Safety shield apparatus and mounting structure for use with medical needle devices.

(54) Title: APPARATUS WITH SAFETY COATING AND ASSEMBLY STRUCTURE FOR USE WITH MEDICAL NEEDLE DEVICES.

(54) Title: SAFETY SHIELD APPARATUS AND MOUNTING STRUCTURE FOR USE WITH MEDICAL NEEDLE DEVICES.

(57) Summary

The present invention relates to a safety liner apparatus including a safety liner and mounting structure for mounting the safety liner to a medical needle. The security liner includes a distant segment, a proximal segment, and a retention member. The distant segment is pivotally secured to the proximal segment and the proximal segment is pivotally secured to the retaining member. The retention member includes an opening for receiving a nose from a medical needle device, for example, a blood collection device. In one embodiment, a retaining collar is provided which is dimensioned to fit snugly around the nose of the medical needle device to secure the safety liner to the medical needle device. Alternatively, the mounting structure is formed directly on the retention member to secure the safety liner to the medical needle device.

(57) Abstract

A safety shield apparatus including a safety shield and mounting structure for mounting the safety shield to a medical needle. The safety shield includes a distal segment, a proximal segment and a retention member. The distal segment is pivotally secured to the proximal segment and the proximal segment is pivotally secured to the retention member. The retention member ineludes an opening for receiving a nose of a medical needle device, eg, a blood collection device. In one embodiment, a retaining collar is provided which is dimensioned to be press-fit about the nose of the medical needle device to secure the safety shield to the medical needle device. Alternatively, mounting structure is formed directly on the retention member to secure the safety shield to the medical needle device.

DEVICE WITH SAFETY COATING AND STRUCTURE OF

ASSEMBLY FOR USE WITH MEDICAL NEEDLE DEVICES

FIELD OF THE INVENTION

The present disclosure relates to a safety coated apparatus for use with a medical needle device and, more specifically, to devices and methods of securing a safety coated apparatus to a medical needle device, eg, a collection device of blood.

BACKGROUND OF THE INVENTION

Safety coatings to protect medical device needles are well known in the art. Safety coatings minimize the risks associated with inadvertent needle-bite injuries that doctors, nurses, and medical personnel undergo exposure to HIV, hepatitis, and other serious pathogens of bacterial biological burden.

It is known to incorporate a safety coating on the body of a medical needle. More specifically, it is known to form a safety coated apparatus integrally with a medical needle device, for example, a blood collection device. This method of assurance increases the

Ref. 196863 complexity of the manufacturing process. It is also known

<td>provide</td><td>a cube in</td><td>the</td><td>apparatus</td><td>with</td><td>coating</td><td>of</td>

<td>security the</td><td>which includes</td><td>a</td><td>accessory</td><td>luer</td><td>to ensure</td><td>the</td>

<td>appliance with</td><td>coating</td><td>of</td><td>security</td><td colspan="2">to a device</td><td>of</td>

<td>medical needle</td><td>The cube</td><td>I know</td><td colspan="2">can form</td><td>integrally</td><td> 0</td>

separately from the appliance with safety coating. This method also increases the cost and complexity of the safety coated appliance.

Accordingly, there is a continuing need in the art for safety clad apparatus for use with medical needle devices for a simple, inexpensive belay device for attaching a safety clad apparatus to a medical needle device.

BRIEF DESCRIPTION OF THE INVENTION

In accordance with the present disclosure, a safety clad apparatus is described which includes a safety cladding including a distant segment having a distant end and a proximal end, a proximal segment having a distant end and a proximal end, and a retention member. The proximal end of the distal segment is pivotally connected to the distal end of the proximal segment and the retaining member is pivotally secured to the proximal end of the proximal segment. The retention member includes an opening dimensioned to be slidably received around a nose of a medical needle device so that the distant segment and the proximal segment of the safety liner are manually movable from a retracted position to an advanced position to protect a needle supported on the medical needle device.

In one embodiment, the safety coated apparatus includes a retention element which secures the retention member to the medical needle device.

In one embodiment, the retention member is a retention collar which is dimensioned to be frictionally coupled, for example, snap fit, around the nose of the medical needle device to secure the safety liner to the collection device of blood.

In another embodiment, the opening in the retaining member includes at least one annular rib sized to be received within an annular recess in a nose of a medical needle device. The annular rib can be sized to be received in the annular recess in a tight fit. Alternatively, the opening in the retention member may include at least one annular recess dimensioned to receive an annular protrusion formed in a nose of a blood collection device. The annular recess can be sized to receive the annular protrusion in a tight fit. In one embodiment, at least one annular recess includes a series of recesses. It is also contemplated that the opening in the retaining member may include a series of annular protrusions and annular recesses which are dimensioned to be received in a series of recesses and annular protrusions formed in the nose of the medical needle device.

In one embodiment, the distal segment includes a bottom or bottom wall having an externally extended bearing member thereof and the retaining member includes a wall extension. The bearing member is positioned to rest on the wall extension when the safety liner is in its retracted position. The bearing member may include an angled top surface which engages the wall extension during the initial movement of the safety liner from the retracted position to the forward position to slidably push the distal end of the distant segment into its forward position.

In another embodiment, the distal segment includes an angled extension having a distal end extending externally from the top wall. The angled extension is configured to engage and slide along at least one of the needle and nose of a medical needle device.

The angled extension may include a proximal end which extends from the top wall to a plane defined by the bottom wall. The proximal end of the angled extension can be positioned to engage a needle from a medical needle device when the safety liner is in its advanced position.

In one embodiment, the proximal segment and the distant segment are pivotally connected by a hinge. The hinge can be formed by cooperating elements in the proximal and distant segments. The retention member can be integrally formed with the proximal segment.

In yet another embodiment, the proximal segment and the distant segment are manufactured as a single piece having a thinned transition region which pivotally interconnects the proximal segment and the distant segment with each other. The retention member can also be integrally formed with the proximal and distant segments.

It is contemplated that in one embodiment, the safety coated apparatus can be configured and adapted for use with a blood collector or hypodermic needle.

In accordance with another aspect of the present disclosure, a manually advanced security cladding apparatus is described which includes a safety cladding having a distant segment having a distant end and a proximal end, a proximal segment having a distant end, and a proximal end, and a retaining member. The proximal end of the distal segment is pivotally connected to the distal end of the proximal segment and the retaining member is pivotally secured to the proximal end of the proximal segment.

The retention member includes an opening dimensioned to be slidably received around a nose of a medical needle device such that the distant segment and the proximal segment of the safety liner are manually movable from a retracted position to an advanced position to protect a needle supported on the medical needle device.

The safety liner additionally includes a retaining collar sized to be frictionally coupled around the nose of the medical needle device to secure the safety liner to the medical needle device. The distal segment includes an angled extension that has a distal end extended externally from the upper wall. The angled extension is configured to engage and slide along at least one of the needle and nose of the medical needle device during movement of the safety liner to the advanced position.

In one embodiment, the distant segment of the safety liner includes a body portion having an upper wall, a lower wall, and a bearing member extending externally from the lower wall. The retaining member includes a wall extension, where the bearing member is positioned to rest on the wall extension when the safety liner is in the retracted position.

In another embodiment, the proximal segment and the distant segment are pivotally connected by a hinge. The hinge can be formed by cooperating elements in the proximal and distant segments. The retention member can be integrally formed with the proximal segment.

In yet another embodiment, the proximal segment and the distant segment can be manufactured as a single piece having a thinned transition region which pivotally interconnects the proximal segment and distant segment with each other. The retention member can also be integrally formed with the proximal and distant segments.

In one embodiment, the distant segment may include a strain relief feature formed therein.

BRIEF DESCRIPTION OF THE FIGURES

Various modalities of the apparatus with safety cladding and mounting structure currently described are

<td>describe</td><td>in the</td><td>Present</td><td>with</td><td>reference</td><td>to the figures, in</td>

<td>where:</td><td colspan="2">Figure 1 is</td><td>a</td><td>view in</td><td>perspective of a</td>

<td>modality</td><td>of the</td><td>apparatus</td><td>with</td><td colspan="2">safety coating</td>

currently described secured to a blood collection device and includes a sheath that protects the needle;

Figure IA is a perspective view of the distant end of a blood collection device in accordance with another embodiment of the present disclosure;

Figure IB is an enlarged view of an indicated area of ​​detail shown in Figure IA;

Figure 2 is a cross-sectional view of the blood collection device and safety liner shown in Figure 1 with the safety liner in a fully retracted position;

FIG. 3A is a bottom perspective view of the distant segment of the safety clad apparatus shown in FIG. 1;

FIG. 3B is a top perspective view of the distant segment of the safety clad apparatus shown in FIG. 3A;

FIG. 3C is a bottom perspective view of a distant segment of the safety clad apparatus shown in FIG. 1, in accordance with another embodiment of the present disclosure;

Figure 3D is a top perspective view of the distant segment of Figure 3C;

Figure 4 is an enlarged view of the indicated area of ​​detail shown in Figure 3B;

FIG. 5 is a bottom perspective view of the proximal segment and retention member of the safety-coated apparatus shown in FIG. 1;

Figure 5A is a top perspective view of a proximal segment and retaining member, in accordance with another embodiment of the present disclosure, for the safety clad apparatus shown in Figure 1;

<td></td><td>The</td><td>figure</td><td>6 is</td><td>a sight</td><td>in</td><td>cross section</td>

<td>side</td><td colspan="2">taken at</td><td>long</td><td colspan="2">of the lines</td><td>section 6-6 of the</td>

<td>figure</td><td> 5;</td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>figure</td><td>7 is</td><td>a sight</td><td>in</td><td>cross section</td>

<td>side</td><td colspan="2">taken at</td><td>long</td><td colspan="2">of the lines</td><td>of section 7-7 of the</td>

<td>figure</td><td>3A;</td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>figure</td><td>8 is</td><td>a sight</td><td>in</td><td>cross section</td>

<td>side</td><td>of the</td><td colspan="2">device</td><td>collection</td><td>of</td><td>blood and apparatus with</td>

<td colspan="5">safety liner shown</td><td>in</td><td>figure 2 with the</td>

<td>apparatus</td><td>with</td><td colspan="5">safety liner in one position</td>

partially advanced;

FIG. 9 is a side cross-sectional view of the blood collection device and safety liner shown in FIG. 8 with the safety liner in a more advanced position;

Figure 10 is a side cross-sectional view of the blood collection device and safety liner shown in Figure 9 with the safety liner in a fully advanced position;

Figure 11 is an enlarged view of the cantilevered tabs of the proximal segment of the safety-coated apparatus when the cantilevered tabs are deformed by the blood collection device;

Figure 12 is an enlarged view of the cantilevered tabs of the proximal segment of the safety-coated apparatus with the cantilevered tabs positioned within the recesses formed in the blood collection device;

Figure 13 is a top perspective view of an alternate embodiment of the safety liner apparatus shown in Figure 1;

<td>The</td><td>figure 14 is</td><td>a</td><td colspan="2">perspective view of</td><td>a</td>

<td>ring of</td><td>interlocking</td><td>for</td><td>secure the</td><td>apparatus</td><td>with</td>

<td>coating</td><td>of security</td><td>yet</td><td>device</td><td>collection</td><td>of</td>

blood;

FIG. 15 is a side cross sectional view of the safety coated apparatus shown in FIG. 13 secured to a blood collection device with the interlocking ring in FIG. 14;

Figure 16 is an enlarged view of the indicated area of ​​detail shown in Figure 15;

Fig. 17 is a perspective view of another embodiment of the currently described safety liner apparatus, a blood collection device and sleeve, shown with separate parts;

Figure 18 is a side cross-sectional view of the safety-lined apparatus, blood collection device, and sheath shown in Figure 17 assembled;

Figure 19 is an enlarged view of the indicated area of ​​detail shown in Figure 18;

FIG. 20 is a perspective view of yet another embodiment of the currently described safety liner apparatus;

Figure 21 is a cross-sectional view of the safety-coated apparatus shown in Figure 20 secured to a blood collection device;

Figure 22 is an enlarged view of the indicated area of ​​detail shown in Figure 21;

Figure 23 is a perspective view of yet another embodiment of a safety-coated apparatus secured to a blood collection device and includes a sheath that protects a needle therefrom;

FIG. 24A is a top perspective view of a safety liner in accordance with another embodiment of the present disclosure;

Figure 24B is a top plan view of the security liner of Figure 24A;

Figure 24C is a side elevation view of the safety liner of Figures 24A-24B;

Figure 24D is a bottom plan view of the security liner of Figures 24A-24C;

Figure 24E is a front elevation view of the safety liner of Figures 24A-24D;

Figure 24F is a rear elevation view of the safety liner of Figures 24A-24E;

Figure 25 is an exploded perspective view of a hypodermic needle syringe including a safety liner in accordance with one embodiment of the present disclosure;

FIG. 26A is a top perspective view of a safety liner in accordance with yet another embodiment of the present disclosure, shown in an extended condition;

Figure 26B is a top plan view of the safety liner of Figure 26A;

Figure 26C is a side elevation view of the safety liner of Figures 26A-26B;

Figure 26D is a bottom plan view of the safety liner of Figures 26A-26C; and

Figure 26E is a top perspective view of the safety liner of Figures 26A-26D, shown in a folded condition.

DETAILED DESCRIPTION OF THE INVENTION

The embodiments of the safety clad apparatus and mounting structure currently described will now be described in detail with reference to the figures where similar reference numerals designate identical or corresponding elements in each of the various views.

In this description, the term proximal is generally used to indicate relative proximity of a referenced point to a user of the device, and the term distant is used to indicate relative distance of a referenced point to a user of the device.

Figure 1 illustrates a blood collection device 10 having a safety liner 12 mounted thereon and a removable sheath 14 positioned around a needle 16 (Figure 2) of the collection device 10. The blood collection device 10 includes a blood collection barrel 11 which defines a cylindrical chamber 18 which is dimensioned to receive a blood collection vial (not shown). A proximal end of needle 16 (not shown) is positioned within cylindrical chamber 18 and configured to pierce a stopper supported at one end of the blood collection vial.

As shown in Figures IA and IB, the blood collection barrel 11 includes a finger flange lia, a pair of spaced towers or extensions 11b and a nose 11c.

Nose 11c defines a through hole perforation (figure IB) which is dimensioned to receive and frictionally retain needle 16 (figure 2) therein. In one embodiment, the finger flange lia is dimensioned or sized to facilitate the creation of a positive seal between a proximal face 13 (figure 1) of finger flange lia and a removable lid lid (figure 1) secured to the proximal face 13 of the finger flange lia. The removable lid lid can be secured to the finger rim by using an adhesive or the like and can function to prevent dust or debris from entering the cylindrical chamber 18 or as a sterile barrier which ensures the sterility of the cylindrical chamber 18.

The spaced extensions 11b are positioned on opposite sides of the nose 11c and include lie recesses (figure

IB) which will be discussed in additional detail later. The inner walls at the distal end of extensions 11b define surfaces llf to frictionally engage a proximal projection 14a of sheath 14 to secure sheath 14 around needle 16. At least one of the extensions 11b includes a groove / indentation / depression / recess llg that defines a location where a hot tool can be applied to the hot minced boss 14a of the sheath 14 to at least one of the extensions 11b, therefore which cover 14 is se cured to barrel 11. The heat spike provides the clinician with an indication that device 10 is new or unused and that cover 14 has not been previously removed or altered.

Each extension 11b may include finger grip sections llh (FIG. 1) defined by an area of ​​ridges, ribs, knurling, roughness, etc. The finger grip sections llh provide the clinician with relatively increased grip, manipulation, and clamping capabilities of the blood collection barrel 11, and, in turn, device 10. Returning momentarily to Figures IA and IB, in an alternate mode, the outer surface of each extension 11b may be smooth or un knurled.

With continued reference to Figure 1, each extension 11b may include a cam, trim, recess, or the like surface formed at a more distant corner thereof. The cam surface works to assist in removing the sleeve 14 from the barrel 11. In particular, in use, to remove the sleeve 14 from the barrel 11, the sleeve 14 is rotated with respect to the barrel 11 (as indicated by date A of Figure 1) until at least one wing or projection 14b of the sleeve 14 engages the cam surface lie. Continuous rotation of sheath 14 relative to barrel 11, in the direction of arrow A, results in cam actuated projections 14b against a respective cam surface lie and movement of sheath 14 in an axial direction away from barrel 11 (as indicated by arrow B in figure 1) facilitating the separation of the sleeve 14 from the barrel

eleven. During the rotation of the sheath 14 relative to the barrel

11, the heat state between the projection 14a of the sheath 14 and the extension 11b of the barrel 11 breaks as a result of the shear forces exerted on them.

Referring generally to Figures 2-7, the safety coated apparatus 12 includes a distant segment 20, a proximal segment 22, and a retaining member or leg 24. The distant segment 20, which is shown in Figures 3A, 3B and Figure 7 includes a body portion 26 having a distal end 26a and a proximal end 26b. A link member 28 is integrally formed with distal segment 20 at proximal end 26b thereof.

Alternatively, the link member 28 can be formed as a separate component of the distal segment 20 which is secured thereto. Additionally, joint member 28 can be formed as a thinned transition region and act as a living joint which is integrally formed between distant segment 20 and proximal segment 22. In this embodiment, hinge member 28 includes a pair of externally directed pivot members 28a to which a distal end of proximal segment 22 is coupled to pivotally secure distal segment 20 to proximal segment 22 as will be discussed in further detail below. Body portion 26 defines a longitudinal channel 30 which extends through hinge member 28 along the length of body 26 to a distant wall 32 of distant segment 20. Channel 30 is sized and configured to receive the needle 16 (figure 2).

The body portion 26 has an upper wall 34 (Figure 3B) which extends from the proximal end 26b of the distal segment towards the distal end 26a. Top wall 34 terminates at an angled extension or hood 36. In one embodiment, hood 36 includes a curved distal end 36a and proximal end 36b (Figure 7). While the proximal end 36b of the hood 36 is shown linearly extended with the distal end 36a, it is contemplated that the proximal end 36b need not extend linearly from the distal end 36a but may extend at an angle to the distal end 36a. Alternatively, the proximal end 36b of the hood 36 can be replaced by any wall (not shown) extending downwardly from an internal surface of the body portion 26 at any location along a length of the body portion 26. Hood 36 is positioned to engage and slide along at least one of nose 11c and needle 16 when safety coated apparatus 12 is moved from a retracted position to an advanced position as will be discussed in further detail below.

In one embodiment, body portion 26 also includes a bottom wall 38 (Figure 3A) positioned at distal end 26a of distal segment 20. A cam or bearing member 40 which includes an angled surface 40a is formed on the bottom wall. 38. The bearing member

40, as will be discussed in further detail below, reduces or minimizes the likelihood of binding or bonding of the safety liner 12 in its retracted position. A through hole or piercing 41 is formed in the distal segment 20 between the hood 36 and bottom wall

38.

Momentarily referring to Figures 3C and

3D, in an alternate embodiment, a neck portion 28b, which interconnects body portion 26 and hinge member 28, of distal segment 20 can be provided with a strain relief feature in the form of an opening 28c formed in a surface of the same. The aperture 28c can be any suitable geometry including and not limited to rectangular (where the longitudinal axis of the aperture is axially aligned with a longitudinal axis of the distant segment, or where the longitudinal axis of the aperture is transverse to the longitudinal axis of the distant segment) , circular, oval or the like.

Opening 28c functions as a strain relief hole, where opening 28c is configured and dimensioned to cause neck portion 28b to structurally fail prior to pivot members

28a fail when the forces applied to the distant segment exceed a predetermined threshold level. Additionally, the opening 28c can be configured and dimensioned to cause the neck portion 28b to flex prior to the pivot members 28a flexing when the forces applied to the distal segment 20 exceed a predetermined threshold level.

Body portion 26 also includes interlocking tabs 42 (Figure 4) and a series of ribs 44.

The locking tabs 42 are positioned on opposite sides of the distal segment 20 to releasably secure the safety clad apparatus 12 in its retracted position as will be discussed later. Ribs 44 provide stiffness to distant segment 20.

Referring also to Figures 5 and 6, proximal segment 22 includes a body 46 having a distal end 46a and proximal end 46b. Body 46 includes an upper surface 48 (Figure 6) and a pair of spaced side walls 50a and 50b. The spaced side walls 50a and 50b define a channel 52 which is dimensioned to receive the distant segment 20 when the safety clad apparatus 12 is in its retracted position. Channel 52 also allows passage of nose 11c of blood collection device 10 and needle 16. Distal end 46a of proximal segment 22 includes an opening 56 formed in each side wall 50a and 50b. The openings 56 are sized to receive pivot members 28a of the link member 28 (FIG. 3A) to pivotally secure the distal segment 20 to the proximal segment 22. As discussed above, link member 28 and openings 56 can be replaced with a living link. Each side wall 50a and 50b of proximal segment 22 also includes a cantilevered tab 58 and a cutout 60. Cantilevered tabs 58 are positioned to be received within the recesses lie of the blood collection device 10, as will be discussed in greater detail below, to lock the safety coated apparatus 12 in an advanced position. Each cutout 60 is positioned to receive a respective tab 42 (FIG. 3B) of the distal segment 20 to releasably secure the safety liner 12 in its retracted position.

In one embodiment, the upper surface 48 of the body 46 of the proximal segment 22 includes a thumb engagement member 62 which is ribbed to provide a slip resistant thumb engagement surface 64. The side walls

50a and 50b also include ribs 65 to provide rigidity to the side walls 50a and 50b of proximal segment 22.

Retaining member 24 is formed monolithically or integrally with proximal segment 22 and is hingedly connected to proximal end 46b of proximal segment 22 by a living link 66. Alternatively, retaining member 24 and proximal segment 22 may be separately formed. and pivotably attached with a separate link member. Retaining member 24 includes base portion 68 which defines a mounting hole 70 for securing safety coated apparatus 12 to blood collection device 10 as will be discussed in further detail below. Retaining member 24 also includes a distal wall 72, a proximal wall 74, and a pair of side walls 76. The distal wall 72 is integrally connected to the living link 66 to pivotally secure the retaining member 24 to the proximal segment 22. The proximal wall 74 includes a cantilevered extension 77 which defines a shelf in which the upper surface 40a of the bearing member 40 rests when safety coated apparatus 12 is in its retracted position. Side walls 76 and top and bottom walls 72 and 74 define a box-like structure around base portion 68 to provide strength and rigidity to retaining member 24.

Referring momentarily to FIG. 5A, in an alternate embodiment, proximal section 22 may be provided with a rib 76a projecting from one surface of each side wall 76 and extending in a direction substantially parallel to a center axis of mounting hole 70. In use, when the proximal section 22 is secured to the blood collection barrel 11, the ribs

76a slidably engage (eg, snap fit with) an inner surface of a respective extension 11b of the blood collection barrel 11 (see Figures IA and IB), providing increased stability therebetween.

Referring to FIGS. 2, in its retracted position, the safety coated apparatus 12 is supported in the blood collection device 10 such that the longitudinal axes of the proximal segment 22 and distant segment 20 are substantially perpendicular to a longitudinal axis of needle 16. In the retracted position of the safety liner 12, the tabs 42 of the distal segment 20 are releasably positioned within the cutouts 60 of the side walls 50a and 50b of the proximal segment 22 to releasably engage the liner. safety in its retracted position. Furthermore, the upper surface 40a of the bearing member 40 rests on the cantilevered extension 77 of the lower wall 74 of the retaining member 24.

Referring to Fig. 8, the safety coated apparatus 12 is moved from its retracted position to its distant position by manually pressing a thumb engaging surface 64 of the proximal segment 22 in the direction indicated by arrow A. As illustrated , the thumb engaging surface 64 defines an angled surface such that the pressure on the surface 64 creates a force having both a horizontal and vertical component. The vertical component slidably pushes the upper surface 40a of the bearing member 40 over the extension 77 of the lower wall 74 of the retaining member 24. Since the upper surface 40a is angled as illustrated in FIG. 8, the engagement between the upper surface 40a and extension 77 pushes the distant end 26a of the distant segment 26 externally in the direction indicated by arrows B. When this occurs, the tabs 42 are forced from the cutouts 60, the distal end 26a moves distally along the nose 11c of the barrel 1 and the proximal end 26b of the distal segment 20 pivots relative to the distal end 46a of the proximal segment 22.

In the retracted position of the safety liner apparatus 12 for the embodiment shown in Figures 2 and 8, the hood 36 is spaced from the nose 11c of the blood collecting barrel 11 and needle 16.

Alternatively, the hood 36 rests against the nose 11c after the sheath 14 is removed and aids the sliding thrust of the distal end 26a of the distal segment 26 externally in the direction indicated by arrows B.

Referring to Figure 9, when the safety coated apparatus 12 is moved in the direction indicated by arrow C to its advanced position, the upper surface 40a of bearing member 14 is moved out of extension 77 and a distant edge 36a of the hood 36 of the distant segment 26 moves in engagement with the needle 16 to guide the distant segment 26 along the needle 16. When the distant segment 26 is moved further away, an internally extended or proximal portion of the hood 36 moves along the needle 16 until only the proximal edge 36b of the hood 36 engages the needle 16 when the security is in its advanced position. See figure 10.

As illustrated in Figures 11 and 12, when the distant segment 26 is moved to its advanced position, the cantilevered tabs 58 of the proximal segment 22 engage an internal wall of the blood collecting barrel extensions 11b 11 and are initially externally deflected (figure

11) prior to rapid placement in lie recesses of barrel 11 (Figure 12). The tabs 58 are positioned within the recess lie to lock the safety clad apparatus 12 in its advanced position. As illustrated in Figure 10, in the advanced position of the safety liner 12, the needle 16 extends along the channel 30 so that the distal end 16a of the needle 16 is positioned behind the distal wall 32 of the distant segment 26 adjacent to the lower wall 38.

FIG. 13 illustrates an alternate embodiment of the currently described safety jacket apparatus generally shown as 112. The safety jacket apparatus 112 is similar to the safety jacket apparatus 12 and includes a distant segment 120, a proximal segment 122 and a member Retainer 124. Proximal segment 122 is pivotally secured to distant segment 120 by a thinned transition region or living joint 126. The safety jacket apparatus 112 operates in a manner substantially similar to the safety jacket apparatus 12 discussed above. Accordingly, the operation of the safety liner apparatus 112 will not be discussed in detail herein.

FIG. 14 illustrates a retaining collar 140 for mounting the safety coated apparatus 112 to a blood collection device 110 (see FIGS. 15 and 16). More specifically, the retaining collar 140 includes an annular body 142 having an inner annular portion 142a and an outer annular portion 142b joined together by a posterior distance 142c. The inner annular portion 142a defines a diameter dimensioned to be received around a proximal portion of the lile nose of the blood collection device 110.

For mounting the appliance with safety liner 112 on the blood collection device

110, the retaining member 124, which defines an opening

124a (Figure 13), it is positioned around the lile nose of the blood collection device 110 as illustrated in Figures 15 and 16. The retaining collar 140 is then pressed onto and along the lile nose to capture the retention member 124 between the retention collar 140 and a distal face llld of the blood collection device 110. The tight fit fit between the inside diameter of the retaining collar 140 and the outside diameter of the nose nose provides secure attachment of the safety liner 112 to the blood collection device 110. The safety liner 12 is noted. shown in Figures 1-12 is mounted on the blood collection device 10 using a retaining collar 90. See Figures 8-10. Retaining collar 90 is substantially identical to retaining collar 140.

Figures 17-19 illustrate an alternate method and structure for securing a safety coated apparatus 212 to a blood collection device 210. More specifically, the blood collection device 210 includes a distant face 210a which includes a plurality of openings 210b. Retaining member 224 of safety coated apparatus 212 includes a plurality of projections 212a. In one embodiment, projections 212a include a tapered tip and are dimensioned to snap into openings 210b to secure the safety clad apparatus 212 to blood collection device 210. Although three openings 210b and three projections 212a are illustrated, It is contemplated that one or more openings and projections can be provided, for example, one, two, four, etc. It is also contemplated that openings may be formed in the retention member and projections may be formed in the blood collection device. As illustrated in Figures 17 and 18, the assembled device may include a protective sleeve

214.

Figures 20-22 illustrate yet another method and structure for securing a safety liner 312 to a blood collection device 310. In this embodiment, the retention member 324 of the safety liner 312 includes an opening 324 to the which defines one or a series of recesses and / or ribs or annular protrusions 330. The nose 311c of the blood collecting device 310 also includes one or a series of recesses and / or annular ribs 340 which are positioned to engage with the recesses and / or annular ribs 330. In this embodiment, opening 324a defines a series of recesses and ribs 330 and nose 311c includes a series of recesses and ribs 340. To mount the safety-coated apparatus 312 to the blood collection device 310, the retaining member 324 is press fit onto the nose 311c of the blood collection device 310 to position the recesses and ribs 330 in mating alignment with the recesses and annular ribs 340. The tight fit between the annular ribs and annular recesses provides secure attachment of the blood collection device 310 and the safety clad apparatus 312. It is noted that although the ribs and recesses are illustrated as being gently curved other configurations are contemplated, by example, rectangular recess protrusions. Furthermore, only the recesses can be provided in the retaining member 324 and the protrusions or ribs in the nose 311c of the blood collection device 310, or vice versa. In addition, rebates and

<td>ribs no</td><td>They need to be</td><td>coupled</td><td>in a setting</td><td>by</td>

<td>squeeze but</td><td>rather I know</td><td>they can</td><td colspan="2">unite in a way</td>

<td>intertwined.</td><td></td><td></td><td></td><td></td>

<td>The</td><td>Figures 23-24F</td><td>illustrate</td><td>a device</td><td>of</td>

<td>collection of</td><td>blood 400</td><td colspan="2">who has a device</td><td>with</td>

<td>coating</td><td colspan="2">safety 412 mounted</td><td colspan="2">in this and a case</td>

<td>removable 414</td><td>positioned</td><td>around</td><td>of a needle</td><td>(not</td>

<td>shown). The</td><td colspan="2">coated appliance</td><td>security 412</td><td>of the</td>

Blood collection device 400 is substantially similar to the safety coated apparatus 112 of blood collection device 110 and therefore will only be discussed in detail herein to the extent necessary to identify differences in construction and / or operation thereof.

As seen in Figures 23-24F, the safety liner 412 includes a proximal segment 44 pivotally secured to a distant segment 420 by a thinned transition region or living joint 426. The safety liner 412 operates in a manner substantially similar to the safety clad apparatus 12 and 112 discussed above.

As best seen in Figures 24A and 24C, distal segment 420 includes an embossed pad or the like 426d projected from an external surface of each side wall 426d of body portion 426. Embossed pads 426d can be placed under or they are in register with the locking tabs 442 of the body portion 426. The embossed pads 426d have a substantially triangular profile where a wider and / or thicker portion thereof is located close to the respective locking tab 442. The embossed pads 426d function to create a frictional engagement with a respective inner surface of a side wall 446c of the body 446 of the proximal segment 422, when the safety clad apparatus 412 is in a retracted position, as shown in Figure 23 . The degree of friction or tightness between the embossed pads 426d against the internal surfaces of the side walls 446c of the body 446 of the proximal segment 422 is adjusted based on the dimensions of the embossed pads 426d (eg, height, width, or thickness) and the distance between the side walls 446c of the body 446.

As seen in FIG. 24D, the distant segment 420 of the safety coated apparatus 412 includes a series of ribs 444 placed on either side of an internal surface thereof and, in turn, defining the longitudinal channel 430. The longitudinal channel 430 extends through hinge member 426 along the length of proximal segment 422. Channel 430 is sized and configured to receive needle 16 therein (Figure 2).

As seen in Figures 24A-24F, proximal segment 424 of safety liner 412 includes a rib 476a projecting from one surface of each side wall 476 thereof. In use, when the proximal section 422 is secured to the blood collection barrel 411, the ribs 476a are slidably coupled (eg, press fit) to an internal surface of a respective extension 411b of the blood collection barrel 411, providing increased stability between these.

Returning now to Figure 25, a hypodermic needle syringe including a safety-coated apparatus, in accordance with one embodiment of the disclosure, is generally designated 500. Syringe 500 includes a syringe barrel 502, a plunger rod 504. slidably available within syringe barrel 502, and a plug 506 selectively supportable at a distal end of plunger rod 504.

As seen in FIG. 25, syringe barrel 502 is configured and adapted to support a safety coated apparatus 510 at a distant end 502a thereof. The security-coated apparatus 510 can be constructed and operated in accordance with any of the security-coated apparatus described herein above. The distal end 502a of the syringe barrel 502 is also configured and adapted to support a sleeve 514 which removably covers a hypodermic (not visible) needle cannula. Needle barrel 502 preferably includes graduation marks 530 in milliliters.

The syringe 500 further includes a plunger rod 504 having an elongated plunger shaft 504a configured and dimensioned for sliding arrangement within a cavity of the syringe barrel 502. A distal end 504b of the plunger shaft 504a can be configured and dimensioned to support plunger 506 on it. The distal end 504b may include a hub 504c distally extended therefrom and a pair of tabs 504 radially extended externally of the hub 504c.

In one embodiment, hub 506 includes a base wall, a pair of spaced apart supports 506a extending from a first surface thereof and defining a space therebetween to selectively receive and engage tabs 504d of plunger rod 504. The Plunger 506 may include a support member 506b extending from a second surface thereof, opposite the first surface. The plunger 506 additionally includes a resilient plunger tip 507 supported on the mime support member 506. Plunger tip 507 includes a proximal surface (not shown) configured and adapted to selectively engage plunger support member 506b 506 in a quick-fit coupling.

The security coated apparatus 512 operates in a manner substantially similar to the security coated apparatus 12 and 112 discussed above and therefore will not be discussed in further detail herein.

Returning now to Figures 26A-26E, a safety coated apparatus, in accordance with another embodiment of the present disclosure, is shown as 612. Safety coated apparatus 612 is substantially similar to safety coated apparatus 412 and by Therefore it will only be discussed in detail here to the extent necessary to identify differences in construction and / or operation thereof.

As seen in Figures 26A-26E, the safety coated apparatus 612 includes a proximal segment

622 pivotally secured to a distant segment 620 by a thinned transition region or living joint 627. The safety jacket apparatus 612 operates in a substantially uniform manner to the safety jacket apparatus 12, 112 and 412 discussed above.

Distant segment 620 includes a body portion 626 having a distal end or wall 626a and a proximal end or wall 626b. As seen in Figures 26A,

26C and 26E, proximal wall 626b is inclined or angled with respect to a longitudinal axis X of safety clad apparatus 612. In one embodiment, proximal wall 626b defines an angled a (see Figure 26C) with respect to longitudinal axis X It is contemplated that the angle a may be between about 20 ° and 40 °, preferably about 30 °.

Thus, when the safety liner 612 is in an extended condition, if a force is applied to the distal end 626a, in the direction of arrow F (eg, transverse to the longitudinal X axis and along a lower surface of the distant segment

620), the distal segment 620 can bend along the living link 627 until the proximal wall 626b contacts a distal wall 664a of the proximal segment 622.

With continued reference to Figures 26A-26E, and in particular Figures 26A, 26B, and 26D, proximal wall 626b of distant segment 626 defines an opening or window 626c formed therein and extending entirely therethrough.

Opening 626c functions as a strain relief hole, where opening 626c is configured and sized to cause proximal side walls

626d of the distant segment 626 are structurally deformed before the living link 627 fails when the forces applied to the distant segment 629 exceed a predetermined threshold level.

It will be understood that various modifications can be made to the modalities described herein. Although the foregoing description is described in association with a blood collection device, it is contemplated that the currently described mounting structure and safety apparatus can be used with other medical needle devices, eg syringes, hypodermic needles, equipment needles wings, blood drawing needles, etc. Therefore, the above description should not be construed as limiting, but only as exemplifications of the preferred modalities. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

It is noted that in relation to this date, the best method known by the applicant to put the aforementioned invention into practice is the one that is clear from the present description of the invention.