Title: Cardiac rhythm management patient report
Abstract: A patient oriented report from an implantable medical device such as a cardiac rhythm management device, e.g. a cardiac pacemaker or cardioverter/defibrillator, and a system and method for producing the same. The report provides the patient with various information regarding the treatment, type of device, manufacturer, physician, device settings, or device status.
Patent Number: 6,987,998 Issued on 01/17/2006 to Kalgren, et al.
| Inventors:
|
Kalgren; James (Lino Lakes, MN);
Lanz; Mitchell (Maple Grove, MN)
|
| Assignee:
|
Cardiac Pacemakers, Inc. (St. Paul, MN)
|
| Appl. No.:
|
795830 |
| Filed:
|
February 28, 2001 |
| Current U.S. Class: |
600/523; 600/509 |
| Current Intern'l Class: |
A61B 5/04 (20060101) |
| Field of Search: |
600/523,509,528,489
340/33
705/3,2
607/5,14,4
|
References Cited [Referenced By]
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| |
Primary Examiner: Robinson; Daniel
Attorney, Agent or Firm: Schwegman, Lundberg, Woessner & Kluth, P.A.
Claims
What is claimed is:
1. A cardiac patient report generating system, comprising:
a cardiac rhythm management device;
a programming unit communicating with said cardiac rhythm management device; and
an output device connected to said programming unit, said output device producing
a report for a patient, wherein said report directly informs a patient about said
cardiac rhythm management device in terminology easy for a non-medically trained
patient to interpret.
2. The system of claim 1, wherein said output device is a printer and said report
is a printed report for a patient.
3. The system of claim 1, wherein said output device includes a write device
and the report for a patient is stored on a removable storage media.
4. The system of claim 3, wherein said write device is an electromagnetic read/write
device and the report is written electromagnetically to a removable electromagnetic
storage media which is given to a patient.
5. The system of claim 3, wherein said write device is an electro-optical read/write
device and the report is written electro-optically to a removable electro-optically
storage media which is given to a patient.
6. The system of claim 1, wherein said report includes at least one of patient's
name, physician's name, cardiac rhythm management device manufacturer, cardiac
rhythm management device model number, and cardiac rhythm management device serial number.
7. The system of claim 6, wherein said cardiac rhythm management device manufacturer,
cardiac rhythm management device model number, and cardiac rhythm management device
serial number are stored in said cardiac rhythm management device and read by said
programming unit.
8. The system of claim 7, wherein said programming unit formats said cardiac
rhythm management device manufacturer, cardiac rhythm management device model number,
and cardiac rhythm management device serial number into a data stream, and transmits
same to said. output device.
9. The system of claim 1, wherein said report includes at least one of a physician's
name, physician's contact information and a date of a patient's next visit to the physician.
10. The system of claim 1, wherein said cardiac rhythm management device includes
leads and said report includes at least one of lead manufacturer, lead model number,
and lead serial number.
11. The system of claim 1, wherein said cardiac rhythm management device is implantable
in a patient and is selected from a group consisting of a cardiac pacemaker, a
cardioverter/defibrillator, and a combination pacemaker/defibrillator.
12. The system of claim 1, wherein said cardiac rhythm management device is implanted
in a patient and said report includes a reason for implantation.
13. The system of claim 12, wherein the reason for implantation is on said report
in brief medical terminology and in plain English terminology for a non-medically
trained patient's understanding.
14. The system according to claim 1, wherein said cardiac rhythm management device
is a pacing device and said report includes at least one of pacing duty rate and
lowest heart rate setting of the pacing device.
15. The system according to claim 1, wherein said report includes information
regarding operation of said cardiac rhythm management device when a patient is active.
16. The system according to claim 1, wherein said cardiac rhythm management device
is a cardioverter/defibrillator and said report includes heart shock application data.
17. The system according to claim 1, wherein said report includes a manufacturer
name of said cardiac rhythm management device and manufacturer contact information.
18. The system according to claim 17, wherein said manufacturer information includes
a global computer system address.
19. A medical device adapted for implantation into a patient, and a report providing
information regarding said medical device, said information being understandable
to a non-medically trained patient, said report comprising:
medical device identifying information;
medical device manufacturer information;
physician information; and
information specific to a relationship between said medical device and a patient.
20. The report according to claim 19, wherein said medical device identifying
information includes at least one of device model number, device serial number,
and device type.
21. The report according to claim 19, wherein said medical device manufacturer
information includes at least one of manufacturer name, manufacturer address, manufacturer
telephone number, and manufacturer global computer network address.
22. The report according to claim 19, wherein said physician information includes
at least one of physician name, physician phone number, physician address, and
next appointment date.
23. The report according to claim 19, wherein said information specific to a
relationship between said medical device and patient includes at least one selected
from a set comprising: a reason for implantation of said medical device in terms
understandable to non-medically trained patients, number of treatments by said
medical device, active duty time of said medical device, and setting parameters
of said medical device.
24. The medical device according to claim 19 comprising a cardiac rhythm management device.
25. A method for generating an implanted cardiac rhythm device report for a patient,
wherein said report is understandable to a non-medically trained patient, comprising:
compiling implanted medical device identifying information;
compiling medical diagnosis information;
composing the medical diagnosis information in terminology understandable to
non-medically trained person; and
producing a report for a patient containing implanted medical device identifying
information and composed medical diagnosis information.
26. The method of claim 25, wherein compiling implanted medical device information
includes inputting manufacturer name and manufacturer contact information into
a computer system and outputting the manufacturer name and the contact information
in the report for patient.
27. The method of claim 25 wherein compiling medical diagnosis information includes
retrieving the diagnosis information from a database.
28. The method of claim 27, wherein retrieving the medical diagnosis information
from the database includes reading a diagnosis code from a database stored in a
memory of a computer system.
29. The method of claim 28, wherein composing the medical diagnosis information
includes associating the diagnosis code with a plain English interpretation stored
in a database in a memory of a computer system.
30. The system of claim 1, wherein said report directly informs a patient about
said cardiac rhythm management device absent interpretation by medical personnel.
Description
This invention pertains to cardiac rhythm management report for patients and
to methods and systems for producing same.
BACKGROUND
Medical devices are implanted in patients to address specific health problems.
Cardiac rhythm management devices are one type of implantable medical device and
are commonly referred to as pacemakers. Cardiac rhythm management devices provide
pacing and defibrillation functions to patients with corresponding heart problems.
Systems communicate with the cardiac rhythm device to program same and retrieve
data from the cardiac rhythm management device for diagnostic and treatment purposes.
Some patients desire to know a great deal about their medical problem, the implanted
medical device, and exactly how the medical device treats their problem. Unfortunately,
many patients lack basic knowledge of anatomy and physiology which is necessary
to understand implant therapy concepts. Consequently, medical care providers may
spend a significant amount of time explaining the reasons for implanting the medical
device and how the medical device treats the patient's problem. However, medical
care providers have a high degree of medical training and may explain the operation
of the device using medical terms which may not be fully understood by a patient.
A patient desiring information may not ask follow up questions until he\she understands
the medical treatment provided by the implanted medical device. On the other hand,
some medical care providers have acquired a skilled bed side manner in addition
to their medical training and explain the medical treatment provided by the implant
in non-medical, easy to understand terms. Unfortunately during times of illness,
a patient may not feel well enough to concentrate on the explanation and remember same.
SUMMARY OF THE INVENTION
It is desirable to provide a patient with information about an implanted medical
device, such as a cardiac rhythm management device, without the need for interpretation
by trained medical personnel. According to one embodiment of the present invention,
a patient report generating system produces a report specifically for the patient.
This would enable a patient, for example, to refer to the report for information
regarding the implanted medical device and where to find additional information
without waiting until the next visit with the physician.
Accordingly, in one embodiment, the present invention is a patient report
generating system providing reports about an implanted medical device, such as
a cardiac rhythm management device, for example a cardiac pacemaker or an implantable cardioverter/defibrillator.
Another embodiment of the invention is a cardiac patient report generating
system including a cardiac rhythm management device, a programming unit communicating
with the cardiac rhythm management device, and an output device producing a report
for a patient.
In another embodiment, the invention is a patient report providing information
regarding a medical device, the information being understandable to a non-medically
trained patient. In another embodiment, the report includes medical device identifying
information, medical device manufacturer information, physician information, and
information specific to the relationship between the medical device and patient.
These and other embodiments, aspects, advantages, and features of the present
invention will be set forth in part in the description which follows, and will
become apparent to those skilled in the art by reference to the following description
of the invention and referenced drawings or by practice of the invention. The aspects,
advantages, and features of the invention are realized and attained by means of
the instrumentalities, procedures, and combinations particularly pointed out in
the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a system diagram of a patient report generating system incorporating
the present invention.
FIG. 2 is a patient report according to the present invention.
FIG. 3 is another embodiment of a patient report.
FIG. 4 is another embodiment of a patient report.
FIG. 5 is a flow chart of a method for producing a patient report.
DESCRIPTION OF THE INVENTION
In the following detailed description of the invention, reference is made to
the
accompanying drawings which form a part hereof, and in which is shown, by way of
illustration, specific embodiments in which the invention may be practiced. These
embodiments are described in sufficient detail to enable those skilled in the art
to practice the invention. Other embodiments may be utilized and structural, logical,
and electrical changes may be made without departing from the scope of the present invention.
FIG. 1 shows a system diagram of a patient medical report generating system
10 for generating a patient report
11. System
10 includes
a cardiac rhythm management device ("CRM device")
12, which is a microprocessor-based
pacemaker with defibrillation and/or antitachycardia pacing capability and includes
a data storage module
14, for example RAM, ROM, EEPROM, etc. Examples of
such devices are found in U.S. Pat. Nos. 6,112,117; 6,108,577; 6,091,990; 6,076,015;
6,067,471; 6,016,446; and 5,978,707, all assigned to the present assignee, and
all herein incorporated in their entirety by reference. The data storage module
14 stores data representing the manufacturer name, contact information,
type of device, device serial number, or other manufacturer identification information.
Module
14 may also store component manufacturer information such as the
name of the lead manufacturer, the lead model number, or the lead serial number.
Module
14 further stores operational parameters of CRM device
12
which include the number of shock pulses applied by CRM device
12 to the
patient's heart, the duty rate of pacing the patient's heart, the lowest allowable
heart rate allowed by the pacemaker, etc. The overall operation of the device is
controlled by a system program running from the memory module
14.
CRM device
12 communicates with a programmer
16 via a bidirectional
communication path
18. Path
18 is typically wireless to allow programmer
16 to read data from the CRM device
12 and transmit programming instructions
to the CRM device with CRM device
12 implanted in a patient. Programmer
16 includes a memory
22 which typically comprises a ROM for program
storage, a RAM for data storage, and a memory device for long term data storage,
such as a hard drive or removable machine readable media. An input device
24,
such as a touch screen or keyboard, allows the medical personnel installing the
CRM device to input data into programmer
16. The input data can include
patient name, diagnosis, CRM device type, CRM device operation parameters, physician
name, physician contact information, and next patient appointment.
An output device
26 is connected to programmer
16 and produces a
patient report
11 based on data sent to it by the programmer. Examples of
the output device
26 are printers, disk drives, CD writers, data storage
writers, etc. In one particular embodiment, output device
26 is a printer
which produces a printed patient report
11 that includes various information
that may be of interest to the patient. Referring to FIG. 2, such information includes
device manufacturer, manufacturer contact information, implant device name, model
and serial number, lead manufacturer, lead type, physician name, physician contact
information, patient activity data, pacing data, heart rate data, exercise data,
CRM system data, and current CRM device settings. Additional data that relates
to the patient and/or the CRM device may also be stored in the programmer and/or
the CRM device. The programmer includes a default patient report which has specific
datafields. However, medical personnel running the programmer can accept the default
patient report or select which data is provided on the patient report
11,
either in a printed form or displayed on a monitor. Thus, the medical personnel
can filter unrelated data or unnecessary data from the patient report.
Reference is now made to FIGS. 3 and 4 which show different embodiments
of formatted patient reports
11A and
11B. Report
11A is a
pacemaker report which is produced when the implanted CRM device
12 is a
pacemaker. Report
11A includes seven distinct fields. The report could have
greater or fewer fields depending on the amount of data to be produced for a patient
report
11 associated with a particular implanted device. Moreover, if one
of the shown fields is not selected by the medical personnel or is not applicable
to the implanted device, then it would be removed from the patient report 11
so as to not imply that information is missing from the report or provide a patient
with information that does not apply to his\her particular implanted device. The
uppermost field on patient report 11A is the manufacturer field 41,
which may include manufacturer name, promotional statements, and manufacturer contact
information. A patient report identification field 43 is directly below
manufacturer field 41. Field 43 may include patient name, another
patient identifier, and the type of report, in FIG. 3 it is shown as a pacemaker
report. An implanted device field 45 is directly below patient report identification
field 43 and is subdivided into a left subfield 46 including device
information, like type, model number and serial number, and right subfield 47
including component information, like lead manufacturer, model number and serial
number. A medical information field 49 is directly below the implanted device
field 45 and includes information explaining, preferably in easy to understand,
plain English terminology (examples of which are provided below), the reason for
the implant, what the implant does, how often the implant activates, the implant
settings, and other information which would be relevant for the particular therapy
provided by the implant. In the FIG. 3 embodiment, field 49 explains that
the implant was needed to account for a slow heart rate in the lower chambers of
the patient's heart. Field 49 goes on to explain that the pacemaker delivers
pacing output a predetermined percentage of time and the lowest heart allowed by
the pacemaker is a predetermined number of beats per minute, both the predetermined
percentage and the predetermined number of beats are CRM device operational parameters
determined by the physician. Field 49 also provides additional information
which a patient receiving a pacemaker may want to know, for example the pacemaker
will pace the patient's heart faster when the patient is active. A physician information
field 51 is directly below the medical information field 49. Field
51 includes the physician's name and contact information, here illustrated
as the physician's phone number. Field 51 also includes the date of the
patient's next appointment. A second manufacturer field 53 is directly below
the physician information field 51. Field 53 includes additional
manufacturer information such as its web address. Field 53 may also provide
a reference to further information regarding pacing and defibrillation as well
as information regarding the implanted CRM device. While the above description
of the patient report positions fields 41-53 relative to each other,
it will be understood that the layout of the fields may be changed.
One aspect of the patient report 11 is to provide easy to understand language
or "plain English" terminology of the treatment provided by the implant to the
patient. The plain English terminology is intended to be understood by non-medically
trained patients and accurately describe the treatment provided by the CRM device.
However, medical terminology need not be completely removed from the patient report
11. Field 49 of FIG. 4 shows both the medical diagnosis of ventricular
fibrillation and its corresponding plain English description of an occasional very
fast heart rate. Modern CRM devices treat a variety of medical conditions and thus
the system must provide a corresponding number of plain English interpretations.
The programmer memory 22 includes a lookup table in which plain English
terminology is associated with the medical treatments provided by the implant device,
in the described embodiments the CRM device 12. One embodiment of the look
up table is shown in table 1.
| TABLE 1 |
|
| Medical Terminology |
Plain English |
|
| Atrial Tachycardia with Block |
Lack of synchronization between heart |
| |
chambers causing very fast heart rate |
| Atrial Flutter |
Occasional very fast, repeating heart rate |
| Atrial Fibrillation |
Occasional very fast heart rate |
| Atrioventricular Nodal |
Abnormally fast heart rhythm |
| Reentrant |
| Atrioventricular Block |
Lack of synchronization between upper |
| |
and lower heart chambers |
| Chaotic Atrial Rhythm |
Irregular heart beat |
| Multifocal Atrial Tachycardia |
Irregular heart beat |
| Sick Sinus Syndrome |
Slow heart rate |
| Sinus Tachycardia |
Very fast heart rate |
| Sinus Arrest |
Pause in a normal heart rhythm |
| Sinus Bradycardia |
Slow heart rate |
| Sinus Node Dysfunction |
Incorrect heart rhythm signal |
| Tachycardia-Bradycardia |
Occasional fast or slow heart rates |
| Syndromes |
| Ventricular Tachycardia |
Fast heart rate |
| Ventricular Flutter |
Occasional very fast, repeating heart rate |
| Ventricular Fibrillation |
Occasional very fast, irregular heart rate |
| Wolff-Parkinson-White |
Fast heart rate |
| syndrome |
|
The above table is not exhaustive of all diagnosis and their corresponding plain
English phrase. Moreover, the plain English phrases may also include other words
or be interpreted differently.
When implanting a device, the medical personnel typically input information
using input device 24 into programmer 16 to create and store medical
records as well as program the implant. The medical personnel typically record
the physician's name, the patient's name, the manufacturer name, and implant model
and serial numbers (step 500). The diagnosis is also stored in the medical
records (step 510), sometimes in medical terminology such as those in Table
1 and sometimes as diagnosis codes. If the diagnosis is input and stored as codes
in memory 22, then the look up table would associate the code with either
the medical terminology and then to the corresponding plain English phrase or directly
associate the diagnosis codes with the corresponding plain English phrase. It is
within the scope of the present invention to access previously stored data representing
certain information for the patient report, for example, the physician name may
be stored in the programmer memory and can be accessed each time the programmer
produces patient report 11. Thus, some information need not be entered each
time a patient report is produced. The present system accesses the stored diagnosis
and associates it with non-medical, plain English terminology written for a patient
(step 515). The information for the patient report is selected by the medical
care provider (step 520) and formatted by the programmer (step 525),
typically in a standard format stored in the programmer memory 22, for example
one of the formats illustrated in FIGS. 2-4. The medical care provider can review
and revise the patient report to fit the individual patient's needs (step 530).
Once the patient report meets the medical care provider's approval, the programmer
sends the report to output device 26 which produces patient report 11
(step 530).
It will be understood that these steps are modifiable for a particular programmer
and/or medical records storage system of the physician. For example, the programmer
may access a medical records database and download physician name and phone number,
diagnosis, and the next appointment information. The programmer may also store
numerous model numbers for the implant device in memory, which is displayed to
the medical care provider in a menu format. The medical care provider would merely
select the implant device's model number from this menu. In another embodiment,
the programmer reads the implant information directly from the implant device itself
or the implant information may be coded on the packaging of the implant, for example
bar coded, which can be read directly into the programmer by an input device, for
example a scanner. In another embodiment, the data for the patient report and the
desired format can be selected for all of a physician's patients. The need for
the medical care provider to review the selected data, format of the report, etc.
need only be performed once and stored in the programmer as a physician specific
default. In an alternative to a physician specific report, a report associated
with a specific diagnosis may also be stored in the programmer which is the default
selection for a specific diagnosis.
Both the patient and the medical care provider benefit by patient report 11
by same providing the patient with easy to understand explanations of the diagnosis
and therapy. The patient report 11 further provides the patient with contact
information for additional sources of information relative to their implant device
and general medical knowledge regarding their condition.
An additional benefit of patient report 11 is it contains vital health
information that is readily accessible and portable with the patient. As a result
when a patient with an implant is away from his/her doctor, for example on vacation,
if the patient takes the patient report 11 along and has a medical emergency,
then the attending medical provider will know some details about the implant and
the patient's physician who implanted the device.
Although the invention has been described in conjunction with the foregoing
specific embodiments, many alternatives, variations, and modifications will be
apparent to those of ordinary skill in the art. For example, it will be recognized
that the format of the patient report may be different than those illustrated in
FIGS. 3 and 4. Such alternatives, variations, and modifications are intended to
fall within the scope of the following appended claims.
*
