Source: http://www.freepatentsonline.com/8961470.html
Timestamp: 2018-06-23 12:39:36
Document Index: 657107661

Matched Legal Cases: ['arts 10', 'art 10', 'art 10', 'arts 20', 'art 20', 'art 20']

Pen needle with safety shield system - SCHRAGA STEVEN
United States Patent 8961470
13/398173
604/110, 604/111, 604/181, 604/192, 604/198
Download PDF 8961470 PDF help
20110288526 Pen Needle Assembly For Intradermal Injection 2011-11-24 Wei
20090254042 NEEDLE PROTECTION DEVICE COMPRISING A DISTAL PROTECTION ELEMENT AND A PROXIMAL PROTECTION ELEMENT 2009-10-08 Gratwohl et al. 604/198
7462168 Safety pen needle with passive safety shield system 2008-12-09 Stonehouse et al. 604/198
20050277895 Pen needle and safety system 2005-12-15 Giambattista et al.
20050171485 Disposable double pointed injection needle, and an insulin injection system comprising a disposable double pointed injection needle 2005-08-04 Larsen et al. 604/198
D445602 Display module 2001-07-31 Tonon
5454828 Lancet unit with safety sleeve 1995-10-03 Schraga
EP2090326 2009-08-19 Safety pen needle with cannula protector element
1. A needle tip for a pre-loaded injection device comprising: a body having a front portion, a back portion configured to be removably connected to the pre-loaded injection device, and a separating wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the separating wall and a second piercing portion projecting forward from the separating wall; a safety shield that is axially movable relative to the body between an initial position, a retracted position, and a post use locking position; and the safety shield having a first portion extending at least partially into an internal space located within the front portion when the safety shield is in the initial position, wherein the safety shield is each of: retained in the initial position wherein a puncturing end of the second piercing portion is exposed; and prevented from retracting fully into the internal space located within the front portion.
10. A single-use needle tip for a pre-loaded injection device comprising: a body having a front portion, a back portion configured to be removably connected to the pre-loaded injection device, and a separating wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the separating wall and a second piercing portion projecting forward from the separating wall; a safety shield that is axially movable relative to the body between an initial position, a retracted position, and a post use locking position; the safety shield having a first portion extending at least partially into an internal space located within the front portion when the safety shield is in the initial position; and a removable cover covering a portion of the safety shield, wherein the safety shield is each of: retained in the initial position wherein a puncturing end of the second piercing portion is exposed; and prevented from retracting fully into the internal space located within the front portion in the retracted position.
11. A single-use needle tip for a pre-loaded injection device comprising: a body having a front portion, a back portion configured to be removably connected to the pre-loaded injection device, and a separating wall separating the front and back portions; a hollow needle having a first piercing portion projecting back from the separating wall and a second piercing portion projecting forward from the separating wall; a safety shield that is axially movable relative to the body between an initial position, a retracted position, and a post use locking position; the safety shield having a first portion extending at least partially into an internal space located within the front portion when the safety shield is in the initial position; a spring biasing the safety shield toward the initial position; and a removable cover covering a portion of the safety shield, wherein the safety shield is each of: retained in the initial position wherein a puncturing end of the second piercing portion is exposed; and prevented, in the retracted position, from retracting fully into the internal space located within the front portion.
FIG. 14 shows another non-limiting embodiment of the pen needle or needle tip 100I in accordance with the invention. The needle tip 100I has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100I has a body portion 10I, e.g., one-piece or integrally formed body, and a safety shield 20, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover PC′ is utilized so that the needle tip 100I can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100I is installed, the protective cap PC′ can be removed and even discarded. Although similar to that of FIGS. 1-13, the protective cap PC′ includes one or more retaining recesses RR which engage with one or more retaining projections RP arranged on the body 10I.
FIGS. 15-18 show another non-limiting embodiment of the pen needle or needle tip 100II in accordance with the invention. The needle tip 100II has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100II has a body portion 10II, e.g., one-piece or integrally formed body, and a safety shield 20II, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100II can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100II is installed, the protective cap can be removed and even discarded. Although similar to that of FIGS. 1-13, the needle shield 20II includes oppositely arranged guiding projections GP which engage with one or more guiding recesses GR arranged on the body 10II.
FIGS. 19-26 show another non-limiting embodiment of the pen needle or needle tip 100III in accordance with the invention. The needle tip 100II has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100III has a body portion 10III, e.g., one-piece or integrally formed body, and a safety shield 20III, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100III can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100III is installed, the protective cap can be removed and even discarded. Although similar to that of FIGS. 15-18, the needle shield 20III includes oppositely arranged guiding projections GP′ which can deflect inwardly and engage with one or more guiding recesses GR′ arranged on the body 10III.
As is evident from FIGS. 23-26, the configuration of each guiding recess GR′ is that they each guide or guidingly engage with one of the guiding projections GP′ of the shield 20III from the initial or intermediate position shown in FIG. 23, to a partially retracted position shown in FIG. 24, to the fully retracted position shown in FIG. 24, and then to the fully extended or locked post-use position shown in FIG. 26. Thus, when the shield 20III moves from the initial or intermediate position shown in FIG. 23 to a partially retracted position shown in FIG. 24, it experiences axial and partial rotation movement in two directions. When the shield 20III moves from the position shown in FIG. 24 to position shown in FIG. 25, it experiences axial and partial rotation movement in one direction. When the shield 20III moves from the position shown in FIG. 25 to position shown in FIG. 26, it experiences only axial linear movement.
Thus, the non-limiting embodiment of FIGS. 19-26 provides for a safety shield 20III that rotates at least partially in opposite directions as it moves from the initial position (see FIG. 23) to the retracted position (see FIG. 25). Additionally or alternatively, the safety shield 20III includes at least one projection GP′ that extends into a guide recess GR′ comprising at least a linear section and a curved section. Additionally or alternatively, the safety shield 20III includes at least one projection GP′ that extends into a guide recess GR′ comprising at least a linear section and an angled section.
FIG. 27 shows another non-limiting embodiment of the pen needle or needle tip 100IV in accordance with the invention. The needle tip 100IV has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100IV has a body portion 10IV, e.g., one-piece or integrally formed body, and a safety shield 20IV, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100IV can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100IV is installed, the protective cap can be removed and even discarded. Similar to that of FIGS. 19-26, the needle shield 20IV includes oppositely arranged guiding projections GP′ which can deflect inwardly and engage with one or more guiding recesses GR″ arranged on the body 10IV.
As is evident from FIG. 27, the configuration of each guiding recess GR″ is that they each guide or guidingly engage with one of the guiding projections GP′ of the shield 20IV from the initial or intermediate position shown in FIG. 27, to a partially retracted position (not shown but similar to that shown in FIG. 24), to the fully retracted position shown (not shown but similar to that in FIG. 24), and then to the fully extended or locked post-use position (not shown but similar to that shown in FIG. 26). Thus, when the shield 20IV moves from the initial or intermediate position shown in FIG. 27 to a partially retracted position, it experiences axial and partial rotation movement in two directions. When the shield 20IV moves from the retracted position to post-use position, it experiences only axial linear movement.
Thus, the non-limiting embodiment of FIG. 27 provides for a safety shield 20IV that rotates at least partially in opposite directions as it moves from the initial position (see FIG. 27) to the retracted position. Additionally or alternatively, the safety shield 20IV includes at least one projection GP′ that extends into a guide recess GR″ comprising at least a linear section and a curved section.
FIG. 28 shows another non-limiting embodiment of the pen needle or needle tip 100V in accordance with the invention. The needle tip 100V has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100V has a body portion 10V, e.g., one-piece or integrally formed body, and a safety shield 20V, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100V can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100V is installed, the protective cap can be removed and even discarded. Similar to that of FIG. 27, the needle shield 20V includes oppositely arranged guiding projections GP′ which can deflect inwardly and engage with one or more guiding recesses GR′″ arranged on the body 10V.
As is evident from FIG. 28, the configuration of each guiding recess GR′″ is that they each guide or guidingly engage with one of the guiding projections GP′ of the shield 20V from the initial or intermediate position shown in FIG. 28, to a partially retracted position (not shown but similar to that shown in FIG. 24), to the fully retracted position shown (not shown but similar to that in FIG. 24), and then to the fully extended or locked post-use position (not shown but similar to that shown in FIG. 26). Thus, when the shield 20V moves from the initial or intermediate position shown in FIG. 28 to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield 20V moves from the retracted position to post-use position, it experiences only axial linear movement.
Thus, the non-limiting embodiment of FIG. 28 provides for a safety shield 20V that rotates at least partially in one direction as it moves from the initial position (see FIG. 28) to the retracted position. Additionally or alternatively, the safety shield 20V includes at least one projection GP′ that extends into a guide recess GR′″ comprising at least two linear sections and can trace at least a partially curved path.
FIGS. 29 and 30 show another non-limiting embodiment of the pen needle or needle tip 100VI in accordance with the invention. The needle tip 100VI has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100VI has a body portion 10VI, e.g., one-piece or integrally formed body, and a safety shield 20VI, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100VI can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100VI is installed, the protective cap can be removed and even discarded. Similar to that of FIG. 28, the needle shield 20VI includes oppositely arranged guiding projections GP′ which can deflect inwardly and engage with one or more guiding recesses GRIV arranged on the body 10VI.
As is evident from FIGS. 29 and 30, the configuration of each guiding recess GRIV is that they each guide or guidingly engage with one of the guiding projections GP′ of the shield 20VI from the initial position shown in FIG. 30 (which covers or extends out past the needle tip unlike previous embodiments), to a partially retracted position shown in FIG. 29, to the fully retracted position shown (not shown but similar to that in FIG. 24), and then to the fully extended or locked post-use position (not shown but similar to that shown in FIG. 26). Thus, when the shield 20VI moves from the initial position shown in FIG. 30 to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield 20VI moves axially further back is rotates in another direction. From the retracted position to post-use position, it experiences only axial linear movement.
Thus, the non-limiting embodiment of FIGS. 29 and 30 provides for a safety shield 20VI that rotates at least partially in two directions as it moves from the initial position (see FIG. 30) to the retracted position. Additionally or alternatively, the safety shield 20VI includes at least one projection GP′ that extends into a guide recess GRIV comprising at least two linear sections and at least two curved sections that can trace at least a partially curved path.
FIGS. 31-35 show another non-limiting embodiment of the pen needle or needle tip 100VII in accordance with the invention. The needle tip 100VII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100VII has a body portion 10VII, e.g., one-piece or integrally formed body, and a safety shield 20VII, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100VII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100VII is installed, the protective cap can be removed and even discarded. The needle shield 20VII includes oppositely arranged guiding projections GP″ which engage with one or more guiding recesses GRV arranged on the body 10VII. Unlike the previous embodiments, however, the needle shield 20VII includes an inner circumferential wall ICW and an outer circumferential wall OCW that is axially longer. The wall OCW provides a further way of preventing the user from attempting to reuse the tip 100VII after being used once and provides a way to locate the guide recess GRV on an outer cylindrical surface of the body 10VII.
As is evident from FIGS. 31-35, the configuration of each guiding recess GRV is that they each guide or guidingly engage with one of the guiding projections GP″ of the shield 20VII from the initial position shown in FIG. 31 to the fully retracted position shown FIG. 32, and then to the fully extended or locked post-use position shown in FIG. 33. Thus, when the shield 20VII moves from the initial position shown in FIG. 31 to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield 20VI moves axially further back is rotates in another direction. From the retracted position to post-use position, it experiences only axial linear movement.
Thus, the non-limiting embodiment of FIGS. 31-35 provides for a safety shield 20VII that rotates at least partially in two directions as it moves from the initial position (see FIG. 31) to the retracted position (see FIG. 32). Additionally or alternatively, the safety shield 20VII includes at least one projection GP″ that extends into a guide recess GRV comprising three linear sections and at least one curved section that can trace at least a partially curved path.
FIG. 36 shows another non-limiting embodiment of the pen needle or needle tip 100VIII in accordance with the invention. The needle tip 100VIII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100VIII has a body portion 10VIII, e.g., one-piece or integrally formed body, and a safety shield (not shown, but similar to that shown in FIG. 33). In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100VIII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100VIII is installed, the protective cap can be removed and even discarded. The needle shield includes oppositely arranged guiding projections which engage with one or more guiding recesses GRVI arranged on the body 10VIII.
FIGS. 37-39 show another non-limiting embodiment of the pen needle or needle tip 100IX in accordance with the invention. The needle tip 100IX has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100IX has a body portion 10IX, e.g., one-piece or integrally formed body, and a safety shield 20IX. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100IX can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100IX is installed, the protective cap can be removed and even discarded. The needle shield includes oppositely arranged guiding projections GP′″ which engage with one or more guiding recesses GRV arranged on the body 10IX.
As is evident from FIG. 39, the configuration of each guiding recess GRV is such that they each guide or guidingly engage with one of the guiding projections of the shield 20IX from the initial position to the fully retracted position, and then to the fully extended or locked post-use position. Thus, when the shield 20IX moves from the initial position to a partially retracted position, it experiences axial and partial rotation movement in only one direction. When the shield moves axially further back past the first deflectable guide member DGM-1 is rotates slightly in another direction. When the shield moves axially forward and past the second deflectable guide member DGM-2 is rotates slightly as well. From the retracted position to post-use position, it experiences both axial and rotational movement. Moreover, the deflectable guide members DGM-1 and DGM-2, which can be moved by the guide projection to allow the safety shield to reach the fully retracted position and to the locked fully extended position respectively, thereafter move back to an original position due to its elastic nature—which prevents the guiding projection(s) GP′″ of the needle shield from moving back into the original position and to the retracted position respectively.
Thus, the non-limiting embodiment of FIGS. 37-39 provides for a safety shield 20IX that rotates at least partially in two directions as it moves from the initial position to the retracted position. Additionally or alternatively, the safety shield includes at least one projection that extends into a guide recess GRV comprising at least one linear section, two angled sections, and/or two deflectable guide members DGM-1 and DGM-2. The non-limiting embodiment of FIGS. 37-39 also provides for a safety shield 20IX that includes at least one projection GP′″ that extends into a guide recess GRV comprising at least one locking mechanism DGM-2 for retaining the safety shield 20IX in the post use locking position.
FIGS. 40-41 show another non-limiting embodiment of the pen needle or needle tip 100X in accordance with the invention. The needle tip 100X has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100X has a body portion 10X, e.g., one-piece or integrally formed body, and a safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100X can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100X is installed, the protective cap can be removed and even discarded. The needle shield includes oppositely arranged guiding projections which engage with one or more guiding recesses GRVI arranged on the body 10X. The arrangement of the one or more guiding recesses GRVI arranged on the body 10X is similar to that of the previous embodiment, except that the portions containing the two deflectable guide members DGM-1 and DGM-2 are separate members which can be inserted into appropriately sized and configured areas of the recess GRVI.
FIGS. 42-43 show another non-limiting embodiment of the pen needle or needle tip 100XI in accordance with the invention. The needle tip 100XI has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XI has a body portion 10XI, e.g., one-piece or integrally formed body, and a safety shield 20XI. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100XI can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100XI is installed, the protective cap can be removed and even discarded. The needle shield 20XI includes oppositely arranged guiding projections GPIV which engage with one or more guiding recesses (not shown but similar to those of FIG. 39 or 40) arranged on the body 10XI. The arrangement of the one or more guiding recesses GRIV arranged on the body 10XI is similar to that of the previous embodiment it that it utilizes the two deflectable guide members DGM-1 and DGM-2. With such an arrangement, at least one projection GPIV extends into a guide recess comprising at least one locking mechanism, i.e., one of deflectable guide members DGM-1 and DGM-2 (see FIG. 39 or 40) and one, i.e., deflectable guide member DGM-2, can be utilized to retain the safety shield 20XI in the post use locking position. In this embodiment, the inner cylindrical wall does not participate in locking the safety shield 20XI in the post use locking position unlike certain previous embodiments. Furthermore, the safety shield 20XI can be formed of two main components 20XIA and 20XIB attachable via, e.g., a snap connection between one or more projections and one or more recesses as shown in FIG. 43.
FIG. 44 shows another non-limiting embodiment of the pen needle or needle tip 100XII in accordance with the invention. The needle tip 100XII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XII has a body portion 10XII, e.g., one-piece or integrally formed body, and a safety shield 20XII. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100XII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100XII is installed, the protective cap can be removed and even discarded. The needle shield 20XII includes oppositely arranged guiding projections (not shown but similar to that of the previous embodiment) which engage with one or more guiding recesses (not shown but similar to those of FIG. 35, 36, 39 or 40) arranged on the body 10XII. The arrangement of the one or more guiding recesses arranged on the body 10XII is can function well with the recesses shown in FIGS. 35 and 36, but can also be similar to that of the previous embodiment it that it can utilize the two deflectable guide members DGM-1 and DGM-2 shown in FIGS. 39 and 40. With such an arrangement, at least one projection GPIV extends into a guide recess comprising at least one locking mechanism, i.e., deflectable guide member DGM-2 (see FIG. 39 or 40), and one of these, i.e., deflectable guide member DGM-2, is utilized to retain the safety shield 20XII in the post use locking position (creating a double, back-up, or redundant locking system). In this embodiment, the inner cylindrical wall can also participate in locking the safety shield 20XII in the post use locking position. Furthermore, the safety shield 20XII can be formed of two main components attachable via a snap connection between one or more projections and one or more recesses similar to that shown in FIG. 43.
FIGS. 45 and 46 show another non-limiting embodiment of the pen needle or needle tip 100XIII in accordance with the invention. The needle tip 100XIII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XIII has a body portion 10XIII, e.g., one-piece or integrally formed body, and a safety shield 20XIII, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100XIII can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100XIII is installed, the protective cap can be removed and even discarded. Although similar to that of FIG. 1, this embodiment also utilizes a support ring 30 which functions as a mechanism for preventing a locking of the safety shield 20XIII when the shield 20XIII in not in the post use locking position, i.e., such as when the shield 20XIII is in the initial position. In the position shown in FIG. 45, the ring 30 prevents inward deflection of the tapered projections. As is evident from FIG. 46, during injection the support ring 30 is moved or slid forward relative to its original position (and slight frictional engagement with) inside the safety shield 20XIII. In this position, it no longer can prevent a locking of the safety shield 20XIII so that when the shield 20XIII is allowed to move to the extended position under the action of the spring S1, it becomes locked in the post use locking position.
FIG. 47 shows another non-limiting embodiment of the pen needle or needle tip 100XIV in accordance with the invention. The needle tip 100XIV has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XIV has a body portion 10XIV, e.g., one-piece or integrally formed body, and a safety shield 20XIV, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100XIV can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100XIV is installed, the protective cap can be removed and even discarded. Although similar to that of FIG. 1, this embodiment also utilizes a support ring 30′ (like the embodiment of FIG. 45) which functions as a mechanism for preventing a locking of the safety shield 20XIV when the shield 20XIV in not in the post use locking position, i.e., such as when the shield 20XIV is in the initial position. The ring 30′ prevents inward deflection of the tapered projections and also, by having a predefined axial length, provides a predetermined depth of penetration. As should be evident from FIG. 47, during injection the support ring 30′ is moved or slid forward relative to its original position (and slight frictional engagement with) inside the safety shield 20XIV until in abuts the wall having the needle opening. This limits injection depth of penetration. Although not shown, the tip 100XIV can include indicia (or other indicators such as color of the body or needle shield) informing the user of the depth of penetration provided by the tip. The indicia or indicator feature can be determined by which of a number of different axial length rings are utilized. For example, a red body may provide an indication for one depth of penetration (determined by how much the puncturing end of the needle N projects out past the shin contact surface of the shield) while a blue body may provide an indication for another depth of penetration, and a green one being different from both the red and blue, etc. When the ring 30′ is moved, the ring 30′ also no longer can prevent a locking of the safety shield 20XIV so that when the shield 20XIV is allowed to move to the extended position under the action of the spring S1, it becomes locked in the post use locking position. As such, this embodiment provides for a mechanism for preventing a locking of the safety shield when the shield in not in the post use locking position and includes a predetermined depth setting mechanism.
FIG. 48 shows another non-limiting embodiment of the pen needle or needle tip 100XV in accordance with the invention. The needle tip 100XV has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XV has a body portion 10XV, e.g., one-piece or integrally formed body, and a safety shield 20XV, e.g., a one-piece or integrally formed safety shield. In embodiments, a protective cap or cover can be utilized (not shown) so that the needle tip 100XV can be safely packaged, shipped and/or installed on the injector 1. Once the needle tip 100XV is installed, the protective cap can be removed and even discarded. Although similar to that of FIG. 1, this embodiment also utilizes a support ring 30″ (like the embodiments of FIG. 45-47) which functions as a mechanism for preventing a locking of the safety shield 20XV when the shield 20XV in not in the post use locking position, i.e., such as when the shield 20XV is in the initial position. The ring 30″ prevents inward deflection of the tapered projections and also, by having a predefined axial length, provides a predetermined depth of penetration. Furthermore, the ring projections RP can provide a visual and/or tactile indicator that the tip 100XV has been used. As should be evident from FIG. 48, during injection the support ring 30″ is moved or slid forward relative to its original position (and slight frictional engagement with) inside the safety shield 20XV until in abuts the wall having the needle opening. This limits injection depth of penetration. Although not shown, the tip 100XV can include indicia (or other indicators such as color of the body or needle shield) informing the user of the depth of penetration provided by the tip. The indicia or indicator feature can be determined by which of a number of different axial length rings are utilized. For example, a red body may provide an indication for one depth of penetration (determined by how much the puncturing end of the needle N projects out past the shin contact surface of the shield) while a blue body may provide an indication for another depth of penetration, and a green one being different from both the red and blue, etc. When the ring 30″ is moved, the ring 30″ also no longer can prevent a locking of the safety shield 20XV so that when the shield 20XV is allowed to move to the extended position under the action of the spring S1, it becomes locked in the post use locking position. As such, this embodiment provides for a mechanism for preventing a locking of the safety shield when the shield in not in the post use locking position and includes a predetermined depth setting mechanism, and also provides includes at least one mechanism for providing a visual and/or tactile indication to the user that the needle tip has been used.
Indeed, in the embodiment of FIG. 49, the ring 30″ has ring projections RP which extend to or can be slightly behind the skin contact surface SCS of the shield—thereby providing a visual indicator that the tip 100XV has been used. This can be made more evident, if the one-piece ring 30″ is one color, e., red, and the shield is another color, e.g., white. Although not shown, the frictional engagement between ring projections RP and the openings in the wall having the skin contact surface SCS can be significant so that once inserted therein, they cannot be moved back out without easily.
In the embodiment of FIG. 50, the ring 30′″ has ring projections RP′ which extend out past the skin contact surface SCS of the shield—thereby providing a visual and tactile indicator that the tip 100XVI has been used. This can also be made more evident, if the one-piece ring 30′″ is one color, e., red, and the shield is another color, e.g., white. Although not shown, the frictional engagement between ring projections RP and the openings in the wall having the skin contact surface SCS can be significant (or non-releasable) so that once inserted therein, they cannot be moved back out without easily.
In the additional embodiment of FIG. 51, which is a modified version of that of FIG. 1 and can be used on any of the herein disclosed embodiments, the skin contact surface includes a concave surface CS—thereby providing a more comfortable contact surface for the tip 100XVII. The needle tip 100XVII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XVII has a body portion 10XVII, e.g., one-piece or integrally formed body, and a safety shield 20XVII, e.g., a one-piece or integrally formed safety shield.
In the additional embodiment of FIG. 52, which is a modified version of that of FIG. 1 and can be used on any of the herein disclosed embodiments, the skin contact wall includes self-sealing puncturable member 40—thereby providing a safe covering for the needle N of the tip 100XVIII. The needle tip 100XVIII has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XVIII has a body portion 10XVIII, e.g., one-piece or integrally formed body, and a safety shield 20XVIII, e.g., a one-piece or integrally formed safety shield. This embodiment thus provides for a pierceable member that is pierced during injection and/or a pierceable and resealable member that is pierced during injection.
In the additional embodiment of FIG. 53, which is a modified version of that of FIG. 1 and can be used on any of the herein disclosed embodiments, the body is made as a two-piece arrangement that is, e.g., threadably connected. The needle tip 100XIX has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip 100XIX has a two-piece body 10XIX,e.g., both parts 10XIXA and 10XIXB can be one-piece or integrally formed members. A safety shield 20XIX, e.g., a one-piece or integrally formed safety shield, is also utilized. Furthermore, by providing a threaded connection between the body parts, this embodiment thus provides a depth adjustment mechanism DAM for controlling a depth of injection and that is limited at least between two stop or axial positions. In the position shown in FIG. 53, the needle N would provide for one injection depth. However, by unthreading the part 10XIXB from the part 10XIXA, the depth of injection would be reduced. These user determined adjustments occur when the depth of penetration is determined by contact between movable stop surface MSS and the set stop surface SSS. Although not shown, indicia can be provided to indicate to the user which depth setting the tip is current set to.
In the additional embodiment of FIG. 54, which is a modified version of that of FIG. 37 and can be used on any of the herein disclosed embodiments, the shield is made as a two-piece arrangement that is, e.g., threadably connected. The needle tip has a rear or distal portion that is removably connected, e.g., threadably connected, to the threaded section 2 of a pen needle injection device 1. More specifically, the needle tip has a two-piece shield 20XX, e.g., both parts 20XXA and 20XXB can be one-piece or integrally formed members. Furthermore, by providing a threaded connection between the shield parts, this embodiment thus provides a depth adjustment mechanism for controlling a depth of injection and that is limited at least between two stop or axial positions. By threading on or unthreading the part 20XXB from the part 20XXA, the depth of injection can be changed. Although not shown, indicia can be provided to indicate to the user which depth setting the tip is current set to.
Pen needle injection device 100-100XX;
Body 10-10XX;
Safety Shield 20-20XX;
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