Automatically operable safety shield system for syringes

AUTOMATIC SAFETY SCREEN FOR SYRINGE

The present invention relates to automatically operating safety screens for use in syringes. There are also automatically functioning safety screens that contain a syringe and protect the needle from accidental puncture injuries.

Needle-stick injuries pose a real health risk as they can often result in the transmission of disease from one person to another. Once the puncture injury has occurred, it is usually necessary to monitor the injured person for significant periods of time, such as HIV and hepatitis infection, and it may also be necessary to limit the amount of work they perform or the circle of people who come into contact with them. This situation, even when the injured person did not receive the infection, is traumatic and extremely costly for health care professionals. The infection is completely unacceptable, especially since the needle stick needle injury could have been avoided. Needle stick injuries are a major concern for healthcare professionals who are most exposed to infection and most frequently exposed to infected patients. Awareness of the risk of accidental needle puncture injections has led to a general desire to prevent them from occurring, and as a result, many different types of restraint systems have been developed that retract or conceal the needle after use to reduce the risk of accidental needle injury. The use of such security systems is encouraged and coerced by several US laws, as well as health insurance and health care professionals.

Examples of prototype security histamines include EP 0966983, the contents of which are incorporated herein by reference in their entirety. EP 0966983 discloses a protective screen system for pre-filled syringes comprising an external syringe holder and an internal screen. In use, the pre-filled syringe containing a tube with a proximal flange and a distal needle and containing a plunger is placed in a housing defined by an outer holder and an inner screen and held in place by an outer housing. When sufficient pressure is exerted by the syringe barrel on the holder (for example, by applying pressure to the plunger of the syringe when the contents of the syringe barrel are fully injected), the screen is released and moved by the spring between

EE 04662 Bl

Unfortunately, prototype devices, including EP 0966983, have numerous drawbacks and potential problems in design and construction. For example, the devices of EP 0966983 are prone to accidental actuation of the screen release mechanism, since sufficient force exerted on the syringe barrel (e.g., the force generated by accidental drop-off) in turn exerts sufficient force on the external holder and actuates the protective mechanism. It may also happen that placing the syringe in the outer holder / inner display mechanism with sufficient force to remain in the holder may cause the protective shield mechanism to release. Alternatively, this can be avoided by placing the syringe in a holder defined by the holder before applying the display to the holder. Unfortunately, this method of manufacturing the device is somewhat cumbersome and cumbersome and takes away the ability to market the holder / screen mechanism and syringes separately. In addition, the actual application of the protection mechanism requires a greater force to be applied to the plunger rod in a discrete step than the force applied to the injection, after removal of the needle from the patient's body (numbered paragraph 27). This means that there is an unacceptable period of time during which an accidental puncture injury may occur and requires one additional step to use the syringe. Another disadvantage is that the spring is located on the syringe barrel. This can be problematic when injecting a patient because the contents of the syringe barrel are no longer fully visible due to the covering spring, although it should be visible to make sure that the correct dose of medication is being administered to the patient. Similarly, the tube-covering spring makes it difficult to look at the label on the syringe barrel, which is needed to make sure the correct medicine is being administered to the patient.

The fact that the screen mechanism, including the screen, the spring, the rescue mechanism and the holder must all be grouped together (see, for example, FIG. 5 of EP 0966983) means that the design of the security screen may be undesirably large.

When using syringes, it is often necessary to insert the needle at a certain sharp angle (for example, it may be necessary to inject the so-called depot drug subcutaneously at a shallow depth) to prevent tissue injury with the needle, which can result in bruising and trauma to the tissue. . Fully protective screens cannot have a finger grip (flange) along the entire lumen size so that a sufficiently sharp (ie low) angle can be reached between the needle and the patient's skin. Instead, they are usually provided with protruding flanges radially disposed relative to one another. They are usually handled in such a way that.

When the needle enters the skin, the flanges are twisted so that they do not come in contact with the skin (i.e., parallel to the plane of the skin). Unfortunately, pushing the plunger (which, for example, may require a relatively high force to be applied in a controlled and careful manner when injecting the depot drug) may be difficult because of the awkward position of the flanges. Users of syringes sometimes overcome this and achieve good grip on the flange by rotating the syringe 90 ° after inserting the needle into the skin (so that the flanges are perpendicular to the skin plane). Unfortunately, the large edges of the needle hole and the sharp edges of the needle tip can cause a piece of tissue to be cut, just as a golf course straightener cuts an opening into the golf course grass. This is of course problematic and should be avoided.

US 5163918 discloses a portable safety syringe having a protruding security screen. Unfortunately, its construction is significantly different from that of the present invention and has a number of significant disadvantages which are overcome by the present invention. Specifically, these deficiencies result from the syringe barrel forming part of the shield mechanism, the use and location of the open spring, the limited range of movement of the plunger, and the safety clips used with the syringe.

The spring is also exposed when the protective sleeve is not retracted. When moving to a protruding position, the movement can easily be obstructed, for example, by a spring being stuck to the user's hand or by being stuck in clothing, etc. The spring used in various applications of the present invention is always concealed and is not obstructed.

US 5163918 protective sleeve is also provided with user-held finger grips. Their use means that the protective sleeve cannot move the needle until the user has released his or her fingers from the sleeve or piston. Doing so while the needle is in the patient's body can cause tissue injury due to sudden movement of the needle. Therefore, the needle can be safely covered only after it has been removed from the patient's body and not until the user deliberately releases the protective sleeve or plunger, resulting in undesirable exposure of the needle. The present invention provides an automatically operative protective system (i.e., one that is actuated in a fully depressed position of the piston rod and without any additional user intervention) that covers the needle at the time it is withdrawn from the patient, ensuring that the needle is not exposed. The automatically operating system of the present invention enables a single, smooth movement (piston rod insertion)

EE 04662 ΒΙ to the patient as well as activation of the screen display system. Specifically, the spring that moves the needle guard extends over the syringe barrel. As explained above, this is a design defect, as the spring may be damaged by the tubular obstruction of the syringe contents, which may make it difficult or impossible to deliver accurately measured doses of the drug. When injecting depot medicines to patients, medical rules require that the presence (or absence) of a depot drug in the syringe can be readily determined before and after eye injection. The syringe barrier spring significantly prevents this.

To prevent accidental triggering of the release mechanism, the plunger of US 5163918 is provided with a removable safety device consisting of a detachable strip or a detachable hat that allows the piston to move freely, but not the trigger of the release mechanism. This may lead to a situation where the medical professional discovers after the injection to the patient that the safety device has not been removed and at this point the plunger must be withdrawn to remove the safety device. This can cause discomfort and trauma to the patient. Embodiments of the present invention provide alternative safety features that must be removed before moving the piston, thereby avoiding the above problem.

Moreover, the locking mechanism of the present invention utilizes (see below) an external screen limiter which, when locked in its retracted position, prevents it from being moved forward or retracted. Instead, US 5,169,318 requires the use of additional ears to accomplish a similar goal, which makes the device unnecessarily complicated. Although not required by the present invention, certain applications are provided with additional fastening means to prevent unwanted advancement of the external display by rendering the present invention mechanically resilient.

Furthermore, the construction of US 5,363,918 syringes inevitably makes them larger (longer) than those of the present invention. When the protective sleeve of US 5163918 is moved into its protruding position, it is left to cover a substantial portion of the syringe tube. This means that a longer protective needle and consequently a longer syringe barrel are needed to cover the longer needle. This makes the entire syringe unnecessarily large and cumbersome and its size can scare the patient. In contrast, when the external display of the present invention is in its protruding position, it will cover a relatively small portion of the clean tube. This means that the devices manufactured according to the present invention are smaller and more convenient.

EE 04662 B1 is expected to produce and sell syringes as complete devices. The present invention enables the manufacture of syringes, optionally containing drugs, separate from the manufacture of a security screen design, whereby the two can subsequently be assembled. This means that you can back up security screens without having to cover the cost of manufacturing complex devices. Similarly, pre-filled syringes with a wide range of medications may be kept in stock and may be combined with security screens if necessary. Ultimately, it allows you to keep fewer individual components in stock (thus saving money on production) and allows the manufacturer to respond quickly to demand for a particular product.

The present invention also has the advantage of US 5163918 when the syringe has to be filled by a doctor before injection - the prototype only allows partial movement of the plunger, which means that there is always air in the syringe when filling, which has to be removed later. Such air removal may be extremely difficult, if not impossible, but injecting air will usually cause tissue damage to the patient. The present invention allows the plunger to move completely within the syringe barrel, thereby removing air from the syringe before drawing in the drug. The pre-filled syringe can then be used with the screen protector device and administered to the patient.

Other security screen devices include US 5201720, US 5,217,744, US 5,855,839, US 4,850,968 and those referred to in EP 0966983.

Thus, the present invention overcomes the drawbacks of prototypes and provides an alternative and improved security screen system for syringes. Particular advantages of the present invention are that it is not as cumbersome as prototypes, that the safety screen mechanism is significantly less prone to accidental triggering, and is elastic to attempts to disassociate the screen and holder, e.g. by force applied to the syringe barrel and is an integral part of the injection process, but not an additional discrete step, and that in various applications, the spring does not extend significantly over the syringe barrel.

According to the present invention, there is provided an automatically operable security screen system for use with a syringe, wherein the security screen system comprises the following components:

EE 04662 B1 inner holder having a proximal and distal portion defining a housing in which the syringe may be mounted;

an outer display having a proximal and distal portion mounted outwardly of the inner holder and axially movable between retracted and extended positions relative to the inner holder;

a spring disposed between the first stop of the inner holder and the second stop of the external display and pushing the outer display in its extended position, the spring being preferably disposed between the first distal stop of the inner holder and the second distal stop of the external display;

an inner holder having at least one first aperture and an outer display having at least one first limiter, the first limiter being engageable with the first aperture when the outer display is in the retracted position;

an inner holder having at least one distal notch relative to the first aperture, wherein the first stroke limiter is engageable with the first notch when the outer display is in a protruding position; and a trigger located within the inner holder and axially movable relative to the inner holder such that it can contact the first stroke stopper when connected to the first opening and disengage from the first opening of the first stroke stopper, allowing the spring to move the outer display to a protruding position.

Typically, syringes consist of a generally cylindrical portion known as a syringe barrel, a needle or other piercing or connecting member attached to one end of the syringe barrel and a plunger or stopper sliding inside the syringe barrel. The piston rod is usually connected to the piston such that movement of the piston rod causes the piston to move. The needle may be removably or permanently attached to the syringe barrel. The plunger rod may slide from the most retracted position (most proximal) in which the syringe may contain the drug to the furthest (most forward) position in which the drug is expelled from the syringe.

The automatically functioning security screen system may further include a syringe comprising a clean tube, a needle, a plunger and a plunger rod moving within the syringe barrel, the plunger rod having a protruding portion, the syringe being operatively connected to the trigger until the first plunger rod

EE 04662 est from the first opening of the stroke limiter, allowing the spring to move the external display into a protruding position.

If desired, the first and second notches may be mounted on the inner holder and the outer screen, for example at their distal or proximal ends. However, placing the first and second notches in the distal portion of the inner holder and outer screen is most preferred because it allows the spring to be kept covered by the outer screen at all times and the spring cannot reach the syringe barrel even when the outer screen is in its protruding position.

The springs used in the systems of the present invention are usually, but not necessarily, coil springs, and those skilled in the art are aware of alternative springs that may be used in the invention. The skilled person will also be aware of special variants of coil springs, such as cone coil springs and variable coil springs, which are equally applicable in the context of the present invention.

The present invention also provides an automatically operating security screen system comprising the following components:

Syringe consisting of a syringe barrel, a needle, a plunger rod and a plunger rod movable within the syringe barrel, the plunger rod having a protruding protrusion;

an inner holder having a proximal and distal portion defining a housing in which the syringe may be mounted;

an outer display having a proximal and distal portion mounted outwardly of the inner holder and axially movable between retracted and extended positions relative to the inner holder;

a spring disposed between the distal first stop of the inner holder and the second stop of the distal outer display and pushing the outer display into its extended position;

an inner holder having at least one first aperture and an outer display having at least one first stroke limiter, the first stop being engageable with the first aperture when the outer display is in the retracted position;

an inner holder having at least one distal notch relative to the first aperture, wherein the first strut limiter is foldable to the first notch when the outer shield is in a protruding position; and

EE 04662 A BI syringe operably coupled to an inner holder and an external display such that axial movement of the piston rod protrusion relative to the inner holder causes the piston rod protrusion to contact the first strut when disengaged with the first opening and to disengage the first strut; to the projection of the screen.

To prevent unwanted movement of the plunger rod of the syringe, the syringe may be provided with a safety clip that is detachably secured to a portion of the plunger rod extending out of the syringe barrel so that movement of the plunger rod is prevented when the safety clamp is attached to the plunger rod.

The outer display and the inner holder may have proximal and distal support surfaces facing each other respectively, which engage with each other to prevent the external display from moving over its protruding position.

The inner holder and the external display can be of any desired shape. For example, they may have a generally cylindrical shape. One example of a cylinder is that which has a circular cross section (commonly referred to as a regular circular cylinder). Alternatively, the cylinder may have an elliptical cross-section. This can be particularly useful to ensure that the inner holder and the external display cannot be misaligned or rotated relative to one another during use. Cylinders also include those that are slightly tapered, for example at least 0.5 degrees.

The inner holder and outer display may also be designed to prevent rotation between them by providing guides for axial movement. The guides may take the form of grooves in the inner holder and / or the outer display. For example, the first stop may slide along a groove on the inner holder. Similarly, the proximal abutment surface of the outer display may be directed toward the distal abutment surface of the inner retainer by a groove on the exterior display.

The inner holder and / or outer display may each be designed as a single detail or may be assembled from more than one detail. Such a construction will be apparent to one of skill in the art

EE 04662 Bl

All embodiments of the present invention provide a clear advantage over this prototype, with the piston rod moving. not, for example, a syringe barrel that allows the spring to move the screen to its outward position. This is usually the position where the plunger rod is fully depressed and the contents of the syringe are ejected, for example, into the patient's body. The opening of the first stroke stop from the first opening may be achieved either by direct contact of the piston rod protrusion or by indirectly coupling the piston rod protrusion to the first stroke stop.

Direct contact can be achieved, for example, by providing the piston rod with a thumb bar which has an axial extension which contacts the first travel stop when the piston rod is depressed. Alternatively, the piston rod may, for example, be provided with a thumb stop and an additional projection which, when depressed by the piston rod, contacts the first stop.

Indirect contact can be achieved by any structure capable of transmitting the movement caused by the piston rod (or piston rod protrusion) to the first stop. The specific nature of the mechanism depends on the design of the piston rod. For example, the piston rod may have a thumb stop which, when depressed by the piston rod, contacts a member (such as a trigger) located inside the inner holder, which in turn contacts the first stroke limiter and causes it to open from the first opening.

The first stroke limiter may be lockable with a first notch. It can apply the first notch in such a way that axial movement of the outer screen, both distal and proximal, with respect to the inner holder is avoided. The first indentation of the inner holder may be replaced by any other mechanism or means, such as a protruding member, such as a truncated cone, which prevents relative movement of the inner holder and the external display, although it is preferred to avoid any axial movement.

The first distal cam may extend outward from the inner holder, and the second distal cam may extend inward from the external display.

The syringe may be held in the inner holder by any suitable means. For example, to ensure the syringe is correctly positioned relative to the inner holder, the syringe may

EE 04662 Bl io rest on a cam in the inner holder, such as the upper surface of the first distal flange of the inner holder. It may also be advantageous to provide the inner holder with syringe application means for actuating and holding the syringe. For example, the inner holder and syringe barrel may be designed so as to be connected to a tongue so that when the syringe is placed in the holder, it is displaceable only by applying a significant force, for example at least 50 N, more specifically at least 70-80 N or 100 N.

Thus, the syringe may be axially stationary with respect to the inner holder.

The use of a tight seat (also called a friction seat) eliminates the need for other syringe retention mechanisms, such as the use of a rotary cone portion designed in the inner portion to hold the syringe in a certain area. This in turn means that the syringe will no longer need any of the flanges that the syringe is usually fitted with in the form of finger grips. As a result, the syringe will become smaller in size than the prototype syringes, so the safety screen mechanism may be smaller. Of course, it may be desirable to retain at least one small flange to facilitate manipulation of the syringe barrel during manufacture, particularly for pre-filled syringes.

The person skilled in the art is familiar with a number of materials suitable for making the device's internal holder and external display. Preferably, the material is transparent enough to allow the contents or labeling of the syringe to be seen in the inner holder. Suitable materials include: polystyrene, modified polystyrenes and polystyrene copolymers, polycarbonates, polyether sulfones, polypropylenes, cyclic olefin copolymer resins, copolesters such as Eastar (RTM) copolester ester DN003 [copolyester, 4 cyclohexanedimethanol] and acrylonitrile-butadiene-styrene copolymer (ABS). A particularly preferred material is Eastar (RTM) copolyester DN003 (Eastman Chemical Company). Useful materials include MABS (Methyl Methacrylate / Acrylonitrile / Butadiene / Styrene Copolymer, Terlux 2812 TR (RTM). Polycarbonates include Lexan (RTM), GR1210, and Lexan 124R-112).

For some applications, the devices of the present invention may be required to be delivered in a sterile condition. Those skilled in the art are familiar with the larmic

EE 04662 B1 sterilization of devices and methods for sterilizing such devices, for example using heat, gas technology or gamma radiation. The physical properties of the materials used in the construction of the devices of the present invention must not be significantly affected during sterilization. For example, in some materials, sterilization by itself may cause the materials to break or make the material opaque to opaque. A preferred method of sterilizing the devices of the present invention is gamma irradiation. Unfortunately, gamma rays can discolour plastics and cause them to break. We found that treatment of Eastar (RTM) copolymer DN003 with gamma radiation does not cause significant color changes and does not significantly affect the physical properties of the material. Thus, Eastar (RTM) copolyester DN003 is a preferred material for the manufacture of devices of the present invention suitable for gamma irradiation sterilization.

The syringe barrel may be made of polypropylene. Alternatively, the syringe barrel may be subdivided into a plurality of compartments, for example, an upper and a lower part made of high density polyethylene, which holds the transparent part made of glass or polystyrene. The lower part may hold the inner holder. The transparent portion may be made as a lens to provide an enlarged view of the contents of the syringe barrel.

In the event that the syringe barrel has no or flanged flanges, the inner holder may be constructed such that the syringe barrel inserted therein minimizes the chance of accidentally releasing the first stroke limiter and first opening, for example, due to fingers or other small object inserted into the inner holder. The syringe plunger rod may have a protruding projection, such as an axially protruding collar, which, when depressed by the plunger rod, moves around the outside of the syringe barrel and directly or indirectly contacts and causes release of the first stop.

The reduced dimensions of the inner holder and outer display (relative to the prototype display and holder mechanism) provide for the presence of at least one radially protruding protrusion that can be used as a finger grip, for example a flange of at least 2mm, 3mm, 4mm or 5mm circumference of the proximal end of the entire inner holder. It also allows the injection of a large diameter needle into the patient's body at an angle that does not cause tissue injury. This is particularly useful as it allows the user to easily hold the internal holder in different positions

EE 04662 B1 and allows you to change hand positions without loosening the finger grip needed for satisfactory injection and no need to turn the syringe, which can cause tissue injury.

The outer display may not have radially protruding projections at its proximal end, such as ears or flanges, which could be used as finger grips.

Syringes for use in the present invention may be used for subcutaneous injection of liquids, suspensions, such as microparticulate dosage forms, or solid dosage forms (depot drugs). Such injection of depot medication requires the plunger of the syringe to extend into the needle hole of the syringe to ensure that all depot medication is expelled from the syringe. The protruding plunger can reduce the chance of needle plugs if the needle is exposed for some reason and holding the plunger in its extended position, ensuring that the plunger rod that is pushed in cannot be retracted, providing an additional safety measure. An example of a microparticulate dosage form for use in the invention is Lupron (RTM) microparticulate leuprolide. An example of a solid drug for use in the present invention is the goserelin depot form Zoladex (RTM).

The inner housing may further comprise piston rod retaining means to prevent piston rod retraction when at least in its most forward position. As mentioned above, the piston rod slides between its most protruding position and the uppermost position. In its most forward position, the piston rod causes the first notch to disengage from the first notch, and is usually the most forward position at which it is desirable to hold the piston rod, although it may be desirable to hold the piston rod in almost the most forward position. For example, the plunger rod retaining means may include a deflection member or members, such as a truncated cone mechanism or an escap or a so-called non-slip tooth in the inner holder that allows the piston rod to be pushed past the upper (i.e. which prevents the piston rod from being removed.

This provides a number of additional advantages to the invention. First of all, in various embodiments of the invention, particularly those using, for example, a trigger to transfer piston rod movement to the first stroke limiter, the piston rod retaining member may make it more difficult to accidentally (or purposefully) release the first stroke limiter from the

EE 04662 Bl when moving, simply reducing the size of the slit. Secondly, if, in some way, when the apparatus according to the invention is used and the external display is in its protruding position, substantial mechanical damage is caused to the apparatus so that the external display is able to return to its retracted position, the first stroke limiter is always the external screen by the spring towards its protruding position.

Providing the spring with the first and second distal stops of the inner holder and the outer display means that, in a protruding position, the spring covers the inner holder from the first distal stop to the second distal stop of the outer display, i.e. the spring does not cover the syringe barrel. Therefore, if the inner holder is made of a transparent material, it is possible to see the contents of the inner holder even after the projections on the external display, which means that when injecting the medication it is possible to monitor at any time whether the medicament is completely ejected from the syringe.

The fact that the spring does not extend to cover the syringe barrel provides the additional advantage that the spring cannot damage the syringe barrel, which was a problem in the design of the prototypes and necessitated the use of additional protectors such as glass tube syringes (see e.g. ).

In order to prevent the display system from being squeezed by its operation, the inner holder may be provided with a finger grip region comprising a flange and a rigid section of the inner holder. Squeezing it does not reduce the internal dimensions of the inner holder and therefore the protective screen system functions properly.

The first stop may engage the support surface of the first aperture. The first limiter may be in the form of an arcuate flexible piece projecting from the external display, i.e. extending outwards and then inward. Such a mechanism allows the first stop to engage the center of rotation of the pivot axis when it engages with the support surface of the first aperture. This means that by accidentally or intentionally attempting to release the first stop and the first aperture by pulling them apart, they will in fact engage with each other even more strongly than before and prevent separation. Such a feature was lacking in prototype devices, which, for example, have flexible struts that are released after applying sufficient force.

EE 04662 ΒΙ

The invention will be further explained by the following description, with reference to the accompanying drawings, which, by way of example only, show one protective screen and a syringe mechanism

<td>sample. Drawings:</td><td></td>

<td>Figure 1</td><td>shows a protective screen and a syringe mechanism according to the invention a side view with the external display in the retracted position;</td>

<td>Figure 2</td><td>Figure 1 is a sectional view along line MM;</td>

<td>Figure 3</td><td>Fig. 1 is a side view of the mechanism of Fig. 1, axial rotated 90 degrees;</td>

<td>Figure 4 Figure 5</td><td>Figure 3 is a sectional view taken along line NN; shows a side view of the inner holder;</td>

<td>Figure 6</td><td>Figure 5 is a sectional view taken along line CC;</td>

<td>Figure 7</td><td>Figure 5 is a sectional view taken along line DD;</td>

<td>Figure 8 Figure 9 Figure 10</td><td>Figure 5 is a sectional view along line EE; Figure 5 is a sectional view taken along line AA; Figure 5 is a side view of the inner holder of Figure 5, which is axially rotated 90 degrees;</td>

<td>Figure 11</td><td>Figure 10 is a sectional view taken along line BB;</td>

<td>Figure 12 Figure 13 Figure 14</td><td>depicts a side view of an external display; Figure 12 is a sectional view taken along line KK of Figure 12; Figure 12 is a sectional view, taken along line HH;</td>

<td>Figure 15</td><td>Figure 5 is a side view of the external screen of Figure 5, which is axially rotated 90 degrees;</td>

Figure 15a is an enlarged view of the area L surrounded by the circle of Figure 15;

<td>Figure 16 Figure 17</td><td>Figure 15 is a sectional view taken along line GG of Figure 15; depicts a side view of the trigger;</td>

<td>Figure 18</td><td>17 is a sectional view taken along line FF in FIG. 17;</td>

<td>Figure 19</td><td>Fig. 17 is a plan view of the trigger of Fig. 17;</td>

<td>Figure 20</td><td>depicts a perspective view of the protective screen and syringe mechanism by Figures 21, 30 and 31 show in more detail;</td>

<td>Figure 21</td><td>illustrates a protective screen and syringe mechanism of the present invention a cut-out perspective view with an external screen of its own in extended position;</td>

EE 04662 Bl. Figure 22 Figure 23 Figure 24 Figure 24 Figure 25 Figure 26

Figure 27 Figure 28 Figure 29 Figure 30

Figure 31 is a front view of the mechanism of Figure 1 in a protruding position;

Figure 22 is a sectional view taken along line BB;

FIG. 1 is a perspective view of the mechanism of FIG.

Figure 24 is a sectional view taken along line CC;

depicts a front view of a second screen and a syringe mechanism before the screen is ejected;

Figure 26 is a sectional view taken along line CC;

Fig. 26 is a perspective view of the mechanism of Fig. 26;

Figure 28 is a sectional view taken along line BB;

represents a sectional view of an alternative embodiment of the present invention that is substantially equivalent to that of Figure 25; and represents an alternative section of the mechanism of Figure 30, which is substantially equivalent to that of Figure 4;

Example 1

In a first embodiment, the security screen and syringe mechanism 10 of the present invention include an inner holder 20, an outer display 30, a metal coil spring 40, a trigger 50, and a syringe 60.

The inner holder 20 is made of Eastar (RTM) copolyester DN003 (Eastman Chemical Company) and has an elongated, generally cylindrical shape defining the sheath 70 and has an inner holder proximal portion 80 and an inner holder distal portion 90 and ends 100, 110, that define the end holes. The proximal portion 80 widens toward the end 100 to form a mouth 111 which is grasped by hand in use. The mouth 111 is remarkably rigid so that the pressure exerted by the user on it does not reduce its diameter or prevent the security screen mechanism 10 from working and thereby the external screen 30 from moving out. The mouthpiece 111 has a radially outwardly extending flange 120 which, when used, acts as a finger grip, allowing the user to easily manipulate the mechanism 10. At the distal end of the mouth, the first two openings 130 are disposed radially opposite each other and have distal surfaces defined by the first two truncated conical portions 140, forming upper abutments 150 and lower inclined surfaces 160. The first truncated conical portions 140 extend axially distally outwardly. In the distal portion 90, the first apertures 130 are axially distal to the first two portions 170 with two foldable tongues 180 extending therefrom proximal to them.

EE 04662 B1 distal direction. The distal ends 181 of the tongues 180 extend radially from the proximal ends 182.

The first openings 130, the first truncated conical portions 140 and the first notches 170 are rotated 90 degrees distally by two second grooves 185. The distal portion 90 has two stops consisting of two outwardly extending second truncated conical portions 190 having upper supporting surfaces 200 and lower inclined surfaces 210. Inside the second truncated conical portion 190, a radially inwardly extending collar 220 is located which (see below) holds the syringe 60. A distal flange 230 radially inwardly extending axially from the collar 220 has an upper and lower support surface 231,232.

The outer display 30, also made of Eastar copolyester DN003, has a shape that fits in the shape of an inner holder 20 so that it can slip axially along the inner holder 20. The outer display 30 has proximal and distal portions 240, 250, and proximal and distal ends 260. , 270. The proximal end 260 is provided with two radially opposed inwardly extending flanges forming support surfaces 280 having axially extending inclined side walls 290. the support surfaces 280 and the side walls 290 are designed to accommodate a second seat of a second truncated cone portion 190. The proximal end 260 is also provided with two strut stops 300 which are rotated axially 90 degrees relative to the bearing surfaces 280. The travel stops 300 consist of foldable shoulders 310 having a generally bilaterally symmetrical trapezoid perimeter shape, and heads 320. The distal end of the shoulders 310 extends inward and the shoulders 310 extend outwards. Heads 320 extend inward from the proximal end of the arms 310 and form proximal support surfaces 330. The distal end 270 is provided with a generally annular projection 340 which forms an inclined support surface 350 from which a second distal stop 370 extending axially distally protrudes 360. The trigger 50 is generally cylindrical and has a proximal and distal end 380. is designed to fit into the mouthpiece 111 of the inner holder 20 so as to be axially slidable in the mouth 111. The distal end 390 has an inwardly sloping neck 400

Syringe 60 is generally comprised of a cylindrical tube 410 containing a depot drug (not shown) having a flange 420 at its proximal end and a needle cover 431 at the distal end with a removable needle cover 440. The piston rod 450 is

EE 04662 B1 is secured to one end of the piston 440, at the other end there is a flange forming a thumb-pressing support 460. A security strip 470 is detachably secured to a portion of the piston rod 450 protruding from the injection tube 410 to prevent movement of the piston rod 450.

The security screen and the syringe mechanism are made by first inserting a metal helical spring 40 into the pin screen so that it contacts the support surface 360 ​​of the distal flange 370. The end 110 of the inner holder 20 is punctured into the proximal end 260 of the outer screen. As they pass, the shoulders 310 and heads 320 of the stop members 300 are tilted outwardly over the oblique surfaces 160 of the truncated conical portion 140 until they have slid past the truncated conical portion 140, at which point they snap inward so that the abutment faces 150, 330 are disposed. Further sliding of the inner holder 20 is prevented by the end 110 that contacts the inclined support surface 350 of the outer display 30. Sliding of the inner holder 20 inside the outer display 30 forces the spring 40 to be compressed between the outer display 30 support surface 360 ​​and the inner holder lower support surface 232. Releasing the grip of the inner holder 20 allows the spring 40 to slightly expand, disengaging the inner holder 20 and the outer display 30, the opposing support surfaces 150, 330 engaging with each other and preventing further relative movement of the inner holder 20 and the outer display 30. Now the external display is applied in its retracted position.

The positioning of the arms 310 and the heads 320 of the struts 300 is such that the center of rotation of the arms 310 is located radially within the contact area of ​​the bearing surfaces 150, 330. In contrast to the prototype device, in which the holder and the screen portion can be disengaged with considerable force, that is, the attempt to disengage (i.e., disengage) the inner holder 20 and the outer display 30 forces the struts 300 to engage more firmly with the inner holder.

20.

The trigger 50 is then slid into the mouth 111 of the inner holder 20 such that the neck 400 contacts the head 320.

The syringe 60 is then inserted into needle 430 upstream of mouth 111 of inner holder 20 and slid toward end 110 such that needle 430 and needle cover 431 extend from end 110. Syringe insertion 410 is stopped when syringe barrel 410 contacts upper distal surface 231 of syringe 60. the proximal and distal ends are made of high density polyethylene and the bench is shaped with a collar 220 so that it does not

EE 04662 BI can be easily removed from the inner holder 20 without applying significant force. The flange 420 prevents the release of the trigger 50 from the mouth 111, but does not exert any force on the trigger 50 and does not cause the trigger 50 to move, which could cause the inner holder 20 and the external screen 30 to release.

In use, safety bar 470 is removed from piston rod 450 and needle cover 431 is removed. Needle 430 is inserted into patient body (not shown) and pressed to thumb pad 460, sliding piston 440 through syringe barrel and ejecting depot drug (not shown) from needle 430. . At the same time (i.e., not as a separate step), the thumb rest 460 enters the mouth 111 and contacts the trigger 50, causing it to move axially. The axial movement of the trigger 50 is obstructed by the heads 320, but the inwardly sloping neck 400 tilts the heads 320 outward as the axial movement of the trigger 50. Sufficient axial movement of the trigger 50 and the resulting outward movement of the heads 320 causes the opposing support surfaces 150, 330 to disengage, allowing axial movement of the external display 30. The spring 40 pushes the inner holder 20 and the outer screen 30 apart, and by removing the needle 430 from the patient 480, the outer screen is forced to slide over the inner holder 20, covering the needle 430, thereby preventing possible needle puncture injuries. During the sliding step, the inner holder 20 of the axle and the outer screen 30 are prevented from rotating with respect to each other by the grooves 145, 185, the guide heads 320 of the limiter 300 and the second truncated conical portion 190, respectively. When needle 430 is completely removed from patient 480, heads 320 move over inclined tongues 180 and snap onto first notch 170, thereby preventing further axial movement of inner holder 20 and outer screen 30. At the same time, the bearing surfaces 280 and the side walls 290 slip tightly over the second truncated cone portion 190, with the bearing surfaces 280 contacting the upper bearing surface 200, preventing further escaping as an additional security measure. The external display is now locked in the outward position. The entire screen and the syringe mechanism of the present invention are handled by one person.

Example 2

Another embodiment of the invention is like Example 1 except that the injection tube 410 does not have a flange 420 and the mouth 111 does not hold the trigger 50, which is instead replaced by an axial extension 600 of the thumb rest. This configuration reduces the possibility of accidental release of the opposing support surfaces 150, 330 60

EE 04662 ΒΙ other accidental release when placed in the inner holder 20 or on opposite support surfaces 150, 330. By omitting the flange 420, it is also possible to reduce the diameter of the mouthpiece 1 1 1 and thereby either reduce the overall dimensions of the inner holder 20 or increase the flange 120 to allow better grip by the user.

Example 3

The third embodiment of the invention is identical to Example 1 except that the mouth 111 is provided with tilt-rotatable conical portions 500 (not shown) having an upper proximal inclined surface 501 (not shown) and a lower distal abutment surface 502 (not shown), which substantially perpendicular to the axis of the inner holder. In use, as the thumb support 460 enters the mouth 111 (and the depot drug is ejected from the needle 430 and the plunger 440 protrudes from the needle 430), it tilts and passes the truncated conical portions 500, then returning to its original shape and 460, preventing it from being removed from the mouth 111. that is, the piston 440 is locked into its protruding position from its needle 430 such that even when the outer screen 30 is removed or damaged so that the needle 430 is exposed, the needle puncture injuries are substantially prevented.

Example 4

An alternative embodiment with modified dimensions of the invention (generally finer than the applications shown in the other figures) is shown in Figures 30, 31, 20 and 21. Specifically, the inner holder 20 is approximately 68 mm in length and approximately 10 mm in diameter at the proximal portion. screen 30 and having a narrowed flange 120. It is worth noting that the construction of the external screen 30 consists of two parts.

The trigger 50 is also provided with first and second curved projections 600, 610 extending radially outwardly along its entire circumference, wherein the trigger 50 (and / or mouth 111) is sufficiently resiliently deformable to permit it to be pressed against the respective third curved projection 620 radially inwards throughout the 111 perimeter of the mouth. In the construction of the mechanism of the present invention, the trigger 50 is mounted in the mouth 111 of the inner holder 20 and the first curved protrusion 600 leans on the third curved protrusion 620. The releaser 50 can be easily operated with a sufficiently downward

EE 04662 ΒΙ force, causing it to elastically deform so that the first curved protrusion 600 can pass the third curved protrusion 620. As the trigger 50 is further pushed down, the second curved protrusion 610 is leaned to the third curved protrusion 320. A sufficiently large downward force is then applied causing it to elastically deform to allow the second curved protrusion 610 to move over the third curved protrusion 620. Thus, the trigger 50 is fully positioned, as shown in Figures 30 and 31. Although a sufficiently downward force can be easily applied to the trigger 50 for insertion into the mouthpiece 111, when it is in place, it is extremely difficult to apply sufficient upward force to the trigger 50, to remove it from the mouth

50 and the trigger can be considered to be permanently installed in the mouth 111.

With a two-stage mounting of such a trigger 50, the devices of the present invention are stored and supplied such that the inner holder 20, outer screen 30 and spring 40 are connected to each other and the trigger 50 is disposed within the mouth 111 of the inner holder 20 Between 600 and 610. The syringe 60 can be inserted into the mouthpiece 111 and connected to the inner holder 20 without contacting the trigger 50. Even if the trigger 50 is accidentally touched during insertion of the syringe 60, the second curved protrusion 610 prevents it from moving over the third curved protrusion 620 and thereby prevents the movers 300 from disengaging from the first apertures 130. When the syringe 60 is fully installed, a second curved protrusion 610 along a third curved protrusion 620. The syringe mechanism 10 is now ready for use.

Depending on the construction and deformability of the mouth 111 and the thumb rest 460, as well as the dimensions of the thumb rest 460, it is possible to prevent the thumb rest from being removed from the mouth 111 by a protrusion extending across the circumference of the mouth 111.