AU699235B2 - Apparatus for detecting surgical objects within the human body - Google Patents

Description

l/UU01 281Wto Regulation 3.2(2)

AUSTRALIA

Patents Act 1990

ORIGINAL

COMPLETE SPECIFICATION STANDARD PATENT Application Number: Lodged: Sr S C I S o S( Invention Title: APPARATUS FOR DETECTING SURGICAL OBJECTS WITHIN THE HUMAN BODY The following statement is a full description of this invention, including the best method of performing it known to me i

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APPARATUS FOR DETECTING SURGICAL OBJECTS WITHIN THE HUMAN BODY Background of the Invention i. Field of the Invention The invention relates to a detection device for surgical objects within the human body. More specifically, the invention relates to a detection device which responds to an alternating electromagnetic field.

2. Description of the Prior Art Despite precautions, surgeons still occasionally leave surgical objects such as sponges and, less frequently, small surgical tools in their patients after an operation. Areas which are badly injured tend tc have a great amount of blood which may cover the .surgical objects, making the objects hard to locate.

Also, objects may find their way under an organ. This is most likely to occur in surgical areas such as the abdomen which are large and have many organs.

The prior art discloses use of X-ray opaque i rmr r material positioned on the surgical devices in order that i after the surgery is completed and the wound is closed, an X-ray can be taken to insure no surgical objects were left within the patient. Although this detection method ~~is effective, it is cumbersome. Most operating rooms do m. sw" Am 1 1, 0 1" go I 1 .0 W11 I I I 2 not have X-ray machines. Hence, the patient must be taken to another room. There the patient often must be moved from his gurney to an X-ray table for X-rays to be taken. If a surgical object is detected after an X-ray has been taken, the patient must be returned to the operating room. Then, the cavity or incision must be reopened to remove the surgical object and then reclosed.

This second surgery can cause a great deal of trauma to the patient, preventing optimum healing. Examples of surgical sponges which are marked by radio opaque material are disclosed in United States Patent No.

2,190,432 to Lewison, United States Patent No. 2,698,270 to Mesek, United States Patent No. 4,185,626 to Jones et al., and United States Patent No. 4,205,680 to Marshall.

A manual counting of the sponges after the surgery is completed is also used to prevent surgical objects from being left in body cavities. This is not a foolproof method. Fatigue, poor handwriting, and misreading of numbers will occur during operations .tto lasting 4 to 12 hours when dealing with badly damaged patients. Consequently, miscounts occur as a result of human error. i Greenberg in United States Patent No. 3,587,583 attempts to overcome the problems of leaving surgical objects within the body. He proposes to mark the surgical object with a permanently magnetized material. p jl ,i-i I n- -3ii i e.

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tiat it C 'teaC it S A surgeon performs an operation in the normal manner.

Before closing the incision the surgeon probes for the presence of a surgical object with a magnetic field detector means which generates an electric signal which is modified in the presence of a magnetic field. If the marked object is present, the magnetic field of the magnetic marker is sensed by the magnetic field detector means, which modifies the electric signal. Yet, an operating room has many types of equipment which generate permanent magnetic fields. The presence of those fields can activate the magnetic field detector means, giving false detection. Because of its unreliability in an operating room, Greenberg's device is not a practical solution to the problem.

In United States Patent No. 5,057,095, Fabian proposes to mark surgical instruments with a marker adapted to produce identifying signal characteristics when exposed to an alternating magnetic field. He discloses three types of resonant markers that are able to resonate at a certain preselected frequency. The first marker is a magnetomechanical device comprised of a permanent magnet overlaying a magnetostrictive metal strip in a plastic housing. The magnetostrictive strip vibrates when the marker is exposed to an alternating electomagnetic field, and its resonance is detected when the frequency of the applied field reaches a ~c 1 4predetermined value. However, such devices are very sensitive to pressure and stress, which will inhibit them. Since a body cavity is under some pressure and the marker may be stressed during surgery, this type of marker is not reliable for use as a marker for surgical objects. The second proposed type is an electromechanical circuit comprised of an air coil, with or without a ferrite core, and a resonant structure such as a piezoelectric crystal. As the first type, this type of marker can be adversely affected by pressure and stress because its principle of detection relies on a it mechanical resonance; therefore, a piezoelectric crystal 4 type marker is also unsatisfactory. The third type of marker proposed by Fabian is an electromagnetic LCR &fit circuit. This type of marker can be either built out of discreet components or made of a flexible printed circuit. In the former case, this unit is expensive to build and bulky, and it is impractical for surgical sponges. In the latter case, due to its high electrical resonance frequency this type of marker can be adversely affected by the presence of metal objects and conductive media. Because the human body is conductive, it is also impractical for surgical sponges. Consequently, none of the markers proposed by Fabian, nor the Greenberg marker, has been available on the market.

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~nri variety of devices In United States Patent No. 5,045,071, McCormick teaches about the use of magnetic materials for accurately locating the position of a catheter which has been inserted into a blood vessel. At column 9, lines 12-16, the patent cross references U.S. Patents 4,416,289, 4,431,005 and 4,445,501 for an explanation of the general method of detection. At column 5, lines 41- 52, the '005 patent explains that a distortion of the magnetic field indicates the presence of the catheter.

Thus, the McCormick patent teaches that merely a change in the magnetic field is a sufficient indicator of the position of the marked object. However, McCormick's measurements can be affected by the presence of other nearby magnetic and conductive materials. Hence, McCormick's technique can and likely will provide "false positives" as to the presence or the position of the 7:,marked object.

Thus, there is a need for a marking method and AN: apparatus for detecting surgical objects within the human body utilizing a material that can be readily identified before the patient leaves the operating suite.

3. TechnicTues for Detecting Electromagnetic Material There are different ways of providing and detecting what we can call generically an 7i"electromagnetic marker." The cited prior art references

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-6all use materials which respond to an electromagnetic field. In order for a material to respond to an electromagnetic field and therefore to create "detectable changes" of the electromagnetic field, a material has to have at least one of the physical properties of electrical conductivity, moderate to high magnetic permeability, and magnetrostriction (in general associated with moderate magnetic permeability).

Moderate magnetic permeability is defined as a permeability comprised of between 5,000 and 20,000 and high magnetic permeability as a permeability above 20,000. In each case, the response to the electromagnetic field and, therefore, the creation of "detectable changes" of the electromagnetic field are heavily dependent upon the geometry and size of the marker. In addition, the response to the electromagnetic field depends upon the intensity and frequency of the electromagnetic field.

In general, a magnetic material subject to an *electromagnetic field of known and fixed frequency f.

fl~v responds to the applied electromagnetic field by creating -VtCC"changes" of the intensity of the applied field and by f C creating harmonics of the frequency If the material is electrically conductive, it responds by creating not only 'changes' of the intensity of the applied field but also "changes"f of the phase of the field. In addition, 44 7 if the material is magnetostrictive, the electromagnetic field creates strains or stress in the material, and the material responds to it by creating a frequency-dependent "change" of the intensity and of the phase of the applied field. Therefore, there are three methods of detection.

First, one can simply look for a change of intensity and/or phase in an applied magnetic field, a method which can only be used for detection of the position of an object at a distance comparable to the size of the object. McCormick uses this method. Second, one could look for the frequency of the applied field to reach a predetermined value that is the electromechnical resonance frequency of the marker. Fabian discloses a ;magnetomechanical device which uses this technique.

Finally, one could look for particular harmonics 6a6* generated by a material in the presence of an applied magnetic field. This method has never been used in a medical environment. Indeed, the teaching of Heltemes in United States Patent No. 4,857,891 indicates that the art Sh: as generally failed to recognize that "open-strip" markers made of selected nonmagnetostrictive materials which generate specific harmonic frequencies upon application of a unidirectional electromagnetic field can be used to identify the presence of particular articles.

Heltemes discloses a Magnetic Marker for Electronic Article Surveillance Systems having multiple 8filaments randomly dispersed in a sheet-like substrate so as to be substantially parallel to the plane thereof.

"The filaments are selected of low coercive force, high permeability material, and the random orientation results in certain filaments intersecting with them being magnetically coupled to other filaments to thereby collect and concentrate lines of flux associated with an applied field of an EAS system into filaments parallel to the field." To take advantage of a high magnetic permeability material a marker has to be elongated (fiber, long strip, with an aspect ratio length/square a.

root or cross-sectional area of a least 200). Heltemes complies only partially to this requirement, but randomly distributes the fibers. In this respect Heltemes defeats :this purpose because the applied electromagnetic field a has to be parallel to the magnetic fibers to generate a high enough level of high harmonics to be recognized as .marker specific. Moreover, Heltemes' marker is not very well suited for generating high harmonics. Consequently, Heltemes, like others in the prior art, failed to recognize that markers could be created for detection of surgical objects which generate specific, detectable, selected harmonic frequencies.

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''It II I(~ Summary of the Invention I provide a marker for a surgical object which responds to the presence of an alternating electromagnetic field. That response is detectable as discrete pulses of radio frequencies. The marker is comprised of at least one elongated member made of nonmagnetostrictive, soft magnetic material encapsulated with biocompatible material. Preferably, the magnetic material is an amorphous metal. However, crystalline materials can be used if the encapsulation material has a high flexibility and plasticity.

I further provide a method for detecting a surgical object within the human body which includes marking the surgical object with my marker, which will emit energy in the form of known frequencies when it is exposed to an alternating electromagnetic field.

Detection is made using a pulse detection technique similar to that used in magnetic resonance imaging (MRI), a common and safe diagnostic procedure. A patient is exposed to an alternating electromagnetic field of about 3-4 Ce (oersteds) for a specific time. This field will cause the elongated member to become magnetized and consequently to generate harmonics of the applied alternating electromagnetic field. A detector placed near the patient will detect the reflected waveform. from the marker as sharp signal peaks at the specific 1 frequency of the applied alternating electromagnetic field.

My marker is particularly useful for surgical sponges. However, other surgical tools forceps, scalpel), plastic or rubber/polymer- surgical implement or equipment used during surgery plastic drain, suction tubes), and implants F7-tificial veins, artificial arteries, knee repl,.cement) may also be marked.

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4000 *9 a 01 When the surgical object is a surgical sponge, the marker can be woven into the sponge. I also provide an improved method of attachirg thie device to a surgical sponge. When the surgical object is a surgical tool such as a forceps, the marker is placed on the tool by an adhesive means.

In the case where the surgical objecL is an implant, the method of detecting the surgical object can be used as a diagnosis of past medical histozy of implants. Each type of implant can contain a specific material or combination of materials that emits a specific signal that corresponds to that surgical object.

Thus, if the patient is incoherent, the doctor can diagnose the patient's past medical history of implants.

I prefer to performn the excitation and detection steps prior to the closing of the surgical incision. I can thereby prevent the usual infection that

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Other details, objects and advantages of the invention will become apparent as the following description of a present preferred embodiment thereof and a present preferred method of practicing the same proceeds.

Brief Description of the Drawings S: In the accompanying drawings I have shown a present preferred embodiment of the invention in which: Figure 1 is a perspective view partially cut .6 away of a present preferred marker; Figure 2 is a perspective view partially cut :away of a second preferred marker; *eo4# Figure 3 is a perspective view of a surgical S.°sponge having one and optionally two markers woven ~through the sponge; Figure 4 is a diagram of a detector of my oo marker; Figure 5 is a graph of responses of a detector in the presence of my marker; and Figure 6 is a perspective view of a pair of forceps having a marker positioned on the exterior handle surface. NPr '1 12 4* 4 .4 4.

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*Ctt CC It C S Detailed Description of the Preferred Embodiments As shown in Figure 1, my marker 2 is comprised of an elongated body 10 of soft magnetic material which is nonmagnetostrictive. It is characteristic of many ferromagnetic materials that even the slightest applied mechanical strain tends to cold work the material and degrade its permeability and other magnetic properties.

Nonmagnetostrictive magnetic materials are insensitive to strain; they have the required magnetic properties for my marker while they are also insensitive to work hardening.

Amorphous materials are very difficult to cold work.

Preferably, the material of my marker is a nonmagnetostrictive amorphous material with very soft magnetic properties. It should have high magnetic permeability, a low coercive field, and induction saturation should be as high as possible. One suitable material is sold by Allied under the trademark "Metglas." The composition of the alloy is recited in United States Patent No. 4,298,862 to Gregor et al. Thus, for example, Allied compositions identified as types 2826MB@ or 270qM may be preferably used. Another suitable amorphous material is Vitrovac 6025Z soft magnetic amorphous alloy with zero magnetostriction sold by Vacuumschmelze GmbH of Hanau, Germany. Although the marker body could be any dimension and shape, I prefer to make the elongated body as a ribbon or a strip or a set of parallel ribbons, LIT-i r -13 -13

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strips, fibers or filaments. The elongated geometry of these members allows me to take advantage of the high magnetic permeability of the materials. Preferably, the elongated members will have an aspect ratio (length/square root of cross-sectional area) of at least 200. Such a sufficiently large value for the aspect ratio will assure generation of a detectable signal according to the teachings of U.S. Pat. No. 3,665,449.

If the direction of an applied electromagnetic field is essentially parallel to the marker, and the intensity of the applied electromagnetic field is greater than a minimum field or threshold, then the marker will generate high harmonics. That is, the marker will emit a spectrum of harmonics whose intensity decreases slowly with the order of the harmonics in the spectrum. In particular, the 9th or the 11th harmonics should be detectable.

Other harmonics could also be detectable. I prefer the ribbon 10 to have a width less than 2 mm, a thickness ranging between 0.01 to 0.03 mm and a length of about to 7 cm. Body 10 could be longer or shorter.

The width and thickness of the ribbon 10 can be selected to obtain flexibility so that when the marker is attached to an object such as a surgical sponge, it will not adversely affect the flexibility of the object. I prefer to encapsulate the elongated body with a polymeric material that is compatible with the human body.

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1 i; 14 ft *s f ft ftt ft..' ft t f ft ft t 4 ftft ft ft ft *f t ft ft ftf* f ft..' ftC 4 f ft I- Suitable coating materials are nylon and delrin plastic.

The coating 12 prevents the body from oxidizing or reacting with body fluids and covers any sharp edges or corners of the ribbon In order to maximize the ratio of the length to the square root of the cross-sectional area, it has been fourd desirable that the material be as thin and as narrow as practical, defending upon off-setting production cost considerations. It is evident that fibers possess the required geometry. The metallic fiber which I prefer to use can be made in accordance with the teachings of U.S. Patents No. 5,003,291, 5,015,992, 5,015,993 and 5,027,886 by Strom-Olsen and Rudkowski.

These fibers are nonmagnetostrictive, amorphous magnetic materials with very high magnetic permeability.

Typically, the diameter of such fibers ranges between .01 and .04 mm.

I further provide marking means in the form of a flexible marker made of fiber laminated between two layers of polymeric materials. In order for detection to occur, one to approximately ten fibers should be placed parallel to each other, and each fiber should be approximately 1 to 3 inches in length. Such a multiple fiber marker assembly is shown in Figure 2. As shown, the marker of this invention comprises two layers 23 in the form of a web or ribbon of polymeric materials. I i ~I i

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-c r 1 provide a plurality of fibers 1la, lb and lic arranged parallel to eacb other and secured between the two layers 23 by adhesion or lamination means. As mentioned earlier and for the same reasons, I prefer to make use of a polymeric material that is compatible with the human body.

However, a marker made of a ribbon or fiber 1 0.* 00 Cr C C should be less than the length or the width of the surgical object or not so long that it would require significant bending or multiple folding for attachment to the object to be marked. When one is outside this preferred range, a response signal from the marker will be less characteristic and therefore more difficult to identify.

Although my markers would be X-ray detectable, one could impregnate the coating or layers with an X-ray opaque material such as a barium compound to improve detectability. Another possibility is to use an X-ray opaque coating material which is currently being used on medical products. Use of such material not only improves the detectability of the marker, but should also reduce the time needed to obtain government and hospital approval of use of the marker.

One could also use nonmagnetostrictive crystalline magnetic materials such as Permalloy alloy for the marker body 10. If a crystalline material is a_ 16 9 *9 9 99 999 4 99*9 19 I used, the cover layer of polymeric material should be designed to minimize the transfer of mechanical stress induced upon bending or folding the marker.

The surgical sponge 4 shown in Figure 3 is a gauze sponge having a marker 2 woven throughout the sponge. It is understood that other means of attachment or securing the marker 2 to the surgical sponge 4 can be used. The marker can be connected to the sponge by means of pressure, heat, adhesive or the like.

Either the marker of Figure 1 or the marker of Figure 2 could be used. I prefer to use markers which are shorter than a length or a diagonal of the sponge to avoid bending or folding. Optionally, I may use a second marker 32, shown in chainline, positioned at a right angle to the first marker 2. This configuration assures that the sponge will be detected regardless of its orientation with respect to the detector. One could use more than two markers on an object. But, as the number of markers increases, the response of the marked object to a detector will likely be less distinctive.

Therefore, I prefer to use one or two markers positioned as in Figure 3. This arrangement provides a distinctive response such as shown in Figure It is relatively easy to detect an object marked with my marker. Once the surgery procedure is completed, the surgeon exposes the surgical cavity to an i j i t

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r r; i-J,' -'b i: 1 17 *0 a, alternating electromagnetic field, using the detection system. Preferably, the patient will be on a nonmagnetic gurney or examination table. A very low magnetic field of approximately 3 to 4 Oe is all that is required. Such a field is relatively easy to establish and will not harm the patient or the equipment which is normally found in an operating room. If desired, one may use as little as Oe and as much as 6 Oe or higher. However, it is normally not practical to exceed 10 Oe because such high fields would interfere with other equipment present in an operating room. This magnetic field will cause the marker body attached to any surgical objects in the surgical cavity to emit specific harmonic frequencies corresponding to the selected marker material. That emission will cause a change in the alternating electromagnetic field, which change can be correlated to the presence of only the selected nonmagnetostrictive, soft magnetic marker material. The detection system can be designed to measure all changes in the applied electromagnetic field and then look for the specific change which would be caused by the presence of the marker. Alternatively, the detection system could be designed to measure only that change or a surrounding band of changes of the type which would be caused by the presence of the selected marker material.

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C C A number of techniques and variety of devices couid be used to detect the presence of the magnetized marker body attached to a surgical object left in the patient. Those techniques and devices should be apparent to those skilled in the art. The detection system circuitry with which the marker 2 is associated can be any system capable of generating within an interrogation zone an incident alternating electromagnetic field, and detecting magnetic field variations at selected harmonic frequencies produced in the vicinity of the interrogation zone by the presence of the marker therewithin. Such systems typically include means for transmitting a varying electrical current from an oscillator and amplifier through conductive coils that form a frame antenna capable of developing an alternating magnetic field.

A fairly simple detector is illustrated in Figure 4. A flat search coil 14 has a first section 13 wound in a clockwise direction from points A to B and a second section 15 with the same number of windings running in a counter-clockwise direction from points B to C. A frame inductor antenna 16 is placed near the search coil. If an AC current is passed through the inductor antenna, an alternating magnetic field will be created.

That field will induce a voltage through the search coil.

One can detect the voltage from points A to B and plot it

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a. on coordinates 34 in Figure 5 as a sine wave 23. The voltage from points B to C can be plotted as a sine wave 180 degrees out of phase from sine wave 25. If the two waves are plotted simultaneously, they will cancel each other and yield a straight line over the time-axis.

In the event a magnetized marker moves within the interrogation zone of coil 14, it will change the AC magnetic field received by the coil 14 and modify waves 23 and 25. For a single marker, that modification can be seen as a series of peaks 27 also shown in Figure 5 on coordinates 35. The points along the time-axis where peaks occur depend upon the size and composition of the marker. If too many markers are used, the peaks would flatten and approach a sine wave. Therefor I prefer not to use more than two markers, preferab. oriented as in Figure 3. The marker produces peaks at particular points along the x-axis. Thus, the detector looks for a response at those intervals. Only if a response occurs at the chosen points is a detection made. It is possible that equipment in the operating room, such as CRTs, will generate electromagnetic fields which will cause a detector response. However, the chances that such interference will produce peaks at the selected intervals is small. Hence, false detections are remote possibilities, and they can be eliminated by predetecting

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20 and electronically cancelling the signals of such equipment.

My markers can be used in other surgical equipment such as forceps, scalpels and hemostats.

Figure 6 shows a pair of forceps 6 which have a marker positioned along the handle. My markers can also be used to mark surgical implants. Hence, a physician could learn about an implant in the patient's past medical i history using my detection method. The area under suspicion of an implant will be excited at a specific frequency. If an implant exists in that area, it will emit energy over a specific spectrum of frequency which e corresponds to the specific implant material. For this diagnostic process to work, a standard must be used for all implants. Standard material should be used for each specific implant differing the material from one implant to another. In that event, the response will identify the specific implant.

I have shown and described the present i preferred embodiment of the invention. It is to be i distinctly understood that the invention is not limited i thereto, but may be otherwise variously embodied within A the scope of the following claims.

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Claims (12)

1. A detectable surgical object used in surgical procedures comprising: a) a surgical object; and b) a marker attached to the surgical object comprised of at least one marker comprised of at least one elongated body of a selected nonmagnetostrictive, soft magnetic material, each said at least one elongate body being parallel to any other elongate body such that said marker will emit a spectrum of harmonics which includes detectable high order harmonics, and which will emit known specific intensity of selected harmonic frequencies when exposed to an alternating electromagnetic field thereby causing a change in the alternating electromagnetic field which change can be correlated to the presence of only the selected nonmagnetostrictive, soft magnetic material.

2. The detectable surgical object of claim 1 wherein the surgical object is a surgical sponge.

3. The detectable surgical object of claim 2 wherein the marker is woven into the sponge.

4. The detectable surgical object of claim 1 wherein the coating is radio opaque.

5. The detectable surgical object of claim 1 wherein the marker comprises a soft magnetic amorphous material.

6. The detectable surgical object of claim 1 wherein the marker comprises a ribbon of soft magnetic amorphous material.

7. The detectable surgical object of claim 1 also comprising a biocompatible coating encapsulating the marker. *r I I I I. r i I It II *i t a 4' 0 -C)I CL:E c o. t;C, 0NRL I, i7 22

8. The detectable surgical object of claim 1 wherein the marker comprises at least one fibre of soft magnetic amorphous material.

9. The detectable surgical object of claim 1 wherein the marker comprises a soft magnetic crystalline material.

The detectable surgical object of claim 1 wherein the marker comprises a ribbon of soft magnetic crystalline material.

11. The detectable surgical object of claim 1 wherein the marker comprises at least one fibre of soft magnetic crystalline material.

12. The detectable surgical object of claim 1 wherein the at least one elongated body has an aspect ratio of at least 200. DATED this 15th day of June 1998. DENNIS W. SZYMAITIS tt i i WATERMARK PATENT TRADEMARK ATTORNEYS I 290 BURWOOD ROAD Sit' HAWTHORN VICTORIA 3122 AUSTRALIA i t SKP/JMK/RES :VAX DOC021 AU2037295.WPC it C t C W TC Si. tr 6 It 6 6 6 o t 66 I t c I If It 61 I I Abstract of the Disclosure An apparatus and method for detecting surgical objects within the human body where the apparatus includes the surgical object utilized in surgical procedures including a marker made of a selected nonmagnetostrictive, soft magnetic material which will emit known specific selected harmonic frequencies when exposed to an alternating electromagnetic field. That emission will cause a change in the alternating electromagnetic field which can be correlated to the presence of only the selected nonmagnetostrictive, soft magnetic material. I I 4f