Catheter locator apparatus and method of use

Abstract

This invention relates to a method of catheter and radiating coil location in a human body and in particular to the determination over time of the location of the tip of a catheter as it is inserted and during its use in the body. In particular when a radiating coil is used in conjunction with a catheter, a coil locating device can be used to determine the distance the coil is from the device and hence its depth in the body of a patient. To assist a clinician using the coil-locating device, a display is provided that shows both a reference image of a part or portion of a body (non-subject body) and an image of the coil located on the display with reference to the reference image. This is achieved by locating the coil-locating device on or over a predetermined landmark on the patient's body. The coil and its associated signal wires can be incorporated into a stylet, guide wire or a catheter. The coil locating device has a preferable triangular shape in plan view that allows it uppermost apex to be orientated towards the head of the patient and for an axis of the device to be aligned with the mid sagittal plane of the patient. Preferable landmarks on a human body include the xiphoid sternal junction and the caudal/mid sagittal aspect of the jugular sternal notch.

1 . A method of guiding a coil used in relation to a catheter to be inserted into a subject body wherein said coil radiates signal energy; the method including the steps of: 
 a) using a coil detection means having at least two signal energy detectors wherein said detection means is located with reference to a predetermined location on or part of said subject body and generating a signal based on a spatial separation of a said radiating coil from said detection means;    b) displaying a predetermined symbol representative of an area on or part of a non-subject body wherein said signal generated by said detection means is used to display a predetermined coil symbol representative of said coil at a position on a display device relative to said predetermined body symbol for use by a clinician to guide a positioning of said coil and said catheter into said subject body.    
     
     
         2 . The method according to  claim 1  wherein said coil detection means is located with reference to a predetermined location being on or over the xiphoid sternal junction of a human body for use with a catheter inserted into the alimentary canal.  
     
     
         3 . The method according to  claim 2  wherein a predetermined body symbol representative of an area on or part of a non-subject body is displayed that is representative of the diaphragm of a non-subject human body thus delineating on said display the upper and lower chest cavities of a human body.  
     
     
         4 . The method according to  claim 1  wherein said coil detection means is located with reference to a predetermined location being on or over the caudal/mid sagittal aspect of the jugular sternal notch of a human body for use with a catheter inserted into the cardiovascular or respiratory system.  
     
     
         5 . The method according to  claim 5  wherein a predetermined body symbol representative of an area on or part of a non-subject body is displayed that is representative of the sternum of a non-subject human body thus delineating on said display a portion of the upper skeleton of a human body.  
     
     
         6 . The method according to  claim 1  includes the further step of: 
 c) displaying a predetermined coil symbol representative of said coil at predetermined intervals of time.  
 
     
     
         7 . The method according to  claim 1  wherein said coil is incorporated into a stylet or guide wire adapted for use with a catheter.  
     
     
         8 . The method according to  claim 7  includes the further step of: 
 d) displaying a predetermined coil symbol representative of said coil at predetermined intervals of time while said stylet or guide wire is inserted or retracted from a catheter located over a said stylet or guide wire so that the path of said coil and thus said catheter can be tracked and displayed.  
 
     
     
         9 . The method according to  claim 8  wherein said track is constructed for display by calculating a line of best fit from two or more signals generated by said coil detection means.  
     
     
         10 . The method according to  claim 1  wherein a coil is incorporated into a catheter for use in a body.  
     
     
         11 . The method according to  claim 10  includes the further step of: 
 e) displaying a predetermined coil symbol representative of said coil at predetermined intervals of time while said catheter is inserted into or retracted from said body and thus said catheter can be tracked and displayed.  
 
     
     
         12 . The method according to  claim 11  wherein said track is constructed for display by calculating a line of best fit from two or more signals generated by said coil detection means.  
     
     
         13 . A catheter locator apparatus for assisting a user's placement of a catheter into a subject body, the catheter locator apparatus comprising: 
 a pair of wires usable with the catheter, the wires having a first end and a second end;    a processor in electronic communication with the first end of the wires;    a radiating coil connected to the second end of the wires, the radiating coil having various locations in the subject body;    a detector device in electronic communication with the processor, the detector device adapted to be positioned in relation to a predetermined portion of the subject body;    reference data retrieved by the processor which specifies at least one reference image which represents at least one predetermined image;    indicator data generated by the processor which specifies at least one indicator image which provides information related to at least one location of the radiating coil in the subject body; and    a monitor in electronic communication with the processor which displays the indicator image and the reference image.    
     
     
         14 . The catheter locator apparatus of  claim 13 , wherein the radiating coil transmits electromagnetic signals.  
     
     
         15 . The catheter locator apparatus of  claim 13 , wherein the pair of wires is a stylet or guide wire or is incorporated into a stylet or guide wire or the catheter.  
     
     
         16 . The catheter locator apparatus of  claim 13 , wherein the detector device includes at least two receiving coils, which receive electromagnetic signals from, said radiating coil.  
     
     
         17 . The catheter locator apparatus of  claim 16 , wherein the processor receives at least one indicator signal from the detector device representative of the received electromagnetic signals after said detector device is located in relation to a predetermined portion of the subject body.  
     
     
         18 . The catheter locator apparatus of  claim 13 , wherein the predetermined portion of the subject body is the caudal/mid sagittal aspect of the jugular sternal notch when the catheter is used in the cardiovascular or respiratory system.  
     
     
         19 . The catheter locator apparatus of  claim 13 , wherein the processor receives at least one indicator signal from the detector device while the radiating coil is in the catheter that is within the subject body.  
     
     
         20 . The catheter locator apparatus of  claim 13 , wherein the predetermined portion of the subject body is the xiphoid sternal junction of the subject body when the catheter is used in the gastrointestinal tract or alimentary canal.  
     
     
         21 . The catheter locator apparatus of  claim 13 , wherein the display provides a user with information related to the catheter's location when the radiating coil is used with the catheter and the catheter is in the subject body.  
     
     
         22 . The catheter locator apparatus of  claim 21 , wherein the indicator image and reference image provide a user with information related to depth of the catheter in the subject body.  
     
     
         23 . The catheter locator apparatus of  claim 21 , wherein the display provides a user with information related to X-Y location of the catheter in the subject body.  
     
     
         24 . The catheter locator apparatus of  claim 21 , wherein the catheter's location is relative to the detector device.  
     
     
         25 . The catheter locator apparatus of  claim 21 , wherein the monitor provides users with information related to direction of travel of the catheter in the subject body.  
     
     
         26 . The catheter locator apparatus of  claim 25 , wherein information related to the direction of travel results from a change in the indicator data.  
     
     
         27 . The catheter locator apparatus of  claim 13 , which includes a data storage device in electronic communication with the processor.  
     
     
         28 . The catheter locator apparatus of  claim 27 , wherein the data storage device includes data which specifies a reference image of at least a portion of a non-subject body.  
     
     
         29 . The catheter locator apparatus of  claim 28 , wherein the non-subject body is a theoretical body.  
     
     
         30 . The catheter locator apparatus of  claim 27 , wherein the data storage device includes data that specifies a reference image comprising a symbol.  
     
     
         31 . The catheter locator apparatus of  claim 13 , wherein the catheter is used in a gastrointestial tract of the subject body.  
     
     
         32 . A catheter locator apparatus of  claim 13 , wherein the catheter is used in an alimentary canal of the subject body.  
     
     
         33 . A catheter locator apparatus of  claim 13 , wherein the catheter is used in a cardiovascular system of the subject body.  
     
     
         34 . A catheter locator apparatus of  claim 13 , wherein the catheter is used in a respiratory system of the subject body.  
     
     
         35 . An apparatus for use in conjunction with a medical instrument, the medical instrument having a first end and a second end, the first end movable between a plurality of anatomical locations within a subject body, the apparatus comprising: 
 at least one energy radiating member operatively coupled to the first end of the medical instrument, the energy radiating member producing a plurality of signals;    at least one energy receiving member receiving energy from the energy radiating member;    at least one processor in communication with the energy receiving member, the processor producing signal data based on the signals;    at least one data storage device in communication with the processor, the data storage device storing the signal data and image data in association with the signal data, the image data representing a plurality of images, each of the images indicating one of the anatomical locations; and    at least one display device communicating with the processor, the display device displaying the images.    
     
     
         36 . The apparatus of  claim 35 , wherein the medical device includes a catheter.  
     
     
         37 . The apparatus of  claim 35 , wherein the signal data includes data related to movement of the first end along an X-axis.  
     
     
         38 . The apparatus of  claim 37 , wherein the signal data includes data related to movement of the first end along a Y-axis.  
     
     
         39 . The apparatus of  claim 38 , wherein the signal data includes data related to movement of the first end along a Z-axis.  
     
     
         40 . The apparatus of  claim 35 , wherein the anatomical locations are selected from the group consisting of a location in an alimentary canal of the patient, a location in a cardiovascular system of the patient, a location in a respiratory system of the patient and a location in a reproduction system of the subject body.  
     
     
         41 . The apparatus of  claim 35 , wherein at least one of the images includes a graphical representation of an anatomical portion of the subject body.  
     
     
         42 . The apparatus of  claim 35 , wherein at least one of the images includes a textual description of an anatomical portion of the subject body.  
     
     
         43 . The apparatus of  claim 35 , wherein at least one of the images includes a symbolic message related to an anatomical portion of the patient.  
     
     
         44 . The apparatus of  claim 35 , which includes at least one printing device in communication with the processor, the printing device adapted to print the images.  
     
     
         45 . The apparatus of  claim 35 , wherein the at least one energy receiving member is positioned with reference to a predetermined location on or part of said subject body.  
     
     
         46 . The apparatus of  claim 45 , wherein said predetermined location is a caudal/mid sagittal portion of a jugular sternal notch of the subject body.  
     
     
         47 . The apparatus of  claim 45 , wherein said predetermined location is a xiphoid sternal junction of the subject body.  
     
     
         48 . An apparatus for use in conjunction with a medical instrument, the medical instrument having a first end and a second end, the first end movable within a subject body along a path having a shape, the apparatus comprising: 
 at least one energy radiating member operatively coupled to the first end of the medical instrument;    at least one energy receiving member receiving energy from the energy radiating member;    at least one processor in communication with the energy receiving member; and    at least one display device communicating with the processor, the display device displaying an image which indicates information related to the shape of the path.    
     
     
         49 . The apparatus of  claim 48 , wherein the medical device includes a catheter.  
     
     
         50 . The apparatus of  claim 48 , wherein the shape of the path has at least one curve.  
     
     
         51 . The apparatus of  claim 50 , wherein the image has at least one curve.  
     
     
         52 . The apparatus of  claim 51 , wherein the image includes a graphical representation of at least part of the path, the representation based on a correspondence of the curve of the image to the curve of the shape of the path.  
     
     
         53 . The apparatus of  claim 48 , wherein the image includes a graphical representation of the path.  
     
     
         54 . The apparatus of  claim 48 , which includes at least one data storage device in communication with the processor, the data storage device storing a program having instructions which direct the processor to produce the image.  
     
     
         55 . The guidance apparatus of  claim 54 , wherein the program has instructions which direct the processor to produce data related to at least one position of the first end of the medical instrument, the position selected from the group consisting of a position on an X-axis, a position on a Y-axis and a position on a Z-axis relative to a predetermined location on or part of said subject body.  
     
     
         56 . The apparatus of  claim 48 , which includes a signal generator in communication with the energy radiating member and a plurality of signals produced by the energy radiating member being received by the energy receiving member.  
     
     
         57 . The apparatus of  claim 56 , wherein the shape of the path is determined from information calculated based on the signals.  
     
     
         58 . The apparatus of  claim 48 , wherein the medical instrument is for use in insertion into an alimentary canal of subject body.  
     
     
         59 . The apparatus of  claim 48 , wherein the medical instrument is for use in insertion into a cardiovascular system of the patient.  
     
     
         60 . The apparatus of  claim 48 , wherein the medical instrument is for use in insertion into a respiratory system of the patient.  
     
     
         61 . The apparatus of  claim 48 , wherein an energy receiving member has a position referenced to a xiphoid sternal junction of the subject body.  
     
     
         62 . The apparatus of  claim 48 , wherein the energy receiving member has a position referenced to a caudal/mid sagittal aspect of a jugular sternal notch of the subject body.  
     
     
         63 . The apparatus of  claim 48 , which includes an image displayed on the visual display device, the image representing a portion of a non-subject body.  
     
     
         64 . The apparatus of  claim 48 , which includes at least one printing device for receiving data to print the image.  
     
     
         65 . An apparatus for graphically depicting data regarding catheter movement during placement of a catheter within a subject body, the catheter having a first end and a second end moveable along a placement path, comprising: 
 an energy radiating member adapted to cooperate with the second end of the catheter;    an energy receiving member external to the patient, the energy receiving member receiving energy from the energy radiating member;    a data processor communicating with the energy receiving member, the data processor capable of producing data indicative of position changes of the second end of the catheter along the placement path; and    a visual display device communicating with the data processor, the visual display device displaying graphically the position change data of the second end of the catheter along the placement path.    
     
     
         66 . The apparatus of  claim 65 , which further comprises a signal generator in communication with the energy radiating member and a plurality of signals produced by the energy radiating member being received by the energy receiving member.  
     
     
         67 . The apparatus of  claim 66 , wherein the data includes information calculated based on the signals.  
     
     
         68 . The apparatus of  claim 65 , wherein the catheter is for use in insertion into an alimentary canal of the subject body.  
     
     
         69 . The apparatus of  claim 65 , wherein the catheter is for use in insertion into a cardiovascular system of the patient.  
     
     
         70 . The apparatus of  claim 65 , wherein the catheter is for use in insertion into a respiratory system of the patient.  
     
     
         71 . The apparatus of  claim 65 , wherein the energy receiving member has a position referenced to a xiphoid sternal junction of the subject body.  
     
     
         72 . The apparatus of  claim 65 , wherein the energy receiving member has a position referenced to a caudal/mid sagittal aspect of a jugular sternal notch of the patient.  
     
     
         73 . The apparatus of  claim 65 , which includes an image displayed on the visual display device, the image representing a portion of a non-subject body.  
     
     
         74 . The apparatus of  claim 65 , which includes at least one printing device in communication with the data processor, the printing device adapted to print a graphical representation of the position change data.  
     
     
         75 . A method for aiding a user in positioning a medical instrument in a portion of a subject body, said method comprising the steps of: 
 (a) coupling at least one energy radiating member to a first end of the medical instrument;    (b) positioning at least one energy receiving member with reference to a predetermined location on or part of said subject body;    (c) the user to insert a predetermined length of the first end into the subject body;    (d) causing the energy radiating member to produce a plurality of signals while the length of the medical instrument is being moved inside the subject body;    (e) transforming received signals into signals for communication to a processor;    (f) performing at least one calculation based on the transformed signals;    (g) producing data based on the calculation; and    (h) graphically representing the data.    
     
     
         76 . The method of  claim 75 , wherein the step of positioning at least one energy receiving member adjacent to an exterior portion of the patient includes the step of positioning the receiving member referenced to a xiphoid sternal junction of the patient.  
     
     
         77 . The method of  claim 75 , wherein the step of positioning at least one energy receiving member adjacent to an exterior portion of the patient includes the step of positioning the receiving member referenced to a caudal/mid sagittal aspect of a jugular sternal notch of the patient.  
     
     
         78 . The method of  claim 75 , wherein the step of enabling the user to insert a predetermined length of the first end of the medical instrument into the patient includes the step of enabling the user to retract a desired length of the first end of the medical instrument.  
     
     
         79 . The method of  claim 75 , wherein steps (d) through (h) are performed in real time.  
     
     
         80 . The method of  claim 75 , wherein the step of graphically representing the data includes the step of displaying an image, which provides information related to a shape of a movement path of the first end in the subject body.  
     
     
         81 . The method of  claim 75 , which includes the step of repeating steps (c) through (h) as the first end is past through the subject body.  
     
     
         82 . A wire bundle for use with a catheter locator apparatus which includes: (a) a processor in electronic communication with a predetermined portion of a proximal end of the wire bundle, (b) a radiating coil connected to a predetermined portion of a distal end of the wire bundle, the radiating coil having various locations in a subject body; (c) a detector device in electronic communication with the processor, the detector device is located with reference to a predetermined location on or part of said subject body; (d) reference data retrieved by the processor which specifies at least one reference image which represents at least one predetermined image; (e) indicator data generated by the processor which specifies at least one indicator image which provides information related to at least one location of the radiating coil in the subject body; and (f) a monitor in electronic communication with the processor which displays the indicator image and the reference image, said wire bundle comprising: 
 a first wire having a predetermined stiffness adapted to control positioning of a flexible tube;    a second wire adapted to transmit signals between the radiating coil and the processor; and    means for binding the second wire to the first wire.    
     
     
         83 . The wire bundle of  claim 82 , wherein the binding means includes winding of the second wire around a circumference of the first wire.  
     
     
         84 . The wire bundle of  claim 82 , wherein the binding means includes a wrapping material.  
     
     
         85 . The wire bundle of  claim 82 , wherein the binding means includes an adhesive.  
     
     
         86 . The wire bundle of  claim 82 , wherein the binding means includes a predetermined fastener.