Source: http://www.google.com/patents/US20040230248?dq=6,587,403
Timestamp: 2016-12-04 18:30:02
Document Index: 409021242

Matched Legal Cases: ['art 102', 'art 102', 'art 102', 'art 102', 'art 102', 'art 102', 'art 102', 'art 102']

Patent US20040230248 - Device programmer with enclosed imaging capability - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsMethods and electronic tools for imaging a chest region of a patient and communicating with a heart stimulation device used by the patient are disclosed. The electronic tool may include a communications device for two-way data transmission of signals encoded with information to and from the heart stimulation...http://www.google.com/patents/US20040230248?utm_source=gb-gplus-sharePatent US20040230248 - Device programmer with enclosed imaging capabilityAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS20040230248 A1Publication typeApplicationApplication numberUS 10/792,562Publication dateNov 18, 2004Filing dateMar 3, 2004Priority dateJul 13, 2001Also published asUS7286877Publication number10792562, 792562, US 2004/0230248 A1, US 2004/230248 A1, US 20040230248 A1, US 20040230248A1, US 2004230248 A1, US 2004230248A1, US-A1-20040230248, US-A1-2004230248, US2004/0230248A1, US2004/230248A1, US20040230248 A1, US20040230248A1, US2004230248 A1, US2004230248A1InventorsDouglas DaumOriginal AssigneeDouglas DaumExport CitationBiBTeX, EndNote, RefManPatent Citations (21), Classifications (10), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetDevice programmer with enclosed imaging capability
DETAILED DESCRIPTION [0021] Various embodiments of the present invention will be described in detail with reference to the drawings, wherein like reference numerals represent like parts and assemblies through the several views. Reference to various embodiments does not limit the scope of the invention, which is limited only by the scope of the claims attached hereto. [0022] Embodiments of the present invention include an electronic tool for application to various activities such as electrical lead placement and implantable device optimization. Providing an imaging system with a device communication system allows a single tool to obtain images of the lead position and the hemodynamic response as well as obtain data signals indicative of the hemodynamic response while also communicating instructions to the implantable device to control its operation. A processing system may be included within the tool to facilitate automatic analysis and corresponding parameter optimization. A display may be included to facilitate user visualization of the lead position and/or hemodynamic response. Including an input device within the tool allows the user to influence the instructions communicated to the implantable device. [0023] [0023]FIG. 1 shows a block diagram of an exemplary electronic tool 100 incorporating programming and imaging functions. The tool 100 in this example includes an imaging device such as an ultrasound transmitter/receiver module 136 that sends and receives electrical signals through line 134 to a phased array transducer 104. The phased array transducer 104 generates ultrasound energy waves 106 that radiate onto the chest of the patient having an implantable device 122. The heart 102 of the patient may have several electrodes installed including an atrial electrode 114, a right ventricle electrode 110, and a left ventricle electrode 112. These electrodes are electrically connected to the implantable device 122 through leads 126, 128, and 130. For embodiments where an ultrasound imaging device 136 is used, the leads 126, 128, and 130 and the electrodes 110, 112, and 114 may be coated with an echogenic material that is opaque to ultrasound energy. The ultrasound imaging device may employ circuitry such as that known in the art for ultrasound imaging. [0024] The transmitter/receiver module 136 is in electrical communication with a processor 146 through line 138. The transmitter/receiver module 136 passes an image signal created from the reception of ultrasound energy by the phased transducer array 104 to the processor 146. The image signal may contain digital data created by an analog-to-digital conversion implemented by the transmitter/receiver module 136. The processor 146 may then employ image processing techniques to the image signal data to analyze various aspects of the signal, as is discussed below. Alternatively, or in addition to feeding the image signal to the processor 146, the transmitter/receiver module 136 may feed the image signal directly to a display device 162 for real-time display of a representation of the image signal. [0025] The electronic tool 100 also includes a communications device such as a telemetry module 140. Telemetry module 140 receives signals from the processor 146 through line 144 and provides signals to the processor through line 142. Telemetry module 140 sends and receives signals from a loop antenna 116, which typically is a wire loop. The loop antenna 116 radiates electromagnetic energy in the form of a signal 118. The signal 118 generally has encoded information such as instructions for the implantable device 122 or trending data to be stored by the implantable device 122. The telemetry communications device 140 may use circuitry such as that known in the art for implantable device communications. [0026] The implantable device 122 receives the signal 118 from the loop antenna 116 and includes its own processing device for interpreting the encoded information and carrying out the instruction. Typically, the instruction involves adjusting the timing of the stimulation pulse provided to one of the electrodes in the heart 102. The implantable device 122 generally includes memory 124 such as for storing instructions received from the loop antenna 116. The memory 124 may also store trending information, such as electrogram information that is recorded by the implantable device 122 through the detection of electrical events by the electrodes 110, 112, and 114 in the heart 102. Other trending information that may be stored by memory 124 includes but is not limited to heart size and left ventricle septum-lateral wall synchronization. [0027] The implantable device 122 radiates a signal 120 that also has encoded information, such as electrogram data being measured in real-time by the electrodes 110, 112, and 114 or trending data that is stored by memory 124. The radiated signal 120 is received by the loop antenna 116 and is converted to an electrical signal that is transferred to the telemetry module 140. The telemetry module 140 may then employ an analog-to-digital conversion to convert the received signal to a data signal that is then passed to the processor 146. Alternatively, or in addition to feeding received signals to the processor 146, the telemetry module 140 may feed signals directly to the display device 162 for real-time display of the information encoded on the signal 120. [0028] In an alternative embodiment, antenna 116 is of a type optimally configured for transmitting and receiving RF signals. The RF antenna radiates electromagnetic energy in the form of an RF signal 118. The signal 118 generally has encoded information such as instructions for the implantable device 122 or trending data to be stored by the implantable device 122. In an embodiment utilizing RF data signals, the telemetry communications device 140 may use basic RF base station circuitry such as that known in the art for a basic RF system. [0029] The implantable device 122, which also includes RF circuitry that allows the implantable device 122 to perform as a mobile RF terminal, has a communications link with the telemetry communications device 140 via antenna 116. The implantable device 122 receives the signal 118 from the antenna 116 and includes its own processing device for interpreting the encoded information and carrying out the instruction. [0030] RF technology provides for wireless transmission of data by digital radio signals at a particular frequency. It provides a means for maintaining bi-directional or two-way, online radio connection between the telemetry communications device 140 and the implantable device 122. [0031] The processor 146 may employ various operations, discussed in more detail below with reference to FIGS. 3, 4, and 5 to utilize the signals received from the imaging device 136 and/or the communications device 140. The processor 146 may store data to and access data from storage device 152, such as electronic memory or magnetic storage. Data is transferred to the storage device 152 through line 154, and data is received from the storage device 152 through line 156. The processor 146 may be a general-purpose computer processor or processor typically used for a programmer. Furthermore as mentioned below, the processor 146, in addition to being a general-purpose programmable processor, may be firmware, hard-wired logic, analog circuitry, other special purpose circuitry, or any combination thereof. [0032] The processor 146 may also transfer a display signal to a display device 162 through line 164. The display signal may include the image signal produced by the imaging device 136 as well as an information signal produced by communication device 140. The image signal component from the imaging device 136 is typically an ultrasound image. The information signal component from the communications device 140 is typically an electrogram. The display device 162 then displays on a screen a representation of the ultrasound image and/or a representation of the electrogram, which can be seen in more detail with reference to FIG. 6 discussed below. [0033] The electronic tool 100 may also include a printer 158 to produce a paper copy of the display. The printer 158 receives the data signal for the paper copy through line 160. An input device 148 may also be included with the electronic tool 100. The input device 148 may include one or more various input interfaces, such as a keyboard, mouse, or stylus. The input device 148 communicates with the processor 146 through line 150. [0034] [0034]FIG. 2 shows an external view of the electronic tool 100 according to a preferred embodiment of the present invention. The tool 100 includes the external transducer 104 for sending and receiving ultrasound energy used for creating images. The tool 100 also includes an antenna 116 for sending and receiving modulated electromagnetic signals that may establish bi-directional communications with the implantable device 122. The tool 100 that is shown includes an input device 148 (see FIG. 1.) having both a keyboard 172 and a stylus 166 that allow the user to input information such as function selections. The stylus 166 communicates with the input device module 148 through line 168. [0035] The electronic tool 100 also includes a display screen 170 controlled by the display device 162. The display screen 170 may be a liquid crystal display (LCD) or other display type such as a cathode ray tube (CRT). The display screen 170 may show various forms of information, such as programmer menus, device parameter settings, the image generated by the image device 136, and any information sent or received by the communications device 140. [0036] The electronic tool 100 may be enclosed within a housing 174 made of metal, plastic, or other rigid material. The keyboard 172 and display screen 170 may be integrated into the housing 174 such that the electronic tool is enclosed within a single housing. Alternatively, multiple housings may be provided for various components, such as including a first housing for the display screen 170, a second housing for the keyboard 174, a third housing for the processor 146, a fourth housing for communications device 140, and a fifth housing for the imaging device 136. [0037] [0037]FIG. 3 shows the operational flow 186 of the processing steps of one embodiment whereby the operation of the heart stimulation device 122 is optimized. The process begins by the processor 146 receiving an input selection from a user at selection operation 176. The display screen 170 may provide a user interface that allows the user to make selections from menus. A measurement menu may be provided to display the response measurements that the user can select to optimize. These may include but are not limited to ejection fraction, stroke volume, end diastolic volume, E/A (early wave/atrial kick) separation, cardiac output, and wall synchronization of the septum-lateral wall displacement. Using an input device 148, the user then selects the desired measurement(s) to optimize. [0038] After receiving the measurement selection(s), the processor 146 then configures the imaging device 136 to produce an image type that corresponds to the selected measurement(s) at configure operation 178. For example, if cardiac output or stroke volume is desired, the processor 146 may configure the imaging device 136 to produce an aortic flow image rather than an ordinary image of the heart. The operator then places the transducer 104 over the aorta. If volume and ejection fraction measurements are desired, the processor 146 may configure the imaging device 136 to produce a ventricular cross-section image, and the operator places the transducer 104 over the ventricle. If a filling profile measurement is desired, the processor 146 may configure the imaging device 136 to produce a mitral flow image, and the operator places the transducer 104 over the mitral valve. [0039] Once the imaging device 136 has been properly configured, the processor 146 may then receive a selection from the user from a menu of device parameters that may be varied to alter the chosen measurement. The parameters may include but are not limited to the atrial-ventricular (A/V) delay, the lower rate limit, the sensed A/V offset, the maximum sensor rate, the maximum tracking rate, and the right ventricle-left ventricle delay. For certain parameters, processor 146 may accept ranges entered by the user, such as an upper and lower limit to the atrial-ventricular (A/V) delay. By this point, the imaging device 136 may be providing the appropriate image signal to the processor 146, which then extracts the measurement(s) from the image signal and displays the measurement(s) on the display screen 170. A representation of the image signal itself may also be displayed so the operator may visualize the response of the heart. [0040] After the desired parameter and corresponding range have been entered, the processor 146 begins to optimize the measurement(s) at optimize operation 182 by varying the chosen parameter within the range by communicating instructions to the heart stimulation device 122. The optimization process is discussed in more detail below with reference to FIG. 4. Once the measurement(s) taken from the image signal reaches the optimum value, the optimization process terminates and the current value of the parameter(s) is taken to be the optimal value for the chosen measurement(s). The processor 146 may make other measurements at this operation as well, such as those to be stored by the tool 100 or the heart stimulation device 122 for trending purposes including measurements such as heart size that cannot be altered through device parameter manipulation. [0041] The processor 146 then programs the heart stimulation device 122 with the optimal value(s) for the parameter(s) at program operation 184. The processor passes the programming instruction including the parameter(s) and optimal value(s) to the heart stimulation device 122 through a telemetered signal provided by the communications device 140. The program operation 184 may also involve the processor 146 sending a programming instruction including a measurement, such as the previously selected measurement or another, that is to be stored in the memory 124 of the processing device so that it can be retrieved by the electronic tool 100 at a later date for trending purposes. [0042] As discussed above, FIG. 4 shows the optimization step 182 in greater detail. The optimization step 182 begins by the processor 146 receiving the image signal taken from the imaging device 136 at image operation 188. At this point, the processor 146 may also be streaming the image signal to the display device 162 for display on the display screen 170, or the image device 136 may provide the image signal to the display device 162 directly. [0043] The processor 146 then processes the data of the image signal at process operation 190 to make the selected measurement(s) by using image processing techniques known in the art. For example, the processor 146 may measure the velocity from the aortic flow image and integrate the velocity with respect to time when determining cardiac output. In another example, to measure lateral wall displacement, the processor 146 may detect and measure motion of an echogenic lead located on the lateral wall. Once the measurement(s) are obtained, the measured value(s) are compared to an optimum value(s) at compare operation 192. In the lateral wall displacement example, the optimum value may be a threshold displacement that must be reached or exceeded to be optimal. The optimum value for each measurement may be one that is stored in memory 152 of the tool 100 or one that is specified by the user when selecting the tool at selection operation 176 of FIG. 3. [0044] After the comparison has occurred, query operation 194 detects whether the measurement(s) equal the optimum value(s), or exceeds it in the case of some measurements such as lateral wall displacement. If so, then the optimization operation 182 reaches stop operation 198 and operation proceeds to program operation 184 of FIG. 3. If query operation 194 detects that the measurement(s) are not equal to the optimum value(s) or is some cases whether the measurement is less than the optimum value, then parameter operation 196 triggers the processor 146 to generate an instruction that alters the parameter value(s) within the heart stimulation device 122 by sending the instruction through a signal provided by communications device 140. [0045] After allowing for the heart stimulation device 122 to implement the new parameter value(s) and allowing the patient's heart 102 to respond to the change, receive operation 188 again retrieves an image signal containing the data showing the heart's response to the change. The optimization process 182 then repeats continuously until the measurement(s) equal the optimum value(s). Finding that the measurement(s) do equal, or is some cases exceeds, the optimum value(s) may require determining whether the measurement(s) lie within a permissible tolerance range centered about the optimum value(s). [0046] [0046]FIG. 5 shows another process that may be implemented using the tool 100. This process 200 involves placing leads of the heart stimulation device 122 within the heart 102 of the patient. This process 200 begins by the processor 146 retrieving the image signal from the imaging device 136 at image operation 202. For determining lead placement, the image signal will typically be an actual picture of the heart 102. The processor 146 retrieves a data signal from the communications device 140 at data operation 204. The data signal may be an intracardiac electrogram signal, a pacing impedance signal, or other device/lead parameter signals that are useful in optimizing the lead position. [0047] At representation operation 206, a representation of the image signal (i.e., an actual picture of the heart) is displayed on the display screen 170, which also displays a representation of the data signal (i.e., an electrogram, etc.). Displaying both the representation of the image signal and the representation of the data signal permits the user to see both the electrical and mechanical responses of the heart 102 and permits the delay between the two to be observed. The process continues to query operation 208, which detects whether the lead is in a proper position. The query operation 208 may function by prompting the user to indicate through the input device 148 that the lead has reached a proper location. Alternatively, the processor 146 may analyze the data signal to determine whether the lead has a proper location based on various measurements of heart activity. If no indication of proper location is detected, operation returns to receive operation 202 where the procedure is repeated. [0048] Once query operation 208 finds that the lead is in a proper location, the processor 146 analyzes the data signal to find optimal parameter settings at analyze operation 207. For example, the processor 146 may determine the natural A/V delay from the data signal by using the lead as a sensor to detect intrinsic heart activity. From this analysis, the processor 146 can determine optimal parameter settings. After completing the analysis, the processor 146 formulates an instruction including the optimal parameter settings that are then transmitted to the heart stimulation device 122 with the communications device 140 at program operation 209. [0049] [0049]FIG. 6 shows an example of the contents 210 of display screen 170 of the electronic tool 100. The contents 210 of this embodiment include a menu area 212 that includes measurement selections 214 and parameter selections 218. Also, measurement area 216 is included to show the current measurement value, and parameter area 220 is included to receive and show the current parameter range. As shown, the selected measurement is cardiac output and it has a current measured value of 5.1 liters per minute. The selected parameter is A/V delay and the designated range is from 30 to 200 milliseconds [0050] The contents 210 of the screen 170 also include an image area 222 for displaying a representation of the image signal, such as displaying an actual picture of the heart or an image of flow. As shown, an image of flow through the mitral valve is being displayed in the image area 222. The display may also include an external cardiac signal area 224 for displaying a representation of a data signal, such as an external or surface electrocardiogram. The external electrocardiogram signal may originate from an EKG machine that feeds an output signal into an analog input port forming part of input device 148 (See FIG. 1). The analog input port may then direct the output signal to the display device 162. Alternatively, the EKG functionality could be included as part of the functionality of the tool 100. [0051] The contents 210 of the display screen 170 also include an intracardiac signal area 226. This area is for displaying a representation, such as an intracardiac electrogram, of a data signal received by the communications device 140 from the heart stimulation device 122. Supplemental image area 228 is also included in the display screen 170 to show an actual but limited image of image of the heart to indicate to the user where the transducer 104 is located relative to the heart 102. The supplemental image area 228 is useful when a flow image is to be used and the user must position the transducer 104 over the aorta or a particular valve where flow is to be measured. [0052] The embodiments of the operations of the invention, such as but not limited to those of FIGS. 3, 4, and 5 are implemented as logical operations in the system. The logical operations are implemented (1) as a sequence of computer implemented steps running on a computer system of the electronic tool comprising a processing module such as processor 146 and/or (2) as interconnected machine modules running within the computing system. [0053] This implementation is a matter of choice dependent on the performance requirements of the computing system implementing the invention. Accordingly, the logical operations making up the embodiments of the invention described herein are referred to as operations, steps, or modules. It will be recognized by one of ordinary skill in the art that the operations, steps, and modules may be implemented in software, in firmware, in special purpose digital logic, analog circuits, and any combination thereof without deviating from the spirit and scope of the present invention as recited within the claims attached hereto. [0054] While the invention has been particularly shown and described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that various other changes in the form and details may be made therein without departing from the spirit and scope of the invention. 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