupled to the piston (104) at an outer end of the piston (104) to facilitate linear movement of the piston (104) by pulling and pushing of the operating part (106) by a user; and a barrier (108) coupled between the proximal end (102-1) of the cylinder (102) and the operating part (106) such that the barrier (108) remains outside of the inner hollow of the cylinder (102).

2. The syringe (100) as claimed in claim 1, wherein the syringe (100) comprises a plunger (110) coupled to the piston (104) at an inner end of the piston (104) for sliding movement within the inner hollow of the cylinder (102) along with the piston (104).

3. The syringe (100) as claimed in claim 1, wherein the operating part (106) is integral to the piston (104) and projects out of the inner hollow of the cylinder (102).

4. The syringe (100) as claimed in claim 3, wherein the syringe (100) comprises a connection portion (126) located between the piston (104) and the operating part (106); the connection portion (126) being configured for coupling a proximal end (108-1) of the barrier (108) to the operating part (106).

5. The syringe (100) as claimed in claim 4, wherein the barrier (108) is configured to provide a seal between the inner hollow of the cylinder (102) and the outside of the cylinder (102), the seal extending between the proximal end (102-1) of the cylinder (102) and the connection portion (126) between the piston (104) and the operating part (106), to prevent contaminants from entering the cylinder (102).

6. The syringe (100) as claimed in claim 1, wherein the barrier (108) is of a cylindrical bellows shape, and is made of an elastomeric material.

7. The syringe (100) as claimed in claim 1, wherein the syringe (100) comprises a first overlapping ring (116) for coupling a proximal end of the barrier (108) to the operating part (106), and a second overlapping ring (118) for coupling of a distal end (108-2) of the barrier (108) to the proximal end (102-1) of the cylinder (102).

8. The syringe (100) as claimed in claim 1, wherein the syringe (100) comprises a barrier cover (114) extending beyond the proximal end (102-1) of the cylinder (102) such that the barrier (108) is located within the barrier cover (114) for protection, wherein the operating part (106) is guided by the barrier cover (114) during the pushing and pulling of the operating part (106) by the user.

9. The syringe (100) as claimed in claim 1, wherein the syringe (100) comprises a locking mechanism (128) to enable collection of a precise volume of the sample, the locking mechanism (128) being adjustably configured on the barrier cover (114) to define a limit to which the piston (104) is pulled, thereby limiting the maximum volume of the sample that is dawn through the nozzle (122), wherein the locking mechanism (128) is slidablly configured over the barrier cover (114) and includes one or more extensions (128-1) that project inwards through one or more apertures (130) provided on the barrier cover (114), the one or more extensions (128-1) functioning as stoppers to limit pulling of the piston (104).

10. The syringe (100) as claimed in claim 5 and 9, wherein the inward projecting one or more extensions (128-1) engage with the connection portion (126) to limit pulling operation of the piston (104).

11. The syringe (100) as claimed in claim 9, wherein the barrier cover (114) comprises a plurality of measurement markings (132) to guide positioning of the locking mechanism (128) for collection of different precise volumes of the sample.

12. The syringe (100) as claimed in claim 11, wherein, the cylinder (104) comprises the plurality of measurement markings (132) indicative of volume of sample collected within the syringe (100) to facilitate extraction of precise volumes.

13. The syringe (100) as claimed in claim 1, wherein, the syringe (100) is pre-sterilized by gamma irradiation or x-ray irradiation or any other known means.

14. The syringe (100) as claimed in claim 1, wherein the cylinder (102), the piston (104), the operating part (106) and the barrier cover (114) are configured such that pulling theoperating part (106) for moving the piston (104) from the collapsed position to the extended position results in intake of a predefined quantity of the sample into the cylinder (102).

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