Device configured to administer a drug

专利摘要:
PALM-ACTIVATED DRUG DELIVERY DEVICE. The present invention relates to a device configured to administer a medication which may comprise a lower housing that includes a housing latch. The device may further comprise a needle shield that is movable relative to the lower housing along a first direction from a first position to a second position to expose a needle, and an upper housing supported relative to the lower housing. The upper housing may be configured to move relative to the lower housing along a second direction from the pre-use position to a dispensed position. The housing latch may releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving to the dispensed position, and movement of the needle shield to the second position. causes the interference to be removed, thereby allowing the upper housing to move from the first to the second position.
公开号:BR112015023470B1
申请号:R112015023470-4
申请日:2014-03-10
公开日:2022-02-01
发明作者:Lorin Olson；Vaclav Vojan；Juergen E. Pfrang；Peter Krulevitch；Jingli Wang；Nicholas Foley；Mingqi Zhao；Paul Tashjian
申请人:Janssen Biotech, Inc；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[001] This application is the continuation-in-part of the U.S. Serial No. 12/905,572 filed October 15, 2010, which claims the benefits of the U.S. Serial No. 61/361,983 filed July 7, 2010 and 61/252,378 filed October 16, 2009, the disclosures of which are fully incorporated herein by reference. FIELD OF TECHNIQUE
[002] The invention generally relates to methods and devices for parenteral application of drugs. The devices provide assisted manual drug delivery with confirmation of completion of the drug delivery process. The devices provide a system with improved safety and ease of use, as well as audible or other feedback to the user to indicate when drug delivery is in process, completed, or both, to avoid one or both of incomplete dosing and wasted medication, as well as to provide a system with improved safety and ease of use. BACKGROUND
[003] For many years, an accepted method for parenteral drug delivery has been through the use of a syringe and needle. The syringe contains an amount of a drug sold in a pre-filled syringe or introduced into a syringe by drawing the drug into a syringe from a vial or other container. Syringes have been widely accepted because of their low manufacturing cost and simple, effective design. For the user, however, syringes and needles have several disadvantages.
[004] A disadvantage is that many patients are afraid of needles. In cases where self-medication is necessary, such as those where multiple daily injections are required, patients may not administer their medication as per the prescribed regimen due to their fear of needles, the pain that is often associated with an injection, dexterity that is required to properly administer a drug through needle and syringe or other similar factors. For some, who have impaired vision, dexterity, or consciousness, self-administration via needle and syringe can present additional difficulties that prevent them from receiving needed medication.
[005] There are also safety and disposal concerns associated with needles and syringes not only for the patient, but for those around them that can result from contaminated needles, accidental punctures, cross-contamination, and the like, in addition to the social stigma associated with a regimen. drug treatment using needle and syringe. Despite these disadvantages, however, many patients are encouraged to use needles and syringes for the delivery of their medication because of the ability to control needle insertion and the speed of drug delivery when the syringe plunger is depressed, and therefore to control their perception of pain and discomfort associated with this type of drug injection.
[006] Several advances have been made over the years to help facilitate self-administration of medication. Such advances include smaller needles with improved tip geometry to reduce pain. Safety syringes that coat the needle before, after or before and after use were used to minimize concerns about accidental needle punctures. Improved ergonomics of the syringe design has also been promoted to reduce the dexterity required to accurately and safely self-administer medication through the needle and syringe. Pre-filled disposable devices, which are shaped like a pen, were developed to optimize dosing accuracy and auto-injectors were used to hide the needle from the patient to reduce fear and safety concerns from both needle retraction and placement. a shield around the needle.
[007] Although some advances have improved needle-and-syringe-based drug delivery, the ergonomic designs, pens, and autoinjectors retain substantial similarity to the original needle-and-syringe concept, thus limiting their acceptance by patients who need to self-administer their drug. medication. Current systems employ a format that suggests the "pick and punch" injection technique, with the user holding the device in the palm of the hand and placing the thumb over an activatable button.
[008] Current autoinjectors transfer the control of drug delivery in the body to a mechanical system. As such a system is highly dependent on the specific mechanical design of the autoinjector, patients may require specialized training to use the device and there is still a risk of inaccurate dosing. This situation is highly problematic when applying very expensive drugs that could only be administered weekly or on an even more infrequent basis.
[009] The typical method of use of current autoinjectors includes the patient holding the device against the skin for several seconds while the device is in the process of delivering the drug. Many users, and the elderly in particular, may experience arm or hand fatigue causing them to exert uneven pressure from the device against the skin, or they may remove the device prematurely. Any of these situations can result in inaccurate dosing, wasted medication, increased discomfort, and the like. Under any of these circumstances, current devices and methods that include, or have evolved from, the traditional syringe and needle system, have deficiencies that compromise the effectiveness of a prescribed drug regimen.
[0010] Finally, as with any healthcare-related device or service, the cost of any frequently used component in a treatment regimen needs to be considered. While delivering drugs in vials that are used to fill empty syringes when, or around, the patient's medication time, he can deliver the least expensive solution, adding an additional opportunity for wastage or loss of an expensive drug. If this drug requires refrigeration, it may degrade each time it is removed and reinserted into the refrigeration device before and after filling the syringe, which can lead to less drug efficacy than expected if the vial contains an amount of drug. which is applied over a long period of time. While pre-filled syringes offer an advantage in both reliability and convenience, such devices still have the inherent disadvantages mentioned above.
[0011] In devices such as pre-filled autoinjectors, the device is most commonly manufactured for use with a wide variety of drugs, but is not customized for a specific drug. As such devices rely on mechanical systems employing springs to control the rate of drug injection, many drugs of different viscosities or that require refrigeration and have their viscosity changed as a result of appreciable changes in temperature can be applied very quickly or very slowly. according to the predetermined spring force of the autoinjector design. In many cases, a spring force that is too low can result in incomplete drug delivery, removal of the device before completion of application, or excessive pain and discomfort to the user resulting from an extended period during which the injection device is inserted into the body. . Too high a spring force, however, may result in drug delivery so rapid that it degrades the drug, may result in the syringe breaking, or may cause injection force pain to the patient caused by the rapid application of an acidic drug or inducing a pressure gradient under the skin or in a vein.
[0012] Thus, there are many opportunities to advance the field of parenteral and episodic drug delivery, which could overcome "needle phobia", reduce patient pain, and increase the safety, reliability, and efficacy of many drug treatment regimens. SUMMARY
[0013] According to one embodiment, a device configured to administer medication may comprise a lower housing that includes a housing latch and a syringe that is supported by the lower housing and configured to retain the medication. The syringe may have a needle configured to be inserted into tissue. The device may further comprise a needle shield that is movable relative to the lower housing along a first direction from a first position to a second position so as to expose the needle and an upper housing supported relative to the lower housing. The upper housing may be configured to receive a manual force and move relative to the lower housing along a second direction opposite the first direction from a pre-use position to a dispensed position in response to the manual force. The device may further comprise a plunger rod supported by the upper housing and movable with the upper housing to advance with respect to the syringe when the upper housing is moved along a second direction. Advancing the plunger rod with respect to the syringe may cause the syringe to release medication from the needle. The housing latch may releasably interfere with the upper housing when the upper housing is in the pre-use position so as to prevent the upper housing from moving to the dispensed position, and movement of the needle shield to the second position. can cause the interference to be removed, thereby allowing the upper housing to move from the first to the second position. BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The above-mentioned summary, as well as the following detailed description of the preferred modalities of the application, will be better understood when read together with the attached drawings. For purposes of illustrating the present disclosure, preferred embodiments are shown in the drawings. It should be understood, however, that the application is not limited to specific embodiments and methods presented, and reference is made to embodiments for this purpose. In the drawings:
[0015] Figure 1A is a side elevation view of an embodiment of the present invention.
[0016] Figure 1B is a side view of the embodiment of Figure 1A after the cover is removed.
[0017] Figure 1C is a side view of the Figure 1B mode after pressing the locking button.
[0018] Figure 1D is a side view of the Figure 1 embodiment after the needle shield has been retracted, exposing the needle.
[0019] Figure 2A is a side view of the embodiment of Figure 1D during drug injection.
[0020] Figure 2B is a side view of the embodiment of Figure 2 upon completion of drug injection.
[0021] Figure 2C is a side view of the embodiment of Figure 2B after the needle shield has been extended, hiding the needle.
[0022] Figure 3 is a representation of an exploded view of the modality of Figure 1A.
[0023] Figure 4 is a representation of a cross-section view of the modality of Figure 1A.
[0024] Figure 5 is a representation of a partial cross-section view of a portion of the embodiment of Figure 1A, representing a lock.
[0025] Figure 6 is a partial cross-sectional view of a portion of the embodiment of Figure 1A, representing a lock.
[0026] Figure 7 is a representation of a cross-section view of the modality of Figure 2A.
[0027] Figure 8 is a representation of a cross-section view of the modality of Figure 2B.
[0028] Figure 9 is a representation of the cross-section view of the modality of Figure 2C.
[0029] Figure 10A is a side view of another embodiment of the present invention.
[0030] Figure 10B is a side view of the embodiment of Figure 10A after the cover is removed.
[0031] Figure 10C is a side view of the embodiment of Figure 10B after the needle shield has been retracted, exposing the needle.
[0032] Figure 11A is a side view of the embodiment of Figure 10C during drug injection.
[0033] Figure 11B is a side view of the embodiment of Figure 11A upon completion of drug injection.
[0034] Figure 11C is a side view of the embodiment of Figure 11B after the needle shield has been extended, hiding the needle.
[0035] Figure 12 is a representation of an exploded view embodiment of Figure 10A.
[0036] Figure 13A is a perspective view of the lower housing of the embodiment of Figure 10A.
[0037] Figure 13B is a perspective view of the middle part of the housing of the embodiment of Figure 10A.
[0038] Figure 14 is a representation of a partial cross-sectional view of a portion of the upper and intermediate housings of the embodiment of Figure 10A.
[0039] Figure 15 is a representation of a locking mechanism of the embodiment of Figure 10A.
[0040] Figure 16 is a representation of another locking mechanism of the embodiment of Figure 10A.
[0041] Figure 17A is a representation of a cross-sectional view of a portion of the embodiment of Figure 10A.
[0042] Figure 17B is a representation of an perspective view of a portion of the lower housing of the embodiment of Figure 10A.
[0043] Figure 18 is a cross-sectional view of the device of Figure 10A.
[0044] Figure 19 is an exploded side view of another embodiment of the present invention.
[0045] Figure 20 is a cross-sectional side view representation of another embodiment of the present invention before use.
[0046] Figure 21A is a perspective view of an alternative design of the lower housing of the embodiment of Figure 10A.
[0047] Figure 21B is a perspective view of an alternative embodiment of the lower housing of Figure 10A.
[0048] Figure 21C is a cross-sectional view of the lower housing of Figure 21B.
[0049] Figure 22A is a front perspective view of another embodiment of the medication delivery device, in a pre-use position, the medication delivery device including a lower housing, an intermediate housing attached to the lower housing, a upper housing movably attached to the intermediate housing from a pre-use position to a dispensed position, and a needle shield movable relative to the lower housing from a first position to a second position and subsequently to an end position.
[0050] Figure 22B is a front elevational view of the medication delivery device shown in Figure 22A in a post-use position with the upper housing substantially covering the intermediate housing.
[0051] Figure 22C is a cross-sectional view of the medication delivery device shown in Figure 22A.
[0052] Figure 22D is a cross-sectional view of the medication delivery device shown in Figure 22B with the needle shield in the second position through which the needle is exposed.
[0053] Figure 22E is a cross-sectional view of the drug delivery device shown in Figure 22D with the needle shield in the final position by which the needle is encapsulated.
[0054] Figure 23 is an exploded view of the medication delivery device shown in Figure 22A, including an ergonomic cap, housing body and upper housing skirt, syringe retainer, syringe and needle guard.
[0055] Figure 24A is a bottom perspective view of the upper housing body shown in Figure 23, the upper housing body including a pair of guides each defining an abutment surface and a guide channel.
[0056] Figure 24B is a side elevation view of the upper housing body shown in Figure 24A.
[0057] Figure 24C is a cross-sectional view of the skirt shown in Figure 23, the skirt including a body and four friction members defined as rails extending from the body.
[0058] Figure 25A is a perspective view of the intermediate housing shown in Figure 23, the intermediate housing including a side wall and four friction members defined as cantilevered portions extending from the side wall.
[0059] Figure 25B is an improved side elevation view of one of the cantilevered portions of the intermediate housing shown in Figure 25A.
[0060] Figure 25C is a cross-sectional view of a drug delivery device shown in Figure 22A showing room ribs that interfere with the cantilevered portions of the intermediate housing when the upper housing is moved along the intermediate housing from position from pre-use to the dispensed position.
[0061] Figure 26A is a perspective view of the lower housing shown in Figure 23, the lower housing including a pair of housing latches that are configured to interfere with the upper housing guides to hold the upper housing in the pre-use position. and are also configured to interfere with the needle shield to maintain the needle shield in the final position to prevent re-use of the device.
[0062] Figure 26B is a front elevation view of the lower housing shown in Figure 26A.
[0063] Figure 27A is a perspective view of the syringe retainer shown in Figure 23, the syringe retainer being configured to retain the syringe.
[0064] Figure 27B is a perspective view of the syringe being inserted into the syringe retainer of Figure 27A.
[0065] Figure 27C is a perspective view of the syringe and syringe retainer combination of Figure 27B being inserted into the lower housing.
[0066] Figure 28 is a perspective view of the needle shield shown in Figure 23, the needle shield including a pair of extensions that include a stop that holds the respective housing latch in interference with the upper housing guides, and a needle shield lock which is configured to interfere with housing lock after the needle shield moves from the second position to the final position.
[0067] Figure 29A is a partial front elevational view of the medication delivery device shown in Figure 22A when the upper housing is in the pre-use position and the needle shield is in the first position such that the extension stops of the needle shield meet the housing latches and maintain the housing latches in interference with the mating surfaces of the upper housing guides to maintain the upper housing in the pre-use position.
[0068] Figure 29B is a partial front elevational view of the medication delivery device shown in Figure 29A with the upper housing guide removed for clarity as the needle shield moves to the second position such that the needle stops are Needle shield extensions no longer meet housing latches.
[0069] Figure 29C is a partial front elevational view of the medication delivery device shown in Figure 29B with the upper housing moving toward the dispensed position and the housing latches being moved in the guide rails of the upper housing.
[0070] Figure 29D is a partial elevational front view of the medication delivery device shown in Figure 29C with the upper housing in the dispensed position.
[0071] Figure 29E is a partial front elevational view of the medication delivery device shown in Figure 29D with the upper housing guide removed for clarity when the upper housing is in the dispensed position and the needle shield begins to move from second position towards the final position.
[0072] Figure 29F is a partial elevational front view of the medication delivery device shown in Figure 29E when the needle shield is in the final position and the needle shield latches are in interference with the housing latches to lock the needle guard in end position.
[0073] Figure 30A is a front elevational view of the medication delivery device shown in Figure 22A in a pre-use position.
[0074] Figure 30B is a front elevational view of the medication delivery device shown in Figure 30A with the cap removed to expose the needle shield.
[0075] Figure 30C is a front elevational view of the medication delivery device shown in Figure 30B with the needle shield in the second position.
[0076] Figure 30D is a front elevational view of the medication delivery device shown in Figure 30C with the upper housing moving toward the dispensed position.
[0077] Figure 30E is a front elevational view of the medication delivery device shown in Figure 30D with the upper housing in the dispensed position.
[0078] Figure 30F is a front elevational view of the medication delivery device shown in Figure 30E with the needle shield in the final position. DETAILED DESCRIPTION OF ILLUSTRATIVE MODALITIES
[0079] The detailed description should be read with reference to drawings in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, represent exemplary embodiments for explanatory purposes only, and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention.
[0080] The present invention is a drug delivery device and methods for its use, which device solves many of the limitations and disadvantages of traditional syringes and needles, as well as those of autoinjector type devices. To overcome the disadvantages and limitations of prior devices and to address unmet needs in the art, the device embodiments and methods presented herein include a device that is configured so that the user cannot see and cannot touch the needle, reducing phobia. by needle and the potential for needle contamination. This includes automatic needle protection after drug application.
[0081] Device modalities have an ergonomic shape that allows for one-handed operation and conveniently allows injections into alternate locations such as the leg, arm or abdomen. In embodiments that include a pressure-sensitive activator, a needle shield lock inhibits needle movement. In this way, the device includes a safety mechanism that will not allow the needle to be exposed if it is not pressed against the injection site.
[0082] In Figures 1A-1D an embodiment of the device of the invention is illustrated which includes a window 104 for viewing the drug before use. A colored indicator may appear in the window after the device has been used, to provide a visual indication to the user that the drug in the device has been used. Additionally, after the drug is applied, increased safety and a reduction in the possibility of accidental needle punctures are provided.
[0083] To ensure that the user is aware of the status of the drug application and whether it is complete, this embodiment of the invention includes pawls and ratchets, such as those illustrated by pawls 117 and ratchets 116 shown in Figures 4 and 7, which engage to produce one or more audible clicks when the injection is complete. Such a mechanism can signal to the user that the dose has been delivered and that the device can be removed from the skin, preventing premature removal of the device from the injection site. Thus, the user actively participates throughout the delivery process, unlike conventional autoinjectors, where the user may need to wait several seconds to be sure that the entire dose has been delivered.
[0084] To provide greater feedback to the user, the featured pawl and ratchet system also provides audible clicks and movement of the device during application to indicate that the injection is proceeding. In yet another embodiment, a higher click at the end of the application, alone or in combination with a visual indicator, provides feedback confirming that the application is complete.
[0085] Furthermore, the present invention has a non-intimidating and user-friendly design and method of operation, unlike conventional needle and auto-injector devices, which are reminiscent of syringes and cause discomfort to the user. Additionally, unlike autoinjectors, the user controls needle insertion and drug injection as described hereinafter.
[0086] In Figures 1 to 9 an exemplifying device of the invention is shown. In Figures 1A to 1D a device modality, in various stages, leading to drug injection is shown and in Figures 2A to 2C the modality during and after drug injection is shown. Figure 1A shows the device 100 in its pre-use configuration as received by the user. In this relaxed position, the upper housing 101 partially overlaps the proximal or uppermost portion of the lower housing 102. In describing the various embodiments of the device, the term proximal is used in relation to the upper end of the device and the term distal is used in relation to the device. relative to the device's bottom surface. For example, in Figure 1B, the term distal is used in relation to the bottom or bottom surface 131 of the device 100.
[0087] As shown, visible external features of the device include upper housing 101, lower housing 102, cover 103, window 104, interlock button 105, grip ring 106, bottom edge 111 of upper housing 101, and dose indicator 107. Figure 3 is an exploded view of the components of this embodiment of the invention.
[0088] A preliminary step in using the device is to remove the cover 103, which is removably attached to the lower housing 102, as shown in Figure 1B. Removing cap 103 simultaneously removes needle shield 113 and exposes needle shield 108. Window 104 and needle shield slot 109, each of which is preferably present on either side of the device, allow the user to view and inspecting an internally stored syringe 118 and drug content.
[0089] In use, the device is picked up by placing the palm of the hand over the top of the upper housing 101, similar to how one picks up a floor-mounted automotive shift lever. The grip ring 106 provides a visual signal to the user on how to pick up the device. In one embodiment, the grip ring 106 is covered, or coated, or is produced from a suitable elastomeric material including, without limitation, neoprene rubber, urethane, polyurethane, silicone, natural rubber, thermoplastic elastomer ("TPE"). , or combinations thereof to provide a non-slip and comfortable gripping surface.
[0090] The user presses the device, by palm-down pressure on the grip ring 106 and interlock button 105, against the body at the desired injection site, typically the top or side of the upper leg, abdomen, or the side or back of the upper arm. Palm pressure on the interlock knob 105 causes it to deflect downwards, as shown in Figure 1C, which in turn releases the needle shield latch 124, shown in Figure 5, allowing the needle shield 108 to slide forward. up and exposing needle 110 (note that some device components have been removed from figure 5 for illustration purposes). The needle shield latch 124 is formed integrally with a distal end portion of the upper housing sleeve 120. The upper housing sleeve 120 is a hollow cylinder, a portion of which resides in the upper housing 101 and a portion of which resides in the upper housing 120. upper housing 102 when the device is in the relaxed position. The upper housing sleeve 120 is fixedly attached to the upper housing 101 and performs the functions of locking and acts to secure the altering member 119 against the upper housing 102, as described in more detail below.
[0091] The needle shield latch 124 includes, facing forward with respect to the central longitudinal axis A-A' of the device, an inclined surface 127 and stop 130 at its uppermost end. To release the needle shield latch 124, an outwardly facing angled surface 128, complementary to the surface 127, which forms the distal end of the interlock knob extension 123, engages the angled surface 127 on the needle shield latch 124. The engagement of surfaces 127 and 128 causes the needle shield latch 124 to be deflected outwardly with respect to the center axis, removing the stop 130 from the upward movement of the needle shield 108. The latch mechanism and the shield of needle 108 are preferably configured so that upward movement of needle shield 108 is prevented unless interlock button 105 is fully depressed. This protects the needle from contamination and damage due to contact with other surfaces, protects the user from accidental needle punctures, and conceals the needle.
[0092] As the user continues to press down on the upper housing 101, the needle shield 108 moves upward, exposing and allowing the needle 110 to penetrate the user's skin, stopping when the lower surface 131 of the upper housing 102 is placed substantially against the skin. Once the needle shield 108 passes beyond the stop 130, the user can release the interlock button 105, or choose not to, without affecting the other steps of the injection. When the interlock button 105 is released, the resilient member 121 returns the interlock button 105 to the upper position. Motion guide 132 acts to ensure that the interlock button goes straight up and down.
[0093] The needle insertion process described here provides insertion control for the user. This feature allows the user to take advantage of a method commonly used and often employed by insulin-dependent diabetics: if the needle is placed in contact with the skin and remains there without penetrating the skin, after a few seconds the user will no longer feel the needle's presence, at the point where the needle can be inserted without pain by increasing the pressure applied to the needle.
[0094] After the needle 110 has been inserted into the user, the injection process typically begins, as shown in Figures 2A to 2C. Referring to Figure 6, the housing latch 122, which is part of the upper housing 102, is shown in close-up detail and prevents the upper housing 101 from moving relative to the upper housing 102 in the device's pre-use state ( note that some device components have been removed from Figure 6 for illustrative purposes). When the needle shield 108 has completed its upward trajectory, the sloped surface 133 on the needle shield 108 contacts a sloped portion of the surface 134 that forms the end of the housing latch 122, causing the housing latch 122 is deflected inwardly, thereby allowing the upper housing 101 and upper housing sleeve 120 to move downwardly.
[0095] After inserting the needle 110 into the body, the user maintains pressure on the upper housing 101. As shown in Figures 3, 4, 7 and 8, a piston rod 115 pushes a piston 112. The piston rod 115 is connected fixedly to the upper housing 101 and the syringe 118 is secured or held in a cylinder formed within the upper housing 102. Thus, when the upper housing 101 moves downwardly relative to and over the upper housing 102, a drug within of syringe 110 is delivered through needle 110 to the patient by downward movement of plunger rod 115 and plunger 112 within syringe 118.
[0096] After the housing latch 122 is disengaged, an altering member 119 that surrounds the distal end of the upper housing sleeve 120 is released from a tensioned state to apply a downward force to the upper housing 101 exerting a downward force on the sleeve. of the upper housing 120, which is fixedly attached at its uppermost end, to the upper housing 101. The altering element 119 may also be used to provide power to assist in advancing the piston rod 115 and the piston 112, with the user providing the additional required force resulting in drug injection or the energy supplied by the altering member 119 may be sufficient only to advance the plunger rod 15 and the plunger 112. In another embodiment of the present invention, the altering member 119 provides sufficient force to inject the drug, with no additional force input required by the user, thus providing an injection device in which the needle is held. inserted and the drug is automatically injected. The altering element may be any component capable of exerting a downward force on the upper housing sleeve 120 to the desired degree and may be, without limitation, a spring, a compressed gas actuator, a hydraulic actuator, a wax actuator, an electrochemical actuator, a shape memory alloy, and the like, and combinations thereof. In the embodiment shown in Figures 1 to 9, the user provides the additional force required to advance the plunger rod 115 and the plunger 112 by pressing down on the upper housing 101. Thus, the force required by the user to inject the drug is reduced, so analogous to the way that power steering in a car reduces the force needed by the driver to turn the steering wheel. Unlike conventional autoinjectors, the user contributes the force required for the injection and the present invention provides the user with control over the drug's injection rate.
[0097] Referring to Figures 4 and 7, cross-sectional views of embodiments of the present invention are shown before and after drug application has commenced, respectively. As the drug is being applied, a pawl 117 that is attached to the sleeve of the upper housing 120 moves along a ratchet 116 that is attached to the upper housing 102. The pawl 117 and the ratchet 116 can perform at least , the following two functions. The first is to prevent the upper housing 101 from separating from the lower housing 102 by pulling them. Second, movement of pawl 117 along ratchet 116 produces a soft clicking noise, providing feedback to the user that upper housing 101 is moving and drug is being applied. Additionally, and as illustrated in Figure 8, at the end of the travel of the upper housing 101, the pawl 117 can be configured to engage a deeper recess in the ratchet 116, thus producing a louder clicking sound, which can provide an audible signal to the ratchet 116. the user that the end of the path has been reached and the drug has been fully applied, and additional locking of the upper housing 101 is done to prevent reconfiguration or reuse of the device.
[0098] With reference to Figures 2B and 8, when the drug is completely injected and the upper housing 101 is at the end of its travel, the lower edge 111 of the upper housing 101 covers the dose indicator 107. The dose indicator 107 is a colored circumferential ring on the distal portion of the lower housing 102. This provides a visual signal to the user that drug delivery is complete.
[0099] Prior to use, the patient can view the drug through window 104 to inspect it for clarity and particulates. After use, the plunger 112 can be seen in the window 104, indicating that the device has been used. Alternatively, the window may be designed so that the plunger rod 115 is also visible after the injection is complete. Plunger 112 and plunger rod 115 may be brightly colored to provide a clear indication to the patient that the device has been used.
[00100] Referring to Figures 2C and 9, after completing the injection, the user removes the device 100 from the skin, and the needle shield return element 114 causes the needle shield 108 to extend over the needle 110, protecting the user and others from accidental needle punctures. The needle shield return may be any element capable of causing the needle shield 108 to extend over the needle 110 including, without limitation, a spring, a compressed gas driver, a hydraulic activator, a wax driver, a electrochemical, a shape memory alloy and the like, and combinations thereof. Once the needle shield 108 is fully extended, a needle shield latch 125 engages a slot in the needle shield 108, preventing it from retracting. The needle shield latch 125 is a cantilever latch that extends inwardly from the inner surface of the upper housing sleeve 120. The lower housing rib 126, a part of the lower housing 102, may be configured to prevent the latch from of the needle shield 125 engages the slot of the needle shield 108 prematurely, during application, by blocking the slit. In another embodiment of the present invention, needle shield 108 can extend and lock in place if device 100 is removed before application is complete, to prevent reuse or sharing of the device.
[00101] With the assisted application approach offered by the present invention, the user actively participates throughout the application process. This is distinguishable from the activation process of conventional auto-inserts, in which after pressing the button, the user passively waits for several seconds for the drug to be applied, sometimes wondering if the injection is in process or not.
[00102] The assisted activation approach of the present invention has the additional advantage of reducing the development time and cost associated with modifying the injection device for the delivery of different drugs because the user controls the speed of delivery by varying the force. applied to the top housing 101. If the plunger gets slightly stuck, the user can apply a little more force, unlike conventional autoinjectors that need to be designed for worst-case force requirements, which vary depending on drug, cartridge, plunger, needle and friction in the mechanism.
[00103] In another embodiment, the interlock button 105 and the interlock spring 121 may be omitted from the design. In this embodiment, the upper housing 101 is free to move downwards before reaching a lock. This movement is used to release the needle shield 108 using a mechanism similar to the interlock mechanism described above, allowing the needle shield 108 to retract. Once the needle shield 108 is fully retracted, another latch can disengage which allows the upper housing 101 to stop downward movement and inject the drug in a similar manner as described above.
[00104] In Figures 10 to 18 is shown yet another embodiment of the invention. In Figure 10A, the device 200 is shown with the upper housing 205, the lower housing 202 and the intermediate housing 201 therebetween. The upper housing 205 includes the ergonomic cover 228. In the relaxed position, the upper housing 205 partially overlaps the proximal portion of the intermediate housing 201. The most distal portion of the intermediate housing 201 is fixedly seated in the lower housing 202. The lower edge of the upper housing 211, the crest of the path 216 and the window 204 are shown in Figure 10A. The window 204 is preferably housed within the distal portion of the lower housing 202. A second window, not shown, is preferably present. on the device on the opposite side of window 204.
[00105] Cap 203 is removably secured to lower housing 202 and, in Figure 10B, is shown removed from device 200 to expose needle guard 213, needle guard jaw 217 and needle shield 208. During Upon removal of cap 203, needle shield grip 217 grasps and simultaneously removes needle shield 213 exposing needle shield 208 to the user. When the user of the device presses the needle shield 208 against the skin, this action causes the needle shield 208 to slide upwards exposing the needle 210, as shown in Figure 10C.
[00106] Figure 12 is an exploded view of the device 200. The ergonomic cover 228 includes the pins of the ergonomic cover assembly 230 which securely holds the ergonomic cover 228 in the upper housing 205. The pins of the assembly 230 match the holes 242 in upper housing 205. Preferably, assembly pins 230 are square in cross-section with rounded corners providing an interference surface between the assembly pins 230 corners and holes 242. Guides 233 and piston rod 215, which are integral with and extend downward from the inner surface of the ergonomic cover 228 are shown. Plunger rod 215 includes a buffer 221 at its distal end. Also shown is syringe 218 with plunger 212 and needle guard 213.
[00107] In a preferred embodiment, the outer surface of the ergonomic cap 228 is coated with or formed from, or the entirety of the ergonomic cap 228 is formed from a material capable of providing a soft, non-slip grip for the wearer. Suitable materials for coating or forming the ergonomic cap include, but are not limited to, elastomeric materials such as neoprene rubber, urethane, polyurethane, silicone, natural rubber, TPE and the like, and combinations thereof.
[00108] Upper housing 205 includes click lock 220, cable rib guide 238, and bottom edge 211. For click lock 220, as well as other locks used in the device, preferably at least two locks are used and the same latches are symmetrically positioned with respect to each other to facilitate smooth movement and operation of the device.
[00109] Intermediate housing 201 is shown in Figure 12 with body 207 and cable guide slots 239 on the outer surface of the proximal portion of body 207. When the device is in use, the cable rib guides 238, which are part integral with upper housing 205, engage and slide within the slots of cable guide 239, maintaining smooth, controlled movement of upper housing 205 during drug delivery.
[00110] The body 207 can serve as a dose indicator because when the device is activated, the upper housing 205 descends onto the body 207. When the complete drug dose is delivered, the body 207 is completely obscured by the upper housing 205 as shown in Figure 11C. The body 207 is preferably colored, preferably still a bright color, or is patterned to provide visual feedback easily visualized by the user that dosing is in progress or has been completed. Optionally, a scale may be included on the body 207 to visually quantify the amount of drug that has been applied or is to be applied.
[00111] Referring to Figure 13, the intermediate housing 201 also includes handle latches 224, click latch capture slots 236, and needle shield latch 237. Handle latch 224 is generally a rectangular element secured in movably to its most distal portion of the inner surface 243 of the intermediate housing 201 so that it is capable of moving outwardly toward the inner surface 243 upon application of force. Handle latch 224 also includes a locking surface 245 and a triangular shaped lock 244 extending inwardly toward the center of the device from a corner of its uppermost portion. At the device rest, the handle latch 224 in the pre-use position prevents the upper housing 205 from moving with respect to the intermediate housing 201 due to the lock 245 that interferes with the downward path of the guides 233 of the ergonomic cover 228.
[00112] Referring to Figures 12 and 13, lower housing 202 is shown with lower housing base 206, path crest end 216, window 204, housing latch 229, guide slots 227 and clip syringe retainer 235. Cap 203 is removably secured to the base of the lower housing 206 via the cap retaining ring 234. In use, the base of the lower housing 206 contacts the user's skin and so is produced. , preferably from any soft flexible materials suitable for use in the 228 ergonomic cap.
[00113] Window 204 provides an opening system in lower housing 202 for viewing the contents of syringe 218. Window 204 is positioned so that the bottom of syringe 218 is visible to the user, allowing the user to verify that the plunger 212 reached the end of its path to the bottom of the syringe. Window 204 can be of any convenient size and shape and is preferably oblong in shape, with its long axis aligned with the long axis of the device and the syringe such that the desired length of the syringe is exposed for viewing.
[00114] Guide slots 227 maintain the alignment of three different components: guides 233 of the ergonomic cover 228; handle latch release 231; and needle shield extensions 241. Guide slots 227 ensure smooth activation of the device by maintaining alignment and vertical path of upper housing 202 and needle shield 208 and reliable locking and unlocking of handle latch 231. outwardly extending housing 229 secures the intermediate housing 201 to the lower housing 202 by engaging a recess, which is not shown, in the inner surface 243 of the intermediate housing 201. In non-reusable embodiments of the device, the shape of the latch 229 and the recess are such that the lower and middle housing cannot be separated. For reusable modes, the recess and latch are configured to allow the lower and middle housings to be separated.
[00115] With reference to Figure. 12, needle shield 208 includes needle shield slot 209 formed on one side by handle latch release 231 and on the other side by needle shield extension 241. Handle latch release 231 includes angled surface 240. Referring to Figures 14 and 15, the sloped surface 240 of the handle latch release 231 faces outward and, as the handle latch 231 travels upward, engages the sloped surface 244 of the handle latch. 224, which faces inward, causing handle latch 224 to deflect outwardly, removing obstruction to downward movement of guide 233 and 205.
[00116] Slit in needle shield 209 allows window 204 to be used to view the syringe and plunger as the plunger engages the syringe at the end of the plunger's downward stroke. Additionally, the return of the needle shield 214 is within and at the bottom of a space formed by the release of the handle latch 231 and the extension of the needle shield 241.
[00117] One aspect of the device 200 invention is the manner in which the syringe 218 is suspended within the device. Referring to Figures 12, 13 and 17, the syringe 218 is held between the needle guard 213 and the buffer 221, each of which is a flexible component to protect the syringe 218 in the event that the device 200 is dropped or otherwise way, mishandled. When the device is assembled, the syringe 218 is loosely held within the cavity 246 of the lower housing 202 by retaining jaws 235. Depending on the volume of medication within the syringe 218, when the device is in use, there may be some path of the upper housing 205 before damper 221 contacts piston 212, and during this initial downward path, damper 221 acts as an air piston to compress air in the gap formed between the end of the piston rod 215 and the piston 212, which provides a rate-dependent resistance to initially moving under the handle. When the 221 damper moves quickly, air cannot escape quickly enough to reduce air pressure build-up. The damper 221 may optionally include through holes, not shown, which allow air to leak past the damper 221. Alternatively, a friction-based damper without buildup uses a damper in which there is no leakage and no dependence. at the rate or combinations of them can be used. Upon contact of the damper 221 with the piston 212, the damper 221 retracts inwardly towards the piston rod 215 reducing friction between the damper 221 and the inner surface of the cavity 246.
[00118] With reference to Figures 10 and 11, when the user wishes to use the device 200, the user removes the cover 203 from the lower housing 202, the action of which simultaneously removes the needle guard 213 and exposes the needle shield 208. The user takes the device 200 by the upper housing 205, places it in the palm of the hand over the ergonomic cap 228 and presses down the ergonomic cap 228, while holding the device 200 against the desired injection site in the body, the pressing action of which the needle shield 208 slides upward exposing the needle 210. Applying continuous pressure to the ergonomic cap 228 results in the needle 210 penetrating the wearer's skin and subdermal tissue, stopping when the base of the lower housing 206 makes contact with the surface of the needle. skin or when tab 245 reaches needle shield 208 and reaches the end of its path within lower housing 202.
[00119] Referring to Figure 15, when the needle shield 208 reaches the end of its upward path within the lower housing 202, the sloped surface 240 of the handle latch release 231 contacts the sloped ramp 244 of the latch handle 224 facing oppositely and complementary to the intermediate housing 201 causing the handle latch 224 to deflect toward the inner wall 243 of the intermediate housing 201. This action removes the retaining surface 245 of the handle latch 224 from interfering with the path to under the guide 233 of the ergonomic cover 228, releasing the guide 233 and allowing the upper housing 205 to move down and over the intermediate housing 201.
[00120] As the upper housing 205 moves down, the medication within the syringe 218 is delivered through the needle 210 as the plunger rod 215 and the damper 221 of the ergonomic cap 228 push down the plunger of the syringe 212. At the end of drug delivery, the body 207 is substantially completely covered by the upper housing 205 and the lower edge 211 of the upper housing 205 fully engages the shaped path ridge 216 of the lower housing 202. Also the plunger rod 215, the damper 221 and plunger 212 are clearly visible within the window 204. All of these features provide the user with visual confirmation that the drug has been applied and the endpoint of the lower edge 211 against the crest of the path 216 provides tactile confirmation to the user. .
[00121] Additionally, a click mechanism is activated at the end of drug delivery to provide audible feedback. Referring to Figure 14, the click latch 220 is deflected outward when the ramp 247 thereof contacts and slides on top of the intermediate housing 201. When the ramp 247 moves far enough down, the ramp 247 collapses. aligns with the catch slot of the click latch 236 and the ramp 247 slides into the catch slot 236, wherein the slot extends through the wall in the proximal portion of the intermediate housing 201 and clicks against the outer surface of the body 207 of the intermediate housing 201, creating a clicking sound. On non-reusable versions of the device, the click lock 220 is permanently captured by the capture slot 236 and cannot be readjusted. In a preferred embodiment, two click latches 220 are positioned at 180 degree positions opposite each other to provide smooth activation of the device and improved click and latch functions.
[00122] As the user removes the device 200 from the skin, the return needle shield 214, shown in Figure 12 as a spring that has been compressed by pressing the device 200 against the user's skin, expands making the shield of the needle 208 extends downwardly over needle 210 protecting the user from accidental puncture. In addition to a spring, the needle shield return can be a compressed gas actuator, a hydraulic actuator, a wax actuator, an electrochemical actuator, a shape memory alloy, and the like and combinations thereof. When needle shield 208 is fully extended, needle shield retainer 232 engages stop 248, shown in Figure 13, over lower housing 202 preventing needle shield 208 from separating from lower housing 202. In Figure 16, needle shield latch 237 is shown movably attached at its distal end to inner surface 243 of intermediate housing 201. When needle shield latch 208 is moving upward, needle shield latch 237 is deflected outward. in contact with the outer surface of the guide 233 or the needle shield extension 241. When the needle shield 208 moves down and extends to cover the needle 210, the needle shield latch 237 slides over the top of the extension. of the needle shield 241 preventing the needle shield 208 from retracting again.
[00123] Prior to use, the extension guides 233 of the ergonomic cap 228 retain the needle shield latch 237 in an outwardly deflected position allowing the needle shield 208 to retract for insertion of the needle 210. needle shield 232 and needle shield latches 237 are preferably used and are located 180 degrees around the central axis of device 200. If device 200 is removed from the skin before delivery of medication is complete, the needle shield 208 will extend to cover needle 210 and locks to prevent re-use of the device. In an alternative reusable embodiment, the needle shield 208 extends but does not lock in place in the event that the device 200 is removed from the skin before delivery of medication is complete.
[00124] Figure 19 is a demonstration of an alternative and reusable embodiment of the device 200 in which the upper housing 205 and the intermediate housing 201 are separable from the lower housing 202. In this embodiment, the user separates the lower and intermediate housings, inserts the syringe 218 in the lower housing and then reattaches the upper and intermediate housings.
[00125] In Figure 20 yet another alternative embodiment of device 200 is shown in which an assisted activator 219 is included. Assisted activator 219 may find its greatest utility in the application of viscous drugs. Assisted activator 219 applies a force between the upper housing 205 and the intermediate housing 201 exerting a downward force on the upper housing sleeve 120. This reduces the amount of downward force the user needs to apply to the ergonomic cap 228 to inject the drug. . Assisted activator 219 may be a spring, an actuator, a hydraulic actuator, a wax actuator, an electrochemical actuator, a shape memory alloy or the like or combinations thereof. Alternatively, the assisted activator can provide sufficient force to inject the drug, with no additional force input required from the user, thus providing an injection device in which the needle is manually inserted and the drug is automatically injected similarly to a conventional autoinjector.
[00126] In Figure 21 an alternative embodiment of the lower housing 202 of the device 200 is shown in which a resettable click mechanism for a reusable device is included. In this embodiment, the slots of the guide 227 engage the guide 225 of the click member 222. The click device 222 is changed by the return of the needle shield 214. To assist the click device 222, the user presses down on one of the guides. from the click element 225 until the click element latch 226 extends over the click device 222 keeping it downwards. As the ergonomic cover 228 moves downwards at the end of the path, the guide 233 contacts an inclined surface on the click member latch 226 causing it to deflect inwardly and releasing the click member 222 to travel towards the end of the path. upward under the force of the return of the needle shield 214. A clicking sound is generated when the click surface 223 of the click member 222 contacts the lower housing 202 signaling that the drug has been completely delivered. Compression from returning needle shield 214 is released when needle shield 208 is retracted during drug injection, increasing the force applied to the click device and the volume of the click sound. Alternatively, the click mechanism can be automatically reset when the user attaches the upper housing to the lower housing by loading a new syringe into the device.
[00127] Figures 22A-30F show yet another embodiment of the drug delivery device. As shown in Figures 22A-22E and 23, a delivery device 300 that is configured to deliver the drug defines a central axis A, a proximal end P, and a distal end D that is spaced from the proximal end D along the central axis A. As shown in Figures 22A and 22B, device 300 may include a lower housing 304, an upper housing 308, and a housing 312 coupled between the lower housing 304 and the upper housing 308. The device 300 may further include a shield needle housing 316 which is supported by lower housing 304 and a cap 320 which is removably coupled to lower housing 304 such that when the cap 320 is removed, the needle shield 316 is exposed. Needle shield 316 is movable relative to lower housing 304 along a first direction X1 from the first position in which a needle 332 of device 300 is stored (e.g., as shown in Figure 22C) to a second position in which the needle 332 is exposed (eg, as shown in Figure 22D). When the device 300 is pressed against the surface of the fabric, the needle shield 316 is configured to move from the first to the second position to thereby allow the needle 332 of the device 300 to be inserted into the fabric. As shown in Figures 22C through 22E and 23, needle shield 316 includes a needle shield return 317, illustrated as a spring 318 that is configured to cause needle shield 316 to move from the second position toward the second position. end along a second direction X2 that is opposite the first direction X1 and over needle 332 as needle 332 is removed from the fabric (as shown in Figure 22E).
[00128] Still referring to Figures 22A, 22B and 23, the upper housing 308 is supported relative to the lower housing 304 and is configured to receive a manual force and move relative to the lower housing 304 along the second direction X2 of a pre-use position to a dispensed position in response to manual force. As shown in Figures 22A and 22B, the intermediate housing 312 includes a body 315 that is exposed between the upper housing 308 and the lower housing 304 when the upper housing 308 is in the pre-use position and substantially completely covered by the upper housing 308 when the upper housing 308 is in the dispensed position. Therefore, the upper housing 308 is configured to move along the body of the intermediate housing 315 as the upper housing 308 moves towards the dispensed position.
[00129] As shown in Figure 22B, the upper housing 308 may define a first or lower edge or mating surface 311 and the lower housing 304 may define a second or upper edge or mating surface 313 that engages with the bottom edge 311 of the upper housing 308 when the upper housing is in the dispensed position. Edges 311 and 313 may be sinusoidal as illustrated and may provide visual indication that upper housing 308 has moved to the dispensed position. It should be recognized, that edges 311 and 313 can have any configuration as desired. For example, edges 311 and 313 can be flat as desired.
[00130] Still referring to Figures 22C to 22E and 23, the delivery device 300 additionally includes a syringe 324 that is supported by the lower housing 304 and a plunger rod 328 that is supported by the upper housing 308 and movable with the upper housing 308 so as to advance with respect to the syringe 324 when the upper housing 308 is movable along the second direction X2. Syringe 324 is configured to retain a drug and support needle 332 which is configured to be inserted into tissue. Advancement of plunger rod 328 with respect to syringe 324 may cause syringe 324 to release medicament out of needle 332 and into tissue. As shown in Figures 22A and 22B , delivery device 300 additionally includes at least one window 336, such as a pair of windows 336 that provides an opening in lower housing 304 for viewing the contents of syringe 324. As shown in Figures 22A, 22B and 23, lower housing 304 and intermediate housing 312 together define windows 336 such that windows 336 are located adjacent a distal end of device 300. Therefore, windows 336 are positioned so that the bottom of syringe 324 visible to the user, thereby allowing the user to verify that the plunger rod 328 has reached the end of its path to the bottom of the syringe 324. The windows 336 may be oblong along the first direction X1 as illustrated, although it should be recognized that windows 336 can be any size and shape as desired.
[00131] As shown in Figure 23, cap 320 is removably secured to lower housing 304 such that removal of cap 320 exposes needle shield 316 and removes needle shield 338 from syringe 324 to thereby exposing needle 332 within needle shield 316. As shown in Figure 23, cap 320 includes a cap body 340 and a needle guard jaw 344 attached to cap body 340. Cap body 340 defines a cavity 348 which receives the needle shield 316 when the cap 320 is attached to the lower housing 304 and a cap retaining ring 352 which grips the lower housing 304 to thereby detachably couple the cap 320 to the lower housing 304. As shown in Figure 23 , the lid retaining ring 352 defines a pair of detents 356 that are configured to receive a pair of protuberances 350 defined by the lower housing 304 to thereby detachably couple the lid 320 to the lower housing 30. 4. To remove the cap 320, the lower housing 304 may define a pair of ridges on each side of the protuberances 350 that allow the cap to be threaded. For example, the reliefs may engage cam surfaces on the cap such that when the cap is screwed on, the reliefs push the cap away from the lower housing 304. It should be recognized, however, that the cap retaining ring 352 may include any facility to detachably couple the cover 320 to the lower housing 304 as desired.
[00132] Still referring to Figures 22C and 23, the needle guard 344 may be coupled to the cap body 340 within the cavity 348. The needle guard 344 is configured to grip the needle guard 338 when the cap 320 is coupled to lower housing 304. Needle guard 338 is attached to syringe 324 such that needle guard 338 surrounds needle 332. When cap 320 is removed from lower housing 304, needle guard jaw 344 grips needle shield 338 so that needle shield 338 is removed from lower housing 304 along cap 320. When cap 320 is removed, device 300 can be positioned against a tissue surface and subsequently activated to inject the tissue drug.
[00133] Referring now to Figures 23, 24A through 24C, upper housing 308 may include a skirt 360, a housing body 364 mounted to skirt 360, and an ergonomic cover 368 mounted to housing body 364. As shown in Figures 24A and 24B, the upper housing 308 and, in particular, the housing body 364 includes an ergonomic cap-mounted member 372 and a pair of guides 376 that extend distally from the ergonomic cap-mounted member 372 along the second direction X2. As shown in Figure 23, the ergonomic cover 368 can be coupled to the ergonomic cover mounted member 372 and the guides 376 can extend through the skirt 360 when the housing body 364 is mounted to the skirt 360.
[00134] The assembled member of the ergonomic cap 372 may be domed so as to define a substantially convex proximal surface 374 and a distal surface 375 which is opposite the proximal surface 374. The ergonomic cap 368 may also be domed and may be mounted to the assembled member of the ergonomic cap 372 so that the ergonomic cap 368 overlaps the proximal surface 374. As shown in Figure 24A, the assembled member 372 may include a plurality of attachment members 380 that extend from the distal surface 375. attachment members 380 may each define an opening 381 which is configured to receive a respective attachment member such that a locking pin 382 defined by skirt 360 thereby couples housing body 364 to skirt 360. It is recognized, however, that the attachment members 380 and 382 may be of any configuration as desired. For example, the attachment members 380 of the assembled member 372 may define locking pins and the attachment members 382 of the skirt 360 may define openings. It should be recognized that the ergonomic cap 368 and housing body 364 can be integrally formed as desired and that the ergonomic cap 368 and assembled member 372 can be of any shape as desired.
[00135] As shown in Figure 24A, the upper housing 308 may additionally include at least one locking latch 390, such that a pair of latching latches 390 extend from the distal surface 375 of the assembled member 372 and toward the housing 304. Locking latches 390 are configured to lock the upper housing 308 in the dispensed position after the upper housing 308 is moved from the pre-use position to the dispensed position so as to prevent re-use of the device 300. The latching latches 390 may be elastically flexible and may each include a flexor member 392 that extends from the assembled member 372 and a protuberance 394 that extends from the distal end of the flexor member 392 toward the central axis A. As shown in Figures 22C a 22E, the locking latches 390 face each other so that the protuberances 394 extend toward each other along a direction that is transverse to the second direction X2. As shown in Figures 22C through 22E, as upper housing 308 is moved along intermediate housing 312, locking latches 390 will engage lower housing 304 and flex away from each other. When the upper housing 308 reaches the dispensed position, the locking latches 390 will move toward each other so that the protuberances 394 will engage a corresponding locking member of the lower housing 304 to thereby lock the upper housing 308 in the dispensed position. When the locking latches 390 engage the corresponding locking members an audible clicking sound may be produced to thereby signal to the user that the injection is complete. It should be recognized, however, that the locking latches 390 can have any configuration as desired and that the upper housing 308 can have any number of latching latches as desired. For example, the upper housing 308 may include a single locking latch, as desired.
[00136] As shown in Figures 22C, 23 and 24A and 24B, each guide 376 of housing body 364 extends through skirt 360 and into intermediate housing 312. Each guide 376 may include a guide body 377 that is elongated along with along the second direction X2 and extends from the assembled member 372 so that the guides 376 face each other along a direction that is transverse to the second direction X2. Guides 376 are configured to temporarily interfere with lower housing 304 so as to maintain upper housing 308 in the pre-use position until needle guard 316 has moved to the second position and needle 332 is inserted into the fabric. In this way, unintentional drug dispensing can be avoided.
[00137] As shown in Figure 24B, each guide 376 may define an abutment surface 398 that at least partially faces the lower housing 304 and a channel 400 that extends through the guide body 377 from a distal end of the guide body 377 and towards the proximal end of the guide body 377. The mating surfaces 398 are configured to engage the lower housing 304 when the upper housing 308 is in the pre-use position to thereby maintain the upper housing 308 in the in-use position. pre-use until needle shield 316 is moved to second position. The abutment surfaces 398 may be disposed adjacent the distal ends of the guide bodies 377. The abutment surfaces 398 may define a plane that is perpendicular to the first direction and may include an angled portion that defines a ramp leading to the respective channel 400. Channels 400 extend completely through guide bodies 377 along a direction that is transverse to the second direction X2 and extend along a substantial portion of guide bodies 377 along the second direction X2. The channels 400 are configured to act as a relief or a guide for the lower housing 304 when the interference between the upper housing 308 and the lower housing 304 is removed and the upper housing 308 moves towards a dispensed position. That is, the portion of the lower housing 304 that interferes with the upper housing 308 will move within the grooves 400 when the interference is removed and the upper housing 308 moves toward the dispensed position. It should be recognized, however, that mating surfaces 398 and channels 400 can be of any configuration as desired. For example, mating surfaces 398 can be angled and channels 400 can extend through but not completely through guide bodies 377, as desired.
[00138] As shown in Figures 24C, the skirt 360 includes a skirt body 404 that has an inner surface 408 that defines a channel 412 that extends completely through the skirt body 404 along the second direction X2. The upper housing 308 is coupled to the intermediate housing 312 so that the intermediate housing 312 is received within the channel 412 and the intermediate housing 312 is configured to move through the channel 412 so that the upper housing 308 is moved towards the dispensed position. . As shown in Figure 24C, skirt 360 includes at least one friction member 416, such that four friction members 416 extend from inner surface 408 and toward central axis A. Friction members 416 are configured to interfere with the respective friction members defined by the intermediate housing 312 to thereby create a frictional force as the upper housing 308 moves from the pre-use position towards the dispensed position. The frictional force adds resistance when manual force is applied to the upper housing 308 to thereby prevent the upper housing 308 from suddenly moving along the second direction X2. For example, frictional force can prevent upper housing 308 from moving suddenly in situations where syringe 324 is only partially filled with medication and plunger rod 328 is not in contact with plunger inside syringe 324. The friction force created by the friction members should be greater than or equal to the force of the compressed needle shield spring 318 when the needle shield 316 is in the second position to thereby prevent the needle shield spring 318 from lifting the lower housing 304 and pulling the needle 332 out of the fabric before the plunger rod 328 contacts the plunger. It should be noted, however, that the friction force can be another desired force. For example, skirt 360 and intermediate housing 312 can be free of friction members so that the friction force is substantially zero. It is further understood that skirt 360 may define any number of friction members 416 as desired.
[00139] Still referring to Figure 24C, each friction member 416 can define a track 420 that projects from the inner surface 408. As shown in Figure 24C, each track 420 can narrow as the track 420 extends from a distal end of the skirt 360 toward the proximal end of the skirt 360. Therefore, the frictional force may be greater when the upper housing 308 begins to move from the pre-use position than the frictional force when the upper housing 308 is in place. close to the dispensed position. It should be noted, however, that the rails 420 can be of any configuration as desired. For example, rails 420 may be free of nip so that the friction force between upper housing 308 and intermediate housing 312 is constant throughout the entire movement of upper housing 308.
[00140] Referring now to Figures 25A and 25B, the body of the intermediate housing 315 includes a side wall 464 and at least one friction member 468, such that four friction members 468 are supported by the side wall 464. Each member friction member 468 is configured to interfere with one of the respective friction members 416 of upper housing 308. As shown in Figure 25A, each friction member 468 may be configured as a cantilevered portion 472 that is coupled to side wall 464 on a hinge. 474 so that each cantilevered portion 472 is configured to flex with respect to the center axis of the intermediate housing 312 (e.g., the center axis A) as the upper housing 308 moves toward the dispensed position. As shown in Figure 25A , sidewall 464 is substantially cylindrical and includes four slots 478 that each define a respective cantilevered portion 472. Each slot 478 extends from a proximal end of the intermediate housing body 315 and terminates at a respective hinge 474. In the illustrated embodiment, the hinges 474 are oriented so that the cantilevered portions 472 flex about respective axes that are parallel to the central axis A. As shown in Figure 25A, the cantilevered portions 472 define the first and second pairs of portions. cantilevered each having a first cantilevered portion 472a and a second cantilevered portion 472b. The first and second cantilevered portions 472a and 472b of each pair extend away from each other. This is the first cantilevered portion 472a of the first and second pairs extending clockwise about the sidewall 464 and the second cantilevered portions 472b of the first and second pairs extending counterclockwise about the sidewall 464. , each cantilevered portion 472 may be curved so as to define the radius with respect to the central axis A. It should be recognized, however, that the cantilevered portions 472 may have any configuration as desired and the hinges 474 may have any configuration as desired. . It should be further recognized that friction members 468 are not limited to cantilevered portions 472 and may include any configuration as desired. For example, friction members 468 may be elastomeric blocks on an outer surface of sidewall 464.
[00141] Still referring to Figures 25A through 25B, each cantilevered portion 472 may be located adjacent the proximal end of the intermediate housing 312. Each cantilevered portion 472 may include an outer elastomeric portion 480 that is configured to be in contact with a respective rail 420. The elastomeric portions 480 may be used to increase the coefficient of friction of the surfaces of the cantilevered portions 472 which are in contact with the rails 420 to thereby modify the strength. As shown in Figure 25C, initially as the upper housing 308 begins to move from the pre-use position the thicker portion of the rails 420 are in contact with the elastomeric portions 480 so that the cantilevered portions 472 flex inwardly. toward the central axis A and apply a changing force against the rails 420. Interference between the rails 420 and the cantilevered portions 472 creates a frictional force that resists the movement of the upper housing 308 toward the dispensed position. As the upper housing 308 moves further toward the dispensed position, the tracks 420 narrow so that the shifting force against the tracks 420 decreases and the resistance to downward movement of the upper housing 308 is decreased.
[00142] Referring now to Figures 26A and 26B, the lower housing 304 includes a base 490 and a lower housing body 494 that extend from the pole 490 along the first direction X1. Base 490 includes a skin-facing surface 498 that is configured to face a subject's skin when needle 332 is inserted into tissue. Base 490 further defines a cavity 502 that extends into the skin facing surface 498 and is configured to receive needle shield 316 when needle shield 316 is moved to the second position. The lower housing body 494 defines a pair of first grooves 506a that extend along the lower housing body 494 along the first direction X1 and a pair of second grooves 506b that extend along the lower housing body 494 along from the first direction X1 adjacent to the first channels 506a. Each channel 506a is sized to receive a respective guide 376 from the upper housing 308 so that the guides 376 advance within the first channels 506a along the second direction X2 as the upper housing 308 is moved toward the dispensed position. Second channels 506b are configured to receive portions of needle shield 316 so that portions of needle shield 316 are disposed between lower housing body 494 and guides 376 and movable between channels 506b along the first and second channels. X1 and X2 direction.
[00143] As shown in Figures 26A and 26B, the lower housing 304 additionally includes at least one housing latch 510, such as a pair of housing latches 510 that releasably interfere with the upper housing 308 when the upper housing 308 is in the pre-use position to prevent upper housing 308 from moving toward the dispensed position. As shown in Figure 26B, each housing latch 510 includes a leg 512 that extends above a respective lower housing body portion 494 and a bulge 514 that extends from a proximal end of the leg 512 away from the central axis A. and into channels 400 are defined by guides 376.
[00144] Housing latches 510 are elastically flexible so housing latches 510 are configured to flex or otherwise move out of interference with upper housing 308 as upper housing 308 moves from pre-use position and towards the dispensed position. In particular, the protrusions 514 engage the mating surfaces 398 of the guides 376 to thereby prevent the upper housing 308 from moving towards the dispensed position. When needle shield 316 moves from the second position and housing latches 510 are free to flex, movement of upper housing 308 toward the dispensed position causes protuberances to move in and along grooves 400 of guides 376 and thus out of interference with the upper housing 308. It should be recognized that the housing latches 510 may have any configurations as desired and may extend from any portion of the lower housing body 494. For example, each leg 512 may extending below a respective lower housing body portion 494.
[00145] Still referring to Figures 26A and 26B, the lower housing 304 additionally includes at least one locking member 530, such as a pair of locking members 530 that are configured to mate with the locking latches 390 of the upper housing 308 when upper housing 308 is in the dispensed position. As shown in Figure 26A, each locking member 530 may define a ramp 532 that extends from the lower housing body 494 and a platform 534 at a distal end of the ramp 532. The platform 534 defines a surface that faces the distal end. of the device. As the upper housing 308 is moved toward the dispensed position, the protuberances 394 of the locking latches 390 will follow along with the ramps 532 and flex away from each other. When the upper housing 308 reaches the dispensed position, the locking latches 390 will snap into the locking members 530 and return substantially to their original positions so that the protuberances 394 will engage the platforms 534 to thereby lock the housing. upper 308 in the dispensed position. In particular, the protrusions 394 meet the surfaces of the platforms 534 so as to prevent the upper housing 308 from moving towards the pre-use position. It should be recognized, however, that the latch members 530 can be of any configuration as desired. For example, the latch members 530 may be slots defined in the lower housing body 494 that receive the protuberances 394.
[00146] Contact between the protuberances 394 of the latching latches 390 and the ramps 532 can create a frictional force that adds to the resistance to the downward hand force that is applied to the upper housing 308 to move the upper housing 308 to the dispensed position. . Thus, locking latches 390 and locking members 530 can also be considered friction members. That is, rails 420 and cantilevered portions 472 can be considered primary friction members and locking latches 390 and locking members 530 may be considered secondary friction members.
[00147] Referring now to Figures 23 and 27A to 27C, syringe 324 may include a lower shoulder 540 that is adjacent to needle 332 and an upper edge 544 spaced from lower shoulder 540 along the first direction X1. As shown in Figures 27A through 27C, device 300 may additionally include a syringe retainer 548 that is configured to receive syringe 324 and support syringe 324 on a lower shoulder 540. Syringe retainer 548 includes a body 552 and a pair of elastically flexible legs 556 extending from the body along the second direction X2. The elastically flexible legs 556 are spaced from one another along a direction that is perpendicular to the second direction X2 to define a gap 560 between the elastically flexible legs 556. Each elastically flexible leg 556 includes a tab 564 that extends in towards the other leg 556 so that when the syringe 324 is moved through the gap 560 along the second direction and towards an accommodated position, the elastically flexible legs 556 move away from the other, and when the syringe 324 is in the accommodated position, the elastically flexible legs 556 move toward each other so that the tabs 564 engage the lower shoulder 540 of the syringe 324. Once the syringe retainer and retainer combination is inserted into the lower housing 304, the legs flexible hoses 556 are held in place and can no longer flex outward, thereby supporting syringe 324. In one illustrated embodiment, tabs 564 are disposed at the distal end of the parts. 556. It should be noted, however, that the tabs 564 can be disposed anywhere along the legs 556 as desired.
[00148] Still referring to Figure 27A, retainer 548 further includes an opening 572 that extends through body 552 and into gap 560 and at least one handle 576 that is supported by body 552 within opening 572. At least one handle 576 is configured to find syringe 324 so as to prevent syringe 324 from moving through slot 560 along the first direction X1 after syringe 324 is in the accommodated position. Handles 576 may be elastomeric portions, ribs, or any other structure capable of preventing syringe 324 from protruding through the gap.
[00149] As shown in Figures 27A and 22C, retainer 548 additionally includes at least one locking tab 580, so that a pair of locking tabs 580 extend outward from body 552 away from central axis A. Locking tabs 580 are configured to meet lower housing 304 to thereby lock syringe retainer 548 within lower housing 304. Locking tabs 580 may be flexible so that retainer 548 is accommodated in lower housing 304 , locking tabs 580 flex toward center axis A and subsequently move back to the original position when retainer 548 is fully accommodated within housing 304 so that locking tabs 580 engage respective portions of lower housing 304 to thus locking the retainer 548 of the syringe 324 within the lower housing 304. It should be recognized, however, that the retainer 548 may have other configurations as desired. O. For example, locking tabs 580 can extend from legs 556 as desired.
[00150] Now referring to Figures 23, 22C to 22E and 28, the needle shield 316 is movable with respect to the lower housing 304 along the first direction X1 from the first position to the second position when the needle shield 316 is pressed against a skin surface and subsequently movable along the second direction X2 from the second position to the final position at which device 300 is removed from the skin surface. As shown in Figure 28, needle shield 316 includes a housing 600 and a pair of extensions 604 extending from housing 600 along the first direction X1. Housing 600 houses needle 332 when needle shield 316 is in the first and end positions. As needle shield 316 moves to the second position, needle 332 protrudes from housing 600 and is inserted into tissue.
[00151] As shown in Figures 23 and 28, the extensions 604 oppose each other and are each configured to move within a respective second channel 506b of the lower housing 304 so that the extensions 604 are each disposed between the lower housing body 494 and a respective guide 376 of the upper housing 308. As shown in Figure 28, each extension 604 defines a stop 612 that is configured to contact or otherwise encounter a respective housing latch 510, so that the bulge 514 of the housing latch 510, when the needle shield 316 is in the first position so as to keep the housing latches 510 in interference with the upper housing 308. When the needle shield 316 moves towards In the second position, stops 612 move out of contact with housing latches 510. Housing latches 510 can then move out of interference with upper housing 308 so that that the upper housing 308 is capable of moving towards the dispensed position. Therefore, the upper housing 308 can be held in the pre-use position until the needle guard 36 is moved to the second position.
[00152] Still referring to Figure 28, the needle shield 316 further defines an aperture 616 in each extension 604 and a needle shield latch 620 that extends above the extension 604 and into the aperture 616. needle shield 620 is resiliently flexible and defines a groove 624 at its proximal end and a hinge 628 at its distal end. The needle shield latches 620 are configured to flex about their hinges 628 as the needle shield 316 moves from the second position to the end position and when the upper housing 308 is in the dispensed position. As shown in Figure 28, each needle shield latch 620 defines a sidewall 632 that extends from hinge 628 to groove 624. At least a portion of each sidewall 632 that is adjacent to groove 624 is angled relative to the first. or second directions. The protuberances 514 of the housing latches 510 may follow along the angled sidewall portions 632 as the upper housing 308 is moved toward the dispensed position so as to cause the needle shield latches 620 to flex and when the needle shield latches 620 needle 316 moves from the second position to the end position. When the device 300 is then removed from the tissue and the needle shield 316 moves to the final position, the needle shield latches 620 flex back to their original positions so that the grooves 624 receive the protuberances 514 of the needle latches 620. housing 510 to thereby lock the needle shield 316 in the end position.
[00153] As shown in Figures 29A through 29F, housing latches 510 can be configured to either selectively hold upper housing 308 in the pre-use position and then hold needle guard 316 in the final position. As shown in Figure 29A, when the upper housing 308 is in the pre-use position and the needle shield 316 is in the first position, the protuberances 514 of the housing latches 510 meet respectively the abutment surfaces 398 of the guides 376 of the upper housing 308 so as to prevent upper housing 308 from moving towards the dispensed position. As shown in Figure 29A, stops 612 of needle shield 316 meet protuberances 514 and hold protuberances 514 in interference with abutment surfaces 398. As shown in Figure 29B, when needle shield 316 is moved to the second position , the stops 612 are moved away from the protuberances 514 so that the housing latches 510 are able to move out of interference with the mating surfaces 398 of the upper housing 308 and the upper housing 308 is able to move towards the position dismissed. As shown in Figures 29C and 29D, as the upper housing 308 moves toward the dispensed position, the protuberances 514 move into and along the grooves 400 of the guides 376. As shown in Figure 29D, the protuberances 514 follow along the angled sidewall portions 632 and cause the needle shield latches 620 to flex so that the protuberances 514 can continue their travel along the grooves 400. As shown in Figures 29E and 29F, as the needle shield 316 becomes moves from the second position towards the final position, the protuberances 514 follow along the side walls 632 until the needle shield latches 620 flex back into their original positions and the grooves 624 receive the protuberances 514 to thereby lock the needle guard 316 in end position. In this way, housing latches 510 can be configured to both selectively hold upper housing 308 in the pre-use position and lock needle guard 316 in the final position.
[00154] In operation and referring to Figures 30A to 30F, the delivery device 300 can be configured to deliver the drug. Prior to use, upper housing 308 may be locked in the pre-use position by housing latches 510, and cap 320 may be coupled to lower housing 304 in order to protect needle shield 316 and needle 332. device 300 is ready for use, cap 320 can be removed from lower housing 304 so that cap 320 removes needle guard 338 from needle 332 as shown in Figure 30B.
[00155] As shown in Figure 30C, the device 300 can be positioned against a skin surface and a manual force can be applied to the upper housing 308 along an insertion direction (e.g., the second direction) so that the needle shield 316 is pressed against the skin surface, the needle shield 316 moves to the second position and the needle 332 is inserted into the tissue. As needle shield 316 moves to the second position, stops 612 move to disengage housing latches 510 so that upper housing 308 is no longer locked in the pre-use position. As shown in Figures 30D and 30E, the upper housing 308 can then be moved along the second direction and over the intermediate housing 312. When the upper housing 308 reaches the dispensed position substantially all of the intermediate housing 312 is covered by the upper housing 308 and the plunger may be visible within the windows 336 thereby providing visual evidence that all of the drug has been applied to the tissue.
[00156] Additionally, when the upper housing 308 reaches the dispensed position, the locking latches 390 of the upper housing 308 engage the locking members 530 of the lower housing 304 to thereby lock the upper housing 308 in the dispensed position so that prevent re-use of application device 300. As locking latches 390 snap into lock members 530, an audible click is produced which signals to the user that upper housing 308 has reached the dispensed position and is locked in the dispensed position. . Upper housing 308 can be permanently locked in the dispensed position so that device 300 is not reusable. It should be recognized, however, that the upper housing 308 can be temporarily locked so that the device 300 can be sterilized and reused.
[00157] As shown in Figure 30F, when the device 300 is removed from the skin surface along a direction opposite to the direction of insertion, the needle shield 316 moves along the second direction to the final position. When in the end position, housing latches 510 interfere with needle shield latches 620 to thereby lock needle shield 316 in end position. In this way, the needle shield 316 can be permanently locked in the end position so that the device 30 is not reusable. It should be recognized, however, that needle shield 316 can be temporarily locked so that device 300 can be sterilized and reused.
[00158] As shown in Figures 30B and 30F, needle shield 316 can be configured to move a first distance d1 along a first direction from the first position to the second position and a second distance d2 along the second direction from the second position to the end position. The second distance d2 may be greater than the first distance d1 to thereby signify to the user that the needle shield 316 is, in fact, in the final and locked position. Needle shield 316 and, in particular, housing 600 of needle shield 316 may include a visual indication 640, such as a band of colors, at a proximal end of housing 600 that is only visible when needle shield 316 is in position. final position. It should be recognized, however, that needle guard 316 can move any distance from the first position to the second position and any distance from the second position to the end position.
[00159] While the aforesaid description and drawings represent the preferred embodiment of the present invention, it will be understood that various additions, modifications, combinations and/or substitutions may be made therein without departing from the spirit and scope of the invention as defined in the embodiments. In particular, it will be clear to those skilled in the art that the invention may be incorporated in other specific forms, structures, arrangements, proportions and with other elements, materials and components, without departing from the spirit or essential characteristics thereof. One skilled in the art will recognize that the invention can be used with many modifications of structure, layout, proportions, materials and components that are particularly adapted to specific environments and operational requirements without departing from the principles of the invention. In addition, the features described herein may be used singly or in combination with other features. For example, features described in conjunction with one component may be used and/or exchanged with features described in another component. The embodiment presented herein should therefore be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the embodiments, and not limited by the aforementioned description.
[00160] It will be understood by those skilled in the art that various modifications and alterations of the invention may be made without departing from the broad scope of embodiments. Some of these have been discussed above and others will be apparent to those skilled in the art. This includes a multi-dose design in which one or both of the upper and middle housings rise to a partial height and deliver a partial syringe when pressed by the user.

权利要求:
Claims (18)
[0001]
1. Device (300) configured to administer a medication, the device (300) comprising: a lower housing (304) including a housing latch (510); a syringe (324) supported by the lower housing (304) and being configured for retaining a medication, the syringe (324) having a needle (332) configured to be inserted into tissue; a needle shield (316) which is movable relative to the lower housing (304) along a first direction (X1) from a first position, wherein the needle shield (316) extends from the lower housing (304) in a second direction (X2) opposite the first direction, so as to cover a needle tip (332) as that the needle (332) extends from the lower housing (304) in the second direction to a second position, wherein the needle shield (316) is retracted with respect to the needle tip (332) so as to expose the needle (316) needle tip (332); an upper housing (308) supported relative to the lower housing (304), the upper housing (308) configured to receive a manual force and move with respect to the lower housing (304) along a second direction opposite the first direction from a pre-use position to a dispensed position in response to manual force; and a plunger rod (328) supported by the upper housing (308) and movable relative to the upper housing (308) so as to advance relative to the syringe (324) when the upper housing (308) moves along the second direction, wherein the advancement of the plunger rod (328) relative to the syringe (324) causes the syringe (324) to deliver medicament away from the needle (332); characterized in that: the needle shield (316) has a stop (612) that abuts the housing latch (510) when the needle shield (316) is in the first position so as to maintain the housing latch (510) ) in interference with the upper housing (308) and the housing latch (510) releasably interferes with the upper housing (308) when the upper housing (308) is in the pre-use position so as to prevent the housing from The upper housing (308) moves to the dispensed position, and movement of the needle shield (316) to the second position causes the interference to be removed, thereby allowing the upper housing (308) to move from the pre-release position. use for the dispensed position.
[0002]
2. Device (300) according to claim 1, characterized in that the needle shield (316) moves towards the second position, the stop (612) moves out of contact with the housing latch (510) such that the housing latch (510) is able to move out of interference with the upper housing (308).
[0003]
Device (300) according to claim 2, characterized in that the needle shield (316) includes a needle shield return (316) configured to cause the needle shield (316) to move. towards the end position along the second direction and over the needle (332) as the needle is removed from the fabric.
[0004]
Device (300) according to claim 3, characterized in that the needle shield (316) includes a needle shield latch (316), the needle shield latch (316) being configured to engage with the housing latch (510) when the needle shield (316) moves to the end position so that the housing latch (510) locks the needle shield (316) in the end position.
[0005]
Device (300) according to claim 1, characterized in that it additionally comprises an intermediate housing (312) coupled between the lower housing (304) and the upper housing (308), the intermediate housing including a body (315) which is exposed between the upper housing (308) and the lower housing (304) when the upper housing (308) is in the pre-use position, and substantially completely covered by the upper housing (308) when the housing (308) is top (308) is in the dispensed position.
[0006]
Device (300) according to claim 5, characterized in that the body of the intermediate housing includes a side wall and at least one friction member supported by the side wall and the upper housing (308) includes at least one friction member that interferes with at least one friction member of the intermediate housing to thereby create a friction force as the upper housing (308) moves from the pre-use position towards the dispensed position.
[0007]
Device (300) according to claim 1, characterized in that the syringe (324) includes a lower shoulder and an upper edge spaced from the lower shoulder along the first direction, the device (300) further comprising a needle retainer that is configured for the syringe (324) and supporting the syringe (324) on the lower shoulder.
[0008]
Device (300) according to claim 7, characterized in that the syringe retainer (324) includes a body and a pair of elastically flexible legs that extend from the body along the second direction, the elastically flexible legs. flexibles being spaced from one another along a direction that is perpendicular to the second direction so as to define a gap between the elastically flexible legs.
[0009]
Device (300) according to claim 1, characterized in that the upper housing (308) includes at least one locking latch, and the lower housing (304) defines at least one corresponding locking member so that that when the upper housing (308) moves to the dispensed position, at least one locking latch closes under pressure on the at least one locking member to thereby lock the upper housing (308) in the dispensed position.
[0010]
10. Device (300) configured to administer a medication, the device (300) comprising: a lower housing (304); a syringe (324) supported by the lower housing (304) and being configured to retain a medication, the syringe (324) ) having a needle (332) configured to be inserted into tissue; characterized in that it further comprises: an intermediate housing (312) attached to the lower housing (304), the intermediate housing (312) including a body (315) and at at least one friction member (468) which is supported by the body (315); an upper housing (308) attached to the intermediate housing (312) and configured to move along the body (315) of the intermediate housing (312) in a from pre-use position to a dispensed position in response to a manual force, the upper housing (308) includes at least one friction member (416) that interferes with at least one friction member (468) of the intermediate housing (312) in order to create resistance a by hand force as the upper housing (308) is moved from the pre-use position to the dispensed position; and a plunger rod (328) supported by the upper housing (308) and movable with respect to the upper housing (308) to advance with respect to the syringe (324) when the upper housing (308) is moved to a dispensed position, being that advancement of the plunger rod (328) with respect to the syringe (324) causes the syringe (324) to release the medication out of the needle (332).
[0011]
Device (300) according to claim 10, characterized in that the body (315) of the intermediate housing (312) includes a side wall and at least one friction member (468) supported by the side wall, and the upper housing (308) includes at least one friction member (416) that interferes with the at least one friction member (468) of the intermediate housing (312) to thereby create a frictional force conforming to the upper housing ( 308) moves from the pre-use position towards the dispensed position.
[0012]
Device (300) according to claim 11, characterized in that each friction member (468) of the intermediate housing (312) is a cantilevered portion that is coupled to the side wall on a respective hinge, each portion cantilever being configured to flex about a respective hinge with respect to a central axis of the intermediate housing (312) as the upper housing (308) moves toward the dispensed position.
[0013]
Device (300) according to claim 12, characterized in that each friction member (468) of the upper housing (308) is a track that is configured to follow along a respective cantilevered portion.
[0014]
Device (300) as claimed in claim 13, wherein the upper housing (308) includes a skirt (360) defining a distal end and a proximal end that is spaced from the distal end along the first direction, and each track extending from a location adjacent the distal end of the skirt (360) and toward the proximal end of the skirt (360) so that the track narrows as the track extends toward the proximal end.
[0015]
Device (300) according to claim 12, characterized in that the intermediate housing (312) includes a first pair of cantilevered portions (472) and a second pair of cantilevered portions (472), each of the first and second pairs of cantilevered portions (472) including a first cantilevered portion (472a) extending clockwise from a respective hinge and a second cantilevering portion (472b) extending counterclockwise from a respective hinge and away from the first cantilevered portion (472a).
[0016]
Device (300) according to claim 15, characterized in that each cantilevered portion includes an elastomeric portion (480), and the upper housing friction members (308) are configured to follow along with the elastomeric portions. (480).
[0017]
17. Device (300) according to claim 12, characterized in that each cantilevered portion (472a, 472b) is integrally formed with the body (315).
[0018]
Device (300) according to claim 11, characterized in that it additionally comprises a needle shield (316) which is movable with respect to the lower housing (304) from a first position to a second position so as to expose the needle (332).

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法律状态:
2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2020-01-14| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-08-03| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-11-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2022-02-01| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/03/2014, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US13/833,978|2013-03-15|

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US13/833,978|US9233213B2|2009-10-16|2013-03-15|Palm activated drug delivery device|

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PCT/US2014/022559|WO2014150201A1|2013-03-15|2014-03-10|Palm activated drug delivery device|

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