Injection device and method of assembly and activation

[0001] This application is a continuation-in-part of U.S. Provisional Patent Application Ser. No. 60/800,769 filed on May. 16, 2006, which is expressly incorporated herein by reference and made a part hereof.

[0002] Not Applicable.

[0003] The present invention relates generally to injection systems for delivering a pharmaceutical product to a patient, and more particularly to a system for expelling a pharmaceutical product from a cartridge or ampoule.

[0004] Pharmaceutical products are often delivered or transferred through the use of a syringe or a syringe system. Syringe systems can include a needle of known construction, thereby enabling delivery of the pharmaceutical product directly into a patient, e.g., through intravenous injection, or through a septum that fluidly seals a port associated with a tube set that is, or can be, fluidly connected to a patient. Alternatively, the syringe system can be provided with a blunt needle that is constructed to be inserted through a pre-pierced septum of a tube set. The syringe system can also include a luer fitment (male or female, locking or non-locking) configured to mate with a complementary luer fitment for transfer of the pharmaceutical product from the syringe system into another medical system, e.g., transfer from the syringe to a luer-activated valve associated with a tube set.

[0005] Many pharmaceutical products in the market today are provided in an ampoule or cartridge. These ampoules or cartridges can be configured for use with an injection device or system that is designed to be connected to the ampoules or cartridges such that a medical professional can expel the pharmaceutical product from the ampoule or cartridge for delivery to the patient or transfer to another medical system. One example of an ampoule or cartridge is the CARPULE® system sold by Hospira, Inc., the Assignee of this application and the inventions disclosed herein.

[0006] U.S. Pat. No. 5,653,698, which is incorporated herein by reference in its entirety, provides detailed insight into the structure and operation of a pharmaceutical cartridge of the type to be used in the present invention. The cartridge system disclosed in U.S. Pat. No. 5,653,698 includes a cartridge 40 configured to retain a pharmaceutical product therein. A piston 52 is positioned within the cartridge and fluidly seals a first, open end of the cylindrical wall 44 of cartridge 40. Piston 52 is movable within cartridge 40 such that it causes the pharmaceutical product contained in the cartridge 40 to be ejected from the cartridge as piston 52 is moved toward the second end of the cartridge. A threaded rod 54 is attached to piston 52, the threaded rod 54 being constructed to threadably attach to a piston stem 62 which can be used to facilitate movement of piston 52 within cartridge 40. The second end of cartridge 40 is fluidly sealed by a pierceable diaphragm 50 which precludes the ejection of the pharmaceutical product from the cartridge so long as the pierceable diaphragm is intact.

[0007] The cartridge system disclosed in U.S. Pat. No. 5,653,698 further includes a hub 20 portion mounted on the second end of cartridge 40. Hub 20 includes a snapping sleeve portion 22 that is movably disposed over the second end of cartridge 40. Hub 20 further includes a needle cannula 18 which, when hub 20 and cartridge 40 are moved toward one another, pierces pierceable diaphragm 50 in order to provide for an egress pathway for the pharmaceutical product contained in cartridge 40.

[0008] In use, cartridge 40 of the cartridge system disclosed in U.S. Pat. No. 5,653,698 is placed into a reusable syringe holder 56 such that ampoule/cartridge 40 and snapping sleeve portion 22 of hub 20 are positioned within the holder 56. Piston stem 62 is then rotated clockwise to lock ampoule 40 within holder 56 and to simultaneously urge ampoule 40 forward. Because hub 20 is prevented from moving forward by holder 56, this forward movement of ampoule 40 causes ampoule 40 and hub 20 to move toward one another, and thus causes needle cannula 18 to pierce pierceable diaphragm 50, and thereby providing fluid communication between the interior of ampoule 40 and the interior of needle cannula 18 such that movement of piston 52 will cause fluid to be drawn into or ejected from the ampoule 40, depending upon the direction of movement imparted to piston 52.

[0009] Systems of the type disclosed in U.S. Pat. No. 5,653,698 can be provided with a variety of structures for delivery or transfer of the pharmaceutical product, including needles for injecting the pharmaceutical product into a patient or for injecting the pharmaceutical product into an add port associated with a drug delivery tube set of known construction. Alternatively, a male or female luer fitting (including both locking and non-locking luer fittings) can be associated with or attached to the hub for delivery of the pharmaceutical product through a medical device having a complementary luer fitting, e.g., a luer-activated valve. Also, a blunt tube can be associated with the hub for delivery of the pharmaceutical product to a medical device having a septum, e.g., a pre-pierced septum, through which the blunt tube can be urged in order to permit the contents of the cartridge to be ejected into the medical device.

[0010] Additional examples of injectors constructed for the delivery of pharmaceutical products from a cartridge can be found in U.S. Pat. Nos. 5,447,500; 5,573,514; and Des. 366,698, each of which is incorporated herein in its entirety. The foregoing examples of the background art are intended to be illustrative and not exclusive.

[0011] Accordingly, syringe systems and injectors constructed for the delivery of pharmaceutical products from a cartridge are known in the art. While such syringe systems and injectors according to the prior art provide a number of advantageous features, they nevertheless have certain limitations. The present invention seeks to overcome certain of these limitations and other drawbacks of the prior art, and to provide new features not heretofore available. A full discussion of the features and advantages of the present invention is deferred to the following detailed description, which proceeds with reference to the accompanying drawings.

[0012] The present invention generally provides an injector device for use with a pharmaceutical cartridge. According to one embodiment, the injector device includes a syringe or injector body, and a plunger rod. The plunger rod is releasably connected to the injector body in a first position, and is disassociated from the injector body in a second position. The plunger rod is constructed for attachment to a piston positioned within the pharmaceutical cartridge after the plunger rod has been disassociated from the injector body.

[0013] According to one embodiment, the injector body has a side wall having proximal and distal end portions and inner and outer surfaces. The inner surface of the injector body defines a cavity configured to receive at least a portion of a pharmaceutical cartridge therein. The injector body further includes one or more retention members disposed on the outer surface of the body. The retention members are constructed to retain the plunger rod in the first position such that it is releasably secured to the injector body. The retention members also are constructed to permit the plunger rod to be moved to the second position such that the plunger rod is disassociated from the injector body.

[0014] According to another embodiment, the retention members are connected to the injector body in the first position of the plunger rod. In a second position of the plunger rod, wherein the plunger rod is axially displaced from the first position, however, the retention members are disassociated from the injector body. In one embodiment, the retention members comprise frangible posts. In another embodiment the posts have a tab extending transversely therefrom for engagement with the plunger rod.

[0015] According to another embodiment, the plunger rod has proximal and distal end portions. The distal end portion of the plunger rod has a connection member constructed for connection to a connecting member associated with a piston positioned within the pharmaceutical cartridge. The plunger rod further has one or more receiving members between the proximal end portion and the distal end portion for cooperation with the one or more retention members on the injector body.

[0016] According to another embodiment, the retention members and the receiving members are constructed to cooperatively retain the plunger rod to the injector body adjacent the outer surface of the injector body when the plunger rod is in a first position. Further, the retention members and the receiving members are constructed to cooperatively release the plunger rod from the injector body when the plunger rod is transitioned axially toward the distal end of the injector body to a second position.

[0017] According to another embodiment, the receiving members comprise apertures configured to receive the retention members. In one embodiment the apertures are constructed to retain a retention member in the form of a post to prevent reverse movement of the post after it has been inserted into the aperture and to retain the post after the post has been detached from the outer surface of the injector body.

[0018] According to another embodiment, the retention members comprise one or more wing members disposed on the outer surface of the injector body. The wing members each have a retaining tab for engaging a complementary receiving member of the plunger rod. In another embodiment the receiving members on the plunger rod comprise one or more ledges for mating with the wing members.

[0019] According to another embodiment, the plunger rod further has a pushing surface for engaging the cartridge positioned within the cavity of the injector body. The pushing surface is constructed to move the cartridge body axially and distally as the plunger rod is moved from the first position to the second position. Additionally, in one embodiment movement of the plunger rod from the first position to the second position releases the plunger rod from the injector body, and movement of the plunger rod from the first position to the second position simultaneously activates the pharmaceutical cartridge.

[0020] According to another embodiment the pushing surface has a nub projecting therefrom. The nub is constructed to preclude access to a piston positioned at a proximal end of the cartridge. In one embodiment, the nub extends partially into a proximal end portion of the cartridge positioned within the cavity of the injector body.

[0021] According to another embodiment, the distal end portion of the plunger rod has a connection member constructed to attach to a connecting member associated with a piston of the pharmaceutical cartridge for transitioning the plunger of the pharmaceutical cartridge. In one embodiment the connection member of the plunger rod has threads formed thereon. In such an embodiment the plunger rod can be threadably secured to a connecting member mounted on a piston associated with the cartridge. In an alternate embodiment the connection member of the plunger rod has a snap-fit member constructed to connect by snap fit to a connecting member mounted on a piston associated with a cartridge.

[0022] According to another embodiment, the pharmaceutical cartridge has a body portion defining an interior space. The interior space is fluidly sealed at a first, proximal end by a piston having a connecting member. The pharmaceutical cartridge is further fluidly sealed at a second, distal end by a pierceable diaphragm. The pharmaceutical cartridge further includes a hub slidably mounted on a distal end portion of the body portion. The hub includes a piercing member constructed to pierce the pierceable diaphragm sealing the second, distal end of the cartridge body portion. The cartridge is slidable relative to the hub between a first, inactivated position in which the piercing member is positioned distal to the pierceable diaphragm and in which the pierceable diaphragm fluidly seals the cartridge, and a second, activated position in which the piercing member is disposed through the pierceable diaphragm and wherein a flow channel defined by the piercing member is in fluid communication with the interior space defined by the pharmaceutical cartridge, thereby allowing the contents of the interior space to be ejected from the cartridge through the piercing member by moving the piston toward the distal end portion of the cartridge body.

[0023] According to another embodiment, the hub is fixed in place within the injector body with a clip in order to prevent relative longitudinal and rotational movement between the hub and the injector body. In one embodiment, the clip has projections that extend through openings in the side wall of the injector body to engage the hub to prevent longitudinal and rotational movement of the hub relative to the injector body.

[0024] According to another embodiment, the injector body further comprises transverse finger grips extending from the proximal end portion of the injector body. Additionally, in one embodiment, the injector body also has grip openings in the sidewall of the injector body. The grip openings are positioned on the distal side of finger grips. The grip openings allow the finger grips to have a decreased transverse dimension.

[0025] According to another embodiment, the injector body is preferably clear or transparent, allowing the cartridge inserted into the cavity of the injector body to be visible through the sidewall of the injector body. In this manner, a bar code on the outer wall of the cartridge may be visible through the sidewall of the injector body and can be scanned through the sidewall when the pharmaceutical cartridge is seated in the injector body.

[0026] According to another embodiment, a combination of a pharmaceutical cartridge and an injector is provided. The combination includes a cartridge body defining an interior space for retaining a pharmaceutical product. A piston is positioned within the interior space defined by the cartridge body at a proximal end portion of the cartridge body. The piston fluidly seals a proximal end of the cartridge body portion. The piston has a connecting member associated therewith. The cartridge also has a pierceable diaphragm fluidly sealing a distal end portion of the cartridge body. The cartridge further includes a hub slidably mounted on the distal end portion of the cartridge body, the hub including a piercing member constructed to pierce the pierceable diaphragm. The piercing member defines a flow channel. The cartridge is slidably movable between a first, inactivated position in which the piercing member is disposed external to the interior space defined by the cartridge body portion and a second, activated position in which the piercing member is disposed through the pierceable diaphragm and in which the flow channel defined by the piercing member is in fluid communication with the interior space defined by the cartridge body, such that a pharmaceutical product disposed in the interior space defined by the cartridge body can be ejected through the flow channel defined by the piercing member by moving the piston toward the distal end portion of the pharmaceutical cartridge. The injector of the combination includes an injector body having a side wall having a proximal end portion and a distal end portion. The side wall has an inner surface and an outer surface, the inner surface of the side wall defining a space for receiving at least a portion of the cartridge body of the pharmaceutical cartridge therein. In one embodiment, though not necessary, either a clip or a portion of the injector body is constructed to prevent movement of the hub of the pharmaceutical cartridge in a distal direction when the pharmaceutical cartridge is disposed within the injector body. The injector also has one or more retention members disposed on the outer surface of the injector body. The plunger comprises a plunger rod having a proximal end portion and a distal end portion. The distal end portion of the plunger rod has a connection member constructed to attach to the connecting member associated with the piston of the pharmaceutical cartridge. The plunger rod has one or more engagement members formed along its length. In various embodiments the engagement members comprise surfaces, projections or receivers. The one or more engagement members and the one or more retention members are constructed to cooperatively retain the plunger rod on the injector body when the plunger rod is in a first position, and the one or more engagement members and the one or more retention members are constructed to cooperatively release the plunger rod from the body when the plunger rod is moved toward the distal end of the injector body to a second position. In another embodiment the plunger rod further includes a surface for engaging the proximal end portion of the cartridge body positioned within the injector body. The surface of the plunger rod is configured to move the proximal end portion of the cartridge body distally as the plunger rod is moved from the first position to its second position, whereby movement of the plunger rod from the first position to the second position releases the plunger rod from the injector body, and whereby movement of the plunger rod from the first position to the second position simultaneously activates the pharmaceutical cartridge. In this combination, at least a portion of the cartridge body is disposed within the injector body.

[0027] According to another embodiment, the one or more engagement surfaces formed along the length of the plunger rod are defined by a ledge. In one possible configuration of this alternative embodiment, the ledge includes notches spaced apart from each other that correspond to complementary retaining tabs provided on the injector body. To attach the plunger rod to the injector body, the plunger rod is placed over the wings with the notches aligned with the retaining tabs. The plunger rod is then moved proximally along the injector body so as to engage the ledge with the retaining tabs. To release the injector rod, the injector rod is moved distally relative to the injector body so as to place the notches in position opposite the retaining tabs on the wings. The injector rod can then be lifted from the injector body and the distal end of the plunger rod attached to a connecting member on a piston positioned with the pharmaceutical cartridge. The distal movement of the injector rod relative to the injector body also causes an engagement surface of the injector rod to move a proximal end portion of a pharmaceutical cartridge distally, thereby simultaneously activating the pharmaceutical cartridge.

[0028] Other features and advantages of the invention will be apparent from the following specification taken in conjunction with the following drawings.

[0099] Referring now to FIGS. 1A-1C, an injector device 100 is illustrated comprising an injector body 105 for receiving and holding a pharmaceutical cartridge or ampoule 155 containing a pharmaceutical product. A depicted in these figures, plunger rod 130 is mounted on injector body 105. As discussed in detail herein, plunger rod 130 is carried on the body 105 prior to activation of pharmaceutical cartridge 155. The body 105 includes a side wall 110 having an outer surface 115 and an inner surface 120. Although side wall 110 is depicted in the accompanying figures as being cylindrical in shape, it will be appreciated that the shape of side wall 110 can be varied based upon the shape of the pharmaceutical cartridge 155 to be used therewith. Inner surface 120 of side wall 110 defines a region or space 125 for receiving at least a portion of cartridge 155 therein. Injector body 105 has a proximal end portion 106 and a distal end portion 107. Plunger rod 130 has a proximal end portion 131 and a distal end portion 132. Cartridge 155 has a proximal end portion 156 and a distal end portion 157.

[0100] In the accompanying figures, injector body 105 is depicted as having a semi-circular cross-sectional configuration. Side wall 110 of injector body 105 defines a gap 111 along a length thereof. In the depicted embodiment of the present invention, gap 111 is sized such that pharmaceutical cartridge 155 can be inserted into side wall 110 of injector body 105 through gap 111. It will be appreciated that side wall 110 can be constructed of a flexible, resilient material such as plastic or metal such that pharmaceutical cartridge 155 can be inserted into side wall 110 through gap 111 despite the fact that the width of gap 111 is less than the overall diameter of pharmaceutical cartridge 155. In this way, side wall 110 of injector body 105 can be manufactured as a single piece. In an alternative embodiment, side wall 110 can be formed by two or more pieces connected by a hinge member, or by a living hinge, which enables the two or more pieces to be moved away from each other in order to enable pharmaceutical cartridge 155 to be inserted into side wall 110.

[0101] It will be appreciated that other methods for placing pharmaceutical cartridge 155 into side wall 110 can be employed and that side wall 110 need not have a gap 111 for allowing placement of the pharmaceutical cartridge 155 into side wall 110. For example, it is possible to construct side wall 110 such that pharmaceutical cartridge 155 is inserted therein from either the proximal end 106 or distal end 107 of side wall 110. In such a configuration, retention portion 185 (discussed in detail below) will need to be configured such that pharmaceutical cartridge 155 can be slid therethrough, for example, by way of diametrically enlarging retention portion 185 or opening retention portion 185 as pharmaceutical cartridge 155 is slid therethrough, and such that retention portion 185 will subsequently interact with pharmaceutical cartridge 155 so as to prevent longitudinal and rotational movement of hub 20 of pharmaceutical cartridge 155, as discussed in detail below. In one embodiment, gap 111 is formed through a limited length of side wall 110 only adjacent to retention portion 185 of injector body 105, thereby allowing for the required diametrical enlargement of retention portion 185 as pharmaceutical cartridge 155 is positioned within side wall 110 of injector body 105.

[0102] As depicted in FIGS. 2A and 2B, injector body 105 includes one or more retention members 135 positioned on outer surface 115 injector body 105. In the embodiment of the present invention depicted in FIGS. 2A and 2B, retention members 135 are in the form of retaining wings 136 disposed on and projecting outwardly from outer surface 115 of side wall 110. Each of the wings 136 includes a respective retaining tab 137. Retaining tabs 137 are used to engage one or more complementary engagement surfaces 133 of plunger rod 130 to releasably attach plunger rod 130 to outer surface 115 of injector body 105. The complementary engagement surfaces 133 are also referred to herein as receiving members.

[0103] In order to enhance the retention of plunger rod 130 by each of retention members 135, each of engagement surfaces 133 includes a radially enlarged portion 134, as depicted in FIG. 7D. It will be appreciated that the presence of radially enlarged portion 134 will enhance the frictional force with which retention members 135 and plunger rod engagement surfaces 133 interact, thereby increasing the retention force with which plunger rod 130 is held on outer surface 115 of injector body 105.

[0104] In the embodiments of the present invention depicted in the accompanying figures, injector body 105 and plunger rod 130 are depicted as separate pieces. These pieces can be injection molded or formed using a variety of other known tooling techniques. It will be appreciated that injector body 105 and plunger rod 130 can be unitarily injection molded without departing from the intended spirit and scope of the present invention.

[0105] In one embodiment of the present invention, plunger rod 130 includes ledge 138 running along the length thereof. Ledge 138 is constructed to cooperate with retention members 135, particularly retention tabs 137, to releasable attach plunger rod 130 to injector body 105. Ledge 138 includes notches 140 defined therein along its length. When plunger rod 130 is positioned axially relative to injector body 105 such that notches 140 are aligned with retaining tabs 137 on wings 136 of retention members 135, plunger rod 130 can be moved radially relative to injector body 105 without physical contact between ledge 138 and retention tabs 137. That is, when notches 140 are aligned with retaining tabs 137, plunger rod 130 can be removed from injector body 105, or plunger rod 130 can be placed in a position for attachment to injector body 105, because the width of ledge 138 at notches 140 is less than the spacing between tabs 137. When plunger rod 130 is positioned axially relative to injector body 105 such that notches 140 are not aligned with retaining tabs 137 on wings 136 of retention members 135, plunger rod 130 cannot be moved radially relative to injector body because the width of ledge 138 is greater than the spacing between tabs 137.

[0106] As depicted in FIG. 3B, ramp portions 141 provide a gradual transition between the width of ledge 138 at notches 140 and the width of ledge 138 at its broadest along the length of ledge 138. It will be appreciated that ramp portions 141 facilitate the attachment and release of plunger rod 130 from injector body 105. Although ramp portions 141 are depicted in the accompanying figures as having a constantly changing diameter along their lengths, it will be appreciated that ramp portions 141 can have other forms so long as they facilitate attachment and release of plunger rod 130. Ramp portions 141 can also be eliminated, if desired.

[0107] Plunger rod 130 is attached to injector body 105 by placing plunger rod 130 over injector body 105 and aligning notches 140 with retaining tabs 137 on wings 136 and passing retaining tabs 137 through notches 140. In this position, radially enlarged portion 134 of plunger rod 130, which is located adjacent to notch 140, is positioned between wings 136 and does not engage injector body 105. Plunger rod 130 is next moved proximally relative to injector body 105, thereby causing ledge 138 to be positioned radially inwardly (beneath) retention tabs 137. As ledge 138 moves beneath retention tabs 137, radially enlarged portion 134 of plunger rod 130 comes into engagement with outer surface 115 of injector body 105, thereby causing plunger rod 130 to move radially outwardly by a distance substantially equal to the thickness of radially enlarged portion 134. This radially outward movement causes ledge 138 to be brought into contact with the underside of retention tabs 137, thereby providing a frictional fit between retention tabs 137 and ledge 138.

[0108] Although the injector device 100 of the present invention is depicted in the accompanying figures as including two retention members 135, e.g., two wings 136 having retention tabs 137, it will be appreciated that a single retention member 135 can be used to secure plunger rod 130 to outer surface 115 of side wall 110 of injector body 105. Further, it will be appreciated that more than two retention members 135 can be used to secure plunger rod 130 to outer surface 115 of side wall 110 of injector body 105. Similarly, the details of the construction of retention members 135 set forth herein are not intended to be limited to the wing and retention tab depicted in the accompanying drawings. One of ordinary skill in the art will recognize that various modifications can be made to the number and configuration of retention members 135 without departing from the spirit and scope of the present invention. Such modifications are the subject of other figures and are discussed in detail below. In short, the accompanying figures are intended to be illustrative, not limiting, with respect to the configuration and number of retention member 135 of the present invention.

[0109] As depicted in FIGS. 1A-1C, injector body 105 includes finger grips 145. Finger grips 145 are configured such that a medical professional using injector device 100 of the present invention will engage them with his/her index and middle fingers during normal use. In the embodiment of the present invention depicted in the accompanying figures, finger grips 145 are convex on a distal side of finger grips 145 and concave on a proximal side of finger grips 145. It will be appreciated that the size and shape of finger grips 145 can be modified without departing from the scope of the present invention.

[0110] Pushing member 150 is provided on proximal end portion 131 of plunger rod 130. Pushing member 150 includes a proximal surface 151 that is constructed for engagement with a medical professional's thumb. In use, and with plunger rod 130 mounted on injector body 105, a medical professional will grasp injector body 105 such that his/her index and middle fingers are in contact with a distal surface of finger grips 145 and such that his/her thumb is in contact with proximal surface 151 of pushing member 150.

[0111] Pushing member 150 also includes a surface for pushing 152 which is constructed to engage proximal end portion 156 of pharmaceutical cartridge 155 and to urge proximal end portion 156 of pharmaceutical cartridge distally as a medical professional squeezes his/her index and middle fingers towards his/her thumb. The importance of surface for pushing 152 will be described in greater detail later in this specification.

[0112] Injector body 105 can be provided separately from pharmaceutical cartridge 155 such that a medical professional, e.g., a pharmacist, inserts pharmaceutical cartridge 155 into injector body 105 prior to use. Alternatively, injector body 105 and pharmaceutical cartridge 155 can be pre-assembled by a manufacturer or assembler and supplied in combination to medical professionals.

[0113] Pharmaceutical cartridge 155 used in conjunction with the present invention can have a variety of configurations. In one embodiment, pharmaceutical cartridge 155 is constructed in the manner described in U.S. Pat. No. 5,653,698 which has been incorporated herein by reference. Using many of the lead numbers set forth in U.S. Pat. No. 5,653,698, FIG. 1C depicts the details of pharmaceutical cartridge 155. Cartridge 155 is constructed to retain a pharmaceutical product within an interior space 40 defined by cartridge 155. Piston/plunger 52 is slidably positioned within the interior space 40 at proximal end portion 156 of pharmaceutical cartridge 155. Piston/plunger 52 fluidly seals proximal end portion 156 of pharmaceutical cartridge 155. A connection member 160, e.g., threaded rod, is attached to piston/plunger 52 such that it is accessible from the exterior of cartridge 155. Connection member 160 can have a variety of configurations, including that of a threaded rod constructed to engage a plunger rod having complementary threads formed thereon. Alternatively, connection member 160 can be a member constructed to provide a snap fit with a complementary connecting member formed on a plunger rod. Other configurations providing locking or frictional connections between connection member 160 and a complementary member on a plunger rod can also be used.

[0114] Distal end portion 157 of the cavity 40 of the cartridge 155 is fluidly sealed by pierceable diaphragm 50, as depicted in FIG. 4A. Pierceable diaphragm 50 can be constructed of a variety of known materials, including elastomeric materials that do not core when a piercing member is passed therethrough. Hub 20 is slidably mounted on cartridge 40 at distal end portion 157 of pharmaceutical cartridge 155. Hub 20 includes a piercing member (or needle cannula) 18 which is constructed to pierce pierceable diaphragm 50 when hub 20 is moved toward cartridge 155. Hub 20 is slidable between a first, inactivated position in which piercing member 18 is positioned outside of cartridge 155 and distally of pierceable diaphragm 50, and a second, activated position in which piercing member is disposed through pierceable diaphragm 50 and in which interior lumen 165 defined by piercing member 18 is in fluid contact with the contents in the cavity 40 of cartridge 155, thereby providing a pathway for the egress of fluids from cartridge 155 through piercing member 18 in response to pressure applied when piston/plunger 52 is moved distally.

[0115] Hub 20 includes a connecting portion 170 which is configured to deliver the pharmaceutical product contained in pharmaceutical cartridge 155 to a patient or to another medical apparatus, e.g., a tube set configured to deliver pharmaceutical products to a patient. As depicted in FIG. 4A, connection portion 170 is a threaded luer member constructed to connect with a complementary luer member. It will be appreciated that connection portion 170 can have a variety of configurations, including: (i) a hypodermic needle for delivery of pharmaceutical products directly to a patient or for delivery through a pierceable septum, e.g., a pierceable septum associated with an add port of a tube set or an add port of a flexible pharmaceutical container; (ii) a blunt needle for delivery of pharmaceutical products from pharmaceutical cartridge 155 to a medical device having the capability of receiving a pharmaceutical product from a blunt needle, e.g., a pre-slit elastomeric seal on a tube set or a flexible pharmaceutical container; (iii) threaded luer; and/or (iv) an unthreaded luer. Cap member 180 can be provided in order to cover connector 170 when injector device 100 of the present invention is not in use.

[0116] Hub 20 includes a necked-down portion 175, as depicted in FIG. 4A. As depicted in FIG. 8F, necked-down portion 175 of hub 20 is constructed to be positioned within retention portion 185 of side wall 110 at distal end portion 107 of injector body 105. When pharmaceutical cartridge 155 is positioned within side wall 110, necked-down portion 175 of hub 20 is positioned within retention portion 185. Retention portion 185 of side wall 110 precludes distal movement of hub 20 relative to side wall 110. Retention portion 185 also is preferably constructed to prevent rotational movement of hub 20 relative to side wall 110. As depicted in the accompanying figures, a portion of hub 20 extends beyond side wall 110 of injector body 105 such that not all of pharmaceutical cartridge 155 is positioned within side wall 110 of injector body 105. It is to be appreciated that side wall 110 and hub 20 can be constructed such that hub 20 is wholly within side wall 110 without departing from the spirit and scope of the present invention.

[0117] In order to activate cartridge 155, a medical professional will engage finger grips 145 with his/her index and middle fingers and will engage proximal surface 151 of plunger push surface 150 with his/her thumb. By squeezing his/her thumb and fingers together, plunger push surface 150 and finger grips 145 are moved closer to one another. Also by squeezing his/her thumb and fingers together, surface for pushing 152 applies a distally directed force on proximal end portion 156 of pharmaceutical cartridge 155. However, because retention portion 185 of side wall 110 precludes distal movement of hub 20, the application of a distally directed force on proximal end portion 156 of pharmaceutical cartridge 155 causes pharmaceutical cartridge 155 to move from its first, inactivated position toward its second, activated position. As above-discussed, the squeezing force also causes plunger rod 130 to move distally relative to injector body 105 from its first, engaged position in which one or more notches 140 in ledge 138 are not aligned with the one or more retention tabs 137 of retention member(s) 135 to its second, released position in which one or more notches 140 in ledge 137 are aligned with the one or more retention tabs 137 of retention member(s) 135. In operation, pharmaceutical cartridge 155 is in its second, activated position when plunger rod 130 is in its second, released position.

[0118] Next, plunger rod 130 is removed from the exterior surface 110 of the injector body 105 and is positioned such that distal end portion 132 is adjacent to connection member 160 on piston/plunger 52. Where connection member 160 is a threaded member, a complementary connection member 190 having complementary threads is provided on distal end portion 132 of plunger rod 130 such that plunger rod 130 can be threadably attached to connection member 160 on piston/plunger 52, thereby enabling a user to move piston/plunger 52 proximally and/or distally through the application of proximally and/or distally directed forces to plunger push surface 150 and/or to plunger rod 130. As discussed above, connection members 160 and 190 can have a variety of configurations so long as they provide the desired attachment of plunger rod 130 to piston/plunger 52. For example, connection members 160 and 190 can be constructed to provide a friction or snap fit therebetween. Other configurations of connection members 160 and 190 will be readily appreciated by persons of ordinary skill in the art of the present invention.

[0119] After plunger rod 130 has been connected to piston/plunger 52 using complementary connection members 160, 190, a pharmaceutical product contained in pharmaceutical cartridge 155 can be delivered to a patient or transferred to another medical device by the application of a distally-directed force to plunger rod 130, e.g., through the application of a distally directed force to proximal surface 151 of plunger push surface 150. If desired, fluids can be aspirated into pharmaceutical cartridge at any time through the application of a proximally directed force to plunger push surface 150.

[0120] In most cases it will be preferable to construct pharmaceutical cartridge 155 from known glass materials due to the relative inactivity between glass and most pharmaceutical products. However, it will be appreciated that in certain cases it may be appropriate or necessary to use non-glass materials due to the possible interaction between the pharmaceutical product to be contained in pharmaceutical cartridge 155 and the material from which pharmaceutical cartridge 155 is constructed.

[0121] Injector body 105, including side wall 110, and plunger rod 130 can be constructed from a variety of known materials, including metals, plastics, and various known composites. In order to minimize cost, plastic may be preferable. A variety of known plastic materials providing the requisite rigidity and other performance characteristics can be used in conjunction with the present invention. Side wall 110 and plunger rod 130 need not be constructed of the same material.

[0122] In one embodiment of the present invention in which plunger rod 130 is constructed of a plastic material, connection member 190 includes a threaded recess formed on distal end portion 132 of plunger rod 130. In this embodiment, plunger rod 130 can be manufactured using a variety of known injection molding techniques. For example, the entirety of plunger rod 130 can be injection molded while a male threaded form is positioned at the distal end of the mold. The male threaded member in the mold will create a complementary female threaded recess in the distal end of the molded part. However, this approach to injection molding plunger rod 130 will require that the male threaded member be removed from the molded part by imparting relative rotational movement between the molded part and the male threaded member. This process can be time-consuming and require complex tooling when large volumes of plunger rods 130 are injection molded at high speeds.

[0123] In an alternative technique for forming plunger rods 130 having connection members 190 in the form of threaded recesses, a new injection molding technique has been developed. In this technique, a mold 200, depicted in FIGS. 12A-12G, is provided. Mold 200 defines all of the above-described features of plunger rod 130 (e.g., engagement surfaces 133, radially enlarged portion 134, ledge 138, and plunger push surface 150). The mold also includes complementary thread-forming members 210A and 210B. Thread-forming members 210A and 210B are constructed such that they create an aperture 220 through the diameter of plunger rod 130 at the distal end portion thereof (see FIG. 3A). Because thread-forming members 210A and 210B do not occupy the entire cross-sectional area of plunger rod 130, distal end portion 132 of plunger rod 130 is provided with side walls 225 that define aperture 220 through the distal end portion 132 of plunger rod 130 (see FIG. 3B). Because thread-forming members 210A and 210B have threads formed thereon, side walls 225 defining aperture 220 through plunger rod 130 have threads 226 molded therein. Core pin 230 also is included in the injection molding process in order to define an axial channel 235 through distal end portion 132 of plunger rod 130, axial channel 235 extending from the extreme distal end of plunger rod 130 to aperture 220.

[0124] In use, a male threaded member, e.g., connection member 160 formed on piston/plunger 52, can be inserted into axial channel 235 defined in plunger rod 130 until the threads on connection member 160 come into contact with threads 226 defined on side walls 225 adjacent to aperture 220. The connection member 160 can then be threadably secured to threads 226. As above-discussed, the use of complementary threaded members is merely illustrative of connection members 160, 190 that can be used in connection with the present invention. Other known approaches for providing the desired mechanical connection between plunger rod 130 and piston/plunger 52 will be understood and appreciated by those of ordinary skill in the relevant art.

[0125] One of the significant benefits from using mold 200 having thread-forming members 210A and 210 and core pin 230 arises in that plunger rod 130 does not need to be rotationally released from the molds after it has been formed. Instead, mold 200 is simply moved radially outwardly relative to the injection molded plunger rod 130 and core pin 230 is moved axially and distally relative to the injection molded plunger rod 130 in order to release plunger rod 130 from mold 200 and core pin 230. The elimination of the need to rotationally remove plunger rod 130 from mold 200 and/or core pin 230 is significant in high speed, high quantity manufacturing.

[0126] FIGS. 6A and 6B illustrate an alternative structure on the distal end of the rod 130 for attaching plunger rod 130 to piston/plunger 52. As shown in FIG. 6A, distal end portion 132 of plunger rod 130 includes a connection member 190 in the form of a pair of resilient flaps 191. Flaps 191 are constructed to engage a complementary barbed post 192 projecting from piston/plunger 52, as is illustrated in FIG. 6B. Those skilled in the art will appreciate that the configuration shown in FIG. 6 is offered by way of example and not limitation and that any number of other alternatives for attaching plunger rod 130 to piston/plunger 52 are possible.

[0127] Another embodiment of the injector device 100′ is shown in FIGS. 13-32. This embodiment of the injector device 100′ is adapted to receive and hold a pharmaceutical cartridge or ampoule 155′ containing a pharmaceutical product. The injector device 100′ generally comprises a syringe or injector body 105′, a plunger rod 130′, a cartridge 155′, a hub 20′, a hub clip 21′, a first hub member 180′ and a hub cap 181′.

[0128] As shown in FIG. 13, the plunger rod 130′ is mounted on injector body 105′ in a first position. In this embodiment the injector body 105′ has a sidewall 110′ with an outer surface 115′ and an inner surface 120′. In a preferred embodiment, the injector body 105′ is preferably tubular in geometry. However, while the sidewall 110′ is illustrated in the accompanying figures as being tubular or cylindrical in shape, it will be appreciated that the shape of side wall 110′ can be varied for different purposes and to accept cartridges 155′ of various shapes. The inner surface 120′ of side wall 110′ defines a cavity or region 125′ for receiving at least a portion of cartridge 155′ therein.

[0129] The injector body 105′ has a proximal end portion 106′ and a distal end portion 107′. The injector body 105′ further has a first opening 127′ to the cavity 125′ at the distal end portion 107′ of the body 105′, and a second opening 129′ to the cavity 125′ at the proximal end portion 106′ thereof. As is shown in FIGS. 14-17, the injector body 105′ also has a pair of grip openings 31′ extending through the sidewall 110′ and into the cavity 125′. As is explained in detail herein, the grip openings 31′ assist the user in activating the cartridge 155′ and dispensing the pharmaceutical product from the cartridge 155′. The grip openings 31′ also allow the finger grips 145′ to have a decreased size.

[0130] In this embodiment the pharmaceutical cartridge 155′ is typically inserted into the cavity 125′ of the body 105′ through the first opening 127′ at the distal end 107′ of the body 105′. In the inactivated position, as shown in FIG. 16, the cartridge 155′ is fitted into the cavity 125′ through the first opening 127′, and pushed axially back toward the second opening 129′. As explained herein, the proximal end portion 156′ of the cartridge 155′ is generally positioned adjacent the pushing surface 152′ of the plunger rod 130′ when plunger rod 130′ is in the inactivated position. Alternately, the pharmaceutical cartridge 155′ can be inserted through an aperture in the sidewall 110′ as described in the prior embodiment, or through the second opening 129′ in the body 105′.

[0131] In a preferred embodiment the injector body 105′ is preferably made of a plastic material, and preferably a relatively rigid plastic material such as acrylic or polystyrene. Additionally, the injector body 105′ is preferably clear or transparent, allowing the cartridge 155′ inserted into the cavity 125′ of the injector body 105′ to be visible through the sidewall 110′ of the injector body 105′. In this manner, a bar code or other indicia (not shown) on the outer wall of the cartridge 155′ can be visible through the sidewall 110′ of the injector body 105′ and can be scanned through the sidewall 110′ when the pharmaceutical cartridge 155′ is seated in the injector body 105′. Alternately, the injector body 105′ can be constructed of a flexible, resilient material such as more flexible plastic, or even a metal. In yet another alternative embodiment, injector body 105′ can be formed by two or more pieces connected by a hinge member.

[0132] As shown in FIGS. 23 and 24, the injector body 105′ has one or more retention members 135′ positioned on the outer surface 115′ of the injector body 105′. In this embodiment the retention members 135′ are utilized to retain the plunger rod 130′ on the injector body 105′ until usage of the syringe 100′ of the cartridge 155′. As explained herein, in this embodiment the plunger rod 130′ cannot be removed from the injector body 105′ unless the retention members 135′ are broken from the injector body 105′, thus providing tamper proof evidence of the security of the cartridge 155′ for the syringe system 100′. That is, because retention members 135′ are broken at the time plunger rod 130′ is released from injector body 105′, plunger rod 130′ cannot be reattached to injector body 105′.

[0133] In the depicted embodiment, the retention members 135′ comprise frangible retention posts 136′ projecting radially outwardly from the outer surface 115′ of the injector body 105′. Further, in the depicted embodiment, two or more posts 136′ are utilized, thereby retaining the plunger rod 130′ in position until activation. Each of the posts 136′ preferably have at least one tab 33′ extending transversely therefrom, and preferably radially outwardly therefrom. As is explained herein, the tabs 33′ are utilized to connect the retention members 135′, i.e., retention posts 136′, to the retaining members 35′ of the plunger rod 130′ to secure the plunger rod 130′ to the outer surface 115′ of the injector body 105′. As depicted in the accompanying figures, retention posts 136′ can have a necked down portion 37′ adjacent the outer surface 115′ of the sidewall 110′ of the injector body 105′. The necked down portion 37′ has a smaller cross-sectional area that allows any force, and particularly transverse or axial forces applied to the plunger rod 130′, to be concentrated at the necked down portion 37′ such that the force necessary to shear the posts 136′ for removal of the plunger rod 130′ from the injector body 105′ and activation of the system 100′ will be reduced.

[0134] Although the second embodiment of the injector system 100′ is depicted in the accompanying figures as include two retention members 135′, e.g., two retention posts 136′ having tabs 33′, it will be appreciated that a fewer number or greater number of retention members 135′ can be used to secure the plunger rod 130′ to outer surface 115′ of side wall 110′ of injector body 105′. Similarly, the details of the construction of retention members 135′ and receiving or retaining members 35′ set forth herein are not intended to be limited to the post and aperture configuration depicted in the accompanying drawings for the second embodiment of the injector system. One of ordinary skill in the art will recognize that various modifications can be made to the number and configuration of retention members 135′ and receiving or retaining members 35′ without departing from the spirit and scope of the present invention. In short, the accompanying figures are intended to be illustrative, not limiting, with respect to the configuration and number of retention member 135′ and receiving or retaining members 35′.

[0135] The injector body 105′ preferably includes finger grips 145′. Finger grips 145′ are configured such that a medical professional using injector device 100′ of the present invention will engage them with his/her index and middle fingers during normal use to push on the pusher member 150′ of the plunger rod 130′. Finger grips 145′ are positioned approximately 90° (about the circumference of injector body 105′) from the retention posts 136′. In the embodiment shown in FIGS. 23-24, the finger grips 145′ are generally planer members extending from the outer surface 115′ of the sidewall 110′ of the injector body 105′. In this embodiment the finger grips 145′ are positioned adjacent respective grip openings 31′ formed in the sidewall 110′ of the injector body 105′. Accordingly, when the user grips the injector body 105′ with his/her fingers to push on the pusher member 150′ of the plunger rod 130′, the user's fingers do not engage the sidewall 110′ of the injector body 105′, but rather extend past the sidewall 110′ of the injector body 105′ and through the grip openings 31′ and partially into the cavity 125′ of the injector body 105′. Thus, whereas in the prior embodiment the maximum distance between the end of the finger grips 145 to the radial finger stop is defined by the distance from the end of the finger grips 145 to the outer surface 115′ of the sidewall 110′ of the injector body 105′, in this embodiment the maximum distance is defined by the distance from the end of the finger grips 145′ to the outer surface of the cartridge 155′. Since the outer surface of the cartridge 155′ is approximately 0.10″ radially inward of the outer surface 115′ of the sidewall 110′ of the injector body 105′, to have the same finger grip surface area as the prior embodiment each finger grip 145′ can be approximately 0.10″ shorter than the prior embodiment. This leads to nearly ¼″ of savings in the overall width of the overall injector body 105′ having finger grips 145′.

[0136] Alternatively, the finger grips may be convex on a distal side of finger grips and concave on a proximal side of finger grips to more closely match the geometry of a user's fingers. It will be appreciated that the size and shape of finger grips can be modified without departing from the scope of the present invention.

[0137] The injector body 105′ also has a receiver 39′ for receiving the hub clip 21′. The receiver 39′ comprises one or more openings 41′ through the sidewall 110′ of the injector body 105′. In a preferred embodiment the receiver 39′ is located toward the distal end portion 107′ of the injector body 105′. The hub clip 21′ is described in greater detail herein.

[0138] Referring now to FIGS. 25-30, the plunger rod 130′ has a body portion 51′ with a proximal end portion 131′ and a distal end portion 132′. The retaining members 35′ are provided as part of the plunger rod 130′. The retaining members 35′ are also referred to as receiving members 35′. In one embodiment, the retaining members 35′ comprise retaining apertures 35′. In a preferred embodiment, a plurality of retaining apertures 35′ are provided in the body portion 51′ of the plunger rod 130′, preferably between the proximal end portion 131′ and the distal end portion 132′ thereof. The retaining apertures 35′ are constructed to cooperate with retention members 135′, e.g., retention posts 136′ having transverse tabs 33′, to retain the plunger rod 130′ to the injector body 105′ until activation of the pharmaceutical cartridge 155′. In the depicted embodiment, the injector body 105′ has two retention posts 136′, and the plunger rod 130′ has two corresponding retaining or receiving apertures 35′. Retaining or receiving apertures 35′ can be constructed so as to retain retention posts 136′ therein after retention posts 136′ have been detached from side wall 110 through the application of an axial force to plunger rod 130′.

[0139] Additionally, in an alternative embodiment the main body portion 51′ of the plunger rod 130′ has a generally C-shaped cross-section, with the outer convex surface of the body 51′ facing radially outward from the sidewall 110′ of the injector body 105′. This configuration makes it more difficult for an individual to grasp the plunger rod 130′ to remove it from the injector body 105′ utilizing a radial outward force.

[0140] In one embodiment of the present invention, retaining apertures 35′ include a plurality resilient fingers 43′ positioned therein. As depicted in the accompanying figures, four resilient fingers 43′ can be included in each retaining aperture 35′. However, it is readily understood by one of ordinary skill in the art that a fewer or greater number of resilient fingers 43′ can be used. Further, as shown in FIGS. 26 and 27, the resilient fingers 43′ are connected to the body of the plunger rod 130′ adjacent the top surface 45′ of the plunger rod 130′, and extend toward the lower surface 47′ of the plunger rod 130′. It is understood that the lower surface 47′ of the plunger rod 130′ contacts or is adjacent the outer surface 115′ of the injector body 105′ when the plunger rod 130′ is secured to the injector body 105′. The top surface 45′ of the plunger rod 130′, however, faces away from the injector body 105′ when the plunger rod 130′ is connected to the injector body 105′ as shown in FIG. 13. Each of the resilient fingers 43′ is hinged or cantilevered from its connection with the plunger rod 130′ adjacent the top surface 45′ of the plunger rod 130′, and the distal end 49′ of each resilient finger 43′ extends into a cavity of the injector rod 130′ beneath the top surface 45′ of the plunger rod 130′. The distal end 49′ of each resilient finger 43′ is depicted as having a flange 53′ extending radially inwardly into the cavity of the retaining aperture 35′. The flanges 53′ of each resilient finger 43′ are utilized to engage the tabs 33′ extending from the retention posts 136′.

[0141] To connect or attach the plunger rod 130′ to the injector body 105′, the lower surface 47′ of the plunger rod 130′ is positioned over the outer surface 115′ of the injector body 105′, with the retention posts 136′ extending from the injector body 105′ aligned with the retaining apertures 35′. The plunger rod 130′ is then forced radially toward the injector body 105′ such that the retention posts 136′ engage the retaining apertures 35′. As the retention posts 136′ are inserted into the retaining apertures 35′ the retention posts 136′ cause the distal end 49′ portion of the resilient fingers 43′ to flex radially outwardly. Additionally, as the retention posts 136′ are inserted further into the retaining apertures 35′, the transverse tabs 33′ on the retention posts 136′ extend past the flanges 53′ on the resilient fingers 43′ and are captured by the flanges 53′. Once the transverse tabs 33′ on the retention posts 136′ are captured by the flanges 53′ the plunger rod 130′ is locked in place on the injector body 105′ and the plunger rod 130′ cannot be removed from the injector body 105′ without fracturing the retention posts 136′. Specifically, the tabs 33′ prevent radial movement of the plunger rod 130′ off the injector body 105′, and the posts 136′ prevent axial movement of the plunger rod 130′ with respect to the injector body 105′. Accordingly, since the plunger rod 130′ is fixedly retained to the injector body 105′ by the cooperation between the retention members 135′ and the receiving apertures 35′, and since the posts 136′ are broken from the exterior wall of the injector body 105′ upon activation of the system 100′, the plunger rod 130′ cannot be re-attached to the injector body 105′ after the posts 136′ are broken, thereby providing a visual safety or tamper-evident indicator as described herein. Further, since the device 100′ provides this tamper-evident feature, the packaging necessary to maintain the system 100′ together may be reduced. For example, instead of having to individually package or overwrap each system 100′ in order to provide tamper evidence, the system 100′ itself provides such tamper evidence and therefore can be sold by itself or in a large package containing multiple system 100′ without the need for separate packaging for each unit.

[0142] As shown in FIGS. 16, 18, 25 and 30, the proximal end portion 131′ of the plunger rod 130′ has a pushing member 150′. In one embodiment the pushing member 150′ comprises a flange extending from the main body of the plunger rod 130′. The pushing member 150′ includes a proximal surface 151′ that is constructed for engagement with a medical professional's thumb. In use, a medical professional will grasp injector body 105′ such that his/her index and middle fingers are in contact with a distal surface of finger grips 145′ and such that his/her thumb is in contact with proximal surface 151′ of pushing member 150′. The pushing member 150′ is utilized to assist the user in both activating the pharmaceutical cartridge 155′ as well as dispensing the contents of the pharmaceutical cartridge 155′.

[0143] The pushing member 150′ also includes a cartridge pushing surface 152′. The pushing surface 152′ is utilized to transition the cartridge 155′ from the inactivated position, as shown in FIGS. 15 and 16, to the activated position, as shown in FIG. 31. More specifically, the pushing surface 152′ is constructed to engage the proximal end portion 156 of pharmaceutical cartridge 155′ and to urge proximal end portion 156′ of pharmaceutical cartridge 155′ distally into the activated position as a medical professional squeezes his/her index and middle fingers towards his/her thumb. The importance of surface for pushing 152′ will be described in greater detail later in this specification. In one embodiment the cartridge pushing surface 152′ includes a nub 153′ extending distally away from the pushing member 150′. In this embodiment, as best shown in FIG. 16, at least a portion of nub 153′ is configured to engage the pharmaceutical cartridge 155′ for activating the pharmaceutical cartridge 155′. Further, nub 153′ is configured to be positioned partially within a cavity 154′ at the proximal end portion 156′ of the cartridge 155′. In this manner, the nub 153′ operates to substantially block or preclude access to the contents of the pharmaceutical cartridge 155′ through the proximal end portion 156′, i.e., through the piston 52 of the pharmaceutical cartridge 155′. Accordingly, in the depicted embodiment, nub 153′ has a semi-circular geometry. It will be appreciated that other shapes of nub 153′ can be used. Since the plunger rod 130′ is connected to the injector body 105′ as above-discussed, and thus the nub 153′ is fixed in place in this position, the nub 153′ will be positioned within the cavity 154′ at the proximal end portion 156 of the cartridge 155′ when cartridge 155′ is inserted into the cavity 125′ of the body 105′ through the first opening 127′ at the distal end 107′ of the body 105′ and pushed axially back toward the second opening 129′.

[0144] In one embodiment, as shown in FIGS. 25-29, the plunger rod 130′ also has a connection member 190′ at the distal end portion 132′ of the plunger rod 130′. The connection member 190′ is utilized to connect the plunger rod 130′ to the piston/plunger 52′ in the pharmaceutical cartridge 155′. Piston/plunger 52′ in the pharmaceutical cartridge 155′ has a connection member 160′ extending out the proximal end portion 156′ of the cartridge 155′. The connection member 190′ of the injector rod 130′ is adapted to connect to the connection member 160′ of the pharmaceutical cartridge 155′. Connection member 160′ of the pharmaceutical cartridge 155′ can be a threaded member. In an embodiment where the connection member 160′ is a threaded member, a complementary connection member 190′ having complementary threads is provided on distal end portion 132′ of plunger rod 130′ such that plunger rod 130′ can be threadably attached to connection member 160′ on piston/plunger 52′, thereby enabling a user to move piston/plunger 52′ proximally and/or distally through the application of proximally and/or distally directed forces to plunger push surface 150′ and/or to plunger rod 130′. As discussed herein, connection members 160′ and 190′ can have a variety of configurations so long as they provide the desired attachment of plunger rod 130′ to piston/plunger 52′. For example, connection members 160′ and 190′ can be constructed to provide a pressure, friction or snap fit therebetween. Other configurations of connection members 160′ and 190′ will be readily appreciated by persons of ordinary skill in the art.

[0145] In the various embodiments illustrated herein, the injector body 105′ and plunger rod 130′ are depicted as separate pieces. These pieces can be individually injection molded or formed using a variety of other known tooling techniques. It will also be appreciated that injector body 105′ and plunger rod 130′ can be unitarily injection molded without departing from the intended spirit and scope of the present invention. Additionally, the injector body 105′ and plunger rod 130′ can be provided separately from the pharmaceutical cartridge 155′ such that a medical professional, i.e., a pharmacist, inserts pharmaceutical cartridge 155′ into the injector body 105′ immediately prior to use. Alternatively, the injector body 105′ and the pharmaceutical cartridge 155′ can be pre-assembled by a manufacturer or assembler and supplied in combination to medical professionals.

[0146] Injector body 105′ and plunger rod 130′ can be constructed from a variety of known materials, including metals, plastics, and various known composites. In order to minimize cost, plastic may be preferable. A variety of known plastic materials providing the requisite rigidity and other performance characteristics can be used in conjunction with the present invention.

[0147] The pharmaceutical cartridge 155′ used in conjunction with the present invention can have a variety of configurations. Generally, the pharmaceutical cartridge 155′ is a thin-walled tubular member constructed to retain a pharmaceutical product within an interior space or cavity 40′ of the cartridge 155′. The pharmaceutical cartridge 155′ has a cartridge body having a proximal end portion 156′ and a distal end portion 157′. The pharmaceutical cartridge 155′ also has an interior space or cavity 40′ wherein the medicament is housed. As shown in FIG. 16, a piston/plunger 52′ is slidably positioned within the interior space 40′ at the proximal end portion 156′ of pharmaceutical cartridge 155′, and fluidly seals the proximal end portion 156′ of pharmaceutical cartridge 155′, and a pierceable diaphragm 50′ fluidly seals the distal end portion 157′ of the cavity 40′ of the cartridge 155′. In a preferred embodiment a connection member 160′, e.g., a threaded rod, is attached to piston/plunger 52′ such that the connection member 160′ is accessible from the exterior of cartridge 155′.

[0148] In most cases it will be preferable to construct pharmaceutical cartridge 155′ from known glass materials due to the relative inactivity between glass and most pharmaceutical products. However, it will be appreciated that in certain cases it may be appropriate or necessary to use non-glass materials due to the possible interaction between the pharmaceutical product to be contained in pharmaceutical cartridge 155′ and the material from which pharmaceutical cartridge 155′ is constructed.

[0149] As shown in FIGS. 14, 16 and 22, a hub 20′ is slidably mounted on the distal end portion 157′ of the pharmaceutical cartridge 155′. In one embodiment the hub 20′ comprises a mounting portion 23′ at a proximal end 25′, a connecting portion 170′ at a distal end 27′, and a necked down portion 175′ between the mounting portion 23′ and the connecting portion 170′. Further, the hub 20′ has a bore 29′ extending from the distal end 27′ to the proximal end 25′ thereof. A piercing member (or needle cannula) 18′ is fixed in place in the bore 29′ of the hub 20′. The piercing member 18′ is constructed to pierce the pierceable diaphragm 50′. The mounting portion 23′ of the hub 20′ has a sidewall 61′ and a bottom wall 63′. The sidewall 61′ of the hub 20′ is slidingly secured to the sidewall of the cartridge 155′ at the distal end portion 157′ of the cartridge 155′ in the inactivated position as shown in FIG. 16. In that inactivated position, a gap 64′ is provided between the distal end 157′ of the cartridge 155′ and the bottom wall 63′ of the mounting portion 23′ of the hub 20′.

[0150] As explained herein, the hub 20′ is fixed in place in the injector body 105′ via the hub clip 21′, however, the pharmaceutical cartridge 155′ is slidable with respect to the hub 20′ between a first, inactivated position in which piercing member 18′ is positioned outside of cartridge 155′ and distally of pierceable diaphragm 50′ (as shown in FIG. 16), and a second, activated position in which piercing member 18′ is disposed through pierceable diaphragm 50′ and in which interior lumen 165′ defined by piercing member 18′ is in fluid communication with the contents in the cavity 40′ of cartridge 155′, thereby providing a pathway for the egress of fluids from cartridge 155′ through piercing member 18′ in response to pressure applied when piston/plunger 52′ is moved distally by the plunger rod 130′. In the inactivated position the gap 64′ is provided between the distal end 157′ of the cartridge 155′ and the bottom wall 63′ of the mounting portion 23′ of the hub 20′. During activation, however, the hub 20′ remains fixed in place and the cartridge 155′ is moved axially distally toward the bottom wall 63′ of the mounting portion 23′ of the hub 20′. In one embodiment, the bottom wall 63′ of the mounting portion 23′ of the hub 20′ operates as a stop for the cartridge 155′.

[0151] Referring to FIGS. 14, 16 and 22, the hub clip 21′ is used to fix the hub 20′ in place in the injector body 105′. As explained above, the injector body 105′ has a receiver 39′ for receiving the hub clip 21′. Receiver 39′ defines one or more openings 41′ through the sidewall 110′ of the injector body 105′. The receiver 39′ is shown in FIGS. 23a and 24. When the pharmaceutical cartridge 155′ and hub 20′ are inserted into the cavity 125′ of the injector body 105′ through the first opening 127′ at the distal end 107′ of the injector body 105′, the cartridge 155′ is pushed axially back toward the second opening 129′ until the proximal end portion 156′ of the cartridge 155′ contacts, or is in close proximity to, the pushing surface 152′ of the pusher member 150′ of the plunger rod 130′. In this position the necked down portion 175′ of the hub 20′ will be aligned with the one or more openings 41′ in the sidewall 110′ of the injector body 105′.

[0152] In one embodiment of the present invention, the hub clip 21′ has a plurality of projections 65′ configured to extend through the one or more openings 41′ in the sidewall 110′ of the injector body 105′ in order to secure hub clip 21′ to sidewall 110′. In the embodiment depicted in the accompanying figures, hub clip 21′ has an outer geometry similar to the shape of the exterior surface of the sidewall 110′ of the injector body 105′, thereby providing a smooth, substantially continuous surface when hub clip 21′ is secured to sidewall 110′. In a preferred embodiment the width of the projections 65′ are generally similar to the width of the necked-down portion 175′ of the hub 20′. Thus, when the hub 20′ is positioned in the injector body 105′, and after the clip 21′ is inserted through the openings 41′ in the sidewall 110 of the injector body 105′, the projections 65′ preclude any axial movement of the hub 20′. Additionally, the shape of the projections 65′ engages fins extending from the body of the hub 20′ in the necked-down region 175′ such that the hub 20′ is also precluded from rotating in the injector body 105′. Finally, the hub clip 21′ has resilient tabs 67′ that snap into the one or more openings 41′ in the injector body 105′ sidewall 110′ to keep the clip 21′ secured in place on the injector body 105′. Tabs 67′ and the one or more openings 41′ can be constructed such that hub clip 21′ can be removed from side wall 110′, as necessary. However, in order to provide greater security and provide tamper evidence, tabs 67′ and the one or more openings 41′ preferably are configured in order to provide a secure, relatively permanent attachment of hub clip 21′ to sidewall 110′. As used herein, the term “relatively permanent attachment” refers to a connection that precludes both inadvertent removal and purposeful removal of hub clip 21′ from sidewall 110′ unless a significant force and/or special tools are used to remove hub clip 21′ from sidewall 110′. Further, in order to prevent the clip 21′ from being removed from the injector body 105′, a label can be placed around the body 105′ and the clip 21′. The label can be constructed of a variety of known materials, including opaque paper and plastic materials. However, in one embodiment of the present invention, the label is constructed of a substantially transparent plastic material. Appropriate indicia, including, but not limited to bar codes, can be placed on the label. The label (not shown) may also secure the cap 181′ to the injector body 105′. To remove the cap 181′ from the body 105′, it will be necessary to tear the label, thereby providing visual evidence of such occurrence.

[0153] Similar to connecting portion 170′ described in the prior embodiment, the connection portion 170′ of the hub 20′ in this embodiment is configured to deliver the pharmaceutical product contained in pharmaceutical cartridge 155′ to a patient or to another medical apparatus, e.g., a tube set configured to deliver pharmaceutical products to a patient. The connection portion 170′ may be a threaded luer member constructed to connect with a complementary luer member. It will be appreciated that connection portion can have a variety of configurations, including: (i) a hypodermic needle for delivery of pharmaceutical products directly to a patient or for delivery through a pierceable septum, e.g., a pierceable septum associated with an add port of a tube set or an add port of a flexible pharmaceutical container; (ii) a blunt needle for delivery of pharmaceutical products from pharmaceutical cartridge to a medical device having the capability of receiving a pharmaceutical product from a blunt needle, e.g., a pre-slit elastomeric seal on a tube set or a flexible pharmaceutical container; (iii) threaded luer; and/or (iv) an unthreaded luer.

[0154] As depicted in FIGS. 14-16, first hub member 180′ is provided to mate with the connection portion 170′ and substantially cover the exposed end of the needle cannula 18′. In this embodiment, a relatively short hub cap 181′ is constructed for attachment to the first hub member 180′, e.g., by a press fit or threaded securement. In the depicted embodiment of the present invention, first hub member 180′ and hub cap 181′ are separate elements because the processing line on which device 100′ of the present invention is assembled will not allow the use of a cap member having an outer diameter greater than the outer diameter of injector body 105′. In the depicted embodiment, first hub member 180′ and hub cap 181′ are configured to provide a secure connection therebetween such that both first hub member 180′ and hub cap 181′ are removed when a medical professional applies a removal force to hub cap 181′. It will be appreciated that first hub member 180′ and hub cap 181′ can be formed as a single cap member without departing from the intended spirit and scope of the present invention.

[0155] In the embodiment of the present invention depicted in FIGS. 14-16, hub cap 181′ and first hub member 180′ are constructed such that a medical professional can readily grasp and remove hub cap 181′ and first hub member 180′ from connection portion 170′ through the application of a reasonable amount of force, thereby allowing use of the device 100′. In this embodiment, first hub members 180′ and hub cap 181′ are configured to cover the connector 170′ and cannula 18′ when the injector device 100′ of the present invention is not in use. The first hub member 180′ and hub cap 181′ are preferably constructed of materials that will preclude access to the contents of the cartridge 155′ through the cap 181′. In the embodiment of the invention depicted in FIGS. 14-16, the end of hub cap 181′ is flat, thereby reducing the overall length of the system 100′. It will be appreciated that the length and diameter of hub cap 181′ can be varied without departing from the spirit and scope of the invention. However, it should be noted that in certain situations it is desirable to minimize the length and diameter of hub cap 181′ in order to minimize the overall dimension of device 100′. For example, for medical facilities that utilize a dispensing system for medical products, e.g., a “PIXIS” system, where the dispensing system has drawers or compartments of varying sizes, it is desirable to dimension device 100, 100′ in accordance with the present invention such that it fits within the assigned drawer or compartment. One way to reduce the overall size of device 100, 100′ is to minimize the size of cap 180, 180′. Another way to reduce the overall size of device 100, 100′ is to minimize the dimension of finger grips 145, 145′. The dimension of finger grips 145′ can be reduced by reducing the thickness of sidewall 110′, or be defining an aperture through sidewall 110′, adjacent to finger grips 145′.

[0156] The cartridge 155′ may be loaded into the cavity of the injector body 105′ from either the proximal end 106′ or the distal end 107′ of the body 105′, as long as the plunger rod 130′ is not connected to the body 105′ first. If the plunger rod 130′ is connected to injector body 105′, then pushing member 150′ of plunger rod 130′ will preclude introduction of the cartridge 155′ through the second opening 129′ at the proximal end 106′, i.e., cartridge 155′ must be inserted through the first opening 127′ at the distal end 107′ of the body 105′ when plunger rod 130′ is connected to injector body 105′.

[0157] In order to use injector device 100′, a medical professional will engage finger grips 145′ with his/her index and middle fingers and will engage proximal surface 151′ of pushing member 150′ with his/her thumb. By squeezing his/her thumb and fingers together, pushing member 150′ and finger grips 145′ are moved closer to one another. Also by squeezing his/her thumb and fingers together, the pushing surface 152′ and associated nub 153′ apply an axial, distally-directed force on proximal end portion 156′ of pharmaceutical cartridge 155′. However, because the hub clip 21′ precludes axial distal movement of the hub 20′, the application of a distally directed axial force on proximal end portion 156′ of pharmaceutical cartridge 155′ causes pharmaceutical cartridge 155′ to move from its first, inactivated position (see FIG. 16) toward its second, activated position (see FIG. 31). The squeezing force also causes plunger rod 130′ to move axially distally relative to injector body 105′ from its first, engaged position (shown in FIG. 16) in which the retention members 135′ are connected to the injector body 105′ and retained in the receiving or retaining apertures 35′, to its second, released position in which the retention posts 136′ are sheared from the injector body 105′ at the necked down portion 37′ of the posts 136′. In one embodiment of the present invention, posts 136′ are retained in the receiving apertures 35′ after they have been sheared from injector body 105′, thereby minimizing the amount of waste material that must be managed by the healthcare professional. In this embodiment of the present invention, the resilient fingers 43′ retain the retention posts 136′ in the receiving apertures 35′ after the retention posts 136′ have been sheared off of injector body 105′. In operation, pharmaceutical cartridge 155′ is in its second, activated position when plunger rod 130′ is in its second, released position. In the second released position the plunger rod 130′ is free from the injector body 105′ and can be removed therefrom.

[0158] After the posts are sheared from the injector body 105′, the plunger rod 130′ can be removed from the injector body 105′ and positioned such that the distal end portion 132′ of the plunger rod 130′ is adjacent to connection member 160′ on piston/plunger 52′. Where connection member 160′ is a threaded member, a complementary connection member 190′ having complementary threads is provided on the distal end portion 132′ of plunger rod 130′ such that plunger rod 130′ can be threadably attached to connection member 160′ on piston/plunger 52′ as shown in FIG. 32, thereby enabling a user to move piston/plunger 52′ proximally and/or distally through the application of proximally and/or distally directed forces to plunger push surface 150′ and/or to plunger rod 130′. As discussed above, connection members 160′ and 190′ can have a variety of configurations so long as they provide the desired attachment of plunger rod 130′ to piston/plunger 52′. For example, connection members 160′ and 190′ can be constructed to provide a friction or snap fit therebetween. Other configurations of connection members 160′ and 190′ will be readily appreciated by persons of ordinary skill in the art of the present invention.

[0159] After plunger rod 130′ has been connected to piston/plunger 52′ using complementary connection members 160′, 190′, a pharmaceutical product contained in pharmaceutical cartridge 155′ can be delivered to a patient or transferred to another medical device by the application of an axial distally-directed force to plunger rod 130′, e.g., through the application of a distally directed force to proximal surface 151′ of plunger push surface 150′. If desired, fluids can be aspirated into pharmaceutical cartridge at any time through the application of a proximally directed force to plunger push surface 150′.

[0160] While various aspects of the invention have been discussed herein in connection with certain preferred embodiments, it will be appreciated that various modifications, permutations, additions and/or sub-combinations of these aspects and embodiments are possible. Such modifications, permutations, additions and/or sub-combinations are intended to be within the spirit and scope of the present invention as claimed in the appended claims.

[0161] It will be understood that the invention may be embodied in other specific forms without departing from the spirit or central characteristics thereof. The present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein. Accordingly, while the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention and the scope of protection is only limited by the scope of the accompanying Claims.