WO2001021236A1 - Auto-destruct syringe - Google Patents
Auto-destruct syringe Download PDFInfo
- Publication number
- WO2001021236A1 WO2001021236A1 PCT/CA2000/001104 CA0001104W WO0121236A1 WO 2001021236 A1 WO2001021236 A1 WO 2001021236A1 CA 0001104 W CA0001104 W CA 0001104W WO 0121236 A1 WO0121236 A1 WO 0121236A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- piston
- syringe
- barrel
- plunger
- auto
- Prior art date
- Legal status (The legal status 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 status listed.)
- Ceased
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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
- A61M5/50—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
-
- 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
- A61M2005/5006—Having means for destroying the syringe barrel, e.g. by cutting or piercing
Definitions
- the invention relates to disposable, auto-destruct syringes which are rendered non-
- a principal function of syringes is in conjunction with hypodermic needles for the
- hypodermic syringes for example, the sharing or reuse of hypodermic syringes.
- hypodermic syringes has become a major problem in third-
- a housing or recess for a small knife which is forced radially outwardly by a
- the knife has a rearward rounded edge and a forward cutting edge.
- a protection strip is inserted
- the syringe includes a barrel, a piston,
- the knives are mounted on
- knives are oriented to be opposite preselected areas of reduced thickness in the barrel wall.
- the reduced wall thickness permits penetration of the knives and cutting of the barrel wall
- the syringe is initially supplied with the plunger in a first position
- the plunger includes a pair of opposing, rearwardly
- the plunger for example for a second aspiration of the syringe, forces the cutter arms
- the cutter arms may not be able to cut or
- the syringe be manufactured from relatively economical materials such as plastics.
- knives may lead to failure of the knives part way during the injection stroke, leaving a
- destruct syringe of this general type is achieved by a mechanism for
- barrel wall and the piston for example by permanently deforming the barrel wall, which
- the auto-destruct mechanism includes a piston provided
- the deforming means is preferably
- deforming means extends beyond the outside diameter of the piston, to cause deformation
- the deforming means is a cutter, at least a part of
- the invention provides an auto-destruct mechanism for a syringe having
- a syringe barrel for holding fluid and having an open rear end and a closed front end with a
- the mechanism includes a piston
- a plunger having a
- connecting means for interlocking the piston with the plunger to permit axial movement of the piston in the barrel by operation of the plunger;
- the connecting means permitting a preselected amount of axial movement of the plunger
- deforming means for permanently deforming the barrel wall to break the seal between the
- the deforming means being pivotally mounted in the piston for
- deforming means is prevented, and an operating position wherein the deforming means
- One feature of the present invention is that the rotation movement of the deforming
- the direction of rotation of the deforming means is preferably selected such that a barrel
- the piston and plunger are shaped and
- the piston has a radial recess in its outer
- deforming means is inserted into the radial recess to extend into the deforming means
- FIGURE 1 is an axial cross-section through the preferred embodiment of the auto-
- FIGURE 2 is an axial cross-section through the auto-destruct mechanism shown in
- FIGURE 1 but during the beginning of the intake stroke with the cutter in the cocked
- FIGURE 3 is an axial cross-section through the auto-destruct mechanism shown in
- FIGURE 1 but during the first aspiration stroke, with the cutter in the cocked position;
- FIGURE 4 is an axial cross-section through the auto-destruct mechanism shown in
- FIGURE 1 during the exhaust stroke, with the cutter in the at rest position
- FIGURE 5 is an axial cross-section through the auto-destruct mechanism shown in
- FIGURE 1 illustrating the primed blade of the cutter at the beginning of the second
- FIGURE 6 is a perspective view of the auto-destruct mechanism shown in FIGURE
- FIGURE 7 illustrates an axial cross-section through the plunger
- FIGURE 8 illustrates an enlarged side view of the front end of the plunger shown in
- FIGURE 7
- FIGURE 9 is a perspective view from above of the plunger front end shown in
- FIGURE 8
- FIGURE 10 is a top plan view of the plunger front end shown in FIGURE 8.
- FIGURE 11 is a side elevational view of the cutter;
- FIGURE 12 is a top plan view of the cutter;
- FIGURE 13 is a top plan view of the piston showing the cutter receiving recess.
- the syringe consists of a syringe body 10
- the auto-destruct mechanism 50 includes the piston 20, a plunger
- the syringe body 10 includes a cylindrical barrel 12 which has an open rear end 7 and
- the front end 1 of the barrel is provided with an integral needle
- the front end 1 further has a fluid passage
- An auto-destruct mechanism 50 is shown in detail in Figures 1 through 4. As can be
- the piston 20 includes a seal or stopper 4 which is made
- elastomeric seal material such as butyl rubber used in conventional syringe piston seals.
- the seal 4 is preferably connected with the piston 20 by way of an interference fit.
- seal 4 at least in a preferred embodiment, is slightly larger than the inner diameter of the
- a circumferential groove 9 is provided in the outer surface of the seal.
- the seal 4 to improve the sealing characteristics thereof.
- the seal 4 can have a
- the piston 20 also contains
- the piston 20 and plunger 40 are constructed such that the
- plunger 40 can move a defined axial distance A (see Figure 3) relative to the piston 20 in
- the piston 20 in the preferred embodiment is sleeve-shaped and
- the plunger front end 9 fits thereinto. In the region of overlap between the plunger and the plunger
- the plunger is divided into two portions, the plunger tongue 41, and the interlocking
- portion 43 which functions as the connecting means (see Figure 8) .
- the plunger tongue 41 has a priming opening 47 for
- plunger tongue 41 has a solid front end 44, the length of which is selected such that it
- a cutter opening 48 is provided in the interlocking portion 43 for receiving the
- the sleeve 20 includes a cutter receiving recess 6 into which the cutter 60 is inserted. It is readily apparent from the drawings that the rearward
- plunger 40 is not interconnected with piston 20 in this embodiment. However, a
- piston 20 can be provided at
- the cutter opening 48 is offset axially forwardly
- the cutter 60 includes a generally cylindrically
- the cutter 60 also includes a pair of lateral
- detents 65 which protrude laterally from the cutter body 63 at a top edge thereof.
- cutter 60 sits in the cutter recess 6 and extends with its lever portion 62 into the cutter
- the cutter recess 6 includes a pair of laterally
- detent receiving cutouts 67 in opposite side walls of the recess for receiving detents 65
- the mechanism 50 is simply assembled by overlapping the plunger 40 and the
- Syringes including the mechanism in accordance with the
- the user pulls back the plunger 40 thereby retracting the piston 20.
- the plunger 40 moves forward relative to the piston 20 until
- tongue 41 snaps back from the deflected condition (see Figure 3) into its straight
- lever portion 62 i.e. the distance of the point of engagement between the lever portion and
Landscapes
- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
The syringe is fitted with a deforming structure (50) for permanently deforming the barrel wall (12) to break the seal (30) between piston (20) and barrel wall. The deforming structure is pivotally mounted in the piston for rotation between an at rest position wherein the deforming structure does not deform the barrel wall and an activation position wherein the deforming means forcibly engages the barrel wall for permanent deformation thereof. An actuator is provided on the plunger for rotating the deforming structure into the barrel wall engaging position upon rearward movement of the plunger subsequent to a full or partial injection stroke. The mechanism renders the syringe non-reusable after a first injection stroke to ensure that the syringe cannot be refilled.
Description
AUTO - DESTRUCT SYRINGE
FIELD OF THE INVENTION
The invention relates to disposable, auto-destruct syringes which are rendered non-
reusable during or after a first use.
BACKGROUND OF THE INVENTION
A principal function of syringes is in conjunction with hypodermic needles for the
treatment of disease by way of intravenous or intramuscular injection in humans or
animals. When treating disease in this way, it is particularly important to prevent infection
of the patient injected.
Communicable diseases are transmitted and infection can be caused in different ways,
such as, by contact with body fluids of an infected person. Infection or transmission of a
communicable disease is undesirable and is especially unfortunate when due to inadvertence
or ignorance, for example, the sharing or reuse of hypodermic syringes.
The practise of sharing hypodermic syringes is especially prevalent among drug
users. Similarly, the reuse of hypodermic syringes has become a major problem in third-
world countries where syringes are used in vaccination campaigns. Often several children
are inoculated with the same syringe either by using large capacity syringes for multiple
small injections, or by refilling or reusing the syringes, often without proper sterilization.
As a result of such misuse of hypodermic syringes, potentially disastrous body fluid
transmitted diseases, especially AIDS and Hepatitis, have spread at an alarming rate among
drug users and in third- world countries, particularly among children. Although not all new
cases are attributable to syringe reuse or sharing, it is estimated by the World Health
Organization that the total number of new cases could be significantly reduced if
transmission through contaminated syringes were prevented. In an effort to frustrate the
reuse of hypodermic syringes, disposable syringes have been developed which are intended
to be functional for only one single injection.
A variety of approaches have been adopted in the design and manufacture of single-
use syringes. These can be grouped into three basic categories: (1) the piston or plunger
lock type wherein retraction of the piston is prevented either always or after completion of
the injection; (2) the plunger separating type wherein the plunger separates from the piston
or the piston seal when the plunger is retracted; and (3) the cutting or deforming type
wherein the barrel wall is cut or deformed during injection. It is a major disadvantage that
in the first two types of single-use syringes, the lock type and the separating type, the
barrel, which is the most important part of any functioning syringe remains intact and may
be tampered with and reused. Thus, single-use syringes wherein the barrel is rendered
unusable, for example through cutting of the barrel wall, are preferable. However, the
cutting type syringes also have certain disadvantages.
Examples of the third type of single-use or cutting-type syringe are known in the art.
Chiquar- Arias in U.S. Patent No. 3,667,657 discloses pre-filled syringes which include a
small stationary knife that is laterally fixed to the syringe plunger and engages an opening
in the wall of the syringe barrel. When the plunger is forced down into the barrel, as
during injection, the barrel wall is cut. This destroys the barrel behind the piston seal and
makes reuse of the syringe impossible. However, it is a disadvantage of pre-filled syringes
that they can only be used in those circumstances where injection of the respectively
included liquid is desired. In other words, numerous syringes filled with different
inoculates are required which increases the manufacturing and storage costs.
In U.S. Patent No. 3,951, 146, Chiquar- Arias describes syringes wherein the plunger
includes a housing or recess for a small knife which is forced radially outwardly by a
spring. The knife has a rearward rounded edge and a forward cutting edge. The plunger
can be moved rearward for filling of the syringe without cutting or damaging the barrel
wall. For insertion of the plunger during manufacture, a protection strip is inserted
between the knife and the barrel wall, which strip is then removed. Use of the protection
strip is disadvantageous since it adds an additional manufacturing step and thus increases
production cost. Furthermore, the spring loaded knife stays in contact with the barrel wall
at all times which, despite the rounded rear edge of the knife, could damage the barrel wall
during aspiration of the inoculate and lead to leakage around the plunger or through the
barrel wall.
An auto-destruct disposable syringe with retractable knives is disclosed in Canadian
Patent Application Serial No. 2,045,499 by Fenet. The syringe includes a barrel, a piston,
and a plunger for moving the piston axially in the plunger. The knives are mounted on
flexible arms which are connected with the plunger and are retracted during the aspiration
stroke of the syringe. When the aspirated liquid is expelled from the barrel, the plunger is
pushed against the piston which moves the free end of the arms along an inclined ramp on
the piston, thereby forcing the knives against the barrel wall. The plunger and, thus, the
knives are oriented to be opposite preselected areas of reduced thickness in the barrel wall.
The reduced wall thickness permits penetration of the knives and cutting of the barrel wall,
thereby destroying the barrel behind the piston as it is forced into the barrel during
injection. As a result, the syringe cannot be reused since the barrel will no longer hold a
vacuum and any liquid contained therein will leak through the cut areas of the barrel wall.
However, rotation of the plunger and knives relative to the barrel wall and especially the
areas of reduced wall thickness will render the syringe reusable.
International publication WO 97/26933 by the present applicant discloses an auto-
destruct syringe in which the integrity of the syringe is destroyed during a second
aspiration stroke. The syringe is initially supplied with the plunger in a first position
relative to the piston. In this position, the piston can be moved rearward in the syringe by
pulling the plunger. To inject, pushing on the plunger forces the head of the plunger
forward to move past a pair of opposing cutter arms on the piston which each carry a knife
blade and into a second position. The plunger includes a pair of opposing, rearwardly
inclined ramps on which the cutter arms slide during movement of the plunger relative to
the piston. Once the plunger is in this second position, any subsequent attempt to withdraw
the plunger, for example for a second aspiration of the syringe, forces the cutter arms
outwardly against the syringe barrel, thereby forcing the associated knife blades against the
barrel wall to permanently destroy the integrity of the syringe.
It is a disadvantage of this prior art syringe construction that the reliability of the
auto-destruct mechanism thereof depends upon the outward force applied against the two-
knife carrying arms by the plunger. Furthermore, the strength of these arms is limited since
they must be small enough to fit between the plunger and the barrel wall. This renders the
arms relatively weak which results in the arms braking off when a large pulling force is
applied to the plunger. Further, the outward force that can be applied by the cutter arms is
limited and directly dependent on the pulling force exerted on the plunger and the angle of
inclination of the ramps. Small angles will result in an insufficient outward force and large
angles may result in such high friction between the cutter arms and the ramps to allow
retraction of the plunger and piston without destruction of the barrel wall. Thus, the
barrel wall must be weakened for reliable operation of the mechanism. However, if the
wall is too thin, the integrity of the syringe during injection may be compromised. On the
other hand, if the wall thickness is too large, the cutter arms may not be able to cut or
score the barrel wall sufficiently to break the piston/ barrel seal. This may render the
syringe impractical. Moreover, since auto-destruct syringes must be discarded after a single
use, they should be made available at the lowest possible price to reduce the financial strain
on the patient, the health care system and international health organizations. This requires
that the syringe be manufactured from relatively economical materials such as plastics.
However, during tests with knives manufactured from inexpensive plastic material, the
inventors of the present application have found that such knives tend to quickly become
blunt, forcing the use of higher priced plastics or metal. Premature wear of ramp-operated
knives may lead to failure of the knives part way during the injection stroke, leaving a
portion of the barrel intact and allowing partial reuse of the syringe. Thus, an economical
tamper resistant auto-destruct syringe is desired which reliably prevents even partial reuse.
SUMMARY OF THE INVENTION
These disadvantages are now overcome with an auto-destruct syringe in accordance
with the present invention wherein the integrity of the syringe is reliably destroyed only
when refilling of the syringe is attempted i.e. during a second aspiration stroke with no
damage to barrel integrity during the injection stroke.
It is an object of the invention to provide an improved mechanism for an auto-
destruct syringe of this general type. Preferably, this is achieved by a mechanism for
cutting of the syringe barrel starting at the front end or for breaking the seal between the
barrel wall and the piston, for example by permanently deforming the barrel wall, which
mechanism is activated upon an attempted refilling of the syringe, the third stroke. By
destroying the seal during the third stroke the axial forces required for permanently
deforming the syringe barrel, for example by cutting, are not superimposed onto the basic
force required for pushing the piston down the barrel during injection. In other words, the
self-destruction operation of the syringe will not interfere with the injection stroke so that
compliance with international guidelines which require that the axial force for pushing the
piston down the barrel during injection not exceed a maximum value, is easily achievable.
In the preferred embodiment, the auto-destruct mechanism includes a piston provided
with a deforming means or cutter which is pivotally mounted therein for rotation between
an at rest position wherein the deforming means is recessed into the piston and does not
forceability engage the barrel wall and an operating position wherein the deforming means
is forced with a deformation edge into the barrel wall. The deforming means is preferably
mounted in an axially fixed location in the piston and rotated by the plunger upon axial
movement of the plunger relative to the piston. In the at rest position, the deforming means
is preferably completely recessed thereby permitting assembly, filling and injection by
manipulation of the plunger. In the operating position, at least the deforming edge of the
deforming means extends beyond the outside diameter of the piston, to cause deformation
of the barrel wall.
In another preferred embodiment, the deforming means is a cutter, at least a part of
which extends radially beyond the piston to cut the barrel wall.
In an alternative embodiment, that part of the cutter extending beyond the piston
merely burrows into or deforms the barrel wall.
Accordingly, the invention provides an auto-destruct mechanism for a syringe having
a syringe barrel for holding fluid and having an open rear end and a closed front end with a
passage extending through the closed front end of the barrel to permit expulsion of fluid
therethrough from the interior of the barrel. The mechanism includes a piston
reciprocatable in the barrel for sealingly engaging the barrel wall; a plunger having a
forward portion normally interlocked with the piston and a rearward portion to be
manipulated by a user of the syringe; connecting means for interlocking the piston with the
plunger to permit axial movement of the piston in the barrel by operation of the plunger;
the connecting means permitting a preselected amount of axial movement of the plunger
relative to the piston between a thrust position wherein the piston is advanced in the barrel
by the plunger and a pull piston where the piston is retracted in the barrel by the plunger;
deforming means for permanently deforming the barrel wall to break the seal between the
piston and the barrel wall, the deforming means being pivotally mounted in the piston for
rotation between an at rest position wherein deformation of the barrel wall by the
deforming means is prevented, and an operating position wherein the deforming means
forcibly engages the barrel wall for permanently deforming the barrel wall; and an
activating means on the plunger for rotating the deforming means into the operating
position upon movement of the plunger into the pull position after at least a partial injection
stroke.
The term permanently deforming the barrel wall in the context of this application is
intended to include puncturing or cutting of the barrel wall, burrowing into the barrel wall
to produce a permanent groove, and other actions which will break the seal between the
piston and the barrel wall and allow leakage around the piston, thereby preventing the
further generation of pressure or vacuum in the barrel.
One feature of the present invention is that the rotation movement of the deforming
means guarantees an engagement of the deforming means with the barrel wall at a constant
force independent of the amount of retraction force applied to the plunger. Furthermore,
the direction of rotation of the deforming means is preferably selected such that a barrel
engaging end or edge thereof moves radially outwardly and axially forwardly into
engagement with the barrel wall upon rotation into the operating position. This will ensure
that the deforming means is kept in the operating position during the third stroke and not
rotated back into the at rest position upon retraction of the piston.
In an especially preferred embodiment, the piston and plunger are shaped and
constructed to partially overlap when interlocked, the piston has a radial recess in its outer
surface for receiving the deforming means and the connecting means has a deforming
means receiving recess such that the piston and the plunger are interlocked when the
deforming means is inserted into the radial recess to extend into the deforming means
receiving recess.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the invention will now be described by way of example
only and with reference to the attached drawings, wherein:
FIGURE 1 is an axial cross-section through the preferred embodiment of the auto-
destruct mechanism in accordance with the invention and with the cutter in the safety
position for insertion of the mechanism into a syringe barrel;
11
FIGURE 2 is an axial cross-section through the auto-destruct mechanism shown in
FIGURE 1 , but during the beginning of the intake stroke with the cutter in the cocked
position;
FIGURE 3 is an axial cross-section through the auto-destruct mechanism shown in
FIGURE 1 , but during the first aspiration stroke, with the cutter in the cocked position;
FIGURE 4 is an axial cross-section through the auto-destruct mechanism shown in
FIGURE 1, during the exhaust stroke, with the cutter in the at rest position;
FIGURE 5 is an axial cross-section through the auto-destruct mechanism shown in
FIGURE 1 , illustrating the primed blade of the cutter at the beginning of the second
aspiration stroke, with the cutter in the operating position;
FIGURE 6 is a perspective view of the auto-destruct mechanism shown in FIGURE
1, illustrating the position of the cutter receiving recess;
FIGURE 7 illustrates an axial cross-section through the plunger;
FIGURE 8 illustrates an enlarged side view of the front end of the plunger shown in
FIGURE 7;
FIGURE 9 is a perspective view from above of the plunger front end shown in
FIGURE 8;
FIGURE 10 is a top plan view of the plunger front end shown in FIGURE 8;
FIGURE 11 is a side elevational view of the cutter;
FIGURE 12 is a top plan view of the cutter;
FIGURE 13 is a top plan view of the piston showing the cutter receiving recess.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The preferred embodiment of an auto-destruct mechanism in accordance with the
invention is preferably used in a disposable syringe into which it is inserted and with which
it is packaged in the empty condition to allow aspiration of an injectable liquid and
subsequent injection without destruction of the syringe. The auto-destruct mechanism
destroys the integrity of the syringe barrel once re-use is attempted after injection by an
attempt of refilling of the syringe during a second aspiration (herein also referred to as
"third stroke").
In particular, the mechanism in accordance with the invention is inserted in a syringe
barrel as shown in Figure 5 of the drawings. The syringe consists of a syringe body 10
including a barrel 12, a piston 20 including a seal 30 and an auto-destruct mechanism 50
for permanent deformation of at least the barrel interior wall 13 to break the seal between
the piston and the barrel. The auto-destruct mechanism 50 includes the piston 20, a plunger
40 with a connecting means in the form of a connecting portion 5 for connecting the
plunger 40 with the piston 20, thereby allowing the user of the syringe to reciprocate the
piston by way of the plunger, and a cutter 60 having a blade portion 61 and a lever portion
62. The syringe body 10 includes a cylindrical barrel 12 which has an open rear end 7 and
a closed front end 1. The front end 1 of the barrel is provided with an integral needle
mount 2 for attachment of a hypodermic needle. The front end 1 further has a fluid passage
3 for the expulsion of fluid from the barrel 12 and into a needle (not shown). Although a
needle (not shown) can be removably attached to the mount 2 for separate disposal, it is
preferably permanently affixed to the needle mount 2 to prevent the re-use of possibly
contaminated needles.
An auto-destruct mechanism 50 is shown in detail in Figures 1 through 4. As can be
seen from reference to Figure 1 , the piston 20 includes a seal or stopper 4 which is made
of elastomeric seal material such as butyl rubber used in conventional syringe piston seals.
The seal 4 is preferably connected with the piston 20 by way of an interference fit. Other
methods of attaching the seal to the piston are known in the art and do not need to be
discussed in detail herein. The outer diameter of at least a circumferential section of the
seal 4, at least in a preferred embodiment, is slightly larger than the inner diameter of the
syringe barrel 12, to ensure a liquid tight sliding engagement therebetween. In one
embodiment of the seal, a circumferential groove 9 is provided in the outer surface of the
seal 4 to improve the sealing characteristics thereof. Alternatively, the seal 4 can have a
diameter which is marginally smaller than the syringe barrel diameter and include one or
more circumferential sealing ribs giving the stopper an overall diameter larger than the
syringe barrel inner diameter, thereby ensuring a reliable seal. The piston 20 also contains
a cutter recess 6. In the assembly position, the cutter or deforming means does not extend
beyond the recess 6, but is contained entirely within the outer diameter of the
plunger /piston combination. The piston 20 and plunger 40 are constructed such that the
plunger 40 can move a defined axial distance A ( see Figure 3) relative to the piston 20 in
the installed/assembled condition of the auto-destruct mechanism 50. The extent of this
axial movement is defined by the interaction of the plunger front end 9, the piston front
end 8 and the cutter 60. The piston 20 in the preferred embodiment is sleeve-shaped and
the plunger front end 9 fits thereinto. In the region of overlap between the plunger and the
piston, the plunger is divided into two portions, the plunger tongue 41, and the interlocking
portion 43 which functions as the connecting means (see Figure 8) . As more clearly
apparent from Figures 8 to 10, the plunger tongue 41 has a priming opening 47 for
receiving the lever portion 62 of the cutter 60. Forwardly of this priming opening 47, the
plunger tongue 41 has a solid front end 44, the length of which is selected such that it
maintains the cutter 60 in the safety position when the plunger 40 is completely inserted
into the piston 20, to prevent the cutter 60 extending beyond the outer diameter of the
piston 20 during assembly of the auto-destruct mechanism and insertion thereof into a
syringe. A cutter opening 48 is provided in the interlocking portion 43 for receiving the
cutter 60 in the assembled condition. The sleeve 20 includes a cutter receiving recess 6 into
which the cutter 60 is inserted. It is readily apparent from the drawings that the rearward
movement of the piston upon rearward pulling of the plunger is only possible when these
two parts are interlocked by the cutter 60 received in the cutter recess 6 (see Figure 1) and
extending into the cutter opening 48. If the cutter 60 is not inserted into the cutter receiving
recess 6, plunger 40 is not interconnected with piston 20 in this embodiment. However, a
separate structure for interconnecting the plunger 40 with the piston 20 can be provided
which interconnects the two components independent of the cutter 6, while still permitting
relative axial movement with an axial length A. For example, piston 20 can be provided at
its rear end 21 with an axially inwardly extending rib or flange (not shown) which would
act as a stop for guide tabs 42 of the plunger 40, to prevent removal of the plunger front
end 5 from the piston 20 while allowing relative axial reciprocating movement. Other
methods and structures for interconnecting the piston 20 and the plunger 40 would be
readily apparent to the art skilled person. The cutter opening 48 is offset axially forwardly
of the priming opening 47 to permit progressive rotation of the cutter from the safety
position into the cocked position, then into the at rest position and finally into the operating
position through repeated reciprocation of the plunger 40 relative to the piston 20.
As is best seen in Figure 6, 11 and 12, the cutter 60 includes a generally cylindrically
central body 63, a blade portion 61, a lever portion 62 and a pair of pivots 64 extending
coaxially laterally from the cutter body 63. The cutter 60 also includes a pair of lateral
detents 65 which protrude laterally from the cutter body 63 at a top edge thereof.
In the assembly position of the preferred embodiment illustrated in Figure 1 , the
cutter 60 sits in the cutter recess 6 and extends with its lever portion 62 into the cutter
opening 48 of the interlocking portion 43. The cutter recess 6 includes a pair of laterally
extending groves 66 for rotatably receiving the pivots 64 of the cutter. The cutter recess 6
has detent receiving cutouts 67 in opposite side walls of the recess for receiving detents 65
of the cutter 60 in the inserted condition as will be described in more detail further below.
When the auto-destruct mechanism 50 is in this assembly position or orientation, the
mechanism can be safely inserted into the syringe barrel 12 without causing any damage to
the barrel wall 13. In this position, the front end surface 11 of the plunger 40 engages a
thrust shoulder 29 on the piston (see Figure 5), while the cutter 60 is maintained in the
safety position by the solid activation end 44 of the plunger 40, in which position the cutter
is completely received within the piston 20. This presents a significant advantage in
manufacturing cost, since no cutter guards or safety strips are required for assembly of the
syringe. The mechanism 50 is simply assembled by overlapping the plunger 40 and the
piston 20 and placing the cutter 60 in the recess 6 and then installed by inserting the
mechanism into a syringe barrel. Syringes including the mechanism in accordance with the
invention are preferably shipped with the mechanism in the assembly position.
OPERATION
To fill a syringe including the auto-destruct mechanism in accordance with the
invention, the user pulls back the plunger 40 thereby retracting the piston 20. Upon the
initial pulling back of the plunger, the plunger moves rearwardly relative to the piston until
a thrust edge 45 of the cutter opening 48 engages the lever portion 62 of the cutter 60 (see
Figure 2). In this condition, the cutter 60 is completely recessed within the piston 20 and
its lever portion 62 is locked in place between the thrust edge 45 and the activation end 44
of the plunger tongue 41. Upon further pulling back of the plunger 40, the thrust edge 45
forces the lever portion 62 rearwardly, thereby rotating cutter 60 forward about the axis
defined by the pivots 64 until the forward end surface 46 of the cutter opening 48 comes to
rest against the cutter (see Figure 3). In this condition, the cutter is in the cocked position,
the lever portion 62 of the cutter 60 forces against the solid activation end 44 of the tongue
41 and deflects it downwardly. The detents 65 of the cutter 60 in this position engage the
respectively associated detent receiving cutouts 67 so that a reverse rotation of the cutter 60
back to the safety position is no longer possible ( see Figure 6). When the plunger 40 is
subsequently pushed into the barrel 12 for injection of the fluid aspirated during the
preceeding aspiration stroke, the plunger 40 moves forward relative to the piston 20 until
the front end surface 11 of the plunger engages the thrust shoulder 29, after which the
piston 20 is moved down the barrel during advancement of the plunger. Since the cutter 60
is in the cocked position in which reverse rotation is prevented, the lever portion 62 slides
along the solid activation end 44 of the tongue 41 during relative displacement of the
plunger and the piston until the lower portion reaches the priming opening 47. At that
point, tongue 41 snaps back from the deflected condition (see Figure 3) into its straight
configuration (see Figure 4), thereby priming the mechanism for future forward rotation of
the cutter 60.
Once the injection is completed, the syringe is supposed to be discarded. However, if
reuse of the syringe is attempted by pulling of the plunger 40 backwards, the cutter 60 is
rotated into the activated position shown in Figure 5 wherein the blade portion 61 and
especially the associated cutting edge 68 is forced into the barrel wall 13 to destroy the seal
between the piston 20 and the barrel 12 by either cutting the barrel wall or sufficiently
scoring it to reliably prevent the generation of another vacuum in the syringe. This rotation
is achieved by the solid activation end 44 of the tongue 41 pulling the lever portion 62
backward so that the cutter 60 rotates further about the pivots 64. Due to the length of the
lever portion 62, i.e. the distance of the point of engagement between the lever portion and
the activation end 44 from the pivot axis, the blade portion 61 and, thus, the cutting edge
68, is pushed at a large force into the barrel wall 13 thereby guaranteeing proper
functioning of the mechanism. Also, the mechanism in accordance with the invention is
more sturdy than the mechanisms in the art wherein relatively fragile components such as
drag arms are relied upon for interconnection between the piston and the plunger.
Moreover, the ramp structures used in the prior art for creating an outward force on the
cutter elements upon relative movement between the plunger and the piston do not operate
to create as large an outwardly directed cutter engagement force as is generated upon
rotation of the cutter 60 with the mechanism in accordance with the present invention.
While only specific embodiments of the invention have been described, it is apparent
that various additions and modifications can be made thereto, and various alternatives can
be selected. It is, therefore, the intention in the appended claims to cover all such
additions, modifications and alternatives as may fall within the true scope of the invention.
Claims
1. An auto-destruct mechanism for a syringe with a syringe barrel for holding a fluid
having an open rear end and a closed front end and a passage extending through the closed
end of the barrel for expulsion of fluid from the interior of the barrel, the mechanism
comprising;
a piston for reciprocation in the barrel and for sealingly engaging the barrel wall;
a plunger having a forward portion for engagement with the piston and a rearward
portion for manipulation by a user of the syringe;
connecting means for interlocking the piston with the plunger to permit axial
displacement of the piston in the barrel by axial operation of the plunger;
deforming means for permanently deforming the barrel wall to break the seal between
the piston and barrel wall, the deforming means being pivotally mounted in the piston for
rotation between an at rest position wherein the deforming means does not deform the
barrel wall an activation position wherein by the deforming means forcibly engages the
barrel wall for permanent deformation thereof; and
an activating means on the plunger for rotating the deforming means into the barrel
wall engaging position upon rearward movement of the plunger after a full or partial
injection stroke.
2. An auto-destruct syringe as defined in claim 1, wherein the whole barrel wall is of
reduced thickness and along the whole circumference thereof.
3. An auto-destruct syringe as defined in claim 1 , further including stop means for
preventing removal of the plunger from the barrel.
4. An auto-destruct syringe as defined in claim 3, wherein the stop means is a
circumferential, radially inwardly extending crimp in the barrel wall.
. An auto-destruct syringe as defined in claim 1 , wherein a cup-shaped piston seal is
attached to a front end of the piston for sealing engagement with the barrel wall.
6. An auto-destruct syringe as defined in claim 5, wherein a collar-shaped seal
circumferentially surrounds the front of the piston sleeve causing sealing engagement to the
barrel wall.
7. An auto-destruct syringe as defined in claims 4 and 5, wherein the outer diameter of
the seal is slightly larger than the inner diameter of the barrel.
8. An auto-destruct syringe as defined in claims 4 to 6, wherein the seal is made of an
elastomeric material.
9. An auto-destruct syringe as defined in claim 7, wherein the elastomeric material is
butyl rubber.
10. An auto-destruct syringe as defined in claim 1, wherein the rotatable deforming
means is provided with means for preventing rotation back to the at rest position.
11. An auto-destruct syringe as defined in claim 8, wherein the means for preventing
back rotation comprises at least one detent.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU73998/00A AU7399800A (en) | 1999-09-22 | 2000-09-21 | Auto-destruct syringe |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2282974 CA2282974A1 (en) | 1999-09-22 | 1999-09-22 | Auto-destruct syringe |
| CA2,282,974 | 1999-09-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2001021236A1 true WO2001021236A1 (en) | 2001-03-29 |
Family
ID=4164176
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CA2000/001104 Ceased WO2001021236A1 (en) | 1999-09-22 | 2000-09-21 | Auto-destruct syringe |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU7399800A (en) |
| CA (1) | CA2282974A1 (en) |
| WO (1) | WO2001021236A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113546250A (en) * | 2020-04-26 | 2021-10-26 | 安徽宏宇五洲医疗器械股份有限公司 | Self-destructible safety syringe |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4034673A1 (en) * | 1990-09-27 | 1992-04-02 | Bader & Partner Medizintechnik | Syringe for medical use - in which unauthorised further use is automatically prevented e.g. by blade which penetrates syringe wall during first use etc. |
| EP0494289A1 (en) * | 1990-07-25 | 1992-07-15 | SERRANO GONZALEZ, Antonio | Single use syringe |
| US5257976A (en) * | 1989-01-10 | 1993-11-02 | Fenet Emeric G | Single use disposable syringe |
| US5290235A (en) * | 1990-02-15 | 1994-03-01 | Alan H. Polyblank | Non-reusable syringe |
| WO1994028955A2 (en) * | 1993-06-03 | 1994-12-22 | Daniel Delannoy | Self destructive single use medical syringe |
| WO1997026933A1 (en) * | 1996-01-26 | 1997-07-31 | Campbell Douglas C V | Auto-destruct disposable syringe |
-
1999
- 1999-09-22 CA CA 2282974 patent/CA2282974A1/en not_active Abandoned
-
2000
- 2000-09-21 AU AU73998/00A patent/AU7399800A/en not_active Abandoned
- 2000-09-21 WO PCT/CA2000/001104 patent/WO2001021236A1/en not_active Ceased
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5257976A (en) * | 1989-01-10 | 1993-11-02 | Fenet Emeric G | Single use disposable syringe |
| US5290235A (en) * | 1990-02-15 | 1994-03-01 | Alan H. Polyblank | Non-reusable syringe |
| EP0494289A1 (en) * | 1990-07-25 | 1992-07-15 | SERRANO GONZALEZ, Antonio | Single use syringe |
| DE4034673A1 (en) * | 1990-09-27 | 1992-04-02 | Bader & Partner Medizintechnik | Syringe for medical use - in which unauthorised further use is automatically prevented e.g. by blade which penetrates syringe wall during first use etc. |
| WO1994028955A2 (en) * | 1993-06-03 | 1994-12-22 | Daniel Delannoy | Self destructive single use medical syringe |
| WO1997026933A1 (en) * | 1996-01-26 | 1997-07-31 | Campbell Douglas C V | Auto-destruct disposable syringe |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113546250A (en) * | 2020-04-26 | 2021-10-26 | 安徽宏宇五洲医疗器械股份有限公司 | Self-destructible safety syringe |
Also Published As
| Publication number | Publication date |
|---|---|
| AU7399800A (en) | 2001-04-24 |
| CA2282974A1 (en) | 2001-03-22 |
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