This application relates to a system and method for monitoring and managing infusion therapy, and in particular, from a remote location.
Infusion pumps are used in the field of health care are electromechanical devices which control the flow rate of medical fluids. These pumps operate, for example, to deliver a drug to a patient at a precisely controlled rate. A vital application for infusing pumps in the human and veterinary medical field is in the delivery of chemicals, drugs, nutrition, or biological products to patients. Typically, one or more drugs or other substances are mixed into a uniform solution in a medical fluid and are then delivered through an infusion pump into the bloodstream of a patient via tubing and/or catheters which conduct the fluid from the pump to the patient's vascular space. The fluid rate or sequence of rates at which an infusion pump operates is typically selected based on desired pattern of drug delivery appropriate to the specific circumstance. Numerous factors should be considered when specifying a specific rate, amount, etc. of fluid to flow from a pump at any given time.
Prior art pumps to deliver fluid include various infusion pump systems having varying degrees of programmability and/or automation. Examples of infusion pump systems that are programmable and/or have some degree of automation include, but are not limited to, those described in U.S. Pat. No. 4,670,007 (Wheeldon et al.); U.S. Pat. No. 4,978,335 (Arthur, III); U.S. Pat. No. 4,976,151 (Morshita); U.S. Pat. No. 4,856,339 (Williams); U.S. Pat. No. 5,256,157 (Samiotes, et al.); U.S. Pat. No. 5,756,327 (Sasanfar, et al.); U.S. Pat. No. 5,683,367 (Jordan, et al.); U.S. Pat. No. 6,269,340 (Ford, et al.); U.S. Pat. No. 6,854,620 (Ramey) and U.S. Pat. No. 6,659,980 (Moberg, et al.) as well as United States Patent Application Publication Nos. 2004/0019607 (Moubayed et al.) and 2004/0172283 (Vanderveen et al.).
Additionally, at least one commercially available infusion system exists that includes a mobile systems manager which communicates by wireless connection to one or more central server(s) and various individual infusion pumps located within range of the wireless network (Alaris Mobile Systems Manager, Cardinal Health, Inc., San Diego, Calif.).
With heightened emphasis on cost-effectiveness and cost-containment in health care, clinic and home infusion therapy is becoming increasingly commonplace. For example, home infusion therapy generally involves the administration of medications, for example, immune globulin infusions using intravenous, or subcutaneous routes, in the patient's home rather than in a physician's office or hospital. Infusion therapies in the home are typically administered by a home health care worker having some degree of training in the operation of infusion equipment and the administration of biologic therapies. In some cases, the patient him/herself administers the therapy.
A system and method for remote monitoring and/or management of infusion therapies. A user can monitor and manage server-connected pumps at a remote location, such as a computer or PDA. Pumps located at an institution, such as a hospital or patients home, are connected, for example, via the Internet to a server that includes a database of information. A user can operate the pump, from a remote location, by using an interface displayed at the remote location. The operator can manage pump operations by use of the interface. In this context, the user can turn the pump on and off, select infusion rates, dose amounts, etc. all from the convenience of the remote location.
The present disclosure provides a system and method wherein one or more remotely located user interface devices (e.g., personal computers, personal digital assistants, etc.) are connected, via the Internet and/or directly into an institutions hard-wired or wireless network, to server(s) and infusion pumps located within an institution (e.g., hospital) or at remote locations (e.g., patient's homes). One embodiment or example of a system of the present disclosure is shown schematically in
As shown in
In this example, the extra-institutional portion 16 of the system 10 comprises one or more extra-institutional user interfaces 24 (e.g., computers or PDAs), one or more extra-institutional infusion pumping devices 26 which may be connected via wired or wireless connection to the Internet and may then communicate with the server 18 through the institution's internet connection. Further, extra-institutional infusion pumping devices 26 may telephonically communicate to the inter-institutional portion 14 via an extra-institutional telephonic modem 12 which connects to an intra-institutional telephonic modem 124 which connects to an intra-institutional server 18.
Examples of the types of infusion pumping devices 22, 26 that may be used in this invention include, but are not limited to, those described in copending U.S. Utility patent application Ser. No. 11/212,931 entitled “Rotary Axial Peristaltic Pumps and Related Methods” filed Aug. 26, 2005 and Ser. No. 11/523,794 entitled “Method and System for Controlled Infusion of Therapeutic Substances” filed Sep. 18, 2006, the entire disclosures of which are expressly incorporated herein by reference.
In operation, the user interface devices 20, 24 act as browsers to web server 18b, of server 18, whereby users may view, monitor, set, reset, control and/or manage the operation of the pumping devices 22, 26 as described herein below.
Upon accessing a login page via a web browser, the operator enters a username and password at, for example, user interface 24. After completing the login, a navigation screen appears as illustrated in
If a user selects the “Pump History File” function, a history file (Hx) directory window of saved pump history files existing in the database is provided. In addition, a scrollable Hx text window is provided to display the contents of a pump history file when the file is selected from the directory, as illustrated in
A pump pull down list allows the user to display a list of serial numbers for all pumps currently connected to the server. A “Get Pump” Hx function obtains the pump history file for the selected network-connected pump. When a network-connected pump is selected, a filename is constructed and entered in both the directory table and the “History File” text box, and the Pump Hx text window displays the contents of the history file. The displayed files may then be saved.
There are several controls and fields common to IVIG, SCIG, Continuous, Intermittent and TPN Rx Programming pages, and include, among other things, safety options, drug data and patient data fields in common, as explained below.
Safety Option Defaults: If pre-determined safety option defaults have been selected, the default values for the Rx will be set according to the selection. Default Safety options, such as Down Occlusion, AIL Sensitivity, and Lock Level, can be selected from parameters suggested from the table below:
Programmable fields for drug data include:
Drug Name pull down list for IVIG Rx Programming page: The name of the DRR(s) on the pull down list includes the name of the drug, the concentration, units of concentration, and route. Once a DRR has been selected, the IVIG Rx Programming page, Drug fields of concentration, total grams, route and DRR notes are populated. A “new” selection allows the user to manually fill-in the drug fields in order to define a drug not found in the DRL.
Drug Name pull down list for non-IVIG Rx Programming page: The name of the DRR(s) on the pull down list on the non-IVIG Rx Programming page include the name of the drug only. Once the drug name from DRR has been selected, the name of the drug and any associated DRR notes are displayed. A “new” selection allows the user to manually fill-in the drug name field in order to define a field not found in the DRL.
Patient Data Fields: Patient information includes patient name, date of birth, weight, weight units, gender and patient notes. On the Rx Programming pages, these fields are read. The user may select a patient from the existing database of patients using the patient name pull down list. Patient data fields are represented in the following table, although not limited to such data.
Calculated steps and time: The fields “calculated steps” and “calculated time” are not data entry fields, but rather calculated values. A DLL is provided that will compute the calculate steps and time, and are calculated after values of fields Volume TBI, Min. Time, Max. Time, Max. Rate, Base Rate, Rate Increment and Step Duration have been entered.
Drug name pull down list: The pull down list displays the DRR(s) from the DRL that are created for IVIG therapies. The entry in the pull down list shows the drug name, concentration, units and route. Upon selection of a drug name, information of the drug name, concentration, units, total grams, and route are populated. Once a valid DRR has been selected, a validate button may be used to validate the Rx against the DRR. Also, the Save, Save to File, or Save to Pump button may also validate the Rx against the DRR selected.
Drug Amount to be Infused: The amount to be infused in mg, is a calculated field, calculated by multiplying concentration (%) times IVIG Bag volume.
Drug Messages: Optional messages can be displayed in the event a user selected a “new” drug selection and manually enters drug information.
Patient name pull down list: This list displays the available patients in the patient database. Once a patient has been selected, date of birth, weight, gender and patient notes are populated in the database information. Once a valid patient record and DRR has been selected, a validate button may be used to validate the DRR and patient information.
Inter-dependent Calculation Rules for SCIG Infusion: Three fields are involved in inter-dependent calculations (Volume TBI, rate and time). Once two of the three interdependent fields have been entered, the third can be dynamically calculated. A user change to any one of the fields causes a recalculation in which the lowest in priority of the non-user changed fields is recalculated. In the example, the order of priority, lowest being first, is: time and rate.
Drug name: A pull down list displays the DRR(s) from the DRL that were created for SCIG therapies.
Inter-dependent Calculation Rules for Continuous Infusion: Three fields are involved in inter-dependent calculations (Volume TBI/Amt TBI, Rate, Time). Once two of the three interdependent fields have been entered, the third can be dynamically calculated. A user change to any one of the fields causes a recalculation in which the lowest in priority of the non-user changed fields is recalculated. In the example, the order of priority, lowest being first, is: time and rate.
Concentration field: This field is disabled whenever the “units” field has been selected as mL.
Dynamic units and label: When the units field has been selected to a value other than mL (e.g., mg or mcg), the numerator of the Concentration unit and the numerator of the Rate unit changes to become the unit field selection.
Drug name: A pull down list displays the DRR(s) from the DRL that were created for CONT therapies.
Call back options check boxes: When KVO rate is zero, the “Before Dose” Call Back Options check box automatically becomes checked. Otherwise, the Before Dose check box can be optionally checked by the operator.
Inter-dependant calculation rules for Intermittent Infusion: Three fields (amount/dose, time/dose and rate/dose) are related by interdependent calculation. Once two of the three fields have been entered, the third is calculated. Once all three fields have been entered or calculated, a user change to any one of the fields will cause another recalculation in which the lowest in priority of the non-user changed fields is recalculated. In this example, the order of priority, lowest being first, is: Time/Dose and Rate/Dose.
Calculated only fields: The Vol. Req. and Total Time fields are calculated fields based on the parameters: Bag. Vol., Amount/Dose, Time/Dose, Rate/Dose, Dose Freq., KVO Rate and #Dose/Bag. If parameters are changed, a these fields are recalculated.
Concentration field: This field is disabled when the “units” field is selected as mL, and concentration units is set to blank.
Dynamic units and label: Concentration units (mg/ml or mcg/ml), amount/dose (mg or mcg) or volume/dose units (mL), and rate/dose units (mg/hr, mcg/hr or mL/hr) is dynamically changed when “units” field selection is made. Additionally, the amount/dose label changes to volume/dose when the “units” selection is mL, and to amount/dose when a mg or mcg selection is made.
Drug name and message: A pull down list will display drug records created for INT therapies, and relevant messages will be displayed. For example, the message “Adverse Reaction Monitoring and Rx Validation Processing related to Drug DRR will not be performed” may be displayed as a message.
Inter-dependent Calculation Rules for Continuous Infusion: Five fields are involved in inter-dependent calculations (Volume TBI, Rate, Up Ramp Time, Down Ramp Time and Total Time). Once four of the five fields have been entered, the fifth field is dynamically calculated. A change to any of the fields results in another recalculation of the lowest in priority of the remaining fields. In this example, the order or priority, lowest being first, is: Total Time and Rate.
Drug Name: A pull down list of drug records is displayed for TPN therapies.
Institution database directory window: The directory window displays the Rx(s) of the institution database in a scrollable and sortable directory window. Columns in the directory provide, for example, RxID, Therapy, Drug, Patient and Date.
Pump Rx database directory window: The pump database directory window displays all Rx(s) in the database of the selected pump in a scrollable, sortable window. Columns in the pump Rx database directory window include, for example, RxID, Therapy, Drug, Patient and Date.
Institution and Pump view: Selection of this button displays the contents of the selected Rx in the therapy specific Rx Programming page. No modification can be made to the Rx in this page.
Institution “to Pump”, “to File” and “Load File”: Selected R×(s) can be copied from the institution database to the pump database. Conflicts may occur if the RxID number of an institution Rx is the same as an existing pump Rx. When a conflict appears, a message is displayed allowing the user to review the pump and institution Rx in order to decide which Rx should prevail. Once R×(s) have been selected, they may be saved to a file or folder for later use (i.e. to be loaded at a later time).
Pump select: A pull down list displays the pumps connected to the host server. Selection of a pump causes the R×(s) in the selected pump database to be downloaded to the host server and displayed in the Pump Rx Database Directory window.
Pump “to INSTITUTE”, “to FILE” and “Load FILE”: These buttons appear on the screen, and allow users to copy selected R×(s) of the selected pump database to the institution database. If conflicts occur, they are resolved in the same manner as those described in Institution “to Pump”, “to File”, and “Load File”. Once copied, the files may be saved and loaded at a later time.
General provisions for DRR pages: DRR(s) are identified by a qualified DRR name. A defined DRR name includes at least a drug name, concentration, units and route. For IVIG, CONT, INT and TPN, the route is set to INTRAVENOUS and displayed on the DRR page. For SCIG, the route is set to SUBCUTANEOUS and displayed on the DRR page. Units for IVIG and SCIG DRR pages are set to “%”, and units for CONTINUOUS and INTERMITTENT are selected from mL, mcg and mg. Units for TPN are set to mL.
For new DRRs, the fields are initially blank, as follows:
DRR page format (e.g.
Manage Symptom List: Displays the DRR Add/Delete Symptoms page.
Symptom Pull Down List: The user may select a symptom from those provided form the symptom Pull Down List.
Yellow Zone Pull Down List: The user may select a yellow zone response from those provided from the Yellow Zone Pull Down List. Once the Yellow Zone response is selected a resultant Red Zone response is automatically made according to the following table.
Add the Selected Symptom: Add the Selected Symptom creates a new box, the symptom name, yellow zone response criteria, and red zone response criteria.
Symptom check box: The user can select the symptom for deleing.
Delete Symptom: Allows a user to delete the selected symptom row.
Maintenance” page, accessible from the navigation bar. This page allows the user to select an ACP for editing, deleting one or more ACP(s), and creating a new ACP. The ACP page also includes a tabbed window in which the user can program parameters.
ACP Global tab (
ACP Users tab (
ACP IVIG tab (
ACP SCIG tab (
ACP CONT tab (
AC INT tab (
ACP TPN tab (
Those of skill in the art will appreciate that the system and method of the present invention may be used for many types of infusions. One particular use is in the administration of Immune Globulin (Ig) therapy. Immune Globulin may be infused intravenously (e.g., Intravenous Immune Globulin (IVIG) Therapy) or subcutaneously (e.g. Subcutaneous Immune Globulin (SQIG) therapy). Immune Globulin therapies have been used to treat primary immunodeficiencies (e.g., congenital agammaglobulinemia, hypogammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyperimmunoglobulin M, severe combined immunodeficiency (SCID) and Wiskott-Aldrich syndrome). Also, IVIG therapy may be used in the treatment of Kawasaki Syndrome, B-Cell Chronic Lymphocytic Leukemia, Idiopathic Thrombocytopenic purpura (ITP), acute graft-versus-host disease associated interstitial pneumonia (infectious or idiopathic) after bone marrow transplantation (BMT), human immunodeficiency virus (HIV), as a treatment for Acute Guillain-Barra Syndrome, refractory dermatomyositis, hyperimmunoglobulinaemia E syndrome, Lambert-Eaton Myasthenic Syndrome, Relapsing-Remitting Multiple Sclerosis, Parvovirus B19 Infection and associated anemia, Chronic Inflammatory Demyelinating Polyneuropathies, Multifocal Motor Neuropathy (MMN), infectious diseases, adrenoleukodystrophy, acquired Factor VII inhibitors, acute lymphoblastic leukemia, anemia, autoimmune hemolytic anemia, aplastic anemia, diamond Blackfan anemia, Aplasia, Pure Red Cell anemia, asthma, inflammatory chest disease, Behcet's syndrome, chronic fatigue syndrome, clostridium difficile toxin, congenital heart block, cystic fibrosis, intractable pediatric epilepsy, juvenile arthritis, myositis, polymyositis, multiple myeloma and immunoproliferative neoplasms, motor neuron syndromes, myasthenia gravis, myelopathy associated with Human T-cell leukemia/lymphoma virus-I, nephrotic syndrome, membraneous neuropathy, paraproteinemic neuropathy, euthyroid opthalmopathy, recurrent otitis media, pemphigus vulgaris, pemphigus foliaceus, paraneoplastic pemphigus, progressive lumbosacral plexopathy, post-transfusion purpura, recurrent fetal loss, renal failure, rheumatoid arthritis, systemic lupus erythematosus and related cytopenia, nephritis, CNS involvement, vasculitis, pericarditis, or pleural effusion, thrombotic thrombocytopenic purpura, nonimmune thrombocytopenia, neonatal alloimmune thrombocytopenia (pre- and postnatal), septic thrombocytopenia, quinine induced thrombocytopenia, transfusion reactions, uveitis, systemic vasculitic syndromes, acquired Von Willebrand's syndrome and others.
Immune Globulin infusions must be carefully prescribed and administered. IVIG infusions are often administered by an infusion protocol whereby the rate of infusion is increased in a step-wise fashion. Prior to each increase in the infusion rate (e.g., each “step up”), the patient is monitored for signs of adverse reaction to the drug infusion. If no adverse reaction is noted and the patient appears to be tolerating the infusion, then the infusion rate is increased (e.g., stepped up). The types of adverse reaction that may occur as a result of IVIG infusion include migraine headache, flushing, nausea, vomiting, chills and others. There is also a risk of more serious, sometimes life-threatening reactions, for example, risk of thrombus formation. Particular care must be given to patients having certain health issues such as a history of stroke, heart attack, blood vessel disease, IgA or IgG deficiencies or blood clots.
Other particular uses for programmable infusion pumps include, but are not limited to, the administration of analgesics, anesthetics, cancer chemotherapy, antibiotics, gene therapy agents, anti-venoms and other drugs or substances that require carefully controlled and/or monitored infusion to avoid harmful reactions, overdosing, allergic responses, anaphylactic responses, other idiosyncratic responses, etc.
As illustrated in the figures, in some embodiments, the infusion pumping devices 22, 26 may incorporate an apparatus for monitoring the patient's bodily or physiologic variables which may indicate or may be predictive of an adverse reaction to the infusion. The user interface devices 20, 24 may access such monitored bodily or physiologic variables and/or may receive alarms when such monitored bodily or physiologic variables are outside of preset limits. The user (e.g., physician, pharmacist, charge nurse, physician assistant, etc.) may then make any desired modifications to the patient's prescription (e.g., infusion rate, infusion profile, etc.) in view of changes in the monitored bodily or physiologic variables.
Also as illustrated in the figures, in some embodiments, the infusion pumping devices 22, 26 may incorporate an apparatus for querying the patient and for receiving the patient's responses to such queries. The query or queries may relate to the absence or presence of symptoms or sensations that may indicate or may be predictive of an adverse reaction to the infusion (e.g., headache, sweating, nausea, shivering, blurred vision, etc.). The user interface devices 20, 24 may access the patient's responses to such queries and/or may receive alarms when the patient's responses to the queries when the patient's responses are outside of preset limits. The user (e.g., physician, pharmacist, charge nurse, physician assistant, etc.) may then make any desired modifications to the patient's prescription (e.g., infusion rate, infusion profile, etc.) in view of changes in the patient's responses to such queries.
It is to be appreciated that the invention has been described herein with reference to certain examples or embodiments of the invention but that various additions, deletions, alterations and modifications may be made to those examples and embodiments without departing from the intended spirit and scope of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless otherwise specified of if to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of a method or process have been described or listed in a particular order, the order of such steps may be changed unless otherwise specified or unless doing so would render the method or process unworkable for its intended purpose. All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims.
This application claims priority under 35 USC 120 to U.S. Provisional Application Ser. No. 60/860,597, filed Nov. 21, 2006, the contents of which are hereby incorporated by reference.
Number | Date | Country | |
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60860597 | Nov 2006 | US |