US20090182277A1 - Disposable infusion device with perceptible actuation - Google Patents
Disposable infusion device with perceptible actuation Download PDFInfo
- Publication number
- US20090182277A1 US20090182277A1 US12/407,324 US40732409A US2009182277A1 US 20090182277 A1 US20090182277 A1 US 20090182277A1 US 40732409 A US40732409 A US 40732409A US 2009182277 A1 US2009182277 A1 US 2009182277A1
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- Prior art keywords
- pump
- actuator
- valve
- medicament
- reservoir
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- Abandoned
Links
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14212—Pumping with an aspiration and an expulsion action
- A61M5/1424—Manually operated pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
- A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
- A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
- A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
Abstract
A wearable infusion device comprises a reservoir that holds a liquid medicament, an outlet port that delivers the liquid medicament to a patient, a pump that displaces a volume of the liquid medicament to the outlet port when actuated, and a control that actuates the pump. The control is arranged to provide a perceptible indication that the pump has been actuated.
Description
- The present application is a Continuation of copending U.S. patent application Ser. No. 11/906,102, filed Sep. 28, 2007, which application is incorporated herein by reference in its entirety.
- The present invention relates to infusion devices and more particularly to such devices that enable liquid medicaments to be conveniently and safely self-administered by a patient.
- Tight control over the delivery of insulin in both type I diabetes (usually juvenile onset) and type II diabetes (usually late adult onset), has been shown to improve the quality of life as well as the general health of these patients. Insulin delivery has been dominated by subcutaneous injections of both long acting insulin to cover the basal needs of the patient and by short acting insulin to compensate for meals and snacks. Recently, the development of electronic, external insulin infusion pumps has allowed the continuous infusion of fast acting insulin for the maintenance of the basal needs as well as the compensatory doses (boluses) for meals and snacks. These infusion systems have shown to improve control of blood glucose levels. However, they suffer the drawbacks of size, cost, and complexity. For example, these pumps are electronically controlled and must be programmed to supply the desired amounts of basal and bolus insulin. This prevents many patients from accepting this technology over the standard subcutaneous injections.
- Hence, there is a need in the art for a convenient form of insulin treatment which does not require significant programming or technical skills to implement to service both basal and bolus needs. Preferably, such a treatment would be carried out by an infusion device that is simple to use and mechanically driven negating the need for batteries and the like. It would also be preferable if the infusion device could be directly attached to the body and not require any electronics to program the delivery rates. The insulin is preferably delivered through a small, thin-walled tubing (cannula) through the skin into the subcutaneous tissue similar to technologies in the prior art.
- While the idea of such a simple insulin delivery device is compelling, many obstacles must be overcome before such a device may become a practical realty. One problem resides in insulin supply. Patients vary greatly on the amount of insulin such a device must carry to provide treatment over a fixed time period of, for example, three days. This is one environment where one size does not fit all. Still further, such devices must be wearable with safety and not subject to possible accidental dosing. Still further, such devices must be capable of delivering an accurately controlled volume of medicament with reliability. While it is preferred that these devices include all of the forgoing features, it would be further preferred if the cost of manufacturing such a device would be economical enough so as to render the device disposable after use. As will be seen subsequently, the devices and methods described herein address these and other issues.
- In one embodiment, the invention provides a wearable infusion device comprising a reservoir that holds a liquid medicament, an outlet port that delivers the liquid medicament to a patient, a pump that displaces a volume of the liquid medicament to the outlet port when actuated, and a control comprising an actuator arranged to provide a perceptible indication that the pump has been actuated.
- The features of the present invention which are believed to be novel are set forth with particularity in the appended claims. The invention, together with further features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:
-
FIG. 1 is a perspective view of a first infusion device embodying certain aspects of the present invention; -
FIG. 2 is a schematic representation of the valves and pump of the device ofFIG. 1 ; -
FIG. 3 is an exploded perspective view of the device ofFIG. 1 ; -
FIG. 4 is a sectional view, in perspective, of the device ofFIG. 1 showing the pump of the device directly coupled to an actuator button; -
FIG. 5 is a sectional view, in perspective, of the device ofFIG. 1 showing the valves and the valve and actuation linkages prior to the delivery of a medicament dose; -
FIG. 6 is a sectional view, to an enlarged scale, illustrating the actuation linkages prior to the delivery of a medicament dose; -
FIG. 7 is a sectional view, like that ofFIG. 6 , illustrating the actuation linkages during the delivery of a medicament dose; -
FIG. 8 is a another sectional view, like that ofFIG. 5 , illustrating the actuation linkages just after the delivery of a medicament dose; -
FIG. 9 is a perspective view of another infusion device embodying various aspects of the present invention; -
FIG. 10 is a schematic representation of the valves and pump of the device ofFIG. 9 between medicament dosage delivery and for filling the pump with the medicament; -
FIG. 11 is a schematic representation of the valves and pump of the device ofFIG. 9 during medicament dosage delivery; -
FIG. 12 is an exploded perspective view of the device ofFIG. 9 ; -
FIG. 13 is a perspective view of one component of the device ofFIG. 9 ; -
FIG. 14 is a lengthwise sectional view in perspective of the device ofFIG. 9 and showing a cannula assembly for use therein in exploded view; -
FIG. 15 is a lengthwise sectional view in perspective of the device ofFIG. 9 similar toFIG. 14 showing the cannula assembly in operative association with the device; -
FIG. 16 is a sectional plan view showing the valve configuration of the device ofFIG. 9 during pump filling; -
FIG. 17 is a sectional plan view showing the valve configuration of the device ofFIG. 9 during medicament delivery; -
FIG. 18 is a sectional view, in perspective, to an enlarged scale, showing the actuation linkages of the device ofFIG. 9 prior to medicament dosage delivery; -
FIG. 19 is a sectional view like that ofFIG. 18 , showing the actuation linkages of the device ofFIG. 9 during medicament dosage delivery; -
FIG. 20 is a sectional view like that ofFIG. 18 , showing the actuation linkages of the device ofFIG. 9 after medicament dosage delivery; -
FIG. 21 is a another sectional view, in perspective, to an enlarged scale, showing the operation of the actuation linkages; -
FIG. 22 is another sectional view like that ofFIG. 21 , in perspective, to an enlarged scale, showing the operation of the actuation linkages; -
FIG. 23 is still another sectional view showing the last dose lock-out and the device pump during normal medicament delivery actuation; -
FIG. 24 is a sectional view, like that ofFIG. 23 , showing the last dose lock-out and device pump after normal medicament delivery; -
FIG. 25 is a sectional view, like that ofFIG. 23 , showing the last dose lock-out being conditioned for disabling the actuator upon return of the device pump after a last normal medicament delivery; -
FIG. 26 is a sectional view, like that ofFIG. 23 , showing the last dose lock-out disabling the actuator upon a final medicament delivery; -
FIG. 27 is another sectional view, to an enlarged scale, showing the device pump and the fill port being blocked during actuation for delivery of medicament; and -
FIG. 28 is another sectional view, like that ofFIG. 22 , showing the device pump and the fill port being locked in a blocked condition by the last dose lock-out. - Referring now to
FIG. 1 it is a perspective view of a first infusion device embodying certain aspects of the present invention. Thedevice 10 generally includes anenclosure 12, abase 14, a firstactuator control button 16, and a secondactuator control button 18. - The
enclosure 12, as will be seen subsequently, is formed by virtue of multiple device layers being brought together. Each layer defines various components of the device such as, for example, a reservoir, fluid conduits, pump chambers, and valve chambers, for example. This form of device construction, in accordance with aspects of the present invention, enables manufacturing economy to an extent rendering the device disposable after use. - The
base 14 preferably includes an adhesive coating to permit the device to be adhered to a patient's skin. The adhesive coating may originally be covered with a releasable cover that may be pealed off of thebase 14 when the patient endeavors to deploy thedevice 10. Such arrangements are well known in the art. - The
device 10 may be mated with a previously deployed cannula assembly. However, it is contemplated herein that the various aspects of the present invention may be realized within a device that may be alternatively first adhered to the patient's skin followed by the deployment of a cannula thereafter. - The
actuator buttons device 10 and directly across from each other. This renders more convenient the concurrent depression of the buttons when the patient wishes to receive a dose of the liquid medicament contained within thedevice 10. This arrangement also imposes substantially equal and opposite forces on the device during dosage delivery to prevent the device from being displaced and possibly stripped from the patient. As will be further seen hereinafter, the concurrent depression of the buttons is used to particular advantage. More specifically, theactuator button 16 may serve as a valve control which, when in a first position as shown, establishes a first fluid path between the device reservoir and the device pump to support pump filling, and then, when in a second or depressed position, establishes a second fluid path between the device pump and the device outlet or cannula to permit dosage delivery to the patient. As will be further seen, a linkage between thecontrol actuator buttons actuator control button 18 only when the second fluid path has been established by the firstactuator control button 16. Hence, the firstactuator control button 16 may be considered a safety control. - Referring now to
FIG. 2 , it is a schematic representation of the valves and pump of thedevice 10 ofFIG. 1 . As may be seen inFIG. 2 , thedevice 10 further includes afill port 20, areservoir 22, apump 24, and thecannula 30. The device further includes afirst valve 32 and asecond valve 34.Fluid conduit 40 provides a fluid connection between thefill port 20 and thereservoir 22,fluid conduit 42 provides a fluid connection between thereservoir 22 and thefirst valve 32,fluid conduit 44 provides a fluid connection between thefirst valve 32 and thepump 24,fluid conduit 46 provides a fluid connection between thepump 24 and thesecond valve 34, andfluid conduit 48 provides a fluid connection between thesecond valve 34 and thedevice outlet 50. Theoutlet 50 is arranged to communicate with thecannula 30. - It may also be noted that the
actuator buttons springs - The
pump 24 of thedevice 10 comprises a piston pump. Thepump 24 includes apump piston 26 and apump chamber 28. In accordance with this embodiment, theactuator control button 18 is directly coupled to and is an extension of thepump piston 26. - With further reference to
FIG. 2 , the device additionally includes afirst linkage 52 and asecond linkage 54. The first linkage is a toggle linkage between thefirst valve 32 and thesecond valve 34. It is arranged to assure that thesecond valve 34 does not open until after thefirst valve 32 is closed. Thesecond linkage 54 is between thefirst actuator button 16 and thesecond actuator button 18. It is arranged to assure that the pump does not pump until after the first valve is closed and the second valve is opened by thefirst actuator button 16. - Still further, the
second valve 34 is a safety valve that closes tighter responsive to increased fluid pressure withinfluid conduit 46. This assures that the liquid medicament is not accidentally administered to the patient notwithstanding the inadvertent application of pressure to the reservoir, for example. In applications such as this, it is not uncommon for the reservoir to be formed of flexible material. While this has its advantages, it does present the risk that the reservoir may be accidentally squeezed as it is worn. Because the second valve only closes tighter under such conditions, it is assured that increased accidental reservoir pressure will not cause the fluid medicament to flow to the cannula. - In operation, the reservoir is first filled through the
fill port 20 to a desired level of medicament. In this state, thevalves first valve 32 will be open and thesecond valve 34 will be closed. This permits thepiston chamber 28 to be filled after the reservoir is filled. Thecannula 30 may then be deployed followed by the deployment of thedevice 10. In this state, thevalves first valve 32 will be open and thesecond valve 34 will be closed. This permits thepump chamber 28 to be filled through a first fluidpath including conduits piston 24 returns to its first position after each applied dose. - When the patient wishes to receive a dose of medicament, the actuator buttons are concurrently pressed. In accordance with aspects of the present invention, the
linkage 52 causes thefirst valve 32 to close and thesecond valve 34 to thereafter open. Meanwhile, thesecond linkage 54 precludes actuation of thepump 24 until thefirst valve 32 is closed and thesecond valve 34 is opened by thefirst actuator button 16. At this point a second fluid path is established from thepump 24 to thecannula 30 throughfluid conduits outlet 50. The medicament is then administered to the patient throughcannula 30. - Once the medication dosage is administered, the
piston 24, and thus theactuator button 18, is returned under the spring pressure ofspring 38 to its initial position. During the travel of the piston back to its first position, a given volume of the liquid medicament for the next dosage delivery is drawn from the reservoir into thepump chamber 28 to ready the device for its next dosage delivery. - Referring now to
FIG. 3 , it is an exploded perspective view of the device ofFIG. 1 . It shows the various component parts of the device. The main component parts include the aforementioned device layers including thebase layer 60, the reservoir membrane orintermediate layer 62, and thetop body layer 64. The base layer is a substantially rigid unitary structure that defines afirst reservoir portion 66, thepump chamber 28, andvalve sockets base layer 60 may be formed of plastic, for example. Thereservoir membrane layer 62 is received over thereservoir portion 66 to form the reservoir 22 (FIG. 2 ). Avalve seat structure 72 is received over thevalve sockets second valves 32 and 34 (FIG. 2 ) respectively. Arocker 74 is placed over thevalves seat structure 72 to open and close the valves as will be seen subsequently. Thepump actuator button 18 carries the pump piston that is received within thepump chamber 28. Thepump actuator button 18 also carries acam cylinder 76 with alock tube 78 therein that form a portion of the second linkage 54 (FIG. 2 ). Thespring 38 returns theactuator button 18 to its first position after each dosage delivery. - The first actuator control button carries a
valve timing cam 80 that rocks therocker 12. Thebutton 16 further carries acam cylinder 82 and acam pin 84 that is received into thecam cylinder 82. Thespring 36 returns theactuator button 16 to its first position after each dosage delivery. Thetop body layer 64 forms the top portion of the device enclosure. It receives aplanar cap 86 that completesfluid paths 85 partially formed in thetop layer 64. Lastly, aneedle 88 is provided that provides fluid coupling from the cannula (not shown) to the outlet of thedevice 10. -
FIG. 4 shows a sectional view, in perspective, of the device ofFIG. 1 . More specifically, the figure shows details of thepiston pump 24 within thedevice 10. Here, it may be seen that thepiston 26 of thepiston pump 24 is received within thepump chamber 28 that is formed in thebase layer 60 of the device. Thepiston 26 may further be seen to be an extension of theactuator button 18. An O-ring 90 provides a seal between thepump chamber 28 and thepiston 26. Thespring 38 returns theactuator button 18 to its shown first position after each dosage delivery. -
FIG. 5 is a sectional view, in perspective, of the device ofFIG. 1 showing thevalves valve seat structure 72 is received within thevalve sockets valve seat structure 72 includesvalve seats valve sockets seats portion sockets - The
rocker 74 opens and closes thevalves timing cam 80 carried by the firstactuator control button 16. As thecontrol button 16 is moved laterally, thecam 80 causes therocker 74 to pivot and to apply pressure to one or the other of the valve seats 92 or 94. The shape of the cam surfaces on therocker 74 and thecam 80 assure that thevalve 34 will not open until thevalve 32 closes. Thecam 80 androcker 74 thus form thefirst linkage 52 shown inFIG. 2 . - While the
cam 80 androcker 74 are operating thevalves first linkage 52, thesecond linkage 54 is controlling when the pump may displace liquid medicament form thepump chamber 28 to the device outlet and cannula.FIGS. 5-8 show details of the second linkage. - As may be seen in
FIGS. 5 and 6 , the second linkage includes thecam cylinder 76, thelock tube 78, theouter cam cylinder 82, and thecam pin 84. The cam cylinder is integral with the secondactuator control button 18 and theouter cam cylinder 82 is integral with the first actuator control button. Thesecond linkage 54 further includes alock cylinder 100. The foregoing are disposed in abore 102 formed in thebase layer 60 of the device. - When the actuator buttons are in their first position as shown in
FIG. 6 , the end of thelock tube 78 abuts the end of thelock cylinder 100. The lock cylinder includesears 104. When a dosage delivery is desired, the concurrent pushing of thebuttons outer cam cylinder 82 to slide over thelock cylinder 100 first and then thecam cylinder 76 to slide over thelock tube 78. The sliding of theouter cam cylinder 82 over thelock cylinder 100 causes the first valve to close and the second valve to open. When this is accomplished, thecam cylinder 76 is then permitted to slide overlock tube 78 to cause thepiston 26 to move through thepump chamber 28. This displaces the liquid medicament in thepump chamber 28 for delivering the medicament to thecannula 30 and the patient. -
FIG. 7 illustrates the manner in which theouter cam cylinder 82 slides along thelock cylinder 100. It may first be noted that thecam pin 84 has a reduced diameter portion creating anannular space 106 between thepin 84 and thelock cylinder 100. Theouter cam cylinder 82 engages the pin at aflange 108 of thepin 84. This engagement will cause thepin 84 to move with theouter cam cylinder 82. The pushing of thefirst actuator button 16 will cause theouter cam cylinder 82 to engage theears 104 of thelock cylinder 100 while at the same time, the end of thepin 84 moves into thelock tube 78. Eventually, theears 104 are depressed enough by theouter cam cylinder 82 as the end of thepin 84 clears the end of thedepressed lock cylinder 100 to permit theears 104 to enterspace 106. This occurs with a snap sound and feel as it occurs suddenly. Theouter cam cylinder 82 is now free to slide its complete travel distance over thelock cylinder 100. Thevalve 32 has now been closed and thevalve 34 has been opened. - The snap action of the
actuator buttons pump actuator button 18 completes it full travel, the patient will also know that a full dosage was delivered. - After the
outer cam cylinder 82 has completed its travel over thelock cylinder 100, theears 104 will be displaced sufficiently intospace 106 to permit thecam cylinder 76 to clear the end of thelock cylinder 100 and slide over thelock tube 78. The condition of thesecond linkage 54 at this time is shown inFIG. 8 . As previously described, as thecam cylinder 76 slides over thelock tube 78, thepump 24 is actuated to deliver the medicament to the patient. - Referring now to
FIG. 9 , it is a perspective view of another infusion device embodying various aspects of the present invention. Thedevice 210 generally includes anenclosure 212, abase 214, a firstactuator control button 216, and a secondactuator control button 218. - The
enclosure 212 is formed by virtue of multiple device layers being brought together. Each layer defines various components of the device such as, for example, a reservoir, fluid conduits, pumps, and valve chambers, for example. This form of device construction, in accordance with aspects of the present invention, enables manufacturing economy to an extent rendering the device disposable after use. - The base 214 preferably includes an adhesive coating to permit the device to be adhered to a patient's skin. The adhesive coating may originally be covered with a releasable cover that may be pealed off of the base 214 when the patient endeavors to deploy the
device 210. Such arrangements are well known in the art. - As will also be seen subsequently, the
device 210 may be mated with a previously deployed cannula assembly. However, it is contemplated herein that the various aspects of the present invention may be realized within a device that may be alternatively first adhered to the patient's skin followed by the deployment of a cannula thereafter. - As in the previous embodiment, the
actuator buttons device 210 and directly across from each other. This again renders more convenient the concurrent depression of the buttons when the patient wishes to receive a dose of the liquid medicament contained within thedevice 210. This arrangement also imposes substantially equal and opposite forces on the device during dosage delivery to prevent the device from being displaced and possibly stripped from the patient. As will be further seen hereinafter, the concurrent depression of the buttons is used to particular advantage. More specifically, theactuator button 216 may serve as a valve control which, when in a first position as shown, establishes a first fluid path between the device reservoir and the device pump to support pump filling, and then, when in a second or depressed position, establishes a second fluid path between the device pump and the device outlet or cannula to permit dosage delivery to the patient. As will be further seen, a linkage between thecontrol actuator buttons actuator control button 218 only when the second fluid path has been established by the firstactuator control button 216. Hence, the firstactuator control button 216 may be considered a safety control. - With continued reference to
FIG. 9 , it may be further noted that thedevice 210 also includes atactile indicator 260 that represents the volume of the liquid medicament delivered by the device with each actuation of thepump 224. The tactile indicator is carried by thepump actuator button 218 and takes the form of a plurality of distinct raised features orbumps bump bumps - The
tactile indicator 260 being carried on the pumpactuator control button 218 provides a very significant feature and advantage. As will be seen subsequently, thepump actuator button 218 has an integral extension that forms thepiston 226 of thepiston pump 224 as represented inFIG. 10 to be described hereinafter. It will also be seen that thepiston chamber 228 is formed in a component of the device that may be used in devices delivering dosage amounts other than two units. The component may be common to all such devices because it would have a fixed piston chamber length and the dosage amount is determined by the throw of thepump piston 226. Each piston throw is integral to the part and corresponds to a respective given dosage amount. Each pump actuator button for a given dosage amount may have then be provided with a corresponding tactile indicator. Hence, if a tactile indicator indicates a dosage amount of two units, for example, it is assured that that is the medicament amount delivered with that particular pump button. Further, this arrangement is advantageous from a manufacturing standpoint because the actuator buttons for the various dosage size devices cannot be confused with each other. - Referring now to
FIGS. 10 and 11 , they are schematic representations of the valves and pump of the device ofFIG. 9 between medicament dosage filling (FIG. 10 ) and medicament dosage delivery (FIG. 11 ) As may be seen inFIGS. 10 and 11 , thedevice 210 further includes areservoir 222, apump 224, and thecannula 230. The device further includes ashuttle valve 231 forming afirst valve 232 defined by O-rings second valve 234 defined by O-rings Fluid conduit 240 extends between thevalves fluid conduit 242 provides a fluid connection between thereservoir 222 and theshuttle valve 231 andfluid conduit 244 provides a fluid connection between theshuttle valve 231 and thepump 224. A furtherfluid conduit 246 provides a fluid connection between theshuttle valve 231 and thedevice outlet 250. Theoutlet 250, in the form of a needle, is arranged to communicate with thecannula 230. - It may also be noted that the
actuator buttons springs - The
pump 224 of thedevice 210 comprises a piston pump. Thepump 224 includes apump piston 226 and apump chamber 228. In accordance with this embodiment, theactuator control button 218 is directly coupled to and is an extension of thepump piston 226. - With further reference to
FIGS. 10 and 11 , the device additionally includes afirst linkage 252 and asecond linkage 254. The first linkage is formed by theshuttle bar 241 of thefirst valve 232 and thesecond valve 234. It is arranged by separating thevalves second valve 234 does not open until after thefirst valve 232 is closed. Thesecond linkage 254 is between thefirst actuator button 216 and thesecond actuator button 218. It is arranged to assure that thepump 224 does not pump until after thefirst valve 232 is closed and thesecond valve 234 is opened by thefirst actuator button 216. - Still further, the
second valve 234 is a safety valve that assures that the liquid medicament is not accidentally administered to the patient notwithstanding the inadvertent application of pressure to the reservoir, for example. In applications such as this, it is not uncommon for the reservoir to be formed of flexible material. While this has its advantages, it does present the risk that the reservoir may be accidentally squeezed as it is worn. Because of thesecond valve 234, it is assured that accidental reservoir pressure will not cause the fluid medicament to flow to the cannula. - In operation, the
pump chamber 228 is first filled as theactuator button 218 returns to the first position after having just delivered a medicament dosage. In this state, theshuttle valve 231 is set so that thefirst valve 232 will be open (thereservoir 222 communicates with the fluid conduit 240) and thesecond valve 234 will be closed (theconduit 246 is closed off from fluid conduit 240). This establishes a first fluid path from thereservoir 222 to thepump 224 throughconduits piston chamber 228 to be filled by the reservoir as the actuator button is returned to its first position under the influence of thespring 238. - When the patient wishes to receive another dose of medicament, the actuator buttons are concurrently pressed. In accordance with aspects of the present invention, the
linkage 252 causes thefirst valve 232 to close and thesecond valve 234 to thereafter open. Meanwhile, thesecond linkage 254 precludes actuation of thepump 224 until the first valve 332 is closed and the second valve 334 is opened by thefirst actuator button 216. At this point a second fluid path is established from thepump 224 to thecannula 30 throughfluid conduits outlet 250. The medicament is then administered to the patient throughcannula 30. - Once the medication dosage is administered, the
piston 224, and thus theactuator button 218, is returned under the spring pressure ofspring 238 to its initial position. During the travel of the piston back to its first position, a given volume of the liquid medicament for the next dosage delivery is drawn from the reservoir into thepump chamber 228 as described above to ready the device for its next dosage delivery. - Referring now to
FIG. 12 , it is an exploded perspective view of the device ofFIG. 9 . It shows the various component parts of thedevice 210. Like thedevice 10 ofFIG. 1 , thedevice 210 is constructed in device layers including abase layer 280, anintermediate layer 282, and thetop body layer 284. - As may also be seen in
FIG. 13 , thebase layer 280 is a substantially rigid unitary structure that defines afirst reservoir portion 286, thepump chamber 228, and avalve chamber 290 for the first andsecond valves base layer 280 may be formed of plastic, for example. - The
valve chamber 290 is arranged to receive thevalve shuttle bar 241 carried by and extending from thefirst actuator button 216. O-rings shuttle bar 241 to form the first andsecond valves FIG. 10 ). Theactuator button 216 also carries afirst portion 292 of the second linkage 254 (FIG. 10 ). The second linkage is received within a suitably configured bore 295 formed in thebase layer 280 and will be described subsequently. - The
pump actuator button 218 carries thepump piston 226 and asecond portion 294 of thesecond linkage 254. Thepump piston 226 is arranged to be received within thepump chamber 228 and thesecond portion 294 of thesecond linkage 254 is arranged to be received within thebore 295 for interacting with thefirst portion 292. O-rings piston 226 to provide a seal against leakage and to prevent external contaminants from entering the piston chamber. Thebase layer 280 further includesfluid channels 304 that serve to form the fluid conduits illustrated inFIG. 10 . Finally, springs 306 and 308 are arranged to spring load theactuator buttons - The
intermediate layer 282 is formed of flexible membrane material. Aportion 296 of the intermediate layer is received over thereservoir portion 286 to form the reservoir 222 (FIG. 10 ). Arigid plate 310 is arranged to be adhered to theportion 296 of the reservoir. Because thelayer 282 is flexible membrane, it will move as the reservoir is filled and emptied. Therigid plate 310 will then move with it. The plate includes aneyelet 312 dimensioned to receive anelongated web 314 that forms a part of a medicament level indicator to be described hereinafter. Theweb 314 carries an indicator line or feature 316. - The
top layer 284 is arranged to be received over theintermediate layer 282 and adhered to the base layer. It includes apanel 320 having aview window 318 through which the medicament level indicator line may be observed. - Lastly with respect to
FIG. 12 , it may be noted thedevice 210 further includes apin 322. Thepin 322 is a locking pin that is employed to lock the actuator buttons after a last medicament dose is delivered. It also serves to maintain the device fill port, to be described subsequently, in a blocked condition after a last medicament dose is delivered. - Referring now to
FIGS. 14 and 15 , they are lengthwise sectional views, in perspective, of the device ofFIG. 9 along with a cannula assembly that may be deployed in the device.FIG. 14 illustrates the previously described layered structure of thedevice 210 including device layers 280, 282, and 284. As may also be noted inFIG. 14 , the device includes a port for receiving acannula assembly 340. The cannula assembly has abase 342, a generallycylindrical docking structure 344, and acannula 346. Thedocking structure 344 is arranged to be received by the port 330 (FIG. 15 ) after thecannula assembly 340 is applied to the patient's skin with the cannula projecting beneath the patient's skin. The device includes aneedle 348 that projects through aseptum 350 of the device when thecannula assembly 340 is received by theport 330. This completes the fluid path from thereservoir 222 to thecannula 346. For a more detailed description of such a cannula assembly and the device that utilizes the same, reference may be had to co-pending U.S. application Ser. No. 11/803,007, filed May 11, 2007, and entitled INFUSION ASSEMBLY, which application is owned by the present assignee and incorporated herein by reference. -
FIGS. 14 and 15 also clearly illustrate a medicament level indicator embodying the present invention. Therigid plate 310 forms a moveable wall that moves as the medicament volume increases and decreases within the reservoir. Theelongated web 316 is preferably formed from a non-elastic, non-compressible, elongated material. It has afirst end 352 and asecond end 354. The web is fixed at thefirst end 352 with respect to therigid plate 310 of thereservoir 222 and is arranged to move in a first plane generally perpendicular to therigid plate 310 intermediate the first and second ends 352 and 354. Because theweb 316 is fixed at thefirst end 352 and free to move within theeyelet 312, itssecond end 354 will move in linear movement in a second plane substantially parallel to the rigid member and transverse to the first plane. - As previously mentioned, a
panel 320 of thetop layer 284 has awindow opening 318 to render the medicament level indicia viewable. Thecover panel 320 forms aguide channel 356 that receives and confines the web second end to guide the web for linear movement in the second plane substantially transverse to the first plane. As the reservoir is filled or emptied, a glance through thewindow 318 will provide an indication of the level of the medicament in thereservoir 222. - Referring now to
FIG. 16 , it is a sectional plan view showing the valve configuration of thedevice 210 ofFIG. 9 during medicament filling of thepump chamber 228 immediately after a dosage delivery. Here, it may be clearly seen that thefirst actuator button 216 has an extension comprising theshuttle bar 241 of thevalves conduit 242 is in fluid communication with the reservoir 222 (FIG. 10 ), theconduit 244 in fluid communication with the pump, and theconduit 246 is in fluid communication with the cannula. The valves are shown with thefirst valve 232 opened and not blocking thereservoir conduit 242, and thesecond valve 234 closed and blocking theconduit 246 to the cannula. This permits medicament to flow from the reservoir throughconduit 242 and to thepump chamber 228 throughconduit 244 as theactuator button 216 returns to its first position. Hence, the pump chamber is filled and ready for the next dosage delivery. - Referring now to
FIG. 17 , it is a sectional plan view showing the valve configuration of thedevice 210 ofFIG. 9 during medicament delivery. Here, the valves are shown with thefirst valve 232 closed and blocking thereservoir conduit 242, and thesecond valve 234 open permitting medicament to flow from the pump throughconduit 244 and to the cannula throughconduit 246. As previously mentioned, the first andsecond valves conduit 242 is blocked beforeconduit 246 is opened. -
FIGS. 18-22 show details of the operation of thesecond linkage 254 of thedevice 210. Through this discussion, simultaneous reference to more than one drawing figure may be necessary. As may be seenFIG. 18 , thefirst actuator button 216 has anextension 380 that terminates in ablock 382 having afirst ramp surface 384 and asecond ramp surface 386. When thedevice 210 is actuated, thebutton 216 is concurrently depressed withpump button 218. It and itsextension 380 andbloc 382 are free to move to the right. As seen inFIGS. 18 and 21 , thepump actuator button 218 hasparallel extensions rod member 404. As seen inFIG. 18 , theextension 400 abuts anabutment 388 which it must clear to be able to move to the left. As shown inFIG. 21 , as thebutton 216 is depressed, itsextension 380 moves to the right causing the first ramp surface to engage therod member 404. Continued movement of the button causes therod member 404 to rise up under thefirst ramp surface 384 which in turn causes theextension 400 to begin to move slightly to the left and bend upward aboutrib 405. Eventually, therod member 404 rides up the length of thefirst ramp 384 causing theend 401 ofextension 400 to clear theabutment 388 as shown inFIG. 19 . Thepump button 216 is now able to move freely to the left. When theend 401 ofextension 400 totally clears theabutment 388, it will snap behind theabutment 388 as shown inFIG. 20 and become temporarily locked. Meanwhile, as shown inFIG. 22 , therod member 404 has traversed down thesecond ramp surface 386. Thebuttons - Hence, from the above, it may be seen that the
pump button 218 could not at first move freely while thefirst actuator button 216 which operates the valves could. As a result, the pump actuation lags behind the valve actuation causing the first valve 232 (FIG. 10 ) to be closed and thesecond valve 234 to be opened, establishing a medicament delivery flow path to the cannula, before the pump is able to begin pumping the medicament to the patient. Because this operation occurs quickly, it appears to the patient that both actuator buttons are moving at the same rate. - When the
extension 400 of the pump button clears theabutment 388, it becomes locked in a snap action. As in the previous embodiment, this provides positive feedback to the patient that a dosage of medicament was delivered as desired. It also causes a full dose to be delivered. By virtue of the snap action of the pump actuator, only full doses may be administered. - When the medicament has been delivered, the spring loading of the actuator buttons returns the buttons to their first or initial position. During this time, the same timing provided by the
block 382 is used for recharging the pump. More specifically, ramp 366 unlatches theend 401 ofextension 400 by liftingrod member 404 so that 246 is closed andconduit 242 is opened before the pump is returned by the spring to its initial position. This assures that the pump does not pull medicament from the patient but only from the reservoir. As thepiston 226 of thepiston pump 224 returns, a full dose of the medicament is drawn up into thepiston chamber 228 to ready the device for the next dosage delivery. -
FIGS. 23 and 24 show the operation of thepiston pump 224 in greater detail. Also shown is a last dose lock-out 420 that will be described subsequently. Here it may be seen that thepiston 226 ofpump 224 is an extension of thepump actuator button 218. Also, it may be seen that the O-rings piston 226 and thechamber 228. The double O-rings both prevent leakage of medicament from thecamber 228 and prevent outside contaminants from entering thechamber 228. - When the pump chamber is filled with medicament as the actuator button is returned from the second position shown in
FIG. 24 to the first or initial position shown inFIG. 23 after a dosage delivery, medicament flows from the reservoir, through a conduit 307 (FIG. 13 ), through adiaphragm chamber 424 and through theconduit 244 to thepump chamber 228. Thechamber 424 is defined by adiaphragm 422 formed of flexible membrane material. Thediaphragm 422 includes an extension which captures thepin 322, previously shown in the exploded view ofFIG. 12 . As long as the reservoir has medicament, and hence is not empty, thediaphragm 422 is not affected. In this state, thebutton 216 is free to be actuated. - As may be noted, the pin is L-shaped at
end 323 with an L-extension 428. Acapture ramp 430, integral with the actuator button, passes adjacent to thepin 322 and over the L-extension 328. This occurs when the actuator button is depressed as long as the reservoir has sufficient medicament to provide at least one more dosage delivery. - Reference may now be had to
FIGS. 25 and 26 as the operation of the last dose lock-out 420 is described. When the reservoir has insufficient medicament to support delivery of another dose of medicament, and during the return of theactuator button 218 after what will be the last dose delivered, a negative pressure is created in thediaphragm chamber 424. This causes thediaphragm 422 to be drawn into thechamber 424 due to the absence of liquid medicament in thechamber 424. As thediaphragm 422 is drawn into thechamber 424, thepin 322 is drawn upward with thediaphragm 422 where it engages anabutment 432 connected to theramp extension 430. Thepin 322 is now caused to be captured between theramp 430 and theabutment 432. Thebutton 216 is now only partially returned to its first position whereas thepump actuator button 218 is free to fully return to its initial position. Upon the next attempted actuation of the device, the L-extension will ride up theramp 430 and fall into a locked position between theramp 430 and ashoulder 434 formed in theactuator button 216. The button is now locked and cannot be returned to its first position. Thepump actuator button 218 will also be locked in its second position as shown inFIG. 26 . This is due to the fact that thefirst button 216 is not able to return from its second position which, as shown inFIG. 20 , causes theend 401 of theextension 400 of thepump actuator 218 be locked between theabutment 388 andactuator button 216. Hence, thedevice 210 is now locked and cannot be reused. - Referring now to
FIGS. 27 and 28 , they illustrate a further aspect of the last dose lock-out. Before thedevice 210 can be used to deliver a medicament, its reservoir must be filled with a medicament. To this end, thedevice 210 is provided with afill port 440 that communicates with the reservoir. When thedevice 210 is filled with medicament, theactuator buttons first actuator button 216 further includes anotherextension 442 which does not cover thefill port 440 when theactuator button 216 is in its initial position. However, when theactuator button 216 is in its fully actuated second position, it does block thefill port 440 as seen inFIG. 28 . When the last dose lock-out has the locked the device, theactuator button 216 is left in its fully actuated second position. As a result, the last dose lock-out not only locks bothactuator buttons device 210, it also blocks thefill port 440 to further render the device disabled. - While particular embodiments of the present invention have been shown and described, modifications may be made. For example, instead of manual actuation and spring loaded return of the valves used herein, constructions are possible which perform in a reversed manner by being spring actuated and manually returned. It is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention as defined by those claims.
Claims (13)
1-10. (canceled)
11. A wearable infusion device comprising:
a reservoir that holds a liquid medicament;
an outlet port that delivers the liquid medicament to a patient;
a pump that displaces a volume of the liquid medicament to the outlet port when actuated; and
a control that actuates the pump, the control comprising an actuator arranged to provide a perceptible indication that the pump has been actuated.
12. The device of claim 11 , wherein the perceptible indication is a tactile indication.
13. The device of claim 12 , wherein the control comprises a snap action actuator and the tactile indication is that of snap action.
14. The device of claim 11 , wherein the perceptible indication is an audible indication.
15. The device of claim 14 , wherein the audible indication is a sharp sound.
16. The device of claim 14 , wherein the control comprises a snap action actuator and wherein the audible indication is a snap sound.
17. The device of claim 11 , wherein the control includes a pair of actuator buttons arranged to require concurrent operation for pump actuation.
18. The device of claim 17 , wherein only one of the actuator buttons causes the actuator to provide a perceptible indication that the pump has been actuated.
19. The device of claim 18 , wherein operation of the other one of the actuator buttons enables actuation of the pump.
20. The device of claim 17 , wherein the perceptible indication is a tactile indication.
21. The device of claim 17 , wherein the perceptible indication is an audible indication.
22. A wearable infusion device comprising:
a reservoir that holds a liquid medicament;
an outlet port that delivers the liquid medicament to a patient;
a pump that displaces a volume of the liquid medicament to the outlet port when actuated; and
a control that actuates the pump, the control comprising a pair of actuator buttons arranged to require concurrent operation for pump actuation and providing a combined perceptible tactile and audible indication that the pump has been actuated.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/407,324 US20090182277A1 (en) | 2007-09-28 | 2009-03-19 | Disposable infusion device with perceptible actuation |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/906,102 US7771391B2 (en) | 2007-09-28 | 2007-09-28 | Disposable infusion device with snap action actuation |
US12/407,324 US20090182277A1 (en) | 2007-09-28 | 2009-03-19 | Disposable infusion device with perceptible actuation |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US11/906,102 Continuation US7771391B2 (en) | 2007-09-28 | 2007-09-28 | Disposable infusion device with snap action actuation |
Publications (1)
Publication Number | Publication Date |
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US20090182277A1 true US20090182277A1 (en) | 2009-07-16 |
Family
ID=40509187
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Application Number | Title | Priority Date | Filing Date |
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US11/906,102 Active 2028-02-04 US7771391B2 (en) | 2007-09-28 | 2007-09-28 | Disposable infusion device with snap action actuation |
US12/407,324 Abandoned US20090182277A1 (en) | 2007-09-28 | 2009-03-19 | Disposable infusion device with perceptible actuation |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US11/906,102 Active 2028-02-04 US7771391B2 (en) | 2007-09-28 | 2007-09-28 | Disposable infusion device with snap action actuation |
Country Status (7)
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US (2) | US7771391B2 (en) |
EP (1) | EP2197516A4 (en) |
JP (1) | JP5539209B2 (en) |
CN (1) | CN101808682B (en) |
CA (1) | CA2739186C (en) |
IL (1) | IL204734A (en) |
WO (1) | WO2009045780A2 (en) |
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Also Published As
Publication number | Publication date |
---|---|
EP2197516A2 (en) | 2010-06-23 |
WO2009045780A2 (en) | 2009-04-09 |
JP5539209B2 (en) | 2014-07-02 |
EP2197516A4 (en) | 2012-10-03 |
CN101808682B (en) | 2012-09-05 |
CN101808682A (en) | 2010-08-18 |
JP2010540095A (en) | 2010-12-24 |
US7771391B2 (en) | 2010-08-10 |
IL204734A (en) | 2014-02-27 |
US20090088689A1 (en) | 2009-04-02 |
CA2739186A1 (en) | 2009-04-09 |
IL204734A0 (en) | 2010-11-30 |
WO2009045780A3 (en) | 2009-06-04 |
CA2739186C (en) | 2015-12-22 |
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