JP2021041185A - Ambulatory infusion pump with contactless power transmission - Google Patents

Abstract

To provide an infusion pump that is more small-sized, simpler, and more inexpensive than conventional infusion pumps but is still more accurate than conventional infusion pumps.SOLUTION: There are provided a combination of an ambulatory infusion pump, a durable assembly 200, a disposable assembly 300, and components and a related method, the infusion pump and the assemblies including an energy source, a reservoir, a base plate 350, and related components. In one embodiment, an infusion pump system comprises a durable assembly including an energy supply source and a disposable assembly including a medicine reservoir. The durable assembly and the disposable assembly are configured to be attached to each other in a form in which energy required for dispensing medicine from the medicine reservoir is supplied by the energy supply source and is transferred from the durable assembly to the disposable assembly without direct mechanical connection or electrical connection.SELECTED DRAWING: Figure 1B

Description

The device and method generally relate to portable injection pumps.

A portable injectable pump (also referred to herein simply as an "injection pump") is used to introduce drugs and other injectable substances (collectively, "drugs") into the patient's body. It is a relatively small and at least virtually self-contained device used. Some injection pumps are configured to be mounted on a belt, transported in a pocket of clothing, and so on. Other injection pumps are configured to be patch-like and attached to the skin. Infusion pumps are advantageous in that they can be used, for example, to introduce (or "inject") the drug out of the clinical environment, either continuously or continuously, percutaneously. Infusion pumps are also advantageous in that they significantly reduce the frequency of subcutaneous access events such as needle-based injections. An example of a drug that can be introduced by an infusion pump is a liquid formulation of insulin. Other exemplary drugs that can be introduced by an infusion pump include, but are not limited to, drugs that treat cancer and drugs that suppress the perception of pain.

Many conventional infusion pumps have improved patient health and quality of life. Nevertheless, we have determined that conventional injection pumps deserve extensive improvement. By way of example, we provide, but not limited to, an injection pump that is smaller, simpler, cheaper, and still more accurate than a conventional injection pump. Was determined to be desirable.

A system according to at least one of the present invention includes an infusion pump durable assembly and an infusion pump disposable assembly. The durable assembly may include one or more energy sources within the housing. The disposable assembly may include a drug reservoir and be configured to be attached to a durable assembly. Energy from the energy source can be transferred to the disposable assembly and the drug can be dispensed from the reservoir. Energy can be transmitted without mechanical coupling or electrical contact, such as by electromechanical torque coupling.

The method according to at least one of the present invention is an injection pump with an energy source such that energy from the energy source is transferred to a disposable assembly and converted into a mechanical force that moves the plunger within the reservoir. Includes steps to secure the durable assembly to an infusion pump disposable assembly with a drug reservoir.

A disposable assembly according to at least one of the present invention includes a base plate, a drug reservoir on the base plate, a plunger movable within the reservoir, a motor rotor, and a gear train. The motor rotor can receive electromagnetic energy from the outside of the disposable assembly, and the gear train can convert that electromagnetic energy into a mechanical force that moves the plunger into the reservoir.

The features and ancillary advantages of the present invention will become apparent when the present invention is considered in conjunction with the accompanying drawings, by a deeper understanding by reference to the detailed description below.

A detailed description of the exemplary embodiment will be provided with reference to the accompanying drawings.
FIG. 1A is a perspective view of an exemplary injection pump in the assembled state. FIG. 1B is an exploded perspective view of the injection pump system illustrated in FIG. 1A, which includes a durable assembly and a disposable assembly. FIG. 2 is a top view of some component of the injection pump system illustrated in FIGS. 1A and 1B. FIG. 2A is a schematic diagram showing the use of the injection pump system illustrated in FIGS. 1A and 1B. FIG. 2B is a schematic diagram showing another use of the injection pump system illustrated in FIGS. 1A and 1B. FIG. 3A is a perspective view of an exemplary durable assembly. FIG. 3B is a perspective view of a component of the durable assembly illustrated in FIG. 3A. FIG. 4A is a perspective view of an exemplary disposable assembly. FIG. 4B is a perspective view of some component of the disposable assembly illustrated in FIG. 4A. FIG. 5A is a perspective view of some components of a durable assembly and a disposable assembly of an exemplary infusion pump system. FIG. 5B is a perspective view of the components of the exemplary durable assembly illustrated in FIG. 5A. FIG. 5C is a perspective view of the components of the exemplary disposable assembly illustrated in FIG. 5A. FIG. 6 is a perspective sectional view of the components of the exemplary injection pump system of FIG. 5A, revealing the gaps between components with durable and disposable assemblies. FIG. 7 is a front view showing that the patient's skin has been cleaned. FIG. 8 is a flow chart illustrating a method of removing and replacing an exemplary disposable assembly. FIG. 9 is a perspective view of an exemplary injection pump system in the assembled state.

The following is a detailed description of the best known modes in which the present invention is practiced. This description is not taken in a limited sense and is provided solely for the purpose of exemplifying the general principles of the present invention.

Here, the present specification is particularly suitable for subcutaneous delivery of high concentrations of insulin such as U-500 insulin (ie, U-200 insulin and above) and lower concentrations of insulin such as U-100 insulin. It should also be noted that certain structures and methods are described. Nevertheless, it should be understood that the present invention is applicable to a wide variety of infusion pumps and agents. By way of example, but not limited to, the present invention may employ a reservoir with a plunger, a fluid displacement device in the form of a plunger pusher, and a drive mechanism including a motor for fluid displacement, or other. Fluid displacement devices (regardless of the type of reservoir employed), piston pumps (eg, electromagnetic pumps), MEMS pumps, peristaltic pumps, and any other suitable pump and corresponding drive mechanism may be employed. An exemplary infusion pump, including a reservoir with a plunger, a fluid displacement device in the form of a plunger pusher, and a drive mechanism, is described in US Patent Application Nos. 12 / 890,207 filed September 24, 2010 and the corresponding Patent Publication No. 2012. / 0078170, both of which are incorporated herein by reference in their entirety. The present invention relates to, for example, drugs for relieving pain, chemotherapy and other cancer-related drugs, antibiotics, hormones, GLP-1, glucagon, various other drugs, including large molecules, and high levels of delivery. Applicable to proteins that may require accuracy, as well as drugs such as high concentrations of insulin such as U-500 insulin (ie, U-200 insulin and above) and lower concentrations of insulin such as U-100 insulin. Is.

As explained above, some portable infusion pumps are to be worn on a belt, to be carried in a pocket, or to another type of holder (collectively, a "pocket". Intended to be supported within) (referred to as a "pump"). Such an injection pump transports fluid from the reservoir to the injection set via an elongated tube. Subcutaneous access can be obtained via a cannula within the infusion set. Other portable infusion pumps are intended to be attached to the skin above the delivery site (sometimes referred to as "patch pumps"). Here, the cannula or other subcutaneous access device can extend directly from the infusion device. Given these usage patterns, patients typically prefer the device to be as small as possible, and therefore more comfortable, less noticeable, and less visible. In addition, patients desire a device that is easy and convenient to use.

Generally, the exemplary portable injection system represented by reference number 100 in FIGS. 1A, 1B, and 2 includes a durable assembly 200 and a disposable assembly 300. An exemplary durable assembly 200 includes a housing 202, one or more batteries or other energy sources 221 and one or more capacitors or other energy storage devices 222, a microprocessor 223, and a coil assembly 224 ( It acts as a motor stator) and includes one or more Hall effect sensors 225. The exemplary disposable assembly 300 includes a base plate 350 that supports components such as a magnetic motor rotor 331, a gear train 332 that includes a lead screw drive gear 333, and a lead screw 334 that is attached to a plunger 335 located within the drug reservoir 336. And include. The cover 302 can be mounted on the base plate 350, and in various embodiments, under the cover 302, a magnetic motor rotor 331, a gear train 332 (with drive gear 333), a lead screw 334, a plunger 335, and a drug reservoir. Part or all of 336 is located.

The exemplary disposable assembly 300 can be secured to the exemplary durable assembly 200, as shown in FIGS. 1A and 2. For this purpose, the exemplary housing 202 includes an upper wall 204, bottom walls 206a and 206b, and side walls 208, which together have a relatively thin housing portion 210 and a relatively thick. The housing portion 212 is defined. A recess 214 is formed in the relatively thick portion 212. An exemplary cover 302 includes an upper wall 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 base plate 350 is not covered by the cover 302, thereby defining a recess 312 edged by a wall 314 extending around the base plate (see also FIG. 4B). When the durable and disposable assemblies 200 and 300 are secured to each other in the manner illustrated in FIG. 1A, the relatively thick portion 212 of the housing 202 will be located within the recess 312 of the disposable assembly 300 ( Wall 314 is in recess 214). The relatively thin portion 210 of the housing 202 will be located on the upper wall 304b of the cover 302. The cover 302 also includes a protrusion 316 that fits into the recess 216 on the housing 202. In addition, as discussed in more detail below, the disposable assembly 300 may be configured for different agents, such as different agent concentrations, different agent amounts, etc., or for different system operating modes.

In other implementations, the cover 302 may be configured to cover less than all of the components on the base plate 350. For example, the cover may be configured such that part of the magnetic motor rotor 331 and gear train 332 is not under the cover, while the remaining components are under the cover. In yet other implementations, the cover 302 may be omitted and the durable assembly 200 may be configured to cover all of the components on the base plate 350.

U.S. Patent Publication No. 2012/0078170 mentioned above, and U.S. Application Nos. 13 / 300,574 filed on November 19, 2011 and the corresponding U.S. Patent Publication No. 2012/0184907, and May 18, 2012. On the base plate, as discussed in U.S. Application No. 13 / 475,843 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 that employs a reservoir can be configured for different types of use. For example, the disposable assembly 300 can be glued to the patient's skin and a cannula operably connected to the reservoir 336 so that the system 100 can be deployed as a "patch pump" as shown in FIG. 2A. Can be used with). Alternatively, as shown in FIG. 2B, the base plate 350 of the disposable assembly 300 allows the system 100 to be employed as a "pocket pump", a "belt-mounted pump", or some other wearable pump. The reservoir 336 may be configured to operably connect to the infusion set 503 (eg, via the illustrated infusion set tube and connector 501 shown in FIGS. 1B and 2). In other words, using the same durable assembly 200, the user simply selects the appropriate disposable assembly and attaches the disposable assembly to the durable assembly to use as a "pocket pump" or "patch pump". The system can be configured for this. The user may switch from one configuration to another by simply removing one disposable assembly and replacing it with another disposable assembly.

Therefore, it should be noted that the present invention includes a kit containing various combinations of disposable assemblies in which at least two of the disposable assemblies can differ. In addition, or as an alternative, the kit or other package may include various disposable assembly components such as an injection set and / or a cannula inserter. The kit may also include a durable assembly. Disposable assemblies in such kits may also include the detection / identification means discussed below. The components of this kit (eg, various disposable assemblies and / or combinations of components) are stored in a common package with individual packages for each component, as needed, and within the common package the user. Can be provided to. The components that can be provided in such a kit include, but are not limited to, a cannula preloaded insert and a cleaning swab. The charger may also be provided in a kit that includes a durable assembly.

Disposable Assembly In addition to packages and markings, different disposable assemblies may include visual markers to distinguish the various disposable assemblies. For example, disposable assemblies with different concentrations of drug or different drug-filled volumes may use different colors for the reservoir and / or base plate of the disposable assembly, or consumables are only for durable consumer goods that are properly programmed. Mechanical features can be used to ensure that it is attachable.

Here, apart from priming issues, the dispensing procedure associated with an infusion system "patch pump" configuration that may include a durable assembly 200 and a disposable assembly 300 may also include an infusion set 503 in a "pocket pump" configuration. It should also be noted that it is substantially identical to the dispensing procedure associated with (see Figure 2B). No priming is required in the "patch pump" configuration. This is because the volume of the associated cannula is very small and there is a direct connection between the cannula and the drug reservoir. However, priming is required to fill the infusion set tube (FIG. 2B) in the "pocket pump" configuration prior to the initiation of drug delivery. For example, 20-30 μl may be required to fill the entire infusion set tube, therefore the priming procedure may involve rapid delivery of 10-15 μl of U-500 insulin into the tube. We prevent the user from initiating a priming procedure when the system is in a "patch pump" configuration if the cannula is essentially positioned to deliver the drug directly from the drug reservoir to the patient. Judging that it would be advantageous to do so. This is because the rapid delivery of 10 to 15 μl of insulin to a patient can adversely affect the patient's health.

Other situations to prevent such undesired outcomes and with options between various disposable assemblies (such as disposable assemblies with different agents, different concentrations of agents, and / or reservoirs containing variable amounts of agents). For the convenience of the user in, at least some of this disposable assembly may be equipped with a baseplate identification device, and at least some of this disposable assembly has a durable assembly microprocessor / controller making a "baseplate type" decision. It may be equipped with a structure that cooperates with the base plate identification device in the manner in which it is obtained. Illustrative baseplate identification means and methodologies can be as described in US Patent Publication Nos. 2012/0078170, 2012/0184907, and 2013/0138078 described above. In addition, base plate identification can be done mechanically. For example, pins or ribs can prevent attachment of some disposable assembly to some durable assembly. In addition, or as an alternative, some durable assemblies will simply not work with some disposable assemblies.

Alternatively, the patient or clinician may program the system to indicate the type of disposable assembly to be attached, such as via remote control. In such a manner, the patient has access to a variety of agents for use with a single durable assembly.

Once the "base plate type" determination has been made (eg, a "pocket pump" fitted with a "patch pump" disposable assembly 300 vs. injection set 503), the durable assembly will be in the appropriate mode or mode of operation for the mounted disposable assembly. Will proceed to. For example, if a "patch pump" disposable assembly 300 is detected, the durable assembly controller does not include priming as part of the delivery process, and in some implementations the user manually implements the priming procedure. Will prevent. On the other hand, if a "pocket pump" disposable assembly is detected, the delivery process may include proper priming of the infusion set tube.

Whether configured as a "pocket pump" or a "patch pump," the system provides basic drug delivery according to the delivery profile provided by the physician using the clinician's programming unit. Can be configured to. For example, the system may include a program that stores several delivery profiles, such as a delivery profile associated with a 24-hour delivery cycle, a delivery profile for a particular situation such as sleep or illness. Each delivery profile defines multiple doses (or pump "operations") over time, eg, a particular number of doses at a particular time or a particular number of doses per unit time. In some implementations, the dose can be the volume associated with the minimum controllable displacement of the plunger 335. The system may also be configured to provide bolus delivery in response to instructions from patient remote control 1000 (FIG. 2A). Bolas commands can occur in response to hyperglycemic level measurements in diabetic patients, increased pain levels in pain management patients, or some other symptom. The system may also be configured to perform other functions such as termination of drug delivery in response to commands from patient remote control 1000.

The injection pump can be used in conjunction with various remote controls. Such remote control may, for example, allow the user to transmit instructions to the endurance assembly 200, or communication between the endurance assembly 200 and the user (eg, an alarm condition message or system 100). Can be used to facilitate other messages) regarding the conditions of. An exemplary remote control 1000 (FIG. 2A) may be configured to facilitate one, some, or all of the following actions: (1) turning the remote control 1000 on or off, (2). ) Associate (or "assign") the remote control 1000 with the durable assembly 20, (3) obtain status information such as drug level, battery charge level, and / or alarm conditions, (4) durable assembly Silence the alarm, (5) select options that can be associated with the endurance assembly alarm, such as the type of alarm (audible, tangible, and / or visible) and the intensity / volume of the alarm, (6) for example. Update the remote control or endurance assembly firmware, load and delete delivery profiles stored within the endurance assembly or remote control, and otherwise reprogram the endurance assembly or remote control. To connect the remote control 1000 to a computer, (7) select drug options such as drug concentration, (8) select and start a memorized drug delivery profile, (9) increase the drug dose rate And to reduce and / or (10) suspend the dispensing operation. The user removes or replaces the structure applied to the patient (eg, disposable assembly), adjusts to current or expected changes in physical conditions (eg, hypoglycemia, strenuous exercise), the physician's Delivery may be suspended to follow the suggestions or to cut the durable assembly from the body for any other reason.

An exemplary remote control 1000 (FIG. 2A) is based on information from microprocessor 223 for a durable assembly 200 that indicates, for example, the amount of time remaining in the current dispensing program, the amount of time until the next disposable assembly replacement, and so on. Can be configured to generate an indicator. The indicator can be audible, visible, tactile, or a combination thereof. The time remaining indicator can be useful for a variety of reasons. For example, grasping the time remaining prior to the next disposable assembly replacement allows the patient to dispense the disposable assembly, at least in part, based on the current time and upcoming events (eg, travel or sleep). Allows you to decide if it would be more convenient to exchange at some time prior to the end.

As described above, some parts of the system can be considered reusable parts, while others can be considered disposable parts. In the illustrated embodiment, the durable assembly 200, which may include structures such as microprocessor 223 and coil assembly 224, may include structures such as motor rotor 331 and reservoir 336 on the base plate 350 while being reusable. The exemplary disposable assembly 300 is disposable.

In terms of dimensions, some embodiments of the exemplary injection pump system 100 may have the following dimensions: 35 mm +/- 1.0 mm, 35 mm +/- 0.10 mm, or 35 mm +/- 5.0 mm length dimensions. , 30 mm +/- 1.0 mm, 30 mm +/- 0.10 mm, or 30 mm +/- 5 mm width dimensions, and 8.5 mm +/- 1.0 mm, 8.5 mm +/- 2 mm, or 8.5 mm +/- 0. Overall thickness or height dimension of 10 mm. Suitable housing materials include, but are not limited to, plastics or other materials having a modulus of elasticity of 0.2-1.0 million psi.

Illustrative Durability Assembly microprocessors and associated circuits, rechargeable batteries and associated battery chargers and recharging methods, batteries and recharge management, temperature sensors, and exemplary alarms and alarm conditions are described in the United States as described above. It is described in detail by Patent Publication Nos. 2012/0078170, 2012/0184907, and 2013/0138078.

The reservoir is not required but can be pre-filled. Pre-filled reservoirs are advantageous for a variety of reasons. As an example, some users, but not limited to, prefer to avoid the reservoir filling procedure because they tend to be inconvenient and accompany needles. User-based refilling increases the likelihood that bubbles will be introduced into the reservoir, while prefilling by the reservoir and / or drug manufacturer uses, for example, a vacuum filling procedure. Can be carried out without any substantial introduction of. Nevertheless, user-filled reservoirs can be employed in some cases. Various exemplary drug reservoirs, including pressure sensors (for detecting blockages, etc.) and other sensors, are described above in US Pat. Nos. 2012/0078170, 2012/0184907, and 2013/01/38078. Explained in detail by.

Looking now at FIGS. 3A and 3B, the exemplary endurance assembly 200 is a power source such as one or more batteries 221 and a temporary power storage device such as one or more capacitors 222 (see FIGS. 2 and 5B). ), A controller such as a microprocessor 223, a coil assembly 224, and a Hall effect sensor 225. Those skilled in the art will appreciate that including the coil assembly 224 of the motor and all other electronics within the durable assembly 200 reduces the cost and complexity of the disposable assembly 300. In addition, microprocessor 223 provides pump 100 with flexibility including features such as user data storage, programs, programmability, adjustability, displays, buttons, wireless communication protocols, and the like. The durable assembly 200 can also be molded with the locking feature, which snaps onto the disposable assembly 300, but the disposable assembly remains in place on the patient (after drug delivery has been suspended). Also allows removal of the durable assembly 200 from the disposable assembly 300, either after the entire system has been removed from the patient.

The power source can be one or more commercially available batteries, such as a commercially available zinc-air battery or a lithium polymer battery. The battery may be selected to have sufficient capacity to operate the system for a certain delivery amount or delivery time, such as for more than 400 delivered insulins. The optional power storage device can be one or more commercially available capacitors or supercapacitors or other temporary storage devices.

Looking now at FIGS. 4A and 4B, the exemplary disposable assembly 300 comprises a base plate 350, a reservoir 336, a plunger 335 located in the reservoir and connected to a lead screw 334, a magnetic motor rotor 331, and the like. The magnetic motor rotor 331 may include elements and is mechanically mounted through the gear train 332 to affect the rotation of the feed screw drive gear 333, the rotation of the feed screw drive gear 333 is the feed screw 334 and the reservoir 336. Causes parallel movement of the plunger 335 inside. The cover 302 is positioned above these components in the illustrated embodiment. The exemplary base plate 350 includes an adhesive backing for attachment to the patient with a removable adhesive cover. The base plate 350 can be molded with the base plate locking feature, which snaps onto the durable assembly 200 (such as a magnet molded into the housing of each assembly) and the disposable assembly 300 of the durable assembly 200. It also allows removal from.

With reference to FIGS. 2 and 4B, the exemplary reservoir 336 includes a barrel 338 with an inner surface 340 defining a fluid storage volume 342 and an oval cross section, but other shapes are also possible. A plunger 335 with a matching cross-sectional shape fits into the barrel and carries, but is not limited to, a fluid seal such as an O-ring to seal the drug within the storage volume 342. The exemplary plunger 335 is made of rubber and includes three O-ring seals. Reservoir 336 can be filled with reservoir 336, fitted with a cannula for "patch pump" type configurations, or connected with an infusion set for "pocket-pump" type configurations (potentially suitable adapters). Includes a connector 501 that can be used to do (via). The plunger 335 moves in the barrel 338 and varies the volume of the drug in the storage volume 342. Reservoir 336 can be pre-filled (or pre-filled by the user) with U-500 insulin in various volumes, for example to match the patient use profile. In other cases, lower concentrations of insulin, such as U-100 insulin and U-200 insulin, may be employed. The plug is inserted into the connector 501 and can maintain a sterile environment until use. Patients will remove the plug in those cases prior to use.

Additional exemplary baseplates for use with disposable assemblies of the invention, as well as exemplary cannula designs, fluid connections between drug reservoirs and cannulas, collaboration between cannulas and disposable assemblies (eg, baseplates and patients). To prevent axial movement of the cannula against), installation of reservoirs for injection sets and disposable assemblies, configuration and use of non-delivery base plates, placement and construction for mounting disposable and durable assemblies, skin adhesive design, and various Can be used in US Patent Application Nos. 12 / 890,207 and corresponding US Patent Publication Nos. 2012/0078170 filed on September 24, 2010, as well as the aforementioned US Patent Publication Nos. 2012/0184907 and 2013. It can be as described in / 0138078.

Looking now at the motor consisting of the two parts shown in FIGS. 5A-5C, the coil assembly 224 (and Hall effect sensor 225) of the motor in the durable assembly 200 is magnetic, which is part of the disposable assembly 300. It is positioned above the motor rotor 331. The exemplary multi-pole motor rotor 331 is disc-shaped and may 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 component and helps control the total cost of the disposable assembly 200. The motor rotor 331 is also parallel to the base plate 350, i.e., the motor rotor rotation axis is perpendicular to the base plate in the illustrated embodiment. The microprocessor 223 continuously excites the coil of the motor coil assembly 224 and directs the rotation of the motor rotor 331 by generating an electromagnetic torque coupling between the motor coil assembly 224 and the motor rotor 331. .. The position / orientation of the rotor poles with respect to the rotating magnetic field generator (coil assembly 224) is measured by a counter electromotive force, a rotary encoder, a Hall effect sensor 225 (FIG. 5A), and the like. For example, a Hall effect sensor mounted on the coil winding can be used to provide the microprocessor with a count, rotator signal, or rotor position, enabling low cost closed loop control of rotor speed. .. This type of brushless motor typically has an efficiency of 85-90% or higher and operates at very low temperatures. Although there may be structural variations, the face-to-face stator coil and flat rotor plate shown in FIGS. 5A-5C provide a compact design. In addition, more coil and / or Hall effect sensors may be used.

As best seen in FIG. 6, there is a gap 240 between the motor coil assembly 224 and the motor rotor 331. Part or all of the gap 240 may be defined (and occupied) by parts of the housing 202 and cover 302, i.e., housing bottom wall 206a and cover top wall 304b, in the illustrated implementation. In other implementations, the gap 240 between the motor coil assembly 224 and the motor rotor 331 may be occupied by only part of the durable assembly housing, or only part of the disposable assembly cover, or the structure may be completely It can simply be a void. The size of the gap defined by the distance between the motor coil assembly 224 and the motor rotor 331 is typically about 0.5 mm to 2.0 mm. Therefore, there is no gear engagement or other mechanical connection between the durable assembly 200 and the disposable assembly 300. As described above, all electronics can be positioned within the durable assembly 200 and the energy required by the disposable assembly 300 can be mechanically coupled or electrically contacted directly from the durable assembly 200. It is transmitted by an electromagnetic torque coupling that couples without accompanying. This exemplary design offers the additional advantage that it is relatively simple to make it waterproof or at least water resistant.

As described above, the rotation of the motor rotor 331 drives the gear train 332, causing the feed screw drive gear 333 to rotate, which in turn attaches to the lead screw 334 and the lead screw 334. Affects parallel movement of 335. Thus, the electromagnetically generated torque is generated when the electromagnetic energy supplied by the durable assembly 200 is converted into a mechanical force in the disposable assembly 300 that advances the plunger 335. A ratchet (not shown) or other similar device can be used to prevent reverse drive of the gear train 332. As the plunger 335 is driven through the reservoir 336, the drug is precisely dispensed in response to the precise movement of the gears and motor rotor. With the gear train, lead screw drive gear, lead screw, and entire plunger permanently contained within the disposable assembly 300, any plunger component is durable assembly 200 prior to separation from the disposable assembly 300. There is no need to retreat inside. As a result, a further advantage of this exemplary design is significantly reduced energy consumption, which allows, for example, the use of a primary battery as a power source.

The use of the exemplary system 100 will be described herein. At the most basic level, patient use of an exemplary infusion pump system (eg, system 100 in FIGS. 1A-2B) is to obtain a new disposable assembly 300, connect the disposable assembly to a durable assembly 200, and liner. Is involved in stripping the base plate adhesive layer, gaining subcutaneous access, and initiating a drug delivery operation. In some cases, use may involve additional steps such as attaching the cannula to connector 501 of the disposable assembly and removing the cannula cap, if desired. Various aspects of the basic operation of the system are described below. The behavior of the system does not necessarily require all of the steps each time the system is deployed, and the order of some of the steps can change. The operation is discussed below in the exemplary context of the aforementioned durable assembly 200 and disposable assembly 300 used as patch pumps through the use of a flow chart (FIG. 8). However, the argument is equally applicable to other patch pump and pocket pump implementations with slight variation. Further, unless otherwise indicated, the activities and decisions made by the endurance assembly 200 are controlled by the endurance assembly microprocessor, but further reference to the controller is limited for brevity.

With reference to FIG. 8, the use of the system may involve removing the disposable assembly from the durable assembly and replacing the disposable assembly. This is because the drug reservoir is empty (as detailed in US Patent Application No. 12 / 890,207 and the corresponding US Patent Publication No. 2012/0078170) (step S101), "disposable assembly replacement". It can occur when a message or alert is presented (step S102), or when the durable assembly controller receives a user-initiated "disposable assembly replacement" signal from the remote control 1000 (step S103). The user may, for example, to adapt to the user's sleep or travel schedule, such as when the drug presents a loss of efficacy, when dispensing problems occur, or due to pre-defined drug changes, and so on. For this reason, it may be desirable to replace the disposable assembly before the drug reservoir is empty.

The user may then obtain a new disposable assembly 300, perhaps from a storage location in the refrigerator, depending on the drug requirements (step S104). The durable assembly 200 and the disposable assembly 300 are then removed from the skin and separated, and the disposable assembly 300 can be discarded (steps S106 and S107).

The new disposable assembly 300 can then be attached to the durable assembly 200 (step S109). The user should clean the skin surface S to which the base plate 350 of the disposable assembly 300 will be adhered (step S116 in FIGS. 7 and 8). The user then peels off the base plate adhesive liner to expose the base plate adhesive layer (step S117) and remove the cannula cap (if present) (step S118). In the exemplary use of FIG. 8, the disposable assembly 30 comprises a cannula pre-attached to the connector 501. In another embodiment, a cannula inserter can be attached to the system, which can be triggered and insert the cannula after the system has been installed against the skin. An exemplary inserter is described in US Patent Publication No. 2013/0138078.

Returning to the step in FIG. 8, the system 100, which includes the durable assembly 200 and the disposable assembly 300, can be positioned on a suitable body location and gently pressed to adhere the adhesive layer to the skin surface S (step S119). .. Finally, if desired, the remote control 1000 can be used to initiate a particular drug delivery operation (step S120). The delivery operation is a predetermined delivery profile (eg, a particular basal rate, a series of time interval bolus deliveries, or some) comparable to the motor rotor rotation at a particular rate and time required to deliver the drug according to the profile. (A combination of them) can be followed. Alternatively, the profile can be entered by the user using remote control 1000 and stored by a durable assembly microprocessor. For example, remote control may memorize several different delivery profiles and bolus deliveries that the patient may select. Such profiles may correspond to, for example, the drug, the days when strenuous exercise is expected, the days when it is not, the occurrence of increased pain, and the like. Alternatively, or in addition, the profile stored in the durable assembly microprocessor can be set by the clinician's programming unit. Remote control may not be required, for example, to initiate basic delivery, as in the case of different disposable assemblies 300 with different defined delivery rates.

The above discussion is also applicable to the use of "pocket pump" systems as shown in FIG. 2B. Minor variations in the above procedure include, for example, the use of an injection set 503 instead of a cannula, potentially attachment of an injection set and connector 501 via an adapter (which may vary with the type of injection set 503), and Includes injection set tube priming.

In general, another exemplary portable injection system, represented by reference number 100a in FIG. 9, includes a durable assembly 200a and a disposable assembly 300a. The system 100a is substantially similar to the system 100. However, here, the intersection of the upper walls is mainly linear. In addition, the disposable assembly 300a has a recess 316a that fits into the corresponding protrusion 216a on the durable assembly 200a. The protrusions 216a and recesses 316a are located on the outer circumference of the assembled system 100a.

Various methodologies are presented here in the context of exemplary structures, described in the above section and illustrated in various figures, for explanatory purposes only. The methodology may employ the structures described above, but they are not limited thereto. In addition, durable assemblies may provide audible, visible, and / or tactile notifications. Remote control may also provide audible, visible, and / or tactile notifications as an alternative to or in addition to any notifications provided by the durable assembly. In addition, embodiments of the present invention may incorporate any one, less than all combinations, or all of the methodologies or devices referred to above.

The invention disclosed herein has been described in terms of the preferred embodiments described above, but numerous modifications and / or additions to the preferred embodiments described above will be readily apparent to those skilled in the art. .. The scope of the invention is extended to all such modifications and / or additions, and the scope of the invention is intended to be limited only by the claims described below or added later.

Finally, note the following regarding the terminology that may be used herein, whether in the description or in the claims. The terms "with", "including", "carrying", "having", "including", "with", etc. are non-limiting and "limited". It does not mean that it contains. An ordinal number such as "first", "second", "third", etc. is itself a temporal order in which one element, or method step, is superior to any priority, preference, or other element. Does not imply. Instead, such terms are simply markers that distinguish one element with a name from another element with the same name (without an ordinal number) and distinguish the elements. "And / or" means that the enumerated items are alternatives, but the alternatives also include any combination of the enumerated items. The terms "approximately," "about," "substantially," and "generally" allow certain variations from any exact dimension, measurement, and arrangement, as disclosed herein. It should be understood within the context of the description and operation of the invention. Terms such as "top", "bottom", "upper", and "lower" are convenient terms that indicate the spatial relationship of parts to each other rather than to any concrete space or gravity orientation. Thus, the term is used regardless of whether the assembly is oriented in a particular orientation shown in the drawings and described herein, upside down from that orientation, or from there to any other rotational variation. It is intended to include an assembly of component parts.

Claims (19)

An injection pump system, the injection pump system
With a durable assembly that includes an energy source,
Equipped with a disposable assembly containing a drug reservoir,
The durable assembly and the disposable assembly are such that the energy required to dispense the drug from the drug reservoir is supplied by the energy source and without direct mechanical coupling or electrical connection. An infusion pump system configured to be attached to each other in a manner such that it is transmitted from a durable assembly to the disposable assembly. The injection pump system of claim 1, wherein the energy is transmitted through an electromagnetic torque coupling. The durable assembly includes a coil assembly that receives energy from the energy source.
The disposable assembly includes a magnetic motor rotor located adjacent to the coil assembly.
The injection pump system according to claim 1, wherein the excitation of the coil is rotated by the motor rotor. The injection pump system according to claim 3, wherein the coil assembly and the magnetic motor rotor are separated by a gap. The injection pump system according to claim 4, wherein the durable assembly includes a housing, and a part of the housing is located in the gap. The injection pump system of claim 4, wherein the disposable assembly includes a base plate and a cover, the portion of which is located in the gap. The injection pump system according to claim 4, wherein the gap is 0.5 mm to 2.0 mm. The drug reservoir comprises a barrel and a plunger within the barrel.
The injection pump system according to claim 3, wherein the magnetic motor rotor is mechanically coupled to the plunger. The injection pump system according to claim 1, wherein the energy supply source includes a battery. The injection pump system of claim 9, wherein the battery comprises either one or more primary batteries or one or more rechargeable batteries. It is a method, and the said method is
Infusion pump with energy source The energy from the energy source includes the step of fixing the durable assembly to the infusion pump disposable assembly with drug reservoir, and the energy from the energy source is the disposable assembly without direct mechanical coupling or electrical connection. A method that is transmitted to and converted into mechanical force that moves the plunger within the reservoir. 11. The method of claim 11, wherein the energy source comprises one or more batteries. The durable assembly includes a coil assembly.
The disposable assembly includes a magnetic motor rotor.
The step of fixing the infusion pump durable assembly to the infusion pump disposable assembly secures the infusion pump durable assembly to the infusion pump disposable assembly so that a gap is between the coil assembly and the magnetic rotor. The method according to claim 11, including the above. 13. The method of claim 13, wherein at least a portion of the durable assembly and the disposable assembly is located in the gap. 11. The method of claim 11, wherein energy is transferred from the energy source to the disposable assembly through electromagnetic torque coupling. It is a disposable assembly, and the disposable assembly is
With the base plate
With the drug reservoir on the base plate
A plunger that can be moved in the reservoir and
A motor rotor that receives electromagnetic energy from the outside of the disposable assembly,
A disposable assembly comprising a gear train that converts the rotation of the motor rotor into a mechanical force that moves the plunger. The disposable assembly according to claim 16, wherein the disposable assembly does not include a motor stator. 16. The disposable assembly of claim 16, wherein the motor rotor comprises a disc parallel to the base plate. The disposable assembly according to claim 16, wherein the motor rotor is in the shape of a disc.

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