|Publication number||US20050021005 A1|
|Application number||US 10/700,913|
|Publication date||Jan 27, 2005|
|Filing date||Nov 4, 2003|
|Priority date||Oct 12, 2001|
|Also published as||CA2460738A1, CN1568201A, CN100435862C, EP1441778A1, EP1441778A4, EP1441778B1, US6669669, US20030073952, WO2003033051A1|
|Publication number||10700913, 700913, US 2005/0021005 A1, US 2005/021005 A1, US 20050021005 A1, US 20050021005A1, US 2005021005 A1, US 2005021005A1, US-A1-20050021005, US-A1-2005021005, US2005/0021005A1, US2005/021005A1, US20050021005 A1, US20050021005A1, US2005021005 A1, US2005021005A1|
|Inventors||J. Flaherty, John Garlbotto|
|Original Assignee||Flaherty J. Christopher, Garlbotto John T.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (99), Referenced by (34), Classifications (17), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application is related to U.S. patent application Ser. No. 09/943,992, filed on Aug. 31, 2001, which is assigned to the assignee of the present application and incorporated herein by reference.
The present invention relates generally to medical devices, systems and methods, and more particularly to small, low cost, portable infusion devices and methods that are useable to achieve precise, sophisticated, and programmable flow patterns for the delivery of therapeutic liquids to a mammalian patient.
Today, there are numerous diseases and other physical ailments that are treated by various medicines including pharmaceuticals, nutritional formulas, biologically derived or active agents, hormonal and gene based material and other substances in both solid or liquid form. In the delivery of these medicines, it is often desirable to bypass the digestive system of a mammalian patient to avoid degradation of the active ingredients caused by the catalytic enzymes in the digestive tract and liver. Delivery of a medicine other than by way of the intestines is known as parenteral delivery. Parenteral delivery of various drugs in liquid form is often desired to enhance the effect of the substance being delivered, insuring that the unaltered medicine reaches its intended site at a significant concentration. Also, undesired side effects associated with other routes of delivery, such as systemic toxicity, can potentially be avoided.
Often, a medicine may only be available in a liquid form, or the liquid version may have desirable characteristics that cannot be achieved with solid or pill form. Delivery of liquid medicines may best be accomplished by infusing directly into the cardiovascular system via veins or arteries, into the subcutaneous tissue or directly into organs, tumors, cavities, bones or other site specific locations within the body.
Parenteral delivery of liquid medicines into the body is often accomplished by administering bolus injections using a needle and reservoir, or continuously by gravity driven dispensers or transdermal patch technologies. Bolus injections often imperfectly match the clinical needs of the patient, and usually require larger individual doses than are desired at the specific time they are given. Continuous delivery of medicine through gravity feed systems compromise the patient's mobility and lifestyle, and limit the therapy to simplistic flow rates and profiles. Transdermal patches have special requirements of the medicine being delivered, particularly as it relates to the molecular structure, and similar to gravity feed systems, the control of the drug administration is severely limited.
Ambulatory infusion pumps have been developed for delivering liquid medicaments to a patient. These infusion devices have the ability to offer sophisticated fluid delivery profiles accomplishing bolus requirements, continuous infusion and variable flow rate delivery. These infusion capabilities usually result in better efficacy of the drug and therapy and less toxicity to the patient's system. An example of a use of an ambulatory infusion pump is for the delivery of insulin for the treatment of diabetes mellitus. These pumps can deliver insulin on a continuous basal basis as well as a bolus basis as is disclosed in U.S. Pat. No. 4,498,843 to Schneider et al.
The ambulatory pumps often work with a reservoir to contain the liquid medicine, such as a cartridge or reservoir, and use electro-mechanical pumping or metering technology to deliver the medication to the patient via tubing from the infusion device to a needle that is inserted transcutaneously, or through the skin of the patient. The devices allow control and programming via electromechanical buttons or switches located on the housing of the device, and accessed by the patient or clinician. The devices include visual feedback via text or graphic screens, such as liquid crystal displays known as LCD's, and may include alert or warning lights and audio or vibration signals and alarms. The device can be worn in a harness or pocket or strapped to the body of the patient.
Currently available ambulatory infusion devices are expensive, difficult to program and prepare for infusion, and tend to be bulky, heavy and very fragile. Filling these devices can be difficult and require the patient to carry both the intended medication as well as filling accessories. The devices require specialized care, maintenance, and cleaning to assure proper functionality and safety for their intended long term use. Due to the high cost of existing devices, healthcare providers limit the patient populations approved to use the devices and therapies for which the devices can be used.
Clearly, therefore, there was a need for a programmable and adjustable infusion system that is precise and reliable and can offer clinicians and patients a small, low cost, light weight, simple to use alternative for parenteral delivery of liquid medicines.
In response, the applicant of the present application provided a small, low cost, light weight, easy to use device for delivering liquid medicines to a patient. The device, which is described in detail in co-pending U.S. application Ser. No. 09/943,992, filed on Aug. 31, 2001, includes an exit port, a dispenser for causing fluid from a reservoir to flow to the exit port, a local processor programmed to cause a flow of fluid to the exit port based on flow instructions from a separate, remote control device, and a wireless receiver connected to the local processor for receiving the flow instructions. To reduce the size, complexity and costs of the device, the device is provided with a housing that is free of user input components, such as a keypad, for providing flow instructions to the local processor.
What is still desired are new and improved devices for delivering fluid to a patient. Preferably, the fluid delivery devices will be simple in design, and inexpensive and easy to manufacture, in order to further reduce the size, complexity and costs of the devices, such that the devices lend themselves to being small and disposable in nature.
In response, the present invention provides a device for delivering fluid to a patient, including an exit port assembly adapted to connect to a transcutaneous patient access tool, and a dispenser including at least two laminated layers of material defining a passageway connected to the exit port assembly, and an expandable accumulator in fluid communication with the passageway for controlling fluid flow from a reservoir to the exit port assembly. The laminated construction provides many benefits including, but not limited to, simplifying the design and manufacturing of the device, and further reducing the size, complexity and costs of the device. The device of the present invention, therefore, lends itself to being small and disposable in nature.
According to one aspect of the present invention, at least one layer of the dispenser comprises a resilient diaphragm. According to another aspect, the at least two laminated layers of the dispenser further include a first layer and a second layer received against the first layer. The second and the first layers define the passageway connected to the exit port assembly, and the second layer includes an opening in fluid communication with the passageway. The resilient diaphragm is received on the second layer covering the opening, and a third layer is received over the diaphragm on the second layer. The third layer has an pulse chamber over the diaphragm and in alignment with the opening of the second layer, and a port in fluid communication with the pulse chamber.
According to another aspect, one of the second and the third layers defines a recess receiving the diaphragm, and wherein the recess has a depth about equal to a thickness of the diaphragm such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers. Preferably, a length and a width of the recess are greater than a length and a width of the diaphragm in order to decrease required manufacturing tolerances of the dispenser.
According to an additional embodiment of the present invention, the at least two laminated layers include a first layer, and a second layer received against the first layer. The second and the first layers define the passageway connected to the exit port assembly. The second layer includes a surface facing away from the first layer and having a recess, and an opening providing fluid communication between the recess and the passageway defined by the first and the second layers. The resilient diaphragm is received on the second layer covering the recess to form the expandable accumulator.
According to one aspect, the device includes an actuator for pushing the diaphragm into the recess to reduce the volume of the accumulator. According to another aspect, the actuator comprises a rotatable cam.
According to another embodiment, a third layer is received against the diaphragm and has a bore aligned with the recess of the second layer, and the actuator comprises a piston slidingly received in the bore. According to one aspect, a magnetic coil is received in the third layer coaxial with the piston for biasing the piston against the diaphragm upon being electrified. According to another aspect, the dispenser includes multiple accumulators arranged sequentially with respect to the passageway, and magnetic coils and pistons associated with each accumulator.
According to another embodiment, a third layer is received against the diaphragm and has a bore aligned with the recess of the second layer, and a fourth layer is received against the third layer and has a bore aligned with the bore of the third layer, and a gas generator is received in the bore of the fourth layer for pressurizing the bore and biasing the piston against the diaphragm upon being actuated. According to one aspect, the dispenser includes multiple accumulators arranged sequentially with respect to the passageway, and gas generators and pistons associated with each accumulator.
According to a further embodiment, the dispenser includes a first layer having a surface defining a groove, with the diaphragm positioned against the surface of the first layer such that the diaphragm and the groove define the passageway connected to the exit port assembly. A second layer is received against the diaphragm and includes a recess separated from the passageway by the diaphragm, and the portion of the passageway opposite the recess comprises the expandable accumulator. An actuator is received in the recess of the second layer for pushing the diaphragm towards the first layer upon being actuated to reduce the volume of the accumulator. According to one aspect, the actuator comprises a piece of piezoelectric material arranged to push the diaphragm upon contracting. According to another aspect, the actuator comprises multiple pieces of piezoelectric material arranged sequentially with respect to the passageway within the recess.
Another embodiment includes a first layer received against a second layer, with the layers defining the passageway connected to the exit port assembly, and the second layer including a recess facing the first layer. The dispenser further includes a piston slidingly received in the recess of the second layer, such that the piston and the recess define the expandable accumulator. According to one aspect, a spring biases the piston towards the first layer. According to another aspect, a magnetic coil is received in the second layer coaxial with the piston for biasing the piston towards the first layer upon being electrified.
These aspects of the invention together with additional features and advantages thereof may best be understood by reference to the following detailed descriptions and examples taken in connection with the accompanying illustrated drawings.
Like reference characters designate identical or corresponding components and units throughout the several views.
Referring first to
The local processor 50 is programmed to cause a flow of fluid to the exit port assembly 70 based on flow instructions from a separate, remote control device 100, an example of which is shown in
As shown, the housing 20 is free of user input components for providing flow instructions to the local processor 50, such as electromechanical switches or buttons on an outer surface 21 of the housing, or interfaces otherwise accessible to a user to adjust the programmed flow rate through the local processor 50. The lack of user input components allows the size, complexity and costs of the device 10 to be substantially reduced so that the device 10 lends itself to being small and disposable in nature.
In order to program, adjust the programming of, or otherwise communicate user inputs to the local processor 50, the fluid delivery device 10 includes the wireless communication element, or receiver 60 for receiving the user inputs from the separate, remote control device 100 of
The remote control device 100 has user input components, including an array of electromechanical switches, such as the membrane keypad 120 shown. The control device 100 also includes user output components, including a visual display, such as a liquid crystal display (LCD) 110. Alternatively, the control device can be provided with a touch screen for both user input and output. Although not shown in
The communication element 60 of the device 10 preferably receives electronic communication from the remote control device 100 using radio frequency or other wireless communication standards and protocols. In a preferred embodiment, the communication element 60 is a two-way communication element, including a receiver and a transmitter, for allowing the fluid delivery device 10 to send information back to the remote control device 100. In such an embodiment, the remote control device 100 also includes an integral communication element 60 comprising a receiver and a transmitter, for allowing the remote control device 100 to receive the information sent by the fluid delivery device 10.
The local processor 50 of the device 10 contains all the computer programs and electronic circuitry needed to allow a user to program the desired flow patterns and adjust the program as necessary. Such circuitry can include one or more microprocessors, digital and analog integrated circuits, resistors, capacitors, transistors and other semiconductors and other electronic components known to those skilled in the art. The local processor 50 also includes programming, electronic circuitry and memory to properly activate the dispenser 40 at the needed time intervals.
In the exemplary embodiment of
Although not shown, the device can include sensors or transducers such as a reservoir volume transducer or a reservoir pressure transducer, for transmitting information to the local processor 50 to indicate how and when to activate the dispenser 40, or to indicate other parameters determining flow, pump flowpath prime condition, blockage in flowpath, contact sensors, rotary motion or other motion indicators, as well as conditions such as the reservoir 30 being empty or leaking, or the dispensing of too much or too little fluid from the reservoir, etc.
The volume of the reservoir 30 is chosen to best suit the therapeutic application of the fluid delivery device 10 impacted by such factors as available concentrations of medicinal fluids to be delivered, acceptable times between refills or disposal of the fluid delivery device 10, size constraints and other factors. The reservoir 30 may be prefilled by the device manufacturer or a cooperating drug manufacturer, or may include external filling means, such as a fill port having needle insertion septum or a Luer connector, for example. In addition, the device 10 can be provided with a removable reservoir.
The exit port assembly 70 can include elements to penetrate the skin of the patient, or can be adapted to connect to a standard infusion device that includes transcutaneous delivery means. A needle connection tubing terminating in a skin penetrating cannula (not shown) can be provided as an integral part of the exit port assembly 70, for example, with the skin penetrating cannula comprising a rigid member, such as a needle. Alternatively, the exit port assembly 70 can be provided with a Luer connector for connecting to a standard infusion device including a skin penetrating cannula, such as a rigid needle. In the preferred embodiment, the exit port assembly 70 includes injection means, such as a spring driven mechanism, to assist in penetrating the skin with the skin penetrating cannula. If the cannula is a flexible tube, a rigid penetrator within the lumen of the tube is driven through the skin by the injection means, and withdrawn leaving the soft cannula in place, such as in the subcutaneous tissue of the patient or other internal site. The injection means may be integral to the device 10, or removable soon after transcutaneous penetration. In any event, the exit port assembly 70 can also be provided with a removable plug (not shown) for preventing leakage during storage and shipment if pre-filled, and during priming if filled by user, and prior to use.
The device 10 can also be provided with an adhesive layer on the outer surface of the housing 20 for securing the device 10 directly to the skin of a patient, as shown in
The dispenser 40 is connected in fluid communication with the reservoir 30, as shown in
The dispenser 40 of the exemplary embodiment of
The inlet valve 41 and the outlet valve 42 of the dispenser 40 and the local processor 50 are designed to prevent both valves from being opened at the same time, precluding the reservoir 30 to ever flow directly to the exit port assembly 70. The prevention of both valves opening at the same time is critical and can be accomplished via mechanical means, electrical means, or both. The prevention can be accomplished in the dispenser 40 design, the local processor 50 design, or both.
The dispenser 40 shown in
The PV may not always be constant enough to be within the accuracy requirements of the fluid delivery device 10. One factor impacting the PV is the pressure of the reservoir 30. The fluid delivery device 10 may include means for monitoring reservoir 30 pressure and adjust the timing between pulses to achieve the desire flow pattern. An example of such compensation would be to decrease time between pulses as the reservoir 30 pressure decreases to maintain the programmed flow rate. An alternative to monitoring reservoir 30 pressure is monitoring the volume of the reservoir 30. Each time a pulse or series of pulses are delivered, a measurement of reservoir 30 volume can indicate whether a proper amount of fluid has been delivered, both for individual pulses and cumulative pulses. The system could also be designed to compensate fluid flow as errors are detected.
Referring now to
The dispenser 240 of
In the embodiment of
The laminated construction of the dispenser 240 allows most manufacturing tolerances of the dispenser 240 to be lowered, and the manufacturing process to be simplified, without effecting the performance and reliability of the dispenser 240. High tolerances are required for only the volume of the pulse chamber 245 and the resilience of the diaphragm 244, since those dimensions affect the resulting PV produced by the dispenser 240. Other dimensions and properties of the dispenser 240 can be relatively relaxed to reduce the costs of the dispenser. For example, in the embodiment shown, at least one of the second and the third layers 254, 256 defines a recess 260 receiving the diaphragm 244. The recess 260 has a depth about equal to a thickness of the diaphragm 244 such that the diaphragm is secured in a substantially fluid-tight manner between the second and the third layers 254, 256. However, a length and a width of the recess 260 are greater than a length and a width of the diaphragm 244 in order to decrease the required manufacturing tolerances of the dispenser 240.
Manufacturing the dispenser 240 is preferably a “drop down” process. First the layers 252, 254, 256 are individually formed with the necessary openings, groove, and recesses. The first layer 252 is then laid down and the valves 241, 242 are dropped into recesses (not shown) in the first layer and correctly positioned within the groove 250. Then the second layer 254 is placed on the first layer 252, and the diaphragm 244 is placed in the recess 260 of the second layer. Finally, the third layer 256 is positioned over the diaphragm 244 and the second layer 254. The layers 252, 254, 256 can be made from a suitably strong and rigid material such as plastic or stainless steel, and can be secured together in a suitable manner, such as with adhesives or by welding. The diaphragm 244 can be made from a suitably expandable yet resilient material, such as rubber or a synthetic rubber.
As shown best on
As also shown in
The diaphragm 288 can be provided with consistent properties, such as resilience, throughout, or can include inconsistent properties. For example, the portion 244 of the diaphragm 288 over the reservoir recess 296 can be provided with a greater thickness to increase the resilience of that portion, while the thickness of the diaphragm 288 over the valve seats 291, 292 may be made thinner to decrease the resilience of those portions. In addition, the diaphragm 288 can be made from a material that allows gas to pass through yet prevents liquid from passing through, such that the diaphragm 288 also acts as a bubble removal filter. Furthermore, the diaphragm 288 can be provided with coatings. For example, surfaces of the diaphragm 288 in contact with flow paths can be coated with material that promotes flow and avoids precipitation (such as insulin crystallization). The diaphragm 288 can also be coated with lines of conductive material, for example, to support transmission of electrical signals between the local processor and other components of the device.
As shown in
The layers of resilient fluid-tight material 334 and piezoelectric material 336 are arranged such that upon contracting, the layer of piezoelectric material 336 forces the layer of resilient fluid-tight material 334 into the opening 332 of the passageway 250 and substantially closes the passageway, as shown in
A valve assembly 350 constructed in accordance with the present invention is shown in
The valve assembly 350 includes a valve member 354, springs 356 and a fluid resistant cover 358. The valve member 354 is received in the valve assembly chamber 352 of the third layer 256 and includes a bar 360 extending parallel with the passageway 250 and pivotally mounted on the third layer about a pivot point 364 aligned with the accumulator 243. An inlet valve 361 and an outlet valve 362 extend from the bar 360 into the passageway 250 on opposite sides of the pivot point 364 (and on opposite sides of the accumulator 243). The springs 356 are positioned between the ends of the bar 360 and the third layer 256 to bias each end towards the second layer 254. The fluid resistant cover 358 is received in the recess 351 of the second layer 254 (the recess preferably being oversized with respect to the cover to reduce manufacturing tolerances), and provides a water-tight seal between the passageway 250 and the valve assembly 350.
Although not shown, the valve assembly 350 also includes an actuator for causing the valve member 354 to pivot. The actuator can comprise a rotary motor, a linear motor, a clock spring, and piezoelectric material, for example. Many different types of actuators can be used for causing the valve member 354 to pivot when desired. The pivoting valve assembly 354 provides the benefit of the valves 361, 362 alternatively blocking the passageway 250 at all times, such that unregulated flow to the exit port assembly is not permitted. As shown in
Another valve assembly 370 constructed in accordance with the present invention is shown in
The valve assembly 370 includes a valve member 374 movably received in the bore 372 and including an opening 376, and a spring 378 biasing the valve member such that the opening 376 of the valve member is normally offset from the passageway 250 and the passageway is blocked by the valve member 374. The assembly 370 also includes an actuator 380 for moving the valve member 374 upon being actuated such that the opening 376 of the valve member 374 aligns with the passageway 250 to thereby allow flow through the passageway. In the embodiment shown, the actuator comprises a gas generator 380 for pressurizing the bore 372 upon being actuated. The gas generator 380 is mounted in a plug 382 fitted in the second layer 254 and having a gas release port 384 communicating with the bore 372. As shown in
During operation, the actuated gas generator 380 pressurizes the bore 372 above the valve member 374 and forces the valve member to move against the spring 378, so that the opening 376 aligns with the passageway 250 and opens the passageway. The gas release port 384 allows a predetermined rate of gas to exit the bore 372 in order to limit the total pressure in the bore and allow a controlled decay of pressure. In one embodiment, the valve assembly 370 is positioned near the exit port assembly of a fluid delivery device to limit the useable life of the fluid delivery device. For example, the fluid delivery device can include automatic or manual means for actuating the gas generator 380 upon the device being secured to a patient's skin, and the gas generator can be provided with enough fuel to maintain the valve member 374 open for three days. When the fuel in the gas generator 380 is depleted, the valve member 374 closes and the fluid delivery device must be replaced with a new device. The valve 370 can also be used to pulse fluid as long as the gas generation rate of the gas generator 380 and the gas release rate of the gas release port 384 have time constants slightly smaller than the maximum pulse rate.
Referring now to
A piston 392 is slidingly received in the pulse chamber 245, and a substantially fluid tight seal is provided between the piston and the wall of the pulse chamber. The piston 392 in effect comprises the expandable membrane of the accumulator 243. The third layer 256 is received on the second layer 254 and closes the pulse chamber 245, and springs 394 are positioned between the third layer and the piston 392 and bias the piston away from the third layer. During operation, the outlet valve 242 is closed and the inlet valve 241 is opened to allow pressurized fluid from the reservoir to move the piston 392 against the springs 392 and into the pulse chamber 245 to expand the accumulator 243 by the predetermined pulse volume. Then the inlet valve 241 is closed and the outlet valve 242 is opened such that the biased piston 392 can force the pulse volume of liquid to the exit port assembly.
The second and the first layers 252, 254 of the dispenser 400 define the passageway 250 connected between the reservoir and the exit port assembly, and the second layer 254 defines a bore 408 communicating with the passageway 250. A piston 410 is slidingly received in the bore 408 and acts as the expandable membrane of the accumulator 404. The dispenser 400 also includes an actuator 412 for moving the piston 410 in the bore 408 to draw fluid from the reservoir through the inlet valve 402 (the one-way outlet valve 406 prevents fluid from being draw though the outlet valve 406) and expel liquid through the outlet valve 406 to the exit port assembly (the one-way inlet valve 402 prevents fluid from being expelled though the inlet valve 402).
In the embodiment show, the actuator comprises a magnetic coil 412 received in an annular groove provided in the second layer 254, coaxial with the piston 410, which is made from magnetic material. A plug 414 seals the piston 410 and the coil 412 in the second layer 254, such that the portion of the bore 408 between the piston 410 and the plug 414 comprises the pulse chamber of the accumulator 404. The dispenser 400 includes a coiled compression spring 416 positioned between the plug 414 and the piston 410 biasing the piston towards the passageway 250. The coil 412 is arranged to bias the piston 410 against the spring 416 upon being energized.
During operation of the dispenser 400, the coil 412 is energized such that movement of the piston 410 expands the accumulator 404, and draws fluid from the reservoir, through the one-way inlet valve 402 and into the bore 408, as shown in
The accumulator 424 includes a pulse chamber 426 formed in a surface of the second layer 254 facing away from the first layer 252, and an opening 428 providing fluid communication between the pulse chamber 426 and the passageway 250. A resilient diaphragm 430 is received on the second layer 254 and covering the pulse chamber 426 in a fluid-tight manner.
The dispenser 420 also includes an actuator 432 for pushing the diaphragm 430 into the pulse chamber 426 to reduce the volume of the accumulator 424 and produce a pulse volume. In the embodiment shown, the actuator comprises a rotatable cam 432 and a motor (not shown) or other rotational device for rotating the cam. During operation, the cam 432 is rotated away from the diaphragm 430 such that the diaphragm expands the accumulator 424, and draws fluid from the reservoir, through the inlet valve 402 and into the pulse chamber 426, as shown in
The second and the first layers 252, 254 of the dispenser 440 define the passageway 250 connected between the reservoir and the exit port assembly. The resilient diaphragm 444 is positioned between the second layer 254 and the third layer 256 in a liquid-tight manner. For each accumulator 442, the second layer 254 defines a pulse chamber 446 communicating with the passageway 250, and the third layer 256 defines a bore 448 aligned with the pulse chamber.
The dispenser 440 also includes actuators for compressing the pulse chambers 446 and expelling pulse volumes of liquid towards the exit port assembly. In the embodiment shown, the actuators comprise pistons 450 made from magnetic material and slidingly received in the bores 448, and magnetic coils 452 received in annular grooves provided in the third layer 256, coaxial with the pistons 450. Each coil 452 is arranged such that, upon being energized, the coil 452 forces the piston 450 against the diaphragm 444 to collapse the pulse chamber 446 and expel a pulse volume of fluid from the accumulator 442 into the passageway 250. Upon being de-energized, the coil 452 releases the piston 450 and allows the diaphragm 444 to push the piston back, and draw a pulse volume of fluid into the pulse chamber 446. During operation of the dispenser 440, the coils 452 are successively energized and de-energized so that fluid is drawn from the reservoir, expelled and drawn successively into the accumulators 442, and expelled to the exit port assembly. Preferably, at least one of the pistons 450 is always in a closed position to occlude the fluid path and prevent the free flow of fluid through the passageway to the exit port assembly. In an alternative embodiment, the pistons 450 can be biased closed, with a spring, and the coils 452 arranged to pull the pistons away from the passageway when energized.
The dispenser 470 includes a first layer 252 having a recess 476, with a diaphragm 474 positioned against the surface of the first layer 252. The second layer 254 is received against the diaphragm 474 and includes a surface defining a groove, such that the diaphragm and the groove define the passageway 250 connecting the reservoir to the exit port assembly.
Each accumulator 472 includes an actuator 478. The actuators 478 are successively positioned with respect to the passageway 250 within the recess 476 of the first layer 252. The actuators 478 are arranged to push the diaphragm 474 towards the second layer 254 upon being actuated. The portion of the recess 476 above the diaphragm 474 comprises the pulse chambers of the accumulators 472.
In the embodiment shown, the actuators comprise segments of piezoelectric material 478. Each segment 478 is mounted and arranged such that, when de-energized, the segment 478 normally assumes a curved geometry to push the diaphragm 474 towards the second layer, and when energized, deforms to a straight geometry to allow the diaphragm to return to its original position. In the preferred embodiment all of the piezoelectric elements 478 are normally in a curved state when de-energized, to occlude the passageway 250 and prevent the free flow of fluid through the passageway to the exit port assembly.
Referring now to
In the specific embodiment shown, the priming mechanism 500 includes a pivotally movable first link 508 operatively connected to the inlet valve 502 such that the inlet valve is opened upon pivoting movement of the first link 508. A pivotally movable second link 510 is operatively connected to the outlet valve 504 such that the outlet valve is opened upon pivoting movement of the second link. The priming mechanism 500 also includes a movable priming rod 516 operatively connected to the first and the second links 508, 510 for pivoting the links upon movement of the rod 516.
As shown, the inlet and the outlet valves 502, 504 each include a valve member 512, 514 movable between open and closed positions. The first link 508 extends between the first valve member 512 and the priming rod 516 and is pivotally movable about a pivot point 518 of the first link located between the valve member 512 and the priming rod. The second link 510 extends between the second valve member 514 and the priming rod 516 and is pivotally movable about a pivot point 520 of the second link located between the valve member 514 and the priming rod. The priming rod 516 is linearly movable to pivot the links 508, 510 and open the valve members 512, 514. The priming rod 516 extends out of the housing 20 of the fluid delivery device, and is depressed into the housing 20 by a user to open the valves 502, 504 prior to filling the reservoir 30 through fill port 522. One-way valves, such as duckbill valves 524, are positioned within the fill port 522 and a passageway 526 of the dispenser 506.
Referring to FIGS. 24 to 26, the present invention also provides fluid delivery devices 10 having automatic priming systems 600, 610, 620. Each device 10 is provided with an exit port assembly comprising an integrated transcutaneous patient access tool 670 having a known internal volume. In the particular embodiments shown, the patient access tool is a needle 670. Because the volume to the tip of the needle 670 is known, the local processor 50 of the device 10 can be programmed to prime the needle 670 automatically.
In the preferred embodiment of
The fluid delivery device 610 of
The device 620 of
Referring now to
Due to issues of infection and contamination, it may be desirable to limit the fluid delivery device of the present invention to a single use. Referring to
In the embodiment of
The multiple, independently deployable needles 974 beneficially extend the useful life of the fluid delivery device 900. According to standards set by the Center for Disease Control (CDC), a single needle, such as an infusion needle or intravenous needle, should not remain deployed in a patient for more than three days, to minimize the chances for infection at the injection site through the skin of the patient. The present invention, therefore, increases the useable life of a single fluid delivery device 900 by providing the device with multiple, independently deployable needles 974. If the device is provided with three retractable needles 974, and each needle is used for the maximum allowable period of three days in accordance to CDC standards, for example, the life of the device 900 can be extended to nine days. The embodiment 900 of
Referring to the specific embodiment 900 as shown in
Although exemplary embodiments of the invention have been shown and described, many changes, modifications and substitutions may be made by those having ordinary skill in the art without necessarily departing from the spirit and scope of this invention.
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|International Classification||A61K9/22, A61M5/142, A61M5/168, A61M5/14|
|Cooperative Classification||A61M39/281, Y10S128/12, A61M5/14248, A61M5/16809, A61M2005/1405, A61M2205/3569, A61M5/16854, A61M5/14224, A61M2205/35, A61M2005/1403, A61M5/16813|
|Nov 4, 2003||AS||Assignment|
Owner name: INSULET CORPORATION, MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:FLAHERTY, J. CHRISTOPHER;GARIBOTTO, JOHN T.;REEL/FRAME:014685/0721
Effective date: 20020116