Patent Application
20100222647
This invention relates to medical systems and methods, and more specifically to such systems and methods for performing a medical procedure.
Systems for analyzing a tissue in order to determine whether the tissue is in need of a treatment are known in the art. Similarly, systems for providing a treatment to a tissue in need of such treatment are also known. Such systems are described in the following publications.
U.S. Pat. No. 6,711,429 describes a system and method for recording and displaying, in an image of the body the location of a point-of-interest in the body during a medical procedure. The method involves (a) establishing the location in the body of the point-of-interest; (b) inserting a catheter, including a first location implement, into the body; (c) obtaining an image of a portion of the body; (d) establishing a location of the imaging instrument in the body; (e) advancing the catheter to the point-of-interest and, using a locating implement, recording the location of the point-of-interest; and (f) displaying and highlighting the point-of-interest in image. In course of the procedure, the locations in the body of the catheter and the imaging instrument are known. Thus, the point-of-interest is projectable and displayable in the image even in cases in which the body moves relative to the imaging instrument. The system of this patent, however, does not determine whether the point of interest is in need of a medical treatment, not does it provide a medical treatment.
WO 02/38064 discloses a catheter apparatus and method for treating a plurality of adjacent locations of a tissue along a line of treatment, so as to form a continuous line of treatment in the tissue. The catheter apparatus includes (a) a catheter having an active site for applying the treatments at the adjacent locations along the line of treatment; (b) a positioning mechanism for sequentially guiding a single active site of the catheter along, or for positioning a plurality of active sites, along the line of treatment; c) an activating mechanism for activating the active site or sites to apply the treatment to the tissue at the adjacent locations; and (d) at least one position sensing mechanism for determining positions in the tissue at which the treatments have been applied. The system of this publication, however, does not determine whether the tissue is need of a treatment or which treatment is needed.
The present invention provides a system and method for treating body tissue. The system of the invention includes a device containing a probe unit. The probe unit includes one or more treatment probes and one or more tissue monitoring probes. The probe unit also includes one or more tissue sensing/characterization probes, for characterizing a tissue site.
During delivery of a treatment to a treatment site, e.g. a tissue site, from the one or more treatment probes, the monitoring probes obtain, essentially in real-time, measurements of one or more parameters of a the state of the tissue site being treated. A processor is configured to receive signals from the one or more monitoring probes indicative of the measurements taken at the tissue site being treated. The processor is further configured to activate the treatment probes and the monitoring probes so as to deliver to the tissue site the determined treatments while receiving, in real-time, instantaneous signals indicative of a state of the treatment site during treatment progression from the tissue monitoring probes. The treatment monitoring signals are used by the processor to determine the optimal manner of treatment progression, modifying the treatment as necessary, in order to achieve the optimal treatment plan.
A treatment probe may be, for example, a treatment probe that performs, a physical treatment such as ablation, cryosurgery, microsurgery or taking a biopsy, a chemical treatment such as application of a toxin or drug to the tissue site, a biological treatment, such as DNA therapy, viral therapy and enzyme therapy.
The measurements obtained by the monitoring probes may include a physical measurement, such as density or fluidity, a chemical measurement, such as acidity, or a biological measurement, such as an enzymatic activity, or a level of gene expression activity. The processor may, on the basis of the sensing measurements, classify the tissue at the tissue site. The tissue classification may relate to the presence or absence of a malignancy or pre-cancerous state or to the presence or absence of a pathology such as internal bleeding. The processor then determines, on the basis of the classification, one or more treatments to be delivered to the tissue site. The processor is further configured to activate the treatment probes and the tissue monitoring probes so as to deliver to the tissue site the determined treatments while receiving, in real-time, instantaneous signals indicative of a state of the tissue site during treatment progression from the tissue monitoring probes. The treatment monitoring signals are used by the processor to determine a manner of treatment progression, modifying the treatment as necessary.
The method of the invention involves delivering the probe unit to a tissue site to be treated. During treatment of the tissue site, signals are obtained from the monitoring probes and input to the processor in order to determine, in real time as the treatment is being carried out, whether the treatment carried out so far is adequate or whether an additional treatment needs to be carried out or whether the parameters of the treatment need to be modified.
The system and method of the invention may be used for treating tissue sites located on the skin surface or just below the skin surface. The system and method of the invention may be used for minimally invasive surgery, for example, by insertion either percutaneously or via a trocar valve. The tissue site to be treated may be located in a body lumen, or adjacent to a body lumen.
Thus, in its first aspect, the invention provides a system for analysis and treatment of a tissue site comprising:
In its second aspect, the invention provides a device for analysis and treatment of a tissue site comprising:
In its third aspect, the invention provides a method for analysis and treatment of a tissue site comprising:
In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
According to some embodiments of the present invention the probe device 130 may be implemented using the embodiments below:
In accordance with an embodiment of the present invention, the probe device 130 may be an extracorporeal, hand-held, and may include a handle, for easy carrying.
In accordance with another embodiment of the present invention, the probe device 130 may be employed for minimally invasive surgery, for example, for insertion via a trocar valve, or for another percutaneous insertion.
In accordance with yet another embodiment of the present invention, the probe device 130 may be an intracorporeal probe, adapted for insertion via body orifice to a body lumen, for characterizing a portion of inner lumen wall.
In accordance with still another embodiment of the present invention, the probe 130 device may be an intracorporeal probe, adapted for percutaneous insertion to a body lumen, for characterizing a portion of inner lumen wall.
In accordance with yet another embodiment of the present invention, the probe device 130 may be an intracorporeal probe, adapted for insertion via body orifice to a body lumen, and for penetrating the lumen, for characterizing a portion of subcutaneous tissue.
In accordance with still another embodiment of the present invention, the probe device 130 may be an intracorporeal probe, adapted for percutaneous insertion to a body lumen, and for penetrating the lumen, for characterizing a portion of subcutaneous tissue.
In accordance with yet another embodiment of the present invention, the probe device 130 may be an adapted for characterizing a portion of subcutaneous tissue
In accordance with yet another embodiment of the present invention, the probe device 130 may be an adapted for characterizing a portion of subcutaneous tissue, in open surgery.
In accordance with yet another embodiment of the present invention, the probe device 130 may be extracorporeal, adapted for characterizing a portion of skin. Other embodiments may have other configurations and capabilities.
The probe unit 140 communicates with a control unit 110. For example, communication between the probe unit 140 and the control unit 110 may be via a wired connection. In this case, as shown in
In the embodiment of
The one or more treatment probes 160 deliver one or more treatments to the tissue site. A treatment probe 160 may be, for example, an injector, or a bombardment device. A treatment probe 160 may also be a device for localized surgery such as a device for resection, cryosurgery, or laser surgery, or a device for ablation, such as an ultrasound, RF, MW ablation device. A treatment probe 160 may also be a dispensing instrument, for example, for dispensing a substance at a tissue site, such as a medication or brachytherapy seeds.
In accordance with the invention, the monitoring probes 155 are adapted to monitor a condition of the treated tissue site in real time during delivery of treatment by the treatment probes 160. The tissue monitoring probes may also function as tissue characterization probes, or the probe device 140 may have different monitoring probes 155 and tissue characterization probes 150, as shown in
In
The probe unit arrangement shown in
A monitoring probe 155 may be, for example, an optical sensor, an X-ray sensor, a radiofrequency (RF) sensor, a microwave (MW) sensor, an infrared thermography sensor, an ultrasound sensor, a magnetic resonance (MR) sensor, an impedance sensor, resistivity sensor, capacitance sensor, electric field sensor, magnetic sensor, radiation sensor, an acoustic sensor a thermistor or temperature sensor, a thermocouple, a biosensor, a chemical sensor, a radioactive-emission sensor, or a mechanical sensor.
A tissue monitoring probe 155 may also be, for example, as disclosed in International Published Application WO 2006/103665, entitled “Electromagnetic sensors for tissue characterization” and assigned to the common assignee of the present application, the contents of which are hereby incorporated herein in their entirety by reference. This published patent application discloses a tissue sensing probe including a resonating element, formed as a conductive structure, and configured to be placed at an edge of a tissue site without penetrating into the tissue. The probe has a diameter-equivalent D, which defines a cross-sectional area of the resonating element on a plane substantially parallel with the edge. The resonating element is configured to resonate with a free-air wavelength in the range of about λ-10λ, wherein λ is at least about ten times the diameter-equivalent D. Upon receiving a signal in the range of about λ-10λ, the sensor induces electric and magnetic fields in a “near zone” in the tissue, the near zone being hemispherical with a diameter of substantially D, while causing negligible radiation in a “far zone”, so that the tissue, in the near zone effectively functions as part of the resonating element, varying a resonating response to the sensor. The tissue, in the near zone is characterized by its electromagnetic properties by the resonating response of the sensor.
By way of another example, a tissue monitoring probe 155 may be a non-irradiative electromagnetic sensor for tissue characterization, for example, as taught in commonly owned U.S. Pat. No. 6,813,515 entitled “method and system for examining tissue according to the dielectric properties thereof”, whose disclosure is incorporated herein in its entirety by reference. This patent describes a non-irradiative electromagnetic sensor, which applies an electrical pulse to a tissue, thus generating an electrical fringe field in the zone of the tissue and producing a reflected pulse therefrom with negligible radiation penetrating into the tissue itself. The sensor detects the reflected electrical pulse and compares the electrical characteristics of the reflected electrical pulse with respect to the applied electrical pulse to provide an indication of the dielectric properties of the examined tissue.
The tissue characterization probes 150, if present, measure a value of one or more parameters of the tissue site in order to facilitate delivery of the probe unit 140 to the tissue site to be treated, and may be for example of any type mentioned above in reference to the tissue monitoring probes 155.
If a plurality of tissue characterization probes 150 or tissue monitoring probes 155 is employed, they may be arranged in the probe unit 140 in a curved array to provide three-dimensional information on the tissue site, for example, using small-scale computerized tomography.
The probe device 130 may be a cannula having one or more working channels configured to receive the treatment probes 160, the monitoring probes 155 and the tissue characterization probes (when present) required for the specific application. The various probes may be introduced into separate working channels and positionable simultaneously in the probe unit 140.
The probe unit 140 is preferably configured to be detectable by an external imaging system 180 such as an X-ray, ultrasound or MRI imaging system, in order to facilitate delivery of the probe unit 140 to a desired body site, and to locate the probe unit 140 in the body. The imaging system 180 may communicate with the CPU 112 over a communication channel 181 that may be wired or wireless. The device 130 may be, for example, a navigable catheter as disclosed in the above cited U.S. Pat. No. 6,947,788.
The CPU 112 may be configured to receive signals from one or more characterization probes 150 during delivery of the probe unit 140 to the tissue site to be treated indicative of the values of tissue parameters measured by the tissue characterization probes at the tissue site where the probe unit 140 is located. The CPU 112 analyzes the signals received from the characterization probes 150 and determines whether or not the probe unit 140 is positioned at a tissue site having one or more properties of the site to be treated.
When the probe unit 140 is located at the tissue site to be treated, one or more treatments are delivered to the tissue site by the treatment probes 160. During delivery of the treatment, the monitoring probes 155 measure in real time values of parameters indicative of the state of the tissue. Signals from the monitoring probes 155 indicative of the state of the tissue being treated are analyzed by the CPU 112, in order to monitor progress of the treatment, to modify the form of the treatment, to adjust the treatment, or the treatment plan.
Reference is now made to
The tissue characterization relating to the abnormal tissue may relate to the detection of a malignancy, or a pre-cancerous state. Additionally or alternatively it may relate to the detection of another pathology, for example, internal bleeding.
In a checking step 430, it is determined whether the location of the probe is correct. If negative, the probe is moved to another location. The relocation of the probe may be manual, semi-manual or automatic employing for example, a two-dimensional or three-dimensional computer controlled stage, as is known in the art. There may be a computer program which controls the stage and defines the sequence of moving the probe from one location to the next. In cases, where the relocation is manual or semi-manual, the system may provide the operator with specific instructions on how and to whereto move the probe.
Additionally or alternatively, further steps of moving the stage may be introduced in response to the results of step 430. Once the probe 130 is relocated, steps 420-430 are repeated. If in step 430, the location of the probe is correct; a process to monitor a tissue site and treat the tissue is preformed.
Thereafter, in a defiling target step 435, the treatment process targets are defined. The treatment of defining target 435 may be selected from, but is not limited to, at least one physical treatment; at least one chemical treatment; at least one biological treatment or to mixtures thereof. Examples of physical treatment include, but are not limited to, ablation, cryosurgery and microsurgery. Examples of chemical treatment include, but are not limited to applying a toxin, or drug to the tissue. Toxins are exemplified, but not limited to neurotoxins, fungal toxins and bacterial toxins. Some examples of drugs which can be used in the method of this invention are chemotherapeutic agents, oxidizing agents and antibiotics, though any other drug known in the art or to be discovered in the future may possibly be used in the method and system of the present invention. Examples of biological treatment include, but are not limited to DNA therapy, viral therapy and enzyme therapy. The treatment may comprise a substance to be applied to the tissue e.g. a nucleic acid encoding, for example, a growth factor, a protein, such as a growth factor, and a cell expressing a protein such as a growth factor, so as to effect gene therapy, revascularization, such as myocardial revascularization, or to accelerate/decelerate cell growth and/or differentiation. The treatment may also comprise a combination treatment such as chemotherapy and laser ablation. Whatever the type of treatment, it may be applied locally employing the system of the present invention.
Following defining target step 435, in step 440 the values of the one or more tissue parameters that need to be monitored by the tissue monitoring probes 155 are set by the CPU 112. In step 450 treatment delivery begins, and the process enters a control cycle 490.
In step 455 the tissue parameters are continuously and in real-time monitored by tissue monitoring probes 155. During the delivery of treatment in step 450, the CPU determines in step 460, essentially in real-time, on the basis of measurements obtained by the one or more monitoring probes 155, whether the treatment targets which were defined in step 435 were achieved or whether additional treatment needs to be carried out (with or without changing the value of the treatment parameters). If yes, the treatment process is complete and the process terminates. If no, then the monitoring and treatment process enters a control cycle 490, which includes the following steps: in step 470 it is determined in real-time during delivery of the treatment, whether the present values of the tissue parameters are equal to the values that were preset in step 440. If yes, then in step 465 the treatment process is continued (and monitored in real time in step 455) and the process returns to step 455. If no, in step 480 the values of the treatment parameters which were set in step 400 are changed, the treatment continues with the new treatment parameters, and the process returns to step 455 as the monitoring process is continued continuously in real time in the a control cycle 490
In step 207 it is determined whether the probe unit 140 is located at the desired tissue site. If no, then the process returns to step 205 with the probe device being moved to a new tissue site. If the probe device is located at the desired tissue site, then in step 210, signals obtained from the one or more tissue sensing probes indicative of one or more measurements obtained by the tissue sensing probes at the tissue site are input to the CPU 112. The measurements may include a physical measurement, such as density or fluidity, a chemical measurement, such as acidity, or a biological measurement, such as an enzymatic activity, or a level of gene expression activity. In step 215 the CPU 112 analyzes the signal or signals from the tissue sensing probes and classifies the tissue at the tissue site. The tissue classification may relate to the detection of a malignancy, or a pre-cancerous state. Additionally or alternatively it may relate to the detection of a pathology such as internal bleeding. The classification may be relative, that is, a comparison of the results obtained by the sensing probes to data previously obtained on one or more reference tissues and stored in the memory 107. The classification generated by the CPU 112 may be displayed on the monitor 102 (step 220). The results may be displayed graphically, numerically or textually.
In step 225, it is determined, preferably in real-time, based upon the classification of the tissue at the present tissue site, whether a treatment is required at the treatment site. If no treatment is required at the present treatment site, then in step 227 a biopsy may be taken and in step 230 it is determined whether the probe unit 140 is to be moved to a new tissue site. If yes, then the process returns to step 205 with the probe unit 140 being moved to a new tissue site. If at step 230 it is determined that the probe unit 140 is not to be moved to a new tissue site then the process ends. If at step 225 it is determined that a treatment is needed at the present tissue site, then in step 229 the values of the tissue parameters to be monitored are initiated and a biopsy may be taken. The monitoring and treatment process then enters a control cycle 290, which includes the following steps. In step 235 the CPU activates one or more of the treatment probes 160 and one or more of the monitoring probes 155 in order to effectuate the required treatment and to monitor the state of the tissue site in real-time during delivery of the treatment. The operator may first input to the CPU 112 using the keypad 109 the parameters of the treatment. The parameters of the treatment may be proportional, inversely proportional, a derivative of, an integral of, or some other relation to results of the tissue classification step. In some cases, the level of treatment is varied over a continuous range, in other cases parameters of the treatment can only take on discrete values.
The treatment carried out in treatment step 235 may be one or more physical treatments; one or more chemical treatments one or more biological treatments or a combination thereof. Examples of physical treatments include ablation, cryosurgery and microsurgery. Examples of chemical treatment include application of a toxin or drug to the tissue site. The applied substance may become activated after having been taken up by the tissue, for example, as in photodynamic therapy. Toxins are exemplified by fungal toxins and bacterial toxins. Some examples of drugs which can be used in the method of this invention are chemotherapeutic agents, oxidizing agents and antibiotics, though any other drug known in the art or to be discovered in the future may possibly be used in the method and system of the invention. Examples of biological treatments include, but are not limited to, DNA therapy, viral therapy and enzyme therapy. The treatment may comprise a substance to be applied to the tissue e.g. a nucleic acid encoding, for example, a growth factor, a protein, such as a growth factor, and a cell expressing a protein such as a growth factor, so as to effect gene therapy, revascularization, such as myocardial revascularization, or to accelerate/decelerate cell growth and/or differentiation. The treatment may also comprise a combination treatment such as chemotherapy and laser ablation. Whatever the type of treatment, it may be applied locally employing the system of the present invention.
During the delivery of treatment in step 235, the CPU determines in step 240, essentially in real-time, on the basis of measurements obtained by the one or more monitoring probes 155, whether the treatment that has been carried out so far at the present tissue site is adequate or whether additional treatment needs to be carried out. If no, in step 245 it is determined in real-time during delivery of the treatment, whether the present values of the tissue parameters are equal to the values that were preset in step 229. If yes, then in step 255 the treatment process is continued and the process returns to step 235 where the treatment is monitored in real time If no, in step 250 the values of the treatment parameters which were set in step 229 are changed and the monitor process is continued continuously in real time in the control cycle 290.
If at step 240 it is determined that the treatment is complete, then the process may return to step 210, if it is desired to classify the tissue site again following the treatment as shown in
The CPU 112 may be configured to generate a status mapping of the tissue sites that have been treated and to display the map on the monitor 103. The map is updated after the completion of the treatment at each tissue site to be treated. Thus, the operator can see whether all areas of the tissue have been treated and to what degree they have been treated.
Some specific embodiments of the present invention are directed to treating respiratory tract abnormalities. For example, the invention may be directed to the treatment of a bronchial carcinoid, formerly known as a bronchial adenoma. The carcinoid may be benign or malignant, typically having a prolonged course. In some cases, an endobronchial portion of the tumor may obstruct the lumen of one or more major bronchi. Other embodiments of the invention are used to treat metastases of the respiratory tract which result from primary cancers of the body, such as from the breast, prostate, colon, kidney, bone and the like or from melanoma.
Reference is now made to
The probe unit 140 is now moved to a third tissue site which is sensed by the one or more tissue sensing probes 150 that send signals to the CPU 112. The signals are analyzed by the CPU 112 and results of the analysis are displayed on the monitor 109 indicating that the tissue at the third tissue site is abnormal. The duration, quantity and quality of the laser ablation treatment may be determined at this stage.
The CPU 112 activates a laser, such as a Yag-Niobium laser. The laser beam is conducted by an optic fiber along the cable 111 and the device 130 to the probe unit 140 where the laser light energy is delivered to the third tissue site. The tissue sensing probes then sense the treated tissue at the third tissue site, and sends signals to the CPU 112. In accordance with the displayed output, the operator can determine, what, if any, further treatment is required at the third tissue site. Alternatively, the determination may be made by the CPU 112, based on a set of predetermined rules.
If the treatment at the third location is complete, the apparatus is moved to a fourth position. The process is repeated until all of the abnormal tissue at the tissue sites 612, 614, 616 and 618 has been treated. Thereafter, the system may perform a full scan at all locations to verify that all the abnormal tissue has been treated.
The probe device 130 may be adapted to leave a body lumen and enter into an adjacent body region. For example, as shown in
Reference is now made to
Reference is now made to
System 1100 includes an apparatus 130 configured for proximal orientation to the tissue in the body. Apparatus 1130 includes an active head 1140 including a sensing probe 1150 for characterizing a sample of tissue from at least one of the proximal locations. Such a sensor may include an optical sensor, an X-ray sensor, an RF sensor, a MW sensor, an infrared thermography sensor, or an ultrasound sensor, an MR sensor, an impedance sensor, a temperature sensor, a biosensor, a chemical sensor, a radioactive-emission sensor, and a mechanical sensor.
System 1100 is configured to be connectable to one or more external units, generally at 1110. The latter is typically a computer system including inter alia a memory utility 1107, a data processing and analyzing utility 1108 associated with a signal analyzer functionality 1118 and a data input utility (keyboard) 1109, and a display unit 1102. Further provided in system 1100 are a locating utility 1104, and at least one treatment unit 1106.
Head 1140 preferably includes a positioning mechanism 1170 to enable sequential guiding of the apparatus from at least one of the plurality of locations to one or more other locations of the plurality of locations. Apparatus 1130 further includes a treatment probe 1160. The treatment probe has at least one active outlet 1162 for applying at least one treatment to at least one of the plurality of proximal locations for treating the sample. Probe 1160 includes an activating mechanism (not shown) adapted to activate the at least one outlet.
Apparatus 1130 and/or treatment probe 1160 may include an instrument for localized surgery, for example, by resection, ablation, for example, of ultrasound, RF, MW or another ablation method, or by cryosurgery, laser surgery, and the like, a dispensing instrument, for example, for dispensing a medication or for implanting brachytherapy seeds, or an instrument for other characterization and/or treatment procedures.
Sensing probe 1150 may be of any known suitable type. In some embodiments of the invention, the sensing probe is configured as disclosed in commonly owned U.S. Patent Application 60/665,842.
Such sensing probe includes a resonating element, formed as a conductive structure, configured to be placed proximally to an edge of a tissue for characterization, without penetrating the tissue; and at least one conductive lead, for providing communication with an external system. The probe has a diameter-equivalent D, which defines a cross-sectional area of the resonating element, on a plane substantially parallel with the edge. The resonating element is configured to resonate at a free-air wavelength range of about λ-10λ, wherein λ is at least about ten times the diameter-equivalent D. Upon receiving a signal in the range of about λ-10λ, the sensor induces electric and magnetic fields, in a near zone, in the tissue, the near zone being a hemisphere having a diameter of substantially D, beginning with the edge, while causing negligible radiation in a far zone, so that the tissue, in the near zone, effectively functions as part of the resonating element, varying a resonating response to the sensor. The tissue, in the near zone, is characterized by its electromagnetic properties, by the resonating response to the sensor.
The sensor probe may be a nonirradiative electromagnetic sensor for tissue characterization, for example, as taught in commonly owned U.S. Pat. No. 6,813,515, whose disclosure is incorporated herein by reference with respect to this specific example. U.S. Pat. No. 6,813,515 describes a nonirradiative electromagnetic sensor, which applies an electrical pulse to a tissue, thus generating an electrical fringe field in the zone of the tissue and producing a reflected pulse therefrom with negligible radiation penetrating into the tissue itself. The sensor detects the reflected electrical pulse and compares the electrical characteristics of the reflected electrical pulse with respect to the applied electrical pulse to provide an indication of the dielectric properties of the examined tissue.
In some other embodiments of the invention, apparatus 1130 includes at least in part an endoscope tool. Such endoscope may be configured as a multi-channel endoscope or cannula, for carrying several instruments, for example, an optical instrument, a sensing probe, and another instrument such as a surgical instrument, which may be operated together. Alternatively, only one or two channels may be available, and instruments are pulled out and replaced with other instruments, as is required.
The sensor probe is preferably visible on other imaging modalities such as x-rays, ultrasound and MRI, and may be guided using another imaging modality, so that it can be guided to zones which are not accessible to an optical instrument or in cases where the optical instrument is not used.
In some cases, system 1100 is configured to measure reflection of electromagnetic fields from the near vicinity of the sensor probe, for example, as taught in commonly owned U.S. Pat. No. 6,813,515, or in commonly owned U.S. Patent Application 60/665,842. It will be appreciated that in accordance with embodiments of the present invention, other electromagnetic sensors may also be used.
Sensor probe 1150 may include a probe as disclosed in U.S. Ser. No. 11/196,732, filed on Aug. 4, 2005, entitled “Tissue-Characterization Probe With Effective Sensor-To-Tissue Contact”, assigned to the assignee of the present application.
Such probe is configured for tissue-characterization, being designed for effective sensor-to-tissue contact. The device includes an element, having a rigid surface of a linear cross-section, on which at least one sensor is arranged, and a mechanism for applying a force to a soft tissue, the line of force being at a sharp angle with the rigid surface, for stretching or stretching and pushing the soft tissue against the rigid surface, thus achieving effective contact between the tissue and the at least one sensor. In consequence, the accuracy of the sensing is improved. In accordance with another embodiment, a plurality of sensors is employed, arranged along a curved element, for providing three-dimensional information regarding the tissue, for example, by small-scale computerized tomography.
It will be appreciated that in accordance with embodiments of the present invention, other electromagnetic sensors may be used.
As indicated above, apparatus 1130 is associated with the external unit, being connected thereto by wires 1120. The external unit includes a sensing functionality 1105 adapted to receive at least one signal from sensing probe 1150 at each location and to analyze the at least one signal so as to provide at least one output. In some cases, functionality 1105 is part of processor 1108. Treatment functionality 1106 is adapted to receive the at least one output and provide at least one treatment to treatment probe 1160 responsive to the output. In some embodiments, the at least one treatment is provided by the treatment probe at one or more outlet 1162. In some cases, the treatment is only provided when the activating mechanism is activated. The activating mechanism is typically activated by a signal from the external unit.
In some embodiments, internal optical guides (of the kind known in the art) may be employed, such as a visual bronchoscope as part of apparatus 1130, connected to head 1140.
Both an external imaging mechanism, being part of locating apparatus 1104, and an internal optical guide may be used for guiding the head 1140 to the required location.
In one embodiment, a position sensing mechanism (locating apparatus 1104 of
Reference is now made to
In a locating step 1210, the apparatus is placed inside a lumen or on the surface of part of the body and is oriented proximal to or touching some tissue. The apparatus used in this method may include, for example, the navigable catheter as disclosed in the above-indicated U.S. Pat. No. 6,947,788.
In a characterizing step 1220, at least one sample of the tissue is characterized to determine the cell type and tissue type. For example, it is determined at this stage, whether some or all of the tissue is abnormal tissue, such as cancerous tissue. In some embodiments, the method of the above-indicated U.S. Pat. No. 6,813,515 is used for examining tissue according to the dielectric properties thereof.
Preferably, the external unit analyzes the reflection proximal to the sensor probe and displays results on screen 1103. In some other embodiments, the results are produced graphically, numerically, or as positive or negative answers. The results may also be presented textually.
The results may be relative, that is, a comparison of results of abnormal tissue (such as tissue 612, 614, 616, 616 in
The tissue characterization relating to the abnormal tissue may relate to the detection of a malignancy, or a pre-cancerous state. Additionally or alternatively it may relate to the detection of another pathology, for example, internal bleeding.
The user typically observes the results on a display of the tissue characterization step 220. In some cases, the user controls the level of treatment in response to the results of the tissue characterization step on a scale ranging from zero to 100%. In other cases, the treatment level scale is controlled automatically. The level of treatment may be proportional, inversely proportional, a derivative of, an integral of, or some other relation to results of the tissue characterization step. In some cases, the level of treatment is in a continuous range, in other cases it is performed in a stepwise manner.
In a checking step 1230, it is determined whether the location of the probe is correct. If negative, the probe is moved to another location. The relocation of the probe may be manual, semi-manual or automatic employing for example, a two-dimensional or three-dimensional computer controlled stage, as is known in the art. There may be a computer program which controls the stage and defines the sequence of moving the probe from one location to the next. In cases, where the relocation is manual or semi-manual, the system may provide the operator with specific instructions on how and to whereto move the probe.
Additionally or alternatively, further steps of moving the stage may be introduced in response to the results of step 1230. Once the probe is relocated, steps 1220-1230 are repeated. If in step 1230, the location of the probe is correct, a process to verify the tissue type is performed in verification step 1240.
Thereafter, in a tissue treating step 1250, the tissue is treated with a unit dosage of treatment. The unit is determined in response to the results of step 1240.
The treatment of treatment step 1250 may be selected from, but is not limited to, at least one physical treatment; at least one chemical treatment; at least one biological treatment or to mixtures thereof. Examples of physical treatment include, but are not limited to, ablation, cryosurgery and microsurgery. Examples of chemical treatment include, but are not limited to applying a toxin, or drug to the tissue. Toxins are exemplified, but not limited to neurotoxins, fungal toxins and bacterial toxins. Some examples of drugs which can be used in the method of this invention are chemotherapeutic agents, oxidizing agents and antibiotics, though any other drug known in the art or to be discovered in the future may possibly be used in the method and system of the present invention. Examples of biological treatment include, but are not limited to DNA therapy, viral therapy and enzyme therapy. The treatment may comprise a substance to be applied to the tissue e.g. a nucleic acid encoding, for example, a growth factor, a protein, such as a growth factor, and a cell expressing a protein such as a growth factor, so as to effect gene therapy, revascularization, such as myocardial revascularization, or to accelerate/decelerate cell growth and/or differentiation. The treatment may also comprise a combination treatment such as chemotherapy and laser ablation. Whatever the type of treatment, it may be applied locally employing the system of the present invention.
Following treatment step 1250, a checking step 1260 is performed to determine whether the treatment has been completed at that location. If affirmative, another checking step 1270 is performed to see whether the tissue has been treated in all locations. If the result of step 1260 is negative, then steps 1230-1260 are repeated. However, if the probe has been inadvertently moved, then this will be determined in step 230, and steps 210-230 will be repeated again. Once in the correct position, as verified in step 1230, the tissue status or type is determined in step 1240 and a further dosage of the treatment is applied to the tissue. In an alternative embodiment, only steps 1240-1260 are repeated.
In step 1270, the system checks to see if the tissue has been treated in all locations. These locations may be largely two dimensional or alternatively, three-dimensional. The system typically records the treatments applied at each location and stores this data in its memory. Processor 1108 (
Alternatively, checking step 1270 may be performed largely manually by moving the probe from location to location and checking the status of the tissue at each location.
In the example of
In further embodiments, the method also includes monitoring the quality of the treatment employing a quality monitoring mechanism (not shown). The quality monitoring mechanism may include, but is not limited to at least one of thermistor, thermocouple, resistivity sensor, capacitance sensor, electric field sensor, magnetic sensor, radiation sensor, or acoustic sensor.
Reference is now made to
In a locating step 1310, the probe is placed inside a lumen or on the surface of part of the body and is oriented proximal to or touching some tissue. This step may be similar to or different from step 1210 of
In a characterizing step 1320, at least one sample of the tissue is characterized to determine the cell type and tissue type. For example, it is determined at this stage, whether some or all of the tissue is abnormal tissue, such as cancerous tissue. This step may be similar to or different from step 1220 of
In a checking step 1330, it is determined whether the location of the probe is correct. If negative, the probe is moved to another location. The relocation of the probe may be manual, semi-manual or automatic employing for example, a two-dimensional or three-dimensional computer controlled stage, as is known in the art. There may be a computer program which controls the stage and defines the sequence of moving the probe from one location to the next. In cases, where the relocation is manual or semi-manual, the system may provide the operator with specific instructions on how and to whereto move the probe.
Additionally or alternatively, further steps of moving the stage may be introduced in response to the results of step 1330. Once the probe is relocated, steps 1320-1330 are repeated. If in step 1330, the location of the probe is correct, a tissue treating step 1340 is performed. Typically a predetermined dosage of the treatment is administered to the tissue at that location.
Thereafter, the treated tissue is characterized in a characterization step 1350. The characterization step may include qualitative and quantitative assessment of the treatment success at the specific location. If the results are unsatisfactory, one or more further types of treatment may be defined in defining step 1380, and step 1340-1360 are repeated, but using a second and or further type(s) of treatment. For example, if the first treatment is laser ablation, the second treatment may be chemotherapy and a third treatment may be ultrasound.
Once it has been determined in step 1360, that the treatment is complete in the first location, the probe is relocated in step 1310 and the treatment procedure is performed at the second location. Steps 1310-1370 or 1310-1380 are performed as many times as is required until all locations of the target tissue have been fully treated.
The method of
Reference is now made to
Referring further to the drawings,
Flexible construction 1075 is configured to bend at a line 1077, so that in operation, spiral 1022 is substantially at a right angle to the remainder of flexible construction 1075. Additionally, flexible construction 1075 is adapted for operation when inserted into a hollow housing 1074, having a top cover 1057 of polycarbon, wherein spiral 1022 forms a proximal cover over top cover 1057 of polycarbon, for forming contact or near contact with the edge 1013 of the tissue. Hollow housing 1074 essentially provides an effective cavity 1051, at the distal side of the sensor 1022.
Reference is now made to
In contrast to system 1100 of
System 1500 is typically designed for in-situ treatment of a tissue at a plurality of locations of a body, so as to form an area of treatment of the tissue and to provide at least one type of treatment to the tissue. In some embodiments, at least two types of treatment are provided. In other embodiments at least three types of treatment are provided. The system includes an apparatus 1530 for proximal orientation to the tissue in the body. This apparatus is connectable to at least one external unit 1510, 1580 including inter alia a memory utility 1507, a data processing and analyzing utility 1508, data input utility 1509, a display unit 1502. The system further includes a locating apparatus 1504, and at least one treatment apparatus 1506, 1509, 1511. The external unit is in electronic communication 1520, which may be wired or wireless with apparatus 530.
Apparatus 1530 includes an active head 1540 having a sensing probe 1550 for characterizing a sample of tissue from at least one of the proximal locations. The head includes a positioning mechanism 570 for sequentially guiding the apparatus from at least one of the plurality of locations to one or more other locations of the plurality of locations. Head 1540 further includes at least one treatment probe 1560, 1562, 1564 for providing one or more type of treatments. The treatment probes include at least one active outlet (not shown) for applying at least one treatment to at least one of the plurality of proximal locations for treating the sample. Probes 1560, 1562, 1564 each include an activating mechanism (not shown) adapted to activate the at least one outlet.
The external units may or may not be in wired communication with apparatus 1530. In some cases, units 1510, 1580 may be configured for appropriate wireless communication and/or via the Internet In some embodiments, unit 1580 is a CT machine known in the art. Unit 1580 performs external imaging.
External unit 1510 includes a sensing functionality 1505 adapted to receive at least one signal from sensing probe 1550 at each location and to analyze the at least one signal so as to provide at least one output. In some cases, functionality 1505 is part of unit 1580, which may be an image analyzer, as is known in the art. One or more of treatment functionalities 1506, 1511, 1513 are adapted to receive the at least one output from unit 1580 and to provide at least one treatment to at least one of treatment probes 1560, 1562, 1564 responsive to the output. In some embodiments, the at least one treatment is provided by one or more of the treatment probes at one or more outlets (not shown). In some cases, the treatment is only provided when the activating mechanism is activated. The activating mechanism is typically activated by a signal from one or more external units 1510, 1580.
Reference is again made to
The example illustrated in
In a pulmonary system, 605 of a human, there is a trachea 620 connected to two bronchi 610, 640 and two lungs 630, 632. Some abnormal tissue 612, 614, 616 was discovered in bronchus 610. It was decided, for example, to laser ablate the abnormal tissue using system 100 of
The apparatus is now moved to a third position x1y1z2. A sample of tissue at the third location is sensed by sensing probe 602. Sensing probe sends signals to sensing module 685; the signals are processed by processor 688; and corresponding output is displayed, being indicative of that the tissue at the third location is abnormal. In an optional verification step, another type and/or another set of signals is relayed by the sensing probe to the processor, and the tissue type at the third position is characterized and/or verified. The type, duration, quantity and quality of the treatment may be determined at this stage.
Treatment functionality 686 activates a laser beam, such as a Yag-Niobium laser via apparatus 600 to treatment probe. The treatment probe provides the laser ablation treatment for a predetermined period of time. The sensing probe then senses the treated tissue and sends signals to the processor. In accordance with the so-provided (displayed) output, the operator can determine, what, if any, further treatment is required at the third location. Alternatively, the determination may be made by the processor, based on a set of predetermined rules.
If the treatment at the third location is complete, the apparatus is moved to a fourth position. The sensing, treating and positioning steps are repeated until all of the abnormal tissue 612, 614, 616 and 618 has been treated. Thereafter, the system may perform a full scan at all locations to verify that all the abnormal tissue has been treated.
Reference is again made to
Using the system of
In some embodiments, the apparatus is designed to treat tissue inside body lumens, such as inside a lung bronchus. The particular design features associated with treating a body lumen are shown in
In some other preferred embodiments, the apparatus is designed to treat skin or an external surface of the body. The particular design features associated with treating skin are shown in
Systems for physical treatment are exemplified by as electrosurgery, cryo-therapy, RF ablation examples. Systems for chemical treatment include, but are not limited to applying a. toxin, or drug examples. Systems for biological treatment include, but are not limited to DNA therapy, viral therapy, enzyme therapy, vial therapy examples. In some embodiments, the sensing apparatus includes a localization mechanism, which is computer controlled with a feedback mechanism examples.
Reference is now made to
In a positioning step 1810, an apparatus, such as apparatus 1130 of
The positioning step of the probe may be manual, semi-manual or automatic employing for example, a two-dimensional or three-dimensional computer controlled stage, as is known in the art. There may be a computer program which controls the stage and defines the sequence of moving the probe from one location to the next. In cases, where the relocation is manual or semi-manual, the system may provide the operator with specific instructions on how and to whereto move the probe.
In a characterizing step 1820, at least one sample of the tissue is characterized to determine the cell type and tissue type. For example, it is determined at this stage, whether some or all of the tissue is abnormal tissue, such as cancerous tissue. This step may be similar to or different from step 1220 of
In a checking step 1830, it is determined whether the characterized “abnormal” tissue is benign. This step may be performed off-line by a pathologist in a lab, or online by a tissue characterization apparatus, such as the system of
If in step 1830, the tissue is characterized as not being benign, one or more treatments are applied to the tissue in step 1850. It should be understood that steps 1820 and 1830 may comprise several substeps, in which the type of tissue may be further characterized. For example, step 1820 may include sub-steps to characterize the size and location of the abnormal tissue relative to the normal tissue. Step 1830 may comprise sub-steps to further determine the sub-type of the abnormal tissue, such as cancer type, tumor type, size, age, density, relative location. Once the non-benign tissue is fully characterized and located, it is treated in step 1850. Typically a predetermined dosage of the treatment is administered to the tissue at that location. The treatment administered may be similar or different to that of step 1250 of
In a characterization step 1860, the treated tissue is characterized to check the success of the treatment step. For example, if the cells of the treated tissue were laser ablated in step 1850, step 1860 is performed to check what percentage of cells were successfully treated and if any of the cells were overlooked in the treatment step.
In a checking step 1870, the results of characterization step 1860 are analyzed to see whether any further treatment is required for that specific tissue. The further treatment may be related to location and or to extent of the treatment. For example, a first result of step 1860 could be that 85% of the cells were successfully treated, but 15% of the cells were not treated. Then the result of step 870 would be negative and the treatment would be repeated for the 15% of the cells. A second result of step 1860 could be that all the cells were almost fully ablated, say 70%, then the result of step 1870 would be negative and the treatment would be repeated for all the cells until 100% treatment was applied for all the cells in the repeat of step 1850.
If the result of step 1870 is that all the cells of the tissue were sufficiently treated, then probe is positioned at the next location in a repeat of step 1810 and the treatment procedure is performed at the second location.
In checking step 1880, it is determined whether tissue at all of the proximal locations, whether three-dimensional or two dimensional locations have been fully treated. If not, the probe is moved to the next location in step 1810 until tissue at all of the locations has been fully treated. Thus, steps 1810-1880 are performed as many times as is required until all locations of the target tissue have been fully treated.
The method of
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IL07/00071 | 1/18/2007 | WO | 00 | 7/18/2008 |
| Number | Date | Country | |
|---|---|---|---|
| 60759555 | Jan 2006 | US |
