Patent Application
20070156125
The following patents and/or patent applications are hereby incorporated by reference herein in their entirety:
U.S. Pat. No. 6,551,255, entitled “Device for Biopsy of Tumors,” filed Oct. 16, 2000; U.S. patent application Ser. No. 10/421,598, entitled “Device for Biopsy of Tumors,” filed Apr. 22, 2003; U.S. Pat. No. 6,789,545, entitled “Method and System for Cryoablating Fibroadenomas,” filed Oct. 4, 2002; and U.S. patent application Ser. No. 10/941,511, entitled “Method and System for Cryoablating Fibroadenomas,” filed Sep. 14, 2004. U.S. patent application Ser. No. 11/210,436, entitled “Rotational Core Biopsy Device with Liquid Cryogen Adhesion Probe,” filed Aug. 23, 2005.
Not Applicable.
Not Applicable
1. Field of the Invention
This invention relates generally to medical devices, and, more particularly, to electronically controlled medical devices used to conduct procedures that involve inserting at least part of a sterile object into the body of a medical subject.
2. Description of Related Art
Many medical procedures involve inserting a sterile object, such as a needle or probe, into the body of a medical subject, such as a human patient. For instance, certain biopsy procedures involve inserting a needle into a patient and removing a portion of suspect tissue.
Medical devices for performing these types of procedures can be complex. One such device is described in U.S. Pat. No. 6,551,255. As described therein, a biopsy device includes a source of cryogenic fluid, a mechanism for releasing the cryogenic fluid, a needle for conducting the cryogenic fluid toward an administration site, a cutting cannula for cutting a core of tissue surrounding the needle, and a drive system for advancing and retracting the cannula.
The design of this biopsy device has evolved over time to become more automated. It has been equipped with a user console, a power source, and a microprocessor. These features allow a biopsy procedure to be conducted largely under electronic control. The microprocessor responds to user button-presses at the console to perform sequences of activities. For example, once a user inserts a biopsy needle into a suspect mass, the user presses a button. The device then automatically performs a sequence of steps, which include administering a designated amount of cryogenic fluid, waiting a designated period of time for tissue to adhere to the needle, and advancing the cutting cannula after the designated period of time expires.
As this biopsy device has become more complex, it has also become more expensive. Expense is an important factor to consumers of these devices because each device can generally be used only once. After its first use, the device is no longer sterile and is generally discarded.
To avoid discarding an entire device after a single use, the device has been modified to be more modular. Reusable portions of the device have been segregated from disposable, single-use portions. The disposable parts of the device include the needle and the cutting cannula, i.e., the portions that are actually insertable into the body of a patient. Other portions of the device are reusable. An example of this type of device is disclosed in U.S. patent application Ser. No. 11/210,436, entitled “Rotational Core Biopsy Device with Liquid Cryogen Adhesion Probe.”
As is known, different biopsy procedures call for needles and cannulas of different gauges, lengths, and/or compositions. There are many reasons for this. One is the type of mass being biopsied—whether it is soft or hard, mobile or immobile, densely or sparsely vascular. Another is the location of the mass within the patient's body—whether it is close to the surface or deep. Yet another is the context in which the device is to be used. For example, ferrous needles and cannulas should generally be avoided for procedures guided by magnetic resonance imaging (MRI).
For optimal results, the conduct of a biopsy procedure is preferably varied to account for differences in the gauge, length, and/or composition of the needle and/or cannula used. For instance, greater amounts of cryogenic fluid may be needed for larger needles. Longer delays may be needed between administering the cryogenic fluid and advancing the cannula for larger cannulas.
Previously, the need for different needles and cannulas has been managed by providing integrated biopsy devices specifically tailored for different applications. Each device was programmed to perform optimally with the needle and cannula that it included.
In making the design more modular, however, it has become desirable to allow the reusable portion of the device to be mated with a wide variety of needles and cannulas. This gives rise to a new problem, however: how to ensure that optimal settings are used for the selected needle and/or cannula. What is needed is an effective way of varying the settings of the reusable portion of a device depending upon the particular disposable parts used.
According to an embodiment of the invention, a medical device for performing a medical procedure includes a disposable unit and a reusable unit. The disposable unit is at least partially insertable into the body of a medical subject and includes an encodable device for storing information. The reusable unit is connectable to the disposable unit and includes a controller for directing actions of the medical device in response to the information stored in the disposable unit.
According to another embodiment, a medical device includes a housing and a mechanical interface portion. The mechanical interface portion is disposed at least partially within or upon the housing and is adapted for mechanically engaging with a disposable unit. The disposable unit is at least partially insertable into a medical subject and stores information pertinent to the medical procedure. A controller is disposed within the housing for conducting automated steps of the medical procedure. These steps are performed in response to information received from the disposable unit.
According to a further embodiment, a medical device for performing a medical procedure includes a disposable unit that is insertable into a medical subject. The disposable unit has an encodable device for storing information and an interface portion for mechanically engaging with a reusable unit.
According to yet another embodiment, a medical device includes a plurality of disposable units and a reusable unit. Each disposable unit is insertable into the body of a medical subject and includes an encodable device for storing information. The reusable unit includes a controller for directing automated actions to be performed by the medical device in response to the information stored in the encodable device. The reusable unit has a mechanical interface portion for mechanically engaging with a respective disposable unit and a communications interface portion for receiving the information from the respective disposable unit.
According to another embodiment, a method for performing a medical procedure includes engaging a first unit with a second unit. The method further includes conveying information stored in the first unit to the second unit, inserting at least part of the first unit into the body of a medical subject, and performing a medical procedure on the medical subject in response to the copied information.
According to yet another embodiment, a method for performing a medical procedure includes engaging a first unit with a second unit. The first unit is insertable into the body of a medical subject. The method further includes conveying information stored in the first unit to the second unit and configuring the second unit for performing automated portions of the medical procedure responsive to the information copied from the first unit.
Additional objects, advantages, and novel features of the invention will become apparent from a consideration of the ensuing description and drawings, in which
As used throughout this document, the words “comprising,” “including,” and “having” are intended to set forth certain items, steps, elements, or aspects of something in an open-ended fashion. Unless a specific statement is made to the contrary, these words do not indicate a closed list to which additional things cannot be added.
The nose portion 116 is threadedly attached the housing 110. By unscrewing the nose portion 116 from the housing 110, the device 100 can be separated into two distinct portions: a reusable portion 210 and a disposable portion 212. A threaded region 220 extends from the housing 110 of the reusable portion 210 and mates with a complementarily threaded region 240 (See
The reusable portion 210 includes components that may be used repeatedly for performing a large number of biopsy procedures. These include the housing 110, user console 112, and knob 114. The reusable portion 210 also includes internal components (not shown), such as a battery, an electronic controller, a motor and gearbox, and various pneumatic tubes and valves. The knob 114 can be unscrewed for inserting a canister of compressed gas, such as CO2 or N2O, which provides both a source of cryogenic fluid and a source of pneumatic pressure.
The disposable portion 212 is preferably used only once. It includes the nose portion 116, the cutting cannula 118, and the biopsy needle 120. The disposable portion 212 also includes a rear portion 230, which fits within the housing 110 of the reusable portion 210. The rear portion 230 includes a coring mechanism (not shown) for both translating and rotating the cutting cannula 118 with respect to the biopsy needle 120. The reusable portion 212 has a proximal end 212p, which is adapted for receiving compressed gas from the reusable unit 210.
A biopsy device substantially as described above is disclosed in U.S. patent application Ser. No. 11/210,436, entitled “Rotational Core Biopsy Device With Liquid Cryogen Adhesion Probe,” which is hereby incorporated by reference.
In contrast with prior devices, however, the device 100 includes an encodable device, housed within the disposable portion 212, for storing information. In the example shown in
Preferably, each of the threaded regions 220 and 240 is composed of or includes a conductive material. An electrical contact, such as a ring 222 of conductive material, is preferably disposed at the front of the housing 110 proximate to the threaded region 220 and electrically insulated from the threaded region 220. An electrical contact, such as a spring-loaded pin 224, is preferably disposed at the rear of the nose 116 and is electrically insulated from the conductive material within the threaded region 240.
Both the pin 224 and the conductive material of the threaded region 240 are electrically connected to the encodable device. In addition, both the ring 222 and the conductive material on the threaded region 220 are electrically connected to the controller within the housing 110. The encodable device thus forms an electrical circuit with the controller when the disposable portion 212 is attached to the reusable portion 210.
The encodable device is preferably a “1-wire®” nonvolatile memory circuit, such as a DS28E04-100 available off-the-shelf from Dallas Semiconductor Corp. of Dallas, Tex. The DS28E04-100 includes a 4 kb EEPROM (Electronically Erasable Programmable Read-Only Memory). As is known, “1-wire” circuits are able to manage serial communications with their environments and receive power from their environment via only two conductors. These circuits are thus well suited for compact implementations in which it is desirable to minimize the number of electrical interconnections.
The controller 410 preferably establishes a connection to the encodable device 310 via a pair of conductors, such as wires 420. One of the wires 420 is connected between the controller 410 and the conductive material of the threaded region 220. The other of the wires 420 is connected between the controller 410 and the conductive ring 222. Connection between the controller 410 and the encodable device 310 is made when the disposable portion 212 is attached to the reusable portion 210.
Applying this process in the context of the device 100, the disposable portion 212 is engaged with the reusable portion 110. Electrical, mechanical, and pneumatic connections between the disposable and reusable portions are made. Data stored in the encodable device 310 is then copied to the controller 410. An incision is made in a medical subject in the vicinity of a suspect mass, such as a fibroadenoma. The biopsy needle 120 is inserted into the suspect mass, generally under ultrasound or MRI guidance. The user then operates a control on the user console 112 to initiate certain automated aspects of the process. The controller 410 responds to the user control by executing a series of actions. These actions are based, in whole or in part, on the data conveyed from the encodable device 310.
The encodable device 310 can be made to store a wide range of data pertinent to the conduct of the biopsy procedure. For example, the encodable device 310 may store the gauge (i.e., diameter), length, composition, and cooling power of the biopsy needle 120, as well as the gauge, length, and composition of the cutting cannula 118. The encodable device 310 can be made to store an indication of whether the biopsy needle 120 and/or cutting cannula 118 are MRI-compatible, e.g., whether they contain any ferrous material. The encodable device 310 can also store information about the mass being biopsied, and how much cooling is required with that mass to obtain an adequate sample.
According to one variant, the encodable device 310 stores parameters for conducting a biopsy procedure. The controller 410 reads the parameters and adjusts its activities accordingly. For example, one parameter can describe the period of time over which cryogenic fluid is conducted to the biopsy needle 120 before the cannula 118 is advanced. The controller 410 responds to this parameter by timing the application of cryogenic fluid and advancing the cannula when the desired time limit is reached.
Another parameter may describe a desired temperature that the biopsy needle 120 should attain before the cutting cannula 118 is advanced. In this instance, the biopsy needle 120 is equipped with a temperature measuring device, such as a thermocouple, which is electrically connected back to the controller 410. The controller responds to this parameter by monitoring the temperature of the biopsy needle 120 and advancing the cannula 118 when the measured temperature reaches the desired temperature.
According to another variant, the encodable device 310 stores code for conducting all automated portions of the biopsy procedure. The code can be in the form of object code directly readable by the controller 410. Rather than simply specifying parameters, an entire program is uploaded to the controller. The controller 410 then executes the code to conduct all of the functions associated with cooling the biopsy needle 120 and advancing the cannula 118.
In the examples given above, the data stored in the encodable device 310 is used for controlling the operation of the biopsy device 100. Data can be stored in the device 310 for other purposes, as well. An adapter (not shown) can be provided for connecting a disposable portion 212 of the device 100 to a computer. The computer can then read and display the data stored in the encodable device 310. This data may include, for example, the name of the patient for whom the disposable portion 212 is intended, or for whom it was used. It may include portions of the patient's medical history, or special instructions for conducting the biopsy procedure.
The encodable device 310 is preferably programmed with appropriate parameters, code, or other information, in the factory where it is assembled. However, the device 310 is also preferably programmable by the user. The computer adapter, described above, preferably allows a user to both read from and write to the device 310. A user may thus modify parameters or store additional information in the encodable device 310 prior to performing the medical procedure.
The controller 414 can preferably write to the encodable device 310 in situ, while the reusable and disposable portions are mated together. The controller 414 preferably monitors activities of the biopsy device 100 during each biopsy procedure, and stores diagnostic information related to any errors or anomalies in the encodable device 310. A user can access this diagnostic information after the biopsy procedure to explore the nature of the error or anomaly.
To prevent unauthorized access, the data stored in the encodable device 310 is preferably encrypted. The controller 414 is provided with an encryption key for decoding data received from the encodable device 310.
The biopsy device 100 offers numerous benefits. Disposable portions having needles and cannulas of different gauges, lengths, and compositions can be used with a single reusable portion. Settings for performing the biopsy with the selected probe needle and cannula are automatically adjusted to optimal values.
Alternatives
Having described one embodiment, numerous alternative embodiments or variations can be made. For instance, the invention is not limited to a biopsy device.
The reusable portion 710 includes a control unit 610. The control unit 610 is preferably plumbed to two cryogenic sources, a first tank 640 containing compressed Argon gas and a second tank 650 containing compressed Helium gas. The control unit 610 has pneumatic connector 724 and an electrical connector 726. The control unit preferably includes electronic and pneumatic components for controlling the application of pressurized Argon and Helium gas to the connector 724. It also includes electronic components for measuring the temperature of the thermocouple by measuring a voltage applied to two terminals of the connector 726.
The disposable portion 712 includes a hand-held unit 614, a hollow treatment needle 612, and a flexible tube 616. The flexible tube 616 encloses a pneumatic tube (not shown), which extends from a distal tip 612d of the treatment needle 612 to a pneumatic connector 624. The flexible tube 616 also encloses an electrical cable 620, which extends from a thermocouple (not shown) attached within the treatment needle 612 to an electrical connector 626. The electrical cable 620 preferably emerges from the flexible tube 616 via a hole 622 in the flexible tube 616.
During operation, the connectors 624 and 626 are respectively mated with the connectors 724 and 726. An incision is made in a medical subject, in a vicinity of a mass to be treated, and the treatment needle 612 is inserted into the mass, generally under ultrasound or MRI guidance. A user then operates one or more controls on the control unit 610. In response, the control unit 610 performs a sequence of timed actions, such as applying pressurized Argon or Helium gas to the disposable portion. These actions may be adjusted based on temperature readings from the thermocouple.
A treatment device substantially as described above is disclosed in U.S. Pat. No. 6,789,545, entitled, “Method and System for Cryoablating Fibroadenomas,” which is hereby incorporated by reference.
In contrast with the prior device, however, the treatment device 600 includes an encodable device 750 for storing information. The encodable device 750 is preferably housed within the hand-held unit 614 and is wired back to the control unit 610 via the cable 620 and connector 626. The encodable device 750 is preferably of the same type as that described above, i.e., a “1-Wire” DS28E04-100, from Dallas Semiconductor. To accommodate the encodable device, the treatment device disclosed in U.S. Pat. No. 6,789,454 is modified. The cable 620 is modified to carry four wires instead of the two previously needed for the thermocouple, and the connectors 626 and 726 are changed to four conductor connectors. Changes are also made within the control unit 610 to accommodate the additional wiring and functionality.
The controller 810 preferably establishes a connection to the encodable device 750 via a pair of conductors, such as wires 820, which are routed to pins of the connector 726. Connections between the controller 810 and the encodable device 750 are made when the disposable portion 712 is attached to the reusable portion 710.
As with the biopsy device 100, optimal conduct of a medical procedure involving the treatment device 600 depends upon proper settings. For example, certain treatment settings are optimally set in response to the gauge, length, and/or composition of the treatment needle, the cooling power of the treatment needle, and the shape of the treatment zone, as well as other factors. These settings describe, for example, the amount of cryogenic fluid to be applied, the sequence of fluid applications, and the timing between fluid applications, all of which are controlled by the (reusable) control unit 610.
The encodable device 750 preferably stores these settings. As described above in connection with the biopsy device 100, these settings may be stored as parameters that the controller 810 reads and applies for adjusting the conduct of a treatment procedure. Alternatively, an entire code section or program for conducting the medical procedure can be stored on the encodable device 750. The code is copied to the controller 810, and the controller runs the program.
The invention is not limited to cryogenic biopsy and treatment devices. It may be used in connection with any type of medical device that includes disposable and reusable portions.
As described herein, the encodable device is preferably a 1-wire device that both receives power and communicates with its environment via two conductors. This is not required, however. The encodable device can be any type of device, component, or assembly, that stores information that is readable by the reusable portion of the device.
Another implementation of the encodable device is an RFID (Radio Frequency Identification) device. The RFID device is made to store information, such as one or more parameters associated with the disposable portion of the device. The reusable portion would then include an RF port for reading the RFID device. When the disposable portion is brought within close proximity of the reusable portion, the RF port is directed to read the information.
The encodable device may also be implemented as an optically readable code, such as one or more barcodes. The reusable portion can be equipped with an optical reader, such as a barcode reader. By sweeping the barcode(s) with the barcode reader, the information encoded in the barcode(s) is then transferred to the reusable portion to be used in conducting a medical procedure.
A very simple implementation of the encodable device is a resistor. The reusable portion of a medical device can be equipped with a resistance measuring device, such as an ohmmeter. Resistors having different resistances could thus be made to indicate different parameters or groups of parameters. For instance, a 3 kilo-ohm resistor could indicate a 3 gauge needle, whereas a 5 kilo-ohm resistor could indicate a 5 gauge needle. Arrays or circuits of resistors or other analog components can be used to store information, as can arrays or circuits of digital components.
As shown and described, electrical connections between the reusable and disposable portions of the devices 100 and 600 are made using two conductors. Alternatively, more conductors may be used, such as for conveying digital signals in parallel form. In addition, the mechanical, electrical and pneumatic connections between the reusable and disposable portions may be integrated together, as they are for the biopsy device 100. Alternatively, they may be separated, as are the electrical and pneumatic connections for the treatment device 600.
Those skilled in the art will therefore understand that various changes in form and detail may be made to the embodiments disclosed herein without departing from the scope of the invention and appended claims.
