Blood collection device with needle protection

ES 2 265 071 T3

DESCRIPTION

Blood collection device with needle protection.

Field of the invention

The invention relates to a medical device with a needle for the extraction or infusion of liquids and with a hinged shield to safely cover the medical device.

Background of the invention

Disposable medical devices having piercing elements for administering a medication or withdrawing a liquid, such as hypodermic needles, blood collection needles, liquid handling needles, and assemblies thereof, require safe and convenient handling. Piercing elements include, for example, pointed needle cannulas or blunt end cannulas.

The medical devices described above often include a pair of flexible plastic wings mounted on or near the needle barrel. The wings can be folded into an opposite fit, and thus define a convenient handle for holding and manipulating the needle cannula. The wings can also be separated from each other by rotating them and can be taped in face-to-face contact with the patient's skin.

Accidental sticks with a needle cannula can be painful and can transmit disease. As a result, most needle assemblies are employed with rigid means to cover the needle cannula both before use and after use. Protection prior to use is typically achieved by a rigid plastic tube having a proximal end friction mounted to the needle barrel and a distal end extending beyond the distal end of the needle cannula. The plastic tube is removed and discarded immediately before using the needle cannula. Post-use protection of the needle cannula is typically achieved by a shield that can be moved relative to the needle cannula from a first position where the needle is exposed to a second where the needle cannula is secure within. protection. Guards of this type typically include means for releasing the shield in its first position and for securing the shield more securely in its second position. Retention of the shield in its second position should prevent any re-exposure of the used needle cannula and preferably should prevent or substantially complicate an intentional attempt to reuse the needle cannula.

There is a demand for a medical device that provides safe protection and easy operation. By way of example, document US-5,147,319 refers to a needle with wings comprising a base to which the needle is attached, wings, which can be bent to cover the needle, in which a part of the protection of the wings wraps the needle on all sides, when the wings are bent, and a coupling device, which couples the wings.

US 2001/0039401 refers to a medical needle guard apparatus for covering a needle after use, in which a guard with two or more segments hingedly connected to each other can be moved from a retracted position, in which needle is exposed, to an extended position, in which the shield extends beyond the end of the needle, and wherein the needle is attached to a barrel of a medical needle device and the shield is hinged relative to the barrel. Summary of the invention

The invention relates to a liquid extraction or infusion equipment. The liquid extraction or infusion set comprises a length of flexible plastic tubing with opposite proximal and distal ends and a conduit extending between the ends. An accessory is securely connected to the proximal end of the flexible plastic tube.

The liquid extraction or infusion set further comprises a safety needle assembly attached to the distal end of the flexible tube. The needle assembly includes a needle barrel with a proximal end, a distal end, and a conduit extending between the ends. Portions of the conduit adjacent the proximal end of the barrel are configured for secure fit with the distal end of the flexible plastic tubing.

The needle assembly further includes a needle cannula having opposite proximal and distal ends and a lumen extending between the ends. The proximal end of the needle cannula is securely attached to the distal end of the needle barrel so that the lumen through the needle cannula communicates with the conduit through the needle barrel and with the conduit through the needle barrel. flexible tube. The needle assembly may further include a needle shield removably mounted on the needle cannula and extending sufficiently to cover the distal end of the needle cannula.

The needle assembly further includes a pair of flexible wings that extend transversely from the needle barrel. The wings can be formed separately from the needle cylinder and can be mounted on a part of the needle cylinder. Thus, the needle cylinder can be formed of a first plastic material selected for its rigidity, while the wings can be formed of a second plastic or elastomeric material selected for its flexibility. Alternatively, the wings can be unitary with the cylinder, and thinned portions of the wings adjacent to the cylinder can function as hinges.

The needle assembly may further comprise a safety shield hingedly connected to the needle barrel for rotation from a first position in which the needle cannula is exposed for use to a second position in which the needle cannula is safely enclosed within the protection. The shield may comprise means for permanently locking the shield in the second position. The locking means may comprise at least one resiliently deflectable cannula projection lock which engages in fit with the needle cannula when the shield reaches the second position. Alternatively, or additionally, the locking means may comprise means for lockingly adjusting the needle barrel and / or the plastic tubes.

The locking means may comprise a first locking means for releasably holding the shield in the first position and

ES 2 265 071 T3 a second locking means for permanently holding the guard in the second position. The first locking means functions to prevent the shield from interfering with normal use of the needle assembly. However, the second locking means permanently protects the needle cannula after use and essentially prevents intentional or unintentional re-exposure of the used needle cannula.

The shield may be hinged to rotate about an axis orthogonally aligned with the needle cannula. The axis of rotation of the shield may be substantially parallel to the wings when the wings are rotated to their substantially coplanar orientation on the respective opposite sides of the cylinder. Alternatively, the axis of rotation of the shield may be aligned substantially normal to the wings when the wings are in their coplanar orientation and project from opposite lateral sides of the needle cylinder.

The needle assembly may further include biasing means to drive the shield to the second position. The biasing means may be unitary formed with the hinge connection of the needle assembly guard. More particularly, the biasing means can be over-center hinges that initially bias the guard towards the first position. However, sufficient rotation of the guard will move the over-center linkage to a position where the link urges the guard to the second position. Alternatively, the biasing means may comprise a separate spring having a first part attached to the needle cylinder and a second part attached to a location on the shield. The spring connections to the guard and cylinder are separated from the hinge connection between the guard and the cylinder.

The needle assembly may further include a dorsal fin that protrudes from the needle barrel at a location angularly spaced from the wings. The dorsal fin can be used to facilitate digital manipulation of the needle assembly during a medical procedure. The dorsal fin may include or be connected to the shield. Therefore, the forces exerted on the dorsal fin after use can allow the shield to move from the first position to the second position.

Brief description of the drawings

Figure 1 is a perspective view of a first embodiment of the invention with the guard in an open position.

Figure 2 is a perspective view similar to Figure 1, but showing the guard in a closed position.

Figure 3 is a cross-sectional view taken along 3-3 in Figure 2.

Figure 4 is a cross-sectional view similar to Figure 3, but showing a second embodiment.

Figure 5 is a cross-sectional view similar to Figures 3 and 4, but showing a third embodiment.

Figure 6 is a perspective view of a safety needle assembly according to a fourth embodiment.

Figure 7 is a cross-sectional view similar to Figures 3-5, but showing the embodiment of Figure 6.

Figure 8 is a partially sectional side elevation view of a safety needle assembly according to a fifth embodiment of the invention.

Figure 9 is a side elevational view of the assembly illustrated in Figure 8, but showing the shield in the closed position.

Figure 10 is a cross-sectional view taken along line 10-10 in Figure 9.

Figure 11 is a perspective view of the safety needle assembly according to a sixth embodiment of the invention.

Figure 12 is a perspective view of the safety needle assembly shown in Figure 11, but showing the shield in the closed position.

Figure 13 is a side elevational view of a seventh embodiment of the safety needle assembly with the shield in an open position.

Figure 14 is a side elevation view of the safety needle assembly shown in Figure 13, but with the shield in the closed position.

Figure 15 is a perspective view of a safety needle assembly according to an eighth embodiment of the invention with the shield in the open position.

Figure 16 is a perspective view of the safety needle assembly of the eighth embodiment, but showing the shield in the closed position.

Figure 17 is a perspective view of a safety needle assembly according to a ninth embodiment, with the shield in an open position.

Figure 18 is a perspective view similar to Figure 17, but showing the guard in the closed position.

Figure 19 is a side elevational view of a safety needle assembly according to a tenth embodiment, with the shield in the open position.

Figure 20 is a side elevation view of the safety needle assembly shown in Figure 19, but with the shield in the closed position.

Figure 21 is a perspective view of the safety needle assembly according to an eleventh embodiment, with the shield in the open position.

Figure 22 is a side elevational view, partially in section, of the safety needle assembly shown in Figure 21 with the shield in the open position.

Figure 23 is a side elevation view, partially in section, showing the safety needle assembly of Figures 21 and 22, but with the shield in the closed position.

Figure 24 is a perspective view of a safety needle assembly according to a twelfth embodiment of the invention, and with the shield in the open position.

Figure 25 is a perspective view of a safety needle assembly shown in Figure 24, but with the shield in the closed position.

Figure 26 is a perspective view of a safety needle assembly according to a thirteenth embodiment of the invention with the shield in the open position.

Figure 27 is a side elevation view of the safety needle assembly shown in Figure 25 at the beginning of the guard operation.

Figure 28 is a side elevation view similar to

Figure 26 is 2 265 071 T3, but showing the safety needle assembly after completion of protection.

Figure 29 is a perspective of a fourteenth embodiment of the invention with the guard in the open position.

Figure 30 is a perspective view of the safety needle assembly shown in Figure 29, but with the shield in the closed position. Detailed description of the invention

A first embodiment of a liquid extraction / infusion set according to the subject invention is generally identified by number 10 in Figures 1-3. The liquid extraction / infusion set 10 includes a length of flexible plastic tubing 12, a proximal fitting 14, a needle assembly 16, a winged grip 18, and a shield 20.

Tube 12 includes a proximal end 26, a distal end 28, and a conduit extending between the ends. Tube 12 may be a conventional intravenous tube used in conventional blood collection or infusion sets. Proximal connector 14 is unitarily molded from a plastic material and includes a proximal end 30, a distal end 32, and a conduit extending between the ends. Portions of the conduit adjacent to the distal end 32 are configured to fold closely over the proximal end 26 of the tube 12 so that the conduit through the tube 12 communicates with the conduit through the proximal connector 14. Adhesive, solder, or the like may be used to achieve a permanent connection between tube 12 and proximal connector 14. Proximal end 30 of connector 14 defines a female luer connector that can be mated with an appropriate male luer connector. The male luer connector can include a proximal needle cannula that can be brought into communication with an emptied tube. Alternatively, a male Luer connector at the distal end of a conventional prior art syringe can be directly connected to the proximal connector 14 to infuse a medication into the patient. In this case, a separate male luer plug may be provided to close the proximal end of the connector 14. Other threaded fittings may be fitted with the proximal connector 14 to achieve specific intended applications. Additionally, proximal connectors of other configurations can be used to achieve a particular goal.

The needle assembly 16 includes a needle cannula 34, a needle barrel 36, and a needle shield 38. Needle cannula 34 has a proximal end 40, a distal end 42, and a lumen 44 extending between the ends. The distal end 42 of the needle cannula 34 is beveled to form a sharp point.

Needle barrel 36 is unit molded from a plastic material such as polycarbonate, polypropylene, polyethylene, acrylic, polystyrene, and ABS. Preferably, needle barrel 36 is molded from a transparent or translucent material to allow viewing of blood or other liquid flowing through needle barrel 36. Needle barrel 36 includes a proximal end 46, a distal end 48, and a stepped conduit (not shown) extending between the ends. Portions of the conduit adjacent the proximal end 46 are dimensioned to accommodate the distal end 28 of the tube 12. More particularly, the distal end 28 of the tube 12 folds into the conduit of the needle barrel 36 and is attached in a position adjacent to the end 46 proximal needle barrel 36. Portions of the conduit adjacent to the distal end 48 of the needle barrel 36 are dimensioned to slidably receive the proximal end 40 of the needle cannula 34. More particularly, the proximal end 40 of the needle cannula 34 is permanently attached to the needle barrel 36 by epoxy resin and / or mechanical attachment.

Needle shield 38 is a rigid cylindrical tube with a length exceeding the length of needle cannula 34 protruding from needle barrel 36. Needle shield 38 defines an inner diameter approximately equal to the outer diameter of the distal tip of needle barrel 36. Thus, needle shield 38 can be folded over needle cannula 34 and frictionally retained on the distal tip of needle barrel 36.

The winged grip 18 is molded from an elastic material such as polyolefin, polyvinyl chloride, or other such elastomeric polymers. Winged grip 18 includes flexible wings 54 and 55 and a tubular support. The tubular support includes an inner conduit that is dimensioned for exact fit over the needle barrel 36. The wings 54 and 55 are respectively formed with locking openings 57 and 58.

The safety shield 20 of the first embodiment has a proximal end 60, a distal end 62, and a generally U-shaped channel 63 extending from the distal end 62 toward the proximal end 60. Proximal end 60 of shield 20 is hinged to needle barrel 36 at a location close to proximal end 46 of needle barrel 36. More particularly, shield 20 may be unitary molded with needle barrel 36, and the hinged connection between shield 20 and needle barrel 36 may define a resilient bond at or near proximal end 60 of shield 20. Alternatively, the proximal end 46 of the needle barrel 36 may define a hinge member that can engage in fit with a coupling hinge at the proximal end 60 of the shield 20. Channel 63 of shield 20 is cross-sectional dimensioned to accommodate needle cannula 34 therein. Additionally, distal end 62 of shield 20 is spaced from proximal end 60 by a distance that exceeds the distance between proximal end 46 of needle barrel 36 and distal end 42 of needle cannula 34. Thus, the shield 20 can be rotated from a first position, as shown in Figure 1, in which the needle cannula 34 is fully exposed for use to a second position, as shown in Figure 2, wherein the needle cannula 34 is securely protected.

Shield 20 includes a structure for locking shield 20 in the second position that substantially surrounds needle cannula 34. More particularly, as shown in FIG. 1, shield 20 is formed with flanges 64 and 65 projecting transversely from proximal portions of shield 20. Tabs 64 and 65 define a large and conveniently located surface to receive finger pressure to rotate shield 20 from the first position to the second position.

ES 2 265 071 T3

The locking lugs 67 and 68 project rigidly from the portions of the flanges 64 and 65 that face the wings 54 and 55. The locking lugs 67 and 68 include locking retainers 70, 71 at spaced locations thereon. flanges 64 and 65 by a distance substantially equal to the thickness of wings 54 and 55. Locking projections 67 and 68 are arranged and sized to pass through locking openings 57 and 58 in wings 54 and 55. The wings 54 and 55 and the locking projections 67 and 68 will deform slightly in response to the forces that move the shield 20 to the second position around the needle cannula 34. After sufficient rotation, the locking retainers 70 will pass entirely through the locking openings 57 and 58 in the respective wings 54 and 55. The wings 54 and 55 and the locking projections 67 and 68 will then spring back to an undisturbed condition to securely lock the shield 20 in the second position around the needle cannula 34 and preventing reuse of the cannula 34. needle. Locking bosses 67 and 68 may be supplemented by cannula boss locks formed in channel 63 and configured to fit cannula 34 when shield 20 is in the second position.

The second embodiment of the needle assembly is illustrated in Figure 4, and is structurally and functionally very similar to the first embodiment. Therefore, comparable parts are provided with identical reference numerals, and a detailed description of the second embodiment is not provided. The second embodiment differs from the first embodiment in that the wings 54 and 55 need not be provided with locking openings. Additionally, flanges 64a and 65a are larger than flanges 64 and 65 in the first embodiment and have a proximal-distal dimension that exceeds the proximal-distal dimension of wings 54 and 55. Two locking protrusions 72 and 74 project from the flange 64a and are dimensioned to fit the proximal and distal edges of wing 54a. Two identical locking projections (not shown) protrude from wing 55. Thus, each wing 54, 55 adjusts to two locations to securely hold the shield 20 in the second position surrounding the needle cannula 34, as shown more clearly in Figure 4. As in the first embodiment, wing locking projections 72 and 74 may be supplemented by cannula locks.

A third embodiment is illustrated in FIG. 5 and includes a needle cannula 34, needle barrel 36, and wings 54 and 55 substantially identical to the first embodiment. At least wing 54 is formed with a locking opening 58 as in the first embodiment. A shield 20 is hinged to the needle barrel 36 as in the first embodiment and can be rotated from a first position in which the needle cannula 34 is exposed to a second position in which the needle cannula 34 is protected. A locking boss 68b protrudes from the shield 20 and is received in the locking opening 56 of the wing 54. The locking projection 68b is in the form of a ratchet, and therefore differs from the locking projections of the first two embodiments. More particularly, ratchet locking projection 68b rigidly extends from guard 20 through an arc substantially concentric with the axis of rotation of guard 20. The ratchet locking projection 68b is formed with a plurality of teeth 82, each of which is configured to slightly resist a forward movement of the guard 20 and to prevent a return movement of the guard 20 back toward the first. position. Shield 20 will be retained in the second position by a locked fit of teeth 82 closest to shield 20 and may be further retained by cannula boss lock.

A fourth embodiment is illustrated in Figures 6 and 7, and includes a needle cannula 34, a needle barrel 36, and wings 54 and 55, substantially as in the second embodiment. A shield 20 is hinged to rotate the needle barrel 36 from a first position in which the needle cannula 34 is exposed to a second exposure in which the needle cannula 34 is protected. Shield 20 includes a slot 84 that extends distally from the hinge connection to cylinder 36. A rigid dorsal fin 86 protrudes from needle cylinder 36 at a location equiangularly spaced from wings 54. Dorsal fin 86 it is arranged to pass through slot 84 for all rotational movements of guard 20 from the first position to the second position. The dorsal flap 86 is formed with a plurality of retainers arranged to engage portions of the shield 20 on either side of the slot 84 in each of a plurality of different rotational orientations of the shield 20 relative to the needle cannula 34 and needle cylinder 36. In particular, a first retainer is dimensioned and arranged to hold the shield 20 releasable in the first position where the shield 20 is rotationally separated from the needle cannula 34. An end stop is arranged to permanently lock shield 20 in the second position surrounding needle cannula 34. One or more additional retainers may be disposed between the first retainer 88 and the last retainer 89. As in previous embodiments, the fit of shield 20 with retainers on dorsal flap 72 may be supplemented by cannula boss locks formed within shield 20.

A fifth embodiment is illustrated in Figures 810, and includes a needle cannula 34, a needle barrel 36, a plastic tube 12 extending from the proximal end of the needle barrel 36, and wings 54 and 55 projecting from needle cylinder 36 substantially as in the second embodiment. The safety needle assembly of Figures 8-10 further includes a shield 90 that is functionally similar to the shield 20 described above and illustrated in Figures 1-7. In particular, shield 90 is hingedly connected to needle barrel 36 and can be rotated from a first position in which needle cannula 34 is exposed to a second position in which needle cannula 34 is securely protected. . However, shield 90 is structurally different from previous embodiments. In particular, shield 90 has a proximal end 92, a distal end 94, and a hinge connection 96 hingedly mounted to the needle barrel 36. Portions of shield 90 adjacent to hinge connection 96 define a window 98 through which needle cylinder 36 extends. One channel 100 is

ES 2 265 071 T3 extends between window 96 and distal end 94 and opens in one direction to accommodate needle cannula 34, substantially as in previous embodiments. Therefore, the distance between the hinged connection 96 and the distal end 94 is large enough to ensure complete protection of the needle cannula 34. The portions of shield 90 between window 98 and proximal end 92 define a channel 102 that is sized to house plastic tube 12. Channel 102 is formed with a plurality of tube locks 104 that can be elastically deflected. Tube locks 104 are sized and configured to elastically deflect in response to contact with flexible tube 12. However, the tube locks 104 will spring back to an undisturbed condition when the guard 90 reaches the second position to prevent rotation of the guard 90 back toward the first position. As in the other embodiments, shield 90 may also be provided with a cannula boss lock in channel 100 to securely and redundantly lock shield 90 in the second position.

A sixth embodiment is illustrated in Figures 11 and 12 and includes a needle cannula 34, a needle barrel 36, and wings 54 and 55 projecting from the needle barrel 36, as in the other embodiments. A shield 110 is hinged relative to the needle barrel 36 for movement from a first position in which the needle cannula 34 is exposed to a second position in which the needle cannula 34 is protected. However, shield 110 is not hinged directly to needle cylinder 36. Instead, shield 110 is hinged to shield base 112 which in turn is securely mounted to proximal end 40 of needle barrel 36. Shield base 112 is formed with a pair of opposing retention members 114 arranged to lock the shield 110 when shield 110 is rotated to the second position. Thus, the shield 110 is part of a structure unitarily formed with the shield base 112 and the retaining elements 114. Completely locking can be achieved with the structures in the unitary formed shield 110 and shield base 112. Shield 110 may further include a cannula boss lock to redundantly lock shield 110 with needle cannula 34.

Aspects of the invention described above pertain to locking the shield in the second position so that the needle is securely protected. Other aspects of the invention pertain to the structure to facilitate movement of the guard to the second position. More particularly, a seventh embodiment of the invention is depicted in Figures 13 and 14, and includes a safety needle assembly having a needle cannula 34, a needle barrel 36, and wings 54 and 55 substantially as in the embodiments. previous. A guard 20 is hingedly connected to the needle cylinder 36. More particularly, proximal end 60 of shield 20 is unitarily connected to distal end 48 of needle barrel 36 by an over-center linkage generally identified by 120. Link 120 includes a primary link 122 and a plurality of legs 124 Hinged connecting links connecting locations on cylinder 36 with locations on guard 20 spaced from primary link 122. The connecting legs 124 are aligned with each other substantially at a right angle when the guard 20 is in the first position of the guard 20. The connecting legs 124 deflect toward a shallow angle as the guard 20 is rotated about the hinge 120 from the first position to the second position. As guard 20 approaches the second position, connecting legs 124 pass beyond a position of maximum extension and deflect back to their original right angle arrangement to accelerate guard 20 to the second position.

An eighth embodiment is illustrated in Figures 15 and 16 and includes a needle cannula 34, a needle barrel 36, and wings 54 and 55 substantially as in previous embodiments. The safety needle assembly of Figures 15 and 16 further includes a shield 20 with opposite proximal and distal ends 60 and 62. Proximal end 60 of shield 20 is unitarily attached to distal end 48 of cylinder 36 by a unitary hinge 130. Hinge 130 deviates to an orientation in which guard 20 extends substantially linearly and distally beyond cylinder 36. However, hinge 130 allows guard 20 to be rotated approximately 180 ° in a proximal direction so that shield 20 substantially abuts barrel 36 to define the first position of shield 20 relative to needle cannula 34 and barrel 36.

Cylinder 36 further includes a guard retainer 132 protruding from proximal end 46 of barrel 36. Retainer 132 is configured to engage distal end 62 of guard 20 when guard 20 is in the first position. An actuator lever 134 projects outwardly and proximally from the guard retainer 132. Actuator lever 134 can be lowered with a thumb or forefinger to deflect retainer 132 sufficiently to disengage it from guard 20. As a result, link 130 elastically expands to the undisturbed condition and urges guard 20 to the second substantially position. surrounding needle cannula 34. As in the other embodiments, shield 20 is provided with at least one cannula boss retention member to trap cannula 34 and hold shield 20 in wraparound relationship with cannula 34.

A ninth embodiment of the invention is illustrated in Figures 17 and 18, and is similar in various functional respects to the eighth embodiment described above. More particularly, the ninth embodiment comprises a needle assembly with a needle cannula 34, a needle barrel 36, and wings 54 and 55 as previously described. Shield 20 is hinged to the distal end 48 of cylinder 36 by a unitary hinge 130 that deflects to drive shield 20 into the second position that substantially surrounds needle cannula 34. However, hinge 130 allows guard 20 to rotate against deflection forces from hinge 130 and in a first position in which guard 20 is aligned substantially at right angles to

ES 2 265 071 T3 relative to needle cannula 34, as shown in Figure 15.

Dorsal fins 134 and 135 project upwardly from respective wings 54 and 55. Dorsal fins 134 and 135 have proximal ends 136 and 137, respectively, and distal ends 138 and 139, respectively. The dorsal fin 134 is connected to a wing 54 at bases 140 disposed intermediate between the proximal and distal ends 136 and 138. A similar base (not shown) attaches the dorsal fin 135 to wing 55. The dorsal fins 134 and 135 are substantially parallel to each other and are sufficiently spaced from each other to allow the shield 20 to be disposed between the dorsal fins 134 and 135 when the shield 20 is in the first position. The dorsal fins 134 and 135 are further formed with protective locks 142 on the opposing and facing surfaces of the dorsal fins 134 and 135. Locks 142 are arranged and configured to lock-catch guard 20 and retain guard 20 in the first position.

The needle assembly of Figures 17 and 18 can be used by grasping opposing dorsal flaps 134 and 135 at distal locations of base 140 to guide needle cannula 34 into a target blood vessel or other source of bodily fluid. Needle cannula 34 is withdrawn from the patient after sufficient fluid has been withdrawn or infused. The portions of the fins 134 and 135 adjacent the proximal ends 136 and 137 are then tightened together. This causes the dorsal fins 134 and 135 to rotate around the bases 140 so that the distal ends 138 and 139 of the dorsal fins 134 and 135 are further apart. As a result, guard retainers 142 disengage from guard 20 and hinge 130 urges guard 20 into the second position. As in the other embodiments, the cannula boss locks on the shield 20 engage the cannula 34 to lock the shield 20 in the second position. Thus, protection can be effected simply by shifting the location of the gripping forces from a more distal position on the dorsal fins 134,135 to a more proximal position.

Embodiments seventh through ninth were assisted in protection by the inherent deflection forces of a unitarily formed joint. However, the tenth embodiment employs a separate spring to facilitate protection. More particularly, the tenth embodiment of the subject invention, as shown in Figures 19 and 20, relates to an assembly with a needle cannula 34 and a needle barrel 36. Needle barrel 36 includes a distal end 48 from which needle cannula 34 extends. A shield 20 is hinged to the needle barrel 36 at a location near the distal end 48 of shield 36. Shield 20 can be rotated from a first position in which shield 20 is spaced from needle cannula 34 to a second position. wherein shield 20 protectively surrounds needle cannula 34. The assembly further includes a spring 150 that functions much like the over-center connecting legs 124 of the sixth embodiment and the offset links 130 of the seventh and eighth embodiments. More particularly, spring 150 extends from barrel 36 to shield 20. Spring 150 has a proximal end 152 connected to barrel 36 and a distal end 154 connected to shield 20. Spring 150 is disposed on one side of the hinge connection between guard 20 and cylinder 36 when guard 20 is in the first position. Thus, the spring 150 helps to hold the guard 20 in the first position. The guard 20 can be manually moved from the first position to the second position. This movement requires the user to overcome the forces exerted by spring 150. This movement also causes the distal end 152 of spring 150 to move through an arc around the hinge connection between guard 20 and cylinder 36. After sufficient movement, spring 150 will move along the hinge connection. between guard 70 and cylinder 36. At that time, spring 150 will begin to assist the movement of guard 20 toward the second position. Shield 20 is provided with cannula boss locks for a locked fit with needle cannula 34 when shield 20 reaches the second position.

The eleventh embodiment of the subject invention is illustrated in Figures 21-23 and employs a spring in a different way than the tenth embodiment. More particularly, the eleventh embodiment includes a needle 34, a needle barrel 36, and wings 54 and 55. The needle barrel 36 includes a distal end 48 and the needle cannula 34 extends therefrom. A needle shield 20 is hingeably connected to the distal end 48 of the needle barrel 36 and is movable from a first position in which the needle cannula 34 is exposed to a second position in which the needle cannula 34 is protected. . A dorsal fin 160 protrudes substantially rigidly upward from cylinder 36 at a location equiangularly spaced between wings 54 and 55. The dorsal fin 160 includes a distal face 162 with a locking retainer 164 projecting distally therefrom. The locking detent 164 is configured to lockably engage the guard 20 when the guard 20 is in the first position. A torsion spring 166 is mounted adjacent to the distal end 48 of cylinder 36 and between the distal face 162 of dorsal fin 160 and shield 20. Torsion spring 166 is collapsed and in a stored energy condition when guard 20 is adjusted by locking catches 164.

The assembly of Figures 21-23 can be used in substantially the conventional manner by grasping the dorsal fin 160 and guiding the needle cannula 34 into a target blood vessel. After completing the medical procedure, the healthcare professional removes the needle cannula 34 from the blood vessel and exerts a distal force on the distal end 62 of the shield 20. The force on guard 20 must be sufficient to overcome the clamping forces of locking detent 164. Torsion spring 166 then releases its stored energy and urges shield 20 from the first position to the second position to securely encircle the needle cannula 34. Torsion spring 166 will continue to exert forces on guard 20 to hold guard 20 in its second position. However, a more positive locked retention of shield 20 in the second position can be provided by a cannula boss lock such as in previous embodiments.

A twelfth embodiment of the subject invention

ES 2 265 071 T3 is illustrated in Figures 24 and 25 and is similar to the eleventh embodiment. More particularly, the twelfth embodiment includes a needle 34 and a needle barrel 36. Needle barrel 36 includes a distal end 48 and needle cannula 34 extends therefrom. The wings 54 and 55 project transversely from the barrel 36. A needle shield 170 is hingeably connected to the distal end 48 of the needle barrel 36. The needle shield 170 is in the form of a dorsal fin, and therefore functions in a similar manner to the dorsal fin 160 of the eleventh embodiment illustrated in Figures 1921 and described above. More particularly, shield 170 is a flat structure with a distal face 172 having an elongated groove 174 formed therein. Groove 174 is sized and configured to house needle cannula 34. The interior portions of the groove 174 may include a structure to block the needle cannula 34. For example, one or more cannula boss locks may be provided. The needle guard 170 is further provided with a structure for releasable adjustment of the proximal portions of the guard 170 with the needle barrel 36. The releasable fit may be a locking retainer similar to the locking retainer 164 of the eleventh embodiment, retention elements similar to the retention elements 114 of the sixth embodiment illustrated in FIG. 20, a similar over-center hinged construction to the seventh embodiment illustrated in Figures 11 and 12 or a frangible connection. With each of these optional constructions, the needle cannula 34 can be used by manipulating the shield 170 in substantially the same way as manipulating the dorsal fin 160 of the eleventh embodiment. After use, the needle cannula 34 is removed from the patient. The healthcare professional then exerts a distal force on the proximal side of the shield 170. As a result, the connection between the shield 170 and the needle barrel 36 is separated, and the shield 170 is urged around the hinge connection to the distal end 48 of the needle barrel 36 and until the shield fits around the cannula 34 of the needle. needle.

A thirteenth embodiment of the subject invention is illustrated in Figures 26-28 and includes a needle cannula 34 protruding from the needle barrel 36. The wings 54 and 55 project transversely from the needle cylinder 36. A shield 180 is hingeably connected to the needle barrel 36 and can be rotated from a first position in which the needle cannula 34 is exposed for use to a second position in which the shield 180 surrounds the needle cannula 34. Shield 180 may be provided with a structure for a locked fit with needle cannula 34, such as cannula locking projections that can be elastically deflected. Unlike the embodiments described above, shield 180 is formed with a narrow longitudinal slot 182 on the side thereof opposite the elongated opening in which needle cannula 34 is housed. The slot 182 may be substantially narrower than the opening that houses the shield needle 180.

The assembly of Figures 26-28 further includes an articulated actuator 184. Actuator 184 has a proximal end 186 hingedly coupled to cylinder 36 at a location proximal to hinged connection of shield 36 to cylinder 34. Actuator 184 further includes a distal end 188. Actuator portions 184 between proximal and distal ends 186 and 188 are slidably housed in slot 182 of shield 180. Additionally, actuator 184 includes proximal and distal retainers 190 and 192 that are spaced apart by a distance that is slightly greater than the thickness of the plastic material from which shield 180 is formed. Distal retainer 192 engages in the slot 182 of shield 180 so that parts of actuator 184 between proximal and distal retainers 190 and 192 can slide into slot 182. With this construction, the shield 180 can be rotated to a first position where the needle cannula 34 is exposed for use. After use, distally directed forces can be exerted on actuator 184 by a thumb of the user of the device. These distally directed forces will cause actuator 184 to rotate about its proximal end 186. Simultaneously, the proximal retainers 190 will exert forces on the top wall of the guard 180 adjacent the slot 182 therein. Thus, shield 180 will rotate around needle barrel 36 and into the second position surrounding needle cannula 34. The locking structures in shield 180 will then lock onto needle cannula 34.

The fourteenth embodiment of the subject invention is illustrated in Figures 29 and 30. The fourteenth embodiment includes a needle cannula 34 and a needle barrel 36 substantially similar to a cannula and needle barrel described with respect to the previous embodiments. The fourteenth embodiment further includes wings 200 and 202 projecting transversely from opposite sides of cylinder 36. However, unlike previous embodiments, at least one wing 200 is basically hollow and includes upper and lower walls 204 with a flat slot 208 extending distally between walls 204 and 206. Upper wall 204 is formed with an arcuate slot 210 formed therethrough and extending through an arc generated around a location at or near the distal end of needle barrel 36. A shield 212 is hingedly connected to cylinder 36 substantially at the center of rotation of arcuate slot 210 in upper wall 204 of wing 200. Shield 212 includes an actuator projection 214 extending through slot 210. The assembly shown in Figures 29 and 30 can be used substantially in a conventional manner by grasping wings 200 and 202 and inserting needle cannula 34 into the target blood vessel or other source of body fluid. Upon completion of the liquid sample collection, the needle cannula 34 is removed from the patient. The healthcare professional then moves drive 214 of shield 212 through slot 210 in wing 200. As a result, shield 212 rotates around needle barrel 36 sufficiently that shield 212 substantially envelops and conforms to needle cannula 34.