Ultrasound localization system with advanced biopsy site markers

Abstract

The disclosed biopsy markers are adapted for use as positioning markers during surgical procedures. Adaptations include incorporation of materials detectable under ultrasound during surgery, and co-registration with image guides or other real-time imaging techniques during surgery. When used as positioning markers, such biopsy markers improve patient comfort and reduce the challenges of surgical coordination and surgical time. Additional disclosed biopsy markers are suitable for use as monitoring and / or detection devices. Positioning of implanted markers can be accomplished by ultrasound technology. Ultrasound image data is analyzed to identify implanted markers. The distance to the marker or lesion can be determined and displayed. The determined distance can be the distance between the ultrasound probe and the marker or lesion, the distance between the marker or lesion and the incision instrument, and / or the distance between the ultrasound probe and the incision instrument.

Description

[0001] Related Applications

[0002] This application was filed as a PCT international patent application on December 11, 2018, and claims priority to U.S. Provisional Patent Application No. 62 / 597,379, entitled “Marker Localization Using Ultrasound” and filed on December 11, 2017; U.S. Provisional Application No. 62 / 660,743, entitled “Ultrasound Localization System” and filed on April 20, 2018; and U.S. Provisional Application No. 62 / 654,071, entitled “Advanced Biopsy Markers” and filed on April 6, 2018. Each of these applications is incorporated herein by reference in its entirety. Background Art

[0003] In the diagnosis of breast cancer, suspicious masses can be found during preliminary inspections involving visual inspection, palpation, ultrasonic imaging, X-rays, magnetic resonance imaging (MRI) or other detection means. After this, a biopsy procedure can be performed to determine whether the suspicious mass is malignant or benign. In order to minimize the invasion of the operation, the biopsy procedure can involve inserting a small biopsy needle into the breast to extract one or more samples (e.g., five samples) from the position around the mass and the center of the mass. In a biopsy procedure, an ultrasonic transducer is usually placed on the breast with one hand, and is used to provide visual guidance for the medical professional performing the biopsy. The biopsy needle held in the other hand of the medical professional is inserted into the lesion.

[0004] Regardless of the imaging modality or instrument used to perform the biopsy procedure, follow-up examination of the biopsy site may be required, either in a follow-up screening examination or in the treatment of a cancerous lesion. In order to mark the location of the lesion for subsequent examination or treatment, a "biopsy site marker" may be surgically inserted during the biopsy procedure.

[0005] In their simplest form, biopsy site markers are used as landmarks to identify the location of lesions for future treatment or further investigation and are the standard of care for breast biopsies. However, due to limited advances in material technology selection, manufacturing, and deployment, coupled with the high skill required to identify markers under different imaging modalities, traditional biopsy site markers have many drawbacks, including poor detection under ultrasound or other visualization modes, inability to co-register with surgical imaging modalities (e.g., in-room image guidance systems, magnetic resonance imaging (MRI), etc.), lack of continuous lesion surveillance capabilities, and lack of differentiation between the biopsy site marker and the patient's anatomical features.

[0006] If the biopsy site is cancerous, then treatment may include mastectomy, lumpectomy, radiation therapy, or chemotherapy procedures, which require the surgeon or radiologist to guide surgery or radiation therapy to the precise location of the lesion. Surgical resection is the gold standard, with more than 50% of cancer patients requiring surgery. There are few successful techniques, which are mainly performed outside the cavity to determine the margins of the tumor (which mainly occurs outside the cavity), which include a margin of normal tissue surrounding the tumor. Ideally, during resection, the surgeon would have "clear" margins, that is, an intact tumor surrounded by healthy tissue. Even so, after resection, the surgeon will stain the resected tumor and then send it for frozen sectioning to be evaluated by a pathologist to understand whether the margins are actually clear or whether more tissue should be removed in a specific direction. In some aspects, this resection can occur days or weeks after the biopsy procedure, by which time the biopsy may have removed or changed the original characteristics of the tissue, or the original characteristics may have been changed due to the growth or progression of the lesion.

[0007] In order to mark the lesion to be removed, an additional positioning procedure is performed before the removal. Regarding positioning, the patient must undergo an additional procedure before surgery to insert a breast lesion positioning wire at the biopsy site. The surgeon then uses the positioning wire to advance the cutting instrument to the lesion to remove the lesion. Generally speaking, a radiosurgeon is required to deploy the wire under an imaging mode (e.g., X-ray) before surgery. However, before the procedure, the positioning wire is not only uncomfortable, but also dislodged or moved as the stainless steel wire protrudes from the patient. In addition, the use of wires can cause serious logistical problems for medical institutions. For example, the radiologist must be available at a certain time before the surgeon is free to perform the operation. Such scheduling requirements are often difficult to achieve, and the radiologist and surgeon may also be located in different buildings on the medical campus. In addition to the above-mentioned defects, traditional biopsy site markers are not well equipped to monitor the progression or regression of lesions before, during or after surgical procedures or other treatments.

[0008] Wireless positioning systems (such as radio frequency guided positioning, electromagnetic reflectors, magnetic tracers and radioactive seeds) are known, but have many disadvantages. Although all of these can reduce patient discomfort, they have the disadvantage of having additional steps in the surgical workflow.

[0009] If the breast radiologist believes there is a possibility that a finding on a diagnostic breast imaging exam is cancer, then an image-guided breast biopsy will be recommended. The current standard of care when a biopsy is done recommends that a biopsy marker be placed in the biopsy site. There are different types of biopsy markers, but some are made of materials that allow for better ultrasound visibility. The markers serve several purposes. First, the marker is used to mark the location in the breast where the tissue is sampled. If the original area of ​​interest is no longer visible through imaging after the biopsy, then the marker can serve as a guide to understand where the diseased tissue was sampled. Second, if surgery is recommended, then the marker can be used as a target for the radiologist to place a localization line to the marked location. Third, the cancerous mass can then be imaged including the marker (and line) that was removed during surgery to ensure that the mass was correctly shown to have been accurately removed from the breast.

[0010] It is with respect to these and other general considerations that aspects of the disclosure herein have been made.Also, while relatively specific problems may be discussed, it should be understood that the examples should not be limited to solving specific problems identified elsewhere in the background or this disclosure. Summary of the invention

[0011] Examples of the present disclosure describe systems and methods for locating implanted markers through ultrasound technology and additional combinations of other modalities.

[0012] In various aspects, a first biopsy marker is provided. The biopsy marker includes a central ball and a plurality of radial spokes connected to the central ball at a proximal end, wherein each of the plurality of radial spokes terminates at a distal ball. At least one of the plurality of radial spokes can be selectively positioned in a condensed configuration and an expanded configuration. When in the condensed configuration, at least one of the plurality of radial spokes is folded to be laterally aligned with a surface of the central ball; and when in the expanded configuration, at least one of the plurality of radial spokes protrudes radially from the surface of the central ball. The biopsy marker is configured to be inserted into a biopsy site in a condensed configuration, and is configured to be deployed from the condensed configuration to an expanded configuration when inserted into the biopsy site. In some cases, the biopsy marker is configured to be deployed into an expanded configuration based at least in part on the shape memory properties of the material from which the biopsy marker is made. The material can be an alloy capable of reflecting ultrasound, such as nitinol. In addition, the biopsy marker can be configured to be positioned using ultrasound imaging. In some cases, at least one distal ball of the biopsy marker includes a contrast agent that is configured to be released into the biopsy site when impacted by ultrasound.

[0013] In other aspects, a second biopsy marker is provided. The biopsy marker includes a central core formed by a first material and at least a first layer formed by a second material and surrounding the central core. In some cases, the second material can be configured to be activated by ultrasound; while in other cases, the second material can include a chemotherapeutic drug that can be configured to become soluble when subjected to ultrasound impact. Alternatively, the second material can include a cancer binding agent that is configured to be released when the second material is subjected to ultrasound impact. Still alternatively, the second material can include a rare earth magnetic metal that is configured to be activated by ultrasound, an ingestion agent, or an external remote control. When the second material is activated, the biopsy marker can be configured to change shape. In other cases, the second material can be configured to be activated by one or more changes in the biological environment (such as changes in pH, changes in temperature, or changes in electrolyte concentration). In response to one or more changes in the biological environment, the second material can be configured to exhibit increased fluorescence, increased solubility, increased echogenicity, release of contrast agents, or release of chemotherapeutic drugs. When the central core is spherical, the second material can form concentric layers surrounding the central core. In addition, a second layer formed by a third material can surround the first layer. The third material can be different from the second material. In some aspects, the biopsy marker can be configured for positioning under ultrasound imaging.

[0014] In addition, a third biopsy marker is provided. The biopsy marker includes a fiber polymer configured to be reactive to one or more conditions of a biological environment surrounding the fiber polymer. The one or more conditions of the biological environment may include one or more of: temperature, pH, electrolyte concentration, and blood flow. The fiber polymer may be configured to react to the biological environment condition by one of: emitting heat, emitting visible light, emitting fluorescence, increasing echogenicity, vibrating, shortening, lengthening, folding, and thickening. In an example, when the fiber polymer reacts by emitting heat, thermal imaging of the biopsy marker can generate a thermal map that can indicate the margins of the lesion. In various aspects, the biopsy marker is configured to be injected near the lesion of the patient during a biopsy procedure.

[0015] In an additional aspect, a method for determining information related to a lesion from a biopsy marker is provided. The method includes implanting a biopsy marker and activating the biopsy marker during a biopsy procedure, wherein activating the biopsy marker may include delivering an agent to the biopsy marker, shocking the biopsy marker by ultrasound, or activating the biopsy marker using an external device. The biopsy marker may be activated in response to a change in the biological environment, wherein the change in the biological environment may include a change in pH, a change in temperature, a change in blood flow, or a change in electrolyte concentration. In various aspects, the change in the biological environment may indicate a change in the lesion. The method also includes receiving data from the biopsy marker and analyzing the received data, wherein analyzing the received data may include determining the position and / or orientation of the biopsy marker. In some cases, the determination of the position and / or orientation of the biopsy marker may be performed during a surgical procedure following the biopsy procedure. Based on the analyzed data, the method includes determining information related to the lesion, wherein determining information related to the lesion may include determining whether the lesion is progressing or regressing or determining the margin of the lesion.

[0016] In one aspect, the technology relates to a method for locating an implanted marker using ultrasound technology. The method includes emitting an array of ultrasonic waves from an ultrasonic transducer of an ultrasound probe; detecting reflected ultrasonic waves by the ultrasonic transducer, wherein the reflected ultrasonic waves include at least a portion of the array of ultrasonic waves after reflection from a marker implanted in a patient's body near a lesion; and generating image data from the reflected ultrasonic waves. The method also includes analyzing the generated image data by a processor to identify a marker in the patient's body; determining, by the processor, a distance to at least one of the marker or the lesion based at least in part on the identification of the marker; and displaying the determined distance to at least one of the marker or the lesion on a display operably connected to the processor.

[0017] In an example, the method includes displaying an ultrasound image including a marker on a display based on reflected ultrasound waves. In another example, the determined distance to at least one of the marker or the lesion is displayed concurrently with the ultrasound image. In yet another example, the marker is visually distinguished from the rest of the ultrasound image by at least one of: highlighting, outlining, a displayed indicator, or a color effect. In yet another example, the determined distance to at least one of the marker or the lesion is one of: a distance from a portion of an ultrasound probe to at least one of the marker or the lesion, a distance from a portion of a scalpel to at least one of the marker or the lesion, or a distance from a portion of an incision instrument to at least one of the marker or the lesion. In yet another example, the incision instrument is one of a cauterization tool, a scalpel, or an internal probe.

[0018] In another example, the method includes receiving a signal from a marker location transceiver, wherein the marker location transceiver is attached to the marker; processing the signal received from the marker location transceiver by a processor to determine at least one of the position of the marker or the orientation of the marker; and wherein determining the distance to at least one of the marker or the lesion is also based on at least one of the position of the marker or the orientation of the marker. In yet another example, the method includes receiving a signal from a probe location transceiver, wherein the probe location transceiver is attached to an ultrasound probe; processing the signal received from the probe location transceiver by a processor to determine at least one of the position of the ultrasound probe or the orientation of the ultrasound probe; and wherein determining the distance to at least one of the marker or the lesion is also based on at least one of the position of the ultrasound probe or the orientation of the ultrasound probe. In yet another example, the method includes receiving a signal from an instrument location transceiver, wherein the instrument location transceiver is attached to an incision instrument; processing the signal received from the instrument location transceiver by a processor to determine at least one of the position of the incision instrument or the orientation of the incision instrument; and wherein determining the distance to at least one of the marker or the lesion is also based on at least one of the position of the ultrasound probe or the orientation of the ultrasound probe.

[0019] In another example, the determined distance includes a directional component. In yet another example, analyzing the generated image data by the processor to identify a marker in the patient also includes using pattern recognition techniques to analyze the generated image data to identify the marker based on a cross-section of the marker. In yet another example, analyzing the generated image data by the processor to identify the marker also includes identifying an orientation of the marker based on a cross-section of the marker. In yet another example, determining the distance to the marker in the patient is also based on the orientation of the identified marker.

[0020] In another aspect, the technology relates to a method for locating an implanted marker using ultrasound technology. The method includes emitting a first array of ultrasound waves from an ultrasound transducer of an ultrasound probe in a first position; detecting a first reflected ultrasound wave by the ultrasound transducer, wherein the first reflected ultrasound wave includes at least a portion of the first array of ultrasound waves after reflection from a marker implanted in a patient's body; generating first image data from the first reflected ultrasound wave. The method also includes analyzing the generated first image data by a processor to identify the marker inside the patient. The method also includes emitting a second array of ultrasound waves from an ultrasound transducer of an ultrasound probe in a second position; detecting a second reflected ultrasound wave by the ultrasound transducer, wherein the second reflected ultrasound wave includes at least a portion of the second array of ultrasound waves after reflection from the patient's body; generating second image data from the first reflected ultrasound wave; and analyzing the generated second image data by a processor to determine that there is no marker in the generated second image data. The method also includes generating a navigation indicator, wherein the navigation indicator indicates the direction of the marker relative to the second position of the ultrasound probe; and displaying the navigation indicator on a display concurrently with the ultrasound image generated from the second image data.

[0021] In an example, the method includes generating a first image from first image data; and displaying the first image on a display operably connected to a processor. In another example, the method includes determining a distance to a marker in a patient's body based at least in part on the identification of the marker in the generated first image data; and displaying the determined distance to the marker on the display concurrently with the display of the first image. In yet another example, the determined distance to the marker is one of: a distance from a portion of an ultrasound probe to the marker, a distance from a portion of a scalpel to the marker, or a distance from a portion of a cautery tool to the marker. In yet another example, the navigation indicator is an arrow pointing to a direction of a second position of the marker relative to the ultrasound probe. In yet another example, the method includes receiving a signal from a marker location transceiver, wherein the marker location transceiver is attached to the marker; processing, by a processor, the signal received from the marker location transceiver to determine at least one of the position of the marker or the orientation of the marker; and wherein generating the navigation indicator is also based on at least one of the position of the marker or the orientation of the marker. In another example, the method includes receiving a signal from a probe positioning transceiver, wherein the probe positioning transceiver is attached to an ultrasound probe; processing, by a processor, the signal received from the probe positioning transceiver to determine at least one of a position of the ultrasound probe or an orientation of the ultrasound probe; and wherein generating a navigation indicator is also based on at least one of the position of the ultrasound probe or the orientation of the ultrasound probe.

[0022] In another aspect, the technology relates to a system for ultrasound positioning. The system includes an implanted marker, wherein the implanted marker is implanted in a patient's body; an ultrasound probe, which includes an ultrasound transducer, which is configured to transmit an array of ultrasound waves and detect reflected ultrasound waves, wherein the reflected ultrasound waves include at least a portion of the array of ultrasound waves after being reflected in the patient's body; a display; at least one processor, which is operably connected to the display and the ultrasound probe; and a memory, which is operably connected to the at least one processor, storing instructions for performing a set of operations when executed by the at least one processor. The set of operations includes generating image data from the reflected ultrasound waves; analyzing the generated image data by the processor to identify the marker in the patient's body; determining the distance to at least one of the marker or the lesion based on the identification of the marker and the reflected ultrasound waves; and displaying the determined distance to at least one of the marker or the lesion on the display.

[0023] In an example, the system further comprises a marker location transceiver attached to the marker, wherein the marker location transceiver transmits data indicating at least one of the position of the marker or the orientation of the marker. In another example, the system further comprises a probe location transceiver attached to the ultrasound probe, wherein the probe location transceiver transmits data indicating at least one of the position of the probe or the orientation of the probe. In yet another example, the system comprises an incision instrument, wherein the incision instrument comprises an instrument location transceiver, wherein the instrument location transceiver transmits data indicating at least one of the position of the incision instrument or the orientation of the incision instrument. In yet another example, the incision instrument is one of a cauterization tool, a scalpel, or an internal probe. In yet another example, the instrument location transceiver is attached to the tip of the incision instrument.

[0024] In another example, at least one of the marker location transceiver, the probe location transceiver, or the instrument location transceiver is a radio frequency identification (RFID) device. In yet another example, the system further comprises an inductive power supply, wherein at least one of the marker location transceiver, the probe location transceiver, or the instrument location transceiver is powered by the inductive power supply.

[0025] In another aspect, the technology relates to a method for ultrasound positioning and navigation. The method includes emitting an array of ultrasound waves from an ultrasound transducer of an ultrasound probe; detecting reflected ultrasound waves by the ultrasound transducer, wherein the reflected ultrasound waves include at least a portion of the array of ultrasound waves after reflection from the body of a patient having an implanted marker near a lesion; generating image data from the reflected ultrasound waves; analyzing the generated image data by a processor to determine whether a marker is present in the image data. The method also includes performing at least one of the following based on determining whether a marker is present in the image data: if the marker is present in the image data, determining by the processor a distance to at least one of the marker or the lesion; and displaying the determined distance to at least one of the marker or the lesion on a display operably connected to the processor; and if there is no marker in the image data, determining the position of the marker; generating a navigation indicator, wherein the navigation indicator indicates the position of the marker relative to the current position of the ultrasound probe; and displaying the navigation indicator on the display concurrently with the ultrasound image.

[0026] In another aspect, the technology relates to a method for locating an implanted marker using ultrasound technology. The method includes emitting an array of ultrasound waves from an ultrasound transducer of an ultrasound probe; detecting reflected ultrasound waves by the ultrasound transducer, wherein the reflected ultrasound waves include at least a portion of the array of ultrasound waves after being reflected by a marker implanted in a patient near a lesion; generating image data from the reflected ultrasound waves; displaying an ultrasound image from the generated image data; receiving user input to identify a marker in the ultrasound image; determining, by a processor, a distance to at least one of the marker or the lesion based at least in part on the identification of the marker; and displaying the determined distance to at least one of the marker or the lesion on a display operably connected to the processor.

[0027] In an example, the method further includes identifying an incision instrument in the ultrasound image. In yet another example, identifying the incision instrument in the ultrasound image is based on user input identifying the incision instrument. In yet another example, the method further includes receiving input identifying a type of the incision instrument. In yet another example, identifying the incision instrument in the ultrasound image is based on the type of the incision instrument. In yet another example, the method further includes receiving input regarding a type of the marker. In another example, the determined distance is a distance between the incision instrument and the marker. In yet another example, determining the distance is based on user input drawing a line between the incision instrument and the marker on the ultrasound image.

[0028] In another aspect, the technology relates to a method for confirming a margin of a sample. The method includes imaging the sample from a first orientation with an ultrasound probe, wherein the sample includes a lesion; determining a location of the lesion in the first orientation; determining, based on the location of the lesion, that a margin between the lesion and an edge of the sample in the first orientation is less than a predetermined margin; and generating an alarm based on the margin being less than the predetermined margin. In an example, determining the location of the lesion includes determining a distance from the ultrasound probe to the lesion. In another example, determining the margin between the lesion and an edge of the sample in the first orientation includes comparing the location of the lesion with a predicted location of the lesion in the first orientation. In yet another example, determining the margin between the lesion and an edge of the sample in the first orientation includes determining a difference between a distance from the ultrasound probe to the lesion and a distance from the lesion to a surface on which the lesion is located. In yet another example, the method also includes rotating at least one of the sample and the ultrasound probe; imaging the sample from a second orientation with the ultrasound probe; determining a location of the lesion in the second orientation; determining, based on the location of the lesion, that a margin between the lesion and an edge of the sample in the second orientation is less than a predetermined margin; and generating another alarm based on the margin being less than the predetermined margin.

[0029] This summary is provided to introduce some concepts in a simplified form, which will be further described in the detailed description below. This summary is neither intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Additional aspects, features, and / or advantages of examples will be set forth in part in the description below, and in part will become clear from the description, or may be learned through practice of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Non-limiting and non-exhaustive examples are described with reference to the following figures.

[0031] Figure 1A An example of an ultrasound positioning system is depicted.

[0032] Figure 1B An example of an ultrasound positioning system in use with a patient is depicted.

[0033] Figure 1C An example of an ultrasound image including implanted markers is depicted.

[0034] Figure 1D An example of an ultrasound image that does not include implanted markers is depicted.

[0035] Figure 1E An example of a suitable operating environment for incorporation into an ultrasound positioning system is depicted.

[0036] Figures 2A-2D An example biopsy site marker is depicted that is configured in a three-dimensional radial spoke shape in both collapsed and expanded states.

[0037] Figure 3 An example biopsy site marker constructed as a multi-layered spherical shape is depicted.

[0038] Figures 4A-4C An example biopsy site marker configured as an expandable spherical lattice structure is depicted.

[0039] Figure 5 An example biopsy site marker constructed as a fibrous polymer is depicted.

[0040] Figure 6 Example methods for determining information related to a lesion from implanted markers are depicted.

[0041] Fig. 7A Example methods for locating lesions or implanted markers are depicted.

[0042] Figure 7B An example of ultrasound imaging is depicted, including a method of calculating the distance from an incision instrument to a marker.

[0043] Fig. 8A Another example method for positioning and navigating an implanted marker is depicted.

[0044] Figure 8B Another example method for positioning and navigating an implanted marker is depicted.

[0045] Fig. 9 Depicted are example methods for locating and detecting implanted markers and incision tools.

[0046] Fig. 10A An example system for imaging a sample is depicted.

[0047] Fig. 10B Depicts the sample rotated Fig. 10A Ultrasound system.

[0048] Fig. 10C Depicts the ultrasound probe rotated Fig. 10A Ultrasound system.

[0049] Fig.11 The method used to confirm the margins of the samples is depicted.

[0050] Figures 12A-12F Examples of implanted markers are depicted. DETAILED DESCRIPTION

[0051] As discussed above, regarding positioning, patients generally must undergo additional procedures to insert breast lesion localization wires at the biopsy site. As detailed above, localization wires are not only uncomfortable for patients, but also cause serious logistical problems for medical institutions.

[0052] As described herein, biopsy markers can be suitable for use as positioning markers during surgical procedures.Previous biopsy site markers are used as bad positioning markers in surgical procedures because they are not easily distinguished after being placed for weeks or months, and are not equipped to monitor the progress or regression of lesions before, during or after surgical procedures or other treatments.The adaptation of biopsy site markers to positioning can include various materials detectable under ultrasound during surgery, and the features of co-registration or other real-time imaging techniques with image guidance during surgery.In this way, the use of biopsy markers inserted with minimal intervention a few days or weeks before surgical procedures improves the comfort of patients and reduces the challenges of surgical coordination and intraoperative patient time.The precise positioning of markers (e.g., placed within 1 cm of lesions) can increase the healthy tissue left after excision of the tumor, and if the marker is only a few millimeters or centimeters away from the correct lesion displacement, so too much tissue removal can be made, thereby causing additional surgery to completely remove or optimize cosmetic effects.

[0053] Additionally or alternatively, the biopsy marker can be adapted for use as a monitoring and / or detection device. For example, the biopsy marker can be equipped with a radio frequency identification (RFID) chip for sending and receiving data, a global positioning (GPS) function for detecting real-time marker location, features for co-registration within the operating room imaging field, a pH meter or a pH-responsive material, a magnetic seed or radioactive material contained therein, a movement detection function (e.g., via a Doppler), a vibration detection function (e.g., via ultrasound elastography), a heat detection function or a heat-responsive material, an electrolyte monitoring function, a tumor recognition function (e.g., via antigen bonding, secretion detection, blood flow or blood pressure monitoring, etc.), etc. Improvements to these and other biopsy markers are the subject of the present invention.

[0054] In addition, the existing solution of locating lesions by using stainless steel wire has several disadvantages from patient discomfort to medical facility logistics. As an example, the use of stainless steel wire on the day of surgery requires a large amount of additional medical facility utilization. For example, on the day of surgery, the patient and any imaging methods must first be prepared in radiology. Then, the radiologist must be free to insert the wire under the imaging modality. After the wire is inserted, further imaging and fixation may be required to allow the patient to be transferred to the operating room. After the patient is transferred to the operating room, the surgeon still cannot view the real-time image of the lesion. Instead, the surgeon is required to rely only on the wire as a guide to the lesion. Even in places where non-wire solutions are implemented (such as using radioactive seeds), radiologists are generally still required to insert seeds. In addition, radioactive seeds also introduce radiation into the patient. Similarly, other non-wire solutions (such as radiofrequency guided, electromagnetic reflectors and magnetic tracers) also require radiologists to spend time placing non-wire technologies before surgery.

[0055] By allowing the implantation of markers into the lesion several days before surgery, and providing real-time visualization and positioning of markers during surgery, examples of the present technology have been improved on the existing technology that requires wires. For example, markers can be placed at the time of biopsy rather than near the time of surgery. In addition, radiologists may no longer be required to place wired or wireless positioning devices in preoperative procedures. During surgery, surgeons can also obtain visualization of markers by using ultrasound. For example, an ultrasound imaging system can detect and identify markers in the patient's body. Once the marker is identified, the distance and / or direction to the marker can be automatically determined and displayed to the surgeon together with the ultrasound image. The distance and direction to the marker can indicate the distance from the ultrasound probe to the marker or the distance from the marker to the incision instrument (such as a cautery tool, a scalpel or an internal probe). In addition, in the case of known marker geometry and lesion geometry, the distance to the edge of the lesion can also be generated. Thus, surgeons can perform surgical incisions more accurately to reach lesions marked by markers.

[0056] Figure 1A An example of an ultrasound positioning system 100 is depicted. The ultrasound positioning system 100 includes an ultrasound probe 102, which includes an ultrasound transducer 104. The ultrasound transducer 104 is configured to transmit an array of ultrasound waves 106. The ultrasound transducer 104 converts electrical signals into ultrasound waves 106. The ultrasound transducer 104 can also be configured to detect ultrasound waves, such as ultrasound waves that have been reflected from a patient's body. In some examples, the ultrasound transducer 104 can incorporate capacitive transducers and / or piezoelectric transducers, as well as other suitable transducing technologies.

[0057] The ultrasound transducer 104 is also operably connected (eg, wired or wireless) to a display 110. The display 110 may be part of a computing system that includes a processor and memory configured to generate and analyze ultrasound images. Figure 1E Further discussion of suitable computing systems is provided. Display 110 is configured to display an ultrasound image based on ultrasound imaging of the patient. The ultrasound imaging performed in ultrasound positioning system 100 is primarily B-mode imaging, which produces a two-dimensional ultrasound image of a cross section of a portion of the patient's body. The brightness of the pixels in the resulting image generally corresponds to the amplitude or intensity of the reflected ultrasound waves. Other ultrasound imaging modes may also be used.

[0058] The ultrasound probe 102 may also include a probe positioning transceiver 108. The probe positioning transceiver 108 is a transceiver that transmits a signal that provides positioning information for the ultrasound probe 102. The probe positioning transceiver 108 may include a radio frequency identification (RFID) chip or device for sending and receiving information. For example, the signal transmitted by the probe positioning transceiver 108 can be processed to determine the orientation or position of the ultrasound probe 102. The orientation and position of the ultrasound probe 102 can be determined or provided in three-dimensional components, such as Cartesian coordinates or spherical coordinates. The orientation and position of the ultrasound probe 102 can also be determined or provided relative to other items (such as incision instruments, markers, magnetic directions, normals to gravity, etc.). With respect to the orientation and position of the ultrasound probe 102, additional information can be generated and provided to the surgeon to help guide the surgeon to the lesion in the patient's body, as further described below. Although the term transceiver is used herein, the term is intended to cover transmitters, receivers, and transceivers, as well as any combination thereof.

[0059] Figure 1B An example of an ultrasound positioning system 100 is depicted for use with a patient 112. In various aspects, the ultrasound positioning system 100 can be utilized during a surgical procedure. In other aspects, the ultrasound positioning system 100 can be utilized during an examination or diagnostic procedure. An ultrasound probe 102 is in contact with a portion of the patient 112, such as a breast of the patient 112. Figure 1B, an ultrasound probe 102 is used to image a portion of a patient 112 that includes an irregularly shaped lesion 114. A marker 116 has been implanted at or near the lesion 114. In various aspects, the marker 116 may be implanted at the lesion during or in conjunction with a biopsy procedure prior to the surgical procedures discussed herein. The marker 116 allows the lesion 114 to be located by using the ultrasound positioning system 100. In order to image the portion of the patient 112 that includes the marker 116, the ultrasound transducer 104 transmits an array of ultrasound waves 106 into the body of the patient 112. When the marker 116 is in the field of view, a portion of the ultrasound waves 106 are reflected from the internal components of the patient 112 and the marker 116 and returned to the ultrasound probe 102 as reflected ultrasound waves 120. The reflected ultrasound waves 120 may be detected by the ultrasound transducer 104. For example, the ultrasound transducer 104 receives the reflected ultrasound waves 120 and converts the ultrasound waves 120 into electrical signals that may be processed and analyzed to generate ultrasound image data on the display 110. The depth of the marker 116 or other object in the imaging plane can be determined based on the time between the pulse of the ultrasonic wave 106 emitted from the ultrasonic probe 102 and the reflected ultrasonic wave 120 detected by the ultrasonic probe 102. For example, the speed of sound is well known, and the effect of the speed of sound based on soft tissue is also determinable. Thus, based on the flight time of the ultrasonic wave 106 (more specifically, half of the flight time), the depth of the object within the ultrasonic image can be determined. Other corrections or methods for determining the depth of the object can also be implemented, such as compensating for the refraction and changing speed of the wave passing through the tissue. Those skilled in the art will understand more details of depth measurement in medical ultrasound imaging technology.

[0060] In addition, multiple frequencies or modes of ultrasound technology can be utilized. For example, real-time and concurrent transmission and reception multiplexing of positioning frequencies and imaging frequencies and capture frequencies can be achieved. Positioning frequencies can be achieved for lesions or marker target determination, and imaging frequencies can be achieved for ultrasound examinations. The utilization of these capabilities provides information from multiple data sets of ultrasound technology to be co-registered or fused to allow real-time visualization of markers 116 and medical images on display 110. Imaging frequencies and capture sequences can include B-mode imaging (with or without compounding), Doppler modes (e.g., color, duplex), harmonic modes, shear waves and other elastic imaging modes, and contrast-enhanced ultrasound, as well as other imaging modes and techniques.

[0061] As described in detail above, the marker 116 can be implanted at or near the lesion 114 before the surgical procedure. For example, when a lesion is detected in the patient 112, a sample may have been obtained by biopsy and then tested to determine whether the lesion is malignant or benign. Thereafter, if the lesion is determined to be malignant, a prescription for treatment and / or further examination may have been issued. Such treatment, including surgical resection, radiation therapy or other targeted treatments, may occur a few days or weeks after the biopsy procedure, by which time the original characteristics of the tissue may have changed. Thus, the marker 116 can be inserted during the biopsy procedure for future identification of the location of the lesion 114. In this way, rather than requiring the placement of coordination and positioning wires at the time of surgery, the previously inserted marker 116 can be used to locate the lesion. Therefore, the logistics and arrangement of the day of surgery are simplified, and the overall surgical time for the patient is reduced. Further benefits can be achieved because the marker 116 can be specifically designed for detection using ultrasound or other imaging techniques to provide real-time imaging and lesion location data during the surgical procedure.

[0062] In the depicted example, the marker 116 is in the shape of a cube. By utilizing a marker 116 in the shape of a cube, the marker 116 can be more easily detected in an ultrasound image because a cube-shaped object should not naturally appear in the human body. For similar reasons, other shapes that are not expected to appear in the human body can also be used for the marker 116. For example, a shape with a symmetry similar to a cube or an elongated rectangular prism also allows the orientation of the marker 116 to be determined based on a cross-section of the marker 116 that appears in the corresponding ultrasound image, as will be discussed in further detail below. In addition, radially symmetrical shapes, multi-layered spherical shapes, or spherical lattice structures (none of which naturally appear in the human body) can be used to distinguish the marker 116 from the surrounding anatomical structures and / or tissues. For example, the marker 116 can have a shape with clear edges (as opposed to a spiral shape), have a uniform echogenicity, be essentially high echogenic, have no rear acoustic shadow, and be wider rather than taller in appearance.

[0063] The marker 116 may also include a marker location transceiver 118. The marker location transceiver 118 is a transceiver that transmits a signal that provides location information for the marker 116. The marker location transceiver 118 may include a radio frequency identification (RFID) chip or device for sending and receiving information. For example, the signal emitted by the marker location transceiver 118 may be processed to determine the orientation or position of the marker 116. The orientation and position of the marker location transceiver 118 may be determined or provided in three-dimensional components, such as Cartesian coordinates or spherical coordinates. The orientation and position of the marker 116 may also be determined or provided relative to other items (such as an incision instrument 126, an ultrasound probe 102, a magnetic direction, a normal to gravity, etc.). As further described below, additional information may be generated and provided to the surgeon regarding the orientation and position of the marker 116 to help guide the surgeon to the lesion in the patient's body.

[0064] In other aspects, the marker 116 may include additional or alternative functions. For example, the marker 116 may include one or more sensors or other detectors for monitoring the progression or regression of the tumor. For example, such sensors may include pH sensors, blood flow (or blood pressure) sensors, electrolyte sensors (e.g., for detecting calcium ions, Ca2+ uptake), thermal sensors, Doppler devices, etc. The sensor associated with the marker 116 or incorporated into the marker 116 may transmit sensor data to one or more devices via the marker positioning transceiver 118 or another transceiver (not shown). The device for receiving sensor data may communicate with the positioning system 100 or may communicate with an independent monitoring system. In some cases, the monitoring system may evaluate the sensor data continuously or semi-continuously during the surgical procedure, between surgical treatments, or any combination thereof. Evaluating the sensor data may enable the monitoring system to detect changes in the tumor. For example, an increase in the blood flow or thermal imaging occupied area may indicate that cell metabolism or vascularization in the tumor area is increasing, which may indicate the progression of the lesion. Conversely, a decrease in the blood flow or thermal imaging occupied area may indicate a decrease in cell metabolism or angiogenesis and a corresponding regression of the lesion. Additionally or alternatively, sensor data indicating a decrease in pH or an increase in calcium ion (Ca2+) uptake at or near a tumor site may indicate tumor progression. As should be appreciated, an increase in pH at or near a tumor site and / or a decrease in calcium ion uptake may indicate tumor regression.

[0065] In still other aspects, the marker 116 may include an implantable chip that includes hardware and / or software for monitoring lesion size and pathology. For example, the implantable chip marker may be configured with hardware and software that utilizes one or more associated sensors to monitor one or more of the above conditions. Additionally or alternatively, the implantable chip marker may provide in situ delivery of prescription drugs or may deliver targeted radiation to the lesion. In some cases, the implantable chip marker may be activated by ultrasound or an external remote control. The implantable chip marker may also include a transceiver for sending data to or receiving data from an external computing device and / or display.

[0066] In some cases, an agent that detects and activates marker 116 can be ingested (e.g., in the form of a pill or other formulation a few days or weeks before surgery). For example, marker 116 can include a receptor surface that is compatible with the agent. After bonding to the receptor surface, the agent can activate marker 116, or the agent itself can be activated. In this way, marker 116 can be used as a localization marker when activated by the agent. Alternatively, the agent can be used as a cancer cell binding agent. After ingestion, the agent can detect lesions 114 (or other cancerous tumors) and bond to the surface of lesions 114. In various aspects, the agent can exhibit characteristics that can be detected by various imaging systems. For example, the agent can emit fluorescence, can vibrate, can emit heat or visible light, can exhibit high echogenicity, etc. In this way, marker 116 and / or lesions 114 can be located by the ingested agent.

[0067] In one embodiment, the marker 116 includes a marker material that is substantially dehydrated in a pre-deployed configuration and is configured to expand when exposed to a fluid after deployment. The marker material can also be configured to remain substantially physically stable when implanted for an extended period of time (e.g., from a biopsy process until at least one subsequent surgical procedure). As described in detail above, in addition to being formed into a recognizable shape, the marker material can also be configured to reflect ultrasound in a manner that allows the marker 116 to be recognizable as artificial. For example, the marker 116 can be sufficiently reflective for detection, but can not significantly block any anatomical structure below it. For example, the ultrasound reflective material can be nitinol. Nitinol is an alloy of nickel and titanium arranged in a lattice. The lattice exhibits the ability to exist in two different phases, called martensite and austenite. The austenite arrangement is more compact and requires more energy to maintain, so under normal conditions, nitinol adopts a lower energy expansion martensite arrangement. Due at least in part to this unique property, Nitinol exhibits shape memory properties, which enables the Nitinol to be formed into a first shape at high temperatures and to be reformed into at least one second shape when cooled. Thereafter, when heated above the transition temperature, the Nitinol returns to the first shape. Nitinol is generally provided in the form of a wire, which may be woven into a mesh, braided wire, or otherwise shaped or configured.

[0068] The marker 116, various sensors and / or the marker location transceiver 118 can be powered via an inductive power supply 122. The inductive power supply 122 generates an electromagnetic wave 124 directed toward the marker 116. The marker 116 includes a coil or similar receiver that can convert the electromagnetic wave 124 into electrical energy to power the marker 116 and / or the marker location transceiver 118. The electromagnetic wave 124 can also be used as a trigger to activate or control the marker 116 and / or the marker location transceiver 118. For example, receiving the electromagnetic wave 124 by the marker location transceiver 118 can trigger the marker location transceiver 118 to send a signal providing location information for the marker 116. In some examples, ultrasound can trigger or activate the marker location transceiver 118. In such examples, the inductive power supply may not be necessary, and the marker location transceiver 118 can be powered by ultrasound by converting the physical energy of the sound wave into electrical energy. In another example, a battery can also be used to power the marker location transceiver 118. In yet another example, the inductive power supply 122 can be incorporated into the ultrasound probe 102. In such an example, electromagnetic waves 124 are emitted from the ultrasound probe 102.

[0069] The incision instrument 126 may also be used as part of the ultrasound positioning system 100. The incision instrument 126 may be any of a cautery tool, a scalpel, or other type of instrument used to make an incision or intended to be used in the patient 112. For example, the incision instrument 126 may also be an internal probe, such as a pH probe or a thermal imaging probe. The incision instrument 126 may include an instrument positioning transceiver 128. The instrument positioning transceiver 128 is a transceiver that transmits a signal that provides positioning information for the incision instrument 126. The instrument positioning transceiver 128 may include a radio frequency identification (RFID) chip or device for sending and receiving information. For example, the signal transmitted by the instrument positioning transceiver 128 may be processed to determine the orientation or position of the incision instrument 126. The orientation and position of the instrument positioning transceiver 128 may be determined or provided in three-dimensional components, such as Cartesian coordinates or spherical coordinates. The orientation and position of the incision instrument 126 may also be determined or provided relative to other items (such as markers 116, ultrasound probe 102, magnetic direction, normal to gravity, etc.). Additional information regarding the orientation and position of the incision instrument 126 may be generated and provided to the surgeon to help guide the surgeon to a lesion in the patient, as further described below. The instrument location transceiver 128 may also be powered and / or triggered via the inductive power supply 122 in a manner similar to the marker location transceiver 118.

[0070] In an example, the instrument positioning transceiver 128 is located at the tip of the incision instrument 126. An indicator on the display 110 or on the incision instrument may indicate the distance from the tip of the incision instrument to the marker 116 or to the edge of the lesion 114. Such a determination may be made by analyzing ultrasound data or information derived from signals of the marker positioning transceiver 118 and the instrument positioning transceiver 128, or a combination thereof. In the case where the incision instrument 126 is a cauterization tool, the cauterization tool may be configured to shut down when the tip of the cauterization tool reaches the edge of the lesion 114. The distance between the tip of the incision instrument 126 and the marker 116 and / or the edge of the lesion 114 may also be determined at a position where the instrument positioning transceiver 128 is not located in the tip of the incision instrument 126. For example, in the case where the size and shape of the incision instrument 126 are known, the position of the tip of the incision instrument 126 may be determined based on the position and orientation of the instrument positioning transceiver 128. In an example, the corresponding distance may be determined based on the depth of the detected object in the ultrasound image and the corresponding lateral distance between the objects. As discussed above, the depth to the object can be determined based on the flight time of the ultrasound wave. The lateral distance between two objects can be based on the amount of space between the objects in the ultrasound image. For example, the lateral distance can be determined based on the number of pixels between the two objects in the image. The lateral distance calculation and process can be programmed into the ultrasound system 100. The lateral distance calculation can also be trained with samples or phantoms with markers of known distances. The lateral distance between any two objects appearing in the ultrasound image can then be calculated. Those skilled in the art will recognize other processing and considerations for calculating the lateral distance in the ultrasound image. Once the depth and lateral distance of the object are determined, the two-dimensional or three-dimensional distance from one object to another can be determined by using triangulation and / or geometric relationships between lines used to measure the depth and lateral distance.

[0071] Similarly, the location of the edge of the lesion can be determined from the location and orientation of the marker 116. For example, when the marker 116 is inserted into the patient, the relative size and shape of the lesion 114 can also be determined. When the marker 116 is inserted, the edge of the lesion 114 can be determined relative to the location and orientation of the marker 116. For example, the edge of the lesion 114 can be represented based on the location and orientation of the marker 116. As such, in some examples, the marker 116 need not be located directly at or above the lesion 114.

[0072] Figure 1CAn example of an ultrasound image 130 on the display 110 is depicted, which includes an image of an implanted marker 116. The ultrasound image 130 is an example of an ultrasound image in which the marker 116 is within the field of view of the ultrasound probe 102. The ultrasound image 130 is generated based on image data generated from the detected reflected ultrasound waves 120. Based on the image data or ultrasound image 130, the marker 116 is identified by using image analysis techniques. Because the shape of the marker 116 is not a shape that naturally occurs in the human body, the image analysis technology can more easily detect and identify the marker 116 from the image data. For example, in the case where the marker 116 is in the shape of a cube, the marker 116 is abnormally prominent in the ultrasound image data. Alternatively, once the marker 116 is within the field of view of the ultrasound probe 102, the marker 116 can be indicated by the user in the ultrasound image 130.

[0073] The image analysis technique may also be based on machine learning techniques, such as neural networks, deep learning algorithms, statistical analysis techniques, enhanced contrast techniques, or other pattern recognition or matching techniques trained based on the shape of the marker 116 implanted in the patient 112. As an example, in the case where the shape of the marker 116 is a cube, the image analysis algorithm may first be trained on a collection of ultrasound images of the cube-shaped marker in different orientations and cross-sectional views. Similar analysis may be achieved by using machine learning to identify or quantify grayscale changes (echoicity levels). The current ultrasound image 130 or image data is then provided as input to the trained image analysis algorithm to detect or identify the marker 116. Identifying the marker 116 is generally based on a cross-section of the marker, because the ultrasound image 130 is a two-dimensional image with a cross-section of the marker 116. In other aspects, the marker 116 may be a three-dimensional radial spoke shape, a spherical lattice structure surrounding a core material, or a multi-layered spherical structure, none of which naturally exists in the human body and may be used to distinguish the marker 116 from the surrounding anatomical structures and / or tissues. In this case, the set of trained ultrasound images may include different orientations, different grayscale values, and cross-sectional views in the shape of radial spokes, multi-layered spheres, or spherical grids.

[0074] In additional examples, an ultrasound technician or other user may provide additional input to help identify the marker 116 in the ultrasound image. For example, an input indicating the type of marker 116 that has been implanted in the patient 112 may be provided. The input may indicate the shape and size of the marker 116. In an example, the input may include providing a model or other identifying information for the marker 116. Based on the input, the dimensions and other information about the marker 116 may be obtained, such as from a local or remote database storing such information. The image analysis technology may then use the dimensions or other shape input of the marker to help identify the marker 116 within the ultrasound image 130. Additional input from the ultrasound technician or other user may also include directly identifying the marker 116 on the ultrasound image 130, such as receiving a pointer, touch, or other input to locate the marker 116. For example, the ultrasound technician may select the marker 116 by clicking the marker 116 with a mouse on the display of the ultrasound image 130. The distance to the marker 116 may then be based on the input provided by the ultrasound technician. For example, the distance to the marker 116 may be determined based on the number of pixels in the image between the marker and another point in the image. Input identifying the marker 116, such as a click on the image of the marker 116, can also be used in the image analysis technique to limit the area of ​​the ultrasound image 130 to be analyzed. For example, upon receiving a selection of the marker 116 from the ultrasound technician, a predetermined area around the selection point can be analyzed to identify the marker 116. In other examples, the ultrasound technician can provide a two-dimensional input, such as a box, to provide boundaries for the area to be analyzed by the image analysis technique to identify the marker 116.

[0075] The marker 116 may also be made of a material that makes the marker easier to detect within the ultrasound image 130 or image data. For example, the material of the marker 116 may be selected to be a material with a high echogenicity, such as nitinol. By forming the marker 116 with a material having a high echogenicity, the marker 116 will appear brighter in the resulting ultrasound image because the material with a higher echogenicity has a higher ability to reflect ultrasound waves. The marker 116 may also have several flat surfaces that can help reflect acoustic waves without blocking the anatomical structure below the marker 116 (which would complicate future follow-up). In some examples, incorporating air or other gases into the marker 116 may make the marker 116 appear brighter in the ultrasound image 130.

[0076] The marker 116 can be configured to provide additional indicators to help the surgeon find the marker 116. For example, the marker 116 can include a fluorescent material or a luminescent material that emits visible light so that the surgeon can see the marker 116 during surgery. In some examples, the marker 116 can include microbubbles that burst due to ultrasound, thereby causing the release of the luminescent material. Alternatively, the marker 116 can include an ultrasound contrast agent, a magnetic resonance imaging (MRI) contrast agent, or air, for example, in a sphere at the distal end of the radial spoke. In other examples, the marker 116 can include a rare earth magnetic metal that is activated in response to ultrasound or by remote control. In yet other examples, the marker 116 can include a material that can convert ultrasound energy into light in the visible spectrum. The marker 116 can also include a light source powered by an inductive power supply 122, a battery, or some other power source. Similarly, the marker 116 can also provide a sound or tactile output to alert the surgeon of the location of the marker. The marker 116 may include a piezoelectric crystal that is activated by ultrasound to generate power for powering the marker 116, various sensors, and / or a marker locating transceiver 118. In some aspects, a piezoelectric powered marker may transmit position data and / or commands to other devices, sensors, transceivers, etc. (e.g., via the marker locating transceiver 118).

[0077] In other aspects, the marker 116 can be composed of or filled with a molecular agent that can be released after being activated by ultrasound to bond to cancer cells of the lesion 114 and / or deliver a chemotherapeutic agent to the site of the lesion 114. When the molecular agent is detectable using a fluorescent or other probe, the specific outline of the margins of the lesion 114 can be identified. For example, a multi-layered spherical marker can contain different molecular agents in different layers to be activated at different times. Alternatively, different layers of the multi-layered spherical marker can become soluble and can respond to different conditions (such as pH and / or electrolyte levels (e.g., Ca 2+ That is, different layers of the multilayer spherical marker can be formed of different materials that are reactive under different conditions.

[0078] In other examples, the marker 116 can be configured to vibrate, thereby causing the temperature of the marker 116 to increase. Alternatively, the marker 116 can be composed of a reactive polymer that can respond to pH or electrolyte concentration (e.g., Ca 2+ ) changes and the temperature increases. In this example, thermal imaging can be performed to help identify the marker 116. For example, the reactive polymer marker can generate a thermal map for detecting the specific contour of the edge of the lesion 114. The temperature probe can also be used as the incision instrument 126, or can be used in addition to the incision instrument 126 to assist in the positioning of the marker 116.

[0079] Identifying the marker 116 may also include identifying, by the processor, a particular cross-section of the marker 116 through image analysis techniques in order to determine the orientation of the marker 116. For example, in the ultrasound image 130, because the marker 116 is in the shape of a cube, the orientation of the marker 116 may be determined from its cross-section. If the marker 116 has 360-degree rotational symmetry (such as a sphere), such orientation determination will be more difficult. Other shapes of markers 116 having more complex cross-sections and incomplete 360-degree rotational symmetry may also be used, such as, for example, cones, stars, pyramids, ovals, tetrahedrons, tetrahedrons, three-dimensional radial spoke shapes, spherical lattice structures surrounding a core material, or multi-layered spherical structures, as well as other shapes such as Fig. 10A -F. In such examples, more complex shapes may provide additional orientation information from their corresponding cross-sections. However, consideration should be given to ensure that the selected shape is still distinguishable or identifiable from the rest of the anatomical structures and / or tissues of the interior of the patient 112.

[0080] In additional examples, different sides of the marker 116 may be distinguished from each other based on sandblasting, patterning, numbering, lettering, or other features that may be distinguishable in a resulting ultrasound image. The numbering, patterning, lettering, etc. may be raised, embossed, or made of a different material to make the marker more visible in the ultrasound image 130. For example, Figure 1C As shown in FIG. 1 , an “A” indicator on the cross section of the marker 116 can be seen in the ultrasound image 130 . Therefore, the orientation of the marker 116 can be determined by detecting the indicator “A” in the ultrasound image 130 .

[0081] If the marker 116 is detected or identified, as in the case of the ultrasound image 130, the marker 116 is highlighted or otherwise emphasized in the ultrasound image 130. In some examples, the marker 116 is highlighted with a specific color effect, its brightness is increased, or the marker is otherwise highlighted. The marker 116 may also be outlined with an artificial outline to emphasize the presence of the marker 116. A graphic indicator may also be displayed on top of or near the marker 116. For example, an arrow pointing to the marker 116 may be displayed in the ultrasound image 130. The color of the marker 116 may also be changed to further highlight or emphasize the marker 116 from the rest of the ultrasound image 130. Ultrasound highlighting or emphasis may be achieved by modifying the ultrasound image itself or by adding a layer on top of the ultrasound image to achieve the desired highlighting or emphasis of the marker 116. The captured ultrasound image may also be fused with an X-ray image of a mammogram (obtained after marker deployment or follow-up) to help confirm the location and shape of the marker. The permanent metal / ceramic material of the markers comes in different shapes, so the fusion of ultrasound and X-ray helps identify the specific marker in the lesion of interest, as multiple lesions can exist in one breast.

[0082] When the marker 116 is identified and in the field of view, other indicators may also be triggered. For example, an audible sound, such as a beep, may be emitted when the marker enters the field of view. In some examples, a tone with a varying frequency or intensity may also be emitted based on the proximity of the marker 116 to the center of the field of view. A light or other visual indicator may also be displayed when the marker 116 enters the field of view. A tactile sense (e.g., a vibrating element) on the ultrasound probe 102 may also be activated when the marker 116 enters the field of view.

[0083] Once the marker 116 has been identified and the distance to the lesion 114 or marker 116 has been determined, the determined distance is displayed on the display 110. For example, the distance may be displayed in a user interface element 132 on the display 110. Other techniques for displaying or otherwise providing an indication of the determined distance are also possible, such as a dedicated indicator panel (e.g., a seven-segment display or a separate LCD screen) or an audible indicator. In other examples, the distance may be displayed or indicated on the ultrasound probe 102 or the incision instrument 126.

[0084] The distance to the marker 116 and the orientation of the marker 116 can then be used to guide the incision instrument 126 to the location of the marker 116 in order to remove the lesion. In one example, the orientation of the marker 116 can indicate to the user the point at which to start the incision. In another example, the distance to the marker 116 can be displayed as a vector on the ultrasound image 130 to provide a possible path for the incision instrument 126 to follow to remove the lesion. In another example, the distance to the marker 116 can be combined with the distance information about the incision instrument 126 to show whether the incision instrument 126 is close to the marker 116. In some examples, the distance information of the incision instrument 126 can show whether the incision instrument deviates from the possible incision path.

[0085] In some cases, the ultrasound probe may be positioned so that marker 116 is not within the field of view. Figure 1D An example of an ultrasound image 134 is depicted in which a marker 116 is not within the field of view. In such an example, it may be difficult for an ultrasound technician to locate the marker 116. As such, a navigation indicator 136 may be displayed that provides navigation guidance for the ultrasound technician to find the marker 116. Based on the ultrasound recognition discussed above and / or a signal from the marker location transceiver 118, the navigation indicator 136 is illuminated to guide the ultrasound technician to the marker 116 from the position and orientation information of the marker 116. In the depicted example, the navigation indicator 136 may include a series of arrows. Each arrow may be highlighted to guide the ultrasound technician to move the ultrasound probe in a particular direction. For example, if the marker 116 is not in the field of view and moving the ultrasound probe to the left will cause the marker 116 to enter the field of view, the left arrow is illuminated. Although the depicted navigation indicator 136 is in the form of an arrow, other types of navigation indicators may be utilized to provide guidance to the ultrasound technician to find the marker 116. For example, different graphical user interface elements may be displayed on the display 110. Other indicators may also be provided in the ultrasound probe 102 itself to help the technician find the marker 116 and bring the marker 116 into the field of view. In examples where the ultrasound probe 102 is automatically controlled and guided (such as by a robotic arm), the position of the marker 116 may be used to automatically guide the ultrasound probe 102 to bring the marker 116 into the field of view.

[0086] Figure 1EAn example of a suitable operating environment 150 for incorporation into an ultrasound positioning system is depicted. In its most basic configuration, the operating environment 150 typically includes at least one processing unit 152 and memory 154. Depending on the exact configuration and type of computing device, the memory 154 (storing instructions to perform the active monitoring embodiments disclosed herein) may be volatile (such as RAM), non-volatile (such as ROM, flash memory, etc.), or some combination of the two. This most basic configuration is Figure 1E 156. In addition, the environment 150 may also include storage devices (removable 158 and / or non-removable 160), including but not limited to disks, optical disks, or tapes. Similarly, the environment 150 may also have (one or more) input devices 164, such as a keyboard, mouse, pen, voice input, etc., and / or (one or more) output devices 166, such as a display, speaker, printer, etc. The input device 164 may also include one or more antennas to detect signals emitted from various transceivers in the ultrasound positioning system 100 (such as the probe positioning transceiver 108, the marker positioning transceiver 118, and / or the instrument positioning transceiver 128). The environment may also include one or more communication connections 162, such as LAN, WAN, point-to-point, etc. In an embodiment, these connections may be operable to perform facility point-to-point communication, connection-oriented communication, connectionless communication, etc.

[0087] The operating environment 150 typically includes at least some form of computer-readable media. Computer-readable media can be any available media that can be accessed by the processing unit 152 or other devices that include the operating environment. As an example and not limitation, computer-readable media can include computer storage media and communication media. Computer storage media include volatile and non-volatile, removable and non-removable media implemented in any method or technology for storing information such as computer-readable instructions, data structures, program modules or other data. Computer storage media include RAM, ROM, EEPROM, flash memory or other storage technology, CD-ROM, digital versatile disk (DVD) or other optical storage device, magnetic cassette, magnetic tape, disk storage or other magnetic storage device, or any other non-transient medium that can be used to store desired information. Computer storage media do not include communication media.

[0088] Communication media implements computer readable instructions, data structures, program modules or other data in a modulated data signal such as a carrier wave or other transport mechanism, and includes any information delivery media. The term "modulated data signal" refers to a signal that has one or more characteristics set or changed in a manner that encodes information as a signal. By way of example and not limitation, communication media include wired media such as a wired network or a direct wired connection, and wireless media such as acoustic, RF, infrared, microwave and other wireless media. Combinations of any of the above should also be included within the scope of computer readable media.

[0089] Operating environment 150 can be a single computer operating in a network environment using logical connections to one or more remote computers. The remote computer can be a personal computer, server, router, network PC, peer device or other public network node, and typically includes many or all of the above elements as well as other elements not mentioned. The logical connection can include any method supported by the available communication medium.

[0090] Figure 2A An example biopsy site marker configured as a three-dimensional radial spoke is depicted. Figure 2A As shown in , in an expanded configuration, a radial spoke marker 200 can include a central ball 202 from which a plurality of radial spokes 204 protrude. In various aspects, the radial spokes 204 can be orthogonal to each other in three-dimensional space, for example, the spokes can radiate from the central ball 202 along the x, y, and z axes. In other examples, the radial spokes 204 can be located at different angles to the central ball 202 and to each other. Each radial spoke 204 can be connected to the central ball 202 at a proximal end and can be connected to a distal ball 206 at a distal end. Any number of radial spokes 204 and distal balls 206 are contemplated. In one example, the central ball 202 can be hollow, and in other examples, it can be a solid fill volume. In Figure 2B In the compressed configuration shown in , the radial spokes 204 can be folded around the central ball 202 so that the radial spokes 204 are substantially laterally aligned with the surface of the central ball 202. In one example, the central ball 202 can have a recess 208 to receive the distal ball 206 in the surface of the central ball 202. For example, in its compressed configuration, the radial spoke marker 200 can be sized to be delivered via an elongated needle as part of a marker deployment device. After insertion at the biopsy site, the radial spoke marker 200 can be deployed into an expanded configuration. Deployment into the expanded configuration can occur in response to the removal of a mechanical force holding the distal ball condensed in place, the presence of fluid in the patient 112, in response to the body temperature of the patient 112, or other reasons.

[0091] For example, the radial spoke marker 200 can be formed of nitinol, which can be configured to a first shape (e.g., an expanded configuration) under heating conditions and to a second shape (e.g., a folded or condensed configuration) under cooling conditions. Although the radial spoke marker 200 can be delivered in a condensed configuration, it can "remember" the first shape and automatically unfold into an expanded configuration based at least in part on the shape memory properties of nitinol. In one example, the radial spoke marker 200 can include multiple wires. The distal ball 206 can be a solid shape or a shape containing an opening, and can also be made of nitinol material or made of a different material visible under ultrasound or other imaging methods (such as biocompatible titanium, polymers, gold or stainless steel or other materials). In one example, the ends of the multiple wires can be assembled inside the distal ball 206 to hold it in place. Alternatively, the distal ball 206 can be attached to the radial spokes 204. Each or some of the distal balls 206 can be made of a different material than other distal balls 206.

[0092] In additional or alternative aspects, radial spoke markers 200 can be delivered at different sizes depending on the initial (or baseline) size of the targeted lesion. In this way, the progression or regression of a lesion can be detected based on the size of the marker compared to the size of the lesion at the time of the surgery or other procedure performed under ultrasound.

[0093] In some aspects, the lengths of radial spokes 204 can be equal. In other examples, the lengths of radial spokes 204 can include: Figure 2C . The different lengths of the radial spokes 204 (e.g., radial spokes 204A and 204B) can indicate the orientation of the marker 200 to the ultrasound system 100. Since the cross-section (or two-dimensional image) of the marker can vary. In some aspects, the distal bulbs 206 can include the same size. In other examples, the distal bulbs 206 can include different sizes and can similarly indicate the orientation of the marker 200. In at least one embodiment, each or some of the distal bulbs can be patterned, for example, indentations of different sizes can increase visibility in some imaging modalities.

[0094] In some aspects, such as Figure 2D As shown, the central ball 202 can be made of a bioabsorbable material (e.g., a blend and / or copolymer of a hydrogel, polyglycolide or polyglycolic acid). In this example, over time, the central ball 202 can be absorbed by the body, while the distal ball that does not include a bioabsorbable material remains in the body.

[0095] In some aspects, one or more distal bulbs 206 may be composed of or comprise different materials. For example, one or more distal bulbs 206 may include MRI or ultrasound contrast agents. Upon activation by ultrasound or magnetic resonance, the distal bulb may rupture or otherwise release the contrast agent. In this way, the radial spoke markers 200 may be co-registered within ultrasound and MRI imaging modalities. In other aspects, the radial spoke markers 200 may be formed of nitinol or some other reflective material that may be a shape memory polymer, which may be discerned using ultrasound imaging techniques. In still other examples, one or more distal bulbs 206 may include a chemotherapeutic drug that is released to the lesion site upon activation by ultrasound and / or MRI or in response to some other condition (such as a change in temperature, a change in pH, a change in electrolyte concentration, etc.). In further examples, each distal bulb 206 may react differently to the amount of radiation or chemotherapy delivered to the lesion site. In this way, the amount of treatment delivered to the lesion may be detected by the radial markers 200. In some cases, as described above, one or more distal bulbs 206 may include a cancer cell binding agent that can be released in response to ultrasound and / or changes in conditions. Such a cancer cell binding agent may have imaging properties to enable mapping of specific margins of a lesion, for example, via fluoroscopy or some other imaging procedure.

[0096] When used as a positioning marker during a surgical procedure, an ultrasound image of the radial spoke marker 200 can be generated as a plurality of cross-sectional two-dimensional views, for example on the display 110. The location of the radial marker 200 in the patient and its relative orientation can be identified based on a collection of trained ultrasound images of the radial marker in different orientations and cross-sectional views. In this way, the radial spoke marker 200, which can be inserted with minimal intervention many days or weeks before a surgical procedure, can improve patient comfort and reduce challenges in surgical scheduling.

[0097] As should be appreciated, the radial spoke marker 200 is not limited to the specific dimensions, materials, configurations, and properties described above.

[0098] Figure 3Describe the example biopsy site marker configured as a multi-layer spherical shape. As described in detail above, the current diagnosis and treatment of breast cancer patients involves several steps. Initially, mammography or other forms of advance imaging can be used to determine whether there is any abnormality in the patient's (one or more) breasts. If yes, then an outpatient biopsy is performed using image guidance to retrieve the sample at the position. During the biopsy procedure, a permanent implant (e.g., a biopsy site marker) can be deployed to "mark" the lesion that is biopsied. This permanent marker allows the doctor to follow up, and may be removed (surgical removal) of the tumor by the surgeon. Traditionally, it is necessary to image the breast using mammography before the radiosurgeon performs surgical removal, and the line is placed perpendicular to the marker position. The line is left in the patient's body all day until surgery, when the surgeon follows the metal wire and removes the marker and lesion in open surgery.

[0099] After surgery, oral systemic chemotherapy can be delivered to reduce any margins or lymph nodes to which the cancer may spread. Because drugs are sometimes irritating and systemic, the focus has shifted to targeted drug delivery to the lesion site. However, current labeling technology is limited by the materials used, the shape, size of the markers, and the ultimate detectability when visualized under advanced imaging (X-ray, MRI, ultrasound). In addition, current commercial markers are passive landmarks and can neither collect or transmit data nor respond to external stimuli. Further limitations include, for example, lack of marker uniqueness, which prevents the markers from being distinguished from anatomical features and scar tissue, and the poor imaging characteristics of the marker manufacturing materials. Using ultrasound as an imaging technique provides many advantages, including no radiation, low cost, easy to use, and wide availability of technicians and machinery. Not only that, but ultrasound imaging also provides better images of lesions, lesion margin appearance, and surrounding tissue. However, finding markers under ultrasound can be troublesome. Metal markers are often very small and show high echoes under ultrasound, which confuses them with natural features (such as bubbles, calcifications, Cooper's ligaments, etc.). The crystallinity of these polymers (e.g., PLA, PGA, etc.) is easily determined compared to natural breast tissue, but most polymer markers are absorbable and do not last long in the body. The shape of some polymer markers appears as a long string of "rice-like" bodies and may be confused with Cooper's ligaments. On the other hand, hydrogel polymers can be easily identified due to their water content, which is unique and hypoechoic in nature (once fully hydrated), but has limitations of degradation and potential scarring, which can appear malignant. Moreover, the appearance of hydrated hydrogels can be like cysts or fibroadenomas (wider and shorter), with clear margins and should have internal features, which helps to distinguish them from naturally occurring benign lesions. Ceramic materials can also be used as markers, but due to their crystalline and hard nature, they exhibit high echoes, are often very small in size, and have no ability to change size or shape.

[0100] In summary, radiologists and surgeons would benefit if biopsy site markers could be used as localization markers during surgery. Ultrasound-detectable markers could fill a current unmet need as it is a highly ergonomic, low-cost, radiation-free, readily available, non-invasive, and patient-friendly solution. Similarly, providing surgeons with a “wireless” option to locate markers and lesions intraoperatively would make the procedure easier and achieve a better surgical plane, leading to better surgical and cosmetic outcomes.

[0101] The multilayer marker can include a central core 310 surrounded by concentric layers of one or more different materials. For example, the multilayer marker 300 can be a multilayer composite structure made of a biocompatible, non-inflammatory polymer (which can be synthetic or animal-derived) and a permanent material (non-biodegradable (such as metal or ceramic), or a non-degradable polymer (such as nylon, PMMA, PEEK, PVP, PVA, etc.). The outer layer of the multilayer structure can have a stent-like appearance with a series of open and closed pores. The closed pores can be filled with air, saline, or drugs. These liquid- or gas-filled pores will act as a medium to help the multilayer marker be positioned within the breast tissue. The multilayer structure can also be composed of a series of biodegradable polymer layers (e.g., 1-500nm thick) with different material properties than the stent layer or central core, which can be deposited using various thin film assembly techniques. In various aspects, each layer can contain a different percentage of porosity (e.g., closed pores filled with liquid or gas). This structure surrounds the permanent core material. The multi-layer marker 300 can be delivered in a minimally invasive manner using image guidance during a biopsy procedure. The radiopaque permanent elements (eg, central core 310) can be clearly distinguished using X-ray, while the polymer layers can be visualized under ultrasound and / or MRI.

[0102] In various aspects, the multi-layer marker 300 can remain in the patient's breast at the biopsy site and will provide clear margins and shapes under ultrasound without rear acoustic shadows. If the results of the biopsy are positive, then in follow-up, the surgeon uses an ultrasonic linear transducer (e.g., approximately 7-14MHz) and places it on the breast. Once the surgeon starts scanning, the multi-layer marker 300 will be visible. That is, once the surgeon places the probe on the target for a few seconds (scanning back and forth), the contents of the pores in the marker composite will resonate, thereby producing a detectable nonlinear echo response to ultrasound. Due to the contents of the pores (e.g., gas or liquid), when the ultrasound hits the marker, these waves will not be able to continue and will rebound. Moreover, the acoustic response of the microscopic size can cause the layers to break or fall off from the outer layer. When the original sound wave is redirected due to the presence of a rough surface (as the layers break), the user will see this response as "scattering", which is easily distinguished by the user from natural tissue and anatomical structures. In this way, the user will be able to locate the multi-layer marker 300, including its depth and position.

[0103] Due to the nature of the multilayer marker 300, multiple types of polymers can be deposited with different degradation lengths (e.g., from six months to a year or more). In this way, the multilayer marker 300 will not be affected by natural degradation and the body's inflammatory response to foreign matter. Moreover, because the different layers can form unique echogenic profiles, the markers can be easily distinguished when each layer is broken. Therefore, the multilayer marker 300 solves a critical need, namely, localization of the marker / biopsy site within three to six months after the biopsy. For example, each time a follow-up ultrasound scan is performed, these multiple layers of varying thickness can be removed to aid visualization. This is a critical period because most chemotherapy regimens last three to six months. During this period, it is now possible to perform ultrasound assessment of the lesion site based on the markers to evaluate the effectiveness of the chemotherapy. The fact that the multilayer marker 300 can be easily seen under ultrasound provides the surgeon with the flexibility to locate the lesion without the need for additional equipment (or the help of advanced imagers) when performing the surgery in the operating room (OR).

[0104] The multilayer marker 300 can also be used for targeted drug delivery, as each layer can be used as a personalized mixture of chemotherapy drugs that can be released remotely and precisely. In other aspects, the multilayer marker 300 can be activated for positioning using remote activation. For example, a permanent core can be made of a rare earth magnetic metal coated with a polymer layer. For later positioning and activation, an external strong magnetic probe can be placed on the breast. When placed in close proximity to the marker, the rare earth magnetic metal can extend its "length" or change its shape due to the magnetic field, causing the outer polymer layer to rupture or move elastically with the core. This "movement" within the marker can be easily seen under ultrasound. However, the use of such a magnetic metal material will prevent the patient from being a candidate for MRI.

[0105] Although multilayer markers 300A, 300B are shown as spherical, multilayer markers can be provided in any suitable shape or size. For example, multilayer markers can be square or any other geometric shape. In various aspects, one or more layers of a multilayer marker can be composed of or contain chemotherapeutic drugs. Alternatively, one or more layers can be composed of or include cancer cell binding agents. For example, emitting ultrasound 306 can dissolve or break one or more layers (e.g., first layer 302 and / or second layer 304) of multilayer marker 300A, as shown by multilayer marker 300B, where third layer 308 is now an outer layer. When first layer 302 and / or second layer 304 are composed of chemotherapeutic drugs, treatment can be delivered directly to the lesion in response to ultrasound. When first layer 302 and / or second layer 304 are composed of cancer cell binding agents that exhibit characteristics that can be detected by different imaging methods, specific margins or boundaries of the lesion can be identified (e.g., via fluoroscopy or other imaging techniques). In some aspects, the first layer 302 and the second layer 304 can exhibit different properties so that the chemotherapeutic drug and / or the cancer cell binding agent are released at different times or under different conditions. In other aspects, one layer can include a chemotherapeutic drug and another layer can include a cancer cell binding agent, and the layers can be activated at different times or under different conditions.

[0106] Alternatively, the first layer 302 or another layer (such as the second layer 304 or the third layer 308) can be composed of a material that is responsive to pH, temperature, electrolyte concentration, or other conditions of the biological environment. For example, in response to a change in conditions, the material can emit fluorescence, become soluble and dissolve, exhibit a change in echogenicity, release a contrast agent, etc. The growth or progression of a tumor can be induced by a decrease in pH (e.g., increased acidity), an increase in the temperature of the surrounding tissue (e.g., due to increased cell metabolism and / or angiogenesis), and / or a decrease in free calcium ions (e.g., due to increased sensitivity of cancer cells to Ca 2+ In this context, materials that are responsive to changes in pH, temperature, and / or electrolyte concentrations could provide an in situ indication of lesion progression or regression.

[0107] In still other examples, one or more layers of the multilayer marker 300A and / or 300B may include or consist of a rare earth magnetic metal that can be activated by ultrasound or external remote control. For example, the rare earth magnetic metal can be extended or shortened in response to activation. In this way, the shape of the multilayer marker 300A and / or 300B can be changed when the rare earth magnetic metal is activated. For example, based on the change in shape, the multilayer marker can be more easily detected as a positioning marker under ultrasound during a surgical procedure.

[0108] As should be appreciated, the multi-layer markers 300A and / or 300B are not limited to the specific dimensions, materials, configurations, and properties described above.

[0109] Figures 4A-4C An example biopsy site marker configured as an expandable spherical lattice structure is depicted. The spherical lattice marker 400 can be formed of nitinol wire or some other shape memory alloy or polymer. The nitinol wire can be formed into a geodesic cage. In an example, the nitinol wire can form a two-dimensional geometric shape (e.g., a pentagon, a triangle, etc.) on a facet or surface (e.g., a pentagonal facet 404 or a triangular facet 406) on the surface of the geodesic cage. In its condensed state (e.g., spherical lattice marker 400A), the wire edges of the geometric facets can fold inward to produce spikes 402. In some cases, the nitinol wire can be configured into a first shape (e.g., an expanded configuration) under a heated condition and configured into a second shape (e.g., a folded or condensed configuration) under a cooled condition. Although the spherical lattice marker 400 can be delivered in a collapsed configuration (e.g., a second shape), it can "remember" the first shape and deploy into an expanded configuration (e.g., spherical lattice markers 400B, 400C) based at least in part on the shape memory properties of Nitinol. Alternatively, the spherical lattice marker 400 can be configured with a wire or other actuator for "pulling" the spherical lattice marker 400 from the collapsed state to the expanded state after insertion into the biopsy site.

[0110] In some cases, the spherical lattice marker 400 can be delivered in various sizes depending on the size of the target lesion. In this way, the progression or regression of the lesion can be detected based on the size of the marker compared to the size of the lesion at the time of surgery or other procedures performed under ultrasound. When used as a positioning marker during a surgical procedure, an ultrasound image of the spherical lattice marker 400 can be generated as multiple cross-sectional two-dimensional views, such as on a display 110. Identification of the location of the spherical lattice marker 400 and its relative orientation within the patient can be based on a collection of trained ultrasound images of the spherical lattice markers that have the same geometric facets in different orientations and cross-sectional views. In this way, the spherical lattice marker 400, which can be inserted with minimal intervention days or weeks before a surgical procedure, can improve patient comfort and reduce challenges in surgical scheduling.

[0111] As should be appreciated, the spherical grid markers 400A-C are not limited to the specific dimensions, materials, configurations, and properties described above.

[0112] Figure 5Describe the example biopsy site marker that is constructed as a fiber polymer. The fiber polymer marker 500 can be injected into the biopsy site after the biopsy procedure of the patient 112. In various aspects, the fiber polymer marker 500 can be injected into the tissue surrounding the lesion 506 by a hollow tube or catheter 504 using an injection device 502. In some aspects, the hollow tube 504 can be biodegradable and reabsorbed by the patient 112. For example, at the time of biopsy, the absorbable tube 504 can be placed after removing the core, or can be pushed out from the distal end of the introducer at the site. The absorbable tube 504 (e.g., about 2 cm in length) can be retained at the biopsy site as a "placeholder" and can be positioned using ultrasound (as a unique flat high echo structure with a hollow low echo core). In addition, the resorbable tube 504 can now be used as an introducer for delivering a "sensing" fiber (e.g., suitable for the fiber polymer marker 500) with a diameter less than about 1 mm. Such sensing fibers can be used by surgeons and / or radiologists to map out the biopsy site area in a minimally invasive manner. In this way, the sensing fiber can be used as a guidance system that can transmit light or sound waves into the biopsy cavity (e.g., where the biopsy core is removed) and it can capture the response from the surrounding tissue. For example, a cancerous area within the cavity wall may have a different stiffness than normal tissue or other properties that reflect or absorb the transmitted waves differently. The cancerous area can then act as a beacon because hard cancerous areas are known to have a different elastic modulus (e.g., as determined by elastography). In some cases, the sensing fiber can be connected to a computing system with a user interface to show a "heat" map of the entire cavity as it fluoresces at a specific wavelength. Additional user interfaces can help image the "hot spots" and can be used with Figure 1C The system can be used to map out the cavity in a minimally invasive manner and confirm that there are no remaining cancerous areas. The user interface can be co-registered with other imaging methods (such as ultrasound or MRI), allowing surgeons to understand the location of "hot spots" relative to anatomical features. The sensing fiber can also be a medium for delivering drugs to the lesion location at the biopsy site. If light is used, then before inserting the fiber, the surgeon can inject a liquid agent designed to bind to a specific cancerous "biomarker" or cell. Thereafter, these spots can be visualized using near-infrared (NIR) or fluorescence principles. In this case, a higher concentration of spots means the presence of cancer. In some cases, after resection, a similar absorbable tube can be placed. In this case, if additional surgery is required (for example, for cosmetic effects, implants, or to handle the remaining margins), the surgeon can use the absorbable tube after resection to mark the remaining tissue and / or margins before performing additional surgical procedures.

[0113] The benefits of using absorbable tubes and / or sensing fibers can be far-reaching. For example, current intraoperative solutions use excised ex vivo tissue for imaging using different techniques, such as X-rays (which cannot provide clear margins), OCT medical imaging, Raman spectroscopy, ultrasound, etc. However, all of these imaging modalities evaluate tissue excised in vitro, so there are currently no (or very limited) in situ intraoperative solutions to detect remaining margins within the cavity. Rather, the surgeon must manually assess and understand where the margin may be and any other tissue that should be retrieved. Therefore, the benefits of sensing fibers include, for example, minimally invasive delivery and in situ imaging after a biopsy or resection, which may ultimately change the way surgeries are planned and performed. Optical fibers placed in situ can overcome the problems of current external NIR probes, which can only detect "targets" less than a few centimeters deep due to light scattering across heterogeneous tissue planes.

[0114] In various aspects, the fiber polymer marker 500 can be composed of any suitable sensory fiber that is biocompatible and remains substantially stable (e.g., insoluble) over a period of time within the patient 112. The sensory fiber can include a fiber polymer that is responsive to light, heat, ultrasound, changes in pH, changes in electrolyte concentration, and the like. For example, the fiber marker 500 can detect an increase in temperature, such as due to increased cellular metabolism and / or increased angiogenesis, which can indicate progression of the lesion 506. Conversely, the fiber polymer marker 500 can detect a decrease in temperature, which can indicate regression of the lesion 506. In another example, the fiber marker 500 can detect a decrease in pH and / or free calcium ion concentration near the lesion 506, which can indicate progression of the lesion 506. Conversely, an increase in pH and / or free calcium ion concentration can indicate regression of the lesion 506.

[0115] In response to detecting light, ultrasound, a change in temperature, a change in pH, a change in electrolyte concentration, etc., the structure or properties of the fiber polymer marker 500 can be modified. For example, the portion of the fiber polymer marker 500 that detects such a condition can emit fluorescence, thicken, emit visible light, emit heat, crystallize, increase echogenicity, or otherwise change structure or properties, as shown by the modified fiber material 508B. In contrast, as shown by the unmodified fiber material 508A, other portions of the fiber polymer marker 500 that do not detect such a condition can remain unchanged. When the modified fiber material emits heat in response to detecting a change in the microenvironment around the lesion 506, infrared thermal imaging (IRT) or thermal imaging can be used to visualize the heat map generated by the modified fiber material near the lesion 506. In this way, changes in the margins of the lesion 506 can be mapped or outlined, new masses can be identified, changes in the biological environment around the lesion 506 (e.g., changes in pH, temperature, or electrolyte concentration) can be detected, etc. Similarly, other changes in the fiber material can be detected using other imaging techniques (e.g., ultrasound imaging, magnetic resonance imaging, etc.). Suitable sensory fibers may include, but are not limited to, aramid fibers, aramid-polymethyl methacrylate (aramid-PMMA), high modulus carbon fibers, hydrogel-based optical fibers, glass fibers, and the like.

[0116] As should be appreciated, the fibrous polymer marker 500 is not limited to the specific dimensions, materials, configurations, and properties described above.

[0117] Figure 6 An example method 600 for determining lesion-related information from an implanted marker is depicted. Operations of method 600 and other methods discussed herein may be performed by at least one processor in conjunction with a system such as Figures 1A-1D 100) within a suitable operating environment (such as Figure 1E to execute by other components of the operating environment 150).

[0118] As described above, a biopsy site marker can be implanted at or near a lesion before a surgical procedure. For example, at operation 602, such as during a biopsy procedure, a biopsy site marker can be implanted near a suspicious lesion in a patient's body. As described above, the implanted marker can be configured to have specific features or characteristics for delivering a drug or treating and / or monitoring the progression or regression of a lesion. Moreover, during the surgical procedure after the biopsy procedure, the implanted marker can be detected as a positioning marker. In this way, the implanted marker can not only be used as a landmark for inspecting the lesion in the future, but can also be configured to monitor or treat the lesion and be used as a positioning marker during subsequent surgical procedures. Therefore, the implanted marker can not only minimize the patient's invasion, but also provide a continuous benefit in the treatment, diagnosis and positioning of the lesion.

[0119] At optional operation 604, the implanted marker can be activated. The implanted marker can be activated in any of a variety of ways. For example, the implanted marker can be activated by ultrasound, an ingested preparation, or an external remote control. Alternatively, the implanted marker can be activated (or made reactive) to changes in conditions in the biological environment of the lesion. For example, the implanted marker can react or respond to changes in pH, changes in temperature, changes in electrolyte concentration, etc. In response to activation, the structure of the implanted marker can be changed (e.g., by thickening, folding, expanding, dissolving, lengthening or shortening, etc.) or the characteristics of the implanted marker can be changed (e.g., by emitting heat, emitting visible light, increasing or decreasing echoes, vibrating, increasing or decreasing solubility, emitting fluorescence, releasing drugs or agents, etc.). In some cases, in response to activation, the implanted marker can send or receive monitored data to or from an external device (e.g., via a transceiver).

[0120] At operation 606, data can be received from the implanted device. In some cases, data can be received by collecting data from the implanted marker by performing imaging or some other technology. For example, one or more of ultrasound imaging, MRI, X-ray imaging, thermal imaging, elastic imaging, fluoroscopy, etc. can be performed to collect data related to the position, orientation, characteristics or structure of the implanted marker. Alternatively, the implanted marker can actively send data to an external device. For example, in the case of an implanted chip, the implanted marker can send monitored data about the lesion (e.g., such as temperature data, pH data, electrolyte concentration data, blood flow or pressure data, etc.).

[0121] At operation 608, the received data may be analyzed. For example, data collected by imaging or other techniques may be analyzed to detect changes in the structure or properties of the implanted markers, such as size, shape, echogenicity, luminosity or fluorescence, heat, etc. Based on the composition of the implanted markers, such changes in structure or properties may indicate changes in the biological environment surrounding the implanted markers, such as changes in temperature, pH, electrolyte concentration, etc. Additionally or alternatively, using ultrasound or other imaging modalities, the position or orientation of the implanted markers may be determined, as described above with reference to Figures 1A-1D Furthermore, the raw data received from the implanted chip or sensor associated with the implanted marker can be processed and analyzed. When processed, the raw sensor data can provide information about the biological environment surrounding the implanted marker, such as temperature, pH, electrolyte concentration, blood flow, blood pressure, etc.

[0122] At operation 610, information about the lesion can be determined from the analyzed data. For example, if the analyzed data indicates an increase in temperature in the biological environment surrounding the implanted marker, it can be determined that the lesion is progressing or growing. Similarly, if the analyzed data indicates a decrease in pH and / or free calcium ion concentration in the biological environment surrounding the implanted marker, it can be determined that the lesion is progressing or growing. Conversely, if the analyzed data indicates a decrease in temperature or an increase in pH and / or free calcium ion concentration, it can be determined that the lesion is regressing or shrinking in the biological environment surrounding the implanted marker. Additionally or alternatively, if the analyzed data indicates a margin of the lesion (e.g., via ultrasound imaging, thermal imaging, fluoroscopy, etc.), the determined margin can be compared with previous margin information to determine whether the lesion is progressing or regressing. In yet other examples, the relative size of the implanted marker can be compared with the size of the lesion (e.g., based on the margin data as described above). When the size of the implanted marker indicates the initial or baseline size of the lesion, the relative size of the implanted marker determined based on the analyzed data can be used to determine whether the lesion is progressing or regressing. As should be appreciated, additional information about lesions may be determined by analyzing data associated with implanted markers, as described throughout this disclosure.

[0123] At operation 612, the determined information about the lesion can be displayed on a display device. For example, the determined information can be in the form of a report, one or more images, etc. In some cases, a notification of the determined information can be forwarded to medical personnel and / or the patient.

[0124] Fig. 7A An example method 700 for locating a lesion or implanted marker is depicted. As detailed above, the marker may have been implanted at or near the lesion prior to the surgical procedure. For example, the marker may have been implanted during a biopsy procedure when a lesion is detected in the patient. In this way, rather than requiring coordination and placement of positioning wires at the time of surgery, the previously implanted marker may be utilized to locate the lesion during the surgical procedure. Thus, logistics and scheduling on the day of surgery are simplified and the overall surgical time for the patient is reduced. Further benefits may be realized because the implanted marker may be specifically designed for detection using ultrasound or other imaging techniques to provide real-time imaging and lesion location data during the surgical procedure. Operation of method 700 and other methods discussed herein may be performed by at least one processor in conjunction with a system such as a Figure 1A-1B 100) within a suitable operating environment (such as Figure 1E to execute by other components of the operating environment 150).

[0125] At operation 702, an ultrasonic array is emitted from an ultrasonic transducer of an ultrasonic probe. As discussed above, the ultrasonic waves enter the patient's body and are reflected from components in the patient's body (including natural tissue and implanted markers). The reflected ultrasonic waves are then detected at operation 704. At operation 706, ultrasonic image data is then generated from the detected reflected ultrasonic waves. The ultrasonic image data may be B-mode ultrasonic imaging data.

[0126] At operation 708, the image data is analyzed by a processor of the ultrasound positioning system to identify or detect implanted markers within the image data. As discussed above, the image analysis technique can be based on image processing techniques and machine learning techniques (such as neural networks, deep learning algorithms, or other pattern matching techniques) trained based on markers implanted in the patient. As an example, in the case where the shape of the marker has a unique cross-section in a 360-degree rotation, the image analysis algorithm can first be trained on a collection of ultrasound images that contain cube-shaped markers in different orientations and cross-sectional views. The current ultrasound image or image data is then provided as input to the trained image analysis algorithm to detect or identify the marker. Since the ultrasound image is a two-dimensional image, identifying the marker can generally be based on the cross-section of the marker.

[0127] Identifying a marker may also include identifying a specific cross section of the marker in order to determine the orientation of the marker. For example, when the marker is detected in at least two different parts based on different viewing angles (such as a cubic or rectangular prism), the orientation of the marker can be determined. If the marker has symmetry in a 360-degree rotation, it will be more difficult to determine the orientation based solely on ultrasound imaging. In some examples, the marker can be identified by a user (such as an ultrasound technician) on a display of an ultrasound image. Such identification can be provided as an input to an ultrasound system (e.g., clicking a pointer on a display) to allow determination of the distance to the marker. For example, the distance can be determined based on the number of pixels between two objects in the image.

[0128] If a marker is detected or identified in operation 708, an ultrasound image that highlights or emphasizes the marker can be displayed. In some examples, the marker is highlighted with a specific color, its brightness is increased, or the marker is otherwise highlighted. The marker can also be outlined with an artificial outline to emphasize the presence of the marker. A graphic indicator can also be displayed on or near the marker. For example, an arrow pointing to the marker can be displayed in the ultrasound image. The color of the marker can also be changed to further highlight or emphasize the marker from the rest of the ultrasound image. Ultrasound highlighting or emphasis can be achieved by modifying the ultrasound image itself or adding a layer on top of the ultrasound image to achieve the desired highlighting or emphasis of the marker.

[0129] When the marker is identified and in the field of view, other indicators may also be triggered. For example, an audible sound, such as a beep, may be emitted when the marker enters the field of view. In some examples, a tone with varying frequency or intensity may also be emitted based on the proximity of the marker to the center of the field of view. It may also display lights for other visual indicators when the marker enters the field of view. A tactile member on the ultrasound probe may also be activated when the marker enters the field of view.

[0130] At optional operation 710, at least one of the processors in the ultrasound positioning system processes signals from various positioning transceivers. As discussed above, the ultrasound positioning system may include at least a probe positioning transceiver, a marker positioning receiver, and / or an instrument positioning transceiver. These transceivers transmit signals to provide positioning information for the devices (e.g., ultrasound probes, markers, and / or incision instruments) to which they are connected or combined. At operation 712, the (one or more) signals transmitted by the (one or more) transceivers may be processed to determine the orientation or position of the ultrasound probe, markers, and / or incision instruments. The orientation may also be determined based on the cross-section of the markers and / or incision instruments in the ultrasound image. The orientation and position of those devices may be determined or provided relative to other items (such as incision instruments, markers, ultrasound probes, magnetic directions, normals to gravity, etc.). With respect to the orientation and position of the device, additional information may be generated and provided to the surgeon to help guide the surgeon to the lesion in the patient's body. For example, the orientation information may help the surgeon determine whether the incision instrument is aligned with a specific axis of the marker and / or the lesion boundary.

[0131] At operation 714, the distance to the lesion and / or the identified marker is determined. For example, the distance can be determined by at least one processor (such as the processor 152 in the operating environment 150 discussed above). The determination can be based on the identification of the marker and the data available from the detected reflected ultrasound. The determined distance can be at least one of the distance from a portion of the ultrasound probe to at least one of the marker or the lesion, the distance from a portion of the scalpel to at least one of the marker or the lesion, or the distance from a portion of the incision instrument (such as the tip) to at least one of the marker or the lesion. When determining the distance from the ultrasound probe to the marker, a calculation is performed based on the speed of sound, which is based on the tissue through which the sound wave passes. For example, the speed of sound is known for various tissues in the human body, and the distance calculation can be performed based on the propagation time of the ultrasound wave. The identification of the orientation of various devices in the ultrasound positioning system also allows the position to be determined in three-dimensional space, and the determined distance can include a directional component, such as a vector.

[0132] In some examples, a portion of the incision instrument (such as the tip of the incision instrument) can be identified in the ultrasound image data. The distance from the ultrasound probe to the incision instrument can be determined based on the detected reflected ultrasound in a manner similar to determining the distance to the marker. Based on the distance from the ultrasound probe to the marker and the distance from the ultrasound probe to the incision instrument, the distance from the marker to the incision instrument can also be determined. In some examples, the determination can be made using trigonometric principles (such as the law of cosines). An example of a method of determining the distance to the marker is described in Figure 7B In this figure, the distance from the ultrasound probe 102 to the marker 116 is shown as "a", the distance between the marker 116 and the incision instrument 126 is shown as "b", and the distance from the ultrasound probe 102 to the incision instrument 126 is shown as "c". The relationship between the distances can be expressed as a 2 +b 2 =c 2 Thus, when two distances are determined from ultrasound depth calculations and / or from lateral distance measurements of ultrasound images, another distance may be determined. Similarly, when one of the distances and one or more interior angles are determined, the other distance may also be determined by using trigonometric principles.

[0133] The determination of the distance to the edge of the lesion can be based on the distance to the marker and the orientation of the marker. As discussed above, the orientation of the marker can be determined from a cross-section of the marker. For example, when the marker is inserted into the patient, the relative size and shape of the lesion can also be determined by various imaging techniques (including ultrasound, mammography, tomography, etc.). When the marker is inserted, the edge of the lesion can be generated relative to the position and orientation of the marker. For example, the edge of the lesion can be represented based on the position and orientation of the marker. Therefore, when the distance and orientation of the marker are determined, the distance to the edge of the lesion can also be determined.

[0134] Once the distance to the lesion or marker is determined by the processor of the ultrasound positioning system, the determined distance is displayed on a display operably connected to the processor at operation 716. For example, the distance can be displayed in a user interface element on the display. Other techniques for displaying or otherwise providing an indication of the determined distance, such as a dedicated indicator or an audible indicator, are also possible. In other examples, the distance can be displayed or indicated on an ultrasound probe or an incision instrument.

[0135] The distance to the lesion or marker can also be determined from multiple orientations. Determining the distance to the lesion or marker in multiple orientations can also define the position of the marker or lesion in three-dimensional space. In an example where the marker has such a geometric shape, based on the fact that the marker has the same shape at two separate locations, the ultrasound system can use software beamforming technology to lock on the shape of the marker. Other image analysis techniques as discussed above can be used to identify the marker and lock on the marker during imaging.

[0136] Fig. 8A An example method 800A for locating and navigating an implanted marker is depicted. As described in detail above, the marker may be implanted at or near the lesion at some time prior to the surgical procedure. For example, the marker may have been implanted during a biopsy procedure when the lesion is detected in the patient. Thereafter, even months later, the marker may also be used for positioning during a treatment or examination procedure. In this way, rather than requiring the placement of coordination and positioning lines at the time of surgery, the lesion may be located using previously implanted markers during the surgical procedure. Thus, logistics and scheduling on the day of surgery are simplified, and the overall surgical time for the patient is reduced. Further benefits may be realized because the implanted marker may be specifically designed for detection using ultrasound or other imaging techniques to provide real-time imaging and lesion location data during the surgical procedure.

[0137] At operation 802, an array of ultrasonic waves is emitted from an ultrasonic transducer of an ultrasonic probe at a first position. As discussed above, the ultrasonic waves enter the patient's body and are reflected from components in the patient's body (including natural tissue and implanted markers). The reflected ultrasonic waves are then detected at the first position at operation 804. At operation 806, ultrasonic image data is then generated from the reflected ultrasonic sound waves detected at the first position of the ultrasonic probe.

[0138] At operation 808, the processor of the ultrasound positioning system analyzes the image data to identify or detect the markers embedded in the image data using any of the techniques discussed above. In some examples, an ultrasound image showing the identified markers may also be displayed. In such examples, the markers may be highlighted or otherwise emphasized using any of the techniques described above.

[0139] When the marker is identified and in the field of view, other indicators may also be triggered. For example, an audible sound, such as a beep, may be emitted when the marker enters the field of view. In some examples, a tone with varying frequency or intensity may also be emitted based on the proximity of the marker to the center of the field of view. It may also display lights for other visual indicators when the marker enters the field of view. A tactile member on the ultrasound probe may also be activated when the marker enters the field of view.

[0140] In some examples, signals from various positioning transceivers are processed by at least one of the processors in the ultrasound positioning system to determine the orientation and / or positioning information of the ultrasound probe, markers, and / or incision instruments. Any of the above techniques can be used to process the signals and use the resulting information. For example, as discussed above, the distance to the marker or lesion edge can be determined and displayed.

[0141] In some cases, the ultrasound technician may move the ultrasound probe from a first position to a second position. The second position may be different from the first position in terms of the orientation of the ultrasound probe, the position of the ultrasound probe, or both. With the ultrasound probe in the second position, at operation 810, an array of ultrasound waves is emitted from an ultrasound transducer of the ultrasound probe at the second position. The ultrasound waves enter the patient's body and are reflected from components within the patient's body. The reflected ultrasound waves are then detected at the second position at operation 812. At operation 812, ultrasound image data is then generated from the reflected ultrasound waves detected at the second position of the ultrasound probe.

[0142] At operation 814, the processor of the ultrasound positioning system analyzes the image data to attempt to detect the implanted marker within the image data using any of the techniques described above. However, at operation 814, the image analysis technique is unable to locate the marker within the image data from the second location because the marker is not within the field of view of the ultrasound probe at the second location.

[0143] Based on the fact that the marker is not detected in operation 816, a navigation indicator is generated at operation 818. As discussed above, the navigation indicator provides navigation guidance for the ultrasound technician to find the marker. The navigation indicator can be based on the ultrasonic recognition of the marker when the ultrasound probe is in the first position. For example, the position and orientation of the ultrasound probe can be tracked or recorded from the first position to the second position. In this way, it is possible to provide guidance to return to the position where the marker can be seen and identified, for example, the position of the marker within the field of view. In other examples, signals from various positioning transceivers can be used to determine the position of the marker and generate navigation indicators. As discussed above, the ultrasound positioning system can include at least a probe positioning transceiver, a marker positioning receiver, and / or an instrument positioning transceiver. These transceivers transmit signals to provide positioning information for the equipment (e.g., ultrasound probe, marker, and / or incision instrument) to which they are connected or combined. The (one or more) signals transmitted by the (one or more) transceivers can be processed to determine the orientation or position of the ultrasound probe, marker, and / or incision instrument. The orientation and position of those devices may be determined or provided relative to other items such as incision instruments, markers, ultrasound probes, magnetic directions, normals to gravity, etc. Additional information may be generated and provided to the surgeon regarding the orientation and position of the devices to help guide the surgeon to the lesion in the patient. For example, when the orientation and position information of the ultrasound probe and the markers is known, the direction information may be determined to position the ultrasound probe to bring the markers within the field of view of the ultrasound probe.

[0144] At operation 820, a navigation indicator is displayed. Displaying the navigation indicator at operation 820 may include illuminating an indicator on a display or creating a graphical user interface element to guide the ultrasound technician to bring the marker into the field of view of the ultrasound probe. For example, the navigation indicator may include a series of arrows. As described above, each arrow may be highlighted to guide the ultrasound technician to move the ultrasound probe in a particular direction. Other types of navigation indicators may also be used to provide guidance to the ultrasound technician to find the marker. For example, an indicator may also be provided in the ultrasound probe itself to help the technician bring the marker into the field of view.

[0145] Figure 8B Another example method 800B for locating and navigating to implanted markers is depicted. Method 800B provides a continuous ultrasound imaging method that allows an ultrasound technician to continuously image a patient with an ultrasound probe and continuously receive feedback about the location of markers and / or lesions. At operation 850, an array of ultrasound waves is emitted from an ultrasound transducer of the ultrasound probe. As discussed above, the ultrasound waves enter the patient's body and are reflected from components within the patient's body. The reflected ultrasound waves are then detected at operation 852.

[0146] At operation 854, ultrasound image data is then generated and analyzed based on the reflected ultrasound waves detected at operation 852. Any of the image analysis techniques discussed above may be used. Based on the analysis of the image data at operation 854, at operation 856 it is determined whether a marker has been identified or detected and is therefore present in the ultrasound image data.

[0147] If it is determined at operation 856 that a marker is present in the ultrasound image data, then method 800B proceeds to operation 858, where the marker is highlighted or otherwise emphasized in the ultrasound image using any of the techniques described above. At operation 860, the distance to the marker and / or lesion may also be determined and displayed using any of the techniques described above. Method 800B then flows back to operation 850, and method 800B repeats.

[0148] If it is determined at operation 856 that there is no marker in the ultrasound image data, then method 800B proceeds to operation 862, where the marker position is determined. The position of the marker can be determined using any of the above techniques based on a priori identification of the marker in the ultrasound image and / or direction and position information derived from the signal from any positioning transceiver. Then, at operation 864, the position of the determined marker is used to generate and display a navigation indicator using any of the above techniques. Then, method 800B flows back to operation 850 from operation 864, and method 800B repeats.

[0149] Fig. 9 An exemplary method 900 for locating and detecting implanted markers and incision tools is depicted. Method 900 or any subset of the operations in method 900 can be combined and / or used in conjunction with any other method discussed above. At operation 902, input about the type of marker is received from a user (such as an ultrasound technician). Input can be received from a user interface presented on the same display for displaying an ultrasound image. For example, an input indicating the type of marker that has been implanted in the patient can be provided. The input can indicate the shape and size of the marker. In an example, the input can include providing the model or other identification information of the marker. Based on the input, the size and other information about the marker can be obtained, such as obtained from a local or remote database storing such information. Then, image analysis techniques can use the size of the marker to help identify the marker within the ultrasound image. At operation 904, based on the input about the marker type, the ultrasound image data is analyzed using image analysis techniques to identify the marker.

[0150] At operation 906, input is received from a user (such as an ultrasound technician) regarding the type of incision tool. The input may be received from a user interface presented on the same display for displaying the ultrasound image. The user interface may be the same user interface as the user interface for collecting information about the type of marker. An input indicating the type of incision instrument being used for the patient may be provided. The input may indicate the shape and size of the incision tool or a portion of the incision tool. For example, the input may indicate the size and shape of the tip of a particular incision tool (such as a scalpel). In an example, the input may include providing a model or other identification information for the incision instrument. Based on the input, the size and other information about the incision instrument may be obtained, such as from a local or remote database storing such information. Then, the image analysis technique may use the size of the incision instrument to help identify the incision instrument within the ultrasound image. At operation 906, based on the input regarding the type of incision instrument, the ultrasound image data is analyzed using image analysis techniques to identify the incision instrument.

[0151] Once the marker and the incision instrument are identified, the distance to the marker, the lesion and / or the incision instrument can be determined at operation 910. The determined distance can be any determined distance discussed above, and any of the techniques discussed above can be used. As an example, the distance from the tip of the incision instrument to the marker can be determined from an ultrasound image. For example, once the incision instrument is identified in the ultrasound image and the marker is identified in the same image, the distance can be determined by measuring the distance between the two identified objects. The determination of the distance can be automatically determined by the processor in conjunction with the identification of the object. The determination of the distance can also be done based on user input. For example, in the case where the marker and the incision instrument are highlighted on the ultrasound image or otherwise visually distinguished, an input can be provided to draw a line between the marker and the incision instrument. The length of the line can then be determined by the processor of the operating environment. Once the distance is determined, the distance is displayed at operation 912.

[0152] Fig. 10AAn example system 1000 for imaging a sample 117 is depicted. Once a lesion 114 is removed during a surgical procedure (such as a lumpectomy), the surgeon can image the sample 113 containing the lesion 114 to confirm that a margin of healthy tissue surrounds the lesion 114. This analysis of the margin helps ensure that all abnormal tissue (such as cancerous tissue) has been removed from the patient's area of ​​interest. If the margin is not sufficient to make the surgeon feel confident that all cancerous tissue has been removed, the surgeon will return to surgery to remove additional tissue. However, current systems for imaging samples generally rely on X-ray exposure. These X-ray systems take up a lot of space and are expensive. The present technology provides an ultrasound-based solution that can reduce the cost and footprint of imaging the margins of samples removed from patients during surgical procedures. The use of ultrasound technology allows for rapid imaging procedures, thereby achieving a faster margin confirmation process. Ultrasound imaging procedures can also be performed directly in the operating room. These benefits can shorten the duration of surgery.

[0153] In order to perform imaging and edge confirmation, the sample 113 is placed on the surface 117. The ultrasound probe 102 is placed on the sample 113 to image the sample 113. In the example shown, for exemplary purposes, the sample is spherical. The theoretical, predicted or ideal sample position 115 (shown in dotted lines) is located at the center of the sample 113. That predicted position 115 can be the position where the surgeon believes the lesion 114 should be within the sample. The predicted position 115 can be based on the position of the marker in the patient's body. In some examples, the marker is located at the position of the predicted position in the sample 113. The predicted position 115 is used for calculations to determine whether the margin of the sample is sufficient. The distance to the predicted position 115 can be expressed as a distance X from the top of the sample to the center of the predicted position 115 and a distance Y from the center of the predicted position 115 to the surface 117. Distances X and Y represent the position of the predicted position 115. In the case where the predicted position 115 is located at the center of the sample 113, the distance X will be equal to the distance Y.

[0154] However, the actual location of the lesion 114 may not be at the predicted location 115. Fig. 10A. The ultrasound probe 102 is used to determine the actual location of the lesion 114 within the sample 113. Through the distance measurement techniques of the ultrasound technology discussed above, the distance A from the ultrasound probe 102 to the center of the lesion 114 and the distance B from the center of the lesion 114 to the surface 117 can be determined. In the example where the predicted location 115 is located at the center of the sample 113, if the difference between the distance A and the distance B is not zero, then the margin of the sample 113 is asymmetric and the actual location of the lesion 114 is different from the predicted location 115. If the difference between the distance A and the distance B is greater than a predetermined threshold, then the margin can be considered insufficient and the surgeon may have to return to surgery to remove additional tissue. In addition, the difference between the distance A and the distance X can be determined, and if the difference exceeds a predetermined threshold, then the margin can be considered insufficient. Similarly, the difference between the distance B and the distance Y can be determined, and if the difference exceeds a predetermined threshold, then the margin can be considered insufficient.

[0155] As for Fig. 10A In the reference frame of the system 1000 depicted in , the y-axis extends vertically through the image, the x-axis extends horizontally through the image, and the z-axis extends into the image. Fig. 10A In the example depicted in , distances X and Y as well as A and B are measured along the X axis.

[0156] To measure or determine additional margins from different orientations, the probe 102 or sample 113 may be rotated. Fig. 10B Depicted Fig. 10A Ultrasound system 1000, wherein the sample is rotated 90 degrees around the z-axis. In this orientation, the distance from the probe 102 to the center of the predicted position 115 is represented by distance V, and the distance from the center of the predicted position 115 to the edge of the surface is represented by distance W. Similar to the measurement in the previous orientation, margin verification can be performed based on the difference between the corresponding distances. For example, in an example where the predicted position 115 is located at the center of the sample 113, if the difference between distance C and distance D is not zero, then the margin of the sample 113 is asymmetric and the actual position of the lesion 114 is different from the predicted position 115. If the difference between distance C and distance D is greater than a predetermined threshold, then the margin can be considered insufficient, and the surgeon may have to return to surgery to remove additional tissue. In addition, the difference between distance C and distance V can be determined, and if the difference exceeds a predetermined threshold, then the margin can be considered insufficient. Similarly, the difference between distance D and distance W can be determined, and if the difference exceeds a predetermined threshold, then the margin can be considered insufficient.

[0157] Fig. 10C Depicted Fig. 10A The ultrasound system 1000 is a system in which the ultrasound probe is rotated so that it is oriented along the x-axis instead of rotating the sample. Fig. 10B 1 and 102. For example, the distance along the x-axis from the probe 102 to the center of the predicted location 115 is represented by the distance V, and the distance from the center of the predicted location 115 to the edge of the sample 113 opposite the probe is represented by the distance W. In some embodiments, rotating the sample 113 may be preferred over rotating the ultrasound probe 102 because the ultrasound waves reflect off the surface 117. This reflection may make the distance measurement from the probe to the edge of the sample 113 on the surface 117 easier to determine.

[0158] Although only two different relative orientations are actually depicted, the probe 102 or sample 113 can be rotated to measure from any other orientation. For example, the probe 102 can be rotated to align with the z-axis, and measurements of the sample 113 and the lesion 114 can be measured along the z-axis. Using the distances to the lesion measured along three planes (such as along the x-axis, y-axis, and z-axis), the position of the lesion in three-dimensional space can be determined. Therefore, the margins of the lesion 114 within the sample 113 can be determined.

[0159] In addition, the distance from the outside of the sample 113 to the edge of the lesion 114 can be directly measured using the ultrasound probe 102. That is, the actual margin between the edge of the lesion 114 and the edge of the sample 113 can be directly measured. The sample 113 can be imaged in any desired orientation to determine whether the actual margin meets the expected or predetermined margin. For example, if the surgeon expects the margins on all sides of the lesion 114 to be greater than 5 mm, the ultrasound system 1000 can measure the margins to verify that such margins exist in the sample 113. In some examples, the measurement and verification can be automated by the ultrasound system 1000. For example, when the ultrasound probe 102 moves around the sample 113, the measurement values ​​of the margins in each orientation can be measured. If the margin is less than the expected, required or predetermined margin (e.g., 5 mm) at any point, an alarm or warning can be generated. The alarm and the position and orientation of the probe relative to the sample can be recorded and displayed or incorporated into a report. In this way, a full scan of the sample can be completed every time a margin less than the expected margin can be recorded and reported or displayed. The surgeon may then access the report or display to determine the direction in which additional tissue needs to be removed from the patient.

[0160] It is also contemplated within the scope of the present disclosure that the sample be placed in a container and placed on a table. The geometry of the container is subtracted from the sample geometry and the depth of the marker is then calculated. It is also contemplated within the scope of the present disclosure that the calculations shown above can be applied to other geometries of the sample. The sample can be of any shape and more complex calculations can be performed to determine the distance to the marker or lesion and the center of the sample. Different shapes of samples can be stored in the ultrasound system and automatically matched to a specific profile to help facilitate calculations and margin determinations.

[0161] Fig.11 A method 1100 for confirming the margins of a sample is depicted. At operation 1102, a sample containing a lesion is imaged using an ultrasound probe in a first orientation. The first orientation can be along a particular axis (such as a y-axis). Imaging the sample can include emitting an array of ultrasound waves from an ultrasound transducer of the ultrasound probe. The ultrasound waves enter the interior of the sample and reflect from components of the interior of the sample, similar to how the ultrasound waves interact with the patient's body as discussed above. The reflected ultrasound waves are then detected, and based on the reflected ultrasound waves, ultrasound image data that can be analyzed is then generated. At operation 1104, based on the imaging of the lesion at operation 1102, the location of the lesion in the first orientation can be determined. Determining the location of the lesion can include determining a distance from the probe to the center of the lesion and / or a distance from the center of the lesion to the surface, such as described above with reference to FIG. Fig. 10A The distance A and distance B discussed above. Determining the location of the lesion may also include determining whether one or more margins in the first orientation are within an acceptable range or greater than the surgeon's desired margin. This determination may be made by directly measuring the distance from the probe to the edge of the lesion and then comparing that measurement to the desired margin. Fig. 10A As discussed, the determination can also be determined by comparing the position of the lesion in the first orientation with the predicted position of the lesion. If the margin of the determined sample is lower than the expected margin, an alarm can be generated at operation 1106. The alarm can be auditory or visual. For example, an alarm indicating that the margin at the current orientation is too small. The alarm can also be recorded or otherwise reported to the surgeon along with the details of the current orientation so that the surgeon can determine the location where additional tissue needs to be removed from the patient.

[0162] At operation 1108, the sample is imaged in a second orientation (such as along the x-axis). Imaging the sample in the second orientation may include rotating the sample to the second orientation or rotating the probe to the second orientation. At operation 1110, based on the imaging of the lesion at operation 1108, a position of the lesion in the second orientation may be determined. Determining the position of the lesion may include determining a distance from the probe to a center of the lesion and / or a distance from the center of the lesion to a surface, such as described above with reference to the accompanying drawings. Figures 10B-10CThe distance C and distance D discussed above. Determining the location of the lesion may also include determining whether one or more margins in the first orientation are within an acceptable range or greater than the surgeon's desired margin. This determination may be made by directly measuring the distance from the probe to the edge of the lesion and then comparing that measurement to the desired margin. Fig. 10B As discussed, the determination may also be determined by comparing the position of the lesion in the second orientation with the predicted position of the lesion. If the margin of the determined sample is lower than the expected margin, an alarm may be generated at operation 1112. The alarm may be substantially the same as the alarm generated in operation 1106, but for the second orientation.

[0163] At operation 1114, the sample is imaged in a third direction (such as along the z-axis). Imaging the sample in the third direction may include rotating the sample to the third direction or rotating the probe to the third direction. At operation 1116, based on the imaging of the lesion at operation 1114, the position of the lesion in the third direction may be determined. Determining the position of the lesion and the margin of the sample may be similar to the techniques discussed above, but for the third direction. If the margin of the determined sample is lower than the desired margin, an alarm may be generated at operation 1118. The alarm may be substantially the same as the alarm generated in operations 1106 and 1112, but for the second direction. Then, method 1000 may be repeated for other directions except the first three directions. For example, the sample may be continuously imaged at various angles or directions. In each direction, a margin determination may be performed and reported.

[0164] As should be appreciated, the operations described in the above method are described for the purpose of illustrating the methods and systems of the present invention, and are not intended to limit the present disclosure to a specific order of steps. For example, the steps may be performed in a different order, additional steps may be performed, and disclosed steps may be excluded without departing from the present disclosure.

[0165] The embodiments described herein may be employed using software, hardware, or a combination of software and hardware to implement and perform the systems and methods disclosed herein. Although specific devices have been described throughout the disclosure as performing specific functions, those skilled in the art will recognize that these devices are provided for illustrative purposes and that other devices may be employed to perform the functions disclosed herein without departing from the scope of the present disclosure.

[0166] The present disclosure describes some embodiments of the present technology with reference to the accompanying drawings, in which only some possible embodiments are shown. However, other aspects may be implemented in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to make the present disclosure thorough and complete and to fully convey the scope of possible embodiments to those skilled in the art.

[0167] Although specific embodiments are described herein, the scope of the present technology is not limited to those specific embodiments. Those skilled in the art will recognize other embodiments or improvements within the scope and spirit of the present technology. Therefore, specific structures, actions or media are disclosed only as illustrative embodiments. The scope of the technology is limited by the attached claims and any equivalent forms therein.

Claims

1. A method for locating an implanted marker using ultrasound technology, the method comprising: transmitting a first array of ultrasonic waves from an ultrasonic transducer of an ultrasonic probe in a first position; detecting, by the ultrasound transducer, first reflected ultrasound waves, wherein the first reflected ultrasound waves include at least a portion of a first array of ultrasound waves after reflection from a marker implanted in the patient proximate to the lesion; generating first image data from the first reflected ultrasonic wave; analyzing, by a processor, the generated first image data to identify markers within the patient; determining, by a processor, a distance to the marker based at least in part on the identification of the marker; as well as displaying the determined distance to the marker on a display operatively connected to the processor; wherein, when the geometric shape of the marker and the geometric shape of the lesion are known, the distance to the edge of the lesion is determined based on the distance to the marker and the orientation of the marker, The distance to the marker determined is one of the following: The distance from one part of the ultrasound probe to the marker, The distance from one part of the scalpel to the marker, or The distance from a portion of the incision instrument to the marker.

2. The method of claim 1 , further comprising displaying an ultrasound image including the marker on a display based on the reflected ultrasound waves, wherein the determined distance to the marker is displayed concurrently with the ultrasound image, and / or wherein the marker is visually distinguished from the rest of the ultrasound image by at least one of: highlighting, outlining, a displayed indicator, or a color effect.

3. The method of claim 1, wherein the incision instrument is one of a cautery tool, a scalpel, or an internal probe.

4. The method according to claim 1 or 2, further comprising: receiving a signal from a marker locating transceiver, wherein the marker locating transceiver is attached to the marker; processing, by a processor, a signal received from the marker location transceiver to determine at least one of a position of the marker or an orientation of the marker; as well as Wherein determining the distance to the marker is further based on at least one of the position of the marker or the orientation of the marker.

5. The method of claim 4, further comprising: receiving a signal from a probe positioning transceiver, wherein the probe positioning transceiver is attached to the ultrasound probe; processing, by the processor, signals received from the probe positioning transceiver to determine at least one of a position of the ultrasound probe or an orientation of the ultrasound probe; and Wherein determining the distance to the marker is further based on at least one of the position of the ultrasound probe or the orientation of the ultrasound probe, and / or further includes: receiving a signal from an instrument positioning transceiver, wherein the instrument positioning transceiver is attached to an incision instrument; processing, by a processor, signals received from the instrument positioning transceiver to determine at least one of a position of an incision instrument or an orientation of the incision instrument; and Wherein determining the distance to the marker is further based on at least one of a position of the ultrasound probe or an orientation of the ultrasound probe.

6. A method as claimed in claim 1 or 2, wherein the determined distance includes a directional component, and / or wherein analyzing the generated image data by the processor to identify a marker in the patient's body also includes using pattern recognition technology to analyze the generated image data to identify the marker based on a cross-section of the marker, and / or wherein analyzing the generated image data by the processor to identify the marker also includes identifying the orientation of the marker based on a cross-section of the marker.

7. The method of claim 6, wherein determining the distance to a marker within the patient's body is further based on the orientation of the identified marker.

8. The method according to claim 1 or 2, further comprising: a second array transmitting ultrasound waves from an ultrasound transducer of the ultrasound probe in a second position; detecting, by the ultrasound transducer, a second reflected ultrasonic wave, wherein the second reflected ultrasonic wave comprises at least a portion of a second array of ultrasonic waves after reflection from within the patient; generating second image data from the first reflected ultrasonic wave; analyzing, by a processor, the generated second image data to determine that a marker is not present within the generated second image data; generating a navigation indicator, wherein the navigation indicator indicates a direction of the marker relative to a second position of the ultrasound probe; as well as The navigation indicator is displayed on the display concurrently with the ultrasound image generated from the second image data.

9. The method of claim 8, further comprising: generating a first image from first image data; as well as displaying a first image on a display operatively connected to the processor; determining a distance to a marker within the patient based at least in part on the identification of the marker in the generated first image data; as well as The determined distance to the marker is displayed on the display concurrently with the display of the first image.

10. The method of claim 9, wherein the determined distance to the marker is one of: a distance from a portion of an ultrasound probe to the marker, a distance from a portion of a scalpel to the marker, or a distance from a portion of a cautery tool to the marker.

11. The method of claim 1 or 2, wherein the navigation indicator is an arrow pointing to the direction of the second position of the marker relative to the ultrasound probe, and / or further comprising: receiving a signal from a marker locating transceiver, wherein the marker locating transceiver is attached to the marker; processing, by a processor, a signal received from the marker location transceiver to determine at least one of a position of the marker or an orientation of the marker; as well as Wherein generating the navigation indicator is further based on at least one of the position of the marker or the orientation of the marker.

12. The method of claim 11, further comprising: receiving a signal from a probe positioning transceiver, wherein the probe positioning transceiver is attached to the ultrasound probe; processing, by the processor, signals received from the probe positioning transceiver to determine at least one of a position of the ultrasound probe or an orientation of the ultrasound probe; and The generating of the navigation indicator is further based on at least one of the position of the ultrasound probe or the orientation of the ultrasound probe.

13. A system for ultrasound positioning, the system comprising: an implanted marker, wherein the implanted marker is implanted into a patient; an ultrasound probe including an ultrasound transducer configured to transmit an array of ultrasound waves and detect reflected ultrasound waves, wherein the reflected ultrasound waves include at least a portion of the array of ultrasound waves after being reflected within a patient; monitor; at least one processor operably connected to the display and the ultrasound probe; as well as A memory operatively connected to at least one processor storing instructions that when executed by the at least one processor perform a set of operations comprising: generating image data from the reflected ultrasonic waves; analyzing the generated image data by a processor to identify markers within the patient; Determining the distance to the marker based on recognition of the marker and the reflected ultrasonic wave; and displaying the determined distance to the marker on a display; wherein, when the geometric shape of the marker and the geometric shape of the lesion are known, the distance to the edge of the lesion is determined based on the distance to the marker and the orientation of the marker, The distance to the marker determined is one of the following: The distance from one part of the ultrasound probe to the marker, The distance from one part of the scalpel to the marker, or The distance from a portion of the incision instrument to the marker.

14. The system of claim 13, further comprising a marker location transceiver attached to the marker, wherein the marker location transceiver transmits data indicative of at least one of a position of the marker or an orientation of the marker.

15. The system of claim 14, further comprising a probe positioning transceiver attached to the ultrasound probe, wherein the probe positioning transceiver transmits data indicating at least one of the position of the probe or the orientation of the probe, or further comprising an incision instrument, wherein the incision instrument comprises an instrument positioning transceiver, wherein the instrument positioning transceiver transmits data indicating at least one of the position of the incision instrument or the orientation of the incision instrument.

16. The system of claim 15, wherein the incision instrument is one of a cauterization tool, a scalpel, or an internal probe, and / or wherein the instrument location transceiver is attached to the tip of the incision instrument, and / or wherein at least one of the marker location transceiver, the probe location transceiver, or the instrument location transceiver is a radio frequency identification (RFID) device, and / or further comprising an inductive power supply, wherein at least one of the marker location transceiver, the probe location transceiver, or the instrument location transceiver is powered by the inductive power supply.

17. A method for ultrasonic positioning and navigation, the method comprising: an array that transmits ultrasonic waves from an ultrasonic transducer of an ultrasonic probe; detecting reflected ultrasonic waves by an ultrasonic transducer, wherein the reflected ultrasonic waves include at least a portion of an array of ultrasonic waves after reflection from within a body of a patient having an implanted marker proximate a lesion; generating image data from the reflected ultrasonic waves; analyzing, by a processor, the generated image data to determine whether a marker is present in the image data; Based on determining whether the marker is present in the image data, at least one of the following is performed: If the marker is present in the image data, then: The distance to the marker is determined by the processor; as well as displaying the determined distance to the marker on a display operatively connected to the processor; as well as If there are no markers in the image data, then: Determine the location of the markers; generating a navigation indicator, wherein the navigation indicator indicates a position of the marker relative to a current position of the ultrasound probe; and displaying a navigation indicator on a display concurrently with the ultrasound image; wherein the navigation indicator guides the sonographer to move the ultrasound probe in a specific direction so that the marker is present in the image data, and wherein, when the geometric shape of the marker and the geometric shape of the lesion are known, the distance to the edge of the lesion is determined based on the distance to the marker and the orientation of the marker, The distance to the marker determined is one of the following: The distance from one part of the ultrasound probe to the marker, The distance from one part of the scalpel to the marker, or The distance from a portion of the incision instrument to the marker.

18. A method for locating an implanted marker using ultrasound technology, the method comprising: an array that emits ultrasonic waves from an ultrasonic transducer of an ultrasonic probe; detecting reflected ultrasonic waves by an ultrasonic transducer, wherein the reflected ultrasonic waves include at least a portion of an array of ultrasonic waves after reflection from a marker implanted in the patient proximate to the lesion; generating image data from the reflected ultrasonic waves; displaying an ultrasound image from the generated image data; receiving user input to identify a marker in the ultrasound image; determining, by a processor, a distance to the marker based at least in part on the identification of the marker; as well as displaying the determined distance to the marker on a display operatively connected to the processor; wherein, when the geometric shape of the marker and the geometric shape of the lesion are known, the distance to the edge of the lesion is determined based on the distance to the marker and the orientation of the marker, The distance to the marker determined is one of the following: The distance from one part of the ultrasound probe to the marker, The distance from one part of the scalpel to the marker, or The distance from a portion of the incision instrument to the marker.

19. The method of claim 18, further comprising identifying an incision instrument in the ultrasound image, and / or further comprising receiving input identifying the type of the incision instrument, and / or further comprising receiving input regarding the type of the marker, and / or wherein the distance determined is the distance between the incision instrument and the marker.

20. The method of claim 19, wherein identifying the incision instrument in the ultrasound image is based on user input identifying the incision instrument.

21. The method of claim 19, wherein identifying the incision instrument in the ultrasound image is based on a type of incision instrument.

22. The method of claim 19, wherein determining the distance is based on user input of drawing a line between the incision instrument and the marker on the ultrasound image.

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