Infusion device assembly

Abstract

A drug delivery device has a pump, a first housing and a second housing configured to couple to the first housing. A partially flexible reservoir is disposed within the second housing. The drug delivery device has a reservoir volume sensing assembly contained within the first housing, including an optical sensor and a reservoir follower with a displaceable portion. The reservoir follower extends out of the first housing and into contact with a wall of the reservoir when the first and second housing are coupled. The displaceable portion changes its position in relation to the fill volume of the reservoir. A controller analyzes an output signal of the optical sensor to observe at least one characteristic of interest which alters as a function of the position of the displaceable portion. The controller determines a fill volume of the reservoir based on the characteristic of interest.

Description

INFUSION DEVICE ASSEMBLYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 638,686, filed April 25, 2024, and U.S. Provisional Patent Application Serial No. 63 / 638,734, filed April 25, 2024, each of which are incorporated herein by reference in their entirety.BACKGROUNDField of Disclosure:

[0002] This disclosure relates to delivery devices. More specifically, this disclosure relates to volume sensors for delivery devices.Description of Related Art

[0003] Many potentially valuable medicines or compounds, including biologicals, arc not orally active due to poor absorption, hepatic metabolism or other pharmacokinetic factors. Additionally, some therapeutic compounds, although they can be orally absorbed, are sometimes required to be administered so often it is difficult for a patient to maintain the desired schedule. In these cases, parenteral delivery is often employed or could be employed.

[0004] Effective parenteral routes of drug delivery, as well as other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration include puncture of the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by millions of diabetic patients. Users of parenterally delivered drugs would benefit from a wearable device that would automatically deliver needed drugs / compounds over a period of time.

[0005] To this end, there have been efforts to design portable devices for the controlled release of therapeutics. Such devices are known to have a reservoir such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from a number of drawbacks including the malfunction rate. Reducing the size, weight and cost of these devices is also an ongoing challenge.SUMMARY

[0006] In accordance with an embodiment of the present disclosure a drug delivery device may comprise a pumping arrangement. The drug delivery device may further comprise a first housing. The drug delivery device may further comprise a second housing configured to couple to the first housing. The drug delivery device may further comprise an at least partially flexible reservoir disposed within the second housing. The drug delivery device may further comprise a reservoir volume sensing assembly contained within the first housing and including an optical sensor and a displaceable tab linked to a wall of the reservoir when the first and second housing are coupled. The displaceable tab may be configured to change its position in relation to the fill volume of the reservoir. The drug delivery device may further comprise a controller configured to analyze an output signal of the optical sensor to observe at least one characteristic of interest which alters as a function of the position of the displaceable tab. The controller may be configured to determine a fill volume of the reservoir based on the characteristic of interest.

[0007] In some embodiments the displaceable tab may extend from a telescoping member which is configured to nest with a stationary body included in the first housing, hi some embodiments, a bias member may be disposed between the telescoping member and the stationary body to link the position of the tab to a position of the wall of the reservoir. In some embodiments, the displaceable tab may be reflective. In some embodiments, the optical sensor may include an illuminator. In some embodiments, the illuminator may be an infra-red illuminator. In some embodiments, the at least one characteristic of interest may include a light intensity value of light reflected off the tab. In some embodiments, the fill volume determined based on the characteristic of interest may be an estimated volume remaining in the reservoir.

[0008] In accordance with another embodiment of the present disclosure a drug delivery device may comprise a pumping arrangement. The drug delivery device may further comprise a first housing. The drug delivery device may further comprise a second housing configured to couple to the first housing. The second housing may include a pivoting hinge plate hingedly coupled to a top cover of the second housing and an at least partially flexible reservoir disposed there beneath. The drug delivery device may further comprise a reservoir volume sensing assembly contained within the first housing and including an optical sensor and a reservoir follower with a displaceable portion. The reservoir follower may extend out of the first housing and into contact with the pivoting hinge plate of the reservoir when the first and second housing are coupled. The displaceable portion of the reservoir follower and pivoting hinge plate may beconfigured to change positions in relation to the fill volume of the reservoir. The drug delivery device may further comprise a controller configured to analyze an output signal of the optical sensor to observe at least one characteristic of interest which alters as a function of the position of the displaceable portion of the reservoir follower. The controller may be configured to determine a fill volume of the reservoir based on the characteristic of interest.[00091 In some embodiments, the displaceable portion of the reservoir follower may be a telescoping member which is configured to nest with a stationary portion of the reservoir follower. In some embodiments, a bias member may be disposed between the telescoping member and the stationary portion. In some embodiments, the displaceable portion of the displaceable member may include a tab. In some embodiments, the optical sensor may include an illuminator. In some embodiments, the illuminator may be an infra-red illuminator. In some embodiments, the illuminator may include at least one LED. In some embodiments, the at least one characteristic of interest may include a light intensity value of light reflected of the displaceable portion of the reservoir follower. In some embodiments, the fill volume determined based on the characteristic of interest may be an estimated volume remaining in the reservoir. In some embodiments, the pivoting hinge plated may include an edge portion, The edge portion may be hingedly coupled to the top cover.

[0010] In accordance with an embodiment of the present disclosure a method of determining a volume of a flexible reservoir may comprise delivering fluid from the reservoir via a pumping mechanism. The method may further comprise displacing a telescoping member out of a stationary housing toward the reservoir under a bias force. The method may further comprise monitoring, with an optical sensor, the position of a reflective tab extending from the telescoping member. The method may further comprise analyzing, with a controller, an output signal of the optical sensor to observe a reflected light intensity which alters as a function of the position of the reflective tab. The method may further comprise determining, with the controller, a volume contained within the reservoir based on the reflected light intensity.

[0011] In some embodiments, the method may further comprise rotating a rotatable member against the reservoir as the reservoir is depleted. In some embodiments, the method may further comprise applying a bias against the rotatable member which presses the rotatable member against a wall of the reservoir. In some embodiments, applying the bias against the rotatable member may comprise applying the bias against the rotatable member with a torsion spring. Insome embodiments, applying the bias against the rotatable member may comprise applying the bias against the rotatable member with a wire form spring.

[0012] In accordance with an embodiment of the present disclosure a drug delivery device may comprise a pumping arrangement; The drug delivery device may further comprise a first housing. The drug delivery device may further comprise a second housing configured to couple to the first housing. The drug delivery device may further comprise an at least partially flexible reservoir. The drug delivery device may further comprise a reservoir volume sensing assembly including a first portion contained within the first housing and a second portion contained within the second housing. The first portion may include an emitter and a detector. The second portion may include a rotatable member with a reflective region. The disposition of the rotatable member may be tied to the fill volume of the reservoir. The drug delivery device may further comprise a controller configured to analyze an output signal of the detector to observe at least one characteristic of interest which alters as a function of the disposition of the rotatable member. The controller may be configured to determine a fill volume of the reservoir based on the characteristic of interest.

[0013] In some embodiments, the second portion may include at least one bias member. In some embodiments, the second portion may include the reservoir and may further comprise a top plate. The rotatable member may be disposed between the top plate and the reservoir. In some embodiments, the rotatable member may be biased against the reservoir.. In some embodiments, the second portion may include a wire form spring. In some embodiments, the second portion may include a torsion spring. In some embodiments, the emitter may be an illuminator. In some embodiments, the detector may be an optical sensor. In some embodiments, the emitter includes an LED. In some embodiments, the reflective region may be disposed in alignment with an aperture in a top plate forming a cover of the second housing. In some embodiments, the reflective region may include a light colored surface. In some embodiments, the reflective region may include a reflective surface finish. In some embodiments, the at least one characteristic of interest may be a reflected light intensity.

[0014] In accordance with another embodiment of the present disclosure a reservoir volume sensor may comprise a first portion included within a first housing and having an emitter and a detector. The reservoir volume sensor may further comprise a second portion included within a second housing and including a compressible foam bias member and a translating memberbiased by the bias member to displace as the volume of a collapsible reservoir adjacent the displaceable member is altered. The reservoir volume sensor may further comprise a controller configured to analyze an output from the detector to observe at least one characteristic of interest which alters as a function of the location of the displaceable member, the controller configured to determine a fill volume of the reservoir based on the characteristic of interest.[00151 In some embodiments, the displaceable member may include a light colored region disposed in alignment with an aperture in a top plate forming a cover of the second housing. In some embodiments, the compressible foam bias member may be disposed between the displaceable member and the top plate. In some embodiments, when the first portion and second portion are coupled, the detector may have a clear line of sight to the light colored region. In some embodiments, the displaceable member may include a reflective region disposed in alignment with an aperture of a top plate forming a cover of the second housing. In some embodiments, the emitter may be an illuminator. In some embodiments, the detector may be an optical sensor. In some embodiments, the emitter may include an LED. In some embodiments, the at least one characteristic of interest may be a reflected light intensity.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] These and other aspects will become more apparent from the following detailed description of the various embodiments of the present disclosure with reference to the drawings wherein:

[0017] FIG. 1 depicts a diagrammatic view of an exemplary delivery system;

[0018] FIG. 2 depicts a diagrammatic view of a fluid path which may be included within a delivery device;

[0019] FIGS. 3-5 are diagrammatic views of a fluid path which may be included within a delivery device;

[0020] FIG. 6 depicts an example diagram of a delivery device and reservoir volume sensor;

[0021] FIG. 7 depicts an example diagram of a delivery device and reservoir volume sensor;

[0022] FIG. 8 depicts a cross sectional view of an example reservoir follower;

[0023] FIG. 9 depicts a cross sectional view of another example reservoir follower;

[0024] FIGS. 10 and 11 show cross sectional views of a portion of a delivery device including an example reservoir volume sensor with the reservoir follower of FIG. 9;

[0025] FIG. 12 depicts an example cross sectional perspective view of an example disposable housing cassette including a pivoting hinge plate;

[0026] FIG. 13 depicts another example cross sectional perspective view of an example disposable housing cassette including a pivoting hinge plate;

[0027] FIG 14 depicts a bottom up plan view of a portion of an example reusable housing having an example reservoir follower;

[0028] FIG. 15 - depicts a perspective views of a portion of an example reusable housing having an example reservoir follower in the retracted position;

[0029] FIG. 16 - depicts a perspective views of a portion of an example reusable housing having an example reservoir follower in the extended position;

[0030] FIG. 17 depicts a cross sectional perspective view of a delivery device including a reservoir volume sensor having an example reservoir follower in the extended position;

[0031] FIG. 18 depicts a diagrammatic views of exemplary drug delivery device including a reservoir volume sensor, whereby the reservoir is full and the reservoir follower is in a first position;

[0032] FIG. 19 depicts a diagrammatic views of exemplary drug delivery device including a reservoir volume sensor of FIG. 18, whereby the reservoir is partially emptied and the reservoir follower is in a second position;

[0033] FIG. 20 depicts a diagrammatic views of exemplary drug delivery device including a reservoir volume sensor, whereby the reservoir is full and the reservoir follower is in a first position;

[0034] FIG. 21 depicts a diagrammatic views of exemplary drug delivery device including a reservoir volume sensor of FIG. 18, whereby the reservoir is partially emptied and the reservoir follower is in a second position;

[0035] FIGS. 22 depicts a diagrammatic view of portions of example drug delivery devices including a reservoir volume sensor with a rotating reservoir follower and a biasing member;

[0036] FIGS. 23 depicts a diagrammatic view of portions of example drug delivery devices including a reservoir volume sensor with a translating reservoir follower and biasing members;

[0037] FIG. 24 depicts an example disposable housing assembly including a translating reservoir follower and a foam biasing member;

[0038] FIG. 25 depicts an example disposable housing assembly including a rotating reservoir follower and a biasing member; and

[0039] FIG. 26 depicts another example disposable housing assembly including a rotating reservoir follower and a biasing member.

[0040] FIG. 27 depicts a cross sectional view of another example disposable housing assembly including a rotating member and a bent wire spring.

[0041] FIG. 28 depicts a cross sectional view of another example disposable housing assembly including a rotating member and a torsional spring.DETAILED DESCRIPTION

[0042] Referring to FIG. 1, an exemplary drug delivery system 10 is shown. The example drug delivery system 10 includes a container assembly or reservoir assembly 100 which may be formed or installed within a cassette or disposable housing assembly 102. Referring to FIG. 1, an exemplary drug delivery system 10 is shown. The reservoir assembly 100 may include a container or reservoir 118 and an access 120 (e.g. a pierceable member such as a septum). The disposable housing assembly 102 may be coupled to a reusable housing assembly 106 having a controller 108 and an actuation assembly 110 which may be controlled to selectively dispense fluid from the reservoir assembly 100 (in some embodiments by acting on valving and pumping components included in the disposable housing assembly 102). A dispensed volume sensor 130 may be included to monitor the volume of fluid dispensed from the delivery device 180.

[0043] As shown, a container assembly 100 may be used in conjunction with an infusion device 186 of a drug delivery system 10. The infusion device 186 may be configured to be inserted into a patient to provide a fluid pathway from the reservoir assembly 100 into the patient 104 (e.g. to a subcutaneous layer of the patient’s 104 skin). To facilitate establishment of a fluid pathway into the patient’s skin 104, the infusion device 186 may include a needle or cannula 188. The infusion device 186 may be fluidly connected to a length of tubing 184 and / or to an infusion pump or delivery device 180. In some embodiments, the tubing 184 may include a connection interface which couples the tubing 184 to the infusion device 186. An outlet of the reservoir 118 may couple the reservoir assembly 100 directly or indirectly to the tubing 184 or infusion device 186 in certain embodiments.

[0044] The various components described in relation to FIG. 1 may be, but are not limited to, those shown and described in one or more of the following: U.S. Patent Application Serial No. 13 / 788,260, filed March 7, 2013 and entitled Infusion Pump Assembly, now U.S. Publication No. US-2014-0107579, published April 17, 2014 (Attorney Docket No. K40); U.S. Patent No. 8,491,570, issued July 23, 2013 and entitled Infusion Pump Assembly (Attorney Docket No. G75); U.S. Patent No. 8,414,522, issued April 9, 2013 and entitled Fluid Delivery Systems and Methods (Attorney Docket No. E70); U.S. Patent No. 8,262,616, issued September 11, 2012 and entitled Infusion Pump Assembly (Attorney Docket No. F51); U.S. Patent No. 7,306,578, issued December 11, 2007 and entitled Loading Mechanism for Infusion Pump (Attorney Docket No. C54); U.S Provisional Application No.: 62 / 597,246, filed December 11, 2017 and entitled Infusion Pump Assembly (Attorney Docket No. P51); U.S Publication No. 2015 / 0281863, published October 5, 2017 and entitled Infusion Set and Inserter Assembly (Attorney Docket No. U64); U.S Application No.: 15 / 961,238, filed April 24, 2018 and entitled Apparatus, System and Method for Fluid Delivery (Attorney Docket No. X37); U.S. Patent No. 9,617,020, issued April 11, 2017 and entitled Apparatus, System and Method for Fluid Delivery (Attorney Docket No. M60); and U.S Provisional Application No.: 62 / 809,248, filed February 22, 2019 and entitled Infusion Set and Inserter Assembly Systems and Methods (Attorney Docket No. Y85), all of which are hereby incorporated herein by reference in their entireties. The systems and methods (including the disposable housing assemblies, reservoirs, filling aids, charging systems, volume sensing arrangements, control systems, inserter assemblies, etc.) described in any of the abovereferenced applications and patents may also be used in conjunction with the various embodiments shown and described herein. The embodiments shown and described herein are not, however, limited to use therewith.

[0045] Referring now to FIG. 2, an exemplary delivery device 180 pumping assembly or arrangement 500 is shown. In order to effectuate the delivery of fluid within the reservoir 118 to the user, the controller 108 included within the delivery device 180 may command energizing of a shape memory actuator 112, which may be anchored on one end using shape memory actuator anchor 604. Referring now also to FIG. 3, energizing of the shape memory actuator 112 may result in the activation of a pump 105 and a reservoir valve assembly 614. The reservoir valve assembly 614 may include a reservoir valve actuator 614A and a reservoir valve 614B. Activation of the reservoir valve assembly 614 may result in the downward displacement of thereservoir valve actuator 614A and the closing of the reservoir valve 614B, resulting in the effective isolation of the reservoir 118. The reservoir valve actuator 614A may press a membrane interface included in the disposable housing assembly 102 against a valve seat of the reservoir valve 614B in order to close the reservoir valve 614B. Pump 105 may include a pump plunger 105A and a pump chamber 105B. The activation of the pump 105 may result in the pump plunger 105A being displaced in a downward fashion into the pump chamber 105B leading to a displacement of the fluid (in the direction of arrow 616). A membrane interface may be included between the pump plunger 105A and the pump chamber 105B.

[0046] A volume sensor valve assembly 612 may include a volume sensor valve actuator 612A and a volume sensor valve 612B. Referring also to FIG. U2, the volume sensor valve actuator 612A may be closed via a spring assembly 612C that provides mechanical force to seal volume sensor valve 612B. The volume sensor valve actuator 612A may press a membrane included in the disposable housing assembly 102 against a valve scat of the volume sensor valve 614B in order to close the volume sensor valve 614B. When the pump 105 is activated, however, if the displaced fluid is of sufficient pressure to overcome the mechanical sealing force of the volume sensor valve assembly 612, displacement of the fluid may occur in the direction of arrow 618. This may result in the filling of a volume sensor chamber 620 included within a volume sensor assembly 148. Through the use of a speaker assembly 622, port assembly 624, reference microphone 626, spring diaphragm 628, invariable volume microphone 630, the volume sensor assembly 148 may determine the volume of fluid within the volume sensor chamber 620. Operation of such a volume sensor assembly 148 may be as discussed in, for example, US Patent No. 8,491,570 incorporated herein by reference in its entirety above. Other suitable dispensed volume sensors may be used in other embodiments.

[0047] Referring also to FIG. 5, a shape memory actuator 632 may be anchored (on a first end) to shape memory actuator anchor 636. Additionally, the other end of the shape memory actuator 632 may be used to provide mechanical energy to a valve actuator 638, which may activate a measurement valve assembly 610. Once the volume of fluid included within the volume sensor chamber 620 is calculated, the shape memory actuator 632 may be energized, resulting in the activation of measurement valve assembly 610. The measurement valve assembly 610 may include a measurement valve actuator 610A and a measurement valve 610B. Once activated and due to the mechanical energy asserted on the fluid within volume sensorchamber 620 by the spring diaphragm 628, the fluid within the volume sensor chamber 620 may be displaced (in the direction of arrow 634) through cannula 188 and into the body of the user. The measurement valve actuator 610A may press a membrane interface included in the disposable housing assembly 102 against a valve seat of the measurement valve 610B in order to close the measurement valve 610B. In some embodiments, the membrane interfaces included over the reservoir valve 614B, pump chamber 105B, volume sensor valve 612B, and the measurement valve 61 OB may be formed in a single piece of material having regions overlying each of these components.

[0048] In certain embodiments, the reservoir 118 may be filled by a user prior to use. To do so, the user may establish a fluid communication pathway to the interior volume of the reservoir 118 from a fluid source. The fluid source may, for example, be a container for a medicament. In certain embodiments, the fluid may be a drug for an endocrine disorder. For example, the fluid may be a diabetes management drug such as insulin. The medicament container may be a syringe, pen type drug delivery device, or the like which may include a sharp (e.g. a needle) for piercing the access 120 and establishing a flow path of fluid into the reservoir 118.

[0049] hi embodiments where the reservoir 118 is manually filled, the user may be instructed to load the reservoir 118 with a particular volume of fluid. Upon completion of a reservoir filling operation, the user may provide an indication to the delivery system 10 that the reservoir 118 has been filled. The indication may be provided through a user interface 122 (e.g. touch screen, hard button(s), or combination thereof) included in a communicatively linked (e.g. wired or wirelessly linked) device 124 or a user interface included on the delivery device 180. Based on the fill volume that the user is instructed to load, the controller 108 of the delivery device 180 may track a remaining volume of fluid as fluid is dispensed from the reservoir 118 to the patient 104. The remaining volume may be used by the controller 108 to determine if sufficient fluid for certain delivery operations is available. Additionally, the volume remaining may be utilized to generate notifications or alerts at the user interface 122 or the user interface included on the delivery device 180, that the remaining volume is below some predefined threshold and the user may need to refill or replace the disposable housing 102 with a new disposable housing 102.

[0050] As there is a possibility for the drug volume loaded into the reservoir 118 by the user to deviate from the initial fill volume that the user is instructed to provide, it may be desirable fora delivery device 180 to include a sensing arrangement monitoring the volume of fluid in the reservoir 118. This may allow the delivery device 180 to have access to a more robustly determined remaining volume calculation. This may help to ensure that, for example, even when a user has under filled the reservoir 118, a patient 104 has sufficient notice of a low remaining volume to afford the opportunity to take action in a manner which is convenient, such as refilling the reservoir 118 or replacing the disposable housing assembly 102 with another disposable housing assembly having a filled reservoir 118.

[0051] Such a sensing arrangement may also be useful as it may provide a redundancy check for measurements of volume delivered by the delivery device 180. For example, a delivery volume sensor 130 may be included to monitor volumes of fluid pumped from the delivery device 180 to the patient 104 and to provide data for the controller 108 to aid in achieving various volume transfer goals during a therapy. Measurements from the delivery volume sensor 130 may be cross checked against data from a sensing arrangement monitoring the reservoir 118 to ensure that the data from each sensor corresponds within some predefined margin. An error may be generated by the pump controller 108 in the event that a divergence greater than the predefined margin is detected. That error can generate warnings or alerts at the user interface 122 or the user interface included on the delivery device 180. Thus, even in embodiments, where a reservoir 118 is prefilled (e.g. by a manufacturer or during manufacture) a reservoir volume sensing arrangement may be desirable.

[0052] Referring now to FIGS. 6 and 7, an exemplary drug delivery device 180 including a sensor arrangement, such as a reservoir volume sensor 200 is shown. The reservoir volume sensor 200 may be disposed within the reusable housing 106 of the delivery device 180. The reservoir volume sensor 200 may include components which are expensive or components which would be impractical to replace frequently and thus advantageous to provide as multiple use components in the reusable housing 106. In some embodiments, the reservoir volume sensor 200 may include a reservoir follower 400 and a detector 206. The reservoir volume sensor 200 may operatively couple with multiple different disposable housings 102. For example, once the reservoir 118 in a first disposable housing 102 is emptied, the first disposable housing 102 may be removed and a second disposable housing 102 with a new reservoir 118 may be installed. The reservoir volume sensor 200 may monitor the reservoir volume in each disposable housing 102 attached to the reusable housing 106.

[0053] The reservoir follower 400 of the reservoir volume sensor 200 may extend out of the reusable housing 106 and protrude into an attached disposable housing 102 such that at least a portion of the reservoir follower 400 is disposed within the disposable housing 102. The reservoir 118, which may include at least one flexible wall, may collapse as fluid is dispensed during pumping by the delivery device 180. The reservoir follower 400 is in contact with the collapsible wall of the reservoir 118. As the collapsible wall of the reservoir 118 collapses, the reservoir follower 400 may displace so as to stay against the reservoir 118 (see FIG. 7) forming a mechanical link between the reservoir volume sensor 200 in the reusable housing 106 and the reservoir 118 in the disposable housing 102. The detector 206 may monitor the position of the reservoir follower 400 as the reservoir 118 is depleted. To help ensure that the reservoir follower 400 maintains intimate contact with the reservoir 118, the reservoir follower 400 may have a bias member which provides a biasing force that presses the reservoir follower 400 against the reservoir 118. Such a biasing member may also aid in resisting any change to reservoir follower 400 position due to movement or the patient 104 or delivery device 180 orientation.

[0054] Referring now to FIG. 8, an example reservoir follower 400 is depicted. As shown, the reservoir follower 400 includes a stationary portion 402 and a telescoping member 404. The telescoping member 404 may seat within the stationary portion 402 and extend out of the stationary portion 402. The telescoping member 404 moves from a retracted position when the reservoir 118 is filled, to an extended second position as the reservoir 118 is emptied. The stationary portion 402 may be a cylindrical member with a hollow interior bore 414 within which the telescoping member 404 may be received. The telescoping member 404 may include a protuberance 412 included at an end of the telescoping member 404 that interfaces with the reservoir 118 by contact. In the example embodiment a bias member 406 is included in the reservoir follower 400. The bias member 406 shown in the example embodiment is a coil type compression spring that biases the telescoping member 404 to the second extended position. The telescoping member 404 includes a cavity 408 which may be sized to accept the bias member 406 and may aid in keeping the bias member 406 centered within the reservoir follower 400.

[0055] To retain the telescoping member 404 within the stationary portion 402, the stationary portion 402 may include a cap member 410. The cap member 410 may seat on an end of the stationary member 402 and define an orifice opening which is, at least in some sections, smaller than the bore 414 of the stationary portion 402. The telescoping member 404 may include astepped region 416 at an end opposite the protuberance 412. The stepped region 416 may be wider than the remainder of the telescoping member 404. The stepped portion 416 may be sized so as to be unable to fit through the orifice opening provided by the cap member 410. The biasing member 406 biases the stepped region 416 against the cap member 410 when the reusable housing assembly 106 is not attached to the disposable housing assembly 102. Additionally, the stepped portion 416 may provide a tighter fit against the wall of the bore 414 to help ensure that movement of the telescoping member 404 is substantially along the long axis of the reservoir follower 400.

[0056] The detector 206 may, in some embodiments, include an optical sensor. In certain examples where an optical sensor is included, the detector 206 may also include a light emitter. The light emitter may emit light in any wavelength or wavelengths and may be an LED. Depending on the embodiment, an infra-red emitting LED may be used. Light from the emitter may be unfocused and bounce off of a sensing surface, some of which being reflected to the optical sensor of the detector 206. This results in a sensed intensity of light by the detector 206 that varies as a function of distance / angle to the reflector. In various embodiments, the reservoir follower 400 or a portion of the reservoir follower 400 (e.g. the telescoping member 404) may be made of a naturally reflective material such as DELRIN. Coatings may alternatively or additionally be added to one or more surface of the reservoir follower 400 to increase reflection, if desired. In some embodiments, changes to the geometry of the surfaces or polishing of these surfaces may also be made to modify the reflection. Additional description of such a sensor arrangement may be found in U.S. Patent No. 8,613,724, issued December 24, 2013 and entitled Infusion Pump Assembly (Attorney Docket No. 140) which is incorporated by reference herein in its entirety.

[0057] Referring now to FIGS. 12 and 13, cross sectional views of exemplary disposable housings 102 are depicted. In some embodiments, a pivoting hinge plate 420 may be included in the disposable housing 102. The hinge plate 426 is hinged at a first edge and free at the opposite second edge of the hinge plate, thereby allowing the hinge plate 426 to move in an arc. The pivoting hinge plate 420 may lay atop the collapsible wall of the reservoir 118 within the disposable housing 102. As the reservoir 118 is filled, the pivoting hinge plate 420 may rotate into a position adjacent the interior surface of a fixed top plate 140 of the disposable housing 102. The pivoting hinge plate 420 may rotate toward the bottom of the disposable housing 102 asthe reservoir 118 is depleted. As shown, the pivoting hinge plate 420 may include a hinge knuckle portion 422. The top plate 140 may include a number of openings which may accept the hinge knuckle portion 422. A pin 425 may extend from the top plate 140 into the openings so as to hold the pivoting hinge plate 420 in place and facilitate rotation of the pivoting hinge plate 420. As shown, the hinge knuckle portion 422 is included at the first edge of the pivoting hinge plate 420. In certain embodiments, the pivoting hinge plate 420 may snap into engagement with the top plate 140 so as to couple the top plate 140 and pivoting hinge plate 422 together while still allowing relative pivoting motion therebetween.

[0058] The top plate 140 may include at least one aperture 424. The reservoir follower 400 may extend through an aperture 424 of the top plate 140 such that the reservoir follower 400 may mechanically interface with the pivoting hinge plate 420 by contact. Bias members 406 included in the reservoir follower 400 may aid in ensuring that the pivoting hinge plate 420 is biased to stay in contact against the collapsible wall of the reservoir 118 as the reservoir 118 depletes. Thus, as the reservoir 118 is emptied over the course of therapy, the free, unhinged second edge of the pivoting hinge plate 420 may pivotally displace toward the bottom of the disposable housing 102. The telescoping member 404 of the reservoir follower 400 may extend out of the reusable housing 106 so as to stay in contact with the upper surface of the pivoting hinge plate 420. The telescoping member 404 is located to contact the away from the first hinged edge and toward the free second edge of the hinge plate 420. The detector 206 may monitor the location of the telescoping member 404 to determine the fill volume of the reservoir 118.

[0059] Depending on the embodiment, the thickness of the top plate 140 over the region where the reservoir 118 is located may vary. The rest of the top plate 140 may be substantially identical thickness. This may allow for different disposable housing types 102 which may interface with a common reusable housing 106. As shown, the region of the top plate 140 over the reservoir 118 is thinner in FIG. 12 than in FIG. 13. Different size reservoirs 118 may be included in each embodiment. Thus, disposable housings 102 having reservoirs 118 with fill volumes appropriate for different drugs, drug concentrations, or the like may be constructed without any alteration to the rest of the disposable housing 102 or the reusable housing 106.

[0060] Referring now to FIG. 9, in certain embodiments, the reservoir follower 400 may include a tab or flag 430. The tab 430 may be coupled to the telescoping member 404. In some embodiments, the tab 430 may be integrally molded with the telescoping member 404 such thatthe tab 430 and telescoping member 404 are a unitary, monolithic part. The stationary portion 402 of the reservoir follower 400 may include a cut out which provides clearance for the tab 430 to extend through from the interior of the stationary portion 402 to the exterior of the stationary portion 402 as the telescoping member 404 displaces with respect to the stationary member 402. The tab 430 may provide a surface which may be monitored by the detector 206 during sensing.[00611 As shown, the tab 430 is disposed at an angle which is substantially perpendicular to the long axis of the reservoir follower 400. This may allow for a greater range of acceptable placements for the detector 206 within the reusable housing 106. In the example, the tab 430 is disposed more proximate the end opposite the protuberance 412. This may allow for any aperture 424 included in the top plate 140 to be made smaller as the tab 430 may not be required to pass through the aperture 424 of the top plate 140 during operation of the reservoir volume sensor 200.

[0062] Referring now to FIGS. 14-16, various views of an example embodiment of a reusable housing 106 including a reservoir follower 400 are shown. The illustrative reservoir follower 400 includes a tab 430. In the example embodiment, the tab 430 is shown as a round disc, though other geometries may be used. In some embodiments, the tab 430 may have a rectangular footprint. As the telescoping member 404 extends out of the stationary member 402 the tab 430 may translationally displace between a retracted first position and an extended second position within a channel 432 included in the reusable housing 106. As shown best in FIG. 16, the detector 206 may be disposed within the channel 432 may monitor a sensed intensity of light reflecting from the tab 430 that varies as a function of distance. The detector 206 and emitter may be included as a single part which is mounted in place within the reusable housing 106 such that the channel 432 is illuminated by the emitter during reservoir volume sensor 200 measurements. Though the channel 432 is shown as open, in certain embodiments, the channel 432 may be covered in some embodiments so as to prevent contact with a user and aid in blocking any ambient light.

[0063] Referring now to FIG. 17 an example cutaway view of a delivery device 180 including a reservoir follower 400 and detailed views of the reservoir follower 400 in different positions are shown. As shown, when the reservoir 118 is in a full state, the telescoping member 404 may be substantially retracted within the stationary portion 402 of the reservoir volume sensor 200 (See FIG 18). As the reservoir 118 is depleted, the flexible membrane shrinksallowing the telescoping member 404 to extend from a first retracted position to a second extended position into the disposable portion 102 (See FIG. 19). The bias member 406 of the reservoir follower 400 may exert a force on the telescoping member 404 which causes the telescoping member 404 to remain in contact with the reservoir 118. Thus, the biased telescoping member 404 may act as a linkage which establishes a relationship between the fill volume of the reservoir 118 and position of the tab 430.

[0064] Referring now to FIGS. 20-21, exemplary drug delivery devices 180 including reservoir volume sensors 200 are shown. As shown, each reservoir volume sensor 200 includes a first portion 201A and a second portion 201B. The first portion 201A may be disposed within the reusable housing 106 of the delivery device 180. The first portion 201A may include stationary components. These components may be more expensive components that would be advantageous to provide as multiple use components. In some embodiments, the first portion 201 A of the reservoir volume sensor 200 may include an emitter 204 and a detector 206. The emitter 204 may be an illuminator and the detector 206 may be an optical sensor. Additional description of such a sensor arrangement may be found in U.S. Patent No. 8,613,724, issued December 24, 2013 and entitled Infusion Pump Assembly (Attorney Docket No. 140) which is incorporated by reference herein in its entirety. The first portion 201 A of the reservoir volume sensor 200 may couple with multiple different second portions 201B. For example, once the reservoir 118 in a first disposable housing 102 is emptied, the first disposable housing 102 may be removed and a second disposable housing 102 with a fresh reservoir 118 and a new reservoir volume sensor second portion 20 IB may be installed.

[0065] The second portion 201B may be disposed within the disposable housing 102 and may include one or more displaceable components or displaceable members. In the example embodiment shown in FIGS. 20-21, a rotating member 202A configured for rotational displacement is included in the second portion 201B and is placed against the reservoir 118. The reservoir 118, which may include at least one flexible wall, may collapse as fluid is dispensed during pumping by the delivery device 180. As the reservoir 118 collapses, the rotating member 202A may displace such that at least a portion of the rotating member stays against the reservoir 118 (see FIG. 21). The rotating member 202A may be hinged at a first edge and the rotating member 202A rotates in an arc as the reservoir 118 is depleted. In the example embodiment shown in FIGS. 22-23, a translating member 202B configured for substantially translationaldisplacement is included in the second portion 201B and is placed against the reservoir 118. As the reservoir 118 collapses, the translating member 202B may displace so as to stay against the reservoir 118 as it depletes. As the reservoir 118 is depleted the translational member 202B moves away from the reusable portion 106.

[0066] There may be no parts which mechanically interface between the first portion 201 A and the second portion 201B during operation. Such a design may provide a number of advantages. For example, this may limit opportunity for any damage to the reservoir volume sensor 200 as a user manipulates the reusable housing 106 and disposable housing 102 (e.g. during coupling of the two housings, filling of the reservoir 118, etc. Additionally, the patient 104 may be protected against accidental bolusing or drug delivery if, for example, a moving part in contact with the reservoir 118 were accessible from the exterior of the disposable housing 102.

[0067] When the reusable housing 106 is coupled to a disposable housing 102, the emitter 204 may output a light emission which is receivable by the detector 206. The location of the rotating member 202A or translating member 202B may alter a characteristic of interest (e.g. intensity of light reflected off the displaceable member) observable by the detector 206. The controller 108 may monitor the output of the detector 206 and based on the characteristic of interest may determine the position of the rotating member 202A or translating member 202B depending on the embodiment. As the position of the displaceable member may be related to the volume of collapsible reservoir 118, changes in the characteristic of interest may be used to determine the volume contained in the reservoir 118. The space between the emitter 204 and detector 206 may provide a clear line of sight unobstructed by components of the disposable housing 102 or reusable housing 106.

[0068] Referring now to FIGS. 24 and 25, example disposable housings 102 are shown. The second portion 20 IB of the reservoir volume sensor 200 may include at least one bias member 208. The bias member 208 may be disposed between the rotating member 202A (FIG. 22) or translating member 202B (FIG. 23) and a top plate 140 which is included in the disposable housing 102. The top plate 140 may include an aperture 141 which may allow for a clear line of sight to the rotating member 202A or translating member 202B from the emitter 204 and detector 206 when the delivery device 180 is assembled. The bias member 208 may exert a force against the rotating member 202A or translating member 202B which presses and keeps it against the reservoir 118 over the range of displacement of the rotating member 202 A or translating member202B. The force may thus be a movement linking force which causes the rotating member 202A or translating member 202B to displace as the volume of the collapsible reservoir 118 is altered. The top plate 140 may be substantially rigid, stationary, and resistant to deflection under the force of the bias member 208.

[0069] In certain embodiments including a translating member 202B (e.g. FIG. 25), the bias member 208 may be constructed of a compressible foam material. The compressible foam material is resiliently deformable, when compressed continually acting to return to an uncompressed state and therefore continually providing a biasing force to the translating member 202B to keep in constant contact with the reservoir 118. See FIG. 26. This material may be positioned over only a portion of the translating member 202. For example, the foam may be present over a segment of the translating member 202 distal to the aperture 141 in the top plate 140 and absent over an area under the aperture 141. This may provide a clear line of sight between the displaceable member, the emitter 204 and the detector 206. In other examples, different types of bias members 208 may be used. The diagrammatic depiction in FIG. 24 shows a torsion spring type bias member 208 in place at the pivot point of the rotating member 202. Wire form springs may also be used in certain examples. The bias member 208 acts to keep the rotating member 202A in constant contact with the reservoir 118 at any orientation of the pump system 10. The force exerted by the bias member 208 may help make the reservoir volume sensor 200 resistant to changes caused by the orientation of the delivery device 180 and or jostling of the delivery device 180. This may help make any readings collected by the reservoir volume sensor 200 more consistent.

[0070] Referring now to FIG. 24, an example embodiment of a disposable housing 102 is shown. The disposable housing 102 in FIG. 26 includes a translating member 202B. The translating member 202B is disposed beneath a top plate 140 and a compressible foam insert intermediate the translating member 202B and top plate 140 which serves as a bias member 208. As shown, the top plate 140 includes an aperture 141. A region 440 of the translating member 202B in line with the top plate 140 may be provided having a different color than the remainder of the translating member 202B. In some examples a light color such as white may be used. This color may help to reflect light from the emitter 204 back to the detector 206. As shown, the foam of the bias member 208 may be asymmetrically disposed over the translating member. The foam may, for example, cover portions of the translating member 202B outside of region 440.

[0071] Referring now to FIG. 27 and FIG. 28, cross sectional views of two additional example embodiments of disposable housings 102 are shown. The disposable housings 102 shown in FIGS. 27 and 28 include a rotating member 202A. Reservoirs 118 are omitted in the illustrations shown in FIGS. 27 and 28. Each of the disposable housings 102 include a bias member 208 which exerts a rotational bias on the rotating member 202A. In FIG. 27, a bent wire spring mounted at the hinge point for the rotating member 202A is utilized as the bias member 208. As shown, the rotating member 202 A may include recesses 442 in a top surface of the rotating member 202A. These recesses may accept the bias member 208 when the rotating member 202A is against the interior surface of the top plate 140. This may ensure that the reservoir 118 of the disposable housing 102 may be fully filled. In FIG. 28, a torsion spring mounted around the hinge for the rotating member 202A is utilized as the bias member 208. Again, a receiving recess 442 is included in the rotating member 202A to accept portions of the torsion spring when the rotating member 202A is displaced toward the interior surface of the top plate 140.

[0072] Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. Additionally, while several embodiments of the present disclosure have been shown in the drawings and / or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. And, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods and techniques that are insubstantially different from those described above and / or in the appended claims are also intended to be within the scope of the disclosure.

[0073] The embodiments shown in drawings are presented only to demonstrate certain examples of the disclosure. And, the drawings described are only illustrative and are nonlimiting. In the drawings, for illustrative purposes, the size of some of the elements may be exaggerated and not drawn to a particular scale. Additionally, elements shown within the drawings that have the same numbers may be identical elements or may be similar elements, depending on the context.

[0074] Where the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. "a" "an" or "the", this includes a plural of that noun unless something otherwise is specifically stated. Hence, the term "comprising" should not be interpreted as being restricted to the items listed thereafter; it does not exclude other elements or steps, and so the scope of the expression "a device comprising items A and B" should not be limited to devices consisting only of components A and B.

[0075] Furthermore, the terms "first", "second", "third" and the like, whether used in the description or in the claims, are provided for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless clearly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operation in other sequences and / or arrangements than arc described or illustrated herein.

Claims

What is claimed is:1.A delivery device or priming aid substantially as shown and described herein.

2. A drug delivery device comprising:A pumping arrangement;A first housing;A second housing configured to couple to the first housing;An at least partially flexible reservoir disposed within the second housing;A reservoir volume sensing assembly contained within the first housing and including an optical sensor and a displaceable tab linked to a wall of the reservoir when the first and second housing are coupled, the displaceable tab configured to change its position in relation to the fill volume of the reservoir;A controller configured to analyze an output signal of the optical sensor to observe at least one characteristic of interest which alters as a function of the position of the displaceable tab, the controller configured to determine a fill volume of the reservoir based on the characteristic of interest.

3. The delivery device of claim 2, wherein the displaceable tab extends from a telescoping member which is configured to nest with a stationary body included in the first housing.

4. The delivery device of claim 3, wherein a bias member is disposed between the telescoping member and the stationary body to link the position of the tab to a position of the wall of the reservoir.

5. The delivery device of claim 2, wherein the displaceable tab is reflective.

6. The delivery device of claim 2, wherein the optical sensor includes an illuminator.

7. The delivery device of claim 6, wherein the illuminator is an infra-red illuminator.

8. The delivery device of claim 2, wherein the at least one characteristic of interest includes a light intensity value of light reflected off the tab.

9. The delivery device of claim 2, wherein the fill volume determined based on the characteristic of interest is an estimated volume remaining in the reservoir.

10. A drug delivery device comprising:A pumping arrangement;A first housing;A second housing configured to couple to the first housing, the second housing including a pivoting hinge plate hingedly coupled to a top cover of the second housing and an at least partially flexible reservoir disposed there beneath;A reservoir volume sensing assembly contained within the first housing and including an optical sensor and a reservoir follower with a displaceable portion, the reservoir follower extending out of the first housing and into contact with the pivoting hinge plate of the reservoir when the first and second housing are coupled, the displaceable portion of the reservoir follower and pivoting hinge plate configured to change positions in relation to the fill volume of the reservoir;A controller configured to analyze an output signal of the optical sensor to observe at least one characteristic of interest which alters as a function of the position of the displaceable portion of the reservoir follower, the controller configured to determine a fill volume of the reservoir based on the characteristic of interest.

11. The delivery device of claim 10, wherein the displaceable portion of the reservoir follower is a telescoping member which is configured to nest with a stationary portion of the reservoir follower.

12. The delivery device of claim 11, wherein a bias member is disposed between the telescoping member and the stationary portion.

13. The delivery device of claim 10, wherein the displaceable portion of the displaceable member includes a tab.

14. The delivery device of claim 10, wherein the optical sensor includes an illuminator.

15. The delivery device of claim 14, wherein the illuminator is an infra-red illuminator.

16. The delivery device of claim 14, wherein the illuminator includes at least one LED.

17. The delivery device of claim 10, wherein the at least one characteristic of interest includes a light intensity value of light reflected of the displaceable portion of the reservoir follower.

18. The delivery device of claim 10, wherein the fill volume determined based on the characteristic of interest is an estimated volume remaining in the reservoir.

19. The delivery device of claim 10, wherein the pivoting hinge plate includes an edge portion, the edge portion being hingedly coupled to the top cover.

20. A method of determining a volume of a flexible reservoir comprising:Delivering fluid from the reservoir via a pumping mechanism;Displacing a telescoping member out of a stationary housing toward the reservoir under a bias force;Monitoring, with an optical sensor, the position of a reflective tab extending from the telescoping member;Analyzing, with a controller, an output signal of the optical sensor to observe a reflected light intensity which alters as a function of the position of the reflective tab; andDetermining, with the controller, a volume contained within the reservoir based on the reflected light intensity.

21. The method of claim 20, wherein the method further comprises rotating a rotatable member against the reservoir as the reservoir is depleted.

22. The method of claim 21, wherein the method further comprises applying a bias against the rotatable member which presses the rotatable member against a wall of the reservoir.

23. The method of claim 22, wherein applying the bias against the rotatable member comprises applying the bias against the rotatable member with a torsion spring.

24. The method of claim 22, wherein applying the bias against the rotatable member comprises applying the bias against the rotatable member with a wire form spring.

25. A drug delivery device comprising:A pumping arrangement;A first housing;A second housing configured to couple to the first housing;An at least partially flexible reservoir;A reservoir volume sensing assembly including a first portion contained within the first housing and a second portion contained within the second housing, the first portion including an emitter and a detector, the second portion including a rotatable member with a reflective region, the disposition of the rotatable member being tied to the fill volume of the reservoir;A controller configured to analyze an output signal of the detector to observe at least one characteristic of interest which alters as a function of the disposition of the rotatable member, the controller configured to determine a fill volume of the reservoir based on the characteristic of interest.

26. The drug delivery device of claim 25, wherein the second portion includes at least one bias member.

27. The drug delivery device of claim 25, wherein the second portion includes the reservoir and further comprises a top plate, the rotatable member disposed between the top plate and the reservoir.

28. The drug delivery device of claim 27, wherein the rotatable member is biased against the reservoir.

29. The drug delivery device of claim 25, wherein the second portion includes a wire form spring.

30. The drug delivery device of claim 25, wherein the second portion includes a torsion spring.

31. The drug delivery device of claim 25, wherein the emitter is an illuminator.

32. The drug delivery device of claim 25, wherein the detector is an optical sensor.

33. The drug delivery device of claim 25, wherein the emitter includes an LED.

34. The drug delivery device of claim 25, wherein the reflective region is disposed in alignment with an aperture in a top plate forming a cover of the second housing.

35. The drug delivery device of claim 25, wherein the at least one characteristic of interest is a reflected light intensity.

36. A reservoir volume sensor comprising:A first portion included within a first housing and having an emitter and a detector;A second portion included within a second housing and including a compressible foam bias member and a translating member biased by the bias member to displace as the volume of a collapsible reservoir adjacent the displaceable member is altered;A controller configured to analyze an output from the detector to observe at least one characteristic of interest which alters as a function of the location of the displaceable member, the controller configured to determine a fill volume of the reservoir based on the characteristic of interest.

37. The drug delivery device of claim 36, wherein the displaceable member includes a light colored region disposed in alignment with an aperture in a top plate forming a cover of the second housing.

38. The drug delivery device of claim 37, wherein the compressible foam bias member is disposed between the displaceable member and the top plate.

39. The drug delivery device of claim 37, wherein when the first portion and second portion are coupled, the detector has a clear line of sight to the light colored region.

40. The drug delivery device of claim 36, wherein the emitter is an illuminator.

41. The drug delivery device of claim 36, wherein the detector is an optical sensor.

42. The drug delivery device of claim 36, wherein the emitter includes an LED.

43. The drug delivery device of claim 36, wherein the at least one characteristic of interest is a reflected light intensity.

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