Microwave antenna apparatus, systems and methods for localizing markers or tissue structures within a body

The present application relates to antenna devices, systems and methods for assisting surgical procedures. In particular, the present application is intended to locate tags, markers, lesions, and / or other body tissues in a patient's body during surgical or other procedures, such as during tumor removal surgery. Regarding microwave antenna devices, systems and methods.

Lesions must be located prior to biopsy or surgical procedures to remove lesions in the chest, such as tumor removal surgery. For example, mammography or ultrasound imaging is used to locate and / or locate lesions before treatment. The resulting image is used by the surgeon during a procedure to locate and guide the surgeon, eg, during an incision to access and / or remove the lesion. However, since such images are generally two-dimensional and the chest and lesions to be removed are three-dimensional structures, they provide only a limited guide for lesion positioning. Moreover, such images also provide a limited guide to determine the appropriate margin around the lesion, i.e., to define the desired biometrics to be removed.

To facilitate positioning just prior to the procedure, a wire is inserted into the chest, eg, via an injection needle, so that the tip of the wire is positioned at the location of the lesion. Once the wire is positioned, it is fixed in place, for example, using a bandage or tape applied to the patient's skin as it emerges from the chest. A wire that is positioned and fixed in place allows the patient to proceed with surgery, for example, performing a biopsy or tumor resection surgery.

One problem with using wires for positioning is that the wires move between positioning and surgical procedures. For example, if the wire is not adequately anchored, the wire will move relative to the tract used to access the lesion, resulting in the tip inaccurately telling the location of the lesion. When this happens, the lesion is not sufficiently removed and / or healthy tissue is unnecessarily removed when the location is accessed. Also, during the procedure, the surgeon simply estimates the location of the tip of the wire and the lesion, based on, for example, a mammogram or other image obtained while the wire is being placed, and proceeds with the surgery without any other further guidance. .. Again, because such images are two-dimensional, they provide only limited guides for positioning lesions to be treated or removed.

Alternatively, it is suggested to place a radioactive seed to provide positioning during the procedure. For example, a needle can be introduced into the lesion through the chest and the seed can be deployed from the needle. The needle is pulled out and the position of the seed is confirmed using mammography. During the subsequent surgical procedure, a handheld gamma probe is placed on the chest to identify the location of the seed. An incision is made and the probe is used to guide the resection of seeds and lesions.

Since the seed is supplied via a needle that is removed immediately afterwards, there is a risk that the seed will move within the patient's body during positioning and during surgical procedures. Therefore, as with the use of positioning wires, the seed cannot accurately identify the location of the lesion, especially because there is no external method for fixing the seed once it has been placed. Moreover, such gamma probes cannot provide predetermined accuracy, for example, in identifying seed positions in three dimensions, and therefore provide only limited guidance in lesion positioning.

Therefore, devices and methods for positioning lesions or other tissue structures prior to and / or during surgical procedures, diagnostic methods or other medical procedures are beneficial.

The present invention is directed to devices, systems and methods for performing surgical procedures or other medical procedures. More specifically, the present invention describes tags, targets, markers, lesions, and lesions within a patient during surgical or other medical procedure, eg, to locate chest lesions before or during tumor removal surgery. / Or directed to antenna devices, systems and methods for finding the location of other tissue structures.

According to one embodiment, the target comprises one or more markers or targets; and probes for transmitting and receiving electromagnetic signals; to locate the target tissue area in the patient's body. A system is provided for detecting a target after being introduced into the tissue area to be, the probe is placed near the target tissue area, and / or directed to that tissue. The probe includes one or more devices that provide spatial information based on the spatial relationship of the target to the probe, such as the distance and / or angular direction between the probe and the target, such as a display, speaker, etc. be able to. Optionally, the system also introduces the target into tissue or into the patient's body, including, for example, an injection needle, a cannula, or other tubing member that can mount one or more targets within it. Can include one or more feeders.

In a typical embodiment, the target can include a plurality of angled surfaces that can enhance the reflection of electromagnetic signals from the probe, eg, as the target provides a passive marker. For example, the target can be an elongated marker that combines with the core element to include multiple beads containing angled faces and / or edges that enhance detection by the probe. The core elements can be biased towards one or more predetermined shapes, such as corrugated, tapered spirals, cylindrical spirals, etc., and are still straight to facilitate the mounting of markers on the feeder, for example. It has sufficient elasticity. In other embodiments, the target can include, for example, a spherical shape, an elliptical shape, a disc shape, or another shape that includes one or more surface features that enhance the reflection of electromagnetic signals.

Optionally, the target can include one or more circuits, features, etc. that modulate the input signal from the probe to facilitate the identification of the target, eg, as the target provides an active reflection marker. For example, the target can give a phase shift to the signal from the probe that attacks the target so as to distinguish the target from other targets, tissue structures, and the like. In other options, the target can include circuits and power supplies that allow the target to generate a given signal depending on the point of view of the signal from the probe, eg, to provide an active transponder marker.

Optionally, the target can include a marker coupled to an elongated flexible tether so that it is releasable or virtually irremovable. Alternatively, the target can include a positioning wire that includes a shaft and a marker on the distal end of the shaft.

According to other examples, one or more markers or targets of the size required to be implanted in or around the target tissue area to locate the target tissue area in the patient's body; And, including probes for transmitting or receiving electromagnetic signals; when the probe is placed near and / or directed at the target tissue area, the target tissue area. A system is provided for detecting one or more markers implanted in or around.

In a typical embodiment, the feeding device has a proximal end and a distal end, and is sized to feed through the tissue in the patient's body into the target tissue area, and a shaft thereof. It can include one or more markers reachable from the distal end. For example, the shaft can include lumens, and multiple markers are implanted such that the markers are substantially fed from the shaft and implanted in or around the lesion or other target tissue area. It is carried in the opposite direction. Expandable markers supplied by the feeder can include passive markers, active markers, and active transponder markers.

A method for finding the location of a target tissue region within the patient's body, according to yet another embodiment, in which a marker or other target is introduced through the tissue into the target tissue region; It includes the steps of placing the probe on or near the target tissue area and / or towards the target tissue area; and driving the probe; thereby causing the probe to be electromagnetic. A method of transmitting spatial information to a target tissue area, receiving an electromagnetic signal reflected from the target, or providing spatial information to provide a spatial relationship between the target and the probe. Provided.

In certain embodiments, the target can be a positioning wire that carries the target and is introduced through the tissue into the target tissue area. In other embodiments, the target can be one or more markers implanted within the target tissue area. In yet another embodiment, the target can be, for example, a catheter or other device that is introduced into the target area and deployed to draw a volume or area. The device can include spatial features configured to find and / or define volume, for example using an electromagnetic probe. Optionally, the target is placed before or between diagnostic, therapeutic and / or surgical procedures, for example using stereotactic fixation, ultrasound or electromagnetic wave based imaging.

In a typical embodiment, the target tissue area includes an area in the chest of a patient having a lesion therein, and the target is placed in or around the lesion. Alternatively, the target tissue region is located in another region of the body, such as inside or around the intestine, fallopian tubes, and the like. For example, the target may include a first marker that is introduced into the target tissue area away from the lesion to define the desired margin for removal of sample volume from the target tissue area. it can. Optionally, a second marker and / or multiple additional markers are introduced into the lesion and the target tissue area away from the first marker to further define the desired margin. Therefore, if necessary, a three-dimensional array of markers is placed within or around the target tissue area to facilitate its positioning. Tissue samples containing lesions and targets are then removed from the target tissue area.

According to still another embodiment, a method for removing a lesion in a target tissue area of a patient's chest, which comprises the step of introducing the target into the target tissue area through the chest tissue. Provided. The probe is placed near the patient's skin, which is generally oriented towards the target tissue region, and the probe sends an electromagnetic signal towards the target tissue region and receives the electromagnetic signal reflected from the target. And provide spatial information to provide the spatial relationship between the target and the probe. Tissue samples containing lesions and targets are removed from the target tissue area.

A method for removing lesions in a target tissue area of a patient's chest according to still another embodiment, the step of introducing the target into the target tissue area through the chest tissue; targeting. The process of placing a probe that sends an electromagnetic signal towards a tissue area and receives an electromagnetic signal reflected from a target, eg, near the patient's skin that is generally oriented towards the target tissue area; The step of using a probe to determine the desired margin within the surrounding target tissue region; and the step of removing the tissue sample containing the lesion and target as defined by the desired margin from the target tissue region; Methods are provided that include.

According to yet another embodiment, an implantable marker for locating a target tissue area within the patient's body, the implantable marker comprising an elongated core member and multiple beads carried by the core member. Provided. Optionally, the bead can include multiple surfaces and / or edges that enhance the reflection of electromagnetic signals to facilitate marker identification. In addition to or otherwise, the marker can include an electrical circuit that is embedded in or carried by either the bead or the core member to provide either an active reflector and an active transponder.

According to certain embodiments, a method for finding the location of a marker in the body is provided. The method can include the step of transmitting a transmitted signal into the body by a transmitting antenna. The transmitting antenna is housed at the tip of the probe. The method can also include the step of receiving the received signal reflected from the marker by the receiving antenna. Like the transmitting antenna, the receiving antenna is also housed at the tip of the probe. The method can also include, by at least one processor, calculating the time difference between when the transmit signal is sent by the transmit antenna and when the receive signal is received by the receive antenna. In addition, the method can include the step of determining the distance from the tip of the probe to the marker by using a time lag by at least one processor. Furthermore, the method can include displaying the distance from the tip of the probe to the marker on the display.

In a typical embodiment, the transmission signal can be a pulse signal. The method also uses a signal generator to generate an oscillating signal; a step of sending the oscillating signal to a transmitting antenna; and a transmitting antenna (which basically acts as a bandpass filter (BPF)) to generate the oscillating signal. The step of converting into a pulse signal; can be included. In a typical embodiment, the vibration signal can be a square wave signal, a triangular wave signal, or a sinusoidal signal, the signal generator can be a reference oscillator, and / or at least one processor. Can be a digital signal processor (DSP).

According to an embodiment, the transmitting antenna can be a bowtie type antenna element and the receiving antenna can be a bowtie type antenna element. For example, both the transmitting antenna and the receiving antenna can form a Maltese cross type antenna. Ceramic elements can also be mounted on top of transmit and receive antennas for impedance matching. Both the transmitting antenna and the receiving antenna may be either linearly polarized light or circularly polarized light. The polarization of the receiving antenna can be the cross-polarization of the polarization of the transmitting antenna (eg, the transmitting antenna can be horizontal polarized light and the receiving antenna can be vertically polarized light). The transmission signal is swept by a predetermined increase in the frequency of the transmission signal from the start frequency to the stop frequency.

According to an embodiment, the display of the distance from the tip of the probe to the marker is performed by displaying a numerical value representing the distance in units of length. Alternatively, or additionally, the display of the distance from the tip of the probe to the marker is performed by displaying a graphic image representing the marker, the probe, and the display of the distance from the tip of the probe to the marker.

According to certain embodiments, the method can further include the step of measuring the angle at which the probe tilts with respect to the marker by an accelerometer, using the time difference and the tilt angle of the probe by at least one processor, the tip of the probe. Can include the step of determining the position of the marker with respect to. In a typical embodiment, the method can further include the step of measuring the amplitude of the received signal by at least one processor, using the amplitude of the signal received by at least one processor as a marker. Can include the step of determining the orientation in which the probe is located with respect to the tip of the probe.

According to other embodiments, a system for finding the location of the marker in the body is provided. The system can include a transmitting antenna for transmitting a transmitting signal into the body. The transmitting antenna can be housed at the tip of the probe. The system can also include a receiving antenna for receiving the received signal reflected from the marker. The receiving antenna can be housed at the tip of the probe. In addition, the system uses the time difference to calculate the time difference between the time the transmitted signal was sent by the transmitting antenna and the time the received signal was received by the receiving antenna, and using the time difference from the tip of the probe to the marker. At least one processor can be included to determine the distance. Furthermore, the system can include a display that displays the distance from the tip of the probe to the marker.

In a typical embodiment, the transmission signal can be a pulse signal. The system can further include a signal generator that generates a vibration signal sent to the transmitting antenna and that converts the vibration signal into a pulse signal. In a typical embodiment, the vibration signal can be a square wave signal, a triangular wave signal, or a sinusoidal signal, the signal generator can be a reference oscillator, and / or at least one processor. Can be a digital signal processor (DSP).

According to certain embodiments, the transmitting antenna can be a bowtie antenna element and the receiving antenna can be a bowtie antenna element. Both the transmitting antenna and the receiving antenna can form a Maltese cross type antenna. The system can further include ceramic elements mounted on the top of the transmit and receive antennas for impedance matching. Both the transmitting antenna and the receiving antenna may be either linearly polarized light or circularly polarized light. The polarization of the receiving antenna can be the cross-polarization of the polarization of the transmitting antenna. The transmission signal is swept by a predetermined increase in the frequency of the transmission signal from the start frequency to the stop frequency.

In a typical embodiment, the distance from the tip of the probe to the marker is displayed as a numerical value representing the distance in units of length. Additional or or the distance from the tip of the probe to the marker is displayed as a graphic image representing the marker, the probe and the distance from the tip of the probe to the marker.

According to certain embodiments, the system can further include an accelerometer that measures the angle at which the probe tilts with respect to the marker, and at least one processor also uses the time difference and the tilt angle of the probe with respect to the tip of the probe. The position of the marker can be determined. At least one processor can also measure the amplitude of the received signal and the amplitude of the received signal can be used to determine the direction in which the marker is located with respect to the tip of the probe.

According to still another embodiment, a probe device for locating a marker in the body is provided. The device can include a transmitting antenna for transmitting a transmitting signal into the body. The transmitting antenna can be housed at the tip of the probe. The device can also include a receiving antenna for receiving the received signal reflected from the marker. The receiving antenna can be housed at the tip of the probe. The device also markers from the tip of the probe to calculate the time difference between the time the transmitted signal was sent by the transmitting antenna and the time the received signal was received by the receiving antenna, and based on at least part of the time difference. At least one processor can be included to determine the distance to.

In a typical embodiment, the device can further include a signal generator that generates a vibration signal sent to the transmitting antenna and that converts the vibration signal into a pulse signal. The device can further include ceramic elements mounted on the tops of the transmit and receive antennas for impedance matching.

According to certain embodiments, the device further determines the position of the marker with respect to the tip of the probe based on an accelerometer that measures the angle at which the probe tilts with respect to the marker, and at least part of the time difference and the tilt angle of the probe. Can include one processor.

According to yet another embodiment, a system for locating a target tissue area within the patient's body, introduced into one or more passive tags, markers or targets; and the target tissue area. To detect the post-target, a system with probes for transmitting and receiving electromagnetic signals; is provided, and the probes are placed near and / or towards the target tissue area. The probe also provides an energy generator, for example, to provide a pulse of energy to the target to open or close the switch or activate the target in a predetermined manner to facilitate the identification of the target. Including. In one embodiment, the energy source has sufficient transmission through tissue to the tag implanted in the patient's body to activate and / or power the tag, eg, infrared. It can be a light source capable of transmitting light such as.

Optionally, the probe includes one or more output devices such as a display, a speaker, etc. that provide spatial information based on the spatial relationship to the probe, such as the distance between the probe and the target and / or the angular direction. be able to. Optionally, the system also comprises one or more supplies for introducing the target into the tissue or into the patient's body, including, for example, an injection needle, a cannula or other tubular member carrying one or more targets inside. The device can be included.

In a typical embodiment, the target can be a passive tag that includes an electrical circuit to modulate the electromagnetic signal to enhance the detection of the target by the probe. The target can also include a plurality of angled beads or other components to enhance the reflection of electromagnetic signals from the probe. In general, an electrical circuit can include an energy transducer or power source for converting energy pulses from a probe into electrical energy, and a switch that opens and closes when electrical energy is generated by the power source. .. In a typical embodiment, the tag is, for example, one or more photosensitive diodes for converting light from a probe into electrical energy, which activates one or more components of an electrical circuit to generate a predetermined voltage. Other parts can be included. In other embodiments, the probe can transmit other forms of energy, such as high frequency (RF) energy, vibrational energy, and the electrical circuit transmits incident energy to activate the electrical circuit. It can include a device for doing so.

Since the electric circuit alternately opens and closes the switch to modulate the signal reflected by the tag and returned to the probe, the energy pulse received from the probe can be used as a power source, for example, an electric field transistor or a Schottky diode. Can include a switch. For example, the circuit can change the phase of the signal from the probe, which can enhance target identification and / or positioning. For example, the signal from the probe can be pulsed, and the probe can use subtraction to facilitate the analysis of the reflected signal, which can substantially increase the signal-to-noise ratio to enhance target identification.

Other aspects and features of the invention will become apparent by considering the following along with the accompanying drawings.

These and other features, aspects and effects of this disclosure will be better understood with respect to the following statements, attached claims, attached drawings, here:<figref num="1">FIG. 1 is a front view of a typical embodiment of a system for locating a target tissue area within the body, including positioning wires and probes.</figref><figref num="2">FIG. 2A is a front view of a patient's body torso showing the positioning wire of FIG. 1 inserted into a target tissue area within the chest, such as a tumor or other lesion. FIG. 2B is a cross-sectional view of the chest taken along line 2B-2B of FIG. 2A, showing the target on a positioning wire located within the tissue area of interest.</figref><figref num="3">FIG. 3 is used to make a first distance measurement of the positioning wire to the target, eg, to determine the distance from the skin to the lesion, the desired margin and / or the size of the sample to be removed from the chest. , FIG. 1 is a cross-sectional view of the chest shown in FIGS. 2A and 2B, showing the probe of FIG.</figref><figref num="4">FIG. 4 shows a probe used to make a second distance measurement, eg, to determine if the sample to be removed is sufficiently incised to reach the desired margin. It is a cross-sectional view of the chest shown in FIGS. 2A, 2B and 3 after the first incision was made.</figref><figref num="5">FIG. 5 shows a probe used to make a third distance measurement, eg, to confirm that the desired margin around the lesion has been achieved, excised from the chest in FIGS. 2A and 2B. It is sectional drawing of the tissue sample.</figref><figref num="6">FIG. 6 is a perspective view of the chest showing a feeding device used to feed a plurality of markers around one or more lesions, such as a non-palpable lesion in the chest.</figref><figref num="7">FIG. 7 is a cross-sectional view of the chest of FIG. 6 showing a plurality of markers placed around the lesion.</figref><figref num="8">FIG. 8 shows a probe used to measure a first set of distance measurements, eg, to determine the distance to one or more positions of a marker, of the chest shown in FIGS. 6 and 7. It is a cross-sectional view.</figref><figref num="9">FIG. 9 shows a cross section of the chest shown in Figure 6-8, showing a probe used to facilitate an incision to a marker, eg, to define the desired margin around the sample to be removed from the chest. It is a figure.</figref><figref num="10">FIG. 10 is a diagram showing typical examples of probes included in various systems for determining the location of markers. FIG. 10A is a typical display output provided on a probe such as the probe device shown in FIG. FIG. 10B is a cross-sectional view of the antenna provided on the probe, as shown in FIG.</figref><figref num="11">FIG. 11 is for locating a target tissue area within the body, including a marker implanted in the chest and a probe device containing a portable probe for placing the marker and a controller attached to the probe. Other typical examples of the system are shown.</figref><figref num="12">FIG. 12 is a side view of the system of FIG. 11 used to place markers to facilitate removal of tissue samples from the chest containing lesions.</figref><figref num="13">FIG. 13 is a side view of the system of FIG. 11 used to place markers to facilitate removal of tissue samples from the chest containing lesions.</figref><figref num="14">FIG. 14 is a side view of the system of FIG. 11 used to place markers to facilitate removal of tissue samples from the chest containing lesions. FIG. 14A is a detail from FIG. 14 showing the probe used to place the marker and thereby identify the desired margin for the tissue sample to be removed from the chest.</figref><figref num="15">FIG. 15 is a side view of the system of FIG. 11 used to place markers to facilitate removal of tissue samples from the chest containing lesions. FIG. 15A is a detail from FIG. 15 showing a probe used to place a marker and thereby confirm that the desired margin for the removed tissue sample has been achieved.</figref><figref num="16">FIG. 16A is a perspective view of another typical embodiment of a probe device including a finger cot with an integrated probe and a controller coupled to the probe. FIG. 16B is a detailed side view of the finger cot of FIG. 16A showing the fingers accepted within it.</figref><figref num="17">FIG. 17 is a cross-sectional view of the chest showing markers implanted near the lesion and placed using the probe devices of FIGS. 16A and 16B during an incision in the chest tissue to remove a tissue sample containing the lesion. Is.</figref><figref num="18">FIG. 18 is a cross-sectional view of the chest showing markers implanted near the lesion and placed using the probe devices of FIGS. 16A and 16B during an incision in the chest tissue to remove a tissue sample containing the lesion. Is.</figref><figref num="19">FIG. 19 is a side view of yet another typical embodiment of a probe device including a probe carrying cannula and a controller coupled to the probe. FIG. 19A is a detail of the pointed distal end of the cannula of FIG. 19 showing the probe inside.</figref><figref num="20">FIG. 20 is a cross-sectional view of the chest showing a method for placing a cannula in the chest to have a marker implanted in the vicinity of the lesion and to provide access to the site of the lesion.</figref><figref num="21">FIG. 21 is a cross-sectional view of the chest showing a method for placing a cannula in the chest to have a marker implanted in the vicinity of the lesion and to provide access to the site of the lesion.</figref><figref num="22">FIG. 22 is a cross-sectional view of the chest showing a method for placing a cannula in the chest to have a marker implanted in the vicinity of the lesion and to provide access to the site of the lesion.</figref><figref num="23">FIG. 23A is a side view of a first typical embodiment of an elongated marker implanted in tissue and placed using a probe. FIG. 23B is a cross-sectional view of the marker of FIG. 23A obtained along line 23B-23B. FIG. 23C is an end view of the marker of FIG. 23A. FIG. 23D is a side view of the marker of FIGS. 23A-23C having the waveform of the unfolded structure.</figref><figref num="24">24A-24C are perspective, end-view and side views of the beads used to create implantable markers, respectively, as in FIGS. 23A-23D.</figref><figref num="25">FIG. 25A is a side view of another embodiment of an elongated marker implanted and placed in tissue using a probe. FIG. 25B is a detail of the marker of FIG. 24A showing the features incorporated in the surface finish of the marker.</figref><figref num="26">26A-26C are side views, perspectives and end views of yet another embodiment of an elongated marker having a helical structure that is implanted and placed in tissue using a probe, respectively.</figref><figref num="27">27A-27C are perspective, end-view and side views of typical embodiments of spherical markers that are implanted and placed in tissue using probes, respectively.</figref><figref num="28">28A-28C are perspective views of other examples of spherical markers that are implanted and placed in tissue using a probe.</figref><figref num="29">29A and 28B are side views of a typical embodiment of a supply cannula used to supply the marker of FIG. 25 into the chest.</figref><figref num="30">FIG. 30A is a side view of another typical embodiment of a supply cannula for supplying a marker. FIG. 30B is a cross-sectional view of the feed cannula of FIG. 30A obtained along line 30B-30B.</figref><figref num="31">FIG. 31A is a side view of the supply cannulas of FIGS. 30A and 30B after feeding the marker. FIG. 31B is a cross-sectional view of the feed cannula of FIG. 31A obtained along line 31B-31B.</figref><figref num="32">FIG. 32 is a cross-sectional view of the chest showing a method for implanting the marker of FIG. 25 within the chest using the feed cannula of FIGS. 30A-31B. FIG. 32A shows the details of the markers implanted in the chest as shown in FIGS. 32 and 33, respectively.</figref><figref num="33">FIG. 33 is a cross-sectional view of the chest showing a method for implanting the marker of FIG. 25 within the chest using the feed cannula of FIGS. 30A-31B. FIG. 33A shows the details of the markers implanted in the chest as shown in FIGS. 32 and 33, respectively.</figref><figref num="34">34A and 34B are side and bottom views of yet another typical example of a marker for implantation in tissue, respectively.</figref><figref num="35">FIG. 35 shows another embodiment of a marker device comprising the markers of FIGS. 34A and 34B coupled to an elongated dessert.</figref><figref num="36">FIG. 36 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 35 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="37">FIG. 37 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 35 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="38">FIG. 38 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 35 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="39">FIG. 39 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 35 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="40">FIG. 40 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 35 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="41">41A and 41B are side and bottom views of yet another typical example of a marker for implantation in tissue, respectively.</figref><figref num="42">FIG. 42 shows another embodiment of a marker device comprising the markers of FIGS. 36A and 36B coupled to an elongated tether.</figref><figref num="43">FIG. 43 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 42 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="44">FIG. 44 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 42 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="45">FIG. 45 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 42 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="46">FIG. 46 is a cross-sectional view of the chest showing a feeder for feeding the marker of FIG. 42 and a method for introducing the feeder into the chest to implant the marker in the vicinity of one or more lesions. is there.</figref><figref num="47">FIG. 47 is a cross-sectional view of the patient's body showing markers introduced into the patient's gastrointestinal system.</figref><figref num="48">FIG. 48 details the markers introduced into the patient's body as shown in FIG.</figref><figref num="49">FIG. 49 is a detail of the patient's body of FIG. 47 showing a device to be introduced into the patient's body based at least in part on the position of a marker introduced into the patient's gastrointestinal system for surgery.</figref><figref num="50">FIG. 50A is a graphical representation of the signal from the probe that hits and is reflected from the marker, while FIG. 50B shows the phase shift between the input signal and the reflected signal.</figref><figref num="51">FIG. 51 is a flow chart of a typical embodiment of a method using a microwave antenna probe for finding the location of a marker in the body.</figref><figref num="52">FIG. 52 is a cross-sectional view of the chest showing a typical microwave antenna probe performing methods such as the method of FIG. 51 for locating markers.</figref><figref num="53">FIG. 53 is a cross-sectional view of the chest showing a typical microwave antenna probe performing methods such as the method of FIG. 51 for locating markers.</figref><figref num="54">FIG. 54 is a schematic representation of typical components of the system for finding the location of markers, performing the method of FIG. 51, for example.</figref><figref num="55">FIG. 55 is a block diagram showing typical components of the probe of FIG. 54.</figref><figref num="56">56A and 56B are side views of a typical embodiment of an antenna structure provided on a probe such as the probe of FIG. 54. FIG. 56C is a typical embodiment of a transmit or receive antenna provided on a probe such as the probe of FIG. 54.</figref><figref num="57">FIG. 57 is a perspective view showing a transmitting antenna and a receiving antenna combined to form a Maltese cross-type antenna provided on a probe such as the probe of FIG. 54.</figref><figref num="58">58A and 58B are perspective details of the Maltese cross antenna shown in FIG. 57.</figref><figref num="59">59A and 59B are perspective views and side views of other examples of antenna probes included in the system as shown in FIG. 54, respectively. FIG. 59C is a partially expanded view of the probe of FIG. 59A. FIG. 59D is a cross-sectional view of the tip of the probe of FIG. 59A obtained along the lines 59D-59D.</figref><figref num="60">FIG. 60 is a perspective view of the antenna Cebu assembly included in the probe of FIG. 59A.</figref><figref num="61">61A-61C are perspective, plan and bottom views of the antenna elements of the antenna subassembly of FIG. 60, respectively.</figref><figref num="62">FIG. 62 is a side view of a typical embodiment of a probe and a target implanted in the chest.</figref><figref num="63">FIG. 63 is a bottom view of the distal end of the probe of FIG. 62.</figref><figref num="64">64A and 64B are perspective views of a typical example of a passive tag targeted in the system shown in FIG. 62. 64C and 64D are side and bottom views of the passive tags of FIGS. 64A and 64B, respectively.</figref><figref num="65">FIG. 65 is a typical example of a schematic diagram of the circuit contained within the passive tags of FIGS. 64A-64D.</figref><figref num="66">FIG. 66 is a diagram demonstrating the operation of the switches in the circuit of FIG. 65.</figref>

In the following description, a number of details are described to provide a more complete description of the system. However, it is clear to those skilled in the art that the disclosed systems can be implemented without their specific details. In other cases, well-known features are not described in detail so as not to unnecessarily obscure the system.

With reference to the drawings, FIG. 1 is typical of a system 10 for positioning targeted tissue regions within the patient's body, such as tumors, lesions or other tissue structures, within the chest or elsewhere in the body. Example is shown. The system 10 typically includes a marker device or positioning wire 20, and a probe 30 for detecting at least a portion of the positioning wire 20 using other signals such as electromagnetic pulses, waves or lasers. The positioning wire 20 may have an elongated member or shaft that includes a target 26 on the proximal end 22a, the distal end 22b and the distal end 22b. Optionally, the system 10 may include one or more additional positioning determination wires and / or targets (not shown) in addition to the positioning wires 20.

The shaft 22 is formed from, for example, a solid rod or a hollow tubular body relatively rigid material having sufficient column strength to facilitate the percutaneous introduction of the positioning wire 20 through the tissue. The shaft 22 can have a length sufficiently extending from a position outside the patient's body through the tissue to the target tissue area, for example between about 0.5 and 10 cm (0.5-10 cm). Optionally, the shaft 22 can be malleable or plastically deformable, eg, so that the shaft 22 can be tilted or formed into a desired shape, if desired.

The target 26 includes one or more features on the distal end 22b of the shaft 22 to facilitate positioning of the distal end 22b using the probe 30. In the typical embodiment shown here, the target 26 is, for example, a sphere between about 0.5 and 5 millimeters (0.5-5 mm), for example a sphere having a diameter larger than the distal end 22b of the shaft 22. It can have a spherical structure. Optionally, the target 26 can include one or more features to facilitate the reception and reflection of electromagnetic signals. For example, the target 26 can be formed from one or more materials and / or enhance radar identification, for example as markers described elsewhere in the specification. In another embodiment, similar to the other embodiments in this document, other embodiments that include one or more corners and / or edges that improve radar reflection and / or detection, such as cubes, triangles, spirals, etc. Shapes and / or shapes may be provided.

In addition or instead, the target 26 can have a size and / or shape that approximates the size and / or shape of the lesion 42, eg, to facilitate the identification of the desired margin around the lesion 42. For example, the size and / or shape of lesion 42 can be determined in advance, and target 26 can be selected from a set of targets of different sizes and / or shapes and can be anchored to shaft 22 (or each). The target is located on its own shaft). If, in addition to or instead, multiple positioning wires and / or targets are provided, each target will have a different shape and shape and, for example, using probe 30 to facilitate distinction between the target and other targets. / Or can have features.

In one embodiment, the shaft 22 and the target 26 can be integrally formed from the same material. Also, the target 26 can be formed from a different material than the shaft 22, and the target 26 can be distant by, for example, adhesive bonding, welding, soldering, clasping, threads or other collaborative connectors. It can be fixed at the position end 22b. Thus, in this variant, the target 26 can be formed from a material that enhances radar identification of the shaft 22.

Optionally, when multiple targets are implanted, each target has surface, shape and / or additional material features that distinguish a particular target from one or more other targets. Can be done. For example, each target can absorb or reflect a particular electromagnetic signal that is specific to that target and is used to uniquely identify it.

In another option, the positioning wire 20 is located, for example, on the distal end 22b near the target 26, even though the anchor element 24 is unnecessarily sufficient for the target 26 itself to stabilize the positioning wire 20. It can contain one or more anchor elements 24.

As shown, the anchor element 24 includes, for example, a plurality of returns 24 (here, two are shown) extending across the shaft 22, angled adjacent to and away from the target 26. Thus, after the positioning wire 20 has been inserted into the tissue, the return 24 allows the positioning wire 20 to advance distally through the tissue, eg, preventing subsequent proximal detachment. The positioning wire 20 can be configured to be anchored at a predetermined position. For example, the return 24 may be sufficient for the return 24 to be compressed with respect to or in the vicinity of the shaft 22, for example to minimize the profile of the positioning wire 20 to facilitate forward movement. It can have flexibility, but on the other hand, it can be elastically biased to return outward with respect to the transverse direction, as shown.

The probe 30 can be a portable device capable of transmitting and receiving electromagnetic signals, such as an impulse radar (MIR) probe with low power consumption. For example, as shown in FIG. 1, the probe 30 is intended to be placed on or near the tissue, such as the patient's skin or tissue beneath it, at the first end 30a. And, for example, a mobile terminal including a second opposed end 30b held by the user. With additional reference to FIG. 10, probe 30 can include one or more antennas, such as transmit antenna 32 and receive antenna 34, one or more processors or controllers 36, and display 38.

Returning to FIG. 10, processor 36 needs one or more controllers, circuits, and signals to generate signals for transmission by transmit antenna 32 and / or process signals received from receive antenna 34. It can include generators, gates, etc. (not shown). The components of the processor 36 can optionally include individual components, semiconductor devices, programmable devices, software components and the like. For example, as shown, the probe 30 is an impulse generator 36b, such as a pulse generator and / or a pseudo-noise generator (not shown), coupled with a transmitting antenna 32, for example to generate a transmitting signal, and It can include an impulse receiver 36c, for receiving the signal detected by the receiving antenna 34. The processor 36 uses an impulse generator 36b and an impulse receiver 36c to transmit an electromagnetic pulse, wave or other signal through the antenna 32 and then receive the electromagnetic signal reflected through the antenna 34. It can include a microcontroller 36a and a range gate control 36d that alternate. Typical signals that can be used can include microwaves, electromagnetic waves, such as microimpulse radar signals, for example in the ultra-low band region.

In a typical embodiment, each of the antennas 32, 34 is a horn-like protruding physical profile, dipole and patch, or, for example, a diamond dipole antenna, a single-ended elliptical antenna ("SEA"), a patch antenna, or , Can be a UWB antenna, such as a coplanar antenna. The processor 36 can also operate a single antenna that alternates as a transmit antenna and a receive antenna (not shown) instead of the separate antennas 32, 34.

For example, antennas 32 and 34 are as disclosed in "TEM Horn Antenna for Ultra Wideband Microwave Chest Imaging" published in Progress in Electromagnetics Research B, Vol.13, 59-74 (2009). It can be a TEM horn type antenna. Also, antennas 32 and 34 are as disclosed in US Patent Application Publication No. 2008/0071169 published on March 20, 2008, and Microwaves, Antennas, &amp; Propagation, IET, Volume 1, Issue. 2 (April 2007), pp.277-281. A patch antenna as disclosed in "Wideband Microstrip Patch Antenna Design for Chest Cancer Tumor Detection" by Nilavalan et al. Can be done. The patch antenna can be coupled with a housing (not shown) filled with a dielectric material, for example to facilitate use with a microimpulse radar.

In another alternative embodiment, each antenna can be a waveguide horn, eg, as shown in FIG. 10B. As shown, the antenna 32'includes a casing 32A that is closed at the first end 32B, opened at the second end 32C, and has a waveguide 32D mounted therein. The walls of casing 32A are Emerson &amp; Cuming Microwave Products NVof It is lined with absorbent material 32E, which is a broadband silicon absorbent material such as Ecosorb-FGM40 sold by Westerlo, Belgium. The volume of the casing 32A can be filled with a dielectric 32F having a relative permittivity of, for example, about 10. In a typical embodiment, the antenna 32'has an area of, for example, about 15 x 15 mm (15 x 15 mm) and is about 30 mm (30 mm) between the first and second ends 32B-32C. It can be a square waveguide horn configured to operate at ultra-wideband frequencies ("UWB") between about 3 and 10 GHz (3-10 Ghz) with a length of. The open end 32B contacts or with tissue through which the antenna 32'is intended to transmit and / or receive a signal, as described elsewhere, for example. It can be directed outwards from a probe with an antenna 32'inside it to couple.

The signal from the impulse receiver 36c may be filtered or processed, for example, by a return signal declutter and shaping circuit 36e before communicating with the microcontroller 36a for further processing, display, storage, transmission, etc. .. Circuit 36e receives signals such as return echo noise and clutter from antenna 34 as needed, declutters these signals using an LPF, and / or includes digitally adapted filtering and / or pulse shaping. It may be. Microcontroller 36a received and / or processed to identify spatial relationships such as distance, angle, orientation, etc. of the target 26 and other structures with respect to the probe 30, for example, as described below. Read the signal. Typical examples of processors and / or other components contained within probe 30 are disclosed in US Pat. Nos. 5,573,012 and 5,766,208 issued to McEwan.

In another embodiment, probe 30 can be configured to operate as a magnetic radar system, as disclosed in US Pat. No. 6,914,552 issued to McEwan. For example, the probe 30 can include, for example, a magnetic field excitation source such as an electromagnet (not shown) coupled to a generator and / or current coil driver (not shown) provided inside or outside the probe 30. For example, the probe may include a magnetic field against a marker or other target that produces pole-to-pole vibrations at specific frequencies that the radar unit can identify and / or recognize to measure distance or adjust position. it can. Such probes have relatively high impedance or permittivity, in tissue, bone, or body fluids that weaken the radar pulse from reaching the target or the reflected signal from reaching the radar antenna. , Useful when the target is implanted.

Returning to FIG. 10, the probe display 38 is coupled to a microcontroller 36a for displaying information, for example spatial or image data obtained via antennas 32, 34, to the user of probe 30. Can be done. Distances, angles, directions, and / or displays 38, which provide data based on predetermined criteria, such as, as in the case of being based on the relative position of the target 26 with respect to the probe 30, as further described below. Easy to read. FIG. 10A shows a typical example of the output for a available display 38, which can include an array of arrows or other indicators 38a and a read distance 38b. For example, the microcontroller 36a analyzes the signal received to determine in which direction the marker (not shown) is located with respect to the probe 30, activates the appropriate arrow 38a, and the distance to the marker. (For example, the indicated "3 cm") is displayed. This allows the user to identify in what direction and how far away the marker is, thereby providing the user with guidance for the marker and the target tissue area in which the marker is embedded. ..

In addition to or instead, the display 38, for example, has the probe 30 oriented there, in other words, an image of a real-time area beyond the first end 30a, the operating parameters of the probe 30, etc. Other information can be provided. Optionally, the probe 30 may include one or more output devices in addition to or instead of the display 38. For example, probe 30 may provide one or more speakers (not shown) that can provide audio output, one or more LEDs or other light sources that can provide visual output to provide information such as spatial information, operational parameters, and so on. And so on. For example, the speaker or LED can be activated when the probe 30 reaches a predetermined threshold distance from a marker, eg, a desired margin, or can be activated when a continuous closer distance is achieved. it can.

Optionally, the probe 30 can include one or more user interfaces, memory, transmitters, receivers, connectors, cables, power supplies, and other features or components (not shown). For example, the probe 30 can include one or more batteries or other internal power sources to operate the components of the probe 30. The probe 30 may also include a cable (not shown) connected to an external power source, such as a standard AC power source, to operate the components of the probe 30.

Returning to FIG. 10, the user control 37 can include one or more input devices (not shown) such as a keypad, touch screen, and individual buttons. User control 37 allows the user to perform simple operations such as turning the probe 30 on and off and resetting the probe 30, and also allows more complex controls on the probe 30. For example, the user A-control 37 enables adjustment of the detection sensitivity of the probe 30 and other parameters, and enables data capture, storage, remote communication, and the like.

Optionally, the probe 30 can include an internal memory 36f and / or a microcontroller 36a capable of recording or storing data obtained via the antennas 32, 34. For example, the microcontroller 36a can automatically record data during operation, or it can be instructed to selectively save the data to memory 36f. In addition to or instead, the microcontroller 36a can transfer data to one or more external devices such as storage, display, etc. For example, the probe 30 can include one or more cables (not shown) that allow such data transfer, and / or the probe 30, for example, via radio frequency, infrared or other signals. Can include transmitters and / or receivers ( not shown ) for transmitting data and / or receiving commands wirelessly .

As shown in FIGS. 1 and 10, all internal components of the probe 30 can be provided within the enclosure or casing 39 such that the probe 30 is built-in. For example, the casing 39 can be relatively small and portable so that, for example, the entire probe 30 can be held in the user's hand. Optionally, as shown in FIG. 1, the first end 30a of the casing 39 is made of a material similar to or different from the other parts of the casing 39. For example, the first end 30a can be formed from a material that easily accommodates the path of the electromagnetic signal through the transmitting antenna 32 and / or the receiving antenna 34 without substantial obstruction. Optionally, the material may be selected to reduce obstruction, impedance matching, or to facilitate the transmission and reception of signals into or out of the patient's body via probe 30. it can. In addition to or instead, if desired, the probe 30 can include handles, finger grips, and / or other features (not shown) to facilitate retention or manipulation of the probe 30.

Further, as shown in FIG. 11, a probe device 130 including a separation controller 139 including one or more components can be provided in a casing away from the portable probe 131. For example, the portable probe 131 can include an elongated housing 131a that includes a tip 131b with one or more antennas 132. The controller 139 can include one or more processors for controlling the antenna 132, the display 138, etc., as in the previous embodiment. The portable probe 131 is connected to the processor in controller 139 by one or more cables 133. For example, the impulse generator, impulse receiver, and / or gate control are provided inside the casing of controller 139 or, if desired, inside housing 131a. In one embodiment, the cable 133 may be detachably connectable to a connector (not shown) of the controller 139 in order to electrically couple the antenna 132 of the portable probe 131 to an electronic device in the controller 139. it can. Thus, the portable probe 131 can be a disposable and disposable device, while the controller 139 can be used by connecting a new portable probe 131 to the controller 139 during a number of procedures. It can be left outside the surgical field, but can also be made accessible and / or viewable, if desired, as described below.

Returning to FIG. 2A-5, the positioning system 10 of FIG. 1 facilitates positioning of, for example, lesions and / or other target tissue areas 41 and / or samples from chest 41 or other body structures. It can be used during medical procedures such as breast biopsy or tumor resection surgery procedures to facilitate incision and / or removal of. Although System 10 has been described as being particularly effective in positioning chest lesions, System 10 also has other objects in other areas of the body, eg, as described elsewhere in the specification. It should be understood that it is used for positioning of.

Prior to treatment, the target tissue area, such as a tumor or other lesion, is identified by a conventionally known method. For example, as shown in FIG. 2A, the lesion 42 within the chest 41 is identified using, for example, mammography and / or other imaging, and a decision is made to remove the lesion 42. The dotted line 44 surrounding the tumor 42 defines a "clear" margin, indicating, for example, the size and shape of the desired tissue sample 46 to be removed during the procedure. For example, margin 44 is selected to ensure that the tissue left after removing sample 46 is substantially clear to cancerous cells or other unwanted cells. In a typical example, the distance between the outer border of lesion 42 and the outer edge or margin 44 of tissue sample 46 is, for example, at least about 2 mm (2 mm) or at least about 1 cm (1 cm). It can be between about 1 and 10 mm (1-10 mm).

Returning to FIGS. 2A and 2B, the positioning wire 20 is introduced percutaneously through the tissue 40, eg, through the tissue intervening from the patient's skin 48, until the target 26 is located within the lesion 42. In a typical embodiment, the positioning wire 20 uses a needle and / or dilator (not shown), similar to the cannula 340 described elsewhere in the specification with reference to FIGS. 20-22. It is introduced via a pre-arranged supply sheath (not shown). For example, a cannula or feed sheath with a pointed tip penetrates into lesion 42 through skin 48 and intervening tissue 40, using, for example, ultrasound or x-ray imaging for guidance, and then positioning. Wire 20 advances through the cannula. Also, the needle with a pointed tip advances through the tissue, and then the feed sheath crosses the needle (not shown), eg, along the dilator between the needle and the feed sheath. And move forward. Once the feed sheath is positioned so that it extends from skin 48 to lesion 42, the needle and any dilator are removed. The distal end 22b of the positioning wire 22 is then advanced through the feed sheath until the target 26 is located within the lesion 42, after which the feed sheath is removed. Optionally, the positioning wire 22 is distant, for example, a marker that produces radiopaque or sound waves on or near the target 26 to facilitate imaging of the target 26 and / or the distal end 22b of the positioning wire 22. One or more markers (not shown) can be included on the edge. External imaging is used during and / or after the introduction of the positioning wire 20 to ensure that the target 26 is properly positioned within the lesion 42.

If the positioning wire 20 includes an anchor element such as a return 24, the return 24 is compressed inward as the positioning wire 20 advances through the feed sheath. Once the target 26 is positioned within the lesion 42, the feed sheath is withdrawn and then the return 24 elastically spreads outward within the adjacent tissue. Thus, the barb 24 on the distal end 22b of the shaft 22 anchors the positioning wire 20 to the lesion 42, eg, so that the target 26 is substantially mounted in a fixed position within the lesion 42. In addition to or in its place, bandages, tapes, etc. (not shown), for example, to attach the proximal end 22a of the positioning wire 22 to the patient's skin 48 to prevent migration of the positioning wire 22. used.

After the positioning wire 20 has been accurately positioned and / or attached, the first end 30a of the probe 30 is usually placed in close proximity to or in contact with the patient's skin 48 on lesion 42, and / or, or. It is oriented in the direction of target 26 and operates as shown in FIG. The transmitting antenna 32 of the probe 30 (not shown, see FIG. 10) radiates an electromagnetic signal 31 that travels through the tissue 40 and is reflected by the target 26. The signal 33 is reflected back in the probe 30 to the receiving antenna 34 (not shown, see FIG. 10). The probe 30 then, for example, is based on, for example, the distance the signal 31 was sent and the passage of time between the transmission of the signal 31 and the reception of the reflected signal 33, for example, the target 26 and the probe 30 (and the first of the probe 30). It is possible to determine the spatial relationship between the target 26 and the first end 30a of the probe 30, such as the distance 52 between the patient's skin 48) if the end 30a of the probe 30 is in contact. it can. Optionally, the probe 30 can also determine the relative angle between the target 26 and the first end 30a, eg, to facilitate determination of the correct orientation of the incision.

In one embodiment, the probe 30 microcontroller 36a (not shown, see FIG. 10) identifies the target 26, eg, based on the size, shape, and / or recognition of other aspects of the target 26. Therefore, the received signal can be filtered or the received signal can be analyzed. As such, the microcontroller 36a can automatically identify the target 26 and distinguish it from other components present in the patient's body. Also, the microcontroller 36a can easily identify any object that reflects back the signal back to the probe 30, which would probably have identified the target 26. For example, the microcontroller 36a can form a distance 52 and / or an angle with respect to an axis extending at right angles from the first end 30a of the probe 30, and this spatial information can be displayed on the display 38. .. This information can provide guidance for the tissue to be incised by the surgeon lying on lesion 42, eg, by providing the direction and depth of the incision to access the target tissue area containing lesion 42, of target 26. As a result of the positioning, the positioning of the lesion 42 can be promoted.

In addition to or instead, other information may be displayed on the display 38 if desired. For example, the display 38 provides a distance 54 between the target 26 and the outer margin 44 of the target tissue sample 46, which can facilitate the definition of the targeted size and shape of the tissue sample 46 to be removed. can do. To determine the distance 54, the probe 30 may, for example, be based on preset parameters programmed into the probe 30's processor 36, or, for example, via user control 37 (not shown, see FIG. 10). A predetermined distance between the desired margin 44 and the target 42 can be automatically subtracted based on the size provided to the microcontroller 36a by the user immediately prior to the procedure.

Optionally, continuing to refer to FIG. 3, the probe 30 is positioned with respect to or in the vicinity of the skin 48 at several locations (and spatial information obtained if desired). Such information can assist the surgeon in determining the optimal approach path for an incision, for example the shortest path to lesion 42, or assist the surgeon in three dimensions with respect to lesion 42. can do. After the distance 52 from the desired position on the skin 48 between the patient's skin 48 and the target 26 has been determined, the tissue 40 reaches the predetermined outer edge 44 of the tissue sample 46, as shown in FIG. An incision is made. For example, an incision is made in the patient's skin 48 where the probe 30 is placed and the intervening tissue is cut in a conventionally known manner until a depth corresponding to the margin 44 is achieved. Optionally, at any time during the incision, the probe 30 is placed against or near the exposed tissue to obtain spatial information to confirm the approach and / or depth of the cut.

Continuing with FIG. 4, if desired, another distance measurement probe probe to verify that once the surgeon has reached the desired margin 44, he has reached a given distance 54 to target 26. Performed by 30. For example, to determine the distance between the bottom surface of the incised tissue area of the probe 30 and the target 26, the first end 30a of the probe 30 can be positioned in contact with the bottom surface of the incised tissue area. , The signal 31 can be transmitted by the transmitting antenna 32, and the signal 33 can be received by the receiving antenna 34. After verifying that the desired margin 44 of the tissue sample 46 has been reached, the tissue sample 46 is cut or removed using conventional tumor resection surgery procedures, along with the target 26 remaining within the removed material 46. Can be done. If desired, the target 26 facilitates the removal of sample 46 by disconnecting, for example, a connector (not shown) between the shaft 22 and the target 26 and cutting the proximal end 22b of the shaft 22. Can be separated from the shaft 22 to do so.

Returning to FIG. 5, if desired, for example, probe 30 takes an incised tissue sample 46 to confirm that the desired margin 44 was achieved around the target 26 and eventually around the lesion 42. Used for analysis. As illustrated, the transmit signal 31 is transmitted by the probe 30, and the signal 33 is reflected by the target 26, which allows the probe 30 to determine and display distance 54 and / or other spatial information. In this way, it can be verified that a predetermined organizational margin has been achieved.

Returning to Figure 6-9, a system 110 containing a probe 30 and multiple implantable markers or targets 120 for locating lesions or other tissue structures, such as multiple non-palpable lesions 142. Other typical examples are shown. The probe 30 can be a portable device capable of transmitting electromagnetic signals and receiving reflected signals, as in any of the embodiments described herein.

Marker 120 can include multiple implantable elements sized for introduction through tissue into the area surrounding lesion 142. For example, marker 120 is described elsewhere in the specification with reference to target 26 described above with reference to FIG. 1 and / or with reference to, for example, FIGS. 23A-28C, 34A, 34B, 41A and 41B. Like the marker, it is formed as a plurality of strips, cylinders, helices, spheres, etc., for example, having features for enhancing the reflection of the electromagnetic signal transmitted by the probe 30.

As shown in FIG. 6, the marker 120 has a length between about 1/2 to 4 mm (0.5-4.0 mm), a width between about 1/2 to 2 mm (0.5-2.0 mm), and It can be an elongated strip having a thickness between about 1/2 to 3 mm (0.5-3.0 mm), such as a rectangular or other shaped marker. The marker 120 can be formed, for example, by a metal or other material having a predetermined dielectric constant that can enhance detection by the probe 30. In addition to or instead, the marker 120, for example, the marker 120 is implanted in the tissue and then dissolved or absorbed by the tissue over time, for example over days, weeks and months. It can be formed from a bioabsorbable material such as

Optionally, the marker 120 can facilitate marker 120 imaging or monitoring, for example during introduction, after placement during treatment, or if marker 120 remains in the patient after treatment. , Can be formed from radiation opaque materials, radioactive materials and / or materials that generate sound waves. Also, if desired, each marker 120 has a surface, shape, and / or addition that distinguishes one or more markers from other markers, as described elsewhere in the specification. Material characteristics can be possessed. For example, each marker 120 can modulate the input signal from the probe 30 in a predetermined manner and / or absorb or reflect a particular electromagnetic signal specific to that marker 120, making it unique. Can be used to identify.

Also, as shown in FIG. 6, the system 110 can include one or more feeders 160 for introducing the marker 120 into the patient's body. For example, a shaft containing a proximal end 162a and a distal end 162b that is sized for introduction through tissue into a target tissue area (not shown) and can carry one or more markers 120. Supply equipment 160 including 162 is provided. The feeder 160 is slidable in the shaft for selectively feeding one or more markers 120 continuous or independent of the lumen 164 with the proximal and distal ends 162a and 162b of the shaft 162. It can include a lumen 164 that extends at least partially between the pusher member 166.

As shown, the distal end 162b of the shaft 162 can be tilted and / or sharpened so that the shaft 162 can be introduced directly through the tissue. Alternatively, the feeder 160 is introduced via a cannula, sheath or other tubular member (not shown) pre-positioned through the tissue, eg, as described elsewhere in the specification. be able to. Optionally, the distal end 162b is formed from, for example, a radiation opaque or sound-generating material that can facilitate monitoring of the distal end 162b during introduction, for example using fluoroscopy, ultrasound, electromagnetic signals, etc. Can include bands or other features that have been made.

As shown, the pusher member 166 advances a piston or other element (not shown) located in lumen 164 near marker 120, and a piston to push marker 120 out of lumen 164. Includes a plunger or other actuator 168, which is coupled to a piston. As shown, the plunger 168 can be manually advanced to continuously supply one or more markers 120 from lumen 164. Alternatively, a trigger device or other automated actuator (not shown) capable of advancing the piston sufficiently in each actuation, eg, to supply the individual markers 120 from the distal end 162b, is on the shaft 162. It can be provided on the proximal end 162a.

Returning to Figure 6-9, a typical method for using markers 120 and probe 30 to locate lesions or other targeted tissue regions 142 in the chest 41 or other tissue structures is It is shown. As shown in FIGS. 6 and 7, marker 120 can be implanted within tissue 40 to outline the desired margin or volume 144 of tissue sample 146 to be removed. For example, the shaft 162 of the feeder 160 can be inserted percutaneously through the patient's skin 48 and through the intervening tissue 40, with the distal end 162b being at the desired position, eg, the distal end 162b. Positioned within or around lesion 142 using external imaging to guide to. Once positioned, the plunger 168 can advance (or the shaft 162 is removed relative to the plunger 168) to feed the marker 120 into the tissue. The feeder 160 can be further advanced to other positions and / or completely removed from the chest 41, eg, elsewhere in the skin 48 to feed one or more additional markers 120. It can be reintroduced into the target organizational area through.

Alternatively, the feeder 160 can carry only a single marker 120 and multiple feeders (not shown) can be provided to feed each marker 120. In addition to or instead, a stereotaxic device (not shown) introduces, for example, one or more feeders into the desired 3D array or other array in the patient's body to locate the lesion 142. Can be used to In yet another example, the marker 120 can be replaced with a plurality of positioning wires similar to the wire 10, one or more catheters (not shown) supplied continuously or simultaneously. Optionally, a catheter, wire or other device can be made expandable, eg, at the distal end (not shown) to facilitate expansion and / or positioning of the sample volume or region.

In a typical example shown in FIGS. 6 and 7, marker 120 surrounds a group of non-palpable lesions 142 before or during treatment, eg, to remove the sample volume surrounding lesion 142. The distance 156 between the outer edge 144 of the tissue sample 146 and the lesion 142 is to ensure that the volume of tissue removed is sufficient to ensure a clear margin, similar to the method described above. , Can be selected.

As shown in FIG. 7, after the marker 120 has been implanted, the probe 30 can be placed on or near the patient's skin 48 (eg, to send and receive signals to and from tissue 40). , The patient's skin 48 does not need to be in contact with the probe 30), the probe 30 has a distance of 152 (and / or other spatial information) between the probe 30 and the marker 120, as in the previous embodiment. Can be used to determine. In particular, the signal 31 emitted by the probe 30 can be received by the marker 120 and reflected back to the receiver in the probe 30 as a signal 33, where the probe 30 is between the patient's skin 48 and the marker 120. A signal can be used to determine the distance 152.

As shown in FIG. 8, the tissue 40 surrounding lesion 142 can then be incised until it encounters one marker 120. In this regard, other measurements are made on the probe 30 to ensure proper incision depth. The probe 30 can be repositioned as shown in the illusion of FIG. 8 to place another marker 120 around the periphery 144 of the tissue sample 146. The resulting distance measurement is used to determine the desired margin volume for the incision around lesion 142. This process can be repeated as long as desired to facilitate the measurement of the desired margin based on the distance to marker 120 during excision of tissue sample 146 around lesion 142. The tissue sample 146 can include the marker 120 therein so that all markers 120 are removed with the tissue sample 146. Alternatively, the desired margin can be defined inside the marker 120 such that the marker 120 remains in the chest after the tissue sample 120 has been removed. In this option, the marker 120 can be bioabsorbable and can remain inactive and permanently in the patient's chest 41.

Returning to Figure 11-15, to locate one or more lesions 142 within the chest 41 and / or to remove tissue sample 146 (shown in Figure 14A-15A) containing lesions 142. Other typical systems and methods are shown. Similar to the previous example, the system can facilitate the identification of lesion 142 and / or assurance that the desired margin has been achieved for tissue sample 146 removed from chest 41, one or more markers. Includes 220 and probe device 130. As described above, the probe device 130 includes a portable probe 131 coupled to a processor 139 that includes one or more processors for controlling the operation of the probe 131. Also, as mentioned above, the portable probe 131 is located on one end of the probe 131, which can be placed on the skin 48 or other tissue and / or directed towards the marker 220 and / or lesion 142. Includes an elongated housing 131a, including one or more antennas 132 on or within the tip 131b.

Processor 139 can include one or more processors for controlling antenna 132, display 138, etc., as in the previous embodiment. The portable probe 131 can be coupled to the processor 139 by one or more cables 133. For example, an impulse generator, impulse receiver, and / or gate control can be provided within the processor 139, which is controlled to transmit and receive signals via the antenna 132.

Optionally, as shown in FIGS. 14 and 14A, the portable probe 131 can include a cutting function 133 extending from, for example, the tip 131b of the housing 131a. In one embodiment, the cutting function 133 is secured to the tip 131b of probe 131, eg, having a length of about 10-50 mm (10-50 mm) and / or a width of about 1-10 mm (1-10 mm). It can be a relatively flat blunt incision device. Alternatively, the cutting function 133 may be selectively deployed, for example, when the cutting function 133 is initially folded within the housing 131a and wishes to cut the tissue layer to access tissue in the vicinity of the marker 220. It can be made foldable, as it does. In yet another example, the cutting function 133 can include a pointed blade or edge that can facilitate cutting through the lower layer of the patient's skin 48 and / or tissue 40.

First, as shown in FIG. 11, during use, one or more markers 220 are implanted within the target tissue area, eg, using markers and / or methods described elsewhere in the specification. be able to. The probe 131 is connected to the processor 139, for example, with a cable 133, the tip 131b of which is placed on the skin 48. The probe 131 can be operated to obtain an initial distance measurement from the tip 131b of the probe 131 to the marker 220, for example using an antenna 132, thereby providing an approximate distance to the lesion 142. Distance measurements can be displayed on display 138 of processor 139 and / or otherwise provided to the user, as shown, for example, in FIG. In addition to or instead, as mentioned above, the speaker provides distance measurement using, for example, synthetic speech, one or more tones to identify the corresponding distance, to identify the distance. can do. For example, the processor 139 can analyze the received signal to determine the actual distance from the tip 131b of the probe 131 to the marker 220 and can provide the actual measurement result via the speaker. Alternatively, the speaker may have, for example, a first threshold distance as the first tone, a second threshold distance as the second tone, and a threshold distance closer than that as multiple tones. It is possible to provide a tone corresponding to a predetermined threshold value to indicate to the user that it is closer to the marker 220.

As shown in FIG. 11, probe 131 on the first flank of chest 41 obtains size L1 and probe 131'located on the second opposite flank of chest 41 is larger than L1. I'm getting L2. With this information, the physician should make an incision on the first aspect to provide a shorter path that requires less tissue incision than the path it makes on the second aspect, as shown in FIG. Can be decided.

Returning to FIG. 13, probe 131 can be used to identify the desired margin L3 around lesion 142 as a result around marker 220. For example, if one desires a desired margin L3 of 1 cm (1 cm), probe 131 can display or provide the actual distance L1 from probe 131 to the marker, as shown on display 138. This can indicate that the probe 131 remains outside the margin L3. Alternatively, if processor 139 knows the desired margin L3, the display 138 can provide the difference between the actual distance L1 and the desired margin L3 (ie L1-L3), thereby achieving the desired margin. You can tell your doctor the depth of incision you need to do.

Optionally, as shown in FIGS. 14 and 14A, if probe 131 includes a blunt incisor 144, the blunt incisor 144 can be deployed from the tip 131b of probe 131, eg, until the desired margin L3 is achieved. Yes (if not permanently deployed), it can move forward in the direction of marker 220 through tissue 40. The probe 131 is then markered using a blunt incisor 144 and / or using one or more additional incisors, a scalpel, or other tool (not shown). It can be manipulated to make an incision in the tissue around 220.

As shown in FIGS. 15 and 15A, a tissue sample 146 containing a marker 220 and a lesion 142 therein is removed from the chest 41. Optionally, probe 131 can then be used to confirm that the desired margin L3 has been achieved around marker 220, thereby providing sufficient tissue in the chest, as in previous examples. It can provide confirmation that it has been removed from 41.

Returning to Figures 16A and 16B, further systems include one or more markers 220, a probe 231 containing a finger cot 231a carrying one or more antennas 232, and a processor 239 coupled to the antennas 232 by, for example, a cable 233. Other examples are shown. The finger cot 231a can be, for example, a flexible sleeve that includes an open end 231b and a closed end 231c into which the finger 90 is inserted and is long enough to safely receive the finger 90. For example, the finger sack 231a in use is flexible enough to be compressed inward to prevent it from slipping off the finger 90, while expanding to accommodate and accommodate the finger 90, for example latex, natural or, similar to surgical or examination gloves. It can be composed of an elastic material, such as a relatively thin layer such as synthetic rubber.

As shown, the antenna 232 can be provided near the closed end 231c. For example, the antenna 232 can include a transmitting antenna and a receiving antenna (not shown) provided in the housing, as in the previous embodiment. The housing can be attached to the finger cot 231a in the vicinity of the closed end 231c, for example by joining with an adhesive, melting, one or more additional bands (not shown), and the like.

Processor 239 is similarly coupled to antenna 232 by, for example, cable 233 and includes display 238, to operate antenna 232 and / or to process signals received from antenna 232, as in the previous embodiment. It can contain one or more components. In the illustrated embodiment, the processor 239 is one or more clips 239a, straps, belts, clamps, or so that the processor 239 can be detachably attached to the user's arm with a finger inserted in the finger cot 231a. Includes other instruments (not shown). For example, clip 239a can be curved to partially extend around the user's forearm, clip 239a can extend it to receive the arm in it, and then at least around the arm. It can be flexible enough to be elastically closed for partial engagement. Alternatively, the processor 239 can be provided in a housing (not shown) that can be placed away from the patient and / or the user, for example, similar to the processor 139 described above.

With additional reference to FIGS. 17 and 18, during use, a portion of a finger 90, such as the index finger or thumb, can be inserted into the finger cot 231a, and as in the previous embodiment, the processor 239 is an antenna. It can be operated to transmit and receive signals via 232.

As shown in FIG. 17, the finger 90 inserted into the finger cot 231a can be placed against the patient's skin 48 and a distance measurement is performed to determine the distance to the marker 220. An incision is made in the tissue covering the marker 220 so that the user can insert the finger 90 into the generated path, thereby giving the user the marker 220 in relation to the finger 90. Direct feedback on the location or location of lesion 142 can be provided. Thus, this example of probe 231 can provide tactile feedback that can facilitate incision and / or removal of tissue sample 146 containing markers 220 and lesions 142 internally, similar to distance measurements. For example, as shown in FIG. 17, an initial distance measurement L1 can be obtained that gives the user information on the required incision depth, while a distance measurement L2 can be obtained as shown in FIG. 18 ( (Corresponding to the desired margin), thereby allowing the user to be informed that a sufficient incision has been achieved and that the tissue sample 146 has been separated and removed, as in the previous embodiment.

Returning to Figure 19-22, yet another system for locating and / or incising a target tissue area containing, for example, one or more lesions 142 is shown. In general, the system includes probe equipment 330, including a portable probe 331 coupled to processor 339, as in the previous embodiment. For example, probe 331 includes one or more antennas 332 and processor 238 includes display 338.

The system also includes a cannula or other tubular member 340, including a proximal end 342, a distal end 344 and a lumen 346 between them. Cannula 340 can be a substantially stiff tubular body having a size that probe 331 can receive within lumen 346, as shown in FIG. As illustrated, the distal end 344 can be formed to tilt, sharpen, and / or facilitate advancement through direct tissue. Alternatively, the distal end 344, as in the previous embodiment, advances beyond the needle (not shown), either before or after, for example, the cannula 340 is introduced into the tissue 40. Can be tapered and / or rounded (not shown) so that it can be.

With reference to FIG. 19, prior to use, the probe 330 can be inserted into the lumen 346 of the cannula 340, eg, such that the antenna 332 is located in the immediate vicinity of the distal end 344 of the cannula 340. Optionally, the cannula 340 and / or the probe 331 is releasably secured to the cannula 340, eg, to maintain the antenna 332 in the vicinity of the distal end 344, while being removed when the probe 331 desires. One or more connectors (not shown) can be included to allow for. In addition to or instead, the cannula 340, for example, to provide a substantially fluid-sealed seal when the probe 331 is placed in lumen 346 and / or when the probe 331 is removed. One or more seals (not shown) can be included within the position 342 and / or the distal end 344. For example, a hemostatic seal (not shown) that can block the flow of fluid through lumen 346 while providing a seal that receives and houses the probe 331 or other device (not shown) through it. Can be provided at the proximal end 342.

Returning to FIG. 20, when probe 331 operates within cannula 340 during use, the distal end 344 of cannula 340 can be inserted towards marker 220 through the patient's skin 48 and tissue 40. As shown, the probe 331 can transmit vibration 31 and the display 338 of the processor 339 is based on the reflected signal received by the antenna 332 of the marker 220 with respect to the antenna 332 and thus to the distal end 344 of the cannula 340. Relative position distance measurements L1 or other indications can be provided. Therefore, the depth of penetration of Cannula 340 and / or the direction of its predecessor can be adjusted based on the information provided by probe 331 and processor 339. For example, as shown in FIG. 21, the cannula 340 can advance until the desired distance L2 is achieved, thereby placing the distal end 344 as a marker within the target tissue area, eg, near lesion 142. It can be placed at a desired distance from 220.

Returning to FIG. 22, the distal end 344 of the cannula 340, which is positioned desirable with respect to the lesion 142, allows the probe 331 to be removed, leaving the cannula 340 in place, as shown. .. The cannula 340 can thereby provide a passage for incising a target tissue area, eg, for performing one or more diagnostic and / or therapeutic procedures. For example, needles and other tools (not shown) are in the cannula to perform a biopsy and / or to supply fluid or other diagnostic or physiotherapy material to the target tissue area. It can move forward through cavity 346. In addition to or in its place, one or more instruments (not shown) via cannula 340 to provide radiation therapy and / or other treatments, eg, to remove tissue samples containing lesion 142. Can be introduced. Cannula 340 can simply be removed when no more access is needed. Alternatively, if it is desired to move the cannula 340 during the procedure, the probe 331 can be reintroduced into the body cavity 346 and the cannula 340 moved into the tissue with the probe 331 can provide additional guidance.

FIG. 11-22 shows a marker 220 that can be implanted or placed in tissue 40, eg, in or near lesion 142, using a method similar to that described above. As shown, the marker 220 is generally an elongated body that includes a relatively narrow intermediate stem portion between the spherical ends. The marker 220 can be formed from the desired material and / or can facilitate the positioning of the marker 220 and / or its distinction from others, similar to the other markers described herein. Features on the surface can be included.

Returning to FIGS. 23A-28C, additional examples of markers that can be used in any of the systems and methods described herein are shown. For example, returning to FIG. 23A-23C, a first typical marker 320 containing a core wire 322 carrying multiple beads or segments 324 is shown. The core wire 322 is a solid or solid having a diameter or other maximum cross section between about 1/2 and 2 mm (0.5-2 mm) and a length between about 1 and 10 mm (1.0-10 mm). It can be an elongated member having a hollow structure. The core wire 322 is further described below from elastic or superelastic materials such as stainless steel, nitinol, and / or shape memory so that the core wire 322 deflects to a predetermined shape as it unfolds in the tissue. It can be formed from a material. Alternatively, the core wire 322 can be made substantially stiff so that the marker 320 remains in a fixed shape, such as linear or curved, as described further below.

As best seen in FIGS. 24A-24C, the bead 324 can include a plurality of single rings, eg, each defining a generally cylindrical or spherical shaped portion, for example. The bead 324 can be formed from the same desirable materials as in the previous embodiment, such as stainless steel, nitinol, metals such as titanium, plastic materials and the like. The bead 324 can be formed by injection molding, machining, cutting, grinding, etc. of the base metal. Also, the desired finishing process can be applied to the bead 324 during the molding or casting process, for example by sandblasting, etching, vapor deposition and the like.

As best seen in FIG. 24B, each bead 324 can include a passage 326 through which it receives the core wire 322 (not shown, see, eg, FIG. 23A-23C). The bead 324 allows the bead 324 to nest at least partially with others in the vicinity when mounted on the core wire 322, while the marker 320 changes shape, for example when the core wire 322 changes shape. It can include shape and / or surface features that allow it to be reshaped. The bead 324 also includes a plurality of surfaces having a nearby surface that defines a steep angle, for example, between about 45 and 135 degrees (45-135 °) or about 90 degrees (90 °). Includes a surface shape that includes one or more grooves around it, such as a radar, that enhances the reflection of electromagnetic waves. For example, as best seen in FIG. 24C, each bead 324 can include a first convex or spherical end 324a and a second concave end 324b that includes a plane 324d. As shown in FIG. 25B, the nearby bead 324'has a first surface 324d'on the concave end 324b'of the first bead 324 and a surface 324e on the spherical end 324a'of the adjacent bead 324'. Water 324c between'can be defined. Surfaces 324d'and 324e'can define steep corners between them that can enhance radar detection, for example defining angles of about 90 degrees (90 °).

Optionally, as shown in FIGS. 25A and 25B, the bead 324'can include a desirable surface finish 324f intended to customize the reflected signal generated when the electromagnetic signal collides with the surface of the bead 324'. .. For example, the surface finish 324f can include multiple holes or dimples formed in the bead 324'and having the desired diameter and / or depth. As described above, probes and processors described elsewhere in the specification, such as individually identifying a particular marker when multiple markers are implanted or placed in the patient's body, for example. The reflected signal can be analyzed.

Returning to Figure 23A-23C, during assembly, multiple beads 324 can be placed beyond and attached to the core wire 322 to provide the completed marker 320. For example, the core wire 322 is inserted continuously through the passage 326 in the bead 324 until the bead 324 extends substantially between the ends of the core wire 322. The bead 324, for example, crimps individual beads 324 onto the core wire 322, slides over sufficient beads 324 and then crimps or expands the ends of the core wire 322, glues them together, melts. It can be attached to the core wire 322 by such means. Thus, the bead 324 can facilitate bending or shaping of, for example, the core wire 322 and thus the marker 320, substantially to the core wire 322 so that the bead 324 does not move and the bead 324 moves freely on the core wire 322. Can be worn forever.

Alternatively, the marker 320, for example, the shape and surface defined by the bead 324 shown in FIG. 23A, can be formed in the work. In this alternative, the core wire 322 can be removed and the passage can be formed through the workpiece to receive the core wire 322.

In certain embodiments, the marker 320 can define a substantially fixed shape, eg, a linear shape as shown in FIGS. 23A and 23B or a curved shape as shown in FIGS. 23D and 26A-26C. For example, the core wire 322 of the marker 320, for example, the marker 320 can be linear to facilitate the loading of the marker 320 into the feeder and / or the supply of the marker 320, while the marker 320 It can be flexible enough to allow deviations to curved or other non-linear shapes.

As shown in FIG. 23D, the marker 320 can be offset to virtualize a wave configuration, for example a winding shape or other curved shape lying in a plane. For example, the core wire 322, which is a shape in which the core wire 322 is set so as to be displaced with respect to the wave configuration and elastically linear with respect to the linear configuration, is an elastic material or superelastic. It can be formed from material. The bead 324 substantially facilitates the change of the core wire 322 between the linear and wave configurations of the bead 324, for example to facilitate the loading of the marker 320 into the feeder and / or the introduction of the marker 320 into the body. Space can be opened or nested so that it does not get in the way.

Alternatively, as shown in FIGS. 34A and 34B, the tapered spiral shape was displaced to virtualize, for example, a relatively wide intermediate region 320a'''' between the tapered end regions 320b''''. Markers 320'''are provided. Another example of the marker 320'''' displaced to virtualize a substantially uniform spiral shape is shown in Figures 41A and 41B. One of the effects of the markers 320'''and 320'''' is that they relate to the angle of reflection and / or position of the markers 320'''' and 320'''' with respect to the antenna of the probe (not shown). Instead, it can provide a relatively constant and / or consistent radar cross section (RCS). For example, as shown in FIGS. 34B and 41B, even when the markers 320'''and 320'''' are viewed along the spiral axis, the marker 320, for example, as shown in FIGS. 34A and 41A. '''And 320'''' can provide a substantially equivalent RCS when viewed laterally with respect to the spiral axis.

Optionally, any of the markers described herein can be provided as a passive marker, an active marker, an active reflector or an active transponder. For example, referring to FIG. 23A-23D, the marker 320 can simply be a "passive reflector", i.e., the marker 320 can simply reflect an incident wave or signal that collides with the marker 320. The incident signal is reflected at the various surfaces and / or edges of the marker 320 to provide the reflected wave or signal, eg, detected by the probe, as further described elsewhere in the specification. Can be done. One of the effects of passive markers is that the radar cross section (RCS) is variable based on the angle of the probe antenna and the marker 320, which can cause changes in the intensity of the return signal reflected from the marker 320. There is a point.

Alternatively, the marker 320 is an "active reflector", i.e., a marker that includes one or more electrical circuits that modulate the signal that collides with the marker 320 in a predetermined manner without applying external energy or power to the reflected signal. 320, can include one or more features to provide. Such markers may include, for example, one or more miniature power diodes and / or FET transistors operating at minimal currents, and may include active reflected radio elements, including modulated dipoles or other types of active reflecting antennas. .. Active reflectors provide a trace of a substantially single radar signal in an embedded tissue environment that can be detected and identified by a probe. The active reflector can also provide a relatively large signal back to the probe, which, for example, maintains the target RCS regardless of the nature of the antenna.

For example, the marker 320 may include one or more circuits or other elements (not shown) coupled to or embedded in the marker 320 that can modulate the incident wave or signal from the probe. it can. In a typical embodiment, a nanoscale semiconductor chip that does not include its own energy source and therefore simply processes and modulates the signal when it is received and reflected by the marker 320 is carried by the marker 320. .. Typical examples of active reflectors that can be provided on markers are disclosed in US Pat. No. 6,492,933.

Figures 50A and 50B show examples of modulation of reflected signal B with respect to incident signal A that can be achieved using an active reflector. The incident signal A can represent a wave or signal transmitted by a probe (not shown), as described elsewhere in the specification. As shown in FIG. 50A, the incident signal A can collide with, for example, the surface of any of the markers described herein and be reflected, resulting in a reflected signal B. In a passive reflector, the surface of the marker can simply reflect the incident signal A, so that the reflected signal B can have properties similar to the incident signal A in, for example, bandwidth, phase, and so on.

On the other hand, in the active reflector, the marker can modulate the incident signal A in a predetermined manner, for example by changing the frequency and / or phase of the reflected signal B. For example, as shown in Figure 50B, the circuit on the marker provides an ultra-wideband radar incident signal A with a relatively narrow band, eg, between about 1 and 10 GHz (1-10 GHz) containing a given phase shift. Can be changed to the reflected signal B of. The relatively narrow band signal B can enhance the RCS of the marker, thereby enhancing the detection by the probe.

Further, as shown in FIG. 50B, the phase of the reflected signal B can be modulated by 90 degrees (90 °) with respect to the incident signal A. If the marker is specific to this phase shift, the phase shift helps the probe identify and distinguish the marker from other structures, eg, from other markers with different phase shifts, tissue structures, and so on. For example, if multiple markers are implanted in the patient's body, the circuits of each marker will have different phase shifts (eg + 90 °, + 180 °, -90 °, etc.) and / or in the reflected signal. It can be configured to superimpose bandwidth. Therefore, the probe can easily identify and distinguish the marker from other markers and / or from other structures in the patient's body.

One effect of active reflectors is that the circuit does not require its own power supply. Therefore, the size of the circuit can be substantially reduced, and if desired, the marker can be implanted in the patient's body for an extended or irregular period, or the marker can locate the marker. And / or can respond to signals from the probe to facilitate identification.

In yet another example, an "active marker" is provided that includes one or more features that generate detectable energy in response to excitation of reference energy. Examples of such active markers are disclosed in US Pat. No. 6,363,940.

In yet another example, an active transponder is provided that retransmits or "relays" the energy of the MIR probe that provides specificity for the traces of radar signals, for example in an embedded tissue environment. An active transponder can include one or more electrical circuits that are embedded in or carried by a marker, including, for example, one or more batteries, capacitors, and other internal energy sources. In a typical embodiment, the active transponder can include a microwave receiver and / or transmitter, data processing and storage elements, and a modulation system for the return signal. The active transponder can generate microwave energy in response to the excitation microwave energy emitted by the probe, for example, because it returns a signal to the probe that is greater than the signal possible with the passive marker alone. For example, the marker can generate RF energy containing formatted data, depending on the unique radar traces and / or frequencies from the probe. In a typical embodiment, the active transponder will emit a single sideband ("SSB") signal in the form of either the upper sideband ("USB") or lower sideband ("LSB") of the MIR radar. Modulated into a square. Such transponders can offer the possibility of multi-channel operation across the RF spectrum.

Returning to Figures 29A and 29B, Marker 320 (or optionally) is sized for introduction through tissue into a target tissue area, such as within the chest 41, including proximal end 262a and distal end 262b. A feeder 260 including a shaft 262 is provided that carries multiple markers (not shown). The feeder 260 is slidable within the lumen 264 extending between the proximal and distal ends 262a and the distal end 262b of the shaft 262 and within the shaft 262 for supplying the marker 320 of FIG. 23A-23D from the lumen 264. The pusher member 266, can be included. As shown, the distal end 262b of the shaft 262 can be inclined and / or pointed so that the shaft 262 is introduced directly through the tissue. Alternatively, the feeder 260 can be introduced via a cannula, sheath or other tubular member (not shown) located through the tissue, eg, as described elsewhere in the specification. Optionally, the distal end 262b can facilitate monitoring of the distal end 262b during introduction, eg, a radioactive opaque material, a sonicating material, or the like, as described elsewhere in the specification. Can include bands or other features formed of the material of.

As shown in FIG. 29A, the pusher member 266 is a plunger for advancing the distal end 267 to push the marker 320 from the distal end 267 and the lumen 264 located within the lumen 264 near the marker 320. Or other actuators 268 are included. As shown in FIG. 29B, once the distal end 264 of the feeder 260 advances to the desired position within the tissue 40, the shaft 262 enters the plunger 268 to continuously push the marker 320 out of the lumen 264. On the other hand, it can be withdrawn. Alternatively, a trigger device or other automatic actuator (not shown) can be provided on the proximal end 262b of the shaft 262 to supply the marker 320 from the distal end 262b.

Returning to FIGS. 26A-26C, another embodiment of the marker 320'' generally similar to the marker 320 shown in FIGS. 23A-23D, including, for example, a core wire 322'' carrying multiple beads 324''. It is shown. However, unlike the marker 320, the core wire 322'' is deflected into a spiral shape, much like the marker 320'' deflects to a helical structure as illustrated. Therefore, the marker 320'' can be linear in shape, for example to facilitate loading into the feeder, as in the feeder 260 shown in FIGS. 29A and 29B, while being elastically spiral. It can be changed back to the structure.

In other embodiments, any of the markers 320, 320'or 320'' is at least partially derived from the shape memory material so that it can be deflected to a given structure, for example when the marker is heated to a target temperature. Can be formed. For example, referring to marker 320 in FIG. 24, the core wire 322 is in a martensite state when the core wire 322 is at or below an air temperature of, for example, 20 degrees Celsius (20 ° C) or lower, and is 37 degrees Celsius (37 degrees Celsius). It can be formed from a shape memory material that goes into an austenitic state at or above body temperature of ° C) or higher, such as nitinol. In the martensite state, the core wire 322 can be relatively soft and malleable so that, for example, the marker 320 can be linearly loaded into the feeder 260 of FIGS. 29A and 29B. The shape memory of the core wire 322 sets the temperature in the material so that when the core wire 322 is heated to a target temperature, the core wire 322 can be deflected to a wavy, spiral, or other non-linear shape. Or it can be programmed. Therefore, even if the marker 320 has a curved or linear shape deformed from its desired deployment structure in the martensitic state, the marker 320 is introduced into the patient's body or other part once heated to the target temperature. When it is done, it can be automatically deflected to the unfolded structure.

Returning to FIGS. 27A-27C, another typical example of marker 420 is shown. Like the marker 320, the marker 420 includes a core wire 422 carrying multiple beads or segments 424. Each of the beads 424 includes a plurality of grooves 424c, for example to enhance the reflection of signals from probes (not shown), as described elsewhere in the specification. The core wire 422 and bead 424 are manufactured and assembled in the same manner as in the previous embodiment, for example, so that the bead 424 rotates freely on the core wire 422 or is fixed to the core wire 422. be able to. Grooves 424c can be completely formed with each bead 424, as in the previous embodiment, or can be defined by coordinating the surfaces of adjacent beads (not shown). Groove 424 can substantially define a plane or curved surface that aligns with the steep edges that define the corners that can enhance radar detection.

Optionally, as shown in FIGS. 28A-28C, other examples of spherical markers 520, 520', 520'' containing grooves 524c, 524c', 524c'' with different shapes and / or structures are shown. ing. Grooves 524c, 524c', 524c'' can generate substantially different reflection signals from each other so that the probe processor can distinguish different markers based on different reflection signals, for example, as shown below.

In the embodiment shown in FIGS. 28A-28C, markers 520, 520', 520'' are formed from a single piece of material and do not include core wires and multiple beads. A core wire and multiple beads can be provided for markers 520, 520', 520'' if desired, and / or a single piece of material if marker 420 in FIGS. 27A-27C is desired. It is understood that it is formed from.

Returning to FIGS. 30A-31B, it can be any marker described elsewhere in the specification, such as the marker 320 shown in FIGS. 23A-23D, used to supply the marker 320. Other embodiments of the feeder 360 that can be shown are shown. Generally, the feeder 360 is sized for introduction through tissue, eg, into a target tissue area within the chest 41, including a proximal end 362a and a distal end 362b, an injection needle or other tubular. Includes a shaft 362 and a lumen 364 extending between the proximal end 362a and the distal end 382b. The feeder 360 also includes a pusher member 366 that is slidable within the shaft 362 to feed the marker 320 from lumen 364. As shown, the distal end 362b of the shaft 362 can be inclined and / or pointed so that the shaft 362 is introduced directly through the tissue. Alternatively, the feeder 360 can be introduced via a cannula, sheath or other tubular member (not shown) located through the tissue, eg, as described elsewhere in the specification. Optionally, the distal end 362b can facilitate monitoring of the distal end 362b during induction, eg, using X-ray or ultrasound imaging, as described elsewhere in the specification. It can include, for example, a band or other feature formed of a radioactive opaque material, a sonicating material, or other material.

Returning to FIGS. 30B and 31B, the pusher member 366 includes a distal end 367 initially provided in lumen 364 near marker 320, for example as shown in FIG. 30B. The pusher member 366 is substantially fixed to the handle 370 of the feeder 360, while the shaft 362 can be retractable to expose, for example, the marker 320, as further described below. For example, as shown in FIG. 30B, the proximal end 366a of the pusher member 366 can be fixed to the pusher member 372 mounted within the handle 370.

The shaft 362 can be coupled to a shaft holder 374 which is slidable within the handle 370. For example, the shaft holder 374 can be axially slidable from the first or distal position shown in FIG. 30B to the second or proximal position shown in FIG. 31B. Therefore, the shaft holder 374 in the first position offsets the distal end 367 of the pusher member 366 near the distal end 362b of the shaft 362, thereby receiving the marker 320, as shown in FIG. 30B. Provides ample space within the shaft lumen 364. When the shaft holder 374 is guided to the second position, the shaft 362 is retracted until the distal end 362b of the shaft 362 is located near the distal end 367 of the pusher member 366, for example as shown in FIG. 31B. .. The distal end 367 of the pusher member 366 prevents the marker 320 from moving closer during the retracting motion of the shaft 362, so that the marker 320 is a shaft as shown in FIGS. 33 and 33A. Eventually unfolds from lumen 364 of 362.

The shaft holder 372 and shaft 362 can be deflected to a second position, but are selective because they allow the marker 320 to be loaded and fed within it, for example using a feeder 360. Can also be held in the first position. For example, as shown in FIGS. 30B and 31B, the handle 370 includes a spring or other mechanism received in the groove 378 of the housing and adjacent to the shaft holder 374. At the first position, the spring 376 is compressed, as shown in FIG. 30B, while at the second position, the spring 376 is in a low latent energy state, as shown in FIG. 31B.

The handle 370 also includes an actuator for selectively holding and releasing the shaft holder 374 and the shaft 362 in the first position. For example, as shown in FIG. 30B, the shaft holder 374 in the first position allows the shaft holder 374 to handle the handle 370 until the proximal end 374a of the shaft holder 374 is close to or engages with the distal end 372a of the pusher holder 372. Can rotate within. Alternatively, the handle 370 may include one or more other features (not shown) capable of selectively engaging the shaft holder 374 in position 1. As shown in FIG. 31B, if the shaft holder 374 rotates within the handle 370 to disengage the distal end 372a of the pusher holder 372 with respect to the proximal end 374a, the proximal end 372a is within the handle 370. Can move freely in close proximity. Therefore, once the shaft holder 374 rotates, the spring 376 can automatically guide the shaft holder 374 closer, thereby deploying the marker 320. Other actuators, such as releasable dents and locks, can releasably mount the shaft 362 in the forward position and interact to allow the shaft 362 to automatically retract when the actuator operates. It will be appreciated that it is provided on the handle 370 and / or the shaft holder 374.

Returning to FIGS. 32 and 33, the feeder 360, as in the previous embodiment, has a marker 320 in the chest 40 or other tissue structure within the target tissue area, including, for example, one or more lumens 142. Used to supply. Once the marker 320 is supplied, the marker 320 is used to locate the target tissue area, eg, using any of the systems and methods described elsewhere in the specification.

Returning to FIG. 35, yet another embodiment of the marker device 610 including the marker 620 coupled with a tether or other elongated element 630 is shown. The tether 630 is a suture formed from, for example, a bioabsorbable or non-absorbable material that has sufficient length to extend from the patient's body when the marker is introduced into the target tissue area, eg, malleable. , Wires formed from hard or malleable materials, and the like. Marker 620 can be similar to any of the markers 320'' shown in FIGS. 34A and 34B or other embodiments described elsewhere in the specification, eg, described elsewhere in the specification. Similar to the positioning wire provided, it can be releasably or substantially permanently attached to the distal end 634 of the tether 630. The addition of an elongated tether 630 extending from the marker 620 can provide an additional reference to the location of the marker 620 when implanted within the tissue. For example, the tether 630 can help guide the surgeon to the exact location of the marker 620 during tumor removal surgery and / or confirm the presence of the marker 620 within the removed tumor volume. The tether 630 can also be used to place tags that help identify the orientation of the marker 620 in the target tissue area, and can be left in place or removed if desired. ..

Returning to FIG. 36-41, the feeder 660 and method for implanting the marker device 610 into the target tissue area, for example, for implanting the marker 620 into the non-palpable lesion 142 in the chest 41, is shown. ing. Similar to the previous embodiment, the feeder device 660 includes the proximal end 262a and the distal end 262b and is sized to be introduced through the tissue into the target tissue area within the chest 41, for example, the marker device 610. Includes shaft 262, which carries. The feeder 660 is at least partially slidable in a lumen 664 extending between the proximal end 662a and the distal end 662b of the shaft 662 and in the shaft 662 for feeding the marker 620 from the lumen 664. Pusher member 666, can be included. As shown, the distal end 662b of the shaft 662 can be tilted and / or sharpened so that the shaft 662 can be introduced directly through the tissue. Alternatively, the feeder 660 can be introduced via a cannula, sheath or other tubular member (not shown) arranged through the tissue, eg, as described elsewhere in the specification. it can. Optionally, the distal end 662b can facilitate monitoring of the distal end 662b, eg, during induction, as described elsewhere in the specification, eg, radiopaque or generate sound waves or other. It can include bands or other features formed from the material.

As shown in FIG. 36, the pusher member 666 includes a lumen 667 for slidably receiving the tether 630 through it. Therefore, at any time during manufacture or before use, the marker device 610 is such that the marker 620 is placed in lumen 664 near the distal end 662b and the tether 630 is placed through lumen 667 of pusher member 666 and pusher member 666 It can be loaded into the feeder 660 so as to extend from the plunger 668 coupled to. If the marker 620 is deflected to a spiral or other shape, the marker 620 can be linear so that it is loaded into the shaft 662, as shown in FIG. The marker device 610 can be implanted prior to tumor removal surgery or at the time of biopsy, instead of a wire positioning procedure. Alternatively, the marker device 610 can also be supplied via a core needle biopsy device or a vacuum core needle system (not shown).

For example, during the procedure, as shown in FIG. 36, the distal end 662b can be inserted through tissue, for example, into a target tissue area within lesion 142. Once the distal end 662b of the feeder 660 advances to the desired position within the tissue, the shaft 662 is coupled to the pusher member 666 to supply the marker 620 from the lumen 664, as shown in FIG. 37. Can be drawn in. As shown, the marker 620 can be automatically and / or elastically reshaped by unfolding, eg, to return to the tapered spiral shape shown in FIG. 37. Returning to FIG. 38, the feeder 660 can be withdrawn from the patient's body, leaving the marker 620 within the target tissue area, for example within lesion 142. The tether 630 can be easily slid through the pusher member 666 until the ends are exposed from the chest 41, as shown in FIG.

Optionally, as shown in FIG. 40, the tether 630 can be separated from the marker 620, leaving the marker 620 in place within lesion 142. For example, the tether 630 can include a weak region (not shown) in the immediate vicinity of the marker 620, which breaks upon application of predetermined tension. Alternatively, the tether 630 may include a threaded distal end 634 or other connector that is released from the marker 620 by rotating the tether 630 to pull the thread at the distal end 634 from the marker 620. it can. In yet another example, the tether 630 can remain attached to the marker 620 during subsequent tumor removal surgery or other procedure.

Returning to FIG. 42, another typical embodiment of the marker device 610' is shown, which is generally similar to the marker device 610, i.e., including the tether 630 and the marker 620'. However, the marker device 610'can also be approximated to the markers 320'''' shown in FIGS. 41A and 41B. Figures 43-46 show typical embodiments of the feeder 620'and method for implanting marker device 610', which is generally similar to that shown in Figure 36-40.

Although the systems and methods described above relate to lesions within the chest, one or more markers or targets are other areas of the patient's body for the next positioning using a probe such as the probe 30 described above. Can be implanted or introduced into. For example, one or more targets can be placed inside or near the bile duct, femoral artery or vein, fallopian tube or other body lumen for the next positioning. The target can be carried into the lumen of the body by a catheter, wire or other feeding device, eg by fixing the catheter or wire, or by placing the marker on or inside the wall of the lumen of the body or it. It can be worn inside the body through or by fixing it in the lumen of the body.

For example, FIG. 47 shows the gastrointestinal tract 3 of a patient who undergoes one or more diagnoses and / or treatments. As shown, the catheter 1 carrying the marker 2 can be introduced into the patient's gastrointestinal tract 3 via, for example, the mouth or rectum. As can be seen from FIG. 48, catheter 1 can include, for example, marker 2 similar to other markers described elsewhere in the specification. For example, marker 2 can include features similar to one or more beads 320 shown in FIGS. 23A-23C and described above. Catheter 1 and marker 2 can be advanced to a desired position within the gastrointestinal tract 3 using, for example, fluoroscopy, ultrasound or other external imaging.

A probe, such as any of the probes described elsewhere in the specification, can then be used to locate marker 2 and thereby locate it within the gastrointestinal tract 3. It will be appreciated that other body lumens can be positioned in a similar manner, eg, in a less invasive manner from outside the patient's body, eg, to facilitate access to the body lumen. For example, as shown in FIG. 49, marker 2 promotes puncture of the wall, for example, to enter the lumen of the body or to close the lumen of the body for clipping, cutting, ligation, gastrointestinal tract. Can be used to find a specific location within 3. FIG. 49 is a cross-sectional view of the inflated abdominal cavity 4 using, for example, conventional laparoscopic procedures. A probe 5, which approximates any of the probes described elsewhere in the specification, can be inserted via an access cannula 6 to scan and / or detect the location of marker 2 on catheter 1. The laparoscope 7 can then be used to visualize the position of the probe 5 with respect to the marker 2. Once the marker 2 is positioned, the access sheath 8 can be used to provide access to the gastrointestinal tract 3 at the desired location, eg, for one or more diagnoses and / or treatments. Marker 2 and catheter 1 can be removed once access is achieved or, if desired, after the procedure is complete.

In a typical embodiment, the marker can be introduced into the fallopian tube using a catheter, and then a needle or other device can access the fallopian tube, for example for ligation, paralysis, or the fallopian tube. For isolation or closure, it can be introduced by a less invasive method such as puncturing the patient's skin and tissue on a marker. Alternatively, if the marker is placed within the bile duct, endoscopic access can be used under the guidance of probe 30 to access the bile duct, for example performing an intestinal procedure in the patient. it can. In yet another example, the marker can be placed in a branch that communicates with the length of the femoral artery, vein or other tube of interest, and then the probe 30 is separated from the nearby tube and contained. It can be used to find each location of the branch outside the tube, for example to allow the length of the tube to be cut, ligated, paralyzed and / or separated.

In yet another example, one or more markers can be implanted within the targeted tissue structure for positioned treatment using the system described herein. For example, markers can carry one or more drugs, radioactive substances or other therapeutic agents that can be released over an extended period of time into or around the target tissue area in which they are implanted. After a sufficient amount of time has passed, for example after the therapeutic agent has been substantially and completely exhausted or fully supplied, the probe 30 recovers and / or removes the marker in a less invasive manner, for example. To facilitate, it can be used to locate the marker.

Returning to FIG. 51, a flowchart of a typical embodiment of method 510 for locating markers in the body using a microwave antenna is shown. At the start of method 510, the transmitting antenna transmits a radio frequency (RF) transmitted signal into the body: 520. The receiving antenna then receives the RF received signal reflected from the marker: 530. After the received signal is received, at least one processor calculates the time difference between when the transmitted signal is sent by the transmitting antenna and when the received signal is received by the receiving antenna: 540. Once the processors form a time lag, at least one processor uses the calculated time lag to determine the distance from the tip of the probe (accommodating both the transmit and receive antennas) to the marker: 550. Once the distance is determined, the distance from the tip of the probe to the marker is displayed on the display: 560. After the distance is displayed, Method 510 ends: 570.

Returning to FIGS. 52 and 53, a cross-sectional view of the chest 41 is shown, including a typical microwave antenna probe 531 performing method 510 of FIG. 51 to locate the marker 521. It should be noted that Method 510 can also be used to locate markers placed in other areas of the body other than the chest. In particular, FIG. 52 shows a microwave antenna probe 531 for transmitting a transmit signal 501 through its transmit antenna 511, and FIG. 53 shows a microwave for receiving a receive signal 502 via its receive antenna 512. The antenna probe 531 is shown.

Returning to FIG. 52, as discussed in detail earlier, the marker 521 is in the skin 48 in tissue 40 of the chest 41 near the lesion (or tumor) 142 that is surgically removed, for example during an ultrasound session. Can be embedded via. Marker 521 can be any type of marker, such as the marker shown in FIGS. 23A-28C. In a typical embodiment, the marker 521 can consist primarily of an inner core wire carrying multiple beads or segments. The inner core wire can be formed from elastic materials, superelastic materials and / or shape recording materials such as stainless steel, nitinol, etc. Can be deflected to form a predetermined shape (eg, coil shape) when unfolded within the tissue 40. The beads or segments of marker 521 can be formed from materials with electromagnetic reflection properties, such as metals such as stainless steel, nitinol, titanium or composites. The bead or segment can include a surface finish customized to reflect electromagnetic signals that collide with the surface of the bead or segment.

After the marker 521 has been deployed in tissue 40, the microwave antenna probe 531 can be used to locate the marker 521 within the chest 41 during surgery by the patient. The location of marker 521 indicates to the surgeon the general location of lesion 142 removed from chest 41. During operation of the microwave antenna probe 531 the transmitting antenna 511 of the microwave antenna probe 531 can transmit a transmitting signal 501 through the tissue 40 of the chest 41. For example, the transmission signal 501 can consist of a series of pulses. Further, the transmission signal 501 can be swept from the start frequency (for example, 1.5 GHz) to the stop frequency (for example, 4.5 GHz) in a predetermined frequency increment (for example, 100 MHz increment). The start frequency can be lower than the stop frequency, and conversely, the start frequency can be higher than the stop frequency. The predetermined increments can be uniform in size or non-uniform in size.

Returning to FIG. 53, once the transmit signal 501 collides with the marker 521, the transmit signal 501 is reflected by at least one, at least one reflective surface of the bead or segment of the marker 521. The reflected signal (ie, the received signal) 502 propagates back towards the microwave antenna probe 531. The receiving antenna 512 of the microwave antenna probe 531 can receive the received signal 502 composed of a series of pulses.

The microwave antenna probe 531 can include an accordion section 534 and a bayonet 535 that are connected to each other by a bayonet or other connector 533. The microwave antenna probe 531 can also include an antenna portion 532 connected to the other end of the bayonet 535. For example, the tip of the antenna unit 532 can include both the transmitting antenna 511 and the receiving antenna 512, for example, as further described below.

After the receiving antenna 512 of the microwave antenna probe 531 receives the received signal 502, it can be contained within the microwave antenna probe 531 or the display unit 536, at least one processor (eg, a digital signal processor (DSP)) (FIG. (Not shown) is the time difference (T) (ie, T =) between the time (T1) that the transmit signal 501 was transmitted by the transmit antenna 511 and the time (T2) that the receive signal 502 was received by the receive antenna 512. T2-T1) can be calculated. After the processor has calculated the time difference (T), at least one processor (eg DSP) should use the time difference (T) to determine the distance (L1) from the tip of the probe to the marker 521. (That is, the processor can perform distance calculations for distance (L1) by using the calculated time delay (T) of the signal response).

Once the processor determines the distance (L1) from the tip of the probe 531 to the marker 521, the processor can send the distance information (L1) to the display unit 536 via the cable 333. In a typical embodiment, the cable 333 can be a coaxial cable such as an RS232 coaxial cable. It should be noted that in one embodiment the distance information (L1) can be sent wirelessly to the display unit 536, for example by a transmitter (not shown) in the probe 531. After the display unit 536 receives the distance information (L1), the display unit 536 can display the distance information (L1) on its display screen 537, for example to inform the surgeon of the position of the marker 521. .. The distance information can be displayed as a numerical value representing the distance in units of length such as inches (in.) Or centimeters (cm). For example, "3 cm" is displayed on the display screen. In place of or in addition to the unit of length, the display screen 537 is a marker, the microwave antenna probe 531 the distance from the tip of the microwave antenna probe 531 to the marker, and / or the physiology of the body part containing the marker. A graphic image (eg, 2D or 3D image) representing a typical painting (eg, chest) can be displayed.

According to one embodiment, after the receiving antenna 512 of the microwave antenna probe 531 receives the received signal 502, it is contained within the microwave antenna probe 531 or the display unit 536 at least one processor (eg DSP) (shown). Can measure the amplitude of the received signal 502. After the processor measures the amplitude of the received signal 502, at least one processor (eg DSP) uses the amplitude of the received signal 502 to determine the direction in which the marker 521 is placed with respect to the tip of the microwave antenna probe 531. can do.

For example, when the surgeon moves the microwave antenna probe 531 at or away from the marker 521 at different angles, the amplitude of the received signal 502 is towards or away from the marker 521. Increases or decreases depending on whether is suitable for. The amplitude of the received signal 502 increases when the microwave antenna probe 531 is held at an angle pointing towards the marker 521; when the microwave antenna probe 531 is held at an angle pointing away from the marker 521. Reduces the amplitude of the received signal 502. As such, the relative or absolute amplitude of the received signal 502 can be used by the processor to position the marker 521 with respect to the tip of the microwave antenna probe 531.

According to another embodiment, the antenna portion 532 of the microwave antenna probe 531 can include an accelerometer (not shown). The accelerometer can measure the angle at which the microwave antenna probe 531 tilts with respect to the marker 521 (ie, the "tilt angle"). After the receiving antenna 512 of the microwave antenna probe 531 receives the received signal 502, at least one processor (eg DSP) (not shown) contained within the microwave antenna probe 531 or the display unit 536 is a microwave antenna. By using the time difference (T) and tilt angle of probe 531 the position of marker 521 with respect to microwave antenna probe 531 can be determined.

FIG. 54 is a schematic representation of typical components of a system capable of performing method 510 of FIG. The components used in Method 510 typically include a feeder 561, a marker 521, a microwave antenna probe 531 and a display unit 536. The feeder 561 can be any type of feeder as shown in FIGS. 29A-31B and described elsewhere in the specification. In general, the feeder 561 has a handle 563 and a shaft for introduction through the tissue into the target tissue area (eg, in the chest) and for injecting the marker 521 into the target tissue area. 562 can be included. As described above, the marker 521 can be any type of marker, as shown in FIGS. 23A-28C and described elsewhere in the specification. For example, the marker 521 can consist of an inner core wire that carries multiple beads or segments.

The microwave antenna probe 531 can include two main parts, a non-sterile reusable part 531A and a sterile disposable non-reusable part 531B. The non-sterile reusable portion 531A can include electronic components used for the generation of transmitted signals and for the processing of received signals. However, it should be noted that these electronic components can be placed somewhere other than the microwave antenna probe 531, such as inside the display unit 536. The electronic components contained in the reusable portion 531A are further discussed elsewhere in the specification, for example as described in FIG. 55.

The sterile, disposable, non-reusable portion 531B can include an antenna portion 535, a bayonet 535, a bayonet connector 533 and an accordion sheath 534. Details of the interior of the antenna section are further discussed in the description in FIGS. 56A-58. One end of the antenna portion 535 can be connected to the bayonet 535. The bayonet 535 can be connected to the accordion sheath 534 via the bayonet connector 533. Prior to the operation of the microwave antenna probe 531, the accordion sheath 534 of the sterile disposable and non-reusable portion 531B can be slidable beyond the non-sterile reusable portion 531A. , The two units 531A and 531B are joined together to form a single unit 531 that becomes the microwave antenna probe 531. After the operation of the microwave antenna probe 531 the sterile disposable and non-reusable part 531B can be removed from the non-sterile reusable part 531A and the sterile disposable and non-reusable part 531B , Can be discarded so that it will not be reused again. The non-sterile reusable portion 531A can be disinfected, sterilized and ready for reuse in other procedures.

One end of the non-sterile reusable portion 531A can be connected to the display unit 536 via cable 333 (eg RS-232 coaxial cable). The display unit 536 can include a display screen 537 for displaying the distance and / or other information from the tip of the microwave antenna probe 531 to the marker 521. Distance information can be displayed on the display screen 537 with respect to the unit of length (eg 10.0 cm as shown in FIG. 54). Further, the amplitude of the received signal 502 can be displayed on the display screen 537 by the bar graph 538 or the numerical measurement value (not shown). The display unit 536 can also include at least one audio speaker 539. The voice speaker 539 can generate audible noise and / or words to indicate the position of the marker 521 with respect to the tip of the microwave antenna probe 531.

FIG. 55 is a block diagram 600 showing typical components of the microwave antenna probe 531 of FIG. 54. The non-sterile reusable portion 531A can include a signal generator 620, an amplifier 640, an analog-to-digital (A / D) converter 650 and a digital signal processor (DSP) 660. For example, a signal generator 620, such as a reference oscillator, generates a vibration signal, such as a square wave signal, a triangle wave signal, or a sine wave signal.

For example, the square wave signal 625 can be sent from the signal generator 620 to the transmitting antenna 511 of the antenna portion 532 of the microwave antenna probe 531. When the square wave signal 625 passes through the transmit antenna 511, the transmit antenna 511 acts as a bandpass filter ("BPF") to convert the square wave signal 625 into a series of pulses 630. As such, the transmit signal 501 transmitted from the transmit antenna 511 includes a series of pulses 630. The transmission signal 501 can be transmitted throughout the tissue and can be reflected from the marker 521. Once the transmit signal 501 is reflected from the marker 521, the reflected signal (ie, the received signal 502) contains a series of attenuated pulses 635.

The receiving antenna 512 of the antenna unit 532 of the microwave antenna probe 531 can receive the received signal 502. A received signal 502 containing a series of attenuated pulses 635 can be input to amplifier 640 to amplify the gain of pulse 635. The output of the amplifier 640 can be input to the A / D converter 650 to convert the amplified analog signal to a digital signal. The digital signal output from the A / D converter 650 can be input to the DSP660 for processing. As explained above, the DSP660 calculates the time difference between the time when the transmission signal 501 is sent and the time when the reception signal 502 is received, from the tip of the microwave antenna probe 531. Determining the distance to marker 521, determining the position of the tip position monitoring marker on the microwave antenna probe 531, measuring the amplitude of the received signal 502, and / or the direction in which the marker 521 is placed with respect to the tip of the microwave antenna probe 531. It can perform a number of functions, including making decisions. The output of the DSP660 can be sent to the display unit 536 by wire (eg cable 333) or wirelessly.

A power source (not shown) for the microwave antenna probe 531 can be included in the display unit 536. For example, the power source for the microwave antenna probe 531 can be a battery and / or can be supplied by a power cord. Alternatively, the power supply for the microwave antenna probe 531 can be contained within the microwave antenna probe 531 itself.

56A-56C show a typical embodiment of the antenna subunit 700, which can be used for either or both of the transmit antenna 511 and the receive antenna 512 of probe 531 of FIG. Returning to Figures 56B and 56C, the microwave antenna probe 531 mimics one antenna subunit 700 for the transmitting antenna 511 and one antenna unit 700 for the receiving antenna 512, the two antenna subunits illustrated. Can accommodate unit 700. It should be noted that the antenna subunit 700 shown in FIG. 56B is the same as the antenna subunit 700 shown in FIG. 56C. FIG. 56C simply shows a different view of the antenna subunit 700 of FIG. 56B.

The antenna subunit 700 can include an antenna unit portion 710, an outer coaxial portion 720, and a portion of the subunit version A (SMA) connector 730. The antenna unit portion 710 can be connected to the SMA connector 730 via the outer coaxial portion 720. The antenna subunit 700 can be housed within the antenna section 532, bayonet section 535 and bayonet connector section 533 of the sterile, disposable and non-reusable portion 531B of the microwave antenna probe 531 (not shown, eg). See Figure 54).

Returning to FIG. 56A, the antenna unit portion 710 can be a bow-tie type antenna 740 that can be housed in the nylon tube 750. The nylon tube 750 can be similarly housed within the brass tube 760. The end of the brass tube 760 can be connected to the outer coaxial portion 720 of the antenna subunit 700. The antenna unit unit 710 may include other types of antennas other than the bow tie type antenna 740, such as a patch type antenna, a horn type antenna, and a spiral type antenna, as described elsewhere in the specification. it can. The polarization of the antenna used by the antenna unit 710 can be linearly polarized (eg, horizontally or vertically) or circularly polarized (eg, right-handed circularly polarized light (RHCP)), depending on the type of antenna used. Alternatively, it can be left-handed circularly polarized light (LHCP).

Returning to FIG. 56C, the bowtie antenna 740 can be formed from two triangular antennas 745a, 745b separated by a stripline 746. The triangular antennas 745a and 745b can be manufactured from a material having electromagnetic reflection characteristics such as a metal or a composite material. The two triangular antennas 745a and 745b shown in FIG. 56C are vertically polarized. If the two triangular antennas 745a, 745b shown in Figure 56C rotate 90 degrees (90 °), the two triangular wave antennas 745a, 745b will be horizontally polarized.

As described earlier, the microwave antenna probe 531 has two antenna subunits, one antenna subunit 700 for the transmitting antenna 511 and the other antenna subunit 700 for the receiving antenna 512. Can accommodate 700. One antenna subsystem 700 for the transmitting antenna 511 can include a horizontally polarized bowtie antenna 740, and the other antenna subsystem 700 for the receiving antenna 512 can include a vertically polarized bowtie antenna 740. Antenna 740 can be included. Therefore, the transmitting antenna can have polarized light (for example, horizontal polarized light) that is cross-polarized light of the polarized light of the receiving antenna (for example, vertical polarized light). During operation of the microwave antenna probe 531 when the horizontally polarized transmit antenna 511 transmits a horizontally polarized transmit signal 501, the horizontally polarized transmit signal 501 collides with the marker 521 and is vertically polarized. It is reflected as a received signal 502 and returns. The vertically polarized receive antenna 512 can then receive the horizontally polarized receive signal 502.

FIG. 57 is a graphical representation of the transmit and receive antennas 512 of probe 531 of FIG. 54 combined to form the Maltese cross antenna 800. To form the Maltese cross antenna 800, the bow tie antenna 740 for the transmit antenna 511 (shown as 800 in FIG. 57) is the bow tie antenna 740 for the receive antenna 512 (shown as 810 in FIG. 57). ) Can be combined. The Maltese cross antenna 800 can be housed within the tip of the antenna portion 532 of the sterile, disposable and non-reusable portion 531B of the microwave antenna probe 531 (not shown, see, eg, FIG. 54). Returning to FIG. 57, the outer coaxial portions 720a, 720b for both the transmitting antenna 511 and the receiving antenna 512 are housed in the bayonet portion 535 of the sterile disposable and non-reusable portion 531B of the microwave antenna probe 531. The SMA connector sections 730a, 730b for both the transmit antenna 511 and the receive antenna 512 can be housed within the bayonet connector section 533 of the sterile disposable and non-reusable portion 531B of the microwave antenna probe 531. (Not shown, see eg Figure 54).

58A and 58B show details of the Maltese cross antenna 800 of FIG. 57. The ceramic material 900 can be mounted on the surface of the Maltese cross antenna 800 for impedance matching. Since the permittivity of air is about one (1) and the permittivity of tissue is about ten (10), to improve the performance of the antenna (ie, the effective isotropic radiation power (EIRP) of the transmitting antenna 501). A ceramic material 900 with a permittivity of about ten (10), which is close to the permittivity of the structure, is mounted on the surface of the Malta cloth 800. The addition of the ceramic material 900 can prevent or reduce the attenuation of the transmitted signal 501 as it propagates through the tissue through the air.

Returning to Figures 59A-59D, other typical examples of the antenna probe 930 are shown that can be used with any of the systems and methods described elsewhere in the specification. Generally, the probe 930 includes a housing 940, an antenna subassembly 950 and a shielding 980. Optionally, to reduce contamination, exposure, and / or to protect the internal components of the probe 930, for example, an outer sleeve or cover that surrounds an opening in the housing 940, surrounds one or more components of the probe 930. (Not shown) can be included.

With additional reference to FIG. 60, the antenna subassembly 950 is usually combined to form a Maltese cross-type antenna, as in other embodiments of the specification, each having a bow-tie type structure, transmission. Includes antenna 960t and receiving antenna 960r. As shown in FIGS. 61A-61C, each antenna 960 includes a pair of antenna elements 962 offset 90 degrees (90 °) from each other on a disk of dielectric material 964 or other base. Each antenna element 962 can be formed separately and then mounted on a disc 964, or it can be deposited directly on top of the disc 964. In a typical embodiment, the antenna element 962 can be formed from a silver film or other material deposited on top of the disk 964.

Circuit 970 can be coupled to antenna 960, including, for example, one or more transformers 974 and a connector 976 coupled to each antenna element 962 by a suitable lead, including a PCB 972 provided on it. Coaxial cable 978 can be coupled to connector 976 to allow the antenna 960 to be coupled to other components of the system, as in other embodiments described elsewhere in the specification. ..

As can be clearly seen in Figures 61A-61C, the disk 964 contains multiple radial slots 966 between the antenna elements 962, so that the antenna elements 962 can be substantially separated from each other by the air in the slots 966. , Thereby increasing the sensitivity and reducing crosstalk and / or noise and the like. Alternatively, slot 966 can be filled with other insulating material, such as foam having a relatively low dielectric constant, which is desirable for substantially separating the antenna elements 962 from each other (not shown).

As can be clearly seen in FIG. 59D, the disc 964 is similarly welded by one or more of adhesive bonding, ultrasonic welding, fusion, synergistic connectors (not shown), etc., as well as the tip of the housing 940 942. It can be mounted in a shielding 980 coupled to. As shown, the Shielding 980 is surrounded by a relatively thin outer shield 984 formed from, for example, copper or other material, for example from the color of nylon or other polymeric material to provide a Faraday shield. Includes the formed inner insulating layer. In a typical embodiment, the layers of copper tape can be wrapped around the inner shield 982 at the fixed ends of each other. Alternatively, the outer shield 984 can be a sleeve of shield material into which the inner shield 982 is inserted and fitted, for example by adhesive bonding, tightening, or the like.

As shown in FIG. 59D, the shielding 980 can have a length substantially greater than the thickness "t" of the disc 964. For example, the inner shield 982 can include an annular groove 986 into which the disc 964 is inserted and fitted, for example by clasping, adhesive bonding, and the like. As shown, the bottom surface of the disc 964 is substantially flush with the distal end of the shielding 980 so that the disc 964 contacts tissue during use, as described elsewhere in the specification. Can be. Optionally, a layer of Mylar film or other relatively thin material (not shown), for example, prevents fluid or other material from entering the tip, reduces contamination, and / or probe 930. Can be applied to the entire bottom surface of the disc 964 and / or shielding 980 to protect the tip of the disc.

With reference to FIG. 59D continuously, the top surface of the disk 964 (with the antenna element 962 on it, not shown) can be exposed to the region of air within the shielding 980. Due to the low dielectric constant of air, the transmission from the transmitting antenna 960t is concentrated in the centrifuge, i.e. towards the tissue in contact with the disk 964. The depth of transmission into the tissue can be increased by the material of the disc 964 selected to substantially match the dielectric constant of the tissue. The air behind the disk 964 can otherwise minimize the energy loss emitted away from the tissue by the transmitting antenna 960t. Similarly, the disc 964 can match the sensitivity of the receiving antenna 960r facing the tissue. The air behind the disk 964 in the shield 980 (also in the slot 966 between the antenna elements 962) can minimize crosstalk and noise, or extend the operation of the probe 930.

Returning to FIG. 62, other systems 1010 for locating targeted tissue areas within the patient's body, such as tumors, lesions or other tissue structures in the chest, or other locations within the body. Typical examples are shown. System 1010 generally detects and detects tag 1020 using tags, markers or targets 1040, and other signals such as electromagnetic pulses, electromagnetic waves or radar, eg, as in other embodiments of the specification. / Or includes probe 1020, for positioning. Optionally, the system 1010 can include one or more additional targets (not shown) in addition to the tag 1040.

The probe 1020 can be a portable device capable of emitting and receiving electromagnetic signals, such as a low power impulse radar (MIR) probe, as in other embodiments herein. For example, as shown in FIG. 62, probe 1020 is intended to be placed on or near tissues such as, for example, the patient's skin or tissue beneath it, with a first or distal end 1024, eg. It can be a handheld sized device, including a second or proximal end 1022 held by the user. In general, the probe 1020, like the other embodiments in the specification, is, for example, a transmit and receive antenna (not shown) mounted on a ceramic disk 1032 (shown in FIG. 63). Includes, one or more antennas, one or more processors or controllers, and a display (not shown).

The probe 1030 is also configured to transmit an optical pulse (represented by a dashed line at 1038a in FIG. 62) into tissue in contact with the distal end 1024, for example chest tissue 90, as shown in FIG. Includes optical transmitters such as, for example, multiple optical fibers 1038 (shown in FIG. 63). Fiber optic 1038 can be coupled to a light source (not shown), for example by coupling 1039, so that light from the light source passes through fiber optic 1038 from the distal end 1024 of probe 1020. In a typical embodiment, the light source is an infrared light source capable of supplying near-infrared light having a wavelength between, for example, 800 and 950 nanometers (800-950 nm). Optionally, the optical fiber is desirable for focusing the light transmitted by the probe 1020 in the desired way, such as as a relatively narrow beam or a wider beam extending substantially parallel to the central axis of the probe 1030. Can include one of lenses, filters, etc. (not shown).

Alternatively, probe 1020 can include other energy sources in place of optical transmitter 1038. Sources (not shown), such as electromagnetic energy, radio frequency (RF) energy, vibrational energy, etc., to provide energy pulses to operate tag 1040, as described elsewhere in the specification. Can be provided on the distal end 1024 of probe 1020. The energy source can be pulsed in a predetermined manner, for example, for example, the circuit of the tag 1040 is alternately put into an operating state and a non-operating state, as described elsewhere in the specification.

Probe 1020 is required for one or more controllers, circuits, and signal generators to generate signals for transmission by the transmitting antenna and / or to process signals received from the receiving antenna. Can include processors, including gates, etc. (not shown). Processor components can optionally include individual components, semiconductor devices, programmable devices, software components, and the like. For example, probe 1020 was detected by an impulse generator and a receiving antenna coupled with a transmitting antenna to generate a transmitting signal, eg, a pulse generator and / or a pseudo-noise generator (not shown). It can include an impulse receiver, for receiving signals. The processor transmits an electromagnetic pulse, electromagnetic wave, or other signal via the transmitting antenna and then any reflected electromagnetic signal via the receiving antenna, as in other embodiments of the specification. It can also include microcontrollers and range gate controls that operate the impulse generator and impulse receiver to a high degree so that they also receive. Typical signals that can be used include microwaves, high frequencies, such as microimpulse radar signals in the ultra-low bandwidth region.

The probe 1020 can be coupled to a display (not shown), eg, by cable 1036, to display information to the user of the probe 1020, such as spatial or image data obtained through an antenna. it can. Optionally, the probe 1020 can include one or more user interfaces, memory, transmitters, receivers, connectors, cables, power supplies, and other features or components (not shown). For example, the probe 1020 can include one or more batteries or other internal power sources to operate the components of the probe 1020. Alternatively, the probe 1020 can include a cable, such as one cable 1036, that can be coupled to an external micropower source, such as a standard AC power source, to operate the components of the probe 1020.

As shown in FIG. 62, the internal components of the probe 1020 can be provided in a housing or casing for inclusion of the probe 1020. For example, the casing can be relatively small and portable so that, for example, the entire probe 1020 can be held by the user. Optionally, a portion of the probe 1020, such as a portion near the distal end 1024, can be disposable, or a disposable cover, sleeve, etc. (not shown), if desired, of the specification. As in other embodiments, at least a proximal portion of probe 1020 can be provided so that it can be reused. Alternatively, a separation controller (not shown) may be provided that includes one or more components away from the hand-held size probe 1020 so that it is coupled to the probe 1020 by, for example, one or more cables 1036. In this other example, the entire probe 1020 can be a disposable, single-use device, while the controller remains accessible and / or visible outside the surgical field if desired. It can be used during multiple procedures by connecting a new probe 1020 to the controller. Additional information regarding the structure and / or operation of probe 1020 can be found in application examples characterized elsewhere in the specification.

Returning to Figures 64A-64D, a typical example of a passive tag 1040 that can be implanted in a patient's body, such as in the chest 90, is shown, as shown in Figure 62. In general, tag 1040 includes an electronic package 1042 coupled to a pair of wires 1044 that can optionally carry one or more beads or other elements (not shown).

For example, similar to the examples described elsewhere in the specification and the applications identified elsewhere in the specification, the wire 1044 has multiple surfaces, angles and to enhance the detection of the tag 1040. It is possible to provide a core wire carrying multiple beads or segments (not shown), including / or edges. Also, as described elsewhere in the specification, the wire 1044 can act as an antenna and / or work with electronic components within the electronic package 1042.

In a typical embodiment, each wire 1044 has a diameter between about 1/2 to 2 mm (0.5-2 mm) or a length between about 1 and 10 mm (1.0-10 mm) with the other maximum cross section. It can be, for example, an elongated member having a solid or hollow structure. The wire 1044 can be formed from elastic or hyperelastic materials and / or shape memory materials such as stainless steel, nitinol, and as described elsewhere in the specification, the wire 1044 is in tissue. When unfolded with, it deflects to a predetermined shape, but can be, for example, a linear shape or an elastically deformed shape to facilitate supply. Alternatively, the wire 1044 can be substantially rigid and the tag 1040 remains in a substantially fixed shape, such as a straight or curved line.

In a typical embodiment, the bead can include a plurality of tubular bodies, each defining a normally cylindrical or spherical portion. Beads can be formed from desirable materials such as metals such as stainless steel, nitinol, titanium, plastic materials or composites, as described in the application examples identified herein. During assembly, the plurality of beads can be placed and mounted on the wire 1044, for example, before and after mounting the wire 1044 on the electronic package, as further described elsewhere in the specification. Alternatively, beads can be excluded.

As shown in FIGS. 64A-64D, the tag 1040 can be deflected around a central vertical axis 1048 to assume curved shapes such as spirals, meanders or other curved shapes. For example, the wire 1044 can be formed from an elastic or superelastic material that is in a shape that can be elastically linear because the wire 1044 is deflected to the indicated spiral structure but is substantially linear. it can. Beads (not shown) can be spaced or nested, thereby facilitating the loading of the tag 1040 into the feeder and / or the introduction of the tag 1040 into the patient's body, for example. , It does not substantially interfere with the deformation of the wire 1044 between the linear and spiral structures.

With additional reference to FIG. 65, tag 1040 accommodates one or more circuits or other electronic components 1050 that are housed or embedded in electronic package 1042 configured to modulate the input signal from probe 1020. Can include. In a typical embodiment, the semiconductor chips (not shown) are, for example, a plurality of photosensitive diodes capable of converting input light (eg, infrared light) colliding with them into electronic energy (eg, minimum voltage), and Can be carried within a package 1042, including a voltage source or power source or other power converter 1052, such as a switch 1054, which can be released and stopped when a diode produces electronic energy.

As shown, multiple pairs of diodes 1052 can be connected directly and they can be spatially located at right angles to each other within package 1042. For example, if the photosensitive diode is directional, for example, at least one pair of diodes will receive light from the optical transmitter of probe 1020 regardless of the orientation of the tag 1040 with respect to probe 1020 after implantation. As such, at least two pairs of diodes 1052 can be mounted within package 1042 with a 180 degree (180 °) offset or in association with each other. Package 1042 can be at least partially transparent, or diode 1052 can be exposed so that light directed at package 1042 can be received by diode 1052.

In other embodiments, the power supply can be another component capable of converting external energy into the desired voltage. For example, if the probe 1020 includes other power sources such as EMF, RF or sources of vibrational energy, the power source 1052 is provided to provide a pickup coil, antenna, or eg capacitor and / or desired voltage to switch 1054. It can include other devices, which can convert the input energy to the desired voltage, including the other components. One advantage of infrared energy is that the probe 1020, placed against the patient's skin, is relatively small, implanted in the patient's body several inches apart, for example chest 90, as shown in Figure 62. The point is that it can pass well through the tissue so that it can provide enough energy to operate the tag 1040.

In the embodiment shown in FIG. 65, the switch 1054 can be, for example, a field effect transistor (FET) such as a junction field effect transistor (JFET), with one end of the diode 1052 coupled to the gate (G) and others. The ends are coupled to the source (S) and a resistor 1056 is coupled between both ends. Also, as shown, the source (S) can be electrically coupled to one wire 1044 and the drain (D) can be the other wire, for example the wire 1044 provides an effective antenna for the tag 1040. Can be combined with 1044. In another embodiment, the switch 1054 can be, for example, a Schottky diode whose opposite end of the diode is coupled to a diode 1052 (or other power source) that couples to a wire 1044. For example, the components of circuit 1050 can be mounted in package 1052 so that they are electrically isolated from each other except that the components are coupled in the diagram of FIG. 65. The wire 1044 can be joined or attached to the package 1052 such that the ends of the wire 1044 are electrically coupled to the switch 1054 as shown.

Each diode 1052 can generate a sufficient voltage (eg 0.5V) when exposed to light to open and can close the switch 1054 when there is little or no load (current draw). Circuit 1050 requires little or no current as it is merely intended to modulate the signal from probe 1020, and is therefore required from diode 1052 (and in the result from probe 1020). Power can be minimized, thereby reducing the power demand of system 1010.

In the arrangement shown in FIG. 65, the light intermittently colliding with the diode 1052 gates (G) to provide a control signal that can open and close the switch 1054, as shown in FIG. And can generate a voltage across the source (S). As a result, the passive tag 1040 contains the equivalent of a high frequency switch in the center of the tag 1040. By being able to change the switch 1054 from the closed state to the open state, the reflection characteristics of the antenna provided by the wire 1044 can vary considerably. For example, the switch 1054 can change its polarity, or the switch 1054 can be in the open and closed states to modulate the signal reflected from the tag 1040.

During use, the probe 1020 can be placed against the patient's skin, for example chest 90 in FIG. 62, in which the tag 1040 is implanted. The signal from the antenna of the probe 1020 is supplied with the pulse signal from the light source in order to move the switch 1054 from the open state to the closed state by reflecting the tag 1040 so that it receives the signal and returns it to the probe 1020. Can be done. Two states (for example, if there is substantial clutter, crosstalk or other noise received by probe 1020 due to probe antennas, tissues or other structures in the patient's body in the vicinity, such as tag 1040). The reflected signals from the switch 1054 (open and closed) can be divided from each other, effectively removing other noise, and the probe 1020 can identify and / or position the tag 1040. Make it possible. As such, probe 1020 can use modulated reflected signals to increase the signal-to-noise ratio of the signal.

Similar to the examples described elsewhere in the specification and the applications identified elsewhere in the specification, the system 1010 of FIG. 62, for example, positions a lesion or other target tissue area. May be used during medical procedures during breast biopsy or tumor resection surgery to facilitate and / or to facilitate incision and / or removal of the sample from chest 90 or other body structures it can. Although System 1010 has been described as particularly effective in positioning chest lesions, as described elsewhere in the specification, System 1010 also has other objects in other areas of the body. It should be noted that it can also be used for positioning.

Prior to treatment, the target tissue area, such as a tumor or other lesion, can be identified using conventional methods. For example, lesions within the chest 90 (not shown) can be identified using, for example, mammography and / or other imaging, and decisions are made to remove the lesion. The tag 1040 uses a needle or other feeder (not shown) that is percutaneously introduced through the patient's skin through intervening tissue, for example, up to the tag 40 in or near the lesion. It can be implanted in the chest 90 near the target lesion. For example, the wire 1044 of tag 1040 in FIGS. 64A-64D can be substantially linear and can be loaded into the feeder. As described in the application examples identified herein, the wire 1044 is at risk of movement to facilitate detection, as the tag 1040 is exposed and / or fed there at the target location. Can be reduced and / or the cross section of the tag 1040 can be increased, elastically returning to a gently curved structure.

After the tag 1040 is implanted as desired, the distal end 1024 of the probe 1020 is placed, for example, near or in contact with the patient's skin on a normal lesion and / or directed towards the normal lesion and tag 1040. It can and works. The transmitting antenna of probe 1020 (not shown) can travel through tissue and emit an electromagnetic signal 1034T reflected by tag 1040. The return signal 1034R can be reflected back to the receiving antenna (not shown) in probe 1020, which in turn facilitates the determination of the correct orientation of the incision for the surgeon, eg distance and The spatial relationship between the tag 1040 and the distal end 1024 of the probe 1020, such as / or orientation angle, can be determined.

Also, substantially at the same time, the probe 1020 can transmit the optical pulse 1038a received by the diode 1052. The diode 1052 can alternately generate voltages that keep the switch 54 open and closed. This causes the tag 40 to change the phase of the signal reflected back to the probe 1020 and, for example, by performing subtraction to identify and / or position the tag 1040 and the resulting lesion. Can process signals.

Tissue can then be incised, for example by making an incision in the patient's skin and by incising the tissue that intervenes to a desired depth corresponding to the target margin around the lesion. Tissue samples can be removed or removed using conventional tumor resection surgery procedures, for example with tag 1040 remaining in the removed material 1046, as in other examples herein.

It is understood that the elements and parts shown in any of the embodiments of the specification are typical for a particular embodiment and can be used in or in combination with the other embodiments described herein. Should be.

The present invention can accept various modifications and alternative forms, examples of which are shown in the drawings and are described in detail in the specification. However, the invention should not be limited to the particular form or method described, and conversely, the invention is within the scope of the appended claims, all variants, equivalents and equivalents. It should be understood that it covers alternatives.