Portable infusion pump and assembly for use therewith

Abstract

Portable infusion pumps, medicament reservoirs, and medicament seal assemblies, including various needle seal assemblies and stopper seal assemblies, and related components, combinations of components, and methods.

Description

[0001] This application is a divisional application of the invention patent application filed on February 12, 2017, with application number 201780023000.5 and invention title "Portable Infusion Pump and Components Used Therewith".

[0002] Cross-references to related applications

[0003] This application claims the benefit and priority of U.S. Provisional Patent Application Serial No. 62 / 294,941, previously filed on February 12, 2016, which is incorporated herein by reference in its entirety. Technical Field

[0004] This apparatus and method generally relate to portable (ambulatory) infusion pumps and seals for those pumps. Background Technology

[0005] Portable infusion pumps (also referred to herein as “infusion pumps”) are relatively small, at least substantially stand-alone devices used to deliver medications and other infusionable substances (collectively, “medications”) into a patient’s body. Some infusion pumps are configured to be worn on a strap, carried in a clothing pocket, etc. Others are configured to adhere to the skin as a patch. The advantage of infusion pumps is that they can be used for the subcutaneous introduction (or “infusion”) of medications, for example, on a continuous or even intermittent basis outside of a clinical setting. Another advantage of infusion pumps is that they significantly reduce the frequency of subcutaneous entry events, such as needle-based injections. An example of a medication that can be delivered via an infusion pump is a liquid formulation of insulin. Other exemplary medications that can be delivered via an infusion pump include, but are not limited to, medications for treating cancer and medications for suppressing pain sensations.

[0006] Many conventional infusion pumps have improved patient health and quality of life. However, the inventors have determined that conventional infusion pumps are susceptible to extensive modifications. By way of example and not limitation, the inventors have determined that it is desirable to provide an infusion pump that is smaller, simpler, and less expensive than conventional infusion pumps, while also being more accurate. Summary of the Invention

[0007] An apparatus according to at least one of the invention comprises a drug reservoir, a reservoir outlet in fluid communication with the drug reservoir, and a needle sealing assembly associated with the reservoir outlet and including a needle having a rod and a tip and movable relative to the reservoir outlet, configured to prevent drug flow through the reservoir outlet when the needle is in a first position, and to allow drug flow through the reservoir outlet in response to movement of the needle from the first position. The invention also includes an infusion pump having such an apparatus.

[0008] An apparatus according to at least one of the invention comprises a drug reservoir, a reservoir outlet in fluid communication with the drug reservoir, a fill port in fluid communication with the drug reservoir, and a filler plug sealing assembly associated with the fill port and the reservoir outlet and including a core pin, configured to prevent drug flow through the reservoir outlet when the core pin is in a first position and to allow drug flow through the reservoir outlet in response to movement of the core pin from the first position. The invention also includes an infusion pump having such an apparatus.

[0009] The features and accompanying advantages of the invention will become apparent as a result of a better understanding of the invention when considered in conjunction with the accompanying drawings and the following detailed description. Attached Figure Description

[0010] A detailed description of exemplary embodiments will be given with reference to the accompanying drawings.

[0011] Figure 1A This is a perspective view of an exemplary infusion pump system in its assembled state.

[0012] Figure 1B Is it like this? Figure 1A The exploded perspective view of the infusion pump system shown includes durable components and disposable components.

[0013] Figure 2 yes Figure 1A and Figure 1B A top view of some components of the infusion pump system shown.

[0014] Figure 2A It is shown as follows Figure 1A and Figure 1B The diagram shows the use of the infusion pump system.

[0015] Figure 2B It is shown as follows Figure 1A and Figure 1B The diagram shows another use of the infusion pump system.

[0016] Figure 3A This is a perspective view of an exemplary durable component.

[0017] Figure 3B yes Figure 3A A perspective view of some parts of the durable component shown.

[0018] Figure 4A This is a perspective view of an exemplary discardable component.

[0019] Figure 4B yes Figure 4A A perspective view of some parts of the discardable component shown.

[0020] Figure 5AThis is a perspective view of certain parts of a durable and disposable component of an exemplary infusion pump system.

[0021] Figure 5B yes Figure 5A A perspective view of a component of the exemplary durable component shown.

[0022] Figure 5C yes Figure 5A A perspective view of the component of the exemplary discardable component shown.

[0023] Figure 6 yes Figure 5A The perspective cross-sectional view of the components of the exemplary infusion pump system shown reveals gaps between certain parts of the durable and discardable components.

[0024] Figure 7 It is a front view showing the patient's skin being cleaned.

[0025] Figure 8 This is a flowchart illustrating an exemplary method for removing and replacing a discardable component.

[0026] Figure 9A This is a perspective view of another exemplary infusion pump system in its assembled state.

[0027] Figure 9B yes Figure 9A A perspective view of an exemplary durable component of an infusion pump system.

[0028] Figure 9C yes Figure 9B A perspective view of some parts of the durable component shown.

[0029] Figure 9D yes Figure 9A A perspective view of an exemplary discardable component of an infusion pump system.

[0030] Figure 9E yes Figure 9D A perspective view of some parts of the discardable component shown.

[0031] Figure 10A This is a perspective view of some exemplary components of a discardable component.

[0032] Figure 10B yes Figure 10A An exploded perspective view of some of the components shown.

[0033] Figure 11A This is an exploded cross-sectional view of some exemplary components of a discardable component.

[0034] Figure 11B yes Figure 11A The cross-sectional view of the components shows their assembled positions.

[0035] Figure 11C-11F It is shown that... Figure 11A The cross-sectional view of the additional exemplary components used in the components shows their assembled positions.

[0036] Figure 12 It is a cross-sectional view showing some alternative parts of the discardable component.

[0037] Figure 13A This is a side view showing the additional, alternative parts of the discardable component.

[0038] Figure 13B yes Figure 13A A cross-sectional view of some exemplary components of the component.

[0039] Figure 13C yes Figure 13B A 90-degree cross-sectional view of the component.

[0040] Figure 13D yes Figure 13A A side view of some exemplary components of the component, shown in a pre-allocated or storage location.

[0041] Figure 13E yes Figure 13D A 90-degree cross-sectional view of the component, showing Figure 13D The button has been pressed.

[0042] Figure 13F yes Figure 13D A side view of some parts of the component.

[0043] Figure 13G yes Figure 13F A cross-sectional view of the component.

[0044] Figure 13H yes Figure 13A A cross-sectional view of some exemplary components of the component, shown in a pre-allocated or storage location.

[0045] Figure 13J yes Figure 13H A cross-sectional view of the component, showing Figure 13H The button has been pressed.

[0046] Figure 13K yes Figure 13A A cross-sectional view of some exemplary components of the component.

[0047] Figure 13M yes Figure 13K A close-up cross-sectional view of a portion of it.

[0048] Figure 13N It is along Figure 13MThe cross-sectional view taken from line 13N-13N in the diagram.

[0049] Figure 13P yes Figure 13A A side view of some exemplary components of the component, shown in a pre-allocated or storage location.

[0050] Figure 13Q yes Figure 13P A perspective view of certain parts of the component.

[0051] Figure 14A It is a perspective view showing the alternative parts of the discardable component.

[0052] Figure 14B yes Figure 14A Partial exploded cross-sectional view of certain exemplary components of the component.

[0053] Figure 14C yes Figure 14A A perspective view of certain parts of the component.

[0054] Figure 14D It is shown Figure 14A A perspective view of the additional parts of the component.

[0055] Figure 15A and Figure 15B This is a side view showing the alternative parts of the discardable component.

[0056] Figures 16A-16C It is a perspective cross-sectional view showing the additional alternative parts of the discardable component, shown in the pre-allocated or storage location.

[0057] Figure 16D yes Figures 16A-16C A perspective cross-sectional view of the component, showing Figure 16C The button has been pressed.

[0058] Figures 17A-17C It is a perspective cross-sectional view showing further alternative parts of the discardable component, shown in a pre-allocated or storage location.

[0059] Figure 17D yes Figures 17A-17C A perspective cross-sectional view of the component, showing Figure 17C The button has been pressed.

[0060] Figure 17E yes Figures 17A-17C Another cross-sectional view of the component shows Figure 17C The button has been pressed.

[0061] Figure 18AThis is a side view of some exemplary components that can be used with discardable components, shown in a pre-assigned or stored location.

[0062] Figure 18B yes Figure 18A A side view of the component, showing an additional exemplary component and in a pre-assigned or stored location.

[0063] Figure 18C Is Figure 18B A perspective view of the components, showing them in their pre-assigned or stored locations. Detailed Implementation

[0064] The following is a detailed description of the currently known best mode for carrying out the invention. This description is not restrictive, but merely for the purpose of illustrating the general principles of the invention.

[0065] It should also be noted that this specification describes structures and methods particularly suitable for subcutaneous delivery of high-concentration insulin such as U-500 insulin (i.e., U-200 insulin and above) and low-concentration insulin such as U-100 insulin. However, it should be understood that the invention is applicable to a variety of infusion pumps and pharmaceutical preparations. By way of example and not limitation, the invention may employ a reservoir with a plunger for fluid transfer, a fluid transfer device in the form of a plunger actuator, and a drive mechanism including a motor, or other fluid transfer devices, regardless of the type of reservoir, piston pump (e.g., electromagnetic pump), MEMS pump, peristaltic pump, and any other suitable pump and corresponding drive mechanism. Exemplary infusion pumps comprising a reservoir with a plunger, a fluid transfer device in the form of a plunger actuator, and a drive mechanism are described in U.S. Patent Application Serial No. 12 / 890,207, filed September 24, 2010, and the corresponding U.S. Patent Publication No. 2012 / 0078170 (both incorporated herein by reference in their entirety). This invention can also be applied to pharmaceuticals, such as, for example, drugs for masking pain, chemotherapy and other cancer-related drugs, antibiotics, hormones, GLP-1, glucagon, and various other drugs including macromolecules and proteins that may require high levels of delivery accuracy, as well as high-concentration insulin such as U-500 insulin (i.e., U-200 insulin and above) and low-concentration insulin such as U-100 insulin. The aforementioned U.S. Patent Publication No. 2012 / 0078170, U.S. Provisional Patent Application Serial No. 62 / 057,273, U.S. Patent Application Serial No. 14 / 869,906, and the corresponding U.S. Patent Publication No. 2016 / 0089491 also describe patient interaction and use with infusion pumps (such as the exemplary infusion pumps described herein).

[0066] As mentioned above, some portable infusion pumps are designed to be worn on a strap, carried in a pocket, or otherwise supported within some type of support (collectively referred to as "pocket pumps"). These infusion pumps deliver fluid from a reservoir to an infusion device via a thin tube. Subcutaneous access can be achieved through a cannula within the infusion device. Other portable infusion pumps are designed to adhere to the skin above the delivery site (sometimes called "patch pumps"). Here, the cannula or other subcutaneous access device extends directly from the infusion device. Given these modes of use, patients generally prefer the device to be as small as possible for greater comfort, less obtrusiveness, and less visibility. Furthermore, patients desire a simple and convenient device.

[0067] An exemplary portable infusion system, which is generally in Figure 1A , Figure 1B and Figure 2 The reference numeral 100 indicates the components, including a durable component 200 and a disposable component 300. The exemplary durable component 200 includes a housing 202, one or more batteries or other energy supply components 221, one or more capacitors or other energy storage components 222, a microprocessor 223, a coil assembly 224 (which serves as a motor stator), and one or more Hall effect sensors 225. The exemplary disposable component 300 includes: a substrate 350 supporting components such as a magneto rotor 331; a gear train 332 including a lead screw drive gear 333 in a reservoir support block 337; and a lead screw 334 attached to a plunger 335 located in a drug reservoir 336, which is mounted to the reservoir support block 337. The exemplary plunger 335 includes a core and a plurality of seals on the core. Cover 302, beneath which some or all of the magneto rotor 331, gear train 332 (with drive gear 333), lead screw 334, plunger 335 and drug reservoir 336 are located in various embodiments and can be mounted to base plate 350.

[0068] The lead screw drive gear 333, lead screw 334, plunger 335, drug reservoir 336, and reservoir support block 337 may also be collectively referred to as a "reservoir assembly". Other exemplary reservoir assemblies, durable components, and sealing assemblies that may be used, for example, in infusion system 100, are referenced below. Figure 9D-18C describe.

[0069] The exemplary disposable component 300 can be fastened to the exemplary durable component 200, such as Figure 1A and Figure 2As shown. For this purpose, the exemplary housing 202 includes a top wall 204, bottom walls 206a and 206b, and a side wall 208, which together define a relatively thin housing portion 210 and a relatively thick housing portion 212. A notch 214 is formed in the relatively thick portion 212. The exemplary cover 302 includes top walls 304a and 304b and a side wall 306, which together define a relatively thin cover portion 308 and a relatively thick cover portion 310. A portion of the substrate 350 is not covered by the cover 302, thereby defining a recess 312, which is defined by a wall 314 extending around the substrate (see also...). Figure 4B When durable and disposable components 200 and 300 are used... Figure 1A When fastened together as shown, the relatively thicker portion 212 of the housing 202 will be located in the recess 312 of the disposable assembly 300 (wherein the wall 314 is located in the notch 214). The relatively thinner portion 210 of the housing 202 will be located on the top wall 304b of the cover 302. The cover 302 also includes a protrusion 316 that engages with the recess 216 on the housing 202. Furthermore, as discussed in more detail below, the disposable assembly 300 can be configured for different agents, such as different agent concentrations, different dosages, or different system operating modes.

[0070] In other embodiments, cover 302 may be configured to cover less than all components on substrate 350. For example, the cover may be configured such that a portion of the magneto rotor 331 and gear train 332 are not covered, while the remaining components are covered. In further embodiments, cover 302 may be omitted, and durable component 200 may be configured to cover all components on substrate 350. In still further embodiments, referred to herein as a "durable" component, it may be disposable, thus forming a completely disposable system.

[0071] As discussed in U.S. Patent Publication No. 2012 / 0078170, and U.S. Application Serial No. 13 / 300,574, filed November 19, 2011, and the corresponding U.S. Patent Publication No. 2012 / 0184907, and U.S. Application Serial No. 13 / 475,843, filed May 18, 2012, and the corresponding U.S. Patent Publication No. 2013 / 0138078, each of which is incorporated herein by reference in its entirety, a portable infusion system employing a reservoir on a substrate can be configured for different types of use. For example, a disposable component 300 can adhere to a patient's skin and can be used in conjunction with a cannula (not shown) operatively connected to a reservoir 336, such that system 100 can be deployed as a "patch pump," as shown in Figure 2A. Alternatively, as Figure 2B As shown, the substrate 350 of the discardable component 300 can be configured to operatively connect the storage device 336 to the infusion apparatus 382 (e.g., via...). Figure 1B and Figure 2 The infusion device tubing and connector 380 shown in the diagram allow the system 100 to be deployed as a "pocket pump," a "wearable pump," or some other wearable pump. In other words, using the same durable component 200, a user can configure the system as a "pocket pump" or a "patch pump" by simply selecting and attaching a suitable disposable component to the durable component. The user can also switch from one configuration to another by simply removing a disposable component and replacing it with another disposable component. Connector 380 can also be used as a filling port, as described below.

[0072] Therefore, it should be noted that the present invention includes kits comprising various combinations of disposable components, wherein at least two of the disposable components may be different. Additionally or alternatively, the kit or other set may include various disposable component parts, such as infusion devices and / or cannula inserters. The kit may also include durable components. Disposable components in such kits may also include detection / identification tools discussed below. The individual parts of this kit (e.g., combinations of various disposable components and / or parts) may be stored in a common set, or, if desired, have separate sets for each part, and be provided to the user in a common set. Other components that may be provided in such kits include, but are not limited to, inserters pre-loaded with cannulas and cleaning swabs. A charger may also be provided in kits that include durable components.

[0073] In addition to removable component kits and labels, different removable components can include visual cues to distinguish them. For example, removable components with different reagent concentrations or different reagent fill volumes can use different colors for the removable component's reservoir and / or substrate, or use mechanical features to ensure that the removable component can only be attached to the correctly programmed durable component.

[0074] However, regarding priming, it should be noted that the dispensing procedure associated with the "patch pump" configuration of the infusion system (which may include durable component 200 and disposable component 300) is essentially the same as that associated with the "pocket pump" configuration (which may also include infusion device 382) (see Figure 2B). For the "patch pump" configuration, priming is not required because the associated cannula will be very small and there is a direct connection between the cannula and the drug reservoir. However, priming is necessary in the "pocket pump" configuration to fill the infusion device tubing before drug delivery begins. Figure 2BFor example, 20-30 μl might be needed to fill the entire infusion device tubing, and correspondingly, the filling procedure might involve the rapid delivery of 10-15 IU of U-500 insulin into the tubing. The inventors have determined that it would be advantageous to prevent the user from initiating the filling procedure when the system is in a "patch pump" configuration, where the cannula is positioned to deliver medication substantially directly from the drug reservoir to the patient, as rapid delivery of 10-15 IU of insulin to the patient could have adverse effects on the patient's health.

[0075] To prevent such undesirable results, and for user convenience in other situations involving selection among various disposable components (such as disposable components having reservoirs containing different agents, different agent concentrations, and / or different drug dosages), at least some of the disposable components of the present invention may be provided with a substrate identification device, and at least some of the disposable components of the present invention may be provided with a structure that cooperates with the substrate identification device in such a way that the durable component microprocessor / controller can perform a "substrate type" determination. Exemplary substrate identification tools and methods may be described in the aforementioned U.S. Patent Publications 2012 / 0078170, 2012 / 0184907, and 2013 / 0138078. Alternatively, substrate identification may be performed mechanically. For example, pins or ribs may prevent certain disposable components from being attached to certain durable components. Alternatively or alternatively, certain durable components will simply not function with certain disposable components.

[0076] Alternatively, patients or clinicians can program the system (e.g., via a remote control) to specify the type of attached disposable component. In this way, patients can have a variety of medications available for use with a single durable component.

[0077] Once the "substrate type" is determined (e.g., "patch pump" disposable component 300 versus "pocket pump" with infusion device 382 attached), the durable component will be handled in a manner or operating mode suitable for the attached disposable component. For example, if a "patch pump" disposable component 300 is detected, the durable component controller will not include filling as part of the delivery process, and in some embodiments, will prevent the user from manually performing the filling process. On the other hand, if a "pocket pump" disposable component is detected, the delivery process may include appropriate filling of the infusion device tubing.

[0078] Whether configured as a "pocket pump" or a "patch pump," the system can be configured to deliver a basic dose of medication based on a delivery profile provided by a physician via a clinician's programming unit. For example, the system may include a program that stores multiple delivery profiles (e.g., delivery profiles associated with a 24-hour delivery cycle, delivery profiles for specific conditions such as sleep or illness, etc.). Each delivery profile specifies multiple doses (or pump "operations") over time, e.g., a specific number of doses at a specific time or a specific number of doses per unit time. In some implementations, the dose may be a volume associated with a minimum controllable displacement of plunger 335. The system can also be configured to respond to a patient remote control 1000 ( Figure 2A The system provides bolus delivery in response to instructions from the patient's remote control 1000. The bolus instruction can be in response to a high glucose level measurement in a diabetic patient, an increase in pain level in a pain management patient, or some other symptom. The system can also be configured to perform other functions, such as ending medication delivery in response to instructions from the patient's remote control 1000.

[0079] This infusion pump can be used in conjunction with various remote controls. Such remote controls can be used, for example, to allow a user to transmit commands to durable component 200 or to facilitate communication between durable component 200 and the user (e.g., alarm status messages or other messages regarding the status of system 100). Example remote control 1000 ( Figure 2A The device can be configured to facilitate one, some, or all of the following operations: (1) turning the remote control 1000 on or off, (2) associating (or “assigning”) the remote control 1000 to the durable component 20, (3) obtaining status information such as drug level, battery charge level, and / or alarm status, (4) silencing the durable component alarm, (5) selecting options that can be associated with the durable component alarm, such as alarm type (audible, tactile, and / or visible) and alarm intensity / volume, (6) connecting the remote control 1000 to a computer, for example, updating the remote control or durable component firmware, loading and deleting delivery curves stored in the durable component or remote control, and otherwise reprogramming the durable component or remote control, (7) selecting drug options such as drug concentration, (8) selecting and activating a stored drug delivery curve, (9) increasing and decreasing the drug dosage rate, and / or (10) pausing the dispensing operation. Users can pause delivery to remove or replace structures applied to the patient (e.g., disposable components), adjust for current or anticipated changes in physical condition (e.g., low glucose, strenuous exercise), follow a doctor's advice, or disconnect durable components from the body for any other reason.

[0080] Example remote control 1000 ( Figure 2AThe device can be configured to generate instructions based on information from the microprocessor 223 for the durable component 200, indicating, for example, the amount of time remaining in the current allocation procedure, the amount of time until the next replacement of the disposable component, etc. The instructions can be auditory, visible, tactile, or a combination thereof. Remaining time instructions can be useful for various reasons. For example, knowing the remaining time before the next replacement of the disposable component allows the patient to determine, at least in part, based on the current time of day and upcoming events (e.g., travel or sleep), whether it would be more convenient to replace the disposable component before the end of the allocation procedure.

[0081] As described above, parts of this system can be considered reusable, while other parts can be considered disposable. In the illustrated embodiment, durable component 200, which may include structures such as microprocessor 223 and coil assembly 224, is reusable, while exemplary disposable component 300, which may include structures such as motor rotor 331 and storage 336 on substrate 350, is disposable. In other embodiments, this system may be entirely disposable.

[0082] Regarding dimensions, some embodiments of the exemplary infusion pump system 100 may have the following dimensions: a length of 35mm + / - 1.0mm, 35mm + / - 0.10mm, or 35mm + / - 5.0mm; a width of 30mm + / - 1.0mm, 30mm + / - 0.10mm, or 30mm + / - 5mm; and an overall thickness or height of 8.5mm + / - 1.0mm, 8.5mm + / - 2mm, or 8.5mm + / - 0.10mm. Suitable housing materials include, but are not limited to, plastics or other materials having an elastic modulus of 0.2-1.0 million psi.

[0083] Exemplary durable component microprocessors and associated circuitry; rechargeable batteries and associated battery chargers and charging methods; battery and charging management; temperature sensors; and exemplary alarms and alarm conditions are described in more detail in the aforementioned U.S. Patent Publications 2012 / 0078170, 2012 / 0184907, and 2013 / 0138078.

[0084] Turn now Figure 3A and Figure 3B The exemplary durable component 200 may include a power source such as one or more batteries 221, a temporary power storage device such as one or more capacitors 222 (see [link to documentation]). Figure 2 and Figure 5BThis includes components such as a controller (microprocessor 223), a coil assembly 224, and a Hall effect sensor 225. Those skilled in the art will understand that including the motor's coil assembly 224 and all other electronics within the durable component 200 reduces the cost and complexity of the disposable component 300. Furthermore, the microprocessor 223 provides flexibility, including features such as user data storage, programs, programmability, adjustability, displays, buttons, wireless communication protocols, etc., incorporated into the pump 100. The durable component 200 may also be molded with locking features that snap onto the disposable component 300; however, this also allows the durable component 200 to be removed from the disposable component 300 while the disposable component remains in place on the patient (after medication delivery has been paused) or after the entire system has been removed from the patient.

[0085] The power source can be one or more commercially available batteries, such as commercially available zinc-air batteries or lithium polymer batteries. The batteries can be selected to have sufficient capacity to operate the system for a given delivery volume or delivery time, such as more than 400 units of insulin. Optional power storage devices can be one or more commercially available capacitors or supercapacitors, or one or more other temporary storage devices.

[0086] Turn now Figure 4A and Figure 4B An exemplary disposable component 300 may include a substrate 350 and components such as a reservoir 336, a plunger 335 within the reservoir and connected to a lead screw 334, and a magneto rotor 331 mechanically attached via a gear train 332 to influence rotation of a lead screw drive gear 333, which causes translation of the lead screw 334 and the plunger 335 within the reservoir 336. In the illustrated embodiment, a cover 302 is positioned to cover these components. The exemplary substrate 350 includes an adhesive backing attached to a patient using a removable adhesive cover. The substrate 350 may also be molded with substrate locking features that snap onto the durable component 200 (such as magnets molded into the housing of each component) and also allow removal of the durable component 200 from the disposable component 300.

[0087] like Figure 2 and Figure 4B As shown, the exemplary reservoir 336 includes a cylinder 338 having an inner surface 340 defining a fluid storage volume 342 and an elliptical cross-section; however, other shapes (such as annular) are also possible, as referenced below. Figure 10A-18CThe plunger 335, having a matching cross-sectional shape, fits within the cylinder and carries a fluid seal, such as, but not limited to, O-rings, to seal the medication within the storage volume 342. An exemplary plunger 335 is made of rubber and includes three O-ring seals. The reservoir 336 includes the previously mentioned connector 380, which can be used to fill the reservoir 336, or, for "patch pump" type configurations, for attaching a cannula, or, for "pocket pump" type configurations, for connecting (potentially via one or more suitable adapters) an infusion device. The plunger 335 moves within the cylinder 338 to change the volume of medication within the storage volume 342. The reservoir 336 may, for example, be pre-filled (or user-filled) with U-500 insulin in various volumes to suit a patient's usage profile. In other cases, lower concentrations of insulin, such as U-100 and U-200 insulin, may be used. A stopper can be inserted into the connector 380 to maintain a sterile environment before use. In those cases, the patient will remove the stopper before use.

[0088] Additional exemplary substrates for use with the disposable components of the present invention, as well as exemplary cannula designs, fluid connections between the drug reservoir and the cannula, cooperation between the cannula and the disposable component (e.g., to prevent axial movement of the cannula relative to the substrate and the patient), attachment of infusion devices to the reservoir of the disposable component, configuration and use of non-delivery substrates, arrangements and structures for attaching disposable and durable components, skin adhesive designs, and various occlusion sensors, may be described as in U.S. Patent Application Serial No. 12 / 890,207, filed September 24, 2010, and the corresponding U.S. Patent Publication No. 2012 / 0078170, as well as the aforementioned U.S. Patent Publications Nos. 2012 / 0184907 and 2013 / 0138078.

[0089] Now turn to Figures 5A-5CThe two-piece motor shown, with the coil assembly 224 (and Hall effect sensor 225) of the durable component 200 positioned above the magneto rotor 331, which is part of the discardable component 300. An exemplary multi-pole motor rotor 331 may be disc-shaped and have an outer diameter of 9.8 mm, an inner diameter of 5.2 mm, and a thickness of 0.8 mm. Another exemplary motor rotor may have an outer diameter of 11 mm, an inner diameter of 5 mm, and a thickness of 1.2 mm. This type of multi-pole motor rotor typically costs less than 5 cents per piece, helping to control the total cost of the discardable component 200. The motor rotor 331 is also parallel to the substrate 350; that is, in the illustrated embodiment, the axis of rotation of the motor rotor is perpendicular to the substrate. The microprocessor 223 guides the rotation of the motor rotor 331 by sequentially exciting the coils of the motor coil assembly 224 to generate electromagnetic torque coupling between the motor coil assembly 224 and the motor rotor 331. The position / orientation of each pole of the rotor relative to the rotating magnetic field generator (coil assembly 224) is determined by the inverse EMF, rotary encoder, and Hall effect sensor 225. Figure 5A Measurements such as those performed on the coil windings are possible. For example, Hall effect sensors mounted on the coil windings can be used to supply a microprocessor with counting, tachometer signals, or rotor position, allowing for low-cost closed-loop control of the rotor speed. This type of brushless motor typically has an efficiency of 85-90% or higher and operates very coolly. Although structural variations may exist, Figures 5A-5C The face-to-face stator coils and flat rotor plate shown provide a compact design. Additionally, more coils and / or Hall effect sensors can be used.

[0090] from Figure 6 As can be best seen, there is a gap 240 between the motor coil assembly 224 and the motor rotor 331. Some or all of the gap 240 may be defined (and occupied) by portions of the housing 202 and the cover 302 (i.e., the bottom wall 206a of the housing and the top wall 304b of the cover in the illustrated embodiment). In other embodiments, the gap 240 between the motor coil assembly 224 and the motor rotor 331 may be occupied only by a portion of the durable component housing, or only by a portion of the disposable component cover, or may have no structure at all and may simply be an air gap. The size of the gap defined by the distance between the motor coil assembly 224 and the motor rotor 331 is generally from about 0.5 mm to 2.0 mm. Thus, there is no gear engagement or other mechanical connection between the durable component 200 and the disposable component 300. And as previously stated, all electronics can be positioned within the durable component 200, wherein the energy required by the disposable component 300 is transferred from the durable component 200 via electromagnetic torque coupling, which is a coupling without direct mechanical coupling or electrical contact. This exemplary design offers the added advantage of relatively simple manufacturing to make it waterproof or at least water-resistant.

[0091] As described above, the rotation of the motor rotor 331 drives the gear train 332, causing the lead screw drive gear 333 to rotate, which in turn affects the translation of the lead screw 334 and the plunger 335 attached to the lead screw 334. In this way, electromagnetically generated torque is produced when the electromagnetic energy supplied by the durable component 200 is converted into a mechanical force propelling the plunger 335 within the disposable component 300. A ratchet (not shown) or other similar device may be used to prevent reverse drive of the gear train 332. As the plunger 335 is driven via the reservoir 336, the medication is precisely dispensed, corresponding to the precise movement of the gears and the motor rotor. Since the entire gear train, lead screw drive gear, lead screw, and plunger are permanently contained within the disposable component 300, it is not necessary to retract any plunger components into the durable component 200 before separating them from the disposable component 300. As a result, another advantage of this exemplary design is the significant reduction in energy consumption, which allows the use of, for example, one or more galvanic cells as a power source.

[0092] The use of the exemplary system 100 will now be described. At the most basic level, the exemplary infusion pump system (e.g., Figure 1A-2B Patient use of System 100 involves obtaining a new disposable component 300, attaching the disposable component to the durable component 200, peeling the liner from the substrate adhesive layer, obtaining subcutaneous access, and initiating the drug delivery operation. In some cases, use may involve additional steps, such as attaching a cannula to the connector 380 of the disposable component and removing the cannula cap, if necessary. The basic aspects of the operation of this system are described below. Not all steps are necessarily required for the operation of the system at each deployment, and the order of some steps may be changed. Operation is also discussed below, within the exemplary context of the durable component 200 and the disposable component 300 used as a patch pump, using a flowchart (…). Figure 8 However, this discussion applies equally to other patch pump implementations, as well as pocket pump implementations with minor variations. Furthermore, unless otherwise stated, the actions performed by the durable component 200 and the determination of these actions are controlled by the durable component microprocessor, and for the sake of brevity, further reference to the controller is limited.

[0093] refer to Figure 8The use of this system may involve removing and replacing the disposable component from the durable component. This may occur when the medication reservoir is empty (as described in more detail in U.S. Patent Application Serial No. 12 / 890,207 and the corresponding U.S. Patent Publication No. 2012 / 0078170) (step S101), and when a “Replace Disposable Component” message or alarm is presented (step S102), or when the durable component controller receives a user-initiated “Replace Disposable Component” signal from the remote controller 1000 (step S103). Users may wish to replace the disposable component before the medication reservoir is empty for various reasons, such as, for example, to accommodate the user's sleep or travel plans, when the medication exhibits loss of effectiveness, when dispensing problems occur, or due to changes in the medication prescription.

[0094] The user may then obtain a new pre-filled disposable component 300 from the storage container in the refrigerator according to the medication requirements, or may then obtain a new disposable component and fill the disposable component with the medication (step S104). The durable component 200 and the disposable component 300 can then be removed from the skin, separated, and the disposable component 300 can be discarded (steps S106 and S107).

[0095] Next, the new disposable component 300 can be attached to the durable component 200 (step S109). The user should clean the skin surface S, and the substrate 350 of the disposable component 300 will adhere to the skin surface. Figure 7 ,and Figure 8 Step S116). Then, the user peels off the substrate adhesive liner to expose the substrate adhesive layer (step S117) and removes the sleeve cap (if present) (step S118). Figure 8 In an exemplary use, the disposable component 30 is supplied with a cannula in fluid communication with the storage volume of the reservoir. In other embodiments, a cannula inserter may be attached to the system and may be triggered to insert the cannula after the system is in place against the skin. An exemplary inserter is described in U.S. Patent Publication No. 2013 / 0138078.

[0096] return Figure 8In each step of the process, the system 100, including the durable component 200 and the disposable component 300, can be positioned over a suitable body location and gently pressed to adhere the adhesive layer to the skin surface S. Once the system has adhered (step S119), the inserter can be activated to position the end of the cannula under the skin. It should be noted that in embodiments that do not include an inserter, but instead simply include a hollow needle (or cannula and removable needle arrangement) protruding outward from the bottom surface of the system, the user only needs to adhere the adhesive layer to position the needle or cannula under the skin. The needle can then be removed (if used). Finally, if desired, the remote control 1000 can be used to initiate a specific drug delivery operation (step S120). The delivery operation can follow a predetermined delivery curve (e.g., a specific base rate, a series of timed bolus deliveries, or some combination thereof), which is equal to the rotation of the motor rotor at a specific rate and time, delivering the drug according to the curve. Alternatively, this curve can be input by the user using the remote control 1000 and stored by the durable component microprocessor. For example, the remote control can store multiple different delivery curves and bolus deliveries, from which the patient can select. Such curves can correspond to, for example, and depend on the medication, days of expected strenuous exercise, days of expected non-strenuous exercise, the occurrence of increased pain, etc. Optionally, or additionally, the curves stored in the durable component's microprocessor can be set by the clinician's programming unit. In this case, as in the case of different discardable components 300 provided with different specified delivery rates, a remote control may not be needed to initiate, for example, a basic delivery.

[0097] The above discussion can also be applied to, for example Figure 2B The use of the “pocket pump” system is illustrated. Minor variations in the above process include, for example, using an infusion device 382 instead of a cannula, attaching the infusion device to the connector 380, potentially via an adapter (which may vary depending on the type of infusion device 382), and the filling of the infusion device tubing.

[0098] Another exemplary portable infusion system, which generally consists of Figure 9A Reference numeral 100a in the figures indicates that the system includes a durable component 200a and a disposable component 400. System 100a is substantially similar to system 100. However, here, the intersections of the top walls are primarily linear. Additionally, the disposable component 400 has a groove 316a that mates with a corresponding protrusion 216a on the durable component 200a. The protrusion 216a and the groove 316a are located at the outer perimeter of the assembled system 100a.

[0099] Exemplary durable component 200a, in Figure 9B and Figure 9CFurther details are shown, which may include a housing 202a, one or more batteries or other power supply components 221a, one or more capacitors or other energy storage components (not shown), a microprocessor (not shown), and a coil assembly 224a (not shown) including one or more Hall effect sensors. An exemplary discardable component 400, in Figure 9D and Figure 9E Further details are shown, which may include a base plate 450 supporting components such as a magneto rotor 431, a gear train 432 including a lead screw drive gear 433, and a lead screw 434 attached to a plunger assembly 435 located in a drug reservoir 436. The magneto rotor 431 may be mechanically attached via the gear train 432 to influence the rotation of the lead screw drive gear 433, causing the lead screw 434 and plunger 435 to translate within the reservoir 436. The reservoir 436 may be pre-filled, for example, with U-500 or U-100 insulin or other concentrations of insulin to suit different patient use profiles, or may be user-fillable via a filling port 415. A reservoir outlet 438 is in fluid communication with the reservoir 436. A diaphragm 446, which may form part of a cannula sealing assembly (such as those described below), is positioned within the reservoir outlet. A disposable assembly 400 may be fastened to a durable assembly 200a, such as... Figure 9A As shown, and further described in U.S. Provisional Patent Application Serial No. 62 / 057,273, the corresponding U.S. Patent Application Serial No. 14 / 869,906 and the corresponding U.S. Patent Publication No. 2016 / 0089491.

[0100] The reservoir may, but is not required, be pre-filled. Pre-filled reservoirs are advantageous for various reasons. By way of example and not limitation, some users prefer to avoid the reservoir filling process because it is inconvenient and tends to involve needles. User-based refilling also increases the likelihood of air bubbles being introduced into the reservoir, whereas prefilling by the reservoir and / or the drug manufacturer can be achieved, for example, using a vacuum filling procedure without any substantial introduction of air bubbles. However, user-filled reservoirs may be used in some cases. Various exemplary drug reservoirs, including those that include pressure sensors (such as those for sensing blockages) and other sensors, are described in more detail in the aforementioned U.S. Patent Publications 2012 / 0078170, 2012 / 0184907, and 2013 / 0138078.

[0101] While prefilled reservoirs would greatly improve the ease of use of patch and pocket pump technologies, there are several challenges in providing such reservoirs. By way of example, and not limitation, long-term storage of insulin has traditionally used glass containers with brominated butyl rubber stoppers, and this has been applied to prefilled insulin pens using glass syringe barrels with brominated butyl plungers. The high coefficient of friction of brominated butyl rubber on glass necessitates coating the inside of the reservoir with silicone oil so that the plunger can easily slide within the barrel during dispensing. Alternatively or additionally, as described in more detail in U.S. Provisional Patent Application 62 / 117,565, filed February 18, 2015, the corresponding U.S. Patent Application Serial No. 15 / 042,093, filed February 11, 2016, and the corresponding U.S. Patent Publication No. 2016 / 0235913, the reservoir assembly may utilize a dual-sealing system having a static seal that minimizes water vapor loss during storage or pre-dispensing, and a dynamic seal that provides low slip / damage as the plunger moves during dispensing.

[0102] As another non-limiting embodiment, any openings used to introduce the agent during filling the reservoir must then be properly sealed to prevent leakage of the pre-dispensed fluid and limit water vapor loss during any storage period. As yet another non-limiting embodiment, the filled reservoir also requires suitable outlet seals along the dispensing path, designed to be agent-compatible and designed to limit vapor loss during any storage in the pre-filled reservoir; and those seals require channels, one or more valves, or other devices to ultimately allow agent dispensing. For example, and as... Figure 10A and Figure 10B Generally shown, an exemplary cannula sealing assembly 540 may be positioned in a reservoir outlet 538 in fluid communication with a reservoir 536. Once the reservoir 536 is filled by the user, the cannula sealing assembly 540 must prevent loss of pre-dispensed fluid, or, if pre-filled before being supplied to the user, must prevent vapor loss during storage. In both cases, however, once properly activated by the patient, medication is allowed to be dispensed from the reservoir 536 through the reservoir outlet 538 and the cannula sealing assembly 540. The exemplary cannula sealing assembly 540 includes a cannula 541, a cannula insert 542, a combined drum / diaphragm 543a (having a drum 543 and an integrated diaphragm 546), and a cannula (not shown), and is referenced below. Figure 11A-11F The described method works. The pin seal assembly 540 (and other pin seal assemblies described below) can, for example, be... Figure 9E The method shown is incorporated into the infusion pump.

[0103] More specific exemplary embodiments are as follows: Figure 11A-11F As shown, a storage outlet 638 having an inner surface 660 is connected via a storage connector 639 (or similarly, such as in...) Figure 14B and Figure 14C The best view of the storage connector 839) is with the fluid storage device (such as, for example, Figure 10A Storage 536 or Figure 12 The drum 643, made of rubber or a similar compliant material, includes an outer surface 662, an inner surface defining a bulging cavity (or "bulging outlet") 664, a drum seal 644 on the outer surface, and a pin seal 645 on the inner surface, positioned within the reservoir outlet 638. The drum 643 also includes a bulging cavity (or "bulging inlet") 649 in fluid communication with the reservoir connection 639 and the drum outlet 664. The pin seal assembly 640 (… Figure 11E and Figure 11F The device includes a drum 643, a diaphragm 646 positioned above the drum 643, a sleeve 641 and a sleeve insert 642, and a needle 647 positioned through the diaphragm 646, the drum 643, the sleeve insert 642 and the sleeve 641. The needle 647 includes an elongated rod having an outer surface 666 and a tip 668. Like the drum 643, the diaphragm 646 may also be made of rubber, such as silicone rubber. The sleeve 641 may be made of polytetrafluoroethylene (PTFE), such as... The cannula 641 may be made of a metal, such as stainless steel, or other relatively rigid biocompatible material. The cannula 642 holds the cannula 641 in place and seals it against the reservoir outlet 638. Additionally, the cannula 642 guides the needle 647 into place within the cannula 641 during assembly and prevents the needle tip from piercing the cannula. The fluid reservoir may be made of a cyclic olefin polymer (COP) or other biocompatible polymer, and the reservoir outlet 638 may also be made of a cyclic olefin polymer (COP) or other biocompatible polymer.

[0104] In another exemplary implementation, such as Figure 12 As shown, the drum and diaphragm are integrated into a drum / diaphragm 643a having a combination of a drum 643' and an integrated diaphragm 646'. The entire body 643a may be made of rubber or other compliant materials, or techniques such as overmolding may be used to form a body 643a made of multiple materials. Figure 11A-11F The other components shown can be used interchangeably with this exemplary embodiment.

[0105] In the exemplary embodiments described above, if the reservoir is filled with medication before delivery to the user (rather than being filled by the user as described elsewhere in this application), the needle 647 acts as a primary packaging seal for the medication, thus preventing the medication from traveling from the fluid reservoir through the reservoir outlet 638 to the sleeve 641, as in the illustrated example, by means of the reservoir connector 639, the drum inlet 649, and the drum outlet 664. In the case of user filling, the needle 647 acts as a medication seal and similarly prevents medication leakage until the user starts the pump. In either case, the drum seal 644 engages the inner surface 660 of the outlet to seal the interface between the reservoir outlet 638 and the drum 643 or (the combined drum / diaphragm 643a). When the needle 647 is in the first (or "sealed") position ( Figure 11E and Figure 11F When in place, the needle seal 645 engages the outer surface 666 of the needle to seal the interface between the needle 647 and the drum 643 (or a combined drum / diaphragm 643a), thereby preventing fluid flow through the drum outlet 664 and into the cannula 641. The needle 647 may be made of stainless steel, rigid plastic, ceramic, or similar rigid biocompatible material and is used to penetrate the skin and enter the flesh a short distance to form a passage to the cannula 641. In at least some cases, an associated pump will be pressed against the patient's skin, thereby driving the cannula 641 and needle 647 below the skin surface. Once the cannula 641 is in place, the needle 647 may be moved to a second (or "unsealed") position to allow fluid to flow from the reservoir outlet 638 into the cannula 641. For example, the needle sleeve 647 can retract into the pump 100 / 100a, or from the pump 100 / 100a and through the needle sleeve sealing assembly 640 via the diaphragm 646 (or the combined drum / diaphragm 643a). Figure 11D The remainder of the tube is removed, thereby removing the sleeve from the drum outlet 664 to allow fluid flow. The diaphragm 646 (or the diaphragm portion of the combined drum / diaphragm 643a) will then seal the end of the drum outlet 664 opposite to the sleeve 641.

[0106] Another exemplary embodiment of the needle used as a pharmaceutical seal or primary packaging seal is shown in Figure 13A , Figure 13B , Figure 13C , Figure 13D , Figure 13E , Figure 13F , Figure 13G Figure 13H Figure 13J , Figure 13K , Figure 13M , Figure 13N , Figure 13P as well as Figure 13QThe exemplary needle sealing assembly 740 includes a drum 743, a sleeve 741, and a needle 747. The drum 743 includes an outer surface 762, a drum seal 744 on the outer surface, an inner surface defining a bulging cavity (or "bulging outlet") 764, and a sleeve seal 745 on the inner surface. Figure 13B and Figure 13C Drum 743 is positioned within reservoir outlet 738 and also includes drum inlet 749 in fluid communication with reservoir connector 739 and drum outlet 764. Sleeve 741 and needle 747, when in the pre-dispensing or storage position, are positioned within drum 743 to seal the fluid path through drum 743 defined by drum outlet 764, as described in more detail below.

[0107] The pin 747 includes an elongated rod having an outer surface 766 and a tip 768, which may be made of stainless steel, rigid plastic, ceramic, or similar rigid biocompatible material, and may be attached to a button 700, as in Figure 13F-13G As shown. For example, a pin 747 (which may have an outer surface 766 with a diameter of about 0.20 mm (about 0.008 inches)) may be adhered to a button 700, which may have an outer diameter of about 10 mm (about 0.4 inches). As another example, the pin 747 may be inserted into the button 700 and may be made of COP, Delrin, polycarbonate, or other injection-molded polymeric materials. Figure 13D , Figure 13E , Figure 13K , Figure 13M and Figure 13N As best shown, the needle 747 carries a cannula 741, which may have an outer surface 770 that contacts a cannula seal 745 and has a diameter of approximately 0.50 mm (0.020 inches). The cannula 741 may be made of PEEK, Made of other polymeric materials. Button 700 is attached to post 702, which carries post hook 704, such as a wing or frame. (See Figure 13G...) Figure 13H and Figure 13J The cross-sectional view shown best illustrates that all these components can, but do not have to, be made of the same material, and can even be manufactured as a single piece, such as through a one-time injection molding. The column 702 slides within the tube 720. Figure 13P-13Q The tube 720 may be made of the same or similar material as the button 700 and the post 702. The tube 720 has a post catch 722, which latches with a post hook 704 to prevent disengagement from the post 702. Similarly, the tube 720 slides within a cavity 755 of the reservoir outlet 738. Figure 13A The tube has a tube catcher 742, which is latched with a tube hook 724 to prevent the tube 720 from disengaging from the reservoir outlet 738.

[0108] When the relevant disposable component is filled with medication but the pump has not yet dispensed it, the needle seal assembly 740 acts as a pre-dispensing seal or primary packaging seal, wherein the button 700 and tube 720 are in their highest, fully extended position, as in Figure 13A As shown in the diagram. In this storage or pre-allocation configuration, the end of the sleeve 741 and the end of the pin 747 are positioned above the bottom of the storage outlet 738, as shown. Figure 13A As shown. For example, the end of the needle 747 and the end of the cannula 741 may be approximately 0.1 mm above the bottom of the reservoir outlet 738. In this storage or pre-dispensing configuration, where the cannula 741 and needle 747 are in a first (or "sealed") position, the cannula inlet 758 is not aligned with the drum inlet 749, so the agent cannot flow through the cannula inlet 758 and into the cannula channel 759. Furthermore, the cannula seal 745 engages the outer surface 770 of the cannula, thereby preventing flow between the inner surface of the drum 743 and the outer surface of the cannula. Cannula channel 759 ( Figure 13M and Figure 13N The cannula 741 is a passageway along the inside of the cannula 741 that allows the agent to pass down the length of the cannula 741 and the needle 747 and exit from the distal end of the cannula 741.

[0109] To initiate the flow of the medication through the pump, press button 700 until the column 702 is fully within tube 720, which is fully within reservoir outlet 738, and button 700 is positioned in the top, wide portion of cavity 755 within reservoir outlet 738. Pressing button 700 downwards causes button spring 706 to compress approximately 0.9 mm (0.035 inches) (see...). Figure 13D and Figure 13E ,as well as Figure 13H and Figure 13J This, in turn, causes the distal end of the ferrule 747 to extend approximately 0.9 mm (0.035 inches) beyond the distal end of the cannula 741 (see [link]). Figure 13D and Figure 13E When button 700 is pressed down into the top, wide portion of the acupoint 755 to drive cannula 741 and needle 747 to the second (or "unsealed") position, the distal end of needle 747 penetrates the skin and extends approximately 6-8 mm beyond the bottom of reservoir outlet 738 and into the patient's flesh, carrying the distal end of cannula 741. In this position, cannula inlet 758 is located between cannula seal 745 and drum inlet 749, and is substantially aligned with drum inlet 749. This allows medication to flow through reservoir connector 739, through drum inlet 749, through cannula inlet 758, into cannula channel 759, and out of cannula 741 (see [link to relevant documentation]). Figure 13K , Figure 13M(See Figure 13N). The cannula channel 759 can be a passage with a width W of approximately 0.15 mm (approximately 0.006 inches) and a depth D of approximately 0.05 mm (approximately 0.002 inches). The cannula channel 759 is closed at the proximal end, so the agent cannot flow upward into the cannula 741 into the button 700 (see Figure 13N). Figure 13M When the button 700 is released by the user, the button spring 706 will drive the button (and the sleeve 474) away from the outlet 738 by a short distance (e.g., 0.9 mm). The sleeve 747 will move toward the first position, but not to the first position, while the sleeve 741 will remain in the second position.

[0110] Another exemplary embodiment of the needle used as a pharmaceutical seal or primary packaging seal is shown in Figures 14A-14D The exemplary needle sealing assembly 840 includes a drum 843, a sleeve 841, a sleeve insert 842, and a needle 847. The drum 843 includes an inner surface defining a bulging cavity (or "drum outlet") 864. A diaphragm 846 may be positioned above the drum 843, or the drum and diaphragm may be integrated into a combined drum / diaphragm (not shown). The exemplary needle 847 includes an elongated rod having an outer surface 866 and a tip 668. In this exemplary embodiment, a reservoir outlet 838 is formed as a portion of the substrate 850 of the discardable assembly 800. Figures 14A-14B The storage connector 839 protrudes from the storage 836 and can form a joint as part of the storage. Figure 14B-14C The drum 843 includes a retainer 849a that holds the drum 843 to the reservoir connector 839 and forms a sealed fluid connection between the connector 839 and the drum inlet 849. Figure 14B-14D Drum 843 is positioned within reservoir outlet 838 and includes pin seal 845. Figure 14B The outer surface 866 of the engaging needle 847 forms a seal around the needle 847, as described in the embodiments above. The reservoir 836 and reservoir connector 839 may be made of COP or other biocompatible polymeric materials, the drum 843 or the drum / diaphragm of the previously described optional combination may be made of brominated butyl rubber or similar elastomeric materials, and the diaphragm 846 may be made of silicone rubber or other resealing elastomeric materials.

[0111] When the disposable component 800 is filled with medication but the pump has not yet dispensed it, the needle sealing assembly 840 acts as a medication seal or primary packaging seal. When the needle 847 is positioned in the first (or “sealed”) position described above within the drum 843 or integrated drum-diaphragm body, the needle seal 845 engages the outer surface 866 of the needle to seal the interface between the needle 847 and the drum 843 or integrated body, thereby sealing the fluid path through the drum 843 (or the combined drum / diaphragm). As in the previous exemplary embodiments, the needle 847 may be made of stainless steel or a similar biocompatible material and is intended to penetrate the skin and enter the flesh in a short distance to form a passage for the cannula 841, which may be made of… Made of other biocompatible materials. In at least some cases, the associated pump will be pressed against the patient's skin, thereby driving the cannula 841 and needle 847 below the skin surface. Once the cannula 841 is in place, the needle can be retracted to a second (or "unsealed") position to allow fluid to flow from the reservoir outlet to the cannula 841. For example, the needle 847 can be retracted into the pump 100 / 100a, or removed from the pump 100 / 100a and the remainder of the needle sealing assembly 840 via the diaphragm 846 or (of the combined drum / diaphragm) to allow fluid flow. The diaphragm 846 (or the diaphragm portion of the combined drum / diaphragm) will then seal the end of the drum outlet 864 opposite to the cannula 841.

[0112] Another type of seal is a seal at the filling port, where the medication is introduced into the reservoir. In some cases, it may be desirable to prevent medication from flowing from reservoirs 636 / 836 / 936 through reservoir connectors 639 / 739 / 839 / 939 until dispensing begins, and this can be achieved by filling plug sealing assemblies 904 / 1004 in filling ports 415 / 515 / 815 / 915. As can be seen in the exemplary embodiments shown in Figures 15A-17E, reservoir 936 is filled with medication through filling port 915. To prevent medication from traveling from reservoir 936 through reservoir connector 939 to the attached reservoir outlet and sleeve (not shown) before dispensing begins, filling plugs 910 / 1010 of filling plug sealing assemblies 904 / 1004 can be inserted into filling port 915 to prevent medication from flowing from reservoir 936 to reservoir connector 939. For example, if preferred, during storage and / or before dispensing, the agent is prevented from being positioned in the reservoir connectors 639 / 739 / 839 / 939 and the drum inlet 649 / 749 / 849, as may be the case in the above embodiments. Instead, all the agent is kept in the reservoirs 636 / 736 / 836 / 936 during storage and / or before dispensing. The following embodiments or their equivalents may be used to replace or supplement the above embodiments.

[0113] In one exemplary embodiment of the seal at the filler plug, the filler plug sealing assembly 904 includes a thin seal 980, such as a thin foil or other material, which, in its intact state, is impermeable to and compatible with the agent contained in the reservoir, for sealing the reservoir 936, as... Figure 16A-16D As shown in the diagram. A filler plug 910, made of rubber or other relatively compliant sealing material, is positioned in the filler port 915. The filler plug 910 includes an inner surface defining an inlet cavity 949. A core pin 940 is positionable through the inlet cavity 949 of the filler plug 910, as shown in the diagram. Figure 16B-16D As shown in the figure. The pin 940 may have a sharp end 944 and may be attached to the button 950 (Figure 16C and). Figure 16D It may or may not be removable from the core pin 940. The filling plug 964 connects the inlet 949 to the storage connector 939.

[0114] When the device 100 / 100a is ready for use and the patient wishes to dispense medication from the reservoir 936, the button 950 should be pressed down until it is fully seated in the filling plug 910. When the button 950 is pressed, the pin 940 advances from a first (or “sealed”) position toward the reservoir 936, and the pointed end 944 penetrates the seal 980 in a second (or “unsealed”) position, allowing medication to flow from the reservoir 936, through the filling plug 910 of the filling plug sealing assembly 904 (by means of cavities 949 and 964), and through the reservoir connector 939. The filling plug 910 includes an outer surface 962 with a seal 912 that engages the inner surface 960 of the filling port 915 to prevent medication leakage around the outside of the filling plug 910. The pin seal 942 prevents medication leakage through the filling plug and around the outside of the pin 940 after the pointed end 944 has penetrated the seal 980. The plug seal 912 and the pin seal 942 may be made of rubber or other relatively compliant sealing materials, such as by injection molding the plug 910, plug seal 912, and pin seal 942 together. The pin 940 may be made of stainless steel, PEEK, ceramic, or other relatively rigid biocompatible materials, while the button 950 may be made of COP, Delrin, polycarbonate, etc.

[0115] Another exemplary embodiment of the primary packaging at the filling plug is shown in Figures 17A-17EIn this example, the filler plug 1010 and the core pin 1040 of the filler plug sealing assembly 1004 seal the reservoir during storage and / or before dispensing. More specifically, the filler plug 1010 includes an inner surface defining an inlet cavity 949, and the core pin 1040 is positioned within the inlet cavity. The filler plug outlet cavity 1064 connects the inlet cavity 949 to the reservoir connector 1039. When the core pin 1040 is in the storage or pre-dispensing position (i.e., the first (or “sealed”) position, where the button 1050 has not yet been pressed), the core end seal 1046 engages the inner surface of the filler plug 1010 to seal the passage from the reservoir 936 through the filler plug 1010 to the reservoir connector 939 (defined by cavities 1049 and 1064), as Figure 17C As shown in the optimal configuration. When the device 100 / 100a is ready to be used, and the patient wishes to dispense medication from the reservoir 936, the button 1050 should be pressed down until it is fully seated in the filling plug 1010. Figure 17E As best shown, when button 1050 is pressed, pin 1040 advances toward reservoir 936 to a second (or "unsealed") position, wherein pin-end seal 1046 disengages from the inner surface of the defining inlet cavity 1049 of filler plug 1010, leaving a gap 1055 through which medication can flow from reservoir 936, around pin-end seal 1046, through cavities 1049 and 1064 of filler plug 1010, and through reservoir connector 939. A plug seal 1012 on the outer surface of filler plug 1010 prevents medication from leaking around the outside of filler plug 1010, while pin-end seal 1042 prevents medication from leaking around the outside of filler plug 1010 and pin 1040 after pin-end seal 1046 has disengaged from filler plug 1010. As described above, the filler plug 1010, the plug seal 1012, and the core pin seal 1042 can be made of rubber or other relatively compliant sealing materials, such as by injection molding; the core pin 1040 can be made of COP, Delrin, polycarbonate, or other biocompatible polymeric materials; and the button 1050 can be made of COP, Delrin, polycarbonate, etc. Figures 17A-17E A core pin 1040 with a blunt end 1044 is shown. This exemplary embodiment and the preceding exemplary embodiment can be combined by adding a thin seal 980 to the end of the reservoir 936 and adding a sharp end like a sharp end 944 to the blunt end 1044, such that a push button 1050 pierces the thin seal 940 and creates a gap 1055 around the core end seal 1046.

[0116] To prevent button 1050 (or button 950) from being accidentally pressed, a button guard can be inserted between button 1050 / 950 and filler plug 1010 / 910. An exemplary button guard 1160... Figures 18A-18C As shown in the diagram. When the button protector 1160 is in place, it is impossible to press the button 950 / 1050 to move the core pin 940 / 1040 to break the seal 980 / 1046 and allow fluid flow through the filler plug 910 / 1010. The button protector 1160 may be made of COP, Delrin, polycarbonate or other similar polymeric materials.

[0117] The various methods and systems described herein are presented within the context of the exemplary structures described in the preceding sections and are illustrated in the various figures for illustrative purposes only. While the methods and systems may employ the structures described above, they are not limited thereto. Furthermore, embodiments of the invention may comprise any, less than all, combinations of, or all of the methods or apparatus mentioned above.

[0118] Although the invention disclosed herein has been described with reference to the preferred embodiments described above, many modifications and / or additions to the preferred embodiments will be apparent to those skilled in the art. By way of example and not limitation, the pharmaceutical sealing assembly of the present invention can be incorporated into a fully disposable infusion pump. The scope of the invention is intended to extend to all such modifications and / or additions, and the scope of the invention is limited only by the claims set forth below or appended thereafter.

[0119] Finally, regarding the terms that may be used herein, whether in the specification or the claims, the following should be noted: The terms “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” etc., are open-ended and mean “including but not limited to.” Ordinal terms such as “first,” “second,” “third,” etc., do not imply a priority, precedence, or order of one element over another, or a chronological order of steps of a method. Rather, these terms are merely labels used to distinguish one element having a particular name from another element having the same name (except for ordinal terms). “And / or” indicates that the listed items are substitutes, but substitutes also include any combination of the listed items. The terms “about,” “generally,” “essentially,” and “generally” allow for a certain degree of variation relative to any precise size, measurement, and arrangement, and should be understood within the context of the description and operation of the invention disclosed herein. Terms such as “top,” “bottom,” “above,” and “below” are convenience terms that indicate the spatial relationship of components relative to each other, rather than any particular spatial or gravitational orientation. Therefore, these terms are intended to cover components that make up parts, regardless of whether the components are oriented in a particular orientation shown in the figure and described in the specification, upside down from that orientation, or any other rotational variation thereof.

Claims

1. An apparatus for a fluid delivery system, the apparatus comprising: Medicine storage container; A storage outlet configured for fluid communication with a pharmaceutical storage tank; and A needle sealing assembly, integrated into the device and associated with the reservoir outlet, includes: A drum having a drum cavity extending therethrough, the drum including a drum inlet configured to be in fluid communication with a reservoir connection, the reservoir connection being in fluid communication with a drug reservoir; A sleeve having a cavity configured for communication with an inlet fluid; A needle sleeve, having a rod and a tip, is movable through a tympanic cavity and relative to a reservoir outlet between a first position and a second position; in the first position, the needle sleeve is at least partially disposed within the cannula cavity; in the second position, the needle sleeve is not disposed within the cannula cavity. The sleeve has a sleeve inlet, and the sleeve and the needle can be moved to a position where the sleeve inlet and the drum inlet are in fluid communication.

2. The apparatus according to claim 1, wherein, The needle sealing assembly further includes a cannula insert at least partially disposed within the cannula cavity, wherein the needle is movable through the cannula insert.

3. The apparatus according to claim 2, wherein, When the needle is in the first position, the needle restricts the flow of medication from the reservoir outlet to the cannula lumen, and when the needle is in the second position, the needle allows the medication to flow from the reservoir outlet to the cannula lumen.

4. The apparatus according to claim 2, wherein, The cannula inserter is configured to guide the needle into the cannula lumen and prevent the tip of the needle from puncturing the cannula.

5. The apparatus according to claim 1, wherein, The pin sealing assembly includes a diaphragm.

6. The apparatus according to claim 1, wherein, The diaphragm is adjacent to or integrated with the drum.

7. The apparatus according to claim 1, wherein, The needle can be removed from the rest of the needle sealing assembly.

8. Infusion pump, including: The apparatus according to claim 1; as well as A fluid displacement device that drives a drug from a drug reservoir.

9. The infusion pump according to claim 8, wherein, The fluid transfer device includes a plunger within a reservoir and a drive mechanism for driving the plunger.

10. The infusion pump according to claim 8, wherein, The drive mechanism includes a motor.

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