US20050171512A1 - Devices, systems and methods for patient infusion - Google Patents

Abstract

A method for transcutaneously delivering fluid to a patient including providing at least one disposable infusion pump, wherein the pump includes a housing adapted to be mounted on a patient's skin, a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient, a reservoir prefilled with a therapeutic fluid, a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool, a processor connected to the dispenser and programmed to cause a flow of fluid from the reservoir to the transcutaneous patient access tool based on flow instructions, and a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation of U.S. patent application Ser. No. 10/695,547, filed Oct. 28, 2003, which is a continuation of U.S. patent application Ser. No. 09/943,992, filed Aug. 31, 2001, now U.S. Pat. No. 6,740,059, which claims priority to provisional U.S. patent application Ser. No. 60/231,476, filed on Sep. 8, 2000. All of these applications are assigned to the assignee of the present application and incorporated herein by reference.
FIELD OF THE DISCLOSURE
• The present disclosure 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 patient.
BACKGROUND OF THE DISCLOSURE
• Today, there are many 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 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 by parenteral delivery. Parenteral 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 is often accomplished by administering bolus injections using a needle and syringe, 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.
• The ambulatory pumps often work with a reservoir to contain the liquid medicine, such as a cartridge or syringe, and use electromechanical 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 (LCD), and may include alert or warning lights and audio or vibration signals and alarms. The devices can be worn in a harness or a 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 or their reservoirs can be difficult and require the patient to carry both the intended medication as well as filling accessories when traveling or even just going to work. The accuracy and safety requirements of these devices are extremely important, based both on the medicine being delivered and the condition of the patient. Therefore, the devices require specialized care, maintenance and cleaning to assure proper functionality and safety for their intended long term use.
• Clearly, therefore, there is 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.
SUMMARY OF THE DISCLOSURE
• The applicant has determined that a sophisticated ambulatory infusion device that can be programmed to reliably deliver variable flow profiles of liquid medications, yet is small, light weight and low cost, is needed. Smaller and lighter devices are easier to carry and are more comfortable for the patient, even allowing the device to be adhesively attached to the patient's skin similar to a transdermal patch. An inexpensive device allows greater flexibility in prescribing the device for use by reducing the financial burden on healthcare insurance providers, hospitals and patient care centers, as well as patients themselves. In addition, low cost devices make more practical the maintenance of one or more replacement devices. If the primary device is lost or becomes dysfunctional, availability of the replacement avoids costly expedited repair and down time.
• Aspects of the present disclosure will enable cost reductions significant enough to make the entire device disposable in nature, being replaced as frequently as every two to five days. A disposable device allows the medication to be prefilled by the manufacturer and does not need the routine cleaning and maintenance required by long term devices, greatly simplifying use for the patient.
• The present disclosure, therefore, provides a method for transcutaneously delivering fluid to a patient, which includes providing at least one disposable infusion pump. The disposable infusion pump is provided with a housing adapted to be mounted on a patient's skin, a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient, a reservoir prefilled with a therapeutic fluid, and a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool. The disposable infusion pump is also provided with a processor connected to the dispenser and programmed to cause a flow of fluid from the reservoir to the transcutaneous patient access tool based on flow instructions, and a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor.
• The method further includes placing the disposable infusion pump on a patient's skin, receiving flow instructions from a remote controller through the wireless receiver of the infusion pump, and delivering the flow instructions to the processor of the infusion pump, so that the processor causes fluid from the reservoir to flow to the transcutaneous patient access tool based on the flow instructions.
• According to one aspect of the present disclosure, the methods also includes the step of remotely supplying flow instructions to each of the disposable infusion pumps through a reusable remote control device.
• These aspects of the disclosure 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.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a sectional side view of a first exemplary embodiment of a fluid delivery device in accordance with this disclosure;
• FIG. 2 is a perspective view of an exemplary embodiment of a remote control device in accordance with this disclosure for use with the fluid delivery device ofFIG. 1;
• FIG. 3 is a sectional side view of a second exemplary embodiment of a fluid delivery device in accordance with this disclosure;
• FIG. 3ais an enlarged partial sectional view of a dispenser for the device ofFIG. 3, shown with an accumulator empty and ready to be filled upon an inlet valve being opened;
• FIG. 3bis an enlarged sectional view of the dispenser for the device ofFIG. 3, shown with the accumulator filled and ready to dispense a pulse of fluid upon an outlet valve being opened;
• FIG. 4 is a sectional side view of a third exemplary embodiment of a fluid delivery device in accordance with this disclosure;
• FIG. 4ais an enlarged sectional side view of a reservoir chamber of the device ofFIG. 4;
• FIG. 4bis an enlarged bottom plan view of a portion of the reservoir chamber of the device ofFIG. 4;
• FIG. 5 is a sectional side view of a fourth exemplary embodiment of a fluid delivery device in accordance with this disclosure;
• FIG. 5ais a bottom plan view of the device ofFIG. 5;
• FIG. 6 is a sectional side view of a fifth exemplary embodiment of a fluid delivery device shown positioned on an outer surface of skin and subcutaneous tissue of a patient;
• FIG. 6ais a bottom plan view of the device ofFIG. 6;
• FIG. 7 is a sectional side view of a sixth exemplary embodiment of a fluid delivery device in accordance with the present disclosure;
• FIG. 8 is a sectional side view of a seventh exemplary embodiment of a fluid delivery device in accordance with the present disclosure;
• FIG. 8ais a top plan view of the device ofFIG. 8;
• FIG. 9 is a sectional side view of an eighth exemplary embodiment of a fluid delivery device in accordance with the present disclosure;
• FIG. 9ais a perspective view of an infusion set compatible with an outlet assembly of the device ofFIG. 9;
• FIG. 10 is a sectional side view of a ninth exemplary embodiment of a fluid delivery device in accordance with the present disclosure, with a mechanical stop button of the device shown in the open position;
• FIG. 10ais an enlarged sectional view of the stop button assembly of the device ofFIG. 10 with the button shown in the closed position;
• FIG. 11 is a sectional side view of a tenth exemplary embodiment of a fluid delivery device in accordance with the present disclosure;
• FIG. 11ais an enlarged sectional view of a bolus button assembly of the device ofFIG. 11;
• FIG. 12 is a perspective view of another exemplary embodiment of a remote control device in accordance with the present disclosure;
• FIG. 12ais a sectional side view of the remote control device ofFIG. 12;
• FIG. 13 is a top plan view of an eleventh exemplary embodiment of a fluid delivery device in accordance with the present disclosure;
• FIG. 13ais a top plan view of a remote controller to be combined with the fluid delivery device ofFIG. 13 as part of a kit in accordance with the present disclosure;
• FIG. 13bis a top plan view of an insulin cartridge to be combined with the fluid delivery device ofFIG. 13 as part of a kit in accordance with the present disclosure; and
• FIG. 13cis a top plan view of a sterile infusion set to be combined with the fluid delivery device ofFIG. 13 as part of a kit in accordance with the present disclosure.
• Like reference characters designate identical or corresponding components and units throughout the several views.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
• Set forth hereinbelow are detailed descriptions of exemplary embodiments of fluid delivery devices, systems and kits, constructed in accordance with the present disclosure, as well as methods for using the devices, systems and kits. The types of liquids that can be delivered by the fluid delivery devices, systems and kits of the present disclosure include, but are not limited to, insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics. The types of medical conditions that the fluid delivery devices, systems and kits of the present disclosure might be used to treat include diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer's Disease, ALS, Hepatitis, Parkinson's Disease or spasticity.
• InFIG. 1, there is illustrated, generally at10, a fluid delivery device according to the present disclosure. Thedevice10 generally includes anexit port assembly70 adapted to connect to a transcutaneous patient access tool, adispenser40 for causing fluid from areservoir30 to flow to the exit port assembly, a processor or electronic microcontroller (hereinafter referred to as the “local” processor)50 connected to the dispenser and programmed to cause a flow of fluid to the exit port assembly based on flow instructions from a separate, remote control device (an example of which is shown inFIG. 2), and awireless receiver60 connected to the local processor for receiving the flow instructions from the separate, remote control device and delivering the flow instructions to the local processor. The device also includes ahousing20 containing theexit port assembly70, thedispenser40, thelocal processor50, and thewireless receiver60. Thehousing20 is free of user input components, such as external buttons connected to theprocessor50, for providing flow instructions to thelocal processor50 in order to reduce the size, complexity and costs of thedevice10, such that the device lends itself to being small and disposable in nature.
• In the exemplary embodiment ofFIG. 1, thedevice10 also includes areservoir30 contained within thehousing20 and connected to thedispenser40. Thereservoir30 is provided with a collapsible design such as a metal bellows or is made of a collapsible material such as a silicone elastomer. The volume of thereservoir30 is chosen to best suit the therapeutic application of thefluid delivery device10 impacted by such factors as available concentrations of medicinal fluids to be delivered, acceptable times between refills or disposal of thefluid delivery device10, size constraints and other factors. For treatment of Type I diabetics, for example, a reservoir of less than 5 ml, and preferably 2 to 3 ml, is appropriate.
• Thelocal processor50 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. Thelocal processor50 also includes programming, electronic circuitry and memory to properly activate the dispenser at the needed time intervals. In the exemplary embodiment ofFIG. 1, apower supply80, such as a battery or capacitor, is included and supplies power to thelocal processor50.
• When thelocal processor50 activates thedispenser40, a specific amount of fluid exits thefluid delivery device10 via theexit port assembly70. Theexit port assembly70 can include elements to transcutaneously enter the patient, such as a needle or soft cannula, or can be adapted to connect to a standard infusion device that includes transcutaneous delivery means.
• As shown, thehousing20 is free of user input components for providing flow instructions to thelocal processor50, such as electromechanical switches or buttons on anouter surface21 of the housing, or interfaces otherwise accessible to a user to adjust the programmed flow rate through thelocal processor50. In order to program, adjust the programming of, or otherwise communicate user inputs to thelocal processor50, thefluid delivery device10 includes the wireless communication element, orreceiver60 for receiving the user inputs from a separate, remote control device, such as the separate,remote control device100 ofFIG. 2. Signals can be sent via a communication element (not shown) of theremote control device100, which can include or be connected to anantenna130, shown inFIG. 2 as being external to thedevice100.
• Theremote control device100 has user input components, including an array of electromechanical switches, such as themembrane keypad120 shown. Thecontrol device100 also includes user output components, including a visual display, such as a liquid crystal display (LCD)110. Although not shown inFIG. 2, theremote control device100 has its own processor (hereinafter referred to as the “remote” processor) connected to themembrane keypad120 and the LCD I10. The remote processor is programmed to receive the user inputs from themembrane keypad120 and translate the user inputs into “flow” instructions for transmission to thefluid delivery device10, and is programmed to send user outputs to the LCD I10.
• A user, such as a patient or a clinician, can thus program thefluid delivery device10 by entering information into theremote control device100, which then downloads information to thereceiver60 of thedevice10 with each key stroke or button pressed or in a batch mode of multiple key strokes. Complex flow algorithms, requests for bolus delivery and other desired infusions of the medicinal fluid can be accomplished by entering information into theremote control device100, which is then transmitted to thefluid delivery device10. The communication can be confirmed as acceptable by thelocal processor50 of thefluid delivery device10 by using one or more features such as standard handshaking protocols, redundant transmissions and other communication confirmation methods, as are known to those skilled in the art.
• The lack of user interfaces, such as electromechanical switches on thefluid delivery device10, results in substantial reductions in the cost, the size, and the weight of thedevice10. The lack of user interfaces also allows the housingouter surface21 of thedevice10 to be relatively smooth, thereby simplifying cleaning and preventing jewelry or clothing items such as sweaters from catching on the device. Since theremote control device100 also includes avisual display110, thefluid delivery device10 can be void of an information screen, further reducing cost, size and weight. Lack of user interfaces, such as electromechanical switches and information screens, greatly simplifies the design of thefluid delivery device10 and allows thedevice10 to be made more flexible and resistant to damage.
• FIG. 3 shows another exemplary embodiment of thefluid delivery device10 of the present disclosure wherein thereservoir30 is made of a flexible material and is enclosed in areservoir chamber35, which can be defined by thehousing20 andhousing reservoir walls27. Theflexible reservoir30 is placed in compression by a compressingmember33 and compressing springs34, which are positioned between the compressingmember33 and thehousing20. The compressed,flexible reservoir30 causes fluid inside thereservoir30 to be at a pressure above atmospheric pressure. In a preferred embodiment, a cross sectional area of the compressingmember33 approximates a cross sectional area of thereservoir30.
• Alternatively, thehousing20 may include a flexible cantilever beam that contacts thereservoir30 creating a pressure within thereservoir30 above atmospheric pressure. In another alternative, thereservoir chamber35 may be sealed and filled with a gas, or a vapor-plus-fluid mixture, to place the fluid within thereservoir30 under pressure above atmospheric pressure. The gas can be air, and the vapor-plus-fluid mixture can be Freon. The Freon vapor-plus-fluid mixture provides the design advantage of near constant pressure if thefluid delivery device10 is maintained at near constant temperature. In still another alternative embodiment, the amount of gas placed in a sealedreservoir chamber35 may be chosen such that thereservoir30 pressure is equal to or less than atmospheric for the entire full to empty conditions of thereservoir30. If the fluid in thereservoir30 is maintained at a pressure equal to or below atmospheric, then thedispenser40 is provided in the form of a pump, such as a peristaltic drive pump, for pumping fluid from thereservoir30 to theoutlet port assembly70.
• Thereservoir30 may be prefilled by the device manufacturer or a cooperating drug manufacturer, or may include external filling means consisting of afill assembly31. If thefluid delivery device10 is prefilled by the manufacturer, thelocal processor50 can be provided with memory containing various information regarding the prefilled drug including but not limited to, the type or name and the concentration and volume of the fluid.
• Thefill assembly31 can include aneedle insertion septum32. Thereservoir30 and other fluid path components may be placed in a vacuum during the final manufacturing process to simplify filling and priming of thefluid delivery device10 for the patient.Needle insertion septum32 may be constructed of a resealing elastomer such as silicone that allows a needle to puncture septum to add fluid to thereservoir30, yet reseal after the needle is withdrawn. An alternative to theneedle insertion septum32 is a standard fluid connection, such as a Luer connector, which can be affixed to thefill assembly31 in combination with a one way valve such as a duck bill valve (not shown). The patient could attach a syringe filled with the liquid medication to the Luer connector and fill thefluid delivery device10. Thefill assembly31 may be designed so that the patient can fill thefluid delivery device10 one time only, such as by having the Luer connection break off when the syringe is removed.
• Thedispenser40 is connected in fluid communication with thereservoir30. When thedevice10 is provided with apressurized reservoir30, as shown in exemplary embodiment ofFIG. 3, the dispenser can include aninlet valve41 connected to the reservoir, andoutlet valve42 connected to theexit port assembly70, and anaccumulator43 connected between the inlet valve and the outlet valve. Since the fluid in thereservoir30 is maintained at a pressure above atmospheric pressure, opening of theinlet valve41 allows the accumulator to fill to the reservoir pressure, after which the inlet valve is41 is closed. At the proper time, as determined by thelocal processor50 programming and instructions received from the remote control device, theoutlet valve42 can be opened to dispense fluid to theexit port assembly70, which is at the pressure of the patient, or atmospheric pressure. Theaccumulator43 will then be at atmospheric pressure, and theoutlet valve42 can be closed, ready for another repeat cycle.
• Thedispenser40 of the exemplary embodiment ofFIG. 3 does not create a driving or pumping force on the fluid passing therethrough, but rather acts as a metering device, allowing pulses of fluid to pass from thepressurized reservoir30, through thedispenser40, to theexit port assembly70 at atmospheric pressure. Theinlet valve41 and theoutlet valve42 of thedispenser40 are controlled by thelocal processor50, which includes electronic programming, controls and circuitry to allow sophisticated fluid delivery programming and control of thedispenser40.
• FIG. 3ashows thedispenser40 with theaccumulator43 at atmospheric pressure. Anaccumulator membrane44 is shown in its non-distended state, caused by atmospheric pressure only.Inlet valve41 is closed, andoutlet valve42 may be open or closed, but must have been opened since the lasttime inlet valve41 was opened.FIG. 3bshows the condition whereoutlet valve42 is closed, andinlet valve41 has been opened. Because of the elevated pressure of the fluid from thereservoir30, theaccumulator membrane44 is distended, thus increasing the volume ofaccumulator43 by anaccumulator volume45. After theinlet valve41 is closed, theoutlet valve42 can be opened, to dispense theaccumulator volume45 and allow theaccumulator membrane44 to retract to the position shown inFIG. 3a.
• Theinlet valve41 and theoutlet valve42 of thedispenser40 and thelocal processor50 are designed to prevent both valves from being opened at the same time, precluding thereservoir30 to ever flow directly to theexit port assembly70. 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 thedispenser40 design, thelocal processor50 design, or both.
• Thedispenser40 shown inFIGS. 3, 3aand3bdispenses finite pulses of fluid volume, called pulse volume (PV), with each activation. The PV is determined by the properties, materials and construction of theaccumulator43 and theaccumulator membrane44. PV's delivered by infusion devices are typically chosen to be small relative to what would be considered a clinically significant volume. For insulin applications at a concentration of 100 units per ml, a PV of less than 2 microliter, and typically 0.5 microliter, is appropriate. If thefluid delivery device10 is programmed via theremote control device100 to deliver2 units an hour, the dispenser will deliver40 pulses an hour, or a pulse every 1.5 minutes. Such pulsitile flow is considered continuous if the PV is small enough. Other drugs or concentrations may permit a much larger PV. Various flow rates are achieved by adjusting the time between pulses. To give a fixed volume or bolus, multiple pulses are given in rapid succession until the bolus volume is reached.
• The PV may not always be constant enough to be within the accuracy requirements of thefluid delivery device10. One factor impacting the PV is reservoir pressure. Thefluid delivery device10 may include means for monitoring reservoir pressure (RP) 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 PV decreases to maintain the programmed flow rate. Means for monitoring such parameters as reservoir pressure RP are described below. An alternative to monitoring reservoir pressure is monitoring the volume of thereservoir30. Each time a pulse or series of pulses are delivered, a measurement of reservoir 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. An example of a reservoir volume transducer means is also described below.
• Thecommunication element60 preferably receives electronic communication from theremote control device100 using radio frequency or other wireless communication standards and protocols. The information transferred includes codes or packets of codes that thelocal processor50 uses to confirm that the information was received correctly, similar to the way standard telephone modem communication is performed. More sophisticated codes can be included to allow the information to be self-corrected or pinpoint the area of bad information. In an even more preferred embodiment, thecommunication element60 is a two-way communication element, including a receiver and a transmitter, for allowing thefluid delivery device10 to send information back to theremote control device100. In such an embodiment, theremote control device100 also includes anintegral communication element60 comprising a receiver and a transmitter, for allowing theremote control device100 to receive the information sent by thefluid delivery device10.
• Thepower supply80 can be integrated into thefluid delivery device10 and not accessible to a user. In an alternative embodiment, however, thepower supply80 can be replaceable, e.g., a replaceable battery. In another embodiment, thepower supply80 can comprise an integrated battery or capacitor, for low power components of thedevice10 such as the electronic memory, and a user-inserted battery for powering the remainder of thedevice10. Other components that may require electrical energy are thecommunication element60, thedispenser40, and other components such as sensors or transducers.
• As shown inFIG. 3, the device can include sensors or transducers such as areservoir volume transducer37. A similar transducer is described in U.S. Pat. No. 5,533,389 to Kamen et al.FIG. 3 also shows apressure transducer221, located on thehousing reservoir walls27 and in contact with a portion of thereservoir30. Thepressure transducer221 may consist of force sensing resistor technology such as that manufactured by Interlink, Inc. of Camarillo, Calif.Reservoir transducer37 orpressure transducer221 can transmit information tolocal processor50 to indicate how and when to activate thedispenser40, or to indicate other parameters determining flow, as well as conditions such as thereservoir30 being empty or leaking, or the dispensing of too much or too little fluid from the reservoir, etc.
• FIG. 4 shows another exemplary embodiment of thefluid delivery device10 including anelastic sock36 for compressing thereservoir30 to a pressure above atmospheric pressure. Thereservoir sock36, constructed of an elastic material, has a very small unexpanded internal volume, no larger than the volume ofreservoir30 in its empty state. Thereservoir sock36 expands to supportreservoir30 when full, and elastically compresses untilreservoir30 is fully empty. Alternatively, theelastic reservoir30 can be provided with a very small internal volume when empty, typically less than 100 microliters, and that expands during the fill process, creating a pressure within the reservoir greater than atmospheric pressure until thereservoir30 is again empty, thereby obviating the need for thereservoir sock36. Thefluid delivery device10 ofFIG. 4 also includes aLuer connector71 for attaching a standard transcutaneous fluid delivery set to theexit port assembly70.
• Since thefluid delivery device10 may be worn close to or even attached to the body of a mammalian patient, it may be desired to prevent the temperature of the fluid in thereservoir30 from elevating toward the body temperature of the patient. In one embodiment, thereservoir chamber35 can be sealed and placed in a vacuum, similar to construction of a thermos bottle. The internal surface of thereservoir chamber35 can be coated with reflective material, also similar to a thermos bottle. Alternatively, thechamber35 can be filled with insulating material such as a low thermal conductance foam, with sufficient cavity size to allow thereservoir30 to expand to a maximum fill capacity. Shown inFIGS. 4aand4bare ventingholes38, placed through thehousing20 and housingouter surface21 in the area ofreservoir chamber35 on the side of thedevice10 away from the skin of the patient. The venting holes38 allow thereservoir chamber35 to vent to ambient temperature and thus help cool thereservoir30.
• FIG. 5 shows another exemplary embodiment of thefluid delivery device10 that includes asecond reservoir90 in fluid communication with asecond dispenser91. Theadditional reservoir90 can be filled during the manufacturing process or can include filling means similar to thefill assembly31. Theadditional dispenser91 may include a separate controller, or can be controlled by the samelocal processor50. Theadditional dispenser91 connects distally totubing lumen74 extending between themain dispenser40 and theexit port assembly70. Similar to themain dispenser40, theadditional dispenser91 is designed and controlled to prevent free flow of fluid from theadditional reservoir90 to theexit port assembly70.
• Thesecond reservoir90 may be filled with a drug different from the drug in themain reservoir30, a diluent of the drug in themain reservoir30 or any inert substance. The fluid from theadditional reservoir90 may be administered to dilute the fluid dispensed from themain reservoir30, to provide more sophisticated or additive therapies, or even to maintain patency of the transcutaneous fluid path by flowing an inert substance at a more frequent rate then the intended infusion of the fluid in themain reservoir30.
• Referring also toFIG. 5a,the device also includes a transcutaneous patient access tool comprisingtranscutaneous micropenetrators75 connected to theexit port assembly70. Thetranscutaneous micropenetrators75 include a series of micro-needles or other micropenetrators that allow fluid to transcutaneously enter the body of the patient without standard needles. Similar transcutaneous micropenetrators are shown, for example, in U.S. Pat. No. 5,983,136 to Kamen et al.
• Thedevice10 further includes anadhesive layer201 on theouter surface21 of thehousing20 for securing thedevice10 directly to the skin of a patient. The adhesive layer is preferably provided in a continuous, oval shape encircling theexit port assembly70 in order to provide a protective seal around the penetrated skin. Thehousing adhesive layer201 can consist of material such as that used in bandages or electro surgery return pads such as those manufactured by the Valley Lab division of Tyco/U.S. Surgical.
• FIGS. 6 and 6ashow another exemplary embodiment of thefluid delivery device10 including ahousing200 having a recessedsurface29 for creating an air pocket between thefluid delivery device10 and theskin210 of a patient. Thedevice10 also includes a secondaryadhesive layer202 attached to the firstadhesive layer201, which is attached to the bottom surface of thehousing200 surrounding the recessedsurface29. The secondaryadhesive layer202 allows thedevice10 to be attached, removed and attached again to a patient. When first attached, the secondaryadhesive layer202 adheres to theskin210. Upon removal of thedevice10, the secondaryadhesive layer202 can be removed from the firstadhesive layer201, and thefluid delivery device10 can then be reattached to theskin210 using theadhesive layer201.
• Aneedle connection tubing73 terminating in askin penetrating cannula72 is shown connected to theexit port assembly70. Theneedle connection tubing73 is flexible, allows various placements and can be reinforced to prevent kinking. Reinforcement can be accomplished through choice of materials and ratio of wall thickness to inner diameter, or thetubing73 can be reinforced with an internal wire coil. Theskin penetrating cannula72 can be a rigid member, such as a needle, or can be flexible. Theskin penetrating cannula72 is inserted through theskin210 prior to attaching thefluid delivery device10 to theskin210 and may be inserted using a needle insertion assistance mechanism. Such a needle insertion assistance mechanism may be integrated into thefluid delivery device10, or can be supplied as a separate mechanism.FIG. 6 shows thecannula72 entering through the surface of theskin210 and enteringsubcutaneous tissue211. Once thefluid delivery device10 is attached to theskin210, theneedle connecting tube73 remains relatively stable due to the direct connection between thedevice10 and theskin210. This stability helps prevent kinking of thetubing73 and resultant occlusion, which is common to other ambulatory devices.
• FIG. 7 shows another exemplary embodiment of thefluid delivery device10 including sensors providing feedback to thelocal processor50, an electronic assembly for the various electronic devices and an optionalsecond power supply83. The sensors include avolume sensor222, for example, provided in proximity with thereservoir30 and anocclusion sensor220 in proximity with the exitport tubing lumen74.
• Themicrocontroller50 can include amicroprocessor51,memory52, anelectronic clock oscillator53, an analog-to-digital converter54 and amultiplexer55. Also shown inFIG. 7 is the optionalsecondary power source83, attached by the user to abattery connector81 connected to themicrocontroller50. Abattery door82 is removed for insertion of thebattery83 and then reattached by sliding the door in direction D1 to thehousing20 of thefluid delivery device10. In a preferred embodiment, thepower supply80 provides electrical power for memory retention and low power electronics only, while thesecondary power source83 provides electrical power for higher consumption components of thedevice10, such as thedispenser40. Both thepower supply80 and thesecondary power source83 may be consumer batteries, such as alkaline or nickel cadmium batteries, or other energy storage devices such as a capacitor. Additionally, both thepower supply80 and thesecondary power source83 may be rechargeable power sources.
• FIG. 8 shows another exemplary embodiment of thefluid delivery device10 including anelectronic module300 including thelocal processor50 and other electronic devices in a modular subassembly, which simplifies manufacture, provides protection from water or other fluid damage, and provides shielding and protection from electromagnetic interference and static discharge. Attached to theelectronic module300 and connected to thecommunication element60 is anoptional antenna61 to enhance transmitting of signals from thefluid delivery device10 via thecommunication element60. Alternatively,antenna61 may be integrated intoelectronic module300.
• The device ofFIG. 8 includes analarm transducer223, such as a beeper or vibration device, which is also integrated into theelectronic module300. Theelectronic module300 is shown encapsulated by anelectronic module housing301, which is a portion of thehousing20. Theelectronic module housing301 can easily be made to be waterproof, potentially by encapsulating the entire assembly in potting material, and can be protected with shielding material or coating for theelectronic module300 to resist electromagnetic interference and electrostatic discharge without having to encapsulate the entire internal portion of thefluid delivery device10. Alternatively, thehousing20, in the portion surrounding theelectronic module300 can be shielded or made waterproof, potentially by using a gasket material. Theoptional antenna61, which can be included internal or external to the shielding material, is shown as external. Theelectronic module300 may include a microprocessor, logic circuitry, read only memory, writeable memory, random access memory, analog to digital conversion circuitry, a multiplexer, thepower supply80, resistors, capacitors, semiconductor components, programmable gate arrays, operational amplifiers and various other analog and digital electronic components.
• FIG. 8ashows atransparent window22 included in thehousing20 of thefluid delivery device10 ofFIG. 8, which allows a user to visually inspect thereservoir30. Also shown is aninformation barcode26, which has information that can be read by aremote control device100 provided with a barcode scanner. Information on thebarcode26 can include amount, type and concentration of drug contained in the reservoir, the device manufacturer and serial number, and expiration dates, and various other pieces of information relative to infusion of liquid medicines into mammalian patients.
• FIG. 9 shows another exemplary embodiment of thefluid delivery device10 which includes ahousing200 having flexible hingedsections23 that allow thefluid delivery device10 to flex during patient movement to prevent detachment and aid in patient comfort. The hingedsections23 run along the length of thehousing20 and allow thefluid delivery device10 to have flex along each axis of the hingedsections23. Directions of the axes of the hingedsections23 can be varied to provide optimum flexibility for various patient contours and areas of placement.
• FIG. 9ashows a standard transcutaneous infusion set400 consisting of a penetratingcannula405, usually consisting of a needle bent to ninety degrees, aflexible tubing404 and aLuer connector401, which includesstandard threads402. The infusion set400 may also include means for attaching to the skin of a patient, such as infusion setwings403, which may have adhesive pads on their bottom side, or may be simply taped to the skin. This connection to the skin may not be necessary when used withfluid delivery device10 with recessedhousing200. Infusion set400 can be attached tofluid delivery device10 by connecting the infusion setLuer connector401 to theLuer connector71 of theexit port assembly70 of thedevice10.
• FIG. 10 shows another exemplary embodiment of thefluid delivery device10 including a means for stopping flow without requiring use of theremote control device100. In this embodiment, the means comprises a “t-shaped”stop button230 that protrudes through thehousing20 and is maintained in a deactivated position through the force ofstop button spring231 Thespring231 is positioned between thestop button230 and aportion24 of thehousing20. Under normal conditions, fluid exits thedispenser40, travels through the exitport tubing lumen74 and exits theexit port assembly70 unencumbered bystop button230. As is shown inFIG. 10a,whenstop button230 is pressed such that it overcomes the force of thestop button spring231, thestop button232 compresses the exitport tubing lumen74 against asecond portion25 of thehousing20, until the exitport tubing lumen74 is fully occluded. In the embodiment shown, thestop button230 protrudes through thehousing20. Alternatively, the device can be constructed such that, in the deactivated position, thestop button230 is flush with the housingouter surface21 to prevent undesired occlusion of flow by inadvertent pressing of thestop button230. The button size and shape can be designed to accommodate an index finger, or the point of a pen. In addition, additional features can be added to have thebutton230 latch and hold after being pressed against thelumen74. The latching feature can be reversible, or can required removal and disposable of thefluid delivery device10.
• FIG. 11 shows another exemplary embodiment of thefluid delivery device10 including a means for delivering a fixed amount of fluid without requiring use of theremote control device100. In certain circumstances, it may be desirable to administer a specific volume or bolus of fluid on demand without the use of theremote control device100. Described here is anembodiment10 wherein the user can press amechanical bolus button180 to release the bolus of the intended medicine.
• As also shown inFIG. 11a,thebolus button180 is t-shaped and protrudes through thehousing20. Thebutton180 is maintained in a deactivated position through the force ofbolus button spring181 positioned between thebolus button180 and an internal portion of thehousing20. Thebolus button180 is attached to abolus release finger183 via a pivotingbolus lever187. Thebolus lever187 has apivot182 attached to thehousing20, and moves thebolus release finger183 away from a bolusdelivery tubing lumen186 and a bolus button stop28 of the housing when thebolus button180 is depressed against thespring181. Thebolus delivery tubing186 is in fluid communication with the exitport tubing lumen74 and, thus, theexit port assembly70. Whenbolus button180 is not pressed, the bias frombolus button spring181 causes thebolus release finger183 to press against bolusdelivery tubing lumen186 which presses against thebolus button stop28 to occlude the bolusdelivery tubing lumen186.
• In order to deliver a fixed amount of fluid when thebolus button180 is pressed, abolus flow restrictor184 and abolus volume accumulator185 are provided in thebolus delivery tubing186. Thebolus flow restrictor184 acts as a flow limiter to prevent free flow of fluid from thereservoir30, and creates a minimum lock-out period between full bolus volumes. Assuming in this particular embodiment that thereservoir30 is maintained at a pressure above atmospheric pressure, the flow rate of theflow restrictor184 is chosen to be much slower than the rate at which the bolus volume should be delivered.
• Thebolus volume accumulator185 expands with the inflow of fluid from theflow restrictor184 as long as thebolus release finger183 is occluding thebolus delivery tubing186. The amount of expansion of thebolus volume accumulator185 equals the bolus volume to be delivered. When thebolus button180 is depressed, the bolus volume of fluid maintained in thebolus volume accumulator185 is dispensed through the bolusdelivery tubing lumen186 and out of theexit port assembly70.
• The time to dispense the bolus dose should be short since there are no downstream flow restrictors, and the user could be instructed to hold the button down for a required time, not more than a few seconds. Alternative designs could latch thebolus button180 for a specific amount of time only, as the button must be released to prevent continued flow via theflow restrictor184. After thebolus button180 is pressed,bolus volume accumulator185 fluid is delivered until the pressure inbolus volume accumulator185 reaches atmospheric pressure. Release ofbolus button180 causes thebolus lever187 to rotate back, pivoting aroundbolus pivot182 untilbolus release finger183 is occluding bolusdelivery tubing lumen186 by pressing it againsthousing button stop28.Bolus volume accumulator185 again expands an amount equal to the next bolus volume to be delivered as fluid fromreservoir30 passes throughbolus flow restrictor184 until the pressure inbolus volume accumulator185 equals the pressure inreservoir30.
• InFIGS. 11 and 11a,thebolus button180 is shown protruding throughhousing20. Alternatively, in the deactivated position,bolus button180 may be flush with the housingouter surface21 to prevent undesired bolus delivery by inadvertent pressing ofbolus button180. In addition, while the figure shows a design that allows multiple depressions of thebolus button180, alternative designs can make thebolus button180 activation a one-time event, requiring the user to replace thefluid delivery device10 or locate theremote control device100.
• FIGS. 12 and 12adepict a exemplary embodiment of theremote control device100 of the present disclosure. Theremote control device100 is a hand held device that includes acontroller housing102, on which is mounted avisual display110, such as a liquid crystal display or LCD. Thevisual display110 can visually indicate status of programming, amounts, timing, and other parameters of medicinal fluid delivery. Other information can include time of day, address book, to do lists, and calendar information and potentially an entertainment interface such as a computer game. Another use of thevisual display110 is to display information received or to be sent to devices other than thefluid delivery device100, such as a glucometer used by diabetic patients or other diagnostic device, especially those whose information is related to the desired infusion rates and volumes to be delivered byfluid delivery device10. Theremote control device100 may have a diagnostic device, such as a blood glucose monitor or glucometer, or an implantable glucose sensor reader, integrated into it, simplifying the requirements of the patient by not having to carry and maintain two separate devices. Other diagnostic devices include but are not limited to blood diagnostic devices, electrocardiography devices and readers, electroencephalogram or EEG devices and readers, blood pressure monitors and pulse oxymetry devices. Alternative to full integration of the diagnostic device, would be connection to the device via wireless or hardwired communication means, to perform a transfer of information.
• Thevisual display110 can also include information such as warning and alarm conditions based on the status of thefluid delivery device100. Elements such as indicator lights, buzzers, and vibrational alarms may also be included in theremote control device100 as alternative or redundant means for communicating information to the user.
• The user can get information and adjust the programming of the device by depressing various electromechanical switches also mounted oncontroller housing102. These switches may be joined in a bank of switches and included inmembrane keypad120 as shown inFIGS. 111 and 11aand as is common with hand held electronic devices. It is preferred that the choice of electromechanical switches of themembrane keypad120 interface with thevisual display110 in a menu driven fashion making reading information and programming the device more user friendly for the user. In an alternative embodiment, thevisual display110 andmembrane keypad120 can be combined into a single device such as a touch screen display, also common to electronic devices. Combination of touch screen displays, membrane keypads and singular switches may all be integrated into theremote control device100.
• Theremote control device100 may include various electromechanical jacks, which can accept electromechanical plugs from various devices. Shown in the figure are three plugs, abar code reader140, aglucometer port150 and acomputer port170. These ports can allow two way transfer of information to enhance the capabilities ofremote control device100 and improve its user friendliness.FIG. 12ashows a schematic cross section of theremote control device100. Themembrane keypad120 andvisual display110 are attached to thecontroller electronics105. Depicted isglucometer port150 attached to thecontroller electronics105.Bar code reader140 andcomputer port170 are also attached to the controller electronics, not shown. The controller electronics are mounted and soldered to the controller printedcircuit board101 as is thecontroller communication element160.
• Thecontroller communication element160 is designed to transmit signals, or information to thecommunication element60 of thefluid delivery device10. Thecontroller electronics105 act as a “translator” in translating user inputs received through theuser interfaces120 into signals for transmission by thecontroller communication element160. In a preferred embodiment, both thecommunication element60 and thecontroller communication element160 are two way communication assemblies allowing two way communication between theremote control device100 andfluid delivery device10. In order to send wireless information thecommunication element60 and thecontroller communication element160 may include inductive wire loops or other transmitting antenna means. Information can be sent using amplitude or frequency modulation, and can be broadcast in the radio frequency, or RF range. Standard information confirmation techniques such as handshaking or checksum protocols can be used to insure accurate information transfer. With two-way communication, when errors are detected, the transfer can be repeated until acceptable, a similar technique to that utilized with two way pager technology commonplace today.
• If thefluid delivery device10 is prefilled prior to patient use, the electronic memory oflocal processor50 may contain information regarding the fluid including but not limited to type or name, concentration, amount, volume, additional drugs in solution and any diluting agents. This information can be transmitted from thefluid delivery device10 via itscommunication element60, and uploaded into theremote control device100 via itscontroller communication element160. Other information may be factory installed into thefluid delivery device10 including but not limited to manufacturing date, expiration date, sterilization date, therapy information such as defined flow profiles and even patient or hospital information. This information can be uploaded into theremote control device100 as described above, and theremote control device100 may adjust its internal programming based on the information received.
• In a preferred embodiment, the electronic memory of thefluid delivery device10 includes the latest program of theremote control device100 available at the time of manufacture of thefluid delivery device10. Similarly, the electronic memory of theremote control device100 includes the latest program of thefluid delivery device10, available at the time of manufacture of theremote control device100. At the first communication between theremote control device100 and thefluid delivery device10, a program check is performed, and if a newer software version for either device is available from the other device, and the existing hardware is compatible, another feature which can be programmed into both devices, the newer program is downloaded into memory and used by the upgraded device. The embedded program may be contained in read only memory, or ROM, while the downloaded program can be written into electronically writeable memory. The automatic update feature, available for each device to upgrade the other, is another way to make sure the user has the best available product for use.
• Another advantageous feature associated with two way communication is the addition of a proximity alarm. The design of thefluid delivery device10 andremote control device100 electronics can be such that when the distance between the two devices is greater than a particular radial length, one or both of the devices will alert the user, potentially with an audio alarm. The alarming distance should be chosen so that it is less than the maximum communication range of the two devices. A method of creating the alarm is for thefluid delivery device10 to send out frequent packets of information at a predetermined rate and at an amplitude or power less than the normal communication power, providing a safety margin for the proximity detection. Theremote control device100 is programmed to expect to receive this communication at the predetermined rate, and lack of receipt of one or more of these packets, causes theremote control device100 to activate itsaudio alarm106. Alternatively or additionally, a vibrational alarm may be included. Proximity alarms may be included that do not require two way communication, by integrating a device such as a magnet into thehousing20 offluid delivery device10, and integrating magnetic field detection means into theremote control device100. When the magnetic field detection means of theremote control device100 do not detect the presence of the magnetic field of thefluid delivery device10, theremote control device100 activates thecontroller audio alarm106.
• Theremote control device100 includes acontroller power supply108 that powers the various electronic components including thecontroller electronics105,controller audio alarm106. Thecontroller power supply108 may be a standard battery and in the preferred embodiment, thepower supply108 may be replaceable by the user by removing a battery door, not shown, and replacing afterpower supply108 is inserted and attached. In an alternative embodiment, the power supply is integrated into theremote control device100, and can be recharged with a separate device or contains enough power to supply the device for its intended length of use.
• Thefluid delivery device10 of the present disclosure may be sold to hospitals, pharmacies, outpatient centers or the patients themselves. If the fluid delivery device is intended for short term or disposable use, it may be practical to sell each device with various accessories or groups of accessories that are convenient for the user. It may be desirable for certain parts of the fluid delivery device, or accessories such as an attachable transcutaneous infusion set, such as that described hereinabove, to be packaged sterilized in a protective packaging. Proper aseptic maintenance of the portion of the skin that receives the transcutaneous access is important to prevent infection. FIGS.13,13a,13band13cdepict various components that may be packaged together in kit form.
• FIG. 13 shows the fluid delivery device of the present disclosure including means for viewing the status of thereservoir30 and aninformation barcode26 with a sterilized device in asterile assembly pack350. The device may be packaged separately or with various other kit components. The fluid delivery device may be packaged sterile entirely in adevice pouch351, intended to allow sterilization and maintain sterility. Such pouches often are constructed of materials such as TYVEK, a product of Dupont. Thesterile assembly pack350 consists of thefluid delivery device10 of the present disclosure, sealed in thedevice pouch351 as is shown inFIG. 13. Alternatively, a portion of the fluid delivery device surrounding theexit port assembly70 may be covered, sealed and sterilized with a sterility maintaining covering (not shown).
• The top of thehousing20, orhousing top side203 includes a housingtransparent window22 located above thereservoir30. The transparency of the housingtransparent window22 and design of thereservoir30 are such that the patient can determine information regarding status of thereservoir30 by viewing through the housingtransparent window22. Such information can include amount of drug remaining or presence of a leak. Alternatively, theentire housing20 may be transparent yielding similar visual indications.
• Also included in thefluid delivery device10 of this embodiment is aninformation barcode26 which can include various pieces of information regarding the status of that particularfluid delivery device10 such as type, volume and concentration of drug prefilled in the device, expiration date of device or drug, manufacture date of device or drug, serial numbers, lot numbers, hospital name, clinician name, patient name, prescription requirements and various other pieces of information. The barcode information can be read into a hospital or home computer, or in the preferred embodiment is uploaded via a barcode reader integral to theremote control device100. Thefluid delivery device10 andremote control device100 electronics and programming can be designed such that the bar code must be read prior to programming or otherwise using thefluid delivery device10. This feature can greatly reduce programming errors such as those associated with the patient entering drug information. If the patient were to enter a drug concentration that was incorrect, and did all the remaining programming in units of drug, instead of volume, which is common practice, while the device would function properly, all of the volumes delivered would be inaccurate based on the ratio of the incorrect concentration entered versus the true concentration of the drug being delivered. Many drugs are available in multiple concentrations such as insulin often made available to patients in 40, 50 and 100 units per ml concentrations.
• FIG. 13ashows theremote control device100 of the present disclosure that could be packaged or provided as a kit with one or more ofsterile package assembly350, including at least onefluid delivery device10. There is no need for theremote control device100 to be sterilized, so if thefluid delivery device10 was sterilized, one or moresterile package assembly350 can be boxed or otherwise packaged with a singleremote control device100 along with one or moreother devices10.
• FIG. 13bshows atherapeutic fluid supply250, which may consist of a vial of drug such as insulin. The drug, in one or more vials, which has been sterilized and made otherwise biocompatible for use, can be packaged with one or moresterile package assemblies350 as well as with one or moreremote control devices100. Additional devices may be included in the kit if desired.
• FIG. 13cshows a sterile infusion setassembly407 including the transcutaneous infusion set400 described hereinabove packaged in an infusion setpouch406. The infusion set400 includes an infusion setLuer401 connected to infusion setflexible tubing404 and terminating in an infusionset penetrating cannula405. An optional set of infusion setwings403 can be included to attach the infusion set400 to the patient's skin. In the preferred embodiment offluid delivery device100, the transcutaneous delivery means are integrated intoexit port assembly70, however in an alternative embodiment, theexit port assembly70 can be attached to infusion set400. In this particular embodiment, it may be desirable to kit sterile infusion setassemblies407 with any quantity of one or more of the sterile assembly packs350, thefluid delivery device10, theremote control device100 or thetherapeutic fluid supply250.
• Thefluid delivery device10 of the present disclosure is intended to be low cost and potentially disposable. It may be advantageous for one or more of the components to be biodegradable, since replacement of the device every two to five days has many advantages, it would also generate a fair amount of waste. Thefluid delivery device10 may include a preinstalled battery as itspower supply80. In order to prevent the battery from powering the electronics offluid delivery device10 before its intended use, a mechanical switch may be included, connecting the battery contacts to the electronics prior to programming with theremote control device100. A simplistic version of the switch design may be an insulating material between the battery contacts ofpower supply80 and the electrical connection to thelocal processor50. The insulating material could be designed to protrude throughhousing20, and be removable by the user, not shown. The user could pull the insulating material and remove it, simultaneously connecting the battery contacts with the electrical connection to the local processor.
• Thefluid delivery device10 of the present disclosure may be filled with the therapeutic fluid by the device manufacture, a pharmaceutical company, or another manufacturer prior to its shipment to the hospital, pharmacy or patient. Certain drugs require refrigeration or other special environmental conditions, requiring the prefilled fluid delivery device to be refrigerated or otherwise handled to meet special requirements. Insulin is a drug that requires refrigeration if it is to be stored for a prolonged period of time. Hoechst, of Frankfurt Germany, is developing insulin that is stable at higher temperatures. Drugs that are stable at room temperature, such as the developmental insulin of Hoechst, allow simple filling and handling of thefluid delivery device10, greatly simplifying the requirements for the patient.
• Various methods of using thefluid delivery device10 are included in the present disclosure and described above. The method of programming thefluid delivery device10 withremote programmer100 as well as the attachment and use of the peripheral devices including transcutaneous infusion sets and diagnostic devices such as glucometers are described. Also relevant is the ability to update the internal programming of either thefluid delivery device10 or theremote control device100 by the corresponding device. Methods of filling thefluid delivery device10 with therapeutic fluid during the manufacturing process as well as by the user have been described. Methods and timing of sterilization and packaging of part or all of thefluid delivery device10 and therapeutic fluid have also been described.
• Although exemplary embodiments of the disclosure 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 disclosure. For example, the fluid delivery device of this disclosure is intended to be low cost, light weight, simple to use and potentially disposable by removing a majority of the user interface, including electromechanical switches, from the fluid delivery device, and including a separate controller to replace those functions. A reservoir, fluid dispenser, transcutaneous fluid administration means, solid state electronics and wireless communications are included in the fluid delivery device to perform its intended function. While various means for reservoir construction, pressurization means, fluid pumping means, fluid metering means, transcutaneous delivery, electronic control and wireless communications have been discussed in this application, alternatives to each of these areas can be made without departing from the spirit of the disclosure.
• In addition, where this patent application has listed the steps of a method or procedure in a specific order, it may be possible (or even expedient in certain circumstances) to change the order in which some steps are performed, and it is intended that the particular steps of the method or procedure claims set forth hereinbelow not be construed as being order-specific unless such order specificity is expressly stated in the claim.

Claims (53)

1. A method for transcutaneously delivering fluid to a patient, comprising the steps of:

a) providing at least one disposable infusion pump including,

a housing adapted to be mounted on a patient's skin,

a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient,

a reservoir prefilled with a therapeutic fluid,

a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool,

a processor connected to the dispenser and programmed to operate the dispenser so that fluid from the reservoir flows to the transcutaneous patient access tool based on flow instructions, and

a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor;

b) placing the disposable infusion pump on a patient's skin;

c) receiving flow instructions from a remote controller through the wireless receiver of the infusion pump; and

d) delivering the flow instructions to the processor of the infusion pump, so that the processor causes fluid from the reservoir to flow to the transcutaneous patient access tool based on the flow instructions.

2. A method according toclaim 1, wherein the reservoir is prefilled with a therapeutic fluid that comprises one of insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

3. A method according toclaim 1, wherein the reservoir is prefilled with a therapeutic fluid for treating one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer's Disease, ALS, Hepatitis, Parkinson's Disease or spasticity.

4. A method according toclaim 1, further comprising the step of adapting the prefilled reservoir so that the reservoir is not refillable.

5. A method according toclaim 1, further comprising the step of providing each of the infusion pumps with an identification tag.

6. A method according toclaim 5, further comprising the step of providing each of the identification tags with information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

7. A method according toclaim 6, wherein the identification tags comprise barcode labels.

8. A method according toclaim 1, further comprising the step of providing the processor with memory containing information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

9. A method according toclaim 1, further comprising the step of providing a plurality of the infusion pumps in a single sterilized package.

10. A method according toclaim 1, further comprising the step of providing the infusion pump with a non-replaceable power supply.

11. A method according toclaim 1, further comprising the steps of providing the infusion pump with skin attachment adhesive, and attaching the infusion pump to the skin of a patient using the skin attachment adhesive prior to receiving the flow instructions.

12. A method according toclaim 1, further comprising the step of freeing the housings, of each of the disposable infusion pumps, of user input components for supplying flow instructions to the processor.

13. A method according toclaim 12, further comprising the steps of placing the infusion pump on the patient's skin and extending the transcutaneous patient access tool from the housing such that the transcutaneous patient access tool penetrates the patient's skin, prior to receiving the flow instructions.

14. A method according toclaim 13, further comprising providing each of the disposable infusion pumps with means for automatically deploying the transcutaneous patient access tool from the housing and into the patient's skin.

15. A method according toclaim 1, further comprising the step of remotely supplying flow instructions to each of the disposable infusion pumps through a reusable remote control device.

16. A method according toclaim 15, further comprising the step of adapting the reusable remote control device to be successively used with the disposable infusion pumps.

17. A method according toclaim 15, further comprising the step of providing the reusable remote control device with a replaceable power supply.

18. A method according toclaim 15, further comprising the step of packaging one of the remote control devices and a plurality of the infusion pumps in a single sterilized package.

19. A method according toclaim 15, further comprising the steps of providing the remote control device with a glucometer and using the glucometer to measure a level of sugar within the patient's blood.

20. A method according toclaim 16, further comprising the steps of providing each disposable infusion pump with a barcode label containing information regarding the therapeutic fluid contained in the prefilled reservoir, providing the remote control device with a barcode scanner, and reading each of the barcode labels using the barcode scanner.

21. A disposable infusion pump comprising:

a housing adapted to be mounted on a patient's skin;

a transcutaneous patient access tool for extending through the housing and providing transcutaneous access to the patient;

a reservoir prefilled with a therapeutic fluid;

a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool;

a processor connected to the dispenser and programmed to operate the dispenser so that fluid from the reservoir flows to the transcutaneous patient access tool based on flow instructions; and

a wireless receiver connected to the processor for receiving flow instructions from a remote controller and for delivering the flow instructions to the processor.

22. A disposable infusion pump according toclaim 21, wherein the reservoir is prefilled with a therapeutic fluid that comprises one of insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

23. A disposable infusion pump according toclaim 21, wherein the reservoir is prefilled with a therapeutic fluid for treating one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer's Disease, ALS, Hepatitis, Parkinson's Disease or spasticity.

24. A disposable infusion pump according toclaim 21, wherein the prefilled reservoir is non-refillable.

25. A disposable infusion pump according toclaim 21, further comprising an identification tag.

26. A disposable infusion pump according toclaim 25, wherein the identification tag includes information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

27. A disposable infusion pump according toclaim 26, wherein the identification tag comprises a barcode label.

28. A disposable infusion pump according toclaim 21, wherein the processor includes memory containing information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

29. A disposable infusion pump according toclaim 21, further comprising a non-replaceable power supply contained in the housing and connected to the processor.

30. A disposable infusion pump according toclaim 21, further comprising skin attachment adhesive on an exterior surface of the housing.

31. A disposable infusion pump according toclaim 21, wherein the housing is free of user input components for supplying flow instructions to the processor.

32. A disposable infusion pump according toclaim 21, wherein the transcutaneous patient access tool includes a sharpened tip for penetrating the patient's skin, and the disposable infusion pump includes means for automatically deploying the transcutaneous patient access tool from the housing and into the patient's skin.

33. A system including a disposable infusion pump according toclaim 21, and further comprising a reusable remote control device for wirelessly providing flow instructions to the receiver of the disposable infusion pump.

34. A system according toclaim 33, comprising one of the reusable remote control devices and a plurality of the disposable infusion pumps.

35. A system according toclaim 33, wherein the remote control device includes a glucometer.

36. A method for distributing therapeutic fluids to patients, comprising the steps of:

a) providing disposable infusion pumps to each patient, wherein the pumps each include,

a housing adapted to be mounted on a patient's skin,

a transcutaneous patient access tool for extending through the housing and providing transcutaneous access for fluid to the patient,

a reservoir prefilled with a therapeutic fluid,

a dispenser for causing fluid from the reservoir to flow to the transcutaneous patient access tool,

a processor connected to the dispenser and programmed to operate the dispenser so that fluid from the reservoir flows to the transcutaneous patient access tool based on flow instructions, and

a wireless receiver connected to the processor for receiving flow instructions from a remote control device and for delivering the flow instructions to the processor,

wherein each infusion pump is adapted to be used only once for a predetermined period; and

b) providing a reusable remote control device to each patient, wherein the remote control device is adapted to be used with only one of the disposable infusion pumps at any one time, and wherein the remote control device is adapted to provide flow instructions to the wireless receiver of the disposable infusion pump.

37. A method according toclaim 36, wherein the reservoirs of the disposable infusion pumps are prefilled with a therapeutic fluid that comprises one of insulin, antibiotics, nutritional fluids, total parenteral nutrition or TPN, analgesics, morphine, hormones or hormonal drugs, gene therapy drugs, anticoagulants, analgesics, cardiovascular medications, AZT or chemotherapeutics.

38. A method according toclaim 36, wherein the reservoirs of the disposable infusion pumps are prefilled with a therapeutic fluid for treating one of diabetes, cardiovascular disease, pain, chronic pain, cancer, AIDS, neurological diseases, Alzheimer's Disease, ALS, Hepatitis, Parkinson's Disease or spasticity.

39. A method according toclaim 36, further comprising the step of adapting the prefilled reservoirs of the disposable infusion pumps so that the reservoirs are not refillable.

40. A method according toclaim 36, further comprising the step of providing each of the infusion pumps with an identification tag.

41. A method according toclaim 40, further comprising the step of providing each of the identification tags with information regarding the therapeutic fluid contained in the prefilled reservoir, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

42. A method according toclaim 41, wherein the identification tags comprise barcode labels.

43. A method according toclaim 36, further comprising the step of providing the processors of the disposable infusion pumps with memory containing information regarding the therapeutic fluid contained in the prefilled reservoirs, and wherein the information includes amount, type, concentration and an expiration date of the therapeutic fluid.

44. A method according toclaim 36, further comprising the step of providing a plurality of the infusion pumps in a single sterilized package for distribution to patients.

45. A method according toclaim 36, further comprising the step of providing the infusion pumps with non-replaceable power supplies.

46. A method according toclaim 36, further comprising the steps of providing the infusion pumps with skin attachment adhesive, so that the infusion pumps can be attached and secured to the skin of a patient using the skin attachment adhesive prior to receiving the flow instructions from the remote control device.

47. A method according toclaim 36, further comprising the step of freeing the housings, of each of the disposable infusion pumps, of user input components for supplying flow instructions to the processor.

48. A method according toclaim 47, further comprising the steps of:

providing the transcutaneous patient access tools of the infusion pumps with sharpened distal ends for penetrating the patient's skin; and

extending the transcutaneous patient access tool from the housing upon placing the infusion pumps on the patient's skin so that the transcutaneous patient access tool penetrates the patient's skin, prior to receiving the flow instructions from the remote control device.

49. A method according toclaim 48, further comprising the step of providing each of the disposable infusion pumps with means for automatically deploying the transcutaneous patient access tool from the housing and into the patient's skin.

50. A method according toclaim 36, further comprising the step of providing the reusable remote control device with a replaceable power supply.

51. A method according toclaim 36, further comprising the step of packaging one of the remote control devices and a plurality of the infusion pumps in a single sterilized package for distribution to new patients.

52. A method according toclaim 36, further comprising the step of providing the remote control device with a glucometer.

53. A method according toclaim 36, further comprising the steps of providing each disposable infusion pump with a barcode label containing information regarding the therapeutic fluid contained in the prefilled reservoirs, and providing the remote control device with a barcode scanner.

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