WO1991014465A1 - Disposable syringe with automatic needle retraction - Google Patents

Disposable syringe with automatic needle retraction Download PDF

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Publication number
WO1991014465A1
WO1991014465A1 PCT/US1991/001768 US9101768W WO9114465A1 WO 1991014465 A1 WO1991014465 A1 WO 1991014465A1 US 9101768 W US9101768 W US 9101768W WO 9114465 A1 WO9114465 A1 WO 9114465A1
Authority
WO
WIPO (PCT)
Prior art keywords
seal member
plunger
barrel
hub
needle hub
Prior art date
Application number
PCT/US1991/001768
Other languages
French (fr)
Inventor
Harry Kaufhold, Jr.
Martin Jasso
Gerald E. Kruckeberg
Original Assignee
Kaufhold Harry Jr
Martin Jasso
Kruckeberg Gerald E
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaufhold Harry Jr, Martin Jasso, Kruckeberg Gerald E filed Critical Kaufhold Harry Jr
Publication of WO1991014465A1 publication Critical patent/WO1991014465A1/en

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Classifications

    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the 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
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3241—Needle retraction energy is accumulated inside of a hollow plunger rod
    • A61M2005/3242—Needle retraction by vacuum
    • 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
    • A61M5/508—Means for preventing re-use by disrupting the piston seal, e.g. by puncturing

Definitions

  • the present invention relates generally to medical instruments, and more particularly to a safety-disposable medicinal syringe. Still more particularly, the present invention relates to a disposable syringe having a releasable needle hub which, when released, is actuated by ambient air pressure into retraction into an evacuated plunger, carrying the needle with it.
  • a problem for doctors, nurses, and other health care personnel who use or handle medicinal syringes is accidental puncture of the skin by the needle. The problem can be very serious if the needle has been used. Potentially fatal diseases, such as hepatitis or Acquired Immune Deficiency Syndrome (AIDS) , can be contracted if the needle has been used on an infected subject.
  • AIDS Acquired Immune Deficiency Syndrome
  • the syringe needle is typically covered with a removable sheath prior to and following use to prevent accidental contact, but the act of replacing the sheath after use can still result in accidental skin puncture. Also, if the sheath is not securely repositioned, the danger exists that personnel subsequently involved in disposal of the device may become infected by accidental puncture.
  • U.S. Patent No. 4,790,822 discloses a disposable syringe in which the needle can be first captured by the plunger and then withdrawn into the barrel in a position with the needle completely protected by the barrel. The plunger can then be broken off, leaving the broken end flush with the end of the barrel, so that the needle cannot be accidentally pushed out from the barrel and exposed.
  • U.S. Patent No. 4,747,830 discloses a similar system, with a plunger that can be broken off once the needle is retracted into the barrel.
  • U.S. Patent No. 4,425,120 discloses a needle guard movable on the syringe barrel between an extended position in which the needle guard shields the needle and a retracted position in which the needle is exposed for use.
  • U.S. Patent 4,816,022 discloses a syringe with a sliding cap for preventing accidental puncture. The '022 patent utilizes a nub and backseat for engagement of a nosepiece for securing the cap around the syringe for safety purposes.
  • U.S. Patent No. 3,008,570 discloses use of a removable cap for the purpose of enclosing and protecting a sterilized syringe in a transport.
  • 4,840,619 discloses a syringe assembly that has a transport held in telescoping position over a syringe by flanges.
  • Other and various means of sheathing or shielding a syringe are shown in the following U.S. Patents: 4,738,663; 4,723,943; 4,666,435; 4,655,751; 4,639,249; 4,592,744; 4,356,822; 4,300,678; 3,976,069; 3,895,633; 3,107,785.
  • U.S. Patent No. 4,826,483 discloses a non-reusable syringe with a one-way movable piston.
  • the present invention improves upon these devices by providing a means of automatically, without the need of unusual manipulation, rendering a used syringe safe for handling immediately after use and throughout subsequent disposal procedures, as well as rendering it unsuitable for further use.
  • the present invention comprises a medicinal syringe including a tubular plunger from which air has been evacuated and a seal member releasably attached on the distal end of the plunger.
  • a seal member releasably attached on the distal end of the plunger.
  • the plunger is slidably disposed in a tubular barrel.
  • a needle is disposed in a hub releasably attached within the distal end of the barrel.
  • the attachment between the hub and the barrel Upon application of a predetermined longitudinal axial force to the hub, the attachment between the hub and the barrel will break, releasing the hub for movement within the barrel.
  • the hub when released will be forced by the pressure differential, along with the distal plunger seal member, into the interior of the tubular plunger, carrying the needle with it.
  • the attachment between the hub and barrel is adapted to rupture prior to that between the seal member and plunger. Once forced into the tubular plunger, the needle and hub will remain there indefinitely, thus eliminating accidental puncturing by the needle of a person in the vicinity of the syringe.
  • the present invention thus comprises a container having a nozzle or needle at its distal end and a central cavity, the volume of which is determined by the position of a proximally disposed plunger.
  • the nozzle or needle is mounted in the container such that application of a predetermined longitudinal axial force to the nozzle or needle will cause its detachment from the container.
  • the plunger contains a hollow and evacuated center, sealed at its distal end by a member that is designed to break free from the plunger upon application of a predetermined longitudinal axial force to the member. This distal member may also serve to provide a leak free seal between the central cavity of the container and the atmosphere.
  • the invention is used in accordance with standard procedures for the subcutaneous, intramuscular, of intravascular injection or aspiration of substances into or out of the body, which procedures are well known to those schooled in the art.
  • longitudinal axial force is applied to the proximal end of the plunger, thereby detaching the needle from the container and rupturing the vacuum seal at the distal end of the plunger.
  • Atmospheric pressure then forces the needle up into the evacuated center of the plunger and holds it there, rendering it incapable of puncturing the ⁇ Kin of the primary u ⁇ er or of per ⁇ onnel involved in secondary handling of the device.
  • Figure 1 is an exploded pictorial view of a syringe of a preferred embodiment of the invention.
  • Figure 2 is a vertical cro ⁇ s-sectional view of the syringe of Figure l prior to use.
  • Figure 3 is a vertical cross-sectional view of the syringe of Figure 1 following use and actuation of the automatically retractable needle of the invention.
  • Figure 4 is an exploded pictorial view of a syringe of a second embodiment of the invention.
  • Figure 5 is a vertical cross-sectional view of the distal end of the second embodiment showing an alternate construction.
  • Figure 6 is a vertical cross-section of the distal end of the preferred embodiment showing an alternate locking construction.
  • Figure 7 is a vertical cross-sectional view of the distal end of the preferred embodiment showing an alternate construction.
  • Figure 8 is a vertical cross-sectional view of a syringe of a third embodiment of the invention prior to use.
  • Figure 9 is an enlarged, vertical cross-sectional view of a portion of the syringe of Figure 8 prior to use.
  • syringe assembly 10 in Figures 1-3 includes a hypodermic needle 14 that is inserted and mounted into a needle hub 16 in such a manner that the interior bore of the needle communicates with the exterior of the hub via a transversely extending hole 22 in the hub.
  • Hub 16 is releasably attached to the interior of syringe barrel 12 in such a manner that it forms a circumferential seal around the inner periphery of the barrel at its distal end a.
  • Barrel 12 and hub 16 may be made of plastic, glass, or other materials suitable to the intended use of the device.
  • a hollow plunger tube 20 made of plastic, glass, or the like, which is sealed at its distal and proximal ends by a barrier seal member 28 and a cap 21, respectively.
  • Cap 21 may be, for example, a thin round disc-like member having a circular boss 61 protruding therefrom and receivable within the interior of plunger 20.
  • the cap may have a circular wall extending from the disc surface and adapted for receiving the exterior of the plunger therewithin.
  • Other means of mounting a cap on the proximal end of plunger 20 will no doubt be readily apparent to those skilled in the art.
  • the air is removed from the sealed interior of the plunger, leaving a vacuum 24 within the plunger tube 20.
  • Cap 21 may be made of plastic, rubber, glass, metal or the like.
  • hub 16 and barrier seal member 28 are constructed so as to comprise annular grooves 26 and 27, respectively, forming relatively thin- walled areas of hub 16 and barrier seal member 27.
  • Grooves 26, 27 may be on the distal, proximal, or both faces of hub 16 and barrier seal member 28, and are so designed that the thin-walled portions of these elements so created will rupture relatively easily upon the application of longitudinal axial force on the elements that is greater than that force required to reciprocate plunger 20 in barrel 28 to dispense fluids from or draw fluids into barrel 28 to achieve normal, pre-disposal syringe functions.
  • Hub 16 and barrier seal member 28 may be subsequent attachments to or an integral part of their respective supporting members, barrel 12 and plunger 20.
  • the plunger 20 is pushed distally into the barrel 12 with enough force to rupture the thin-walled areas of hub 16 and seal member at grooves 26 and 27.
  • the needle hub center 16B, along with the central disc portion 28A of the barrier seal member 28, will be forced by the differential pressure between the atmosphere and the vacuum 24 up into the interior of vacuum tube 20A.
  • the hub center portion 16B and the central disc portion 28A are sized so that they will closely engage the interior wall of the plunger 20 and will be retained in their retracted positions by friction.
  • the hub center portion 16B and the central disc portion 28A may also be sized, and made of a sufficiently resilient material, to sealingly engage the interior wall of the plunger 20 in their retracted positions, in which case they will also be retained inside plunger 20 by the difference in pressure between the atmosphere and the interior of the relatively evacuated area 24. With the hub portion 16B, and hence the needle 14, retracted within plunger 20, the syringe assembly 10 may be safely disposed of without fear of accidental puncture.
  • Figures 4 and 5 show an alternate construction of syringe assembly 10, in which hub 16 is constructed with an annular shoulder 30 around its distal end which seats in and forms a seal against a correlatively shaped annular groove 32 around the inner periphery of the distal end of barrel 12.
  • End seal member 18 is mounted on the distal end of plunger 20.
  • End seal member 18 has a distally extending skirt portion 63 therearound, designed so that its longitudinal distal advancement in barrel 12 will spread apart the inner walls of barrel 12 and open groove 32, thereby releasing needle 14 and hub 16 to be drawn into plunger tube 20 when annular thin-walled ring portion 27 on end seal member 18 is ruptured.
  • Figure 6 shows an alternate construction in which hub 16 contains a locking recess 33 in its proximal end.
  • the distal end face of end seal member 18 has centrally disposed thereon a projection or locking hub 34 which is shaped correlatively to recess 33.
  • Recess 33 and hub 34 which may have any of a variety of configurations or profiles, are so designed that when plunger 20 is advanced toward hub 16, the hub 16 and end seal member 18 will engage and lock together just prior to the subsequent rupture of grooves 26 and 27, respectively.
  • the recess 33 can be disposed in the end seal member 18, and the locking hub 34 can be disposed on the needle hub 16.
  • the needle 14 and hub 16 are drawn into the vacuum space 24 of plunger tube 20.
  • Figure 7 shows an alternate construction of the distal portion of she preferred embodiment of the syringe assembly of the present invention.
  • Hub 16 includes a frustoconical- shaped recess or concavity c in its proximal end face, and a frustoconical-shaped or sloped exterior surface extending from location a to location b.
  • the recess or concavity c, and the sloped surface ab form a thin walled, compressible, flexible annular lip which, when drawn into vacuum space 24 of plunger tube 20, will result in an enhanced seal against the interior of plunger tube 20.
  • Hub 16 also includes a frustoconical-shaped surface or taper e at its distal end, and barrel 12 includes a frustoconical- shaped surface or taper d at its distal end. Tapers d and e serve to reduce the resultant volume of the space 40 surrounding hub 16 and integral to barrel 12 when in the pre-use condition as well as to reduce space 41, distal to the hub 16 and open to atmosphere.
  • FIGS 8 and 9 show another alternate construction of syringe assembly 10.
  • a slidable seal member 65 of soft rubber or similar elastomeric material is disposed within the evacuated plunger 20 at its distal end and as close as possible to the vacuum wall side of the barrier seal member 28.
  • Sealing member 65 is disc-shaped and has raised radius features 65A circumferentially disposed at its distal and proximal ends. When slidable seal member 65 is positioned within the plunger 20, the radius features 65A create a slidable seal against the interior wall of the plunger 20.
  • the radius sealing features may be of any compound geometric shape to cause the intended seal. Sealing member 65 helps to assure that the vacuum 24 is not compromised or lost at the time of initial rupture of groove 27 of barrier seal member 28.
  • the seal member 65 is forced into the plunger along with the hub.
  • the wall of the plunger 20 has been extended longitudinally beyond plunger seal 28 to create a recess 20C defined by the interior recess wall 20D and chamfer 20E.
  • the inside diameter of recess 20C and its length, from the vertex of groove 27 to the distal end of chamfer 20E, are such that a slip fit between the hub surface 16C and the interior surface 20D of the recess is created.
  • the length of the recess 20C and chamfer 20E is less than the length of the longitudinal surface of wall 16C of the major diameter of the hub 16.
  • a plurality of ridges or raised features 2OF are disposed on the outer circumferential distal surface of the plunger 20. Although frustoconical ridges are shown, these ridges may be of any geometric shape that will allow the addition of rubber-like sealable member 66.
  • the sealable member or grommet 66 has raised radius features 66A circumferentially disposed about the surface of the grommet 66 and creates a seal between the radius features and the interior wall of the barrel 12.
  • the longitudinal extension of the plunger 20 to create recess 20C in conjunction with the addition of the grommet 66 extended over the plunger's distal end result in decreasing the volume 40 and thus improve the force of differential pressure needed to cause the hub 16 to be drawn into the plunger 20 at the time that the plunger seal 28 is ruptured.
  • the distance between the hub distal face 16E and the surface (a) of barrel internal distal features 12A is such that when breaking force is applied to the hub 16, groove 26 will rupture just before the two surfaces, (a) of the barrel 12 and 16E of the hub 16, make contact.
  • the clearance between the outer wall 14A of needle 14 and the thru-wall 12B of the distal end of barrel 12 which surrounds the needle 14 should be minimal yet allow the needle 14 to slip within the barrel's distal thru-hole containing the needle 14.
  • a bondable ferrous plastic member or ring 67 may be used to permit the joining of separately molded plastic hub member 16 and the syringe barrel 20. Further, in the event that the barrel 20 itself is made from two separately molded pieces, a cylindrical barrel and a distal end, all three pieces, hub 16, cylindrical barrel, and the distal end feature of the barrel, can be joined simultaneously by use of the bondable ferrous plastic ring 67.

Abstract

A medicinal syringe including a tubular plunger (20) from which air has been evacuated and a seal member (28) releasably attached on the distal end of the plunger. Upon application of a predetermined longitudinal axial force to the seal member, the attachment between the seal member and plunger will rupture, releasing the seal member for movement within the plunger. The seal member when released will be forced by the differential pressure between the vacuum and the ambient air into the interior of the tubular plunger. The plunger is slidably disposed in a tubular barrel (12). A needle (14) is disposed in a hub (16) releasably attached within the distal end of the barrel. Upon application of a predetermined longitudinal axial force to the hub (16), the attachment between the hub and the barrel (12) will rupture, releasing the hub for movement within the barrel. The hub when released will be forced by the pressure differential, along with the distal plunger seal member, into the interior of the tubular plunger, carrying the needle with it. The attachment between the hub and barrel is adapted to rupture prior to that between the seal member and plunger. Once drawn into the tubular plunger, the needle and hub will remain there indefinitely, thus eliminating accidental puncturing by the needle of a person in the vicinity of the syringe.

Description

DISPOSABLE SYRINGE WITH AUTOMATIC NEEDLE RETRACTION BACKGROUND OF THE INVENTION
The present invention relates generally to medical instruments, and more particularly to a safety-disposable medicinal syringe. Still more particularly, the present invention relates to a disposable syringe having a releasable needle hub which, when released, is actuated by ambient air pressure into retraction into an evacuated plunger, carrying the needle with it.
A problem for doctors, nurses, and other health care personnel who use or handle medicinal syringes is accidental puncture of the skin by the needle. The problem can be very serious if the needle has been used. Potentially fatal diseases, such as hepatitis or Acquired Immune Deficiency Syndrome (AIDS) , can be contracted if the needle has been used on an infected subject.
The syringe needle is typically covered with a removable sheath prior to and following use to prevent accidental contact, but the act of replacing the sheath after use can still result in accidental skin puncture. Also, if the sheath is not securely repositioned, the danger exists that personnel subsequently involved in disposal of the device may become infected by accidental puncture.
Solutions that attempt to better protect the health care worker include that disclosed in U.S. Patent No. 4,790,822. The *822 patent discloses a disposable syringe in which the needle can be first captured by the plunger and then withdrawn into the barrel in a position with the needle completely protected by the barrel. The plunger can then be broken off, leaving the broken end flush with the end of the barrel, so that the needle cannot be accidentally pushed out from the barrel and exposed. U.S. Patent No. 4,747,830 discloses a similar system, with a plunger that can be broken off once the needle is retracted into the barrel. U.S. Patents Nos. 4,692,156 and 4,675,005 both disclose disposable syringes wherein the needle can be retracted into the barrel. U.S. Patent No. 4,643,200 discloses a similar system, used with a blood donor assembly, which allows retraction of a needle into a barrel.
U.S. Patent No. 4,425,120 discloses a needle guard movable on the syringe barrel between an extended position in which the needle guard shields the needle and a retracted position in which the needle is exposed for use. U.S. Patent 4,816,022 discloses a syringe with a sliding cap for preventing accidental puncture. The '022 patent utilizes a nub and backseat for engagement of a nosepiece for securing the cap around the syringe for safety purposes. U.S. Patent No. 3,008,570 discloses use of a removable cap for the purpose of enclosing and protecting a sterilized syringe in a transport. U.S. Patent No. 4,840,619 discloses a syringe assembly that has a transport held in telescoping position over a syringe by flanges. Other and various means of sheathing or shielding a syringe are shown in the following U.S. Patents: 4,738,663; 4,723,943; 4,666,435; 4,655,751; 4,639,249; 4,592,744; 4,356,822; 4,300,678; 3,976,069; 3,895,633; 3,107,785. U.S. Patent No. 4,826,483 discloses a non-reusable syringe with a one-way movable piston.
The present invention improves upon these devices by providing a means of automatically, without the need of unusual manipulation, rendering a used syringe safe for handling immediately after use and throughout subsequent disposal procedures, as well as rendering it unsuitable for further use. SUMMARY OF THE INVENTION
The present invention comprises a medicinal syringe including a tubular plunger from which air has been evacuated and a seal member releasably attached on the distal end of the plunger. Upon application of a predetermined longitudinal axial force to the seal member, the attachment between the seal member and plunger will break, releasing the seal member for movement within the plunger. The seal member when released will be forced by the differential pressure between the vacuum and the ambient air into the interior of the tubular plunger. The plunger is slidably disposed in a tubular barrel. A needle is disposed in a hub releasably attached within the distal end of the barrel. Upon application of a predetermined longitudinal axial force to the hub, the attachment between the hub and the barrel will break, releasing the hub for movement within the barrel. The hub when released will be forced by the pressure differential, along with the distal plunger seal member, into the interior of the tubular plunger, carrying the needle with it. The attachment between the hub and barrel is adapted to rupture prior to that between the seal member and plunger. Once forced into the tubular plunger, the needle and hub will remain there indefinitely, thus eliminating accidental puncturing by the needle of a person in the vicinity of the syringe.
The present invention thus comprises a container having a nozzle or needle at its distal end and a central cavity, the volume of which is determined by the position of a proximally disposed plunger. The nozzle or needle is mounted in the container such that application of a predetermined longitudinal axial force to the nozzle or needle will cause its detachment from the container. The plunger contains a hollow and evacuated center, sealed at its distal end by a member that is designed to break free from the plunger upon application of a predetermined longitudinal axial force to the member. This distal member may also serve to provide a leak free seal between the central cavity of the container and the atmosphere.
In its preferred embodiment, the invention is used in accordance with standard procedures for the subcutaneous, intramuscular, of intravascular injection or aspiration of substances into or out of the body, which procedures are well known to those schooled in the art. Immediately following the procedure, longitudinal axial force is applied to the proximal end of the plunger, thereby detaching the needle from the container and rupturing the vacuum seal at the distal end of the plunger. Atmospheric pressure then forces the needle up into the evacuated center of the plunger and holds it there, rendering it incapable of puncturing the βKin of the primary uβer or of perβonnel involved in secondary handling of the device.
The invention will now be described in further detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is an exploded pictorial view of a syringe of a preferred embodiment of the invention.
Figure 2 is a vertical croβs-sectional view of the syringe of Figure l prior to use.
Figure 3 is a vertical cross-sectional view of the syringe of Figure 1 following use and actuation of the automatically retractable needle of the invention.
Figure 4 is an exploded pictorial view of a syringe of a second embodiment of the invention.
Figure 5 is a vertical cross-sectional view of the distal end of the second embodiment showing an alternate construction.
Figure 6 is a vertical cross-section of the distal end of the preferred embodiment showing an alternate locking construction.
Figure 7 is a vertical cross-sectional view of the distal end of the preferred embodiment showing an alternate construction.
Figure 8 is a vertical cross-sectional view of a syringe of a third embodiment of the invention prior to use.
Figure 9 is an enlarged, vertical cross-sectional view of a portion of the syringe of Figure 8 prior to use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
While the invention is satisfied in many different forms, there is shown in the drawings and will herein he described in detail preferred embodiments of the invention, with the understanding that the present disclosure is to be considered as exemplary of the principles of the invention and is not intended to limit the scope of the invention to the embodiments illustrated.
The embodiment shown as syringe assembly 10 in Figures 1-3 includes a hypodermic needle 14 that is inserted and mounted into a needle hub 16 in such a manner that the interior bore of the needle communicates with the exterior of the hub via a transversely extending hole 22 in the hub. Hub 16 is releasably attached to the interior of syringe barrel 12 in such a manner that it forms a circumferential seal around the inner periphery of the barrel at its distal end a. Barrel 12 and hub 16 may be made of plastic, glass, or other materials suitable to the intended use of the device.
Slidably disposed within the barrel 12 is a hollow plunger tube 20 made of plastic, glass, or the like, which is sealed at its distal and proximal ends by a barrier seal member 28 and a cap 21, respectively. Cap 21 may be, for example, a thin round disc-like member having a circular boss 61 protruding therefrom and receivable within the interior of plunger 20. Alternatively, the cap may have a circular wall extending from the disc surface and adapted for receiving the exterior of the plunger therewithin. Other means of mounting a cap on the proximal end of plunger 20 will no doubt be readily apparent to those skilled in the art. During or after the process of sealing cap 21 to plunger tube 20, the air is removed from the sealed interior of the plunger, leaving a vacuum 24 within the plunger tube 20. Cap 21 may be made of plastic, rubber, glass, metal or the like.
In Figure 2 it can be seen that hub 16 and barrier seal member 28 are constructed so as to comprise annular grooves 26 and 27, respectively, forming relatively thin- walled areas of hub 16 and barrier seal member 27. Grooves 26, 27 may be on the distal, proximal, or both faces of hub 16 and barrier seal member 28, and are so designed that the thin-walled portions of these elements so created will rupture relatively easily upon the application of longitudinal axial force on the elements that is greater than that force required to reciprocate plunger 20 in barrel 28 to dispense fluids from or draw fluids into barrel 28 to achieve normal, pre-disposal syringe functions. Hub 16 and barrier seal member 28 may be subsequent attachments to or an integral part of their respective supporting members, barrel 12 and plunger 20.
At the election of the operator, normally after completion of a specific procedure, the plunger 20 is pushed distally into the barrel 12 with enough force to rupture the thin-walled areas of hub 16 and seal member at grooves 26 and 27. The needle hub center 16B, along with the central disc portion 28A of the barrier seal member 28, will be forced by the differential pressure between the atmosphere and the vacuum 24 up into the interior of vacuum tube 20A. The hub center portion 16B and the central disc portion 28A are sized so that they will closely engage the interior wall of the plunger 20 and will be retained in their retracted positions by friction. The hub center portion 16B and the central disc portion 28A may also be sized, and made of a sufficiently resilient material, to sealingly engage the interior wall of the plunger 20 in their retracted positions, in which case they will also be retained inside plunger 20 by the difference in pressure between the atmosphere and the interior of the relatively evacuated area 24. With the hub portion 16B, and hence the needle 14, retracted within plunger 20, the syringe assembly 10 may be safely disposed of without fear of accidental puncture.
Figures 4 and 5 show an alternate construction of syringe assembly 10, in which hub 16 is constructed with an annular shoulder 30 around its distal end which seats in and forms a seal against a correlatively shaped annular groove 32 around the inner periphery of the distal end of barrel 12. End seal member 18 is mounted on the distal end of plunger 20. End seal member 18 has a distally extending skirt portion 63 therearound, designed so that its longitudinal distal advancement in barrel 12 will spread apart the inner walls of barrel 12 and open groove 32, thereby releasing needle 14 and hub 16 to be drawn into plunger tube 20 when annular thin-walled ring portion 27 on end seal member 18 is ruptured.
Figure 6 shows an alternate construction in which hub 16 contains a locking recess 33 in its proximal end. The distal end face of end seal member 18 has centrally disposed thereon a projection or locking hub 34 which is shaped correlatively to recess 33. Recess 33 and hub 34, which may have any of a variety of configurations or profiles, are so designed that when plunger 20 is advanced toward hub 16, the hub 16 and end seal member 18 will engage and lock together just prior to the subsequent rupture of grooves 26 and 27, respectively. It should be understood that the recess 33 can be disposed in the end seal member 18, and the locking hub 34 can be disposed on the needle hub 16. As in the preferred construction shown in Figures 1-3, the needle 14 and hub 16 are drawn into the vacuum space 24 of plunger tube 20.
Figure 7 shows an alternate construction of the distal portion of she preferred embodiment of the syringe assembly of the present invention. Hub 16 includes a frustoconical- shaped recess or concavity c in its proximal end face, and a frustoconical-shaped or sloped exterior surface extending from location a to location b. Combined, the recess or concavity c, and the sloped surface ab, form a thin walled, compressible, flexible annular lip which, when drawn into vacuum space 24 of plunger tube 20, will result in an enhanced seal against the interior of plunger tube 20. Hub 16 also includes a frustoconical-shaped surface or taper e at its distal end, and barrel 12 includes a frustoconical- shaped surface or taper d at its distal end. Tapers d and e serve to reduce the resultant volume of the space 40 surrounding hub 16 and integral to barrel 12 when in the pre-use condition as well as to reduce space 41, distal to the hub 16 and open to atmosphere.
Figures 8 and 9 show another alternate construction of syringe assembly 10. In this alternate construction, a slidable seal member 65 of soft rubber or similar elastomeric material is disposed within the evacuated plunger 20 at its distal end and as close as possible to the vacuum wall side of the barrier seal member 28. Sealing member 65 is disc-shaped and has raised radius features 65A circumferentially disposed at its distal and proximal ends. When slidable seal member 65 is positioned within the plunger 20, the radius features 65A create a slidable seal against the interior wall of the plunger 20. The radius sealing features may be of any compound geometric shape to cause the intended seal. Sealing member 65 helps to assure that the vacuum 24 is not compromised or lost at the time of initial rupture of groove 27 of barrier seal member 28. When the hub 16 is forced into plunger 20 after rupturing of groove 26, the seal member 65 is forced into the plunger along with the hub.
Additionally, the wall of the plunger 20 has been extended longitudinally beyond plunger seal 28 to create a recess 20C defined by the interior recess wall 20D and chamfer 20E. The inside diameter of recess 20C and its length, from the vertex of groove 27 to the distal end of chamfer 20E, are such that a slip fit between the hub surface 16C and the interior surface 20D of the recess is created. The length of the recess 20C and chamfer 20E is less than the length of the longitudinal surface of wall 16C of the major diameter of the hub 16.
The sequential breaking of, first, groove 26 on the hub 16 distal end and, second, groove 27 on the plunger seal 28 are not affected by the foregoing.
A plurality of ridges or raised features 2OF are disposed on the outer circumferential distal surface of the plunger 20. Although frustoconical ridges are shown, these ridges may be of any geometric shape that will allow the addition of rubber-like sealable member 66. The sealable member or grommet 66 has raised radius features 66A circumferentially disposed about the surface of the grommet 66 and creates a seal between the radius features and the interior wall of the barrel 12.
The longitudinal extension of the plunger 20 to create recess 20C in conjunction with the addition of the grommet 66 extended over the plunger's distal end result in decreasing the volume 40 and thus improve the force of differential pressure needed to cause the hub 16 to be drawn into the plunger 20 at the time that the plunger seal 28 is ruptured.
The distance between the hub distal face 16E and the surface (a) of barrel internal distal features 12A is such that when breaking force is applied to the hub 16, groove 26 will rupture just before the two surfaces, (a) of the barrel 12 and 16E of the hub 16, make contact. The clearance between the outer wall 14A of needle 14 and the thru-wall 12B of the distal end of barrel 12 which surrounds the needle 14 should be minimal yet allow the needle 14 to slip within the barrel's distal thru-hole containing the needle 14.
A bondable ferrous plastic member or ring 67 may be used to permit the joining of separately molded plastic hub member 16 and the syringe barrel 20. Further, in the event that the barrel 20 itself is made from two separately molded pieces, a cylindrical barrel and a distal end, all three pieces, hub 16, cylindrical barrel, and the distal end feature of the barrel, can be joined simultaneously by use of the bondable ferrous plastic ring 67.
Having described certain embodiments of the present invention, many modifications thereof may be made within the scope of the inventive concept taught herein and set out in the following claims. The preferred embodiments described in the foregoing specification are exemplary only, and not limiting. The scope of protection herein

Claims

sought also includes all equivalents of the subject matter of the claims.CLAIMS
1. A disposable syringe assembly, comprising: a barrel having a proximal end and a distal end and an internal central bore; a tubular plunger having a closed proximal end, said plunger being telescopingly insertable within the proximal end of said barrel and adapted for sliding reciprocating movement therewithin; a needle hub sealingly mounted around the inner wall of said barrel, said needle hub having a releasable center portion adapted for movement within said barrel when released, the distal end of said barrel having an opening therein exposing the distal face of said releasable center portion of said needle hub to the atmosphere; a needle retained in said releasable center portion of said needle hub and projecting out said opening in said distal end of said barrel prior to release of said center portion of said hub; a barrier seal member sealingly mounted on the distal end of said plunger, said barrier seal member having a releasable center portion adapted for movement within said tubular plunger when released, said barrier seal member closing and sealing the distal end of said plunger prior to release of said releasable center portion of said barrier seal member, the interior of said tubular plunger being relatively evacuated; said releasable center portions of said hub and said barrier seal member being engageable with one another and releasable upon application of a predetermined longitudinal axial force thereon, the distal face of said releasable center portion of said barrier seal member being exposed to the atmosphere when said releasable center portion of said hub has been released, said releasable center portions of said hub and said barrier seal member being forced when released into the relatively evacuated interior of said plunger by differential pressure between said evacuated interior and the atmosphere.
2. The disposable syringe assembly of claim 1, wherein said predetermined force is imparted by longitudinal distal movement of said plunger within said barrel.
3. The disposable syringe assembly of claim 1, wherein said needle hub includes an annular groove in one of its distal and proximal faces forming a thin-walled hub portion, said releasable center portion of said hub being circumscribed by said thin-walled hub portion.
4. The disposable syringe assembly of claim 1, wherein said barrier seal member includes an annular groove in one of its distal and proximal faces forming a thin-walled barrier seal member portion, said releasable center portion of said barrier seal member being circumscribed by said thin-walled barrier seal member portion.
5. The disposable syringe assembly of claim 3, wherein one of the proximal end of said needle hub and the distal end of said barrier seal member includes a locking recess therein, and the other of the proximal end of said needle hub and the distal end of said barrier seal member includes a locking hub shaped correlatively to said locking recess, said locking hub being lockingly received in said locking recess when said barrier seal member engages said needle hub.
6. The disposable syringe assembly of claim 3, wherein said needle hub includes a frustoconical recess in its proximal end face and the proximal end portion of said needle hub comprises a frustoconical-shaped exterior surface tapering distally, forming a thin-walled annular lip around the proximal end of said needle hub.
7. The disposable syringe assembly of claim 6, wherein the distal end of said releasable center portion of said needle hub comprises a frustoconical-shaped exterior surface tapering distally, and said barrel includes a correlatively shaped frustoconical surface around the distal end of said barrel adjacent to and spaced from said frustoconical- shaped surface on the distal end of said needle hub, prior to release of said releasable center portion of said needle hub.
8. A disposable syringe assembly, comprising: a barrel having a proximal end and a tapering distal end and an internal central bore; a tubular plunger having a closed proximal end, said plunger being telescopingly insertable within the proximal end of said barrel and adapted for sliding reciprocating movement therewithin; a needle hub releasably and sealably mounted around the inner wall of said barrel, said needle hub having an annular shoulder around its distal end, said barrel having an annular groove around its inner periphery for releasably retaining said annular shoulder of said needle hub therewithin, said needle hub being adapted for movement within said barrel when said shoulder is released from said groove, the distal end of said barrel having an opening therein exposing the distal face of said needle hub to the atmosphere; a needle retained in said needle hub and projecting out said opening in said distal end of said barrel prior to release of said needle hub from said barrel groove; a barrier seal member sealingly mounted on the distal end of said plunger, said barrier seal member having a releasable center portion adapted for movement within said tubular plunger when released, said barrier seal member closing and sealing the distal end of said plunger prior to release of said releasable center portion of said barrier seal member, the interior of said tubular plunger being relatively evacuated; said barrier seal member having a distally extending skirt portion engageable with the interior of the tapering distal end of said barrel, spreading the inner wall of said barrel at said groove, when said plunger is advanced distally within said barrel releasing said annular needle hub shoulder from said groove, said releasable center portion of said barrier seal member being releasable upon application of a predetermined longitudinal axial force thereon, the distal face of said releasable center portion of said barrier seal member being exposed to the atmosphere when said needle hub has been released, said needle hub and said releasable center of said barrier seal member being forced when released into the relatively evacuated interior of said plunger by differential pressure between said evacuated interior and the atmosphere.
9. The disposable syringe assembly of claim 1, and further including a slidable seal member disposed within said evacuated interior of said tubular plunger, said slidable seal member comprising a solid plug forming a sliding seal around the interior wall surface of said tubular plunger, said slidable seal member being disposed closely adjacent the proximal face of said barrier seal member prior to release of said releasable center portion of said barrier seal member.
10. The disposable syringe assembly of claim 9, wherein said slidable seal member comprises a body having an outer diameter smaller than the internal diameter of said tubular plunger, and a circumferentially extending raised portion at its proximal and distal ends in sealing engagement with said interior wall surface of said plunger.
11. The disposable syringe assembly of claim 1, wherein said needle hub has a major diameter proximal portion extending distally from its proximal end, a minor diameter distal portion extending proximally from its distal end, and an annular shoulder separating said major and minor diameter portions, and wherein said tubular plunger includes a longitudinally extending recess disposed distally of said barrier seal member, said major diameter proximal portion of said needle hub being telescopingly insertable in said longitudinally extending recess and forming a slip fit therewith prior to release of said releasable center portions of said hub and said barrier seal member.
12. The disposable syringe assembly of claim 11, wherein the axial length of said longitudinally extending recess is less than the axial length of said major diameter proximal portion of said needle hub.
13. The disposable syringe assembly of claim 11, wherein said barrier seal member includes an annular groove in one of its distal and proximal faces forming a thin-walled barrier seal member portion, said releasable center portion of said barrier seal member being circumscribed by said thin-walled barrier seal member portion, and wherein said needle hub further includes a frustoconical-shaped recess in the proximal end face of said major diameter proximal portion, forming a thin-walled annular lip around the proximal end of said needle hub, said thin-walled annular lip being engageable with said thin-walled barrier seal member portion when said major diameter proximal portion of said needle hub is fully telescoped into said longitudinally extending recess of said tubular plunger.
PCT/US1991/001768 1990-03-22 1991-03-15 Disposable syringe with automatic needle retraction WO1991014465A1 (en)

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US5000736A (en) 1991-03-19

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