Apparatus for self-guided intubation

[0001] This application is a continuation of copending International Application PCT/IL01/01121 filed on Dec. 5, 2001, which designated the U.S., claims the benefit thereof and incorporates the same by reference.

[0002] The present invention relates to systems and methods for automatic insertion of an element into a living organism in vivo.

[0003] Applicants hereby claim priority of Israel Patent Application No. 140,136 filed Dec. 6, 2000, entitled “Apparatus For Self-Guided Intubation”.

[0004] The following patents are believed to represent the current state of the art:

[0005]

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

[0006] Reference is also made to: http://www.airwaycam.com/system.html

[0007] The present invention seeks to provide improved systems and methods for automatic insertion of an element into a living organism in vivo.

[0008] 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.

[0009] 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.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] Preferably, the surface characteristic information includes surface contour information.

[0014] Additionally in accordance with a preferred embodiment of the present invention the surface characteristic information includes surface hardness information.

[0015] Preferably, the surface contour information is three-dimensional,

[0016] Preferably, the surface contour information is two-dimensional.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] Preferably, the reference pathway includes a standard contour map of a portion of the human anatomy.

[0022] Further in accordance with a preferred embodiment of the present invention the standard contour map is precisely adapted to a specific patient.

[0023] Still further in accordance with a preferred embodiment of the present invention the standard contour map is automatically precisely adapted to a specific patient.

[0024] Further in accordance with a preferred embodiment of the present invention the reference pathway is operator adaptable to designate at least one impediment.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] Additionally, the driving subsystem is also operative to selectably bend a front end of the insertable element.

[0029] Further in accordance with a preferred embodiment of the present invention the surface following element includes a tactile sensing element.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] Preferably, the navigation subsystem operates to load the reference pathway from a memory.

[0041] Further in accordance with a preferred embodiment of the present invention the driving subsystem is operative to push the tube forward.

[0042] 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.

[0043] 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

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] Preferably, the insertion instruction includes instruction to at least one of extend, retract and bend the insertable element.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] Still further in accordance with a preferred embodiment of the present invention the computer transmits the reference pathway to the medical insertion device.

[0055] Further in accordance with a preferred embodiment of the present invention the insertable element includes a guiding element and a guided element.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] There is further 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.

[0060] 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.

[0061] 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.

[0071] Appendices 1 to 3 are computer listings which, taken together, form a preferred software embodiment of the present invention.

[0072] Reference is now made to FIGS. 1A to 1L, 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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's mouth and trachea 44.

[0092] Reference is now made to FIGS. 2A to 2F, which, taken together, are a flowchart of the process of the intubation of a human shown in FIGS. 1A to 1K.

[0093] FIGS. 2A and 2B, taken together, correspond to the step of the intubation process shown in FIG. 1A.

[0094] In step 100 of FIG. 2A the intubator assembly 12 is set to perform intubation.

[0095] In step 102 the intubator loads an intubation pattern map 10 from its memory.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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'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's organ structure (step 148).

[0100] 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's organ structure.

[0101] 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.

[0102] Reference is now made to FIG. 2F, which corresponds to FIGS. 1G to 1K. 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, 1J) 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).

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] It is appreciated that the term “microprocessor” also includes inter alia a “microcontroller”.

[0108] 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.

[0109] Communication interface (not shown), preferably employing infra-red communication technology, is provided to enable communication with external data processing equipment.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] Reference is now made to FIGS. 5A to 5H, 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 2F.

[0116] Reference is now made to FIGS. 6A to 6K, 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.

[0117] 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.

[0118] 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:

• • [0119] (1) The tube 18 may be replaced with a different insertable device;
  • [0120] (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
  • [0121] (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.

[0122] 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.

[0123] Due to limitations of the graphical representation, a two-dimensional imaging and map is shown in FIGS. 6A to 6K.

[0124] 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.

[0125] 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 1K. 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.

[0126] Reference is now made to FIG. 7 together with FIG. 8 and with FIGS. 6C to 6K. 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 6K. 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:

[0127] (a) Initial bend 294 contains two values for bending the guide from a straight position, in two perpendicular planes.

[0128] (b) Initial insertion 295 contains a longitudinal value for extending or retracting the guide in centimeters.

[0129] (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.

[0130] (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.

[0131] (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.

[0132] 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.

[0133] 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 6K. 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.

[0134] 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).

[0135] 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).

[0136] 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.

[0137] 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.

[0138] 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.

[0139] 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.

[0140] 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.

[0141] 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.

[0142] 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.

[0143] 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.

[0144] 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.

[0145] 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.

[0146] 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.

[0147] 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. 2A–2F and FIG. 8. The improved algorithm can be transmitted to the present invention as necessary.

[0148] Appendices 1 to 3 are software listings of the following computer files:

[0149] Appendix 1: containing file intumed.asm.

[0150] Appendix 2: containing file c8cdr.inc.

[0151] Appendix 3: containing file ram.inc.

[0152] 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:

• [0153] 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.
• [0154] 2. Install Microsoft Windows 95 or Microsoft Windows 98 Operating System.
• [0155] 3. Install the Testpoint Development kit version 40 available from Capital Equipment Corporation. 900 Middlesex Turnpike, Building 2, Billereca, Mass. 0821, USA.
• [0156] 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
• [0157] 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.
• [0158] 6. Copy the files intumed.asm, c8cdr.inc, and ram.inc, respectively labeled Appendix 1, Appendix 2 and Appendix 3 to a temporary directory.
• [0159] 7. Load the file intumed.asm by using the operating software available with the COP8EM Flash device from National Semiconductors.
• [0160] 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 5H, where the microcontroller is designated by reference numeral 278.

[0161] 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.

[0162] 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.

[0163] 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.

[0164] 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.