# US 8,543,188 B2 · Method and apparatus for calibrating medical devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,543,188 B2 - Document ID: US8543188B2 - Status: Granted - Kind: B2 - Application number: 11/550,010 - Filed: 2006-10-17 - Published: 2008-07-03 - Granted: 2013-09-24 - Earliest claimed: 2006-10-17 - Assignees: General Electric Company - Applicants: Ron Andrew von Jako; Daniel Eduardo Groszmann - Inventors: Ron Andrew von Jako; Daniel Eduardo Groszmann - Web page: https://patentgrep.com/patent/US8543188B2 ## CPC - A61B 5/06: Devices, other than using radiation, for detecting or locating foreign bodies {; Determining position of diagnostic devices within or on the body of the patient} - A61B 5/062: {using magnetic field} - A61B 5/066: {Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging} - A61B 34/20: Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis - A61B 5/061: {Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body (A61B1/00158 takes precedence)} - A61B 2034/107: {Visualisation of planned trajectories or target regions} - A61B 2034/2051: {Electromagnetic tracking systems} - A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A calibration apparatus for a medical device is disclosed herein. The calibration apparatus includes a locating member configured to locate a first predetermined portion of the medical device. The calibration apparatus also includes a calibration member positioned relative to the locating member such that, when the calibration apparatus is attached to the medical device, the calibration member aligns with a second predetermined portion of the medical device. A corresponding method for determining the location of the second predetermined portion of the medical device is also provided. ## Claims ### Claim 1 A navigation system for a medical device to be at least partially inserted into a patient during a surgical procedure, the system comprising: a reference unit configured to attach to a patient; a field generator disposed within the reference unit, the field generator creates an electromagnetic field about the field generator; a remote unit configured to attach to a proximal end of the medical device, the remote unit generates a signal based upon the location of the remote unit within the electromagnetic field; a processor connected to the remote unit to receive the signal from the remote unit, the signal being indicative of the position and/or the orientation of the remote unit relative to the reference unit; and a calibration apparatus removably attachable to a distal end of the medical device, said calibration apparatus having a calibration member that aligns with a work end of the medical device when the calibration apparatus is attached to the medical device; wherein the processor determines a location and an orientation of said remote unit with respect to the reference unit when the calibration member is physically engaged with the reference unit to calibrate the navigation system by relating the distal end of the medical device represented by the calibration apparatus to the proximal end of the medical device; and wherein the calibration apparatus prohibits use of the medical device for the surgical procedure when attached to the distal end of the medical device, therefore the calibration apparatus is attached to the distal end of the medical device to calibrate the navigation system and removed from the medical device for the surgical procedure. ### Claim 2 (depends on 1) The navigation system of claim 1, wherein said reference unit includes a reference feature that receives the calibration member. ### Claim 3 (depends on 1) The navigation system of claim 1, wherein said reference unit is an electromagnetic field generator mounted to the patient. ### Claim 4 (depends on 3) The navigation system of claim 3, wherein the processor determines a location of the remote unit within an electromagnetic field generated by the reference unit. ### Claim 5 (depends on 4) The navigation system of claim 4 wherein the remote unit comprises at least one field sensor that produces a signal indicative of a location of the remote unit within the electromagnetic field, wherein the signal is sent to the processor. ### Claim 6 (depends on 1) The navigation system of claim 1, wherein the calibration member is a first calibration member that aligns with a front tip of the distal end and said calibration apparatus further includes a second calibration member that aligns with a back tip of the distal end of the medical device when the calibration apparatus is attached to the medical device. ### Claim 7 A method for electromagnetically determining the location of a predetermined portion of a medical device configured for insertion into a patient, the medical device comprising an electromagnetic remote unit, said method comprising: providing a calibration apparatus having a first calibration member, the calibration apparatus being configured for removable attachment to a distal end of the medical device; attaching the calibration apparatus to the medical device such that the first calibration member aligns with a work end of the medical device, the first calibration member representing a front tip of the work end; providing a reference unit secured to the patient, the reference unit comprising a field generator; generating an electromagnetic field from the field generator of the reference unit; determining a location of the remote unit with respect to the reference unit by locating the remote unit within the electromagnetic field generated by the reference unit; physically engaging the reference unit with the first calibration member; calibrating the medical device by locating a position and an orientation of the remote unit with respect to the reference unit and the first calibration member; and removing the calibration apparatus from the medical device after calibrating the medical device and before the medical device is used in a surgical procedure such that the work end of the medical device is inserted into the patient without encumbrance by the calibration apparatus or the calibration member. ### Claim 8 (depends on 7) The method of claim 7, further comprising engaging a dimple in the reference unit with the calibration member; and pivoting the medical device about the calibration member within the dimple in the reference unit. ### Claim 9 (depends on 8) The method of claim 8, further comprising rigidly attaching the reference unit to a patient. ### Claim 10 (depends on 9) The method of claim 9, wherein said providing a calibration apparatus having a calibration member includes providing an apparatus having a first calibration member and a second calibration member. ### Claim 11 A medical device navigation system comprising: a medical device configured to be inserted into a patient during a surgical procedure, the medical device having a proximal end and a distal end opposite the proximal end, the distal end being a working end without a well-defined tip; a calibration apparatus removably attachable to the distal end of the medical device such that when the calibration apparatus is attached to the distal end, a first calibration member of the calibration apparatus defines a tip of the medical device; a reference unit configured to attach to the patient and configured with a complementary feature to receive the first calibration member of the calibration apparatus, a field generator within the reference unit generates a position characteristic field; a remote unit attached to the proximal end of the medical device, the remote unit produces a signal indicative of the position of the remote unit within the position characteristic field of the reference unit; and a processor connected to the remote unit, the processor receives the signal from the remote unit; wherein the processor determines a position and an orientation of the distal end of the medical device relative to the proximal end of the medical device by determining the position of the remote unit within the position characteristic field when the first calibration member physically engages the complimentary feature of the reference unit. ### Claim 12 (depends on 11) The system of claim 11 wherein the complimentary feature of the reference unit is a dimple in the reference unit that approximates the center of the position characteristic field. ### Claim 13 (depends on 11) The system of claim 11 wherein the medical device is a surgical instrument. ### Claim 14 (depends on 11) The system of claim 11 wherein the medical device is a surgical implant. ### Claim 15 (depends on 11) The system of claim 11 wherein the calibration apparatus is removed from the medical device after calibration and before the medical device is inserted into the patient. ### Claim 16 (depends on 11) The system of claim 11 wherein the first calibration member defines a front tip of the medical device, and further comprising a second calibration member of the calibration apparatus, the second calibration member defines a back tip of the medical device, when the calibration apparatus is attached to the distal end of the medical device. ### Claim 17 (depends on 16) The system of claim 16 wherein the processor further determines a trajectory of the distal end of the medical device by determining the position of the remote unit within the position characteristic field when the second calibration member engages the complimentary feature of the reference unit, and wherein the processor identifies the trajectory of the distal end as a line connecting a determined position of the first calibration member with a determined position of the second calibration member. ### Claim 18 (depends on 11) The system of claim 11 wherein the remote unit comprises at least one field sensor that produces the signal indicative of the position of the remote unit. ### Claim 19 A method for tracking the position and orientation of a medical device during a surgical procedure, the medical device having a distal end and a proximal end opposite the distal end, and the surgical procedure inserts at least the distal end of the medical device into a patient, the method comprising: providing an electromagnetic remote unit attached to the proximal end of the medical device; securing an electromagnetic reference unit to the patient; generating an electromagnetic field with the reference unit; removably attaching a calibration apparatus to the distal end of the medical device, a calibration member of the calibration apparatus aligning with a front tip of the distal end; physically engaging the reference unit with the calibration member; locating with a processor a position and an orientation of the remote unit within the electromagnetic field and with respect to the engaged reference unit and calibration member by processing the received signal with the processor; calibrating a navigation system for the medical device by relating the position and orientation of the remote unit to the calibration member; removing the calibration apparatus from the distal end of the medical device; and inserting the distal end of the medical device into the patient to perform the surgical procedure. ### Claim 20 (depends on 19) The method of claim 19 further comprising: sensing the electromagnetic field with at least one field sensor in the electromagnetic remote unit; and providing a signal indicative of the sensed electromagnetic field from the at least one field sensor to the processor.