Fluid interconnection scheme between reservoir, pump and filling member

A filling member (43) in a medicament delivery device (1), the filling member (43) includes a first conduit (12) that fluidly communicates with a reservoir (4) and a second conduit (14) that fluidly communicates with a pump (3) and with the first conduit (12), wherein the filling member (43) provides two-way medicament flow that enters the reservoir (4) via the first conduit (12), exits the reservoir (4) into the first conduit (12) and the second conduit (14), and exits the second conduit (14) to the pump (3). The reservoir (4) includes a reservoir tube (44A) having one end that is formed with the reservoir (4), and the reservoir tube (44A) having another end that is press fit to the filling member (43) to establish fluid communication with the reservoir (4).

FIELD OF THE INVENTION

The present invention relates to medical devices, and more particularly, to medical devices with a filling member that is in fluid communication with a reservoir and a pump to deliver medicament to a patient.

BACKGROUND OF THE INVENTION

Diabetes is a group of diseases characterized by high levels of blood glucose resulting from the inability of diabetic patients to maintain proper levels of insulin production when required. Diabetes can be dangerous to the affected patient if it is not treated, and it can lead to serious health complications and premature death. However, such complications can be minimized by utilizing one or more treatment options to help control the diabetes and reduce the risk of complications.

The treatment options for diabetic patients include specialized diets, oral medications and/or insulin therapy. The main goal of diabetes treatment is to control the diabetic patient's blood glucose or sugar level. However, maintaining proper diabetes management may be complicated because it has to be balanced with the activities of the diabetic patient. Type 1 diabetes (T1D) patients are required to take insulin (e.g., via injections or infusion) to move glucose from the bloodstream because their bodies generally cannot produce insulin. Type 2 diabetes (T2D) patients generally can produce insulin but their bodies cannot use the insulin properly to maintain blood glucose levels within medically acceptable ranges. In contrast to people with T1D, the majority of those with T2D usually do not require daily doses of insulin to survive. Many people are able to manage their condition through a healthy diet and increased physical activity or oral medication. However, if they are unable to regulate their blood glucose levels, they will be prescribed insulin. For example, there are an estimated 6.2 million Type 2 diabetes patients (e.g., in the United States, Western Europe and Canada) taking multiple-daily-injections (MDI) which consist of a 24-hour basal insulin and a short acting rapid insulin that is taken at mealtimes for glycemic management control.

For the treatment of Type 1 diabetes (T1D) and sometimes Type 2 diabetes (T2D), there are two principal methods of daily insulin therapy. In the first method, diabetic patients use syringes or insulin pens to self-inject insulin when needed. This method requires a needle stick for each injection, and the diabetic patient may require three to four injections daily. The syringes and insulin pens that are used to inject insulin are relatively simple to use and cost effective.

Another effective method for insulin therapy and managing diabetes is infusion therapy or infusion pump therapy in which an insulin pump is used. The insulin pump can provide continuous infusion of insulin to a diabetic patient at varying rates to more closely match the functions and behavior of a properly operating pancreas of a nondiabetic person that produces the required insulin, and the insulin pump can help the diabetic patient maintain his/her blood glucose level within target ranges based on the diabetic patient's individual needs. Infusion pump therapy requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the diabetic patient's skin and through which infusion of insulin takes place. Infusion pump therapy offers the advantages of continuous infusion of insulin, precision dosing, and programmable delivery schedules.

In infusion therapy, insulin doses are typically administered at a basal rate and in a bolus dose. When insulin is administered at a basal rate, insulin is delivered continuously over 24 hours to maintain the diabetic patient's blood glucose levels in a consistent range between meals and rest, typically at nighttime. Insulin pumps may also be capable of programming the basal rate of insulin to vary according to the different times of the day and night. In contrast, a bolus dose is typically administered when a diabetic patient consumes a meal, and generally provides a single additional insulin injection to balance the consumed carbohydrates. Insulin pumps may be configured to enable the diabetic patient to program the volume of the bolus dose in accordance with the size or type of the meal that is consumed by the diabetic patient. In addition, insulin pumps may also be configured to enable the diabetic patient to infuse a correctional or supplemental bolus dose of insulin to compensate for a low blood glucose level at the time when the diabetic patient is calculating the bolus dose for a particular meal that is to be consumed.

Insulin pumps advantageously deliver insulin over time rather than in single injections, typically resulting in less variation within the blood glucose range that is recommended. In addition, insulin pumps may reduce the number of needle sticks which the diabetic patient must endure, and improve diabetes management to enhance the diabetic patient's quality of life. For example, many of the T2D patients who are prescribed insulin therapy can be expected to convert from injections to infusion therapy due to an unmet clinical need for improved control. That is, a significant number of the T2D patients who take multiple-daily-injections (MDI) are not achieving target glucose control or not adhering sufficiently to their prescribed insulin therapy.

Typically, regardless of whether a diabetic patient uses multiple direct injections (MDIs) or a pump, the diabetic patient takes fasting blood glucose medication (FBGM) upon awakening from sleep, and also tests for glucose in the blood during or after each meal to determine whether a correction dose is required. In addition, the diabetic patient may test for glucose in the blood prior to sleeping to determine whether a correction dose is required, for instance, after eating a snack before sleeping.

To facilitate infusion therapy, there are generally two types of insulin pumps, namely, conventional pumps and patch pumps. Conventional pumps use a disposable component, typically referred to as an infusion set, tubing set or pump set, which conveys the insulin from a reservoir within the pump into the skin of the user. The infusion set includes a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal infusion needle or flexible plastic catheter, extends. The base typically has an adhesive that retains the base on the skin surface during use. The cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit employed by the user.

Another type of insulin pump is a patch pump. Unlike a conventional infusion pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components in a single housing. Generally, the housing is adhesively attached to an infusion site on the patient's skin, and does not require the use of a separate infusion or tubing set. A patch pump containing insulin adheres to the skin and delivers the insulin over a period of time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separate controller device (as in one device sold by Insulet Corporation under the brand name OmniPod®, while others are completely self-contained. Such patch pumps are replaced on a frequent basis, such as every three days, or when the insulin reservoir is exhausted. Otherwise, complications may occur, such as restriction in the cannula or the infusion site.

As patch pumps are designed to be a self-contained unit that is worn by the patient, preferably, the patch pump is small, so that it does not interfere with the activities of the user. Thus, to minimize discomfort to the user, it is preferable to minimize the overall thickness of the patch pump. However, to minimize the thickness of the patch pump, the size of its constituent parts and the number of parts should be reduced as much as possible.

In current patch pump designs, tubes, such as plastic tubes, are employed as fluid pathways to route fluid flow from one internal component to another. The use of multiple tubes can create multiple flow paths to transfer medicament. For example, there can be two flow paths connected to a reservoir. One flow path fills the reservoir with medicament and another flow path routes the medicament from the reservoir to various internal components in the patch pump. The use of tubes can increase cost and can result in additional complexity during device assembly. For example, such device assembly includes connecting the tubes, which adds steps to the assembly process. In addition, preventing leaks from such connections can give rise to additional challenges.

Accordingly, a need exists for an improved fluid path design for use in a limited space environment, such as in a patch pump device, which can cost-effectively transport medicament, while minimizing or reducing the overall size and complexity of the device.

SUMMARY OF EMBODIMENTS OF THE INVENTION

It is an aspect of the present invention to provide a patch pump in which a filling member is substantially simultaneously in fluid communication with a reservoir and a pump to effectively and efficiently administer the medicament to the patient.

The foregoing and/or other aspects of the present invention can be achieved by providing a filling member in a medicament delivery device, the filling member comprising a first conduit that fluidly communicates with a reservoir, and a second conduit that fluidly communicates with a pump and with the first conduit, wherein the filling member provides two-way medicament flow that (1) enters the reservoir via the first conduit, (2) exits the reservoir into the first conduit and the second conduit, and (3) exits the second conduit to the pump.

The foregoing and/or other aspects of the present invention can also be achieved by providing a device for delivering medicament into skin of a patient, the device comprising a filling member including a septum cavity for housing a septum, a first conduit that fluidly communicates with a reservoir, and a second conduit that fluidly communicates with the first conduit and a pump, wherein the filling member provides two-way medicament flow that (1) enters the reservoir via the first conduit, (2) exits the reservoir into the first conduit and the second conduit, and (3) exits the second conduit to the pump.

Moreover, the foregoing and/or other aspects of the present invention can be further achieved by providing a medicament delivery method comprising inserting at least a portion of a medicament container through a septum of a filling member, transporting medicament from the medicament container into a conduit of the filling member to fill a reservoir, removing the medicament container from the septum, transporting the medicament from the reservoir into the conduit of the filling member, and transporting the medicament to exit the filling member.

The foregoing and/or other aspects of the present invention can also be further achieved by providing a medicament filling method comprising inserting at least a portion of a medicament container into a septum of a filling member, transporting medicament from the medicament container to a reservoir via a first conduit of the filling member, and to a pump via a second conduit of the filling member, and removing the medicament container from the septum.

Additionally, the foregoing and/or other aspects of the present invention can be achieved by providing a medicament delivery device comprising a pump disposed in the device, wherein the pump controls flow of medicament to a patient, a filling member including a septum adapted to provide access to an interior of the filling member via penetration therethrough, a septum cavity for housing the septum, a first conduit that fluidly communicates with a reservoir, and a second conduit that fluidly communicates with the first conduit and the pump, and a delivery cannula that receives the medicament from the pump and delivers the medicament into skin of the patient, wherein the filling member provides two-way medicament flow that: (1) enters the reservoir via the first conduit, (2) exits the reservoir into the first conduit and the second conduit, and (3) exits to the pump.

The foregoing and/or other aspects of the present invention can also be further achieved by providing a device for delivering medicament into skin of a patient, the device comprising a housing including a base with a filling opening, the housing including a pump that controls flow of the medicament to a patient, a reservoir that houses the medicament, a filling member that transports the medicament, and a septum disposed between the filling opening and the filling member, the septum sealing the filling opening, wherein the filling member includes a region adjacent to the septum, the region being in fluid communication with both the reservoir and the pump.

Additional and/or other aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention. The present invention may comprise delivery devices and methods for forming and operating same having one or more of the above aspects, and/or one or more of the features and combinations thereof. The present invention may comprise one or more of the features and/or combinations of the above aspects as recited, for example, in the attached claims.

Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings.

It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Also, it will be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled” and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as up, down, bottom, and top are relative, and are employed to aid illustration, but are not limiting.

The illustrative embodiments are described with reference to diabetes management using insulin therapy. It is to be understood that these illustrative embodiments can be used with different drug therapies and regimens to treat other physiological conditions than diabetes using different medicaments than insulin.

FIG. 1is a perspective view of an exemplary embodiment of a medicine delivery device comprising a patch pump1according to an exemplary embodiment of the invention. The patch pump1is illustrated with a see-through cover for clarity and illustrates various components that are assembled to form the patch pump1.FIG. 2is an exploded view of the various components of the patch pump ofFIG. 1, illustrated with a main cover2. The various components of the patch pump1may include: a reservoir4for storing insulin; a pump3for pumping insulin out of the reservoir4; a power source5in the form of one or more batteries; an insertion mechanism7for inserting an inserter needle with a catheter into a user's skin; control electronics8in the form of a circuit board with optional communications capabilities to outside devices such as a remote controller and computer, including a smart phone; a pair of dose buttons6on the cover2for actuating an insulin dose, including a bolus dose; and a base9to which various components above may be attached via fasteners91. The patch pump1also includes various fluid connector lines that transfer insulin pumped out of the reservoir4to the infusion site.

FIG. 3is a perspective view of an alternative design for a patch pump1A having a flexible reservoir4A, and illustrated without a cover. Such arrangement may further reduce the external dimensions of the patch pump1A, with the flexible reservoir4A filling voids within the patch pump1A. The patch pump1A is illustrated with a conventional cannula insertion device7A that inserts the cannula, typically at an acute angle, less than 90 degrees, at the surface of a user's skin. The patch pump1A further comprises: a power source5A in the form of batteries; a metering sub-system41that monitors the volume of insulin and includes a low volume detecting ability; control electronics8A for controlling the components of the device; and a reservoir filling member43for receiving a refill syringe45to fill the reservoir4A.

FIG. 4is a patch-pump fluidic architecture and metering sub-system diagram of the patch pump1A ofFIG. 3. The power storage sub-system for the patch pump1A includes batteries5A. The control electronics8A of the patch pump1A may include a microcontroller81, sensing electronics82, pump and valve controller83, sensing electronics85, and deployment electronics87, which control the actuation of the patch pump1A. The patch pump1A includes a fluidics sub-system that may include a reservoir4A, volume sensor48for the reservoir4A, a reservoir filling member43for receiving a refill syringe45to refill the reservoir4A. The fluidics sub-system may include a metering system comprising a pump and valve actuator411and an integrated pump and valve mechanism413. The fluidics sub-system may further include an occlusion sensor, a deploy actuator, as well as the cannula47for insertion into an infusion site on the user's skin. The architecture for the patch pumps ofFIGS. 1 and 2is the same or similar to that which is illustrated inFIG. 4.

With reference toFIG. 5, the wearable medical delivery device (e.g., insulin delivery device (IDD) such as patch pump1is operable in conjunction with a remote controller that preferably communicates wirelessly with the pump1and is hereinafter referred to as the wireless controller (WC)500. The WC can comprise a graphical user interface (GUI) display502for providing a user visual information about the operation of the patch pump1such as, for example, configuration settings, an indication when a wireless connection to the patch pump is successful, and a visual indication when a dose is being delivered, among other display operations. The GUI display502can include a touchscreen display that is programmed to allow a user to provide touch inputs such as a swipe to unlock, swipe to confirm a request to deliver a bolus, and selection of confirmation or settings buttons, among other user interface operations.

The WC500can communicate with the delivery device (e.g., patch pump1) using any one or more of a number of communication interfaces504. For example, a near field radiation interface is provided to synchronize the timing of the WC and patch pump1to facilitate pairing upon start up. Another interface can be provided for wireless communication between the WC and the patch pump1that employs a standard BlueTooth Low Energy (BLE) layer, as well as Transport and Application layers. Non-limiting examples of Application layer commands include priming, delivering basal dose, delivering bolus dose, cancelling insulin delivery, checking patch pump1status, deactivating the patch pump1, and patch pump1status or information reply.

FIG. 6is a perspective view of a patch pump1according to an exemplary embodiment of the present invention. The patch pump1has a housing10, which includes a main cover2liquid sealed or, preferably, hermetically sealed to a base9. The base9carries various components as described below in detail. The hermetic seal prevents fluid ingress and prevents other particles from passing the seal. Embodiments of the patch pump1also include a vent or a vent membrane along with a sealing method described herein to provide pressure equalization.

Embodiments of the seal include, for example, a liquid-tight seal, an O-ring seal or another mechanical seal, a gasket, an elastomer, a heat seal, an ultra-sonically welded seal, a laser weld, chemical joining, an adhesive, a solvent weld, or an adhesive weld. Laser welding is the preferred sealing method because when laser welding is properly performed, a seamless fully hermetic seal is formed. The vent or the vent membrane continues to have the functional purpose of equalizing internal pressure and providing a sterile environment. One skilled in the art will appreciate that other seals can be used without departing from the scope of the present invention.

FIG. 7is a cross-sectional view of the patch pump1illustrating various internal components. The main cover2and the base9house the components of the patch pump1. According to one embodiment, the patch pump1preferably includes a reservoir4for storing medicament (such as insulin) and a pump3for pumping the medicament to exit the reservoir4. The patch pump1also preferably includes electronics8for programming and operating the patch pump1, and an insertion mechanism7for inserting a cannula47into a skin of the patient to deliver medicament. Examples of the electronics8include semiconductor chips, controllers, diodes, antennas, coils, batteries, discrete components (resistors and capacitors, for example) and circuit boards used to operate and control the patch pump1and operate the pump1in conjunction with the WC500.

FIG. 8illustrates some of the main components of the patch pump1in a perspective view with the main cover2and the reservoir4removed for clarity. According to one embodiment, a filling member43is a conduit for supplying the medicament to the reservoir4. In some embodiments, the filling member43includes a portion that serves as part of the flow path for medicament exiting the reservoir4. The filling member43and the reservoir4will be described in further detail below.

FIG. 9illustrates a bottom surface23of the base9of the patch pump1. The base9is preferably composed of a stiff material such as a thermoplastic resin (e.g., LG Chem Ltd. product no. TR-558ai MABS (clarified)) or similar material that can support and be configured with various components of the pump1and recessed channels24,26as shown, for example, inFIGS. 8 and 9, and which favorably reacts with laser welding and insulin upon contact. The base9is preferably clear and laser transmissive. During use, the bottom surface23is oriented toward the skin of the patient. In some embodiments, the bottom surface23can include adhesive that removably attaches the base9to the skin of the patient. Alternatively, an adhesive pad adheres to both the bottom surface23and the skin of the patient. Preferably, 3M™ medical tape (e.g., product no. 1776) is the adhesive used, although various types of known industry adhesives can be used. However, the adhesive is carefully selected to ensure compatibility with human skin to prevent undesired reactions. Also, compatibility of the adhesive and the insulin is considered in case that the adhesive and the insulin accidentally mix. The adhesive or adhesive pad are also placed over a fluid channel cover28covering first and second fluid channels24,26.

The bottom surface23of the base9includes first and second fluid channels24,26. The first and second fluid channels24,26provide fluid pathways between various components in the patch pump1. According to one embodiment, the first and second fluid channels24,26advantageously establish fluid communication between various components such as the reservoir4, the filling member43, the pump3, and the insertion mechanism7.

Preferably, the first and second fluid channels24,26are recessed from the bottom surface23or etched or inscribed into the bottom surface23of the base9. As examples, the first and second channels24,26are formed by a molding process, such as injection molding, or by a cutting process, such as milling. In other embodiments, the first and second fluid channels24,26are disposed on the main cover2, or on the base9within the interior of the patch pump1. Similar fluid channels can be positioned in a plurality of locations in embodiments of the device.

According to one embodiment as illustrated inFIG. 9, the first and second fluid channels24,26are encapsulated by a fluid channel cover28which is illustrated as being transparent for clarity. One skilled in the art will appreciate that the opacity of the fluid channel cover28or other portions of the device can vary without departing from the scope of the present invention. The fluid channel cover28is, for example, clear film, foil, a flexible sheet/film or a semi-rigid/rigid part made of any suitable material.

According to one embodiment, the film channel cover28is composed of foil available from Oliver-Tolas Healthcare Packaging (e.g., TPC-0777A foil) or similar material. Preferably, the film channel cover28is composed of Oliver-Tolas Healthcare Packaging product no. IDT-6187 clear film or similar material and is heat sealed or heat staked to the bottom surface22of the base9to embed the first and second fluid channels24,26. Laser welding, for example, applies laser light through the clear film to fix the film channel cover28to the bottom surface22of the base9. The fluid channel cover28is sealed to the base9via any of the processing methods described above. The sealed fluid channel cover28encloses and protects the medicament from any contamination while travelling through the first and second fluid channels24,26. Laser welding is advantageous because a laser can straddle the channel edge of the fluid channels224,26during the welding process and join (or adhere) the film to the base9in areas that are closer to the channel edges than other methods.

FIG. 10is a perspective view of a filling member43in the patch pump ofFIG. 8. According to one embodiment, the filling member43includes a septum18disposed in a septum cavity16. As described below, the septum18is adapted to provide access to an interior of the filling member43. Specifically, a user pierces the septum18with a portion of a medicament container, such as a needle of a syringe, to fluidly communicate with the various passageways in the filling member43.

FIG. 11is a cross-sectional perspective view of the filling member taken along line11-11ofFIG. 10. Although the filling member43can be formed of multiple, joined parts, the filling member43is preferably injection molded and integrally formed as a unitary structure. Alternatively, the filling member43can be a casting that is integrally formed as a unitary structure and subsequently machined to precision. As another alternative, the filling member can be milled. The unitary structure of the filling member43advantageously reduces the number of components, improves subassembly processing, and simplifies the design of the patch pump1.

According to one embodiment, the filling member43is clear. Preferably, the filling member43is a carbon black based fill port composed of Lustran 348 with PolyOne CC1021.3952 Carbon Black in 3% let down ratio (LDR) or similar material. Alternately, the filling member43is LG Chem Ltd. product no. TR-558ai MARS (clarified). These materials advantageously provide less stringent number of critical to qualities (CTQ) tolerances, thus resulting in improved manufacturability. Additionally, these materials include a laser welding additive that supports and facilitates laser welding.

FIG. 12is a partial cross-sectional view of the filling member43installed within the patch pump1. The filling member43is sealed to the base9in a liquid-tight manner or hermetically sealed. According to one embodiment, the sealing interface between the filling member43and the base9includes adhesives, for example, adhesive material 1162-M or Loctite 3922 or similar material. It is desirable for the adhesive not to mix with the medicament because, for example, the insulin concentration is reduced by 5%-15%. Adhesive contamination into the medicament can be detrimental to the health and safety of the patient receiving the medicament. In accordance with one embodiment of the present invention, the filling member43is press fit to a tube44A configured with or without a receptacle93, thereby connecting to the reservoir4. Illustrative reservoir connections are described below in connection withFIGS. 16-22.

Alternatively, other sealing arrangements can include a mechanical seal, a heat seal, an ultra-sonically welded seal, a laser weld, chemical joining, a solvent weld, or an adhesive weld. Some examples of the mechanical seal include O-rings and gaskets. For the reasons described below, the sealing interface between the filling member43and the base9prevents contamination of the medicament.

Preferably, the filling member43is bonded to the base9by laser welding. The filling member43is configured to include additives for laser absorbency. Laser welding advantageously avoids the mixing of insulin and adhesive. Moreover, laser welding advantageously provides flexibility in positioning the filling member43in the base9. Laser welding also regulates the compression of the septum18by controlling the melt collapse (described below) of the filling member43. Specifically, under a standard interference fit, the septum18is compressed radially and axially. However, laser welding can limit the pressure on the septum18to solely axial compression. The filling member43collapses a controlled amount during laser welding to set the proper septum compression while considering all part and process tolerances. For example, the septum18is compressed by approximately 10% compared to a nominal axial length, whereas the septum18is very slightly compressed radially when assembled so that the septum18does not fall out during assembly.

As shown inFIG. 12, the base9preferably includes a filling opening20. According to one embodiment, the filling opening20is a counter-sunk through-hole that contacts the septum18. One skilled in the art will appreciate that the through-hole could be counter-bored, straight-sided, or have some other shape without departing from the scope of the present invention.

FIG. 13illustrates a cross-sectional view of the filling member43and the septum18taken along line13-13ofFIG. 10. As illustrated inFIGS. 12 and 13, the septum18is housed in a septum cavity16at a position above and adjacent to the filling opening20. The septum cavity16is defined by walls30,32in the filling member43and walls34,36in the base9. Specifically, the base9, as illustrated inFIG. 12, forms a bottom surface36and a circumferential, side surface34of the septum cavity16. The filling member43, as illustrated inFIG. 13, forms a top surface32and an opposing circumferential, side surface30of the septum cavity16. As a result, the septum18is positioned between the base9and the filling member43and seals the filling opening20.

Preferably, the septum18is composed of a material known in the industry as Kokoku Rubber Inc. product no. A1N-4509-M 40A durometer or similar material. According to one embodiment, a round septum18is held by the filling member43by the use of an adhesive. The round septum design provides ease in assembly. According to another illustrative embodiment, a keyhole septum18is press fitted into the base9and the filling member43to prevent adhesive from mixing with the insulin. The keyhole septum design provides a simpler configuration and improved manufacturability compared to the round septum design.

When the filling member43is sealed to the base9during assembly, the septum18is advantageously compressed in the septum cavity16to seal the filling member43at the filling opening20. In the round septum design, the septum18is compressed a predetermined amount both axially and radially with respect to the centerline of the filling opening20to ensure proper sealing. Specifically, the septum18is compressed between the top and bottom surfaces32,36of the septum cavity16in an axial direction via the filling member43and the base9. Additionally, the septum18is compressed radially between the circumferential, side surfaces30,34of the septum cavity16via the filling member43and the base9.

The use of the septum18in the septum cavity16of the filling member43provides several benefits. For example, the septum18advantageously seals the filling member43from the base9and the remaining interior of the patch pump1to protect particles or fluid contamination from entering the fluid path inside the filling member43. This arrangement advantageously provides appropriate sealing for the filling member43while minimizing the number of internal components and simplifying the overall design of the patch pump1. Additionally, if an adhesive is used to secure the filling member43to the base9, the septum18prevents the adhesive at the interface of the filling member43and the base9from entering the filling member43and contaminating the medicament.

According to one embodiment, a user inserts a portion of a medicament container, such as a needle of a syringe, into the filling member43by piercing through the septum18. As a result, the portion of the medicament container enters into an interior of the filling member43to fill the filling member43with the medicament. The septum18creates a seal around the inserted medicament container to maintain protection of the medicament from foreign liquids, adhesives, and particles. The septum18also advantageously prevents the medicament from leaking during and after the filling of medicament into the filling member43, as well as during insertion and removal of the medicament container, and during operation of the patch pump1.

FIG. 13illustrates a central communication region22above and adjacent to the septum cavity16that houses the septum18. According to one embodiment, the region22is in fluid communication with a first conduit12and a second conduit14. The first conduit12is a reservoir conduit that is in fluid communication with the reservoir4. Accordingly, during filling, the medicament enters the region22, travels into the first conduit12, and travels into the reservoir4. In this manner, the reservoir4is filled with medicament.

The reservoir4can either be a flexible reservoir or a rigid reservoir. Typically, a device having a rigid reservoir does not use a pump. Rather, a piston operates inside the rigid reservoir to drive the medicament out of the reservoir, into the flow path and through the various components of the device, and administer the medicament to the patient. On the other hand, a device having a flexible reservoir typically uses a pump within the device. The medicament is pulled from the reservoir by the pump, pushed through the various components of the device, and administered to the patient. Preferably, the patch pump1incorporates a flexible reservoir design where the reservoir4does not include a piston. Instead, the medicament is pulled from the reservoir4by the pump3, and the pump3is external to the reservoir4.

As illustrated inFIG. 13according to one embodiment, while the reservoir4is being filled with medicament via the first conduit12, the medicament also fills the second conduit14and the fluid pathway to an inflow portion (entrance) of the pump3. Path50represents the medicament flow path when the medicament container pierces the septum18. Path52represents the medicament flow path as the medicament fills the reservoir4, the filling member43and the fluid path leading to the entrance of the pump3. The medicament in path52travels to the reservoir4and to the pump3substantially simultaneously. Path54represents the medicament flow path during operation of the patch pump1. During operation, the medicament exits the reservoir4, travels through the first conduit12, the region22and the second conduit14, and ultimately exits the filling member43to various components of the patch pump1.

The second conduit14is a pump conduit that is in fluid communication with the pump3. In the assembled state of one embodiment, the second conduit14is a narrow passageway that is located above the base9. The first and second conduits12,14intersect at the region22, and are substantially perpendicular to each other. One skilled in the art would understand, however, that the first and second conduits12,14can have other angular relationships, or other positions relative to each other, without departing from the scope of the present invention. Path50advantageously establishes fluid communication with the first and second conduits12,14and the region22when the medicament container pierces the septum18.

As previously noted, the first and second conduits12,14are in fluid communication with each other via the region22. In this manner, when the reservoir4is being filled with the medicament, the first and second conduits12,14, the region22and the flow path leading to the pump3are substantially simultaneously filled with medicament (see path52). Accordingly, the filling member43advantageously allows the reservoir4and the pump3to be in fluid communication with each other.

The patch pump1, according to one embodiment, advantageously provides two-way medicament flow via the first conduit12. Specifically, as previously described and as illustrated inFIG. 13, the medicament enters the reservoir4via the first conduit12and path52. During operation of the patch pump1, the medicament exits the reservoir4into the first conduit12, travels to the region22via path54, and enters the second conduit14of the filling member43. Thus, the medicament flows through the first conduit12in two separate directions, path52and path54, providing two-way medicament flow. Such a configuration advantageously provides simplicity in design and a reduction in the number of components within the patch pump1.

According to one embodiment, the user inserts the portion of the medicament container into the filling opening20and penetrates the septum18to advantageously establish fluidly communication between the first and second conduits12,14, the region22and the reservoir4. During operation, however, the septum18seals and prevents fluid communication between the first and second conduits12,14of the filling member43and the filling opening20in the base9. Such a configuration advantageously provides selective fluid communication between the filling member43and the filling opening20to ensure liquid sealing and prevent adhesive or particles from mixing with the medicament.

When the medicament exits the second conduit14, the medicament preferably enters into a passageway27in the base9, as shown inFIG. 12. According to one embodiment, the passageway27is a through hole and is substantially parallel to the first conduit12. During operation, the medicament in the passageway27is pulled by the pump3and subsequently travels into the first fluid channel24at the bottom surface23of the base9.FIGS. 8, 9 and 12illustrate an exemplary embodiment of the medicament flow path in the fluid channels24,26that communicate with the pump3and ultimately travel to the cannula47via the insertion mechanism7. Accordingly, during operation of the patch pump1, the medicament flows from the reservoir4to the first conduit12, the region22, the second conduit14, the passageway27, the fluid channels24,26, and the pump3, and then to the insertion mechanism7and the cannula47.

The cannula47receives the medicament from the pump3via the fluid channels24,26and delivers the medicament into the skin of a patient. A porous frit is commonly used in the industry to block the needle end of a cannula. The porous fit creates back pressure in a device that incorporates a rigid reservoir to allow the rigid reservoir to be filled with medicament. Upon operation of the device having the rigid reservoir, the porous frit is manually removed by a health care professional or a user. Subsequently, the piston in the rigid reservoir is driven to begin administering the medicament to the patient. The porous frit is applied for a single use.

Preferably, the patch pump1does not use a porous frit. Because the patch pump1uses a pump3that is separate from a flexible reservoir4, and intervenes in the medicament flow path between the reservoir3and the cannula47, a porous frit is not necessary to apply back pressure. Rather, the pump3blocks the fluid path to the cannula47during filling so that the reservoir4is filled with medicament. Additionally, during operation of the patch pump1, the pump3pulls the medicament from the reservoir4and drives the medicament to the cannula47to be administered to the patient. Thus, the pump3controls the flow of the medicament in the patch pump1and advantageously provides fluid communication among the reservoir4, the filling member43and the cannula47.

FIGS. 14 and 15illustrate melt collapse features of the filling member43. Specifically, inFIG. 14, the filling member43includes a bottom surface38that is expected to collapse when the filling member43is laser welded to the base9. In this manner, the melt collapse of the filling member43controls how much the septum18is compressed (seeFIG. 12). Since the bottom surface38of the filling member43is subject to melt collapse, the septum18is only compressed axially and not radially.

FIG. 15illustrates a skirt39that is placed around the septum cavity16at an outer surface of the filling member47. The skirt39does not melt when the filling member47is laser welded to the base9. Instead, the skirt39controls the melt collapse of the filling member47during laser welding to prevent the filling member47from radially contracting. As a result, the skirt39prevents the filling member47from radially collapsing at the septum cavity16and thus prevents any undesirable radial compression of the septum18(seeFIG. 12).

FIGS. 16-19depict alternative illustrative embodiments for a reservoir port connector or joint44B that connects a reservoir tube44A to the reservoir4. The reservoir4is of a compact, smaller size compared to what is generally used in the industry. The reservoir4is a flexible, collapsible reservoir made from film materials ranging in thickness between 0.002-0.015 inches. The thickness can be varied depending on the need for structural integrity, flexibility, barrier properties, filling/emptying operational behavior and drug type. For example, material type and thickness can be selected to accommodate a selected pressure (e.g., which is affected by how much fluid is being delivered and by fluid properties), to preserve the integrity of reservoir4during shipping and handling, to achieve desired flexibility to conform to the reservoir port44B or to a tube44A and to prevent leakage of reservoir fluid, and/or to achieve a desired fill rate and/or volume.

Barrier properties include non-blocking characteristics that are considered in film material selection so that the film does not stick to itself as it collapses during emptying and blocks insulin flow. Barrier characteristic selection prevents contamination of the contents of the reservoir4(e.g., by external gases such as room air or fluids such as condensation). The material of the reservoir4can consist of one or more layers. For example, a three layer material can be used with an internal layer with properties conducive to heat sealing to a tube44A and one or more outer layers having the afore-mentioned barrier properties or characteristics to prevent contamination of the contents of the reservoir4and protection of the integrity of the reservoir4during shipping, handling and use.

The film perimeter is sealed according to a variety of methods such as heat-sealing, radio frequency welding, laser welding, or other joining techniques that cause melting of the two film faces together. The preferred material of the reservoir4is sealed Air M312A film that is heat sealed. This material is advantageously compatible to insulin over an extended period of time up to at least three days. Additionally, the reservoir4is packaged with an oil film to protect the reservoir4during storage and prior to operation.

The reservoir4can be formed in a variety of ways. According to one embodiment, the reservoir4is formed by using two film sheets at each of the top and bottom surfaces that flexibly goes around the reservoir tube44A. Such a configuration can provide optimal sealing between the reservoir4and the reservoir tube44A. According to another embodiment, the reservoir4is formed by folding a single film on one edge and sealing the remaining edges. In another embodiment, the reservoir4may be formed by taking a tubular film and sealing at two opposite ends. The reservoir4is formed in another embodiment by using a rigid backing on the top surface and a flexible film on the bottom surface. During the perimeter sealing process, the reservoir4can be formed in any desired shape. The reservoir4can also be formed to include features to enable attachment to specific anchor points in the patch pump1for mounting purposes. The reservoir4satisfies industry sterilization and aging requirements and all operational loads/conditions.

A reservoir tube44A is attached to the reservoir4on one end (e.g., forming a reservoir port connector or joint44B), and to the filling member43at the other end. According to one embodiment, the reservoir tube44A is a rigid port connection. Specifically, the reservoir tube44A is laser welded to the reservoir4and the filling member43at each end. According to another embodiment, the reservoir tube44A is a flexible port connection that is heat sealed to the reservoir4. According to another embodiment, the reservoir tube44A is molded or formed with the reservoir4. For example, the processes of heat sealing, molding or forming the reservoir tube44A and the reservoir4simultaneously advantageously improves manufacturability and sealing effectiveness. In another embodiment, the reservoir tube44A is mechanically pressed to the reservoir4. Finally, another embodiment adhesively bonds the reservoir tube44A to the reservoir4.

The reservoir tube44A is preferably made of a tubular material commonly known in the industry as Teknor Apex MD-50273 or similar material. This material is compatible to the material of the reservoir4and the insulin. Similar to the reservoir4, the reservoir tube44A also satisfies industry sterilization and aging requirements and all operational loads/conditions. The reservoir tube44A can be of a variety of cross-sectional shapes that facilitates sealing to the film material of the reservoir4. Such shapes include round and oval shaped with varying degrees of tapered ends.

A flexible port connector or joint44B can be heat sealed by applying heat and pressure to join two parts at a joining surface (joint). Specifically, the joint44B is where the reservoir tube44A is sealed directly into the perimeter seal of the reservoir4. In accordance with another embodiment of the present invention as shown inFIGS. 17-19, a receptacle93can be used that includes flanges95that join at the perimeter seal of the reservoir4. Regardless of which embodiment is used, the joint44B is advantageously leak-proof and can withstand mechanical vibrations, loads and pressures such as when the patch pump1is in operation and worn by the user. Additionally, heat sealing advantageously provides greater flexibility in port configurations considered for connection. The other end of the reservoir tube44A is press fitted to the filling member43. This embodiment advantageously provides only mechanical assembly, which improves and simplifies the overall reservoir assembly. The mechanical connections also advantageously remove the use of adhesives and provide flexibility in positioning the reservoir port connector or joint44B and the filling member43.

FIGS. 20-22illustrate the receptacle93in more detail. In particular, the receptacle93can include the flexible reservoir tube44A as a single unitary structure, or as a separate tube that is press fit or otherwise secured to a recess of the receptacle93. Two flanges95are disposed on either side of the receptacle93to increase the surface area and thus strengthen the bond between the receptacle93and the reservoir4as described above. Additionally, the two flanges95improve assembly of the reservoir4because the flanges95provide a surface for a user to hold the receptacle93.

FIG. 22illustrates a cross sectional view of the receptacle93. The flexible reservoir tube44A of the receptacle93has a first diameter and the body of the receptacle93has a second diameter. The first diameter is preferably smaller than the second diameter.

According to one embodiment, the reservoir port connector or joint44B ofFIG. 19can include filters to eliminate air in the flow path of the patch pump1and to improve sterilization. The reservoir film may further include an integral filter or vent film attached by heat sealing, mechanical or chemical joining to also aid to eliminate air in the patch pump1and to provide a more sterile environment.

In operation, the reservoir4is prefilled in a device or filled in the patch pump1prior to use by providing an appropriate filling port. When the flexible reservoir4is filled, it will expand to a final, filled shaped that is dependent on material properties, size and shape. When the reservoir4is connected to the pump3during operation, the fluid is driven and withdrawn from the reservoir4. The reservoir4generally immediately collapses (self-collapsing) by an amount equal to the volume of fluid removed. The flexibility of the film of the reservoir4allows for the emptying (reservoir collapsing) behavior. The flexibility of the reservoir4advantageously provides optimal use of the internal volume of the patch pump1. The fluid subsequently travels to the filling member43upon exiting the reservoir4and the receptacle93.

FIGS. 23-29illustrate an alternate embodiment of the patch pump101that is similar to the patch pump1illustrated in the embodiments ofFIGS. 8-13andFIG. 16with the following distinctions.FIG. 23is a perspective view of another embodiment of a patch pump101, omitting a cover. The patch pump101includes a filling member143directly connected to a reservoir104via a flexible reservoir tube144A engaging a reservoir port connector144B in the reservoir104. The filling member143is also in fluid communication with the base109.

FIG. 24is a partial cross-sectional view of the filling member143in the patch pump101ofFIG. 23. The base109is preferably clear and laser transmissive. The base109includes a protruding portion111that extends from a bottom portion of the base109and is disposed in the filling member143. As illustrated inFIGS. 24 and 25, the protruding portion111in the base109includes a through hole115that provides fluid communication between a pump and the reservoir104. The distal end of the protruding portion111includes a slot113. When the filling member143is being filled with medicament, the slot113receives the medicament and directs the medicament to the pump and the reservoir104. The operation of the filling member143is described in further detail below.

The reservoir104is preferably flexible, as described above, and is connected to the filling member143via the flexible tubing144A. As illustrated inFIGS. 24 and 25, the flexible tubing144A is mechanically pressed to the filling member143by an interference fit. As a result, no adhesives are used to secure the flexible tubing144A to the filling member143. This advantageously improves assembly and prevents adhesive from mixing with the medicament. The interference fit also meets sterilization requirements, aging requirements and all operation loads and conditions of the patch pump101.

The protruding portion111in the base109is advantageously positioned in the filling member143to control the end position of the flexible tubing144A while establishing fluid communication. Specifically, the flexible tubing144A contacts or bottoms out on a top surface of the protruding portion111. This contact advantageously ensures proper mechanical capture of the flexible tubing144A in the filling member143. Accordingly, fluid from the reservoir104travels through the flexible tubing144A, into the protruding portion111and into the flow channels.

A septum118is disposed in the filling member143. The filling member143, as illustrated inFIGS. 26-29, includes a septum cavity116having an inner diameter septum cavity wall130that secures the septum118. The inner diameter septum cavity wall130is specifically sized to axially trap the septum118in the filling member143. The septum118is then secured between the filling member143and the base109to create a full seal. The septum118is compressed and sealed in the axial direction only and not radially. Specifically, the filling member143collapses a controlled amount during laser welding to set the proper compression for the septum118while considering all part and process tolerances. Such a configuration improves assembly and reduces the manufacture of critical features while providing optimal sealing.

Additionally, a centerline of the septum118is disposed substantially parallel to and offset from a centerline of the flexible tubing144A and a centerline of a protruding portion111of the base109. This configuration advantageously prevents the flexible tubing144from contacting the medicament container when filling the filling member143. Specifically, if the flexible tubing144A and the septum118are in-line, the user may possibly inadvertently push the flexible tubing144A out of the filling member143when the septum118is pierced with a portion of a medicament container to fill the filling member143with medicament as described above. Accordingly, this configuration avoids the inadvertent movement of the flexible tubing144A after securement to the filling member143.

After the septum118is installed into the filling member143and the base109, the filling member143is secured to the base109preferably via laser welding. The filling member143includes laser absorbent additives to facilitate laser welding.

As illustrated inFIGS. 26-29, and similar to the embodiment disclosed above, the filling member143includes a first conduit112, a second conduit114, as well as a region122adjacent to the septum118. The medicament fills the first and second conduits112,114in order to fill the reservoir104and the fluid pathway to an inflow portion (entrance) of the pump with medicament. As illustrated inFIG. 29, path150represents the medicament flow path when the medicament container pierces the septum118. Path152represents the medicament flow path as the medicament fills the reservoir104, the filling member143and the fluid path leading to the entrance of the pump. The medicament in path152travels to the reservoir104and to the pump substantially simultaneously. Path154represents the medicament flow path during operation of the patch pump101.

During operation, the medicament exits the reservoir104, travels through the reservoir tube144A and the protruding portion111of the base109disposed in the first conduit112and ultimately exits the filling member143to various components of the patch pump101. A centerline of the reservoir tube144A and a centerline of the protruding portion111of the base109are substantially parallel to and in-line with a centerline of the first conduit112.

The second conduit114is a filling conduit that provides one way fluid communication with the first conduit112during filling. In the assembled state of one embodiment, the second conduit114is a narrow passageway that is located above the protruding portion111of the base109. The first and second conduits112,114are substantially perpendicular to each other. One skilled in the art would understand, however, that the first and second conduits112,114can have other angular relationships, or other positions relative to each other, without departing from the scope of the present invention. Path150advantageously establishes fluid communication with the first and second conduits112,114and the region122when the medicament container pierces the septum118.

As previously noted, the first and second conduits112,114are in fluid communication with each other during filling. When the reservoir104is being filled with the medicament, the first and second conduits112,114, the region122and the flow path leading to the pump are substantially simultaneously filled with medicament (see path152). Accordingly, the filling member143advantageously allows the reservoir104and the pump to be in fluid communication with each other.

The patch pump101, according to one embodiment, advantageously provides two-way medicament flow via the first conduit112. Specifically, the medicament enters the reservoir104via the first conduit112and path152. During operation of the patch pump101, the medicament exits the reservoir104into the first conduit112via the reservoir tube144A and the protruding portion111of the base109. Thus, the medicament flows through the first conduit112in two separate directions, path152and path154, providing two-way medicament flow. Such a configuration advantageously provides simplicity in design and a reduction in the number of components within the patch pump101.

According to one embodiment, the user inserts the portion of the medicament container into the filling opening120and penetrates the septum118to advantageously establish fluidly communication between the first and second conduits112,114, the region122and the reservoir104. During operation, however, the septum118is closed and prevents fluid communication between the first conduit112and the filling opening220in the base109. That is, the second conduit114, the region122and the slot113in the protruding portion111of the base109are not used during medication delivery. The region122acts as a dead volume where a substantial amount of fluid is never removed because the filling member143cannot decapitate. In order to maintain pressure equilibrium of the filling member143, a substantial amount of fluid does not exit the region122, the second conduit114and the slot113during medication delivery. Such a configuration advantageously provides selective fluid communication between the filling member143and the filling opening120, and streamlines medicament flow through the protruding portion111, into various other components of the patch pump101and ultimately delivers the medicament as described above.

FIGS. 30 and 31illustrate another embodiment of a keyhole septum218in a similar manner as described above. The keyhole septum218includes a first circular portion221A and a second circular portion221B. The second circular portion221B of the keyhole septum218includes a through hole219that provides an additional sealing surface.

As illustrated inFIG. 31, the keyhole septum218is disposed in a filling member243and seals the filling member243at both a centerline axis of the reservoir tubing244A and a centerline axis of region222. Specifically, the through hole219in the first circular portion221A of the keyhole septum218seals an outer diameter of a protruding portion211of a base209. Also, the second circular portion221B of the keyhole septum218seals at a septum cavity wall230of the filling member243.

This arrangement advantageously allows for the preferable use of adhesive bonding between the base209and the filling member243. Since the keyhole septum218seals at both of the interfaces described above, the risk of mixing adhesive with medicament is significantly reduced. Accordingly, the medicament does not contact and mix with the adhesive during operation. Specifically, the adhesive is not able to enter a filling opening220or travel past the septum218to mix with the adhesive. In this embodiment, the filling member243can also be laser welded to the base209, although adhesive is preferred for processing advantages.

Although only a few embodiments of the present invention have been shown and described, the present invention is not limited to the described embodiments. Instead, it will be appreciated by those skilled in the art that changes may be made to these embodiments without departing from the principles and spirit of the invention. It is particularly noted that those skilled in the art can readily combine the various technical aspects of the various elements of the various exemplary embodiments that have been described above in numerous other ways, all of which are considered to be within the scope of the invention, which is defined by the appended claims and their equivalents.