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.

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&#39;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&#39;s heart, the duty rate of pacing the patient&#39;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  11 A and  11 B. Report  11 A is a pacemaker report which is produced when the implanted CRM device  12  is a pacemaker. Report  11 A 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  11 A 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&#39;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&#39;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&#39;s name and contact information, here illustrated as the physician&#39;s phone number. Field  51  also includes the date of the patient&#39;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&#39;s name, the patient&#39;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&#39;s needs (step  530 ). Once the patient report meets the medical care provider&#39;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&#39;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&#39;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&#39;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.