Devices for drug delivery

Abstract

A drug delivery device includes a housing, a needle, and a pressure chamber. The pressure chamber includes a shell and a port, and a flexible drug reservoir disposed in the pressure chamber and contains a drug. A pressure source is operable to provide a fluid to the pressure chamber and thereby apply fluidic pressure to an external surface of the flexible drug reservoir and compress the flexible drug reservoir. The device further includes a deformation inhibition interface including an aperture defined on one of the shell and the port. A post is coupled to the other of the shell and the port and disposed in the aperture, and the post inhibits deformation of the shell when the pressure chamber receives the fluid. Compression of the flexible drug reservoir causes the drug to flow from an internal chamber of the flexible drug reservoir to the needle.

Description

DEVICES FOR DRUG DELIVERYFIELD OF THE DISCLOSURE

[0001] The present disclosure relates to processes and devices for parenteral delivery of therapeutic agents or drugs. More particularly, the present disclosure relates to processes and devices for parenteral delivery of relatively high volumes of drugs (for example, volumes greater than 2mL).BACKGROUND OF THE DISCLOSURE

[0002] Various injection devices have been developed to advantageously administer therapeutic agents or drugs to patients without the presence of medical professionals. Such devices are also capable of maintaining needles in sterile environments prior to injection. Similarly, such devices are also capable of obscuring their needles, which may be beneficial for patients that are uncomfortable with seeing or directly handling needles. However, improved devices for efficient parenteral delivery of drugs would be beneficial, particularly improved devices for delivering relatively high volumes of drugs (for example, volumes greater than 2mL).SUMMARY

[0003] In one aspect, the present disclosure provides a drug delivery device that includes a housing, a needle coupled to the housing, and a pressure chamber coupled to the housing. The pressure chamber includes a shell and a port coupled to the shell, and a flexible drug reservoir is disposed in the pressure chamber. The flexible drug reservoir includes an external surface and an internal chamber containing a drug. A pressure source is coupled to the housing, and the pressure source is operable to provide a fluid to the pressure chamber and thereby apply fluidic pressure to the external surface of the flexible drug reservoirand compress the flexible drug reservoir. The device further includes a deformation inhibition interface including an aperture defined on one of the shell and the port. A post is coupled to the other of the shell and the port and disposed in the aperture, and the post inhibits deformation of the shell when the pressure chamber receives the fluid. Compression of the flexible drug reservoir causes the drug to flow from the internal chamber of the flexible drug reservoir to the needle.

[0004] In another aspect, the present disclosure provides a drug delivery device that includes a housing, a needle coupled to the housing, and a pressure chamber coupled to the housing. The pressure chamber includes a shell and a port coupled to the shell. A flexible drug reservoir is disposed in the pressure chamber, and the flexible drug reservoir includes an external surface and an internal chamber containing a drug. A pressure source is coupled to the housing, and the pressure source is operable to provide a fluid to the pressure chamber and thereby apply fluidic pressure to the external surface of the flexible drug reservoir and compress the flexible drug reservoir. The device further includes a deformation inhibition interface including a rib coupled to one of the shell and the port. The rib contacts the other of the shell and the port to inhibit deformation of the shell when the pressure chamber receives the fluid. Compression of the flexible drug reservoir causes the drug to flow from the internal chamber of the flexible drug reservoir to the needle.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:

[0006] FIG. 1 is a perspective view of a drug delivery device according to an embodiment of the present disclosure;

[0007] FIG. 2 is a schematic view of the drug delivery device of FIG. 1 .

[0008] FIG. 3 is a perspective view of a drug container assembly of the drug delivery device of FIG. 1 .

[0009] FIG. 4 is an exploded perspective view of the drug container assembly of FIG. 3.

[0010] FIG. 5 is a partial perspective view of a pressure chamber of the drug container assembly of FIG. 3

[0011] FIG. 6 is a front view of the pressure chamber of FIG. 3, including an exemplary deformation inhibition interface.

[0012] FIG. 7 is a partial side section view of the deformation inhibition interface along line 7-7 of FIG. 6.

[0013] FIG. 8 is a front view of the pressure chamber of FIG. 3, including another exemplary deformation inhibition interface.

[0014] FIG. 9 is a partial side section view of the deformation inhibition interface along line 9-9 of FIG. 8.

[0015] FIG. 10 is a front view of the pressure chamber of FIG. 3, including yet another exemplary deformation inhibition interface.

[0016] FIG. 11 is a partial side section view of the deformation inhibition interface along line 11 -11 of FIG. 10.

[0017] FIG. 12 is a front view of the pressure chamber of FIG. 3, including yet another exemplary deformation inhibition interface.

[0018] FIG. 13 is a partial side section view of the deformation inhibition interface along line 13-13 of FIG. 11 .

[0019] FIG. 14 is a front view of the pressure chamber of FIG. 3, including yet another exemplary deformation inhibition interface.

[0020] FIG. 15 is a partial side section view of the deformation inhibition interface along line 15-15 of FIG. 12.

[0021] 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

[0022] The present disclosure relates to devices for parenteral delivery of therapeutic agents or drugs, such as relatively high volumes of drugs (for example, volumes greater than 2mL).1 . Drugs / Therapeutic Agents

[0023] Drug delivery devices including containers or reservoirs according to the present disclosure may carry and facilitate delivery of a drug to a subject. The term “drug” or “medication” refers to one or more therapeutic agents including but not limited to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, basal insulins, insulin efsitora alfa, 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 or retatrutide, oxyntomodulin analogs, oxyntomodulin derivatives, lepodisiran (LPA siRNA), volenrelaxin, amylin agonist long acting, PNPLA3 siRNA, APOC3 siRNA, DACRA qw II, GIPR agonist long acting, glucose sensing insulin receptor agonists, nisotirostide, bimagrunab, NRG4 agonist, SCAP siRNA, mazdutide, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab for treatment of Crohn’s disease or ulcerative colitis, IL-17 antibody analogs or derivatives, such as ixekizumab for treatment of plaque psoriasis, IL-13 antibody analogs or derivatives, such as lebrikizumab that can be used for treatment of atopic dermatitis, therapeutic agents such as galcanezumab or lasmiditan for pain- related and / or migraine treatments, lebrikizumab or ucenprubart for treatment of atopic dermatitis, donanemab or remternetug for treatment of Alzheimer’s and / or dementia, eltrekibart for treatment of Hidradenitis Suppurativa, peresolimab fortreatment of rheumatoid arthritis, and any therapeutic agent that is capable of delivery by devices according to the present disclosure. The drug may be formulated with one or more excipients. Devices according to the present disclosure are operated in a manner generally as described herein by a patient, caregiver, or healthcare professional to deliver a drug to a subject.

[0024] The drug may be a protein, such as a monoclonal antibody or some other protein which is therapeutically useful. The protein may have a concentration of from about 75 mg / mL to about 500 mg / mL in a fluid. The protein may have a concentration of about 150 mg / mL, 200 mg / mL, 250 mg / mL, or more. A drug may further contain a solvent or non-solvent, such as water, perfluoroalkane solvent, safflower oil, or benzyl benzoate.2. Drug Delivery Devices

[0025] FIGS. 1 and 2 illustrate a drug delivery device 100 according to an embodiment of the present disclosure. Illustratively, the drug delivery device 100 generally includes a relatively compact and non-linear profile, although other profiles may alternatively be used. The drug delivery device 100 generally includes a device housing 102 that carries a user input 104 (illustratively, a depressible button). The user input 104 is actuatable to actuate the device 100. More specifically, the user input 104 is actuatable to cause the device 100 to deliver a drug 106 (FIG. 2) to a subject via a drug delivery needle 108 (FIG. 2). The device housing 102 illustratively carries a transparent or translucent window 110 (FIG. 1) that facilitates visualization of one or more internal components of the device 100.

[0026] With specific reference to FIG. 2, the device housing 102 also carries various internal components that facilitate delivering the drug to a subject. Generally, the device housing 102 carries a fluidic pressure source 112, such as a pneumatic pump or a hydraulic pump, that is operable to provide fluidic pressure, such as pneumatic pressure or hydraulic pressure, to a pressure chamber 114 of a drug container assembly 115 and apply the pressure to an external surface of a flexible drug reservoir 116 of the drug container assembly 115 disposed within thepressure chamber 114. The flexible drug reservoir 116 initially carries the drug 106 within an internal chamber (shown elsewhere), and compression of the flexible drug reservoir 116 by the pressure source 112 causes the drug to flow from the internal chamber. Additional details of the pressure chamber 114 and the flexible drug reservoir 116 are provided below.

[0027] The flexible drug reservoir 116 delivers the drug 106 to a needle assembly 118 including the drug delivery needle 108. The needle assembly 118 may illustratively move the needle 108 from a first, or stowed, configuration to a second, or deployed, configuration. In the first configuration, the needle 108 may be completely positioned within the device housing 102. In the second configuration, the needle 108 may at least partially extends outwardly from the device housing 102 and thereby be configured to pierce the skin of the subject. As such, the needle 108 is configured to deliver the drug to the subject in the second configuration. Alternatively, the needle assembly 118 may take other forms.

[0028] With continued reference to FIG. 2, the device 100 also includes various other components that facilitate delivering the drug to a subject. For example, the device 100 includes a controller 120 that operably couples to various components and thereby controls delivery of the drug to the subject. The controller 120 may be or include, for example, one or more dedicated processors (e.g., microprocessors), one or more Field Programmable Gate Arrays (FPGAs), one or more Programmable Logic Devices (PLDs), one or more Complex PLDs (CPLDs), one or more custom Application Specific Integrated Circuits (ASICs), or the like. The controller 120 operably couples to the user input 104, the pressure source 112, and the needle assembly 118. The controller 120 also operably couples to a power source, for example, one or more batteries (not shown). In addition, the controller 120 operably couples to one or more sensors 122 and, based on inputs received from the sensors, causes, modifies, and / or inhibits delivery of the drug to the subject. In some embodiments, the sensors 122 include a skin sensor, a pressure sensor, and / or a reservoir sensor.

[0029] A skin sensor may facilitate determining whether the device 100 is properly positioned against the skin of the subject, and the controller 120 may not actuate the pressure source 112 if the skin sensor indicates that the device 100 is not properly positioned against the skin of the subject. The skin sensor may take various forms, such as a contact-based sensor (for example, a mechanical switch or plunger), a non-contact sensor (for example, an optical sensor), or the like.

[0030] A pressure sensor may operably couple to the controller 120 and the pressure chamber 114, and the pressure sensor may facilitate determining the pressure applied to the external surface 136 of the drug reservoir 116. Based on the sensed pressure, the controller 120 determines an end-of-dose state of the device (that is, when the drug has been completely delivered, or a therapeutically effective of amount of the drug has been delivered, to the subject). The pressure sensor may take various specific forms.

[0031] A reservoir sensor, as the name implies, may operably couple to the flexible drug reservoir 116 to detect a configuration of the reservoir 116. Based on a configuration change (for example, a shape change) of the flexible drug reservoir 116 sensed by the reservoir sensor, the controller 120 may determine an end-of-dose state of the device 100. The reservoir sensor may take various forms, such as an optical sensor.

[0032] FIGS. 3 and 4 further illustrate the drug container assembly 115 comprising the pressure chamber 114 and the flexible drug reservoir 116, and FIG. 5 partially illustrates the pressure chamber 114. The pressure chamber 1 14 includes a wall or shell 124 having an open end 126 defined by a rim 128. In the illustrated embodiment, the shell 124 is made of a rigid material such as a rigid polymer and may be translucent or transparent. The pressure chamber 114 couples to the flexible drug reservoir 116 at the open end 126. More specifically, a frame or port 130 of the pressure chamber 114 couples to the flexible drug reservoir 116 at the open end 126. The port 130 supports a flexible bag 132 of the flexible drug reservoir 116, and the flexible bag 132 includes the internal chamber 134 that initially carries the drug 106 (shown elsewhere). The flexiblebag 132 also includes the external surface 136 to which pressure is applied to cause the drug to flow from the internal chamber 134.

[0033] The flexible bag 132 may be constructed, for example, of one or more sheets (illustratively, two sheets, or an upper sheet and a lower sheet) of a flexible polymer, more specifically a thermoplastic copolymer, and more specifically, for example, ethylene-vinyl alcohol copolymer (“EVOH”). Appropriate materials may have, for example, a Young’s modulus in a range of 3000 to 4000 MPa, more specifically 3250 to 3750 MPA, and more specifically about 3500 Mpa. Appropriate materials may have, for example, a flexural modulus in a range of 2800 to 3800 MPa, more specifically 3050 to 3550 MPA, and more specifically about 3300 MPa.

[0034] The port 130 of the pressure chamber 114 includes an outlet 138 (FIGS. 4 and 5) in fluid communication with the internal chamber 134 of the flexible drug reservoir 116. The outlet 138 illustratively includes a reservoir septum 140 (FIG. 4) that is pierceable by a second needle (not shown) of the needle assembly 1 18 (shown elsewhere) to permit fluid communication between the internal chamber 134 of the flexible drug reservoir 1 16 and the needle assembly 118. The outlet 138 illustratively further includes a cap 142, such as a laser welded cap, a snap-on cap, or a crimped cap, that secures the reservoir septum 140 to the port 130. The port 130 illustratively further includes an inlet 144 for initially filling the flexible drug reservoir 1 16 with the drug 106 and a blind aperture 146 (FIG. 5) for receiving one of the sensors 122 (FIG. 2), such as the reservoir sensor.

[0035] The pressure chamber 1 14 includes a deformation inhibition interface to inhibit the shell 124 from deforming upon receiving the fluid (e.g., air) from the pressure source 112, thereby reducing the likelihood of a leak path forming between the shell 124 and the port 130 when pressurizing the chamber 114. Referring to FIGS. 6 and 7, the pressure chamber 1 14, more specifically the port 130, the shell 124, and an exemplary deformation inhibition interface 250, are illustrated. The deformation inhibition interface 250 includes one or moreapertures 252, illustratively two apertures 252, and one or more posts 254, illustratively two posts 254, and each aperture 252 receives one of the posts 254. Illustratively, the apertures 252 and posts 254 are disposed on opposite top and bottom ends of the port 130 and centered between sides of the port 130. Alternatively, the deformation inhibition interface 250 may include a different number and / or arrangement of apertures 252 and posts 254. More specifically, the apertures 252 and posts 254 may be evenly or unevenly spaced around the port 130. Illustratively, the apertures 252 are defined by the port 130 and the posts 254 are coupled to the shell 124. Alternatively, the apertures 252 may be defined by the shell 124 and the posts 254 are coupled to the port 130. In either case, the posts 254 apply inward resistance forces F1 (FIG. 7) to the shell 124 by bearing against the structure that defines the apertures 252 (illustratively, the port 130) when the pressure chamber 1 14 receives the pressurizing fluid, which applies outward forces F2 to the shell 124 along an elongated upper end 148 (FIG. 6) and an elongated lower end 150 (FIG. 6) of the pressure chamber 114. The posts 254 thereby inhibit deformation of the shell 124. Illustratively, the deformation inhibition interface 250 further includes an adhesive 256 (FIG. 7) that couples the port 130 to the shell 124. Referring specifically to FIG. 7, the adhesive 256 may be disposed in each aperture 252, between at least a portion or the entirety of the inner perimeter 152 of the rim 128 of the shell 124 and the outer perimeter 154 of the port 130, or, as illustrated, in both of these locations. Illustratively, the adhesive 256 has a tapering shape between the inner perimeter 152 of the rim 128 of the shell 124 and the outer perimeter 154 of the port 130. More specifically, the adhesive 256 has a conical shape near the exterior of the deformation inhibition interface 250 and one or more rectangular shapes in the interior of the deformation inhibition interface 250.

[0036] Referring to FIGS. 8 and 9, the pressure chamber 114, more specifically the port 130, the shell 124, and another exemplary deformation inhibition interface 350, are illustrated. Referring specifically to FIG. 9, the deformation inhibition interface 350 includes a rib 352 coupled to the port 130, and more specifically, the rib 352 extends outwardly from the outer perimeter 154of the port 130. The rib 352 contacts the shell 124 to inhibit deformation of the shell 124 when the pressure chamber 114 receives the pressurizing fluid. More specifically, when the pressure chamber 1 14 receives the pressurizing fluid, outward forces F4 (FIG. 8) are applied to the shell 124 along the elongated upper end 148 and the elongated lower end 150 of the pressure chamber 114, which in turn apply inward contractive forces F5 to the shell 124 along the short left end 156 and the short right end 158 of the pressure chamber 114. The rib 352 applies outward resistance forces F3 (FIG. 9) against the shell 124 to counteract the inward contractive forces F5. Stated another way, the rib 352 provides a relatively tight fit between the port 130 and the shell 124, thereby inhibiting deformation of the shell 124 when the pressure chamber 114 receives the pressurizing fluid. Illustratively, the rib 352 is disposed around the entire outer perimeter 154 of the port 130. In such embodiments, the forces F3 and F4 are both in outward directions at the elongated upper end 148 and the elongated lower end 150, and because the shell 124 is already being urged outward by the ribs 352 at the elongated upper end 148 and the elongated lower end 150, any additional outward force F4 at the elongated upper end 148 and the elongated lower end 150 due to the pressuring fluid is minimal. Alternatively, the rib 352 extends discontinuously around the outer perimeter 154 of the port 130; stated another way, the port 130 includes a plurality of ribs 352 that are positioned in certain locations along the outer perimeter 154 of the port 130. For example, in one embodiment the ribs 352 are provided only at the short ends 156, 158 of the port 130, so as to only apply the force F3 in the two opposite elongated directions (opposite the forces F5) to limit outward flexing of the shell 124 due to the forces F4. Illustratively, the deformation inhibition interface 350, particularly the ribs 352, are sized to provide space for an adhesive 354 that couples the port 130 to the shell 124. The adhesive 354 is illustratively disposed between the inner perimeter 152 of the rim 128 of the shell 124 and the outer perimeter 154 of the port 130. Illustratively, the adhesive 354 has a tapering shape. More specifically, the adhesive 354 has a conical shape near the exterior of the deformation inhibitioninterface 350 and a rectangular shape in the interior of the deformation inhibition interface 350.

[0037] Referring to FIGS. 10 and 1 1 , the pressure chamber 114, more specifically the port 130, the shell 124, and another exemplary deformation inhibition interface 450 are illustrated. Referring specifically to FIG. 11 , the deformation inhibition interface 450 includes a rib 452 coupled to the shell 124, and more specifically the rib 452 extends inwardly from the inner perimeter 152 of the shell 124. The rib 452 contacts the port 130 to inhibit deformation of the shell 124 when the pressure chamber 1 14 receives the pressurizing fluid. More specifically, when the pressure chamber 1 14 receives the pressurizing fluid, outward forces F6 (FIG. 10) are applied to the shell 124 along the elongated upper end 148 and the elongated lower end 150 of the pressure chamber 114, which in turn apply inward contractive forces F8 to the shell 124 along the short left end 156 and the short right end 158 of the pressure chamber 114. The port 130 applies outward resistance forces F6 (FIG. 1 1 ) against the rib 452 to counteract the inward contractive forces F8. Stated another way, the rib 452 provides a relatively tight fit between the port 130 and the shell 124, thereby inhibiting deformation of the shell 124 when the pressure chamber 114 receives the pressurizing fluid. Illustratively, the rib 452 is disposed around the entire inner perimeter 152 of the rim 128 of the shell 124. In such embodiments, the forces F6 and F7 are both in outward directions at the elongated upper end 148 and the elongated lower end 150, and because the shell 124 is already being urged outward by the port 130 at the elongated upper end 148 and the elongated lower end 150, any additional outward force F7 at the elongated upper end 148 and the elongated lower end 150 due to the pressuring fluid is minimal. Alternatively, the rib 452 extends discontinuously around the inner perimeter 152 of the shell 124; stated another way, the shell 124 includes a plurality of ribs 452 that are positioned in certain locations along the inner perimeter 152 of the shell 124. For example, in one embodiment the ribs 452 are only provided at the short ends 156, 158 of the port 130, so as to only apply the forces F6 in the two opposite elongated directions (opposite the forces F8) to limit outward flexing of the shell124 due to the forces F7. Illustratively, the deformation inhibition interface 450, particularly the ribs 452, are sized to provide space for an adhesive 454 that couples the port 130 to the shell 124. The adhesive 454 is illustratively disposed between the inner perimeter 152 of the rim 128 of the shell 124 and the outer perimeter 154 of the port 130. Illustratively, the adhesive 454 has a tapering shape. More specifically, the adhesive 454 has a conical shape near the exterior of the deformation inhibition interface 450 and a rectangular shape in the interior of the deformation inhibition interface 450.

[0038] Referring to FIGS. 12 and 13, the pressure chamber 114, more specifically the port 130, the shell 124, and another exemplary deformation inhibition interface 550 are illustrated. Referring specifically to FIG. 13, the deformation inhibition interface 550 includes a first rib 552 coupled to the port 130, more specifically the first rib 552 extending outwardly from the outer perimeter 154 of the port 130, and a second rib 554 coupled to the shell 124, more specifically the second rib 554 extending inwardly from the inner perimeter 152 of the shell 124. The first rib 552 and the second rib 554 contact each other to inhibit deformation of the shell 124 when the pressure chamber 114 receives the pressurizing fluid. More specifically, when the pressure chamber 114 receives the pressurizing fluid, outward forces F10 (FIG. 12) are applied to the shell 124 along the elongated upper end 148 and the elongated lower end 150 of the pressure chamber 114, which in turn apply inward contractive forces F11 to the shell 124 along the short left end 156 and the short right end 158 of the pressure chamber 114. The first rib 552 applies outward resistance forces F9 (FIG. 13) against the second rib 554 to counteract the inward contractive forces F11 . Stated another way, the first rib 552 and the second rib 554 provide a relatively tight fit between the port 130 and the shell 124, thereby inhibiting deformation of the shell 124 when the pressure chamber 114 receives the pressurizing fluid. Illustratively, the first rib 552 and the second rib 554 are disposed around the entire inner perimeter 152 of the rim 128 of the shell 124. In such embodiments, the forces F9 and F10 are both in outward directions at the elongated upper end 148 and the elongated lower end 150, and because the shell 124 is already being urged outward by thefirst ribs 552 at the elongated upper end 148 and the elongated lower end 150, any additional outward force F10 at the elongated upper end 148 and the elongated lower end 150 due to the pressuring fluid is minimal. Alternatively, the first rib 552 and the second rib 554 extend discontinuously around the inner perimeter 152 of the shell 124. For example, the ribs 552, 554 could only be provided at the short ends 156, 158 of the port 130, so as to only apply the forces F9 in the two opposite elongated directions (opposite the forces F11 ) to limit outward flexing of the shell 124 due to the forces F10. Illustratively, the deformation inhibition interface 550, particularly the ribs 552 and 554, are sized to provide space for an adhesive 556 that couples the port 130 to the shell 124.The adhesive 556 is illustratively disposed between the inner perimeter 152 of the rim 128 of the shell 124 and the outer perimeter 154 of the port 130. Illustratively, the adhesive 556 has a tapering shape. More specifically, the adhesive 556 has a conical shape near the exterior of the deformation inhibition interface 550 and a non-conical shape in the interior of the deformation inhibition interface 550.

[0039] Referring to FIGS. 14 and 15, the pressure chamber 114, more specifically the port 130, the shell 124, and an exemplary deformation inhibition interface 650 are illustrated. Referring specifically to FIG. 15, the deformation inhibition interface 650 includes one or more high roughness surfaces to facilitate coupling the port 130 and the shell 124 via an adhesive 652. More specifically, the high roughness surfaces provide a relatively large surface area for contact with the adhesive 652, which provides relatively high adhesive forces and thereby inhibits deformation of the shell 124 when the pressure chamber 114 receives the pressurizing fluid. As used herein, a high roughness surface has an average roughness (“Ra”) of 0.3 to 0.5. Illustratively, the outer perimeter 154 of the port 130 comprises a first high roughness surface 654 and the inner perimeter 152 of the rim 128 of the shell 124 includes a second high roughness surface 656. The deformation inhibition interface 650 may additionally include any of the features of the other deformation inhibition interfaces contemplated herein, such as the apertures 252, the posts 254, and / or the ribs 352, 452, 552 and 554.

[0040] Deformation inhibition interfaces according to the present disclosure may take various other forms, such as interfaces including combinations of the features described above. More specifically, deformation inhibition interfaces may include the apertures 252 and the posts 254, the ribs 352, 452, 552 and 554, one or more high roughness surfaces, and / or adhesives.

[0041] 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 and which fall within the limits of the appended claims.

Claims

CLAIMSWHAT IS CLAIMED IS:1 . A drug delivery device comprising: a housing; a needle coupled to the housing; a pressure chamber coupled to the housing, the pressure chamber comprising: a shell; a port coupled to the shell; a flexible drug reservoir disposed in the pressure chamber, the flexible drug reservoir comprising an external surface and an internal chamber containing a drug; a pressure source coupled to the housing, the pressure source being operable to provide a fluid to the pressure chamber and thereby apply fluidic pressure to the external surface of the flexible drug reservoir and compress the flexible drug reservoir; a deformation inhibition interface comprising: an aperture defined on one of the shell and the port; a post coupled to the other of the shell and the port and disposed in the aperture, and the post inhibiting deformation of the shell when the pressure chamber receives the fluid; wherein compression of the flexible drug reservoir causes the drug to flow from the internal chamber of the flexible drug reservoir to the needle.

2. The drug delivery device of claim 1 , wherein the aperture is a first aperture and the post is a first post, and the deformation inhibition interface further comprising: a second aperture formed on the one of the shell and the port; anda second post coupled to the other of the shell and the port and disposed in the second aperture, and the second post inhibiting deformation of the shell when the pressure chamber receives the fluid.

3. The drug delivery device of any of claims 1 -2, wherein the aperture is defined by the port and the post is coupled to the shell.

4. The drug delivery device of any of claims 1 -3, wherein the deformation inhibition interface further comprises an adhesive coupling the port to the shell.

5. The drug delivery device of claim 4, wherein the adhesive is disposed in the aperture.

6. The drug delivery device of any of claims 4-5, wherein the adhesive is disposed between a rim of the shell and an outer perimeter of the port.

7. The drug delivery device of claim 6, wherein at least one of the rim of the shell and the outer perimeter of the port comprises a high roughness surface.

8. The drug delivery device of claim 6, wherein the rim of the shell comprises a first high roughness surface and the outer perimeter of the port comprises a second high roughness surface.

9. The drug delivery device of any of claims 1 -8, wherein the port comprises an outlet through which the drug flows from the internal chamber of the flexible drug reservoir to the needle.

10. A drug delivery device comprising: a housing; a needle coupled to the housing; a pressure chamber coupled to the housing, the pressure chamber comprising: a shell; a port coupled to the shell; a flexible drug reservoir disposed in the pressure chamber, the flexible drug reservoir comprising an external surface and an internal chamber containing a drug; a pressure source coupled to the housing, the pressure source being operable to provide a fluid to the pressure chamber and thereby apply fluidic pressure to the external surface of the flexible drug reservoir and compress the flexible drug reservoir; a deformation inhibition interface comprising a rib coupled to one of the shell and the port, the rib contacting the other of the shell and the port to inhibit deformation of the shell when the pressure chamber receives the fluid; wherein compression of the flexible drug reservoir causes the drug to flow from the internal chamber of the flexible drug reservoir to the needle.1 1 .The drug delivery device of claim 10, wherein the rib is coupled to the port.

12. The drug delivery device of claim 1 1 , wherein the rib extends outwardly from an outer perimeter of the port.

13. The drug delivery device of claim 10, wherein the rib is coupled to the shell.

14. The drug delivery device of claim 13, wherein the rib extends inwardly from an inner perimeter of a rim of the shell.

15. The drug delivery device of any of claims 10-14, wherein the rib is disposed around an entire perimeter of the port.

16. The drug delivery device of claim 10, wherein the rib is a first rib, and the deformation inhibition interface further includes a second rib coupled to the other of the shell and the port, the second rib contacting the one of the shell and the port to inhibit deformation of the shell when the pressure chamber receives the fluid.

17. The drug delivery device of claim 16, wherein the first rib contacts the second rib to inhibit deformation of the shell when the pressure chamber receives the fluid.

18. The drug delivery device of any of claims 10-17, wherein the deformation inhibition interface further comprises an adhesive coupling the port to the shell.

19. The drug delivery device of claim 18, further comprising a high roughness surface in contact with the adhesive.

20. The drug delivery device of any of claims 10-19, wherein the port comprises an outlet through which the drug flows from the internal chamber of the flexible drug reservoir to the needle.

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