Needle with ultrasound depth and injection monitoring

Abstract

A computer-implemented method comprises: receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information; receiving confirmation from a user based on the visualization of the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

Description

NEEDLE WITH ULTRASOUND DEPTH AND INJECTION MONITORINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 737,330, filed December 20, 2024, to U.S. Provisional Application No. 63 / 737,428, filed December 20, 2024, and to U.S. Provisional Application No. 63 / 737,503, filed December 20, 2024, the contents of each of which are incorporated by reference herein in their entirety.BACKGROUND

[0002] Pharmaceutical products (including large and small molecule pharmaceuticals, hereinafter “drugs”) are administered to patients using a variety of different drug delivery devices for the treatment of a variety of different medical indications. Drug delivery devices for delivering liquid drugs include, for example, syringes, manual injectors, pen injectors, autoinjectors, on-body delivery devices, and off-body delivery devices. These delivery devices commonly include an actuator, a drug container, and a needle or cannula. The drug container contains the liquid drug and the actuator drives the liquid drug from the drug container, and through the needle or cannula to the patient.SUMMARY

[0003] In one aspect, a computer-implemented method is described. The computer implemented method includes receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information; receiving confirmation from a userMEI 48657880v. 1based on the visualization of the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

[0004] In another aspect, a non-transitory processor readable medium is described. The non- transitory processor readable medium contains a set of instructions thereon, wherein when executed by a processor, the instructions cause the processor to perform a method including receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information; receiving confirmation from a user based on the visualization of the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

[0005] In yet another aspect, an apparatus is described. The apparatus includes one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform a method comprising receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information; receiving confirmation from a user based on the visualization of2MEI 48657880v. 1the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

[0006] In yet another aspect, a needle for delivering a fluid is described. The needle includes a distal end; a bevel located at the distal end, the bevel being at a fluid exit of the needle to deliver fluid from the needle; a proximal end opposite the distal end; a plurality of ultrasound sensors located near the distal end of the needle and located axially along the needle between the bevel and the proximal end; and a plurality of fluid exits located axially along the needle between the bevel and the proximal end, each of the plurality of fluid exits being located between two of the ultrasound sensors.

[0007] In yet another aspect, an ultrasound sensing apparatus is described. The ultrasound sensing apparatus includes an extended working channel comprising a distal end, a proximal end, and a channel, the distal end adapted for insertion in a subject and opposite the proximal end, the channel extending from the distal end to the proximal end, the distal end comprising an end face and at least one ultrasound sensor located on the end face of the distal end of the extended working channel and configured to measure acoustic impedance in the subject. When viewed in a direction perpendicular to the end face of the distal end, the at least one ultrasound sensor is forward facing.

[0008] In yet another aspect, a computer-implemented method is described. The computer- implemented method includes receiving acoustic impedance information from at least one ultrasound sensor located on an end face at a distal end of an extended working channel inserted in a subject and providing visualization of the acoustic impedance information.3MEI 48657880v. 1

[0009] In yet another aspect, a non-transitory processor readable medium is described. The non-transitory processor readable medium contains a set of instructions thereon, wherein when executed by a processor, the instructions cause the processor to perform a method comprising receiving acoustic impedance information from at least one ultrasound sensor located on an end face at a distal end of an extended working channel inserted in a subject and providing visualization of the acoustic impedance information.

[0010] In yet another aspect, an apparatus is described. The apparatus includes one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform a method comprising receiving acoustic impedance information from at least one ultrasound sensor located on an end face at a distal end of an extended working channel inserted in a subject and providing visualization of the acoustic impedance information.

[0011] In yet another aspect, a computer-implemented method is described. The computer- implemented method includes receiving acoustic impedance information from at least one first ultrasound sensor located on an end face at a distal end of an extended working channel inserted into a subject; receiving acoustic impedance information from at least one second ultrasound sensor located near a distal end of a needle extend from the extended working channel into the subject; calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor; and providing, on a display, an indication of the calculated volume of the fluid injected into the subject.

[0012] In yet another aspect, a non-transitory processor readable medium is described. The non-transitory processor readable medium containing a set of instructions thereon, wherein when4MEI 48657880v. 1executed by a processor, the instructions cause the processor to perform a method comprising receiving acoustic impedance information from at least one first ultrasound sensor located on an end face at a distal end of an extended working channel inserted into a subject, receiving acoustic impedance information from at least one second ultrasound sensor located near a distal end of a needle extend from the extended working channel into the subject, calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor, and providing, on a display, an indication of the calculated volume of the fluid injected into the subject.

[0013] In yet another aspect, an apparatus is described. The apparatus comprising one or more processors and memory accessible by the one or more processors. The memory storing instructions that when executed by the one or more processors, cause the apparatus to perform a method comprising receiving acoustic impedance information from at least one first ultrasound sensor located on an end face at a distal end of an extended working channel inserted into a subject, receiving acoustic impedance information from at least one second ultrasound sensor located near a distal end of a needle extend from the extended working channel into the subject, calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor, and providing, on a display, an indication of the calculated volume of the fluid injected into the subject.

[0014] In yet another aspect, an ultrasound sensing apparatus is described. The ultrasound sensing apparatus comprising an extended working channel comprising a distal end, a proximal end, and a channel, the distal end adapted for insertion in a subject and opposite the proximal end,5MEI 48657880v. 1the channel extending from the distal end to the proximal end, the distal end comprising an end face, at least one first ultrasound sensor located on the end face of the distal end of the extended working channel, the at least one first ultrasound sensor configured to measure acoustic impedance in the subject, and a needle having at least one second ultrasound sensor, the at least one second ultrasound sensor configured to measure acoustic impedance in the subject, the needle configured to be extended and retracted from the channel at the distal end of the extended working channel.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIGS. 1A-1D depict examples of needles with ultrasound sensors according to one or more embodiments described herein.

[0016] FIG. 2 depicts an example needle with ultrasound sensors injecting a fluid in a subject according to one or more embodiments described herein.

[0017] FIG. 3 depicts an example needle with ultrasound sensors injecting a fluid in a subject according to one or more embodiments described herein.

[0018] FIG. 4 depicts an example needle with ultrasound sensors injecting a fluid in a subject according to one or more embodiments described herein.

[0019] FIG. 5 depicts an example of a flow diagram of a method for monitoring a fluid being injected into a subject according to one or more embodiments described herein.

[0020] FIG. 6 depicts an example of a flow diagram of a method for monitoring a fluid being injected into a subject according to one or more embodiments described herein.

[0021] FIG. 7 depicts an example of a flow diagram of a method for monitoring a fluid being fractionally injected into a subject according to one or more embodiments described herein.6MEI 48657880v. 1

[0022] FIGS. 8 A- 8 J depict examples of extended working channels according to one or more embodiments described herein.

[0023] FIG. 9 depicts an example extended working channel with ultrasound transducers and an extended needle according to one or more embodiments described herein.

[0024] FIGS. 10A-10D depicts example visualizations based on acoustic impedance produced by ultrasound transducers of FIG. 9 according to one or more embodiments described herein.

[0025] FIG. 11 depicts an example extended working channel with ultrasound transducers and an extended needle injecting a fluid in a subject according to one or more embodiments described herein.

[0026] FIG. 12 depicts an example extended working channel with inflatable members according to one or more embodiments described herein.

[0027] FIG. 13 depicts an example extended working channel with ultrasound transducers, an extended needle injecting a fluid in a subject, and an extended member having additional ultrasound transducers according to one or more embodiments described herein.

[0028] FIGS. 14A and 14B depict an example flowchart for a method of using an example extended working channel according to one or more embodiments described herein.

[0029] FIG. 15 depicts an example flowchart for a method of using an example extended working channel according to one or more embodiments described herein.

[0030] FIGS. 16A-16B depict an example extended working channel according to one or more embodiments described herein.

[0031] FIGS. 17A-17D depict examples of needles with ultrasound transducers according to one or more embodiments described herein.7MEI 48657880v. 1

[0032] FIGS. 18A-18D depict an example extended working channel with an example needle injecting a fluid in a subject according to one or more embodiments described herein.

[0033] FIGS. 19A-19E depict example visualizations based on acoustic impedance produced by ultrasound transducers of an example extended working channel according to one or more embodiments described herein.

[0034] FIGS. 20A-20C depict an example flowchart for a method of using an example extended working channel according to one or more embodiments described herein.

[0035] FIG. 21 depicts an example computer apparatus for use with one or more embodiments described herein.DETAILED DESCRIPTION

[0036] To treat certain tumors, drugs in fluid form are injected directly into the tumor. In some cases, it may be desirable to inject contrast agents into a tumor to perform medical imaging. Currently, clinicians have limited access to tumor quantitative data that describe the biomechanical properties of the tumor microenvironment. Furthermore, when a liquid-like contrast agent or drug is injected into a tumor, the exact location of the fluid is unknown. That is, it is unknown whether the fluid will stay in place or leak out of the tumor. For example, chemotherapy is systemically delivered into a subject’s veins causing the drug to distribute throughout the subject’s body. However, there are some limitations to this approach. The drug may not penetrate the tumor because of the tumor’s microenvironment, which reduces the drug’s effectiveness. Also, the drug is exposed to the entire body system, which can harm healthy cells. Intra-tumor drug delivery is the injection of a fluid drug directly into the target tumor through various routes of administration, such as through the subject’s chest wall or through a8MEI 48657880v. 1bronchoscopy procedure. This approach has several advantages including the tumor is treated with a higher concentration of drug, less volume of drug is used to treat the tumor, and the drug is less likely to reach surrounding healthy cells. However, there are limitations with this approach. Since the drug has a higher concentration, the drug should preferably stay within the tumor. To maximize the drug effectiveness, the drug should preferably be distributed throughout the tumor. These limitations result in a complex procedure. Furthermore, existing technology does not provide feedback to the clinician if the drug enters the tumor, if the drug leaks out of the tumor, if there is a blockage, etc.

[0037] As discovered by the inventors, a fluid delivery system that monitors needle position and medicant flow by collecting real-time acoustic impedance data (e.g., ultrasound impedance data) can be used to more accurately and precisely deliver fluids (e.g., medicant) to a subject (e.g., to a tumor of a subject). By using acoustic impedance data received from an array of ultrasound sensors located near a distal end of the drug delivering needle, the needle entering the tumor can be tracked in real time, the flow of fluid being delivered to the tumor can be tracked in real time, and when the needle exits the tumor can be tracked in real time. Based on such received acoustic impedance data, decisions on when to start, stop, decrease, and / or increase fluid being delivered by the needle may be made by a user, by a computer, and / or by a user based on computer analysis of the received acoustic impedance data. Based on such received acoustic impedance data, fractionation delivery of a drug may be beneficially monitored in real time. Based on such received acoustic impedance data, detection of medicant flow back along the needle may be beneficially monitored for and determined.

[0038] According to some embodiments, the inventive techniques provide a practical application in being able to monitor needle position and medicant flow in real time. Further, the9MEI 48657880v. 1inventive techniques address a technical problem of not being able to visualize in real-time a tumor in a subject, a surgical tool (e.g., a needle) in relation to a tumor in the subject, and a flow of medicant being delivered to the tumor in the subject. Moreover, the inventive techniques provide a technical solution to this technical problem by allowing for the real-time visualization of a tumor in a subject, a surgical tool (e.g., a needle) in relation to a tumor in the subject, and a flow of medicant being delivered to the tumor in the subject.

[0039] FIGS. 1A-1D depict examples of needles with ultrasound sensors according to one or more embodiments described herein.

[0040] FIG. 1 A depicts a needle 101 with a distal end 110 and a proximal end 112 opposite the distal end 110. The distal end 110 may include a bevel 116, and the bevel 116 may be at a fluid exit of the needle 101 to deliver fluid from the needle 101. Near the distal end 110 is a set of ultrasound sensors 114(1), 114(2), 114(3), 114(4), and 114(5). The ultrasound sensors 114 may be aligned in one more rows along an axial length 119 of the needle 101. In some embodiments, the ultrasound sensors 114 may be aligned with equidistant spacing in a row along the axial length 119 of the needle 101. As an example, the ultrasound sensors 114(1), 114(2), 114(3), 114(4), and 114(5) are aligned with equidistant spacing in a row along the axial length 119 of the needle 101.

[0041] In some embodiments, the ultrasound sensors 114 may wrap around the circumference of the needle 101 forming one or more rings of ultrasound sensors 114. As depicted in FIG. 1 A, the ultrasound sensors 114 wrap around the circumference of the needle 101 forming five rings 118(1), 118(2), 118(3), 118(4), and 118(5), collectively rings 118. In some embodiments, the ultrasound sensors 114 may wrap partially around the circumference of the needle 101 forming one or more partial rings of ultrasound sensors 114. Although the needle10MEI 48657880v. 1101 is depicted with five rings 118 of ultrasound sensors 114, any number of rings and / or partial rings of ultrasound sensors 114 may be used as needed. In some embodiments, the ultrasound sensors 114 may be aligned with equidistant spacing around the circumference of the needle 101 and / or with equidistant spacing between rings 118 around the needle 101. As an example, the ultrasound sensors 114 in FIG. 1 A are depicted with equidistant spacing around the circumference of the needle 101 and with equidistant spacing between rings 118 around the needle 101.

[0042] FIG. IB depicts a needle 102 with a distal end 120 and a proximal end 122 opposite the distal end 120. The distal end 120 may include a bevel 126 and a fluid exit for the needle 102 at the bevel 126. Near the distal end 120 is a set of ultrasound sensors 124(1), 124(2), 124(3), 124(4), 124(5), 124(6), and 124(7), collectively ultrasound sensors 124. Similar to the ultrasound sensors 114, the ultrasound sensors 124 may wrap around the circumference of the needle 102 forming rings of ultrasound sensors 124. Near the distal end 120 is a set of fluid exits 128(1), 128(2), 128(3), and 128(4), collectively fluid exits 128. In some embodiments, the fluid exits 128 may be aligned along an axial length 129 of the needle 102. The fluid exits 126 may allow fluid to flow through the fluid exists outside the needle and along the axial length 129 of the needle 102. Different from the needle 101, the rings of ultrasound sensors 124 may be spaced apart by at least one fluid exit 128 between two rings of ultrasound sensors 124. In some embodiments, one fluid exit 128 may be located between and adjacent to two rings of ultrasound sensors 124. As an example, fluid exit 128(1) is located between and adjacent to a first ring of ultrasound sensors that includes ultrasound sensor 124(1) and a second ring of ultrasound sensors that includes ultrasound sensor 124(2). The fluid exits 128 may be aligned in one more rows along the axial length 129 of the needle 102. In some embodiments, the fluid exits 128 may be11MEI 48657880v. 1aligned with equidistant spacing in a row along the axial length 129 of the needle 102. As an example, the fluid exits 128(1), 128(2), 128(3), and 128(4) are aligned with equidistant spacing in a row along the axial length 129 of the needle 102. In some embodiments, the fluid exits 128 may wrap around the circumference of the needle 102 forming rings of fluid exits 128 (not shown in FIG. IB).

[0043] In some embodiments, one or more rings of ultrasound sensors 124 may have no fluid exits 128 located adjacent to the ring. As an example, the ring of ultrasound sensors 124 that includes ultrasound sensor 124(6) and the ring of ultrasound sensors 124 that includes ultrasound sensor 124(7) have no fluid exits 128 adjacent to the ring. In some embodiments, two adjacent rings of ultrasound sensors 124 may have no fluid exits 128 located between the rings. As an example, the ring of ultrasound sensors 124 that includes ultrasound sensor 124(5) and the ring of ultrasound sensors 124 that includes ultrasound sensor 124(6) do not have a fluid exit 128 located between the rings. In some embodiments, one or more rings of ultrasound sensors 124 that have no fluid exits 128 located adjacent to the ring may be located closer to the proximal end 122 and / or the distal end 120 of the needle 102 than any of the fluid exits 128. As an example, the ring of ultrasound sensors 124 that includes ultrasound sensor 124(6) and the ring of ultrasound sensors 124 that includes ultrasound sensor 124(7) are located closer to the proximal end 122 of the needle 102 than any of the fluid exits 128.

[0044] FIG. 1C depicts a needle 103 with a distal end 130 and a proximal end 132 opposite the distal end 130. The distal end 130 may include a bevel 136 and a fluid exit for the needle 103 at the bevel 136. Near the distal end 130 is a set of ultrasound sensors 134(1), 134(2), 134(3), 134(4), and 134(5), collectively ultrasound sensors 134. The ultrasound sensors 134 may be aligned in a row along an axial length 139 of the needle 103. In some embodiments, the12MEI 48657880v. 1ultrasound sensors 134 may be aligned with equidistant spacing in a row along the axial length 139 of the needle 103.

[0045] FIG. ID depicts a needle 104 with a distal end 140 and a proximal end 142 opposite the distal end 140. The distal end 140 may include a bevel 146 and a fluid exit for the needle 104 at the bevel 146. Near the distal end 140 is a set of ultrasound sensors 144(1), 144(2), 144(3), 144(4), and 144(5), collectively ultrasound sensors 144. The needle 104 may include a recess 143 with the ultrasound sensors 144 located in the recess 143. The ultrasound sensors 144 may be aligned in the recess 143 in a row along an axial length 149 of the needle 104.

[0046] Referring to FIG. 1A, FIG. IB, FIG. 1C, and / or FIG. ID, the needle 101, 102, 103, 104 may have a plurality of ultrasound sensors 114, 124, 134, 144 located along an axial length 119, 129, 139, 149 of the needle 101, 102, 103, 104 near the distal end 110, 120, 130, 140. The needle 101, 102 may have a plurality of ultrasound sensors 114, 124 located circumferentially around the needle 101, 102 near the distal end 110, 120. The ultrasound sensors 144 may be located in a recess 143 of the needle 104 near the distal end 140 of the needle 104. The needle 101, 102, 103, 104 may comprise a lumen having a single fluid exit at the distal end 110, 120, 130, 140 of the needle 101, 102, 103, 104, wherein the ultrasound sensors 114, 124, 134, 144 are located on the proximal side of the single fluid exit of the needle 101, 102, 103, 104. The needle 102 may comprise a lumen having a plurality of fluid exits 128 near the distal end 120 of the needle 102, wherein a portion of the fluid exits 128 of the needle are located between the ultrasound sensors 124 near the distal end 120 of the needle 102. The various features of the needles 101, 102, 103, 104 may be interchanged and / or used together in various combinations and / or with a computer-based system, having a computer. The computer may receive acoustic impedance information from the ultrasound sensors 114, 124, 134, 144 (e.g., acoustic13MEI 48657880v. 1impedances measured by each of the ultrasound sensors 114, 124, 134, 144) of the needle 101, 102, 103, 104. The ultrasound sensors 114, 124, 134, 144 are not spun to obtain the acoustic impedance information. In some embodiments, the computer may receive a first acoustic impedance, which may correspond to, for example, normal tissue of the subject (e.g., normal lung tissue). When entering the location of the tumor in the subject, the acoustic impedance information may change. Using the acoustic impedances measured at the distal end 110, 120, 130, 140 of the needle 101, 102, 103, 104, the computer may provide a visualization to a user of the location of the needle, a visualization of the location of the needle with respect to the tumor, a visualization of the location of the needle when entering the tumor, and / or a visualization of the location of the needle within the tumor. When fluid (e.g., medicant) flows from the needle into the tumor, the acoustic impedance changes. At this point, the computer may provide a visualization of the locations of the needle, the tumor, and the medicant, and this visualization may be used by a user to verify that the fluid is flowing into the tumor. These features are discussed further with respect to FIG. 2, FIG. 3, and FIG. 4.

[0047] FIG. 2 depicts an example needle 201 with ultrasound sensors 214 injecting a fluid in a subject according to one or more embodiments described herein. The needle 201 may include features from one or more of needles 101, 102, 103, 104. In the example of FIG. 2, the needle 201 includes eight ultrasound sensors 214(1), 214(2), 214(3), 214(4), 214(5), 214(6), 214(7), and 214(8), collectively ultrasound sensors 214. The ultrasound sensors 214 may be arranged as an array with equidistant spacing in a row along an axial length 219 of the needle 201. The needle 201 may have a fluid exit at the bevel 216 of the needle 201. The needle 201 may be inserted into a tumor 200 and dispense a fluid medicant. As the medicant flows from the needle 200 out of the fluid exit at the bevel 216 of the needle 201, the medicant may spread within the tumor14MEI 48657880v. 1200. The ultrasound sensors 214 may measure a first acoustic impedance 250 of tissue outside the tumor 200, a second acoustic impedance 252 of the tumor 200, and a third acoustic impedance 254 of the medicant.

[0048] With a computer (such as computer apparatus 800), the locations of the needle 200, the tumor 200, and the medicant may be visualized. The ultrasound sensors 214 may measure multiple acoustic impedances 250, 252, 256. The ultrasound sensors 214 are not spun to obtain the acoustic impedance information. The computer may be connected to the needle 201 and may provide real-time visualizations of the acoustic impedances provided by the ultrasound sensors 214. The computer may receive acoustic impedance information from the ultrasound sensors 214. The acoustic impedance information received by the computer may comprise acoustic impedances measured by each of the ultrasound sensors 214(1), 214(2), 214(3), 214(4), 214(5), 214(6), 214(7), and 214(8). The acoustic impedances measured by each of the ultrasound sensors 214(1), 214(2), 214(3), 214(4), 214(5), 214(6), 214(7), and 214(8) may change over time as the needle 201 interacts with different portions of the subject, such as healthy tissue, tumor, and medicant. Based on the needle 201 interacting with different portions of the subject, different acoustic impedances (e.g., the first acoustic impedance 250, the second acoustic impedance 252, and / or the third acoustic impedance 254) may be measured by one or more of the ultrasound sensors 214(1), 214(2), 214(3), 214(4), 214(5), 214(6), 214(7), and 214(8).

[0049] In some embodiments, with the acoustic impedance information received by the computer, the acoustic impedances and their associated visualization may be used to view in real time positions of the needle 201, the tumor 200, and / or the medicant, and / or with respect to each other. In some embodiments, the acoustic impedances and their associated visualization may be used to view in real time a position of the needle 201 with respect to the tumor 200 and the15MEI 48657880v. 1surrounding tissue of the subject. In some embodiments, the acoustic impedances and their associated visualization may be used to view in real time the needle 201 being inserted into the tumor 200, the medicant being injected in the tumor 200, and / or the needle 201 being withdrawn from the tumor 200. In some embodiments, the acoustic impedances and their associated visualization may be used to view in real time the flow of the medicant along the length of the needle 201 form the distal end to the proximal end of the needle 201.

[0050] The changes in acoustic impedance detected by the ultrasound sensors 214 may correspond to changes in the visualization of the acoustic impedance, which may be viewed by a user and / or analyzed by the computer to: determine when the needle 201 has entered the tumor; determine the dispersion, the flow, and / or the flow direction of the medicant; and / or determine when the needle 201 has exited the tumor. In some embodiments, based on the visualization of the acoustic impedance, the computer may provide one or more recommendations to a user for controlling a flow of the medicant to the tumor 200 and / or the computer may control the flow of the medicant to the tumor 200. As an example, the flow of the medicant to the tumor 200 may be controlled by starting, stopping, increasing, and / or decreasing the flow of the medicant to the tumor 200. As an example, the flow of the medicant to the tumor 200 may be controlled by adjusting a fluid flow and / or an injection rate of the medicant to the tumor 200.

[0051] In some embodiments, the acoustic impedances from the ultrasound sensors 214 and their associated visualization may be used to view in real time the needle 201 being inserted into the tumor 200. Before the needle 201 enters the tumor 200, the ultrasound sensors 214(1) to 214(8) measure the first acoustic impedance 250 of the tissue outside the tumor 200. As the ultrasound sensors 214 approach and enter the tumor 200, the measured acoustic impedance may change from the first acoustic impedance 250 to the second acoustic impedance 252. As an16MEI 48657880v. 1example, referring to FIG. 2, before the needle 201 is inserted in the tumor 200, the ultrasound sensor 214(1) is outside the tumor and may measure the first acoustic impedance 250. As the needle moves 201 moves into the tumor 200, the acoustic impedance measured by the ultrasound sensor 214(1) changes from the first acoustic impedance 250 to the second acoustic impedance 252. Once the bevel 216 of the needle 201 is situated in the tumor 200, the acoustic impedance measured by the ultrasound sensor 214(1) may be the second acoustic impedance 252. For this example, the ultrasound sensor 214(8) is outside the tumor 200 the entire time and may measure the first acoustic impedance 250.

[0052] As the user confirms that the needle 201 is in the tumor 200, the computer may record an image of the visualization of the acoustic impedance information. In some embodiments, the confirmation from the user that the distal end of the needle 201 is inserted into the tumor 200 may be further based on at least one of: a computer tomography (CT) image of the subject, a cone beam CT (CBCT) image of the subject, an x-ray image of the subject, or a fluoroscopy image of the subject.

[0053] In some embodiments, the acoustic impedances from the ultrasound sensors 214 and their associated visualization may be used to view in real time the flow of medicant from the needle 201. The ultrasound sensors 214 may provide associated acoustic impedances, which may be used to view and measure the dispersion, the flow, and / or the direction of the flow of the medicant within the tumor. The dispersion, the flow, and / or the direction of the flow of the medicant within the tumor may be detected by the change of the acoustic impedances from ultrasound sensors 214 located axially along the needle 201.

[0054] As an example, at a first medicant time, the medicant may be dispersed in a location 256. When the medicant is in location 256, the medicant is partly touching the ultrasound sensor17MEI 48657880v. 1214(1), and as such, the ultrasound sensor 214(1) may measure an acoustic impedance somewhere between the second acoustic impedance 252 and the third acoustic impedance 254. The medicant is not touching the ultrasound sensors 214(2) and 214(3), which are in the tumor 200, and as such, the ultrasound sensors 214(2) and 214(3) may measure the second acoustic impedance 252. The ultrasound sensor 214(4) is partly in and partly out of the tumor 200 and as such, the ultrasound sensor 214(4) may measure an acoustic impedance somewhere between the first acoustic impedance 250 and the second acoustic impedance 252. The ultrasound sensors 214(5) to 214(8) are outside the tumor 200, and as such, the ultrasound sensors 214(5) to 214(8) may measure the first acoustic impedance 250.

[0055] As an example, at a second medicant time after the first medicant time, the medicant may be dispersed in a location 258. The location 256 of the medicant may be smaller than the location 258 of the medicant, and the location 258 of the medicant may be larger than the location 256 of the medicant. When the medicant is in location 258, the medicant is touching the ultrasound sensors 214(1) and 214(2), and as such, the ultrasound sensors 214(1) and 214(2) may measure the third acoustic impedance 254. The medicant is very close to the ultrasound sensor 214(3), and as such, the ultrasound sensor 214(3) may measure an acoustic impedance somewhere between the second acoustic impedance 252 and the third acoustic impedance 254. As such, the acoustic impedance measured by the ultrasound sensors 214(1), 214(2), and 214(3) changes from when the medicant is in location 256 to when the medicant is in location 258. Due to this change in acoustic impedance, a difference 260 in the dispersion of the medicant from location 256 to location 258 along the axial length 219 of the needle 201 may be seen in the visualization of the acoustic impedance. Further, the difference 260 may be determined by the computer, and a value for the distance 260 may be calculated by the computer and provided to18MEI 48657880v. 1the user. The ultrasound sensors 214(4) to 214(8) may continue to measure the same acoustic impedance as when the medicant is in location 256.

[0056] In some embodiments, the acoustic impedances from the ultrasound sensors 214 and their associated visualization may be used to view in real time the needle 201 being retracted or withdrawn from the tumor 200. As the needle 201 is retracted from the tumor, the acoustic impedances measured by the ultrasound sensors 214 change. As an example, as the ultrasound sensor 214(1) is retracted from the tumor, the measured acoustic impedance changes from the third acoustic impedance 254 to the second the acoustic impedance 252 when the ultrasound sensor 214(1) is withdrawn from location 256 and location 258, and finally from the second the acoustic impedance 252 to the first the acoustic impedance 250 when the ultrasound sensor 214(1) is fully retracted from the tumor 200.

[0057] In some embodiments, the ultrasound sensors 214 may be used to determine directional dispersion information regarding the fluid flow of the medicant. The directional dispersion information may be determined by, for example: obtaining first acoustic impedance information (e.g., acoustic impedance information when the medicant is in location 256); obtaining second acoustic impedance information (e.g., acoustic impedance information when the medicant is in location 258); comparing the second acoustic impedance information to the first impedance acoustic information to obtain a comparison result; and comparing the comparison result to a dispersion threshold. When the comparison result satisfies the dispersion threshold, the injection rate of the medicant may be adjusted (e.g., a fluid flow of the medicant injected into the subject may be decreased). When the comparison result does not satisfy the dispersion threshold, the injection rate may be maintained. The directional dispersion rate may be determined by calculating by the computer a change or a rate of change of the medicant along19MEI 48657880v. 1the needle 201 over a time period as determined using the second acoustic impedance information. The directional dispersion information may correspond to a change or a rate of change in distance, area, or shape of the medicant over time from the first acoustic impedance information to the second acoustic impedance information. The dispersion threshold may be determined by the characteristics of the tumor of the subject. Based on the dispersion threshold, the flow of medicant may be maintained or may be reduced substantially to zero. The adjustment of the injection rate of the medicant may be performed in order to maintain a substantially constant dispersion rate of the medicant being injected in the tumor of the subject. The adjustment of the injection rate to decrease the flow of medicant being injected into the subject may be based on user input.

[0058] FIG. 3 depicts an example needle 301 with ultrasound sensors 314 injecting a fluid in a subject according to one or more embodiments described herein. The needle 301 may include features from one or more of needles 101, 102, 103, 104. As an example, the ultrasound sensors 314 may be arranged as an array with equidistant spacing in a row along an axial length 319 of the needle 301. The needle 301 may have a fluid exit at the bevel 316 of the needle 301. The needle 301 may be inserted into a tumor 300 of the subject. The ultrasound sensors 314 may measure the acoustic impedance of their surroundings. As the medicant is injected from the bevel 316 of the needle 301, the medicant may disperse in a location 356 in the tumor 300 and flow back in a location 358 along the axial length 319 of the needle 301 in a direction 360. The ultrasound sensors 314 may measure the acoustic impedance 354 of the medicant flowing in the direction 360. In some embodiments, as the medicant flows in the direction 360, a change in acoustic impedance 354 as measured by successive ultrasound sensors 314 in direction 360 indicates the progress or distance traveled by the medicant in direction 360. In some20MEI 48657880v. 1embodiments, the medicant approaching an ultrasound sensor 314 at or near the boundary of the tumor as indicated by acoustic impedance 352 may trigger an alert or control step to slow, stop, or reverse the injection of the medicant so as to prevent leaking of the medicant through the entry point of needle 301 into the tumor.

[0059] FIG. 4 depicts an example needle 401 with ultrasound sensors 414 injecting a fluid in a subject according to one or more embodiments described herein. The needle 401 may include features from one or more of needles 101, 102, 103, 104. As an example, the ultrasound sensors 414 may be arranged as an array with equidistant spacing in a row along an axial length 419 of the needle 401. The needle 401 may have a fluid exit at the bevel 416 of the needle 401. The needle 401 may be inserted into a tumor 400 of the subject. The ultrasound sensors 414 may measure the acoustic impedance of their surroundings. As the needle exits tumor 400 in a fractionation process 450, the acoustic impedances of the ultrasound sensors 414 may be monitored. As an example, with the needle 401 at a first location, a first fraction dosage of the medicant may be delivered to the tumor 400 at a first location 456. The needle 401 may be withdrawn from the tumor 400 and situated at a second location. With the needle 401 at the second location, a second fraction dosage of the medicant may be delivered to the tumor 400 at a second location 458. With the fractionation process 450, two to more fraction dosages of the medicant may be delivered to the tumor 400 as needed. Using the real-time visualization of the fluid flow provided by the ultrasound sensors 414, fluid flow of the medicant can be controlled to provide the fractionation process to deliver the medicant to the tumor 400. As an example, fluid flow of the medicant may be started and stopped in order to deliver the fraction dosages of the medicant. In some embodiments, the acoustic impedance measured by the ultrasound sensors 414 may change as the needle 401 is withdrawn from the tumor 400, which may aid in21MEI 48657880v. 1determining placement of the needle 401 for a next fraction dosage of the medicant to the tumor 400.

[0060] Referring to FIG. 4, when the medicant is delivered to the tumor 400 as a first fraction dosage, a third acoustic information 454 may be measured by some of the ultrasound sensors 414 located closer to the distal end of the needle 401. After the injection of the medicant is complete at the first site, the needle 401 may be slightly withdrawn from the tumor 400. Once situated, the needle 401 may inject a second fraction dosage into the tumor 400, and third acoustic information 454 may again be measured by some of the ultrasound sensors 414 located closer to the distal end of the needle 401. The third acoustic information 454 may be measured by the ultrasound sensors 414 after the medicant is injected from the needle 401 at the first location 456 and again after the medicant is injected from the needle 401 at the second location 458, and a visualization may be provided of the third acoustic impedance information each time. The second location 458 may be located away from the first location 456 along a withdrawal path of the needle 401 out of the tumor 400.

[0061] FIG. 5 depicts an example of a flow diagram of a method 500 for monitoring a fluid being injected into a subject according to one or more embodiments described herein. The needle of method 500 may include features from one or more of needles 101, 102, 103, 104. Certain steps of the method 500 are described as computer-implemented steps. The computer may be, for example, any device comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the relevant steps of the method 500. The method 500 can be implemented by any suitable device or apparatus, such as the computing apparatus 800 of FIG. 21 and / or the like including combination and / or multiples thereof. While22MEI 48657880v. 1an order of operations is indicated in FIG. 5 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0062] In step 502, a needle with a plurality of ultrasound sensors located near a distal end of the needle (e.g., in a pattern of fixed distances along a distal portion of the needle) may be inserted into a subject. In some embodiments, the plurality of ultrasound sensors may be located circumferentially around the distal end of the needle. In some embodiments, the plurality of ultrasound sensors may be located along an axial line of the needle near the distal end of the needle. In some embodiments, the plurality of ultrasound sensors may be located in a recess of the needle near the distal end of the needle. In some embodiments, the needle may comprise a lumen having a single fluid exit at the distal end of the needle, and the plurality of ultrasound sensors may be located at a proximal side of the single fluid exit of the needle. In some embodiments, the needle may comprise a lumen having a plurality of fluid exits near the distal end of the needle, and at least a portion of the plurality of fluid exits of the needle may be located between the ultrasound sensors near the distal end of the needle.

[0063] In step 504, first acoustic impedance information may be received by a computer from the ultrasound sensors. The first acoustic impedance information may indicate a position of the needle with respect to the tumor in the subject and tissue external to the tumor in the subject.

[0064] In step 506, visualization of the first acoustic impedance information may be provided by the computer.

[0065] In step 508, confirmation may be received by the computer from a user based on the visualization of the first acoustic impedance information that the distal end of the needle is23MEI 48657880v. 1inserted in a tumor of the subject. As such, the needle may be located in a first site in the tumor of the subject.

[0066] In step 510, the medicant may be injected from the needle into the tumor of the subject.

[0067] In step 512, second acoustic impedance information may be received by the computer from the ultrasound sensors, where the second acoustic impedance information may be received after the medicant is injected from the needle into the tumor of the subject. The second acoustic impedance information indicates a position of the needle with respect to the tumor in the subject, the fluid being injected into the subject, and tissue external to the tumor in the subject. In some embodiments, the ultrasound sensors are not spun to obtain the second acoustic impedance information.

[0068] In step 514, visualization of the second acoustic impedance information may be provided by the computer.

[0069] In step 516, directional dispersion information of the medicant being injected into the tumor may be determined by the computer based on the second acoustic impedance information. The directional dispersion information of the fluid being injected into the tumor may be determined with respect to a portion of the ultrasound sensors located axially along the needle. The directional dispersion information of the fluid being injected into the tumor may indicate whether the fluid is flowing along an exterior of the needle from the distal end of the needle to a proximal end of the needle. In some embodiments, if the needle includes fluid exits located between the ultrasound sensors near the distal end of the needle, directional dispersion information may be determined for the fluid exiting from the fluid exits based on the second acoustic impedance information.24MEI 48657880v. 1

[0070] In optional step 518, responsive to determining the directional dispersion information, an injection rate of the medicant being injected into the subject may be maintained or adjusted.

[0071] FIG. 6 depicts an example of a flow diagram of a method 600 for monitoring a fluid being injected into a subject according to one or more embodiments described herein. Method 600 may implement steps 516 and 518 of method 500. The needle of method 600 may include features from one or more of needles 101, 102, 103, 104. Certain steps of the method 600 are described as computer-implemented steps. The computer may be, for example, any device comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the relevant steps of the method 600. The method 600 can be implemented by any suitable device or apparatus, such as the computing apparatus 800 of FIG. 21 and / or the like including combination and / or multiples thereof. While an order of operations is indicated in FIG. 6 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0072] In step 602, directional dispersion information of the medicant may be calculated by the computer based on the second acoustic impedance information. The dispersion information may be calculated based on a change in the fluid in the subject over a time period as determined from the second acoustic impedance information. The directional dispersion information may correspond to a change or a rate of change in distance, area, or shape of the fluid over the time period as determined from the second acoustic impedance information. The directional25MEI 48657880v. 1dispersion information may be based on a change or a rate of change of the fluid along the needle over the time period as determined from the second acoustic impedance information.

[0073] In step 604, the directional dispersion information may be compared by the computer to a dispersion threshold to determine whether the directional dispersion information satisfies the dispersion threshold. The dispersion threshold may be defined based on a characteristic of the tumor of the subject.

[0074] In step 606, responsive to determining that the directional dispersion information satisfies the dispersion threshold, an injection rate of the medicant may be adjusted to decrease a flow of the medicant being injected into the subject. In some embodiments, adjusting the injection rate may comprise reducing the injection rate to substantially zero. In some embodiments, adjusting the injection rate may comprise reducing the injection rate to maintain a substantially constant dispersion of the fluid being injected into the tumor of the subject. In some embodiments, adjusting the injection rate of the fluid to decrease the flow of the fluid being injected into the subject may be based on user input.

[0075] In step 608, responsive to determining that the directional dispersion information fails to satisfy the pressure threshold, the injection rate of the medicant may be maintained.

[0076] Steps 606 and 608 may be performed by the computer and / or by the user.

[0077] FIG. 7 depicts an example of a flow diagram of a method 700 for monitoring a fluid being fractionally injected into a subject according to one or more embodiments described herein. Method 700 may occur after steps 516 and optionally 518 of method 500. The needle of method 700 may include features from one or more of needles 101, 102, 103, 104. Certain steps of the method 700 are described as computer-implemented steps. The computer may be, for example, any device comprising one or more processors and memory accessible by the one or26MEI 48657880v. 1more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the relevant steps of the method 700. The method 700 can be implemented by any suitable device or apparatus, such as the computing apparatus 800 of FIG. 21 and / or the like including combination and / or multiples thereof. While an order of operations is indicated in FIG. 7 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0078] In step 702, the needle may be moved from the first site in step 508 to a next site (e.g., a second site) in the tumor along a withdrawal path of the needle from the tumor. The second site may be located away from the first site and along a withdrawal path of the needle from the tumor. As such, the needle may be moved to a next location in order to deliver a next fractional dosage of the medicant.

[0079] In step 704, the medicant is injected from the needle into the tumor of the subject.

[0080] In step 706, third acoustic impedance information may be received by the computer from the ultrasound sensors. The third acoustic impedance information may be received during and / or after the medicant is injected from the needle into the tumor of the subject.

[0081] In step 708, visualization of the third acoustic impedance information may be provided by the computer. If an additional fractional dosage is desired, flow may proceed from step 708 to step 702.

[0082] To treat certain tumors, drugs in fluid form may be injected directly into the tumor. However, as the tumor is often obscured by different tissues of a subject, it is often difficult to detect and determine the presence and location of the needle and / or fluid (e.g., medicant or drug) injected into the tumor using the needle. As discovered by the inventors, a system and method27MEI 48657880v. 1can provide visual information to a user regarding position of the needle, injected fluid, and the tumor that is not otherwise available.

[0083] The present disclosure provides a way to periprocedurally follow a tool tip in real time to locate and access an optimal nodule location for delivering patients undergoing bronchoscopy in order to increase confidence in the location and retention of the medicant. In addition, tumor targeted from pre-procedure planning is not real time accurate to the exact position when the tumor is accessed within a real-time procedure. The disclosed system and method can be utilized to sense the position of an instrument in the tumor with respect to zones, and confirm that a drug delivery tool has accessed a lesion beyond a bronchial wall in patients in order to confirm the drug will be deposited within the lesion. The disclosed system and method can also be utilized to determine how to access a tumor, determine and stay at a desired position inside the tumor, determine distribution of a medicant with respect to a needle or the tumor during real-time procedures.

[0084] FIGS. 8A-8J depict examples of an ultrasound sensing apparatus according to one or more embodiments described herein. In some embodiments, the ultrasound sensing apparatus may include an extended working channel having a distal end, a proximal end opposite to the proximal end, and a channel. The distal end may be adapted for insertion in a subject (for example, a patient or an organ of a patient).

[0085] In some embodiments, the distal end includes an end face, where at least one ultrasound sensor may be located on the end face of the distal end of the extended working channel and may be configured to measure acoustic impedance in the subject. In some embodiments, when viewed in a direction perpendicular to the end face of the distal end, the at least one ultrasound sensor may be forward facing. In some embodiments, when viewed in a28MEI 48657880v. 1direction perpendicular to the end face of the distal end, at least two of the ultrasound sensors may surround the channel.

[0086] In some embodiments, the at least one ultrasound sensor may include at least three ultrasound sensors. In some embodiments, when viewed in the direction perpendicular to the end face of the distal end, the at least one ultrasound sensor may include a plurality of ultrasound sensors space equidistantly on the end face of the distal end around the channel. In some embodiments, the channel may be sized to convey a needle out of the distal end and into the subject.

[0087] In some embodiments, the ultrasound sensing apparatus may further include a needle having a distal end, where the at least one ultrasound sensor may be configured to measure acoustic impedance of the distal end of the needle when the distal end of the needle is extended from the distal end of the extended working channel. In some embodiments, the needle may include an etching detectable by the plurality of ultrasound sensors.

[0088] FIG. 8A illustrates an ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 8A illustrates, the ultrasound sensing apparatus includes an extended working channel 1100A having a distal end 1103 A, a proximal end 1105 A, a channel 1107A, and an end face 1101 A, where three ultrasound sensors 1102 A are deployed on the end face 1101 A. The ultrasound sensors 1102A on the end face 1101 A may be referred to as forward facing ultrasound sensors 1102A since the ultrasound sensors 1102A may measure acoustic impedance in front of the opening of the channel 1107A of the extended working channel 1100A.

[0089] FIG. 8B illustrates another ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 8B illustrates, the29MEI 48657880v. 1ultrasound sensing apparatus includes an extended working channel 1100B having a distal end 1103B, a proximal end 1105B, a channel 1107B, and an end face 1101B, where a plurality of ultrasound sensors 1102B are space equidistantly deployed on the end face 1101B. In some embodiments, the end face 110 IB may include a number of ultrasound sensors 1102B as dictated by the size of the end face 1101B, the size of the ultrasound sensors 1102B, and a desired number of ultrasound sensors 1102B to measure acoustic impedance. As an example, the end face 1101B includes sixteen ultrasound sensors 1102B.

[0090] FIG. 8C illustrates another ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 8C illustrates, the ultrasound sensing apparatus includes an extended working channel 1100C having a distal end 1103C, a proximal end 1105C, a channel 1107C, an end face 1101C, and a needle 1104C. As shown in FIG. 8C, a plurality of ultrasound sensors 1102C are deployed on the end face 1101C, where the plurality of ultrasound sensors 1102C are configured to measure acoustic impedance of a distal end 1109C of the needle 1104C, when the distal end 1109C of the needle 1104C is extended from the distal end 1103 C of the extended working channel 1100C.

[0091] In some embodiments, the ultrasound sensing apparatus may further include a distal inflatable member located at the distal end of the extended working channel, where the distal inflatable member provides the end face of the distal end of the extended working channel, and where the at least one ultrasound sensor is located on the distal inflatable member.

[0092] In some embodiments, the distal inflatable member may be configured to provide a pliable surface for the at least one ultrasound sensor to touch a tissue wall of the subject when the extended working channel is inserted in the subject.30MEI 48657880v. 1

[0093] In some embodiments, the distal inflatable member may be inflatable to provide contact between the at least one ultrasound sensor and the tissue wall within the subject. As an example, the tissue wall within the subject may be an intrabronchial tissue wall within the subject. In some embodiments, when the extended working channel is inserted in the subject and the distal inflatable member is inflated, the at least one ultrasound sensor may be configured to measure acoustic impedance in the subject on an opposite side of the tissue wall of the subject.

[0094] FIG. 8D illustrates an ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. FIG. 8E illustrates a side view of the ultrasound sensing apparatus of FIG. 8D. As FIG. 8D and FIG. 8E illustrate, the ultrasound sensing apparatus includes an extended working channel HOOD having a distal end 1103D, a proximal end 1105D, a channel 1107D, and an inflatable member 1106D that provides an end face 1101D for the extended working channel HOOD. In some embodiments, the inflatable member 1106D may be a solenoid-shaped balloon. A plurality of ultrasound sensors 1102D may be deployed on the end face 1101D. As an example, the plurality of ultrasound sensors 1102D may include three ultrasound sensors space equidistantly on the end face 1101D.

[0095] In some embodiments, the ultrasound sensing apparatus may further include at least one second ultrasound sensor located on an extendable member, where the extendable member has a distal end and a proximal end opposite the distal end, and where the at least one second ultrasound sensor is located near the distal end of the member. In particular, the extendable member may be configured to be extended and retracted from the channel at the distal end of the extended working channel.

[0096] In some embodiments, the member may have a plurality of second ultrasound sensors aligned in a linear array near the distal end of the member. In some embodiments, the member31MEI 48657880v. 1may be configured to face an axial center of the extended working channel when the member is extended from the channel.

[0097] In some embodiments, the ultrasound sensing apparatus may further include a working instrument having a distal end, wherein the at least one ultrasound sensor and the at least one second ultrasound sensor are configured to measure acoustic impedance of the distal end of the working instrument when the at least one second ultrasound sensor and the distal end of the working instrument are extended from the distal end of the extended working channel. In some embodiments, the working instrument may be a needle.

[0098] FIG. 8F illustrates an ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. FIG. 8G illustrates a front view of the ultrasound sensing apparatus of FIG. 8F. As FIG. 8F and FIG. 8G illustrate, the ultrasound sensing apparatus includes an extended working channel HOOF having a distal end 1103F, a proximal end 1105F, a channel 1107F, and an end face 1101F. A plurality of first ultrasound sensors 1102F are deployed on the end face 1101F. A extendable member 1108F is configured to be extended and retracted from the channel 1107F. The member 1108F has a distal end 1113F and a proximal end (not shown) opposite to the distal end 1113F. A plurality of second ultrasound sensors 1110F aligned in a linear array may be located near the distal end 1113F of the member 1108F. As FIG. 8G illustrates, the member 1108F is configured to face an axial center 1115F of the extended working channel 11 OOF when the member 1108F is extended from the channel 1107F.

[0099] In some embodiments, the ultrasound sensing apparatus may further include a plurality of light emitting diodes located on the end face of the distal end of the extended working channel and configured to emit visible light and a visible light camera. In some32MEI 48657880v. 1embodiments, the visible light camera may be located on a distal end of a member, the member having a proximal end opposite the distal end, the member configured to be extended and retracted from the channel at the distal end of the extended working channel.

[0100] In some embodiments, the ultrasound sensing apparatus may further include a distal inflatable member located at the distal end of the extended working channel, the distal inflatable member providing the end face of the distal end of the extended working channel, the at least one ultrasound sensor and the plurality of light emitting diodes may be located on the distal inflatable member. In some embodiments, the camera may be located on the distal inflatable member.

[0101] FIG. 8H illustrates an ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 8H illustrates, the ultrasound sensing apparatus includes an extended working channel 1100H having a distal end 1103H, a proximal end 1105H, a channel 1107H, and a distal inflatable member 1106H providing an end face 1101H for the extended working channel 1100H. A plurality of ultrasound sensors 1102H and a plurality of light emitting diodes 111 OH are located on the end face 1101H of the distal inflatable member 1106H. In some embodiments, the end face 1101H may include a number of ultrasound sensors 1102H and a number of light emitting diodes 111 OH as dictated by the size of the end face 1101H, the size of the ultrasound sensors 1102H, the size of the light emitting diodes 1110H, a desired number of ultrasound sensors 1102H to measure acoustic impedance, and a desired number of light emitting diodes 1110H to view the area in front of the end face 1101H. As an example, the end fac 1101H includes three ultrasound sensors 1102H and three light emitting diodes 1110H. A member 1112H is configured to be extended and retracted from the channel 1107H. The member 1112H has a distal end 1113H and a proximal end (not shown)33MEI 48657880v. 1opposite to the distal end 1113H. A visible light camera 1114H is located on the distal end 1113H of the member 1112H.

[0102] FIG. 81 illustrates another ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 81 illustrates, the ultrasound sensing apparatus includes an extended working channel 11001 having a distal end 11031, a proximal end 11051, a channel 11071, and an distal inflatable member 11061 providing an end face 11011 for the extended working channel 11001. A plurality of ultrasound sensors 11021 and a plurality of light emitting diodes 11101 are located on the end face 11011 of the distal inflatable member 11061. A visible light camera 11141 is also located on the end face 11011 of the distal inflatable member distal end 11061.

[0103] FIG. 8J illustrates another ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 8J illustrates, the ultrasound sensing apparatus includes an extended working channel 1100J having a distal end 1103J, a proximal end 1105 J, a channel 1107J, and an end face 1101 J. A plurality of ultrasound sensors 1102J and a plurality of light emitting diodes 1110J may be located on the end face 1101 J. A visible light camera 1114J is also located on end face 1101 J.

[0104] In some embodiments, an ultrasound sensing apparatus may include features from one or more of the extended working channels discussed above and / or illustrated in FIGS. 8A-8J.

[0105] FIG. 9 depicts an example extended working channel with ultrasound transducers and an extended needle according to one or more embodiments described herein. As FIG. 9 illustrates, an extended working channel 1200 of an ultrasound sensing apparatus has three ultrasound sensors 1202. As situated in a subject, the extended working channel 1200 may be inserted in a subject (e.g., a patient) and may touch or abut an airway wall 1206 of the subject.34MEI 48657880v. 1In some embodiments, the extended working channel 1200 may be used to detect a proper position in a tumor for medicant injection. A tissue 1250 in the subject may have one or more tumors. As an example, the tissue 1250 includes two tumors, a tumor 1252 and a tumor 1254. A needle 1204 may extend forward and out of the channel 1207 through an opening encircled by the end face 1201. The needle 1204 may pierce through the airway wall 1206 of the subject and go into the tissue 1250 to reach the tumor 1252 and / or the tumor 1254 for medicant injection.

[0106] In some embodiments, an ultrasound sensing system may include the ultrasound sensing apparatus described above and a computer coupled to the at least one ultrasound sensor. The computer may include one or more processors and memory accessible by the one or more processors. The memory may store instructions that when executed by the one or more processors, cause the computer to perform a method of visualization including receiving acoustic impedance information from the at least one ultrasound sensor and providing visualization of the acoustic impedance information. In particular, the acoustic impedance information may be received from the at least one ultrasound sensor located on the end face at the distal end of the extended working channel inserted in the subject. In some embodiments, the method of visualization may include detecting when a needle extended from the distal end of the extended working channel is at a desired needle location in relation to tumor tissue of the subject.

[0107] In some embodiments, the visualization may include an overlay target of a desired position of a needle, where the overlay target may have a first appearance if the needle is not in the desired position and has a second appearance if the needle is in the desired position. In some embodiments, the visualization may include an overlay designation of a tumor of the subject. In some embodiments, the visualization may include visualization of tumor tissue and non-tumor tissue. In some embodiments, the visualization may include visualization of the needle. As an35MEI 48657880v. 1example, the visualization may include an overlay target for a desired needle location of a needle in relation to the tumor tissue and the non-tumor tissue.

[0108] In some embodiments, the method of visualization may include: determining, from the acoustic impedance information, a location of tumor tissue in the subject; determining, from the determined location of the tumor tissue, a desired needle location; determining, from the acoustic impedance information, a location of a needle in the subject; determining whether the determined location of the needle is at the desired needle location; and providing a first indication when the needle is at the desired needle location and a second indication when the needle is not at the desired needle location, wherein the first indication is different from the second indication. As one example, the first indication may include an overlay target having a first appearance when the needle is at the desired needle location, and the second indication may include the overlay having a second appearance when the needle is not at the desired needle location. As another example, the first indication may include at least one of a first audio alert or a first visual alert for a user of the needle, and the second indication may include at least one of a second audio alert or a second visual alert for the user of the needle.

[0109] In some embodiments, the method of visualization may include permitting, by the computer, delivery of a fluid via the needle when the needle is at the desired needle location, and not permitting, by the computer, delivery of a fluid via the needle when the needle is not at the desired needle location.

[0110] FIGS. 10A-10D depicts example visualizations based on acoustic impedance produced by ultrasound transducers of FIG. 9 according to one or more embodiments described herein.36MEI 48657880v. 1

[0111] FIG. 10A shows a visualization area 1300A of area of the tissue 1250 including the first tumor 1252 and the second tumor 1254.

[0112] FIG. 10B shows a visualization area 1300B of a first appearance when the needle 1204 is not in an overlay target 1355 of a desired position of the needle 1204 for the second tumor 1254. As the needle 1204 is not in the desired position, delivery of the medicant by the needle 1204 to the second tumor 1254 may not be permitted by the computer. The visualization area 1300B may illustrate the position of needle 1204 as depicted in FIG. 9.

[0113] FIG. 10C shows a visualization area 1300C of a second appearance when the needle 1204 is in overlay target 1355 of the desired position of the needle 1204 on the second tumor 1254. As the needle 1204 is placed in the desired position, the overlay target 1355 changes from the first appearance to the second appearance. As an example, the first appearance and the second appearance of the overlay target 1355 may differ in color and / or shape. As the needle 1204 is in the desired position, delivery of the medicant by the needle 1204 to the second tumor 1254 may be permitted by computer.

[0114] FIG. 10D shows medicant injection in the visualization area 1300D, including a first medicant area 1362 after medicant injection at a first medicant time and a second medicant area 1364 after medicant injection at a second medicant time. The first medicant time may occur before the second medicant time. The visualization area 1300D may illustrate the position of needle 1204 as depicted in FIG. 11.

[0115] FIG. 11 depicts an example extended working channel with ultrasound transducers and an extended needle injecting a fluid in a subject according to one or more embodiments described herein. As shown in FIG. 11 , the extended working channel 1200 of FIG. 9 has been inserted in the subject, the needle 1204 inserted in the tissue 1250, and the needle 1204 has37MEI 48657880v. 1injected medicant in the second tumor 1254. The medicant is in the first medicant area 1362 after medicant injection at the first medicant time and in the second medicant area 1364 after medicant injection at the second medicant time.

[0116] In some embodiments, the ultrasound sensing apparatus may include a plurality of inflatable members located along an exterior of the extended working channel, where the plurality of inflatable members may be configured to stabilize a position of the extended working channel when the extended working channel is inserted in a subject. As one example, a distal inflatable member of the plurality of inflatable members may be located at the distal end of the extended working channel, and a second inflatable member of the plurality of inflatable members may be located between the distal inflatable member and the proximal end of the extended working channel. In particular, the distal inflatable member located at the distal end of the extended working channel may provide an end face of the distal end of the extended working channel, where at least one ultrasound sensor is located on the distal inflatable member. In some embodiments, the ultrasound sensing apparatus may further include a variable inflation source coupled to the plurality of inflatable members, where the variable inflation source may be configured to individually inflate the plurality of inflatable members.

[0117] FIG. 12 depicts an example extended working channel with inflatable members according to one or more embodiments described herein. As FIG. 12 illustrates, an ultrasound sensing apparatus includes an extended working channel 1500, which is inserted in an airway 1516 of a subject. The ultrasound sensing apparatus includes a plurality of inflatable members located along an exterior of the extended working channel 1500. The plurality of inflatable members includes a distal inflatable member 1506 and at least one second inflatable member 1508. The distal inflatable member 1506 and the at least one second inflatable member 1508 are38MEI 48657880v. 1configured to stabilize a position of the extended working channel 1500 when the extended working channel 1500 is inserted in a subject (e.g., in the airway 1516 of the subject).

[0118] As shown in FIG. 12, the distal inflatable member 1506 is located at a distal end 1503 of the extended working channel 1500, and the at least one second inflatable member 1508 is located between the distal inflatable member 1506 and a proximal end 1505 of the extended working channel. The distal inflatable member 1506 may provide an end face 1501 of the distal end 1503 of the extended working channel 1500, where at least one ultrasound sensor (not shown) is located on the end face 1501 of the distal inflatable member 1506. An inflation connection channel 1510 may couple a variable inflation source (not shown) and the plurality of inflatable members 1506, 1508. The inflation connection channel 1510 may be configured to individually inflate the plurality of inflatable members 1506, 1508.

[0119] FIG. 13 depicts an example extended working channel with ultrasound transducers, an extended needle injecting a fluid in a subject, and an extended member having additional ultrasound transducers according to one or more embodiments described herein. As shown in FIG. 13, an extended working channel 1600 is similar to the extended working channel 1200 of FIG. 9, except the extended working channel 1600 includes second ultrasound sensors 1610. A member 1608 may be configured to be extended and retracted from the channel 1207 of the extended working channel 1600. A plurality of second ultrasound sensors 1610 may be aligned in a linear array and located near a distal end 1613 of the member 1608. The member 1608 may be configured to face an axial center of the extended working channel 1600 when the member 1608 is extended from the channel 1207. As depicted in FIG. 13, the needle 1604 is extended forward from the channel 1207, pierced through the airway wall 1206 of the subject, and medicant is administered in a first medicant area 1362 at a first medicant time and in a second39MEI 48657880v. 1medicant area 1364 at a second medicant time. The second ultrasound sensors 1610 are configured to detect and visualize an area of the tissue 1250 and the tumors 1252 and 1254 in order to assist a user to direct and guide the needle 1204 to enter the tissue 1250 and to further monitor medicant injection progress in terms of impedance change as the medicant spreads through tumor 1254, tissue 1250, and to tumor 1252. In some embodiments, the visualization provided by the second ultrasound sensors 1610 may be separate from the visualization provided by the second ultrasound sensors 1202 on the end face 1201. In some embodiments, the visualization provided by the second ultrasound sensors 1610 and the visualization provided by the second ultrasound sensors 1202 on the end face 1201 may be combined to provide a unified visualization.

[0120] FIGS. 14A-14B (collectively, FIG. 14) depict an example flowchart for a method 1700 of using an example extended working channel according to one or more embodiments described herein. Certain steps of the method 1700 are described as computer- implemented steps. The computer may be, for example, any device comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the relevant steps of the method 1700. While an order of operations is indicated in FIG. 14 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein. The method 1700 can be implemented by any suitable device or apparatus, such as the computing apparatus 800 of FIG. 21 and / or the like including combination and / or multiples thereof. According to one or more embodiments described herein, the method 1700 may treat a subject utilizing an ultrasound sensing apparatus based on the embodiments illustrated in FIG. 8A to FIG. 13.40MEI 48657880v. 1

[0121] In step 1702, the method 1700 may include inserting an extended working channel of an ultrasound sensing apparatus into a subject, where the extended working channel includes an end face having at least one ultrasound sensor.

[0122] In optional step 1704, the method 1700 may include inflating one or more inflatable members of the extended working channel. In some embodiments, step 1704 may include inflating a distal inflatable member located at a distal end of the extended working channel, where the distal inflatable member provides an end face of the distal end of the extended working channel, and the at least one ultrasound sensor is located on the distal inflatable member. In some embodiments, step 1704 may include inflating a plurality of inflatable members located along an exterior of the extended working channel, where the plurality of inflatable members may be configured to stabilize a position of the extended working channel when the extended working channel is inserted in the subject.

[0123] In optional step 1706, the method 1700 may include extending a member with second ultrasound sensors. In some embodiments, step 1706 may include extending a member from the distal end of the extended working channel, where the member has a distal end and a proximal end opposite the distal end, where the member has at least one second ultrasound sensor located near the distal end of the member, where the member is configured to be extended and retracted from the channel at the distal end of the extended working channel. In some embodiments, the member may have a plurality of second ultrasound sensors aligned in a linear array near the distal end of the member.

[0124] In step 1708, the method 1700 may include extending a retractable needle from the extended working channel into the subject.41MEI 48657880v. 1

[0125] In step 1710, the method 1700 may include receiving acoustic impedance information from the at least one ultrasound sensor on the end face of the extended working channel and providing visualization of the acoustic impedance information. Step 1710 may be performed using a computer.

[0126] In optional step 1712, the method 1700 may include receiving second acoustic impedance information from at least one second ultrasound sensor on the member extended from the extended working channel and providing visualization of the second acoustic impedance information. Step 1712 may be performed using a computer.

[0127] In step 1714, the method 1700 may include positioning the retractable needle based on visualization produced from acoustic impedance information from the at least one ultrasound sensor located on the extended working channel. In some embodiments, positioning the retractable needle may also be based on visualization produced from second acoustic impedance information from the second ultrasound sensors of the member extended in step 1706. Step 1714 may be performed using a computer.

[0128] In step 1716, the method 1700 may include upon receiving confirmation from a user, based on the visualization, that a distal end of a needle is inserted in a desired location of the subject, recording an image of the visualization. In some embodiments, the confirmation from the user that the distal end of the needle is inserted in the desired location of the subject may further be based on at least one of a computed tomography (CT) image of the subject, a conebeam CT (CBCT) image of the subject, an x-ray image of the subject, or a fluoroscopy image of the subject. Step 1716 may be performed using a computer.

[0129] In step 1718, the method 1700 may include injecting a fluid into the subject from the positioned retractable needle. Step 1718 may be performed using a computer.42MEI 48657880v. 1

[0130] In step 1720, the method 1700 may include determining directional dispersion information of the fluid being injected into the subject based on the acoustic impedance information from the at least one ultrasound sensor on the end face of the extended working channel. In some embodiments, the directional dispersion information of the fluid being injected into the subject may indicate whether the fluid is flowing in a direction perpendicular to the end face of the distal end of the extended working channel. Step 1720 may be performed using a computer.

[0131] In optional step 1722, the method 1700 may include determining directional dispersion information of the fluid being injected into the subject based on the second acoustic impedance information the second ultrasound sensors on the member extended from the extended working channel. In some embodiments, the directional dispersion information of the fluid being injected into the subject may indicate whether the fluid is flowing from the distal end of the member to a proximal end of the member. In some embodiments, the visualization of the acoustic impedance information in step 1720 and the visualization of the second acoustic impedance information in step 1722 may be combined to provide a unified visualization. Step 1722 may be performed using a computer.

[0132] In step 1724, the method 1700 may include observing the subject for bleeding based on visualization produced from acoustic impedance information from at least one ultrasound sensor and applying treatment for bleeding cessation to the subject upon observing bleeding.

[0133] In step 1726, the method 1700 may include retracting the retractable needle into the extended working channel and thereafter removing the extended working channel from the subject.43MEI 48657880v. 1

[0134] FIG. 15 depicts an example flowchart for a method 1800 of using an example extended working channel according to one or more embodiments described herein. Certain steps of the method 1800 are described as computer-implemented steps. The computer may be, for example, any device comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors cause the computer to perform the relevant steps of the method 1800. The method 1800 can be implemented by any suitable device or apparatus, such as the computing apparatus 800 of FIG. 21 and / or the like including combination and / or multiples thereof. While an order of operations is indicated in FIG. 15 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0135] At step 1810, the method 1800 may include inserting an extended working channel (EWC) with a stabilizing stylet into a therapeutic bronchoscope.

[0136] At step 1812, the method 1800 may include turning on a camera on the stylet or, alternatively, on the extended working channel. Step 1812 may be performed using a computer.

[0137] At step 1814, the method 1800 may include driving the extended working channel, either manually or robotically, to a location of a tumor that is preprocedural planned based on CT images. Step 1814 may be performed using a computer.

[0138] As step 1816, the method 1800 may include turning on forward facing ultrasound sensors on the end face of the extended working channel and inflating inflation members of the extended working channel to compress the extended working channel in place in the vicinity of the tumor. In embodiments where the camera is positioned on the stabilizing stylet, the44MEI 48657880v. 1stabilizing stylet may be retracted such that the camera is positioned at the distal opening of the extended working channel. Step 1816 may be performed using a computer.

[0139] At step 1818, the method 1800 may include steering a position of the extended working channel to a target tumor. Step 1818 may be performed using a computer.

[0140] At step 1820, the method 1800 may include determining whether the extended working channel is in position for the tumor to be accessed by a working instrument (or working tool). Upon determining yes, the process continues to step 1822. Upon determining no, the process returns to step 1818.

[0141] At step 1822, the method 1800 may include locking the extended working channel by inflating inflation members. Alternatively, if the extended working channel was driven robotically, the method 1800 may include, at step 1822, locking the extended working channel such as by robotic stabilization pull wires. Step 1822 may be performed using a computer.

[0142] At step 1824, the method 1800 may include communicating readiness to remove the stabilizing stylet and inserting a working instrument. The communication may be via a computing device, such as by electronically logging readiness, or to attending personnel such as a field clinical manager. Step 1824 may be performed using a computer.

[0143] At step 1826, the method 1800 may include inserting and activating the working instrument. In particular, the working instrument may include one or more of: a microwave tool, cryo ablation tool, an injection needle, or a biopsy tool. Step 1826 may be performed using a computer.

[0144] At step 1828, the method 1800 may include tracking the working instrument position and tumor effect with the forward facing ultrasound sensors. Step 1828 may be performed using a computer.45MEI 48657880v. 1

[0145] At step 1830, the method 1800 may include determining if action on the tumor is competed. Contemplated actions include medicant injection, implant insertion, biopsy extraction, tissue excision, and the like. Upon determining that action on the tumor is completed, the completion is confirmed on a user interface device (UID), and the process moves to step 1832. Upon determining that action on the tumor is not completed, the process returns to step 1824. Step 1830 may be performed using a computer.

[0146] At step 1832, the method 1800 may include removing the working instrument. In embodiments where the extended working channel does not have a camera, a stabilizing stylet with a camera may be inserted. Step 1832 may be performed using a computer.

[0147] At step 1834, if desired, the successful completion of the action on the tumor may be confirmed with CBCT. Step 1834 may be performed using a computer.

[0148] At step 1836, the method 1800 may include determining if the tumor is showing bleeding or a visible leak. This step may be performed by viewing a visualization of the area based on acoustic impedance information from the forward facing ultrasound sensors. Upon determining yes, the process moves to step 1838. Upon determining no, the process moves to step 1840. Step 1836 may be performed using a computer.

[0149] At step 1838, the method 1800 may include addressing with standard of care as needed (e.g., compression or repair procedure) to stop the bleeding or the leak.

[0150] At step 1840, the method 1800 may include recording a view of the procedure in the electronic record and complete the case. Step 1840 may be performed using a computer.

[0151] Additional steps also may be included in method 1700 and / or method 1800, and it should be understood that methods depicted in FIG. 14 and FIG. 15 represent illustrations, and that other processes may be added or existing processes may be removed, modified, or46MEI 48657880v. 1rearranged without departing from the scope of the present disclosure. It should also be understood that the processes depicted in FIG. 14 and FIG. 15 may be implemented as programmatic instructions stored on a non-transitory computer-readable storage medium that, when executed by a processor (e.g., the one or more processors 802 of FIG. 21) of a computing system (e.g., the apparatus 800 of FIG. 21), cause the processor to perform the processes described herein.

[0152] The present disclosure provides a way to periprocedurally follow a tooltip in real time to locate and access an optimal nodule location for delivering patients undergoing bronchoscopy in order to increase confidence in the location and retention of the medicant. In addition, tumor targeted from pre-procedure planning is not real time accurate to the exact position when the tumor is accessed within a real-time procedure. The disclosed system and method can be utilized to sense the position of an instrument in the tumor with respect to zones, and confirm that a drug delivery tool has accessed a lesion beyond a bronchial wall in patients in order to confirm the drug will be deposited within the lesion. The disclosed system and method can also be utilized to determine how to access a tumor, determine and stay at a desired position inside the tumor, and / or determine distribution of a medicant with respect to a needle or the tumor during real-time procedures.

[0153] According to some embodiments, the inventive techniques provide a practical application in being able to monitor needle position and medicant flow in real time. Further, the inventive techniques address a technical problem of not being able to visualize in real-time a tumor in a subject, a surgical tool (e.g., a needle) in relation to a tumor in the subject, and a flow of medicant being delivered to the tumor in the subject. Moreover, the inventive techniques provide a technical solution to this technical problem by allowing for the real-time visualization47MEI 48657880v. 1of a tumor in a subject, a surgical tool (e.g., a needle) in relation to a tumor in the subject, and a flow of medicant being delivered to the tumor in the subject.

[0154] FIGS. 16A-16B depict an example extended working channel according to one or more embodiments described herein. In some embodiments, the ultrasound sensing apparatus may include an extended working channel having a distal end, a proximal end opposite to the proximal end, and a channel extending from the distal end to the proximal end. The distal end may be adapted for insertion in a subject (for example, a patient or an organ of a patient).

[0155] In some embodiments, the distal end includes an end face, where at least one first ultrasound sensor may be located on the end face of the distal end of the extended working channel and may be configured to measure acoustic impedance in the subject. In some embodiments, when viewed in a direction perpendicular to the end face of the distal end, the at least one first ultrasound sensor may be forward facing. In some embodiments, when viewed in a direction perpendicular to the end face of the distal end, at least two, three, four, five, six, seven, eight, nine, ten, or more of the first ultrasound sensors may surround the channel.

[0156] In some embodiments, the at least one first ultrasound sensor may include at least three first ultrasound sensors. In some embodiments, when viewed in the direction perpendicular to the end face of the distal end, the at least one first ultrasound sensor may include a plurality of first ultrasound sensors space equidistantly on the end face of the distal end around the channel. In some embodiments, the channel may be sized to convey a needle out of the distal end and into the subject.

[0157] In some embodiments, the ultrasound sensing apparatus may further include a needle having a distal end and a proximal end opposite the distal end, where the needled may be configured to be extended and retracted from the channel at the distal end of the extended48MEI 48657880v. 1working channel. In some embodiments, the needle may include an etching detectable by the plurality of ultrasound sensors. In some embodiments, the needle may further include a bevel located at the distal end, where the bevel may be a fluid exit to deliver fluid from the needle.

[0158] In some embodiments, at least one second ultrasound sensor may be located near the distal end of the needle and may be configured to measure acoustic impedance. In some embodiments, the at least one second ultrasound sensor may be configured to be extended and retracted from channel at the distal end of the extended working channel.

[0159] In some embodiments, at least two of the second ultrasound sensors may be located on a line approximately perpendicular to the plane on the end face at the distal end of the extended working channel. As an example, at least two second ultrasound sensors may be located near the distal end of the needle and may be located axially along the needle between the bevel and the proximal end of the needle, or between the distal end and the proximal end of the needle. In some embodiments, the needle may further include a plurality of fluid exits located axially along the needle between the bevel and the proximal end of the needle, or between the distal end and the proximal end of the needle, and each of the fluid exits may be located between two of the second ultrasound sensors.

[0160] FIG. 16A illustrates an ultrasound sensing apparatus in a perspective view according to the above-referenced one or more embodiments. As FIG. 16A illustrates, the ultrasound sensing apparatus includes an extended working channel 2100 having a distal end 2103, a proximal end 2105, a channel 2107, and an end face 2104, where three first ultrasound sensors 2102 are deployed on the end face 2104. The first ultrasound sensors 2102 on the end face 2104 may be referred to as forward facing ultrasound sensors 2102 since the first ultrasound sensors49MEI 48657880v. 12102 may measure acoustic impedance in front of the opening of the channel 2100 of the extended working channel 2100.

[0161] A needle 2101 may be configured to be extended and retracted from the channel 2107. The needle 2101 has a distal end 2116. At least one second ultrasound sensors 2106 may be deployed near the distal end 2116 and on the outer surface of the needle 2101.

[0162] FIG. 16B illustrates a front view of the ultrasound sensing apparatus from FIG. 16A. As FIG. 16B illustrates, the three first ultrasound sensors 2102 may be spaced equidistantly on the end face 2104. The second ultrasound sensors 2106 may be space equidistantly around an outer surface of the needle 2101 in a ring shape.

[0163] FIGS. 17A-17D depict examples of needles with ultrasound transducers according to one or more embodiments described herein.

[0164] FIG. 17A depicts a needle 2201 with a distal end 2210 and a proximal end 2212 opposite the distal end 2210. The distal end 2210 may include a bevel 2216, and the bezel 2216 may be at a fluid exit of the needle 2201 to deliver fluid from the needle 2201. Near the distal end 2210 is a set of ultrasound sensors 2214(1), 2214(2), 2214(3), 2214(4), and 2214(5), collectively ultrasound sensors 2214. The ultrasound sensors 2214 may be aligned in one or more rows along an axial length 2219 of the needle 2201. In some embodiments, the ultrasound sensors 2214 may be aligned with equidistant spacing in a row along the axial length 2219 of the needle 2201. As an example, the ultrasound sensors 2214(1), 2214(2), 2214(3), 2214(4), and 2214(5) are aligned with equidistant spacing in a row along the axial length 2219 of the needle 2201.

[0165] In some embodiments, the ultrasound sensors 2214 may wrap around the circumference of the needle 2201 forming one or more rings of ultrasound sensors 2214. As50MEI 48657880v. 1depicted in FIG. 17A, the ultrasound sensors 2214 wrap around the circumference of the needle 2201 forming five rings 2218(1), 2218(2), 2218(3), 2218(4), and 2218(5), collectively rings 2218. In some embodiments, the ultrasound sensors 2214 may wrap partially around the circumference of the needle 2201 forming one or more partial rings of ultrasound sensors 2214. Although the needle 2201 is depicted with five rings 2218 of ultrasound sensors 2214, any number of rings and / or partial rings of ultrasound sensors 2214 may be provided. In some embodiments, the ultrasound sensors 2214 may be aligned with equidistant spacing around the circumference of the needle 2201 and / or with equidistant spacing between rings 2218 around the needle 2201. As an example, the ultrasound sensors 2214 in FIG. 17A are depicted with equidistant spacing around the circumference of the needle 2201 and with equidistant spacing between rings 2218 around the needle 2201.

[0166] FIG. 17B depicts a needle 2202 with a distal end 2220 and a proximal end 2222 opposite the distal end 2220. The distal end 2220 may include a bevel 2226 and a fluid exit for the needle 2202 at the bevel 2226. Near the distal end 2220 is a set of ultrasound sensors 2224(1), 2224(2), 2224(3), 2224(4), 2224(5), 2224(6), and 2224(7), collectively ultrasound sensors 2224. Similar to the ultrasound sensors 2214, the ultrasound sensors 2224 may wrap around the circumference of the needle 2202 forming rings of ultrasound sensors 2224. Near the distal end 2220 is a set of fluid exits 2228(1), 2228(2), 2228(3), and 2228(4), collectively fluid exits 2228. In some embodiments, the fluid exits 2228 may be aligned along an axial length 2229 of the needle 2202. The fluid exits 2226 may allow fluid to flow through the fluid exists outside the needle and along the axial length 2229 of the needle 2202. Different from the needle 2201, the rings of ultrasound sensors 2224 may be spaced apart by at least one fluid exit 2228 between two rings of ultrasound sensors 2224. In some embodiments, one fluid exit 2228 may be located51MEI 48657880v. 1between and adjacent to two rings of ultrasound sensors 2224. As an example, fluid exit 2228(1) is located between and adjacent to a first ring of ultrasound sensors that includes ultrasound sensor 2224(1) and a second ring of ultrasound sensors that includes ultrasound sensor 2224(2). The fluid exits 2228 may be aligned in one more rows along the axial length 2229 of the needle 2202. In some embodiments, the fluid exits 2228 may be aligned with equidistant spacing in a row along the axial length 2229 of the needle 2202. As an example, the fluid exits 2228(1), 2228(2), 2228(3), and 2228(4) are aligned with equidistant spacing in a row along the axial length 2229 of the needle 2202. In some embodiments, the fluid exits 2228 may wrap around the circumference of the needle 2202 forming rings of fluid exits 2228 (not shown in FIG. 17B).

[0167] In some embodiments, one or more rings of ultrasound sensors 2224 may have no fluid exits 2228 located adjacent to the ring. As an example, the ring of ultrasound sensors 2224 that includes ultrasound sensor 2224(6) and the ring of ultrasound sensors 2224 that includes ultrasound sensor 2224(7) have no fluid exits 2228 adjacent to the ring. In some embodiments, two adjacent rings of ultrasound sensors 2224 may have no fluid exits 2228 located between the rings. As an example, the ring of ultrasound sensors 2224 that includes ultrasound sensor 2224(5) and the ring of ultrasound sensors 2224 that includes ultrasound sensor 2224(6) do not have a fluid exit 2228 located between the rings. In some embodiments, one or more rings of ultrasound sensors 2224 that have no fluid exits 2228 located adjacent to the ring may be located closer to the proximal end 2222 and / or the distal end 2220 of the needle 2202 than any of the fluid exits 2228. As an example, the ring of ultrasound sensors 2224 that includes ultrasound sensor 2224(6) and the ring of ultrasound sensors 2224 that includes ultrasound sensor 2224(7) are located closer to the proximal end 2222 of the needle 2202 than any of the fluid exits 2228.52MEI 48657880v. 1

[0168] FIG. 17C depicts a needle 2203 with a distal end 2230 and a proximal end 2232 opposite the distal end 2230. The distal end 2230 may include a bevel 2236 and a fluid exit for the needle 2203 at the bevel 2236. Near the distal end 2230 is a set of ultrasound sensors 2234(1), 2234(2), 2234(3), 2234(4), and 2234(5), collectively ultrasound sensors 2234. The ultrasound sensors 2234 may be aligned in a row along an axial length 2239 of the needle 2203. In some embodiments, the ultrasound sensors 2234 may be aligned with equidistant spacing in a row along the axial length 2239 of the needle 2203.

[0169] FIG. 17D depicts a needle 2204 with a distal end 2240 and a proximal end 2242 opposite the distal end 2240. The distal end 2240 may include a bevel 2246 and a fluid exit for the needle 2204 at the bevel 2246. Near the distal end 2240 is a set of ultrasound sensors 2244(1), 2244(2), 2244(3), 2244(4), and 2244(5), collectively ultrasound sensors 2244. The needle 2204 may include a recess 2243 with the ultrasound sensors 2244 located in the recess 2243. The ultrasound sensors 2244 may be aligned in the recess 2243 in a row along an axial length 2249 of the needle 2204.

[0170] Referring to FIG. 17A, FIG. 17B, FIG. 17C, and / or FIG. 17D, the needle 2201, 2202, 2203, 2204 may have a plurality of ultrasound sensors 2214, 2224, 2234, 2244 located along an axial length 2219, 2229, 2239, 2249 of the needle 2201, 2202, 2203, 2204 near the distal end 2210, 2220, 2230, 2240. The needle 2201, 2202 may have a plurality of ultrasound sensors 2214, 2224 located circumferentially around the needle 2201, 2202 near the distal end 2210, 2220. The ultrasound sensors 2244 may be located in a recess 2243 of the needle 2204 near the distal end 2240 of the needle 2204. The needle 2201, 2202, 2203, and 2204 may comprise a lumen having a single fluid exit at the distal end 2210, 2220, 2230, 2240 of the needle 2201, 2202, 2203, 2204, wherein the ultrasound sensors 2214, 2224, 2234, 2244 are located on the proximal side of the53MEI 48657880v. 1single fluid exit of the needle 2201, 2202, 2203, 2204. The needle 2202 may comprise a lumen having a plurality of fluid exits 2228 near the distal end 2220 of the needle 2202, wherein a portion of the fluid exits 2228 of the needle are located between the ultrasound sensors 2224 near the distal end 2220 of the needle 2202. The various features of the needles 2201, 2202, 2203, 2204 may be interchanged and / or used together in various combinations.

[0171] The needle 2201, 2202, 2203, 2204 may be integrated with and / or as part of a computer-based system, having a computer. The computer may receive acoustic impedance information from the ultrasound sensors 2214, 2224, 2234, 2244 (e.g., acoustic impedances measured by each of the ultrasound sensors 2214, 2224, 2234, 2244) of the needle 2201, 2202, 2203, 2204. The ultrasound sensors 2214, 2224, 2234, 2244, are not spun to obtain the acoustic impedance information. In some embodiments, the computer may receive a first acoustic impedance, which may correspond to, for example, normal tissue of the subject (e.g., normal lung tissue). When entering the location of the tumor in the subject, the acoustic impedance information may change. Using the acoustic impedances measured at the distal end 2210, 2220, 2230, 2240 of the needle 2201, 2202, 2203, 2204, the computer may provide a visualization to a user of the location of the needle, a visualization of the location of the needle with respect to the tumor, a visualization of the location of the needle when entering the tumor, and / or a visualization of the location of the needle within the tumor. When fluid (e.g., medicant or drug) flows from the needle into the tumor, the acoustic impedance changes. At this point, the computer may provide a visualization of the locations of the needle, the tumor, and the fluid, and this visualization may be used by a user to verify that the fluid is flowing into the tumor.

[0172] FIGS. 18A-18D depict an example extended working channel with an example needle injecting a fluid in a subject according to one or more embodiments described herein.54MEI 48657880v. 1

[0173] FIG. 18A illustrates a side view 2300A(l) of an extended working channel 2300 with an example needle 2301 extended therefrom and a forward view 2300A(2) from the extended working channel 2300. In FIG. 18 A, the side view 2300A(l) illustrates the extended working channel 2300 having the needle 2301 with ultrasound sensors 2314 extended from the extended working channel 2300 and situated in a tumor 2320 of a subject. From this position, the needle 2301 may inject fluid into the tumor 2350 of the subject. In the example of FIG. 18 A, an extended working channel 2300 may include a distal end 2303, a channel 2307, and an end face 2304. At least one first ultrasound sensor 2302 may be deployed on the end face 2304. The needle 2301 may extend from and retract into the channel 2307. The needle 2301 may include features from one or more of needles 2101, 2201, 2202, 2203, 2204. In the example of FIG.18A, the needle 2301 includes six second ultrasound sensors 2314(1), 2314(2), 2314(3), 2314(4), 2314(5), and 2314(6), collectively ultrasound sensors 2314. The ultrasound sensors 2314 may be arranged as an array with equidistant spacing in a row along an axial length 2319 of the needle 2301. The needle 2301 may have a fluid exit at the bezel 2316 of the needle 2301. The needle 2301 may be inserted into the tumor 2320 and be readied to dispense a fluid. As the fluid flows from the needle 2301 out of the fluid exit at the bezel 2316 of the needle 2301, the fluid may spread within the tumor 2320. Zone 2360 may be a fluid full volume limit zone, which may represent a desired dose of the fluid injected into the tumor 2320. A visualization of the desired dose of the fluid as zone 2360 may be provided as an overlay on a visualization of the acoustic impedance measured by the first ultrasound sensors 2302 and / or by the second ultrasound sensors 2314. Forward view 2300A(2) illustrates a visualization of the acoustic impedance captured by the first ultrasound sensors 2302 and depicts the tumor 2320 and an overlay of the55MEI 48657880v. 1zone 2360. Side view 2300A(l) illustrates a visualization of the acoustic impedance captured by the second ultrasound sensors 2314 and depicts the tumor 2320 and an overlay of the zone 2360.

[0174] FIG. 18B illustrates a side view 2300B(l) of the extended working channel 2300 with the example needle 2301 extended therefrom and a forward view 2300B(2) from the extended working channel 2300, where the needle 2301 has injected a fluid 2370 (e.g., medicant or drug). FIG. 18B further illustrates the extended working channel 2300 at a second time after a first time depicted in FIG. 18B. In FIG. 18B, the fluid 2370 has been injected from the needle 2301, and the location of the fluid 2370 at the second time is depicted in FIG. 18B. As the fluid 2370 is injected from the bezel 2316 of the needle 2301 into the tumor 2320 of the subject, the fluid 2370 may disperse in a location 2356 in the tumor 2320 and flow back in a location 2357 along the axial length 2319 of the needle 2301 in a direction 2366. As the fluid 2370 flows from the needle out of the fluid exit at the bezel 2316 of the needle 2301, the fluid 2370 may spread within the tumor 2320. In some embodiments, the flow of fluid 2370 in direction 2366 to location 2357 may be due to the fluid 2370 following the path of least resistance, such as the entry path of the needle 2301. In some embodiments, the needle 2301 may have fluid exits, such as fluid exits 2228 as shown in FIG. 17B, and in such embodiments, the fluid 2370 may be further dispersed in the location 2357 along the axial length 2319 of the needle 2301 in the direction 2366.

[0175] FIG. 18C illustrates a side view 2300C(l) of the extended working channel 2300 with the example needle 2301 extended therefrom and a forward view 2300C(2) from the extended working channel 2300, where the needle 2301 has injected a fluid 2370. FIG. 18C further illustrates the extended working channel 2300 at a third time after the second time depicted in FIG. 18B. As FIG. 18C illustrates, as the fluid 2370 is further injected from the bezel 2316 of56MEI 48657880v. 1the needle 2301, the fluid 2370 may disperse in a location 2358. The dispersion pattern of fluid 2370 may vary due to tumor heterogeneity, such as variations in tumor density, composition, necrotic zones, adjacency to vasculature, and the like. Accordingly, an approximation of a spherical or ellipsoid dispersion pattern of fluid 2370 may not be accurate. By coupling the side view 2300C(l), as detected by ultrasound sensors 2314, with the forward view 2300C(2), as detected by ultrasound sensors 2302, the whole volume dispersion pattern of fluid 2370 may be visualized and monitored against the desired zone 2360. As depicted in side view 2300C(l), the fluid 2370 has reached the left side of the zone 2360, which may trigger an alert by the computer.

[0176] FIG. 18D illustrates a side view 2300D(l) of the extended working channel 2300 with the example needle 2301 extended therefrom and a forward view 2300D(2) from the extended working channel 2300, where the needle 2301 has injected a fluid 2370. FIG. 18D further illustrates the extended working channel 2300 at a fourth time after the third time depicted in FIG. 18D. In FIG. 18D, the fluid 2370 has ruptured from the location 2358 into a leak location 2359. As the fluid 2370 is further injected from the bezel 2316 of the needle 2301, the fluid 2370 may disperse in the leak location 2359 outside the location 2358 and further leak outside the zone 2360. Fluid in the leak location 2359 may flow outside the zone 2360, which may indicate a desired dose of the fluid 2370, and may disperse into a portion of the tumor 2320 or the subject where the fluid 2370 is unwanted or should be avoided. Upon detecting such a leak location 2359, the computer may generate an alert may to user, so that the user may stop fluid injection and / or relocate the needle insertion position. In some embodiments, upon detection of a leak location 2359, the computer may, in addition to or instead of the alert, slow, stop, or reverse fluid injection from the needle 2301. In some embodiments, a leak may be detected by the computer analyzing the acoustic information and / or the associated visualizations from the57MEI 48657880v. 1first ultrasound sensors 2302 and / or the second ultrasound sensors 2314. As an example, the leak location 2359 may be detected to be outside the zone 2360 in the forward view 2300D(2) but not in the side view 2300D(l).

[0177] In some embodiments, the second ultrasound sensors 2314 may measure a first acoustic impedance 2350 of tissue outside the tumor 2320, a second acoustic impedance 2352 of the tumor 2320, and a third acoustic impedance 2354 of the fluid 2370 flowing in the direction 2366. Side views 2300 A(l), 2300B(l), 2300C(l), and 2300D(l) illustrate visualizations of the acoustic impedances (e.g., the first acoustic impedance 2350, the second acoustic impedance 2352, and the third acoustic impedance 2354) captured by the second ultrasound sensors 2314 and depict the tumor 2320, the locations 2356 and 2357 of the fluid 2370, and an overlay of the zone 2360 for the desired dose of the fluid 2370. The visualizations may be provided on a display for viewing by a user (e.g., a physician or a physician’s assistant).

[0178] In some embodiments, the first ultrasound sensors 2302 may measure a first acoustic impedance 2350 of tissue outside the tumor 2320, a second acoustic impedance 2352 of the tumor 2320, and a third acoustic impedance 2354 of the fluid 2370 flowing in the direction 2366. Forward views 2300A(2), 2300B(2), 2300C(2), and 2300D(2) illustrate visualizations of the acoustic impedances (e.g., the first acoustic impedance 2350, the second acoustic impedance 2352, and the third acoustic impedance 2354) captured by the first ultrasound sensors 2302 and depict the tumor 2320, the locations 2356 and 2357 of the fluid 2370, and an overlay of the zone 2360 for the desired dose of the fluid 2370. The visualizations may be provided on a display for viewing by a user (e.g., a physician or a physician’s assistant).

[0179] With a computer (such as computer apparatus 2600), the locations of the needle 2301, the tumor 2320, and the fluid 2370 may be visualized. The first ultrasound sensors 2302 may58MEI 48657880v. 1measure multiple acoustic impedances 2350, 2352, 2354. The second ultrasound sensors 2314 may measure multiple acoustic impedances 2350, 2352, 2354. In some embodiments, the second ultrasound sensors 2314 are not spun to obtain the acoustic impedance information. The computer may be connected to the first ultrasound sensors 2302 and may provide real-time visualizations of the acoustic impedances provided by the first ultrasound sensors 2302. The computer may be connected to the needle 2301 and may provide real-time visualizations of the acoustic impedances provided by the second ultrasound sensors 2314. The computer may receive acoustic impedance information from the first ultrasound sensors 2302 and the second ultrasound sensors 2314. The acoustic impedance information received by the computer may comprise acoustic impedances measured by each of the first ultrasound sensors 2302 and each of the second ultrasound sensors 2314(1), 2314(2), 2314(3), 2314(4), 2314(5), and 2314(6). The acoustic impedances measured by each of the first ultrasound sensors 2302 and the second ultrasound sensors 2314 may change over time as the needle 2301 interacts with different portions of the subject and injects the fluid 2370 into the subject. Based on the needle 2301 interacting with different portions of the subject and the spread of the fluid 2370, different acoustic impedances (e.g., the first acoustic impedance 2350, the second acoustic impedance 2352, and / or the third acoustic impedance 2354) may be measured by one or more of the first ultrasound sensors 2302 and one or more of the second ultrasound sensors 2314

[0180] In some embodiments, a width of the tumor 2320 may be calculated by the computer, from a direction perpendicular to the end face 2304 of the extended working channel 2300, based on the acoustic impedance information from the at least one first ultrasound sensor 2302. In some embodiments, a depth of the tumor 2320 may be calculated by the computer, from a direction perpendicular to the end face 2304 of the extended working channel 2300, based on the59MEI 48657880v. 1acoustic impedance information from the at least one second ultrasound sensor 2314. The computer may then use the calculated width and the calculated depth of the tumor 2320 to calculate a volume of the tumor 2320. This calculation may occur in real time as the needle 2301 is being inserted into the tumor 2320. The calculated volume of the tumor 2320 may be displayed for the user.

[0181] In some embodiments, a width of the fluid 2370 injected into the subject may be calculated by the computer, from a direction perpendicular to the end face 2304 of the extended working channel 2300, based on the acoustic impedance information from the at least one first ultrasound sensor 2302. In some embodiments, a depth of the fluid 2370 injected into the subject may be calculated by the computer, from a direction perpendicular to the end face 2304 of the extended working channel 2300, based on the acoustic impedance information from the at least one second ultrasound sensor 2314. The computer may then use the calculated width and the calculated depth of the fluid 2370 injected into the subject to calculate a volume of the fluid 2370 injected into the subject. This calculation may occur in real time as the fluid 2370 is being injected into the subject. The calculated volume of the fluid 2370 injected into the subject may be displayed for the user.

[0182] In some embodiments, with the acoustic impedance information received by the computer, the acoustic impedances and their associated visualization may be used to view in real time positions of the needle 2301, the tumor 2320, and / or the fluid 2370, and / or with respect to each other. In some embodiments, the acoustic impedances and their associated visualization may be used to view in real time a position of the needle 2301 with respect to the tumor 2320 and the surrounding tissue of the subject. In some embodiments, the acoustic impedances and their associated visualization may be used to view in real time the needle 2301 being inserted60MEI 48657880v. 1into the tumor 2320, the fluid being injected in the tumor 2320, and / or the needle 2301 being withdrawn from the tumor 2320. In some embodiments, the acoustic impedances and their associated visualization may be used to view in real time the flow of the fluid 2370 into the tumor 2320 and / or along the length of the needle 2301 form the distal end to the proximal end of the needle 2301.

[0183] The changes in acoustic impedance detected by the first ultrasound sensors 2302 and the second ultrasound sensors 2314 may correspond to changes in the visualization of the acoustic impedance, which may be viewed by a user and / or analyzed by the computer to: determine when the needle 2301 has entered the tumor; determine the dispersion, the flow, and / or the flow direction of the fluid; and / or determine when the needle 2301 has exited the tumor. In some embodiments, based on the visualization of the acoustic impedance, the computer may provide one or more recommendations to a user for controlling a flow of the fluid to the tumor 2320 and / or the computer may control the flow of the fluid to the tumor 2320. As an example, the flow of the fluid to the tumor 2320 may be controlled by starting, stopping, increasing, and / or decreasing the flow of the fluid to the tumor 2320. As an example, the flow of the fluid to the tumor 2320 may be controlled by adjusting a fluid flow and / or an injection rate of the fluid to the tumor 2320.

[0184] In some embodiments, the visualization of the acoustic impedance may include a forward view (e.g., forward view 2300A(2), 2300B(2), 2300C(2), and 2300D(2)) of the tumor 2320 in the subject based on the acoustic impedance information from at least one first ultrasound sensor 2302, where the forward view of the tumor 2320 in the subject is from a perspective of a plane parallel to the end face 2304 at the distal end 2303 of the extended working channel 2300. In some embodiments, the visualization of the acoustic impedance may61MEI 48657880v. 1include a side view (e.g., side view 2300A(l), 2300B(l), 2300C(l), and 2300D(l)) of the tumor 2320 in the subject based on the acoustic impedance information from at least one second ultrasound sensor 2314, where the side view of the tumor in the subject is from a perspective of a plane perpendicular to the end face 2304 at the distal end 2303 of the extended working channel 2300. In some embodiments, the visualization of the acoustic impedance may include a three- dimensional visualization based on a combination of the acoustic impedance information from at least one first ultrasound sensor 2302 and the acoustic impedance information from at least one second ultrasound sensor 2304.

[0185] In some embodiments, the acoustic impedances from the first ultrasound sensors 2302 and the second ultrasound sensors 2314 and their associated visualizations may be used to view in real time the needle 2301 being inserted into the tumor 2320. Before the needle 2301 enters the tumor 2320, the first ultrasound sensors 2302 and the second ultrasound sensors 2314 (e.g., second ultrasound sensors 2314(1) to 2314(6)) may measure the first acoustic impedance 2350 of the tissue outside the tumor 2320. As the second ultrasound sensors 2314 approach and enter the tumor 2320, the measured acoustic impedance may change from the first acoustic impedance 2350 to the second acoustic impedance 2352. As an example, before the needle 2301 is inserted in the tumor 2320, the second ultrasound sensor 2314(1) is outside the tumor (not shown) and may measure the first acoustic impedance 2350. As the needle moves 2301 moves into the tumor 2320, the acoustic impedance measured by the second ultrasound sensor 2314(1) changes from the first acoustic impedance 2350 to the second acoustic impedance 2352. Once the bezel 2316 of the needle 2301 is situated in the tumor 2320, the acoustic impedance measured by the second ultrasound sensor 2314(1) may be the second acoustic impedance 2352. For this62MEI 48657880v. 1example, the second ultrasound sensor 2314(6) is outside the tumor 2320 the entire time and may measure the first acoustic impedance 2350.

[0186] As the user confirms that the needle 2301 is in the tumor 2320, the computer may record an image of the visualization of the acoustic impedance information. In some embodiments, the confirmation from the user that the distal end of the needle 2301 is inserted into the tumor 2320 may be further based on at least one of: a computer tomography (CT) image of the subject, a cone beam CT (CBCT) image of the subject, an x-ray image of the subject, or a fluoroscopy image of the subject.

[0187] In some embodiments, the acoustic impedances from the first ultrasound sensors 2302 and the second ultrasound sensors 2314 and their associated visualizations may be used to view in real time the flow of the fluid 2370 from the needle 2301. The first ultrasound sensors 2302 and the second ultrasound sensors 2314 may provide associated acoustic impedances, which may be used to view and measure the dispersion, the flow, and / or the direction of the flow of the fluid within the tumor. The dispersion, the flow, and / or the direction of the flow of the fluid within the tumor may be detected by the change of the acoustic impedances from first ultrasound sensors 2302 and / or the second ultrasound sensors 2314.

[0188] As an example, the fluid 2370 may be dispersed in the location 2356. When the fluid is in location 2356, the fluid is partly touching the second ultrasound sensor 2314(1), and as such, the second ultrasound sensor 2314(1) may measure an acoustic impedance somewhere between the second acoustic impedance 2352 and the third acoustic impedance 2354. The fluid 2370 is not touching the second ultrasound sensors 2314(2) and 2314(3), which are in the tumor 2320, and as such, the second ultrasound sensors 2314(2) and 2314(3) may measure the second acoustic impedance 2352. The second ultrasound sensor 2314(5) is partly in and partly out of63MEI 48657880v. 1the tumor 2320 and as such, the second ultrasound sensor 2314(5) may measure an acoustic impedance somewhere between the first acoustic impedance 2350 and the second acoustic impedance 2352. The second ultrasound sensor 2314(6) is outside the tumor 2320, and as such, the second ultrasound sensor 2314(6) may measure the first acoustic impedance 2350.

[0189] As an example, the fluid 2370 may be dispersed in the location 2357, as well as the location 2356. The location 2356 of the fluid 2370 may be smaller than the location 2357 of the fluid 2370, and the location 2357 of the fluid may be larger than the location 2356 of the fluid. When the fluid is in location 2357, the fluid 2370 is touching the second ultrasound sensors 2314(1), 2314(2), and 2314 (3), and as such, the second ultrasound sensors 2314(1), 2314(2), and 2314 (3) may measure the third acoustic impedance 2354. The fluid 2370 may be very close to the second ultrasound sensor 2314(4), and as such, the second ultrasound sensor 2314(4) may measure an acoustic impedance somewhere between the second acoustic impedance 2352 and the third acoustic impedance 2354. As such, the acoustic impedance measured by the second ultrasound sensors 2314(1), 2314(2), 2314 (3), and 2314(4) may change from when the fluid 2370 is in location 2356 to when the fluid 2370 is in location 2357. Due to this change in acoustic impedance, a difference in the dispersion of the fluid from location 2356 to location 2357 along the axial length 2319 of the needle 2301 may be seen in the visualization of the acoustic impedance. Further, the difference may be determined by the computer, and a value for the distance may be calculated by the computer and provided on a display to the user. The second ultrasound sensor 2314(6) may continue to measure the same acoustic impedance as when the fluid is in location 2356.

[0190] In some embodiments, the acoustic impedances from the first ultrasound sensors 2302 and the second ultrasound sensors 2314 and their associated visualizations may be used to view64MEI 48657880v. 1in real time the needle 2301 being retracted or withdrawn from the tumor 2320. As the needle 2301 is retracted from the tumor, the acoustic impedances measured by the first ultrasound sensors 2302 and the second ultrasound sensors 2314 change. As an example, as the second ultrasound sensor 2314(1) is retracted from the tumor 2320, the measured acoustic impedance changes from the third acoustic impedance 2354 to the second the acoustic impedance 2352 when the second ultrasound sensor 2314(1) is withdrawn from location 2356 and location 2357, and finally from the second the acoustic impedance 2352 to the first the acoustic impedance 2350 when the second ultrasound sensor 2314(1) is fully retracted from the tumor 2320.

[0191] In some embodiments, the first ultrasound sensors 2302 and the second ultrasound sensors 2314 may be used to determine directional dispersion information regarding the fluid flow of the fluid. The directional dispersion information may be determined by, for example: obtaining first acoustic impedance information (e.g., acoustic impedance information when the fluid 2370 is in location 2356); obtaining second acoustic impedance information (e.g., acoustic impedance information when the fluid 2370 is in location 2357); comparing the second acoustic impedance information to the first impedance acoustic information to obtain a comparison result; and comparing the comparison result to a dispersion threshold. When the comparison result satisfies the dispersion threshold, the injection rate of the fluid may be adjusted (e.g., a fluid flow of the fluid 2370 injected into the subject may be decreased). When the comparison result does not satisfy the dispersion threshold, the injection rate may be maintained. The directional dispersion rate may be determined by calculating by the computer a change or a rate of change of the fluid 2370 along the needle 2301 over a time period as determined using the second acoustic impedance information. The directional dispersion information may correspond to a change or a rate of change in distance, area, or shape of the fluid over time from the first acoustic impedance65MEI 48657880v. 1information to the second acoustic impedance information. The dispersion threshold may be determined by the characteristics of the tumor 2320 of the subject. Based on the dispersion threshold, the flow of fluid 2370 may be maintained or may be reduced substantially to zero. The adjustment of the injection rate of the fluid 2370 may be performed in order to maintain a substantially constant dispersion rate of the fluid 2370 being injected in the tumor of the subject. The adjustment of the injection rate to decrease the flow of fluid 2370 being injected into the subject may be based on user input.

[0192] FIGS. 19A-19E depict example visualizations based on acoustic impedance produced by ultrasound transducers of an example extended working channel according to one or more embodiments described herein. In some embodiments, the acoustic impedance information may from the at least one first ultrasound sensors 2302 and / or at least one second ultrasound sensors 2314 from FIGS. 18A-18D. The example visualization in FIGS. 19A-19E are based on a forward view obtained from the first ultrasound sensors 2302 on the end face 2304 at the distal end 2303 of the working channel 2300.

[0193] FIG. 19A illustrates a user interface having a field of view portion 2401 providing a pre-operation image 2401 of a target tumor injection site and an information portion 2402. The field of view portion 2401 may include a tumor (e.g., tumor 2302) outlining the outer boundaries of tumor or the outer boundaries of a target injection site. The information portion 2402 may include a calculated volume of the tumor (e.g., “total volume”).

[0194] FIG. 19B illustrates the user interface of FIG. 19A combining a real time visualization 2412 of acoustic impedance information of the tumor as captured by the first ultrasound sensors 2302 with the pre-operation image 2410 of the target tumor injection site. Registration is performed by aligning the real time visualization 2412 with the pre-operation66MEI 48657880v. 1image 2410 such that the boundaries of the tumor or the boundaries of the target injection site of the real time visualization 2412 and the pre-operation image 2410 are overlaid. The motion of alignment is depicted by the arrow 2414. Accurate alignment places the needle 2301 in a desired position for injection. In the information portion 2402, feedback (e.g., a checkmark) may be provided to the user to indicate alignment is obtained, and registration is successful.

[0195] FIG. 19C illustrates the user interface of FIG. 19B after real time visualization 2412 and pre-operation image 2410 registration is successful and the system is ready for injection. In FIG. 19C, an overlay 2420 of a desired dose of a fluid to be injected in the tumor (e.g. zone 2370) is provided in the field of view portion 2401.

[0196] FIG. 19D illustrates the user interface of FIG. 19B after injection of the fluid has begun. In the field of view portion 2401, the fluid 2424 can be seen in real time being injected into the tumor of the subject. The four arrows 2426 indicate direction of the fluid being injected in the tumor. In the information portion 2402, a calculation of the fluid injected into the tumor (e.g., “total fill volume”) may be provided.

[0197] FIG. 19E illustrates the user interface of FIG. 19B after injection of the fluid has reached the desired dose. In the field of view portion 2401, the fluid 2424 can be seen in real time reaching the boundary of the overlay 2420 of the desired dose. In the information portion 2402, feedback (e.g., a checkmark) may be provided to the user that the desired dose is achieved.

[0198] FIGS. 20A-20C depict an example flowchart for a method of using an example extended working channel according to one or more embodiments described herein. Certain steps of the method 2500 are described as computer-implemented steps. The computer may be, for example, any device comprising one or more processors and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more67MEI 48657880v. 1processors cause the computer to perform the relevant steps of the method 2500. The method 2500 can be implemented by any suitable device or apparatus, such as the computing apparatus 2800 of FIG. 21 and / or the like including combination and / or multiples thereof. While an order of operations is indicated in FIG. 20 for illustrative purposes, the timing and ordering of such operations may vary where appropriate without negating the purpose and advantages of the examples set forth in detail herein.

[0199] At step 2502, the method 2500 may include inserting an extended working channel into a subject having a tumor.

[0200] At step 2504, the method 2500 may include extending a needle from the extended working channel into the subject. In particular, the needle of method 2500 may include features from one or more of needles 2101, 2201, 2202, 2203, and 2204. For example, FIG. 18A and the accompanying description may illustrate the operation executed at step 2504, where the needle2301 extends from the extended working channel 2300 into the subject.

[0201] At step 2506, the method 2500 may include receiving, by a computer, acoustic impedance information from first ultrasound sensors located on an end face at a distal end of an extended working channel inserted into a subject. In some embodiments, the acoustic impedance information from the first ultrasound sensors may be measured by the first ultrasound sensors2302 in FIG. 18B.

[0202] At step 2508, the method 2500 may include receiving, by the computer, acoustic impedance information from second ultrasound sensors located at a distal end of a needle extend from the extended working channel into the subject. In some embodiments, the acoustic impedance information from the second ultrasound sensors may be measured by the second ultrasound sensors 2314 in FIG. 18B.68MEI 48657880v. 1

[0203] At step 2510, the method 2500 may include providing, on a display, visualization of at least one of the acoustic impedance information from the first ultrasound sensors or the acoustic impedance information from the second ultrasound sensors. In some embodiments, the visualization may be provided as real time image or video on the display. For example, the visualization provided on the display may be illustrated as in FIG. 19A. Step 2510 may be performed using the computer.

[0204] The method 2500 may include receiving a confirmation, by the computer, from a user based on the visualization that a distal end of the needle is inserted in a tumor of the subject. If the needle is not in position, step 2512 may be performed.

[0205] At step 2512, the method 2500 may optionally include repositioning, as needed, the needle with respect to the tumor based on the visualization. For example, the procedure at step 2512 may be executed under assistance of the registration illustrated in FIG. 19B. Upon showing an unregistered or unaligned image in the field of view, the needled may be repositioned in order to successfully register the tumor outline with the field of view in FIG. 19B. Step 2512 may be performed using the computer.

[0206] At step 2514, the method 2500 may include providing, on the display, an indication of the needle being in a desired position. For example, as illustrated in FIG. 19B, a checkmark is shown in the information portion 2402 of the user interface upon successful registration. Step 2514 may be performed using the computer.

[0207] At step 2516, the method 2500 may include calculating, by the computer, a volume of a tumor in the subject based on the acoustic impedance information from the first ultrasound sensors and the acoustic impedance information from the second ultrasound sensors.69MEI 48657880v. 1

[0208] At step 2518, the method 2500 may include providing, on the display, an indication of calculated volume of the tumor in the subject. For example, in FIG. 19 A, the information portion 2402 provides the calculated volume of the tumor in the subject. In some embodiments, the calculated volume of the tumor may be based on a calculated width of the tumor and a calculated depth of the tumor. In some embodiments, an indication of the calculated width of the tumor and an indication of the calculated depth of the tumor may be provided on the display. Step 2518 may be performed using the computer.

[0209] At step 2520, the method 2500 may include providing, on the visualization on the display, an overlay of a desired dose of a fluid to be injected into the subject. In particular, the overlay may be repositioned after the needle is situated intratumorally in the subject. In some embodiments, the needle may be determined to be situated intratumorally in the subject based on at least one of a computed tomography (CT) image of the subject, a cone-beam CT (CBCT) image of the subject, an x-ray image of the subject, or a fluoroscopy image of the subject. For example, FIGS. 18 A and 19C illustrate the overlay 2420 of the desired dose of a fluid to be injected in the zone 2360. Step 2520 may be performed using the computer.

[0210] At step 2522, the method 2500 may include injecting the fluid into the subject, wherein the visualization on the display depicts, in real time, the fluid being injected into the subject. In some embodiments, the visualization may depict, in real time, the fluid being injected or administered to the subject from the needle. For example, FIG. 18B may illustrate injecting the fluid 2370 into the subject. FIG. 19D may illustrate the visualization on the display, which depicts the fluid being injected into the subject in real time. Step 2522 may be performed using the computer.70MEI 48657880v. 1

[0211] At step 2524, the method 2500 may include calculating, by the computer, a volume of the fluid injected into the subject based on the acoustic impedance information from the plurality of first ultrasound sensors and the acoustic impedance information from the plurality of second ultrasound sensors.

[0212] At step 2526, the method 2500 may include providing, on the display, an indication of the calculated volume of the fluid injected into the subject. In some embodiments, the indication may be provided in real time on the display. For example, in FIG. 19D, the information portion 2402 illustrates providing an indication of the calculated volume of the fluid injected into the subject. Step 2526 may be performed using the computer.

[0213] At step 2528, the method 2500 may include calculating, by the computer, a boundary of the fluid injected into the subject from the needle based on the acoustic impedance information from the first ultrasound sensors and the acoustic impedance information from the second ultrasound sensors.

[0214] At step 2530, the method 2500 may include providing, on the visualization on the display, an indication of the calculated boundary of the fluid injected into the subject. For example, FIGS. 18B, 18C. 19D, and 19E may illustrate a boundary of the fluid injected into the subject. In FIG. 19D, the information portion 2402 may provide the calculated boundary of the fluid injected into the subject (e.g., a volume of the injected fluid). Step 2530 may be performed using the computer.

[0215] At step 2532, the method 2500 may include comparing, by the computer, the calculated boundary of the fluid to a boundary of the desired dose of the fluid. As an example, the boundary of the overlay 2420 may be compared to the boundary of the fluid 2424.71MEI 48657880v. 1

[0216] At step 2534, the method 2500 may include providing, by the computer and the comparison from step 2532, an alert if the calculated boundary of the fluid leaks outside the boundary of the desired dose of the fluid. For example, as illustrated in FIG. 18D, an alert may be provided since the calculated boundary of the fluid 2370 leaked outside the boundary of the desired dose of the fluid 2370 at leak location 2359.

[0217] At step 2536, the method 2500 may include providing, by the computer, an alert when the desired dose of the fluid injected into the subject is obtained based on the boundary of the fluid and the boundary of the desired dose of the fluid. The boundary for the desired dose of the fluid may be based on a desired volume of the fluid to be injected into the subject. For example, in FIG. 19E, the information portion 2402 may provide feedback (e.g., a checkmark) when the boundary of the injected fluid sufficiently meets the boundary of the desired dose of the fluid, indicating that the desired dose of the fluid injected into the subject is obtained.

[0218] At step 2538, the method 2500 may include retracting the extended working channel from the subject, or moving the extended working channel to a next location for a next injection of the fluid.

[0219] FIG. 21 depicts an example computer apparatus for use with one or more embodiments described herein. As an example, the apparatus 800 may be a computer to implement certain inventive techniques disclosed herein, such as a first computing device to implement receiving acoustic impedance information from the ultrasound sensors and a second computing device to implement providing visualization of the acoustic impedance information. As an example, a computing device for receiving acoustic impedance information from the ultrasound sensors may be implemented by a first apparatus 800, and a display device for providing visualization of the acoustic impedance information may be implemented by a second72MEI 48657880v. 1apparatus 800. As an example, certain steps of the methods of FIGS. 5, 6, 7, 14A, 14B, 15, and 20 may be performed using or with the assistance of a single apparatus 800. As an example, the apparatus 800 of the user may be a portable computer device (e.g., a tablet or a laptop), a desktop computer, and the like.

[0220] The apparatus 800 may include one or more processors 802, memory 803, one or more input devices 805, and one or more output devices 806.

[0221] Input to the apparatus 800 may be provided by one or more input devices 805, provided from one or more input devices in communication with the apparatus 800 via link 801 (e.g., a wired link or a wireless link; e.g., with a direct connection or over a network), and / or provided from another computer(s) in communication with the apparatus 800 via link 801.

[0222] Output for the apparatus 800 may be provided by one or more output devices 806, provided to one or more output devices in communication with the apparatus 800 via link 801, and / or provided from another computer(s) in communication with the apparatus 800 via link 801. The one or more output devices 806 may include one more displays and one or more speakers. The output device(s) 806 may provide visualization of the acoustic impedance information according to one or more embodiments described herein.

[0223] In some embodiments, one or more input devices 805 and one or more output devices 806 may be combined into one or more unitary input / output devices (e.g., a touch screen on computing device).

[0224] In some embodiments, based on input from one or more input devices 805 or input from outside the apparatus 800 via the link 801, the one or more processors 802 may perform operations as described herein. As an example, user input may be received from the one or more input devices 805. As an example, input may be from another computer in communication with73MEI 48657880v. 1the apparatus 800 via link 801. As an example, input may be from one or more input devices in communication with the apparatus 800 via link 801.

[0225] In some embodiments, the one or more processors 802 may perform operations as described herein and provide results of the operations as output. As an example, output may be provided to the one or more output devices 806. As an example, output may be provided to another computer in communication with the apparatus 800 via link 801. As an example, output may be provided to one or more output devices in communication with the apparatus 800 via link 801.

[0226] The memory 803 may be accessible by the one or more processors 802 so that the one or more processors 802 may read information from and write information to the memory 803. The memory 803 may store instructions that, when executed by the one or more processors 802, implement one or more embodiments described herein. The memory 803 may be a non- transitory computer readable medium (or a non-transitory processor readable medium) containing a set of instructions thereon for controlling and / or monitoring fluid delivery (e.g., monitoring injection of a medicant in a subject), wherein when executed by a processor (such as one or more processors 802), the instructions cause the processor to perform one or more methods discussed herein. As an example, the apparatus 800 may be a computing device, and memory of the computing device may store a program to perform embodiments described herein.

[0227] The apparatus 800 may be an apparatus for monitoring fluid delivery (e.g., monitoring injection of a medicant in a subject), the apparatus including: one or more processors (such as one or more processors 802); and memory (such as memory 803) accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform one or more methods described herein.74MEI 48657880v. 1

[0228] The memory 803 may be a non-transitory processor readable medium containing a set of instructions thereon for controlling and / or monitoring fluid delivery (e.g., monitoring injection of a medicant in a subject), wherein when executed by one or more processors (such as one or more processors 802), the instructions cause the one or more processors to perform one or more methods described herein.

[0229] Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context. For example, and without limitation, embodiments described in dependent claim format for a given embodiment (e.g., the given embodiment described in independent claim format) may be combined with other embodiments (described in independent claim format or dependent claim format).

[0230] Numerous modifications, alterations, and changes to the described embodiments are possible without departing from the scope of the present invention defined in the claims. It is intended that the present invention need not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

[0231] In addition to the embodiments and disclosures provided above, which may be claimed individually, separately, in part or in combination, with features from the entire disclosure provided herein, the following numbered embodiments may be claimed individually, separately, in part or in combination, with features from the entire disclosure provided herein:1. An ultrasound sensing apparatus comprising:75MEI 48657880v. 1an extended working channel comprising a distal end, a proximal end, and a channel, the distal end adapted for insertion in a subject and opposite the proximal end, the channel extending from the distal end to the proximal end, the distal end comprising an end face; and at least one ultrasound sensor located on the end face of the distal end of the extended working channel and configured to measure acoustic impedance in the subject, wherein, when viewed in a direction perpendicular to the end face of the distal end, the at least one ultrasound sensor is forward facing.2. The ultrasound sensing apparatus of numbered embodiment 1, further comprising a needle having a distal end, wherein the at least one ultrasound sensor is configured to measure acoustic impedance of the distal end of the needle when the distal end of the needle is extended from the distal end of the extended working channel.3. The ultrasound sensing apparatus of numbered embodiment 2, wherein the needle comprises an etching detectable by the plurality of ultrasound sensors.4. The ultrasound sensing apparatus of numbered embodiment 1, further comprising: a distal inflatable member located at the distal end of the extended working channel, the distal inflatable member providing the end face of the distal end of the extended working channel, the at least one ultrasound sensor located on the distal inflatable member.76MEI 48657880v. 15. The ultrasound sensing apparatus of numbered embodiment 1, wherein the distal inflatable member is configured to provide a pliable surface for the at least one ultrasound sensor to touch a tissue wall of the subject when the extended working channel is inserted in the subject6. The ultrasound sensing apparatus of numbered embodiment 1, further comprising: a plurality of inflatable members located along an exterior of the extended working channel, the plurality of inflatable members configured to stabilize a position of the extended working channel when the extended working channel is inserted in the subject.7. The ultrasound sensing apparatus of numbered embodiment 6, wherein a distal inflatable member of the plurality of inflatable members is located at the distal end of the extended working channel, and a second inflatable member of the plurality of inflatable members is located between the distal inflatable member and the proximal end of the extended working channel.8. The ultrasound sensing apparatus of numbered embodiment 6, further comprising: a variable inflation source coupled to the plurality of inflatable members, wherein the variable inflation source is configured to individually inflate the plurality of inflatable members.9. The ultrasound sensing apparatus of numbered embodiment 1, further comprising: at least one second ultrasound sensor located on a member, the member having a distal end and a proximal end opposite the distal end, the at least one second ultrasound sensor located77MEI 48657880v. 1near the distal end of the member, the member configured to be extended and retracted from the channel at the distal end of the extended working channel.10. The ultrasound sensing apparatus of numbered embodiment 9, further comprising a working instrument having a distal end, wherein the at least one ultrasound sensor and the at least one second ultrasound sensor are configured to measure acoustic impedance of the distal end of the working instrument when the at least one second ultrasound sensor and the distal end of the working instrument are extended from the distal end of the extended working channel.11. The ultrasound sensing apparatus of numbered embodiment 1, further comprising: a plurality of light emitting diodes located on the end face of the distal end of the extended working channel and configured to emit visible light; and a visible light camera.12. The ultrasound sensing apparatus of numbered embodiment 11 , wherein the visible light camera is located on a distal end of a member, the member having a proximal end opposite the distal end, the member configured to be extended and retracted from the channel at the distal end of the extended working channel.13. The ultrasound sensing apparatus of numbered embodiment 11, further comprising: a distal inflatable member located at the distal end of the extended working channel, the distal inflatable member providing the end face of the distal end of the extended working78MEI 48657880v. 1channel, the at least one ultrasound sensor and the plurality of light emitting diodes located on the distal inflatable member.14. The ultrasound sensing apparatus of numbered embodiment 13, wherein the visible light camera is located on the distal inflatable member.15. A method of treating a subject, comprising: inserting the extended working channel of the ultrasound sensing apparatus of numbered embodiment 1 into a subject; extending a retractable needle from the extended working channel into the subject; and positioning the retractable needle based on visualization produced from acoustic impedance information from the at least one ultrasound sensor.16. The method of numbered embodiment 15, further comprising: injecting a fluid into the subject from the positioned retractable needle; and retracting the retractable needle into the extended working channel.17. The method of numbered embodiment 15, further comprising: inflating a distal inflatable member located at the distal end of the extended working channel, the distal inflatable member providing the end face of the distal end of the extended working channel, the at least one ultrasound sensor located on the distal inflatable member.18. The method of numbered embodiment 15, further comprising:79MEI 48657880v. 1inflating a plurality of inflatable members located along an exterior of the extended working channel, the plurality of inflatable members configured to stabilize a position of the extended working channel when the extended working channel is inserted in the subject.19. The method of numbered embodiment 15, further comprising: extending a member from the distal end of the extended working channel, the member having a distal end and a proximal end opposite the distal end, the member having at least one second ultrasound sensor located near the distal end of the member, the member configured to be extended and retracted from the channel at the distal end of the extended working channel.20. An ultrasound sensing system comprising: the ultrasound sensing apparatus of numbered embodiment 1 ; and a computer coupled to the at least one ultrasound sensor, the computer comprising one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the computer to perform a method comprising: receiving acoustic impedance information from the at least one ultrasound sensor; and providing visualization of the acoustic impedance information.21. A computer-implemented method comprising: receiving acoustic impedance information from at least one ultrasound sensor located on an end face at a distal end of an extended working channel inserted in a subject; and providing visualization of the acoustic impedance information.80MEI 48657880v. 122. The computer-implemented method of numbered embodiment 21, wherein the visualization comprises an overlay target of a desired position of a needle.23. The computer-implemented method of numbered embodiment 22, wherein the overlay target has a first appearance if the needle is not in the desired position and has a second appearance if the needle is in the desired position.24. The computer-implemented method of numbered embodiment 21, wherein the visualization comprises visualization of tumor tissue and non-tumor tissue.25. The computer-implemented method of numbered embodiment 24, wherein the visualization further comprises an overlay target for a desired needle location of a needle in relation to the tumor tissue and the non-tumor tissue.26. The computer-implemented method of numbered embodiment 21, further comprising detecting when a needle extended from the distal end of the extended working channel is at a desired needle location in relation to tumor tissue of the subject.27. The computer-implemented method of numbered embodiment 21, further comprising: determining, from the acoustic impedance information, a location of tumor tissue in the subject;81MEI 48657880v. 1determining, from the determined location of the tumor tissue, a desired needle location; determining, from the acoustic impedance information, a location of a needle in the subject; determining whether the determined location of the needle is at the desired needle location; and providing a first indication when the needle is at the desired needle location and a second indication when the needle is not at the desired needle location, wherein the first indication is different from the second indication.28. The computer-implemented method of numbered embodiment 27, wherein the first indication comprises an overlay target having a first appearance when the needle is at the desired needle location, wherein the second indication comprises the overlay having a second appearance when the needle is not at the desired needle location.29. The computer-implemented method of numbered embodiment 27, further comprising: permitting delivery of a fluid via the needle when the needle is at the desired needle location; and not permitting delivery of a fluid via the needle when the needle is not at the desired needle location.82MEI 48657880v. 130. The computer-implemented method of numbered embodiment 21, further comprising determining directional dispersion information of a fluid being injected into the subject based on the acoustic impedance information.31. The computer-implemented method of numbered embodiment 30, wherein the directional dispersion information of the fluid being injected into the subject indicates whether the fluid is flowing in a direction perpendicular to the end face of the distal end of the extended working channel.32. The computer-implemented method of numbered embodiment 21, further comprising upon receiving confirmation from a user, based on the visualization, that a distal end of a needle is inserted in a desired location of the subject, recording an image of the visualization.33. The computer- implemented method of numbered embodiment 21, wherein confirmation from the user that the distal end of the needle is inserted in the desired location of the subject is further based on at least one of a computed tomography (CT) image of the subject, a cone-beam CT (CBCT) image of the subject, an x-ray image of the subject, or a fluoroscopy image of the subject.34. The computer-implemented method of numbered embodiment 21, further comprising:83MEI 48657880v. 1receiving second acoustic impedance information from at least one second ultrasound sensor located on a member extended from the distal end of the extended working channel into the subject, the member having a distal end and a proximal end opposite the distal end, the at least one second ultrasound sensor located near the distal end of the member; and providing visualization of the second acoustic impedance information.35. The computer-implemented method of numbered embodiment 34, further comprising determining directional dispersion information of a fluid being injected into the subject based on the second acoustic impedance information.36. The computer-implemented method of numbered embodiment 35, wherein the directional dispersion information of the fluid being injected into the subject indicates whether the fluid is flowing from the distal end of the member to a proximal end of the member.37. The computer-implemented method of numbered embodiment 34, wherein the visualizations of the acoustic impedance information and the second acoustic impedance information are combined to provide a unified visualization.38. A non- transitory processor readable medium containing a set of instructions thereon, wherein when executed by a processor, the instructions cause the processor to perform a method comprising: receiving acoustic impedance information from at least one ultrasound sensor located on an end face at a distal end of an extended working channel inserted in a subject; and84MEI 48657880v. 1providing visualization of the acoustic impedance information.39. An apparatus comprising: one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform a method comprising: receiving acoustic impedance information from at least one ultrasound sensor located on an end face at a distal end of an extended working channel inserted in a subject; and providing visualization of the acoustic impedance information.40. A computer-implemented method comprising: receiving acoustic impedance information from at least one first ultrasound sensor located on an end face at a distal end of an extended working channel inserted into a subject; receiving acoustic impedance information from at least one second ultrasound sensor located near a distal end of a needle extend from the extended working channel into the subject; calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor; and providing, on a display, an indication of the calculated volume of the fluid injected into the subject.41. The computer-implemented method of numbered embodiment 40, further comprising:85MEI 48657880v. 1calculating, from a direction perpendicular to the end face of the extended working channel, a width of the fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor, wherein the calculated volume of the fluid injected into the subject is based on the calculated width of the fluid injected into the subject.42. The computer-implemented method of numbered embodiment 41, further comprising: providing, on the display, an indication of the calculated width of the fluid injected into the subject.43. The computer- implemented method of numbered embodiment 40, further comprising: calculating, from a direction perpendicular to the end face of the extended working channel, a depth of the fluid injected into the subject based on the acoustic impedance information from the at least one second ultrasound sensor, wherein a calculated volume of the fluid injected into the subject is based on the calculated depth of the fluid injected into the subject.44. The computer- implemented method of numbered embodiment 43, further comprising: providing, on the display, an indication of the calculated depth of the fluid injected into the subject.86MEI 48657880v. 145. The computer- implemented method of numbered embodiment 40, wherein the at least one first ultrasound sensor is located on a plane on the end face at the distal end of the extended working channel, wherein, when the at least one second ultrasound sensor is extended from the extended working channel into the subject, at least two of the second ultrasound sensors are located on a line approximately perpendicular to the plane on the end face at the distal end of the extended working channel.46. The computer-implemented method of numbered embodiment 40, further comprising: calculating a volume of a tumor in the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor; and providing, on the display, an indication of the calculated volume of the tumor in the subject.47. The computer-implemented method of numbered embodiment 40, further comprising: providing, on the display, visualization of at least one of: the acoustic impedance information from the at least one first ultrasound sensor, or the acoustic impedance information from the at least one second ultrasound sensor.87MEI 48657880v. 148. The computer-implemented method of numbered embodiment 47, wherein the visualization comprises a forward view of the tumor in the subject based on the acoustic impedance information from the at least one first ultrasound sensor.49. The computer-implemented method of numbered embodiment 47, wherein the visualization comprises a side view of the tumor in the subject based on the acoustic impedance information from the at least one second ultrasound sensor.50. The computer-implemented method of numbered embodiment 47, wherein the visualization comprises a three-dimensional visualization based on a combination of the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor.51. The computer- implemented method of numbered embodiment 47, further comprising: providing, on the display, an overlay of a desired dose of a fluid for the subject, wherein the overlay is provided on the visualization.52. The computer- implemented method of numbered embodiment 51 , wherein the overlay is repositioned after the needle is situated intratumorally in the subject.53. The computer- implemented method of numbered embodiment 47, further comprising:88MEI 48657880v. 1determining a boundary of a fluid injected into the subject from the needle, the boundary determined based on the at least one of the acoustic impedance information from the at least one first ultrasound sensor or the acoustic impedance information from the at least one second ultrasound sensor; and providing, on the display, an indication of the calculated boundary of the fluid injected into the subject.54. The computer- implemented method of numbered embodiment 53, further comprising: providing, on the display, an overlay of a desired dose of the fluid injected into the subject, wherein the overlay is provided on the visualization.55. The computer-implemented method of numbered embodiment 53, further comprising: comparing the boundary of the fluid to a boundary of a desired dose of the fluid; and providing, based on the comparing, an alert if the boundary of the fluid leaks outside the boundary of the desired dose of the fluid.56. The computer- implemented method of numbered embodiment 53, further comprising: comparing the boundary of the fluid to a boundary of a desired dose of the fluid; and providing, based on the comparing, an alert when the desired dose of the fluid injected into the subject is obtained.89MEI 48657880v. 157. The computer-implemented method of numbered embodiment 47, further comprising: receiving confirmation from a user based on the visualization that the distal end of the needle is inserted in a tumor of the subject; providing further visualization, after a fluid is injected from the needle into the tumor of the subject, of at least one of the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor.58. The computer-implemented method of numbered embodiment 47, wherein the visualization is provided as real time video on the display.59. A non-transitory processor readable medium containing a set of instructions thereon, wherein when executed by a processor, the instructions cause the processor to perform a method comprising: receiving acoustic impedance information from at least one first ultrasound sensor located on an end face at a distal end of an extended working channel inserted into a subject; receiving acoustic impedance information from at least one second ultrasound sensor located near a distal end of a needle extend from the extended working channel into the subject; calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor; and90MEI 48657880v. 1providing, on a display, an indication of the calculated volume of the fluid injected into the subject.80. An apparatus comprising: one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform a method comprising: receiving acoustic impedance information from at least one first ultrasound sensor located on an end face at a distal end of an extended working channel inserted into a subject; receiving acoustic impedance information from at least one second ultrasound sensor located near a distal end of a needle extend from the extended working channel into the subject; calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor; and providing, on a display, an indication of the calculated volume of the fluid injected into the subject.81. An ultrasound sensing apparatus comprising: an extended working channel comprising a distal end, a proximal end, and a channel, the distal end adapted for insertion in a subject and opposite the proximal end, the channel extending from the distal end to the proximal end, the distal end comprising an end face; at least one first ultrasound sensor located on the end face of the distal end of the extended working channel, the at least one first ultrasound sensor configured to measure acoustic impedance in the subject; and91MEI 48657880v. 1a needle having at least one second ultrasound sensor, the at least one second ultrasound sensor configured to measure acoustic impedance in the subject, the needle configured to be extended and retracted from the channel at the distal end of the extended working channel.82. The ultrasound sensing apparatus of numbered embodiment 81, wherein, when viewed in a direction perpendicular to the end face of the distal end, at least two first ultrasound sensors surround the channel.83. The ultrasound sensing apparatus of numbered embodiment 81, wherein the needle comprises: a distal end; a bevel located at the distal end, the bevel being a fluid exit to deliver fluid from the needle; and a proximal end opposite the distal end, wherein at least two second ultrasound sensors are located near the distal end of the needle and located axially along the needle between the bevel and the proximal end.84. The ultrasound sensing apparatus of numbered embodiment 83, wherein the needle further comprises: a plurality of fluid exits located axially along the needle between the bevel and the proximal end, each of the fluid exits being located between two of the second ultrasound sensors.85. An ultrasound sensing system comprising:92MEI 48657880v. 1the ultrasound sensing apparatus of numbered embodiment 81; and a computer coupled to the at least one first ultrasound sensor and to the at least one second ultrasound sensor, the computer comprising one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the computer to perform a method comprising: receiving acoustic impedance information from the at least one first ultrasound sensor; receiving acoustic impedance information from the at least one second ultrasound sensor; calculating a volume of a fluid injected into the subject based on the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor; and providing, on a display, an indication of the calculated volume of the fluid injected into the subject.86. An ultrasound sensing system comprising: the ultrasound sensing apparatus of numbered embodiment 81; and a computer coupled to the at least one first ultrasound sensor and to the at least one second ultrasound sensor, the computer comprising one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the computer to perform a method comprising: receiving acoustic impedance information from the at least one first ultrasound sensor; receiving acoustic impedance information from the at least one second ultrasound sensor; and93MEI 48657880v. 1providing visualization of at least one the acoustic impedance information from the at least one first ultrasound sensor and the acoustic impedance information from the at least one second ultrasound sensor.94MEI 48657880v. 1

Claims

CLAIMSWhat is claimed is:

1. A computer-implemented method comprising: receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information; receiving confirmation from a user based on the visualization of the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

2. The computer- implemented method of claim 1 , further comprising determining directional dispersion information of the fluid being injected into the tumor based on the second acoustic impedance information.

3. The computer- implemented method of claim 2, wherein the directional dispersion information of the fluid being injected into the tumor is determined with respect to a portion of the ultrasound sensors located axially along the needle.95MEI 48657880v.

14. The computer-implemented method of claim 2, wherein the directional dispersion information of the fluid being injected into the tumor indicates whether the fluid is flowing along an exterior of the needle from the distal end of the needle to a proximal end of the needle.

5. The computer- implemented method of claim 2, further comprising, responsive to determining the directional dispersion information, adjusting an injection rate of the fluid to decrease a flow of the fluid being injected into the subject.

6. The computer-implemented method of claim 2, wherein determining directional dispersion information of the fluid comprises: calculating directional dispersion information of the fluid based on the second acoustic impedance information; and comparing the directional dispersion information to a dispersion threshold to determine whether the directional dispersion information satisfies the dispersion threshold, and wherein the method further comprises, responsive to determining that the directional dispersion information satisfies the dispersion threshold, adjusting an injection rate of the fluid to decrease a flow of the fluid being injected into the subject.

7. The computer-implemented method of claim 6, wherein the dispersion information is calculated based on a change in the fluid in the subject over a time period as determined from the second acoustic impedance information.96MEI 48657880v.

18. The computer-implemented method of claim 6, further comprising, responsive to determining that the directional dispersion information fails to satisfy the pressure threshold, maintaining the injection rate of the fluid.

9. The computer- implemented method of claim 1, further comprising upon receiving confirmation from the user that the distal end of the needle is inserted in the tumor of the subject, recording an image of the visualization of the first acoustic impedance information.

10. The computer- implemented method of claim 1, wherein the second acoustic impedance information is received during and after the fluid is injected into a first site of the tumor, the method further comprising: receiving third acoustic impedance information from the plurality of ultrasound sensors, the third acoustic impedance information being received during and after the fluid is injected from the needle into a second site of the tumor; and providing visualization of the third acoustic impedance information.

11. The computer- implemented method of claim 10, wherein the second site is located away from the first site and along a withdrawal path of the needle from the tumor.

12. The computer- implemented method of claim 1, wherein the plurality of ultrasound sensors are located circumferentially around the distal end of the needle.97MEI 48657880v.

113. The computer- implemented method of claim 1, wherein the plurality of ultrasound sensors are located along an axial line of the needle near the distal end of the needle.

14. The computer- implemented method of claim 1, wherein the needle comprises a lumen having a single fluid exit at the distal end of the needle, wherein the plurality of ultrasound sensors are located at a proximal side of the single fluid exit of the needle.

15. The computer-implemented method of claim 1, wherein the needle comprises a lumen having a plurality of fluid exits near the distal end of the needle, wherein at least a portion of the plurality of fluid exits of the needle are located between the ultrasound sensors near the distal end of the needle.

16. The computer- implemented method of claim 15, further comprising determining directional dispersion information of the fluid for each of the plurality of fluid exits based on the second acoustic impedance information.

17. A non- transitory processor readable medium containing a set of instructions thereon, wherein when executed by a processor, the instructions cause the processor to perform a method comprising: receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information;98MEI 48657880v. 1receiving confirmation from a user based on the visualization of the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

18. An apparatus comprising: one or more processors; and memory accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform a method comprising: receiving first acoustic impedance information from a plurality of ultrasound sensors located near a distal end of a needle inserted into a subject; providing visualization of the first acoustic impedance information; receiving confirmation from a user based on the visualization of the first acoustic impedance information that the distal end of the needle is inserted in a tumor of the subject; receiving second acoustic impedance information from the plurality of ultrasound sensors located near the distal end of the needle inserted into the subject, the second acoustic impedance information being received after a fluid is injected from the needle into the tumor of the subject; and providing visualization of the second acoustic impedance information.

19. A needle for delivering a fluid, comprising:99MEI 48657880v. 1a distal end; a bevel located at the distal end, the bevel being at a fluid exit of the needle to deliver fluid from the needle; a proximal end opposite the distal end; a plurality of ultrasound sensors located near the distal end of the needle and located axially along the needle between the bevel and the proximal end; and a plurality of fluid exits located axially along the needle between the bevel and the proximal end, each of the plurality of fluid exits being located between two of the ultrasound sensors.

20. The needle of claim 19, wherein the plurality of ultrasound sensors are further located circumferentially around the needle.

21. A method of injecting fluid in a subject using the needle of claim 20, the method comprising: fractionally injecting fluid in the subject using the needle.100MEI 48657880v. 1

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