JP2001524339A - System and method for directing operation of a device, particularly to a medical target - Google Patents

Abstract

(57) Abstract A system and method are provided for guiding device operation to a medical target in particular. In one aspect of the invention, the system guides movement of the device relative to a target viewed as an image. The system includes at least one scanning device for forming an image including the target, at least one transmitter at a first reference position for transmitting radiant energy from the reference position, several position detectors, and A data processing device is included. The position detector includes at least one position detector in an instrument for receiving radiant energy, at least one position detector in a scanning device for receiving radiant energy, and radiant energy in either the device or the scanning device. At least one position detector for receiving the position information. The data processing device is in operative communication with the transmitter and each position detector to monitor the accuracy of the instrument's calculated position relative to the scanning device.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] Technical Field The present invention relates to the induction system and the safety system, in which further relates to a method of their use for inducing device operation with respect to targets. The present invention connects to an imaging (image forming) system such as ultrasound, CT, or MRI to perform suction of a target in the body through a living tissue, operation of a biopsy needle, an endoscope, and other medical devices. It is particularly effective for medical use such as guidance.

BACKGROUND guidance system invention, for medical as its object to induce various types of medical devices (e.g., aspiration and biopsy needle, an endoscope, etc.) towards a specific target of the body Used for For example, when guiding a biopsy needle, usually a position sensor is attached to the top of the needle to determine its absolute position in space. The part of the body where the target tissue is located is imaged by an imaging system such as ultrasound, CT, MRI. The absolute position of the plane displayed by the imaging system can be similarly determined by the position sensor, so that the relative position and orientation of the needle with respect to the target tissue can be calculated. Once these values have been determined, the expected path of the needle towards the target to allow the physician to determine the direction of the biopsy needle (or other medical device) towards the target. Can be calculated and displayed as an image. Such a hybrid instrument that uses ultrasound images for guidance is described in patent application PCT / IL96 / 00050 (published February 6, 1997; incorporated herein by reference). It has been disclosed. In such cases, the position and direction of the ultrasound scan plane is measured by a sensor mounted on the ultrasound transducer.

[0003] The most common way to achieve the required measurements is by transmitting a set of signals from a transmitter located at a fixed location in space, the signals being transmitted by a biopsy. It is received by a set of sensors attached to the needle (or other device to be guided). In this case, each of the transmitter and the receiver is associated with an individual set of rectangular coordinates. The relative position and orientation of the receiver's Cartesian coordinates relative to the transmitter's Cartesian coordinates are given by the motion vector from the transmitter Cartesian coordinate origin to the receiver Cartesian coordinate origin and by a three-dimensional rotation matrix. . The transmitter signal received by the receiver is sufficient to determine the components of the vector and matrix. Therefore, the position and direction of the device with respect to the rectangular coordinates of the transmitter can be calculated. The signals used for this purpose are light, high frequency (RF) or low frequency (LF) electromagnetic waves, and the like.

[0004] The foregoing method is unstable with respect to measurement errors caused by obstacles and / or interfering electromagnetic fields present near the receiving sensor. In the case of medical intervention procedures, such measurement errors can cause irreparable harm to the patient's body and must be prevented.

[0005] disclosure purposes of the present invention the invention is to provide a an effective system and method to induce the operation of the device towards the targets described above. In particular, it is an object of the present invention to provide a system and method used to guide a medical device toward a target within the body, the system and method providing instructions, i.e., critically affecting the patient's body. Activate an alarm when there are obstacles and / or interfering electromagnetic fields that cause measurement errors that can cause serious harm.

In one aspect of the present invention, a system for directing movement of a device toward a target, comprising: a transmitter at a reference position for transmitting radiant energy from a reference position in space; A position sensor in a device guided toward an object, the position sensor receiving radiant energy from a transmitting device to generate an output corresponding to the position of the device with respect to a reference position in space, and receiving an output of the position sensor. A data processing device for calculating the position of the device with respect to a reference position, and a position sensor in the scanning device for scanning a target, wherein the position of the scanning device with respect to the reference position in space receiving radiant energy from a transmitting device A position sensor that produces an output corresponding to the position sensor, and receives the output of the position sensor to calculate the position of the device relative to a reference position. And a data processing device for calculating the position of the guided equipment with respect to the scanning plane / imaging plane. Such a system is disclosed in our patent application PCT / IL96 / 00050, which is hereby incorporated by reference and which is referred to as the first guidance system.

[0007]

[Outside 3]

(A) measuring the position and orientation of a position sensor with respect to a first transmitter (T1), also defined by a first vector, (b) a second, similarly defined by a second vector Measuring the position and direction of the position sensor with respect to the transmitter (T2) of (c), and calculating a measurement vector (→) (T ₁₂ ) _m between the two transmitters from the first vector and the second vector. (D) comparing the known vector (→) (T ₁₂ ) with the measured vector (→) (T ₁₂ ) _m, and (e) measuring the measured vector (→) (T ₁₂ ) _m with the known vector (→) An output corresponding to the absolute value of the difference from (T ₁₂ ) is generated.

According to still further features in the described preferred embodiments the data processing device includes an alarm and compares the output produced in step (e) with a predetermined threshold. Activate the alarm when exceeding.

[0010] According to still further features in the described preferred embodiments the device is a medical device, and in particular an interventional device such as a biopsy needle guided through the body to a target in the body. In. An image forming system is prepared for scanning a body with a scanning device along a plurality of scan lines. The scanning device includes a second position sensor that receives radiant energy from the first and second transmitters. The data processing device produces an output corresponding to the position of the second position sensor relative to a known position in the space, ie, the position of the scanning device. The data processing device may perform the step (a) with respect to the second position sensor.
) To (e) to produce an output error for the measurement vector (→) (T ₁₂ ) _m for the scanner and to activate the alarm in comparison with a predetermined threshold. Use the one with the larger error.

According to still further features in the described preferred embodiments, the scanning device is an ultrasound scanner (transducer) and the first and second transmitters are vectors known in space (→) ( attached to opposite ends of the arm having a known length and direction defined by T _12).

[0012] The present invention also provides a method for directing operation of a device toward a target.

The present invention provides redundant (redundant) transmitters, redundant receivers and / or alternate communication mechanisms.
(Alternating signaling mechanisms) Provided are an apparatus and a method for ensuring system security by providing (alternating signaling mechanisms).

The present invention discloses additional guidance systems, devices and methods for ensuring system security by providing extra transmitters, extra receivers, and / or alternate communication mechanisms.

In particular, it is an object of the present invention to provide a system and method for use in directing a medical device to a target within the body, the system and method providing instructions, ie, providing a patient with Activate an alarm when there are obstacles and / or interfering electromagnetic fields that cause measurement errors that can cause serious harm to the body.

[0016] Further features and advantages of the present invention will become apparent from the following description.

DESCRIPTION OF THE PREFERRED EMBODIMENT The system shown in FIG. 1 is described in patent application PCT / IL96 / 00050 (herein incorporated by reference and hereby referred to as the first guidance system). 1 shows an embodiment of an ultrasonic imaging system according to the present invention based on the guidance system described in (1), for guiding a biopsy needle 2 through a body 3 to a target 4 in the body in an operation area 1. The body 3, the needle 2 and the target 4 are connected to an ultrasound transducer (scanner) 5 (or other similar scanning device) connected to a data processing device 6 that produces an image of the target 4 on a display screen 7. ) Are all imaged.

A safety system based on two or more transmitters (at least one of these transmitters being “redundant” or additional) is incorporated into the first guidance system. The needle 2 has a position sensor 8 (usually a receiver (R _n )) at a predetermined position. The ultrasonic transducer 5 has a position sensor 9 (usually a receiver (R _u )) at a predetermined position.

The transmitter, designated 10, transmits radiant energy, such as optical, magnetic or electromagnetic radiation, to the two position sensors 8, 9 in the frequency range, generally from DC to higher frequencies, preferably by signal. Send. The two position sensors 8 and 9 comprise a transmitter 10 (preferably two transmitters 10a, 10b (also known as transmitter units).
T ₁ , T ₂ )) receives radiant energy and produces an output corresponding to the position of each of the needle 2 and the transducer 5 relative to a reference position in the space occupied by the transmitting device 10.
The data processing device 6 receives information from the transmitting device 10, the needle position sensor 8, and the transducer position sensor 9. The data processing device processes the data and displays the data on the display screen 7.
Displays the expected position and trajectory of the needle 2 with respect to the target 4, thereby assisting the physician in guiding the movement of the needle 2 toward the target 4.

Further details of the construction and operation of the system in FIG. 1 as well as another similar system that can be used are disclosed in patent application PCT / IL96 / 00050, which is hereby incorporated by reference. Part).

In the system described in PCT / IL96 / 00050, a single transmitter is included in the transmitter 10 for sending signals to the position sensor 8 of the needle 2 and for transmitting to the position sensor 9 of the transducer. (See U.S. Pat. No. 4,945,305 (Blood)). Transmitter position is 2
Serves as a reference in space for one position sensor.

As mentioned above, obstacles and / or interfering fields such as electromagnetic fields in that area (especially in the vicinity of the position sensors 8, 9) cause measurement errors, which in the guidance of the needle 2 cause the physician to Can be seriously harmful to patients. Thus, in the system of FIG. 1, a physician is alerted (eg, by activating alarm 18) when there are nearby obstacles or interference fields that cause significant measurement errors that could harm the patient. A valid device is included so that the physician does not rely on the displayed measurements until the obstacle is removed.

For this purpose, the transmitting device 10 preferably comprises two transmitters 10 a, 10 b (T ₁ and T ₂ ), known as transmitter units, one being “extra”
That is, they are additive and are each located at opposite ends of an arm 11 having a known spatial relationship defined by a vector (→) T ₁₂ .
The arm 11 is supported by a stand 12 installed on a base 13.

In the example shown, the two transmitters 10a, 10b (T ₁ , T ₂ ) are in any direction, so that the two sets of Cartesian coordinates associated with the two transmitters are parallel to each other,
Alternatively, they may be non-parallel. As shown in FIG. 2, apart from the origin of the coordinate is indicated by known fixed vector (→) T _12, it is determined by the configuration of the device is therefore capable already known or previously measured. The security system shown in FIGS. 1 and 2 is based on the redundancy of the transmitters, and the position of each receiver is measured relative to the position of each transmitter unit (the position of the transmitter unit is a reference position). ).

The arm 11, the fixed vector (→) T _12, is large enough to increase the effect of the error, and if such occurs due to the presence of obstacles or interference fields, the device is relatively small. So it should be short enough. For the application described here, the length of the arm 11 is preferably between 0.1 and 1.0 m (most preferably about 35 cm).

In FIG. 2, the position and direction of the transmitter 10b (T ₂ ) from the transmitter 10a (T ₁ ) are indicated by a known vector (→) T ₁₂ . The direction and position of the position sensor 8 of the needle 2 is represented by a first vector (→) d _{n, t1} for the transmitter T _{1 and} a second vector (→) for the transmitter T ₂ . ) D _{n, t2} . Similarly, the position and orientation of the position sensor 9 of the ultrasonic transducer 5, the third for the transmitter T ₁
Is represented by the vector (→) d _{u, t1,} with respect to the transmitter T ₂ represented by a fourth vector (→) d _{u, t2.}

The position of the tip 2 ′ with respect to the needle position sensor 8 is indicated by (→) L _n , and the position of the tip with respect to the ultrasonic position sensor 9 is indicated by (→) d _{nt, u, Ti} i = 1,2. represented (where the index T _i indicates that the measurement is performed by the transmitter T ₁ or T _2).

Arm 11 supporting _two transmitters 10a, 10b (T ₁ , T ₂ ) at opposite ends
Is fixed in space, the vector (→) T ₁₂ (previously known as described above) indicating the position and direction of the transmitter T ₂ with respect to the transmitter T ₁ is fixed during operation of the system. It has been done. However, when the needle 2 is handled in the operation of the system, first and second vectors (→) d _{n, t1} and () representing the position and orientation of the needle sensor 8 with respect to each of the _two transmitters T ₁ and T _2. →) d _{n, t2} changes continuously with the movement of the needle. Similarly, third and fourth vectors (→) d _{u , t 1} and (→) d representing the position and direction of the position sensor 9 of the ultrasonic transducer with respect to each of the transmitters 10 a and 10 b (T ₁ and T ₂ ). _{u and t2} change continuously with the movement of the ultrasonic transducer 5.

The outputs of the position sensors 8, 9 and the data for the transmitting device 10 are communicated to the data processing device 6 by any suitable method (eg, each of wired or wireless 14, 15, 16, 17). Based on the data received therefrom, the data processing unit 6 measures the position of the transmitter 10a, the sensor 8, 9 for 10b (T ₁ and T _2).

The data processing device 6 processes the input data for calculation, and processes the above-mentioned patent application PCT /
The expected trajectory of the needle 2 toward the target 4 is displayed on the display screen 7 in the manner disclosed in IL96 / 00050. However, details will be described later, but preferably algorithms 11, 12,
In the methods 13 and 14, the data processing device performs additional processing continuously (see FIGS. 3A to 3C constituting an error analysis procedure).

As described below, the purpose of the error analysis procedure (as well as the purpose of the safety system) is to rely on the physician to rely on these calculations and screen displays to guide the needle to the target and harm the patient. Even if there is a nearby obstacle causing a measurement error as a factor, the doctor is warned by operating the alarm 18 (FIG. 1) or the like.

Algorithm 11 The vector (→) T ₁₂ can be determined by mechanical measurements. It can also be determined by measurements in an interference-free environment. For example, a needle having a position sensor mounted on the tip is placed in an interference free environment where the transmitters 10a and 1
The position of the sensor can be measured relative to the coordinates associated with 0b (T ₁ and T ₂ ). The actual measurement can be measured by optical means, for example a laser, or by any other known method for measuring position.

In the case of this algorithm, the block 120 (measured off-line generally) shown in FIG. 3 a is the starting state of the error analysis procedure performed by the data processor 6 to define the vector (→) T _12. is there. First, the data processing device measures a position vector distance (→) d _{n, t1} and a direction matrix M _{n, t1} that defines the position and direction of the position sensor 8 of the needle 2 with respect to the transmitter 10a (T ₁ ). (Block 121). Next, a position vector (→) d _{n, t2} and a matrix M _{n, t2} that defines the position and direction of the needle position sensor 8 with respect to the transmitter 10b (T ₂ ) are measured. From these measurements, the data processor then calculates the measurements of the vector (→) (T ₁₂ ) _m that defines the position of transmitter T ₂ with respect to transmitter T ₁ by the following calculation (block 123): ).

[0034]

(Equation 1)

As shown below, the value of the known vector (→) T ₁₂ between the _two transmitters T ₁ and T ₂ is subtracted from the value of the measured vector between the two transmitters, The error (Δn) is calculated (block 124).

[0036]

(Equation 2)

[0037]

[Outside 4]

[0038]

(Equation 3)

At block 129, a calculation is made for the greater of the two errors determined in each of blocks 124 and 128. Greater than the two errors that are defined by E _11, the analysis of one step at block 130 or a continuous analysis is made (see Figure 3e details). One step of the analysis consists in comparing the E ₁₁ and the threshold Th _{1 1} (maximum allowable error) (block 131), the alarm 18 is activated if the if exceeds it (block 132). This alerts the doctor that the calculated values and display on the screen 7 are not reliable due to errors caused by obstacles.

Algorithm 12 As will be described later, the execution of the algorithm 12 shown in FIG. 3B does not require information on the relative position between the _two transmitters 10a and 10b (T ₁ and T ₂ ).

After measuring the position of the needle sensor 8 and the ultrasonic transducer sensor 9 with respect to T ₁ (blocks 141 and 142; similar to each of blocks 121 and 125), the data processing device determines the ultrasound by the following equation: The position of the needle position sensor 8 relative to the transducer position sensor 9 is calculated (block 143).

[0042]

(Equation 4)

Similarly, at block 146, the data processor calculates the position of the needle position sensor 8 relative to the position sensor 9 of the ultrasound transducer, which is based on the measurement for T ₂ (→
) D _{n, u, T2} (blocks 144 and 145; similar to blocks 122 and 126, respectively).

At block 147, the calculated vector difference is defined as E ₁₂ and is calculated as follows:

[0045]

(Equation 5)

The value of E ₁₂ can be processed in a similar manner as E ₁₁ in FIG. 3a.

Algorithm 13 As described below, the execution of algorithm 13 shown in FIG.
No information on the relative spatial relationship between b is needed.

The algorithm 13 is similar to the algorithm 12 except that it is based on the calculation of the position of the needle tip 2 ′ (indicated by the subscript “nt”) with respect to the position transducer 9 of the ultrasonic transducer. The vector is represented by (→) d _{nt, u} .

First, block 16 corresponding to blocks 141 and 142 (FIG. 3b) described above
The steps indicated at 1,162 are performed. Next, the data processing device 6, based on the T ₁ transmitted by the formula shown below, the tip 2 of the needle relative to the position sensor of the ultrasonic transducer '
Is calculated (block 163).

[0050]

(Equation 6)

Similarly, by measuring for T ₂ in blocks 164 and 165, the data processor calculates the position of the needle tip 2 ′ with respect to the ultrasonic transducer position sensor 9 in block 166 (based on the T ₂ transmission). (→) defined as d _{nt, u, T2} ). The difference of two vectors defined by E _{1 3} is calculated in block 167 using the following equation.

[0052]

(Equation 7)

Next, the value E ₁₃ can be processed in the same way as E ₁₁ or E ₁₂ in FIGS. 3a and 3b described above.

The algorithm 13 can be changed by using a vector other than (→) L _n in Expression 6.

Algorithm 14 Algorithm 14 shown in the flow chart of FIG. 3d is a modification of algorithm 11. The algorithm starts with steps 120-122 of algorithm 11 described above. Next, the data processing device 6 calculates a directional matrix of the transmitter 10b (T ₂ ) with respect to another transmitter 10a (T ₁ ) at block 173 based on the measured values of the blocks 121 and 122. The direction matrix is defined as follows.

[Outside 5]

Next, at block 174, the value of the directional matrix is compared with the known directional matrix [M _{T2, T1} ] according to the following equation, resulting in an output E _141:

[0057]

(Equation 8)

Here, L _ref is a predefined vector.

[Outside 6]

The value E ₁₄ can be processed in a manner similar to E ₁₁ or E ₁₂ in FIGS. 3a and 3b described above.

Since in many cases the algorithm 13 and its proposed variant are preferred, since they are based on parameters similar to the calculation of the guidance (needle tip 2 ′ with respect to the ultrasound-imaging target 4). Note that

A variation of the transmitter redundancy algorithms 12 and 13 may be based on similar measurements made by N transmitter units, where N> 2 and preferably odd. In this case, the data processing device 6 checks whether or not the measurements P (an integer greater than or equal to N / 2) performed for different transmitter units match in order to clarify the measurements.

While algorithms 11 to 14 and their variants are disclosed, additional algorithms for systems with extra transmitters are also recognized.

If the transmitter units are not transmitting at the same time, additional considerations should be taken in using this method to avoid movement effects. In particular, operation should be observed and / or compensated. Such algorithms including Kalman filters or other linear or non-linear estimation rules are used here.

FIG. 3 e is a flowchart showing the sequential analysis (see block 130 in FIGS. 3 a to 3 d). The input to the sequential analysis may be the output of any of the algorithms 11, 12, 13, 14 and / or another algorithm described herein, all separate. Value for monitoring the measurement error, such as E ₁₁ (block 181a), E ₁₂ (block 181b) is available register switches S11, S12, S13, etc. with essential switches S11, S12 that are available As a result, it is possible to perform sequential analysis together or individually as desired. Available values are buffer 183
Where one of the following analyzes is performed on them:

(A) Investigate m “bad” values out of m out of k = k measurements (block 184) (b) Counter = Receive “wrong” measurements Increases by ₁ when received and decreases by ₂ when a "good" measurement is received (block 185). (C) Other Analysis: This means, for example, that each security measurement has a threshold. the difference (block 186) suitable analysis used including sequential analysis to receive coefficients (weights) in accordance with the from is selected by the enable switch such as a desired switch SW _11, SW _12, SW ₁₃ . The output of the analysis block is continuously input to a decision-maker block 188, which signals an alarm if necessary (block 189). As long as the guidance system functions, the safety system monitors the accuracy of the measurement by continuing the safe measurement (block 190).
).

FIG. 4 is similar to the guidance and safety systems shown in FIG. 1, except that transmitters 10 a (T ₁ ) and 10 b (T ₂ ) in a known spatial relationship are not required. The vector diagram of the safety system follows that shown in FIG. Algorithm 12,
Thirteen or variations thereof can be used with the safety system and its use.

FIG. 5 a shows the guidance and safety system shown in FIG. 1 except that the positions of the transmitters T ₁ and T ₂ and the receivers 8 (R _n ), 9 (R _u ) are exchanged. Is the same as The receivers 8 ′, 9 ′ (R ₁ , R ₂ ) (corresponding to the receivers 8, 9 in FIG. 1 described above) are at the reference position, and the transmitters 10 a ′, 10 b ′ (T _u and T _n ) (described above) (Corresponding to the transmitters 10a and 10b in FIG. 1) are attached to the ultrasonic transducer 5 and the needle 2, respectively. FIG.
As shown in FIG. 2B, a system consisting only of the receiver 9 '(R ₁ ) and the transmitters 10a' and 10b '(T ₁ , T ₂ ) is similar to the first guidance system described in PCT / IL96 / 00050. System. As described above, the positions of the ultrasonic transducer 5 and the needle 2 with respect to the reference position are measured. The vector diagram of the guidance and safety system (receivers R ₁ , R ₂ and transmitters T _n , _Tu ) follows that shown in FIG. 2 (from T _i to R _i (i = 1,2) appropriate) Excluding the replacement of various metrics). The algorithms 11, 12, 13, 14 or variations thereof can be used with the safety system and its use.

FIG. 5 b shows that the transmitter is replaced by transceivers 20 a, 20 b (TR ₁ , TR ₂ ) (usually formed by a transmitter unit connected to the receiver) and the receiver is attached to the needle 2 ₁ except that the reflector 21 (RL ₁ ) and the reflector 22 (RL ₂ ) attached to the ultrasonic transducer 5 are replaced. is there. The vector diagram of the safety system follows that shown in FIG. Algorithms 11, 12, 13, 14 or variations thereof can be used with the safety system and method.

FIG. 6 shows a second security system used with the first guidance system disclosed in PCT / IL96 / 00050, based on receiver redundancy. The device of the invention is slightly modified as described below. The transmitter 10 has a single transmitter unit 10a
Only (T ₁ ) is included, but additional transmitter units are allowed. Either the needle 2 or the ultrasound transducer 5 or both have an additional (extra) sensor receiver. In order to maximize the possibility of any interference affecting each of the individual sensors 8, 9 (at the needle 2 and the ultrasound transducer 5), the sensors (one extra) should be separated as far as possible. And preferably in different directions in the equipment.

Alternatively, the control position sensors 23 a, 23 b (usually the receivers RC _a , RC _b ; equivalent to those described above) are installed in the open area 1. These control position sensors 23a, 23b serve only to monitor any of the aforementioned interferences and are arranged as a group of sensors in a known or fixed positional relationship with each other. Furthermore, a reference control position sensor 24 (usually a receiver R _ref ; equivalent to the one described above) is arranged on the element 11 at a known or fixed position with respect to the transmitter 10a (T ₁ ).

The safety system used with the first guidance system, based on receiver redundancy, is based on the arrangement of one or more receivers described above, and not all need to be performed together. Please be careful.

The sensor 8 (receiver) of the needle 2 and the sensor 9 (receiver) of the ultrasonic transducer 5, the transmitter unit 10a (T ₁ ) and the control sensors 23a, 23b (receiver) (if used) ) And the reference sensor 24 (receiver) (if used) are connected to the data processing device 6 by wireless or wired connections 14, 16, 17, 25, 26 (supra). Next, the data processing device detects the sensors 8, 9, 23a,
3b, 24 and the data received from the transmitter unit 10a (T ₁ ) are processed according to one of the algorithms 21, 22, 23 (described below) to monitor interference and the quality of the measurement is below a predetermined limit. Alert your doctor if you do.

Alternatively, a security system with both extra transmitters and extra receivers can build a system for use with the first guidance system described above.
Similarly, the extra transmitters and extra receivers described above can be used in a security system with a second or third guidance system or alternative as described below.

FIG. 7 is a diagram illustrating various vectors required in using the guidance and safety systems of FIG.

The algorithms 21, 22, 23 used with the safety system of FIG. 6 are as follows.

Algorithm 21 Algorithm 21 is based on the process that the relative positions of two receivers are known. It may be, for example, a set of sensors 8 (R _na , R _nb ) mounted on the needle 2 and / or a set of sensors 9 (R _ua , R _ub ) mounted on the ultrasonic transducer 5 (receiver) , and / or a set of control sensors 23a, 23b to be applied to (RC _a, RC _b) of any receiver located at known, fixed spatial relationship such as (receiver) set it can. The set of all these receivers is generally denoted below (in the algorithm) as _Ra and _Rb .

The vector between a set of position sensors can be determined (a priori) by mechanical measurements. It can also be determined by measurements in an interference free environment. The actual measurement is made by optical means, for example a racer, or by any other known method for measuring position.

The algorithm 21 is as follows.

For this algorithm, the block 220 (usually measured off-line) for defining the vector between the two position sensors in FIG. 8 a is the starting state of the error analysis procedure.

[0080] The data processing device measures the position of the receiver R _a for transmitter unit T ₁ (block 221), the position vector (→) d _Ra, similarly define _T1 and orientation matrix M _{Ra, T1.} Then measures the position of the receiver R _b for the transmitter unit T ₁ (block 222),
A position vector (→) d _{Rb, T1} and a direction matrix M _{Rb, T1} are similarly defined.

At block 224, the data processing device determines that the two receivers (R _a and R _b ) from (→) d _{Ra, T1} and M _{Ra, T1 and} (→) d _{Rb, T1} and M _{Rb, T1} Calculate the measured vector (→) (d _{Rb, Ra} ) _m between. At block 226, the measured vector (
d _{Rb, Ra) m} is compared with the known vector between two receivers (d _{Rb, Ra),} produces an output E ₂₁ for those differences.

The value E ₂₁ can be processed in a similar way to E ₁₁ in FIG. 3a.

Algorithm 22 In the algorithm 22, the reference control position sensor 24 (R _ref ) transmits the signal to the transmitter 10a (T ₁ ).
Can be applied whenever it is placed in a known fixed position with respect to In block 240, the actual position of the control position sensor R _{ref with} respect to the transmitter T ₁ defined as the position vector (→) d _{Rref, T1} and the direction matrix M _{Rref, T1} is determined by the value (→) T ₁₂ of the algorithm 11 or It can be determined in the same way as the value (→) d _{Rb, Ra of the} algorithm 21.

The data processing device measures the position of the receiver R _ref with respect to the transmitter unit T ₁ (block 241), and the position vector (→) (d _{Ref, T1} ) _m and the direction matrix [M _{Ref, T1} ] _m Is similarly defined. The measured value (vector) (→) (d _{Ref, T1} ) _m is a known vector (
→) is compared with d _{Ref, T1} (block 244), producing an output of their difference as defined by E ₂₂₁ . The measured direction matrix [M _{Ref, T1} ] _m is compared with the known direction matrix M _{Ref, T1} (block 246), producing an output of their difference defined by E ₂₂₁ .

The values E ₂₂₁ and E ₂₂₂ can then be processed in a manner similar to E ₁₁ in FIG. 3a.

[0086]Algorithm 23 This algorithm uses at least two receivers 8 (R_naAnd R _nb ) (One of which is extra) and / or two receivers attached to the ultrasonic transducer 5
Shinki 9 (R_uaAnd R_ub) (One of them is extra) whenever it exists
be able to.

[0087] The data processing device measures the position of the receiver R _na for the transmitter T ₁ (block 26 1), the position vector (→) d _Rna, similarly define _T1 and orientation matrix M _{Rna, T1.}

[0088] The data processing device measures the position of the receiver R _ua for the transmitter T ₁ (block 26 2), (→) d Rua, similarly define _T1 and M _{Rua, T1.}

Based on the measured values of R _na and R _ua , the position of the tip 2 ′ of the needle with respect to the ultrasonic position sensor 9 is calculated (block 264), and (→) d _{nt, u, pair (Rna, Rua)} is _calculated. Define similarly.

The position of the receiver R _ub with respect to the transmitter 10a (T ₁ ) is measured (block 265) and (→) d _{Rnb, T1} and M _{Rnb, T1} are defined similarly.

Based on the measured values of R _nb and R _ua , the position of the tip 2 ′ of the needle with respect to the ultrasonic position sensor 9 is calculated (block 266), and (→) d _{nt, u, pair (Rnb, Rua)} is _calculated. Defined similarly.

The data processing device calculates the calculated vector (→) d_{nt, u, pair (Rna, Rua)}And (→) d _{nt, u, pair (Rnb, Rua)} (Block 268) and output E as_{twenty three}Cause.

[0093]

(Equation 9)

The value E ₂₃ can be processed in a similar way to E ₁₁ in FIG. 3a.

If an additional extra receiver (R _ub ) is attached to the ultrasonic transducer 5, additional measurements can be added to this algorithm. These two additional measurements are now based on the fact that there are four sets of receivers, from which the position of the needle tip with respect to the ultrasound transducer 5 can be calculated.

A variant of the algorithm 23 is based on making similar measurements for N position sensors located on the (guided) device (where N> 2, preferably odd). In this case, to clarify the measurements, the algorithm verifies that the measurements P (an integer greater than or equal to N / 2) made on different position sensors are consistent (within certain predetermined limits). I do.

While algorithms 21 to 23 and their variants are disclosed, the addition of algorithms for systems with extra receivers is also permitted.

The extra receiver for the safety system described above can be used with the guidance system of FIG. 5a. Here, the receiver serves as a reference position. Furthermore, the implementation of the system includes the addition of an extra transmitter of the needle 2 and / or the ultrasound transducer 5. As described above, this security system can use algorithm 23.

Alternatively, the extra transceiver for the safety system described above can be used with the guidance system in FIG. 5b. Here, the transceiver serves as a reference position. Further, the implementation of the system requires the needle 2 and / or the ultrasonic transducer 5
Includes the addition of extra reflectors. As described above, this security system can use algorithm 23.

First Guidance System (disclosed in PCT / IL96 / 00050) (and Guidance System described below)
Another security system used with may be transmission / signal / frequency alternating (hopping).

For example, in a first guidance system, as disclosed in US Pat. No. 4,495,305 (Blood) and US Pat. No. 4,054,881 (Raab), which are incorporated herein by reference. Do positioning (positioning) system is used, transmission of the transmitter T ₁ as shown in FIG. 9 a to be described later can be changed.

In one cycle of the measurement (cycle K), transmitter T ₁ initially receives antenna X
, Then from antenna Y, and finally from antenna Z. In the next cycle of measurement (cycle K + 1), the transmitter T _1, from the antenna X and Y (co), then from the antenna X and Z (co), from the last antenna Y and Z (co) Send. The measurements performed in the two cycles are variously affected by obstacles and / or interfering electromagnetic fields. The data processing device 6 measures the tip 2 ′ of the needle with respect to the ultrasonic position sensor 9 according to the measurement performed in the cycle K, and similarly defines (→) _{dnt, u, Cycle K.} The data processor then measures the tip 2 'of the needle relative to the ultrasonic position sensor 9 according to the measurements performed in cycle K + 1, and similarly defines (→) _{dnt, u, Cycle K + 1.} . Next (→) d _nt, compared _{u, Cycle K} and (→) d _{nt, u,} the _{Cycl e K + 1,} causing a difference equal to the output of the two measurements that are defined by E _S1. The value E _S1 can be processed in a similar way to E ₁₁ in FIG. 3a.

Although US Pat. No. 4,495,305 (Blood) discloses both types of measurement cycles, in order to monitor measurement errors due to interference, a positioning system in a possible complex system and a system in which it is not, are described. The execution is distinguished.

Signals for use with the first guidance system are transmitted alternately (sig
Another safety system based on nal alternation) is U.S. Pat.No. 4,945,305 (Blood)
When using a positioning system as described in Fig. 9b, it is shown as Fig. 9b described below.

A transmitter such as described in US Pat. No. 4,945,305 (Blood) transmits various pulse waveforms and / or pulse widths in the resulting measurement cycle (eg, cycle K and cycle K + 1). . The data processing device calculates (→) _{dnt, u, Cycle K} and (→) _{dnt, u, Cycle K + 1} (described above). The measurements made in the two cycles are affected differently by obstacles and / or interfering electromagnetic fields. Next, the data processing device 6 compares the measurements described above, causing them equal output which is defined by E _S2. The value E _S2 can be processed in the same way as E ₁₁ in FIG. 3a.

When using a system as described in US Pat. Nos. 4,054,881 and 4,314,251 (both Raab) (herein incorporated by reference), as shown in FIG. , A safety system based on frequency hopping can be used.

The transmitter transmits various frequency carriers in the resulting measurement cycle (frequency hopping). The measurements performed in the two cycles are variously affected by obstacles and / or interfering electromagnetic fields. Thus, the data processor compares the two measurements and produces an output equal to the difference between the two measurements defined by _ES3 . The value E _S3 can be treated in the same manner as E ₁₁ in Figure 3a.

An additional safety system for use with the first guidance system is disclosed in US Pat.
When using a positioning system as described in '305 (Blood), and' 881 (Raab) and '521 (Raab), it can be formed by examining the unitarity of matrix A. it can. Here, matrix A is the attitude matrix of the receiver in U.S. Pat.
attitude marix). Therefore, the data processing device performs the calculation as follows.

[0109]

(Equation 10)

[0110]

[Equation 11]

Here, matrix_norm represents a matrix normal form, and λ _max (A ^T * A) and λ _min (A ^T * A) represent the maximum eigen value and the minimum eigen value of the matrix A ^T * A.

The value E _un1 or E _un2 can be processed in the same way as E ₁₁ in FIG. 3a.

FIG. 10 shows a second guidance system. More specifically, FIG. 10 provides a second guidance system and method for guiding a medical device to a target within a body.

In this guidance system, the joint arm 30 installed on the stand 32
Except for the needle 2 attached to the first, all components are similar and have a similar function to the first guidance system described in PCT / IL96 / 00050 mentioned above. An articulating arm 30 and stand are disclosed in U.S. Patent No. 5,647,373, which is hereby incorporated by reference.

The transmitter 10a (T ₁ ) is arranged at a reference position on the stand 32. Sensor 9 (
Preferably the receiver R _u) is installed in the ultrasonic transducer 5. As described above, the sensor 9 and the transmitter 10a communicate with the data processing device 6 by wire or wireless 14, 17, whereby the data processing device 6 measures the position of the ultrasonic transducer 5 with respect to the reference position. Becomes possible.

As described above, this second guidance system and its alternatives may have a receiver and a transmitter arranged such that a positioning system and a tracking system are defined. These receivers and transmitters can be modified so that PCT /
In accordance with IL96 / 00050, the required positioning and tracking systems are:
Magnetic, acoustic, or electro-optical, or a combination thereof (in addition to those described above).

The arm 30 is mechanically calibrated to a reference position, and its operation including the needle 2 is transmitted to the data processing device 6 by the aforementioned wire or wireless connection. Thereby, the data processing device 6 can measure the position of the needle with respect to the reference position. From these measurements, the data processor 6 calculates the position of the needle 2 with respect to the ultrasound imaging plane. The predicted trajectory of the needle 2 with respect to the target 4 can be displayed on the screen 7, thus guiding the movement of the needle 2 towards the target 4 to assist the doctor.

The second guidance system and its alternatives can also be used with another scanning device such as X-ray, computed tomography (see PCT / IL96 / 00050)
.

All safety systems related to the first guidance system described above can be used with this second guidance system. For example, if the second transmitter (T ₂ )
When installed at 2, a security system based on extra transmitters is formed. These "transmitter redundancy" security systems have a vector diagram according to that shown in FIG. 2 above, and can use any of the security algorithms 11, 12, 13, 14 described above.

Alternatively, two or more position sensors, receivers (at least one extra) are arranged on the ultrasonic transducer 5, or control position sensors (23a, 23b, 24 in FIG. 6)
Are located in the operating area 1 as shown in FIG. 6, resulting in a safety system of receiver redundancy which is consistent with the above. These "receiver redundancy" security systems have the vector diagram according to FIG. 7 described above and can use any of the security algorithms 21, 22, 23 described above.

Safety systems based on the alternating transmission of the aforementioned signals can be used with these second types of guidance systems.

[0122] Additional modifications of the second type of guidance system, by exchanging the position of the transmitter T ₁ and receiver R _u, also by placing the receiver at the reference position,
Alternatively, it can be constructed by replacing the transmitter with a transceiver and replacing the receiver with a reflector.

When the needle 2 is in the released state and the ultrasonic transducer 5 is mounted on the articulated arm 30 and the stand 32, another guiding system according to FIG. 10 is constructed.
As mentioned above, the needle 2 has a sensor 8 (preferably a receiver (R ₁ )) attached to it.
) And the stand 32 includes a transmitter (T ₁ ) attached to it,
Here, each of the sensor 8 and the transmitter (T ₁ ) communicates with the data processing device 6 by wire or wirelessly. All modifications to the second guidance system described above also apply to this type of system.

FIG. 11a shows a third guidance system. In particular, FIG. 11a provides a third guidance system and method for guiding a medical device to a target within a body.

The third guidance system differs from the first and second guidance systems in that the position of the needle 2 relative to the ultrasonic transducer 5 is measured directly without using an additional reference position in space. (In the first and second guidance systems, the position of the needle 2 and the position of the ultrasonic transducer 5 are first measured relative to a reference position in space. From these two measurements, the ultrasonic conversion is performed. The relative position of needle 2 with respect to instrument 5 is calculated (PCT / IL96
/ 00050). This third guidance system includes a position sensor 8 (usually a receiver (R)) attached to the needle 2 and a transmitter 10b '(T) attached to the ultrasonic transducer 5 (see FIG. 1 above).
Corresponding to the transmitter 10b). As described above, the position sensor 8 and the transmitter 1
0b ′ (T) communicates with the data processing device 6 by wire or wireless 16, 35. Transmitter 10b '(and thus scanning device and scanning plane)
The position of the needle tip 2 ′ with respect to is measured directly according to the following equation without the need for an additional reference position (as in the first guidance system).

[0126]

(Equation 12)

Here, the expected trajectory of the needle 2 with respect to the target 4 can be displayed on the display screen 7, thus guiding the movement of the needle 2 toward the target 4 as described in PCT / IL96 / 00050. Assist the doctor by doing.

This third guidance system and its alternatives can be used with another scanning device such as X-ray, computed tomography as described in PCT / IL96 / 00050. As mentioned above, this third guidance system and its alternatives may have a receiver and a transmitter arranged such that a positioning system and a tracking system are defined. These receivers and transmitters can be modified, resulting in PCT / IL
According to 96/00050, the positioning and tracking systems required are magnetic, acoustic, or electro-optical, or a combination thereof (in addition to those described above).

FIG. 11b shows an alternative to the system shown in FIG. 11a. In this system, the positions of the receiver R and the transmitter T in the needle 2 and the ultrasonic transducer 5 are exchanged, respectively. FIG. 11c shows an alternative to the system of FIG. 11a. In this system, the transmitter 12 has been replaced by a transceiver 20 '(supra) and the receiver has been replaced by a reflector 21. Alternatively, the transceiver is located on the needle 2 and the reflector 21 is
Placed in

FIG. 12 is a vector diagram of the calculation of the guidance implemented in the system of FIG.
It can be modified according to the principles of the method as applicable to FIGS. 11b and 11c and its alternatives.

All the safety systems described above can be used with this third guidance system and its alternatives. For example, FIG. 13 shows a security system based on an extra transmitter. This safety system is used in conjunction with a third guidance system, wherein a sensor 8 (usually a receiver R) is located on the needle 2 and at least two (preferably two) transmitters 10b '(T ₁ , T ₂ ) are placed in the ultrasonic transducer 5 (one of the transmitters is “extra”). As mentioned above, all transmitters and receivers communicate with the data processing device 6 by wire or wireless communication. Or the transmitter (T ₁ , T ₂ )
May be located on the needle 2 and a sensor (receiver) 8 may be located on the ultrasonic transducer 5. These transmitter redundancy security systems can use any of the previously described algorithms 11, 12, 13, 14 with the necessary modifications to account for vector changes.

FIG. 14 is a vector diagram of the system of FIG. This figure can be modified according to the principles of the method to apply to those alternatives.

FIG. 15 shows a security system using an extra receiver. It is possible to mount two position sensors 8 (receivers) (R _{na ,} R _nb ) (at least one of the receivers is extra) on the needle 2. The transmitter 10b '(T) is attached to the ultrasonic transducer 5. Alternatively, the control receivers 23a and 23b in the known spatial positional relationship (described above) (
RC _a , RC _b ) can be arranged in the operation area 1. In addition, a reference position sensor (control receiver) 24 (R _ref ) (corresponding to that of FIG. 6) is located at a fixed position known from the transmitter (as described for the first guidance system). Is preferred. Alternatively, two receivers 8 can be arranged in the ultrasonic transducer 5, while the transmitter 1
It is also possible to place 0b 'on needle 2. All transmitters and receivers communicate with the data processing device 6 by wire or wireless communication as described above. These receiver redundancy security systems can use any of the security algorithms 21, 22, 23 with the necessary modifications to account for vector changes.

FIG. 16 shows a vector diagram of the receiver redundancy system shown in FIG.

FIG. 17 shows a security system used with a third guidance system where both the transmitter and the receiver are redundant. Position sensor 8 (typically a receiver (R _n)) (supra) and a transmitter 10a '(T _n) (corresponding to the transmitter 10a of FIG. 1) is disposed in the needle, and the position sensor 9 (the normal reception The transmitter (R _u )) (described above) and the transmitter 10 b ′ (T _u ) are arranged in the ultrasonic transducer 5. As mentioned above, all transmitters and receivers communicate with the data processing device 6 by wire or wireless communication.

Alternatively, a security system with extra transmitters and extra receivers can build a security system for use with the second and third guidance systems described above.

A safety system based on the alternating transmission of the aforementioned signals can be used with these third types of guidance systems.

Although the invention has been described with respect to several embodiments, it will be recognized that they are merely illustrative and that various modifications and applications are possible. The scope of the present invention is defined in the appended claims.

[Brief description of the drawings]

The present invention will be described by way of example only with reference to the accompanying drawings. In this specification, the same or similar elements are denoted by the same reference numerals.

FIG. 1 is a diagram showing an embodiment of a system for guiding the operation of a device by ultrasonic waves constructed according to the present invention. In this case, a medical biopsy needle aimed at the target, using an extra transmitter-based safety system, where the relative positional relationships between the transmitters are known.

2 illustrates various vectors associated with using the system of FIG. 1 to direct movement of a biopsy needle toward a target.

FIG. 3a is a flowchart showing a safety algorithm 11 for system operation of the present invention.

FIG. 3b is a flowchart illustrating a security algorithm 12 for system operation of the present invention.

FIG. 3c is a flowchart illustrating a security algorithm 13 for system operation of the present invention.

FIG. 3d is a flowchart illustrating a security algorithm 14 for system operation of the present invention.

FIG. 3e is a flowchart showing the execution of a sequential analysis that can be performed on the outputs of the safety algorithms 11, 12, 13, and 14.

FIG. 4 is a diagram showing an embodiment of a system for guiding the operation of a device by using ultrasonic waves constructed according to the present invention. In this case, a medical biopsy needle aimed at the target, using an extra transmitter-based safety system, where the relative positional relationships between the transmitters are unknown.

FIG. 5a shows the guidance system and the safety system of FIG. 1, wherein the positions of the transmitter and the receiver are exchanged.

FIG. 5b shows the guidance system and the safety system of FIG. 1, wherein the transmitter has been replaced by a transceiver and the receiver has been replaced by a reflector.

FIG. 6 is a diagram showing one embodiment of a system for guiding the operation of a device by ultrasonic waves constructed according to the present invention. In this case, a medical biopsy needle aimed at the target, using a safety system based on an extra receiver.

FIG. 7 illustrates various vectors associated with using the system of FIG. 6 to guide movement of a biopsy needle toward a target.

FIG. 8a is a flowchart illustrating a security algorithm 21 for system operation of the present invention.

FIG. 8b is a flowchart illustrating a safety algorithm 22 for system operation of the present invention.

FIG. 8c is a flowchart illustrating a security algorithm 23 for system operation of the present invention.

FIG. 9a shows various waveforms for a safety system based on alternating signals (hopping).

FIG. 9b shows various waveforms for a safety system based on alternating signals (hopping).

FIG. 9c shows various waveforms for a safety system based on alternating signals (hopping).

FIG. 10 is a diagram showing a second guidance system for guiding the operation of a device by ultrasonic waves constructed according to the present invention. In this case, a medical biopsy needle aimed at the target.

FIG. 11a is a diagram showing a third guidance system for guiding the operation of a device by ultrasonic waves constructed according to the present invention. In this case, a medical biopsy needle aimed at the target.

FIG. 11b shows the guidance system of FIG. 11a, wherein the positions of the transmitter and the receiver are exchanged.

FIG. 11c shows the guidance system of FIG. 11a, where single / multiple transmitters are replaced by transceivers and single / multiple receivers are replaced by reflectors.

FIG. 12 shows various vectors associated with the use of the system of FIGS. 11a to 11c.

FIG. 13 shows a third guidance system of the present invention using a safety system based on redundant transmitters.

FIG. 14 illustrates various vectors associated with using the system of FIG. 13 to direct needle movement toward a target.

FIG. 15 illustrates a third guidance system of the present invention using another security system based on redundant receivers.

16 illustrates various vectors associated with using the system of FIG. 15 to direct needle movement toward a target.

FIG. 17 shows a third embodiment of the present invention using a security system based on extra transmitters and extra receivers.
It is a figure which shows the guidance system of.

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IS, JP, KE, KG , KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, US, UZ, VN, YU, ZW (72) Inventor Nager Ron Haifa 35847 Halotems Treat, Israel 5 (72) Invention Halleben Michael Haifa 34753, Freud's Treat, Israel 22 F term (reference) 4C060 MM24 4C301 EE11 EE19 FF17 GD02 GD06 JA04

Claims (84)

[Claims] 1. A system for directing movement of a device toward a target, comprising: a transmitting device at a reference position for transmitting radiant energy from a reference position in space; and a system directed to the target. A position sensor in the device, the position sensor receiving radiant energy from the transmitting device to generate an output corresponding to the position of the device with respect to the reference position in space, and receiving an output of the position sensor in the system having a data processor to calculate the position of the device relative to the reference position, the on transmission apparatus, a first transmission in a known spatial relationship defined by a known vector (→) T ₁₂ A second transmitter (T1) and a second transmitter (T2), wherein the data processing device comprises: (a) the first transmitter (T1) also defined by a first vector; (B) measuring the position and orientation of the position sensor with respect to the second transmitter (T2), also defined by a second vector, (c) measuring the position and orientation of the position sensor with respect to the second transmitter (T2). Calculating a measurement vector (→) (T ₁₂ ) _m between the two transmitters from the first vector and the second vector; (d) a known vector (→) (T ₁₂ ) and a measurement vector (→ (T ₁₂ ) _m, and (e) producing an output corresponding to the difference between the measured vector (→) (T ₁₂ ) _m and the known vector (→) (T ₁₂ ). System to do. 2. The data processing device includes an alarm and compares the output generated in step (e) with a predetermined threshold to activate the alarm if the threshold is exceeded. The system of claim 1, wherein: 3. The data processing device according to claim 1, wherein the measured vector (→) (T ₁₂ ) _m is compared with an absolute value of the known vector (→) (T ₁₂ ). System. 4. The system according to claim 2, wherein the device is a medical device guided through a living tissue in a body toward a target in the body. 5. The medical device according to claim 4, wherein the medical device is an intervention device, and the position sensor is arranged at a predetermined position with respect to the invasive device. The described system. 6. The system of claim 5, wherein the body is imaged by an imaging system that scans the body with a scanning device along a plurality of scan planes. 7. The scanning device receives radiant energy from the first and second transmitters and adjusts the position of the second position sensor with respect to the reference position in space, that is, the position of the scanning device. Including a second position sensor that produces a corresponding output; 8. The system according to claim 7, wherein said scanning device is an ultrasound scanner. 9. The method according to claim 1, wherein the first and second transmitters are opposed to each other in an arm having a known length and a direction with respect to a known position in a space defined by a known vector (→) (T ₁₂ ). 9. A system according to any of the preceding claims, wherein the system is attached to the end of the vehicle. 10. The system according to claim 9, wherein the arm has a length of 0.1 to 1.0 m. 11. The system according to claim 10, wherein said arm has a length of 35 cm. 12. A method for directing operation of a device toward a target, comprising: transmitting radiant energy from a transmitter at a reference location in space; and the device being directed toward the target. Installing the position sensor on the position sensor, wherein the position sensor receives radiant energy from the transmitting device to produce an output corresponding to the position of the device relative to the reference position in space; and in the method of processing the output of the data processing apparatus and a process of calculating the position of the device relative to the reference position, the transmission device, known space defined by the known vector (→) T ₁₂ Each of a first transmitter (T1) and a second transmitter (T2) in a logical relationship, and wherein the data processing device comprises: Measuring the position and orientation of the position sensor with respect to one transmitter (T1); and (b) determining the position and orientation of the position sensor with respect to the second transmitter (T2), also defined by a second vector. (C) calculating a measurement vector (→) (T ₁₂ ) _m between the two transmitters from the first vector and the second vector; (d) a known vector (→) (T ₁₂₎ and the measurement vector (→) (T ₁₂₎ compares the _m, an output corresponding to the difference between (e) measurement vector (→) (T _{12) m} and the known vector (→) (T ₁₂₎ Producing. 13. The data processing device, wherein the data generated in step (e) is compared with a predetermined threshold value, and the alarm device is activated if the threshold value is exceeded. The method according to claim 12. 14. The data processing device according to claim 12, wherein the data processing device compares the absolute value of the measurement vector (→) (T ₁₂ ) _m with the absolute value of the known vector (→) (T ₁₂ ). The method described in. 15. The method according to claim _12, wherein the known vector (→) (T ₁₂ ) is measured mechanically. 16. The known vector (→) (T ₁₂ ) is determined by attaching a position sensor to the tip of a needle, the needle is placed in an interference free environment, and the first and second transmissions are determined. A method according to any of claims 12 to 14, wherein the position of the latter position sensor with respect to the machine is measured. 17. The method according to claim 12, wherein the device is a medical device guided through living tissue in a body toward a target therein. 18. The method of claim 17, wherein the medical device is a biopsy needle and the position sensor is located at a predetermined position relative to the biopsy needle. 19. The method of claim 18, wherein the body is imaged by an imaging system that scans the body with a scanning device along a plurality of scan planes. 20. The scanning device receives radiant energy from the first and second transmitters and adjusts the position of the second position sensor with respect to the reference position in space, that is, the position of the scanning device. Second to produce a corresponding output
Including the position sensor of 21. The method according to claim 20, wherein said scanning device is an ultrasound scanner. 22. The first and second transmitters transmit a known vector (→) (T ₁₂ 15. An arm having a known length and direction with respect to a reference position in a space defined by the formula (1), attached to opposite ends.
The method according to any of the above. 23. The method according to claim 22, wherein the arm has a length of 0.1 to 1.0 m. 24. The method according to claim 23, wherein said arm has a length of 35 cm. 25. A system for directing operation of a device towards a target viewable as an image, the system comprising: at least one scanning device for forming the image including the target; At least one transmitter at the reference position for transmitting radiant energy from one reference position; at least one first position sensor in the device for receiving the radiant energy; and for receiving the radiant energy At least one second position sensor in said at least one scanning device; and at least one third position sensor for receiving said radiant energy in either said device or at least one said scanning device. Calculating the device for at least one of the scanning devices And a data processing device operatively communicating with at least one of said transmitter and each of said at least one of said first, second and third position sensors to monitor accuracy of said position. System to do. 26. The system of claim 25, wherein each of the at least one first, second, and third position sensors includes a receiver. 27. The system according to claim 25, wherein each of the at least one position sensor is one position sensor. 28. The system according to claim 25, wherein the first reference position is a fixed known position in space. 29. The system according to claim 25, wherein the reference position is unknown. 30. The system according to claim 25, wherein the at least one scanning device comprises one scanning device. 31. At least one said third position sensor is present in said device, at least one said first position sensor and at least one said third position sensor.
31. The system of claim 30, wherein the relative positions of the position sensors are known. 32. At least one said third position sensor is present in said scanning device, and said relative position of at least one said second position sensor and at least one said third position sensor is known. 31. The system of claim 30, wherein the system is. 33. The apparatus of claim 25, further comprising at least one fourth position sensor at a second reference position for receiving the radiant energy and functionally communicating with the data processing device. The described system. 34. The system according to claim 33, wherein the at least one fourth position sensor includes two receivers at a position relative to each other. 35. The system according to claim 34, wherein the second reference position is a fixed known position. 36. The system according to claim 34, wherein the second reference position is unknown. 37. At least one fourth position sensor at a known and fixed position relative to the first reference position for receiving the radiant energy and functionally communicating with the data processing device. 26. The method of claim 25, comprising. 38. The system of claim 25, wherein at least one of said transmitters comprises one transmitter. 39. The system of claim 25, wherein at least one of the transmitters comprises two transmitters, one of which is redundant. 40. A system for directing operation of an instrument towards a target viewable as an image, the system comprising: at least one scanning device for forming the image including the target; At least one transmitter at the reference position for transmitting radiant energy from a location, wherein the radiant energy is in the form of a signal transmitted alternately in different measurement cycles; and At least one position sensor in the device for receiving the radiant energy to produce an output corresponding to a position of the device with respect to the reference position in space; and the device for receiving the radiant energy with respect to the reference position in space. At least one of said scanning devices to produce an output corresponding to the position of At least one position sensor; and operatively communicating with each of the at least one transmitter and the at least one position sensor to monitor accuracy of a calculated position of the device with respect to the at least one scanning device. And a data processing device. 41. The system according to claim 40, wherein said position sensor is a receiver. 42. The system of claim 41, wherein said receiver is magnetic and at least one said transmitter emits electromagnetic energy. 43. The system of claim 40, wherein the signals are transmitted alternately in different measurement cycles including DC or AC signals. 44. The system of claim 43, further comprising three independent antennas. 45. The transmitter transmits at least partially continuously from each antenna in a first measurement cycle and in a second measurement cycle
The system of claim 44, wherein the transmission is at least partially continuous from the paired antennas. 46. The system according to claim 40, wherein the first reference position is a fixed known position in space. 47. The system according to claim 40, wherein the reference position is unknown. 48. The system of claim 40, wherein at least one of said transmitters comprises one transmitter. 49. The system of claim 40, wherein at least one of the transmitters comprises two transmitters, one of which is redundant. 50. A system for guiding an instrument toward a target viewable as an image, comprising: an imager for forming the image; and the reference for transmitting radiant energy from a reference position. At least one transmitter at a location, and at least one location for receiving an image of said radiant energy to produce an output proportional to the location of said imaging device relative to said reference location. An imaging device including a sensor; an articulated arm for holding the guided device calibrated with respect to the reference position; and calculating a position of the device with respect to the imaging device to target the image. At least one of said transmitter, at least one of said position sensors, and said articulating System characterized in that it comprises a data processing device communicating beam functionally. 51. The system according to claim 50, wherein said device comprises a needle. 52. The system of claim 50, wherein said device is selected from the group consisting of an ultrasound device, a CT device, an MRI device, and an X-ray device. 53. at least one additional position sensor in the imaging device for receiving the radiant energy, the data processing device for monitoring the accuracy of a calculated position of the device with respect to the imaging device; The system of claim 5, further comprising at least one additional said position sensor operatively communicating.
The system according to claim 0. 54. In the form of a signal transmitted at at least one of the transmitters such that the transmitted radiant energy alternates in different measurement cycles, the data processing device comprising: 51. The method of claim 50, operatively communicating with at least one of the transmitters, at least one of the position sensors, and the articulating arm to monitor the accuracy of the calculated position of the joint. system. 55. The system of claim 50, wherein the at least one transmitter comprises one transmitter. 56. At least one said transmitter comprising two transmitters, one of which is redundant, wherein said data processing device monitors the accuracy of a calculated position of said device with respect to said video device. 51. The system of claim 50, wherein the system is in operative communication with the two transmitters, at least one of the position sensors, and the articulating arm. 57. A system for navigating a device towards a target viewable as an image, comprising: an imager for forming the image; and the reference for transmitting radiant energy from a reference location. At least one transmitter at a location, an articulated arm for holding an imaging device, calibrated against the reference location, and a guided device for receiving the radiant energy and relative to the reference location. The device including at least one position sensor for producing an output proportional to the position of the device; and calculating a position of the device with respect to the video device to display the position of the device with respect to a target in the image. , The at least one transmitter, the at least one position sensor, and the data processing in operative communication with the articulating arm System characterized in that it comprises a location. 58. The system of claim 57, wherein said device comprises a needle. 59. At least one additional position sensor in the device for receiving the radiant energy to produce an output proportional to the position of the device relative to the reference position, and a calculated value of the device for the imaging device 58. The system of claim 57, further comprising at least one additional said position sensor in operative communication with said data processing device for monitoring position accuracy. 60. In the form of a signal transmitted at at least one of the transmitters such that the transmitted radiant energy alternates in different measurement cycles, the data processing device comprising: 58. The system of claim 57, operatively communicating with at least one of the transmitters, at least one of the position sensors, and the articulating arm to monitor the accuracy of the calculated position of the at least one transmitter. system. 61. The system of claim 57, wherein the at least one transmitter comprises one transmitter. 62. at least one of said transmitters including two transmitters, one of which is redundant, wherein said data processing device monitors the accuracy of a calculated position of said device with respect to said video device. 58. The system of claim 57, further comprising operably communicating with the two transmitters, at least one of the position sensors, and the articulating arm. 63. A system for freehand-directing a device guided to a target imaged by a scanning device, said radiant energy being attached to said scanning device at a predetermined location. At least one transmitter for transmitting radiated energy from the at least one transmitter to produce an output proportional to a relative position of the guided device with respect to the scanning device. At least one position sensor attached to the scanning device; and at least one position sensor for calculating a position of the guided device with respect to the scanning device and displaying the position of the guided device with respect to a target in the image.
A system comprising: one of said transmitters; and a data processing device in operative communication with at least one of said position sensors. 64. The data processing device comprising: at least one of the transmitter;
64. The system of claim 63, operatively communicating with at least one of said position sensors by wire or wirelessly therebetween. 65. The system of claim 63, wherein the at least one transmitter and the at least one position sensor define a positioning system and a tracking system. 66. The system according to claim 65, wherein said positioning system and tracking system are magnetic. 67. The system according to claim 65, wherein said positioning system and tracking system are acoustic. 68. The system according to claim 65, wherein said positioning system and tracking system are electro-optical. 69. The system of claim 63, wherein said at least one transmitter comprises one transmitter. 70. The at least one transmitter includes two transmitters, one of which is redundant, wherein the data processing device monitors the accuracy of the calculated position of the device with respect to the scanning device. 64. The system of claim 63, wherein the system is in operative communication with the two transmitters and at least one of the position sensors. 71. The system of claim 63, wherein said at least one position sensor comprises one position sensor. 72. At least one of said position sensors includes two position sensors, one of which is redundant, and wherein said data processing device is adapted to calculate a calculated position accuracy of said guided equipment with respect to said scanning device. 64. The system of claim 63, operatively communicating with at least one of the transmitter and the two position sensors to monitor. 73. At least one of the transmitters is in the form of a signal transmitted such that the transmitted radiant energy is alternated in different measurement cycles, wherein the data processing device comprises: 6. The method of claim 5, further comprising: operatively communicating with at least one of the transmitters and at least one of the position sensors to monitor the accuracy of the calculated position of the guided equipment.
The system according to claim 0. 74. A system for freehand-directing an instrument guided to a target imaged by a scanning device, the system comprising a radiant energy attached to the scanning device at a predetermined location. At least one transmitter for transmitting the signal; and the scanning for receiving radiant energy from the at least one transmitter to produce an output proportional to a position of the scanning device relative to the guided equipment. At least one position sensor attached to the device; and at least one to calculate a position of the guided device with respect to the scanning device and display the position of the guided device with respect to a target in the image.
A system comprising: one of said transmitters; and a data processing device in operative communication with at least one of said position sensors. 75. The data processing device comprising: at least one of the transmitters;
75. The system of claim 74, operatively communicating with at least one of the position sensors by wire or wireless between them. 76. The system of claim 74, wherein at least one of the transmitter and at least one of the position sensors define a positioning system and a tracking system. 77. The system according to claim 74, wherein said positioning system and tracking system are magnetic. 78. The system of claim 74, wherein said positioning system and tracking system are acoustic. 79. The system according to claim 74, wherein said positioning system and tracking system are electro-optical. 80. The system of claim 74, wherein the at least one transmitter comprises one transmitter. 81. At least one of the transmitters includes two transmitters, one of which is redundant, wherein the data processing device monitors the accuracy of the calculated position of the device with respect to the scanning device. 75. The system of claim 74, wherein the system is in operative communication with the two transmitters and at least one of the position sensors. 82. The system of claim 74, wherein at least one of said position sensors comprises one position sensor. 83. The at least one position sensor includes two position sensors, one of which is redundant, wherein the data processing device is configured to calculate the accuracy of the calculated position of the guided device with respect to the scanning device. 75. The system of claim 74, wherein the system is in operative communication with at least one of the transmitter and the two position sensors to monitor. 84. In at least one of the transmitters, the transmitted radiant energy is in the form of a signal transmitted such that the radiant energy alternates in different measurement cycles, wherein the data processing device is configured to transmit the radiant energy to the scanning device. 8. The method of claim 7, further comprising: operatively communicating with at least one of the transmitters and at least one of the position sensors to monitor accuracy of a calculated position of a guided device.
5. The system according to 4.