Imaging system with needle aligned with field of view

Abstract

An apparatus may include an imaging probe including a passageway extending through the imaging probe and terminating in an opening, and an imaging device configured to generate image data having a field of view. The apparatus may also include a tool configured to slidably extend within the passageway. A portion of the tool may be flexible and may flex away from the imaging device when the portion of the tool extends distally of the opening.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 406,181, filed on September 13, 2022, entitled “IMAGING SYSTEM WITH NEEDLE ALIGNED TO FIELD OF VIEW,” the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to systems and methods for aligning a tool within a field of view of an imaging system. Background Art

[0004] Minimally invasive medical technology aims to reduce the amount of tissue damaged during medical treatment, thereby reducing the patient's recovery time, discomfort and harmful side effects. This minimally invasive technology can be performed through natural orifices in the patient's anatomical structure or through one or more surgical incisions. Through these natural orifices or incisions, the operator can insert minimally invasive medical tools to reach the target tissue location. Minimally invasive medical tools include instruments such as treatment, diagnosis, biopsy and surgical instruments. Medical tools can be inserted into anatomical channels and navigated toward the area of ​​interest within the patient's anatomical structure. Optical or ultrasonic images of anatomical channels and surrounding anatomical structures obtained during surgery can be used to assist navigation. Intraoperative imaging of the tool through an imaging probe or catheter inserted by the tool can provide improved navigation guidance and confirmation of the tool's engagement with the target tissue. Improved systems and methods are needed to align the tool in the field of view of the imaging probe inserted through the tool to improve the imaging of the tool and the process performed using the tool. Summary of the invention

[0005] In accordance with some examples, an apparatus may include an imaging probe including a passage extending through the imaging probe and terminating at an opening, and an imaging device configured to generate image data having a field of view. The apparatus may also include a tool configured to slidably extend within the passage. A portion of the tool may be flexible and may bend away from the imaging device when the portion of the tool extends distally of the opening.

[0006] In some examples, a system may include an imaging probe and an imaging device, the imaging probe including a passage extending through the imaging probe and terminating at an opening, the imaging device being configured to generate image data having a field of view. The system may also include a tool configured to extend slidably within the passage. A portion of the tool may be flexible and may bend away from the imaging device when the portion of the tool extends distally of the opening. The system may also include a control system including one or more processors configured to deploy a portion of the tool distally of the opening and into the field of view, and receive image data including the portion of the tool in the field of view.

[0007] It should be understood that the above general description and the following detailed description are exemplary and explanatory in nature, and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In this regard, through the following detailed description, additional aspects, features and advantages of the present disclosure will be apparent to those skilled in the art. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 An imaging probe with tools is shown according to some examples.

[0009] Figure 2 According to some examples Figure 1 An imaging probe having a field of view image including a tool image.

[0010] Figure 3 A tool including a plurality of perforations that facilitate preferential bending is shown according to some examples.

[0011] Figure 4 An imaging probe with tools is shown according to some examples.

[0012] Figure 5 An imaging probe with tools is shown according to some examples.

[0013] Figure 6A-6E Cross-sectional views of working pathways and tools of imaging probes according to various examples are shown.

[0014] Figure 7 Cross-sectional views of working pathways and tools of an imaging probe are shown according to some examples.

[0015] Fig. 8A An imaging probe having a tool rotationally constrained relative to a working pathway is shown according to some examples.

[0016] Figure 8B Cross-sectional views of working pathways and tools of an imaging probe are shown according to some examples.

[0017] Fig. 9A tool having a flexible bend is shown according to some examples.

[0018] Fig.10 is a flow chart illustrating a medical imaging process using an imaging probe and tools.

[0019] Fig.11 A simplified diagram of a robotic-assisted medical system according to some examples of the present disclosure is shown.

[0020] Examples of the present disclosure and its advantages can be best understood by referring to the following detailed description. It should be understood that the same reference numerals are used to identify the same elements shown in one or more figures, wherein the illustrations in the figures are for illustrating examples of the present disclosure, not for limiting the present disclosure. DETAILED DESCRIPTION

[0021] The systems and techniques disclosed herein can be used to enhance minimally invasive procedures that use, for example, ultrasound imaging to provide intraoperative visualization. Imaging data from an imaging probe can be used to verify the real-time accurate placement of a therapeutic or diagnostic tool within an anatomical target during a medical procedure. In some examples, the imaging probe includes a passage through which the tool is inserted. The size of the imaging probe can be minimized by having a tool with a curved shape once it leaves the imaging probe, so that the distal end of the tool is within the field of view of the imaging probe. In some examples, the tool can also or alternatively be constrained to prevent rotation relative to the imaging probe, so that the tool is bent into the field of view. Although described in the context of an ultrasound imaging probe, it is contemplated that the systems and methods described herein can be applied to other imaging modalities without departing from the scope of the present disclosure. For example, when a tool is delivered to a target via a flexible, elongated device (e.g., a catheter or an imaging probe), an imaging probe including a camera can be used to provide direct visual guidance of the tool. In another example, the imaging probe can be a fluoroscope imaging device, or some other type of imaging device.

[0022] The systems and techniques described herein can be used for various medical procedures that can improve accuracy and results by using intraoperative imaging. For example, intraoperative imaging can be used to biopsy lesions or other tissues, for example, to assess the presence or extent of a disease such as cancer or for monitoring a transplanted organ. As another example, intraoperative imaging can be used for cancer staging to determine via biopsy whether the disease has spread to lymph nodes. Medical procedures can be performed using imaging probes and tools (e.g., bronchoscopes) that are handheld or otherwise manually controlled. In other examples, the imaging probes and tools described can be manipulated by a robotic-assisted medical system.

[0023] Figure 11 shows a partial cross-sectional view of an imaging probe 100 extending within a passage 102 of a patient's anatomy near a target tissue 104, which may be the subject of imaging by the imaging probe 100. The reference system of the imaging probe 100 may have a coordinate system X p , Y p , Z p In some examples, passage 102 may be an airway of a lung and target tissue 104 may be a lymph node, suspected tumor, nodule, or lesion that is imaged by endobronchial ultrasound imaging during a biopsy procedure.

[0024] The imaging probe 100 may include at least one passage 106 through which a tool, device or other elongated instrument may extend. In the example shown, a tool system 108 may be slidably extended through the passage 106, extending from an opening or eyelet 107 at the distal end of the passage 106, and entering the target tissue 104. In some examples, the imaging probe 100 may include a flexible shaft 109 and an imaging head 110, which provides visualization of the extended tool system 108 and the target tissue 104. The imaging head 110 may include an imaging device 111 for capturing images. In use, the imaging head 110 may be placed against or near the wall of the channel 102 to minimize or eliminate air between the imaging head and the tissue. The imaging head 110 may include, for example, an ultrasound or optical imaging array for capturing images in an imaging field of view 112. The imaging head 110 may include a plurality of (e.g., one or more arrays) imaging elements. The imaging elements may be arranged in any size, configuration or shape. For example, the imaging elements may be arranged along a surface to form an array having a moon, ring, circle or rectangular pattern. In some embodiments, the imaging element includes a transducer array (e.g., a lead zirconate titanate (PZT) transducer) that generates ultrasonic waves and / or detects reflected ultrasonic waves. In some embodiments, the imaging element includes an array of ultrasonic receivers (e.g., a whispering gallery mode (WGM) resonator) and an array of ultrasonic transmitters (e.g., a piezoelectric array). The imaging probe 100 can be manipulable to navigate the imaging probe 100 to a deployment position near the target tissue 104. For example, a plurality of pull wires or tendons (not shown) can extend along the length of the imaging probe 100 and can be manipulated to manipulate the distal end of the imaging probe. Alternatively, the imaging probe 100 can be passively flexible and can be navigated to a deployment position by a manipulable catheter or sheath having a lumen through which the imaging probe is disposed. In some examples, the imaging probe 100 may include a lumen for receiving a guide wire to navigate the imaging probe to a deployment position.

[0025] The tool system 108 may include, for example, a biopsy tool (e.g., a tissue piercing tool, such as a needle for tissue cutting and / or coring, a cryobiopsy tool, a forceps instrument, a brush tool) or a treatment tool (e.g., a cryotool, a radiofrequency (RF) or microwave (MW) ablation tool, an electroporation tool, a suction device). In some examples, the tool system 108 may include a (e.g., tissue piercing) tool 116 extending through a sheath 118. When the tool 116 is located within the passage 106 of the imaging probe 100, the tool 116 may be covered by the sheath 118 to protect the passage 106 and the distal end of the tool 116. When the distal end of the tool 116 is located distal to the eyelet 107, the tool 116 may extend distally to the sheath 118. Image data from the imaging device 111 may be captured to indicate whether the tool 116 has pierced or failed to engage the tissue 104. The image data may also reveal where the tool 116 has penetrated the tissue 104 , whether the tool 116 is within a threshold distance from delicate tissue (such as vasculature or pleural tissue), or other interactions between the tool 116 and anatomical structures within the field of view 112 .

[0026] exist Figure 1 In an example of the present invention, the shaft 109 of the imaging probe 100 can extend generally along the longitudinal axis A1, and the passage 106 can also extend generally parallel to the axis A1. The eyelet 107 can be near the bottom of the imaging head 110. The passage 106 extending parallel to the axis A1 can allow the imaging probe to be constructed with a reduced diameter compared to an example in which the passage has a distal curvature that the width of the imaging probe must accommodate. In some examples, the outer width of the shaft 109 of the imaging probe 100 can be between about 3.0 and 20.0 mm, and the outer width of the tool 116 can be between about 1.0 and 3.5 mm.

[0027] In some examples, the imaging head 110 can be offset from the longitudinal axis A1 by an angle 114. If the tool system 108 extends from the aperture 107 in a direction generally parallel to the longitudinal axis A1 or at an angle that is too close or too far from the imaging head 110, the tool 116 may not be visible within the field of view 112 of the imaging device 111. As described in the examples herein, the tool 116 and / or the imaging probe 100 can be configured so that the tool 116 predictably and repeatably extends into the field of view 112 or a specific or predetermined portion of the field of view 112 when deployed from the passage 106.

[0028] In some examples, the distal portion 117 of the tool 116 can be biased to form a bend at the curved portion 120. In one example, the bias can be due to the curved portion 120 having a curved shape. As used herein, "curved shape" refers to the curvature of the curved portion 120 in a static state when no external force is applied to the tool 116. The tool 116 can be flexible so that when a force is applied to the tool 116, the curved shape can change (e.g., straighten or bend at other angles). In another example, the bias can be due to a flexible tool with a straight shape passing through a curved path portion of the camera probe. The curved portion 120 can bend in a single direction (e.g., around the axis Z) to form a curved path portion. P ) or bends in a single plane (e.g. plane X P Y P ) to ensure that tool 116 is visible within the plane of field of view 112.

[0029] In some examples, distal portion 117 can be the length of tool 116 distal to (and including) curved portion 120. In some examples, curved portion 120 can include all or a majority of distal portion 117, such as would occur if the distal portion forms a continuous arc. In some examples, a section of distal portion 117 distal to curved portion 120 can be relatively straight. In some examples, distal portion 117 of tool 116 can be offset to form a bend angle 122 between imaging tip 110 and tool 116. Bend angle 122 can include angle 114 between imaging tip 110 and axis A1 and angle 123 between axis A1 and tool 116. In some examples, angle 114 can be approximately 35 degrees, and angle 123 can be between approximately 30 and 45 degrees. In some examples, bend angle 122 can be between approximately 20 and 80 degrees. The curved portion 120 may extend at least a section of the distal portion 117 or the distal tip 119 of the tool 116 into the field of view 112. The curved portion 120 may also allow the tool 116 to resist bending outside of a predetermined bending plane.

[0030] In some examples, the curved portion 120 or the entire distal portion 117 can be formed of a flexible shape memory material (e.g., Nitinol) that allows the portion 120 to straighten when the distal portion 117 is extended within the passage 106 (e.g., when the inner wall of the passage 106 exerts a force on the portion 120), and to form a curved shape when the distal portion is extended outside the passage 106 and released from the constraints of the passage 106. The shape memory material forming the curved portion 120 can predictably and repeatedly generate the same bend angle 122 between the distal portion 117 of the tool 116 and the imaging head 110. In some examples, the shape of the curved portion 120 can be heat set during the manufacturing process to form the curved shape. In some examples, the tool 116 can include a passage into which a curved member such as a stylet can be inserted. The stylet can have a preformed bend and can be formed of a flexible shape memory material (e.g., Nitinol). For example, the shape of the Nitinol stylet can be set in a specific curve. The stylet can guide the tool in an appropriate curved path and can be removed when the tool is in use, for example for extracting a tissue sample through a needle. The stylet can also have an oval, elliptical or rectangular profile that is more flexible in a first curved plane than in a second perpendicular curved plane.

[0031] Figure 2 An image 130 is shown of the field of view 112 of the imaging probe 100 relative to capturing the image 130. In this example, the field of view 112 can have a fan-shaped shape that is smaller or narrower near the tool 116 and larger or wider away from the tool 116. In other words, the field of view can increase as the distance from the imaging device increases. In this example, the plane of the image 130 can generally correspond to the X-axis direction of the imaging probe. P Y PThe image 130 of the field of view 112 may include the target tissue 104 and a segment of the distal tip 119 or distal portion 117 of the tool 116. The bend angle 122 extends the tool 116 within the field of view 112 for visualization within the image 130. In particular, the field of view 112 may expand as the distance from the imaging probe 100 increases. If the tool 116 is not bent away from the imaging probe 100, the tool 116 may be located at a region where the field of view 112 is smaller or narrower and may not be as visible within the field of view 112. If the tool 116 is bent away from the imaging probe 100, the tool may be located at a farther region where the field of view 112 is larger or wider and therefore more fully visible within the field of view 112. In addition, the image resolution directly adjacent to the imaging probe 100 may be lower, for example, due to ring down associated with the transducer. Therefore, placing the tool away from the imaging probe may provide a better image. In addition, guiding the tool away from the imaging probe can allow the tool to extend deeper (e.g., in a direction transverse to the wall) into the tissue outside the anatomical channel wall to enter more distal tissue. For example, image 130 can show whether tool 116 has pierced target tissue 104, and can further illustrate whether the location of the piercing, the depth of the piercing and / or any vulnerable tissue nearby is in danger. In addition, information about the positioning of the tool (e.g., biopsy tool) can help to sample at the central necrosis and the edge or margin of the lymph node. These types of tissues may have echoes and may contain cancerous tissue. For example, if tool 116 is a biopsy tool, visualizing tool 116 in an image 130 associated with the lesion can allow a clinician to observe whether the lesion is engaged by the biopsy tool, and decide whether to engage other blocks of the lesion to perform additional biopsies. In some examples, image 130 can be displayed to a clinician or other user (e.g., on a display system 1110). In some examples, image analysis software can analyze the image data to record various information, such as the location of the puncture, the depth of the puncture, and / or the proximity to delicate tissue.

[0032] The curved shape of the tool can be achieved in a variety of ways. In some examples, such as Figure 3 As shown, the curved portion 120 may include a surface feature 140 located at the inner radius of the curved portion 120 of the tool 116, which creates a wall weakness area, promotes preferential bending, and reduces the bending stiffness of the tool 116 in the curved block. The surface feature 140 may include a slit (e.g., formed via laser cutting), a hole, or other perforation. A sealing member (not shown) in the form of a flexible tube or sleeve (e.g., a polyethylene terephthalate (PET) sleeve) may extend through the perforation to allow vacuum forces to evacuate material through the tool and prevent fluid or material from migrating through the perforation.

[0033] In some examples, such as Figure 4As shown, the imaging probe 150 may include a curved section 152 generated by a curved passage portion 154 extending within the imaging probe 150. The curved passage portion 154 refers to a distal portion of the passage of the imaging probe 150, which has a curved shape to impose a bend on the flexible tool 156. The curved passage portion 154 can form the flexible tool 156 into a curved shape and guide the flexible tool 156 away from the longitudinal axis A2 at the curved section 152, so that the distal portion 157 of the tool 156 extends distally from the passage 154 at a bend angle 122 and enters the field of view 158. The curved passage portion 154 allows the flexible tool 156 having an unbent shape to conform to the bend of the curved passage 154. Optionally, the flexible tool 156 may also include a curved section 152 such as Figure 1 The preformed bend is described to facilitate the formation of the bend portion and the bend angle. In other respects, imaging probe 150 can be similar to probe 100, and tool 156 can be similar to tool 116. In some examples, if the tool has a curved shape, such as Figure 1 As described above, the probe may not additionally include a curved passage portion to form a bend in the tool. Therefore, if the tool has a curved shape, the imaging probe may have a smaller diameter because it may include a straight passage or a straighter passage omitting the curved passage portion.

[0034] The imaging tip of the imaging probe can be curved or straight relative to the longitudinal axis of the imaging probe. Figure 5 As shown, the imaging probe 160 may include an imaging head 161 that is generally aligned with the longitudinal axis A3 of the probe 160 (e.g., at an angle of 0 degrees relative to the longitudinal axis A3). The imaging probe 160 may include a predetermined curved section 162 generated by a curved passage portion 164 extending within the imaging probe 160. The curved passage portion 164 can bend a flexible tool 166 extending therethrough at the curved section 162 away from the longitudinal axis A3, so that a distal portion 167 of the tool 166 extends distally from the passage 164 at a predetermined bend angle 122 and enters a field of view 168. Figure 4 Compared to the example of FIG. 1 , the bending of tool 166 relative to axis A3 can be greater so that tool 166 extends into the field of view of the imaging head. Figure 4 ) can be less curved relative to axis A2 than tool 166 because the imaging tip is angled in the opposite direction of the curve. Figure 4 As shown, the imaging head at an angle (relative to axis A2) can allow the tool (with Figure 5 A more gradual or smaller bend (relative to axis A2) occurs compared to the example of FIG. 1 , while maintaining a bend angle 122 that places the tool within the field of view of the imaging probe. Figure 4 In the example of FIG. 1 , the curved path portion may have a larger radius of curvature (compared to FIG. 1 ). Figure 5 161) because the pathway does not require as much curvature to be imposed on the tool. However, a straight imaging tip may be easier to pass through a small anatomical passage. In examples where the tool (e.g., tool 116) itself forms a curved shape, the shape offset provides the curvature rather than the curved pathway portion, so that a curved tool can also be used with a straight imaging tip to minimize the imaging probe diameter. The angle and curved pathway portion of imaging tip 161 are independent features. For example, either a curved or uncurved imaging tip can be used with a straight pathway. Optionally, the flexible tool may also include a curved tool such as Figure 3 The preformed bend is provided to facilitate the formation of the bend portion and the bend angle. In other respects, the imaging probe 160 may be similar to the probe 100 , and the tool 166 may be similar to the tool 116 .

[0035] The tool can be rotationally constrained in various ways to ensure that bends are away from the imaging probe and into the imaging probe's field of view, and to prevent rotations in the field of view plane (e.g., X P Y P In some examples, such as Fig. 6A , Figure 6B , Figure 6C and Figure 7 As shown, the cross-sectional shape of the passage of the tool and / or imaging probe can facilitate the rotational locking of the tool relative to the imaging probe and facilitate the bending of the tool along the desired plane (e.g., corresponding to the imaging plane of the imaging probe). The passage of the tool and / or imaging probe may include a cross-sectional shape that is asymmetric (e.g., different sizes) in an orthogonal direction. For example, an asymmetric cross-sectional shape may include a large dimension that is wider than a small dimension defined orthogonal to the large dimension. The tool may be bent along the small dimension based on having a curved shape or having a straight shape that is bent along the small dimension by the curved passage portion of the imaging probe. The asymmetric cross-sectional shape may cause the tool to resist bending along the large dimension and may facilitate bending along (e.g., only along) the small dimension. In some embodiments, the passage of the imaging probe may have an asymmetric cross-sectional shape that constrains the rotational orientation of the tool within the passage. These rotational constraints may help ensure that the tool (e.g., a tool with shape memory bending) extends from the imaging probe in the desired direction and prevents undesirable bending along other directions.

[0036] Fig. 6A The imaging probe passage 176 and tool 172 are shown along a cross-sectional plane (eg Figure 1124). When tool 172 is located within passage 176 of the imaging probe, the entire length or a portion of the length of tool 172 may be covered by sheath 174. In some examples, tool 172 may be similar to tool 116 except as described. For example, tool 172 may be a tissue piercing tool or some other type of tool. In this example, tool 172 may have a cross-sectional shape in the form of an ellipse, sized to fit within elliptical passage 176. The corresponding shapes of tool 172 and passage 176 may cooperate to rotationally constrain the tool to prevent tool 172 from rotating or twisting within passage 176 and when the tool is extended outside of passage 176. For example, the cross-sectional shape of the tool along the Z direction may be angular. p The axis has a wider dimension and is along the Y p The axis has a narrower dimension. In addition, the tool 172 can have a curved shape that includes an X P Y P This causes the tool 172 to resist the X P Z P bending in the plane and promotes only the X P Y P In other words, tool 172 may have a moment of inertia about the small dimension b that is greater than the moment of inertia about the large dimension a. For example, the moment of inertia I Y =[π(b / 2)(a / 2) 3 ] / 4 can be greater than the moment of inertia I Z =[π(a / 2)(b / 2) 3 ] / 4. The cross-sectional shape of the tool and / or passage can have various other shapes that provide such rotational constraints. In some examples, the cross-sectional shape of the tool and / or passage can be rectangular, oval, or other symmetrical or asymmetrical shapes with unequal moments of inertia around orthogonal axes.

[0037] In some examples, a fluid (such as air or irrigation fluid) may be allowed to flow through the passage 176 around the sheath 174. In one example, if an imaging system (such as a camera) is incorporated into the tool or delivery catheter, saline may be injected to clean debris from the anatomical area to improve visibility. Saline or other fluids may also aid in ultrasonic coupling between the ultrasound probe and the channel wall.

[0038] Figure 6B The imaging probe passage 186 and tool 182 are shown along a cross-sectional plane (eg Figure 1124). When tool 182 is located within passage 186 of the imaging probe, the entire length or a portion of the length of tool 182 may be covered by a sheath (not shown). In some examples, tool 182 may be similar to tool 116 except as described. For example, tool 182 may be a tissue piercing tool or some other type of tool. In this example, tool 182 may have a D-shaped cross-section sized to fit within oval passage 186. The shapes of tool 182 and passage 186 may cooperate to constrain the tool to prevent rotation or twisting of the tool within passage 186 and when the tool is extended outside of passage 186. For example, the cross-sectional shape of the tool along the Z P The axis has a wider dimension and is along the Y P The axis has a narrower dimension. In addition, the tool 182 can have a curved shape that includes an X P Y P This causes the tool 182 to resist the X P Z P bending in the plane and promotes only the X P Y P The tool 182 may be formed by a flat side of the tool 182 and the passage 186. The fluid passage 188 may be formed by a flexible tubing, or may be a remaining portion of the open space not occupied by the tool 182. In general, the fluid passage may extend along a length between the passage of the probe and the tool where the cross-sectional shape of the passage is different from the cross-sectional shape of the tool.

[0039] Figure 6C The passage 196 and the tool 192 are shown along a cross-sectional plane (eg Figure 1 When tool 192 is located within passage 196 of the imaging probe, all or part of the length of tool 192 may be covered by a sheath (not shown). In some examples, tool 192 may be similar to tool 116 except as described. For example, tool 192 may be a tissue piercing tool or some other type of tool. For example, the cross-sectional shape of the tool along the Z direction may be P The axis has a wider dimension and is along the Y p The axis has a narrower dimension. In addition, the tool 192 can have a curved shape that includes an X p Y p This causes the tool 192 to resist the X p Z p bending in the plane and promotes only the X p Y p196 (e.g., it is aligned with the imaging plane of the imaging probe). In this example, tool 192 can have a D-shaped cross-section that is sized to fit within a larger D-shaped passageway 196. The shapes of tool 192 and passageway 196 can cooperate to constrain the tool to prevent rotation or twisting of the tool within passageway 196 and when the tool is extended outside of passageway 196. In this example, a fluid channel 198 can extend through passageway 196. Channel 198 can be formed by a flexible tubing, or can be the remainder of the open space not occupied by tool 192. Figure 6B Compared to the example, Figure 6C The example may allow passage 196 to be in X p Y p The size decreases in the direction.

[0040] Fig.6D The passage 226 and the tool 222 are shown along the cross-sectional plane (eg Figure 1 When tool 222 is located within passage 226 of the imaging probe, all or part of the length of tool 222 may be covered by a sheath (not shown). In some examples, tool 222 may be similar to tool 116 except as described. For example, tool 222 may be a tissue piercing tool or some other type of tool. For example, the cross-sectional shape of the tool along the Z direction may be p The axis has a wider dimension and is along the Y p The axis has a narrower dimension. In addition, the tool 222 can have a curved shape that includes an X P Y P This causes the tool 222 to resist the X P Z P bending in the plane and promotes only the X P Y P The tool 222 may be formed into a shape 226 that is shaped like a bowed-rectangle and sized to fit within a passage 226 that is shaped like a bowed-rectangle. The shapes of the tool 222 and passage 226 may cooperate to constrain the tool to prevent the tool from rotating or twisting within the passage 226 and when the tool extends outside the passage 226. In this example, a forming mandrel may be used to form the shape 226. For example, a metal mandrel shape may be formed from a round rod having two machined flat faces to achieve the shape shown. In some examples, the tool 222 may be made into an oval shape by first starting with a round pin and flattening it into an oval profile with a press.

[0041] Fig. 6E The passage 236 and the tool 232 are shown along the cross-sectional plane (eg Figure 1When tool 232 is located within passage 236 of the imaging probe, all or part of the length of tool 232 may be covered by a sheath (not shown). In some examples, tool 232 may be similar to tool 116 except as described. For example, tool 232 may be a tissue piercing tool or some other type of tool. For example, the cross-sectional shape of the tool along the Z direction may be p The axis has a wider dimension and is along the Y p The axis has a narrower dimension. In addition, the tool 232 can have a curved shape that includes an X p Y p This causes the tool 232 to resist the X p Z p bending in the plane and promotes only the X p Y p The tool 232 may be formed into a shape 236 that is shaped like a circle or a curve in a plane (e.g., which is aligned with the imaging plane of the imaging probe). In this example, the tool 232 may have an oval or racetrack shape that is sized to fit within the oval or racetrack shaped passage 236. The shapes of the tool 232 and passage 236 may cooperate to constrain the tool to prevent rotation or twisting of the tool within the passage 236 and when the tool is extended outside the passage 236. In this example, a forming mandrel may be used to form the shape 236. In some examples, the tool 232 may be made into an oval shape by first starting with a round needle and flattening it into an oval profile with a press.

[0042] Figure 7 The passage 206 and the tool 202 are shown along a cross-sectional plane (eg Figure 1 124). When tool 202 is located in passage 206 of the imaging probe, all or a portion of tool 202 may be covered by a sheath (not shown). In some examples, tool 202 may be similar to tool 116 except as described. For example, tool 202 may be a tissue piercing tool or some other type of tool. In this example, tool 202 may have an egg shape that is sized to fit within circular passage 206. A guide 207 such as a protrusion, track, or groove may constrain the rotational motion of tool 202. The constraint may cause tool 202 to resist X-ray penetration. p Z p bending in the plane and promotes only the X P Y P In this example, fluid channel 208 can extend on the side of tool 202. Channel 208 can be formed by flexible tubing, or can be the remainder of open space not occupied by tool 202.

[0043] Fig. 8AAn imaging probe 250 is shown in which a tool 252 is rotationally constrained relative to a working passage 254 of the probe. The imaging probe 250 may include a section 256 having a bend caused by a curved passage portion 258 extending within the imaging probe 250. The curved passage portion 254 may bend a flexible tool 252 extending therethrough away from the longitudinal axis A4, such as at the section 256, so that a distal portion 257 of the tool 252 extends distally from the passage 254 and into the field of view at a desired bend angle. In this example, the tool 252 may be a tissue piercing tool having a beveled tip 260. The tool 252 may be rotationally constrained relative to the passage 254 (as described in any of the above examples) so that when the tool 252 is inserted or retracted in the passage 254, the beveled tip 260 travels along an inner radius 259 of the curved section 256. This reduces the likelihood or force of contact between the beveled tip 260 and the outer radius of the curved section 256, thereby preventing damage to the tool 252 or the passage 254. In other examples, the tip 260 of the tool can bend inward (e.g., toward the center of the tool) to prevent contact with a sheath lining the passage 254 or with the passage 254 itself.

[0044] Figure 8B The passage 266 and the tool 262 are shown along the cross-sectional plane (eg Figure 1 124). When tool 262 is located in passage 266 of the imaging probe, all or part of the length of tool 262 may be covered by a sheath (not shown). In some examples, when tool 262 is located in passage 266 of the imaging probe, all or part of the length of passage 266 may be lined with a sheath (not shown). In some examples, tool 262 may be similar to tool 116 except as described. For example, tool 262 may be a tissue piercing tool with a sharp tip 264 or some other type of tool. For example, the cross-sectional shape of the tool along the Z direction may be p The axis has a wider dimension and is along the Y p The axis has a narrower dimension. In addition, the tool 262 can have a curved shape that includes an X p Y p This causes the tool 262 to resist the X p Z p bending in the plane and promotes only the X p Y pThe tool 262 may be configured to have a curvature in a plane (e.g., which is aligned with the imaging plane of the imaging probe). In this example, the tool 262 may have an oval or racetrack shape that is sized to fit within the passage 266. The passage 266 may have a generally oval or racetrack shape, but a portion of the interior profile may have a recessed area 265 to accommodate the tip 264 and prevent contact between the tip 264 and the passage 266. The shapes of the tool 262 and the passage 266 may cooperate to constrain the tool to prevent rotation or twisting of the tool within the passage 266 and when the tool is extended outside of the passage 266.

[0045] Fig. 9 Tool 300 is shown, which can be similar to tool 116 and can be used as any tissue penetration tool previously described. In this example, tool 300 includes a curved portion 302, which can be formed of a flexible material (e.g., an elastomeric material) that allows the tool to extend to a straightened configuration when constrained within a working passage and return to a curved shape when released from the constraint distal to the passage. Portion 304 of tool 116 distal to curved portion 302 can be made of a more rigid material (e.g., stainless steel or a rigid polymer). Rigid portion 304 can resist deformation when penetrating tissue compared to a more flexible or bendable material.

[0046] In some examples, the tool can be bent to various angles. For example, a variable bias or bend in the angle of the distal end of the tool relative to the probe axis can be achieved by extending an adjustable pull wire through the tool. As another example, a variable bias can be achieved by a bimetallic strip in the distal portion of the tool, which can cause the strip to bend via resistive heating of an electric current. As another example, a stylet extending with a variable curvature within the tool or multiple stylets with different curvatures can be used to change the bend in the tool. If the tool has a variable bend, a clinician or other user viewing the field of view image can adjust the bend in the tool to bend the tool into the field of view plane.

[0047] Fig.10 A flow chart is provided showing a method 400 for performing a medical imaging procedure using an imaging probe and a tool (e.g., a tissue piercing tool). The method 400 is shown as a set of operations or steps that can be performed in the same or different order than shown. In some examples of the method, one or more of the steps shown may be omitted. In addition, Fig.10One or more steps not explicitly shown in the method 400 may be included before, after, between, or as part of the steps shown. In some examples, one or more of the steps of method 400 may be implemented at least in part by a control system that executes code stored on a non-transitory, tangible, machine-readable medium that, when executed by one or more processors (e.g., a processor of the control system), may cause the one or more processors to perform one or more of the steps.

[0048] Before or after navigating an imaging probe (e.g., imaging probe 100) to a deployment position near a target tissue (e.g., target tissue 104), in step 402, a tool (e.g., tool 116) may be extended into a passage of the imaging probe. In step 404, a distal portion of the tool may be deployed from the imaging probe. The distal portion of the tool may include a curved shape that bends the distal portion of the tool into the field of view of the imaging probe. In some examples, the tool may be constrained by the shape of the passage and the tool (e.g., an asymmetric shape) to resist bending outside the plane of the field of view of the imaging probe. This allows all or substantially all of the distal portion of the tool to be captured in the field of view. In step 406, the imaging probe may generate an image as the tool extends distally from the probe. In some examples, the imaging probe may continuously generate images throughout the method 400, including during steps 402, 404, and 408. Thus, images may be generated before the tool is deployed, when the tool is deployed, when the tool is in an operating position, when the tool is retracted into the probe, and after the tool is withdrawn from the imaging probe. An assessment may be performed using image analysis techniques or clinician observation at optional step 408. The assessment may include determining whether the tool is visible in the field of view of the probe, whether the tool has penetrated the target tissue, the depth to which the tool has extended into the target tissue, and whether the positioning of the tool may or has compromised delicate tissue.

[0049] In some examples, medical procedures can be performed using handheld or otherwise manually controlled imaging probes and tools of the present disclosure. In other examples, the imaging probes and tools described can be used as Fig.11 The robot-assisted medical system is shown for manipulation. Fig.11A robot-assisted medical system 1100 is shown. The robot-assisted medical system 1100 generally includes a manipulator assembly 1102 for operating a medical instrument system 1104 (including, for example, an imaging probe 100 and a tool system 108) in a surgical environment 1101 to perform various procedures on a patient P positioned on a table T. The manipulator assembly 1102 can be a robot-assisted, non-assisted, or hybrid robot-assisted and non-assisted assembly having selected degrees of freedom of motion that can be motorized and / or robot-assisted and selected degrees of freedom of motion that can be non-motorized and / or non-assisted. A main assembly 1106, which can be inside or outside the surgical environment 1101, generally includes one or more control devices for controlling the manipulator assembly 1102. The manipulator assembly 1102 supports the medical instrument system 1104 and can include a plurality of actuators or motors that drive inputs on the medical instrument system 1104 in response to commands from a control system 1112. The actuator may include a drive system that, when coupled to the medical device system 1104, can advance the medical device system 1104 into a natural or surgically created anatomical orifice. Other drive systems can move the distal end of the medical device system 1104 in multiple degrees of freedom, which can include three degrees of freedom for linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and three degrees of freedom for rotational motion (e.g., rotation about the X, Y, and Z Cartesian axes). In addition, the actuator can be used to actuate an articulated end effector of the medical device system 1104 to grasp tissue in the jaws of a biopsy device, etc.

[0050] The robot-assisted medical system 1100 also includes a display system 1110 (which can display Figure 2 The display system 1110 and the main assembly 1106 may be oriented so that the operator O can control the medical instrument system 1104 and the main assembly 1106 through the perception of the telepresentation.

[0051] In some examples, the medical device system 1104 may include components for surgery, biopsy, ablation, illumination, irrigation, or suction. The medical device system 1104, together with the sensor system 1108, may be used to collect (i.e., measure) a set of data points corresponding to positioning within an anatomical passage of a patient (e.g., patient P). In some examples, the medical device system 1104 may include components of an endoscopic imaging system 1109, which may include an imaging mirror assembly or an imaging device (e.g., an imaging probe 100), which records concurrent or real-time images of the surgical site and provides the images to an operator or operator O through a display system 1110. The concurrent image may be, for example, a two-dimensional or three-dimensional image captured by an imaging device located within the surgical site. In some examples, the endoscopic imaging system components may be integrally or detachably coupled to the medical device system 1104. However, in some examples, a separate endoscope attached to a separate manipulator assembly may be used with the medical device system 1104 to image the surgical site. The endoscopic imaging system 1109 may be implemented as hardware, firmware, software, or a combination thereof, interacting with or otherwise executed by one or more computer processors, which may include a processor of the control system 1112 .

[0052] The sensor system 1108 may include a position / location sensor system (eg, an electromagnetic (EM) sensor system) and / or a shape sensor system for determining the position, orientation, velocity, speed, posture, and / or shape of the medical device system 1104 .

[0053] The robotic-assisted medical system 1100 may also include a control system 1112. The control system 1112 includes at least one memory 1116 and at least one computer processor 1114 for implementing control between the medical device system 1104, the main assembly 1106, the sensor system 1108, the endoscopic imaging system 1109, the intraoperative imaging system 1118, and the display system 1110. The control system 1112 (which may include a controller in operational communication with the imaging device 111) also includes programming instructions (e.g., a non-transitory machine-readable medium storing instructions) to implement some or all of the methods described according to the aspects disclosed herein, including instructions for providing information to the display system 1110.

[0054] The control system 1112 may also include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical instrument system 1104 during the image-guided surgery. Virtual navigation using the virtual visualization system may be based on reference to a preoperative or intraoperative dataset of an acquired anatomical passage. The virtual visualization system processes images of the surgical site imaged using imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, etc.

[0055] The intraoperative imaging system 1118 can be arranged in the surgical environment 1101 near the patient P to obtain images of the anatomical structures of the patient P during the medical procedure. The intraoperative imaging system 1118 can provide real-time or near real-time images of the patient P. In some examples, the intraoperative imaging system 1118 may include an ultrasound imaging system for generating two-dimensional and / or three-dimensional images. For example, the intraoperative imaging system 1118 can be at least partially integrated into an imaging probe (such as the imaging probe 100). In this regard, the intraoperative imaging system 1118 can be partially or completely integrated into the medical device system 1104.

[0056] In the description, the specific details of describing some examples have been set forth. In order to provide a thorough understanding of the examples, many specific details have been set forth. However, it is apparent to those skilled in the art that some examples may be practiced without some or all of these specific details. The specific examples disclosed herein are intended to illustrate rather than to limit. Those skilled in the art will recognize that other elements (although not specifically described here) are also within the scope and spirit of the present disclosure.

[0057] Whenever feasible, elements described in detail with reference to one example, implementation or application may optionally be included in other examples, implementations or applications where they are not specifically shown or described. For example, if an element is described in detail with reference to one example, but not described with reference to a second example, the element may still be required to be included in the second example. Therefore, in the following description, in order to avoid unnecessary repetition, unless otherwise specifically described, unless one or more elements will make an example or implementation inoperative, or unless two or more elements provide conflicting functions, one or more elements shown and described in association with one example, implementation or application may be incorporated into other examples, implementations or aspects.

[0058] Any changes and further modifications to the described equipment, apparatus, methods, and any further applications of the principles of the present disclosure are generally expected by those skilled in the art to which the present disclosure relates. In particular, it is entirely conceivable that the features, components, and / or steps described with respect to one example can be combined with the features, components, and / or steps described with respect to other examples of the present disclosure. In addition, the dimensions provided herein are for specific examples, and it is conceivable that different sizes, dimensions, and / or ratios can be utilized to implement the concepts of the present disclosure. In order to avoid unnecessary descriptive repetitions, one or more components or actions described according to an illustrative example can be used in other illustrative examples or omitted from other illustrative examples where applicable. For the sake of brevity, multiple iterations of these combinations will not be described separately. For simplicity, in some cases, the same reference numerals are used throughout the accompanying drawings to refer to the same or similar parts.

[0059] The systems and methods described herein may be applicable to imaging any of a variety of anatomical systems via natural or surgically created connecting channels, including lungs, colon, intestines, stomach, liver, kidneys and calyces, brain, heart, circulatory system including vascular system, etc. Although some examples of medical procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-restrictive. For example, the instruments, systems and methods described herein may be used for non-medical purposes, including industrial uses, general robotic uses, and sensing or manipulating non-tissue artifacts. Other example applications relate to cosmetic improvements, imaging of human or animal anatomical structures, collecting data from human or animal anatomical structures, and training medical or non-medical personnel. Additional example applications include processes for tissue removed from human or animal anatomical structures (not returned to human or animal anatomical structures), and processes performed on human or animal corpses. In addition, these technologies may also be used for surgical and non-surgical medical or diagnostic processes.

[0060] The methods described herein are shown as a set of operations or steps. Not all of the steps shown can be performed in all examples of the method. In addition, one or more steps not explicitly shown or described may be included before, after, between, or as part of the example steps. In some examples, one or more of the steps may be performed by a control system (e.g., control system 1112), or may be implemented at least in part in the form of executable code stored on a non-transient, tangible, machine-readable medium, which, when run by one or more processors (e.g., processor 1114 of control system 1112), may cause one or more processors to perform one or more of the steps.

[0061] Any "imaging device" described herein may include an ultrasound array, an optical imaging device, or any other suitable imaging hardware. Any described "imaging probe" may include an ultrasound probe, an optical imaging probe, or a probe incorporating any other suitable imaging modality. In addition, any "ultrasound array," "imaging array," or "imaging device" described herein may include a single imaging element (e.g., a transducer) or a plurality of such devices.

[0062] One or more elements in the examples of the present disclosure may be implemented in software to be executed on a processor of a computer system such as a control processing system. When implemented in software, the elements of the examples of the present invention are essentially code segments that perform the necessary tasks. The program or code segment may be stored in a processor-readable storage medium or device, which may be downloaded via a computer data signal embodied in a carrier wave over a transmission medium or a communication link. The processor-readable storage device may include any medium that may store information, including optical media, semiconductor media, and magnetic media. Examples of processor-readable storage devices include electronic circuits; semiconductor devices, semiconductor storage devices, read-only memories (ROMs), flash memories, erasable programmable read-only memories (EPROMs); floppy disks, CD-ROMs, optical disks, hard disks, or other storage devices. The code segments may be downloaded via a computer network (such as the Internet, an intranet, etc.). Any of a variety of centralized or distributed data processing architectures may be employed. The programming instructions may be implemented as multiple separate programs or subroutines, or they may be integrated into multiple other aspects of the systems described herein. In one example, the control system supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE 802.11, DECT, and wireless telemetry.

[0063] Note that the steps and displays presented may not be related to any particular computer or other device per se. Various general purpose systems may be used with the programs according to the teachings herein, or it may prove convenient to build more specialized devices to perform the described operations. The structures required for various of these systems will appear as elements in the claims. In addition, examples of the present invention are described without reference to any particular programming language. It should be understood that various programming languages ​​may be used to implement the teachings of the present invention as described herein.

[0064] In some cases, well-known methods, processes, components and circuits are not described in detail to avoid unnecessarily blurring the various aspects of the examples. The present disclosure describes various instruments, instrument parts and anatomical structures according to their states in three-dimensional space. As used herein, the term "position" refers to the positioning of an object or a part of an object in three-dimensional space (e.g., three translational degrees of freedom along Cartesian x, y and z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a part of an object (three rotational degrees of freedom, such as roll, pitch and yaw). As used herein, the term "posture" refers to the position of an object or a part of an object on at least one translational degree of freedom, and the orientation of the object or a part of an object on at least one rotational degree of freedom (up to six total degrees of freedom). As used herein, the term "shape" refers to a set of postures, positions or orientations measured along an object.

[0065] Although certain exemplary examples of the present invention are described and shown in the accompanying drawings, it should be understood that these examples are merely illustrative of the present invention and not restrictive thereof, and that the examples of the present invention are not limited to the specific constructions and arrangements shown and described, since various other modifications may occur to those skilled in the art.

Claims

1. A device comprising: An imaging probe, the imaging probe comprising: a passage extending through the imaging probe and terminating in an opening; and an imaging device configured to generate image data having a field of view; and A tool is configured to slidably extend within the passageway, wherein a portion of the tool is flexible and flexes away from the imaging device as the portion of the tool extends distally of the opening.

2. The apparatus of claim 1, wherein the portion of the tool is bent in a direction that causes the distal tip of the tool to be located within the field of view of the imaging device.

3. The device of claim 1, wherein the portion of the tool resists bending in a direction that causes the distal tip of the tool to be outside of an imaging plane of the field of view.

4. The device according to claim 1, wherein: The field of view increases with increasing distance from the imaging device.

5. The device of claim 1, wherein the portion of the tool has a curved shape.

6. The device of claim 5, wherein the curved shape of the tool is formed from a flexible shape memory material.

7. The apparatus of claim 5, wherein the curved shape of the tool is formed by surface features on the portion of the tool.

8. The apparatus of claim 1, wherein the portion of the tool has a straight shape and the passageway of the imaging probe includes a curved passageway portion that curves the portion.

9. The device of any one of claims 1-8, wherein the tool is constrained to prevent rotation of the tool within the passageway.

10. The apparatus of claim 9, wherein each of the tool and the passageway has a cross-sectional shape that is asymmetric in an orthogonal dimension.

11. The device of claim 10, wherein the cross-sectional shape of the passage is oval and the cross-sectional shape of the tool is oval.

12. The device of claim 10, wherein the cross-sectional shape of the passage is oval, and the cross-sectional shape of the tool is D-shaped.

13. The device of claim 10, wherein the cross-sectional shape of the passage is D-shaped, and the cross-sectional shape of the tool is D-shaped.

14. The device of claim 1, wherein the cross-sectional shape of the passageway is different than the cross-sectional shape of the tool.

15. The apparatus of claim 1, wherein the imaging device is bent away from a longitudinal axis of the passageway in a first direction and the portion of the tool is bent away from the longitudinal axis of the passageway in a second direction opposite the first direction.

16. The apparatus of claim 15, wherein a bending angle between the imaging device and the tool is between 20 degrees and 80 degrees.

17. The device of any one of claims 1-8, wherein the tool is a tissue piercing tool including a beveled tip, and the tool is rotationally constrained relative to the passageway.

18. The device of any one of claims 1 to 8, wherein the outer width of the imaging probe is between about 3.0 mm and 20 mm, and the outer width of the tool is between about 1.0 mm and 3.5 mm.

19. A system comprising: an imaging probe including a passageway extending through the imaging probe and terminating in an opening, and an imaging device configured to generate image data having a field of view; as well as a tool configured to slidably extend within the passageway, wherein a portion of the tool is flexible and flexes away from the imaging device as the portion of the tool extends distally of the opening; and A control system comprising one or more processors, the control system being configured to: deploying the portion of the tool distal to the opening and into the field of view; and Image data including the portion of the tool in the field of view is received.

20. The system of claim 19, wherein the control system is further configured to evaluate the image data to determine a position of the tool relative to target tissue in the field of view.

21. The system of claim 19, wherein the control system is further configured to evaluate the image data to determine a position of the tool relative to delicate tissue in the field of view.

22. The system of claim 19, wherein: Deploying the portion of the tool includes bending the tool in a direction that causes a distal tip of the tool to be within the field of view.

23. The system of claim 19, wherein the portion of the tool resists bending in a direction that causes the distal tip of the tool to be outside of an imaging plane of the field of view.

24. The system of claim 19, wherein: The field of view increases with increasing distance from the imaging device.

25. The system of claim 19, wherein the portion of the tool has a curved shape.

26. The system of claim 25, wherein the curved shape of the tool is formed from a flexible shape memory material.

27. The system of claim 25, wherein the curved shape of the tool is formed by surface features on the portion of the tool.

28. The system of claim 19, wherein the portion of the tool has a straight shape and the pathway of the imaging probe includes a curved pathway portion that curves the portion.

29. The system of any one of claims 19-28, wherein the tool is constrained to prevent rotation of the tool within the passageway.

30. The system of claim 29, wherein each of the tool and the passageway has a cross-sectional shape that is asymmetric in an orthogonal dimension.

31. The system of claim 30, wherein the passageway is oval in cross-sectional shape and the tool is oval in cross-sectional shape.

32. The system of claim 30, wherein the cross-sectional shape of the passageway is oval and the cross-sectional shape of the tool is D-shaped.

33. The system of claim 30, wherein the passageway has a D-shaped cross-sectional shape and the tool has a D-shaped cross-sectional shape.

34. The system of claim 19, wherein the cross-sectional shape of the passageway is different than the cross-sectional shape of the tool.

35. The system of claim 19, wherein the imaging device is bent in a first direction away from a longitudinal axis of the passageway, and the portion of the tool is bent in a second direction opposite the first direction away from the longitudinal axis of the passageway.

36. The system of claim 35, wherein the bending angle between the imaging device and the tool is between 20 degrees and 80 degrees.

37. The system of any one of claims 19-28, wherein the tool is a tissue piercing tool including a beveled tip, and the tool is rotationally constrained relative to the passageway.

38. The system of any one of claims 19 to 28, wherein the imaging probe has an outer width between approximately 3.0 mm and 20.0 mm, and the tool has an outer width between approximately 1.0 mm and 3.5 mm.

Images