EP1034461A4 - System and method for guiding the movements of a device to a target particularly for medical applications - Google Patents
System and method for guiding the movements of a device to a target particularly for medical applicationsInfo
- Publication number
- EP1034461A4 EP1034461A4 EP98955889A EP98955889A EP1034461A4 EP 1034461 A4 EP1034461 A4 EP 1034461A4 EP 98955889 A EP98955889 A EP 98955889A EP 98955889 A EP98955889 A EP 98955889A EP 1034461 A4 EP1034461 A4 EP 1034461A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- transmitter
- position sensor
- respect
- data processor
- vector
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
- A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
- A61B2034/107—Visualisation of planned trajectories or target regions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/37—Surgical systems with images on a monitor during operation
- A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
- A61B2090/3929—Active markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3937—Visible markers
- A61B2090/3945—Active visible markers, e.g. light emitting diodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
- A61B8/4472—Wireless probes
Definitions
- the present invention relates to guidance systems and safety systems • ⁇ associated therewith, and also to methods for their use for guiding the movements of a device towards a target
- the invention is particularly useful in medical applications for guiding the movements of a medical device, such as an aspiration, biopsy needle, or an endoscope, through biological tissue in a body to a target therein, in conjunction with an imaging system, such as ultrasound, CT or
- a position sensor is usually rigidly affixed to the top of the needle, and its absolute position in space is determined
- the part of the body in which the target tissue is located is usually imaged by an imaging system, such as ultrasound, CT, MRI
- the absolute position of the plane displayed by the imaging system can likewise be determined with the aid of a similar position sensor, so 0 that the relative location and orientation of the needle with respect to the target tissue can be calculated
- the most prevalent method for effecting the required measurements is by transmitting a set of signals from a transmitter located at a fixed location in space, which signals are received by a set of sensors mounted on the biopsy needle (or other device being navigated) Both the transmitter and the receiver are linked, in this case, to a separate set of Cartesian coordinates
- the relative position and orientation of the receiver Cartesian coordinates with respect to the transmitter ones is given by a translation vector pointing from the transmitter's to the receiver ' s origin of coordinates and by a three-dimensional rotation matrix
- the transmitter signals received by the receivers are sufficient to determine the components of the said vector and matrix
- the location and orientation of the device can be calculated with respect to the transmitter's coordinates
- signals utilized for this purpose may be light, radio frequency (RF) or low-frequency (LF) electromagnetic waves, etc.
- RF radio frequency
- LF low-frequency
- An object of the present invention is to provide systems, and also methods having advantages in the above respects for guiding the movements of • 4 a device towards a target More particularly, an object of the present invention is to provide systems and methods that may be used for guiding medical devices towards a target in a body, which method and system will produce an indication, more particularly will actuate an alarm, if interfering objects and/or interfering electromagnetic fields are present which might produce measurement errors that
- a system for guiding the movements of a device towards a target comprising transmitter apparatus at a reference location in space for transmitting radiant energy from said reference location, position sensor(s) on said device to be
- said position sensor(s) receiving radiant energy from the transmitter apparatus and producing an output corresponding to the position of said device with respect to said reference location in space, and a data processor receiving the output of said position sensor and calculating the position of said device with respect to said reference location, position sensor(s) on said scanning
- the guiding system is employed with a safety system characterized in that transmitter apparatus includes a first transmitter (T ⁇ and a second transmitter (T 2 ) in a known spatial
- said data processor (a) produces a measurement of the location and orientation of the position sensor with respect to said first transmitter (Tj) and defines same by a first vector
- step (e) compares the output produced in step (e) with a predetermined threshold value, and actuates said alarm if the output produced in step (e) exceeds said predetermined threshold value
- the device is a medical device, more particularly an interventional device such as a biopsy needle, to be guided through the body to a target therein
- An imaging system is provided which scans the body by a scanning device along a plurality of scan lines
- the scanning device also includes a second position sensor receiving radiant energy from the first and second transmitters
- the data processor produces an output corresponding to the position of the second position sensor, and thereby of the scanning device with respect to said known location in space
- the data processor performs said step (a) - (e) also with respect to said second position sensor to produce an output error with respect to the measured vector
- the scanning device is an ultrasound scanner (transducer) and the first and second transmitters are mounted at the opposite ends of an arm having a known length
- the invention also provides methods for guiding the movements of a device towards a target
- the invention also provides apparatus and methods for ensuring the safety of the system by providing redundant transmitters, redundant receivers and/or alternating signaling mechanisms
- the invention also discloses additional guidance systems and apparatus and methods for ensuring the safety of these systems by providing redundant transmitters, redundant receivers and/or alternating signaling mechanisms
- an object of the present invention is to provide systems and methods that may be used for guiding medical devices towards a target in a body, which method and system will produce an indication, more particularly will actuate an alarm, if interfering objects and/or interfering electromagnetic fields are present which might produce measurement errors that could cause serious injury to the patient's body
- Fig 1 picto ⁇ ally illustrates one form of a system constructed in accordance with the present invention for guiding the movements of a device by ultrasound, in this case a medical biopsy needle, towards a target, employing a safety system based on redundant transmitters, where the relative positional relationship between the transmitters is known
- Fig 2 diagrammatically illustrates the various vectors involved in using the system of Fig 1 for guiding the movements of the biopsy needle towards the target
- Fig 3a is a flowchart illustrating Safety Algorithm 11 for the operation of the systems of the present invention
- Fig 3b is a flowchart illustrating Safety Algorithm 12 for the operation of the systems of the present invention
- Fig 3c is a flowchart illustrating Safety Algorithm 13 for the operation of the systems of the present invention
- Fig 3d is a flowchart illustrating Safety Algorithm 14 for the operation of the systems of the present invention
- Fig 3e is a flowchart illustrating the sequential analysis that can be performed on the output of Safety Algorithms 11 , 12, 13 or 14,
- Fig 4 pictonally illustrates one form of a system constructed in accordance with a present invention for guiding the movements of a device by ultrasound, in this case a medical needle, towards a target employing a safety system based on redundant transmitters, where the relative positional relationship between the transmitters is unknown,
- Fig 5a shows the guidance system and safety system of Fig 1 , where the locations of the transmitters and receivers have been switched
- Fig 5b shows the guidance system and safety system of Fig 1 , where the transmitters are replaced by transcievers and the receivers are replaced by reflectors,
- Fig 6 picto ⁇ ally illustrates one form of a system constructed in accordance with the present invention for guiding the movements of a device by ultrasound, in this case a medical needle, towards a target, employing a safety system based on redundant receivers,
- Fig 7 diagrammatically illustrates the various vectors involved in using the system of Fig 6 for guiding the movements of the needle towards the target
- Fig 8a is a flowchart illustrating Safety Algorithm 21 for the operation of the systems of the present invention
- Fig 8b is a flowchart illustrating Safety Algorithm 22 for the operation of the systems of the present invention
- Fig 8c is a flowchart illustrating Safety Algorithm 23 for the operation of the systems of the present invention.
- Figs 9a-9c illustrate various waveforms associated with a safety system based on signal alternating (hopping)
- Fig 10 picto ⁇ ally illustrates a second guidance system constructed in accordance with the present invention for guiding the movements of a device by ultrasound, in this case a medical needle, towards a target,
- Fig 11 a picto ⁇ ally illustrates a third guidance system constructed in • > accordance with the present invention for guiding the movements of a device by ultrasound, in this case a medical needle, towards a target,
- Fig 11 b shows the guidance system of Fig 11a, where the positions of the transmitters and receivers are switched
- Fig 11c shows the guidance system of Fig 11a, where the lo transm ⁇ tter(s) is/are replaced by a transceiver and the rece ⁇ ver(s) is/are replaced by reflectors,
- Fig 12 diagrammatically illustrates the various vectors involved in using the system of Figs 11a-11 c
- Fig 13 picto ⁇ ally illustrates the third guidance system of the present ID invention, employing a safety system based on redundant transmitters,
- Fig 14 diagrammatically illustrates the various vectors involved in using the system of Fig 13 for guiding the movements of the needle towards the target
- Fig 15 picto ⁇ ally illustrates the third guidance system of the present invention, employing an alternate safety system based on redundant receivers
- Fig 16 diagrammatically illustrates the various vectors involved in using the system of Fig 15 for guiding the movements of the needle towards the target
- Fig 17 picto ⁇ ally illustrates the third guidance system of the present invention, employing a safety system based on redundant transmitters and redundant receivers
- FIG 1 shows the invention of the present application embodied in an ultrasound imaging system based on the guidance system described in the above-cited Patent Application PCT/IL96/00050, hereby incorporated by reference (also referred to herein as a first guidance system), in an operating area 1 , for guiding a biopsy needle 2 through a body 3 to a target 4 within the body
- the body 3, the needle 2, and the target 4 are all imaged by an ultrasound transducer (scanner) 5, or other similar scanning device, connected to a data processor 6 which produces an image of the target 4 on a display screen 7
- the needle 2 includes a position sensor 8, typically a receiver (R n ), at a predetermined location on the needle 2
- the ultrasound transducer 5 also includes a position sensor 9, typically a receiver (R u ), at a predetermined
- Transmitter apparatus transmits radiant energy, preferably in signals, such as light, magnetic or electromagnetic radiation at frequencies ranging from approximately DC to approximately high frequency, to the two position sensors 8 and 9
- the two position sensors 8 and 9 receive this radiant energy from transmitter apparatus 10, preferably including two transmitters 10a, 10b (Ti T 2 ), also known as transmitter units, and produce outputs corresponding to the positions of the needle 2 and the transducer 5, respectively, with respect to a reference location in space occupied by the transmitter apparatus 10
- Data processor 6 receives the information from the transmitter apparatus 10, the needle position sensor 8, and the transducer position sensor 9 It processes this data and displays on the display screen 7 the expected position and trajectory of the needle 2 with respect to the target 4, thereby aiding the physician to guide the movement of the needle 2 towards the target 4
- the transmitter apparatus 10 includes a single transmitter, such as described in U S Patent 4,945,305 (Blood), for transmitting the signals to position sensor 8 on the needle 2, and to position sensor 9 on the transducer 5
- the position of the transmitter serves as a reference in space for the two position sensors
- interfering objects and/or interfering fields such as electromagnetic fields
- the system illustrated in Fig 1 includes an arrangement which is effective to alert the physician, e g by the actuation of an alarm 18, in the event that there are interfering objects or interfering fields in the immediate vicinity which could produce measurement errors of a magnitude that could cause injury to the patient, so that the physician will not rely on the displayed measurements until the interfering objects are removed
- the transmitter apparatus 10 preferably includes two transmitters 10a, 10b (Ti and T 2 ), also known as transmitter units, one
- Arm 11 is supported on a
- the two transmitters 10a, 10b are both oriented in arbitrary directions; that is, the two sets of Cartesian coordinates to which the two transmitters are linked may be parallel or non-parallel to each other.
- the safety system detailed in Figs. 1 and 2 is based on transmitter redundancy and the position of each receiver is measured relative to the position of each transmitter unit, the positions of the transmitter units being reference positions.
- the length of arm 11 is preferably from 0.1 to 1.0 meters, most preferably about 35 cm.
- Fig. 2 illustrates the location and orientation of transmitter 10b (T 2 ) from
- orientation of position sensor 8 on the needle 2 is represented by a first vector d n with respect to transmitter Ti, and by a second vectoriser , 2 with respect to
- ultrasound transducer 5 is represented by a third vector u ,,with respect to
- transmitter Ti and by a fourth vector d u t2 , with respect to transmitter T 2 .
- ultrasound transducer position sensor 9 with respect to transmitters 10a and 10b (Ti and T 2 ) respectively, also continuously change with the movement of the
- the output of the position sensors 8, 9 and data for the transmitter apparatus 10 are communicated in any suitable manner, e.g. by wired or wireless links 14, 15, 16, 17 respectively, to the data processor 6. Based on the data received therefrom, the data processor 6 measures the position of the sensors 8, 9 with respect to the transmitters 10a, 10b (T-, and T 2 ).
- the data processor 6 processes the inputted data to calculate, and display the expected trajectory of the needle 2 towards the target 4 on the display screen 7, in the manner described in the above-cited Application PCT/IL96/00050.
- data processor continuously performs additional operations, preferably in the form of Algorithms 11 , 12, 13 and 14, detailed immediately below, and illustrated in Figs. 3a-3c, constituting an error-analysis procedure.
- the purpose of the error-analysis procedure is to alert the physician, as by actuating an alarm 18 (Fig. 1), should there be in the immediate vicinity interfering objects which might produce measurement errors which could lead to injury to the patient should the physician rely on these calculations and on the display on screen 7 for guiding the needle to the target.
- the vector f n can be determined by a mechanical measurement. It can
- a needle containing a position sensor attached to its tip may be placed in an environment free of interference, and the position of the sensor may then be measured with respect to the coordinates linked to transmitters 10a and 10b (Ti and T 2 ).
- the actual measurement may be by optical means, e.g. lasers, or any other known method for measuring position.
- block 120 illustrated in Fig. 3a (generally measured off-line) is the starting state of the error-analysis procedure performed by data
- the data processor 6 to define the vector f .
- the data processor first measures the
- a computation is made as to the larger of the two errors, determined in blocks 124 and 128, respectively.
- the larger of the two errors, defined by En is then subject to a one step analysis or a sequential analysis in block 130 (detailed in Fig. 3e).
- the one step analysis consists of comparing En with a threshold Thn, (a maximum permissible error) (block 131), which, if exceeded, actuates alarm 18 (block 132). This alerts the physician that the calculations and display on screen 7 are not to be relied upon because of the errors produced by the intervening objects.
- the data processors calculates the location of the needle position sensor 8 relative to ultrasound transducer position sensor 9, in block 143 is as follows:
- cC,n [M u , ⁇ ] • ⁇ djr ⁇ - d-T ⁇ ⁇ (Eq. 4)
- the data processor calculates in block 146 the location of the needle position sensor 8 relative to ultrasound transducer position sensor 9 defined as d n u T2 based on measurements made relative to T 2 , as in blocks 144 and 145 (similar to blocks 122 and 126 respectively).
- the value E 12 can then be processed in the same manner as En in Fig.
- Algorithm 13 does not require knowing the relative spatial relationship between the transmitters 10a, 10b.
- Algorithm 13 is similar to Algorithm. 12, except it is based on calculating the position of the needle tip 2' (referred by subscript "nt") relative to the
- steps shown as blocks 161 , 162, corresponding to those detailed as blocks 141 and 142 (Fig. 3b above) are performed.
- the data processor 6 calculates the position of the needle tip 2' with respect to the ultrasound transducer position sensor, based on Ti transmissions, block 163, as follows:
- nTu, ⁇ [Mu. ⁇ ] * ⁇ cC ⁇ - ⁇ ⁇ + [M n , T1 ] T * ⁇ U ⁇ (Eq. 6)
- the data processor calculates in block 166, the position of the needle tip 2' with respect to the ultrasound transducer position sensor 9, defined as d nt
- the difference between the two vectors, defined as E 13 is then calculated in block 167 as follows:
- E1 3 can then be processed in the same manner as En or E 12 in Figs. 3a and 3b above.
- a variation to Algorithm 13 can be made by employing in Eq. 6 a vector other than L n .
- Algorithm 14 shown by a flowchart in Fig. 3d, is a variation to Algorithm 11. It begins with the steps detailed as blocks 120-122 as detailed for Algorithm 11 above.
- the data processor 6 then calculates, based on the measurements made in blocks 121 and 122, the orientation matrix of the transmitter 10b (T 2 ) with respect to the other transmitter 10a (Ti) in block 173, and defines this orientation
- Measurements in accordance with blocks 125 and 126 are then performed, whereby these measurements are used to calculate the orientation matrix, [M T2 Tl ]" m , in block 177.
- This value for the orientation matrix is then compared with the known orientation matrix, [M ⁇ 2 , ⁇ ], in block 178, resulting in output E 142 (similar to the calculation made in block 174 above).
- the maximum for the values E 14 ⁇ and E ⁇ 42 is calculated in block 179, and defined as E .
- the value E can then be processed in the same manner as En or E 12 in Figs. 3a and 3b above. It must be emphasized that in most cases Algorithm 13 and its proposed variations are preferred, since they are based on the same parameters as the guiding calculation (the needle tip 2' relative to the ultrasound imaging target 4).
- a variation to the transmitter redundancy Algorithms 12 and 13 can be based on making the same measurement by N transmitter units, where N>2 and
- the data processor 6 checks that more than P (an integer greater than N/2) of the measurements made relative to different transmitter units are in accord in order to clear the measurement.
- Fig 3e is a flowchart illustrating sequential analysis (see block 130 of Figs 3a-3d)
- the input to the sequential analysis can be the output of any of Algorithms 11 , 12, 13 or 14, and/or other Algorithms detailed herein (together all separately)
- the values monitoring measurement errors, such as En (block 181a), E 12 (block 181b) etc can be subject to a sequential analysis together or separately as desired by enabling the register switches Sn, S ⁇ 2 , S ⁇ 3 , etc , with the requisite switch Sn, S ⁇ 2 , enabled
- the enabled values are stored in a buffer 183 and then they are subjected to one of the following analysis
- Fig. 4 is similar to the guidance and safety system shown and described in Fig. 1 , except the transmitters 10a (Ti) and 10b (T 2 ) are not necessarily in a known spatial relationship.
- the vector diagram for the safety system would be in accordance with that shown and described for Fig. 2. Algorithms 12, 13, or variations thereof can be employed with the safety system and method for its use.
- Fig. 5a is similar to the guidance and safety system shown and described in Fig. 1 , except the positions of the transmitters Ti and T 2 and receivers 8 (R n ), 9 (R u ) have been switched.
- the receivers 8', 9' (Ri, R 2 ) (in accordance with receivers 8, 9 detailed in Fig. 1 above) are located on reference positions, and the transmitters 10a', 10b' (T u and T n ) (in accordance with transmitters 10a and 10b detailed in Fig. 1 above) are affixed to the ultrasound transducer 5 and on the needle 2, respectively.
- a system comprising only the receiver 9' (Ri) and transmitters 10a', 10b' (T-i, T 2 ) as illustrated in Fig.
- Fig. 5b is similar to the guidance and safety system shown and described in Fig. 1 , except, the transmitter apparatus is replaced by transceivers 20a, 20b (TR.,, TR 2 ), typically formed of a transmitter unit coupled with a receiver, and the receivers are replaced by reflectors 21 (RLJ mounted on the needle 2,
- Fig 6 illustrates a second safety system based on receiver redundancy, to be employed with the first guidance system as disclosed in our PCT IL/96/00050
- the apparatus of the invention would be modified slightly as follows
- the transmitter apparatus 10 would include only a single transmitter unit 10a (T,),
- the ultrasound transducer 5 or both would have an additional sensor receiver (redundant) It is preferred that the sensors (one sensor being redundant) be spaced as far apart as possible and at different orientations on the device to maximize the probability that any interference will affect each individual sensor 8, 9 (on the needle 2 and ultrasound transducer 5) differently
- control position sensor(s) 23a, 23b typically receivers RC a .
- control position sensors 23a, 23b would function only to monitor any interference, described above and are placed as a group of sensors with known or fixed positional relationship to each other Additionally, a reference control position sensor 24 typically a receiver R ref (in accordance with those
- the safety system based on receiver redundancy to be employed together with said first guiding system can be based on one or more of the above receiver arrangements, and it is not necessary to implement all of the above together
- control sensors 23a, 23b (receivers) (if employed) and the reference sensor 24 (receiver) (if employed) are connected by wireless or wired connections 14, 16, 17, 25, 26 (detailed above) to the data processor 6
- the data processor 6 then processes the received data, from the sensors 8, 9, 23a, 23b, 24 and transmitter unit 10a (TJ, in accordance with any one of Algorithms 21 , 22 or 23 (below), such
- Fig 7 diagrammatically illustrates the various vectors involved in using the guidance system and safety system detailed in Fig 6
- Algorithms 21 , 22 and 23 as employed with the safety system detailed in Fig 6 are as follows Algorithm 21
- Algorithm 21 is based on the assumption that the relative position between two receivers is known It can be applied to any pair of receivers placed at a known and fixed spatial relationship, such as a pair of sensors 8 (R na , R nb ) (receivers) affixed on the needle 2, and/or a pair of sensors 9 (R ua , R ub ) (receivers) affixed on the ultrasound transducer 5, and/or a pair of control sensors 23a, 23b (RC a , RC b ) (receivers), all of these receiver pairs generally referenced below (in the Algorithm) as R a and R b
- the vector between a pair of position sensors can be determined (ap ⁇ o ⁇ ) by a mechanical measurement It can also be determined by measurement in an interference-free environment
- the actual measurement may be by optical means, e g lasers, or any other known method for measuring position
- Algorithm 21 is as follows For this algorithm, block 220 illustrated in Fig 8a (generally measured off-line) to define the vector between the two position sensors is the starting state of the error-analysis procedure
- the data processor measures the position of receiver R a with respect to transmitter unit Ti (block 221), and defines same as the location vector d Ra ⁇ and orientation matrix M Ra ⁇ I then measures the position of receiver R b with respect to transmitter unit Ti, and defines same (block 222) as location vector d Rb T ⁇ and orientation matrix M Rb - ⁇
- the data processor calculates in block 224 from d Ra ⁇ and M Ra ⁇ and d R T ⁇ and M Rb T ⁇ a measured vector (d Rb a )m between the two receivers R a and R b It compares the measured vector (d Rb Ra ) m with the known vector (d Rb Ra ) between the two receivers and produces an output, E 2 ⁇ , in block 226, relative to the difference between them
- Algorithm 22 can be applied whenever a reference control position sensor 24 (R ref ) is placed a known and a fixed position with respect with respect to transmitter 10a (T-i)
- the actual position of the control position sensor R ref with respect to the transmitter T ⁇ defined as the location vector d Rre f ⁇ , and orientation matrix M Rr ⁇ f ⁇ , can be determined in block 240 similarly to that for the value T 12 for Algorithm 11 or the value d Rb Ra for Algorithm 21
- the data processor measures the position of receiver R re f with respect to transmitter unit Ti in block 241 , and defines the same as location vector (d Ref ⁇ )m and orientation matrix [M Re f ⁇ ]m
- the measured value (vector) (d Re f ⁇ )m is compared with the known vector d Re f ⁇ , m block 244, to produce an output relative to the difference between them defined as E 221
- the measured orientation matrix [M Ref ⁇ ] m is then compared to the known orientation matrix M Ref ⁇ in block 246 to produce an output relative to the difference between them, defined as E 222
- This algorithm can be implemented whenever there are at least two
- receivers 8 (R na and R n b )(one of them redundant) affixed to the needle and/or two
- the data processor measures the position of receiver R na with respect
- the data processor measures the position of receiver R ua with respect
- I transmitter 10a (T-,), and defines same as d Rn t, T1 and M n t > ⁇
- the data processor compares in block 268 the calculated vectors 0 d nt u ,P a ⁇ r ( R na R ua) and d nt ⁇ U ⁇ Pa ⁇ r(Rnb Rua) , and produces an output E 23 as follows
- E 23 l
- the value E 23 can then be processed in the same manner as the En in Fig 3a
- a variation to Algorithm 23 is based on making the same measurement relative to N position sensors placed on the said (guided) device, N > 2, ⁇ o (preferably odd number) In this case the algorithm checks that more than P (an integer greater than N/2) of the measurements made relative to different position sensors are in accord (in accord defined as within a certain predefined margin) in order to clear the measurement
- the redundant receivers for the safety system above can be employed with the guidance system detailed in Fig 5a
- the rece ⁇ ver(s) serves as the reference position
- Further implementation of the system includes the addition of 0 redundant transmitters on the needle 2 and/or the ultrasound transducer 5
- This safety system can employ Algorithm 23 as detailed above
- redundant transceivers for the safety system above can be employed with the guidance system detailed in Fig 5b
- the transce ⁇ ver(s) serve as the reference position
- Further implementation of the system includes the addition of redundant reflectors on the needle 2 and/or the ultrasound transducer 5
- This safety system can employ Algorithm 23 as detailed above
- Another safety system to be employed together with the first guidance system (disclosed in PCT/IL96/00050) (and the guidance systems detailed below), could be transmission/signal/frequency alternating (hopping)
- transmitter T-i can be altered, as illustrated in Fig 9a, and described as follows
- Cycle K the transmitter T ⁇ emits first
- Cycle K + 1 the transmitter Ti, emits from antennae X
- the data processor 6 measures the needle tip 2' with respect to the ultrasound position sensor 9 according to measurements made in Cycle K and defines the same as d nt u cy c l e K
- the data processor measures the needle tip 2' with respect to the ultrasound position sensor 9 according to measurements 0 made in Cycle K + 1 and defines the same as d n t u cy c ie ⁇ + ⁇ It then compares d ⁇ tu cy c le K and dnt u cy c le ⁇ + ⁇ and then produces an output equal to the difference between the two measurements, defined as E s1 , whose value can then be processed in the same manner as the value En m Fig 3a
- U S Patent No 4,945,305 (Blood) describes both types of measurement cycles, however as separate implementations of the positioning system and not in a possible combined system in order to monitor measurement errors caused by interference Another safety system, based on signal alternation to be
- the transmitter as detailed in the '305 (Blood) patent, emits different pulse shapes and/or pulse lengths in consequent measurement cycles, e g ,
- Cycle K and Cycle K+1 Data processor 6 calculates d n t u cycie K and d n t u cycie ⁇ +1 (both defined above) The measurements made in the two cycles should be differently affected by interfering objects and/or interfering electromagnetic fields The data processor 6 then compares the above measurements and produces an output equal to them, defined as E s2 , whose value can then be processed in the same manner as the En in Fig 3a
- the transmitter emits on different frequency carriers on consequent measurement cycles (frequency hoping)
- the measurements made in the two cycles should be differently affected by interfering objects and/or interfering electromagnetic fields Therefore, the data processor can compare between the measurements and produce an output equal to the difference between the two measurements, defined as E s3 , whose value can then be processed in the same manner as the value En in Fig 3a
- An additional safety system to be employed with said first guidance system when using positioning systems as described in the '305 (Blood) patent, and the '881 (Raab) and '521 (Raab) patents, can be made by checking the unita ⁇ ty of matrix A, this matrix A being the receiver attitude matrix in the '305 patent Accordingly, the data processor calculates
- mat ⁇ x_norm stands for matrix norm
- ⁇ max (A T* A), ⁇ m ⁇ n (A ⁇ *A)
- E un ⁇ or E un2 can then be processed in the same manner
- Fig 10 is directed to a second guidance system More particularly, it is directed to provide a second guidance system and method that may be used for guiding medical devices towards a target in a body
- This second guidance system and alternates, detailed above, can have its receivers and transmitters arranged such that a positioning and tracking system is defined
- receivers and transmitters could be modified such that the desire positioning and tracking system are magnetic, acoustic, or electro-optical or combination thereof (in addition to that detailed above), in accordance with PCT/IL96/00050
- the arm 30 is mechanically calibrated to the reference position, such that its movements, including those of the needle 2, are sent to the data processor 6, by wired or wireless connections as detailed above
- This enables the data processor 6 to measure the position of the needle with respect to the reference position
- the data processor 6 calculates from these measurements, the position of the needle 2 with respect to the ultrasound imaging plane
- the expected trajectory of the needle 2 with respect to the target 4 is now viewable on the display screen 7, thereby aiding the physician to guide the movement of the needle 2 toward the target 4
- This second guidance system and alternates may also be employed together with other scanning apparatus such as computerized tomography, X - ray, as detailed in the above cited PCT/IL96/00050 All the above safety systems, as described in connection with the first guidance system, can be employed with this second guidance system
- a safety system based on redundant transmitters is formed when a second transmitter (T 2 ) is placed on the stand 32
- T 2 second transmitter
- safety systems would have vector diagrams in accordance with that detailed in Fig 2 above, and could employ any of the safety algorithms, detailed as Algorithms 11 , 12, 13 and 14 above
- two or more, position sensors, receivers could be placed on the ultrasound transducer 5, or control position sensors (23a, 23b and 24 as shown in Fig 6) could be placed in the operating area 1 , as described above for Fig 6, resulting in receiver redundant safety systems, in accordance with those described above
- receiver redundant safety systems would have vector diagrams in accordance with that detailed in Fig 7 above, and could employ any of the safety Algorithms, detailed as Algorithms 21 , 22 and 23 above
- Safety systems based on signal alternating as described above can also be employed together with these second types of guidance systems
- An alternate guidance system based on that shown in Fig 10, is formed when the needle 2 is free and the ultrasound transducer 5 is mounted on the articulated arm 30 and stand 32, as detailed above
- the needle 2 includes a sensor 8, preferably a receiver (RJ , attached thereto, and the stand 32 includes a transmitter (TJ, attached thereto, as detailed above, both the sensor 8 and Transmitter (TJ communicating with the data processor 6 by wired or wireless links, detailed above All above variations to the second guidance system apply to D this type of system also
- Fig 11a is directed to a third guidance system More particularly, it is directed to provide a third guidance system and method that may be used for guiding medical devices towards a target in a body
- This third guidance system differs from the first and second guidance o systems detailed above, in that it directly measures the position of the needle 2 with respect to the ultrasound transducer 5 without employing an additional reference location in space (In the first and second guidance systems, the position of the needle 2 and the position of the ultrasound transducer 5 are first measured, relative to a reference position in space From these two s measurements, the relative position of the needle 2 with respect to the ultrasound transducer 5 is calculated, as detailed above and in PCT/IL96/00050 )
- This third guidance system includes a position sensor 8, typically a receiver (R) attached to the needle 2, as detailed above and a transmitter 10b' (T) (in accordance with transmitter 10b detailed in Fig 1 above), affixed to the o ultrasound transducer 5
- the position sensor 8 and the transmitter 10b' (T) communicate with the data processor 6 by wired or wireless links 16, 35, as detailed above
- This third guidance system and alternates may also be employed together with other scanning apparatus such as computerized tomography, X -
- This third guidance system and alternates, detailed above, can have its receivers and transmitters arranged such that a positioning and tracking system is defined These receivers and transmitters could be modified such that the desire positioning and tracking system are magnetic, acoustic, or electro-optical or combination thereof (in addition to that detailed above) in accordance with PCT/IL96/00050
- Fig 11 b shows an alternate system to that shown in Fig 11a
- the positions of the receiver R and transmitter T have been switched on the needle 2 and ultrasound transducer 5 respectively
- Fig 11c shows an alternate system to that shown in Fig 11a
- the transmitter 12 has been replaced by a transceiver 20' (detailed above), and the receiver has been replaced by reflectors 21
- the transceiver is positioned on the needle 2 and the reflectors 21 are positioned on the ultrasound transducer 5
- Fig 12 shows a vector diagram guidance calculation performed for the system of Fig 11a, that could be modified in accordance with the principles therewith, so as to be applicable to Figs 11b and 11c and alternates thereto
- Fig 13 shows a safety system based on redundant transmitters
- This safety system is used in conjunction with the third guidance system as a sensor 8, typically a receiver R, is on the needle 2 and at least two, preferably two, transmitters 10b' Cn, T 2 ) are on the ultrasound transducer 5, such that one of the transmitters is "redundant" (as detailed above) All transmitters and receivers would communicate with the data processor 6 by wired or wireless communications, as detailed above Alternately the transmitters (T 1 ⁇ T 2 ) could be on the needle 2 and the sensor (receiver) 8 on the ultrasound transducer 5
- These transmitter redundant safety systems could employ any of the safety algorithms detailed as Algorithms 11 , 12, 13 or 14 above, with the necessary adjustments to account for the changes in vectors
- Fig 14 shows a vector diagram for the system of Fig 13 This diagram could be modified in accordance with the principles therewith, so as to be also applicable to the alternates thereto Fig 15 details a safety system employing redundant receivers It is
- receiver redundant safety systems could employ any of the safety algorithms detailed as Algorithms 21 , 22 or 23 above, with the necessary modifications that account for the changes in vectors
- Fig 16 shows a vector diagram for the receiver redundant system detailed in Fig 15 above
- Fig 17 details a safety system employed with the third guidance system that is both transmitter and receiver redundant
- a position sensor 8 typically a receiver (R n ) as detailed above, and a transmitter 10a' (T n ) (in accordance with transmitter 10a detailed in Fig 1 above) are on the needle 2, and a position sensor 9, typically a receiver (R u ), as detailed above, and a transmitter 10b' (T u ) are on the ultrasound transducer 5 All transmitters and receivers would communicate with the data processor 6 by wired or wireless communications, as detailed above
- safety systems with both redundant transmitters and redundant receivers are permissible to form the safety system for use with the above detailed second and third guidance systems
- Safety systems based on signal alternating as described above can also be employed together with these third types of guidance systems.
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IL12233697A IL122336A0 (en) | 1997-11-27 | 1997-11-27 | System and method for guiding the movements of a device to a target particularly for medical applications |
IL12233697 | 1997-11-27 | ||
PCT/IL1998/000578 WO1999027837A2 (en) | 1997-11-27 | 1998-11-26 | System and method for guiding the movements of a device to a target particularly for medical applications |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1034461A2 EP1034461A2 (en) | 2000-09-13 |
EP1034461A4 true EP1034461A4 (en) | 2002-01-23 |
Family
ID=11070902
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP98955889A Withdrawn EP1034461A4 (en) | 1997-11-27 | 1998-11-26 | System and method for guiding the movements of a device to a target particularly for medical applications |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP1034461A4 (en) |
JP (1) | JP2001524339A (en) |
AU (1) | AU1257599A (en) |
IL (1) | IL122336A0 (en) |
WO (1) | WO1999027837A2 (en) |
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Also Published As
Publication number | Publication date |
---|---|
IL122336A0 (en) | 1998-04-05 |
WO1999027837A3 (en) | 1999-07-22 |
JP2001524339A (en) | 2001-12-04 |
AU1257599A (en) | 1999-06-16 |
WO1999027837A2 (en) | 1999-06-10 |
EP1034461A2 (en) | 2000-09-13 |
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