Barrett's Esophagus (BE) is a condition of the esophagus that is pre-cancerous, a precursor to cancer of the esophagus. The standard practice for diagnosing Barrett's Esophagus uses a flexible endoscopy procedure, often with the esophageal lumen insufflated with air. A normal esophagus is usually light pink in color, while the stomach appears slightly darker pink. Barrett's Esophagus usually manifests itself as regions of slightly darker pink color above the lower esophageal sphincter (LES) that separates the stomach from the esophagus.
It is preferable to diagnose BE early, since this condition has been found to be a precursor of esophageal adenocarcinoma. Accordingly, it would be desirable to provide a general screening procedure for the condition, even though doing so would require evaluating the condition of the esophagus in millions of people with chronic heartburn and gastric reflux. However, Barrett's Esophagus and early stage cancers can occur without telltale symptoms, so mass screenings have been proposed as the only viable approach to identify the condition as early as possible to enable treatment and avoid the onset of or provide a curative therapy for the cancerous condition. Unfortunately, the numbers of people that are likely candidates for esophageal screening and the current cost associated with the practice of flexible endoscopy performed by a physician compared to the reimbursement associated with such mass screenings make this solution currently impractical because of the expense involved.
What is needed is a much more efficient and cost effective approach for identifying those people having Barrett's Esophagus. Only a doctor can perform an examination of the esophagus using a conventional flexible endoscope, and the procedure is thus relatively expensive. It would be preferable to develop a different scanning technique that need not be performed by a physician, but instead, can be performed by a trained medical technician or nurse. Indeed, it would also be desirable to automate the evaluation of images produced by imaging the internal surface of the esophagus just proximal of the LES so that the existence of Barrett's Esophagus can be automatically detected either in real time during the scanning operation or immediately thereafter.
To facilitate mass screenings of individuals who may be afflicted with Barrett's Esophagus, it would be desirable to employ a screening device that can readily be introduced into the esophagus, without invoking any gag reflex. Ideally, the scanning device should be embodied in a capsule-shaped housing so that it can simply be swallowed with a glass of water. Accordingly, the device must be sufficiently small in size to enable it to be swallowed by most patients. Further, although such a device might be reusable if properly sterilized, it may be desirable to employ a screening device that is sufficiently low in cost as to be disposable after a single use.
The above-noted earlier related application discloses an approach for monitoring a position in a person's esophagus of an endoscope that is well-suited for providing images that can be used to evaluate the condition of the esophagus and thereby detect BE. In this earlier approach, a tether attached to a capsule endoscope that includes an imaging device passes over a wheel that rotates as the capsule is moved axially within the esophagus, to enable the relative position of the capsule in the esophagus to be continually monitored. The axial position of the capsule is important so that the locations of regions, which may be of interest in images of the inner surface of the esophagus, can be identified and to enable the axial scaling of any panoramic images taken. However, the measurement of the axial position depends upon the frictional contact between the tether and the measurement wheel. There are three reasons why this method may not produce sufficiently accurate results. In this earlier described approach, the tether must be kept under tension, and the measurement technique relies on no-slip friction between the measurement wheel and the moving tether. Slippery saliva and mucus within the person's mouth and esophagus can adhere to the tether creating slippage between the measurement wheel that is rotated and the tether. In addition, the clinician performing the procedure may want to feel the progression of the tethered capsule scope as it passes through the lower esophageal sphincter and other parts of the esophagus, and the additional applied tension produced by the measurement wheel (which was disclosed as a pinch wheel) is likely to interfere with that feel. Similarly, the clinician may want to move the capsule scope up and down within the esophagus in a repeated manner, which will likely introduce measurement error in a mechanical system that is based on the friction between the measurement wheel and the tether. Any hysteresis in the measurement can be a further source of error.
Accordingly, a better technique for monitoring the axial position of the capsule scope is desired. The approach that is used should monitor the movement of the capsule by detecting the motion of the tether without actual contact between the tether and the axial position monitoring apparatus. The presence of saliva and mucus should have minimal impact on the monitoring technique used, and the feel as the capsule scope is moved up and down should be readily experienced by the clinician without interference from the apparatus used to monitor the position of the capsule.
A scanning fiber endoscope (SFE) includes a scanning capsule having a scanning device and a tether coupled to the capsule for controlling a position of the scanning capsule within a body lumen. Since it is important to monitor at least a relative position of the scanning capsule without introducing errors as a result of bodily fluids that may coat the tether and to avoid interfering with the “feel” of a clinician who is controlling the position of the scanning capsule within the body lumen, a novel method has been developed to achieve this function. The method thus enables monitoring a relative position of a scanning capsule within a body lumen. The tether that has a distal end coupled to the capsule extends externally of the body lumen and carries a scan signal produced in the scanning capsule that is useful to produce an image of an interior surface of the body lumen. The method includes the step of providing an indicia along an axial length of at least a portion of the tether, which is indicative of a position. Using a sensor that responds to the indicia without requiring physical contact with the tether, the indicia are automatically sensed, producing a position signal indicative of the position of the tether and thus, of the disposition of the scanning capsule axially within the body lumen.
At least one non-numeric visible reference mark can be provided on the tether to indicate an expected reference position. This reference mark can thus enable a user to manually position the capsule at about a desired location based upon the visual indication provided by the non-numeric visible reference mark on the tether. While not a requirement, the body lumen can comprise an esophagus. In this case, the expected reference position might correspond to a position on the tether that should indicate when the capsule is expected to be disposed at about a gastroesophageal junction in the esophagus. A plurality of additional non-numeric visible marks can also be provided both distally and proximally of the at least one non-numeric visible reference mark, to visually indicate positions or distances on either side of the expected reference position.
In one exemplary embodiment, the step of automatically sensing the indicia can include the step of using a magnetic sensor for producing the position signal in response to a varying parameter of a magnetic field that is produced by the indicia on the tether. The position signal that is produced can be either a digital position signal or an analog position signal, both of which are indicative of a current position along the axial length of the tether, adjacent to the magnetic sensor.
In a different exemplary embodiment, an optical sensor can be used for producing the position signal in response to an optical parameter of the indicia that varies along the axial length of the tether. Again, the step of producing the position signal can produce either a digital position signal or an analog position signal, either of which is indicative of a current position along the axial length of the tether, adjacent to the optical sensor. The indicia can comprise an optical code that produces the position signal in response to at least one parameter selected from a group of parameters. These parameters include: a color of the optical code that is sensed by the optical sensor; a digital value indicated by the optical code; an intensity of light reflected from the optical code compared to an intensity of light reflected from a background area; a pattern of the optical code that conveys digital information; a relative size of markings comprising the optical code; a shape of the markings comprising the optical code; a scattering of light by the optical code compared to a scattering of light from the background area; and a wavelength of light reflected by or absorbed by the optical code.
In a further alternative exemplary embodiment, an additional sensor can be provided to monitor the indicia on the tether, to increase a resolution with which the relative position of the capsule in the body lumen is determined.
The step of providing the indicia can include applying the indicia by either affixing the indicia to the tether as a longitudinally extending tape, or by applying the indicia to the tether as a longitudinally extending coating. Optionally, the indicia can be protected with a protective coating that is applied over the indicia. In some exemplary embodiments, the method can include the step of providing a scraper for gently wiping bodily fluids from the tether as the tether is withdrawn from the body lumen, and before the tether passes the position sensor.
In some applications, the exemplary method includes the step of determining a reference position for the capsule within the body lumen relative to which the indicia are used, to determine the position of the capsule within the body lumen. For example, the reference position can be determined by moving the capsule to a known position within the body lumen based upon the images of an interior surface of the body lumen. The disposition of the capsule at the known position thus represents the reference position that is then used to determine subsequent positions of the capsule as the tether is used to move the capsule within the body lumen.
Another aspect of the present technology is directed to exemplary apparatus for measuring a relative position in a body lumen of a capsule used for scanning an inner surface of the body lumen to produce images. The apparatus includes a tether and a non-contact position sensor that are generally consistent with the method discussed above.
Yet another aspect of this technology is directed to an exemplary method for measuring an axial extent of a region of interest within a body lumen in regard to images produced by a scanning device in a capsule that is coupled to a tether having a proximal end that extends outside the body lumen and is used to move the capsule. The method includes the step of monitoring the distance that the capsule is moved through the body lumen with the tether by monitoring movement of the tether past a sensor disposed outside the body lumen. Successive images of an internal surface of the body lumen are captured as the tether is used to move the capsule axially through the body lumen. A region of interest on the internal surface of the body lumen is detected in the successive images, and based upon a first position of the capsule within the body lumen corresponding to an axial start and a second position corresponding to an axial end of the region of interest, the axial extent of the region of interest is measured, with reference to the distance between the first position and the second position that the tether moves the capsule. Also disclosed below is an apparatus for carrying out this distance measuring function.
Still another aspect of the technology is directed to a method for use with a capsule having a scanner for imaging an inner surface of an esophagus, where the capsule is coupled to a tether for moving the capsule within the esophagus and through a gastroesophageal junction. In this method (and in regard to corresponding apparatus) using the tether, the capsule is moved within the esophagus to a position adjacent to the gastroesophageal junction. A pulse of pressurized fluid is then delivered to a region adjacent to the capsule. The pulse of pressurized fluid causes a lower portion of the esophagus to autonomously be distended, thereby facilitating movement of the capsule through the gastroesophageal junction and into and out of a stomach of a patient, while a scanner in the capsule is used for imaging the inner surface of the esophagus.
This Summary has been provided to introduce a few concepts in a simplified form that are further described in detail below in the Description. However, this Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
Various aspects and attendant advantages of one or more exemplary embodiments and modifications thereto will become more readily appreciated as the same becomes better understood by reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:
Figures and Disclosed Embodiments are not Limiting
Exemplary embodiments are illustrated in referenced Figures of the drawings. It is intended that the embodiments and Figures disclosed herein are to be considered illustrative rather than restrictive. No limitation on the scope of the technology and of the claims that follow is to be imputed to the examples shown in the drawings and discussed herein.
Exemplary Application of Scanning Capsule
Although an exemplary embodiment of a scanning capsule was initially conceived as a solution for providing relatively low cost mass screening of the general population to detect BE without requiring interaction by a physician, it will be apparent that this embodiment is also generally applicable for use in scanning, providing diagnoses, rendering therapy, and monitoring the status of therapy thus delivered to an inner surface of almost any lumen in a patient's body. Accordingly, although the following discussion often emphasizes the application of the scanning capsule in the detection of BE, it is not intended that the application of this device be in any way limited to that specific application.
The manner in which an esophagus can be scanned is illustrated in
The exemplary embodiment of
A chemical sensor 40 is optionally included to sense a chemical parameter. For example, chemical sensor 40 can detect hydrogen ion concentration, i.e., pH, within the lumen. Alternatively or additionally, the chemical sensor can include a temperature sensor for monitoring an internal temperature of the lumen. Similarly, a pressure sensor can be employed in addition to or in place of chemical sensor 40, which is thus intended to represent any one or all of these sensors.
As a further option, a selectively releasable connection 42 can be provided to pneumatically or electrically disconnect the capsule from the tether when desired. When thus released from its connection with the tether, the capsule will be conveyed through the body lumen and if the lumen is involved with the digestive tract, the capsule will pass through and be expelled. The releasable connection can be activated with a pressurized pulse that is propagated through a lumen (not shown) in tether 22 from an external source (not shown), or can be an electrical signal that magnetically actuates releasable connection 42 using an electrical current provided through a lead in the tether. A similar releasable joint might also or alternatively be provided near the proximal end of the tether, to release the tether and capsule to pass on through the lumen together.
System Processing Overview
Externally, the illumination optics are supplied light from illumination sources and modulators, as shown in a block 56. Further details concerning several preferred embodiments of external light source systems for producing RGB, UV, IR, and/or high intensity light conveyed to the distal end of an optical fiber system are disclosed below. A block 58 indicates that illumination sources, modulators, filters, and detectors are optionally coupled to the electromechanical scan actuator(s) within the capsule, and/or to the scanner control actuators provided in the capsule. Scanner motion detectors are optionally used for controlling the scanning and produce a signal that is fed back to the scanner actuators, illumination source, and modulators to implement more accurate scanning control, if needed.
In a block 60, image signal filtering, buffering, scan conversion, amplification, and other processing functions are implemented using the electronic signals produced by the imaging photon detectors and for the other photon detectors employed for diagnosis/therapy, and monitoring purposes. Blocks 56, 58, and 60 are interconnected bi-directionally to convey signals that facilitate the functions performed by each respective block. Similarly, each of these blocks is bi-directionally coupled in communication with a block 62 in which analog-to-digital (A/D) and digital-to-analog (D/A) converters are provided for processing signals that are supplied to a computer workstation user interface employed for image acquisition and processing, for executing related programs, and for other functions. The computer workstation can be employed for mass screening of the population when programmed to process images produced by scanning inside an esophagus to detect BE so that near real-time results are provided, and normally without requiring a physician's evaluation.
Control signals from the computer workstation are fed back to block 62 and converted into analog signals, where appropriate, for controlling or actuating each of the functions provided in blocks 56, 58, and 60. The A/D converters and D/A converters within block 62 are also coupled bi-directionally to a block 64 in which data storage is provided, and to a block 66. Block 66 represents a user interface for maneuvering, positioning, and stabilizing the capsule with the scanner inside a lumen within a patient's body. Further description of several exemplary techniques for determining a location of a capsule in a lumen are discussed below. The procedure for maneuvering and positioning the capsule in a lumen is discuss in further detail below. Also discussed is a technique for stabilizing the capsule in the lumen.
In block 64, the data storage is used for storing the image data produced by the detectors within a patient's body, and for storing other data related to the imaging and functions implemented by the scanner in the capsule. Block 64 is also coupled bi-directionally to the computer workstation and to interactive display monitor(s) in a block 70. Block 70 receives an input from block 60, enabling images of the ROI on the inner surface of the lumen to be displayed interactively. In addition, one or more passive video display monitors may be included within the system, as indicated in a block 72. Other types of display devices, for example, a head-mounted display (HMD) system, can also be provided, enabling medical personnel to view an ROI in a lumen as a pseudo-stereo image.
In addition, therapy can be rendered to the inner surface of a lumen using scanning optical fiber 242. For example, by illuminating the points scanned by it using a relatively high powered laser, high intensity light for the purposes of drug activation or photodynamic therapy (PDT), or thermotherapy can be applied to the ROI. Since the signals produced by the RGB photon detectors correspond to successive points in the ROI, the image resulting from the signal that they produce is based upon a time series accumulation of image pixel data. Scanning optical fiber 242 is preferably a single mode or hollow optical fiber, of telecommunications grade or better. One significant advantage of this integrated system is that the mechanisms employed for generating the visual image are the same used for diagnostic, therapeutic, and surgical procedures. The directed optical illumination employed for image acquisition enables the most sophisticated diagnoses and therapies to be integrated into this single imaging system within a capsule sized to pass through a body lumen (by sharing the scan engine, display, and user interface).
At the illumination plane, the beam of optical radiation is focused to achieve maximum intensity and/or optical quality, which is the goal for all modes of scanning. When tissue is coincident with the illumination plane, the optical irradiance is a function of the optical power and size of the light spot on the tissue. Thus, with regard to imaging, diagnoses, and therapy, the resolution of the scanner disposed in the capsule is determined by this spot size at the image plane and may also be limited by the sampling density (i.e., samples per unit area of tissue), since higher resolution is achieved by providing more scan lines per area. With regard to image acquisition, the image resolution is determined by the illumination spot size, detector bandwidth (and scan rate), and signal-to-noise ratio (illumination intensity and collection efficiency), while image resolution is not limited by the physical size or number of the photon detectors.
Since diagnoses and therapies require accurate spatial discrimination, there is a need for directed illumination that is pre-calibrated before delivery. By integrating the optical imaging with diagnostic and therapeutic scanning delivered in a capsule, a medical practitioner can easily see the spatial discrimination of the optical scanning by viewing the displayed image before proceeding to diagnostic or therapeutic applications within the lumen in which the capsule is disposed. Finally, the integration of computer image capture electronics and image processing software enables the image, diagnostic, and therapeutic data to be analyzed on a pixel-by-pixel basis. Since each pixel corresponds to the same area or volume of tissue, the single fiber integrated system maintains spatial registration for all three functions; imaging, diagnosis, and therapy. Consistent spatial registration from the same point of view for all three functions makes the single optical fiber scanning system, delivered within a capsule passing through a lumen, highly accurate and easy to use by medical practitioners.
The advantages afforded by using the scanning device integrated within a relatively small capsule are:
A schematic diagram illustrating an exemplary light source system 340 for producing light of different spectral composition that is coupled through the tether and into an optical fiber 360 disposed within the capsule is illustrated in
An alternative light source system 362 for use with the present invention is illustrated in
As indicated above, it is desirable to develop a scanning device with a small cross-sectional area that can be manufactured at relatively low cost and high volume to ensure that the endoscopic capsule scanning system is economical and thereby facilitate its widespread use. Micro-electromechanical systems (MEMS) technology using an integrated thin film device may be beneficially employed when producing economical scanners to more readily achieve this goal.
In this thin film exemplary embodiment of a scanner, electrostatic actuators 386 act on a thin film optical waveguide 380, which is supported on a raised ledge 378. The thin film optical waveguide is only about 0.003 mm in diameter. A distal portion 382 of the thin film optical waveguide is caused to scan in the two orthogonal directions indicated by the curved arrows in
Optical fiber 374 can be affixed to silicon substrate 376 within a centering V notch 390 to ensure that it is aligned with thin film optical waveguide 380. Since the optical fiber is approximately 0.1 mm in diameter, care must be taken to provide accurate alignment between the ends of the optical fiber and the thin film optical waveguide.
In the embodiments shown in
Automated System for Mass Screening
One of the contemplated uses of the present invention is that it might eventually enable a nearly automated esophageal screening process to be carried out by a medical practitioner (not requiring that the procedure be done by a medical doctor) to screen a patient for BE.
Tether 22 is coupled to computer processor 394 after passing through a non-contact axial motion measuring device 396 that is used for monitoring the movement of tether 22. As explained above, tether 22 is used for retracting or enabling advancement of a capsule within the esophagus of patient 395. An electrical cable 402 conveys a signal produced by non-contact axial motion measuring device 396 that is indicative of the position or axial movement of the tether, to computer processor 394. Tether 22, which includes one or more optical fibers and one or more electrical leads that convey optical and electrical signals to and from the scanner disposed in the capsule (neither shown in this view), is retracted or allowed to advance in the esophagus with the capsule. The tether extends between lips 404 and down the esophagus of the patient. Indicia (e.g., magnetic or optical as described in detail below, enable the position and movement of the tether to be detected as the tether passes through device 396. Patient 395 is initially provided a glass 406 of liquid, such as water, to facilitate swallowing the capsule and attached tether 22. The liquid is swallowed after the capsule is inserted into the patient's mouth and helps to advance the capsule through the esophagus with the normal peristalsis of the muscles comprising the walls of the esophagus as the patient swallows the liquid.
The capsule is allowed to advance into the stomach of the patient and is then withdrawn past the LES by medical practitioner 408 grasping handle 402 and rotating reel 396. Additionally, it is possible that a computer-controlled withdrawal of the capsule might use a motorized reel (not shown) to fully automate the screening process by withdrawing the capsule up through the esophagus. Thus, the computer might determine how fast to withdraw the capsule, in response to criteria that determine the quality and content of the images being scanned by the capsule in real time, and in response to the signal output from non-contact axial motion measuring device 396. In addition to controlling the speed of the withdrawal of the capsule, the computer can control the intensity of light provided for scanning and patient-specific variables, and can carry out automated image stitching to form panoramic images of the interior surface along a length of a lumen. An example of currently available automated image stitching software is available, for example, from Matthew Brown as “AutoStitch,” (see the URL regarding this software at http://www.cs.ubc.ca/˜mbrown/autostitch/autostitch.html). Such images can be used in connection with image recognition software to determine the location of the LES and to automate the determination of whether a patient has BE or some other medical problem. Also, images automatically stitched together to form a full 360° panoramic view can be calibrated to form a ruler-like measure in pixels of the length of the capsule from the LES, as an alternative measure to define the location of the capsule in a patient's esophagus. As a further alternative, the signal produced by non-contact axial motion measuring device 396 may be employed to speed up the process of stitching together the successive axial images of a lumen such as the esophagus, to form the full continuous panoramic image of the lumen.
By viewing a display 398 that is coupled to computer processor 394, the medical practitioner can readily observe images of the stomach and then, as the reel rewinds the tether to retract the capsule above the LES, the medical practitioner can observe images of the inner surface of the esophagus on the display. An indicator 400b is displayed at one side of the display to show the relative speed and direction with which the capsule is moving through the esophagus.
Computer processor 394 can detect the LES based upon the changes in an image 399 and display a distance 400a of the capsule above the LES, and can be programmed to automatically evaluate the images of the portion of the inner surface of the esophagus immediately above the LES to determine if the patient has the characteristic dark pink color at that point, which is indicative of BE. The medical practitioner should only be required to manipulate tether 22 and assist the patient in initially swallowing the capsule, since the results of the image scanning process can thus be sufficiently automated to detect the condition of the esophagus in near real time, providing an immediate indication of whether the patient is afflicted with BE. The efficiency of such a system should thus enable mass screenings of the population to be conducted at minimal cost, so that esophageal cancer of which BE is often a precursor, can be avoided by early detection of BE.
Functional Block Diagrams
As indicated in a box 432, the exemplary system may include additional high or low power UV, and/or visible, and/or IR detectors associated with collection optical fibers for use by one or more spectrophotometers or spectrum analyzers. For example, spectrophotometers and spectrum analyzers indicated in a block 434 can receive light conveyed through light collection optical fibers and/or as signals conveyed over conductors as indicated in a block 436. The system may include additional photon detectors disposed inside the capsule within the patient's body as a further option. Signals are exchanged bi-directionally between block 432 and 434 and a computer processor (or workstation) and data acquisition component in a block 440. The computer processor can execute algorithms that provide for non-linear scanning patterns and control algorithms and also can be programmed to carry out intensity data acquisition, image mapping, panoramic image stitching, and storage of data. In addition, tasks including real-time filtering (e.g., correction for motion and scanner artifacts), real-time determination of ratios and background subtraction, deconvolution, pseudo-stereo enhancement, and processing of the signals produced by the various detectors are implemented by the computer processor. Signals provided by the computer processor are output to image display devices (such as shown in
Since commercially available displays typically require rectilinear video format, any non-rectilinear optical scanning patterns must be stored in data buffers (memory) and converted to the standard raster scanning format for the display monitors, to make use of the many advantages of non-rectilinear scanning, (such as a simplified single actuator, cylindrical scanner size, and lower scanning rates) used for the one or more scanners in the exemplary capsule. This additional step in signal conditioning and remapping is technically trivial with programmable computing devices.
In addition, image analysis software for carrying out spectral and multivariate analysis and for locating and calculating the limits of regions of interest are carried out using the computer processor or other computing device. In regard to the ROI on the inner surface of the lumen, the computations may determine its distribution, boundary, volume, color, and optical density, and based upon the data collected from the ROI, can determine a tissue disease state such as BE, and medical staging, as well as calculate and monitor therapeutic dosage. All of these functions are indicated in a block 444, which may use the normal imaging computer processor of block 440. Block 444 is coupled to a block 446, in which additional interactive displays and image overlay formats are provided. Associated with block 444 is a block 448, which indicates that scanner power and control electronics are provided for actuating the electromechanical scanner and for receiving signals from servo sensors in a block 450, which are used for both normal image acquisition and enhancements involved in screening, monitoring, and diagnosis, as well as pixel accurate delivery of therapy to a desired site within the lumen.
Various embodiments of optical fiber scanning actuators have been described above, in connection with moving a scanner disposed in the capsule to image an ROI within a lumen. A block 454 indicates that provision is made for manual control of the distal tip of the scanning optical fiber, to enable the capsule containing the scanning optical fiber to be inserted into a patient's body and positioned at a desired location adjacent an ROI. The manual control will perhaps include turning the tether to rotate the capsule and/or axially positioning the capsule and scanner relative to the ROI in the lumen, and possibly employing automated servo sensors, as indicated in a block 456 to facilitate the positioning of the capsule and one or more scanners at the desired location. Once positioned, automatic vibration compensation for the scanner can be provided, as noted in a block 452, to stabilize the image in regard to biological motion (breathing and cardiovascular movement) and physical movement of the patient. In addition, other mechanisms can be provided in at least one exemplary embodiment, for stabilizing the capsule where desired within the lumen of a patient's body.
Details of the various functions that can be implemented with the capsule imaging system are as follows:
It is contemplated that one of the two displays might be interactive, such as by using a touch screen monitor or interactive foot mouse or pedal that enables the medical practitioner to select (draw the outline of) an ROI for laser surgery. Since the image may be moving, the touch screen monitor will require the image to be captured and frozen in time. However, once this ROI is outlined, image segmentation and object recognition algorithms may be implemented to keep the ROI highlighted during real-time image acquisition and display. The interactive monitor can provide sidebar menus for the practitioner to set parameters for the laser therapies, such as power level and duration of laser radiation exposure. The second display would not be used interactively, but is preferably a high resolution monitor displaying the real-time optical image in full-color or grayscale. If IR photon detectors are integrated into the endoscope, the high resolution display with pseudo-color will allow the practitioner to monitor the progress of laser therapies, such as tissue heating and/or tissue irradiation in laser surgery.
The scanning optical fiber within the capsule is positioned at a desired location within the patient's body, opposite ROI 486, using the tether and an optional manual controller that facilitates tip navigation and stabilization, as indicated in a block 466. The disposition of the capsule within the lumen can be automatically determined based upon a position sensor signal or simply by monitoring the distance that the tether extends into the lumen, with reference to a scale provided on the tether, as discussed below in connection with
To facilitate control of the motion of the scanning optical fiber or light waveguide, electrical power for microsensors and control electronics are provided, as indicated in a block 470. The signals provided by the control electronics enable amplitude and displacement control of the optical fiber when the actuator that causes it to scan is controlled by both electrical hardware and software within block 470. A spectrophotometer and/or spectrum analyzer 474 is included for diagnostic purposes, since the spectral composition of light received from ROI 486 and distribution of optical biopsy spots 485 can be used for screening and diagnosis for such diseases as cancer by a medical practitioner evaluating the condition of the ROI in the lumen, based upon spectral photometric analysis. To illuminate the ROI so that it can be imaged, red, green, and blue light sources 476, 478, and 480 are combined and the light that they produce is conveyed through the optical fiber system to scanning optical fiber 484 within the capsule. The light source used for spectral analysis may be a high power pulse from one of the external RGB light sources (e.g., lasers), or a secondary laser or white light source. Since signal strength, time, and illumination intensity are limiting, a repeated single-point spectroscopic method will be initially employed, using flash illumination. In addition, the same or a different high power laser source 482 can be employed to administer therapy, such as PDT, the laser ablation of dysplasia, neoplasia, and tumors, and other types of therapy rendered with a high intensity source.
In using system 460, a medical practitioner navigates and maneuvers the flexible tether and attached capsule that includes the scanner, to an appropriate region of the lumen in a patient's body while watching the high resolution color monitor displaying the standard, full-color endoscopic image. The search for tumors, neoplasia, and/or pre-cancerous lesions in the lumen can begin by simply watching the monitor. A second monitor (not separately shown) included with spectrophotometer and spectrum analyzer 474 displays a fluorescence mapping in pseudo-color over a grayscale version of the image produced by the scanner in the capsule. When abnormal appearing tissue is found, the capsule is optionally mechanically stabilized (e.g., by inflating an attached balloon, as explained below). The ROI on the lumen wall is centered within the FOV of the scanner, then magnified using a multi-resolution capability provided by the scanner. The size of the ROI or cancer is estimated and a pixel boundary is determined by image processing either the visible image or the fluorescence image. If spectroscopic diagnosis is required, such as LIFS, the distribution of optical biopsy points is estimated along with illumination levels. The diagnostic measurements are performed by automatically delivering the illumination repeatedly over many imaging frames. The user can cease the diagnosis or have the workstation continue to improve signal-to-noise ratio and/or density of sampling until a clear diagnosis can be made from the images produced of the lumen inner surface by the scanner in the capsule. The results of diagnosis is expected to be in real-time and overlaid on top of the standard image.
If optical therapy is warranted, such as PDT, then an optical radiation exposure is determined and programmed into the interactive computer workstation controlling the scanner system in the capsule. The PDT treatment is an optical scan of high intensity laser illumination typically by high power laser source 482, pre-selected for the PDT fluorescent dye, and is controlled using dichroic filters, attenuators, and electromechanical shutters, as explained above. In a frame-sequential manner, both fluorescence images and visible images are acquired during PDT treatment rendered using the scanner in the capsule. The medical practitioner monitors the progress of the PDT treatment by observing these images acquired with the scanner, on both displays.
With reference to
When using system 460′, a medical practitioner again searches for neoplasia by moving the tether and capsule to reposition the scanner while watching high resolution color monitor 464, which shows the visible wavelength (full-color) image. When an ROI is found, the capsule can be mechanically stabilized, e.g., by inflating a balloon attached to it, as discussed below. Again, the ROI is centered within the FOV, and then magnified with the multi-resolution capability. However, if the surrounding tissue is moving so the acquired image is not stationary, a snapshot of the image is captured and transferred to the interactive computer workstation monitor, which is preferably an interactive display. The boundary of the stationary ROI is outlined on the interactive display screen, and an area of dysplasia or volume of the tumor is estimated from a diameter measurement in pixels and a distance measurement between the scanner and the tissue using IR optical phase detector 492 for range finding. An optical biopsy is taken with UV-visible biopsy light source 494, which can be an optical fiber-coupled arc lamp for elastic scattering spectroscopy (ESS). If warranted for this cancerous or pre-cancerous tissue, the optical radiation exposure is calculated, and a treatment protocol is programmed into interactive computer workstation monitor 462. Digital image processing algorithms can be calibrated for automatically segmenting the ROI or processing the scanner signal to eliminate motion artifacts from the acquired images in real-time, which may be equivalent or less than the display frame rate. The laser surgical treatment and/or cauterization can occur with high intensity laser 482 (IR) that is optically coupled with the visible optical scanner. If the IR range finding option is not required, but an IR temperature monitor or laser monitor is desired, then the IR source can instead be used for these alternative monitoring functions. In a frame-sequential manner, both the IR and visible images are acquired during the laser surgery and/or cauterization. The IR image is either a mapping of the back scatter from the laser illumination as it scans the ROI in the lumen, or a thermal image of the ROI, which can be displayed on the interactive computer display as pseudo-color over a grayscale visible image. The medical practitioner monitors the progress of the IR radiation treatment by observing these acquired images on both the high resolution and interactive display monitors.
Determining Disposition of Capsule in Body Lumen
An earlier exemplary embodiment of the scanning flexible endoscope employed a wheel that rotated with the axial movement of the tether as the tether was manipulated to control the position of the capsule within the esophagus of a patient. However, the use of a contact sensor of that type may be inaccurate if the presence of saliva, mucous or other bodily fluids causes the tether to slip on the rotating sensor wheel, so that the position of the capsule within the esophagus is not accurately reported. In addition, the requirement that friction be maintained between the tether and the rotating sensor wheel may interfere with the “feel” that medical personnel may want to experience when controlling the capsule with the tether. Accordingly,
In
Those of ordinary skill in the art will understand that many optical sensors are readily available to read either analog or digital encoded data provided on the indicia on the tether. For example, a light source (not separately shown) on an optical sensor 638 can be directed toward indicia 634. Alternatively, ambient light can be used to illuminate the indicia. Light reflected or scattered by the indicia on tether 630 is then received by optical sensor 638, which may include a photodiode or other appropriate photodetector—not separately shown in this Figure. Also, one or more lenses can be included in the optical sensor to focus the light source (if used) on the indicia and/or the received light on the photodetector. It is also contemplated that the light source may direct light through the indicia so that the transmitted light is received by a photodetector on the opposite side of the indicia from the light source. However, since that approach is less likely to be implemented because of issues related to transmission of light through the periphery of a tether, it is not shown in the drawings.
The optical sensor can employ ultraviolet, visible, or infrared light from a light emitting diode (or other appropriate light source) and can use an optical fiber (not shown) to convey the light from such a source toward the indicia on the tether. Similarly, another optical fiber (not shown) can be used to collect the light from the indicia and convey it toward the photodetector. Use of shorter wavelength light and higher numerical aperture lenses for the collection optical fiber can improve the spatial resolution with which the indicia are read on the tether. The indicia can be applied axially around the entire circumference of at least a portion of the tether, so that the indicia can be read by the optical detector regardless of the rotational orientation of the tether about its longitudinal axis.
In
The relative position of the tether and the capsule in a body lumen can be important for several reasons. First, the medical practitioner can relate the condition of the internal surface of body lumen that is evident in the images being produced by the image scanner included in the capsule with the position of the capsule in the body lumen, so that a condition such as BE as a specific location in the body lumen is clearly known. With this information, the same location in the body lumen can subsequently be accessed for further diagnostic procedures or to render a therapy.
The data provided by position determination function 648 can indicate the actual distance that the capsule has moved from a reference position to any subsequent position. For example, if a reference position for the capsule corresponding to its disposition at the gastroesophageal junction is determined from images produced by the capsule, subsequent motion of the capsule up the esophagus can be expressed as an actual distance from that reference position using the signal produced by non-contact position sensor 646. Thus, once this reference position is determined, the distance from the reference position to a region on the internal surface of the esophagus where apparent BE conditions are observed in the images can be determined from the position data. This region can then be readily found again by repeating the step of establishing the reference and advancing the capsule upwardly the same distance noted previously.
Optionally, it may be desirable to gently clean bodily fluids such as saliva and mucous from tether 652 as it is pulled from the body lumen or esophagus, before the bodily fluids on the tether reach non-contact position sensor 646. As illustrated in
Use of a Balloon Coupled to Capsule
The balloon can be inflated to serve one or more distinct purposes, as follows. For example, balloon 574 can be inflated so that peristaltic muscle tissue action advances the balloon and the capsule through the lumen; the larger diameter of the balloon enables the force applied by the muscle tissue to more efficiently advance the balloon and the connected capsule through the lumen. As a further option, the balloon, when inflated, can convey a pressure from a wall of a lumen in which the balloon is disposed, to a pressure sensor (not shown here—but discussed above) that is on the capsule or otherwise in fluid communication with interior volume 586, so that the pressure exerted by the lumen wall can be monitored externally of the lumen. The pressure can be determinative of various conditions or provide other information of interest to a clinician.
Instead of enabling the capsule to advance, the balloon can be at least partially inflated to enlarge a cross-sectional size of the balloon, thereby preventing further movement of the capsule through a portion of a lumen or other passage having a cross-sectional size that is smaller than that of the balloon. Finally, the balloon can be inflated to generally center and stabilize the capsule within a lumen of the patient's body so that scanning of the inner surface of the lumen to produce images can be more effectively carried out.
Electrical Contacts to Stimulate Peristalsis
A capsule 590 is shown within a lumen 592 in
Mechanical Biopsy
Multiple Images
As noted above, it is contemplated that a plurality of scanners can be included in the capsule, in accord with the present invention. Since each of the scanners are relatively small in size, they can be configured in a spaced-apart array that can image a large field of view, encompassing, for example, an entire 360° view of the inner surface of a lumen. Alternatively, as shown in
Multiple Tether/Capsule Position Sensors
To increase the precision and accuracy with which the relative position of the tether/capsule is measured, two optical or magnetic sensors can be used concurrently to read the indicia on the tether. Interpolation between the optical or magnetic scaling provided by the indicia can also be employed. The spacing of these two or more sensors will be precisely determined, and one sensor can be employed for measuring a full-step, while the other sensor is measuring a half-step.
As another option, actual high-resolution scaling can be printed in optical contrast lettering on the tether, and the non-contact sensor can include an optical character reader that enables the processor in the SFE base unit to “read” the scaling at high spatial resolution. Further, the clinician can also visually directly read the scales on the tether, as well, during use of the tether for positioning the capsule in the body lumen.
For use in screening for BE in the esophagus, a clinician will generally want to initially employ the scanning capability of the capsule for imaging the region immediately above and adjacent to the gastroesophageal junction where the esophagus is joined to the stomach. The average distance from the mouth of a patient down the esophagus to a position of the capsule suitable for scanning to produce images of this region is about 39 cm. To facilitate the initial positioning of the capsule, as shown in
Another exemplary embodiment for delivering the air pulse shown in
Although the concepts disclosed herein have been described in connection with the preferred form of practicing them and modifications thereto, those of ordinary skill in the art will understand that many other modifications can be made thereto within the scope of the claims that follow. Accordingly, it is not intended that the scope of these concepts in any way be limited by the above description, but instead be determined entirely by reference to the claims that follow.
This application is a continuation-in-part (CIP) of a patent application Ser. No. 11/069,826, filed on Feb. 28, 2005, now U.S. Pat. No. 7,530,948 the benefit of the filing date of which is hereby claimed under 35 U.S.C. §120.
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Number | Date | Country | |
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20070299309 A1 | Dec 2007 | US |
Number | Date | Country | |
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Parent | 11069826 | Feb 2005 | US |
Child | 11852227 | US |