Abstract
Needle assembly having the following modes of operation; a first mode wherein the safety shield can move to a first retracted position allowing injection of the piercing portion of needle from a position at least partially covering the piercing portion of the needle and a second mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the first mode and is prevented from moving back to a position exposing the piercing portion of the needle.
Claims
1. A needle assembly connectable to an injection device, the needle assembly comprising: a body; a luer-lock interface arranged on a rear side of the body; a needle for injecting or withdrawing fluids; the needle having a portion retained in the body and a piercing portion projecting forwardly from the portion retained in the body; a safety shield that is axially movable relative to the body at least between an initial position, an at least partially retracted position, and a post-use locking position; and a spring biasing the safety shield away from the at least partially retracted position, wherein the safety shield: locks in the post-use locking position via an internal locking system, wherein the internal locking system is prevented from being contacted by a user's fingers; and rotates at least partially as it moves from the initial position to the at least partially retracted position; and wherein the needle assembly has the following modes of operation when installed on an injection device: a first mode wherein the safety shield can move to a first retracted position during injection of the piercing portion of the needle into a container containing a substance that can be suctioned into the injection device; a second mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the first mode; a third mode wherein the safety shield can move to a second retracted position during injection of the piercing portion of the needle into a surface that will receive the substance forced out of the injection device; and a fourth mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the third mode.
2. The needle assembly of claim 1, wherein in the second mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the first mode.
3. The needle assembly of claim 1, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.
4. The needle assembly of claim 1, wherein in the fourth mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the third mode.
5. The needle assembly of claim 1, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.
6. The needle assembly of claim 1, wherein when in the fourth mode, the safety shield is prevented from moving back to a position exposing the piercing portion of the needle.
7. The needle assembly of claim 1, wherein the surface that will receive the substance forced out of the injection device is a skin surface.
8. The needle assembly of claim 1, wherein the needle assembly can be removably installed on the injection device.
9. A needle assembly connectable to an injection device, the needle assembly comprising: a body; a luer-lock interface arranged on a rear side of the body; a needle for injecting or withdrawing fluids; the needle having a portion retained in the body and a piercing portion projecting forwardly from the portion retained in the body; a safety shield that is axially movable relative to the body at least between an initial position, an at least partially retracted position, and a post-use locking position; and a spring biasing the safety shield away from the at least partially retracted position, wherein the safety shield: locks in the post-use locking position via an internal locking system, wherein the internal locking system is prevented from being contacted by a user's fingers; and rotates at least partially as it moves from the initial position to the at least partially retracted position; and wherein the needle assembly has the following modes of operation when installed on an injection device: a first mode wherein the safety shield can move to a first retracted position during injection of the piercing portion of the needle into a container containing a substance that can be suctioned into the injection device; a second mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the first mode; a third mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the second mode; a fourth mode wherein the safety shield can move to a second retracted position during injection of the piercing portion of the needle into a surface that will receive the substance forced out of the injection device; and a fifth mode wherein the safety shield moves to a position protecting the piercing portion of the needle after the fourth mode and is prevented from moving back to a position exposing the piercing portion of the needle.
10. The needle assembly of claim 9, wherein in the second mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the first mode.
11. The needle assembly of claim 9, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.
12. The needle assembly of claim 9, wherein in the fourth mode the safety shield automatically moves to the position protecting the piercing portion of the needle after the third mode.
13. The needle assembly of claim 9, wherein in the fourth mode, the safety shield is locked in the position protecting the piercing portion of the needle so as to prevent re-use or re-injection of the needle.
14. The needle assembly of claim 9, wherein when in the fourth mode, the safety shield is prevented from moving back to a position exposing the piercing portion of the needle.
15. The needle assembly of claim 9, wherein the surface that will receive the substance forced out of the injection device is a skin surface.
16. The needle assembly of claim 9, wherein the needle assembly can be removably installed on the injection device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The present invention is further described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:
(2) FIG. 1 shows an enlarged partial side cross-section view of a front portion of a standard or known syringe which can be used with the invention. The syringe has a luer-lok type interface. The plunger and piston are not shown;
(3) FIG. 2 shows a side-cross-section view of a needle assembly mounted to the syringe of FIG. 1 in accordance with one non-limiting embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A packaging needle cover (not shown but similar to that shown in FIG. 26) is removed from the same;
(4) FIG. 3 shows the needle assembly of FIG. 2 prior to being installed on the syringe of FIG. 1;
(5) FIG. 4 shows the needle assembly of FIG. 3 in an injection position, i.e., a position wherein the shield is retracted so that the piercing portion of the needle can pierce a surface. In this position, when installed on a syringe, the needle can be used to withdraw a fluid into the syringe or inject a substance in the syringe;
(6) FIG. 5 shows a needle assembly of FIG. 4 after the needle shield is automatically moved by a spring to the non-releasably locked position. In this position, the needle assembly is rendered unusable and can be safely disposed of. The needle shield is thus prevented from moving back by an amount sufficient to allow exposure to the piercing portion of the needle;
(7) FIG. 6 shows a side cross-section view of a known needle assembly which can be used in accordance with another embodiment of the invention;
(8) FIG. 7 shows a side partial cross-section view of a needle assembly in accordance with another embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A packaging needle cover (not shown but similar to that shown in FIG. 26) removed from the same;
(9) FIG. 8 shows the needle shield used on the needle assembly of FIG. 7;
(10) FIG. 9 shows the body used on the needle assembly of FIG. 7;
(11) FIG. 10 shows an alternative body which can be used on the needle assembly of FIG. 7;
(12) FIG. 11 shows a side cross-section view of needle assembly mounted to the syringe of FIG. 1 in accordance with another non-limiting embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A packaging needle cover (not shown but similar to that shown in FIG. 26) is removed from the same;
(13) FIG. 12 shows a view of the body used in the needle assembly of FIG. 11 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 11;
(14) FIG. 13 shows a side cross-section view of needle assembly of FIG. 11 when the shield is in a first retracted position;
(15) FIG. 14 shows a view of the body used in the needle assembly of FIG. 11 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 13;
(16) FIG. 15 shows a side cross-section view of needle assembly of FIG. 11 when the shield is in a second extended or needle covering position;
(17) FIG. 16 shows a view of the body used in the needle assembly of FIG. 11 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 15;
(18) FIG. 17 shows a side cross-section view of needle assembly of FIG. 11 when the shield is in a second retracted position;
(19) FIG. 18 shows a view of the body used in the needle assembly of FIG. 11 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 17;
(20) FIG. 19 shows a side cross-section view of needle assembly of FIG. 11 when the shield is in a third extended or needle covering position;
(21) FIG. 20 shows a view of the body used in the needle assembly of FIG. 11 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 19;
(22) FIG. 21 shows the needle assembly of FIG. 19 and illustrates how the shield can move back slightly when in the locked needle covering position;
(23) FIG. 22 shows a view of the body used in the needle assembly of FIG. 19 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 21;
(24) FIG. 23 shows a side view of needle assembly similar to that of FIG. 11 but utilizing a visual and/or tactile indication system. In the position shown in FIG. 23, a recess or projection arranged on the shield is shown in the position indicated by the number “0” on the body. This is characteristic of the initial shield position shown in FIGS. 11 and 12;
(25) FIG. 24 shows the needle assembly of FIG. 23 with the shield in another rotational position. In the position shown in FIG. 24, a recess or projection arranged on the shield is shown in the rotational position indicated by the number “1” on the body. This is characteristic of the second extended shield position shown in FIGS. 15 and 16;
(26) FIG. 25 shows the needle assembly of FIG. 23 with the shield in yet another rotational position. In the position shown in FIG. 25, a recess or projection arranged on the shield is shown in the rotational position indicated by the number “2” on the body. This is characteristic of the third extended shield position shown in FIGS. 19 and 20;
(27) FIG. 26 shows a side cross-section view of a needle assembly mounted to the syringe of FIG. 1 in accordance with another non-limiting embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A packaging and/or protective needle cover is shown installed on the needle assembly which will be removed at the point of use and which prevents movement of the needle shield;
(28) FIG. 27 shows the needle assembly of FIG. 26 with the shield in the locked post-use position and with an indicator of the locked position being visible. This indicator can be a visual indicator band, e.g., a red band, or a tactile band, e.g., a rough or knurled band. The band is no visible when the shield is in the initial position;
(29) FIG. 28 shows a side cross-section view of a needle assembly mounted to the syringe of FIG. 1 in accordance with another non-limiting embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A packaging and/or protective removable strip is shown wound onto or installed on the needle assembly which will be removed by peeling off (upon griping the pull tab) at the point of use and which prevents movement of the needle shield;
(30) FIG. 29 shows a side cross-section view of a needle assembly mounted to the syringe of FIG. 1 in accordance with another non-limiting embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A proximal end of the shield has a receiving interface which makes it easier to align the needle assembly with the neck of a medicine container. Once in the position shown in FIG. 29, the user can move the syringe toward the medicine container and then withdraw fluid into the syringe via the needle;
(31) FIG. 30 shows a side cross-section view of needle assembly similar to that of FIG. 11 but utilizing a different cam-guiding system. In FIG. 30, the shield is in a second extended or needle covering position;
(32) FIG. 31 shows a view of the body used in the needle assembly of FIG. 30 and shows the relative position of the guiding projection in the generally W-shaped guiding groove arrangement when the shield is in the position shown in FIG. 30. In the position shown in FIG. 31, the safety shield is prevent from moving axially back until a user manually or selectively rotates the shield at least partially so that the guidable projection can move back along the middle guide track;
(33) FIG. 32 shows a side partial cross-section view of a needle assembly interface for a fluid sampling device which can be utilized in accordance with another non-limiting embodiment of the invention. The interface includes a luer-lock interface connectable with the luer-lok interface of the needle assemblies disclosed herein;
(34) FIG. 33 shows the needle assembly interface of FIG. 32 with rear needle exposed. This occurs when the interface is installed on a fluid sampling device and a sample container in inserted therein;
(35) FIG. 34 shows the needle assembly interface of FIG. 32 installed on a fluid sampling device. While in the configuration shown in FIG. 34, a user can install any one of the needle assemblies shown in FIGS. 2-29 on the needle assembly interface in a manner similar to being installed on the syringe of FIG. 1;
(36) FIG. 35 shows a side cross-section view of a spike needle assembly mounted to an end of flexible tubing in accordance with another non-limiting embodiment of the invention. The shield of needle assembly is shown in an initial, intermediate, or prior-use configuration. A distal end of the needle assembly has a connecting interface which can be connected to an end of flexible tubing. Unlike the previous embodiments, the needle in this embodiment is a large gauge spike for use in IV applications and can puncture things such as medical bags and the like or other things typically punctured with a medical spike; and
(37) FIGS. 36 and 37 show one way in which one or more of the herein disclosed embodiments can utilize depth of penetration adjustment.
DETAILED DESCRIPTION OF THE INVENTION
(38) FIG. 1 shows a partial view of a luer-lock type interface of a syringe S that can be used to practice one or more non-limiting embodiments of the invention. The syringe S includes a syringe body S1 and a standard interface or luer-lock type connecting interface S2. As the art of syringes or injections devices is vast and known, additional details are not herein provided regarding these features. However, the knowledge of such devices can advantageously be utilized to practice aspects of the invention.
(39) FIGS. 2-5 show a needle assembly 1 mounted to the syringe of FIG. 1 in accordance with one non-limiting embodiment of the invention. The assembly 1 includes a body 10, a needle N, a needle shield 30 and a spring 50. In FIG. 2, the needle assembly 1 is shown in an initial, intermediate, or prior-use configuration. Although not shown, a packaging needle cover (similar to that shown in FIG. 26) can be removably mounted to the same. Another cap (not shown) can be arranged to cover the connecting interface CI. Additionally or alternatively, the device of FIG. 2 (or that shown in FIG. 26) can be packaged in the form shown. FIG. 3 shows the needle assembly of FIG. 2 prior to being installed on the syringe of FIG. 1. As is apparent from FIG. 3, the assembly 1 can be connected to the syringe interface S2 via the connecting interface CI portion of the body 10. This standard interface CI will be complementary to that of the interface S2 such that if the interface S2 is, by way of example, a female luer-lock type interface, then the distal interface CI should be a male luer-lock type interface so as to properly and sealingly connected thereto. In embodiment, this connection is a removable or releasable connection.
(40) FIG. 4 shows the needle assembly of FIG. 3 in an injection position, i.e., a position wherein the shield 30 is axially retracted against the biasing force of the spring 50 so that the piercing, proximal or free end portion of the needle N can pierce a surface, e.g., skin, tissue, medicine container, etc. In this position, when installed on a syringe S, the needle N can be used to withdraw a fluid into the syringe S or inject a substance already within the syringe S. FIG. 5 shows a needle assembly 1 of FIG. 4 after the needle shield 30 is automatically moved by the spring 50 to the non-releasably locked position. In this position, the needle assembly 1 is rendered unusable and can be safely disposed of. The needle shield 30 is thus prevented from moving axially back by an amount sufficient to allow exposure to the piercing portion of the needle N.
(41) To understand how the shield 30 can become locked in the position shown in FIG. 5, one should compare FIG. 3 to FIG. 5 and see how the needle shield 30 is axially retained in an intermediate position between FIG. 5 and FIG. 4. This position is maintained by the biasing force of the spring 50 causing a tapered surface of one or more delectable locking mechanisms DLM of the shield 30 to engage or contact one or more guiding projections GP of the body 10. Each guiding projection GP is guided within a respective guiding arrangement GA, e.g., a guiding groove, formed in the shield 30. This sliding engagement between the guiding projections GP and the guiding recesses GA allows the shield 30 to move axially or be guided axially relative to the body 10 without also rotating relative thereto. When, however, the shield 30 is moved back to the position shown in FIG. 4 and released, the spring 50 develops sufficient expansion force to overcome the engagement shown in FIG. 3. Although this occurs quickly (in a fraction of a second), what happens is that when the tapered surface of the deflectable locking member DLM contacts the projection GP, it is deflected inwardly thereby until the deflectable locking member DLM actually moves past the projection GP whereupon it deflects outwardly again. This movement occurs because each delectable locking member DLM is coupled to a delectable arm DLMA which functions like a leaf spring. Once the member DLM moves axially past the projection GP along the proximal direction and assumes an relaxed position shown in FIG. 5, the shield 30 becomes non-releasably or permanently locked to the body 10 such that it cannot move back to the position shown in either FIG. 3 or FIG. 4. If the user tries to move the shield 30 axially back to again compress the spring 50, each member DLM contacts a respective projection GP which prevents further movement. Moreover, as each guiding recess GA extends only up to a stop shoulder SH, the shield 30 becomes axially retained by the engagement between the projection GP and elements SH and DLM. Furthermore, because elements GP, SH and DLM are arranged on an inner sleeve portion 33 which is concealed within an outer sleeve portion 31 and an annular face portion 32, the user cannot deactivate the locking system without destroying the assembly 1.
(42) To facilitate assembly of the device 1, the needle shield 30 can be made of, e.g., two components as shown in FIG. 5. These include the outer sleeve component portion 31 and another component including the face portion 32 and inner sleeve portion 33. These components can be non-releasably connected to one another via, e.g., a non-releasable snap connection SC. Other connections can also be utilized such as threads, adhesives, etc. Still further, a threaded connection between these two components can also be utilized to provide the device with depth of penetration adjustment as shown in FIGS. 36 and 37. Indicia and an indicator can also be used on the two component parts 32 and 33 making up the needle shield to provide the user with an indicator of depth of penetration setting (see FIGS. 36 and 37).
(43) The embodiment shown in FIGS. 2-5 can thus have the form of needle assembly 1 that utilizes a body 10 having a front portion, a back portion CI configured to be connected to device S configured to inject or withdraw fluids, and a wall or needle support separating the front and back portions (see FIG. 3). A needle N has a piercing portion projecting forwardly from the wall or needle support. A safety shield 30 is axially movable relative to the body 10 at least between an initial position (FIG. 3), at least partially retracted position (FIG. 4), and a post use locking or locked position (FIG. 5). The safety shield 30 at least one of: is at least partially disposed within the front portion of the body 10, includes a locking system DLM/GP which is prevented from being contacted by a user's fingers, and moves linearly without also rotating. Additionally or alternatively, the shield 30 includes at least one mechanism DLM for preventing a locking of the safety shield 30 when said shield in not in the post use locking position. Additionally or alternatively, the shield 30 includes a first portion 33 that is at least partially disposed within the front portion of the body 10, a second portion 31 that at least partially covers the front portion, and has its movement limited by engagement between at least one projection GP extending into a guide recess GA.
(44) FIG. 6 shows a needle assembly disclosed in US 2010/0286611 to SCHRAGA which is herein expressly incorporated by reference in its entirety and which can be used in accordance with another embodiment of the invention. In this embodiment, the assembly 100 can be installed on an injection device or syringe S of FIG. 1 and includes a body 110, a needle shield 130, a spring 150, a needle N, a trigger sleeve 140, deflectable locking members 114 and a standard connecting interface CI. An advantage of this embodiment relates to the fact that the needle shield 130 can be releasably retained in the retracted position and does not automatically move to the locked fully extended position until the user moves the trigger sleeve 140 into engagement with projections 115 to cause release of the locking engagement between the body 110 and the needle shield 130.
(45) FIGS. 7-9 show a needle assembly 1′ in accordance with another embodiment of the invention. The assembly 1′ includes a body 10′, a needle N, a needle shield 30′ and a spring 50′. In FIG. 7, the needle assembly 1′ is shown in an initial, intermediate, or prior-use configuration. Although not shown, a packaging needle cover (similar to that shown in FIG. 26) can be removably mounted to the same. FIG. 8 shows the needle shield 30′ used on the needle assembly of FIG. 7 and show the location of at least one inward facing guiding projection GP′ which is configured to move within at least one external guiding recess formed on the body 10′ shown in FIG. 9.
(46) The device shown in FIGS. 7-9 can function as follows with reference to FIG. 9. After the assembly 1′ is installed on the injection device S; a first mode includes moving the safety shield 30′ from the position shown in FIG. 7 to a first retracted position during injection of the piercing portion of needle N into a surface, e.g., into a container containing a substance that can be suctioned into the injection device. When this happens, the guiding projection GP′ moves from position A in guide recess portion “a” of a complex cam guiding recess arrangement until it contacts and deflects out of the way deflectable locking member DLM1. Once it enters portion “b” and contacts the bottom wall bw, the deflectable locking member DLM1 will move back to the relaxed position shown in FIG. 9 and function to prevent the guiding projection GP′ from moving back into the recess portion “a”. A second mode results when the safety shield 30′ automatically moves to a position protecting the piercing portion of the needle N after the first mode. When this happens, the guiding projection GP′ moves from position adjacent the wall bw in guide recess portion “b” until it contacts and deflects out of the way deflectable locking member DLM2. Once it enters portion or position “B”, the deflectable locking member DLM2 will move back to the relaxed position shown in FIG. 9 and functions to prevent the guiding projection GP′ from moving back into the recess portion “b”. At this point, the needle shield 30′ has become locked in the fully extended or needle covering position. It cannot be moved backwards or distally as it is prevented from doing so by the member DLM2 and also cannot move forward as it contacts a wall defining the space or position B. The user has no choice by to discard the assembly 1′ after it is used a single time and this can be done safely as the needle N is fully covered and protected by the needle shield 30′. When the needle shield 30′ moves from the initial position A to the final locked position B, the needle shield 30′ experiences both backward and forward axial movement, but also rotation relative to the body 10′.
(47) The device shown in FIG. 7 can also be modified so that the body shown in FIG. 9 is replaced with that shown in FIG. 10. After the assembly is installed on the injection device S; a first mode includes moving the safety shield from the position shown in FIG. 7 to a first retracted position during injection of the piercing portion of needle N into a surface, e.g., into a container containing a substance that can be suctioned into the injection device. When this happens, the guiding projection moves from position A in guide recess portion “a” until it contacts but does not deflect out of the way deflectable locking member DLM1. This allows the user to only partially expose the needle N if desired. Once it enters portion “b” and contacts the member DLM1, if the user then releases of the needle shield, it will move under the action of the spring to position B. Furthermore, with this arrangement, the user can make a further injection. When this happens, the guiding projection moves from position B in guide recess portion “b” until it contacts and deflects out of the way deflectable locking member DLM1. Once it enters portion “c” and contacts the bottom wall bw, the deflectable locking member DLM1 will move back to the relaxed position shown in FIG. 10 and function to prevent the guiding projection from moving back into the recess portion “b”. A third mode results when the safety shield automatically moves to a position protecting the piercing portion of the needle N after the second mode. When this happens, the guiding projection moves from position adjacent the wall bw in guide recess portion “c” until it contacts and deflects out of the way deflectable locking member DLM2. Once it enters portion or position “C”, the deflectable locking member DLM2 will move back to the relaxed position shown in FIG. 10 and functions to prevent the guiding projection from moving back into the recess portion “c”. At this point, the needle shield has become locked in the fully extended or needle covering position. It cannot be moved backwards or distally as it is prevented from doing so by the member DLM2 and also cannot move forward as it contacts a wall defining the space or position C. The user has no choice by to discard the assembly after it is used a couple of times and this can be done safely as the needle N is fully covered and protected by the needle shield. When the needle shield moves from the initial position A to the final locked position C, the needle shield experiences both backward and forward axial movement, but also rotation relative to the body 10″.
(48) FIGS. 11-22 show a needle assembly 1′″ in accordance with another embodiment of the invention. The assembly 1′″ includes a body 10′″, a needle N, a needle shield 30′″ and a spring 50′″. In FIG. 11, the needle assembly 1′″ is shown in an initial, intermediate, or prior-use configuration. In FIGS. 13 and 17, the needle assembly 1′″ is shown in injection positions. FIGS. 15 and 19 show the shield 30′″ is extended covering positions. Although not shown, a packaging needle cover (similar to that shown in FIG. 26) can be removably mounted to the same.
(49) The device shown in FIGS. 11-22 can function as follows. After the assembly 1′″ is installed on the injection device S as shown in FIG. 11, a first mode includes moving the safety shield 30′″ from the position shown in FIGS. 11 and 12 to a first retracted position during injection of the piercing portion of needle N into a surface shown in FIGS. 13 and 14, e.g., into a container containing a substance that can be suctioned into the injection device. When this happens, the guiding projection GP′″ moves from position A in guide recess portion “a” as shown in FIG. 12 of a complex cam guiding recess arrangement until it contacts bottom surfaces “b” and “c”. Due to the offset nature of the cam arrangement, once the spring 50″ causes the needle shield 30′″ to move axially in the proximal direction, the projection GB′″ shown in FIG. 14 will be guided into recess portion “d” (leftward and upward in FIG. 14) by the surface “c” and the angled surface at the bottom of island portion X. Once it enters portion “d” and reaches position B as shown in FIGS. 15 and 16. Another mode results when the safety shield 30′″ is caused to move to a second injection position as shown in FIGS. 17 and 18. When this happens, the guiding projection GP′″ moves from position B in guide recess portion “d” as shown in FIG. 16 of the complex cam guiding recess arrangement until it contacts bottom surfaces “e” and “f”. Due to the offset nature of the cam arrangement, once the spring 50′ causes the needle shield 30′ to move axially in the proximal direction, the projection GB′″ shown in FIG. 18 will be guided into recess portion “g” (leftward and upward in FIG. 18) by the surface “f” and the angled surface at the bottom of island portion Y. Upon approaching angled surface “h”, the projection GP′ is guided thereby leftward until it reaches position C as shown in FIG. 20. Due to the offset nature of the cam arrangement, once the spring 50′″ causes the needle shield 30′″ to again move axially in the proximal direction until it reaches position C, the projection GB′ shown in FIG. 20 will be axially confined between position “C” and surface “i”. The space between these surfaces is such that the needle shield 30′ can move, at most, the slight axial amount MM, but that is sufficient to maintain at least a desirable spacing as shown in FIGS. 21 and 22, and designated with the dimension ME. In the position shown in FIGS. 19-22, the needle shield 30′″ is effectively locked in the fully extended position such that the user is prevented from reusing the device 1′″ and can safely discard the same.
(50) FIGS. 23-25 shows a needle assembly similar to that of FIG. 11 but utilizing a visual and/or tactile indication system. Like previous embodiments, the assembly 1.sup.IV includes a body 10.sup.IV and a needle shield 30.sup.IV. This system includes first indicia or an indicator FI and a second indicia or indicator SI and provides information to the user of the rotational position of the needle shield 30.sup.IV in relation to the body 10.sup.IV. In the position shown in FIG. 23, the indicia FI can have the form of a recess or projection arranged on the shield 30.sup.IV and is shown in the position indicated by the number “0” on the body. This is characteristic of or corresponds to the initial shield position A shown in FIGS. 11 and 12. FIG. 24 shows the needle assembly of FIG. 23 with the shield 30.sup.IV in another rotational and fully extended position. In the position shown in FIG. 24, the recess or projection FI arranged on the shield 30.sup.IV is shown in the rotational position indicated by the number “1” on the body 10.sup.IV. This is characteristic of or corresponds to the second extended shield position B shown in FIGS. 15 and 16. FIG. 25 shows the needle assembly of FIG. 23 with the shield 30.sup.IV in yet another rotational position, i.e., a final locked extended position. In the position shown in FIG. 25, the recess or projection FI arranged on the shield 30.sup.IV is shown in the rotational position indicated by the number “2” on the body 10.sup.IV. This is characteristic of the third or final extended shield position C shown in FIGS. 19 and 20.
(51) FIGS. 26 and 27 show a needle assembly 1.sup.V mounted to the syringe S of FIG. 1 in accordance with another non-limiting embodiment of the invention. Like previous embodiments, the assembly 1.sup.V includes a body 10.sup.V and a needle shield 30.sup.V. The shield 30.sup.V of needle assembly is shown in an initial, intermediate, or prior-use configuration. A packaging and/or protective needle cover PC is shown installed on the needle assembly which can be removed at the point of use and which prevents movement of the needle shield. Furthermore, in this embodiment, the body 10.sup.V includes an external shoulder or flange SF which can function as a distal (and or secondary) stop for shield 30.sup.V and also as a stop for the protective cover PC. The cover PC can function to prevent or minimize the chance of axial movement of the needle shield 30.sup.V relative to the body 10.sup.V. Additionally, this embodiment utilizes a visual indicator ILP in the form of a ring-shaped band. FIG. 27 shows the needle assembly of FIG. 26 with the shield 30.sup.V in the locked post-use position in and with an indicator ILP of the locked position being visible. This indicator ILP can be a visual indicator band, e.g., a red band, or a tactile band, e.g., a rough or knurled band. The band is not visible when the shield 30.sup.V is in the initial position shown in FIG. 26. One can implement such a system on any of the herein disclosed embodiment if desired. In an optional embodiment, the cover PC can also be threaded or otherwise removably coupled to the body or the shoulder SF which would prevent the user from accidentally removing the cover PC.
(52) FIG. 28 shows a needle assembly 1.sup.VI mounted to the syringe S of FIG. 1 in accordance with another non-limiting embodiment of the invention. Like previous embodiments, the assembly 1.sup.VI includes a body 10.sup.VI, a spring and a needle shield 30.sup.VI. The shield 30.sup.VI of needle assembly 1.sup.VI is shown in an initial, intermediate, or prior-use configuration. A packaging and/or protective removable strip PT is shown installed onto the needle assembly 1.sup.VI which will be removed by, e.g., peeling off (upon griping the pull tab) at the point of use and which prevents movement of the needle shield 30.sup.VI. Until the band PT is removed, it serves, among other things, to provide the use a visual indicator that the product has not yet been used and prevents intentional or accidental distal axial movement of the needle shield 30.sup.VI relative to the body 10.sup.VI.
(53) FIG. 29 shows a needle assembly 1.sup.VII mounted to the syringe S of FIG. 1 in accordance with another non-limiting embodiment of the invention. Like previous embodiments, the assembly 1.sup.VII includes a body 10.sup.VII, a spring and a needle shield 30.sup.VII. The shield 30.sup.VII of needle assembly 1.sup.VII is shown in an initial, intermediate, or prior-use configuration. A proximal end of the shield 30.sup.VII has a receiving interface RI which makes it easier to align the needle assembly 1.sup.VII with the neck of a medicine container MC. Once in the position shown in FIG. 29, the user can move the syringe S toward the medicine container MC in order to cause the needle to enter into the container MC and then withdraw the substance or fluid into the syringe S via the needle.
(54) FIGS. 30 and 31 shows a needle assembly 1.sup.VIII which can be similar to that of FIG. 11 but which can utilize a different cam-guiding system. In FIGS. 30 and 31, the shield 30.sup.VIII is shown in a second extended or needle covering position relative to the body 10.sup.VIII. The position of the guiding projection GP.sup.IV in the generally W-shaped guiding groove arrangement of the body 10.sup.VIII when the shield 30.sup.VIII is in the position shown in FIG. 30 is that shown in FIG. 31. In the position shown in FIG. 31, the safety shield 30.sup.VIII is prevent from moving axially back (and/or is releasably retained in position B) until a user manually or selectively rotates the shield 30.sup.VIII at least partially so that the guidable projection GP.sup.IV can move back along the middle guide track “d”. The assembly 1.sup.VIII otherwise functions in a manner similar to the embodiment shown in FIG. 11.
(55) In addition to the herein disclosed features, each herein disclosed needle assembly can also utilize one or more features disclosed in U.S. application 61/443,958 filed on Feb. 17, 2011 to SCHRAGA and/or U.S. application Ser. No. 13/398,173 to SCHRAGA filed Feb. 16, 2012. The disclosure of each of these applications is hereby expressly incorporated by reference in its entirety. In accordance with at least one embodiment, the device of the instant application additionally includes an embodiment similar to FIG. 1 (or other figures such as e.g., FIG. 31) of U.S. 61/443,958 or U.S. Ser. No. 13/398,173 (but otherwise resembling FIG. 2 of the instant application) wherein the puncturing end of the needle projects past the skin contacting end of the needle shield when the device is in the original or pre-use position. This allows the user to see the needle end after a protective cap is removed and before the device is used. It should be understood that embodiments other than FIG. 2 can be so modified so that the needle end is visible and/or not covered by the needle shield when the device is in the pre-use or initial position.
(56) FIGS. 32-34 shows a needle assembly interface 60 for a fluid sampling device 80 which can be utilized in accordance with another non-limiting embodiment of the invention. The interface 60 includes a luer-lock interface connectable with the luer-lok interface of any of the needle assemblies 1-1.sup.VIII disclosed herein. The interface 60 includes a connecting interface end 61 having an interface 62 that can connect to a needle assembly discuss above. Portion 63 serves to axially retain and mount the unit 60 to the device 80 (see FIG. 34). A flexible and retractable cover member 65 covers an inner needle 64. Additional details of such fluid sampling devices are disclosed in among other documents, U.S. Application No. 61/480,787 filed Apr. 29, 2011 to SCHRAGA, U.S. application No. 61/498,133 filed Jun. 17, 2011 to SCHRAGA, and US 2010/0286558 published on Nov. 11, 2010. The disclosure of each of these applications is hereby expressly incorporated by reference in their entireties.
(57) FIG. 35 shows a spike needle assembly 1.sup.IX mounted to an end of flexible tubing FT in accordance with another non-limiting embodiment of the invention. The shield 30.sup.IX of needle assembly 1.sup.IX is shown in an initial, intermediate, or prior-use configuration and is biased via a spring 50.sup.IX. A distal end of the needle assembly 1.sup.IX has a connecting interface which can be connected to an end of flexible tubing FT. Unlike the previous embodiments, the needle in this embodiment is a large gauge spike SN for use in IV applications and can puncture things such as medical bags and the like (or other things typically punctured with a medical spike). The assembly 1.sup.IX can otherwise function is a manner similar to that of other herein disclosed needle assemblies.
(58) The devices described herein can also utilize one or more features disclosed in the documents expressly incorporated by reference herein. Furthermore, one or more of the various parts of the device can preferably be made as one-piece structures by e.g., injection molding, when doing so reduces costs of manufacture. Non-limiting materials for most of the parts include synthetic resins such as those approved for syringes, blood collection devices, or other medical devices. Furthermore, the invention also contemplates that any or all disclosed features of one embodiment may be used on other disclosed embodiments, to the extent such modifications function for their intended purpose.
(59) It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.
