EP2015810A2 - Seringue améliorée - Google Patents
Seringue amélioréeInfo
- Publication number
- EP2015810A2 EP2015810A2 EP07794445A EP07794445A EP2015810A2 EP 2015810 A2 EP2015810 A2 EP 2015810A2 EP 07794445 A EP07794445 A EP 07794445A EP 07794445 A EP07794445 A EP 07794445A EP 2015810 A2 EP2015810 A2 EP 2015810A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- syringe
- shaft
- piston
- brake
- needle
- 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
Links
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- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M2005/3151—Means for blocking or restricting the movement of the rod or piston by friction
-
- 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
- A61M5/3221—Constructional features thereof, e.g. to improve manipulation or functioning
- A61M2005/3223—Means impeding or disabling repositioning of used needles at the syringe nozzle
- A61M2005/3224—Means to disalign the needle tip and syringe nozzle
-
- 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
Definitions
- Hypodermic needles are used on a regular basis by medical professionals such as doctors, nurses and other medicine related fields.
- the typical hypodermic needle has a syringe body with a hollow interior cavity.
- a piston is slideably disposed within the syringe body and may be traversed between a proximal position and a distal position.
- a shaft may be fixedly attached to the piston and extend through a proximal portion of the syringe body.
- a thumb platform may be attached to the proximal portion of the shaft. The thumb platform may be traversed toward or away from the proximal portion of the syringe body to traverse the piston toward the distal position or the proximal position, respectively.
- the distal portion of the syringe body may have a needle attached thereto.
- the syringe body piston and the distal portion of the syringe body define a variable fluid chamber.
- the variable fluid chamber may be filled with fluidic medication to be injected into a patient.
- the needle is fixedly engaged to the distal portion of the syringe body.
- the piston may be positioned anywhere between the proximal position and the distal position. The user may release the thumb platform and the piston will remain at such position because there is no biasing force urging the piston back toward the retracted position.
- the hypodermic needle may be provided to the medical professional without fluidic medication filled within the variable fluid chamber. The user may traverse the piston toward the distal position.
- the needle of the hypodermic needle may be inserted into a fluidic medication container.
- the user may retract the piston toward the proximal position thereby transferring fluidic medication from the container into the variable fluid chamber.
- the user may release the thumb platform and the piston is not traversed to the proximal position because there is no biasing force which urges the piston back toward the proximal position.
- the medical professional may remove trapped air within the variable fluid chamber by inverting the syringe such that the needle is pointing upwardly, tapping the outside of the syringe body to urge the air bubbles toward the needle, and depressing the thumb platform slightly to eject the air bubbles from the variable fluid chamber.
- the medical professional may release the thumb platform, and the piston is not retracted back toward the proximal position.
- the medical professional may insert the needle into a skin of the patient and inject the fluidic medication into the patient by traversing the piston toward the distal position. Once the piston is at the distal position, the fluidic medication is injected into the patient and the medical professional removes the needle from the patient. At this point, the needle contaminated and exposed and is a health-risk to the medical professional or other people who may handle the syringe. Also, drug addicts may reuse the needle.
- safety syringes using a spring mechanism are the most common for automatically retracting a hollow needle after injecting a fluid.
- these safety syringes are typically more expensive because of the required incorporation of additional materials for manufacture.
- Standard or conventional hypodermic needle syringes typically cost from five to seven cents each.
- the median increase in cost for a safety syringe is approximately thirty cents or more. At first glance, this minimal cost increase does not seem significant. However, after considering the thousands, if not millions, of needles used each year, the resultant increase in annual cost for utilizing the more expensive safety syringe is unfortunately excessive.
- the safety syringe is configured to automatically retract the needle portion of the syringe into the body of the syringe utilizing a vacuum within the syringe, such that after a single use, the syringe may not be reusable nor lead to an accidental pricking.
- the syringe of Patent No. 6,413,236 utilizes vacuum pressure to exert an automatic retracting force upon the needle.
- the syringe includes a plunger and a needle holder (to which the needle is attached) and is configured to frictionally engage the plunger with the needle holder.
- the vacuum pressure inside the syringe exerts the retracting force upon the plunger, which causes the plunger to remove the needle holder/needle and pull it into the syringe itself.
- the needle does not protrude out of the syringe body and the syringe cannot be reused nor accidentally prick an individual.
- the aforementioned retractable safety syringes have helped alleviate many of the problems associated with accidental needle prickings and reuse of hypodermic needles.
- the user of the syringe may often experience difficulties in its use.
- the plunger may automatically retract at an undesirable time.
- a retractable needle safety syringe is provided with mitigated retraction.
- the syringe comprises a syringe body defining opposing top and bottom syringe body portions and including a syringe cavity; an attachment base defining a shaft orifice and being attached to the top syringe body portion; a plunger assembly including a plunger shaft and a piston, the plunger shaft defining opposing top and bottom shaft portions, the plunger shaft being disposed through the shaft orifice in the syringe cavity, the piston being disposed at the bottom shaft portion, the plunger being slidably engaged with the syringe body within the syringe cavity; a variable vacuum compartment being disposed within the syringe cavity between the piston and the attachment base, the variable vacuum compartment being operative to provide a retraction force on the plunger shaft directed from the bottom syringe body portion toward the top syringe body portion with the retraction
- the first frictional force may have an associated first normal force.
- the second frictional force may have an associated second normal force.
- the shaft brake substantially disengages from the plunger shaft upon engagement of the ram member with the shaft brake.
- the shaft brake may define a body perimeter and include an aperture and a bridge, the aperture being disposed within the shaft brake and f ⁇ ctionally engaging the plunger shaft, the bridge defining a bridge width and extending radially from the aperture toward the body perimeter, the shaft brake being operative to exert the second frictional force upon the plunger shaft in response to an increase in bridge width, the bridge width increasing in response to the engagement of the ram member with the shaft brake.
- the ram member may at least partially sever the bridge to increase the bridge width.
- the shaft brake may further include a release member being disposed upon the shaft brake, the bridge width increasing in response to the engagement of the ram member with the release member.
- the release member may be a shoulder protruding upwardly from the shaft brake opposite the syringe body, and the ram member includes a shoulder press being sized and configured to engage the shoulder upon the piston approaching the bottom syringe body portion, the bridge width increasing in response to the engagement of the shoulder press with the shoulder.
- the bridge width may increase upon deformation of the bridge in response to engagement of the shoulder press with the shoulder and continued movement of the piston toward the bottom syringe body portion.
- the brake body may define a body thickness and the bridge may define a bridge thickness, the bridge thickness being less than the body thickness, the bridge being operative to deform in response to the engagement of the shoulder press with the shoulder.
- the bridge may comprise a non-continuous slit including a hinge element, and the bridge width may increase upon deformation of the hinge element in response to engagement of the shoulder press with the shoulder and continued movement of the piston toward the bottom syringe body portion.
- the shaft brake may be formed to include an anchor member being disposed upon the shaft brake, the anchor member being operative to mechanically couple the shaft brake to the attachment base.
- the syringe may further include a needle being removably mounted to the bottom syringe body portion and extending therefrom opposite the top syringe body portion, the piston including a punch may engage the needle upon the piston reaching the bottom syringe body portion, the piston being operative to remove the needle into the syringe cavity upon exertion of the retraction force upon the plunger shaft.
- a method is provided of mitigating retraction of a retractable needle safety syringe.
- the syringe comprises a syringe body, an attachment base, a plunger assembly, a variable vacuum compartment, a shaft brake, and a ram member, the syringe body defining opposing top and bottom syringe body portions and including a syringe cavity, the attachment base defining a shaft orifice and being attached to the top syringe body portion, the plunger assembly including a plunger shaft and a piston, the plunger shaft defining opposing top and bottom shaft portions, the plunger shaft being disposed through the shaft orifice in the syringe cavity, the piston being disposed at the bottom shaft portion, the plunger being slidably engaged with the syringe body within the syringe cavity, the variable vacuum compartment being disposed within the syringe cavity between the piston and the attachment base, the variable vacuum compartment being
- the method comprises: (a) exerting the first frictional force upon the plunger shaft in opposition to the retraction force prior to the piston reaching the bottom syringe body portion; (b) engaging the ram member with the shaft brake; and (c) exerting the second frictional force upon the plunger shaft in opposition to the retraction force in response to the engagement of the rarh member with the shaft brake.
- the shaft brake defines a body perimeter and includes an aperture and a bridge, the aperture being disposed within the shaft brake and being operative to frictionally engage the plunger shaft, the bridge defining a bridge width and extending radially from the aperture toward the body perimeter, the shaft brake being operative to exert the second frictional force upon the plunger shaft in response to an increase in bridge width, the bridge width increasing in response to the engagement of the ram member with the shaft brake, and step (b) of the method may further include: increasing the bridge width in response to the engagement of the ram member with the shaft brake.
- step (b) may further include: severing the bridge in response to the engagement of the ram member with the shaft brake.
- the shaft brake further includes a shoulder being disposed upon the shaft brake and protruding upwardly from the shaft brake opposite the syringe body
- the ram member includes a shoulder press being sized and configured to engage the shoulder upon the piston approaching the bottom syringe body portion, the bridge width increasing in response to the engagement of the shoulder press with the shoulder
- step (b) of the method may further include: engaging the shoulder press with the shoulder; and deforming the bridge to increase the bridge width.
- the syringe further includes a needle being removably mounted to the bottom syringe body portion and extending therefrom opposite the top syringe body portion, the piston may engage the needle upon the piston reaching the bottom syringe body portion, the piston being operative to remove the needle into the syringe cavity upon exertion of the retraction force upon the plunger shaft, and the method may further include the steps of: engaging the needle with the punch; and automatically removing the needle into the syringe cavity.
- the same may further have a braking mechanism disposed at a proximal portion of the syringe body.
- the braking mechanism may be attached to the proximal portion of the body via an attachment base.
- the attachment base may be fixedly attached to the proximal portion of the body.
- the braking mechanism which may comprise a cover and split brake members may be disposed within the attachment base. More particularly, the attachment base may have a through hole through which the shaft of the plunger is slideably traversed or disposed.
- the attachment base defines an interior cavity having an upper step and a lower step.
- the upper step may have inner surface having an inner diameter greater than an inner diameter of the lower step inner surface. A lip may join the upper step and the lower step.
- the cover may be inserted into the interior cavity of the attachment base. More particularly, an outer surface of the cover may be sized and configured to match the inner surface of the upper step. An inner diameter of an inner surface of the cover may be smaller than the inner diameter of the lower step.
- the split brake members may be disposed within the cover. When the split brake members are disposed within the cover, fingers of the split brake members press against an outer surface of the shaft and frictionally engage the outer surface of the shaft. To release the braking mechanism, the split brake members may be traversed from the braking position to a released position. The released position is when the split brake members are disposed within the second step of the attachment base. When the split brake members are traversed to the released position, the split brake members are spread apart. As such, the fingers of the brake members do not frictionally engage the outer surface of the shaft of the plunger. In this manner, the retraction force urging the piston back toward the retracted position may traverse the piston to the retracted position.
- the split brake members may be traversed from the braking position to the released position by a ram.
- the ram may be formed on a proximal portion of the plunger.
- the ram may initially contact an upper surface of the split brake members.
- the ram displaces the brake members into the second step of the attachment base.
- the brake member may have other various configurations.
- the brake member may be a unitary member with a single split on one side and a living hinge on an opposed side.
- the brake member may be a unitary member with a single split on one side and no living hinge on the opposed side.
- the brake member may be a unitary member without any splits.
- the brake member may have a plurality of lobes and bases.
- Figure 1 a cross sectional view of a retractable needle safety syringe with mitigated retraction in accordance with an aspect of the present invention
- Figure 2 is a cross sectional view of the syringe illustrating the interaction between a ram member and a shaft brake
- Figure 3 is a top plan view of the shaft brake in accordance with another embodiment of the present invention.
- Figure 4 is a side view of the shaft brake in accordance with another embodiment of the present invention
- Figure 5 is a top plan view of the shaft brake in accordance with another embodiment of the present invention
- Figure 6 is a perspective view of another embodiment of a retractable safety syringe with a braking mechanism
- Figure 7 is a cross- sectional perspective view of the safety syringe shown in Figure 6;
- Figure 8 is an enlarged view of a proximal portion of the safety syringe shown in Figure 7 with the brake member engaged to the shaft of the plunger;
- Figure 9 is a partial exploded view of the safety syringe shown in Figure 8;
- Figure 10 is a cross-sectional top view of the braking mechanism shown in Figure 8;
- Figure 11 is a cross-sectional perspective view of the braking mechanism with the brake member disengaged from the shaft of the plunger;
- Figure 12 is a front cross-sectional view of a distal portion of the safety syringe of Figure 6 with a piston closely adjacent to a needle holder;
- Figure 13 is a front cross-sectional view of the distal portion of the safety syringe of Figure 6 with the piston engaged to the needle holder;
- Figure 14 is a front cross-sectional view of the safety syringe shown in Figure
- Figure 15 is a top view of another embodiment of the brake member wherein the brake member is split on one side with a living hinge on the opposed side
- Figure 16 is another embodiment of the brake member wherein the brake member is split on one side and does not have a living hinge on the opposed side;
- Figure 17 is a perspective view of a retractable safety syringe with another embodiment of the brake member wherein the brake member is a unitary member; and Figure 18 is a top view of the brake member shown in Figure 17.
- Figure 1 is a cross sectional view of a retractable needle safety syringe 10 with mitigated retraction in accordance with an aspect of the present invention.
- An embodiment of the syringe comprises a syringe body 12, an attachment base 14, a plunger assembly 16, a variable vacuum compartment 18, a shaft brake 20, and a ram member 22.
- the syringe body 12 defines opposing top and bottom syringe body portions 24, 26 and includes a syringe cavity 28.
- the attachment base 14 defines a shaft orifice 30 and is attached to the top syringe body portion 24.
- the attachment base 14 may form a seal with the body 12.
- the plunger assembly 16 includes a plunger shaft 32 and a piston 34.
- the plunger shaft 32 defines opposing top and bottom shaft portions 36, 38.
- the plunger shaft 32 is disposed throughout the shaft orifice 30 in the syringe cavity 28.
- the piston 34 is disposed at the bottom shaft portion 38.
- the plunger is slidably engaged with the syringe body 12 within the syringe cavity 28.
- the variable vacuum compartment 18 is disposed within the syringe cavity 28 between the piston 34 and the attachment base 14.
- the variable vacuum compartment 18 is operative to provide a retraction force on the plunger shaft 32 directed from the bottom syringe body portion 26 toward the top syringe body portion 24 with the retraction force increasing upon movement of the piston 34 toward the bottom syringe body portion 26.
- the shaft brake 20 is attached to the top syringe body portion 24 and is operative to frictionally engage the plunger shaft 32 to provide first and second frictional forces in opposition to the retraction force.
- the first frictional force is exerted upon the plunger shaft 32 prior to the piston 34 reaching the bottom syringe body portion 26.
- the ram member 22 is attached to the top shaft portion 36 and is formed to engage the shaft brake 20 upon the piston 34 reaching the bottom syringe body portion 26.
- the shaft brake 20 exerts the second frictional force upon the plunger shaft 32 in response to the engagement of the ram member 22 with the shaft brake 20.
- the second frictional force is less than the first frictional force.
- the syringe may further include a needle 46 being removably mounted to the bottom syringe body portion 26 and extending therefrom opposite the top syringe body portion 24.
- the piston 34 may include a punch 48 engageable to a needle holder 50 upon the piston 34 reaching the bottom syringe body portion 26.
- the piston 34 may be operative to remove the needle 46 into the syringe cavity 28 upon exertion of the retraction force upon the plunger shaft 32.
- the punch 48 may engage the needle holder 50 of the needle 46 upon the piston 34 reaching the bottom syringe body portion 26.
- a thumb platform 52 of the plunger in order to effectuate an intake of fluid into a variable fluid chamber 51 of the syringe, a thumb platform 52 of the plunger should first be depressed by thrusting the thumb platform 52 toward the syringe body 12 to remove a majority of the air present within the variable fluid chamber 51 between the bottom syringe body portion 26 and the piston 34.
- the piston 34 of the plunger assembly 16 is forced to slide within the syringe cavity 28 toward the bottom syringe body portion 26.
- the attachment base 14 and the piston 34 are substantially air tight and fluid tight. Therefore, a corresponding influx of air molecules and fluid molecules into the variable vacuum compartment 18 of the syringe body 12 is prevented.
- variable vacuum compartment 18 the volume within the variable vacuum compartment 18 is increased without a corresponding influx of air molecules or fluid molecules therefore creating a vacuum within the variable vacuum compartment 18.
- a piercing tip end 54 of the needle 46 is submerged into a fluid contained within a fluid container.
- the thumb platform 52 is allowed to move.
- the piston 34 is withdrawn toward the top portion 24 of the syringe body 12 thus effectuating a withdraw of a desired amount of fluid from a fluid container into the variable fluid chamber 51.
- the operation of the syringe may be as follows.
- the piercing tip of the needle 46 may be inserted into a patient or other instrument wherein the fluid is to be injected.
- the fluid may be evacuated from the variable fluid chamber 51 and injected.
- a vacuum may be created within the variable vacuum compartment 18 as a result of an increase in volume within the variable vacuum compartment 18 without a corresponding influx of air molecules due to the attachment base 14 and the piston 34 creating an air tight and fluid tight seal, as mentioned above.
- the punch 48 may frictionally engage the needle holder 50. Due to the retraction force, the needle 46 may immediately and automatically be withdrawn within the syringe cavity 28 such that the entire needle 46 may permanently reside enclosed within and protectively pressed against the body 12. This alleviates needle 46 reuse and accidental needle 46 prickings and, therefore, ultimately prevents the transmission of blood born pathogens and other diseases by contaminated syringe needles 46.
- variable vacuum compartment 18 when the variable vacuum compartment 18 is enlarged upon movement of the piston 34 toward the bottom syringe body portion 26, the vacuum created within the variable vacuum compartment 18 may exert a retraction force upon the plunger shaft 32.
- the retraction force may be exerted upon the plunger shaft 32 indirectly via exertion upon the piston 34.
- the retraction force may vary as the piston 34 moves toward the bottom syringe body portion 26 or toward the top syringe body portion 24. Thus, the retraction force may increase or decrease, respectively.
- the retraction force may be exerted on the plunger shaft 32 directed from the bottom syringe body portion 26 toward the top syringe body portion 24.
- the retraction force may be caused due to a vacuum pressure in the variable vacuum compartment 18.
- the retraction force may also be produced due to a spring mechanism that is housed in the variable vacuum compartment 18.
- the retraction force therefore need not be produced only due to the vacuum within the variable vacuum compartment 18.
- the variable vacuum compartment 18 need not be air tight when such a spring mechanism is used therein to produce the retraction force.
- the shaft brake 20 is attached to the top syringe body portion 24 and is operative to frictionally engage the plunger shaft 32 to provide the first frictional force in opposition to the retraction force.
- the first frictional force may be exerted upon the plunger shaft 32 prior to the piston 34 reaching the bottom syringe body portion 26.
- the first frictional force may be exerted upon the plunger shaft 32 even after the piston 34 has reached the bottom syringe body portion 26.
- the first frictional force may be continuously exerted upon the piston 34 shaft as the piston 34 moves toward and away from the bottom syringe body portion 26.
- the first frictional force exerted upon the plunger shaft 32 may be equivalent to or greater than the retraction force.
- This advantageous embodiment of the present invention may provide that the user need not maintain continuous forcible depression of the thumb platform 52 after intaking fluid in preparation for the injection. Otherwise, the retraction force exerted upon the plunger shaft 32 would require the user to either maintain the thumb platform 52 being depressed or intake air into the variable fluid chamber 51. An even more troublesome situation may be resolved with an embodiment of the present invention. If the user does not maintain the forcible depression of the thumb platform 52 after injection and prior to withdrawal of the piercing tip end 54 from the patient or instrument, the retraction force may cause intake of fluids from the patient or instrument.
- Risks associated with this type of accident may be alleviated by implementing aspects of the present invention.
- continuous exertion of the first frictional force by the shaft brake 20 upon the plunger shaft 32 may counteract the retraction force and help avoid such difficulties of syringe use.
- equalization of the retraction force by the first frictional force may provide the user with greater control over intake and injection using the syringe.
- the ram member 22 is attached to the top shaft portion 36 and is formed to engage the shaft brake 20 upon the piston 34 reaching the bottom syringe body portion 26.
- the ram member 22 may be integrally formed with the thumb platform 52. Nevertheless, the ram member 22 may be attached and configured as required in order to provide optimal mechanical engagement with the shaft brake 20.
- the engagement of the ram member 22 with the shaft brake 20 is therefore contemplated to be primarily a mechanical engagement as shown in Figure 2. As such, the mechanical engagement contemplated herein may likely provide a cost effective, efficient and safe means for releasing the shaft brake 20.
- the engagement of the ram member 22 with the shaft brake 20 may be indirect through other elements, or that the engagement may be other than mechanical, such as electrical or chemical.
- the shaft brake 20 may be variously modified.
- the shaft brake 20 may exert the second frictional force upon the plunger shaft 32.
- the first frictional force may be exerted by the shaft brake 20 upon the plunger shaft 32 upon the piston 34 moving toward and away from the bottom syringe body portion 26.
- the piston 34 may approach the bottom syringe body portion 26, engagement may not occur.
- the ram member 22 may be configured to engage the shaft brake 20 only upon the piston 34 being thrusted to the bottom syringe body portion 26.
- the ram member 22 and the shaft brake 20 may contact each other prior to engagement of the piston 34 with the shaft brake 20.
- the engagement process is depicted in Figure 2. As shown therein, the continued movement of the plunger assembly 16 toward the bottom syringe body portion 26 may be operative to cause complete engagement of the ram member 22 with the shaft brake 20.
- Certain other advantageous features may also be incorporated into embodiments of the present invention such as prophylactic measures to prevent premature engagement.
- the user may be aware that further displacement of the piston 34 toward the bottom syringe body portion 26 will result in engagement of the ram member 22 with the shaft brake 20, which may be accomplished through sound, feel, or other possible indications from the syringe.
- Such a prophylactic measure may allow the user to control the engagement of the ram member 22 with the shaft brake 20, which in turn may coincide with the engagement of the piston 34 with the needle 46 and retraction of the needle 46 into the syringe cavity 28. Therefore, various designs may be incorporated into aspects of the present invention to ensure that deliberate engagement and retraction take place.
- the shaft brake 20 may exert the second frictional force upon the plunger shaft 32.
- the second frictional force may be less than the first frictional force.
- the first frictional force may be equivalent to or greater than the retraction force, it is contemplated that the second frictional force may be less than the retraction force. Therefore, in operation after the injection stroke, the ram member 22 may engage the shaft brake 20, and simultaneously, the syringe may be configured to engage the piston 34 with the needle 46.
- the first frictional force may be replaced by the second frictional force, which may be less than the retraction force, resulting in substantially unrestrained retraction of the needle 46 into the syringe cavity 28.
- the first frictional force may have an associated first normal force 56.
- the first normal force 56 may therefore be directly related to the configuration and placement of the shaft brake 20 about the plunger shaft 32, the pressure exerted thereon being the first normal force 56.
- the first normal force 56 may be increased or decreased according to design requirements.
- the shaft brake 20 and the first normal force 56 exerted by the shaft brake 20 upon the plunger shaft 32 may be configured according to user requirements.
- the first normal force 56 may be exerted in certain embodiments, with the shaft brake 20 entirely encircling and contacting the plunger shaft 32 about the entire circumference of the plunger shaft 32. However, in alternative embodiments, it is contemplated that the first normal force 56 may be exerted by the shaft brake 20 by contacting only a portion of the circumference of the plunger shaft 32.
- the shaft brake 20 may be at least partially released from the plunger shaft 32 upon engagement of the ram member 22 with the shaft brake 20 and thus exert the second frictional force, which may be greater than or equal to zero. In such circumstances where the shaft brake 20 is not completely disengaged from the plunger shaft 32, the second normal force 58 may likely be greater than zero, but it is contemplated that the second normal force 58 may most frequently be less than the first normal force 56. For example, where the shaft brake 20 substantially disengages from the plunger shaft 32, the second normal force 58 may be less than or negligible relative to the first normal force 56, but may be greater than zero.
- the shaft brake 20 and the plunger shaft 32 may be fabricated from various materials.
- the coefficients of static and kinetic friction may vary depending on the material from which the shaft brake 20 and the plunger shaft 32 are fabricated.
- the first frictional force may be equivalent to or greater than the retraction force during intake of fluid into the syringe.
- a suitable material may be selected based upon its coefficient of static friction and its coefficient of kinetic friction in order to facilitate use of the syringe such as allowing the user to not be required to maintain depression of the thumb platform 52 during the intake operation. Other considerations and requirements may also be addressed by manipulating the characteristics of various materials and their frictional properties as is known in the art.
- the shaft brake 20 may define a body perimeter 60 and include an aperture 62 and a bridge 64.
- the body perimeter 60 may be generally defined as the outer most portion of the shaft brake 20.
- the aperture 62 may be disposed within the shaft brake 20 and frictionally engage the plunger shaft 32.
- the bridge 64 may define a bridge width 66 and extend radially from the aperture 62 toward the body perimeter 60.
- the shaft brake 20 may be operative to exert the second frictional force upon the plunger shaft 32 in response to an increase in bridge width 66, the bridge width 66 increasing in response to the engagement of the ram member 22 with the shaft brake 20. It is contemplated that prior to the increase in bridge width 66, the shaft brake 20 may exert the first frictional force upon the plunger shaft 32, as discussed above.
- the increase in bridge width 66 may directly or indirectly cause a corresponding increase in the size of the aperture 62 of the shaft brake 20. With an increase of the size of the aperture 62, the plunger shaft 32 may therefore be disengaged from the aperture 62, and correspondingly from the shaft brake 20, as discussed above. In situations where the aperture 62 increases dramatically in size, as mentioned previously, the second frictional force may be negligible or approximately zero. However, where the increase in bridge width 66 is minimal, and results in a corresponding minimal increase in the size of the aperture 62, the second frictional force may be at most less than either the first frictional force or the retraction force.
- the bridge width 66 may increase due to deformation of the bridge 64 of the shaft brake 20. This deformation may therefore allow the shaft brake 20 to disengage from the plunger shaft 32 and exert the second frictional force upon the plunger shaft 32.
- the deformation of the bridge 64 may be permanent or elastic. In use, it is contemplated that the deformation need only be permanent until the needle 46 is fully retracted into the syringe cavity 28.
- the shaft brake 20 may be fabricated from a material that experiences prolonged plastic deformation.
- the ram member 22 may at least partially sever the bridge
- the shaft brake 20 may further include a release member 68 being disposed upon the shaft brake 20, as illustrated in Figures 1 and 2.
- the bridge width 66 may increase in response to engagement of the ram member 22 with the release member 68.
- the release member 68 may be configured in various ways, as dictated by design requirements.
- the ram member 22 may be operative to deform or to sever the bridge 64 of the shaft brake 20, which may be done directly or indirectly.
- the ram member 22 may engage the release member 68 and effectuate an increase in the bridge width 66.
- the release member 68 may be a shoulder 70 protruding upwardly from the shaft brake 20 opposite the syringe body 12, and the ram member 22 may include a shoulder press 72 being sized and configured to engage the shoulder 70 upon the piston 34 approaching the bottom syringe body portion 26, the bridge width 66 increasing in response to the engagement of the shoulder press 72 with the shoulder
- shoulder press 72 The engagement of the shoulder press 72 with the shoulder 70 may be done as illustrated in Figure 2, with the shoulder press 72 being oriented at an angle relative to the thumb platform 52, and the shoulder 70 being configured to substantially mate with the shoulder press 72. Other various designs and configurations may also be implemented.
- the bridge width 66 may increase upon deformation of the bridge 64 in response to engagement of the shoulder press 72 with the shoulder 70 and continued movement of the piston 34 toward the bottom syringe body portion 26. Therefore, as discussed above, the syringe may include a contact position whereat the user may know that further displacement of the piston 34 toward the bottom syringe body portion 26 will result in engagement of the ram member 22 or shoulder press 72 with the shaft brake 20 or shoulder 70. Upon further displacement then, the shaft brake 20 may exert the second frictional force upon the plunger shaft 32. This may be accomplished by increasing the bridge width 66.
- the shaft brake 20 may be configured to various embodiments in order to increase the bridge width 66 in response to engagement of the ram member 22 with the shaft brake 20.
- the brake body may define a body thickness 74 and the bridge 64 may define a bridge thickness 76, as shown in Figure 4.
- the bridge thickness 76 may be less than the body thickness 74, and the bridge 64 may be operative to deform in response to the engagement of the shoulder press 72 with the shoulder 70.
- the ram member 22 may be configured to produce a deformation in the shaft brake 20.
- having the bridge thickness 76 less than the body thickness 74 may result in deformation along the bridge 64 and subsequent increase in the bridge width 66, which then triggers exertion of the second frictional force upon the plunger shaft 32.
- the bridge thickness 76 may be less than the body thickness 74 by allowing the bridge 64 to comprise a slit and a laminated material extending across the slit.
- the laminate material may have a lesser tensile strength than the shaft brake 20, and therefore, as described previously, deform upon exertion of a tensile force by the ram member 22 upon the shaft brake 20. This deformation would likewise result in an increase in the bridge width 66 and subsequent exertion of the second frictional force upon the plunger shaft 32.
- Other embodiments and designs may be employed to create desirable results.
- the bridge 64 may comprise a non- continuous slit 78 including a hinge element 80, and the bridge width 66 increases upon deformation of the hinge element 80 in response to engagement of the shoulder press 72 with the shoulder 70 and continued movement of the piston 34 toward the bottom syringe body portion 26.
- the bridge width 66 may simply vary relative to the brake body. In such an embodiment, modifications such as this would result in deformation of the bridge 64 and a resulting increase in the bridge width 66 upon engagement of the ram member 22 and exertion of a tensile force across the shaft brake 20.
- the shaft brake 20 may be formed to include an anchor member being disposed upon the shaft brake 20, as shown in Figures 1, 2 and 4.
- the anchor member may be operative to mechanically couple the shaft brake 20 to the attachment base 14, as shown in Figures 1 and 2.
- the anchor member may provide other various advantages for the shaft brake 20, other than simple mechanical coupling to the attachment base 14.
- the anchor member be operative to provide at least a portion of the first and second frictional forces upon the plunger shaft 32.
- the anchor member may be configured as shown in Figures 1 , 2 and 4. Nevertheless, the anchor member may be configured otherwise to simply provide mechanical coupling to the attachment base 14.
- a method of mitigating retraction of a retractable needle safety syringe 10 comprising a syringe body 12, an attachment base 14, a plunger assembly 16, a variable vacuum compartment 18, a shaft brake 20, and a ram member 22, the syringe body 12 defining opposing top and bottom syringe body portions 26 and including a syringe cavity 28, the attachment base 14 defining a shaft orifice 30 and being attached to the top syringe body portion 24, the plunger assembly 16 including a plunger shaft 32 and a piston 34, the plunger shaft 32 defining opposing top and bottom shaft portions 38, the plunger shaft 32 being disposed through the shaft orifice 30 in the syringe cavity 28, the piston 34 being disposed at the bottom shaft portion 38, the plunger being slidably engaged with the syringe body 12 within the syringe cavity 28, the variable vacuum compartment 18 being disposed within the syringe cavity 28 between the piston 34 and the attachment base 14, the variable vacuum
- the method comprises (a) exerting the first frictional force upon the plunger shaft 32 in opposition to the retraction force prior to the piston 34 reaching the bottom syringe body portion 26; (b) engaging the ram member 22 with the shaft brake 20; and (c) exerting the second frictional force upon the plunger shaft 32 in opposition to the retraction force in response to the engagement of the ram member 22 with the shaft brake 20.
- a further step in the method may include automatically retracting the needle 46 to a position within the syringe cavity 28.
- the shaft brake 20 may define a body perimeter 60 and include an aperture 62 and a bridge 64, the aperture 62 being disposed within the shaft brake 20 and being operative to frictionally engage the plunger shaft 32, the bridge 64 defining the bridge width 66 extending radially from the aperture 62 toward the body perimeter 60, the shaft brake
- step (b) of the method may further include: increasing the bridge width 66 in response to engagement of the ram member 22 with the shaft brake 20.
- Step (b) may also further include: severing the bridge 64 in response to engagement of the ram member 22 with the shaft brake 20. The severing may be done with a sharp edge disposed upon the ram member 22. Alternatively, the severing may be done utilizing a tool disposed on or incorporated into the bridge 64 itself, with the ram member 22 merely providing actuating the tool's severing of the bridge 64.
- the bridge 64 may be variously configured to facilitate the severance thereof.
- the properties of the material used to fabricate the bridge 64 may also be manipulated as desired.
- the bridge 64 may be fabricated from a brittle material that may sever or break upon engagement with the ram member 22.
- the shaft brake 20 may further include a shoulder 70 being disposed upon the shaft brake 20 and protruding upwardly from the shaft brake 20 opposite the syringe body 12, the ram member 22 including a shoulder press 72 being sized and configured to engage the shoulder 70 upon the piston 34 approaching the bottom syringe body portion 26, the bridge width 66 increasing in response to the engagement of the shoulder press 72 with the shoulder 70, and step (b) of the method may further include: engaging the shoulder press 72 with the shoulder 70 and deforming the bridge 64 to increase the bridge width 66.
- the engagement of the shoulder press 72 with the shoulder 70 may be done as shown in Figure 2, with the shoulder press 72 being oriented at an angle relative to the thumb platform 52, and the shoulder 70 being configured to substantially mate with the shoulder press 72.
- Other various designs and configurations may also be implemented.
- the syringe may further include a needle 46 being removably mounted to the bottom syringe body portion 26 and extending therefrom opposite the top syringe body portion 24, the piston 34 may engage the needle 46 upon the piston 34 reaching the bottom syringe body portion 26, the piston 34 being operative to remove the needle 46 into the syringe cavity 28 upon exertion of the retraction force upon the plunger shaft 32, and the method may further include the steps of: engaging the needle 46 with the piston 34; and automatically removing the needle 46 into the syringe cavity 28.
- Figures 6-11 illustrate a syringe 100 with a braking mechanism 112 (see Figure 7).
- a retracted position is when a piston 104 is closer to a proximal portion 114 of a syringe body 110 than a distal portion 1 16 of the syringe body 110.
- the retracted position may include situations when the piston 104 does not contact a needle holder 106 and the piston 104 is closer to the distal portion 116 of the syringe body 110 than the proximal portion 114 of the body 110.
- An engaged position is when the piston 104 is in contact with the needle holder 106 and engaged to the needle holder 106.
- a filling position is when the piston 104 is between the engaged position and the retracted position and closely adjacent the needle holder 106.
- the filling position may be when the piston 104 is closely adjacent to the needle holder 106 than the proximal portion 114 of the syringe body 110 or in contact with the needle holder 106 but not engaged to the needle holder 106 (see Figure 12).
- Figure 6 is a perspective view of the retractable safety syringe 100.
- Figure 7 is a cross-sectional view of the retractable safety syringe 100 shown in Figure 6.
- the syringe 100 may have a variable vacuum compartment 102 which creates a retraction force to urge the piston 104 as well as the needle holder 106 and needle 108 toward the retracted position when the piston 104 engages the needle holder 106.
- the retraction force urges the piston 104, needle holder 106 and needle 108 toward the retracted position such that the needle 108 may be disposed within a body 110 of the syringe.
- the syringe 100 may further have a braking mechanism 112 (see Figure 7) disposed at a proximal portion 114 of the body 110 which holds the piston 104 in place at any position between the retracted position and a filling position prior to engagement of the piston 104 with the needle holder 106.
- the braking mechanism 112 permits the automatic retractable safety syringe 100 to be operated in a substantially similar manner to prior art non-retracting conventional syringes except that the syringe 100 automatically retracts the needle into the body immediately after fluidic medication has been injected into a patient or user.
- the piston does not traverse back toward the retracted position when thumb pressure is released from the thumb platform.
- prior art non retracting safety syringes do not have a retraction force acting on the piston. This is beneficial during the step of filling the variable fluid chamber with fluid.
- the piston 104 does not traverse back toward the retracted position when thumb pressure is released from the thumb platform 124 because of the braking mechanism 112.
- the braking mechanism 112 of syringe 100 counteracts the retraction force of the variable vacuum compartment 102 such that the needle 108 does not automatically retract when thumb pressure is released from a thumb platform 124.
- the piston 104 engages the needle 108, and the needle 108 is automatically retracted into the body
- the safety syringe 100 also incorporates the safety feature of retracting the needle 108 into the body 110.
- the safety syringe 100 may comprise the syringe body 110 having an elongate cylindrical configuration.
- the body 110 may define a proximal portion 114 and a distal portion 116 as well as an inner surface 118.
- a needle holder 106 may be removeably engageable to the distal portion 116 of the syringe body 110, as will be discussed further below.
- the needle 108 may be fixedly attached to the needle holder 106 wherein the needle 108 and needle holder 106 provides fluidic communication into a variable fluid chamber 120 of the syringe.
- a plunger 122 may comprise a thumb platform 124, shaft 126 and the piston 104.
- a distal portion 128 of the shaft 126 may be fixedly attached to the piston 104.
- the piston 104 and the distal portion 128 of the shaft 126 may be disposed within the body 110.
- the shaft 126 may proceed through the proximal portion 114 of the body 1 10 and extend out of the body 1 10 with the proximal portion 130 of the shaft 126 disposed outside of the body 110 and fixedly attached to the thumb platform 124.
- the thumb platform 124 may be traversed toward the proximal portion 114 of the body 110 and also away from the proximal portion 114 of the body 110. When the thumb platform 124 is traversed toward the proximal portion 114 of the body 110, the piston 104 is traversed toward the filling position and/or the engaged position.
- the piston 104 When the thumb platform 124 is traversed away from the proximal portion 114 of the body 110, the piston 104 is traversed toward the retracted position. The piston 104 is traversable within the syringe body 110 between the retracted position and the filling position/engaged position.
- the needle holder 106 and the distal portion 116 of the body 110 may form an airtight and fluid tight seal therebetween!
- the distal portion 116 of the body 110 may have a frustal conical configuration 131 with a cylindrical nub 132.
- the needle holder 106 may contact a base 134.
- the base 134 may have a corresponding configuration as an inner surface 136 of the cylindrical nub 132.
- An outer surface 138 of the base 134 and the inner surface 136 of the cylindrical nub 132 may be permanently fixed to each other and form an airtight and fluid tight seal.
- the base 134 may have a through hole through which the needle 108 attached to the needle holder 106 may be slideably traversed.
- the base 134 and the frustal conical portion may have an interference fit (see Figures 7, 12 and 13) such that the needle holder 106 is not pushed out the distal portion 116 of the body 110 as a wedge element 152 is traversed to the releasing position (discussed below).
- the needle holder 106 may have a flange 140, stop 142, a holding surface 144 and a releasing surface 146.
- the holding surface 144 may have an outer diameter 148 greater than an outer diameter 150 of the releasing surface 146.
- a wedge element 152 may be disposed between the holding surface 144 and the inner surface 118 of the body 110.
- the wedge element 152 may f ⁇ ctionally engage the holding surface 144 and the inner surface 118 of the body 110 (i.e., holding position; see Figure 12). In this manner, the needle holder 106 is engageable to the distal portion 116 of the body 1 10.
- the wedge element 152 is also traversable off of the holding surface 144 and about the releasing surface 146 (i.e., releasing position; see Figure 13). Since the releasing surface 146 has a smaller outer diameter 150 than the outer diameter 148 of the holding surface 144, the wedge element 152 may still engage the inner surface 118 of the body 110 but is disengaged from the needle holder 106 when the wedge element 152 is disposed about the releasing surface 146. In this manner, the needle holder 106 is disengageable from the distal portion 116 of the body 110.
- the stop 142 is formed above the holding surface 144 and protrudes radially outward from a central axis 154 of the needle holder 106.
- the stop 142 abuts the wedge element 152 and prevents the wedge element 152 from being dislodged into the variable fluid chamber 120.
- the flange 140 of the needle holder 106 engages the piston 104 when the piston 104 is traversed to the engaged position. More particularly, the flange 140 may protrude radially outward from the central axis 154 of the needle holder 106. Longitudinal offset tabs 156 formed on the piston 104 may engage the flange 140 of the needle holder 106 when the piston 104 is traversed to the engaged position.
- an upper proximal block tab 158 pushes against the flange 140, whereas a lower distal wedge tab 160 hooks onto the flange 140 to cant (see Figure 14) when the needle 108 is retracted into the body 110.
- the lower distal wedge tab 160 is operative to pull on the flange 140 under the retraction force to retract the needle 108 and needle holder 106 into the body 110 of the syringe to protect against accidental needle pricking and needle reuse.
- the lower distal wedge tab 160 pulls on the flange 140, and the upper proximal block tab 158 pushes against the flange 140 so as to cant the needle 108 toward one side of the body 110 (see Figure 14) such that the needle
- the wedge element 152 may form a water tight and airtight seal between the needle holder 106 and the syringe body 110 when the wedge element 152 is disposed about the holding surface (see Figure 12) such that fluid may not escape out of the variable fluid chamber 120 between the needle holder 106 and syringe body 110.
- the piston 104 may have a punch 162 sized and configured to mate with the wedge element 152 as the piston 104 is traversed to the engaged position (see Figure 13).
- the punch 162 may define a lower surface 164 (see Figure 12) having a mating configuration with an upper surface 166 (see Figure 12) of the wedge element 152.
- the lower surface 164 of the punch 162 initially contacts the upper surface 166 of the wedge element 152.
- the punch 162 applies a force against the wedge element 152 to slide the wedge element 152 off of the holding surface 144 and about the releasing surface. More particularly, the force applied on the wedge element 152 by the punch 162 is greater than the frictional forces between the wedge element 152 and the inner surface 118 of the syringe body 110 and the holding surface 144 of the needle holder 106.
- the punch 162 fully displaces the wedge element 152 off of the holding surface 144 and the wedge element 152 is now disposed about the releasing surface 146.
- the longitudinal offset tabs 156 which may be formed on the inner surface of the punch 162 engages the flange 140.
- the piston 104 is engaged to the needle holder 106 and the needle holder 106 is disengaged from the distal portion 116 of the body 110.
- the braking mechanism 112 is disengaged.
- the retraction force created by the variable vacuum compartment 102 urges the piston 104 back toward the retracted position.
- the engagement between the piston 104 and the needle holder 106 causes the needle holder 106 and needle 108 to retract into the body 110 when the piston 104 is traversed toward the retracted position. Once retracted, the needle 108 is canted toward one side of the body 110 to prevent accidental needle pricking and needle reuse, as shown in Figure 14.
- the piston 104 may have undercut groove 168 about an outer periphery of the piston 104.
- a piston seal 170 may be disposed within the undercut groove 168 and operative to form a water tight and airtight seal between the piston 104 and the syringe body 110. More particularly, the piston seal 170 may slide against the inner surface 118 of the syringe body 110 as the piston 104 is traversed between the retracted position and the engaged position.
- the needle holder 106 may have a proximally facing frustal conical surface 172.
- the piston 104 may have a distally facing frustal conical surface 174 which mates with the proximally facing frustal conical surface 172.
- the variable vacuum compartment 102 may be formed on the opposite side of the variable fluid chamber 120 with respect to the piston 104. Initially when the safety syringe 100 is provided to a medical professional, the piston 104 may be positioned at the retracted position.
- variable fluid chamber 120 may be larger than the variable vacuum compartment 102.
- the volume of the variable vacuum compartment 102 varies inversely with respect to a volume of the variable fluid chamber 120.
- the volume of the variable vacuum compartment 102 increases, whereas the volume of the variable fluid chamber 120 decreases.
- the variable vacuum compartment 102 does not permit air molecules to be introduced into the variable vacuum compartment 102 as the piston 104 is traversed toward the engaged position. Since the volume of the variable vacuum compartment 102 increases without any additional air molecules being introduced into the variable vacuum compartment 102, a vacuum is formed within the variable vacuum compartment 102. The vacuum creates the retraction force that urges the piston 104 back toward the retracted position.
- an attachment base 176 may be attached to the proximal portion 114 of the body 110.
- the attachment base 176 may have an attachment base seal 178 disposed in a first undercut groove 180.
- the first undercut groove 180 is formed about an outer periphery of the attachment base 176, and the attachment base seal 178 forms an airtight seal between the attachment base 176 and the syringe body 110.
- the attachment base 176 may be fixedly attached to the proximal portion 114 of the body 110 via sonic welding, adhesive, or other methods that are known in the art.
- the attachment base 176 may have a lip 182 which engages a mating lip 184 of the body 110.
- the attachment base 176 may also have an inner undercut groove 186 sized and configured to receive a shaft seal 188 which forms an airtight seal between the shaft 126 of the plunger 122 and the attachment base 176.
- the airtight seal is maintained as the shaft 126 is slid through the attachment base 176 and, more particularly, as the thumb platform 124 is traversed toward and away from the proximal portion 114 of the body 110.
- the shaft seal 188 may be a wiper type seal.
- the safety syringe 100 may be provided to the medical professional or user with the piston 104 at the retracted position.
- the variable vacuum compartment 102 does not have a vacuum which creates a retraction force.
- no fluid is disposed within the variable fluid chamber 120.
- the user depresses a thumb platform 124 so as to traverse the piston 104 from the retracted position toward the filling position.
- the volume of the variable vacuum compartment 102 increases without any additional air molecules being introduced therein.
- the variable vacuum compartment 102 produces a retraction force which urges the piston 104 back toward the retracted position.
- the braking mechanism 112 counteracts the retraction force such that even if the medical professional releases the thumb platform 124, the piston 104 is not traversed back toward the retracted position.
- the braking mechanism 112 equalizes or creates a counteracting force equal or substantially equal to the retraction force. If the medical professional is interrupted while depressing the thumb platform 124 toward the filling position, the medical professional may attend to the task at hand and return at a later time to finish the filling procedure. When the piston 104 is traversed to the filling position, the medical professional may release the thumb platform ' 124 and grasp the body 110 of the syringe to guide the needle 108 into a fluidic medication container. Even though the thumb platform 1244 is released, the piston
- the user may hold the container and the body 110 of the syringe with one hand while the other hand pulls on the thumb platform 124 to overcome the counteracting force of the braking mechanism 112 and to traverse the piston 104 back toward the retracted position.
- fluid from the fluidic medication container is transferred from the container into the variable fluid chamber 120.
- the medical professional stops traversing the piston 104 back toward the retracted position.
- the medical professional may release the thumb platform 124 without the piston 104 being traversed further back toward the retracted position due to the counteracting force of the braking mechanism 112 on the retraction force.
- the needle 108 is inserted into the medication container before the piston 104 is traversed toward the filling position to pressurize the medication container and assist the viscous fluidic medication through the needle 108 and into the variable fluid chamber 120 when the piston is traversed back toward the retracted position.
- the user or medical professional may remove any trapped air within the variable fluid chamber 120 by inverting the syringe 100 with the needle 108 pointing upward.
- the user may grasp finger platforms 192 (see Figure 7) of the syringe body 110 with his/her first and second fingers, tap the body 110 to urge the trapped air toward the needle 108, and depress the thumb platform 124 with his or her thumb to traverse the piston 104 toward the engaged position to remove the trapped air from the variable fluid chamber 120.
- the user may release the thumb platform 124 and grasp the body 110 of the syringe to have a better grip as the user or medical professional inserts the needle
- the retraction force does not urge the piston 104 back toward the retracted position due to the counteracting force of the braking mechanism 112 on the retraction force.
- the user may depress the thumb platform 124 to overcome the counteracting force of the braking mechanism 112 and to traverse the piston 104 toward the engaged position.
- the fluid from the variable fluid chamber 120 is transferred to the patient.
- the lower surface 164 of the punch 162 of the piston 104 initially contacts the upper surface 166 of the wedge element 152.
- the punch 162 begins to displace the wedge element 152 off of the holding surface 144 and about the releasing surface 146 as the piston 104 is further traversed to the engaged position.
- the punch 162 displaces the wedge element 152 off of the holding surface 144 and the wedge element 152 is disposed about the releasing surface 146.
- the needle holder 106 is disengaged from the distal portion 116 of the body 110.
- the longitudinal offset tabs 156 are engaged to the flange 140 of the needle holder 106.
- the braking mechanism 1 12 is disengaged such that there is no counteracting force against the retraction force created by the variable vacuum compartment 102.
- the retraction force urges the piston 104 back toward the retracted position.
- the needle holder 106 is traversed back toward the retracted position and the needle holder 106 and needle 108 are also retracted into the body 110 of the syringe.
- the needle 108 is canted to one side of the syringe body 110 (see Figure 14) to prevent the needle 108 from being pushed out of the distal portion 116 of the body 110 after retraction.
- the braking mechanism 112 may be disposed at the proximal portion 114 of the syringe body 110. More particularly, the braking mechanism 112 may comprise a cover 194 (see Figure 9) and a brake member 196 (see Figure 9) which are engaged to the attachment base 176.
- the attachment base 176 may define an inner cavity.
- the inner cavity may have a stepped configuration.
- An upper step 198 may have a larger inner diameter 200 compared to an inner diameter 202 of a lower step 204.
- the upper step 198 and the lower step 204 may be joined to each other via a lip 206.
- the cover 194 may have an outer diameter 208 sized to fit the upper step 198.
- a top surface 210 of the cover 194 may be flush with a top surface 212 of the attachment base 176, as shown in Figure 8.
- the cover 194 may be fixedly attached to the attachment base 176 via sonic welding, adhesive and other joining methods known in the art.
- the cover 194 may have a through hole 214 (see Figure 9) through which the shaft 126 may be disposed and slidingly traversed.
- An inner surface 216 of the cover 194 may have an inner diameter 218 which is smaller than the inner diameter 202 of the lower step 204.
- the brake member 196 may be disposed and frictionally engaged to the cover
- the brake member 196 may be split into two (see Figure 10) or more pieces. Preferably, the brake member 196 is split into two pieces which are mirror configurations of each other.
- an outer diameter 220 of the brake member 196 may be equal to or slightly greater than the inner diameter 218 of the inner surface 216 of the cover 194.
- the brake member 196 frictionally engages the cover 194 and the inner surface 216 of the cover 194 biases the brake member 196 inwardly toward the shaft 126.
- the amount of inward bias may be pre-set by changing the relative sizes of the inner diameter 218 and outer diameter 220.
- the brake member 196 When the brake member 196 is disposed in the cover 194, the brake member 196 is in a braking position (see Figure 8). At the braking position, the brake member 196 may have a plurality of fingers 224 (see Figure 10) protruding inwardly. The inner surface 216 of the cover 194 biases the fingers 224 inwardly, and the fingers 224 press against the outer surface of the shaft 126 inducing a frictional force between the fingers 224 of the brake member 196 and the outer surface of the shaft 126. Alternatively, it is also contemplated that the brake member 196 may have a cylindrical inner surface. The entire inner surface of the brake member 196 may contact or press against the outer surface of the shaft 126.
- the friction surface of the brake member 196 which presses against the outer surface of the shaft 126 may have other configurations to change the amount of inward bias. It is also contemplated the amount of friction force between the brake member 196 and the outer shaft 126 may be varied to meet the requirements of the syringe. For example, the inner diameter 218 of the inner surface 216 of the cover 194 may be reduced so as to further bias the fingers 224 against the outer surface of the shaft 126. Also, distal tips 226 (see Figure 10) of the fingers 224 may be inwardly extended.
- the friction force between the brake member 196 and the shaft 126 may also be varied by changing the material of the brake member 196 and the shaft 126 or having different finishes at the interface of the outer surface 225 of the shaft 126 and the friction surface of the brake member 196.
- the friction force between the fingers 224 of the brake member 196 and the shaft 126 is less than the friction force between the brake member 196 and the cover 194. In this manner, the brake member
- the shaft 126 may slide against the fingers 224 of the brake member 196 as the piston 104 is traversed between the retracted position and the engaged position without the brake member 196 being dislodged from the braking position due to the frictional forces of the fingers 224 of the brake member 196 and the shaft 126 being less than the frictional forces of the brake member 196 and cover 194.
- the brake member 196 is traversable between the braking position and a released position.
- the brake member 196 When the brake member 196 is traversed to the released position (see Figure 11), the brake member 196 is disposed within the lower step 204 of the interior cavity of the attachment base 176. The inner surface 216 of the cover 194 no longer biases the fingers 224 inwardly to press the fingers 224 of the brake member
- the brake member 196 against the plunger shaft 126 creating the frictional force which counteracts the retraction force of the variable vacuum compartment 102.
- the brake member 196 is loose because the lower step 204 defines a larger volume and the brake member 196 such that the brake member 196 falls apart when disposed within the lower step 204.
- the fingers 224 do not press against the outer surface of the shaft 126 and does not produce any counteracting forces such that the piston 104 may be freely retracted toward the retracted position when the user releases the thumb platform 124.
- the plunger 122 may be formed with a ram 228 (see Figure 8) which initially contacts an upper surface 230 (see Figure 9) of the brake member 196 and pushes the brake member 196 out of the cover 194 and within the lower step 204 (see Figure 11). More particularly, when the piston 104 is traversed toward the engaged position, a lower surface 232 (see Figure 8) of the ram 228 contacts the upper surface 230 (see Figure 9) of the brake member 196.
- An outer diameter 234 (see Figure 9) of the ram 228 may be smaller than an inner diameter of the through hole 214 of the cover 194 such that there is no frictional engagement between the ram 228 and the cover
- the ram 228 may be formed as a part of the thumb platform 124.
- the thumb platform 124 has a receiver portion 238 which receives the proximal portion 130 of the shaft 126. It is also contemplated that the ram 228 may be formed as part of the shaft 126 or that the thumb platform 124 and shaft 126 are integrally formed such that the ram 228 is formed as part of the plunger
- the braking mechanism 112 prevents the piston 104 from retracting toward the retracted position during operation of the syringe as long as the brake member 196 is maintained at the braking position.
- the user may release the thumb platform 124 without any concern that the piston 104 will be traversed back toward the retracted position.
- variable fluid chamber 120 With fluidic medication filled in the variable fluid chamber 120, the user or medical professional may remove trapped air within the variable fluid chamber 120 via the method discussed above.
- the medical professional may release the thumb platform and the piston will not be urged back toward the retracted position due to the counteracting forces of the braking mechanism.
- the medical professional injects or inserts the needle 108 into a skin of the patient and begins to depress the thumb platform 124 thereby traversing the piston 104 toward the engaged position.
- the medical professional overcomes the retraction force and the counteracting force of the braking mechanism to traverse the piston toward the engaged position.
- the lower surface 164 of the punch 162 contacts the upper surface 166 of the wedge element 152.
- the punch 104 is further traversed to the engaged position, the punch
- the ram 228 contacts the brake member 196 and traverses the brake member 196 from the braking position to the released position. At this point, the braking mechanism 112 is disengaged.
- the piston 104 is held at the distal portion of the syringe solely via thumb pressure applied to the thumb platform 124 by the medical professional.
- the medical professional removes the needle 108 from the patient and releases the thumb platform 124.
- the retraction force of the variable vacuum compartment 102 urges the piston 104 back toward the retracted position.
- Engagement of the piston 104 with the needle holder 106 retracts the needle holder 106 into the syringe body 110 thereby preventing accidental needle pricking and needle reuse.
- the brake member 250, 252, 254 may have various other configurations.
- the brake member 250 may be a unitary split member with a living hinge 256, as shown in Figure 15.
- the brake member 250 shown in Figure 15 may function similar to the brake member 196 discussed above except that the brake member 250 shown in Figure 15 does not fall apart when the brake member 250 is traversed to the released position. Rather, the brake member 250 enlarges by pivoting about the living hinge 256 when the brake member 250 is traversed to the released position. As shown by the dashed lines in Figure 15, the brake member 250 may be pivoted inwardly when in the braking position.
- the solid lines shown in Figure 15 illustrate the brake member 250 when traversed to the released position.
- the brake member 250 pivots about the living hinge 256 inwardly and fingers 258 frictionally engage the outer surface 260 of the shaft 126.
- the brake member 250 opens up or enlarges by pivoting about the living hinge such that the fingers 258 release the outer surface 260 of the shaft 126, as shown by the solid lines in Figure 15.
- the brake member 252 may be a split unitary member 252 without a living hinge. As shown in Figure 16, when the brake member 252 is traversed from the braking position (i.e., shown in dashed lines) to the released position (i.e., shown in solid lines), the brake member 252 enlarges or opens up.
- the brake member 250, 252 may be disposed in the cover 194 (see Figure 9; i.e., the braking position). At the braking position, the brake member 250,
- the piston 104 is not urged toward the retracted position because the frictional force between the brake member 250, 252 and the shaft 126 is about equal to the retraction force of the variable vacuum compartment 102. Even if the medical professional or user releases the thumb platform 124 during the filling step and the injecting step, the piston 104 will not traverse back toward the retracted position.
- the brake member 250, 252 is not dislodged out of the cover 194 (see Figure 9) to the lower step 204 (see Figure 9) because the friction force between the brake member 250, 252 and the cover 194 is greater than the frict ⁇ onal force created between the brake member 250, 252 and the shaft 126.
- the medical professional After the medical professional or user has filled the variable fluid chamber 120 and injected the fluidic medication into the patient, the medical professional removes the needle 108 from the patient and releases the thumb platform 124. Thereafter, the needle 108 is automatically traversed into the body 110 of the syringe 100 under the retraction force of the variable vacuum compartment thereby preventing accidental needle pricking and needle reuse.
- the piston 104 engages the needle holder 106 and the needle holder 106 is disengaged from the syringe body 110. Additionally, the braking mechanism 112 is disengaged such that the retraction force of the variable vacuum compartment 102 is now greater than any frictional force between the brake member 250, 252 and the shaft 126.
- the brake member 250, 252 is traversed from the braking position to the released position.
- a lower surface 232 (see Figure 8) of the ram 228 (see Figure 8) contacts the upper surface 262, 264 (see Figures 15 and 16) of the brake member 250, 252.
- the ram 228 continues to push downwardly on the brake member 250, 252 displacing the brake member 250, 252 off of the inner surface 216 (see Figure 9) of the cover 194 (see Figure 9) and within the lower step 204 (see Figure 9).
- the brake member 250, 252 When the piston 104 is traversed to the engaged position, the brake member 250, 252 is also disposed within the lower step 204 (see Figure 9) (i.e., traversed to the released position). At the released position, the brake member 250, 252 pivots outwardly (see Figure 15) or uncurls outwardly (see Figure 16) such that the fingers 258 release the shaft 126 of the plunger 122.
- the medical professional may remove the needle 108 from the patient and release the thumb platform 124. At this point, the retraction force of the variable vacuum compartment 102 urges the piston 104 toward the retracted position. Engagement of the piston 104 with the needle holder 106 traverses the needle 108 into the body 110 as the piston 104 is traversed toward the retracted position.
- the brake members 250, 252 shown in Figures 15 and 16 may have a cylindrical inner surface such that the entire cylindrical surface contacts the outer surface 260 of the shaft 126. This increases the surface area contact between the shaft 126 and the brake member 250, 252 thereby also increasing the frictional force therebetween.
- the brake member 254 is shown as a unitary member without any splits (see Figure 18).
- the brake member 254 may have one or more lobes 266 (see Figure 18) which engage the outer surface 260 of the shaft 126 when the brake member 254 is in the braking position.
- the brake member 254 has three lobes 266 which are symmetrical with respect to each other.
- Each of the lobes 266 may have a v-shaped configuration which deforms and is biased inwardly onto the outer surface 260 of the shaft 126 when the brake member 254 is in the braking position.
- the brake member 254 may also have a plurality of bases 268. Outer surfaces 270 of the bases 268 may form a circular configuration defining an outer diameter 272 of the brake member 254.
- the relaxed position of the brake member 254 defines the outer diameter 272 of the brake member 254 which is greater than an inner diameter 218 of the inner surface 216 of the cover 194 and less than the inner diameter 202 of the lower step 204.
- the inner surface 216 (see Figure 17) of the cover 194 has an inner diameter 218 (see Figure 17) which may be smaller than or about equal to the outer diameter 272 of the brake member 254.
- the ram 228 (see Figure 17) contacts the upper surface 274 of the brake member 254 and pushes the brake member 254 out of the cover 194 as the piston 104 is traversed to the engaged position.
- the ram 228 displaces the brake member 254 into the lower step 204 (see Figure 17).
- the lower step 204 has an inner diameter 202 (see Figure 17) which may be greater than the outer diameter 272 of the brake member 254 when the brake member 254 is in the relaxed position or released position.
- the brake member 254 when the .brake member 254 is disposed within the lower step 204, the brake member 254 expands such that the lobes 266 no longer contact or frictionally engage the outer surface 260 of the shaft 126. In use, the brake member 254 may be initially disposed within the cover 194.
- the inner surface 216 (see Figure 17) of the cover 194 has an inner diameter 218 which may be less than or equal to about the outer diameter 272 of the brake member 254.
- the inner surface 216 of the cover 194 inwardly biases the bases 268 of the brake member 254 thereby deforming the lobes 266 into frictional engagement with the outer surface 260 of the shaft 126.
- the medical professional may fill the variable fluid chamber 120 and inject fluidic medication into the patient by pushing and pulling on the thumb platform 124.
- the shaft 126 slides through the brake member 254 and may be held at any position between the piston's retracted position and the filling position due to the frictional engagement between the brake member 254 and the shaft 126.
- the lobes 266 of the brake member 254 frictionally engage the outer surface 260 of the shaft 126 and such frictional engagement is greater than the frictional force between the brake member 254 and the cover 194. As such, the brake member 254 is not dislodged out of the cover 194 and into the lower step 204 during the injecting and filling steps.
- the needle 108 may be retracted into the body 110 of the syringe 100 to prevent accidental needle pricking and needle reuse.
- the piston 104 is engaged to the needle holder 106, the needle holder 106 is disengaged from the body 110 of the syringe 100, and the braking mechanism 112 is disengaged.
- the piston 104 is engaged to the needle holder 106 and the needle holder 106 is disengaged from the body 110, as discussed above.
- the lower surface 232 (see Figure 17) of the ram 228 initially contacts the upper surface 274 of the brake member 254 as the piston 104 is traversed toward the engaged position.
- the medical professional continues to depress the thumb platform 124 until the piston 104 is engaged to the needle holder 106 thereby further pushing downwardly on the brake member 254.
- the brake member 254 is traversed to the released position (i.e., within the lower step 204).
- the braking mechanism 112 is disengaged.
- the brake member 254 may spring outwardly such that the lobes 266 do not frictionally engage the outer surface 260 of the shaft 126.
- the lobes 266 of the brake member 254 disengage the outer surface 260 of the shaft 126 when disposed within the lower step 204.
- the frictional force created between the brake member 20, 196, 250, 252, 254 and the shaft 32, 126 may be varied and adjusted to meet the requirements of the safety syringe 10, 100 by altering the materials of the brake member 20, 196, 250, 252, 254 and the shaft 32, 126, changing the relative dimensions of the inner diameter 218 of the cover 194 and the outer diameter 272 of the brake member 254 as well as other methods disclosed herein.
- the retraction force may be alternatively or additionally produced with a spring mechanism which may be housed in the variable vacuum compartment 102.
- the retraction force therefore need not be produced only due to the vacuum within the variable vacuum compartment 102.
- the variable vacuum compartment 102 need not be air tight when such a spring mechanism is used therein to produce the retraction force.
- the various seals may be fabricated from rubber or resilient sealing material.
- the other components of the syringe may be fabricated from plastic or other generally rigid material.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Environmental & Geological Engineering (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
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/429,301 US7572247B2 (en) | 2005-05-09 | 2006-05-05 | Syringe |
US11/439,802 US7972300B2 (en) | 2006-05-05 | 2006-05-24 | Syringe |
PCT/US2007/010517 WO2007130388A2 (fr) | 2006-05-05 | 2007-05-01 | Seringue améliorée |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2015810A2 true EP2015810A2 (fr) | 2009-01-21 |
EP2015810A4 EP2015810A4 (fr) | 2009-04-29 |
Family
ID=38987273
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP07794445A Ceased EP2015810A4 (fr) | 2006-05-05 | 2007-05-01 | Seringue améliorée |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP2015810A4 (fr) |
JP (1) | JP5437060B2 (fr) |
WO (1) | WO2007130388A2 (fr) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2596826A1 (fr) * | 2011-11-24 | 2013-05-29 | Sanofi-Aventis Deutschland GmbH | Seringue de sécurité |
JP6446042B2 (ja) * | 2013-07-01 | 2018-12-26 | クレデンス メドシステムズ インコーポレイテッド | 安全注射器 |
WO2015073991A1 (fr) | 2013-11-15 | 2015-05-21 | Credence Medsystems Inc. | Système et procédé pour l'administration de médicament avec une seringue de sécurité |
EP3868427B1 (fr) | 2014-04-24 | 2024-10-30 | Credence Medsystems Inc. | Système pour seringue de sécurité |
JP6573761B2 (ja) * | 2015-01-06 | 2019-09-11 | 小林製薬株式会社 | 押出器具 |
CN107530500B (zh) * | 2015-03-10 | 2020-10-30 | 杰·亨·拉索尔 | 流体注射系统及其方法 |
IL239366B (en) * | 2015-06-11 | 2018-07-31 | Kriheli Marino | Components of a fluid transfer device |
EP3781235B1 (fr) | 2018-04-19 | 2024-10-16 | Sanofi | Réduction de force dans des dispositifs d'injection |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0480862A1 (fr) * | 1990-10-09 | 1992-04-15 | Adolfo Ibanez Garcia | Seringue à usage unique avec dispositif automatique de sécurité |
US6077245A (en) * | 1999-02-18 | 2000-06-20 | Texas Applied Biomedical Services, Inc. | Disposable syringe with retractable needle |
US6193695B1 (en) * | 2000-01-14 | 2001-02-27 | Wayland J. Rippstein, Jr. | Disposable safety syringe having a retractable needle |
US6413236B1 (en) * | 1999-10-08 | 2002-07-02 | Lewis R. Van Dyke | Automatically retractable needle safety syringe |
WO2006121513A2 (fr) * | 2005-05-09 | 2006-11-16 | Safeshot Technologies, Llc | Seringue amelioree |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2084705T3 (es) * | 1989-09-18 | 1996-05-16 | Robb Pascal Patent Pty Ltd | Jeringuilla. |
US5578015A (en) * | 1989-09-18 | 1996-11-26 | Robb Pascal Patent Limited | Safety syringe incorporating automatic needle holder release |
US6953449B2 (en) * | 2003-01-17 | 2005-10-11 | Taiject Medical Device Co., Ltd. | Hypodermic syringe having plunger pull-out stopping structure |
-
2007
- 2007-05-01 WO PCT/US2007/010517 patent/WO2007130388A2/fr active Application Filing
- 2007-05-01 EP EP07794445A patent/EP2015810A4/fr not_active Ceased
- 2007-05-01 JP JP2009509655A patent/JP5437060B2/ja not_active Expired - Fee Related
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0480862A1 (fr) * | 1990-10-09 | 1992-04-15 | Adolfo Ibanez Garcia | Seringue à usage unique avec dispositif automatique de sécurité |
US6077245A (en) * | 1999-02-18 | 2000-06-20 | Texas Applied Biomedical Services, Inc. | Disposable syringe with retractable needle |
US6413236B1 (en) * | 1999-10-08 | 2002-07-02 | Lewis R. Van Dyke | Automatically retractable needle safety syringe |
US6193695B1 (en) * | 2000-01-14 | 2001-02-27 | Wayland J. Rippstein, Jr. | Disposable safety syringe having a retractable needle |
WO2006121513A2 (fr) * | 2005-05-09 | 2006-11-16 | Safeshot Technologies, Llc | Seringue amelioree |
Non-Patent Citations (1)
Title |
---|
See also references of WO2007130388A2 * |
Also Published As
Publication number | Publication date |
---|---|
EP2015810A4 (fr) | 2009-04-29 |
WO2007130388A2 (fr) | 2007-11-15 |
JP2009540875A (ja) | 2009-11-26 |
WO2007130388A3 (fr) | 2008-09-25 |
JP5437060B2 (ja) | 2014-03-12 |
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