JP2008526347A - Endoscopic system for in vivo procedures - Google Patents

Abstract

An endoscopic system for in vivo tissue characterization using a non-irradiated electromagnetic sensor is described. The endoscopic system is further configured to use several subsequent procedures, such as biopsy sampling, local surgery, drug treatment, etc., so overall, the endoscopic system is in vivo. Provided for the early detection of cancer and precancerous tissues, and for applying procedures immediately followed to any such tissues.
[Selection figure] None

Description

  The present invention relates to an endoscope system for in vivo tissue characterization using non-irradiated electromagnetic sensors.

  The impact of cancer is great. Despite the tremendous consumption of finances and human resources, early detection of malignant tumors remains unfulfilled for medical purposes. Although many cancers are known to be treatable when detected at an early stage, the lack of reliable screening procedures has resulted in their presence not being detected and untreated.

  Various forms of endoscope are currently in use. For example, diagnosis of various states of the colon generally involves the use of a colonoscope. A typical colonoscope includes a light source, a video chip and a suction conduit at its distal end with respect to the operator. All of these elements are all communicated to the proximal end of the colonoscope via conduits and wires housed in a flexible tube. The distal end can be inserted into the patient's rectum and guided along the length of the colon. The colonoscope is inserted sufficiently far into the patient's colon so that the distal end can enter the patient's cecum. The tip of the colonoscope can also be guided through the ileocecal valve into the terminal ileum.

  A colonoscope provides a visual image of only the area of the colon in the immediate vicinity of the light source and video chip, and at any given time produces visual information only for a narrow area of the colon. Lesions in the patient's colon are typically identified by continuous and thorough visual inspection of the entire colon. However, a single colonoscopy is typically not sufficient to identify the source of colonic bleeding, which is often scattered and often best located by observing the entire colon over a period of time Often.

  Various attachments to the colonoscope allow small surgical procedures such as tissue biopsy to be performed during colonoscopy.

  Small intestine endoscopy is also known. For example, US Pat. No. 5,984,860 by Shan entitled “Pass-through dual enteroscopic device”, the disclosure of which is incorporated herein by reference, describes a constrained swallowable enteroscopic video camera, In order to advance the video camera through the small intestine at approximately the same speed as any other object in the small intestine, it utilizes the natural contraction waves of the small intestine. The video camera includes an illumination source at its forward end. The camera lens and illumination source coating is a transparent inflatable balloon that is adapted to gently dilate the small intestine just in front of the camera for a better view. A small diameter communication and power cable extends through an opening in the rear of the camera as it moves through the small intestine. Upon completion of movement through the small intestine, the cable is automatically disconnected, allowing the cable to be pulled through the stomach and intestine. The camera continues to move through the large intestine and exits the patient through the rectum.

  The endoscope described above provides a means for approaching and visualizing parts of the gastrointestinal tract, but does not provide a means for detecting gastrointestinal pathologies that are not clearly visible. In particular, the endoscopes described above do not provide a means for localization and differentiation of potential tumors. Typically, large tumors are easily located by visualization. However, for the success of subsequent surgery, as well as for other forms of treatment, it is necessary to somehow locate the tumor at the potential stage of the tumor where it cannot be detected visually and tactilely.

  Similarly, lung cancer is a leading cause of cancer death in both male and female in Western society. When lung cancer is detected and treated at an early stage before spreading to lymph nodes or other organs, the 5-year survival rate is about 42%. However, detection at an early stage is rare. The combined 5-year survival rate for all stages of lung cancer is about 14%-three times lower.

  Most patients are diagnosed when symptoms appear, for example, by bronchoscopy using an endoscope specifically designed for the lungs. The bronchial wall can be examined, for example, visually, and a small piece of tissue can be removed for biopsy. Alternatively, a needle aspiration biopsy is performed by inserting a needle between the ribs to remove cells from the lung. Alternatively, surgery is performed to remove tissue for biopsy. Diagnosis for malignant tumors is generally made in the laboratory on biopsy samples that have been removed by examination of cellular properties under a microscope.

However, subsequent procedures based on laboratory biopsy diagnostics and laboratory biopsies have the following inherent disadvantages:
i. A biopsy is generally performed when symptoms are observed and the cancer is in an advanced stage;
ii. It can happen that the biopsy material is taken from an area near the tumor and not the tumor itself, leading to false inaccurate negative results;
iii. The exact location from which the biopsy was obtained may be difficult to reproduce; and iv. Biopsy results are not straightforward.

  Accordingly, devices and methods for early detection of cancer and precancerous tissue in vivo are highly desirable.

SUMMARY OF THE INVENTION The present invention successfully addresses the shortcomings of currently known configurations by providing an endoscopic system for in vivo tissue characterization using non-irradiated electromagnetic sensors. The endoscopic system is further configured to use several subsequent procedures, such as biopsy sampling, local surgery, drug treatment, etc., so that, as a whole, the endoscopic system is in vivo. For early detection of cancer and pre-cancerous tissue, and to apply procedures immediately followed to any such tissue.

According to one aspect of the invention, an endoscope is provided that includes:
A body part configured for insertion into the body, comprising a non-irradiated electromagnetic sensor for tissue characterization and a communication line on which the non-irradiated electromagnetic sensor is mounted; and an extracorporeal part.

  In addition, the communication lines are formed as instrument bundles.

  In addition, the distal end of the instrument bundle is manipulated outside the body so that the instrument bundle extends beyond the distal most end of the endoscope with respect to the operator and the non-irradiated electromagnetic sensor is in contact with the tissue for characterization. Can.

  Additionally, the body part further includes an instrument conduit and a non-irradiated electromagnetic sensor for tissue characterization is inserted into the instrument conduit.

  Furthermore, non-irradiated electromagnetic sensors for tissue characterization can be removed from the instrument conduit and replaced with another instrument.

  Additionally, the endoscope can further include a catheter, a non-irradiated electromagnetic sensor is inserted into the catheter, and the catheter is inserted into the instrument conduit.

  Further, the catheter can extend beyond the most distal end of the endoscope with respect to the operator, and the most distal end of the catheter can be manipulated independently of the most distal end of the endoscope.

  Additionally, the body part further includes an optical conduit for the optical instrument.

  Furthermore, an optical instrument is configured for observing the non-irradiated electromagnetic sensor.

  Additionally or alternatively, the body part further includes a second instrument.

  Furthermore, the second instruments are optical sensors, X-ray sensors, RF sensors, MW sensors, infrared temperature recording sensors, ultrasonic sensors, MR sensors, impedance sensors, temperature sensors, biosensors, chemical sensors, radiation emission sensors and machines. Selected from the group consisting of sensors.

  Additionally, the second instrument is configured to sense a non-irradiated electromagnetic sensor.

  Furthermore, the body part is designed for movement in the body cavity.

  Additionally, the body part is designed to reach the body cavity by percutaneous insertion.

  In addition, an endoscope is configured to characterize the tissue along the body cavity wall.

  Alternatively, an endoscope is configured to characterize tissue outside the body cavity by penetrating the body cavity wall.

  Additionally, the body cavity is selected from the group consisting of oral cavity, nostril, esophagus, gastrointestinal tract, rectum, colon, bronchi, vagina, cervix, urethra, bladder, uterus and blood vessels.

  Alternatively, the body part is designed for insertion through a trocar valve.

  In addition, tissue characterization relates to the detection of malignant tumors.

  Additionally or alternatively, tissue characterization relates to detection of precancerous conditions.

According to another aspect of the invention, there is provided a method for tissue characterization comprising the following steps:
Insert a non-irradiated electromagnetic sensor into the body; and characterize the tissues in the body.

According to yet another aspect of the invention, an in vivo method is provided comprising the following steps:
Providing an endoscope having an instrument conduit;
Inserting a tissue characterization sensor mounted on the communication line into the instrument conduit;
Characterize the organization;
Removing sensors for tissue characterization;
A second instrument is inserted into the instrument conduit at the characterized tissue location; and the second procedure is performed using the second instrument.

According to yet another aspect of the invention, an in vivo method is provided comprising the following steps:
Providing an endoscope having an instrument conduit;
Inserting a tissue characterization sensor mounted on the communication line into the instrument conduit;
Extend the sensor mounted on the communication line beyond the reach of the instrument conduit;
Characterize the organization;
Inserting a guide wire into the characterized tissue location;
Removing sensors for tissue characterization;
A second instrument is inserted into the instrument conduit, along the guide wire, at the characterized tissue location; and the second procedure is performed using the second instrument.

According to yet another aspect of the invention, a method for tissue characterization is provided that includes the following steps:
Insert a guide wire into the body;
A tissue characterization sensor mounted on the communication line is inserted into the body along the guide wire; and the sensor is used to characterize the tissue.

According to yet another aspect of the invention, an endoscopic system is provided that includes:
A body part configured for insertion into the body, including a non-irradiated electromagnetic sensor for tissue characterization and a communication line on which the non-irradiated electromagnetic sensor is mounted;
Extracorporeal part;
A control device; and a signal analysis device.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention is described herein by way of example only and with reference to the drawings. The details shown are only intended to illustrate the preferred embodiments of the present invention by way of example, with particular reference to the drawings in detail, and the most useful and easily understood aspects of the principles and concepts of the present invention. It is emphasized that it is presented to provide what is believed to be the explanation given. In this regard, details of the structure of the present invention are not shown in more detail than is necessary for a basic understanding of the present invention, but a method of implementing some forms of the present invention by way of explanation with reference to the drawings is not intended. It will be clear to the contractor.

In the drawing:
1A and 1B schematically illustrate an overall endoscopic system according to an embodiment of the present invention;
FIG. 2 schematically illustrates an internal part of an endoscope according to an embodiment of the invention;
3A-3C schematically illustrate the synergistic effect between an optical instrument and a sensor at the distal end of the endoscope body and at the distal end according to an embodiment of the present invention;
Figures 3D-3H schematically illustrate various embodiments of the internal portions of the endoscope of the present invention;
4A-4D further illustrate an endoscope system according to an embodiment of the present invention;
5A-5D summarize various aspects of movement in the body, according to embodiments of the present invention;
6A-6D schematically illustrate tissue characterization coupled with at least one additional procedure according to an embodiment of the present invention;
7A and 7B schematically illustrate tissue characterization coupled with at least one additional procedure according to another embodiment of the present invention; and FIGS. 8A-8C illustrate a guidewire according to an embodiment of the present invention. Fig. 6 schematically illustrates the insertion of a sensor along

  The present invention relates to an endoscope system for in vivo tissue characterization using non-irradiated electromagnetic sensors. The endoscopic system is further configured to use several subsequent procedures such as biopsy sampling, local surgery, drug treatment, etc., so that the endoscopic system as a whole is Provided for the early detection of cancer and precancerous tissue in vivo, and for applying procedures that follow immediately to any such tissue.

  The principles and operation of apparatus and methods according to embodiments of the present invention may be better understood with reference to the drawings and accompanying descriptions.

  Before describing at least one embodiment of the present invention in detail, the present invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. I have to understand that. The invention is capable of other embodiments or of being practiced in various ways or being carried out in various ways. Also, it should be understood that the terminology and terminology used herein is for purposes of illustration and should not be considered limiting.

  Referring to the drawings, FIGS. 1A and 1B illustrate an overall endoscope system 10 according to an embodiment of the present invention.

  The endoscopic system 10 preferably includes an extracorporeal control station 20 having a controller 22, which preferably includes a control button 23, possibly an input interface such as a keyboard 26, and a read / write device. 27. The controller 22 is in communication with the signal analyzer 25 and possibly the display screen 24.

  The control station 20 can be placed on a shelf 28. Alternatively, known handheld devices or laptops can be used.

  Additionally, the endoscope system 10 includes an endoscope 30 having an extracorporeal portion 34, which preferably is coupled to an operating device 36 and an extracorporeal control station 20 for operating the endoscope 30. The connecting device 38 is included.

  Furthermore, the endoscope 30 is designed for insertion into a body, such as a body cavity or trocar valve, and is formed as a flexible tube 40 having a distal end 42 with respect to an operator (not shown). 32.

  The operating device 36 is preferably held by hand. The operating device 36 can include both mechanical and electrical control functions to control the position of the tube 40 and its end 42. Preferably, the operating device 36 is capable of applying to the flexible tube 40 both lateral movement as seen by arrow 31 and rotational movement as seen by arrow 33.

  Still referring to the drawings, FIG. 2 schematically illustrates an internal portion 32 of an endoscope 30 according to an embodiment of the present invention.

  Preferably, the flexible tube 40 of the body portion 32 includes an instrument conduit 44. Additionally, sensor 52 is configured for insertion into instrument conduit 44 (preferably within catheter 48). The sensor 52 is mounted on a communication line 50 for signal transmission, and the communication line 50 is preferably formed as an instrument bundle 50. The instrument bundle 50 can include power cables, communication lines for signal transmission, data cables, and mechanical control cables.

  Sensor 52 can be, for example, a non-irradiated electromagnetic sensor for tissue characterization as taught in US Pat. No. 6,813,515 by Applicant Hashimsony, the disclosure of which is incorporated herein by reference. . US Pat. No. 6,813,515 describes a non-irradiated electromagnetic sensor, which applies an electrical pulse to tissue, creates a fringe electric field in the region of tissue, and is reflected from the region of tissue with very little radiation penetrating into the tissue itself. Generated pulses. 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 nature of the tissue being examined.

  Alternatively, sensor 52 is a non-irradiated electromagnetic sensor for tissue characterization as taught in Applicant's US patent application 60/665842, the disclosure of which is incorporated herein by reference. be able to. US patent application 60/665842 is a resonant element formed as a conductive structure configured to be positioned proximal to a tissue edge for characterization without penetrating tissue, A tissue characterization comprising: a resonant element having an equivalent diameter D defining a cross-section of the resonant element on a plane substantially parallel to an edge of the lip; and at least one conductive line for providing communication with an external system A sensor for is described. Here, the resonant element is configured to resonate in a range of free air wavelengths from about λ to about 10λ, where λ is at least about 10 times the equivalent diameter D. Also, when a signal is received in the range of about λ to about 10λ, when the sensor emits negligible radiation in a distant region, the near region in the tissue (the near region begins with an edge substantially D). In a nearby hemisphere), so that tissue in the nearby region effectively functions as part of the resonant element that changes the resonant response to the sensor, so tissue in the nearby region is Characterized by electromagnetic properties due to the resonant response to the sensor.

  It will be appreciated that other electromagnetic sensors may be used in accordance with embodiments of the present invention.

  In general, it will be appreciated that the flexible tube 40 also includes an optical conduit 46 for an optical instrument 43 mounted on an optical communication line 45, preferably formed as an optical fiber 45. Alternatively, an optical bundle 45 can be used including, for example, a power cable, an optical data cable, and a mechanical control cable.

  Preferably, tissue characterization is performed both visually by optical instrument 43 and via sensor 52. However, the present invention can be operated without the optical conduit 46 and without the optical instrument 43.

  Still referring to the drawings, FIGS. 3A-3C schematically illustrate the synergistic effect between the distal end 42 of the endoscope 30 and the optical instrument 43 and sensor 52, according to an embodiment of the present invention.

  Preferably, the catheter 48 has a distal end 47 that can extend beyond the distal end 42 of the endoscope. Additionally, the catheter 48 can be operated independently of the tube 40 via the instrument bundle 50 as seen in FIGS. 3A-3C, and thus the sensor 52 can be seen in FIGS. 3A and 3B. In order to characterize the suspected anomaly 62, it can be brought into contact with a specific location in tissue 60, such as the inner wall of a body cavity, or another tissue location. The operation of the catheter 48 can be mechanical, for example via a wire, or electrical, as is known.

  Additionally, sensor 52 can be contacted with a healthy portion of tissue 60 as shown in FIG. 3C for reference tissue characterization.

  Alternatively, the catheter 48 is not used, but the instrument bundle 50 can extend beyond the distal end 42 of the endoscope, and the distal most end of the instrument bundle 50 is connected to the tissue 60 for characterization. It can be operated outside the body to bring the sensor 52 into contact.

  Still referring to the drawings, FIGS. 3D-3H schematically illustrate various embodiments of the body portion 32 of the endoscope 30 of the present invention.

  FIG. 3D describes another embodiment in which the catheter 48 is not used and the sensor 52 mounted on the instrument bundle 50 is inserted directly into the instrument conduit 44.

  FIG. 3E describes yet another embodiment in which the flexible tube 40 has a single cavity that forms an instrument conduit 44. The optical conduit 46 is not used.

  FIG. 3F describes yet another embodiment in which instrument bundle 50 is integrated with flexible tube 40.

  FIG. 3G describes yet another embodiment in which instrument bundle 50 and optical bundle 45 form a flexible tube 40.

  FIG. 3H describes yet another embodiment, where the body portion 32 is on two conduits, an instrument conduit 44 in which a sensor 52 mounted on instrument bundle 50 travels, and a second instrument bundle 82. The second instrument 84 attached to the second has a second conduit 88 into which it can be inserted.

  The second sensor 84 is an optical sensor, X-ray sensor, RF sensor, MW sensor, infrared temperature recording sensor, ultrasonic sensor, MR sensor, impedance sensor, temperature sensor, biosensor, chemical sensor, radiation emission sensor, mechanical sensor. And / or any one of the other known tissue characterization sensors.

  Preferably, sensor 52 is recognizable on the second mode of second sensor 84.

  Still referring to the drawings, FIGS. 4A-4D further illustrate the body portion 32 of the endoscope 30 according to an embodiment of the present invention.

  As seen in FIG. 4A, the endoscope 30 can be inserted into the body cavity 64 to characterize the tissue 60 formed as the wall of the body cavity 64. The insertion can be made through a body opening 66, such as the mouth, nose, or another body opening or hole.

  As shown in FIG. 4B, endoscope 30 is inserted percutaneously through skin 68 to characterize tissue 60 formed as a wall of body cavity 64, for example when body cavity 64 is a blood vessel. Can then be inserted into the body cavity 64.

  Additionally, as seen in FIG. 4B, the tissue to be characterized can be a body cavity junction 65.

  As seen in FIGS. 4C and 4D, endoscope 30 may be inserted through trocar valve 35 through skin 68 to characterize tissue 60, for example, during minimally invasive surgery. it can.

  According to an embodiment of the present invention, the tissue 60 characterized by the sensor 52 is opened during the walls and / or junctions of the body cavity 64, the walls of other body cavities that can be reached by the body cavity, such as during minimally invasive surgery. It can be meat or uterus or stomach. Additionally, tissue characterization can include plunging into a body cavity and characterizing a tissue mass.

  According to one embodiment of the present invention, the sensor 52 can be guided along a body cavity 64 that characterizes the tissue 60 substantially along its entire length.

  Alternatively, the sensor 52 can be guided along a predetermined portion of the body cavity 64 that characterizes the tissue 60.

  Additionally or alternatively, optical instrument 43 may visually detect suspicious anomaly 62 and sensor 52 may be operated to contact and characterize suspicious anomaly 62. .

  Additionally or alternatively, other imaging modalities such as X-ray, MRI, ultrasound, or another non-invasive manner detect suspicious anomaly 62 and sensor 52 is brought into contact with suspicious anomaly 62. Manipulated to characterize it.

Alternatively, as seen in FIGS. 4C and 4D, during minimally invasive surgery, sensor 52 can be used in the following two ways:
i. Characterizing the tissue 60 and identifying abnormalities 62; and ii. During removal of the abnormal location 62 by the surgical instrument 70, the wall of the cut location 72 is removed to ensure that the cut location 72 is formed of healthy tissue and that the abnormal location 62 is contained therein. Determine characteristics.

  Endoscope 30 can be a multi-conduit endoscope, so that several instruments, such as optical instrument 43, sensor 52, and another instrument such as surgical instrument 70 can be operated together. Will be recognized. Alternatively, only one or two conduits are available and the instrument is withdrawn and replaced with other instruments when needed.

  Preferably, the sensor 52 is recognizable on other imaging modalities such as X-ray, ultrasound and MRI and can be guided using other imaging modalities, so that the sensor 52 is optical instrument 43. Can be guided to an inaccessible area or when the optical instrument 43 is not used.

  Preferably, the catheter 48 is about 0.5-4 mm in diameter, the sensor 52 is about 0.3-3 mm in diameter, the instrument bundle is about 2 mm in diameter, and the body part 32 is about 2-5 mm. It will be appreciated that other dimensions larger or smaller can be used as well.

  The measurement is preferably performed by reflection of an electromagnetic field from the vicinity of sensor 52, which is taught, for example, in Applicant's US Pat. No. 6,813,515 by Hashimhoney, the disclosure of which is incorporated herein by reference. Alternatively, the measurements are performed as taught in Applicant's US patent application 60/665842, the disclosure of which is hereby incorporated by reference. It will be appreciated that other electromagnetic sensors may also be used in embodiments of the present invention.

  Preferably, the controller 22 of the extracorporeal control station 20 analyzes the reflection and displays the result. It will be appreciated that other computers can be used as known. The results can be used for characterization of tissue 60 and anomaly 62, such as cavity wall 60 of bronchial wall 60, for example. It will be appreciated that the tissue 60 can be a portion of tissue that is not part of a cavity wall, for example, as illustrated below in FIGS. 5C and 5D. Results can be shown graphically, numerically, or as a positive or negative answer. Results can also be presented as data.

  The result can be relative, ie, a comparison of various types of anomalies 62 with reference tissue 60 or several references of tissue 60 obtained from various locations. Alternatively, the results can be based on literature data, where the tissue is characterized based on preliminary tests and / or data found in the literature.

  Tissue characterization for the abnormal location 62 may relate to detection of a malignant tumor or a precancerous condition. Additionally or alternatively, it can relate to the detection of another pathology, such as bleeding in the body.

  Still referring to the drawings, FIGS. 5A-5D summarize various methods of movement of an endoscopic system in the body, according to embodiments of the present invention.

  As seen in FIG. 5A, the flexible tube 40 of the endoscope 30 moves exclusively within the body cavity 64 to characterize the tissue 60 along the cavity wall. The entry site is a body hole such as the oral cavity, nostril, rectum, vagina, urethral orifice or another hole in the body.

  As seen in FIG. 5B, the flexible tube 40 of the endoscope 30 moves within the body cavity 64, but the intrusion is percutaneous and occurs at the intrusion site 74. Preferably, the sensor 52 is coupled with a sharp edge 76 to facilitate penetration. For example, the body cavity can be a blood vessel and the entry site can be the deep femoral vein or the jugular vein. It will be appreciated that other sites of percutaneous penetration are possible as well.

  As seen in FIG. 5C, the entry site is a body hole, but beyond the body cavity 64, the sensor 52 enters the body cavity 64 at location 72 to characterize the tissue 60. Preferably, the sensor 52 moves within the body cavity as close as possible to the site for measurement and then enters the body cavity. Preferably, sensor 52 is coupled with a sharp edge 76 to facilitate entry.

  As seen in FIG. 5D, sensor 52 percutaneously enters the body cavity at entry point 74 and penetrates body cavity 64 at point 72 to characterize tissue 60 beyond body cavity 64.

As has been pointed out, biopsy diagnostics performed in the laboratory and subsequent procedures based on laboratory biopsies have the following inherent disadvantages:
i. A biopsy is generally performed when symptoms are observed and the cancer is in an advanced stage;
ii. It can happen that the biopsy material is taken from an area near the tumor and not the tumor itself, leading to false inaccurate negative results;
iii. The exact location from which the biopsy was obtained may be difficult to reproduce; and iv. Biopsy results are not straightforward.

  The present invention seeks to provide an application of procedures that are immediately followed immediately for the detection of cancer and pre-cancerous tissue in vivo. Thus, the method is provided for the insertion of additional instruments into the characterized site once an abnormal location is detected. These instruments can be directed to additional characterization by other sensors, biopsy sampling, performing local surgery, administering drug therapy, and / or other procedures. These methods are described below in connection with FIGS. 6A-6D and 7A-7B.

  Still referring to the drawings, FIGS. 6A-6D schematically illustrate another method of tissue characterization, preferably coupled with at least one additional procedure, according to an embodiment of the present invention.

  In some cases, the scope of the endoscope is limited by its diameter of about 2-3 mm, but the endoscope is on the instrument bundle 50 (its diameter can be as small as about 0.3 mm). It is desirable to reach the sensor 52 attached to the vehicle beyond its limit.

  Thus, as seen in FIG. 6A, the sensor 52 extends beyond the distal end 42 of the instrument conduit 44 and characterizes the anomaly 62 in the tissue 60.

  As seen in FIG. 6B, guidewire 80 is inserted into instrument conduit 44 to the location of sensor 52.

  As seen in FIG. 6C, after characterization, sensor 52 is removed.

  As seen in FIG. 6D, the second instrument 84 mounted on the second instrument bundle 82 is moved to the position of the sensor 52 to perform at least one additional procedure on the tissue 60. It is inserted into the conduit 44. At least one additional procedure can be directed to additional characterization by performing another sensor, biopsy sampling, performing local surgery, administering medication, and / or another procedure.

  It will be appreciated that the second instrument 84 can then be removed and another instrument can be inserted further in place.

  It will be appreciated that the second instrument 84 can be inserted without removal of the sensor 52.

  Still referring to the drawings, FIGS. 7A and 7B schematically illustrate performing a second procedure without a guidewire, according to another embodiment of the present invention.

  As can be seen in FIG. 7A, tissue characterization is performed by sensor 52.

  As seen in FIG. 7B, the sensor 52 is then removed, the second instrument 84 mounted on the second instrument bundle 82 is inserted, and the second procedure is characterized by the second instrument 84. Performed at the site.

  The second instrument 84 of FIGS. 6D and 7B includes a biopsy instrument such as a biopsy brush, needle or knife, local surgery (eg, ablation, ablation (eg, ultrasound, RF, MW or another ablation method), Or for instruments for cryosurgery, laser surgery, etc., for enforcement instruments (eg for administering drug therapy or for implanting brachytherapy seeds), or for other characterization and / or treatment procedures Can be an instrument.

  It will be appreciated that the second instrument 84 can be a second sensor 84 for characterizing tissue in a second manner. The second sensor 84 is an optical sensor, X-ray sensor, RF sensor, MW sensor, infrared temperature recording sensor, ultrasonic sensor, MR sensor, impedance sensor, temperature sensor, biosensor, chemical sensor, radiation emission sensor, mechanical sensor. And / or any one of the other known tissue characterization sensors.

  Still referring to the drawings, FIGS. 8A-8C schematically illustrate the insertion of a sensor along a guidewire, according to an embodiment of the present invention.

  As seen in FIG. 8A, the guide wire 80 is inserted into the body.

  As seen in FIGS. 8B and 8C, the sensor 52 mounted on the instrument bundle 50 is wrapped around the guide wire 80 by a wire loop 86 and inserted along the guide wire 80 into the body.

  According to embodiments of the present invention, the endoscope 30 may be a body cavity, such as the oral cavity, nostril, esophagus, gastrointestinal tract, rectum, colon, bronchi, vagina, cervix, urethra, bladder, uterus, and blood vessels, or another body cavity. Can be designed for insertion. Additionally or alternatively, the endoscope 30 can be designed for insertion in a trocar valve.

  During the lifetime of this patent, it is expected that many related devices and methods for tissue characterization in body cavities using electromagnetic probes mounted on endoscopic devices can be developed. The scope of the invention is intended to include all such new techniques a priori.

  As used herein, the term “about” refers to ± 20%.

  It will be appreciated that certain features of the invention described in separate embodiments for clarity may also be provided in combination in a single embodiment. Conversely, the various features of the invention described in a single embodiment for the sake of brevity can be provided separately or in any suitable sub-combination.

  While the invention has been described in terms of specific embodiments thereof, it will be apparent to those skilled in the art that there are many alternatives, modifications, and variations. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

  All publications, patents, and patent applications cited in this specification are herein in their entirety as if each individual publication, patent, and patent application were specifically and individually cited. It is used in the book. In addition, citation or identification in this application should not be regarded as a confession that it can be used as prior art to the present invention.

1 schematically illustrates an overall endoscopic system according to an embodiment of the present invention. 1 schematically illustrates an internal part of an endoscope according to an embodiment of the present invention. FIG. 2 schematically illustrates the distal end of an endoscope body and the synergistic effect between an optical instrument and a sensor at the distal end according to an embodiment of the present invention. Figure 2 schematically illustrates various embodiments of the internal body portion of the endoscope of the present invention. 3 further illustrates an endoscope system according to an embodiment of the present invention. 3 further illustrates an endoscope system according to an embodiment of the present invention. Summarizes various aspects of movement in the body, according to embodiments of the present invention. Fig. 4 schematically illustrates tissue characterization linked to at least one additional procedure according to an embodiment of the present invention. Fig. 4 schematically illustrates tissue characterization linked to at least one additional procedure according to another embodiment of the present invention. Fig. 6 schematically illustrates insertion of a sensor along a guide wire according to an embodiment of the present invention.

Claims (69)

Endoscope including:
A body part configured for insertion into the body, comprising a non-irradiated electromagnetic sensor for tissue characterization and a communication line on which the non-irradiated electromagnetic sensor is mounted; and an extracorporeal part.   The endoscope according to claim 1, wherein the communication line is formed as an instrument bundle.   The distal end of the instrument bundle is manipulated outside the body so that the instrument bundle extends beyond the distal most end of the endoscope with respect to the operator and the non-irradiated electromagnetic sensor is in contact with the tissue for characterization. The endoscope according to claim 2, wherein the endoscope is capable of.   The endoscope according to claim 1, wherein the body part further comprises an instrumental conduit, and a non-irradiated electromagnetic sensor for tissue characterization is inserted into the instrumental conduit.   The endoscope according to claim 4, wherein the non-irradiated electromagnetic sensor for tissue characterization can be removed from the instrument conduit and replaced with another instrument.   The endoscope according to claim 4, wherein the endoscope further includes a catheter, a non-irradiated electromagnetic sensor is inserted into the catheter, and the catheter is inserted into the instrument conduit.   The endoscope according to claim 6, wherein the catheter extends beyond the distal-most end of the endoscope with respect to the operator, and the distal-most end of the catheter can be operated independently of the distal-most end of the endoscope. mirror.   The endoscope according to claim 1, wherein the body part further includes an optical conduit for the optical instrument.   The endoscope of claim 1, wherein the optical instrument is configured to observe a non-irradiated electromagnetic sensor.   The endoscope according to claim 1, wherein the body part further includes a second instrument.   Second instrument is from optical sensor, X-ray sensor, RF sensor, MW sensor, infrared temperature recording sensor, ultrasonic sensor, MR sensor, impedance sensor, temperature sensor, biosensor, chemical sensor, radiation emission sensor and mechanical sensor The endoscope according to claim 10, selected from the group consisting of:   The endoscope according to claim 10, wherein the second instrument is configured to sense a non-irradiated electromagnetic sensor.   The endoscope according to claim 1, wherein the body part is designed for movement in a body cavity.   The endoscope according to claim 13, wherein the body part is designed to reach the body cavity by percutaneous insertion.   The endoscope of claim 13 configured to characterize tissue along a body cavity wall.   The endoscope of claim 13, configured to characterize tissue outside the body cavity by penetrating the body cavity wall.   The body cavity is selected from the group consisting of oral cavity, nostril, esophagus, gastrointestinal tract, rectum, colon, bronchus, vagina, cervix, urethra, bladder, uterus and blood vessel. Endoscope.   The endoscope according to claim 1, wherein the body part is designed for insertion through a trocar valve.   The endoscope according to claim 1, wherein the tissue characterization relates to the detection of malignant tumors.   The endoscope according to claim 1, wherein the tissue characterization relates to detection of a precancerous condition. Method of tissue characterization including the following steps:
Insert a non-irradiated electromagnetic sensor into the body; and characterize the tissues in the body.   The method of claim 21, wherein a non-irradiated electromagnetic sensor is mounted on the instrument bundle.   23. The method of claim 22, further comprising manipulating the distal most end of the instrument bundle outside the body to bring the non-irradiated electromagnetic sensor into contact with the tissue for characterization.   The method of claim 21, wherein a non-irradiated electromagnetic sensor for tissue characterization moves within the instrument conduit. The method of claim 24 further comprising the following steps:
After characterizing the tissue in the body, the non-irradiated electromagnetic sensor for tissue characterization is removed from the instrument conduit;
Insert the second instrument into the instrument conduit; and perform the second procedure with the second instrument.   26. The method of claim 25, wherein the second procedure includes obtaining a biopsy sample.   26. The method of claim 25, wherein the second procedure includes local surgery.   26. The method of claim 25, wherein the second procedure comprises administering a drug therapy.   26. The method of claim 25, wherein the second procedure includes characterizing the tissue with an additional sensor.   25. The method of claim 24, wherein a non-irradiated electromagnetic sensor for tissue characterization moves within a catheter inserted within the instrument conduit.   32. The method of claim 30, further comprising manipulating the distal most end of the catheter outside the body to bring the non-irradiated electromagnetic sensor into contact with the tissue for characterization.   The method of claim 21, further comprising inserting an optical instrument for visually observing the non-irradiated electromagnetic sensor when the non-irradiated electromagnetic sensor contacts the tissue.   23. The method of claim 21, further comprising inserting a second instrument for characterizing tissue in a second manner with a non-irradiated electromagnetic sensor.   Second instrument is from optical sensor, X-ray sensor, RF sensor, MW sensor, infrared temperature recording sensor, ultrasonic sensor, MR sensor, impedance sensor, temperature sensor, biosensor, chemical sensor, radiation emission sensor and mechanical sensor 34. The method of claim 33, selected from the group consisting of:   34. The method of claim 33, wherein the second instrument is configured to sense a non-irradiated electromagnetic sensor. The method of claim 21, wherein the insertion comprises the following steps:
Insert into body cavity through body opening; and characterize tissue along body cavity. The method of claim 21, wherein the insertion comprises the following steps:
Inserted into a body cavity through an opening in the body;
Rush into the body cavity; and characterize the tissue across the body cavity. The method of claim 21, wherein the insertion comprises the following steps:
Inserted percutaneously;
Reach the body cavity;
Move along the body cavity; and characterize the tissue along the body cavity. The method of claim 21, wherein the insertion comprises the following steps:
Inserted percutaneously;
Reach the body cavity;
Move along the body cavity;
Rush into the body cavity; and characterize the tissue across the body cavity.   40. The body cavity according to any one of claims 36 to 39, wherein the body cavity is selected from the group consisting of oral cavity, nostril, esophagus, gastrointestinal tract, rectum, colon, bronchi, vagina, cervix, urethra, bladder, uterus and blood vessels. the method of.   The method of claim 21, wherein inserting comprises inserting through a trocar valve.   The method of claim 21, wherein the tissue characterization relates to the detection of malignant tumors.   24. The method of claim 21, wherein tissue characterization relates to detection of a precancerous condition. In vivo method comprising the following steps:
Providing an endoscope having an instrument conduit;
Inserting a tissue characterization sensor mounted on the communication line into the instrument conduit;
Characterize the organization;
Removing sensors for tissue characterization;
A second instrument is inserted into the instrument conduit at the characterized tissue location; and the second procedure is performed using the second instrument.   45. The method of claim 44, wherein the sensor for tissue characterization is a non-irradiated electromagnetic sensor.   Sensors for tissue characterization include optical sensors, X-ray sensors, RF sensors, MW sensors, infrared temperature recording sensors, ultrasonic sensors, MR sensors, impedance sensors, temperature sensors, biosensors, chemical sensors, radiation emission sensors and 45. The method of claim 44, selected from the group consisting of mechanical sensors.   45. The method of claim 44, wherein the second procedure comprises obtaining a biopsy sample.   45. The method of claim 44, wherein the second procedure comprises a local operation.   45. The method of claim 44, wherein the second procedure comprises administering a drug therapy.   45. The method of claim 44, wherein the second procedure comprises characterizing the tissue with an additional sensor. In vivo method comprising the following steps:
Providing an endoscope having an instrument conduit;
Inserting a tissue characterization sensor mounted on the communication line into the instrument conduit;
Extend the sensor mounted on the communication line beyond the reach of the instrument conduit;
Characterize the organization;
Inserting a guide wire into the characterized tissue location;
Removing sensors for tissue characterization;
A second instrument is inserted into the instrument conduit, along the guide wire, at the characterized tissue location; and the second procedure is performed using the second instrument.   52. The method of claim 51, wherein the sensor for tissue characterization is a non-irradiated electromagnetic sensor.   Sensors for tissue characterization include optical sensors, X-ray sensors, RF sensors, MW sensors, infrared temperature recording sensors, ultrasonic sensors, MR sensors, impedance sensors, temperature sensors, biosensors, chemical sensors, radiation emission sensors and 52. The method of claim 51, selected from the group consisting of mechanical sensors.   52. The method of claim 51, wherein the communication line further comprises an instrument bundle.   52. The method of claim 51, wherein the second procedure comprises obtaining a biopsy sample.   52. The method of claim 51, wherein the second procedure includes local surgery.   52. The method of claim 51, wherein the second procedure comprises administering a drug therapy.   52. The method of claim 51, wherein the second procedure comprises characterizing the tissue with an additional sensor. Method for tissue characterization including the following steps:
Insert a guide wire into the body;
A tissue characterization sensor mounted on the communication line is inserted into the body along the guide wire; and the sensor is used to characterize the tissue.   60. The method of claim 59, wherein the sensor for tissue characterization is a non-irradiated electromagnetic sensor.   Sensors for tissue characterization include optical sensors, X-ray sensors, RF sensors, MW sensors, infrared temperature recording sensors, ultrasonic sensors, MR sensors, impedance sensors, temperature sensors, biosensors, chemical sensors, radiation emission sensors and 60. The method of claim 59, selected from the group consisting of mechanical sensors.   61. The method of claim 60, wherein the communication line comprises an instrument bundle. 60. The method of claim 59, further comprising the following steps:
After characterizing the tissue, the tissue characterization sensor is removed; and a second instrument mounted on the second communication line is inserted into the body along the guide wire.   64. The method of claim 63, wherein the second instrument is a biopsy instrument.   64. The method of claim 63, wherein the second instrument is configured for local surgery.   64. The method of claim 63, wherein the second instrument is configured to administer medication.   The second instrument is a sensor, optical sensor, X-ray sensor, RF sensor, MW sensor, infrared temperature recording sensor, ultrasonic sensor, MR sensor, impedance sensor, temperature sensor, biosensor, chemical sensor, radiation emission sensor and 64. The method of claim 63, selected from the group consisting of mechanical sensors.   64. The method of claim 63, wherein the second communication line comprises an instrument bundle. Endoscope system including:
A body part configured for insertion into the body, including a non-irradiated electromagnetic sensor for tissue characterization and a communication line on which the non-irradiated electromagnetic sensor is mounted;
Extracorporeal part;
A control device; and a signal analysis device.

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