Patent Application
20160128602
The invention relates to the detection (i.e. identification) of the presence of, and border determination of cancerous tissues on the tissue surface and/or inside the tissue in open or non-open surgeries.
Breast cancer is one of the common diseases of today. One of the basic treatment modalities in breast cancer disease is to remove cancerous tissue by surgery. During surgery, it is the surgeon who decides whether the suspected tissue is cancerous or not, as well as making the decision on the borders of the cancerous tissue. While making this decision, the surgeon uses a pathological method, which is known as “Frozen” in literature, besides his/her own knowledge and experience. This method yields 60-70% accurate results regarding the tissue.
Success criteria of a surgery are to detect cancerous tissue and boerders thereof accurately, and to remove the cancerous tissue completely. In order to be successful in the operation, i.e. to guarantee that the cancerous tissue is fully removed, removing the whole breast, unless really required, is an undesired situation. Therefore, detecting the cancerous tissue and borders thereof as accurately as possible is important in order for the surgery to be successful. In case the surgery fails, the disease cannot be treated and it recurs.
As known in the literature, dielectric permittivity of the cancerous tissue and healthy tissue is different from one another. In this respect, it is a common procedure to detect the presence of cancerous cells by measuring dielectric parameters of the tissues in order to detect the presence of cancerous tissue. However, it is a difficult process to measure dielectric permittivity of the tissue during surgery when it comes to practice. The main reason for that is the environment and bleeding during surgery. Moreover, the tissue is not always exposed during the surgery, and thus it is not possible understand how deep the borders of the cancerous tissues get. Slicing a tissue with a clean surface, or a tissue with tumor, to see what is present therein and controlling over the sliced surfaces, or sectioning for Frozen procedure, are neither practical, nor possible for the surgeon.
In the state of the art, dielectric constant can be measured using open-ended coaxial probe. Said probe measures 1 port scattering parameters (S11). The data obtained from the measurements are analyzed using the known technical methods and the complex dielectric constant of the tissue is determined. However, the use only of 1 port S parameters during dielectric constant determination reduces the accuracy of the determination.
As a result, the aforementioned problems have made it necessary to make a novelty for identifying the presence of cancerous tissue on the tissue surface and/or in the tissue and for determining the borders thereof in open or non-open surgeries in the related technical field.
The present invention relates to a microwave tissue identification device and method developed for eliminating the above disadvantages and providing new advantages in the related technical field.
An object of the invention is to introduce a microwave tissue identification device in order to detect the presence and borders of the cancerous tissues in the deep, in addition to the cancerous tissues on the surface, in open and/or non-open surgeries.
Another object of the invention is to introduce a tissue identification device and method in order to increase the accuracy of the identification regarding whether a tissue is cancerous or not when compared to the known methods.
And another object of the invention is to present a tissue identification device, which is practical and ergonomic while being used in open and/or non-open surgeries and, which is directive (i.e. guiding) and informative for the surgeon who will perform the surgery. In order to achieve all the objectives that have been mentioned above and will be further understood from the following description, the present invention relates to a tissue identification device for determination (i.e. identification) of the presence/absence and borders of the cancerous tissues. Said tissue identification device is characterized in comprising;
Tissue identification method performed using said tissue identification device and aiming to determine the presence and borders of the cancerous tissues basically comprises the process steps of;
In order for the embodiment of the invention and the advantages thereof, together with additional components, to be better understood, it should be evaluated together with the figures, the descriptions of which are given below.
11 Computer
12 Hand Tool
13 Hand Tool Computer Connection
14 Camera Computer Connection
15 RF-Microwave cable
16 Measurement Probe
17 S Parameter Measurement Unit
18 S Parameter Measurement Unit-Computer Connection
19 Calibration and Sterilization Unit
21 Energy Supply
22 Power Distribution Unit
23 On/Off Button
In this detailed description, the tissue identification device (10) according to the invention will only be described in order for the subject matter to be better understood by way of illustrations, without any limitations.
In addition to the above components, the tissue identification device (10) according to the invention comprises a hand tool (12), which carries the measurement probe (16) thereon and operates in association with the computer (11). Moreover, a calibration and sterilization unit (19), which comprises the required components for providing calibration and sterilization of the measurement probe (16) during surgery is also provided. Also provided herein is an energy module (20) for providing the required power for the operation of the computer (11), hand tool (12), calibration and sterilization unit (19), which are disposed in the tissue identification device (10). Said energy module (20) is activated by on/off button of the device (10). The energy module (20) comprises an energy supply (21), which enables the device (10) to be connected to a power source, e.g. electric supply system, battery, as well as comprising a power distribution unit (22) for distributing the energy to the components comprised by the device (10).
The measurement probe (16) is the concentric, 2 port coaxial measurement probe (16); and in
The measurement probe (16) is preferably thinner than 1.5 mm diameter. The guide (161), on the other hand, has a width such that the measurement probe (16) will pass therethrough. Thus, the measurement probe (16) can easily operate inside the guide (161); and measurement beneath the tissue, besides over tissue measurements, can be performed in open or non-open surgeries, e.g. biopsy.
The S parameter measurement unit (17) measures 1 port or 2 port S parameters of the tissue by means of the measurement probe (16) connected thereto via RF/Microwave cable (15). The measurement of S parameters is performed in a frequency band range. This frequency band preferably ranges from 100 MHz to 6 GHz. In this way, dielectric permittivity of the tissue are expressed as frequency function and frequency-related changes in the tissue are assessed for identifying the tissue. Hence, a more accurate result will be achieved compared to the result obtained from a single frequency. S parameter measurement unit (17) transfers the measurement results to the computer (11) through the S parameter measurement unit-computer connection (18), said connection being provided between the computer (11) and itself.
The measurement probe (16) is used by being attached to the hand tool (12) during surgeries. The overall view of the hand tool (12) is given in
The hand tool (12) is associated with the computer (11) by way of hand tool-computer connection (13). The hand tool (12) comprises a micro-control card (123) and a hand tool embedded software block (124) running over said micro-control card (123). The management of the hand tool (12), as well as its communication with the computer (11), is provided by the micro-control card (123) and the hand tool embedded software block (124). When the user pushes the measurement button (122) on the holder (121) during the measurement process, the micro-control card (123) directs the information determined by the hand tool embedded software block (124) to the computer (11). The data from the computer (11) are sent to the micro-control card (123) and indicated on the hand tool (12) screen (125) by the hand tool embedded software block (124).
The computer (11) comprises an application software block (112), which processes the data transferred by the S parameter measurement unit (17), hand tool (12), and hand tool (12) camera (126) and manages the measurement process in line with this data. Prior to the surgery, the information on patient, surgery, and potential diagnosis are saved in a database by means of the application software block (112). The measurement results from the S parameter measurement unit (17) and the images taken by the camera (126) are transferred to a tissue identification software block (113) disposed in the computer (11) via the application software block (112). Said tissue identification software block (113) processes S parameters by using the predetermined algorithm thereof and allows the determination of the dielectric constant of the tissue. The determined result and camera (126) images are shown on the computer (11) screen (111). The required information for directing and informing the surgeon who will perform the surgery during the measurement process are shown on the computer (11) screen (111) and hand tool (12) screen (125) simultaneously. It is the application software block (112), which determines what information will be shown on the screen (111) at what process step.
When supply voltage is given to the tissue identification device (10) and when the surgeon pushes the measurement button of the hand tool (12), the application software block (112) automatically starts the calibration and sterilization process of the measurement probe (16). This process is performed in the calibration and sterilization unit (19). This unit comprises;
The surgeon pushes the measurement button (122) while passing/switching from one process step to another during calibration and sterilization process, thereby making the tissue identification device (10) pass to the next step. Thus, surgeon can perform measurement and calibration processes only by pushing the measurement button (122) disposed on the hand tool (12) and by observing the screen (125) provided on the hand tool (12), and hence s/he does not have any difficulty in concentrating during the surgery.
In line with the above explanations, the main operations/processes performed by the tissue identification device (10) according to the invention are as follows; calibration and sterilization of the measurement probe (16); measurement of S parameters of the target tissue; evaluation of measurement results; and identification of the tissue.
Switching on the tissue identification device (10) is performed as follows: First, the device (10) is connected to a power source, e.g. electric supply system, battery, by means of the energy supply (21). The device (10) is activated by means of the on/off button on the device (10). The required energy for the operation of all units of the device (10) is transferred by the power distribution unit (22). Activation duration of the device (10) is shown on the computer screen (111).
The calibration and sterilization unit (19) starts to operate with the energy supply (21). The thermoelectric temperature control unit (193) and the temperature control circuit (192) start to stabilize the pure water in the pure water tank (191) at a temperature of 25° C. +/−0.5° C. The temperature indicator (194) displays the current temperature of the pure water. After the surgeon sees on the computer screen (111) that the switching on process of the device (10) is completed, s/he checks the temperature indicator (194) and controls whether the temperature of the pure water is 25° C. Since the device (10) has just been switched on, the application software block (112) directly starts the calibration and sterilization process. At this stage, the operations to be performed by the surgeon are shown on the computer screen (111) and the hand tool (12) screen (125). The following processes are respectively performed at calibration and sterilization stage:
After the surgeon finishes a process step, s/he pushes the hand tool (12) measurement button (122), thereby the information on the next process step being shown on the hand tool (12) screen (125) and computer screen (111).
Upon completion of the calibration and sterilization process, the device (10) gets ready for the measurement process. The measurement method of the tissue identification device (10) according to the invention is based on the principle of measuring the 1 port or 2 port scattering parameters of the tissue in a certain frequency band, and of determining the complex dielectric permittivity of the tissue by the algorithm defined in the tissue identification software block (113) in line with these measurements.
The basic process steps of the measurement process are as below, although there are some different process steps depending on whether the surgery is open or non-open:
During an open surgery, the surgeon opens the breast first. In case that the tissue to be measured is on the surface, the surgeon performs measurement process by repeating the above process steps.
If the tissue identification device (10) is to be used in an open surgery where the tissue to be measured is in the deep, or in a non-open surgery such as biopsy, the measurement probe (16) is immersed in the tissue through said guide (161). When the tip of the guide (161) contacts with the tissue desired to be measured, the surgeon pushes the measurement probe (16) and opens the elastic stopper (162) inside the guide (161), and then makes the measurement probe (16) contact with the tissue. Afterwards, the above measurement steps are performed and the dielectric constant of the tissue is identified.
| Number | Date | Country | Kind |
|---|---|---|---|
| 2013/07254 | Jun 2013 | TR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/TR2014/000206 | 6/11/2014 | WO | 00 |
