MXPA99002094A - Pre-filled retractable needle injection devices - Google Patents

Abstract

A pre-filled injection device having a retractable needle (25) with a sharpened tip for penetrating the skin of a patient for administering medicinal fluids is provided. The pre-filled injection device of the present invention allows the needle to be manually retracted, thereby reducing the risk of transmission of various pathogens, most notably human immune virus (HIV), to uninfected personnel, due to an inadvertent prick. The present pre-filled injection device has a hollow housing (7) which receives a pre-filled cartridge (1) containing medicinal fluids. A needle retainer (22) initially holds a needle (25) projecting forward from the hollowing housing (7). The rear end (27) of the needle (25) pierces the pre-filled cartridge (1) when sufficient pressure is applied to the end (27) of the pre-filled cartridge (1) to advance it in the forward direction. A plunger (35) is slidably displaceable within the hollow housing (7). A latch member (72) is operable in a latched position to prevent forward movement of the plunger (35). The latch member is operable in an unlatched position to permit forward movement of the plunger (35) and retract the needle (25) into the hollow housing.

Description

PRE-FILLED INJECTION DEVICES, WITH CELL RETR NEEDLE FIELD OF THE INVENTION The present invention relates to pre-filled ampoules, capsules or cartridges for administering injections of medicinal fluids to patients. More specifically, the invention relates to such devices having a retractable needle device to render them non-reusable and disposable in a safe manner. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a cross-sectional view of an ampoule and an apparatus for housing the ampule according to a first embodiment of the invention and showing the apparatus in an armed condition; Figure 2A is an exploded view of a needle and spring in which the spring is shown attached to the needle using adhesive or epoxy; Figure 2B is an exploded view of a needle and spring in which the spring is shown attached to the needle when folding the spring toward the needle; Figure 3 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Figure 1 shown before assembly for the injection of fluids; Figure 4 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Figure 1 showing the ampoule and the plunger after the medicament has been expelled; Figure 5 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Figure 1 showing a lever lock to prevent premature retraction of the needle and showing the lever in the alternate positions of locked and unlocked; Figure 6 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Figure 1 showing the condition of the apparatus after retraction of the needle; Figure 7 is an exploded perspective view of a spring needle and a needle retainer with spaced apart portions of the needle and spring; Fig. 8 is an enlarged cross-sectional view of the needle, the spring and the needle retainer of Fig. 7 and showing the needle and spring in place within the needle retainer and showing part of the needle housing. the separated vial; Figure 9 is a cross-sectional view of an ampoule and the ampoule housing apparatus according to a second embodiment of the invention, showing the apparatus in an armed condition; Fig. 10 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Fig. 9 showing the apparatus before assembly for injection of the fluid; Figure 11 is a cross-sectional view of the ampule and the apparatus of the ampule of Figure 9 showing the condition of the apparatus after the medicament has been expelled from the ampule; Fig. 12 is a cross-sectional view of the ampule and the apparatus of the ampule of Fig. 9 showing the condition of the apparatus after retraction of the needle; Figure 13 is a cross-sectional view of an ampoule and apparatus housing the ampule according to a third embodiment of the invention and showing the apparatus in an armed condition; Fig. 14 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Fig. 13 assembled prior to injection of the fluid; Fig. 15 is a cross-sectional view of the ampule and the apparatus of the ampule of Fig. 13 showing the condition of the apparatus after the medicament has been expelled from the ampule; Fig. 16 is a cross-sectional side view of the ampule and the apparatus of the ampule of Fig. 13 showing a retention mechanism of the apparatus to prevent premature retraction; Figure 17A is a cross-sectional view taken along line 17-17 of Figure 16, showing the retention member in its secured position; Figure 17B is a cross-sectional view, similar to Figure 17A, except that the hitch member is shown in its unlocked position; Figure 18 is a further cross-sectional view of the ampoule and the ampoule apparatus showing the needle retracted in the apparatus; Figure 19 is a cross-sectional view of an ampoule and an apparatus that houses the ampule according to a fourth embodiment of the invention, showing the apparatus in an armed condition; Figure 20 is a cross-sectional view of the ampoule and the apparatus of the ampoule of Figure 19 showing its condition before use; Figure 21 is a cross-sectional view of the ampule and the apparatus of the ampule of Figure 19 showing the condition of the apparatus after the medicament has been expelled from the ampule; Figure 22 is a cross-sectional view of the ampoule and the apparatus of the ampoule of the figure 21 showing a retention mechanism in the apparatus to prevent premature retraction and with the bolt in its secured position; Figure 23 is a cross-sectional view of the ampule and the apparatus of the ampule of Figure 19, showing the needle retracted towards the apparatus; Figure 24 is a cross-sectional view of the front end of an ampoule according to the present invention; Figure 25 is a cross-sectional view of a retainer formed within the interior of a vial housing for retaining a vial within the vial housing according to the present invention; and Figure 26 is a fragmentary cross-sectional view of a piston assembly according to the present invention, in which the dashed lines represent a central line of the piston; Figure 27 is a side elevational view of a device for imparting fluid from a pre-filled cartridge, which is shown in cross section; Figure 28 is a sectional view of the device of Figure 27 taken along line 27-28 thereof, with the cartridge inserted therein; Fig. 29 is a sectional view of a sealing support member for providing a fluid anti-ejection mechanism for the device of Fig. 27; and Fig. 30 is a rear elevational view of the plug support member of Fig. 29. DETAILED DESCRIPTION Referring now to Figs. 1-6, a first embodiment of a pre-filled injection vial 1 and an ampoule apparatus 5 are shown. The ampoule apparatus 5 has a main body or housing 7, comprising a tubular body 8, a front tubular portion of reduced diameter 9, and a nose portion of additionally reduced diameter 10. The interior of the body 8 defines a chamber 11 to receive the vial 1. A piston assembly 14 with the piston 15 is slidably positioned at the rear end 17 of the vial 1. The piston assembly 14 is placed within the walls of the vial 1 forming a seal to prevent the Fluid escaping from ampoule 1 through its rear opening 12. An annular groove can be formed for additional protection against leakage of fluid from ampoule 1 near the extr Emo piston front 15 to retain a sealing member. Inside the vial 1 there is contained, between the piston 15 and the front end 13 of the vial 1, a volume of medicinal fluid, preferably in an amount sufficient for a single dose of the fluid or in a preferred amount for administration to a single patient,.

The front end 13 of the ampoule 1 is sealed by a pierceable membrane 16 which is preferably made of an elastomeric material. The membrane 16 is joined to cover the front 13 of the bulb 1. As shown in Figure 24, the membrane 16 can be held in place by an annular sealing ring 18 which engages within a circumferential groove 19 formed around the outer side of the front end 13 of the bulb 1. The sealing ring 18 can be an O-ring that is formed integrally with the membrane 16. Alternatively, the sealing ring 18 can be a separate semi-rigid structure for compressively supporting the membrane 16 to the front end 13 of the bulb 1. As shown in Figure 25, a retainer 20 is formed within the interior of the housing 7 to receive the periphery of the sealing member 18 when placed around the front end 13 of the bulb 1, and to retain the vial 1 within the ampoule apparatus 5 in the assembled configuration before use. Referring to Figure 1, external projections, such as the finger holders 21 are formed along the outside of the ampoule apparatus 5 to enable the user to more easily maneuver the ampoule 1 and the ampoule housing 7. A needle retainer 22 is placed inside the front portion 23 of the ampoule apparatus 5 to retain the needle 25 projecting from the apparatus 5., as shown in figures 1, 2 and 8. The needle 25 is preferably made of stainless steel for chemical compatibility with various drugs. The front portion 26 of the needle 25 is preferably surrounded by a cap or sheath 28 which removably connects in a connective manner to the exterior of the front portion 23 of the ampoule apparatus 5, as indicated in Figure 1. the back portion 27 of the needle 25 extends generally axially towards the apparatus 5 and projects rearwardly beyond the needle retainer 22. The needle retainer 22 is held within the front portion 23 of the ampoule apparatus 5 by a adjustment under pressure or by means of a glue. A spring 29 surrounds the needle 26 within the needle retainer 22 and has a rear portion 30 fixed to the needle 26, as shown in Figure 24 and explained more fully below. A plunger member 35 is provided for connection to the trailing end 32 of the piston 15, as shown in Figure 3. The plunger 35 is manually depressed to move the piston 15 to eject the medicament from the ampule 1. In the embodiment shown in Figure 1, the plunger member 35 is shaped to wrap from side to side the exposed needle 25 and its protective sheath 28. The plunger member 35 can be detachably coupled to the front end 23 of the ampoule apparatus 5 on the needle 25 and its protective cover 28, to facilitate transportation, as shown in Figure 1. The plunger member 35 comprises a plunger rod 36 having an axial channel or cavity 37. The cavity 37 is sized appropriately to receive the needle 25 and its protective cover 28 therein. Further, when the plunger rod 36 is coupled to the piston 15, as shown in Figs. 3-6, the cavity 37 is adapted to receive the needle 25 when the needle 25 is retracted, as shown in Fig. 6. The end rear 39 of plunger rod 36 includes an enlarged maneuvering surface 40 on which the user applies force to push piston rod 36 in the forward direction during injection of fluid from ampoule 1. As shown in figure 26, the piston 15 and the bulb 1 preferably include cooperating surfaces for positioning and retaining the piston 15 on the rear part 17 of the bulb 1. For this purpose, an annular cavity 41 may be circumferentially formed around the inner surface of the bulb 1 for clutching by means of one or more tongues 42 projecting radially from the outside of the piston 15. The cavity 41 preferably has an obliquely angled rear surface 43 and a 44 closest perpendicular front surface. The tabs 42 have complementary angled surfaces 45 to allow the piston 15 to be inserted into the body 2 and fixed in position during the assembly of the vial 1 but preventing the piston from being withdrawn from the back of the vial. A removable back cover may be provided to cover the back portion 17 of the ampoule 1 before use, in order to prevent the back portion 32 of the piston 15 from being accidentally or inadvertently depressed during transportation, storage, or other handling of the ampoule. 1. The rear portion 32 of the piston 15 includes a receptacle 46 for receiving the rear end 38 of the piston rod 36. As shown in Figure 1, the receptacle 46 comprises an interior surface that is dimensioned to engage and hold the portion. front 38 of plunger rod 36, as shown, for example in Figure 3. Alternatively, as shown in Figure 26, receptacle 46 may comprise a threaded interconnect 47. In this installation, a member is provided. tip 48 attached to the front end 38 of the plunger rod 36 to engage with the receptacle 46 of the piston 15, and is preferably threaded To engage with the threaded surface 47 of the receptacle 46. The ampoule 1 is preferably transparent and may have graduations thereon to indicate the volume of fluid contained therein. Before administering the medicinal fluid to the patient, the user can expel an initial volume of fluid from the vial 1 in order to obtain a smaller desired dose of the fluid to be delivered to the patient. The vial 1 is preferably formed of a material that is chemically compatible with the fluid medication in the vial 1. For the storage of some medicaments, the polypropylene is a suitable inert material. For storing some other type of medication, the glass for the ampoule 1 may be preferred. The cover 28 is held on the front portion 23 of the housing 7, by for example, the cooperative clutch between a lateral protrusion formed on the exterior of the front portion 23 of the housing 7 and an annular coupling pocket formed within the back of the lid 28. Optionally a sealing member can be located or formed within the sheath 28, to receive and seal the tip 26 of the needle 25 during transport. The sealing member is preferably held inside the lid 28, so that when the lid 28 is removed from the housing 7 to expose the needle 25, immediately prior to administering an injection, the sealing member is likewise removed from the tip 26 of the needle 25. The sealing member may be formed within the cover 28 during assembly thereof by depositing an amount of a silicone elastomer, or other suitable material. As the cap is placed on the housing 7 the needle 25 penetrates the sealing member to seal the same. As shown in Figure 2A, the spring 29 is preferably attached to the needle 25 using adhesive or epoxy 31. When the spring 29 is attached to the needle 25 using adhesive or epoxy 31, it is preferred to use an ultraviolet light-curable adhesive ( UV) such as Loctite 3001, which is distributed by LOCTITE. To facilitate processing, the spring 29 is attached to the needle 25 at a location 30 spaced from the rear end 49 of the spring 29, as indicated in Figure 2A, so that one or more turns of the spring 29 can be grasped during the joining process to ensure that the spring 29 and the needle 25 are properly oriented. Alternatively, as shown in Figure 2B, the spring 29 can be attached to the needle 25 by crimping the spring 29 to the needle 25 in a reduced diameter portion 51 of the spring 29. In this installation, the portion of reduced diameter 51 of the spring 29 may also be attached to the needle 25 to ensure engagement of the parts together. As best shown in Figures 7 and 8, the needle retainer assembly 22 includes a front alignment portion 55 and a rear needle retainer 56. The front alignment portion 55 of the needle retainer 22 has a guide 57 formed in the front portion thereof, through which the needle 25 extends in the projection configuration, as shown in Figure 8. The needle guide 57, is dimensioned to maintain the needle 25 in axial alignment in the apparatus 5. A sealing member 58, such as a resilient cap, washer, silicone plug, or pierceable disk, may be placed in the front inner diameter of the front alignment portion 55. The sealing member 58 is compressed and surrounds the needle 25. The sealing member 58 further promotes axial alignment of the needle 25, and also serves to prevent fluid from passing through the guide of the needle 57 subsequent to retraction of the needle 25 by expanding the pair. to seal the guide 57.

The front alignment portion 55 of the needle retainer 22 is firmly engaged within the front portion 23 of the ampule housing 7 by friction. The engagement of the alignment portion 55 of the needle retainer 22 within the front portion 23 of the housing 7 can be further secured by epoxy or ultrasonic welding. Other effective means for securing the alignment portion 55 within the front portion 23 of the housing 7 will be apparent to those skilled in the art. The tubular needle retainer 22 is formed in two portions and retains the spring 29 and the needle 25, as shown in Figure 8. The front end 59 of the needle retainer 22 holds the spring 29 and has a front opening 57 for aligning needle 25, as previously explained. The back portion 60 of the needle retainer 22 includes the retainer mechanism 56, the operation of which is more fully explained hereafter. Referring to Figure 5, the plunger 35 further includes an annular projection 70 that forms a stop. The projection 70 engages a retaining stop member 71 having a detent stop 77 at the rear end 73 of the lever bolt 72. The annular projection 70 is positioned at a point along the length of the plunger 35. to allow the plunger 35 to be pushed through the body 2 to completely eject the medicament inside the vial 1 before the projection 70 makes contact in the lever bolt 72. More specifically, the lever bolt 72 comprises a limb member. retainer 71 which is pivotally connected to the outer side of the housing 7 in the pivot pin 75 held between the fixed side membranes 76 to the headloop 7. The retaining member 71 on one side extends in parallel along the outer side of the housing 7 and curving inwardly at the end of the housing to end in the detent stop 77, which is adapted to make contact with the projection 70 of the plunger 35. On the other side of the pivot pin ote 75, the retention member extends toward the front end 23 of the ampoule apparatus 5 but curves outwardly from the housing 7 to pivot the retention member 71 about the pivot pin 75. A tab 78 separates from the member and rests downward to rest on the housing 7 by diverting the retainer member 71 to firmly engage the detent stop 77 with the projection 70, thereby restricting the forward movement of the plunger 35 in the apparatus 5. The The retaining stop 77 is disengaged from the projection 70 by pressing the forward end 74 of the retaining member 71, thereby pivoting the retaining stop 77 of the retaining member 71 away from the projection 70, as shown in the alternative shown in FIG. retaining member (in dotted lines) in Figure 5. With the detent stop 77 disengaged from the projection 70, the plunger 35 can advance further in the forward direction to do the retraction of the needle. The operation of the ampoule 1 and the ampoule housing apparatus 5 will now be described. Referring to Fig. 1, in order to administer the medicinal fluid to a patient, the front end 13 of the ampoule is inserted in the posterior part. of the ampoule apparatus 5. The ampoule 1 advances inside the body 8 until the rear end 27 of the needle 25 makes contact, but does not pierce the membrane 16, which seals the front end 13 of the ampoule 1. To prevent the vial 1 advancing within the housing 5 beyond the desired initial position, a first detent formed along the inner surface of the body 8 of the vial housing 5 can be provided, to inhibit the vial 1 from advancing beyond the desired point. To prepare the apparatus 5 for injecting the medicament, the vial 1 then advances in the forward direction within the body 8 of the ampoule housing 5., by applying sufficient pressure to the trailing end 17 of the vial 1 to advance the vial 1 past the first detent, so that the trailing end 27 of the needle 25 pierces the membrane 16. A second detent 79 is formed along the the inner surface of the body 8 of the ampoule housing 5 to inhibit the ampoule 1 from advancing further. beyond the second detent 79. The plunger member 35 is then separated from the front end 23 of the housing of the ampule 5 and secured to the piston 15 at the rear 17 of the ampule 1. The cover 28 is then removed to expose the needle 25. The user can then administer the medicinal fluid to a patient by penetrating the patient's skin with the needle 25 and then pushing the plunger 35 in the forward direction to cause the piston 15 to eject the medicinal fluid from the ampule 1, and through the needle 25 towards the patient. Alternatively, the needle 25 can be used to penetrate an injection port of an intravenous access device connected to the patient for the administration of the so-called "IV pulse" ("push IV"). The piston rod 36 is advanced inside the body 8 until the retaining member 71 engages the projection 70 formed in the piston 35. In this position of the piston 35, the piston 15 contacts against the rear end 60 of the needle retainer 22. After the fluid has been delivered to the patient, the needle 25 is removed from the patient or the injection port. The user presses on the forward end 74 of the retention member 72 to disengage the retaining member 71 from the projection 70 formed in the plunger 35 to allow the plunger 35 to advance further. A firm compressive force, preferably greater than the force required to eject the fluid during an injection stroke, is applied to the rear part 39 of the piston rod 36. The force also advances the piston 15 forward against the rear end 27 of the piston. the needle 25 for breaking a frangible end member 85 of the piston 15, as explained more fully below. A retraction mechanism responsive to such compressive force, which will be described below, then causes the needle 25 to move away from the cavity 37 within the plunger 35, so that the needle 25 no longer presents a risk of puncture damage. . The plunger 35, the bulb 1 and the bulb housing 5 can then be safely disposed of. The retraction mechanism 56 for effecting removal of the needle 25 selectively retains the needle 25 in the projection configuration shown in FIGS. , 3 and 4. The releasable catch mechanism 56 is formed to cooperate with the forward end 33 of the piston 15 to release the needle 25 in response to the firm force movement of the piston 15. The retainer mechanism 65 will now be described with further reference to Figures 6-8 The retainer mechanism 56 includes a plurality of retention projections or projections 66 formed on the rear end 60 of the needle retainer 22. The fingers extend from the backward portion of the needle retainer 22 into the interior of the housing of vial 5 The fingers 66 are provided with substantially flat surfaces 67 formed integrally as part of the fingers 66. flat surfaces 67 extend in a direction that is substantially parallel to the longitudinal axis of the needle 25. In addition flat surfaces 67 are made to contact the outer surface of the needle 25 to thereby maintain the needle 25 in proper orientation. Preferably the flat surfaces 67 are secured or attached to the outer surface of the needle 25 using an adhesive or epoxy, such as one of the adhesives or epoxies listed in Table 1 below.

TABLE 1 In the currently preferred embodiment of the device, four fingers 66 are used, but more or fewer fingers 66 may be employed depending on the size of the device, the nature of any deviation member (here, spring) and the related structure in the device for effect the optimal operation. The fingers 66 are attached to the needle 25 to hold the needle in its position in the needle retainer 22, and consequently in the vial housing 5. The spring 29 surrounding the needle 25 is compressed within the needle retainer 22. and surrounds a backward portion 27 of the needle 25. In the configuration of Figure 8, the spring 29 is held in compression between the forward end of the guide 57 and the portion 30 in which the spring 29 is attached to the needle 25. An axial cavity or hollow area 61 is provided in the needle retainer mechanism 56 as well as in the front alignment member 55, which together define the needle retainer 22 in which the needle portion 25 and its spring 29 that surrounds it. Consequently, the needle 25 is held in a deflected relationship that urges the needle 25 toward the back 17 of the vial 1, while being held by the attachment to the retaining fingers. The fingers 66 are preferably flexible to allow outward movement to break the joint and free the fingers 66 from the needle 25. It should also be appreciated that the fingers 66 will fracture when they move outward to release the needle 25. The fingers 66 they form so as to have inclined or wedge-shaped rear facing surfaces 62 for engaging with the front end 33 of the piston 15. When the fingers 66 deform or externally fexuate radially when engaging the piston clutch surface 15 to release the fingers 66 of the needle 25, the expansive force of the spring 29 immediately pushes the needle 25 towards the rear towards the rear portion 17 of the bulb 1. The retention projections or fingers 66 with their flat surfaces 67 form a circular opening 63 in the rear end 60 of the needle retainer 22 for receiving the needle 25. The needle retainer 22 is p rovisto with longitudinal slots or score lines 64 running along the outer side of the fingers 66 to facilitate breaking and detachment of the fingers 66. The flat surfaces 67 of the fingers 66 preferably form a continuous axial surface within the interior of the needle retainer 22, for improving the sealing characteristics of the clutch with the needle 25. The continuous surfaces between the fingers 66 provide a seal with the needle 25, so that the fluid is kept out of the chamber 11 in the ampoule apparatus 5. Additionally, a flange 68 projecting radially around the exterior of the needle retainer 22 may be formed to contact a complementary relief on the interior of the housing 5 to secure the needle retainer 22 against being pushed back by the expansive force. of the compressed spring 29. Referring to FIGS. 1 and 6, the piston 15 includes more specifically the structural provisions for the effective release of the needle 25 of the needle retainer 22. The front end 33 of the piston 15 has a cavity 34 at its center which is sealed by the frangible end plug 85 inserted centrally in the cavity 34 in the front end 33 of the piston 15. The frangible end member 85 is broken or separated from the piston 15 after application of sufficient force to separate the frangible end member 85 from the piston 15, when the frangible end plug 85 makes contact against the rear end 27 of the needle 25. The needle retainer 22 and the plunger 35 are preferably constructed to have the needle 25 provided with adequate force to break the frangible end plug 85 prior to retraction of the needle. The piston 15 is chemically compatible with the stored medication. For example, polystyrene provides such characteristics for use with various medications. The properties of providing adequate frangibility for the frangible end plug 85 of the piston 15 and chemical compatibility can be provided separately by, for example, providing a conformal coating or layer of a chemically inert material, such as polytetrafluoroethylene, on the surfaces of the piston 15 that keeps in contact with the stored medication. The periphery of the front end 33 of the piston is contoured or sharpened to engage with and contact the wedge-shaped engaging surfaces 62 of the fingers 66 to separate the fingers 66 to release the joint between the flat surfaces 67 of the fingers 66 and the needle 25. The forward progress of the piston 15 causes the fingers 66 to be radially outwardly separated by bending or breaking, thereby releasing the needle 25. When the needle 25 is released from the needle retainer 22, the needle 25 is pushed back by the force of the spring compressed 29 and is urged by the spring 29 through the opening 69 in the front end 33 of the piston 15, which has been closed by the frangible end member 85. The needle 25 is then received, and substantially retained within the cavity 37 in the plunger 35, as shown in figure 6.

A second embodiment of the present invention is characterized as a pre-filled injection vial 101 and an ampoule holder 105, as shown in Figures 9-12. Similar parts in Figures 9-12 to those shown in Figures 1-8 are denoted by the same reference number with the addition of 100 thereto. The ampoule housing 105 of FIG. 9 differs from the ampoule housing 5 of FIG. 1 primarily in that the ampoule housing 105 has a cooperating needle guide 187, which receives the main needle 125 in a telescopic fashion. The main needle 125 has its front portion 188 piercing the patient and its rear portion 189 which is dimensioned to slidably receive within the needle guide 187. In this installation, the length of the ampule 101 and the ampoule housing 105 in its Armed condition, can be reduced considerably. As shown in Figure 9, the needle guide 187 is generally cylindrical and is adapted to be slidably received within the body 108 of the ampoule housing 105. The needle guide 187 has a first axial hole 190 toward the rear end 191 of the needle guide 187. The diameter of the first axial hole 190 is selected to receive tightly the injection needle 125. The front end 192 of the needle guide 187 has an elongated second or axial hole 193 communicating with the first orifice axial 190. The diameter of the second axial hole 193 is dimensioned to allow the injection needle 188 together with the attached spring 129 to be received within the second axial hole 193. When the needle retainer 122 is actuated for retraction of the needle injection 18.8-, the compressed spring 129 drives the injection needle 188 backwards. The injection needle 188 and the spring 129 thus enter the second axial hole 193 and the transition 194 between the second axial hole 193 and the first axial hole 190 acts as a stop for the spring 129 and the needle 188 does not retract further passing. to the vial 101 as shown in Fig. 12. The apparatus of Fig. 9 is shown in its transport mode, and in Fig. 10 it is shown assembled for use. Figure 11 shows the apparatus after ejecting the medicament from the ampoule 101. The perforating needle 188, as previously established, is shown retracted in Figure 12, the retraction being performed as described below. The radial free space provided between the injection needle 125 and the first axial hole 190 in the needle guide 187 are selected to substantially prevent leakage of fluid between the needle and the guide 187 while the injection is being made. These dimensional tolerances substantially allow all of the fluids initially contained within the ampule 101 to be injected to a patient, with minimal retention of fluid within the injection device after an injection. As best seen in Figure 9, the needle guide 187 at its rearward end 191 has an axially extending enhancement or perforating portion. externally 189 bevelled at its end to provide a piercing surface 195. The piercing surface 195 is adapted to penetrate the membrane 116 at the front end 113 of the ampule 101 to have the fluid injected from the ampule 101 toward the piercing portion 189 and from here to the injection needle 125. The front end 192 of the needle guide 187 further includes an embossment 196 which extends generally axially. The protruding periphery 196 is contoured or sharpened inwardly to engage with, and contacting the cooperating surfaces flared outwards 162 of the fingers 166 to separate the fingers 166 to break the junction with the needle 125 to release the surfaces 167 of the needle 125. It will be appreciated that in this embodiment, the piston 115 in the vial it does not need to have a front end 133 contoured, since it does not work to maneuver the needle retainer 122. - 2í In operation of the apparatus of Figs. 9-12, the ampule 101 is placed within the body 108 of the ampule housing 105 such that the leading end 113 of the ampule 101 contacts, but is not pierced by the rear end 197 of the piercing member 189. As shown in Figure 9, the body 108 of the ampoule housing 105 is sufficiently long to allow the ampoule 101 to be placed within the interior of the body 108 of the housing 105. The plunger 135 is then separated from the front end 123 of the housing 105 and is attached to the piston 115. The ampule 101 then advances into the body 108 of the ampoule housing 105 until the trailing end 197 of the piercing member 189 pierces the membrane 116, which seals the front end of the ampoule 101. The medicament can then be administered substantially in the same manner as described with respect to Figures 1-6. To retract the injection needle 125 pressure is applied to the plunger 135. The pressure advances the ampule 101 forward to cause the needle guide 187 to puncture the piston 115 to open a duct towards the ampule 101. At the same time, the periphery of the front relief 196 on the needle guide 187 is pressed against the needle retainer 122, thereby releasing the injection needle 125 to move through the spring. 129. The injection needle 125 and the spring 129 are thus pushed towards the rear toward the second axial hole 193 in the needle guide 187 for retraction of the injection needle 125 towards the plunger 135 in the ampule 101, as shown in FIG. shown in Figure 12. The third embodiment of the present invention is shown in Figures 13-18. The third embodiment is the preferred embodiment and differs from the second embodiment primarily in that in the third embodiment the vial 201 is evacuated without the use of a plunger and the third embodiment has a different latch mechanism or closure 271 to prevent premature retraction of the plunger. needle 225. Similar parts in figures 13-18 to those shown in figures 9-12 are denoted by the same reference number with the addition of 100 thereto. The ampoule housing 205 of Figures 13-18 is similar to the ampoule housing 105 of Figures 9-12. However, the needle guide 287 in the needle housing 205 of FIGS. 13-18 is received snugly within the housing 205, such as by a finger 299, which is held between the detents 200 along the inner surface of the vial housing 201. Additionally, the trailing end 291 of the needle guide 287 includes a piston adapter, such as an axial extension member 280 having external threads. The axial extension member 280 is shaped to engage with the internal threads of the axial hole 246 in the piston 215, which seals an end of the vial 201. Additionally, the central hole 281 through the needle guide 287 allows to retract the injection needle 288 through the needle guide 287. Preferably, the first axial hole 246 of the needle guide 287 and the axially extending perforating enhancement or portion may be provided by a piercing needle 289, as shown in the figure 16, which is adapted to receive the injection needle 288 in a telescopic arrangement, when the needle is retracted as shown in Figure 18. In the operation of the embodiment of Figures 13-18, the end of the piston or forward 213 of the * vial 201 is inserted into the body 208 of the vial housing 205. The vial 201 is rotated to engage the thread on the needle guide 287 with the threaded cavity of the piston in the ampoule at 201. When the needle guide 287 is fully engaged with the piston 215, the trailing end 227 of the piercing needle 289 pierces the piston 215 from side to side and into the interior cavity 282 of the ampule 201, as shown in FIG. Figure 14. Pressure is applied to the rear end 217 of the vial 201 to advance the vial 201 toward the vial housing 205. As the vial 201 advances within the vial housing 205 with its piston 215 fixed in position, the medicament is expelled from the cavity 282 in the vial 201 by the force of the piston 215 relative to the advancing vial 201. The vial 201 advances a sufficient distance to expel all the medication from the vial 201. When all the medicament has When ejected, the piston 215 contacts the rear end 217 of the vial 201 and the front end 213 of the vial 201 contacts the nose 299 of the needle guide 287. As shown in Figures 16, 17A and 17B , the needle guide 287 also has a front abutment surface 270 which contacts a retention member 271, which extends toward the ampoule housing 205 through a slot 286 in the side wall. The retaining member 271 is adapted to extend through the axial area of the vial 201 and is held by a contact surface 204, which captures the latch member 271 and prevents the lower portion 203 of the retaining member 271 from moving toward it. the front end 223 of the housing 205. When the nose or abutment surface 270 of the needle guide 287 makes contact with the retaining member 271, as shown in FIGS. 16 and 17A, the retaining member 271 must be pressed towards the nose. blister housing 205 for releasing the abutment surface of needle guide 287, as indicated in FIG. 17B, to allow additional forward movement of needle guide 287. Retainer member 271 includes lugs 206 for biasing the member of retention 271 towards its secured position. When the retaining member 271 is depressed, as shown in FIG. 17B, the lugs 206 are deformed to count their normal deviation condition to allow movement of the retaining member 271 toward its unlocked position, when it remains deflected to its position secured by the lugs 206. To retract the injection needle 288, additional pressure is applied to the rearward end 217 of the vial 201 to dislodge the projection 270 of the detent 200 along the inner surface of the vial housing 205, while the retaining member 271 is pressed towards its unsecured position. In this installation, the forward end 292 of the needle guide 287 is advanced to make contact with the needle retainer 222 by causing the fingers 266 of the needle retainer 222 to release the needle 225 by breaking the joint therebetween. Therefore the needle 225 is retracted, as shown in Figure 18. A fourth embodiment of the present invention is shown in Figures 19-23. The fourth embodiment is similar to the third embodiment, except that the plunger 335 is used to advance the piston 315 to eject the medicament and activate the retraction of the needle 325 in a manner similar to the structure of the embodiment of Figures 9-12. , except that the lever lock 172 is replaced by the retainer member 271 of FIG. 16. Like parts in FIGS. 19-23 to those shown in FIGS. 13-18 are designated by the same reference number with the addition from 100 to them. In the embodiment of Figures 19-23, the needle guide 387 includes a posterior tubular member 383 and a front tubular member 384. The posterior tubular member 383 is beveled to pierce the membrane 316 at the front end 313 of the ampule 301. The front tubular member 384 extends from the rear tubular member 383 and has a larger diameter than the rear tubular member 383. The diameter of the front tubular member 384 is sized to allow the injection needle 388 together with the connecting spring 329 are received within the front tubular member 384. The forward end 352 of the front tubular member 384 is shaped to engage with and make contact with the outwardly beveled end 362 of the fingers 366 in the needle retainer 322 to move the fingers 366. to break the union of the needle 325 to perform the retraction of the needle 325. The transition 394 between the front and back tubular members 384 and 383 provide a stop for spring 329, which is attached to the injection needle 388, as described in relation to the embodiment of Figures 9 and 10. The fins 354 project radially along the length of the front and rear tubular members 384 and 383 and make contact with the inner surface of the body 308 of the ampoule housing 305, thereby ensuring that the tubular members 383 and 384 are properly aligned within the body 308 of the ampoule housing 305. The fins 354 also serve to align suitably the needle guide 387 as it advances within the body 308 of the vial housing 305 to contact the fingers 366 of the needle retainer 322, as shown in Figure 23. In the operation of the embodiment of the figures 19-23, the bulb 301 is placed inside the body 308 of the bulb housing 305 so that the front end 313 of the bulb 301 contacts, but is not pierced by the outer rear pad 397 of piercing portion 289. Body 308 of blister housing 305 is sufficiently long to essentially allow entry of ampoule 301 to be placed within the interior of body 308 of housing 305. Plunger 335 is removed from above the injection needle 388 and then attached to the piston 315. If provided with a sheath 328, the sheath 328 is removed from above the trailing end 326 of the injection needle 388. The ampoule 301 then advances into the housing body 308 of ampoule 305 until the trailing end 397 of the perforating portion 389 pierces the membrane 316, which seals the leading end 313 of the ampoule 301 as shown in Figure 20. The medicament may then be administered in substantially the same manner as described above with respect to the embodiment of Figure 9. Figure 21 shows the apparatus after the medicament has been expelled from the ampoule 301 ha ia the patient. To retract the injection needle 388, additional pressure is applied to the plunger 335 and thence to the piston 315. The pressure on the piston 315 advances the bladder 301 against the needle guide 387. The retaining member 371 is then pressed towards its unsecured position, as described with respect to the third modality. The vial 301 is then pressed against the fins 354 of the needle guide 387 for further advancement of the needle guide 387 to separate the fingers 366 from the needle retainer 322 to break the joint therebetween. More particularly, the forward end 352 of the front tubular member 384 contacts the flared surfaces 367 of the fingers 366 on the needle retainer 322 that releases the injection needle 388. The injection needle 388 is retracted by the force of the spring 329 and pushes back toward the tubular member at the back 383. The injection needle 388 and the spring 329 are prevented from passing through the posterior tubular member 383 as previously described and shown in Fig. 23. 3 &; b < * appreciate that the needle retention method between the needle and the needle retainer by joining, as well as the method of releasing the needle retainer from the needle by breaking the joint, is applicable to a wide variety of medical devices beyond the ampoule devices described herein. More particularly, the needle housing and retraction facility can be used in syringes, phlebotomy devices and catheter insertion devices to effect support and retraction of the needle piercing the patient. The retraction of the needle facilitates the safety of medical personnel in the elimination of such devices after use and avoids the reuse of used devices. Referring now to Figure 27, there is shown an injection device 405 for injecting fluid from a pre-filled container or cartridge 401 to a patient through the needle 413. The device 405 includes a body 408 sized to receive a cartridge 401 in the rear end of the body 408. The cartridge 401 contains a supply of fluid to be injected into the patient. The front end of the cartridge 401 is sealed by a movable piston or seal 415, which is pierceable by a rear needle 481 axially positioned within the body 408. A pair of finger holders 421 are formed to extend outwardly from the body 408 to allow the user stabilizes the 405 device while administering an injection. In order to avoid unwanted premature retraction of the. 413, the device 405 includes a safety latch having a button or other maneuvering surface 472 projecting outwardly through an opening 473 formed in the body 408. When an injection is administered, the cartridge 401 is advanced towards the rear of the body 408, thus piercing the obturator 415 with the rear needle 489. Further advancement of the cartridge 401 drives the cartridge over the obturator 415 to eject the fluid through the needle 413. At the end of an injection stroke, the device 405 and the cartridge 401 are configured as shown in Figure 28. When the cartridge 401 is driven over the plug 415, the rear end of the fixed piston 435 holds the plug in relation to the cartridge. The cartridge 401 is driven over the plug 415 until the plug contacts the back of the cartridge. The fixed piston 435 is axially positioned in the body 408 and has a threaded lug 480 formed at the rear end thereof to engage with the obturator 415. The piston 435 has an axial cavity 493 formed therein that has a rear portion of diameter reeduced to support the rear needle 489 and to drive the fluid from the container to the front needle 413 during an injection. The front needle 413 extends in a projecting configuration from the forward end of the body 408. The needle 413 is surrounded by a compressed spring 429 within the front inner portion of the body 408, the rear portion of the spring 429 is attached to the needle 413 or otherwise installed to exert a backward deflection on the needle 413. The needle 413 is maintained in the projection configuration by the clutch with a needle retainer 422 substantially of the type described hereinabove. The forward end of the plunger 435 is configured to release the clutch between the needle 413 and the needle retainer 422.

After the end of an injection stroke, the movement of the plunger 435 to release the needle 413 is prevented by a latch 481 extending outwardly from the plunger 435. The latch 481 has a releasable latch 482 formed thereon to make contact with the latch 435. the edge of the opening 473 formed in the body 408. The latch 481 further includes a flexible draw arm 483 connected to the plunger 415. The arm 483 deflects the catch 482 to extend through the opening 473 during use of the device 405 When inward pressure is exerted to count the maneuvering surface 472 of the detent 482, the arm 483 is internally deflected to allow the detent 482 to move out of contact with the edge of the aperture 473. Then, while maintaining such pressure against the surface -472, the user can push the cartridge 401 forward within the body 408 to move the piston 435 in the forward direction, and thus effect the retraction of the needle to. Centering means are provided, such as edges 485 formed inside the body 408 to maintain axial alignment between the forward end of the plunger 415 and the rear part of the needle retainer 422. The device 405 preferably incorporates means to prevent the residual fluid is undesirably ejected from needle 413 during retraction. In the embodiment shown in Figure 28, the rear portion of the needle 413 extends toward the forward portion of the axial cavity 493 of the embolus 413. A shutter support member 490. is placed in the cavity 493 to hold the obturator 492. in axial alignment with the rear end of the needle. When the needle is to be retracted, the obturator support member 490 and consequently the obturator 492, move forward with. the plunger 435 to allow the obturator 492 to contact and seal the trailing end of the needle 413. As the plunger moves toward the adductor, the needle retainer 422 is released from the needle and the obturator 492 separates from the member of obturator support 490 in order to remain in the end portion of needle 413 to provide a partial vacuum in the posterior portion of needle 413 protruding rearwardly 413. Thus residual fluid is retained in needle 413. Referring now to Figure 29 the obturator 492 and the obturator support member 490 are preferably formed integrally of an elastomeric material. The obturator support member 490 preferably has a central part 494 formed around its exterior to engage an additional interior surface of the plunger 435. Additionally, the obturator support member has an axial cavity formed therein for receiving and maintaining the back portion of the front needle 413 during the assembly of the devices 405. As can be seen in Figure 30, the obturator 492 is supported to align with the rear end of the needle by a stringer 495 which forms the posterior portion of the needle. fastener support member 490. Stringer 495 includes openings 493 formed therein to provide a fluid flow path through the rear portion of the obturator support member 490 contiguous with the central cavity thereof. When the plunger is actuated to effect the retraction of the needle, the leading end of the obturator is driven over the trailing end of the needle. The central part 494 provides sufficient holding force for the obturator support member 490 within the plunger 435 such that further forward movement of the plunger will break the spar 495 and consequently allow the obturator 492 to be retained at the rear end of the needle as it retracts. The terms and expressions that have been used are used as terms of the description and not of the limitation. There is no intent in the use of such terms and expressions to exclude any equivalent of the characteristics shown and described or portions thereof. However, it is recognized that various modifications are possible within the scope and spirit of education.

Claims (18)

1. NOVELTY OF THE INVENTION Having described the present invention is considered as a novelty and therefore the content of the following claims is claimed as property. A medical device operable in connection with a cartridge containing fluid and having a pierceable member, comprising: a hollow housing comprising a receptacle for receiving the cartridge; a first needle having a sharp tip operable in a projection position in which the sharp tip projects forwardly from the housing and a retracted position in which the sharp tip retracts into the housing; a second needle projecting towards the receptacle for piercing the cartridge; a releasable needle retainer that holds the needle in the projection position, the needle retainer having a maneuvering surface that faces toward the rear; a plunger displaceably slidable within the housing, the plunger having a front portion cooperating with the maneuvering surface of the needle retainer; and a bolt manually operable between a secured position in which the bolt prevents forward axial movement of the piston, and the unlocked position in which the piston can move axially forward; wherein the operation of the bolt and the plunger releases the first needle from the needle retainer so that the first needle can retract into the housing. The device according to claim 1, characterized in that the simultaneous operation of the bolt and the plunger release the first needle from the needle retainer so that the first needle can be retracted into the housing. The device according to claim 1, characterized in that it comprises a spring connected to the first needle, which deflects the first needle towards the rear part in the housing. The device according to claim 1, characterized in that the plunger comprises a chamber for receiving the first needle in the retracted position. The device according to claim 1, characterized in that the needle retainer comprises a plurality of fingers longitudinally elongated circumferentially extending projecting inward to retain the needle. The device according to claim 1, characterized in that the plunger comprises a cavity receiving the fluid. The device according to claim 3, characterized in that it comprises a spring chamber for receiving the spring, wherein the needle retainer forms the rear end of the spring chamber. The device according to claim 1, characterized in that the bolt comprises a maneuvering portion external to the housing. 9. A medical device, comprising: a hollow housing; a needle projecting forward from the housing; a needle retainer releasably retaining the needle projecting forward from the housing; a first actuator cooperating with the needle retainer to release the needle from the needle retainer; and a second actuator for preventing operation of the first actuator, wherein the simultaneous operation of the first actuator and the second actuator releases the needle from the needle retainer so that the needle can retract into the housing. The device according to claim 9, characterized in that the housing comprises a receptacle configured to receive a cartridge containing fluid and having a pierceable member. The device according to claim 10, characterized in that it comprises a second needle in fluid communication with the first needle, wherein the second needle projects towards the receptacle for piercing the pierceable member of the cartridge. The device according to claim 9, characterized in that the second actuator is a bolt having a maneuvering surface projecting externally from the housing. 13. The device according to claim 9, characterized in that the needle retainer comprises a plurality of circumferentially separated longitudinally elongated fingers projecting inwardly to retain the needle. The device according to claim 9, characterized in that it comprises a spring connected to the needle, which biases the needle towards the back inside the housing. 15. The device according to claim 9, characterized in that the first actuator comprises a chamber for receiving the needle. The device according to claim 9, characterized in that the needle retainer comprises a maneuvering surface facing the rear and the first actuator comprises a front portion configured to cooperate with the maneuvering surface, such that after the forward movement of the first actuator, the front portion engages the maneuvering surface, radially deforming the maneuvering surface, thereby releasing the needle retainer needle. 17. A device for injecting fluid from an ampule comprising: a bulb housing having a closed end with a hole formed therein and an open end; a needle placed inside the hole; a spring fixed to the needle to exert a backward deflection on the needle, the spring being fixed to the needle; and a needle retainer positioned within the ampoule housing and having at least a portion of the retainer extending rearwardly within the ampoule housing; the retainer portion having a flat surface for contacting the needle and retaining the needle within the hole against the backward deflection exerted by the spring; the vial being received insertable within the open end of the vial housing, the vial having a piston to eject the medicament from the vial and an actuator connected to the piston to cause the piston to eject the medicament from the vial through the needle; and a retainer actuator actuated by the ampule or piston to separate the needle retainer from the needle to allow retraction of the needle toward the ampule housing. The device according to claim 17, characterized in that the flat surface of the needle retainer contacting the needle is attached to the needle, and the retainer actuator is adapted to break the joint between the retainer portion and the needle for the needle. retraction of the needle.