Systems and methods for fluid infusion device with automatic reservoir fill

Systems and methods for a fluid reservoir for use with a fluid infusion device, which is automatically filled are provided. The fluid reservoir includes a barrel having a proximal end and a distal end. The fluid reservoir also includes a stopper received in the barrel and movable within the barrel from the distal end to the proximal end to dispense a fluid from a passageway of the barrel. The fluid reservoir includes at least one engagement feature defined along a portion of a perimeter of the barrel near the proximal end that removably couples the fluid reservoir to the fluid infusion device.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally to fluid infusion devices for delivering a medication fluid to the body of a user. More particularly, embodiments of the subject matter relate to systems and methods for a fluid infusion device having a fluid reservoir, which is automatically filled.

BACKGROUND

Certain diseases or conditions may be treated, according to modern medical techniques, by delivering a medication or other substance to the body of a user, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is commonly treated by delivering defined amounts of insulin to the user at appropriate times. Some common modes of providing insulin therapy to a user include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to a user.

A fluid infusion device suitable for use as an insulin pump may be realized as an external device or an implantable device, which is surgically implanted into the body of the user. External fluid infusion devices include devices designed for use in a generally stationary location (for example, in a hospital or clinic), and devices configured for ambulatory or portable use (to be carried by a user). External fluid infusion devices may establish a fluid flow path from a fluid reservoir to the patient via, for example, a suitable hollow tubing. In many instances, the fluid reservoir requires filling by the patient prior to use in the external fluid infusion device. This process can be tedious and time consuming.

Accordingly, it is desirable to provide systems and methods for automatically filling a fluid reservoir of a fluid infusion device. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.

BRIEF SUMMARY

According to various embodiments, a fluid reservoir for use with a fluid infusion device is provided. The fluid reservoir comprises a barrel having a proximal end and a distal end. The fluid reservoir also comprises a stopper received in the barrel and movable within the barrel from the distal end to the proximal end to dispense a fluid from a passageway of the barrel. The fluid reservoir comprises at least one engagement feature defined along a portion of a perimeter of the barrel near the proximal end that removably couples the fluid reservoir to the fluid infusion device.

A fluid reservoir for use with a fluid infusion device is also provided. The fluid reservoir comprises a barrel having a proximal end and a distal end. The fluid reservoir also comprises a stopper received in the barrel and movable within the barrel from the distal end to the proximal end to dispense a fluid from a passageway of the barrel. The fluid reservoir comprises a mounting projection coupled to the proximal end of the barrel and defining at least a second passageway in fluid communication with the passageway of the barrel. A portion of the mounting projection is movable to obstruct the second passageway.

Further provided is a fluid reservoir for use with a fluid infusion device. The fluid reservoir comprises a barrel having a proximal end and a distal end. The fluid reservoir also comprises a stopper received in the barrel and movable within the barrel from the distal end to the proximal end to dispense a fluid from a passageway of the barrel. The fluid reservoir comprises a mounting projection coupled to the proximal end of the barrel and defining a bore and a second passageway. A housing is received in the bore and defines a third passageway and a fourth passageway. The third passageway is in fluid communication with the fourth passageway and the fourth passageway is in fluid communication with the passageway of the barrel. The housing is movable within the bore between a first, closed position in which the second passageway is obstructed, and a second, open position in which the second passageway and third passageway are coaxially aligned to allow fluid to exit the barrel.

According to various embodiments, provided is a fluid infusion device for automatically filling a fluid reservoir associated with the fluid infusion device. The fluid infusion device comprises a source of input and a fluid reservoir system including the fluid reservoir having a barrel and a stopper disposed within the barrel. The fluid infusion device also comprises a drive system coupled to the stopper of the fluid reservoir system and a control module that outputs one or more control signals to the drive system to move the stopper to fill the barrel of the fluid reservoir with a fluid based on the input.

Also provided is a fluid infusion device for automatically filling a fluid reservoir associated with the fluid infusion device. The fluid infusion device comprises a source of input and a housing. The fluid infusion device comprises a fluid reservoir system disposed within the housing and including the fluid reservoir having a barrel and a stopper disposed within the barrel. The fluid infusion device also comprises a drive system disposed within the housing and having a motor coupled to a slide. The slide is coupled to the stopper of the fluid reservoir system and movable via the motor. The fluid infusion device comprises a control module that outputs one or more control signals to the motor to move the stopper relative to the barrel to fill the barrel of the fluid reservoir with a fluid based on the input.

According to various embodiments, provide is a method for automatically filling a fluid reservoir associated with a fluid infusion device. The method comprises receiving an input to request automatic filling of the fluid reservoir; outputting one or more control signals to a motor of a drive system of the fluid infusion device to advance a stopper in the fluid reservoir and outputting one or more control signals to the motor of the drive system to retract the stopper within the fluid reservoir based on the receiving the input; and repeating the outputting of the control signals until the fluid reservoir is filled with the fluid.

Also provided according to various embodiments is a set connector for use with a fluid reservoir of a fluid infusion device. The set connector comprises a body for defining a fluid flow path out of the fluid reservoir. The body includes at least one locking tab that cooperates with a portion of the fluid infusion device to removably couple the body to a proximal end of the fluid reservoir. The body is movable between a first position, in which the fluid flow path is obstructed, and a second position, in which the fluid flow path is open.

Also provided is a set connector for use with a fluid reservoir of a fluid infusion device. The set connector comprises a piercing device for defining a fluid flow path out of the fluid reservoir and a body coupled to the piercing device. The body includes at least one locking tab that cooperates with a proximal end of the fluid reservoir to removably couple the body to the fluid reservoir.

According to various embodiments, provided is a set connector for use with a fluid reservoir of a fluid infusion device. The set connector comprises a body for defining a fluid flow path out of the fluid reservoir. The body including a top surface and a bottom surface. The top surface includes an engagement feature to engage a portion of the fluid reservoir and the bottom surface includes at least one locking tab. The body is movable between a first position, in which the fluid flow path is obstructed, and a second position, in which the fluid flow path is open. The engagement feature moves the portion of the fluid reservoir as the body moves from the first position to the second position.

DETAILED DESCRIPTION

As used herein, the term module refers to any hardware, software, firmware, electronic control component, processing logic, and/or processor device, individually or in any combination, including without limitation: application specific integrated circuit (ASIC), an electronic circuit, a processor (shared, dedicated, or group) and memory that executes one or more software or firmware programs, a combinational logic circuit, and/or other suitable components that provide the described functionality.

Embodiments of the present disclosure may be described herein in terms of functional and/or logical block components and various processing steps. It should be appreciated that such block components may be realized by any number of hardware, software, and/or firmware components configured to perform the specified functions. For example, an embodiment of the present disclosure may employ various integrated circuit components, e.g., memory elements, digital signal processing elements, logic elements, look-up tables, or the like, which may carry out a variety of functions under the control of one or more microprocessors or other control devices.

The following description relates to a fluid infusion device of the type used to treat a medical condition of a user. The infusion device can be used for infusing fluid into the body of a user. The non-limiting examples described below relate to a medical device used to treat diabetes (more specifically, an insulin pump), although embodiments of the disclosed subject matter are not so limited. Accordingly, the infused medication fluid is insulin in certain embodiments. In alternative embodiments, however, many other fluids may be administered through infusion such as, but not limited to, disease treatments, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, medications, vitamins, hormones, or the like. For the sake of brevity, conventional features and characteristics related to infusion system operation, insulin pump and/or infusion set operation, fluid reservoirs, and fluid syringes may not be described in detail here. Examples of infusion pumps and/or related pump drive systems used to administer insulin and other medications may be of the type described in, but not limited to: U.S. Patent Publication Nos. 2009/0299290 and 2008/0269687; U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,351; 6,659,980; 6,752,787; 6,817,990; 6,932,584; 7,621,893; 7,828,764; and 7,905,868; which are each incorporated by reference herein.

FIG. 1is a perspective view of an exemplary embodiment of a system100for automatically filling a fluid reservoir102of a fluid infusion device104. The system100includes the fluid infusion device104, a transfer guard106and a vial108. One or more components of the system100can be packaged together in suitable packaging for use by a consumer. The system100enables the consumer to automatically fill the fluid reservoir102of the fluid infusion device104with all or a portion of the contents of the vial108, as will be discussed in greater detail herein.

The fluid infusion device104is designed to be carried or worn by the patient. The fluid infusion device104may leverage a number of conventional features, components, elements, and characteristics of existing fluid infusion devices. For example, the fluid infusion device104may incorporate some of the features, components, elements, and/or characteristics described in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated by reference herein.

With reference toFIG. 1, the fluid infusion device104includes a user interface110and a display112coupled to a housing114. The user interface110includes one or more input devices116, which can be activated by the user. The user interface110can be used to automatically fill the fluid reservoir102, administer a bolus of insulin, to change therapy settings, to change user preferences, to select display features, and the like. Although not required, the illustrated embodiment of the fluid infusion device104includes the display112. The display112can be used to present various types of information or data to the user, such as, without limitation: the current glucose level of the patient; the time; a graph or chart of the patient's glucose level versus time; device status indicators; an indication that the fluid reservoir102is filled; a graphic illustrating a fill level of the fluid reservoir102, etc. In some embodiments, the display112is realized as a touch screen display element and, therefore, the display112also serves as a user interface component.

With reference toFIG. 2, the housing114of the fluid infusion device104accommodates a power supply120, a controller or control module122, a drive system124and a fluid reservoir system126, which includes the fluid reservoir102. Generally, the power supply120, the control module122and the drive system124are accommodated in a pump chamber defined by the housing114, and the fluid reservoir system126is accommodated in a reservoir chamber defined by the housing114. As will be discussed in greater detail herein, the drive system124can be used to substantially automatically fill the fluid reservoir102of the fluid reservoir system126.

The power supply120is any suitable device for supplying the fluid infusion device104with power, including, but not limited to, a battery. In one example, the power supply120can be removable relative to the housing114, however, the power supply120can also be fixed within the housing114. The control module122is in communication with the user interface110, display112, power supply120and drive system124. The control module122controls the operation of the fluid infusion device104based on patient specific operating parameters. For example, the control module122controls the supply of power from the power supply120to the drive system124to activate the drive system124to dispense fluid from the fluid reservoir system126. Further detail regarding the control of the fluid infusion device104can be found in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which was previously incorporated herein by reference.

In addition, as will be discussed, the control module122controls the automatic filling of the fluid reservoir102based on the receipt of one or more input signals from the input devices116. In this regard, the control module122outputs one or more control signals to a portion of the drive system124based on one or more input signals received from the input devices116to automatically fill the fluid reservoir102with the drive system124.

The drive system124cooperates with the fluid reservoir system126to dispense the fluid from the fluid reservoir system126to fill the fluid reservoir102with fluid. In one example, the drive system124includes a motor130, a gear box132, a drive screw134and a slide136. The motor130receives power from the power supply120as controlled by the control module122. In one example, the motor130is an electric motor. The motor130includes a sensor130afor position feedback and an output shaft138. The sensor130ameasures and observes the rotation of the output shaft138and generates sensor signals based thereon. Given the number of rotations of the output shaft138, the control module122can calculate the location of the slide136within the housing114. The output shaft138is coupled to the gear box132. In one embodiment, the gear box132is a reduction gear box. The gear box132includes an output shaft140, which is coupled to the drive screw134.

The drive screw134includes a generally cylindrical distal portion142and a generally cylindrical proximal portion144. The distal portion142has a diameter, which can be larger than a diameter of the proximal portion144. The distal portion142includes a plurality of threads146. The plurality of threads146are generally formed about an exterior circumference of the distal portion142. The proximal portion144is generally unthreaded, and can be sized to be received within a portion of the slide136. Thus, the proximal portion144can serve to align the drive screw134within the slide136during assembly, for example.

With continued reference toFIG. 2, the slide136is substantially cylindrical and includes a distal slide end148, a proximal slide end150and a plurality of threads152. The distal slide end148is adjacent to the motor130when the slide136is in a first, fully retracted position and the proximal slide end150is adjacent to the drive screw134when the slide136is in the first, fully retracted position. The proximal slide end150includes a projection154and a shoulder156, which cooperate with the fluid reservoir system126to dispense the fluid from the fluid reservoir system126. The projection154also aids in maintaining a portion of the fluid reservoir system126within the fluid reservoir102during an automatic fill procedure, as will be discussed herein. The shoulder156is defined adjacent to the projection154and contacts a portion of the fluid reservoir system126to dispense fluid from the fluid reservoir system126.

In one example, the projection154can be substantially hollow and cylindrical, and can have a diameter that is smaller than a diameter of a remainder of the slide136. The projection154includes a first side158, a second side160and a coupling feature162. The first side158can be substantially opposite the second side160, and the first side158can comprise the proximalmost end of the slide136. The second side160is adjacent the shoulder156. In one example, the coupling feature162is defined between the first side158and the second side160. The coupling feature162enables a stopper164of the fluid reservoir system126to be removably coupled to the slide136to facilitate an automatic fill procedure. In this example, the coupling feature162comprises a groove or channel defined about a perimeter of the projection154between the first side158and the second side160. It should be understood, however, that the coupling feature162can comprise any suitable mechanism, feature or device that enables removable coupling between the slide136and the stopper164, as known to one skilled in the art.

The plurality of threads152of the slide136are formed along an interior surface136aof the slide136between the distal slide end148and the proximal slide end150. Generally, the plurality of threads152do not extend into the projection154of the proximal slide end150. The plurality of threads152are formed so as to threadably engage the threads146of the drive screw134. Thus, the rotation of the drive screw134causes the linear translation of the slide136.

In this regard, the slide136is generally sized such that in a first, retracted position, the motor130, the gear box132and the drive screw134are substantially surrounded by the slide136. The slide136is movable to a second, fully extended position through the operation of the motor130. The slide136is also movable to a plurality of positions between the first, retracted position and the second, fully extended position via the operation of the motor130. Generally, the operation of the motor130rotates the output shaft138, which is coupled to the gear box132. The gear box132reduces the speed and increases the torque output by the motor130, and the output shaft140of the gear box132rotates the drive screw134, which moves along the threads152formed within the slide136. The movement or rotation of the drive screw134relative to the slide136causes the movement or linear translation of the slide136within the housing114. The forward advancement of the slide136(i.e. the movement of the slide136toward the fluid reservoir102) into the fluid reservoir102of the fluid reservoir system126causes the fluid reservoir system126to dispense fluid. Further, as will be discussed, the rearward displacement of the slide136(i.e. the movement of the slide136away from the fluid reservoir102toward the motor130) causes the filling of the fluid reservoir102with fluid.

The fluid reservoir system126includes the fluid reservoir102, a sealing member166and a retaining ring167. The sealing member166is coupled between the fluid reservoir102and the retaining ring167to prevent the ingress of fluids into the fluid reservoir chamber of the housing114. In one example, the sealing member166comprises an O-ring, however, any suitable device can be used to prevent the ingress of fluids, as known to one skilled in the art.

The fluid reservoir102includes a body or barrel170and the stopper164. The barrel170has a first or distal barrel end172and a second or proximal barrel end174. Fluid F is retained within the barrel170between the distal barrel end172and the proximal barrel end174. The distal barrel end172is positioned adjacent to the slide136when the fluid reservoir102is assembled in the housing114. Generally, the distal barrel end172can have a substantially open perimeter or can be substantially circumferentially open such that the slide136is receivable within the barrel170through the distal barrel end172. As illustrated inFIGS. 2 and 3, the distal barrel end172also includes at least one retaining device176. The at least one retaining device176protrudes at least slightly into the open perimeter of the distal barrel end172to aid in retaining the stopper164with the barrel170. In this regard, with the stopper164coupled to the slide136to enable automatic filling of the fluid reservoir102, upon the removal of the fluid reservoir102from the housing114the at least one retaining device176prevents the stopper164from remaining in the housing114and coupled to the slide136upon the removal of the fluid reservoir102. In one example, the at least one retaining device176comprises an inward projection or stake, however, any suitable device or mechanism can be employed to retain the stopper164within the barrel170.

With reference back toFIG. 2, the proximal barrel end174can have any desirable size and shape configured to mate with at least a portion of a set connector, as will be discussed in further detail herein. In one example, with reference toFIGS. 2 and 4, the proximal barrel end174includes a mounting projection178, a retaining system179(FIG. 4) and one or more vents181(FIG. 4). The mounting projection178extends outwardly from a surface170aof the barrel170and is sized and shaped to mate with a set connector to provide a pathway for the fluid F to flow out of the fluid reservoir102. The mounting projection178can also serve as at least one grip surface to assist in coupling the fluid reservoir102to the fluid infusion device104.

In one example, the mounting projection178defines a bore178aand a passage178b, and includes a housing186received in the bore178a. The housing186defines a first passageway180, which is in communication with a passageway182of the barrel170. The passage178bof the mounting projection178and a passage186aof the housing186cooperate to define a second passageway184. The housing186is receivable within the bore178aof the mounting projection178, and can be movably coupled to the mounting projection178. The housing186is generally movable relative to the mounting projection178between a first, closed position and a second, open position. In this regard, in the first, closed position, a portion of the housing186obstructs the passage178b, and thus, prevents the formation of the second passageway184. This prevents fluid from flowing out of the fluid reservoir102, during an automatic fill procedure for example. In the second, open position, the passage186aof the housing186is coaxially aligned with the passage178bof the mounting projection178to enable the formation of the second passageway184. Thus, in the second, open position the housing186enables fluid to flow out of the fluid reservoir102.

The housing186can include a tab190, which can be manipulated or moved to enable the movement of the housing186between the first, closed position and the second, open position. As will be discussed in further detail herein, a set connector can be used to move the tab190, thereby moving the housing from the first, closed position to the second, open position. It should be noted that the tab190can be optional, as the housing186can be movable within the bore178athrough any desired technique.

The first passageway180is defined through the housing186and is closed by a septum188. The septum188is received within a portion of the housing186, and is coupled to the housing186through any suitable technique, such as ultrasonic welding, press-fit, etc. The septum188serves as a barrier to prevent the ingress of fluids into the fluid reservoir system126, and prevents the egress of fluids from the fluid reservoir102. As will be discussed further herein, the septum188is pierceable by a needle or similar instrument to enable the automatic filling of the fluid reservoir102with fluid in the vial108. The second passageway184is in fluid communication with a set connector, and defines a fluid passageway out of the fluid reservoir102. It should be noted that the location of the second passageway184is merely exemplary, as the second passageway184can be defined at any desired position about the mounting projection178.

With reference toFIG. 4, the mounting projection178also includes a first surface192, a first ledge or lip194and a second ledge or lip196. The first surface192comprises the proximalmost surface of the mounting projection178and includes a cut-out192a. The cut-out192aenables the tab190to move along the first lip194, thereby enabling the housing186to move between the first, closed position and the second, open position. In other words, the cut-out192aand the first lip194cooperate with the tab190to constrain the movement of the housing186relative to the bore178a. In one example, the cut-out192aextends for about 90 degrees about the perimeter of the mounting projection178along the first surface192, however, the cut-out192acan extend for any desired angle about the mounting projection178to facilitate the movement of the housing186relative to the bore178a.

The first lip194extends around only a portion of the perimeter of the mounting projection178and is generally spaced apart from the first surface192along a longitudinal axis L of the fluid reservoir102. The second lip196is formed only about a portion of the perimeter of the mounting projection178, and can be formed substantially opposite the first lip194. The second lip196is also spaced part from the first surface192along the longitudinal axis L of the fluid reservoir102. The first lip194and the second lip196cooperate to receive a set connector, as will be discussed in greater detail herein. In one example, the second lip196can assist in preventing the axial movement of a set connector relative to the fluid reservoir102when the set connector is coupled to the fluid reservoir102.

With reference toFIG. 4, the retaining system179couples the fluid reservoir102to the housing114and a set connector to the fluid reservoir102. In one example, the retaining system179comprises one or more threads179aand one or more locking arms198. The one or more threads179athreadably engage corresponding threads114a(FIG. 2) defined in the housing114to couple the fluid reservoir102to the housing114. Thus, the one or more threads179aserve as at least one engagement feature defined along a portion of a perimeter of the barrel170near the proximal barrel end174that removably couples the fluid reservoir102to the fluid infusion device104.

The one or more locking arms198also assist in coupling the fluid reservoir102to the fluid infusion device104. In one example, the one or more locking arms198provide an audible and tactile feedback that the fluid reservoir102is connected to the fluid infusion device104by allowing the fluid reservoir102to snap into place in the fluid infusion device104. The one or more locking arms198comprise a first locking arm198a, and a second locking arm198b. The first locking arm198aand the second locking arm198bcan be mirror-symmetric relative to the longitudinal axis L of the fluid reservoir102. The first locking arm198aand the second locking arm198bare movable relative to the fluid reservoir102to couple the fluid reservoir102to the fluid infusion device104. Each of the first locking arm198aand the second locking arm198bincludes a locking tab200, which can engage a respective portion of the set connector to releasably couple the set connector to the fluid reservoir102.

With reference toFIGS. 4 and 4A, the one or more vents181equalize pressure between the pump chamber of the housing114of the fluid infusion device104and the atmosphere. In one example, the one or more vents181comprises one or more atmosphere vents181a,181b, which can be defined into the barrel170adjacent to the one or more locking arms198. Generally, the one or more atmosphere vents181a,181bare defined in the barrel170so as to be symmetric about the longitudinal axis L of the fluid reservoir102. The one or more atmosphere vents181a,181bcan each include a semipermeable membrane or plug, such as a hydrophobic membrane or plug, if desired, to prevent fluid from entering or exiting the fluid reservoir102through the one or more atmosphere vents181a,181b.

As best shown inFIG. 4A, the one or more vents181can also include one or more chamber vents183. The one or more chamber vents183can be defined into the barrel170adjacent to the thread179a. Generally, the fluid reservoir102includes two chamber vents183defined in the barrel170so as to be symmetric about the longitudinal axis L of the fluid reservoir102. The one or more chamber vents183allow pressure to be equalized in the fluid reservoir system126by venting to the inside of the pump chamber of the housing114.

With reference toFIG. 2, the stopper164is disposed within the barrel170. The stopper164is movable within and relative to the barrel170to dispense fluid from the fluid reservoir102. When the barrel170is full of fluid, the stopper164is adjacent to the distal barrel end172, and the stopper164is movable to a position adjacent to the proximal barrel end174to empty the fluid from the fluid reservoir102. In one example, the stopper164is substantially cylindrical, and includes a distal stopper end202, a proximal stopper end204, at least one friction element206and a counterbore208defined from the distal stopper end202to the proximal stopper end204.

The distal stopper end202is open about a perimeter of the distal stopper end202, and thus, is generally circumferentially open. In one example, the distal stopper end202includes at least one coupling device210. In this example, the distal stopper end202includes two coupling devices210a,210b, which cooperate with the coupling feature162of the slide136to couple the stopper164to the slide136. The coupling devices210a,210beach comprise flexible arms or tabs, which are receivable into the coupling feature162. In one example, the coupling devices210a,210bsnap into the coupling feature162. It should be noted that the use of the coupling devices210a,210band the coupling feature162of the slide136is merely exemplary, as any suitable mechanism can be employed to releasably couple the stopper164to the slide136.

The proximal stopper end204is closed about a perimeter of the proximal stopper end204, and thus, is generally circumferentially closed. The proximal stopper end204includes a slightly conical external surface, however, the proximal stopper end204can be flat, convex, etc. The at least one friction element206is coupled to the stopper164about an exterior surface164aof the stopper164. In one example, the at least one friction element206comprises two friction elements, which include, but are not limited to, O-rings. The friction elements206are coupled to circumferential grooves203defined in the exterior surface164aof the stopper164.

The counterbore208receives the projection154of the slide136and the movement of the slide136causes the shoulder156of the slide136to contact and move the stopper164. In one example, the counterbore208includes threads212, however, the projection154of the slide136is not threadably engaged with the stopper164. Rather, the slide136is coupled to the stopper164via the cooperative engagement between the coupling devices210a,210band the coupling feature162. Thus, the threads212illustrated herein are merely exemplary.

The retaining ring167aids in retaining the fluid reservoir102within the housing114, and also cooperates with a set connector to aid in coupling the set connector to the fluid reservoir102, as will be discussed in greater detail herein. The retaining ring167is coupled onto a portion of the housing114, such that the sealing member166is between the housing114and the retaining ring167. For example, the retaining ring167can be ultrasonically welded onto the housing114, however, any suitable technique can be used to couple the retaining ring167to the housing114, such as a press-fit, mechanical fasteners, etc. In one example, the retaining ring167is substantially annular, however, the retaining ring167can have any suitable shape that corresponds to the shape of the portion of the housing114that receives the fluid reservoir102. As illustrated inFIG. 1, the retaining ring167can include one or more lock tabs214. The lock tabs214project upward from a surface167aof the retaining ring167, and are formed along a perimeter of the retaining ring167. In one example, the lock tabs214are formed so as to be substantially symmetrical about the longitudinal axis L of the fluid reservoir102, however, the lock tabs214can be arranged about the perimeter of the retaining ring167at any desired location. The retaining ring167can also include a locating feature216, which can aid in the assembly of the retaining ring167to the housing114.

With reference toFIGS. 1 and 5, the transfer guard106facilitates the transfer of fluid from the vial108to the fluid reservoir102. The transfer guard106includes a first end250, a second end252, a midsection254that couples the first end250to the second end252and at least one needle256(FIG. 5). The first end250couples the transfer guard106to the fluid reservoir102. In one example, with reference toFIG. 5, the first end250defines a bore258and a needle guide260. The bore258is sized and shaped to fit over and substantially circumferentially surround the mounting projection178. The bore258can include one or more slots258a, which can enable the bore258to flex outwardly to aid in coupling the first end250to the mounting projection178. A surface250aof the first end250can rest upon the surface170aof the barrel170when the transfer guard106is coupled to the fluid reservoir102. The needle guide260receives and guides a portion of the at least one needle256such that the at least one needle256can be placed in fluid communication with the fluid reservoir102. The needle guide260can be formed so as to be coaxial with the longitudinal axis L of the fluid reservoir102when the transfer guard106is coupled to the fluid reservoir102. Stated another way, the needle guide260can be formed at the first end250such that when the transfer guard106is positioned about the mounting projection178, the needle guide260is coaxially aligned with an axis of the first passageway180such that the at least one needle256, received through the needle guide260, pierces the septum188, thereby creating a fluid flow path between the needle and the fluid reservoir102.

The second end252includes a bore262. The bore262is sized and shaped to fit over a portion of the vial108, and can include one or more retaining features264to aid in coupling the second end252to the vial108. In one example, the one or more retaining features264is a rib, which is sized to fit around a flange266of the vial108. The bore262can also include one or more slots268, which can enable the second end252to flex outwardly to secure the retaining features264about the flange266of the vial108. It should be noted that the configuration of the second end252is merely exemplary, as the second end252can have any desired size and shape to mate with the vial108. The bore262can be substantially circumferentially open at either end to enable the at least one needle256to pierce the vial108to create a fluid flow path between the vial108and the at least one needle256.

The midsection254couples the first end250to the second end252, and provides structural support for supporting a weight of the vial108when the vial108is coupled to the transfer guard106, and the transfer guard106is coupled to the fluid reservoir102. The midsection254can also include one or more grip surfaces270, which can allow a user to easily manipulate the transfer guard106to couple the transfer guard106to both the vial108and the fluid reservoir102.

The first end250, second end252and midsection254can be integrally formed for receipt of the at least one needle256, which can be discrete from the first end250, second end252and midsection254. In this example, the at least one needle256comprises a single needle, which can include a piercing point or pointed tip at both ends256a,256bof the needle256to enable the needle256to pierce a septum272of the vial108and the septum188of the fluid reservoir102. The needle256can be a hollow needle, to enable fluid to flow from the vial108to the fluid reservoir102through the needle256. The needle256is received through the needle guide260, and is generally press-fit into the needle guide260to fixedly couple the needle256to the transfer guard106. Generally, the needle256is sized such that when the needle256is assembled to the transfer guard106, the needle256extends only within the bore258and the bore262.

The vial108can comprise any suitable vial for storing a fluid. In one example, the vial108stores insulin, and defines a chamber274for storing the fluid. The chamber274narrows or necks to the flange266. The flange266is couplable to the second end252of the transfer guard106. The septum272of the vial108is disposed in the flange266and serves to prevent the ingress and egress of fluids out of the chamber274of the vial108.

With reference toFIG. 2, with the housing114assembled with the power supply120, the control module122and the drive system124, the fluid reservoir system126can be coupled to the housing114. In one example, an empty fluid reservoir102is threadably inserted into the reservoir chamber of the housing114with the one or more threads179a(FIG. 4) engaging the threads of the pump chamber of the housing114, such that the coupling devices210a,210bof the stopper164snap into engagement with the retaining feature160of the slide136. Once the fluid reservoir102is fully seated in the housing114, the first locking arm198aand the second locking arm198bengage with the retaining ring167to provide audible feedback that the fluid reservoir102is fully seated or positioned within the housing114.

With reference toFIG. 5, with the fluid reservoir102fully seated or positioned within the housing114, the first end250of the transfer guard106is coupled to the mounting projection178of the fluid reservoir102such that the end256aof the needle256pierces the septum188of the fluid reservoir102. The vial108is coupled to the second end252of the transfer guard106such that the end256bof the needle256pierces the septum272of the vial108. With reference toFIG. 6, once the transfer guard106is coupled between the vial108and the fluid reservoir102, the needle256creates a fluid flow path from the vial108to the fluid reservoir102.

With the fluid flow path created by the needle256of the transfer guard106, the control module122of the fluid infusion device104can substantially automatically fill the fluid reservoir102with the fluid from the vial108. In this regard, with reference toFIG. 2, the control module122outputs one or more control signals to the motor130of the drive system124based on one or more of the input from the input devices116, one or more signals from the sensor130a, and further based on the automatic reservoir fill systems and methods of the present disclosure, to substantially automatically fill the fluid reservoir102with fluid from the vial108. It should be noted that while the control module122is discussed herein as outputting the one or more control signals based on the receipt of input from the input devices116, the control module122can also output the one or more control signals based on signals received from one or more sensors, such as a pressure sensor, for example, and thus, the following description is merely exemplary.

Referring now toFIG. 7, and with continued reference toFIGS. 2 and 5, a dataflow diagram illustrates various embodiments of a control system300for the fluid reservoir system126(FIG. 2) that may be embedded within the control module122. Various embodiments of the control system according to the present disclosure can include any number of sub-modules embedded within the control module122. As can be appreciated, the sub-modules shown inFIG. 7can be combined and/or further partitioned to similarly control the motor130and output one or more control signals to the motor130based on the input data from the input devices116. Inputs to the system can be sensed by systems of the fluid infusion device104, received from other control modules (not shown), and/or determined/modeled by other sub-modules (not shown) within the control module122. In various embodiments, the control module122includes an automatic fill control module302.

The automatic fill control module302receives as input sensor data304and input data306. The input data306comprises one or more inputs received from the input devices116and/or display112to begin an automatic fill procedure. The sensor data304comprises one or more sensor signals from the sensor130aof the motor130. Based on the one or more sensor signals from the sensor130a, the automatic fill control module302determines a position or location of the slide136with the housing114. In this regard, as the dimensions of the housing114are known, and an amount of movement of the slide136per revolution of the output shaft138is known, given the amount of rotation of the output shaft138measured and observed by the sensor130a, the automatic fill control module302determines the position of the slide136within the housing114, and thus, within the fluid reservoir102. It should be noted that the position of the slide136can also be a predefined or default position. For example, the control system could output one or more control signals to the motor130to move the slide136to a start position or home position if a sensor associated with the control system observes or detects that the fluid reservoir102is no longer coupled to or received within the housing114. Furthermore, the position of the slide136can be determined based on input data306received to move the slide136to a predefined or default position.

Based on the position of the slide136determined from the sensor data304and the receipt of the input data306, the automatic fill control module302outputs one or more control signals308to the motor130to rotate the output shaft138of the motor130to advance or retract the slide136. Generally, the automatic fill control module302advances or retracts the slide136over a series of intervals to allow the fluid reservoir102to fill with fluid from the vial108with little to no air bubbles. In this regard, the incremental advancing and retracting of the slide136prevents a significant pressure gradient from forming between the inside of the vial108and the atmosphere (i.e. vacuum forming and bubbles coming out of the fluid in the vial108).

Referring now toFIG. 8, and with continued reference toFIGS. 1-6, a flowchart illustrates a control method that can be performed by the control module122ofFIG. 2in accordance with the present disclosure. As can be appreciated in light of the disclosure, the order of operation within the method is not limited to the sequential execution as illustrated inFIG. 8, but may be performed in one or more varying orders as applicable and in accordance with the present disclosure.

The method starts at400. At402, the method determines if input data306has been received from the input devices116and/or display112. If input data306has not been received, the method loops. Otherwise, at404, the method determines the position of the slide136based on the sensor data304and the known dimensions of the slide136and housing114. At406, if the slide136is at a start position, the method proceeds to408. Generally, the start position is a predefined position for the slide136, and can comprise the position of the slide136at the first, retracted position. If the slide136is not in the start position, at410, the method outputs the one or more control signals308to the motor130to move the slide136, and the method loops to406.

At408, the method outputs the one or more control signals308to the motor130to advance the slide136from the first, retracted position, to a second position. As the stopper164is coupled to the slide136, the advancement of the slide136causes the stopper164to move or advance within the fluid reservoir102in a direction towards the first passageway180. The advancement of the slide136and stopper164increases the pressure in the fluid reservoir102and the pressure in the vial108. Generally, the one or more control signals308instruct the motor130to advance the slide136a predetermined number of millimeters (mm), for example, about 4.0 (mm).

At412, the method outputs the one or more control signals308to the motor130to move or retract the slide136from the second position, towards the first, retracted position. As the stopper164is coupled to the slide136, the retraction or movement of the slide136towards the first, retracted position causes the stopper164to move or retract within the fluid reservoir102in a direction toward the distal barrel end172. The retraction of the slide136and stopper164decreases the pressure in the fluid reservoir102, and thereby causes fluid from the vial108to flow from the vial108into the fluid reservoir102. Generally, the one or more control signals308instruct the motor130to retract the slide136a predetermined number of millimeters (mm), for example, about 4.0 (mm).

At414, the method determines if the fluid reservoir102is filled with a desired amount of fluid from the vial108. The method determines the fill level of the fluid reservoir102through any suitable technique, such as based on the sensor data304, and/or based on pressure data observed by a pressure sensor, for example. The method can also determine the fill level of the fluid reservoir102based on the number of movements (advancements/retractions) of the slide136and/or based on a position of the stopper164. In one example, the position of the stopper164can be determined with a motor encoder associated with the motor130. If the fluid reservoir102is filled to the desired level or with the desired amount of fluid, the method ends at416. Otherwise, the method loops to408.

With reference now toFIG. 9, a fluid infusion device500is shown, which can be used with the transfer guard106and vial108ofFIG. 1. As the fluid infusion device500can be similar to the fluid infusion device104discussed with regard toFIGS. 1-8, the same reference numerals will be used to denote the same or similar components. The fluid infusion device500includes the user interface110and the display112(not specifically shown inFIG. 9) coupled to the housing114. The housing114of the fluid infusion device500accommodates the power supply120, the controller or control module122, a drive system502and a fluid reservoir system504. Generally, the power supply120, the control module122and the drive system502are accommodated in a pump chamber defined by the housing114, and the fluid reservoir system504is accommodated in a reservoir chamber defined by the housing114.

The drive system502cooperates with the fluid reservoir system504to dispense the fluid from the fluid reservoir system504and to fill the fluid reservoir system504with fluid. In one example, the drive system502includes the motor130, the gear box132(not specifically shown), the drive screw134(not specifically shown) and a slide506. The slide506is substantially cylindrical and includes the distal slide end148, a proximal slide end508and the plurality of threads152(not specifically shown). The proximal slide end508includes a plurality of threads510, which cooperate with the fluid reservoir system504to dispense the fluid from the fluid reservoir system504.

The slide506is generally sized such that in a first, retracted position, the motor130, the gear box132and the drive screw134are substantially surrounded by the slide506. The slide506is movable to a second, fully extended position through the operation of the motor130. The slide506is also movable to a plurality of positions between the first, retracted position and the second, fully extended position via the operation of the motor130. Generally, as discussed with regard toFIG. 2, the operation of the motor130rotates the output shaft138, which is coupled to the gear box132. The gear box132reduces the torque output by the motor130, and the output shaft140of the gear box132rotates the drive screw134, which moves along the threads152formed within the slide506. The movement or rotation of the drive screw134relative to the slide506causes the movement or linear translation of the slide506within the housing114. The forward advancement of the slide506(i.e. the movement of the slide506toward the fluid reservoir system504) into a portion of the fluid reservoir system504causes the fluid reservoir system504to dispense fluid. Further, as will be discussed, the rearward displacement of the slide506(i.e. the movement of the slide506away from the fluid reservoir system504toward the motor130) causes the filling of the fluid reservoir system504with fluid.

The fluid reservoir system504includes a fluid reservoir512, the sealing member166and the retaining ring167. The fluid reservoir512includes a body or barrel514and a stopper516. The barrel514has a first or distal barrel end518and the second or proximal barrel end174. Fluid F is retained within the barrel514between the distal barrel end518and the proximal barrel end174. The distal barrel end518is positioned adjacent to the slide506when the fluid reservoir512is assembled in the housing114. Generally, the distal barrel end518can have a substantially open perimeter or can be substantially circumferentially open such that the slide506is receivable within the barrel514through the distal barrel end518.

The stopper516is disposed within the barrel514. The stopper516is movable within and relative to the barrel514to dispense fluid from the fluid reservoir512. When the barrel514is full of fluid, the stopper516is adjacent to the distal barrel end518, and the stopper516is movable to a position adjacent to the proximal barrel end174to empty the fluid from the fluid reservoir512. In one example, the stopper516is substantially cylindrical, and includes a distal stopper end520, the proximal stopper end204, the at least one friction element206and a counterbore522defined from the distal stopper end520to the proximal stopper end204.

The distal stopper end520is open about a perimeter of the distal stopper end520, and thus, is generally circumferentially open. The counterbore522receives the proximal slide end508of the slide506. In one example, the counterbore522includes a plurality of threads524. The plurality of threads524threadably engage the plurality of threads510of the slide506to couple the stopper516to the slide506. By coupling the stopper516to the slide506, the movement of the slide506results in a movement of the stopper516, which enables the drive system502to fill the fluid reservoir512with fluid.

With the housing114assembled with the power supply120, the control module122and the drive system502, the fluid reservoir system504can be coupled to the housing114. In one example, an empty fluid reservoir512is threadably inserted into the reservoir chamber of the housing114with the one or more threads179a(not specifically shown) engaging the threads of the pump chamber of the housing114, such that the plurality of threads524of the stopper516threadably engage with the plurality of threads510of the slide136. Once the fluid reservoir512is fully seated in the housing114, the first locking arm198aand the second locking arm198bengage with the retaining ring167to provide audible feedback that the fluid reservoir512is fully seated or positioned within the housing114.

As the remainder of the method for automatically filling the fluid reservoir512with fluid can be substantially similar to the method described with regard toFIGS. 5-8, the method of automatically filling the fluid reservoir512will not be discussed in great detail herein. Briefly, however, with the fluid reservoir512fully seated or positioned within the housing114, the first end250of the transfer guard106is coupled to the mounting projection178of the fluid reservoir512such that the end256aof the needle256pierces the septum188of the fluid reservoir512. The vial108is coupled to the second end252of the transfer guard106such that the end256bof the needle256pierces the septum272of the vial108. Once the transfer guard106is coupled between the vial108and the fluid reservoir512, the needle256creates a fluid flow path from the vial108to the fluid reservoir512.

With the fluid flow path created by the needle256of the transfer guard106, the control module122of the fluid infusion device104can substantially automatically fill the fluid reservoir102with the fluid from the vial108using the control system ofFIG. 7and the method ofFIG. 8.

With reference now toFIG. 10, a fluid reservoir600for use with the fluid infusion device104or fluid infusion device500is shown. As the fluid reservoir600can be similar to the fluid reservoir102discussed with regard toFIGS. 1-8, the same reference numerals will be used to denote the same or similar components.

In this example, the fluid reservoir600includes a body or barrel602and the stopper164. It should be understood, that if the fluid reservoir600were for use with the fluid infusion device500ofFIG. 9, the fluid reservoir600would include the barrel602and the stopper516. The barrel602has the first or distal barrel end172and a second or proximal barrel end603. Fluid F is retained within the barrel602between the distal barrel end172and the proximal barrel end603.

The proximal barrel end603can have any desirable size and shape configured to mate with at least a portion of a set connector, as will be discussed in further detail herein. In one example, the proximal barrel end603includes a septum604and at least one wing606. In addition, the proximal barrel end603also comprises the one or more threads179a(FIG. 10). The one or more threads179athreadably engage corresponding threads114a(FIG. 2) defined in the housing114to couple the fluid reservoir600to the housing114. Thus, the one or more threads179aserve as at least one engagement feature defined along a portion of a perimeter of the barrel602near the proximal barrel end603that removably couples the fluid reservoir600to the fluid infusion device104.

The septum604is disposed in a passageway608at the proximal barrel end603. The passageway608provides a fluid flow path from an interior of the barrel170to a set connector through the proximal barrel end603. The septum604closes the passageway608. The septum604is coupled to the passageway608through any suitable technique, such as ultrasonic welding, press-fit, etc. The septum604serves as a barrier to prevent the ingress of fluids into the fluid reservoir600, and prevents the egress of fluids from the fluid reservoir600. The septum604is pierceable by a needle or similar instrument to enable the automatic filling of the fluid reservoir600with fluid in the vial108(FIG. 1).

With continued reference toFIG. 10, and with additional reference toFIG. 11, the at least one wing606provides at least one grip surface to enable the user of the fluid reservoir600to couple or decouple the fluid reservoir600from the housing114of the fluid infusion device104. In one example, the wing606extends outwardly or upwardly from a surface603a(FIG. 11) of the proximal barrel end603, to facilitate the manipulation of the wing606. It should be noted that while the wing606is illustrated herein as being rounded and semi-circular in shape, the wing606can have any desired shape to facilitate the insertion and removal of the fluid reservoir600from the housing114.

Thus, the fluid reservoir600enables the user to easily insert and remove the fluid reservoir600from the housing114of the fluid infusion device104,500via the wing606. As the fluid reservoir600can be used in the same manner and operates similarly to the fluid reservoir102, further detail regarding the use and automatic filling of the fluid reservoir600will not be discussed in great detail herein.

With reference now toFIG. 12, a fluid reservoir700for use with the fluid infusion device104or fluid infusion device500is shown. As the fluid reservoir700can be similar to the fluid reservoir102discussed with regard toFIGS. 1-8, the same reference numerals will be used to denote the same or similar components.

In this example, the fluid reservoir700includes a body or barrel702and the stopper164. It should be understood, that if the fluid reservoir700were for use with the fluid infusion device500ofFIG. 9, the fluid reservoir700would include the barrel702and the stopper516. The barrel702has the first or distal barrel end172and a second or proximal barrel end704. Fluid F is retained within the barrel702between the distal barrel end172and the proximal barrel end704.

The proximal barrel end704can have any desirable size and shape configured to mate with at least a portion of a set connector, as will be discussed in further detail herein. In one example, the proximal barrel end704includes a septum706and one or more posts708. In addition, the proximal barrel end704also comprises the one or more threads179a(FIG. 12). The one or more threads179athreadably engage corresponding threads114a(FIG. 2) defined in the housing114to couple the fluid reservoir700to the housing114. Thus, the one or more threads179aserve as at least one engagement feature defined along a portion of a perimeter of the barrel702near the proximal barrel end704that removably couples the fluid reservoir700to the fluid infusion device104.

The septum706is disposed in a passageway710at the proximal barrel end704. The passageway710provides a fluid flow path from an interior of the barrel170to a set connector through the proximal barrel end704. The septum706closes the passageway710. The septum706is coupled to the passageway710through any suitable technique, such as ultrasonic welding, press-fit, etc. The septum706serves as a barrier to prevent the ingress of fluids into the fluid reservoir700, and prevents the egress of fluids from the fluid reservoir700. The septum706is pierceable by a needle or similar instrument to enable the automatic filling of the fluid reservoir700with fluid in the vial108(FIG. 1).

With continued reference toFIG. 12, and with additional reference toFIG. 13, the one or more posts708provide at least one grip surface to enable the user of the fluid reservoir700to couple or decouple the fluid reservoir700from the housing114of the fluid infusion device104. In one example, the posts708extend outwardly or upwardly from a surface704a(FIG. 13) of the proximal barrel end704, to facilitate the manipulation of the posts708. It should be noted that while the posts708are illustrated herein as being cylindrical in shape, the posts708can have any desired shape to facilitate the insertion and removal of the fluid reservoir700from the housing114. Furthermore, while two posts708are illustrated herein, any number of posts708can be provided. In addition, the posts708need not be of the same diameter or have similar shapes.

Thus, the fluid reservoir700enables the user to easily insert and remove the fluid reservoir700from the housing114of the fluid infusion device104,500via the posts708. As the fluid reservoir700can be used in the same manner and operates similarly to the fluid reservoir102, further detail regarding the use and automatic filling of the fluid reservoir700will not be discussed in great detail herein.

With reference toFIG. 14, a set connector800for use with the fluid infusion device104is shown. It should be noted that although the set connector800is described and illustrated herein as being used with the fluid infusion device104, the set connector800can be used with any suitable fluid infusion device, and thus, the use of the fluid infusion device104is merely exemplary. The set connector800provides a fluid flow path from the fluid reservoir102to the user or patient. In one example, the set connector800includes a hollow tubing802and a body804.

The hollow tubing802is coupled to the body804at a first end802aso as to define a fluid flow path out of the body804. The hollow tubing802can be coupled to the body804through any desired technique, such as ultrasonic welding, adhesive bonding or molding. Another end of the hollow tubing802is coupled to the user or patient via an infusion set, for example, as known to one skilled in the art. Thus, the hollow tubing802provides a flow path from the body804to the user or patient.

In this example, the body804is coupled to the fluid reservoir102. Generally, the body804is coupled so as to substantially circumferentially surround the mounting projection178and such that a portion of the body804is able to contact the lock tabs214of the retaining ring167. With reference toFIGS. 14-16, the body804can be substantially cylindrical, and includes an exterior surface806, an interior surface808(FIG. 16) and a tab engagement surface810.

With reference toFIGS. 14 and 15, the exterior surface806can be arcuate and substantially smooth. The exterior surface806includes at least one pinch surface812and at least one locking tab814. In one example, the exterior surface806includes two pinch surfaces812, as best shown inFIG. 17. As illustrated inFIG. 17, the pinch surfaces812can be defined on the exterior surface806to be substantially symmetric about a longitudinal axis L2of the set connector800. With reference toFIG. 15, each of the pinch surfaces812are generally defined in the exterior surface806so as to be concave in shape to facilitate the receipt of the user's finger. In this example, the pinch surfaces812extend from a bottom surface804aof the body804to a top surface804bof the body804. It should be noted, however, that the pinch surfaces812can have any desired shape or size to facilitate engagement of the pinch surfaces812by the user. The pinch surfaces812enable the user to connect and disconnect the set connector800from the mounting projection178of the fluid reservoir system126.

In this regard, with reference toFIG. 15, the exterior surface806can also include one or more reliefs816. The reliefs816can be defined through a portion of the exterior surface806to enable the exterior surface806to flex or compress upon the receipt of force input to the pinch surfaces812. In one example, a relief816ais defined near a side of the pinch surface812and a relief816bis defined near a side of the locking tab814. It should be noted that although only one side of the body804is shown inFIG. 15, the reliefs816a,816bare also formed near a corresponding side of the pinch surface812and a corresponding side of the locking tab814defined on the other side or opposite side of the body804, which is not shown. Thus, when a force is applied to the pinch surfaces812to squeeze the pinch surfaces812towards each other, the reliefs816enable the body804to flex inward. As will be discussed, the inward movement of the body804at the pinch surfaces812enables the release of the locking tabs814, thereby releasing the set connector800from the fluid reservoir102.

The at least one locking tab814extends outwardly or away from the exterior surface806. In one example, with reference toFIG. 17, the at least one locking tab814includes two locking tabs814, which are each formed on the exterior surface806adjacent to a respective one of the pinch surfaces812. Each of the locking tabs814extend outwardly or away from the exterior surface806for a distance that enables each of the locking tabs814to engage the lock tabs214of the retaining ring167. While the locking tabs814are illustrated herein as being substantially triangular in shape, it should be understood that the locking tabs814can have any desired shape to engage the lock tabs214of the retaining ring167. The locking tabs814can each include a ramp surface814aand a lock surface814b. The ramp surface814acan engage a corresponding ramp surface214aof the lock tabs214to assist in moving the locking tab814past the corresponding lock tab214. The lock surface814bcan engage a corresponding lock surface214bof the lock tabs214to prevent the further movement of the body804of the set connector800relative to the mounting projection178. As will be discussed herein, the engagement between the locking tabs814and the lock tabs214provides a tactile feedback to the user that the set connector800is firmly secured and the second passageway844is open to allow fluid to exit the fluid reservoir102. The locking tabs814and lock tabs214also cooperate to prevent the rotation of the set connector800relative to the fluid reservoir102when the set connector800is coupled to the fluid reservoir102.

With reference toFIG. 16, the interior surface808is shown. The interior surface808includes a first passage820. The first passage820is fluidly coupled to the hollow tubing802, and fluidly coupled to the second passageway184of the mounting projection178. In this regard, when the second passageway184of the mounting projection178is in the opened position, the fluid can flow from the fluid reservoir102, through the passageway182, the first passageway180, the second passageway184defined by the passage178band the passage186a, and exit the second passageway184through the first passage820. Thus, the first passage820cooperates with the mounting projection178to define a fluid flow path from the fluid reservoir102to the hollow tubing802.

With reference toFIG. 15, the tab engagement surface810can be defined about an inner periphery or circumference822of the body804. In one example, the tab engagement surface810comprises a lip824that extends outwardly from the inner circumference822near the top surface804bof the body804. The lip824defines an aperture826. The aperture826is sized and shaped to receive a portion of the tab190. The engagement of the tab190with the aperture826defined by the lip824enables the tab190to move with the body804of the set connector800, as will be discussed herein. In addition, the tab190and the first surface192cooperate to prevent the rotation of the set connector800relative to the fluid reservoir102when the set connector800is coupled to the fluid reservoir102.

With reference toFIGS. 18 and 19, with the body804coupled to the mounting projection178such that the tab190is received in the aperture826, the body804can be moved from a first position (FIG. 17) to a second position (FIG. 18). In this regard, the body804can rotate about the mounting projection178until a respective one of the ramp surfaces814aof the locking tabs814contacts a respective one of the ramp surfaces214aof the lock tabs214. The continued movement of the body804relative to the mounting projection178causes each of the locking tabs814to move up the ramp surfaces214aof the lock tabs214until the locking tabs814move past the ramp surfaces214aand snap into place with a respective one of the lock surfaces814bof the locking tabs814in contact with a respective one of the lock surfaces214bthe lock tabs214. The engagement of the locking tabs814on the ramp surfaces214aof the lock tabs214provides tactile feedback and audible feedback once the body804is in the second position. The movement or rotation of the body804about the mounting projection178, causes the tab190to move from the first, closed position (FIG. 17) to the second, opened position (FIG. 18) along the cut-out192a. In the second, opened position, the second passageway184is fluidly coupled to the first passage820of the body804, thereby allowing fluid to flow out of the fluid reservoir102, through the body804and into the hollow tubing802. Thus, the set connector800provides a needleless fluid flow path out of the fluid reservoir102.

In order to remove the set connector800from the mounting projection178of the fluid reservoir102, the user can apply a force to the pinch surfaces812. The application of force to the pinch surfaces812causes the body804to flex inward. With the body804flexed inward, the body804can be rotated relative to the mounting projection178such that the ramp surfaces814aof each of the locking tabs814contact a respective ramp surface214aof each of the lock tabs214to assist in moving the body804from the second position (FIG. 18) to the first position (FIG. 17).

With reference toFIG. 19, a set connector900for use with the fluid infusion device104is shown. It should be noted that although the set connector900is described and illustrated herein as being used with the fluid infusion device104, the set connector900can be used with any suitable fluid infusion device, and thus, the use of the fluid infusion device104is merely exemplary. The set connector900provides a fluid flow path from the fluid reservoir102to the user or patient. As the set connector900can be similar to the set connector800discussed with regard toFIGS. 14-18, the same reference numerals will be used to denote the same or similar components. In one example, the set connector900includes a hollow tubing902and a body904.

The hollow tubing902is coupled to the body904at a first end902aso as to define a fluid flow path out of the body904. The hollow tubing902can be coupled to the body904through any desired technique, such as ultrasonic welding, adhesive bonding or molding. Another end of the hollow tubing902is coupled to the user or patient via an infusion set, for example, as known to one skilled in the art. Thus, the hollow tubing902provides a flow path from the body904to the user or patient.

In this example, the body904is coupled to the fluid reservoir102. Generally, the body904is coupled so as to substantially circumferentially surround the mounting projection178and such that a portion of the body904is able to contact the retaining ring167. The body904can be substantially cylindrical, and includes the exterior surface806, an interior surface908and the tab engagement surface810.

The interior surface908includes a first passage920. The first passage920is fluidly coupled to the hollow tubing902, and fluidly coupled to the second passageway184of the mounting projection178. In this regard, when the second passageway184of the mounting projection178is in the opened position, the fluid can flow from the fluid reservoir102, through the passageway182, the first passageway180, and the second passageway184; and exit the second passageway184through the first passage920. Thus, the first passage920cooperates with the mounting projection178to define a fluid flow path from the fluid reservoir102to the hollow tubing902.

Thus, the set connector900allows for a fluid flow path in which the hollow tubing902is coupled to the body904near a top surface904aof the body904. As the set connector900can be used in the same manner and operates similarly to the set connector800, further detail regarding the use of the set connector900will not be discussed in great detail herein.

With reference now toFIGS. 20 and 21, a fluid reservoir1000for use with the fluid infusion device104or fluid infusion device500is shown. The fluid reservoir1000can be used with a set connector1002. As the fluid reservoir1000can be similar to the fluid reservoir102discussed with regard toFIGS. 1-8, the same reference numerals will be used to denote the same or similar components.

In this example, with reference toFIG. 21, the fluid reservoir1000includes a body or barrel1004and the stopper164. It should be understood, that if the fluid reservoir1000were for use with the fluid infusion device500ofFIG. 9, the fluid reservoir1000would include the barrel1004and the stopper516. The barrel1004has the first or distal barrel end172and a second or proximal barrel end1006. Fluid F is retained within the barrel1004between the distal barrel end172and the proximal barrel end704.

The proximal barrel end1006can have any desirable size and shape configured to mate with the set connector1002. In one example, the proximal barrel end1006includes a septum1008and a flange1010. The septum1008is disposed in a passageway1012at the proximal barrel end1006. The passageway1012provides a fluid flow path from an interior of the barrel1004to the set connector1002through the proximal barrel end1006. The septum1008closes the passageway1012. The septum1008is coupled to the passageway1012through any suitable technique, such as ultrasonic welding, press-fit, etc. The septum1008serves as a barrier to prevent the ingress of fluids into the fluid reservoir1000, and prevents the egress of fluids from the fluid reservoir1000. The septum1008is pierceable by a needle or similar instrument to enable the automatic filling of the fluid reservoir1000with fluid in the vial108(FIG. 1). In one example, the septum1008is located in the passageway1012in a projection1007, which extends upwardly from a surface1000aof the fluid reservoir1000.

With continued reference toFIG. 21, and with additional reference toFIG. 22, the flange1010provides a grip surface to enable the user of the fluid reservoir1000to couple or decouple the fluid reservoir1000from the housing114and couples the set connector1002to the fluid reservoir1000. The flange1010extends outwardly or upwardly from the surface1000a(FIG. 21) of the proximal barrel end1006, to facilitate the engagement of the set connector1002with the flange1010. It should be noted that while the flange1010is illustrated herein as being cylindrical in shape and extending substantially entirely around a perimeter or circumference of the fluid reservoir1000(FIG. 22), the flange1010can have any desired shape to facilitate the insertion and removal of the fluid reservoir1000from the housing114and the coupling of the set connector1002to the fluid reservoir1000.

In one example, with reference toFIG. 23, the flange1010includes at least one groove1014for receipt of a portion of the set connector1002. The at least one groove1014can be defined through the flange1010along an interior surface1010aof the flange1010. In this example, the at least one groove1014comprises a first groove1014athat is defined in the interior surface1010aof the flange1010substantially opposite a second groove1014b. It should be noted that the grooves1014a,1014billustrated herein are merely exemplary, as the at least one groove1014can be defined as a single substantially continuous groove about the interior surface1010aof the flange1010, for example. The at least one groove1014can have a height sized to receive a portion of the set connector1002to couple the set connector1002to the fluid reservoir1000.

With reference toFIG. 21, the set connector1002can be removably coupled to the fluid reservoir1000via the grooves1014a,1014bof the flange1010. It should be noted that although the set connector1002is described and illustrated herein as being used with the fluid reservoir1000, the set connector1002can be used with any suitable fluid reservoir of a fluid infusion device, and thus, the use of the fluid reservoir1000is merely exemplary. The set connector1002provides a fluid flow path from the fluid reservoir1000to the user or patient. In one example, with reference toFIGS. 21 and 23, the set connector1002includes a hollow tubing1020, a piercing device1022and a body1024.

The hollow tubing1020is coupled to the piercing device1022at a first end1020aso as to define a fluid flow path. The hollow tubing1020can be coupled to the piercing device1022through any desired technique, such as ultrasonic welding or molding. Another end of the hollow tubing1020is coupled to the user or patient via an infusion set, for example, as known to one skilled in the art.

The piercing device1022is coupled to the hollow tubing1020and the body1024. The piercing device1022includes a first end1026, a second end1028and can be substantially hollow from the first end1026to the second end1028to provide a fluid flow path. It should be noted that the piercing device1022can comprise any suitable hollow instrument for piercing the septum1008and providing a fluid flow path out of the fluid reservoir1000, such as a pointed hollow tubing, needle, etc. The first end1026is pointed to pierce the septum1008when the set connector1002is coupled to the fluid reservoir1000. With reference toFIG. 21, the second end1028is coupled to the body1024and to the hollow tubing1020. Generally, the second end1028is received in a bore1030of the body1024and fixedly coupled to the bore1030via ultrasonic welding, adhesives, etc. The proximalmost end1028aof the second end1028is coupled to the hollow tubing1020. The proximalmost end1028acan be coupled to the hollow tubing1020through any desired technique, and can be integrally formed with the hollow tubing1020as is known to those skilled in the art. Thus, the piercing device1022and the hollow tubing1020provide a fluid flow path from the fluid reservoir1000to the user or patient.

The body1024is coupled to the fluid reservoir1000via the at least one groove1014of the flange1010. In one example, the body1024includes a first end1032and a second end1034. The first end1032includes the bore1030, which can be defined along a longitudinal axis of the set connector1002. The first end1032also includes at least one pinch surface1036. The at least one pinch surface1036can be formed at a periphery1024aof the body1024, and in one example, the at least one pinch surface1036includes two pinch surfaces1036formed at opposite points on the periphery1024a. The pinch surfaces1036are placed on the periphery1024ato enable the user to compress or squeeze the body1024to couple or uncouple the set connector1002from the fluid reservoir1000. It should be noted that while the set connector1002illustrated herein is not cylindrical in shape, the set connector1002can be cylindrical in shape, if desired.

The second end1034of the body1024is substantially hollow, and defines a guiding projection1038and at least one locking tab1040. The guiding projection1038can be defined along the longitudinal axis of the set connector1002and extends outwardly or away from a surface1034aof the second end1034. The guiding projection1038can be sized and shaped to receive the projection1007of the fluid reservoir1000, and thus, the guiding projection1038is generally coaxially aligned with the bore1030and the piercing device1022.

The at least one locking tab1040is at the second end1034. In one example, the at least one locking tab1040comprises two locking tabs1040, each locking tab1040extending from the body1024adjacent to a respective one of the pinch surfaces1036. It should be noted, however, the at least one locking tab1040can comprise a single locking tab, if desired. The each locking tab1040includes a protrusion1040athat engages a respective one of the grooves1014a,1014bof the flange1010to couple the set connector1002to the fluid reservoir1000. The locking tabs1040are defined on the second end1034so as to be adjacent to the pinch surfaces1036such that the compression of the pinch surfaces1036causes the protrusions1040ato move into and out of the grooves1014a,1014b. Thus, by applying a compressive force to the pinch surfaces1036, the set connector1002can be engaged and disengaged from the fluid reservoir1000.

As the fluid reservoir1000can be used in the same manner and operates similarly to the fluid reservoir102, further detail regarding the use and automatic filling of the fluid reservoir1000will not be discussed in great detail herein. In order to couple the set connector1002to the fluid reservoir1000, the pinch surfaces1036can be compressed to draw the locking tabs1040towards the guiding projection1038(FIG. 21). Then, the set connector1002can be positioned onto the fluid reservoir1000such that the piercing device1022pierces the septum1008and the guiding projection1038is disposed about the projection1007. Once the septum1008is pierced, the pinch surfaces1036are released, and the protrusion1040aof the at least one locking tab1040engages the at least one groove1014of the flange1010to couple the set connector1002to the fluid reservoir1000(FIG. 24).

In order to remove the set connector1002from the fluid reservoir1000, a compressive force can be applied to the pinch surfaces1036. The application of the compressive force to the pinch surfaces1036causes the at least one locking tab1040to move towards the guiding projection1038, removing the protrusion1040aof the at least one locking tab1040from the groove1014and uncoupling the set connector1002from the fluid reservoir1000.