US20230241320A1 - Low Cost Syringe with Durable and Disposable Components - Google Patents
Low Cost Syringe with Durable and Disposable Components Download PDFInfo
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- US20230241320A1 US20230241320A1 US18/300,010 US202318300010A US2023241320A1 US 20230241320 A1 US20230241320 A1 US 20230241320A1 US 202318300010 A US202318300010 A US 202318300010A US 2023241320 A1 US2023241320 A1 US 2023241320A1
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- United States
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- syringe
- fluid
- tubular insert
- reusable
- disposable
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- 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
- A61M5/31—Details
- A61M5/3129—Syringe barrels
-
- 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
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
-
- 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
- A61M5/31—Details
- A61M5/32—Needles; 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
-
- 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
- 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
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
- A61M2005/3139—Finger grips not integrally formed with the syringe barrel, e.g. using adapter with finger grips
-
- 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
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M2005/3142—Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
-
- 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
- A61M2205/27—General characteristics of the apparatus preventing use
- A61M2205/273—General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables
-
- 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
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
-
- 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
- A61M5/31—Details
- A61M5/3129—Syringe barrels
- A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
Definitions
- the present invention relates generally to syringes for transferring (i.e., injecting or withdrawing) fluids.
- embodiments of the present invention relate to low cost insulin injection syringes in which the low cost is achieved by separating the syringe into two types of components, namely, durable components that that do not contact the fluid path and can be reused, and disposable or single-use components that contact the fluid path and are not reused.
- Methods for making, using and packaging such syringes are also disclosed and claimed herein.
- a typical disposable syringe is made primarily of plastic and has several key components. The largest, and the one containing the most material, is the plastic barrel. The scale printing on the barrel is a critical and costly assembly step that is needed to assure proper dosing by the user. Inside the barrel is a rubber stopper that is used to create a hermetic seal and displace the liquid medication or other fluid into and out of the barrel. A plastic plunger rod interfaces with the rubber stopper to move it back and forth under the user's control. A metal needle or cannula is usually attached to the distal end of the barrel to allow fluids to be injected into or removed from the body, although this is not always the case. For example, a syringe having a male Luer connector at its distal end can be attached to a female Luer connector on a catheter or IV line to inject or withdraw fluids without the use of a needle or cannula.
- disposable plastic syringes are often used to administer liquid insulin to a user several times a day.
- These single-use syringes typically have clear polymeric barrels with printed scale numbers that allow the user to draw up an accurate dose of insulin from a vial, and fine-gauge metal needles (usually about 6 to 12 mm in length) that inject the dose into the skin with minimal discomfort to the user.
- the needles may be detachably connected to the barrels using Luer-LokTM or Luer slip connections, or they may be permanently attached or “staked” to the barrels during manufacture of the syringes.
- Insulin syringes usually have a capacity of 1 ml or less (with 0.3 ml, 0.5 ml and 1.0 ml barrel sizes being common), with scale markings on the barrel representing units of a specific type of insulin (e.g., U-100 or U-500 insulin). Insulin syringes may also be provided with safety features to prevent reuse of the syringe, to shield the used needle, or both. Because insulin syringes are used only once and a user usually requires several of them each day, they are commonly sold in boxes or bags containing multiple syringes.
- a low cost syringe is provided by separating the syringe into two types of components, namely, durable components that do not contact the fluid path and can be reused, and disposable or single-use components that contact the fluid path and are not reused.
- the ability to reuse the durable components reduces the effective per-unit cost of the syringe when multiple syringes are used. Since these components do not contact the fluid path, sterility is not affected. The disposal burden is also reduced because not all of the syringe components need to be disposed of each time a syringe is used.
- Two different syringe components a reusable outer sleeve containing scale markings for the syringe, and a reusable syringe plunger—are provided as durable components in embodiments of the present invention.
- Syringes manufactured according to the present invention can employ one or both of these durable components.
- one aspect of the present invention relates to a syringe comprising a barrel assembly having a disposable tubular insert and a reusable outer sleeve, the tubular insert forming a fluid reservoir and having a fluid opening at a distal end thereof, the reusable outer sleeve being detachably received on an outer surface of the tubular insert and having visible scale markings thereon; a stopper movably received in the tubular insert for sealing a proximal end of the tubular insert and for displacing fluid into or out of the tubular insert through the fluid opening upon movement of the stopper within the tubular insert; and a user-operable plunger coupled to the stopper for causing the stopper to move within the tubular insert and thereby displace fluid into or out of the tubular insert through the fluid opening under the control of the user.
- the present invention relates to a syringe comprising a disposable portion including a fluid reservoir having a fluid opening at a distal end thereof and a stopper movably received in the fluid reservoir for sealing a proximal end of the fluid reservoir and for displacing fluid into or out of the fluid reservoir through the fluid opening upon movement of the stopper within the fluid reservoir; and a reusable portion comprising a user-operable plunger detachably coupled to the stopper for causing the stopper to move within the fluid reservoir and thereby displace fluid into or out of the fluid reservoir through the fluid passage under the control of the user.
- Additional aspects of the invention relate to methods for using syringes of the type described for transferring fluids, and syringe multipacks in which the durable and disposable components of the syringe are packaged for sale or use.
- FIGS. 1 and 2 A- 2 D illustrate a syringe according a first embodiment of the invention, which employs a collar lock between a disposable tubular insert and a reusable outer sleeve;
- FIGS. 3 and 4 A- 4 F illustrate a syringe according a second embodiment of the invention, which employs a side lock between the disposable tubular insert and the reusable outer sleeve;
- FIGS. 5 and 6 illustrate a syringe according a third embodiment of the invention, which employs a bayonet lock between the disposable tubular insert and the reusable outer sleeve;
- FIGS. 7 and 8 illustrate a syringe according a fourth embodiment of the invention, which employs a twist lock between the disposable tubular insert and the reusable outer sleeve;
- FIG. 9 A illustrates a modified version of the syringe shown in FIGS. 7 and 8 ;
- FIGS. 9 B and 9 C illustrate the disposable tubular inserts used in the syringe embodiments of FIG. 9 A and FIGS. 7 - 8 , respectively;
- FIGS. 9 D and 9 E are front and back views of the reusable outer sleeve used in the syringe embodiment of FIGS. 7 - 8 ;
- FIGS. 10 and 11 A- 11 D illustrate a syringe according a fifth embodiment of the invention, which employs a press lock between the disposable tubular insert and the reusable outer sleeve;
- FIGS. 12 and 13 illustrate two different embodiments of a stopper and reusable plunger assembly for use in any of the previous syringe embodiments, or in a conventional syringe;
- FIG. 14 illustrates the manner in which multiple syringe assemblies according to any of the previous embodiments can be packaged for sale or use.
- connection is used broadly and encompass direct and indirect connections, couplings, and mountings.
- connection is not restricted to physical or mechanical connections or couplings.
- terms such as “up”, “down”, “bottom”, “top”, “distal” and “proximal” are relative, and are employed to aid illustration, but are not limiting.
- FIGS. 1 and 2 A- 2 D illustrate a syringe 20 according a first embodiment of the invention.
- the syringe 20 comprises a tubular barrel assembly that includes a disposable tubular insert 22 and a reusable outer sleeve 24 that is open at both ends and coaxially receives the insert 22 .
- the disposable tubular insert is preferably made of a plastic (polymeric) material, such as polypropylene, that can be inexpensively injection molded.
- the reusable outer sleeve 24 is preferably also made of a plastic material, such as polypropylene, polystyrene, polycarbonate or ABS, but can also be made of a metal such as stainless steel.
- the reusable outer sleeve 24 be made from a relatively stiff and durable material, whereas the disposable insert 22 can be made from a thinner, less rigid material.
- the upper portion of the tubular insert 22 can be seen in the partially disassembled view of FIG. 1 .
- the lower portion of the tubular insert 22 is partially obscured by the outer sleeve 24 in FIG. 1 , but is visible through an elongated rectangular slot 26 formed lengthwise in the outer sleeve 24 .
- FIG. 2 A shows the tubular insert 22 fully received in the outer sleeve 24 as would be the case during use of the syringe 20 .
- the tubular insert 22 which is shown alone in FIG. 2 B , is designed to be disposable and forms a fluid reservoir for the fluid (not shown) that is to be injected or withdrawn by the syringe 20 .
- the volume of the fluid reservoir varies according to the position of a separate rubber stopper 28 which seals the proximal end of the insert 22 .
- the stopper 28 is movably received in the tubular insert 22 for displacing fluid into or out of the tubular insert 22 through a fluid opening 30 at the distal end of the tubular insert 22 .
- a plastic plunger 32 (shown in FIG. 1 but omitted from FIGS. 2 A and 2 B ) having its distal end connected to the stopper 28 causes the stopper 28 to move up or down within the tubular insert 22 and thereby displace fluid into or out of the tubular insert 22 through the fluid opening 30 under the control of the user.
- a thumb press 34 integrally formed at the proximal end of the plunger 32 allows the user to pull or push on the plunger 32 as required.
- a flange 36 with opposed arms is integrally formed near the proximal end of the tubular insert 22 and can be held by a user's fingers when operating the plunger 32 .
- An annular collar 38 is integrally formed at the proximal end of the tubular insert 22 , above the flange 36 , to receive a removable sterile cap (not shown) that covers the proximal end of the syringe 20 before use.
- the fluid opening 30 is formed in a reduced diameter distal end portion 40 of the tubular insert 22 which is intended to receive a permanently attached or “staked” needle or cannula (not shown).
- a staked needle can be advantageous in reducing fluid dead space within the insert 22 .
- the distal end portion 40 can be formed as a male Luer slip or Luer LokTM connector which allows the tubular insert 22 to be affixed to a separately provided needle or cannula 42 via a hub 43 .
- the Luer connector can also be used to couple the syringe 20 directly to a female Luer connector on a catheter or IV line without the use of a needle or cannula.
- the tapered Luer tip can be formed integrally with the insert 22 , and the internally threaded locking collar can be formed integrally with the sleeve 24 .
- both portions can be formed integrally with the insert 22 .
- Another possibility is to provide a snap fit between the hub 43 and the reduced diameter distal end portion 40 of the tubular insert, in lieu of a Luer connection.
- the needle or cannula may have a sharp tip for penetrating the skin or a pro re nata (PRN), or it may consist of a blunt cannula of the type used to access a needleless connector.
- the disposable tubular insert 22 is preferably devoid of any printed indicia that require separate manufacturing steps, including the printed scale markings that are typically needed for proper operation of the syringe 20 .
- the required scale markings 44 are provided on the outer sleeve 24 , which can be detached from the used syringe 20 and reused.
- the scale markings 44 on the outer sleeve 24 may take the form of a combination of lines and numerals representing milliliters or units of insulin, as shown in FIGS. 1 and 2 , or any other suitable form as may be required for the specific application.
- the scale markings 44 may be ink-printed or laser-printed, embossed, engraved, laser-etched, or a combination of these (e.g., embossed with an ink-printed overlay for increased legibility).
- the embossing or engraving may be accomplished as part of the injection molding process that is used to manufacture the outer sleeve 24 (if it is made of plastic), with any desired ink-printing carried out during a separate manufacturing step.
- the lengthwise slot 26 in the outer sleeve 24 allows the user to directly view the tubular insert 22 , which is transparent or translucent, so that the fluid level in the tubular insert 22 can be viewed and compared with the scale markings 44 on the outer sleeve 24 . Due to the presence of the slot 26 , the outer sleeve 24 can be made partially or completely opaque if desired, although it will normally be preferable to make the outer sleeve 24 transparent or translucent so that the fluid level can be seen to some extent through its walls (although perhaps less clearly than through the slot 26 ).
- the slot 26 can be omitted if the outer sleeve 24 is made sufficiently transparent or translucent so that the fluid level in the tubular insert 22 can be seen through the walls of the outer sleeve 24 with enough precision for proper dosing.
- the slot 26 can be replaced by a transparent or translucent window in embodiments where the outer sleeve 24 is partially or completely opaque.
- a detachable connection is provided between the disposable tubular insert 22 and the reusable outer sleeve 24 so that the two components can be coupled together and used in the same manner as a conventional syringe, and then separated to allow for reuse of the outer sleeve 24 .
- This connection can be a simple friction or press fit between all or portions of the cylindrical outer surface of the tubular insert 22 and the cylindrical inner surface of the outer sleeve 24 , or a clamshell connection if the sleeve 24 is split or hinged.
- a more precise and positive releasable locking arrangement will usually be desired.
- the locking function is primarily needed in the axial direction because that is the direction in which the fluid level is compared with the scale markings 44 , but in some applications rotational locking (i.e., prevention of relative rotation between the tubular insert 22 and the outer sleeve 24 ) may also be needed or desired.
- FIGS. 1 and 2 A- 2 D One axial locking arrangement, referred to as a collar lock, is shown in FIGS. 1 and 2 A- 2 D .
- the tubular insert 22 bottoms out on an annular lip 45 formed at the bottom of the sleeve 24 when it reaches its full insertion point within the sleeve.
- a separate collar 46 with internal threads 47 which is received on an externally threaded proximal end portion 48 of the sleeve 24 , is rotated so that it advances from a location 49 on the sleeve 24 to a slightly more proximal location 50 .
- the threaded end portion 48 has a slightly greater outside diameter at the location 50 than it does at the location 49 .
- Cuts or gaps 51 divide the proximal end portion 48 into three or more portions which are relatively flexible.
- the increasing diameter of the threaded end portion 48 causes these flexible portions to be squeezed inwardly to grip the insert 22 and thereby lock the sleeve 24 and the insert 22 to each other both axially and rotationally.
- the threaded end portion 48 has a slightly greater outside diameter at the location 49 than it does at the location 50 , and the collar 46 is rotated so that it advances from the location 50 to the location 49 to secure the sleeve 24 to the insert 22 .
- the user initially receives the syringe 20 with the outer sleeve 24 either already attached or provided as a separate component which the user attaches to the insert 22 before use. If a needle or cannula 42 is required for the intended fluid transfer but is not pre-affixed or pre-attached to the insert 22 , the user also attaches the required needle or cannula. The user then performs the fluid transfer, which may consist of a fluid aspiration (e.g., of insulin from a vial), an injection of fluid into the body, a delivery of fluid into a catheter or IV line, or a withdrawal of fluid from the body (e.g., a blood sample), or some combination of these steps.
- a fluid aspiration e.g., of insulin from a vial
- an injection of fluid into the body e.g., a delivery of fluid into a catheter or IV line
- a withdrawal of fluid from the body e.g., a blood sample
- the user can observe the amount of fluid in the syringe 20 by comparing the fluid level that is visible through the slot 26 with the scale markings 44 on the outer sleeve 24 .
- the user removes the outer sleeve 24 by unscrewing the collar 46 and discards the remaining portion of the syringe 20 .
- the outer sleeve 24 and collar 46 can then be reused as part of another syringe 20 by attaching it to another insert 22 and repeating the steps above.
- the reusable outer sleeve 24 can be made of a sufficiently rigid material, such as polycarbonate or even metal, to reduce the rigidity required of the insert 22 .
- the walls of the insert 22 can be made thinner than would otherwise be required to withstand handling by the user and the internal fluid pressures generated by an injection, because the insert 22 is snugly received in a closely conforming sleeve 24 that can provide some of the required strength. This results in less waste of material when the insert 22 is discarded than would be the case for the barrel of a conventional single-use syringe.
- FIGS. 3 and 4 A- 4 F illustrate a syringe 20 A according a second embodiment of the invention (the needle or cannula 42 is not shown in this or subsequent embodiments, but will typically be present).
- the syringe 20 A is constructed in much the same manner as the syringe 20 of FIGS. 1 and 2 , except that a different locking arrangement is provided between the disposable tubular insert 22 A and the reusable outer sleeve 24 A.
- the flange 36 A of the insert 22 A is received in the cavity of a correspondingly shaped receptacle 37 formed at the proximal end of the sleeve 24 A.
- the flange 36 A and the adjoining receptacle 37 together form a combined flange that can be held by the user's fingers.
- the underside of the flange 36 A has a distally facing cavity with a pair of shallow indents 52 (visible in FIGS. 4 B and 4 C ) that interface with a sleeve collar 53 (shown alone in FIG. 4 D ).
- the sleeve collar 53 is captured and affixed within the sleeve 24 A and the receptacle 37 , and has two protruding, cantilevered, proximally extending arms 55 that are flexible and normally biased outwardly.
- each arm 55 engages a corresponding indent 52 of the flange 36 A, while the other end protrudes through an aperture 61 (visible in FIG. 4 F ) in the sleeve 24 A.
- the engagement of the ends 57 of the arms 55 with the indents 52 in the flange 36 A locks the sleeve 24 A and the insert 22 A to each other both axially and rotationally.
- the sleeve 24 A and the insert 22 A can be separated from each other after the syringe 20 A is used by squeezing the arms 55 inwardly to disengage the ends 57 of the arms from the indents 52 , and then pulling the sleeve 24 A and insert 22 A apart.
- FIGS. 5 and 6 illustrate a syringe 20 B according a third embodiment of the invention.
- the syringe 20 B is constructed in much the same manner as the syringes 20 and 20 A of FIGS. 1 - 4 F , except that a different locking arrangement is provided between the disposable tubular insert 22 B and the reusable outer sleeve 24 B.
- the insert 22 B is molded with a laterally extending lug or projection 54
- a proximal portion of the reusable outer sleeve 24 B has an open-ended, L-shaped bayonet slot 56 for slidably receiving the projection 54 to detachably secure the sleeve 24 B to the insert 22 B by a combination of axial and rotational movement.
- the bayonet connection provides both axial and partial rotational locking between the sleeve 24 B and the insert 22 B, and can be released by rotating and axially displacing these two components in the reverse direction with respect to each other. This allows the sleeve 24 B and the insert 22 B to be separated from each other after the syringe 20 B is used so that the sleeve 24 B can be reused.
- FIGS. 7 and 8 illustrate a syringe 20 C according a fourth embodiment of the invention.
- the flange 36 C of the insert 22 C is received in the cavity of a correspondingly-shaped receptacle 52 C formed at the proximal end of the sleeve 24 C.
- the receptacle 52 C has slots 58 in its front and rear sidewalls to receive the arms of the flange 36 C when the insert 22 C is rotated 90 degrees and depressed relative to the sleeve 24 from the position shown in FIG. 7 to the position shown in FIG. 8 .
- the receptacle 52 C also has diagonally opposed side openings 60 in its front and rear walls to frictionally receive and retain the arms of the flange 36 C when the insert 22 C is rotated an additional 90 degrees relative to the sleeve 24 from the position shown in FIG. 8 .
- Top closures 62 , 64 are located over the side openings 60 to prevent the insert 22 C from being axially withdrawn from the sleeve 24 C following this second 90 degree rotation, and the closed sidewalls of the receptacle 22 C prevent any further rotation of the insert 22 C in the same direction. In this way, the insert 22 C is locked both axially and rotationally within the sleeve 24 C.
- the frictional engagement between the arms of the flange 36 C and side openings and walls of the receptacle 52 C can be augmented, if desired, by providing mating or interlocking structures (not shown) on these structures.
- the flange 36 C and the adjoining receptacle 52 C together form a combined flange that can be held by the user's fingers during use of the syringe 20 C.
- the insert 22 C and the sleeve 24 C can be separated from each other after use of the syringe 20 C by first rotating and then axially displacing them with respect to each other in the reverse directions. This allows the sleeve 24 C to be reused and the remainder of the syringe 20 C to be disposed of.
- FIG. 9 A is similar to that of FIGS. 7 and 8 , except that the length of the flange 36 D is reduced (truncated) to save additional material in the manufacture of the insert 22 D.
- FIG. 9 B shows the insert 22 D of FIG. 9 A removed from the outer sleeve 24 D and more clearly illustrates the reduced length of the flange 36 D.
- FIG. 9 C shows the insert 22 C of FIGS. 7 and 8 with the full length flange 36 C.
- FIGS. 9 D and 9 E are front and back views of the reusable outer sleeve 24 C of FIGS. 7 and 8 as it would appear when removed from the disposable insert 22 C.
- the reusable outer sleeve 24 D of FIG. 9 A would have essentially the same appearance.
- FIGS. 10 and 11 A- 11 D illustrate a syringe 20 E according a fifth embodiment of the invention.
- the syringe 20 E is constructed in much the same manner as the syringes 20 - 20 D of FIGS. 1 - 9 E , except that a different locking arrangement is provided between the disposable tubular insert 22 E and the reusable outer sleeve 24 E.
- a proximal portion of the disposable tubular insert 22 E has a pair of diametrically opposed lateral projections or studs 66 , 68
- a proximal portion of the reusable outer sleeve 24 E has an expandable section comprising a pair of opposing deflectable flaps 70 , 72 with channels 71 and holes 73 for receiving the projections 66 , 68 .
- the sleeve 24 E and insert 22 E can be separated from each other after the syringe 20 E is used by depressing the squeeze tabs 75 , which flexes the flaps 70 , 72 outward and disengages the holes 73 from the projections 66 , 68 .
- the sleeve 24 E and the insert 22 E can then be pulled apart.
- FIGS. 12 and 13 illustrate two different embodiments of a stopper and reusable plunger assembly 80 , 80 ′ for use in any of the previous syringe embodiments (i.e., in combination with a disposable insert 22 and a reusable outer sleeve 24 ) or for use in a conventional single-use syringe with no other reusable components.
- the plunger 32 , 32 ′ is a durable plastic component which can be separated from the rubber stopper 28 , 28 ′ after the syringe is used, and then reused as part of another syringe. Such reuse does not compromise the sterility of the syringe, because the plunger 32 , 32 ′ does not come into contact with body fluids or with the fluid being transferred by the syringe.
- the separation of the plunger 32 , 32 ′ from the stopper 28 , 28 ′ can be initiated by the user in various ways, depending on the nature of the structural connection between these components. For example, if the distal end 82 of the plunger 32 is provided with external annular rings 84 that mate with internal annular grooves 86 in the stopper cavity 88 as illustrated in FIG. 12 , the separation can be achieved by forcefully pulling on the plunger 32 in the proximal direction while the stopper 28 is held in the insert 22 either by the user manually blocking the proximal opening of the insert 22 or by providing a constriction at the proximal opening of the insert 22 (the stopper 28 can be forced past this constriction during initial assembly).
- the separation can be achieved by simply unscrewing the plunger 32 ′ from the stopper 28 ′.
- the friction of the stopper 28 ′ within the insert 22 will ordinarily provide enough resistance to rotation of the stopper 28 ′ to allow the plunger 32 ′ to be unscrewed from it, but if this is not the case, the user can apply manual pressure to the stopper 28 ′ through the walls of the insert 22 and/or sleeve 24 to increase the friction.
- Such application of pressure can also be used to assist in restraining the stopper 28 when the plunger 32 is removed by axial pulling in the embodiment of FIG. 12 .
- the stopper 28 is preferably located at the most proximal end of the insert 22 prior to use. This positioning can be seen, for example, in FIGS. 9 B and 9 C .
- the user can push the stopper 28 distally with the plunger tip where it bottoms out and engages with the plunger tip. Additionally, there may be lubricant on the inside of the insert 22 to aid the movement of the stopper 28 . Having the stopper 28 initially located at the proximal end of the insert 22 will aid lubricant migration within the insert as well.
- FIG. 14 illustrates one possible way in which syringes 20 constructed in accordance with any of the foregoing embodiments may be packaged for use or sale.
- a plurality of inserts 22 e.g., 10 inserts
- a sealed plastic bag 100 along with a single reusable sleeve 24 and a single reusable plunger 32 .
- the user couples the sleeve 24 and plunger 32 (and a separately provided needle or cannula, if required for the intended use) to one of the inserts 22 to form a first syringe 20 , uses the first syringe 20 , removes the sleeve 24 and plunger 32 , and discards the insert 22 (including the stopper 28 ).
- the removed sleeve 24 and plunger 32 are then attached to another insert 22 to form a second syringe 20 , which is used and subsequently disassembled in the same way. This process is repeated until the supply of inserts 22 is exhausted, at which point the sleeve 24 and plunger 32 may also be discarded.
- Syringes 20 constructed in accordance with the present invention may be used in any application in which it is desired to inject, withdraw or otherwise transfer fluids. These applications include the administration of insulin and other liquid medications, the withdrawal of blood and other body fluids for sampling purposes, and the transfer of fluids for non-medical purposes.
Abstract
Insulin injection syringes are disclosed that include two types of components, namely, durable components that that do not contact the fluid path and can be reused, and disposable or single-use components that contact the fluid path and are not reused. The durable components do not contact the fluid path so that sterility is not affected. Two different syringe components include a reusable outer sleeve containing scale markings for the syringe and a reusable syringe plunger are provided as durable components in embodiments of the present invention. Syringes manufactured according to the present invention can employ one or both of these durable components. Methods for making, using and packaging such syringes are also disclosed.
Description
- This application is a divisional application of U.S. Ser. No. 16/957,639 filed on Jun. 24, 2020, which claims priority from U.S. provisional application Ser. No. 62/611,876, filed on Dec. 29, 2017, which are expressly incorporated herein by reference in their entireties.
- The present invention relates generally to syringes for transferring (i.e., injecting or withdrawing) fluids. In particular, but not by way of limitation, embodiments of the present invention relate to low cost insulin injection syringes in which the low cost is achieved by separating the syringe into two types of components, namely, durable components that that do not contact the fluid path and can be reused, and disposable or single-use components that contact the fluid path and are not reused. Methods for making, using and packaging such syringes are also disclosed and claimed herein.
- Most syringes in use today are of the disposable or single-use type. A typical disposable syringe is made primarily of plastic and has several key components. The largest, and the one containing the most material, is the plastic barrel. The scale printing on the barrel is a critical and costly assembly step that is needed to assure proper dosing by the user. Inside the barrel is a rubber stopper that is used to create a hermetic seal and displace the liquid medication or other fluid into and out of the barrel. A plastic plunger rod interfaces with the rubber stopper to move it back and forth under the user's control. A metal needle or cannula is usually attached to the distal end of the barrel to allow fluids to be injected into or removed from the body, although this is not always the case. For example, a syringe having a male Luer connector at its distal end can be attached to a female Luer connector on a catheter or IV line to inject or withdraw fluids without the use of a needle or cannula.
- In the management of diabetes, disposable plastic syringes are often used to administer liquid insulin to a user several times a day. These single-use syringes typically have clear polymeric barrels with printed scale numbers that allow the user to draw up an accurate dose of insulin from a vial, and fine-gauge metal needles (usually about 6 to 12 mm in length) that inject the dose into the skin with minimal discomfort to the user. The needles may be detachably connected to the barrels using Luer-Lok™ or Luer slip connections, or they may be permanently attached or “staked” to the barrels during manufacture of the syringes. Insulin syringes usually have a capacity of 1 ml or less (with 0.3 ml, 0.5 ml and 1.0 ml barrel sizes being common), with scale markings on the barrel representing units of a specific type of insulin (e.g., U-100 or U-500 insulin). Insulin syringes may also be provided with safety features to prevent reuse of the syringe, to shield the used needle, or both. Because insulin syringes are used only once and a user usually requires several of them each day, they are commonly sold in boxes or bags containing multiple syringes.
- In insulin syringes of the type described above, there are no durable (reusable) components. The entire syringe is disposed of after a single use, and none of the components are reused. While disposal of a single-use syringe is advantageous in ensuring sterility and preventing the spread of blood-borne diseases, the expense of providing all of the required syringe components and assembly steps for only a one-time use is higher than might be desired. Discarded syringes also create a disposal burden in hospitals and other medical facilities, since they cannot be mixed with other types of medical waste and must instead be placed in dedicated sharps disposal containers. Therefore, a need exists for a syringe in which the expense and disposal burden associated with one-time use is reduced, while preserving the sanitary advantages of a single-use syringe.
- In accordance with embodiments of the present invention, a low cost syringe is provided by separating the syringe into two types of components, namely, durable components that do not contact the fluid path and can be reused, and disposable or single-use components that contact the fluid path and are not reused. The ability to reuse the durable components reduces the effective per-unit cost of the syringe when multiple syringes are used. Since these components do not contact the fluid path, sterility is not affected. The disposal burden is also reduced because not all of the syringe components need to be disposed of each time a syringe is used.
- Two different syringe components—a reusable outer sleeve containing scale markings for the syringe, and a reusable syringe plunger—are provided as durable components in embodiments of the present invention. Syringes manufactured according to the present invention can employ one or both of these durable components.
- More specifically, one aspect of the present invention relates to a syringe comprising a barrel assembly having a disposable tubular insert and a reusable outer sleeve, the tubular insert forming a fluid reservoir and having a fluid opening at a distal end thereof, the reusable outer sleeve being detachably received on an outer surface of the tubular insert and having visible scale markings thereon; a stopper movably received in the tubular insert for sealing a proximal end of the tubular insert and for displacing fluid into or out of the tubular insert through the fluid opening upon movement of the stopper within the tubular insert; and a user-operable plunger coupled to the stopper for causing the stopper to move within the tubular insert and thereby displace fluid into or out of the tubular insert through the fluid opening under the control of the user.
- In another aspect, the present invention relates to a syringe comprising a disposable portion including a fluid reservoir having a fluid opening at a distal end thereof and a stopper movably received in the fluid reservoir for sealing a proximal end of the fluid reservoir and for displacing fluid into or out of the fluid reservoir through the fluid opening upon movement of the stopper within the fluid reservoir; and a reusable portion comprising a user-operable plunger detachably coupled to the stopper for causing the stopper to move within the fluid reservoir and thereby displace fluid into or out of the fluid reservoir through the fluid passage under the control of the user.
- Additional aspects of the invention relate to methods for using syringes of the type described for transferring fluids, and syringe multipacks in which the durable and disposable components of the syringe are packaged for sale or use.
- Aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, in which:
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FIGS. 1 and 2A-2D illustrate a syringe according a first embodiment of the invention, which employs a collar lock between a disposable tubular insert and a reusable outer sleeve; -
FIGS. 3 and 4A-4F illustrate a syringe according a second embodiment of the invention, which employs a side lock between the disposable tubular insert and the reusable outer sleeve; -
FIGS. 5 and 6 illustrate a syringe according a third embodiment of the invention, which employs a bayonet lock between the disposable tubular insert and the reusable outer sleeve; -
FIGS. 7 and 8 illustrate a syringe according a fourth embodiment of the invention, which employs a twist lock between the disposable tubular insert and the reusable outer sleeve; -
FIG. 9A illustrates a modified version of the syringe shown inFIGS. 7 and 8 ; -
FIGS. 9B and 9C illustrate the disposable tubular inserts used in the syringe embodiments ofFIG. 9A andFIGS. 7-8 , respectively; -
FIGS. 9D and 9E are front and back views of the reusable outer sleeve used in the syringe embodiment ofFIGS. 7-8 ; -
FIGS. 10 and 11A-11D illustrate a syringe according a fifth embodiment of the invention, which employs a press lock between the disposable tubular insert and the reusable outer sleeve; -
FIGS. 12 and 13 illustrate two different embodiments of a stopper and reusable plunger assembly for use in any of the previous syringe embodiments, or in a conventional syringe; and -
FIG. 14 illustrates the manner in which multiple syringe assemblies according to any of the previous embodiments can be packaged for sale or use. - Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described and illustrated herein exemplify, but do not limit, the present invention, and the drawings are not necessarily to scale with respect to each other or with respect to actual physical embodiments. Further, it will be understood by one skilled in the art that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. 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. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as “up”, “down”, “bottom”, “top”, “distal” and “proximal” are relative, and are employed to aid illustration, but are not limiting.
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FIGS. 1 and 2A-2D illustrate asyringe 20 according a first embodiment of the invention. Thesyringe 20 comprises a tubular barrel assembly that includes a disposabletubular insert 22 and a reusableouter sleeve 24 that is open at both ends and coaxially receives theinsert 22. The disposable tubular insert is preferably made of a plastic (polymeric) material, such as polypropylene, that can be inexpensively injection molded. The reusableouter sleeve 24 is preferably also made of a plastic material, such as polypropylene, polystyrene, polycarbonate or ABS, but can also be made of a metal such as stainless steel. In general, it is preferred that the reusableouter sleeve 24 be made from a relatively stiff and durable material, whereas thedisposable insert 22 can be made from a thinner, less rigid material. The upper portion of thetubular insert 22 can be seen in the partially disassembled view ofFIG. 1 . The lower portion of thetubular insert 22 is partially obscured by theouter sleeve 24 inFIG. 1 , but is visible through an elongatedrectangular slot 26 formed lengthwise in theouter sleeve 24.FIG. 2A shows thetubular insert 22 fully received in theouter sleeve 24 as would be the case during use of thesyringe 20. - The
tubular insert 22, which is shown alone inFIG. 2B , is designed to be disposable and forms a fluid reservoir for the fluid (not shown) that is to be injected or withdrawn by thesyringe 20. The volume of the fluid reservoir varies according to the position of aseparate rubber stopper 28 which seals the proximal end of theinsert 22. Thestopper 28 is movably received in thetubular insert 22 for displacing fluid into or out of thetubular insert 22 through afluid opening 30 at the distal end of thetubular insert 22. - A plastic plunger 32 (shown in
FIG. 1 but omitted fromFIGS. 2A and 2B ) having its distal end connected to thestopper 28 causes thestopper 28 to move up or down within thetubular insert 22 and thereby displace fluid into or out of thetubular insert 22 through thefluid opening 30 under the control of the user. Athumb press 34 integrally formed at the proximal end of theplunger 32 allows the user to pull or push on theplunger 32 as required. Aflange 36 with opposed arms is integrally formed near the proximal end of thetubular insert 22 and can be held by a user's fingers when operating theplunger 32. Anannular collar 38 is integrally formed at the proximal end of thetubular insert 22, above theflange 36, to receive a removable sterile cap (not shown) that covers the proximal end of thesyringe 20 before use. With theplunger 32 fully depressed, thethumb press 34 is slightly elevated above thecollar 38 so that thethumb press 34 can be grasped to operate theplunger 32. - In the embodiment shown, the
fluid opening 30 is formed in a reduced diameterdistal end portion 40 of thetubular insert 22 which is intended to receive a permanently attached or “staked” needle or cannula (not shown). The use of a staked needle can be advantageous in reducing fluid dead space within theinsert 22. Alternatively, thedistal end portion 40 can be formed as a male Luer slip or Luer Lok™ connector which allows thetubular insert 22 to be affixed to a separately provided needle orcannula 42 via ahub 43. The Luer connector can also be used to couple thesyringe 20 directly to a female Luer connector on a catheter or IV line without the use of a needle or cannula. In the case of a Luer Lok™ connector, the tapered Luer tip can be formed integrally with theinsert 22, and the internally threaded locking collar can be formed integrally with thesleeve 24. Alternatively, both portions can be formed integrally with theinsert 22. Another possibility is to provide a snap fit between thehub 43 and the reduced diameterdistal end portion 40 of the tubular insert, in lieu of a Luer connection. Whether separate or permanently affixed, the needle or cannula may have a sharp tip for penetrating the skin or a pro re nata (PRN), or it may consist of a blunt cannula of the type used to access a needleless connector. - For cost reasons, the disposable
tubular insert 22 is preferably devoid of any printed indicia that require separate manufacturing steps, including the printed scale markings that are typically needed for proper operation of thesyringe 20. Instead, the requiredscale markings 44 are provided on theouter sleeve 24, which can be detached from the usedsyringe 20 and reused. Thescale markings 44 on theouter sleeve 24 may take the form of a combination of lines and numerals representing milliliters or units of insulin, as shown inFIGS. 1 and 2 , or any other suitable form as may be required for the specific application. Thescale markings 44 may be ink-printed or laser-printed, embossed, engraved, laser-etched, or a combination of these (e.g., embossed with an ink-printed overlay for increased legibility). The embossing or engraving may be accomplished as part of the injection molding process that is used to manufacture the outer sleeve 24 (if it is made of plastic), with any desired ink-printing carried out during a separate manufacturing step. - The
lengthwise slot 26 in theouter sleeve 24 allows the user to directly view thetubular insert 22, which is transparent or translucent, so that the fluid level in thetubular insert 22 can be viewed and compared with thescale markings 44 on theouter sleeve 24. Due to the presence of theslot 26, theouter sleeve 24 can be made partially or completely opaque if desired, although it will normally be preferable to make theouter sleeve 24 transparent or translucent so that the fluid level can be seen to some extent through its walls (although perhaps less clearly than through the slot 26). Theslot 26 can be omitted if theouter sleeve 24 is made sufficiently transparent or translucent so that the fluid level in thetubular insert 22 can be seen through the walls of theouter sleeve 24 with enough precision for proper dosing. Alternatively, theslot 26 can be replaced by a transparent or translucent window in embodiments where theouter sleeve 24 is partially or completely opaque. - A detachable connection is provided between the disposable
tubular insert 22 and the reusableouter sleeve 24 so that the two components can be coupled together and used in the same manner as a conventional syringe, and then separated to allow for reuse of theouter sleeve 24. This connection can be a simple friction or press fit between all or portions of the cylindrical outer surface of thetubular insert 22 and the cylindrical inner surface of theouter sleeve 24, or a clamshell connection if thesleeve 24 is split or hinged. However, given the importance of axially positioning thescale markings 44 in such a way that they accurately and consistently represent the correct fluid volume within thetubular insert 22, a more precise and positive releasable locking arrangement will usually be desired. The locking function is primarily needed in the axial direction because that is the direction in which the fluid level is compared with thescale markings 44, but in some applications rotational locking (i.e., prevention of relative rotation between thetubular insert 22 and the outer sleeve 24) may also be needed or desired. - One axial locking arrangement, referred to as a collar lock, is shown in
FIGS. 1 and 2A-2D . In this arrangement, thetubular insert 22 bottoms out on anannular lip 45 formed at the bottom of thesleeve 24 when it reaches its full insertion point within the sleeve. At this point aseparate collar 46 withinternal threads 47, which is received on an externally threadedproximal end portion 48 of thesleeve 24, is rotated so that it advances from alocation 49 on thesleeve 24 to a slightly moreproximal location 50. The threadedend portion 48 has a slightly greater outside diameter at thelocation 50 than it does at thelocation 49. Cuts orgaps 51 divide theproximal end portion 48 into three or more portions which are relatively flexible. When thecollar 46 is rotated to thelocation 50, the increasing diameter of the threadedend portion 48 causes these flexible portions to be squeezed inwardly to grip theinsert 22 and thereby lock thesleeve 24 and theinsert 22 to each other both axially and rotationally. In an alternative embodiment, the threadedend portion 48 has a slightly greater outside diameter at thelocation 49 than it does at thelocation 50, and thecollar 46 is rotated so that it advances from thelocation 50 to thelocation 49 to secure thesleeve 24 to theinsert 22. - The user initially receives the
syringe 20 with theouter sleeve 24 either already attached or provided as a separate component which the user attaches to theinsert 22 before use. If a needle orcannula 42 is required for the intended fluid transfer but is not pre-affixed or pre-attached to theinsert 22, the user also attaches the required needle or cannula. The user then performs the fluid transfer, which may consist of a fluid aspiration (e.g., of insulin from a vial), an injection of fluid into the body, a delivery of fluid into a catheter or IV line, or a withdrawal of fluid from the body (e.g., a blood sample), or some combination of these steps. In doing so, the user can observe the amount of fluid in thesyringe 20 by comparing the fluid level that is visible through theslot 26 with thescale markings 44 on theouter sleeve 24. When the fluid transfer is complete, the user removes theouter sleeve 24 by unscrewing thecollar 46 and discards the remaining portion of thesyringe 20. Theouter sleeve 24 andcollar 46 can then be reused as part of anothersyringe 20 by attaching it to anotherinsert 22 and repeating the steps above. - Several advantages of the disclosed
syringe 20 will be apparent. For example, there is a reduction in the effective per-unit cost of the syringe (perhaps up to 25%) because a labor intensive manufacturing step (printing of the scale markings) is performed on a component of the syringe 20 (the outer sleeve 24) that can be used multiple times before being discarded. Such reuse does not compromise the sterility of the syringe because theouter sleeve 24 andcollar 46 do not come into contact with body fluids or with the fluid being transferred by thesyringe 20. Another advantage is that the reusableouter sleeve 24 can be made of a sufficiently rigid material, such as polycarbonate or even metal, to reduce the rigidity required of theinsert 22. In other words, the walls of theinsert 22 can be made thinner than would otherwise be required to withstand handling by the user and the internal fluid pressures generated by an injection, because theinsert 22 is snugly received in a closely conformingsleeve 24 that can provide some of the required strength. This results in less waste of material when theinsert 22 is discarded than would be the case for the barrel of a conventional single-use syringe. -
FIGS. 3 and 4A-4F illustrate asyringe 20A according a second embodiment of the invention (the needle orcannula 42 is not shown in this or subsequent embodiments, but will typically be present). Thesyringe 20A is constructed in much the same manner as thesyringe 20 ofFIGS. 1 and 2 , except that a different locking arrangement is provided between the disposabletubular insert 22A and the reusableouter sleeve 24A. In particular, theflange 36A of theinsert 22A is received in the cavity of a correspondingly shapedreceptacle 37 formed at the proximal end of thesleeve 24A. In use, theflange 36A and the adjoiningreceptacle 37 together form a combined flange that can be held by the user's fingers. The underside of theflange 36A has a distally facing cavity with a pair of shallow indents 52 (visible inFIGS. 4B and 4C ) that interface with a sleeve collar 53 (shown alone inFIG. 4D ). Thesleeve collar 53 is captured and affixed within thesleeve 24A and thereceptacle 37, and has two protruding, cantilevered, proximally extendingarms 55 that are flexible and normally biased outwardly. Oneend 57 of eacharm 55 engages acorresponding indent 52 of theflange 36A, while the other end protrudes through an aperture 61 (visible inFIG. 4F ) in thesleeve 24A. The engagement of theends 57 of thearms 55 with theindents 52 in theflange 36A locks thesleeve 24A and theinsert 22A to each other both axially and rotationally. Thesleeve 24A and theinsert 22A can be separated from each other after thesyringe 20A is used by squeezing thearms 55 inwardly to disengage theends 57 of the arms from theindents 52, and then pulling thesleeve 24A and insert 22A apart. -
FIGS. 5 and 6 illustrate asyringe 20B according a third embodiment of the invention. Thesyringe 20B is constructed in much the same manner as thesyringes FIGS. 1-4F , except that a different locking arrangement is provided between the disposabletubular insert 22B and the reusableouter sleeve 24B. In particular, theinsert 22B is molded with a laterally extending lug orprojection 54, and a proximal portion of the reusableouter sleeve 24B has an open-ended, L-shapedbayonet slot 56 for slidably receiving theprojection 54 to detachably secure thesleeve 24B to theinsert 22B by a combination of axial and rotational movement. The bayonet connection provides both axial and partial rotational locking between thesleeve 24B and theinsert 22B, and can be released by rotating and axially displacing these two components in the reverse direction with respect to each other. This allows thesleeve 24B and theinsert 22B to be separated from each other after thesyringe 20B is used so that thesleeve 24B can be reused. -
FIGS. 7 and 8 illustrate asyringe 20C according a fourth embodiment of the invention. In this embodiment, theflange 36C of theinsert 22C is received in the cavity of a correspondingly-shapedreceptacle 52C formed at the proximal end of thesleeve 24C. Thereceptacle 52C hasslots 58 in its front and rear sidewalls to receive the arms of theflange 36C when theinsert 22C is rotated 90 degrees and depressed relative to thesleeve 24 from the position shown inFIG. 7 to the position shown inFIG. 8 . Thereceptacle 52C also has diagonally opposedside openings 60 in its front and rear walls to frictionally receive and retain the arms of theflange 36C when theinsert 22C is rotated an additional 90 degrees relative to thesleeve 24 from the position shown inFIG. 8 .Top closures side openings 60 to prevent theinsert 22C from being axially withdrawn from thesleeve 24C following this second 90 degree rotation, and the closed sidewalls of thereceptacle 22C prevent any further rotation of theinsert 22C in the same direction. In this way, theinsert 22C is locked both axially and rotationally within thesleeve 24C. The frictional engagement between the arms of theflange 36C and side openings and walls of thereceptacle 52C can be augmented, if desired, by providing mating or interlocking structures (not shown) on these structures. Theflange 36C and the adjoiningreceptacle 52C together form a combined flange that can be held by the user's fingers during use of thesyringe 20C. Theinsert 22C and thesleeve 24C can be separated from each other after use of thesyringe 20C by first rotating and then axially displacing them with respect to each other in the reverse directions. This allows thesleeve 24C to be reused and the remainder of thesyringe 20C to be disposed of. - The embodiment of
FIG. 9A is similar to that ofFIGS. 7 and 8 , except that the length of theflange 36D is reduced (truncated) to save additional material in the manufacture of theinsert 22D.FIG. 9B shows theinsert 22D ofFIG. 9A removed from theouter sleeve 24D and more clearly illustrates the reduced length of theflange 36D. For comparison,FIG. 9C shows theinsert 22C ofFIGS. 7 and 8 with thefull length flange 36C.FIGS. 9D and 9E are front and back views of the reusableouter sleeve 24C ofFIGS. 7 and 8 as it would appear when removed from thedisposable insert 22C. The reusableouter sleeve 24D ofFIG. 9A would have essentially the same appearance. -
FIGS. 10 and 11A-11D illustrate asyringe 20E according a fifth embodiment of the invention. Thesyringe 20E is constructed in much the same manner as the syringes 20-20D ofFIGS. 1-9E , except that a different locking arrangement is provided between the disposabletubular insert 22E and the reusableouter sleeve 24E. In particular, a proximal portion of the disposabletubular insert 22E has a pair of diametrically opposed lateral projections orstuds outer sleeve 24E has an expandable section comprising a pair of opposingdeflectable flaps channels 71 and holes 73 for receiving theprojections outer sleeve 24E is advanced proximally over the outer surface of thetubular insert 22E during initial assembly of thesyringe 20E, theprojections channels 71 and ultimately settle into theholes 73 to detachably secure thesleeve 24E to theinsert 22E. This holds thesleeve 24E and insert 22E together in an axially and rotationally locked manner. Thesleeve 24E and theinsert 22E can be separated from each other after thesyringe 20E is used by depressing thesqueeze tabs 75, which flexes theflaps holes 73 from theprojections sleeve 24E and theinsert 22E can then be pulled apart. -
FIGS. 12 and 13 illustrate two different embodiments of a stopper andreusable plunger assembly disposable insert 22 and a reusable outer sleeve 24) or for use in a conventional single-use syringe with no other reusable components. In each ofFIGS. 12 and 13 , theplunger rubber stopper plunger - The separation of the
plunger stopper distal end 82 of theplunger 32 is provided with externalannular rings 84 that mate with internalannular grooves 86 in thestopper cavity 88 as illustrated inFIG. 12 , the separation can be achieved by forcefully pulling on theplunger 32 in the proximal direction while thestopper 28 is held in theinsert 22 either by the user manually blocking the proximal opening of theinsert 22 or by providing a constriction at the proximal opening of the insert 22 (thestopper 28 can be forced past this constriction during initial assembly). Alternatively, if the if thedistal end 82′ of theplunger 32′ is provided on its outside surface with a raisedhelical screw thread 90 that mates with an internalhelical groove 92 in thestopper cavity 88′ as illustrated inFIG. 13 , the separation can be achieved by simply unscrewing theplunger 32′ from thestopper 28′. The friction of thestopper 28′ within theinsert 22 will ordinarily provide enough resistance to rotation of thestopper 28′ to allow theplunger 32′ to be unscrewed from it, but if this is not the case, the user can apply manual pressure to thestopper 28′ through the walls of theinsert 22 and/orsleeve 24 to increase the friction. Such application of pressure can also be used to assist in restraining thestopper 28 when theplunger 32 is removed by axial pulling in the embodiment ofFIG. 12 . - In all of the embodiments described, the
stopper 28 is preferably located at the most proximal end of theinsert 22 prior to use. This positioning can be seen, for example, inFIGS. 9B and 9C . The user can push thestopper 28 distally with the plunger tip where it bottoms out and engages with the plunger tip. Additionally, there may be lubricant on the inside of theinsert 22 to aid the movement of thestopper 28. Having thestopper 28 initially located at the proximal end of theinsert 22 will aid lubricant migration within the insert as well. -
FIG. 14 illustrates one possible way in whichsyringes 20 constructed in accordance with any of the foregoing embodiments may be packaged for use or sale. In the illustrated example, a plurality of inserts 22 (e.g., 10 inserts) havingindividual stoppers 28 but lacking some or all of the scale markings required for proper use of the syringes is packaged in a sealedplastic bag 100 along with a singlereusable sleeve 24 and a singlereusable plunger 32. After opening the bag, the user couples thesleeve 24 and plunger 32 (and a separately provided needle or cannula, if required for the intended use) to one of theinserts 22 to form afirst syringe 20, uses thefirst syringe 20, removes thesleeve 24 andplunger 32, and discards the insert 22 (including the stopper 28). The removedsleeve 24 andplunger 32 are then attached to anotherinsert 22 to form asecond syringe 20, which is used and subsequently disassembled in the same way. This process is repeated until the supply ofinserts 22 is exhausted, at which point thesleeve 24 andplunger 32 may also be discarded. - It will be apparent that variations are possible in which only one of the
sleeve 24 andplunger 32 is reusable, in which case the other component is either provided separately for each insert 22 (as in the case where theplunger 32 is not reused) or is not provided at all (as in the case where theinserts 22 are provided with scale markings directly and do not require a separate outer sleeve 24). It will also be apparent that variations are possible in which more than onereusable sleeve 24 and/orplunger 32 is provided in the bag 100 (e.g., two or more reusableouter sleeves 24 with different types ofscale markings 44 for different types of insulin), and in which a box or other form of packaging is substituted for thebag 100. The ratio of disposable to reusable components could be higher than 10:1 (e.g., 50:1, 100:1 or higher), and the reusable components could also be packaged separately from the disposable components if desired. -
Syringes 20 constructed in accordance with the present invention may be used in any application in which it is desired to inject, withdraw or otherwise transfer fluids. These applications include the administration of insulin and other liquid medications, the withdrawal of blood and other body fluids for sampling purposes, and the transfer of fluids for non-medical purposes. - Although only a few embodiments of the present invention have been shown and described, the present invention is not limited to the described embodiments. Instead, it will be appreciated by those skilled in the art that changes may be made to these embodiments without departing from the scope of the invention. In addition, any of the embodiments, features and/or elements disclosed herein may be combined with one another to form various additional combinations not specifically disclosed, as long as the embodiments, features and/or elements being combined do not contradict each other. All such changes and combinations are considered to be within the scope of the invention as defined by the appended claims and their equivalents.
Claims (20)
1. A syringe comprising:
a barrel assembly comprising a disposable tubular insert forming a fluid reservoir and having a fluid opening at a distal end thereof;
a reusable outer sleeve detachably received on the tubular insert and having visible scale markings thereon, the reusable outer sleeve having a proximal externally threaded end portion;
a threaded collar engaging the externally threaded end portion for detachably retaining the reusable outer sleeve on the disposable tubular insert by moving the threaded collar from a distal position to a proximal position on the externally threaded end portion;
a stopper movably received in the tubular insert for sealing a proximal end of the tubular insert and for displacing fluid into or out of the tubular insert through the fluid opening upon movement of the stopper within the tubular insert; and
a user-operable plunger coupled to the stopper for causing the stopper to move within the tubular insert and thereby displace fluid into or out of the tubular insert through the fluid opening under the control of the user.
2. The syringe of claim 1 , wherein the reusable outer sleeve has a distal end wall for engaging the disposable tubular insert and limiting axial movement of the disposable tubular insert toward a distal end of the reusable outer sleeve.
3. The syringe of claim 1 , wherein a proximal end portion of the threaded end of the reusable outer sleeve has an outer diameter greater than an outer diameter of a distal end portion of the threaded end of the reusable outer sleeve whereby movement of the collar to the proximal end portion retains the reusable outer sleeve on the disposable tubular insert.
4. The syringe of claim 3 , wherein the externally threaded proximal portion of the reusable outer sleeve has axial slits and a variable diameter along its length for allow for inward compression by the internally threaded collar.
5. The syringe of claim 1 , wherein a proximal portion of the disposable tubular insert has a proximal portion of the reusable outer sleeve are each formed with adjoining portions of a flange that can be held by a user's fingers when operating the plunger.
6. The syringe of claim 1 , wherein the proximal portion of the disposable tubular insert also includes one or both of a flange that can be held by a user's finger when operating the plunger, and an annular collar beneath a thumb press of the plunger.
7. A syringe comprising:
a disposable portion comprising a fluid reservoir having a fluid opening at a distal end thereof and a stopper movably received in the fluid reservoir for sealing a proximal end of the fluid reservoir and for displacing fluid into or out of the fluid reservoir through the fluid opening upon movement of the stopper within the fluid reservoir; and
a reusable portion comprising a user-operable plunger detachably coupled to the stopper for causing the stopper to move within the fluid reservoir and thereby displace fluid into or out of the fluid reservoir through the fluid passage under the control of the user.
8. The syringe of claim 4 , further comprising a thumb press at a proximal end of the plunger.
9. The syringe of claim 4 , further comprising an annular collar at a proximal end of the fluid reservoir.
10. The syringe of claim 4 , further comprising a Luer connector at the fluid opening of the fluid reservoir.
11. The syringe of claim 4 , further comprising a hollow needle or cannula at the fluid opening of the fluid reservoir.
12. The syringe of claim 4 wherein the fluid reservoir comprises a disposable insert that is detachably received within a reusable outer sleeve having visible scale markings thereon.
13. The syringe of claim 4 , further comprising a lengthwise slot or window in the reusable outer sleeve through which a fluid level in the disposable tubular insert can be viewed.
14. A method for performing first and second fluid transfers, comprising:
performing a first fluid transfer using a first syringe constructed as set forth in claim 22;
after the first fluid transfer is complete, detaching the reusable plunger from the stopper of the first syringe and attaching it to the stopper of a second syringe, the second syringe being constructed as set forth in claim 22 but lacking a plunger; and
performing a second fluid transfer using the second syringe having the reusable plunger of the first syringe.
15. A syringe multipack comprising:
a plurality of disposable syringe assemblies having syringe barrels lacking at least some of the scale markings required for use of the syringe assemblies; and
one or more reusable outer sleeves releasably attachable to the syringe barrels, the outer sleeves having the required scale markings lacked by the syringe assemblies; and
a package in which the disposable syringe assemblies and reusable outer sleeves are enclosed for sale or use;
wherein the number of disposable syringe assemblies in the package is greater than the number of reusable outer sleeves in the package.
16. The syringe multipack of claim 30, further comprising one or more reusable plungers in the package that are releasably attachable to stoppers contained within the syringe barrels of the disposable syringe assemblies, wherein the number of disposable syringe assemblies in the package is greater than the number of reusable plungers in the package.
17. A syringe multipack comprising:
a plurality of syringe assemblies comprising syringe barrels having stoppers therein; and
one or more reusable plungers that are releasably attachable to the stoppers in the syringe barrels of the syringe assemblies; and
a package in which the syringe assemblies and the reusable plungers are enclosed for sale or use;
wherein the number of syringe assemblies in the package is greater than the number of reusable plungers in the package.
18. The syringe multipack of claim 14 , further comprising one or more reusable outer sleeves in the package that are releasably attachable to disposable inserts in the package to form the syringe barrels of the syringe assemblies, wherein the number of disposable inserts in the package is greater than the number of reusable outer sleeves in the package.
19. A packaged tubular insert for a syringe, the tubular insert forming a fluid reservoir and having a fluid opening at a distal end thereof and a stopper movably received in the tubular insert for sealing a proximal end of the tubular insert and for displacing fluid into or out of the tubular insert through the fluid opening upon movement of the stopper within the tubular insert, the tubular insert lacking a plunger, printed scale markings, or both.
20. A method for reducing the effective per-unit cost of a syringe and for reducing the waste and environmental impact resulting from use of the syringe without compromising sterility, comprising using a first syringe to transfer a fluid, disposing of one or more components of the first syringe that contacted a fluid path of the first syringe during such use, and reusing in a second syringe one or more components of the first syringe that did not contact a fluid path of the first syringe during such use.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US18/300,010 US20230241320A1 (en) | 2017-12-29 | 2023-04-13 | Low Cost Syringe with Durable and Disposable Components |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US201762611876P | 2017-12-29 | 2017-12-29 | |
PCT/US2018/067137 WO2019133492A1 (en) | 2017-12-29 | 2018-12-21 | Low cost syringe with durable and disposable components |
US202016957639A | 2020-06-24 | 2020-06-24 | |
US18/300,010 US20230241320A1 (en) | 2017-12-29 | 2023-04-13 | Low Cost Syringe with Durable and Disposable Components |
Related Parent Applications (2)
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PCT/US2018/067137 Division WO2019133492A1 (en) | 2017-12-29 | 2018-12-21 | Low cost syringe with durable and disposable components |
US16/957,639 Division US11654239B2 (en) | 2017-12-29 | 2018-12-21 | Low cost syringe with durable and disposable components |
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US20230241320A1 true US20230241320A1 (en) | 2023-08-03 |
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US18/300,010 Pending US20230241320A1 (en) | 2017-12-29 | 2023-04-13 | Low Cost Syringe with Durable and Disposable Components |
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US16/957,639 Active 2039-12-27 US11654239B2 (en) | 2017-12-29 | 2018-12-21 | Low cost syringe with durable and disposable components |
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US (2) | US11654239B2 (en) |
EP (1) | EP3731903A4 (en) |
JP (2) | JP7295859B2 (en) |
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CA (1) | CA3085354A1 (en) |
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2018
- 2018-12-21 WO PCT/US2018/067137 patent/WO2019133492A1/en unknown
- 2018-12-21 EP EP18897765.6A patent/EP3731903A4/en active Pending
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US20200324052A1 (en) | 2020-10-15 |
WO2019133492A1 (en) | 2019-07-04 |
JP2021508512A (en) | 2021-03-11 |
EP3731903A1 (en) | 2020-11-04 |
JP2023116638A (en) | 2023-08-22 |
EP3731903A4 (en) | 2021-09-22 |
CA3085354A1 (en) | 2019-07-04 |
CN111526906A (en) | 2020-08-11 |
CN111526906B (en) | 2023-01-31 |
US11654239B2 (en) | 2023-05-23 |
JP7295859B2 (en) | 2023-06-21 |
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