|Publication number||US20050004559 A1|
|Application number||US 10/847,699|
|Publication date||Jan 6, 2005|
|Filing date||May 17, 2004|
|Priority date||Jun 3, 2003|
|Also published as||CA2527233A1, CA2527233C, EP1628580A1, EP1628580B1, US8652121, US8696650, US20090030405, US20100114335, US20140155771, WO2004107989A1|
|Publication number||10847699, 847699, US 2005/0004559 A1, US 2005/004559 A1, US 20050004559 A1, US 20050004559A1, US 2005004559 A1, US 2005004559A1, US-A1-20050004559, US-A1-2005004559, US2005/0004559A1, US2005/004559A1, US20050004559 A1, US20050004559A1, US2005004559 A1, US2005004559A1|
|Inventors||Richard Quick, Martin Shabaz, James Dabney, Daniel Kussman, Frank Louw, Paul Lubock|
|Original Assignee||Senorx, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (24), Referenced by (24), Classifications (20), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is related to, and hereby claims the benefit of U.S. provisional application No. 60/475,747, filed on Jun. 3, 2003, entitled BIOPSY CONTROL STATION, attorney docket number R0367-03500.
The present invention relates generally to medical devices, and more particularly to a universal control consol for operating with a variety of medical devices. Still more particularly, the present disclosure relates to the design of a universal medical equipment control consol that interfaces with a variety of handheld medical instruments, and the method to control the same.
Conventional medical equipment design typically requires separate, dedicated hardware and software control modules for each handheld medical device. Each of these devices requires a graphical display, microprocessor, interface circuitry and software to operate the medical device, and to provide the operator with pertinent status/action information. An “operator” is defined as any medical personnel capable of operating the medical device. The operator may be a nurse, a medical doctor, or a medical assistant.
The graphical user interface (GUI) will vary from device to device, thereby resulting in additional cost for operator training, proficiency, and certification. As the number of dedicated control modules increases, surgical and storage spaces must necessarily increase, as must the complexity of inventory logistics.
What is needed is a universal control consol that can control a variety of medical devices, thereby eliminating the need for separate, dedicated control hardware for each medical device.
In view of the foregoing, a universal medical equipment control consol is provided that interfaces with a variety of medical devices.
This disclosure will provide a detailed description of how a medical device interacts with the universal medical equipment control consol. Additional medical devices may be implemented. This concept allows for a universal control consol with all the necessary hardware interface modules and software modules that can control a variety of medical devices, thereby eliminating the need for separate, dedicated control hardware for each medical device.
This universal control consol will provide a graphical user interface (GUI) for all devices that would decrease the need for operator training and certification requirements while increasing the simplicity of operation. Additional benefits include reduced surgical space, storage space, and inventory logistics costs. Some advanced models of the universal control consol may have the ability to handle multiple devices simultaneously.
In one example, a control consol is disclosed for controlling one or more medical devices. The control consol communicates to at least one medical device and, if needed, at least one peripheral device module associated with the medical device. The control consol is microprocessor based for directing an operation of the connected medical device.
The construction and method of operation of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings.
In one embodiment, each of the devices 104, 106, and 108 may represent a biopsy probe, temperature probe, heart rate monitor device, drug infusion tools, anesthesia tools, or other surgical or medical device that may operate with the universal control consol 102. These devices may serve various surgical or non-surgical functions such as separating specimen from tissue bed, encapsulating the separated specimen, insulating a cutter from body, fixing one end of a cutter while S5 moving another end thereof. These devices may be made by or operated with products of SenoRx of Aliso Viejo, Calif. such as the SenoCor Biopsy Device and the EnCor Biopsy Device. The surgical devices may be energized mechanically or through radio frequency (RF) energy for performing the surgery. For instance, a RF surgical tool uses RF energy to remove unwanted body parts while the same function may be achieved by a mechanical tool such as a blade. Each of these medical devices may require a unique set 112 of peripheral modules 114, 116 and 118, which are connectable to and controlled by the universal control consol 102 via connectors 120, 122 and 124, respectively. As an example, the device 104 may be a biopsy probe, which in turn may require a plurality of peripheral modules 114, 116 and 118, which further in turn may be an electro surgical generation (ESG) module, an illumination device, a footswitch module, and a vacuum/fluid pump module. It is understood that peripheral modules provides additional features or functions for the operation of the medical device, and can be of different forms and functions, and they may not be required to be physically connected to the universal control consol as long as they can communicate therewith. In some cases, the peripheral devices are controlled by the medical device through the universal control consol.
The universal control consol 102 is a microprocessor-based electrical device with built-in software functions necessary to operate various medical devices. Each medical device contains a software script, stored in a memory device within the medical device for operating that particular device when connected to the universal control consol 102. For example, the said software script may be stored in non-volatile memories such as erasable programmable read only memories (EPROMs), electrically erasable programmable read only memories (EEPROMs) or flash memories. When a medical device is connected to the universal control consol 102, this software script will be downloaded into the universal control consol random access memory (RAM). This software script will enable the universal control consol 102 to control the functionalities of the particular medical device and to display its pertinent information. During the operation of a medical device, the Graphical User Interface (GUI) software will display information relevant to the operation of the universal control consol 102 and the medical device to the operator. It is understood by those skilled in the art that the information displayed may vary depending upon the type of medical device connected, the operational state of the medical device as well as other environmental factors affecting the operation of both the medical device and the universal control consol 102.
It is understood that although traditionally the medical devices are connected to the universal control consol 102 through wired connections (including connectors and wires) or battery powered for their operations, the control of the medical devices by the universal control consol 102 can be easily implemented through wireless communications. Needless to say, certain peripheral devices may have to be physically connected to the medical device to deliver fluid or assert vacuum. The conventional wired connections have certain advantages such as low signal interferences, but the wireless technology can turn the operation of the medical device to mobile operation, which benefits the operator as well. For example, other than the power output provided by the universal control consol 102, almost all the control signals can be sent through a predetermined wireless communication channel using technologies such as Bluetooth or 802.11 compliant wireless technologies. When the medical device is battery powered, then the operation may be all mobile. It is also practical that the wired communication channels may be used together with the wireless communication channels so that the universal control consol can take advantage of the available wireless technologies for providing convenience to the operator, while still benefiting from using some conventional wired technologies. Similarly, analog signals used in the communications can be replaced by digital signals if appropriate since the digital signal processing technology has also advanced. In short, while the present disclosure only provides some examples for illustrating the inventions, it should be understood that communications between devices can take various forms and the universal control consol 102 is designed to use the most practical technologies for fulfilling the need of the operators.
A housing module may also be provided to house, and to supply electrical power to, some of the aforesaid modules and equipments. An example is provided in
The graphics module 202 may include a cathode ray tube (CRT) display, a liquid crystal display (LCD) or any other type of display that may be used to display information relevant to the operation of the universal control consol 102 and medical devices. The graphics module 202 may also require a piece of Graphical User Interface (GUI) software that is used to display all pertinent information to the operator.
The microprocessor module 204 may include microprocessors, motherboard circuitries, memories and other functional electronic devices that enable the universal control consol 102, the operator controls thereof, the functions of medical device, and the functions of peripheral modules. It may also interface with an external computer via an external computer interface connector for system troubleshooting, software upgrade, and other shop functions.
The software module 206 controls the logical and interface functions of the universal control consol 102, the logical and interface functions of the medical devices attached thereto, the logical and interface functions of the peripheral modules attached thereto, and the operator control switches therein. The software module 206 may also generate various control signals such as audible tones (for example, sounds of Bong, Click, and Alarm) that are applied to a speaker located within the universal control consol 102. The Bong and Click tones may be adjustable by a predetermined setting. Depending on software specification, the alarm tone may or may not be adjustable. As an example, the software may be written in “C” code, although it is understood by those skilled in the art that various other software languages may be used to write the software for the universal control consol 102. Specifically, the software module 206 may include any combination of the following: core software operating the universal control consol 102, GUI software for presenting graphics in the graphics module 202, built-in self-test (BIST) software, and software for controlling and interfacing with medical devices and peripheral modules. Each medical device, when connected to the universal control consol 102, may download a software script. This software script will allow for the control of the particular medical device functions and display its pertinent information.
The hardware interface module 208 may include circuitries and connecting modules necessary to allow medical devices or peripheral modules to be connected to the universal control consol 102. These connecting modules may be general connectors compliant with various well-known standards, including but not limited to Institute of Electrical and Electronics Engineers (IEEE) standards and International Organization of Standardization (ISO) standards. These connectors may also be proprietary connectors specific to a particular medical device or peripheral modules, or a particular line of medical devices or peripheral modules. In addition, the connecting modules may be a circuitry for communicating wirelessly with a device controlled by the universal control consol.
For example, the hardware interface module 208 may have a computer interface connector. The computer interface connector is used for system troubleshooting, software upgrades, and other shop functions. This connector contains connectors for RS-232 communication, connectors for background debug mode (BDM), and connectors for other shop activities. In another example, the hardware interface module 208 may have an AC power input connector, which may be a three-wire connector connectable to 100-120 VAC and/or 220-240 VAC, at 50-60 Hz. In yet another example, the hardware interface module 208 may have an AC power output connector, which is connectable to other peripheral equipments and which provides the other equipments with AC power. In yet another example, the hardware interface module 208 may have a DC power output connector, which is connectable to other peripheral equipments and which provides the other equipments with DC power. It is understood that either DC or AC power can be delivered to an illumination device such as a light bulb or any surgical lighting device attached to or integrated with a medical device such as a biopsy probe used with the control consol. The control consol may provide further remote operation control for the illumination device.
Other hardware interface circuitry and connectors implemented into the universal control consol 102 may depend upon the medical devices and its associated peripheral equipment that have been certified to operate with the universal control consol 102. As additional medical devices are selected, upgrades to the hardware and software may be required. Since analog and digital signals may co-exist in various operations, the universal control consol may have analog-to-digital (A/D) converters or even digital-to-analog (D/A) converters contained therein for processing various signals coming in or going out from the universal control consol.
Referring back to the previous embodying example, the biopsy probe may require an ESG module, a footswitch module, and a vacuum pump module. The biopsy probe and its associated peripheral modules in turn may require the following interface connectors: a medical device connector, an ESG connector, a footswitch connector, and a vacuum pump connector.
The medical device connector may contain a plurality of copper wires for bi-directional digital communications, EEPROM communication, encoder functions, light emitting diode (LED) & relay control, motor control, power, and ground. The ESG connector may provide bi-directional communication for the control and status of the ESG module and the universal control consol 102, and may include a RS-485 data bus for status communication. The footswitch connector may pass information from the footswitch module to the universal control consol 102, thereby allowing the operator to control the ESG module and the universal control consol 102 by the tapping of the foot. Finally, the vacuum pump connector may provide data and control information between the vacuum system and universal control consol 102. It may contain system data and clock lines, vacuum level and control lines, and status lines.
The operator module 210 may include various pushbutton switches and indicators that assist the operator to operate the universal control consol 102. For example, there may be, adjacent to the display screen, three operator pushbutton switches that are under software control. The function of the switches may be dependent upon the display screen at a particular instance. The display screen displays the required actions and what action may be activated with a particular switch at a given instance.
To further illustrate how the operator module 210 assists the operator, the operator module 210 may have two indicator lights, one of which is an orange standby indicator light on the front panel that may be activated when the rear mounted power switch is depressed and the system enters a standby state, while the other of which is a green indicator light on the front panel that may be activated when a front mounted power switch is depressed for a minimum of 2 seconds, thereby signaling the universal control consol 102 to kick-start its boot up sequence. When the front mounted power switch is depressed again for a minimum of 2 seconds, the display may indicate that the universal control consol 102 is in the process of shutting down. During an orderly shutdown, the universal control consol 102 may complete any actions required by the medical device, save any required settings, and then return to the standby mode.
The power module 212 may include a transformer, AC power input and output connectors, a power system, fuse, and a power switch. The power module 212 may supply power to the rest of the universal control consol 102, and may supply power to other peripheral modules and medical devices attached thereto.
In particular, the flowchart 500 illustrates the software flowchart covering the initial boot-up, medical device connection, utility mode setup, boot-up alarm sequence and the downloading of the medical device script. A general high-level software flow 502 illustrates how the software module generally handles any medical device that is connected to the universal control consol 102. This software flow may be unique for each medical device operation.
The flowchart 500 begins at a boot-up process 504 that occurs when the power-on sequence is started. In decision box 506, the universal control consol 102 checks the shop mode jumper to determine if the system should go into the shop mode for troubleshooting/upgrade, as illustrated by box 508, or continue the normal boot-up process. A decision box 510 determines whether a language selection screen should be displayed to the operator to select the desired operator language. If the language selection screen should be displayed, a language screen, which may look like the screen 602, may be displayed. This selection is accomplished through the use of the pushbutton switches located adjacent to the graphical display screen. The universal control consol software script controls the functions of these switches. Once the desired language is selected, a boot-up splash screen that may look like the screen 604 is displayed.
If the medical device has been connected, the script will go directly to download the medical device script, and a screen that may look like the screen 606 is displayed to the operator. If an alarm is generated during the boot-up process, the script will transfer to the boot-up alarm screen 608 to ask the operator to reset the system. If no medical device has been connected, a bypass mode screen that may look like the screen 610 may be displayed, wherein the operator is asked to connect the medical device or to access the utility menu. If the operator connects the medical device, then the script goes directly to the device script download mode and the screen 606 may be displayed. If the operator wishes to enter the utility mode, then the operator depresses the “SELECT” pushbutton switch, thereby switching to the utility screen, which may look like the screen 612. The utility menu allows the operator to adjust the volume level, which may be accomplished in a volume level screen that may look like the screen 614, to adjust the display screen intensity level, which may be accomplished in a display screen intensity level screen that may look like the screen 616, or to go back to the screen 610 such that the operator may connect the medical device. Once the correct volume or display screen intensity is selected, the operator is transferred back to the bypass mode screen. When the medical device is connected to the universal control consol 102, the script goes directly to the device script download mode and screen 606 may be displayed. Once the script is downloaded, the downloaded script controls the universal control consol 102 and its display as determined by the type of medical device connected. In flow 502, the connected medical device determines the system operation and display screens. One example of the system operation and display screens in flow 502 are presented, in detail, in FIGS. 10 to 17. Through this flow, the appropriate control configuration of a medical device is managed by the universal control consol 102. For example, it detects and configures itself to match the operating configuration of the medical device. For example, it detects and provides an appropriate voltage supply for operating the medical device. It may also provide control signals to control the motor in the medical device. It may provide appropriate GUI windows to the operator with regard to the medical device so that the operator only needs to deal with relevant GUI windows for operating the medical device. If a vacuum pump is needed to be used in conjunction with the medical device, it not only will indicate to the operator whether a vacuum pump is properly connected, it will also provide the appropriate operating voltage to the vacuum pump. In short, the universal control consol 102 is to assist the operator to operate multiple medical devices with ease. To the extent possible, all configurable items for operating the medical device are either automatically provided to the device or prompted to the operator to be chosen so that they can be then provided to the connected device.
The three pushbutton switches are utilized in the displays that require an operator action, such as language selection, volume adjust, reset, etc. It is understood by those skilled in the art that all display screens in
The main module 702 contains software functions for the operation. For example, it includes a reset function in assembly code that is required to start the controller and run a portion of the self-test. The main module 702 also includes a high-level code that runs the main loop and performs some additional self-tests, including memory and processor tests.
The tool-code module 704 loads the tool code from nonvolatile memories into the code buffer of the volatile memories and then runs tests thereon. The tool code may be tested by a variety of methods. For example, one tool code testing method is by using cyclic redundancy check (CRC). The tool-code module 704 may also allow the universal control consol 102 to write to nonvolatile memories.
Another functionality of the tool-code module 704 may include the testing of nonvolatile memories. In other words, the tool-code module 704 may run periodic tests to ensure that nonvolatile memories are not corrupted.
The API module 706 may include an API called by the tool code, and an API manager that is used to manage the said API. The API is used by the tool-code module 704 to request the universal control consol 102 to act in a certain manner. As an example, one implementation strategy may call for the use of software interrupts to request certain API routines, via the API module 706.
The self-test module 710 may include built-in, self-test (BIST) software that is used to perform various self-testing operations. Most of these self-testing operations should be non-invasive, i.e., they should test for mis-configuration, but should not actively induce one.
The GUI module 712 may include software that is used to draw outputs to the screen. This GUI module 712 may also include functions such as the initialization of the color palette upon boot-up, the drawing of the first splash display screen, and the refreshing of subsequent display screens.
The communication control module 716 may include software that controls the inputs and outputs through the RS-485 connector. The communication control module 716 keeps all information about a port in a table, which is typically indexed to ensure fast referencing. The interrupt callback routines of the communication control module 716 may be passed to a hardware access layer, thereby enabling the universal control consol 102 to receive incoming data.
The vacuum pump control module 718 may include software that controls the vacuum pump system interface. For example, the vacuum pump control module 718 may be able to detect vacuum and pump power. It may also be able to translate commands sent by the universal control consol 102 to actual pressure, and vice versa.
The motor control module 720 may include software that controls the motors located in the medical device. The motor control module 720 may provide the universal control consol 102 with various operating modes. For example, the motor control module 720 may provide a feedback-controlled operating mode, which may employ a variety of discrete proportional-integral-derivative (PID) feedback algorithms to provide feedback functionality. The motor control module 720 may also provide various constant operating modes, including constant current and constant voltage operating modes, which may be necessary for medical devices that require a steady motor. The RF control module 721 is dedicated to control devices using RF energy.
The binary I/O module 722 may include software that performs the binary input and output. For example, the binary I/O module 722 maps an array of binary outputs to its corresponding array of hardware address registers, and writes data flags to the latter. For example, when the “power-off” button is pressed, the binary I/O module 722 first searches for and locates the corresponding hardware address register, and then begins a power-off sequence. In another example, when a motor is stopped, the binary I/O module 722 may read the corresponding hardware address and return a flag indicating that the particular motor has been stopped.
The universal control consol embodying features of the present invention may be operated in regular ambient temperature and usually requires no special sterilization. The operating voltage may be from 100 to 240 VAC with corresponding standard current limits. It also meets other industry required environmental conditions such as the CISPR 11 or IEC 60601-1-2:2001 for electromagnetic generation and IEC601-2-2 Section 44.3 for drip, splash and immersion requirement. It also meets various international standards including various safety requirements for medical equipments in different countries such as Japan, Canada, EU, and US.
General Design Specifications
In this embodying design 1000, the medical device such as a biopsy device 1002 consists of the SenoCor DR3000 biopsy driver 1004 and a surgical element such as the SenoCor 360 biopsy probe 1006. The biopsy probe 1006 and biopsy driver 1004, when used in conjunction with the universal control consol 102, a VS3000 vacuum system 1008 and a SenoRx ES300 ESG module 1010, are designed to obtain breast tissue biopsy samples. The specifications of SenoCor DR3000, SenoCor 360, VS3000 and SenoRx ES300 may be found at SenoRx's website, at:
With reference to
The embodying design 1000 provides many features, four of which are highlighted below:
1) Radiofrequency (RF) Cutting Tip
The biopsy probe 1006 that attaches to the biopsy driver 1004 incorporates a disposable RF cutting tip. The RF cutting tip enables the device to slide easily through difficult heterogeneous breast tissue, and to penetrate through dense lesions, thereby improving the targeting capability of the device. RF energy is developed by the ESG module 1010, which is controlled by a dual footswitch 1014 and the universal control consol 102. The generator-enable signal is routed from the footswitch 1014 via a cable 1016 to the connector 406, and then through the ESG connector 410 via a cable 1018 to a footswitch input connector on the ESG module 1010. The cable 1018, which may be designed for RS485 communication, provides a communication path to allow the universal control consol 102 to configure the ESG module 1010 for the biopsy device 1002. The RF output from the ESG module 1010 is fed, via a RF cable 1024, to a RF cable connector 1026 of the biopsy driver 1004. The patient return pad 1028 is connected to the ESG module 1010 via a cable 1030.
2) Integrated Coaxial Probe
The disposable biopsy probe 1006 consists of an inner cutting trocar and sample chamber with an outer probe. A trocar is a sharply pointed surgical instrument fitted with a probe and used to insert the probe into a body cavity, typically, as a drainage outlet. An outer probe is typically a small tube for insertion into a body cavity. After a lesion has been targeted, the outer probe remains in place while the inner sample chamber is removed following the removal of a biopsy specimen. The above functions are generated by DC motors in the biopsy driver 1004 that provide linear or rotary motions for the disposable biopsy probe 1006. Medical devices may contain up to four DC motors and each motor is driven by a DAC output located in the universal control consol 102. These signals and the other required signals are routed through the medical device connector 308 and the control cable 1012 to the biopsy driver 1004.
3) Circumferential Vacuum Assisted Biopsy System
The device 1002 harvests tissue from a full 360-degree radius, thereby enabling harvesting of tissue directly from the center of the suspicious mass. This process is assisted by the use of the vacuum switch located on the driver 1004 to remove any excess fluid from the biopsy area. Vacuum is applied by the vacuum system 1008 to a vacuum tube connector 1034 of the biopsy driver 1004 via a vacuum tube 1036. The vacuum system 1008 is under the control of the universal control consol 102 via a cable 1038, which connects to the vacuum connector 408.
4) Control Buttons
With reference to
Specifications for seven of many connectors, cables and tubes associated with the universal control consol 102 are shown as follows:
1) The Medical Device Connector
With reference to
2) The Footswitch Connector
The connector 406 is a 12-pin connector, with shielded cable and with isolated I/O. The footswitch may use two wires for the active signals, one wire for the common return signal, one wire for a shielded signal and eight spare wires for future expansion.
The ESG connector 410. The connector 410 is a 15-pin connector, with shielded cable and with isolated I/O. The connector 410 may contain inputs and output to and from the ESG module 1010 for communicating its status or configuring the ESG module 1010 using a RS-485 communication bus; The connector 410 may also contain several spare wires for future expansion.
3) The Vacuum Connector
The connector 408 is an 18-pin connector, with shielded cable and with isolated I/O. The connector uses two wires for vacuum system data and clock. The inputs contain four bits for vacuum level plus two bits for control. Also included are wires that carry power-on and vacuum-ready status signals.
The external computer interface connector 414. The connector 414 is a 14-pin connector, with non-shielded cable and with non-isolated I/O. It contains 10 wires for BDM communication, three wires for RS-232 communication, and one wire for the shop mode switch that is in turn used for system troubleshooting and/or upgrade.
4) The Input Power Connector
The connector 418 is a 3-pin connector, with a non-shielded, removable cord. The input power may be 100/220 VAC, at 50 or 60 Hz, with a 2 Amps maximum input limit.
5) The Output Power Connector
The connector 420 is a 3-pin connector, with a non-shielded, removable cord. The output power may be 100/220 VAC, at 50 or 60 Hz.
6) Driver Components
The device 1002 has the following components that are controlled by the software script downloaded into the universal control consol 102:
7) Stroke Motor
The stroke motor controls the axial motion of the cutting sleeve of the device 1002. The motor is in turn controlled by the motor control module 720.
8) Cutting Motor
The cutting motor controls the rotational motion of the cutting sleeve of the device 1002. The motor is in turn controlled by the motor control module 720.
9) Vacuum And Sample Switches
The vacuum and sample switches of the device 1002 are contact inputs to digital inputs of the control module 102. The script uses the API as specified in the API module 706 to retrieve the values of these inputs from the control module 102.
10) Vacuum LED
The Vacuum LED of the device 1002 is an output of the control module 102. The script uses the API as specified in the API module 706 to control its state.
The driver unit receives its power, control and status information via the control cable 1012 that connects to the medical device connector 308 of the universal control consol 102. The device 1002 requires a vacuum to remove any excess fluid in the biopsy area and to pull tissue into the biopsy area for subsequent cutting. This vacuum is applied via the vacuum connector 1034 and controlled by the “vacuum” button 1104 or the script software depending on the state of the tool. Controlled RF power or a mechanical cutter may also be necessary for the device 1002 to cut through breast tissue. The RF power is applied through the RF cable connector 1026 and controlled by the footswitch 1014. Also the script software can inhibit the footswitch use or turn on the RF power without the footswitch. Whenever a sample of the tissue is desired, the “sample” button 1102 may be pressed to obtain the tissue sample.
There may be other components that are needed for the medical operation. For example, sterile water or saline line is needed for various surgical operations, and it can be provided through and controlled by the control consol as well.
11) Flow Logic
With reference to
In the tool initialization state 1206, tools are initialized without a probe inserted. The tool cycles the stroke motor, by ensuring that it operates at the full stroke and is left in the closed position. On the closing stroke the tool operates the cutting motor, thereby checking for its function. The tool polls the probe's phototransistors to ensure that a tool is not inserted. The tool polls the switches available to the user (“vacuum”, “sample” and “foot switches”) to ensure that none of them is pressed at the end of the cycle of the stroke motor, a situation that may indicate a stuck contact. If a probe is inserted during this state, the software exits to the tool failure state and may display a display screen 1214. If an error further occurs, the script will exit to the appropriate error state.
In the calibration state 1216, if the tool initialization state 1206 is successful, the screen 1218 is displayed while waiting for the surgical component such as a probe or a blade to be inserted. Once the probe is inserted, the calibration state 1216 first waits for the “sample” button to be pressed by the operator and then performs two short strokes to calibrate the tool, when the screen 1220 may be displayed. If an error occurs during calibration, such as when the stroke motor is not responding properly or the probe becomes unlatched, the script will exit to a tool failure state 1222 and displays the screen 1224. If an error further occurs, the script will exit to the appropriate error state.
If calibration is successful, the flow goes to a biopsy area closed state 1226. The biopsy area closed state 1226 first waits for the “sample” button to be pressed and then opens the cutter. In state 1226, the script performs the following functions:
Some of the possible screens in the state 1226 are: screen 1228, wherein the biopsy area is closed and RF is inactive; screen 1230, wherein the biopsy area is closed but RF is active; screen 1232, wherein the biopsy area is closed and RF is disabled; screen 1234, wherein distal trim is enabled; and screen 1236, wherein the biopsy area is closed, RF is inactive and the footswitch is still pressed from previous RF activation.
The state 1226 typically goes to the state 1238 when the “sample” button is pressed. In the state 1238, the script performs an open stroke if the distal trim is not enabled and displays the screen 1240. It is understood that the operator may select a full or half stroke opening of a biopsy cutter, and some necessary GUI may be provided. When the open stroke is successfully completed, the flow goes to the biopsy area open state 1242. If an error occurs during the state 1238, such as when the stroke motor is not responding properly or probe becomes unlatched, the script will exit to the tool failure state 1222. If other errors further occur, the script will exit to the appropriate error state.
In the state 1242, the operator is allowed to activate the vacuum module or ESG module (e.g., if distal trim is not enabled). When the “sample” switch is pressed, the flow typically goes to the closing biopsy area state 1244. The ESG module is disabled if this state is entered from the probe unlatched state PUS, where the probe became unlatched during the close & cut processing of the state 1244.
In state 1242, the script performs the following functions:
Some of the possible screens in the state 1242 are: the screen 1246, which is displayed upon successful completion of the state 1238, or other states defaulting to the state 1242 even as the state 1242 is not explicitly listed; the screen 1248, which is displayed after fast-closing processing failed but biopsy area is subsequently opened; the screen 1250, which is displayed after entering from the state 1238 after the state 1244 and close and cut processing state have failed but biopsy area is subsequently opened; the screen 1252, which is displayed after entering from the completion of the state 1238 after the timer expired or the stroke motor has stopped during the state 1238; the screen 1254, which is displayed after entering from the state PUS, which is in turn entered from the state 1244 during the close and cut processing state; the screen 1256, which is displayed when ESG module is active; the screen 1258, which is displayed when the vacuum module is active; the screen 1260, which is displayed when entering from the successful completion of the state 1238, or other entry points not explicitly listed; the screen 1262, which is entered from the state 1238 after the state 1244 and the close and cut processing state have failed but biopsy area is subsequently opened; the screen 1264, which is entered from the completion of the state 1238 after the time expired or after the stroke motor has stopped during the state 1238; and the screen 1266, which is entered from the successful completion of the state 1238 when distal trim is enabled.
In state 1244, the vacuum module is activated for two seconds, and then the state 1244 starts the stroke motor to close the cutter and starts the cutting motor. If the “vacuum” button is pressed during the two-second vacuum period, the script will immediately start the stroke motor, at a rate faster than used when cutting, and will not start the cutting motor. When the close stroke is successfully completed, the flow goes to the state 1226. If an error further occurs, the script will exit to the appropriate error state.
In state 1244, the script performs the following operations:
Some of the possible screens in the state 1244 are: the screen 1268, which is displayed during pre-sample vacuum processing; the screen 1270, which is displayed during fast-closing processing; the screen 1272, which is displayed during close and cut processing; the screen 1274, which is displayed during the pause sample processing; and the screen 1276, which is displayed during distal trim processing. It is further understood that if in any one of the states 1216, 1222, 1226, 1238, 1242, 1244, a medical device such as the biopsy driver is removed, all these states are routed to state 1212.
The state PUS is entered from any operational (non-error) state that has a probe inserted in the device. The script prompts the user to reseat the probe as is displayed to the operator as screen 1278. In most cases, this state exits back to the state the script was in when the error occurred. The exception is if the script was in the state 1244, in either the pre-sample vacuum or close and cut processing. In those cases, the state PUS exits to the state 1242, with the ESG module disabled if the error occurred during the close and cut processing.
With reference to both
With reference to both
The following screens are displayed in the vacuum failure state: the screen 1604, which is displayed while the vacuum is recovering; the screen 1606, which is displayed after the vacuum is not recovered; and the screen 1608, which is displayed after vacuum has failed to recover.
The following screens are displayed in the tool exit state: the screen 1702, which is displayed after an integrity check for the ESG module has failed; the screen 1704, which is displayed after an integrity for the tool has failed; the screen 1706, which is displayed after the pump fails to initialize; and the screen 1708, which is displayed after the tool script exits normally.
The above disclosure provides many different embodiments or examples for implementing different features of the disclosure. Specific examples of components and processes are described to help clarify the disclosure. These are, of course, merely examples and are not intended to limit the disclosure from that described in the claims.
Although the invention is illustrated and described herein as embodied in a design and method for a universal reusable medical equipment control module, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the scope of the disclosure, as set forth in the following claims.
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|International Classification||A61B10/02, A61B10/00, A61B18/14, A61B19/00, A61B17/00|
|Cooperative Classification||A61B19/46, A61B2017/008, A61B10/0283, A61B10/0266, A61B2017/00482, A61B2017/00225, A61B5/024, A61B10/02, A61B2017/00973, A61B2017/00199, A61B5/01, A61B18/14|
|European Classification||A61B10/02P8, A61B10/02P6|
|Sep 10, 2004||AS||Assignment|
Owner name: SENORX, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:QUICK, RICHARD L.;SHABAZ, MARTIN V.;DABNEY, JAMES H.;ANDOTHERS;REEL/FRAME:015802/0318;SIGNING DATES FROM 20040618 TO 20040707