Needle system for drug delivery

Abstract

A needle injection and retraction system mounted within a housing allowing the needle to move upon manual activation. An outer face of an inner housing of the system is pushed onto the injection site. As proximal force is applied to the outer face, an injection needle becomes exposed to insert into a patient's skin. An internal rack mechanism allows travel of a cartridge needle to move through a container septum to establish a fluid path between the container and the patient. Once each needle is fully deployed, a latch releases a biasing member which allows the inner housing to return to the starting position once proximal force is removed (i.e., once the system is removed from the injection site). A lockout feature restricts further movement.

Description

NEEDLE SYSTEM FOR DRUG DELIVERYFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to a needle assembly to deliver a fluid. More specifically, the present disclosure relates to an extendable and retractable needle assembly configured to be manually activated to deliver a fluid through a surface.BACKGROUND OF THE DISCLOSURE

[0002] Conventional injection devices are often used to drive a needle through a surface, for example, in the injection of a drug, removing a fluid from a sealed container such as a vial, sampling within chemical instrumentation, and so on. Considering the example of injecting a patient with a drug, it is sometimes advantageous for the drug to be administered without the presence of a medical professional (e.g., when taken frequently). It may be a challenge to ensure that the needle is maintained in a sterile environment prior to injection, as well as to ensure that the drug is administered safely and efficiently. Furthermore, some patients are uncomfortable with seeing or directly handling needles.SUMMARY

[0003] A needle injection and retraction system mounted within a housing allowing the needle to move upon manual activation. An outer face of an inner housing of the system is pushed onto the injection site. As proximal force is applied to the outer face, an injection needle becomes exposed to insert into a patient’s skin. An internal drive mechanism allows travel of a cartridge needle to move through a container septum to establish a fluid path between the container and the patient. Once each needle is fully deployed, a latch may release a biasing member which allows the inner housing to return to the starting position once proximal force is removed (i.e., once the system is removed from the injection site). An optional lockout feature may restrict further movement, such as, for example, for a single-use system.

[0004] In a first aspect of the disclosure, a needle assembly is disclosed. The needle assembly comprises a first housing and a second housing telescopically arrangedrelative to the first housing. The second housing is axially movable relative to the first housing. A first needle support is coupled to an inner surface of the second housing. The first needle support includes a first needle. A second needle support is movable relative to the first needle support. In response to an application of a proximal force to the second housing, the first needle support is moved in a proximal direction and is configured to cause movement of the second needle support in a distal direction. The second needle support has a second needle fluidly coupled to the first needle.

[0005] In a second aspect of the disclosure, a medication delivery device is disclosed. The device comprises a drug container configured to contain a medication. The drug container defines an opening and a septum sealing the opening. A first delivery housing is attached to the drug container. A second delivery housing is arranged telescopically relative to the first delivery housing. The second delivery housing is axially movable relative to the first delivery housing. A first needle support is fixedly coupled to the second delivery housing. The first needle support includes a first needle having a first tip pointed toward the drug container and having an extended position and a retracted position. The first needle and the second needle are fluidly coupled. In response to application of a proximal force to the second delivery housing, the first needle support is moved from the retracted position to the extended position and the septum is pierced by the first tip of the first needle.

[0006] In a third aspect of the disclosure, a method of delivery a therapeutic agent to a patient is disclosed. The method comprises one or more of the following steps. The step of moving an inner housing of a medication delivery device axially in a first direction relative to an outer housing of the medication delivery device by continually applying a proximal force to the inner housing against a skin of the patient. During movement of the inner housing in the first direction, a septum of a drug container of the medication delivery device is pierced with a first needle and a needle support is moved distally so that a second needle supported by the needle support pierces the skin of the patient for the delivery of the therapeutic agent to the patient. The step of removing the proximal force from the inner housing of the medication delivery device by removing the medication delivery device from the skin of the patient after delivery of the therapeutic agent. During removal of the proximal force the first needle is moved distally andremoved from the septum and the second needle is moved proximally and removed from the skin of the patient.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0008] FIG. l is a schematic illustration of a first side of a medication delivery device having a needle assembly and corresponding needle mechanism in a retracted configuration;

[0009] FIG. l is a schematic illustration of a second side of the medication delivery device of FIG. 1 having a needle assembly and corresponding needle mechanism in the retracted configuration;

[0010] FIG. 3 is a schematic illustration of the first side of the medication delivery device of FIG. 1 having a needle assembly and corresponding needle mechanism in an extended configuration;

[0011] FIG. 4 is a schematic illustration of the second side of the medication delivery device of FIG. 1 having a needle assembly and corresponding needle mechanism in the extended configuration;

[0012] FIG. 5 is a perspective view of a first side of a needle mechanism of a medication delivery device;

[0013] FIG. 6 is a perspective view of a second side of the needle mechanism of FIG. 5;

[0014] FIG. 7 is a side elevational view of the first side of the needle mechanism of FIG. 5 without a pinion;

[0015] FIG. 8 is a side elevational view of the second side of the needle mechanism of FIG. 5 without the pinion;

[0016] FIG. 9 is a perspective view of a first side of the pinion of the needle mechanism of FIG. 5;

[0017] FIG. 10 is a perspective view of a second side of the pinion of the needle mechanism of FIG. 5;

[0018] FIG. 11 is a side view of the first side the needle mechanism of FIG. 5, showing a the needle mechanism in a retracted configuration prior to moving to an extended configuration;

[0019] FIG. 12 is a side view of the second side of the needle mechanism of FIG. 5, showing a the needle mechanism in the extended configuration;

[0020] FIG. 13 is a first side view of an inner housing and an outer housing of a needle assembly in a locked-out configuration;

[0021] FIG. 14 is a second side view of the inner housing and the outer housing of FIG. 13 in a locked-out configuration;

[0022] FIG. 15 is a top view of the inner housing and the outer housing of FIG. 13;

[0023] FIG. 16 is a perspective view of a medication delivery device having a needle assembly and corresponding needle mechanism in a locked-out configuration;

[0024] FIG. 17 is a flowchart of a method for delivering a therapeutic agent to a patient; and

[0025] FIG. 18 is schematic illustration of a side of a medication delivery device having another embodiment of the needle assembly and corresponding needle mechanism in a retracted configuration.

[0026] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the invention and such exemplifications are not to be construed as limiting the scope of the invention in any manner.DETAILED DESCRIPTION

[0027] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity.

[0028] FIGS. 1 and 2 illustrate a schematic embodiment of medication delivery device 100; FIG. 1 illustrates a first side of medication delivery device 100, while FIG. 2 illustrates a second, opposite side of medication delivery device 100. The medication delivery device 100 includes a drug container 102, such as a septum syringe or a cartridge, which may be configured to contain a medication or other therapeutic agent. Drug container 102 defines an opening 104, illustratively at a distal end 106 of drug container 102, for accessing the contained medication or therapeutic agent. Opening 104 may be sealed by a septum 108 as described further herein. The medication delivery devices described herein have a plunger drive system 111 configured to drive the plunger 113 located in the drug container to expel the therapeutic agent. The plunger drive system may be a mechanical or electro-mechanical drive. Actuation of the plunger drive system to initiate the dose delivery may be done manually by the patient continually pressing an actuation button or knob during the dose delivery or automatically by the patient pressing the actuation button which actuates an electric motor or spring drive. Examples of devices are described in the following: International Publication No. WO2022 / 132675, filed December 14, 2021, US Patent No. 10,898,652, issued on January 26, 2021, US Patent App. Publ. No. US2021 / 0379289, filed December 9, 2021, US Patent No. 11,179,522, issued on November 23, 2021, and US Prov. App. No 63 / 354,323, filed June 22, 2022, as well as the KwikPen® and delivery devices used in Forteo® and Trulicity®, which are provided by Eli Lilly and Company.

[0029] Devices according to the present disclosure may carry and dispense one or more liquid therapeutic agents, which may also be referred to as medications or drugs and maybe held in the fluid chamber of the drug container 102. Such therapeutic agents may include, for example, epinephrine, anaesthetics, analgesics, steroids, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide and retatrutide, basal insulins, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab, IL- 17 antibody analogs or derivatives, such as ixekizumab, therapeutic agents for pain-related treatments, such as galcanzeumab or lasmiditan, or lebrikizumab and any therapeutic agent that is capable of delivery by the devices described herein. Device may be used for treatment of various disease states or conditions, including, ulcerative colitis, Alzheimer’s, atopic dermatitis, cancer, diabetes, Crohn’s, obesity, and / or pain. Devices according to the present disclosure may be operated in a manner generally as described herein by a user (for example, a healthcare professional, a caregiver, or another person) to deliver one or more medications to a patient (for example, another person or the user).

[0030] A needle assembly 110 is arranged at distal end 109 of medication delivery device 100. In some embodiments, the medication delivery device comes packaged with the needle assembly permanently attached to the drug container, while in other embodiments, the needle assembly can be detached from the drug container after a single use and the medication delivery device can receive an unused needle assembly. Needle assembly 110 includes a first housing, also referred to first delivery housing or outer housing 112, and a second housing, also referred to as second delivery housing or inner housing 114. Outer housing 112 is coupled to drug container 102 so that septum 108 is positioned within a circumference of a sidewall 116 of outer housing 112. In some embodiments, outer housing 112 may be fixedly attached to drug container 102. Inner housing 114 may be telescopically arranged with outer housing 112 so that inner housing 114 is axially and / or rotationally movable relative to outer housing 112. Inner housing 114 may be shaped and sized to fit within outer housing 112 as described further herein. In other embodiments, the inner housing may be coupled to the device housing, and theouter housing may be telescopically arranged with the inner housing and axially and / or rotationally movable relative to the inner housing.

[0031] Referring specifically to FIG. 1, needle assembly 110 includes a needle mechanism 118 arranged within inner housing 114 and outer housing 112. Needle mechanism 118 includes a first needle support 120 coupled to and axially fixed relative to an inner surface 122 of inner housing 114. The first needle support may be formed separately from the inner housing and then coupled in a permanent means, such as by fixtures, adhesives, or other means, or the first needle support may be formed integrally with the inner housing by a molding process. First needle support 120 supports a first needle 124, which may point in a first, proximal direction. First needle support 120 is operatively coupled to a second needle support 126. Second needle support 126 supports a second needle 128, which may point in a second, distal direction. Illustratively, first needle support 120 may include a first rack 130 and second needle support 126 may include a corresponding second rack 134. A pinion 136 may mate with each of first rack 130 and second rack 134, so that movement of one of first rack 130 or second rack 134 in a first direction results in movement of the other of first rack 130 or second rack 134 in a second direction opposite the first direction.

[0032] Now referring specifically to FIG. 2, first needle support 120 includes a first needle holder 138 to support first needle 124 as discussed above. First needle holder 138 may be configured to couple first needle 124 to first needle support 120 in a secure and fixed arrangement relative to first needle support 120 to ensure precise, accurate, and safe deployment of first needle 124 as described further herein. Similarly, second needle support 126 includes a second needle holder 140 to support second needle 128 as discussed above. Second needle holder 140 may be configured to couple second needle 128 to second needle support 126 in a secure and fixed arrangement relative to second needle support 126 to ensure precise, accurate, and safe deployment of second needle 128 as described further herein. A flexible tube, such as a flexible hose 132 may fluidly couple first needle 124 and second needle 128. First needle support 120 can be coupled to the inner wall of the inner housing. For example, a mounting feature may extend from the inner wall of the inner housing to which first needle holder 138 is mounted. Guide features may be formed along the inner wall of the outer housing tofacilitate movement of the first needle holder. Pinion 136 can be coupled to the inner wall of the outer housing. For example, a pinion shaft may extend from the inner wall to which the pinion is rotatably mounted. Second needle support 126 can be movably coupled to the inner wall of the inner housing. For example, a guiding feature, such as a pair of rails, may extend from the inner wall of the inner housing to which second needle holder 140 is slidably mounted. Various mount and guide features described herein may be integrated into the respective housing such as by injection molding and / or additive manufacturing.

[0033] FIGS. 1, 2 illustrate needle assembly 110 in a retracted position. In the retracted position, first needle support 120 and second needle support 126 are arranged so that at least one of first needle 124 and second needle 128 are positioned completely within needle assembly 110. First needle support 120 may be positioned distal of second needle support 126. FIGS. 3, 4 illustrate needle assembly 110 in an extended position. In the extended position, first needle support 120 and second needle support 126 are arranged so that first needle 124 has pierced septum 108 and second needle 128 extends beyond inner housing 114, i.e., to pierce a patient’s skin as discussed further herein. The medication or other therapeutic agent contained by drug container 102 may travel through flexible hose 132 from first needle 124 to second needle 128 as described further herein.

[0034] Now referring to FIGS. 5-8, various views of needle mechanism 118 in the retracted position are illustrated. In the retracted position, first needle 124 and second needle 128 are approximately aligned parallel to one another in the direction of central axis Al. As shown, first needle 124 and second needle 128 are pointed in approximately opposite directions along axis Al. First needle 124 is pointed toward the proximal end 142 of the medication delivery device 100, and second needle 128 is pointed toward the distal end 106 of the medication delivery device. First needle 124 and second needle 128 are configured to move generally along axis Al as discussed further herein.

[0035] Referring to FIGS. 5-12, an exemplary embodiment of needle mechanism 118 is shown. First needle support 120 and second needle support 126 are positioned generally along a common plane and are slidably coupled to one another through first rack 130, second rack 134, and pinion 136. A first side of first needle support 120 includes first rack 130 configured to interact with pinion 136, and a first side of second needle support 126 includes second rack 134 configured to interact with pinion 136. Asecond side of first needle support 120 is configured to interact with and support first needle 124, and a second side of second needle support 126 is configured to interact with and support second needle 128. In the illustrated embodiment, first and second needle supports 120, 126 are generally rectangular in shape and are configured to fit within needle assembly 110, as shown in FIGS. 1, 2. In other embodiments, first and second needle supports 120, 126 may be any shape to accommodate motion of needles 124, 128 and fit within needle assembly 110. In the illustrated embodiment, and as discussed above, needle mechanism 118 comprises a rack and pinion configuration, wherein each of first needle support 120 and second needle support 126 comprise a rack for interacting with pinion 136. First needle support 120 comprises a support body 144, support engagement features 146, and a first needle holder 138, the first needle holder 138 coupling the first needle 124 to the first needle support 120. Similarly, second needle support 126 comprises a support body 148, support engagement features 150, and second needle holder 140, the second needle holder 140 coupling the second needle 128 to the second needle support 126. As shown best in FIGS. 6, 8, one or both of first needle support 120 and second needle support 126 may additionally comprise a needle guard 152, which may function to protect the needle and / or to provide additional strength to the needle. The illustrative needle guard 152 is a cylindrical housing with a bore extending therein, through which the respective needle 124, 128 extends.

[0036] First needle 124 and second needle 128 are fluidly coupled to one another through flexible hose 132. Flexible hose 132 is configured to be movable relative to each of the needles 124, 128. Flexible hose 132 may be movable by flexing, bending, stretching, or otherwise deforming. Accordingly, flexible hose 132 may be composed of a flexible material, such as an elastomer, thermoset polymer, or rubber. In an exemplary embodiment, flexible hose 132 is composed of silicone. In another embodiment, flexible hose 132 may be composed of rigid materials coupled together through flexible connections. In yet another embodiment, flexible hose 132 may be formed of relatively rigid materials and may move through a telescoping action. In the illustrated embodiment of FIG. 8, flexible hose 132 has a first end 154 fluidly coupled to the end of the first needle 124 and a second end 156 fluidly coupled to the end of the second needle 128. The ends 154, 156 of the flexible hose 132 may be coupled directly to the needle ends 124, 128 or to the respective needle holders 138, 140. As described further below, the ends154, 156 of the flexible hose 132 are configured to move with the needles 124, 128. In some embodiments, needles 124, 128 each have an inner tip 124a, 128a and an outer tip 124b, 128b (as shown in FIG. 6), wherein the inner tips 124a, 128a are fluidly coupled via flexible hose 132 and outer tips 124b, 128b are configured to point in opposite directions to facilitate piercing of their respective surfaces (e.g., septum and patient’s skin).

[0037] As shown best in FIGS. 9 and 10, pinion 136 comprises driving engagement features 158, and an actuating member 160. The driving engagement features 158 are configured to interact with the support engagement features 146 and 150 (FIG. 7). In the illustrated example, driving engagement features 158 and support engagement features 146 and 150 are teeth or protrusions configured to mesh together in a rack and pinion mechanism. In other embodiments, any of the engagement features within needle mechanism 118 may be other features configured to interact with one another such as protrusions and recessions, screws and threads, zipper type features, or any other complimentary engagement features.

[0038] Referring now to FIGS. 11-12, the needle mechanism 118 is configured to allow for movement of first needle support 120 and second needle support 126 upon activation of pinion 136. Needle mechanism 118 is movable between a first, retracted configuration before use and / or after use, as shown in FIG. 11, and a second, extended configuration during use, as shown in FIG. 12.

[0039] In the first, retracted position of FIG. 11, both first needle 124 and second needle 128 are axially positioned entirely within needle assembly 110. Flexible hose 132 may be arranged in a compressed (e.g., bent or looped) state between closely-positioned tube ends 154, 156 and needles 124, 128 in the retracted position, where the closely- positioned tube ends 154, 156 are separated by a first distance. Upon application of proximal force to the inner housing 114, such as by pressing the distal end of the inner housing against a patient’s skin for subcutaneous delivery of the therapeutic agent, first needle support 120 and first needle 124 are driven in a direction D2, and pinion 136 rotates in a direction Cl and second needle support 126 and second needle 128 are driven in a direction DI until the rotation of pinion 136 stops once the needle mechanism 118 is in the extended position. In the illustrated embodiment, DI and D2 are approximatelyparallel within a plane and are generally opposite of one another. Furthermore, they are approximately parallel to axis Al (See FIG. 5). In other embodiments, DI and D2 may be angled relative to one another, and may not be approximately parallel to Al. The proximal force applied is to overcome the force required for the first needle to pierce the septum and overcome any biasing force, if a biasing member is present.

[0040] In the second, extended position, second needle 128 extends axially beyond needle assembly 110 and passes through an outer seal 162 (described further herein) and into whatever surface medication delivery device 100 is positioned against (e.g., a patient’s skin). Additionally, first needle 124 extends axially beyond needle assembly 110 and passes through septum 108 into drug container 102. Because the flexible hose 132 is movable, it maintains fluid communication between first needle 124 and second needle 128 throughout movement of the needle mechanism 118. Flexible hose 132 may be arranged in an extended state between the now-distant tube ends 154, 156 and needles 124, 128 in the extended position, where the now-distant tube ends 154, 156 are separated by a second distance larger than the first distance of the retracted position. In the extended position, second needle 128 is fluidly coupled to drug container 102, so the fluid within drug container 102 is capable of flowing through first needle 124, flexible hose 132, and second needle 128 into whatever body or surface second needle 128 has pierced. In an exemplary embodiment, a number of components of needle mechanism 118, and / or the needle assembly 110 comprise a stopping feature to physically stop the movement of first needle support 120 and second needle support 126 once needle mechanism 118 reaches the extended position. Such a stopping feature may be a blocking member, a protrusion, a detent, or an absence of engagement members within a portion of the needle mechanism 118.

[0041] From the extended position, needle mechanism 118 is configured to be movable back to the retracted position through reverse activation of pinion 136 as well. As shown in FIG. 12, upon removal of proximal force from inner house 114, pinion 136 rotates in a direction C2, which is generally opposite to Cl, in order to drive first needle support 120 in the direction DI, and second needle support 126 in the direction D2. In an exemplary embodiment, needle mechanism 118 is moved from the extended position to the retracted position upon removal of a proximal force to inner housing 114 as describedfurther herein. In an embodiment where medication delivery device 100 is being used to deliver the above-described medication to the patient, extending the second needle 126 from needle assembly 110, and then retracting the second needle 126 back into the needle assembly 110 after injection would allow the patient to be injected with a medication without needing to directly observe or handle the second needle 126.

[0042] Now referring to FIGS. 13-15, inner housing 114 and outer housing 112 are illustrated. Inner housing 114 is arranged at a distal end 164 of outer housing 112 and has an outer circumference generally less than the inner circumference of outer housing 112 so that inner housing 114 and outer housing 112 form a telescoping relationship. Inner housing 114 may be axially and / or rotationally coupled to outer housing 112 so that outer housing 112 is configured to at least partially receive inner housing 114 when a proximal force 166 is applied to the distal end 168 of inner housing 114. While inner housing 114 and outer housing 112 are illustrated as being circular in shape, inner housing 114 and outer housing 112 may include other shapes - including edged shapes - capable of performing the functions described herein.

[0043] Inner housing 114 may include a rigid cover 170 defining an opening, which may be covered with outer seal 162. When rigid cover 170 is subjected to proximal force 166, rigid cover 170 is configured to impart movement onto inner housing 114 to axially move inner housing 114 relative to outer housing 112. Rigid cover 170 may be comprised of a polymer or another rigid material allowing for transfer of force from rigid cover 170 to inner housing 114. In some embodiments, rigid cover 170 is fixedly attached to inner housing 114. In other embodiments, rigid cover 170 may be removably attached in inner housing 114. In yet other embodiments, rigid cover 170 may be manufactured as one piece with inner housing 114.

[0044] A biasing member 172 may be coupled between inner housing 114 and outer housing 112. Illustratively, biasing member 172 may be a torsional spring. In other embodiments, a biasing member 172 may comprise any biasing member known in the art capable of performing the function described herein. When proximal force 166 is applied to inner housing 114 and inner housing 114 is moved axially relative to outer housing 112 in the proximal direction, the biasing member 172 is loaded. A latch may interact with biasing member 172 to retain the load until proximal force 166 is removed from innerhousing 114. Once proximal force 166 is removed, the latch may release biasing member 172. Biasing member 172 unloads and inner housing 114 is moved axially in the distal direction relative to outer housing 112. Unloading of biasing member 172 may also move inner housing 114 in a rotational direction relative to outer housing 112. In one embodiment, the proximal end of biasing member 172 engages against an inner lip of outer housing 112, and the distal end of biasing member 172 engages against the proximal end of inner housing 114. Biasing member 172 may have ends fixedly secured with the outer and inner housing, respectively, to allow the biasing member to impart a torsional force to the housing components.

[0045] In another embodiment, biasing member 172 may be associated with the pinion. When biasing member 172 is a torsional spring having an end thereof fixedly secured with one of the outer and inner housing and the opposite end fixedly secured to the pinion. When proximal force 166 is applied to inner housing 114 and inner housing 114 is moved axially relative to outer housing 112 in the proximal direction, and pinion is rotated in a direction such that the biasing member 172 can be loaded like a clock spring. In this pinion rotation, the needle assembly transitions to the extended configuration for drug delivery. Removal of the proximal force from inner housing 114 and biasing member 172 can provide force as it unwinds to drive inner housing 114 axially relative to outer housing 112 in the distal direction. In response, the needle assembly transitions from the extended configuration to the retracted configuration.

[0046] FIG. 18 illustrates one embodiment of this feature of the biasing member attached to the pinion, with additional features. The housing 315 of the needle assembly 310 for the medication delivery device 300 may be a single component that is in telescopic relationship with device 300. The second needle support 326 is fixedly secured to the distal end of the device 300 by a rigid mount 327. Biasing member 372 is shown coupled between housing 315 and pinion 336. Application of a proximal force to housing 315 will shift the housing 315 closer to the distal end 306 of device 300, if not over it, and drive the first needle support 320 proximally. The force is generated during the placement of the device against the skin at the treatment site. Proximal movement of the first needle support 320 allows the needle 324 to pierce the septum for in fluid communication with the drug container and rotates pinon 336 via rack 330 to wind the biasing member 372.The second needle support 326 is axially fixed relative to the moving housing 315 so that needle 328 enters into patient’s skin by force and transfers medication into patient. Rack 334 of second needle support 326 may be modified to permit pinion to remain axially fixed relative to the device 300. When drug delivery is complete, patient removes device from skin and biasing member 372 unloads to move housing 315 distally so that needle 328 is preferably covered by housing 315.

[0047] Needle assembly may also include a lockout mechanism to inhibit re-use of the needle assembly once it has been used. In one embodiment, inner housing 114 may include a first lockout feature 176 positioned on a sidewall 178 of inner housing 114. A corresponding second lockout feature 180 is positioned on sidewall 116 of outer housing 112. First lockout feature 176 and second lockout feature 180 are configured to mate with the other. In a pre-lockout configuration, the first lockout feature and the second lockout feature may be at a first angular and / or axial position relative to each other and are free to move relative to one another. In a lockout configuration, the first lockout feature and the second lockout feature may be at a second angular and / or axial position relative so the lockout features are now aligned (as shown in FIG. 14) to each other and movement relative to one another is inhibited. First lockout feature 176 and second lockout feature 180 may include, for example, a detent system, a tongue-in-groove system, or another locking mechanism. Upon removal of proximal force 166 from inner housing 114 and axial and / or rotational movement of inner housing 114 relative to outer housing 112 in response to biasing member 172, first lockout feature 176 and second lockout feature 180 may mate to prevent further movement of inner housing 114 relative to outer housing 112 in a locked-out position. Once first lockout feature 176 and second lockout feature 180 mate, application of a second proximal force to inner housing 114 will not move inner housing 114 relative to outer housing 112, preventing the re-use of medication delivery device 100 if a single use device or the needle assembly if removable from a device that is multi-use, as described further herein.

[0048] Now referring to FIG. 16, an illustrative embodiment of medication delivery device 100 is shown in the locked-out position. As illustrated, first lockout feature 176 and second lockout feature 180 are in a mated position, biasing member 172 has been unloaded, and needle mechanism 118 is in the retracted position, as discussedabove. The locked-out position prevents needle mechanism 118 from moving to the extended position from the retracted position after the first use of medication delivery device 100.

[0049] As shown, first needle 124 is aligned with outer seal 162 so that first needle 124 is configured to pierce outer seal 162 and enter the surface (e.g., patient’s skin) against rigid cover 170 of inner house 114 as needle mechanism 118 moves from the retracted position to the extended position. Similarly, second needle 128 is aligned with septum 108 so that second needle 128 is configured to pierce septum 108 and enter drug container 102 to create a fluid connection between drug container 102 and the surface against rigid cover 170 when needle mechanism 118 is in the extended position via first needle 124, second needle 128, and flexible hose 132. As discussed above, first needle support 120 is attached to inner housing 114 so that first needle support 120 moves with inner housing 114. In other words, when proximal force 166 is applied to inner housing 114 causing inner housing 114 to move axially relative to outer housing 112, first needle support 120 also moves axially relative to outer housing 112 a corresponding distance. First needle support 120 may be attached to an inner surface of sidewall 178 or attached to an inner surface of rigid cover 170 as shown in FIG. D.

[0050] Now referring to FIG. 17, a method 181 for delivering a therapeutic agent to a patient is illustrated. While the steps of the method are illustrated as separate and distinct boxes in a flowchart, the steps of the method are not necessarily separate and distinct in practice. In other words, the steps of the boxes illustrated may chronologically overlap, either in portion or in whole.

[0051] At box 182, proximal force 166 is applied to inner housing 114. Proximal force 166 may be applied by pushing inner housing 114 in a proximal direction and / or by pushing inner housing 114 against a surface (e.g., a patient’s skin). As proximal force 166 is applied to inner housing 114, at box 184 inner housing 114 moves in a first, proximal direction toward drug container 102, so that outer housing 112 telescopically receives inner housing 114. As inner housing 114 moves in the first, proximal direction, biasing member 172 is loaded. Additionally, as inner housing 114 moves in the first, proximal direction, attached first needle support 120, including first needle holder 138 and corresponding first needle 124, also move in the first, proximal direction toward drugcontainer 102 until first needle 124 meets and pierces septum 108 to enter drug container 102 and contact the therapeutic agent (e.g., medication, saline, etc.) contained within at box 186. In other words, first needle support 120 moves from the retracted position to the extended position.

[0052] As first needle support 120 moves in the first, proximal direction toward drug container 102, support engagement features 146 of first rack 130 of first needle support 120 engage with engagement features 158 of pinion 136, causing pinion 136 to rotate. Rotation of pinion 136 further causes engagement features 158 of pinion 136 to engage with support engagement features 150 of second rack 134 of second needle support 126, causing second needle support 126, including second needle holder 140 and second needle 128, to move in a second, distal direction away from drug container 102 until second needle 128 extends beyond inner housing 114 and pierces the surface (e.g., patient’s skin) adjacent inner housing 114 at box 188. In other words, second needle support 126 moves from the retracted position to the extended position.

[0053] With first needle 124 in fluid contact with the therapeutic agent contained within drug container 102 and second needle 128 in fluid contact within patient’s skin, i.e., with needle mechanism 118 in the extended position, a fluid connection is made between drug container 102 and the patient via first needle 124, second needle 128, and flexible hose 132, allowing delivery of the therapeutic agent to the patient from drug container 102 at box 190. The medication delivery device is configured to allow the plunger to start moving within the drug container so that the therapeutic agent can begin flowing under pressure through the first needle, the flexible hose and the second needle, and into the patient’s skin. To this end, the patient may press the actuation button after the proximal force is applied to the inner housing. A latch may hold biasing member 172 in place to prevent premature unloading of biasing member 172.

[0054] Once the therapeutic agent has been delivered to the patient, proximal force 166 is removed from inner housing 114 at box 192. With removal of proximal force 166, the latch may release biasing member 172, or biasing member 172 is otherwise released, causing inner housing 114 to move axially in the second, distal direction at box 194. As inner housing 114 moves axially in the second, distal direction, biasing member 172 may additionally bias to cause inner housing 114 to rotate relative to outer housing112. As inner housing 114 moves in the second, distal direction, attached first needle support 120, including first needle holder 138 and corresponding needle 124, also move in the second, distal direction away from drug container 102 until first needle 124 is retracted from septum 108 and first needle support 120 reaches the retracted position at box 196.

[0055] As first needle support 120 moves in the second, proximal direction away from drug container 102, support engagement features 146 of first rack 130 of first needle support 120 engage with engagement features 158 of pinion 136 to engage with support engagement features 150 of second rack 134 of second needle support 126, including second needle holder 140 and second needle 128, to move in the first, proximal direction toward drug container 102 until second needle 128 is retracted from patient’s skin and second needle support 126 reaches the retracted position at box 198.

[0056] As mentioned above, as inner housing 114 moves axially in the second, distal direction, first lockout feature 176 of inner housing 114 may mate with second lockout feature 180 of outer housing 112, placing needle assembly 110 in a lock-out position at box 200. In this position, needle mechanism 118 is in the retracted position and located entirely within needle assembly 110 so that neither of needles 124, 128 are exposed outside of medication delivery system 100. The lock-out position further prevents further movement of inner housing 114 relative to outer housing 112 to prevent re-use of medication delivery device 100 and corresponding needles 124, 128. For medication delivery device embodiments having a removable needle assembly, the exhausted needle assembly may be removed from the drug container and an unused needle assembly may be coupled to the drug container for a second dosing event with the medication delivery device.

[0057] The terms “first”, “second”, “third” and the like, whether used in the description or in the claims, are provided for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless clearly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operation in other sequences and / or arrangements than are described or illustrated herein.

[0058] The terms “installed”, “provided with”, “sleeved / connected”, “connected”, etc., whether used in the description or in the claims, should be understood broadly. For example, “connected” can be a fixed connection, a detachable connection, or an integral connection, a mechanical connection, an electrical connection, a direct connection, or an indirect connection through an intermediate medium, and it can be a connection between two members. For those of ordinary skill in the art, the specific meaning of the above terms in the present disclosure can be understood under specific conditions. The terms “couples”, “coupled”, “coupler”, and variations thereof are used to include both arrangements wherein two or more components are in direct physical contact and arrangements wherein the two or more components are not in direct contact with each other (e.g., the components are “coupled” via at least a third component, but yet sill cooperate or interact with each other).

[0059] While this invention has been described as having exemplary designs, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

[0060] Various aspects are described in this disclosure, including the summary, which include, but are not limited to, the following aspects:

[0061] In various aspects of the disclosure, the first needle support and the second needle support form a rack with a pinion therebetween.

[0062] In various aspects of the disclosure, wherein, in response to a removal of the proximal force from the second housing, the first needle support is moved in the distal direction and is configured to cause movement of the second needle support in the proximal direction.

[0063] In various aspects of the disclosure, further including a seal configured to cover an opening through which the second needle is movable.

[0064] In various aspects of the disclosure, wherein an inner tip of the first needle and an inner tip of the second needle are fluidly coupled by a flexible hose.

[0065] In various aspects of the disclosure, wherein an outer tip of the first needle and an outer tip of the second needle point in opposite directions.

[0066] In various aspects of the disclosure, wherein the second housing is at least one of rotationally and axially movable relative to the first housing.

[0067] In various aspects of the disclosure, further including a second needle support movably coupled to the first needle support and including a second needle having a second tip pointed away from the drug container.

[0068] In various aspects of the disclosure, wherein application of the proximal force to the second delivery housing is configured to cause: the second delivery housing to move proximally relative to the first delivery housing; and the second needle support to move distally so that the second needle is configured to pierce a skin of a patient.

[0069] In various aspects of the disclosure, wherein removal of the proximal force is configured to cause: the second delivery housing to move distally relative to the first delivery housing; the first needle to move from the extended position to the retracted position, wherein the first tip of the first needle is distally withdrawn from the septum; and the second needle to move proximally within the second delivery housing so that the second needle is proximally withdrawn from the skin of the patient.

[0070] In various aspects of the disclosure, further including a biasing member coupled between the first delivery housing and the second delivery housing, the biasing member configured to cause distal movement of the second delivery housing relative to the first delivery housing upon removal of the proximal force to the second delivery housing, wherein the first needle is configured to move from the extended position to the retracted position, and the first tip of the first needle is distally withdrawn from the septum.

[0071] In various aspects of the disclosure, wherein the biasing member is configured to cause rotational movement of the second delivery housing relative to the first delivery housing upon removal of the proximal force to the second delivery housing.

[0072] In various aspects of the disclosure, further including a first lockout feature corresponding with the first delivery housing and a second lockout feature corresponding with the second delivery housing, wherein the first lockout feature is configured toengage with the second lockout feature following at least one of a distal movement and a rotational movement of the second delivery housing relative to the first delivery housing so that the axial position of the second delivery housing is fixed relative to the first delivery housing.

[0073] In various aspects of the disclosure, wherein a pinion is coupled between the first needle support and the second needle support, the device further including: a biasing member coupled between one of the first delivery housing and the second delivery housing and the pinion, the biasing member configured to cause rotation of the pinion and drive distal movement of the first needle support.

[0074] In various aspects of the disclosure, wherein moving the inner housing in the first direction also includes loading a torsional spring disposed between the inner housing and the outer housing.

[0075] In various aspects of the disclosure, wherein removing the proximal force from the inner housing further includes unloading the torsional spring so that the inner housing moves axially in a second direction relative to the outer housing of the delivery device.

[0076] In various aspects of the disclosure, further including engaging a first lockout detent corresponding with the inner housing with a second lockout detent corresponding with the outer housing.

[0077] In various aspects of the disclosure, wherein removing the proximal force from the inner housing further includes unloading the torsional spring so that the inner housing moves rotationally relative to the outer housing of the delivery device.

Claims

WHAT IS CLAIMED IS:

1. A needle assembly comprising: a first housing; a second housing telescopically arranged relative to the first housing, the second housing axially movable relative to the first housing, the second housing having an inner surface; a first needle support coupled to the inner surface of the second housing, the first needle support including a first needle; a second needle support movable relative to the first needle support, wherein, in response to an application of a proximal force to the second housing, the first needle support is moved in a proximal direction and is configured to cause movement of the second needle support in a distal direction, the second needle support having a second needle fluidly coupled to the first needle.

2. The needles assembly of claim 1, wherein the first needle support and the second needle support form a rack with a pinion therebetween.

3. The needle assembly of any one of claims 1-2, wherein, in response to a removal of the proximal force from the second housing, the first needle support is moved in the distal direction and is configured to cause movement of the second needle support in the proximal direction.

4. The needle assembly of claim 3, further comprising a seal configured to cover an opening through which the second needle is movable.

5. The needle assembly of any one of claims 1-4, wherein an inner tip of the first needle and an inner tip of the second needle are fluidly coupled by a flexible hose.

6. The needle assembly of any one of claims 1-5, wherein an outer tip of the first needle and an outer tip of the second needle point in opposite directions.

7. The needle assembly of any one of claims 1-6, wherein the second housing is at least one of rotationally and axially movable relative to the first housing.

8. A medication delivery device, comprising: a drug container configured to contain a medication, the drug container defining an opening and a septum sealing the opening; a first delivery housing attached to the drug container; a second delivery housing arranged telescopically relative to the first delivery housing, the second delivery housing axially movable relative to the first delivery housing; a first needle support fixedly coupled to the second delivery housing, the first needle support including a first needle having a first tip pointed toward the drug container and having an extended position and a retracted position, wherein the first needle and the second needle are fluidly coupled, wherein, in response to application of a proximal force to the second delivery housing, the first needle support is moved from the retracted position to the extended position and the septum is pierced by the first tip of the first needle.

9. The medication delivery device of claim 8, further comprising a second needle support movably coupled to the first needle support and including a second needle having a second tip pointed away from the drug container.

10. The medication delivery device of claim 9, wherein application of the proximal force to the second delivery housing is configured to cause: the second delivery housing to move proximally relative to the first delivery housing; and the second needle support to move distally so that the second needle is configured to pierce a skin of a patient.

11. The medication delivery device of claim 10, wherein removal of the proximal force is configured to cause:the second delivery housing to move distally relative to the first delivery housing; the first needle to move from the extended position to the retracted position, wherein the first tip of the first needle is distally withdrawn from the septum; and the second needle to move proximally within the second delivery housing so that the second needle is proximally withdrawn from the skin of the patient.

12. The medication delivery device of any one of claims 8-11, further comprising a biasing member coupled between the first delivery housing and the second delivery housing, the biasing member configured to cause distal movement of the second delivery housing relative to the first delivery housing upon removal of the proximal force to the second delivery housing, wherein the first needle is configured to move from the extended position to the retracted position, and the first tip of the first needle is distally withdrawn from the septum.

13. The medication delivery device of claim 12, wherein the biasing member is configured to cause rotational movement of the second delivery housing relative to the first delivery housing upon removal of the proximal force to the second delivery housing.

14. The medication delivery device of claim 12, further comprising a first lockout feature corresponding with the first delivery housing and a second lockout feature corresponding with the second delivery housing, wherein the first lockout feature is configured to engage with the second lockout feature following at least one of a distal movement and a rotational movement of the second delivery housing relative to the first delivery housing so that the axial position of the second delivery housing is fixed relative to the first delivery housing.

15. The medication delivery device of claim 8, wherein a pinion is coupled between the first needle support and the second needle support, the device further comprising: a biasing member coupled between one of the first delivery housing and the second delivery housing and the pinion, the biasing member configured to cause rotation of the pinion and drive distal movement of the first needle support.

16. A method of delivering a therapeutic agent to a patient, the method comprising: moving an inner housing of a medication delivery device axially in a first direction relative to an outer housing of the medication delivery device by continually applying a proximal force to the inner housing against a skin of the patient, wherein during movement of the inner housing in the first direction, a septum of a drug container of the medication delivery device is pierced with a first needle and a needle support is moved distally so that a second needle supported by the needle support pierces the skin of the patient for the delivery of the therapeutic agent to the patient; removing the proximal force from the inner housing of the medication delivery device by removing the medication delivery device from the skin of the patient after delivery of the therapeutic agent, wherein during removal of the proximal force the first needle is moved distally and removed from the septum and the second needle is moved proximally and removed from the skin of the patient.

17. The method of claim 16, wherein moving the inner housing in the first direction also includes loading a torsional spring disposed between the inner housing and the outer housing.

18. The method of claim 17, wherein removing the proximal force from the inner housing further includes unloading the torsional spring so that the inner housing moves axially in a second direction relative to the outer housing of the delivery device.

19. The method of claim 18, further comprising engaging a first lockout detent corresponding with the inner housing with a second lockout detent corresponding with the outer housing.

20. The method of claim 17, wherein removing the proximal force from the inner housing further includes unloading the torsional spring so that the inner housing moves rotationally relative to the outer housing of the delivery device.

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