Abstract:
An automatically operative medical insertion device and method including an insertable element which is adapted to be inserted within a living organism in vivo, a surface following element, physically associated with the insertable element and being arranged to follow a physical surface within the living organism in vivo, a driving subsystem operative to at least partially automatically direct the insertable element along the physical surface and a navigation subsystem operative to control the driving subsystem based at least partially on a perceived location of the surface following element along a reference pathway stored in the navigation subsystem.

Description:
FIELD OF THE INVENTION  
         [0001]    The present invention relates to systems and methods for automatic insertion of an element into a living organism in vivo.  
         REFERENCE TO CO-PENDING APPLICATIONS  
         [0002]    Applicants hereby claim priority of Israel Patent Application No. 140,136 filed Dec. 6, 2000, entitled “Apparatus For Self-Guided Intubation”.  
         BACKGROUND OF THE INVENTION  
         [0003]    The following patents are believed to represent the current state of the art:  
                                                               6,248,112;   6,236,875;   6,235,038;   6,226,548;   6,211,904;   6,203,497;   6,202,646;   6,196,225;       6,190,395;   6,190,382;   6,189,533;   6,174,281;   6,173,199;   6,167,145;   6,164,277;   6,161,537;       6,152,909;   6,146,402;   6,142,144;   6,135,948;   6,132,372;   6,129,683;   6,096,050;   6,096,050;       6,090,040;   6,083,213;   6,079,731;   6,079,409;   6,053,166;   5,993,424;   5,976,072;   5,971,997;       5,957,844;   5,951,571;   5,951,461;   5,885,248;   5,720,275;   5,704,987;   5,592,939;   5,584,795;       5,506,912;   5,445,161;   5,400,771;   5,347,987;   5,331,967;   5,307,804;   5,257,636;   5,235,970;       5,203,320;   5,188,111;   5,184,603;   5,172,225;   5,109,830;   5,018,509;   4,910,590;   4,672,960;       4,651,746                  
 
           [0004]    Reference is also made to: http://www.airwaycam.com/system.html  
         SUMMARY OF THE INVENTION  
         [0005]    The present invention seeks to provide improved systems and methods for automatic insertion of an element into a living organism in vivo.  
           [0006]    There is thus provided in accordance with a preferred embodiment of the present invention an automatically operative medical insertion device including an insertable element which is adapted to be inserted within a living organism in vivo, a surface following element, physically associated with the insertable element and being arranged to follow a physical surface within the living organism in vivo, a driving subsystem operative to at least partially automatically direct the insertable element along the physical surface and a navigation subsystem operative to control the driving subsystem based at least partially on a perceived location of the surface following element along a reference pathway stored in the navigation subsystem.  
           [0007]    There is also provided in accordance with a preferred embodiment of the present invention an automatically operative medical insertion method, which includes inserting an insertable element within a living organism in vivo, physically associating a surface following element with the insertable element and causing the surface following element to follow a physical surface within the living organism in vivo, automatically and selectably directing the insertable element along the physical surface and controlling direction of the insertable element based at least partially on a perceived location of the surface following element along a reference pathway stored in the navigation subsystem.  
           [0008]    Further in accordance with a preferred embodiment of the present invention the driving subsystem is operative to fully automatically direct the insertable element along the physical surface.  
           [0009]    Still further in accordance with a preferred embodiment of the present invention the driving subsystem is operative to automatically and selectably direct the insertable element along the physical surface.  
           [0010]    Additionally in accordance with a preferred embodiment of the present invention the navigation subsystem receives surface characteristic information relating to the physical surface from the surface following element and employs the surface characteristic information to perceive the location of the surface following element along the reference pathway.  
           [0011]    Preferably, the surface characteristic information includes surface contour information.  
           [0012]    Additionally in accordance with a preferred embodiment of the present invention the surface characteristic information includes surface hardness information.  
           [0013]    Preferably, the surface contour information is three-dimensional,  
           [0014]    Preferably, the surface contour information is two-dimensional.  
           [0015]    Further in accordance with a preferred embodiment of the present invention the insertable element is a endotracheal tube and wherein the physical surface includes surfaces of the larynx and trachea.  
           [0016]    Still further in accordance with a preferred embodiment of the present invention the insertable element is a gastroscope and wherein the physical surface includes surfaces of the intestine.  
           [0017]    Additionally in accordance with a preferred embodiment of the present invention the insertable element is a catheter and wherein the physical surface includes interior surfaces of the circulatory system.  
           [0018]    Further in accordance with a preferred embodiment of the present invention the insertion device also includes a reference pathway generator operative to image at least a portion of the living organism and to generate the reference pathway based at least partially on an image generated thereby.  
           [0019]    Preferably, the reference pathway includes a standard contour map of a portion of the human anatomy.  
           [0020]    Further in accordance with a preferred embodiment of the present invention the standard contour map is precisely adapted to a specific patient.  
           [0021]    Still further in accordance with a preferred embodiment of the present invention the standard contour map is automatically precisely adapted to a specific patient.  
           [0022]    Further in accordance with a preferred embodiment of the present invention the reference pathway is operator adaptable to designate at least one impediment.  
           [0023]    Additionally in accordance with a preferred embodiment of the present invention the insertable element includes a housing in which is disposed the driving subsystem, a mouthpiece, a tube inserted through the mouthpiece and a flexible guide inserted through the tube, the surface following element being mounted at a front end of the guide.  
           [0024]    Preferably, the mouthpiece includes a curved pipe through which the tube is inserted and the driving subsystem operates to move the guide in and out of the housing, through the curved pipe and through the tube.  
           [0025]    Preferably, the driving subsystem also operates to selectably bend a front end of the guide and to move the insertable element in and out of the living organism.  
           [0026]    Additionally, the driving subsystem is also operative to selectably bend a front end of the insertable element.  
           [0027]    Further in accordance with a preferred embodiment of the present invention the surface following element includes a tactile sensing element.  
           [0028]    Preferably, the surface following element includes a tip sensor including a tip integrally formed at one end of a short rod having a magnet on its other end, the rod extends through the center of a spring disk and is firmly connected thereto, the spring disk being mounted on one end of a cylinder whose other end is mounted on a front end of the insertable element.  
           [0029]    Further in accordance with a preferred embodiment of the present invention the tip sensor also includes two Hall effect sensors, which are mounted inside the cylinder on a support and in close proximity to the magnet, the Hall effect sensors being spaced in the plane of the curvature of the curved pipe. Each Hall effect sensor includes electrical terminals operative to provide electric current representing the distance of the magnet therefrom. The tip sensor operates such that when a force is exerted on the tip along an axis of symmetry of the cylinder, the tip is pushed against the spring disk, causing the magnet to approach the Hall effect sensors and when a force is exerted on the tip sideways in the plane of the Hall effect sensors, the tip rotates around a location where the rod engages the spring disk, causing the magnet to rotate away from one of the Hall effect sensors and closer to the other of the Hall effect sensors.  
           [0030]    Still further in accordance with a preferred embodiment of the present invention the driving subsystem operates, following partial insertion of the insertable element into the oral cavity, to cause the guide to extend in the direction of the trachea and bend the guide clockwise until the surface following element engages a surface of the tongue, whereby this engagement applies a force to the surface following element.  
           [0031]    Additionally in accordance with a preferred embodiment of the present invention the navigation subsystem is operative to measure the changes in the electrical outputs produced by the Hall effect sensors indicating the direction in which the tip is bent.  
           [0032]    Moreover in accordance with a preferred embodiment of the present invention the navigation subsystem operates to sense the position of the tip and the past history of tip positions and to determine the location of the tip in the living organism and relative to the reference pathway.  
           [0033]    Preferably, the navigation subsystem operates to navigate the tip according to the reference pathway and operates to sense that the tip touches the end of the trough beneath the epiglottis.  
           [0034]    Further in accordance with a preferred embodiment of the present invention the navigation subsystem is operative to sense that the tip reaches the tip of the epiglottis.  
           [0035]    Still further in accordance with a preferred embodiment of the present invention the navigation subsystem operates to sense that the tip reached the first cartilage of the trachea.  
           [0036]    Additionally in accordance with a preferred embodiment of the present invention the navigation subsystem operates to sense that the tip reached the second cartilage of the trachea.  
           [0037]    Further in accordance with a preferred embodiment of the present invention the navigation subsystem is operative to sense that the tip reached the third cartilage of the trachea.  
           [0038]    Preferably, the navigation subsystem operates to load the reference pathway from a memory.  
           [0039]    Further in accordance with a preferred embodiment of the present invention the driving subsystem is operative to push the tube forward.  
           [0040]    Still further in accordance with a preferred embodiment of the present invention the driving subsystem includes a first motor which operates to selectably move the insertable element forward or backward, a second motor which operates to selectably bend the insertable element and electronic circuitry operative to control the first motor, the second motor and the surface following element.  
           [0041]    Preferably, the electronic circuitry includes a microprocessor operative to execute a program, the program operative to control the first and second motors and the surface following element and to insert and bend the insertable element inside the living organism along the reference pathway  
           [0042]    Further in accordance with a preferred embodiment of the present invention the driving subsystem is operative to measure the electric current drawn by at least one of the first and second motors to evaluate the position of the surface following element.  
           [0043]    Still further in accordance with a preferred embodiment of the present invention the reference pathway is operative to be at least partially prepared before the insertion process is activated.  
           [0044]    Preferably, the medical insertion device includes a medical imaging system and wherein the medical imaging system is operative to at least partially prepare the reference pathway.  
           [0045]    Preferably, the medical imaging subsystem includes at least one of an ultrasound scanner, an X-ray imager, a CAT scan system and an MRI system.  
           [0046]    Further in accordance with a preferred embodiment of the present invention the medical imaging system operates to prepare the reference pathway by marking at least one contour of at least one organ of the living organism.  
           [0047]    Additionally in accordance with a preferred embodiment of the present invention the medical imaging system operates to prepare the reference pathway by creating an insertion instruction table including at least one insertion instruction.  
           [0048]    Preferably, the insertion instruction includes instruction to at least one of extend, retract and bend the insertable element.  
           [0049]    Further in accordance with a preferred embodiment of the present invention the navigation subsystem is operative to control the driving subsystem based at least partially on a perceived location of the surface following element and according to the insertion instruction table stored in the navigation subsystem.  
           [0050]    Additionally in accordance with a preferred embodiment of the present invention the operative medical insertion device operates to at least partially store a log of a process of insertion of the insertable element and transmits the log of a process of insertion of the insertable element.  
           [0051]    Further in accordance with a preferred embodiment of the present invention the computer operates to aggregate the logs of a process of insertion of the insertable element and to prepare the reference pathway based at least partially on the aggregate.  
           [0052]    Still further in accordance with a preferred embodiment of the present invention the computer transmits the reference pathway to the medical insertion device.  
           [0053]    Further in accordance with a preferred embodiment of the present invention the insertable element includes a guiding element and a guided element.  
           [0054]    Additionally in accordance with a preferred embodiment of the present invention the driving subsystem operates to direct the guiding element and the guided element at least partially together.  
           [0055]    Further in accordance with a preferred embodiment of the present invention the driving subsystem operates to direct the guiding element and the guided element at least partially together.  
           [0056]    Still further in accordance with a preferred embodiment of the present invention the step of directing includes automatically and selectably directing the insertable element in a combined motion, including longitudinal motion and lateral motion.  
           [0057]    There is farther provided in accordance with a preferred embodiment of the present invention an automatically operative medical insertion device including an insertable element which is adapted to be inserted within a living organism in vivo, a surface following element, physically associated with the insertable element and being arranged to follow a physical surface within the living organism in vivo, a driving subsystem operative to at least partially automatically direct the insertable element along the physical surface and a navigation subsystem operative to control the driving subsystem based at least partially on a perceived location of the surface following element along a reference pathway stored in the navigation subsystem. The insertable element preferably includes a disposable mouthpiece.  
           [0058]    There is further provided in accordance with yet another preferred embodiment of the present invention an automatically operative medical insertion method. The method includes inserting an insertable element within a living organism in vivo, physically associating a surface following element with the insertable element and causing the surface following element to follow a physical surface within the living organism in vivo, automatically and selectably directing the insertable element along the physical surface and controlling direction of the insertable element based at least partially on a perceived location of the surface following element along a reference pathway stored in the navigation subsystem. The insertable element preferably includes a disposable mouthpiece.  
           [0059]    It is appreciated that the distances and angles referenced in the specification and claims are typical values and should not be construed in any way as limiting values. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS AND APPENDICES  
       [0060]    The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings and appendices in which:  
         [0061]    [0061]FIGS. 1A to  1 L are a series of simplified pictorial illustrations of a process of employing a preferred embodiment of the present invention for the intubation of a human;  
         [0062]    [0062]FIGS. 2A to  2 F taken together are a flowchart illustrating a preferred implementation of the present invention, operative for an intubation process as shown in FIGS. 1A to  1 L;  
         [0063]    [0063]FIG. 3 is a simplified illustration of the internal structure of a preferred embodiment of the present invention for intubation of a human;  
         [0064]    [0064]FIG. 4 is a simplified block diagram of a preferred embodiment of the present invention;  
         [0065]    [0065]FIGS. 5A to  5 H are electrical schematics of a preferred embodiment of the present invention for intubation of a human;  
         [0066]    [0066]FIGS. 6A to  6 K are a series of simplified pictorial illustrations of a process of employing a preferred embodiment of the present invention for insertion of an element into the intestine of a human,  
         [0067]    [0067]FIG. 7 is a preferred embodiment of a table comprising instruction, operative in accordance with a preferred embodiment of the present invention, for insertion of an element into the intestine of a human as shown in FIGS. 5A to  5 K;  
         [0068]    [0068]FIG. 8 is a flowchart illustrating a preferred implementation of the present invention, operative for a process of insertion of an element into the intestine of a human as shown in FIGS. 6A to  6 K.  
       LIST OF APPENDICES  
       [0069]    Appendices 1 to 3 are computer listings which, taken together, form a preferred software embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0070]    Reference is now made to FIGS. 1A to  1 L, which are a series of simplified pictorial illustrations of a system and methodology for the intubation of a human in accordance with a preferred embodiment of the present invention.  
         [0071]    It is appreciated that the general configuration of the mouth and trachea is generally the same for all humans except for differences in scale, such as between an infant, a child and an adult. In a preferred implementation of the present invention, a standard contour map  10  of the human mouth and trachea is employed. The scale of the map  10  may be further precisely adapted to the specific patient, preferably automatically. Alternatively, the scale of the map  10  is adapted to the specific patient semi-automatically. In this alternative the operator can select the scale of the map  10 , for example by selecting between a child and an adult. Thereafter the scale of the map  10  is automatically adapted to size of the specific patient as a part of the intubation process. As a further alternative or in addition the operator is enabled to designate one or more typical impediments such as: a tumor, a swelling, an infection and an injury. Selecting an impediment preferably creates a suitable variation of the general map  10 .  
         [0072]    [0072]FIG. 1A shows the map  10  and the location therein where a tip sensor  11  of an intubator engages the mouth and trachea of the patient. It is a particular feature of the present invention that intubation is at least partially automatically effected by utilizing the contour map  10  to monitor the progress of tip sensor  11  and thus to navigate the intubator accordingly.  
         [0073]    As seen in FIG. 1A, an intubator assembly  12 , suitable for the intubation of a human, is partially inserted into an oral cavity of a patient. The intubator assembly  12  preferably comprises a housing  14  in which is disposed a guide driver  15 , a mouthpiece  16 , a tube  18  inserted through the mouthpiece  16 , a flexible guide  20  inserted through the tube  18 , and tip sensor  11  mounted at the distal end of the guide  20 . The mouthpiece  16  preferably comprises a rigid curved pipe  24  through which the tube  18  is inserted. Preferably the curved pipe  24  comprises a slit  49  on each side. Alternatively, the curved pipe  24  is eliminated.  
         [0074]    It is appreciated that some of the components comprising the intubator assembly  12  may be disposable, for example, the tube  18  and the mouthpiece  16 .  
         [0075]    The guide driver  15  is operative to move the guide  20  in and out of the housing  14 , through the curved pipe  24  and through the tube  18 . The guide driver  15  is also operative to selectably bend the distal end of the guide  20  clockwise and counterclockwise in the plane of the curvature of the curved pipe  24  in the sense of FIG. 1A.  
         [0076]    Referring now to an enlargement of the tip sensor  11 , it is seen that tip sensor  11  preferably comprises a tip  28  preferably integrally formed at one end of a short rod  30  having a magnet  32  on its other end. The rod  30  preferably extends through the center of a spring disk  34  and is firmly connected thereto. The spring disk  34  is preferably mounted on one end of a cylinder  36  whose other end is mounted on the distal end of the guide  20 . Preferably, the tip sensor  11  also comprises two Hall effect sensors,  38  and  40 , which are mounted inside the cylinder  36  on a support  41  and in close proximity to the magnet  32 . The Hall effect sensors  38  and  40  are preferably spaced in the plane of the curvature of the curved pipe  24 . Typically, each Hall effect sensor has electrical terminals operative to provide electric current representing the distance of the magnet  32  therefrom.  
         [0077]    When a force is exerted on the tip  28  along the axis of symmetry  42  of cylinder  36 , the tip  28  is pushed against the spring disk  34 , causing the magnet  32  to approach the Hall effect sensors  38  and  40 . Since the distance between the magnet  32  and each of the Hall effect sensors  38  and  40  decreases, both Hall effect sensors  38  and  40  produce an increase in their output electric current. When a force is exerted on the tip  28  sideways in the plane of the Hall effect sensors  38  and  40 , the tip  28  rotates around the location where the rod  30  engages the spring disk  34 , as is shown in FIG. 1A. This causes the magnet  32  to rotate away from the Hall effect sensor  40  and closer to the Hall effect sensor  38 . The output electric current of the Hall effect sensor  40  typically decreases and the output electric current of the Hall effect sensor  38  typically correspondingly increases. Thus, it may be appreciated that the tip sensor  11  enables electronic circuitry (not shown) to measure the amplitude and the direction of force exerted on the tip  28  in the plane of the Hall effect sensors  38  and  40  and to compute the orientation of a surface of a tissue against which the sensor tip  28  is depressed, relative to the axis of symmetry  42 .  
         [0078]    It is appreciated that sensors other than Hall effect sensors can be used to measure the direction and the amplitude of the force exerted on the tip  28 , or otherwise to measure the proximity and the orientation of the adjacent surface.  
         [0079]    During automatic operation of the system, following partial insertion of the intubator assembly  12  into the oral cavity, as shown in FIG. 1A, the guide driver  15  typically causes the guide  20  to extend in the direction of the trachea  44  and bends the guide  20  clockwise until the tip  28  engages a surface of the tongue  46 . This engagement applies a force to tip  28 , which causes the tip to rotate counterclockwise wherein the magnet  32  approaches the Hall effect sensor  38 . Electronic circuitry (not shown) inside the housing  14 , which measures the changes in the electrical outputs produced by the Hall effect sensors  38  and  40 , indicates that the tip  28  is bent clockwise.  
         [0080]    By sensing the position of the tip and employing the past history of tip positions, the system of the present invention determines the location of the tip sensor  11  in the oral cavity and relative to the map  10 . This location is employed in order to navigate the intubator correctly, as described hereinbelow.  
         [0081]    Reference is now made to FIG. 1B, which illustrates a further step in the intubation in accordance with the present invention. FIG. 1B shows the guide  20  extended further and reaching an area between the base of the tongue  46  and the epiglottis  48  of the patient.  
         [0082]    As seen in FIG. 1C, the guide  20  extends further forward until the tip  28  touches the end of the trough beneath the epiglottis  48 .  
         [0083]    As seen in FIG. 1D, the guide  20  bends counterclockwise and touches the bottom surface of the epiglottis  48 . Then the guide  20  retracts a little, while preserving continuous tactile contact between the tip  28  with the bottom surface of the epiglottis  48 .  
         [0084]    As seen in FIG. 1E, the guide  20  retracts further until the tip  28  of the tip sensor  11  reaches the tip  165  of the epiglottis  48  and then the tip  28  loses tactile contact with the surface of the tip  165  of the epiglottis  48 .  
         [0085]    As seen in FIG. 1F, the guide  20  bends further counterclockwise, then extends forward and then bends clockwise until the tip  28  touches the upper surface of the epiglottis  48 .  
         [0086]    As seen in FIG. 1G, the guide  20  extends forward, preserving continuous tactile contact with the epiglottis  48 , until the tip  28  senses the first trough of the trachea  44 .  
         [0087]    As seen in FIGS. 1H and 1I, the guide  20  extends further forward until the tip  28  senses the second trough of the trachea  44 .  
         [0088]    As seen in FIGS. 1J and 1K, the guide  20  extends further forward until the tip  28  senses the trough of the third cartilage of the trachea  44 . Then the guide  20  further extends, typically for adults by 5 centimeters, to ensure that the tube  16  reaches to the third cartilage.  
         [0089]    As seen in FIG. 1L, the guide driver  15  is pulled out with the guide  20  leaving the mouthpiece  16  and the tube  18  inside the patient&#39;s mouth and trachea  44 .  
         [0090]    Reference is now made to FIGS. 2A to  2 F, which, taken together, are a flowchart of the process of the intubation of a human shown in FIGS. 1A to  1 K.  
         [0091]    [0091]FIG. 2A and 2B, taken together, correspond to the step of the intubation process shown in FIG. 1A.  
         [0092]    In step  100  of FIG. 2A the intubator assembly  12  is set to perform intubation.  
         [0093]    In step  102  the intubator loads an intubation pattern map  10  from its memory.  
         [0094]    In steps  104 ,  106  and  108  the intubator enables the operator to set the scale of the intubation pattern map to the corresponding size of the patient by selecting between an infant, a child and an adult.  
         [0095]    In steps  110 ,  112  and  114  the intubator enables the operator to adapt the intubation pattern map  10  to a type of intubation impediment, preferably by selecting from a menu. As seen in FIG. 2A the menu typically provides the operator with four optional impediments: an infection, a swelling, a tumor and an injury, and a fifth option not to select any impediment. It is appreciated that various types of impediments can be defined as is typical for a specific organ.  
         [0096]    As seen in FIG. 2B, steps  120 ,  122 ,  124 ,  126 ,  128  and  130  cause the guide  20  to extend in the direction of the throat and simultaneously bend clockwise until the tip sensor is depressed against the surface of the tongue or until extension and bending limits are reached. As seen in step  128 , the bending limit is preferably 50 degrees and the extension limit is preferably 2 centimeters. If the tip sensor is depressed, the scale of the intubation pattern map  10  is preferably updated (step  132 ) to match the particular scale or size of the intubated patient. If at least one of the extension limit and the bending limit is reached an error message is displayed (step  134 ) and the intubation process is stopped.  
         [0097]    Reference is now made to FIG. 2C, which corresponds to FIGS. 1B and 1C. As illustrated in FIG. 2C, the guide driver  15  performs sequential steps  140 ,  142 ,  144  and  146  in a loop, extending (step  140 ) guide  20  further into the patient&#39;s throat and along the throat surface, following the intubation pattern map  10  and keeping the tip in contact with the surface (steps  144 ,  146 ). When the output electric currents from both Hall effect sensors  38  and  40  increase, the intubator assumes (step  142 ) that the tip  28  has reached the end of the trough beneath the epiglottis  48 . The point of engagement between the tip  28  and the body is designated in FIG. 1C by reference numeral  147 . The scale of the intubation pattern map  10  is then preferably updated to match the patient&#39;s organ structure (step  148 ).  
         [0098]    Reference is now made to FIG. 2D, which corresponds to FIGS. 1D and 1E. As seen in FIG. 2D the guide driver  15  performs steps  150 ,  152  and  154  in a loop, bending the distal end of the guide  20  counterclockwise until the tip  28  touches the epiglottis  48 , or until a bending limit, preferably of 45 degrees is reached (step  154 ) and the intubation stops (step  156 ). The preferred point of engagement between the tip  28  and the surface of the epiglottis is designated in FIG. 1D by reference numeral  155 . After sensing an engagement between the tip  28  and the surface of the epiglottis, the guide driver  15  performs steps  158 ,  160 ,  162 , and  164  in a loop, retracting the guide  20  further (step  158 ), and increasing the bending of the guide  20  (step  164 ), until the tip of the guide reaches the tip of the epiglottis  48 , designated in FIG. 1E by reference numeral  165 . When the tip  28  reaches the tip of the epiglottis  48 , the tip  28  is released and the output electric currents from both Hall effect sensors decrease to a minimum. Preferably the intubation pattern map  10  is updated (step  166 ) to match the patient&#39;s organ structure.  
         [0099]    Reference is now made to FIG. 2E, which corresponds to FIGS. 1E and 1F. As seen in FIG. 2E, the guide driver  15  causes the guide  20  to move above and around the tip of the epiglottis  48  by causing the guide  20  to bend counterclockwise, preferably by 45 degrees, then to move forward down the throat by 5 millimeters and then to bend clockwise, preferably by 10 degrees (Step  170 ). Then the guide driver  15  performs steps  172 ,  174  and  176  in a loop, bending and extending (step  174 ) until the tip  28  of the guide touches the upper surface of the epiglottis  48  or until an extension limit, preferably of 1 centimeter, or a bending limit, preferably of 50 degrees, is reached, and the intubation is stopped (step  178 ). A preferred point of engagement between the tip  28  and the epiglottis is designated in FIG. 1F by reference numeral  177 .  
         [0100]    Reference is now made to FIG. 2F, which corresponds to FIGS. 1G to  1 K. As seen in FIG. 2F, a “cartilage crest counter N” is first zeroed (step  180 ). Then the guide driver  15 , performing steps  182  to  198  in a loop, causes the guide  20  to move the sensor tip  11  forward (step  182 ) along the surface of the trachea  44 , preserving contact between the tip  28  and the surface of the trachea (steps  186  and  188 ) by increasing the bend (step  188 ) as needed. Each time a crest ( 189  in FIGS. 1H, 1I,  1 J) of a cartilage of the trachea  44  is located the “cartilage crest counter” is incremented (step  190 ), the tip  28  is moved about the crest (steps  192 ,  194 ,  196  and  198 ) and the loop process repeats until the third cartilage is located. Then the guide  20  further extends, typically for adults by 5 centimeters, to ensure that the tube  16  reaches to the third cartilage. The guide driver  15  then signals to the operator that the insertion is completed successfully (step  200 ).  
         [0101]    Reference is now made to FIG. 3, which is a simplified illustration of the internal structure of a preferred embodiment of the present invention useful for intubation of a human. The intubator assembly  12  preferably comprises the housing  14 , the guide driver  15 , the mouthpiece  16 , the tube  18 , the flexible guide  20  inserted inside the tube  18  and the tip sensor  11  mounted at the distal end of the guide  20 . Preferably the mouthpiece comprises a curved pipe  24 .  
         [0102]    Preferably, the guide driver  15  comprises a first motor  210  that drives a gearbox  212  that rotates a threaded rod  214 . A floating nut  216  is mounted on the threaded rod  214 . As the motor  210  rotates the threaded rod  214 , the floating nut  216  is moved forward or backward according to the direction of the rotation. The floating nut  216  is operative to move a carriage  218  along a bar  220  and thus to push or pull the guide  20 . When the carriage  218  touches a stopper  222  the stopper  222  moves with the carriage  218  along the bar  220  and pushes the tube  18  forward.  
         [0103]    A second motor  224  is connected to a disk  226  to which two guide angulation wires  228  are attached at first end thereof. The guide angulation wires  228  are threaded inside the guide  20  and their other ends are connected to the distal end of the guide just short of the tip sensor  11 . When the motor  224  rotates the disk  226  clockwise one of the wires  228  is pulled and the second wire is loosened. The wire that is pulled pulls and bends the distal end of the guide  20  counterclockwise in the sense of FIG. 3. Accordingly, when the motor  224  rotates counter-clockwise the second wire of the two wires  228  is pulled and the first wire is loosened. The wire that is pulled pulls and bends the distal end of the guide  20  clockwise in the sense of FIG. 3.  
         [0104]    Electronic circuitry  229  is provided within the housing  14  and is preferably electrically connected to operating switches  230 , a display  232 , the motors  210  and  224  and to the Hall effect sensors  38  and  40  (FIG. 1A) in the tip sensor  11 . Preferably, the electronic circuitry  229  also comprises a microprocessor, operative to execute a program. The program is preferably adapted to control the switches  230 , the display  232 , motors  210  and  224  and the Hall effect sensors  38  and  40  and to insert and bend the guide inside a living organism, according to a predefined map until the tip of the guide reaches a destination point inside the living organism. Preferably the program is operative to cause the tip  28  of the guide  20  to follow a predefined internal contour of an organ of the living organism. Preferably program is operative employ tactile sensing to measure the position of the tip of the guide relative to the surface organ of the living organism.  
         [0105]    It is appreciated that the term “microprocessor” also includes inter alia a microcontroller”.  
         [0106]    Electrical batteries (not shown) are preferably provided within the housing  14  to supply electric power to the electronic circuitry, the tip sensor  11 , the motors  210  and  224 , the display  232  and all other elements of the present invention that consume electricity. It is appreciated that external sources of electricity can also be employed to provide power to the intubator assembly  12 .  
         [0107]    Communication interface (not shown), preferably employing infra-red communication technology, is provided to enable communication with external data processing equipment.  
         [0108]    Preferably, a balloon  234  is provided at the distal end of the tube  18  and a thin pipe (not shown) is inserted through the pipe  18  and is connected, through the side of the pipe, to the balloon. The thin pipe enables an operator to inflate the balloon when the distal end of the pipe  18  reaches the appropriate place in the trachea, thus securing the distal end of the pipe to the trachea.  
         [0109]    Reference is now made to FIG. 4, which is a simplified functional block diagram of a preferred embodiment of the guide driver  15  described hereinabove. In FIG. 4 the guide  20  is driven by two drivers. A longitudinal driver  240  preferably comprises a motor  210 , the gear  212 , the threaded rod  214 , the floating nut  146  and the carriage  218  of FIG. 3. A bending guide driver  242  preferably comprises the motor  224 , the disk  226  and wires  228  ((FIG. 3). The longitudinal driver  240  and the bending guide driver  242  are controlled by two software driver modules. A longitudinal software driver module  244  controls the longitudinal driver  240  and comprises two functions: an extend function  246  and a retract function  248 . A bending software driver  250  controls the bending guide driver  242  and comprises two functions: a bend counterclockwise function  252  and a bend clockwise function  254 . The functions  246 ,  248 ,  252  and  254  are operated by a propagation control software module  256 .  
         [0110]    At the other end of the guide  20 , the tip sensor  11  measures the proximity and orientation of an adjacent surface. In a preferred embodiment of the present invention the tip sensor  11  performs the proximity and orientation measurements by measuring the force applied to a tactile tip by a surface of an adjacent tissue. A tip sensor software driver module  260 , operative to receive input signals from the tip sensor  11 , provides two input functions: a counterclockwise tip rotation function  262  and a clockwise tip rotation function  264 . The measurements of the tip positions as provided by the tip sensor software driver module  260  are collected and stored by a sensor log module  266 .  
         [0111]    The map  10  is loaded into memory and serves as an updatable map  268 . A comparator  270  compares the accumulated measurements from the tip sensor  11  with the updated reference map  268 . The results of the comparisons are calculated by an update scale module  272  to provide a scaling factor that is applied to update the updated map  268 . Consequently a navigation module  274  employs the updated map information to instruct the propagation control  256  to execute the next step of the insertion program.  
         [0112]    It is appreciated that a measurement of the electric current drawn by at least one of the longitudinal guide drive and the bending guide drive can also serve as an input to the comparator  270  to evaluate the position of the tip sensor.  
         [0113]    Reference is now made to FIGS. 5A to  5 H, which are, taken together, an electrical schematic of a preferred embodiment of the present invention useful for intubation of a human. Reference is especially made to microprocessor  278 , which is preferably operative to operate a program to control the elements of the intubator assembly  12 , such as the operating switches  230 , the display  232 , the motors  210  and  224  (FIG. 3), and the Hall effect sensors  38  and  40  in the tip sensor  11  (FIG. 1A), and to perform the intubation process, such as the process shown and described hereinabove with reference to FIGS. 2A to  2 F.  
         [0114]    Reference is now made to FIGS. 6A to  6 K, which are a series of simplified pictorial illustrations of ten typical steps in a process of employing a preferred embodiment of the present invention useful for insertion of an element into the intestine of a human.  
         [0115]    It is appreciated that some of the organ systems of a living organism are generally similar up to a scale factor, such as the mouth and trachea system. Other organs, such as the intestine system, are generally different from one human body to the other. Therefore, in order to employ the present invention to insert a medical device or apply a medicine to a specific location within a generally variable organ, a map of the organ, at least from the entry point and until the required location, is prepared before the insertion process is activated. The required map is preferably prepared by employing an appropriate medical imaging system, such as an ultrasound scanner, an x-ray imager, a CAT scan system or a MRI system. The map can be a two dimensional map or a three-dimensional map as appropriate for the specific organ. Typically for the intestine system a three dimensional map is required.  
         [0116]    It is appreciated that an inserter according to a preferred embodiment of the present invention for use in organs that are variable in three dimensions is similar to the intubator assembly  12 , preferably with the following modifications:  
         [0117]    (1) The tube  18  may be replaced with a different insertable device;  
         [0118]    (2) An additional guide bending system employing elements similar to motor  222 , disk  224  and wires  226  is added and mounted perpendicularly to the first system of motor  222 , disk  224  and wires  26 , so that it is possible to bend the end of the guide in three dimensions. It is appreciated that three-dimensional manipulation is possible also by employing three or more motors; and  
         [0119]    (3) The tip sensor  11  preferably comprises four Hall effect sensors to sense the motion of the tip  28  in three dimensions. It is appreciated that it is possible to operate the tip sensor in a three-dimensional space also by employing three Hall effect sensors. It is also appreciated that other types of sensors can be employed to measure the proximity and orientation of an adjacent surface in three dimensions.  
         [0120]    In a preferred embodiment of the present invention, when the guide  20  performs longitudinal motion, such as insertion or retraction, the guide  20  also performs a small and relatively fast lateral motion. The combined longitudinal and lateral motions are useful for sensing the surface of the organ in three dimensions and hence to better determine the location of the tip sensor  11  in the organ and relative to the map  10 .  
         [0121]    Due to limitations of the graphical representation, a two-dimensional imaging and map is shown in FIGS. 6A to  6 K.  
         [0122]    As seen in FIG. 6A, a human organ, the intestine in this example, is imaged, typically by a CAT scan system  280 , and an image  282  of the internal structure of the organ is produced.  
         [0123]    In FIG. 6B the image  282  of the organ is used to create an insertion map  284 . Typically the image  282  is displayed on a computer screen (not shown) and a pointing device, such as a computer mouse or a light pen, is used to draw a preferred path  286  that the tip of the guide is to follow. The path is typically drawn by marking a contour of the organ, and optionally marking the guide bending points, as is shown and described with reference to FIGS. 1A to  1 K. Alternatively, a preferred path is created, such as path  286 , not necessarily continuously following the contours of the organ. As a further alternative, the map  10  or the path  286  is converted into a set of insertion steps as is shown and described hereinbelow with reference to FIG. 7.  
         [0124]    Reference is now made to FIG. 7 together with FIG. 8 and with FIGS. 6C to  6 K. As shown in FIG. 7, a table  290  is provided for storage in a computer memory and for processing by a computer processor. The table  290  contains rows  292 , wherein each row  292 , preferably comprises an instruction to perform one step in the process of insertion of a medical insertion device into a living organism such as shown and described with reference to FIGS. 6C to  6 K. Preferably each row  292  contains the expected values or the maximal values for the extension of an insertion guide such as guide  20 , the bending of the insertion guide and the electrical outputs from the Hall effect sensors  38  and  40  (FIG. 1A). In a preferred embodiment of the present invention the row  292  contains five sets of values:  
         [0125]    (a) Initial bend  294  contains two values for bending the guide from a straight position, in two perpendicular planes.  
         [0126]    (b) Initial insertion  295  contains a longitudinal value for extending or retracting the guide in centimeters.  
         [0127]    (c) Initial sensor measurements  296  contains expected output values of four sensors such as four Hall effect sensors, for example, Hall effect sensors  38  and  40  of FIG. 1A. The initial sensors measurements  296  are expected to be measured by the time the guide reaches the value of the initial insertion  295 .  
         [0128]    (d) Insert distance  297  contains a longitudinal value for further extending or retracting the guide in centimeters. Typically the initial sensor measurements  296  are expected to be preserved, while the guide is extended or retracted, by adapting the bending of the guide.  
         [0129]    (e) Final sensor measurements  298  contain expected output values of the four sensors of step (c). The initial sensor measurements  298  are expected to be measured by the time the guide reaches the value of the insert distance  297 .  
         [0130]    It is appreciated that the path drawn in FIG. 6B can be employed to prepare a table of instructions such as table  290  of FIG. 7.  
         [0131]    Referring to FIG. 8, which is a flowchart illustrating a preferred implementation of the present invention, operative for a process of insertion of an element into the intestine of a human as shown in FIGS. 6A to  6 K. The flowchart of FIG. 8 is a preferred embodiment of a program, operative to be executed by a processor, such as microprocessor  278  of FIG. 5A, comprised in a preferred embodiment of the present invention, for insertion of an element into a living organism, preferably by employing a table  290  shown and described with reference to FIG. 7.  
         [0132]    The preferred flowchart shown in FIG. 8 starts by loading the table (step  300 ) such as the map shown in FIG. 7. The program then reads a first row  292  from the map (step  302 ) and causes the distal end of the guide  20  to bend according to the initial bending values  294 . Then the program causes the guide  20  to extend or retract according to the initial insertion distance  295  of the first row in the map. The program continues to bend and insert the guide  20  until output values of the sensors match the expected initial sensor measurement  296  of the row (steps  304 ,  306  and  308 ), or until a limit is surpassed, an error message is displayed and the program is stopped (step  310 ).  
         [0133]    Preferably, the initial values of the sensors are measured and then the program continues to extend or retract the guide  20  (step  312 ) until the sensors produce the final sensors measurements  298  values (step  314 ), while keeping in contact with the surface (steps  316  and  318 ) or until at least one of predefined limits is surpassed (step  320 ) where the program is stopped (step  310 ). If the final sensor measurements  298  values are measured the program proceeds to step  320  and loops through steps  302  and  320  until all the rows  292  of the table are processed. Then the program displays an insertion success message on the display  232  and halts (step  322 ).  
         [0134]    As indicated by row No.  1  of FIG. 7 and FIG. 6C the guide is bent, preferably by up to 45 degrees, to the left in the plane of FIG. 6C and, while preserving contact with the left side of the intestine, is extended up to 5 centimeters or until the sensor tip engages the internal surface of the intestine head on at a point in the map  284  designated by reference numeral  330 .  
         [0135]    As indicated by row No. 2  of FIG. 7 and FIG. 6D the guide is bent by up to 45 degrees to the right in the plane of FIG. 6D and, while preserving contact with the left side of the intestine, is extended up to 2.5 centimeters or until the sensor tip does not sense the internal surface of the intestine at a point in the map  284  designated by reference numeral  332 .  
         [0136]    As indicated by row No. 3  of FIG. 7 and FIG. 6E the guide is bent by up to 110 degrees to the left in the plane of FIG. 6E and, while preserving contact with the left side of the intestine, is extended by 1 centimeter to a point in the map  284  designated by reference numeral  334 .  
         [0137]    In accordance with row  4  of FIG. 7 and FIG. 6F the guide is bent by up to 45 degrees to the right in the plane of FIG. 6F and is extended by 6 centimeter to a point in the map  284  designated by reference numeral  336 .  
         [0138]    As indicated by row No. 5  of FIG. 7 and FIG. 6G the guide is bent by up to 20 degrees to the right in the plane of FIG. 5G and, while preserving contact with the right side of the intestine, is extended by 4 centimeters to a point in the map  284  designated by reference numeral  338 .  
         [0139]    As indicated by row No. 6  of FIG. 7 and FIG. 6H the guide is bent by up to −60 degrees to the left in the plane of FIG. 6H and is extended by up to 3 centimeters or until the sensor tip engages the internal surface of the intestine head on at a point in the map  284  designated by reference numeral  340 .  
         [0140]    As indicated by row No. 7  of FIG. 7 and FIG. 61 the guide is bent by up to 45 degrees to the right in the plane of FIG. 61 and is extended by up to 1 centimeter or until the sensor tip engages the internal surface of the intestine with its right side in a point in the map  284  designated by reference numeral  342 .  
         [0141]    As indicated by row No. 8  of FIG. 7 and FIG. 6J the guide is extended by up to 1 centimeters or until the sensor tip engages the internal surface of the intestine with its left side at a point in the map  284  designated by reference numeral  344 .  
         [0142]    As indicated by row No. 9  of FIG. 7 and FIG. 6K the guide is bent by up to 45 degrees to the right in the plane of FIG. 6K and is extended by up to 1 centimeter or until the sensor tip engages the internal surface of the intestine head on at a point in the map  284  designated by reference numeral  346 .  
         [0143]    In a preferred embodiment of the present invention the system and the method are operative for automatic operation. Alternatively the present invention can be operated manually, by providing to the operator the information collected by the sensor log  266  form the tip sensor  11  and enabling the operator to control manually the guide  20 . In another alternative part of the procedure is performed automatically and another part is performed manually. For example, the guide  20  may be inserted automatically and a medical device, such as the tube  18  may be inserted manually.  
         [0144]    It is appreciated that a log of the process of insertion of an insertable element into a living organism such as a human body is preferably stored in an internal memory of the present invention and that this log can be transmitted to a host computer. It is appreciated that the host computer can aggregate insertion process logs and thereby continuously improve relevant insertion pattern maps such as the standard contour map  10 . Thereafter, from time to time or before starting an insertion process, the present invention is capable of loading an updated map such as standard contour map  10 .  
         [0145]    It is also appreciated that the accumulated logs of processes of insertions cab be employed to improve the algorithm for processing the maps, such as the algorithms shown and described with reference to FIGS.  2 A- 2 F and FIG. 8. The improved algorithm can be transmitted to the present invention as necessary.  
         [0146]    Appendices 1 to 3 are software listings of the following computer files:  
         [0147]    Appendix 1: containing file intumed.asm.  
         [0148]    Appendix 2: containing file c8cdr.inc.  
         [0149]    Appendix 3: containing file ram.inc.  
         [0150]    The method for providing the software functionality of the microprocessor  278 , in accordance with a preferred embodiment of the present invention includes, the following steps:  
         [0151]    1. Provide an Intel compatible computer with a Pentium II CPU or higher, 128 MB RAM, a Super VGA monitor and an available serial port.  
         [0152]    2. Install Microsoft Windows 95 or Microsoft Windows 98 Operating System.  
         [0153]    3. Install the Testpoint Development kit version 40 available from Capital Equipment Corporation. 900 Middlesex Turnpike, Building 2, Billereca, Mass. 0821, USA.  
         [0154]    4. Connect a flash processor loading device COP8EM Flash, COP8 In Circuit Emulator for Flash Based Families to the serial port of the Intel compatible computer. The COP8EM flash processor loading device is available from National Semiconductors Corp. 2900 Semiconductor Dr., P.O.Box 58090, Santa Clara, Calif. 95052-8090, USA  
         [0155]    5. Place a COP8CDR9HVA8 microcontroller available from National Semiconductors Corp., 2900 Semiconductor Dr., P.O.Box 58090, Santa Clara, Calif. 95052-8090, USA in the COP8EM Flash.  
         [0156]    6. Copy the files intumed.asm, c8cdr.inc, and ram.inc, respectively labeled Appendix 1, Appendix 2 and Appendix 3 to a temporary directory.  
         [0157]    7. Load the file intumed.asm by using the operating software available with the COP8EM Flash device from National Semiconductors.  
         [0158]    8. To run the intumed.asm; Install the COP8CDR9HVA8 microcontroller in its socket in the electrical circuit, which detailed electronic schematics are provided in FIGS. 5A to  5 H, where the microcontroller is designated by reference numeral  278 .  
         [0159]    It is appreciated that the software components of the present invention may, if desired, be implemented in ROM (read-only memory) form. The software components may, generally, be implemented in hardware, if desired, using conventional techniques.  
         [0160]    It is appreciated that the particular embodiment implemented by the Appendix is intended only to provide an extremely detailed disclosure of the present invention and is not intended to be limiting.  
         [0161]    It is appreciated that various features of the invention which are, for clarity, described in the contexts of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment may also be provided separately or in any suitable subcombination.  
         [0162]    It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove as well as variations and modifications which would occur to persons skilled in the art upon reading the specification and which are not in the prior art.