Source: https://patents.google.com/patent/US20100030575A1/en
Timestamp: 2019-03-19 23:35:05
Document Index: 253723768

Matched Legal Cases: ['art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art 105', 'art.\n10']

US20100030575A1 - Patient management system - Google Patents
US20100030575A1
US20100030575A1 US12/181,429 US18142908A US2010030575A1 US 20100030575 A1 US20100030575 A1 US 20100030575A1 US 18142908 A US18142908 A US 18142908A US 2010030575 A1 US2010030575 A1 US 2010030575A1
US12/181,429
US8290791B2 (en
Luc Roland Mongeon
Susan Heilman Kilbane
Christopher John Gennaro
2008-07-29 Application filed by Medtronic Inc filed Critical Medtronic Inc
2008-10-28 Assigned to MEDTRONIC INC. reassignment MEDTRONIC INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KILBANE, SUSAN H, MONGEON, LUC R, WILLENBRING, JAMES E, GENNARO, CHRISTOPHER J, PATEL, AMISHA S
2010-02-04 Publication of US20100030575A1 publication Critical patent/US20100030575A1/en
2012-10-16 Publication of US8290791B2 publication Critical patent/US8290791B2/en
Embodiments of the present invention provide a system in which a medical device selects less than all of its stored information and provides the selected subset of information to a data mart for storage, processing, and/or communication to one or more interested parties. In many embodiments, customers, patients, or even components of the medical device or of the remote patient management system can access selected medical device information (e.g., customers can access medical device information tailored to the care they are providing to one or more patients). In many embodiments, customers can receive such medical device information according to a schedule that best suits their care (or whenever they desire such information, irrespective of a schedule). In many embodiments, providing less than full transmissions to the data mart reduces the strain on medical device batteries.
In many cases, different customers may desire different information at different intervals in caring for the same patient. For example, an electrophysiologist is generally interested in reviewing certain information related to a pacemaker or ICD patient once every three to six months, as long as the patient is not experiencing adverse symptoms. Customers other than electrophysiologists are often interested in reviewing different information related to the same pacemaker or ICD patients at different intervals. For example, a heart failure specialist may desire different information on a more frequent basis. A heart failure specialist is often interested in looking at the clinical trends in the device diagnostics in order to better manage the heart failure. The frequency of data review depends on the condition of the patient. Immediately after a decompensation (heart failure episode where lungs get fluid accumulation), the physician may want to review the device diagnostic data on a daily basis for 1 or 2 weeks after the event but once the patient has stabilized may want to only review these data once a month or once a quarter.
FIG. 2 is a flow chart of a method of remotely caring for a patient having a medical device, the method involving providing less than all information stored in a medical device to a data mart.
FIGS. 3A-3B are a more detailed flow chart of an illustrative method of remotely caring for a patient having a medical device, the method involving managing a limited data set at a data mart.
FIG. 1 shows an illustrative remote patient management system 100. The remote patient management system 100 forms part of a system used for remotely managing patients prescribed with medical monitoring or therapy delivery devices. The remote patient management system 100 allows customers to monitor and treat multiple patients located at multiple locations. The illustrative remote patient management system 100 of FIG. 1 shows three locations—Location A, Location B, and Location C. Remote patient management systems are not, however, limited to three locations. Locations A, B, and C can represent, e.g., the residences of three patients. Some embodiments of the remote patient management system 100 allow customers to access data from patients' medical devices without those patients having to visit a clinical facility. The remote patient management system 200 saves valuable time—both for the participating customers and for the patients.
Many different kinds of customers interact with the illustrative remote patient management system 100. Such customers include physicians such as hematologists, electrophysiologists, interventional cardiologists, neurologists, endocrinologists, heart failure specialists, and others. FIG. 1 shows two illustrative customers-Customer X and Customer Y. Remote patient management systems are not, however, limited to two customers. Multiple customers can monitor and treat the same patient. For example, both Customer X and Customer Y can monitor the patients located at Location A, Location B, and/or Location C. Both Customer X and Customer Y can have a computer for communicating electronically with other components of the illustrative remote patient management system 100.
An implantable medical device (“IMD”) 115, 120, 125 (implanted inside of a patient) and an external medical device (“EMD”) 130, 135, 140 are located remotely at each of Locations A, B, and C of the illustrative remote patient management system 100. The IMD 115, 120, 125 can be a cardiac stimulation device (e.g., a pacemaker), cardioverter/defibrillator (ICD), a cardiac monitor, a hemodynamic monitor, a neuromuscular stimulator, a drug delivery device, a glucose monitor, or other IMD. The IMD 115, 120, 125 at one location can be the same as or different than the IMD 115, 120, 125 at the other locations. The EMD 130, 135, 140 can be a remote home monitor, programmer, or other EMD. The EMD 130, 135, 140 collects various physiological indicators from IMD patients, such as weight, systemic blood pressure, symptoms, and others. The EMD 130, 135, 140 at one location can be the same or different than the EMD 130, 135, 140 at the other locations. The IMD 115, 120, 125 and/or the EMD 130, 135, 140 can include some or all of the programmable options that are resident in the data mart 105 (e.g., as add-on external algorithms).
The illustrative remote patient management system 100 of FIG. 1 includes a computer 150. In some embodiments, the computer 150 is located in the same location as the data mart 105. In some embodiments, the computer 150 is located remotely from data mart 105. The computer 150 can be a device, or multiple devices working together, that accepts information (in the form of digitalized data) and manipulates it for some result based on a program or sequence of instructions on how the data is to be processed. In some embodiments, the computer 150 may include storage for storing data for some necessary duration.
The data mart 105, the network 110, the IMD 115, 120, 125, the EMD 130, 135, 140, and the computer 150 can be configured to communicate in a variety of ways. In one example, the IMD 115, 120, 125 is configured to communicate with the EMD 130, 135, 140, which is configured to communicate with the data mart 105 via the network 110. In some embodiments, the IMD 115, 120, 125 is configured to communicate with the data mart 105 directly through the network 110. In some embodiments, the data mart 105 communicates directly with either the IMD 115, 120, 125 or the EMD 130, 135, 140 without use of the network 110. Communication between the data mart 105, the network 110, the IMD 115, 120, 125, the EMD 130, 135, 140, and/or the computer 150 can be, for example, bi-directional. The communication configuration can be the same or different with respect to Locations A, B, and C. For example, in some embodiments, the data mart 105 can be configured to communicate with Location B's IMD 120 through the network 110 while being configured to communicate with Location C's IMD 125 through the EMD 140 without the use of the network 110. Each communication among the data mart 105, the network 110, the IMD 115, 120, 125, the EMD 130, 135, 140, and the computer 150 can be initiated by the recipient of the communication (“pull”) or by the transmitter (“push”).
In some embodiments, all of the information gathered and/or stored in the IMD can be provided to the data mart 105. Such a full transmission of data from the IMD 115, 120, 125 to the data mart 105 can occur on a periodic basis, according to a pre-selected schedule. For example, a full transmission can occur every go days. The data mart 105 can index data received from the IMD 115, 120, 125 according to patient, transmission date, IMD serial number, and/or any other factor that would aid in being able to access the data at a later date.
In many cases, the customer can access historical data in remotely caring for patients. For example, the patient at Location C can provide a full transmission related to IMD 125 to the data mart 105 on a transmission date, and the data mart can provide that information to Customer Y. If Customer Y then detected a potentially noteworthy, e.g., blood pressure level in the patient at Location C, Customer Y could retrieve information from the data mart 105 that had been transmitted by the patient at Location C to the data mart 105 at a previous date (e.g., go days earlier). Customer Y could then compare the patient's blood pressure on the transmission date with his/her blood pressure on the previous date before determining whether something should be done.
In some preferred embodiments, the IMD 115, 120, 125 can provide less than all of the information gathered and/or stored in the IMD 115, 120, 125 to the data mart 105. In some embodiments of the present invention, the IMD 115, 120, 125, the EMD 130, 135, 140, the computer 150, the processor 108 of the data mart 105, and/or a computer at one of the customer sites can have access to a computer-readable medium programmed with instructions for causing a programmable processor to perform one or more methods. FIG. 2 shows an illustrative method of remotely caring for a patient having a medical device. As can be seen, the method can involve providing less than all information stored in a medical device to a data mart. The method of FIG. 2 can provide one or more of the advantages discussed elsewhere herein (e.g., tailoring information to specific requests, preserving IMD batteries, etc.).
In the method of FIG. 2, an instruction calling for medical device information can be received, and the instruction's origin and content can be determined. As shown, an instruction can be received by the medical device calling for medical device information (205). The medical device can receive many kinds of instructions. For example, the medical device can have recently identified and addressed a patient episode (e.g., ventricular tachycardia, ventricular fibrillation, arrhythmia, etc.), and the instruction can call for medical device information related to that patient episode. That medical device information can then be assessed to verify that the medical device is functioning properly.
In another example of an instruction that can be received by the medical device, when a component of the medical device detects that available storage in the medical device has fallen below a threshold level, the instruction can call for information stored since a previous transmission (e.g., all information occurring since the previous transmission, only such information that is related to any patient episode(s), etc.). Absent this feature, when a medical device transmits information on a periodic basis, the medical device storage can fill up before the next scheduled transmission, resulting in overwriting previously stored (and perhaps not yet transmitted) medical device information. Customers often desire all such information for optimum patient care. Additionally, the medical device storage is more likely to fill up during an unexplained “storm” of patient episodes or when a patient transitions from moderate risk to high risk, for example. Often customers are especially interested in medical device information from these periods and are thus especially interested in preventing it from being overwritten. In some embodiments, one or more components of the medical device can detect when a variable is at, or has fallen below or risen above, a predetermined threshold, and can provide an instruction seeking pertinent medical device information.
FIGS. 3A-3B provide illustrations for some of the ways in which the limited data set can be managed at the data mart according to the instruction information. As mentioned above, and as shown in FIG. 3A, the data mart can receive the limited data set, with or without instruction information (405). Some embodiments involve forming an assessment of the limited data set (410) (e.g., at the data mart or at a separate computer). In such embodiments, an algorithm can be retrieved from the data mart (415). For example, in embodiments in which the data mart is asked to verify that the medical device properly identified a patient episode, the data mart can retrieve an algorithm for determining whether the patient indeed experienced that patient episode based on the limited data set. The same would hold true for embodiments in which the data mart is asked to monitor device performance. Forming an assessment of a limited data set, as opposed to a full transmission, poses significantly less stress to the data mart. If no assessment is to be formed, the data mart can proceed to the method illustrated in FIG. 3B.
Referring again to FIG. 3A, in some embodiments, the algorithm calls for historical information related to the patient and/or the medical device in addition to the limited data set (420). As is discussed above, the data mart can store large volumes of information from a wide variety of patients. In some cases, the data mart may be able to provide an improved assessment of the limited data set by taking into account such historical information as previously gathered medical device information from the patient, information related to other patients who have similar characteristics or similar medical devices, and so on. Taking historical information into account can identify the presence or absence of one or more trends, which can provide significant benefit to customers in their care for the patients. Accordingly, in many embodiments, historical information can be retrieved from the data mart (430), and the algorithm can be applied to the limited data set and the historical information to form an assessment (435). If the algorithm does not call for historical information, the algorithm can be applied to the limited data set to form an assessment (425).
Once an assessment of the limited data set is made, some embodiments provide that the assessment can be investigated in greater detail (440). For example, the instruction can ask the data mart to assess whether a particular condition merits further investigation. If the data mart determines that the condition does indeed merit further investigation, the data mart can proceed with that investigation. If the assessment is not investigated in greater detail, the data mart can proceed to the method illustrated in FIG. 3B.
Referring again to FIG. 3A, the further investigation can take a variety of forms. In some embodiments, the investigation can involve sending verification software to the medical device (445), and verification information can be received at the data mart based on the verification software (450). In many embodiments, the verification software can perform a clinical test on a patient. For example, a customer can determine, based on the medical device information he/she has reviewed, that a patient may have sleep apnea. The customer can then prescribe a sleep apnea test to verify his/her initial determination. The software to run the test can be downloaded to the patient's device, and the results can then be uploaded back to the data mart and reported to the customer. Such an investigation often comes into play in the context of a possible device performance issue. The assessment can then be investigated in greater detail based on the verification information (455).
In some embodiments, modification instructions can be transmitted to the medical device (485). In such embodiments, the data mart transmits modification instructions to the medical device (490). In many such embodiments, the modification instructions call for modification of (i) how the medical device monitors for and/or treats conditions, (ii) how the medical device stores medical device information, and/or (iii) the time intervals at which the medical device transmits medical device information to the data mart. At the end of the process illustrated in FIGS. 3A-3B, the data mart can prepare to receive new information from a medical device (499).
1. A method of remotely caring for a patient having a medical device, the method comprising the steps of:
providing an instruction to a medical device, the instruction calling for medical device information that (a) was collected by the medical device during a specific time period and/or (b) is related to a specific subject matter;
selecting a limited data set from medical device information stored in the medical device based on the instruction;
transmitting the limited data set from the medical device to a data mart, along with instruction information that is related to the instruction if the data mart does not otherwise have access to the instruction information; and
managing the limited data set at the data mart according to the instruction information.
2. The method of claim 1, wherein the instruction is provided to the medical device by a component of the medical device.
3. The method of claim 1, wherein the instruction is provided to the medical device from outside of the medical device.
4. The method of claim 1, wherein managing the limited data set includes (i) retrieving an algorithm from the data mart, (ii) applying the algorithm to the limited data set to form an assessment of the limited data set, (iii) retrieving a full transmission from the medical device, and (iv) investigating the assessment in greater detail based on the full transmission.
5. The method of claim 1, wherein managing the limited data set includes (i) retrieving an algorithm from the data mart, (ii) applying the algorithm to the limited data set to form an assessment of the limited data set, (iii) sending verification software to the medical device, (iv) receiving verification information at the data mart based on the verification software, and (v) investigating the assessment in greater detail based on the verification information.
6. The method of claim 1, wherein managing the limited data set includes (i) retrieving an algorithm from the data mart, (ii) applying the algorithm to the limited data set to form an assessment of the limited data set, the method further comprising communicating information to a customer based on the assessment.
7. The method of claim 1, wherein managing the limited data set includes (i) retrieving an algorithm from the data mart, (ii) retrieving historical information related to the patient and/or the medical device from the data mart, and (iii) applying the algorithm to the limited data set and the historical information.
8. The method of claim 1, wherein managing the limited data set includes transmitting the limited data set from the data mart to a customer without performing any analysis on the limited data set.
9. The method of claim 1, wherein managing the limited data set includes transmitting modification instructions to the medical device, the modification instructions calling for modification of (i) how the medical device monitors for and/or treats conditions, (ii) how the medical device stores medical device information, and/or (iii) time intervals at which the medical device transmits medical device information to the data mart.
10. A computer-readable medium programmed with instructions for performing a method of providing less than all information stored in a medical device to a data mart, the medium comprising instructions for causing a programmable processor to:
receive an instruction calling for medical device information that (a) was collected by the medical device during a specific time period and/or (b) is related to a specific subject matter;
select a limited data set from medical device information stored in the medical device based on the instruction;
provide the limited data set to the data mart; and
provide information related to the instruction to the data mart if the data mart does not otherwise have access to such information.
11. The computer-readable medium of claim 10, wherein the instruction (i) is received from a component of the medical device upon identifying and addressing a patient episode, (ii) calls for information related to the patient episode, and (iii) asks the data mart to determine whether the patient episode was correctly identified.
12. The computer-readable medium of claim 10, wherein the instruction (i) is received from a component of the medical device upon detecting that available storage in the medical device has fallen below a threshold level and (ii) calls for information related to any patient episode(s) occurring since a previous transmission.
13. The computer-readable medium of claim 10, wherein the instruction (i) is received from a component of the medical device upon detecting a device performance issue, (ii) calls for information related to the device performance issue, and (iii) asks the data mart to investigate the device performance issue further.
14. The computer-readable medium of claim 10, wherein the instruction (i) is received from a customer and (ii) calls for information requested by the customer.
15. The computer-readable medium of claim 14, wherein the instruction further (iii) is received according to a regular schedule and (iv) calls for information that both (a) has been collected by the medical device since a previous transmission to the customer and (b) is related to care being provided by the customer.
16. The computer-readable medium of claim 10, wherein the instruction (i) is received from a patient and (ii) calls for information related to a symptom he/she is experiencing or has recently experienced.
17. A method of remotely caring for a patient having a medical device, the method comprising the steps of:
receiving a limited data set at a data mart from a medical device, the limited data set having been selected based on an instruction calling for medical device information stored in the medical device that (a) was collected by the medical device during a specific time period and/or (b) is related to a specific subject matter;
receiving at the data mart instruction information that is related to the instruction if the data mart does not otherwise have access to the instruction information; and
18. The method of claim 17, wherein managing the limited data set includes (i) verifying that the patient and the medical device are working properly and (ii) not communicating with a customer.
19. The method of claim 17, wherein managing the limited data set includes providing at least part of the limited data set to a separate computer for analysis.
20. The method of claim 17, wherein managing the limited data set includes (i) retrieving an algorithm from the data mart, (ii) applying the algorithm to the limited data set to form an assessment of the limited data set.
US12/181,429 2008-07-29 2008-07-29 Patient management system Active 2029-12-06 US8290791B2 (en)
EP09790668.9A EP2335173B1 (en) 2008-07-29 2009-07-21 Patient management system
US20100030575A1 true US20100030575A1 (en) 2010-02-04
US8290791B2 US8290791B2 (en) 2012-10-16
US12/181,429 Active 2029-12-06 US8290791B2 (en) 2008-07-29 2008-07-29 Patient management system
EP2335173B1 (en) 2018-05-16
US8731648B2 (en) 2014-05-20 System and method for prioritizing medical conditions
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PATEL, AMISHA S;MONGEON, LUC R;KILBANE, SUSAN H;AND OTHERS;SIGNING DATES FROM 20080730 TO 20080812;REEL/FRAME:021746/0406