AU2018200454B2 - Segmented safety cover for needle delivery - Google Patents

Abstract

A segmented safety cover which may include a) a proximal segment combined with a needle hub; b) a needle cannula that extends from the proximal needle hub to a distal sharpened end; c) a distal end cap with a hollow bore through which the cannula shaft passes; d) a centrally mounted toggle locking mechanism, separating the proximal needle hub from the distal end cap; e) wherein the toggle locking mechanism is torsion spring assisted; f) wherein the proximal cover segment is connected to the hub via a proximal hinge and the distal cover segment is connected to the end cap via a distal hinge; g) said proximal cover segment and said distal cover segment of said toggle locking mechanism being configured with abutting faces when the segmented safety cover is in a safety mode; and h) wherein the proximal hinge, abutting faces and distal hinge are in line in the safe mode. 3507692vl 1 24 FIG-] FIG-2 22 25 FIG-3 FIG-4 13 5 FIG-5

Description

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SEGMENTED SAFETY COVER FOR NEEDLE DELIVERY BACKGROUND OF THE INVENTION

Field of the Invention

[0001]This invention relates to safety guards to protect against needle stick injuries

used in medical and veterinary medical use of material delivery and material removal

needles.

Background of the Art

[0002] Reference to background art herein is not to be construed as an admission

that such art constitutes common general knowledge.

[0003] According to the Occupational Safety and Health Administration (OSHA),

needle stick injuries occur during all aspects of handling. 50% of incidents occur

during the invasive procedure (while introducing needle, by accidental needle

withdrawal during procedure, or during needle withdrawal at the end of the

procedure).

[0004] Ironically, the vast majority of safety needle devices currently on the market

only give protection to the healthcare worker after completion of the invasive

procedure.

[0005] Examples of disclosures of safety devices which protect needles by moving a

protective shield over the sharp end of the needle are bountiful. Most of the

disclosures describe a technique where the needle tip is exposed by first removing a

protective cap and where the protective shield is moved form a collapsed position

proximal to the user to a distal and extended position to cover the needle tip only

after the invasive procedure has been completed.

[0006] US Patent No 6,280,420 (Ferguson) describes an active (user activated)

retractable and extendable medical needle protective shield which provides

opportunity for accessing and re-accessing a medical needle and associated

sharpened needle tip and recovering the needle and tip for safety between

accesses.

[0007] A method for infusing fluids to a subject is disclosed - A needle cover is first

removed to reveal an unbiased segmented shield in the folded back state which fully

exposes the needle. The segmented shield is manually extended over the needle

cannula and tip after use. A releasable latch is described which can be unlatched to

permit refolding of shield and allow re-access to said needle and sharpened tip

Once extended, the segmented shield completely covers the tip of the needle and it

relies on an un-releasable latch/catch to permanently lock it into its extended

position after use. One limitation of this device is that it doesn't give any protection

until manually engaged and manually locked by fully extending it over the needle tip

[0008] US Patent 2002/0165498 (Ward) discloses a passively (automatically)

activated needle assembly, a shield assembly and a safety cap. The needle

assembly includes a hub and a needle cannula that projects from the hub. The

shield assembly includes a safety shield that is mounting for sliding movement along

the needle cannula. The shield assembly also includes a plurality of arms articulated

to one another to permit sliding movement of the safety shield along the needle

cannula from a proximal position to a distal position where the tip of the needle

cannula is shielded. A spring is mounted to the shield assembly and is operative to

drive the safety shield from its proximal to its distal position. A safety cap is mounted

over the shield assembly and holds it in the proximal position. The arms are held

during usage of the safety needle. The device is not secure when extended and has to rely on an irreversible biasing clip (item 40) to physically block the path of the needle when fully extended.

[0009]The limitations of this device are that it requires the user to hold the arms

back during procedure and if unintended activation does occur, the syringe would

have to be discarded prior to the infusion procedure

[0010] US Patent No. 7,361,159 (Fisher) describes a passive (automatically

activating) safety apparatus which includes a needle hub having an arm extending

therefrom and an extensible frame connected to the needle hub. The extensible

frame includes a proximal segment that is hingedly connected to a distal segment.

The extensible frame is resiliently biased from a retracted position to an extended

position, wherein the arm releasably engages the proximal segment to fix the

extensible frame in a position between the retracted position and the extended

position. In an alternate embodiment, the safety apparatus includes an extensible

frame including a proximal segment which is hingedly connected to a distal segment.

A resilient member is coupled to the proximal segment and the distal segment. The

resilient member is configured to bias the extensible frame from a retracted position

to an extended position. A method for infusing fluids to a subject is disclosed.

[0011] The extendable frame is constrained in a position between the retracted and

extended. To activate, a separate sheath cap is first removed to expose the needle

cannula. The extendable frame extends a needle cover over the needle cannula tip

and the device relies on an irreversible biasing clip to physically block the path of the

needle when fully extended. Different removable sheath configurations are utilized

to prevent the automatic locking cover from actuating when liquid is drawn from a

vial in preparation for the infusion procedure.

[0012]The limitations of this device are that it relies on removable sheaths to

prevent automatic locking and if unintended activation does occur the syringe would

have to be discarded prior to the infusion procedure

[0013]Although Ferguson describes a device of which the needle can be re

accessed, these features have to be activated intentionally and manually. Simply

adding a spring to this device is not an option as the locking features present in this

device are latched in place and has to be manually de-latched for re-access. All the

relevant disclosures including Ferguson, Ward and Fisher describe a device where a

needle cover first has to be removed thereby exposing the needle tip rendering it

unprotected.

[0014] US Patent No. 5,634,909 (Schmitz) discloses a hypodermic injection system

utilizes disposable medicament ampules having self-contained needles operated by

a re-useable actuator to extend the needle from complete enclosure within the

ampule out and into the flesh and inject the medicament as it moves,

the needle automatically retracting into the disposable ampule after exhausting its

contents, completely eliminating any need to handle the exposed needle before or

after use.

[0015] US Patent Nos. 5,188,599 and 4,994,034 (Botich) disclose a hypodermic

injection system (7) with a retractable needle (9) wherein the needle (9) retracts

within an interior cavity (71) of a syringe plunger (59), such that the needle (9) is

confinedly held within the plunger (59). A cylindrical spring housing (21) has resilient

fingers (23) which captures a spring (15) biasly holding a needle holder (11) against

the retaining force of resilient fingers (23). The plunger (59) has a frangible end (65),

which dissociates when the outwardly tapered shoulders (68) spread the resilient

fingers (23), allowing the coiled spring (15) to eject the needle (9) and its holder (11) into the interior cavity (71) of the syringe plunger (59). A body fluid sampling embodiment employs the same functional elements except the plunger (59") is shorter and contains a linking needle (137) that communicates with a vacuum container (147). The container allows fluid sampling and provides the structure to release the spring (15") retracting the needle (9").

[0016]US Patent No. 4,955,866 (Corey) provides a recapping device for use

with medical devices including all hollow and solid medical needles of the type used

for entry into the body and into closed intravenous and intraarterial systems for

access, sampling, and injection of medications, and are withdrawn after use. The

recapping device includes a hollow sleeve encircling a portion of the needle and

having a distal end aperture adapted to permit the sleeve to slide between a first

position on the medical device wherein the needle is exposed to enable use of

the needle, and a second position characterized by the distal end of

the needle being contained within the distal end capped hollow sleeve, and the

device may optionally contain a housing for a free-floating fenestrated disk, which,

upon movement of the device to its second position wherein the tip of

the needle exits the distal end aperture, shifts position to provide an obstruction at

that aperture. A securing means for the hollow sleeve, such as a tether, is provided

for permitting substantially free slidable movement of the hollow sleeve between the

first and second positions.

[0017] US Published Patent Application Nos. 20080132838 20100100039

20110226646 (Wyrick) disclose a reloadable medicine injector and methods are

described in which a barrel with a receiving cavity is adapted to slidably receive a

syringe subassembly for axial movement therein. Upon removal of a safety and

release of a syringe driver, the syringe driver moves forward and injects the syringe needle. A plurality of penetration controls are shown for controlling injection needle penetration depth. The penetration controls have an abutment and various lengths to provide different needle penetration depth positions. In one form of penetration control a sleeve is used against which the syringe or related parts contact. In another form the front return spring is used as a penetration control. A cushioning ring may be used to reduce syringe breakage. A load distribution and guide ring may be used to distribute loading applied to the syringe and help guide the moving syringe.

[0018] US Published Patent Application No. 20070078409 (Salyz) describes a

protective needle guard assembly features a hub that is removably secured to a

reusable syringes, a first and a second needle extending outwardly from the hub in

opposite directions, and a moveable sheath that moves about an outer surface of

the syringe. The needle guard includes an engagement device that engages the

moveable sheath to secure the moveable sheath in an extended position wherein

the moveable sheath extends beyond the distal end of the first needle. The

moveable sheath features a retracted position wherein the first needle is

substantially exposed. A cavity formed in the hub substantially covers and protects

the second needle.

[0019] Other possibly relevant disclosures are included in US 5,348,544; 5,910,130;

,256,152; 4,935,013; 4,735,618; 5,250,031; 5,295,972; and 5,584,818; and

US20110066107; and EPO654281.

[0020] Apart from Ferguson, most of the disclosures describe a way of blocking the

needle path by means of a metallic clip or rotating member located in the distal

needle cap and this only after the invasive procedure has been completed. The

limitations of this approach means that the medical device has to be discarded if unintentionally activated. As can be seen, these disclosures still are not believed to offers high levels of security and additional advances are still needed. These disclosures are incorporated herein by reference in their entirety by reference.

[0021] It is an aim of this invention to provide a safety cover which overcomes or

ameliorates one or more of the disadvantages or problems described above, or

which at least provides a useful commercial alternative. Other preferred objects of

the present invention will become apparent from the following description.

SUMMARY OF THE INVENTION

[0022] A segmented safety cover may include:

a) a proximal segment combined with a needle hub;

b) a needle cannula that extends from the proximal needle hub to a distal

sharpened end;

c) a distal end cap with a hollow bore through which the cannula shaft

passes;

d) A centrally mounted toggle locking mechanism, separating the proximal

needle hub from the distal end cap, hingedly connected to both and

maintaining the needle guard in a position where it completely covers the

needle tip;

e) wherein the toggle locking mechanism is torsion spring assisted and

consist of proximal and distal cover segments which overlays the cannula

shaft and is linked together through a central hinge;

f) wherein the proximal cover segment is connected to the hub via a

proximal hinge and the distal cover segment is connected to the end cap

via a distal hinge; g) said proximal cover segment and said distal cover segment of said toggle locking mechanism being configured with abutting faces that contact each other above said central hinge when the segmented safety cover is in a safety mode; and h) wherein the proximal hinge, abutting faces and distal hinge are in line in the safe mode so that a force exerted on the distal end cap is translated directly onto the abutting faces above the central hinge thereby maintaining the device in its locked state.

[0023] Preferably, the abutting faces each have one flat face, and the two flat faces

form a plane at the intersection of the two flat faces with each face having a top

portion on the flat face and a bottom portion on the flat face. Preferably, when a

linear force is applied parallel to the plane of the abutting two faces it will result in the

central hinge to be elevated, the two flat faces are forced to separate, with the two

top portions of the faces initially being separated from each other at a faster rate

than that at which the two bottom portions separate under the influence of the linear

force. Preferably, this linear force may also be considered as a vector force passing

near the two abutting faces from below the plane of all contact points between the

two abutting faces. Preferably, the proximal hinge, distal hinge and central hinge are

configured to form a triangle configuration when the segmented safety cover is in a

delivery mode for a needle with the distal cover segment and the distal end cap slide

with respect to the needle cannula. Preferably, the proximal cover segment appears

to rotate relative to the hub, and the distal cover segment appears to rotate relative

to the sliding distal end cap as it slides horizontally with respect to the needle

cannula.

BRIEF DESCRIPTION OF THE FIGURES

[0008] By way of example only, preferred embodiments of the invention will be

described more fully hereinafter with reference to the accompanying figures,

wherein:

Fig. 1 is an isometric view of the device

Fig. 2 is an isometric view of the device mounted on a syringe

Fig. 3 is an isometric view of the device configured as a phlebotomy

needle.

Fig. 4 is an isometric view of the phlebotomy configuration mounted on its

holder

Fig. 5 is an exploded view of the device

Fig. 6 is an isometric view with hidden detail

Fig. 7 is a sectioned view of the device

Fig. 8 is a sectioned view of the device with the central hinge of the toggle

locking mechanism forced upwards to expose the abutting faces.

Fig. 9 is a side view of the device in its normal secured position with the

central hinge below the proximal and distal hinges indicating the inverted triangular

configuration

Fig. 10 is a side view of the device with the central hinge forced up to a

position higher than the proximal and distal hinges indicating the upright triangular

configuration.

Fig. 11 is a side view of the device in its temporarily dislocated position

which shows a digital force being applied to the distal end to expose the needle tip.

Fig. 12 is a top view with the toggle locking mechanism removed, showing

the position of the unidirectional double torsion spring with its coil loops on either

side of the needle cannula.

Fig. 13 is a side view showing the spring coils over the cannula center.

Fig. 14 is an isometric view of the spring position relative to the needle

cannula.

Fig. 15 is an isometric view of the distal cover segment with the resiliently

biased or spring loaded wedge extension.

Fig. 16 is a side view of the device in its temporary dislocated position

with the resiliently biased wedge pushed up against the abutting face of the distal

cover segment.

Fig. 17 is a rear view of the device in its temporary dislocated position

with the resiliently biased wedge pushed up against the abutting face

Fig. 18 is an isometric view of the device in its temporary dislocated

position with the resiliently biased wedge pushed up against the abutting face

Fig. 19 is a rear view of the device shown with the resiliently biased

wedge dislocated by a digital force applied to the distal end cap.

Fig. 20 is an isometric view of the device shown with the resiliently biased

wedge dislocated by a digital force applied to the distal end cap.

Fig. 21 is a side view of the device with the latch disk hidden to show the

exposed locking faces.

Fig. 22 is a side view of the device with a section through the latch disk

cover exposing the wedge in its arrested position.

Fig. 23 is a rear view of the device showing the latch disk in its arrested

position.

Fig. 24 is a rear view of the device showing the latch disk dislocated by a

digital force applied to the distal end cap.

Fig. 25 is a sectioned view through the center hinge showing the latch

disk in its dislocated position.

Fig. 26 is an isometric view of the distal cover segment with the latch disk

secured in place by the retention disk.

Fig 27 is an bottom isometric view of the distal cover segment and latch

disk showing the multiple recess features (20, 21) on its inside face.

Fig. 28 is a side view of the device in its first temporally recessed and

arrested position exposing the tip of the needle cannula.

Fig. 29 is a side view of the device in its second temporally recessed and

arrested position exposing a longer portion of the needle cannula.

Fig. 30 is an isometric view of the device with the cover segments and

end cap configured in the shape of an animal to act as a child friendly object.

Fig 31 is a sectioned side view of the device with a non-reuse clip un

activated

Fig 32 is a sectioned side view of the device with the non-reuse clip

activated.

Fig 33 shows a perspective view of a device according to the present

invention having a design feature for use with children, in this case the image of an

alligator molded into the front of the device.

DETAILED DESCRIPTION OF THE INVENTION

[0024] This invention preferably addresses shortcomings by enabling a device that

renders the medical needle (e.g., injection, biopsy, sampling, and sensor needles)

safe at all times. This invention device has the needle tip exposed by manual

intervention just prior to being inserted into the patient. It then passively returns to its

secured position while the needle is withdrawn from the patient.

[0025] This device of the invention has a hinged cover arrangement that is in its

extended position prior to being used and where a protective cap and protective

shield is integrated and thus not removed to offer protection at all times. The needle

tip is exposed just prior to the invasive procedure by manually exposing the needle

tip. It then automatically secures itself again as the needle is removed from the

patient.

[0026] A segmented safety cover may include:

a) a proximal segment combined with a needle hub. The hub is a

structural element that may abut, secures or connects the proximal

segment to another component such as a support or medical

delivery or removal system (e.g., syringes, vacuum pressure,

sampling pressure, sensing electronics, etc.);

b) a needle cannula that is mounted in the needle hub and extends

from the hub to a distal sharpened end

c) a distal end cap with a hollow bore through which a cannula shaft

passes. -. The segments and other components are made of

substantive structural material that will not bend or distort under

common forces encountered during normal use. The various

segments of the cover may comprise polymeric materials

(thermoplastic or thermoset), metallic materials, ceramics,

composites or the like. Transparent, opaque or translucent

materials may be used;

d) an engaged, torsion spring assisted, centrally hinged toggle locking

mechanism that overlays the cannula shaft; The spring must be a resilient material, such as metals, or polymers that do not elastically deform during the full motion of the segments.

e) wherein the toggle locking mechanism consist of a proximal and

distal cover segments linked together through a central hinge.

f) The central hinge is also preferably a full construction that allows

rotation of one side (top or bottom) of the distal and proximal cover

segments, such as the abutting sides.

g) said proximal cover segment and said distal cover segment are

configured with abutting faces that contact each other above (not

necessarily along the entire abutting faces, but at least the tops of

those faces) said central hinge when the segmented safety cover is

in a safety mode;

h) said proximal cover segment is hingedly connected to said

proximal needle hub and said distal cover segment is hingedly

connected to said distal end cap

i) wherein the proximal hinge, abutting faces and distal hinge are in

line and the central hinge below the abutting faces so that any force

exerted on the distal end cap would be translated directly onto the

abutting faces thereby maintaining the device in its locked and safe

state.

[0027] The abutting faces each have one flat face, and the two flat faces are

relatively perpendicular to an access port or cannula in the segmented cover. Each

of the flat faces is rotationally engaged with the central hinge and from an abutting

position, the two flat faces are configured to rotate away from each other. The two

flat faces, in the safe configuration of the segmented cover form a plane at the intersection of the two flat faces with each face having a top portion on the flat face in contact with the other flat face and a bottom portion on the flat face in contact with the other flat surface. When a linear force is applied parallel to the plane of the abutting two faces and a vector of the force passes near the two abutting faces from below the plane of the two abutting faces, the two flat faces are forced to separate as the central hinge is elevated, with the two top portions of the faces initially being separated (from the abutting safe configuration) from each other at a faster rate than that at which the two bottom portions separate (from the safe configuration) under the influence of the linear force. The application of the force, without movement of any other elements of the segmented cover (the stabilization of ends of the segmented cover to allow motivating action of the force is not movement of an element of the segmented cover). This can be referred to as dislocating force applied parallel to the abutting faces, as it causes separation or dislocation of the abutting faces from each other. The proximal, distal and central hinge are configured to form a triangle configuration when the segmented safety cover is in a delivery mode for a needle with the distal cover segment rotated in a clockwise direction away from the proximal cover segment and the distal cover segment appears to rotate clockwise towards and with respect to the distal end cap as the distal end cap slides horizontally with respect to the needle cannula.

[0028] The segmented safety cover will have a needle present in the needle hub and

an injection end of the needle is within the distal end cap during a medical

procedure. Upon forming the triangular configuration, the distal end cap is

configured to retract over the needle and towards the needle hub, the distal segment

appears to rotate with respect to the distal end cap as the distal end cap retracts and

exposes the injection end of the needle. In the safety mode, the distal segment and proximal segment are in a secured mode, resisting movement of the distal segment and the proximal segment by the torsion spring.

[0029] Two manually operated pressure plates overlap sides of the distal cover

segment and the proximal cover segment and the plates are configured to unlock

the locked mode when pressure is applied to the two pressure plates.

[0030] The pressure plates are resiliently biased to disengage from the

dislocated mode to return to a secured ready mode when triggered by said distal

end cap as it pushes against a patient's skin during the injection procedure. This

frees the device to return to its initial secured and safe mode as the needle is

withdrawn from the patient.

[0031]A non-reuse clip is configured to permanently lock the device in its safe mode

to eliminate re-use. Said clip extends across a top of the abutting faces of the distal

segment and the proximal segment.

[0032] The torsion spring may be a single or preferably a double coil spring with a

first extension of the double coil spring extending approximately parallel to the distal

cover segment in the safety mode, and a second extension of the double coil spring

extending approximately parallel to the proximal cover segment in the safety mode.

The first one coil of the double coil spring may be on a first side of the cannula shaft

and a second one coil of the double coil spring may be on a second and opposite

side of the cannula shaft with respect to the first coil.

[0033] The segmented safety cover will have a needle present within the cover, and

the segmented safety cover is configured so that the pointed injection end of the

needle is completely covered by the distal end cap when the torsion spring is

secured in the safety mode, and the pointed injection end of the needle is exposed

out of the distal end cap when the safety mode is removed and compressive force applied by the torsion spring retracts the distal end cap by rotation of both the proximal cover segment and the distal cover segment about the central hinge.

[0034] A method for enabling injection of fluids using the segmented safety cover

with a needle present within the cover of the present technology may include

applying force to both the proximal cover segment and the distal cover segment from

the torsion spring to elevate the central hinge and retract the distal end cap to slide

the hollow bore within the distal end cap over the needle to expose the needle.

[0035] A segmented safety cover may be alternatively described as including:

[0036] A proximal segment fixed with a needle hub, said proximal segment also

being integrated with a syringe body or a blood collecting needle;

[0037] A distal end cap with a hollow bore that covers a cannula shaft through which

said cannula shaft may pass;

[0038] A rigidly interlocked, torsion spring assisted centrally hinged toggle locking

mechanism that covers the cannula shaft, where said toggle locking mechanism

comprises of a hollow proximal cover segment and hollow distal cover segment

linked through a central hinge;

[0039] Wherein said proximal cover segment and distal cover segment are

configured with vertical protruding abutting faces above said central hinge;

[0040] Wherein a proximal cover segment of said toggle locking mechanism is

hingedly connected to said proximal hub by a proximal hinge and said distal cover

segment of said toggle locking mechanism is hingedly connected to said distal end

cap by a distal hinge;

[0041] Wherein the proximal hinge, distal hinge and central hinge are arranged in the

form of an inverted triangle formed by a line connecting said proximal and said distal hinges that lies parallel to the cannula shaft and said central hinge defining a vertex of the inverted triangle below said proximal and distal hinges.

[0042] The torsion spring is biased to maintain the toggle locking mechanism in a

secured position. The torsion spring may be centered to and fitted on an inside of

said center hinge and comprises single or double coil loops on one or either side of

the needle that allows the center hinge with coil loops to be lowered past said needle

cannula without interference by said cannula shaft.

[0043] The toggle locking mechanism may include a resilient wedge mechanism

which is configured to be pressure activated to arrest said toggle locking mechanism

in a temporary dislocated position to enable exposure of said cannula tip prior to the

invasive procedure. The wedge mechanism may include a resilient wedge extension

mounted on the distal cover segment or proximal cover segment, and the resilient

wedge extension is located above the center hinge. The wedge may be configured

to be clamped into a wedged-in position by spring force generated by the torsion

spring, and the wedge is resiliently biased to dislocate from a wedged-in position

when pressure applied by the torsion spring is reduced when said distal end cap

pushes against a patient's skin.

[0044] The wedge may be integrated into a latch disk with single or multiple recess

features on an inside face of the latch disk and a retention face on the wedge that

allows it to wedge into/ against a retention face on the proximal cover segment or

distal cover segment when the wedge is pressure activated.

[0045] A further alternative description of the device and its operation is herein

provided as follows. The segmented needle-protection cover may have at least five

segments which are, in order from a point distal from the point on insertion of a

needle: a) a hub element; b) a proximal first needle cannula cover segment; c) a central hinge; d) a distal second needle cannula cover segment; and e) a distal end cap.

[0046] The features of the present technology that may be further considered in this

description may include facts wherein:

1) This device is locked in rest/start position - all other devices is partly

collapsed in rest

2) The center segment may be an element that is locked and that this

locked central element is what separates the end cap from the hub and retains the

end cap over and in a fixed position of protruding past the needle tip.

3) The proximal and distal members aren't arms above the needle as in

the other devices but bodies that completely covers the needle shaft (cannula).

4) The way in which the members lock to form a rigid center segment is a

unique application of a (toggle locking mechanism) and is further described herein.

5) The way in which the members can be manipulated to unlock to

present the needle tip is preferably performed just prior to the injection

6) A method and apparatus is provided for arresting (by wedging an

element in-between the vertical locking faces) the device with the needle exposed.

7) How the wedge escapes (when the tip touches the patents skin) is to

free the lock to return to its home position upon release of the wedge.

9) A second locking device manually activated to permanently lock the

device to eliminate re-use.

[0047] Looking at a horizontal axis along which a needle would lie, passing through

the needle cannula (a bore, not necessarily fully inclosing the needle, but nesting the

needle in contact with an open groove in the a proximal first needle cannula cover

segment and the distal second needle cannula cover segment, with the bottom of

the needle length uncovered below the proximal first needle cannula cover segment

and the distal second needle cannula cover segment) from the hub, past the

proximal first needle cannula cover segment, the central hinge and the distal second

needle cannula cover segment and into the distal end cap. The hub is in hinged

connection to the proximal first needle cannula cover segment, and the distal second

needle cannula cover segment is in hinged connection with the distal end cap. The

elements operate with respect to rotation and alignment changes adjacent the

hinges as follows, with the axis of the needle cannula being considered as

approximately horizontal during a needle-safe alignment along the approximate

horizontal alignment of a), b), d) and e):

1) When the proximal first needle cannula cover segment and the distal

second needle cannula cover segment are in the safe, approximately horizontal

alignment, the central hinge holds adjacent opposing faces of proximal first needle

cannula cover segment and the distal second needle cannula cover segment in an

abutting, locking (anti-rotational) position;

2) Rotation with respect to the hinge of the proximal first needle cannula

cover segment (in a counter-clockwise movement with respect to the central hinge)

and the distal second needle cannula cover segment (in a clockwise movement with

respect to the central hinge) elevates tops of each of the opposing faces and

elevates the central hinge and draws together the two most respectively distal faces

or ends of the proximal first needle cannula cover segment and the distal second needle cannula cover segment, which are respectively adjacent the hub element and the distal end cap. This movement also shortens the distance between the distal end cap and the hub element, retracting the distal end cap towards the hub element.

3) Retraction of the distal end cap does not apply harmful sideways stress

against any needle nesting in the needle cannula as rotation between both i) the

proximal first needle cannula cover segment and hub and ii) the distal end cap and

the distal second needle cannula cover segment causes both the proximal first

needle cannula cover segment, the central hinge and the distal second needle

cannula cover segment to elevate above the needle, removing the needle from the

grooves in the proximal first needle cannula cover segment and the distal second

needle cannula cover segment. This may momentarily expose the shaft of the

needle, but not the pointed tip of the needle, except as the point of the needle

extends beyond a distal end of the distal end cap as intended when the device is

changed from the needle-safe position to the active needle insertion position.

4) During these movement, a rotating hinge between the hub element and the

proximal first needle cannula cover segment, and a separate rotating hinge between

the distal second needle cannula cover segment and the distal end cap are

configured to keep the needle in the approximately horizontal position, with the

portion of the needle cover cannula within the distal end cap remaining in the

approximately horizontal alignment as the distal end cap retracts over the needle,

exposing the needle tip during the conversion of the device to the active needle

position. There is some modest stress placed on the needle from the rotation of

respective elements, but essentially only at the hub element and the distal end cap.

However, because little or no manual or finger (digit or digital) forces are directly

applied to the end cap (where torsion stress would be most likely to deflect or stress the needle shaft), there is little significant deflecting stress applied to the needle shaft by the cover device when the needle is exposed to its active position during medical procedures, including insertion.

5) Downward force on the elevated central hinge (between the proximal first

needle cannula cover segment and the distal second needle cannula cover segment

lowers the central hinge, reverses all rotation of segments and extends the distal

end cap over the needle tip, returning the device to its original needle safe position.

The needle will again nest within the grooves in the proximal first needle cannula

cover segment and the distal second needle cannula cover segment. The central

hinge may or may not have a groove for nesting of the needle in the safe position.

[0048] It is to be noted that the opposed adjacent faces of the proximal first needle

cannula cover segment and the distal second needle cannula cover segment resist

any deflection of the length of the device by downward pressure on the central

hinge. This prevents any deflecting or bending stress being applied against the

included needle during handling.

[0049] FIG. 1 shows a perspective view of the Passive Safety Cover (1) in its

secured position.

[0050] FIG. 2 shows a perspective view of the Passive Safety Cover (1) attached to

a syringe (24).

[0051] FIG. 3 shows a perspective view of an embodiment of the Passive Safety

Device as a Phlebotomy Needle (26).

[0052] Fig. 4 shows a perspective view of the Phlebotomy embodiment (26) of Fig. 3

mounted to a tube holder (25).

[0053] FIG. 5 shows an isometric exploded view of the Passive Safety Cover. The

Central toggle locking mechanism (4) consist of a hollow Proximal cover segment (6) linked to a hollow Distal cover segment (7) by means of a centrally mounted hinge

(8). The unidirectional double torsion spring (13) urges the central toggle locking

mechanism towards its secures, needle safe position.. The Needle Hub (2) is

hingedly connected to the proximal hinge of the central toggle locking mechanism

(4). The distal end cap (3) slides over the needle cannula (5) and is also hingedly

connected to the distal hinge of the centrally hinged segment.

[0054] FIG. 6 is an isometric view of the device (1) in its secured, needle-safe

position with the unidirectional double torsion spring (13) in place to maintain the

central toggle locking mechanism in its extended and secured position where it

separates the Hub (2) from the End Cap (3) which surrounds the Cannula shaft (5)

and extends past the Cannula tip (14) within the distal end cap (3).

[0055] FIG. 7 is a sectioned view of the device (1) in its secured, needle safe

position. The vertical abutting faces, the opposed distal ends of the proximal cover

segment and the opposed proximal end of the distal cover segment are shown. The

vertical abutting faces (9,10) are positioned above the central hinge (8) and is

pushed against each other to retain the device in its secured position. The proximal

hinge (11) connects the Hub (2) to the proximal cover segment (6) of the central

toggle locking mechanism of which the Distal cover segment (7) connects to the

End Cap (3) via the distal hinge (12). The relatively lower position of the central

hinge (8) in relation to the needle cannula (5) is also shown.

[0056] FIG. 8 is a sectioned view of the device in a partly dislocated position. The

central hinge (8) is advanced up to a position above the needle cannula (5 in Fig. 7)

The vertical abutting faces (9,10) on the proximal and distal cover segments (6,7)

respectively are moving away from each other.

[0057] FIG. 9 is a side view of the device in its secured position. The proximal hinge

(11) and distal hinge (12) are in line and generally above the height of the central

hinge (8) with the vertical abutting faces (9, 10) pushed against one another. The

hinges (11 and 12) may be living hinges or pins passing through securing holes in

the structural elements.

[0058] FIG. 10 is a side view of the device with a digital (fingered) upwards force (15)

applied to pull or push the central hinge (8) to a position above the cannula (5 in Fig.

), proximal hinge (11) and distal hinge (12). The upward force (15) is an example of

the dislocating force mentioned earlier. Its vector is approximately parallel to the

original position/plane of the abutting faces 9, 10 in Figure 9 and the vector is

applied through the central hinge to elevate the hinge and to force apart the two

abutting faces, and as shown in FIG. 10, with the top portions of the flat faces

moving farther apart from each other than do the bottom portions of the faces 9, 10

after the force has dislocated or elevated the top portions of the abutting faces by

rotation around the center hinge. As the hinge rotates from the dislocation force 15,

the flat abutting faces separate more rapidly at the top of the flat faces than do the

bottom portions because of a larger radius for movement of the top portions as

compared to the bottom portions of the two faces. The proximal cover segment's

(6) vertical abutting face (9) is parting from the vertical abutting face (10) of the distal

cover segment (7) as the centrally hinged section dislocates and elevates.

[0059] FIG. 11 is a side view of the device in its dislocated position where a digital

(fingered) axial force (16) causes the toggle locking mechanism to collapse towards

the hub (2) or the end cap (3) to retract, thereby exposing the cannula tip(14)

[0060] FIG. 12 is a open top view of the device with the toggle central locking

mechanism removed to show the position of the unidirectional double torsion spring

(13) with its with its coil loops on either side of the needle cannula (5).

[0061] FIG. 13 is a side view of the device with the toggle locking mechanism

removed to show the position of the unidirectional double torsion spring (13) in

relation to the needle cannula (5).

[0062] FIG, 14 is a isometric view of the device with the central toggle locking

mechanism removed to show the position of the unidirectional double torsion spring

(13) between the Hub (2) and distal End Cap (3) and over the needle cannula (5).

[0063] FIG. 15 shows an angular configuration of the distal cover segment (7) of the

toggle locking mechanism with a resilient wedge extension (17).

[0064] FIG. 16 shows a side view of the device in an unlocked and arrested needle

(14) delivery position. The resilient wedge extension (17) is engaged and wedges

against the vertical abutting face (9) of the proximal cover segment (6) of the central

toggle locking mechanism. In this position, the end cap (3) has moved towards the

hub (2) thereby exposing the needle tip (14).

[0065] FIG. 17 is a rear view of the device in the dislocated and arrested delivery

position. The resilient wedge extension (17) is shown under tension after being

forced in position by an external digital force and pushing up against the vertical

abutting face (9) of the proximal cover segment (6), exposing the needle tip.

[0066] FIG. 18 is an isometric view again showing the device in its unlocked and

arrested delivery position. The unidirectional double torsion spring (not shown, but

see 13 in Figs. 13 and 14) force urges the central toggle locking mechanism to

extend, thus clamping and retaining the resilient wedge extension (17) in this

position.

[0067] FIG-19 is a rear view of the device with the resiliently biased wedge escaping

(18) at the introduction of the external digital force (16).

[0068] FIG. 20 is an isometric view of the device and shows a digital, axial force (16)

being exerted onto the end cap (3) in Fig. 16). This would take place as the patient's

skin pushes onto the end cap (3). This action relieves the pressure between the

vertical locking face (9) and resiliently biased wedge (17) and causes the resiliently

biased wedge (17) to move as its tension is released.

[0069] FIG. 21 is an embodiment of this device in its arrested delivery position where

the wedge is integrated into a latch disk (not shown) and the locking face is

extended (22) to the side of the proximal cover segment (6). The latch disk is hidden

for clarity.

[0070] FIG. 22 is a side view of the device in its arrested position with the resiliently

biased latch disk (19) wedged up against the extended retention face (22) on the

proximal cover segment (6).

[0071] FIG. 23 is a rear view of the device in its arrested position again showing the

resiliently biased latch disk (19) wedged up against the extended retention face (22)

on the proximal cover segment (6).

[0072] FIG. 24 is a rear view of the device with the resiliently biased latch disk (19) in

its escaped position after the introduction of an external digital force.

[0073] FIG. 25 is a cross sectioned view of the resiliently biased latch disk (19) in its

escaped position.

[0074] FIG. 26 is an isometric view of the distal cover segment (7) with the resiliently

biased Latch disk (19) mounted on it. The latch disk (19) has multiple recess

features (20, 21) on its inside face that allows it to wedge into/ against the proximal

cover segment's said retention face extension when digitally activated. The multiple features add convenience for the user to selectively choose how far they need the needle (14) to extend past said distal end cap (3).

[0075] FIG 27 is an bottom isometric view of the distal cover segment and latch disk

showing the multiple recess features (20, 21) on its inside face.

[0076] FIG. 28 is a side view of the arrested device at its first recessed feature (20 in

Fig. 16) thereby exposing a small portion of the needle cannula (5 in earlier Figures).

[0077] FIG. 29 is a side view of the arrested device at its second recessed feature

(21 in Fig. 16) thereby exposing a longer section of the needle tip (14) from the

cannula (5 in earlier Figures).

[0078] Fig. 30 is an isometric view of an embodiment of the device in its secured and

safe position with a non-reuse clip (23) which is integrated into the proximal cover

segment (6). This non-reuse clip is applied to permanently secure the device in its

safe mode after the invasive procedure to eliminate re-use.

[0079] Fig. 31 is a sectioned side view of the device showing the direction of an

external digital force (24) exerted onto the non-reuse clip to permanently secure the

device in its safe mode to eliminate re-use.

[0080] Fig. 32 is a sectioned view of the device showing the non-reuse clip applied to

permanently secure the device in its safe state to eliminate re-use.

[0081] Fig. 33 shows a perspective view of a device according to the present

invention having a design feature for use with children, in this case the image of an

alligator molded into the front of the device.

[0082] The above descriptions enable practice of the generic scope of the claims. It

is to be noted that specific shapes, materials and relative dimensions in the

disclosure may be altered to implement the device in varying medical fields without

altering the underlying nature and performance of the invention.

[0083] In this specification, the terms 'comprises', 'comprising', 'includes', 'including',

or similar terms are intended to mean a non-exclusive inclusion, such that a method,

system or apparatus that comprises a list of elements does not include those

elements solely, but may well include other elements not listed.

Claims (22)

The claims defining the invention are as follows:

1. A segmented safety cover comprising:

a) a proximal segment combined with a needle hub;

b) a needle cannula that extends from the proximal needle hub to a distal

sharpened end;

c) a distal end cap with a hollow bore through which the needle cannula

passes;

d) a centrally mounted toggle locking mechanism, separating the proximal

needle hub from the distal end cap, hingedly connected to both and maintaining the

segmented safety cover in a safety mode position where it completely covers a

needle tip;

e) wherein the toggle locking mechanism is resistively bias-assisted and

comprises a proximal cover segment and a distal cover segment which overlay the

needle cannula and is linked together through a central hinge;

f) said proximal cover segment and said distal cover segment of said toggle

locking mechanism being configured with abutting faces that contact each other

above said central hinge when the segmented safety cover is in the safety mode;

g) wherein the proximal cover segment is connected to the hub via a proximal

hinge and the distal cover segment is connected to the end cap via a distal hinge;

and

h) wherein the proximal hinge, abutting faces and distal hinge are in line and

the central hinge is below the abutting faces in the safety mode so that a force

exerted on the distal end cap is translated onto the abutting faces above the central

hinge thereby maintaining the device in its locked state, without exposing a needle

out of the needle cannula in the distal end cap from within the needle cannula; wherein the toggle locking mechanism further comprises a torsion double coil spring, wherein a first one coil of the double coil spring is on a first side of the needle cannula and a second one coil of the double coil spring is on a second and opposite side of the needle cannula with respect to the first coil that allows the center hinge to be lowered past said needle cannula without interference by the needle cannula.

2. The segmented safety cover of claim 1 wherein the proximal hinge, distal

hinge and central hinge are configured to form a triangular configuration when the

segmented safety cover is in a delivery mode for the needle within the needle

cannula, and the distal cover segment and the distal end cap are configured to slide

with respect to the needle within the hollow bore.

3. The segmented safety cap of claim 2 wherein upon forming the triangular

configuration, the distal end cap is configured to retract over the needle and towards

the needle hub, and relative to the distal cover, appears to rotate away from the

distal cover segment and expose the injection end of the needle.

4. The segmented safety cover of claim 2 wherein in the safety mode, the distal

cover segment and proximal cover segment are in a locked mode, resisting

movement of the distal cover segment and the proximal cover segment by the

torsion spring.

5. The segmented safety cover of claim 4 wherein two manually operated

pressure plates that overlap sides of the distal cover segment and the proximal cover segment are configured to unlock the locked mode when pressure is applied to the two pressure plates.

6. The segmented safety cover of claim 5 where said pressure plates are

resiliently biased to dislocate from the unlocked mode to return to a locked ready

mode when triggered by said distal end cap when it pushes against a patient's skin

during the injection procedure, wherein said dislocated pressure plates release the

segmented safety cover to return to its original locked mode as the needle is

withdrawn from the patient.

7. The segmented safety cover of claim 5 wherein a second locking mechanism

configured to establish the locked mode extends across a top of the abutting faces of

the distal cover segment and the proximal cover segment.

8. The segmented safety cover of claim 6 wherein the second locking

mechanism comprises a clip on the proximal cover segment that snaps into a

receiving opening on the distal cover segment.

9. The segmented safety cover of claim 6 wherein the second locking

mechanism comprises a clip on the distal segment that snaps into a receiving

opening on the proximal segment.

10. The segmented safety cover of claim 1 wherein the double coil spring

comprises a first extension of the double coil spring extending approximately parallel to the distal segment in the safety mode, and a second extension of the double coil spring extending approximately parallel to the proximal segment in the safety mode.

11. The segmented safety cover of claim 2 wherein the double coil spring

comprises a first extension of the double coil spring extending approximately parallel

to the distal segment in the safety mode, and a second extension of the double coil

spring extending approximately parallel to the proximal segment in the safety mode.

12. The segmented safety cover of claim 1 wherein the needle is present within

the cover, and the segmented safety cover is configured so that the pointed injection

end of the needle is completely covered by the distal end cap when the torsion

spring is secured in the safety mode, and the pointed injection end of the needle is

exposed out of the distal end cap when the safety mode is removed and

compressive force applied by the torsion spring retracts the distal end cap by rotation

of both the proximal cover segment and the distal cover segment about the central

hinge.

13. The segmented safety cap of claim 1 where said safety cover is configured

having a design feature for use with children, with the image of an animal or other

object moulded in front of the device to act as a paediatric distracting feature.

14. A method for enabling injection of fluids using the segmented safety cover

with a needle present within the cover of claim 2 comprising applying force to both

the proximal cover segment and the distal cover segment from the torsion spring to elevate the central hinge and retract the distal end cap to slide the cannula within the distal end cap over the needle to expose the needle; wherein the proximal hinge, distal hinge and central hinge are arranged in the form of an inverted triangle formed by a line connecting said proximal and said distal hinges that lies parallel to the cannula shaft and said central hinge defining a vertex of the inverted triangle below said proximal and distal hinges, and an exposure position for a needle within the cannula is created only when the central hinge is elevated above the line connecting said proximal and said distal hinges from the position of the central hinge as the vertex of the inverted triangle.

15. A segmented safety cover comprising: a) a proximal segment fixed with a

needle hub, said proximal segment also being integrated with a syringe body or a

blood collecting needle;

b) a distal end cap with a hollow bore that covers a cannula shaft through

which a needle may pass;

c) a rigidly interlocked, torsion spring assisted centrally hinged toggle locking

mechanism that covers the cannula shaft, where said center segment comprises a

hollow proximal cover segment and distal hollow cover segment linked through a

central hinge;

d) wherein said proximal cover segment and distal cover segment are

configured with vertical protruding abutting locking faces above said central hinge;

e) wherein a proximal cover segment of said central toggle locking

mechanism is hingedly connected to said proximal segment by a proximal hinge and

said distal cover segment of said central toggle locking mechanism is hingedly

connected to said distal end cap by a distal hinge; f) wherein the proximal hinge, distal hinge and central hinge are arranged in the form of an inverted triangle formed by a line connecting said proximal and said distal hinges that lies parallel to the cannula shaft and said central hinge defining a vertex of the inverted triangle below said proximal and distal hinges; and g) wherein an exposure position for a needle from within the cannula shaft is created only when the central hinge is elevated above the line connecting said proximal and said distal hinges from the position of the central hinge as the vertex of the inverted triangle; wherein the torsion spring comprises a double coil spring, wherein a first one coil of the double coil spring is on a first side of the cannula shaft and a second one coil of the double coil spring is on a second and opposite side of the cannula shaft with respect to the first coil that allows the center hinge to be lowered past said cannula shaft without interference by the cannula shaft.

16. The segmented safety cover of claim 15 wherein said torsion spring is biased

to maintain the central toggle locking mechanism in a locked position.

17. The segmented safety cover of claim 15 where said torsion spring is centered

to and fitted on an inside of said center hinge.

18. The segmented safety cover according to claim 15 wherein said central toggle

locking mechanism includes a resiliently biased wedge mechanism which is

configured to be pressure activated to arrest said toggle locking mechanism in a

temporary unlocked position to enable exposure of said cannula tip prior to the

invasive procedure.

19. The segmented safety cover according to claim 18 wherein said wedge

mechanism comprises a resiliently biased wedge extension mounted on the distal

cover segment or proximal cover segment, and the spring-locked wedge is located

above the center hinge.

20. The segmented safety cap of claim 19 wherein said wedge is configured to be

clamped into a wedged-in position by spring force generated by the torsion spring.

21. The segmented safety cap of claim 19 where the wedge is configured to be

resiliently biased to dislocate from a wedged-in position when pressure applied by

the torsion spring is reduced when said distal end cap pushes against a patient's

skin.

22. The segmented safety cap of claim 18 wherein said resiliently biased wedge

is integrated into a latch disk with single or multiple recess features on an inside face

of the latch disk and a locking face on the wedge that allows it to wedge into/ against

a locking face on the proximal cover segment or distal cover segment when the

wedge is pressure activated.