Hinged distal tip of endobronchial ultrasound bronchoscope

Abstract

A medical device can include an elongate member extending from a handle and an end effector assembly at a distal end of the elongate member. The end effector assembly has a first member coupled at a distal end that defines a lumen to position a resection element at an angle. The end effector assembly has a second member rotatably coupled with the first member that can rotate between a first position and a second position. The second member has an ultrasonic transducer that creates a first field of view in the first position and creates a second field of view in the second position. The first member positions the resection element at the angle in the first field of view in the first position and positions the resection element at the angle in the second field of view in the second position.

Description

HINGED DISTAL TIP OF ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPE PRIORITY CLAIM

[0001] This application claims priority to U.S. Provisional Patent Application Serial No.63 / 535,815, filed August 31, 2023; the contents of which are incorporated herein by reference. TECHNICAL FIELD

[0002] This document pertains generally, but not by way of limitation, to surgical devices that can be used for various surgical procedures. More specifically, but not by way of limitation, the present application relates to a surgical device that can be used during a bronchoscopy. BACKGROUND

[0003] Suspicious tissue can grow in bronchi that can be cancerous. The suspicious tissue can be nodules located in an airway wall or just outside an airway wall. In order to determine if the suspicious tissue is cancerous, a practitioner removes a portion of the suspicious tissue during a lung biopsy procedure for testing. A practitioner uses a bronchoscope to navigate to the area having the suspicious tissue and uses the bronchoscope to remove a portion of the suspicious tissue. The bronchoscope can include a light source, an ultrasound transducer, and a camera which allows visualization of the area having the suspicious tissue along with a needle that can be used to remove a portion of the suspicious tissue. The light source and the camera can be arranged in close proximity to the ultrasound transducer, in both a radial and an axial direction.

[0004] In order to provide an adequate rendering of a field of view of the suspicious tissue in instances when the tissue is just outside an airway wall, the ultrasound transducer should contact airway tissue that is near the suspicious tissue. However, due to the close proximity of the camera to the ultrasound transducer, a gap may exist between the airway tissue and the ultrasound transducer. An airgap can be created in the gap between the airway tissue and the ultrasound transducer. Due to airhaving a low acoustic impedance relative to the airway tissue, an impedance mismatch can occur because of the airgap. As a result, ultrasonic waves which strike an airway tissue-air surface at the airgap will be mostly reflected back. Therefore, penetration of ultrasonic waves into the airway tissue and beyond the airway tissue where the suspicious tissue is located is limited, which can result in poor imaging of a field of view.

[0005] When suspicious tissue is identified, the needle can be deployed to remove the suspicious tissue. However, a number of issues can arise. First, poor imaging as described above can make it difficult to remove the suspicious tissue where a practitioner could remove tissue that is in fact healthy with the needle. Second, the needle exits the bronchoscope from a location that is offset from the ultrasonic transducer in an axial direction. The ultrasonic transducer can be at a first position of the bronchoscope that is rigidly fixed relative to a second position at which the needle exits the bronchoscope. Therefore, if the field of view of the suspicious tissue is not along a trajectory of the needle when the needle exits the bronchoscope, the practitioner must reposition the bronchoscope.

[0006] In addition to the ultrasonic transducer being rigidly fixed relative to an exit point of the needle, typically, the ultrasonic transducer is rigidly fixed relative to the light source and the camera, thereby increasing an overall length of the bronchoscope. The increased length of the bronchoscope can limit the maneuverability of the bronchoscope in outer lung airways. SUMMARY

[0007] Accordingly, what is needed is a bronchoscope having an end effector that is capable of minimizing an airgap between airway tissue and an ultrasound transducer of the end effector. The end effector should be able to provide a field of view of a target site that is adjustable based on an expected trajectory of a resection element. The end effector should also allow for increased maneuverability of the bronchoscope in outer lung passageways. This problem can be addressed by providing a bronchoscope having an end effector that includes a first member and a second member rotatably coupled with the first member. The end effector can include a hinge that operatively couples the first member with the second member and allows rotation of the secondmember relative to the first member. By having the first member rotatable relative to the second member, a maneuverability of the end effector is increased, thereby allowing passage into more tortuous anatomy, such as outer lung airways.

[0008] The first member can include a ramp having a first angle and an opening through which a resection element (e.g., a biopsy needle) can extend from the distal section. The ramp can control the orientation of the resection element as the resection element extends from the first member and into a target site. Moreover, the first angle can be used to determine an expected trajectory of the needle within a field of view of the target site. By virtue of the first member being hinged relative to the second member, the trajectory of the needle within the target site can be adjusted and controlled by rotating the first member relative to the second member.

[0009] The second member can have an ultrasonic transducer that can create the field of view within the target site. The field of view can be used to determine if an expected trajectory of the resection element overlaps with a target within the target site. If a determination is made that the expected trajectory will not overlap the target within the target site, the first member can be rotated relative to the second member until a determination is made that the resection element will overlap the target within the target site.

[0010] If the target within the target site is not visible in the field of view, the second member can be rotated relative to the first member until the target within the target site becomes visible. If only a portion of the target within the target site is visible within the field of view, the second member can be rotated relative to the first member until enough of the target within the target site is visible in the field of view to allow for a proper biopsy. By virtue of the second member being hinged relative to the first member, the field of view can be controlled by rotating the second member relative to the first member, thereby causing the transducer of the second member to come into contact with the airway wall to generate an ultrasound field of view including the target and further causing the expected needle trajectory to intersect the target.

[0011] The first member can be positionable against a first surface, such as a first portion of airway tissue near a target site. The second member can be positionable against a second surface, such as a second portion of airway tissue near the target site.In some instances, the first portion of the airway tissue may be non-planar with the second portion of the airway tissue. Since the first member and the second member are rotatable with respect to each other, the second member can remain flush with the airway tissue while the first member remains planar or at least in close proximity to the first portion for the airway tissue. When the second member remains flush with the second portion of the airway, airgaps between the second portion of the airway tissue and the second member are minimized, thereby improving imaging quality of the target site and the target and avoiding the problems discussed above.

[0012] A potential advantage of having a hinge between first and second members of an end effector is the reduction of a rigid length from a distal end of a device at which the end effector is located to a distal tip of the end effector.

[0013] A further advantage of having a hinge between first and second members of an end effector is the use of a linear array with a small diameter device, which can be a diameter of 4.9 mm.

[0014] A potential advantage includes a device having the ability to access more tortuous pathways by rotating the first member relative to the second member in areas that require greater maneuverability.

[0015] Another potential advantage relates to a device that can more accurately image a target site since airgaps can be minimized between tissue and members that include ultrasonic transducers.

[0016] A further potential advantage relates to adjusting a trajectory of a resection element when an expected trajectory does not overlap with a target. BRIEF DESCRIPTION OF FIGURES

[0017] Figure 1 illustrates a bronchoscope system having a bronchoscope, in accordance with some examples.

[0018] Figure 2 is a schematic diagram of the bronchoscope system of Figure 1, in accordance with some examples.

[0019] Figures 3A and 3B illustrate an end effector assembly of the bronchoscope of Figure 1, in accordance with some examples.

[0020] Figures 4 and 5 shows a member of the end effector assembly of Figures 3A and 3B, in accordance with some examples.

[0021] Figures 6A and 6B illustrate the positioning of the end effector assembly of Figures 3A and 3B at a target site, in accordance with some examples.

[0022] Figures 7-9 show the formation of fields of view at a target site by the end effector assembly of Figures 3A and 3B, in accordance with some examples.

[0023] Figure 10 illustrates a configuration of electromagnetic sensors in a member of end effector assembly of Figures 3A and 3B, in accordance with some examples.

[0024] Figures 11 and 12 illustrates a distal end of an end effector assembly, in accordance with some examples.

[0025] Figure 13 illustrates a method for positioning a device having a first member and a second member rotatably coupled with the first member at a target site to view a target in accordance with some examples. DETAILED DESCRIPTION

[0026] A bronchoscope can have an end effector that includes a first member and a second member rotatably coupled with the first member. The end effector can include a hinge that operatively couples the first member with the second member and allows rotation of the second member relative to the first member. An example of a bronchoscope 100 having this type of end effector 102 is shown in Figure 1.

[0027] Figure 1 is a schematic diagram of a bronchoscope system 104 that can include an imaging and control system 106 along with the bronchoscope 100. The bronchoscope system 104 is an illustrative example of a system suitable for use with the devices and methods described herein, such as a bronchoscope with an integrated stabilizer or cannulation elements.

[0028] The bronchoscope 100 can be insertable into a target site for imaging or to provide passage of or attachment to (e.g., via tethering) one or more sampling devices for biopsies, or one or more therapeutic devices for treatment of a disease state associated with the target site. The bronchoscope 100 can interface with and connect to imaging and control system 106. The bronchoscope 100 can also include a duodenoscope, though other types of endoscopes can be used with the features discussed herein. The imaging and control system 106 can include an output unit 110,an input unit 112, a light source 114, a fluid source 116, a suction pump 118, and a control unit 120.

[0029] The imaging and control system 106 can include various ports for coupling with the bronchoscope system 104. For example, the control unit 120 can include a data input / output port for receiving data from and communicating data to the bronchoscope 100. The light source 114 can include an output port for transmitting light to the bronchoscope 100, such as via a fiber optic link. The fluid source 116 can include a port for transmitting fluid to the bronchoscope 100. The fluid source 116 can include, for example, a pump and a tank of fluid or can be connected to an external tank, vessel or storage unit. A suction pump can include a port used to draw a vacuum from the bronchoscope 100 to generate suction, such as for withdrawing fluid from the target site into which the bronchoscope 100 is inserted and withdrawing samples from a target resected from the target with a resection element. The output unit 110 and the input unit 112 can be used by an operator of the bronchoscope system 104 to control functions of the bronchoscope system 104 and view output of the bronchoscope 100. The control unit 120 can additionally be used to generate signals or other outputs for treating the target site into which the bronchoscope 100 is inserted. The control unit 120 can generate electrical output, acoustic output, a fluid output and the like for treating the target site with cauterizing, cutting, freezing, and the like.

[0030] The control unit 120 can include an imaging engine that can receive ultrasound signal data from sensors at the end effector 102. The imaging engine can process the received ultrasound signal data to produce real-time ultrasound images for display on the output unit 110. While the control unit 120 is described as having this functionality, the bronchoscope system 104 can include separate componentry that provides an imaging engine and the functionality described herein.

[0031] The bronchoscope 100 can include an insertion section 122, a handle 124, which can be coupled to a cable section 126, and a coupler section 200 (Figure 2). The insertion section 122 can extend distally from the handle 124 to the end effector 102 and the cable section 200 can extend proximally from the handle 124. The insertion section 122 can be elongate and include a bending section, and a distal end to which the end effector 102 can be attached. The bending section can be controllable (e.g., by a control knob on the handle 124) to maneuver the distal end through tortuouspassageways (e.g., stomach, duodenum, kidney, ureter, etc.). The insertion section 122 can also include one or more working channels (e.g., an internal lumen) that can be elongate and can support insertion of one or more therapeutic tools of the end effector 102. The working channel can extend between the handle 124 and the end effector 102. Additional functionalities, such as fluid passages, guide wires, and pull wires can also be provided by the insertion section 122 (e.g., via suction or irrigation passageways, or the like).

[0032] The coupler section 200 can be connected to the control unit 120 to connect the bronchoscope 100 to multiple features of the control unit 120, such as the input unit 112, the light source unit 114, the fluid source 118, and the suction pump.

[0033] The handle 124 can include a knob 128 as well as a port 202. The knob 128 can be connected to a pull wire, or other actuation mechanisms, extending through insertion the insertion section 122. The port 202, as well as other ports, can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle 124, such as for coupling with the insertion section 122.

[0034] The imaging and control system 106 can be provided on a mobile platform (e.g., a cart 130) with shelves for housing the light source 114, the suction pump, an image processing unit 204 (Figure 2), etc. Alternatively, several components of imaging and the control system 106 can be provided directly on the bronchoscope 100 so as to make the endoscope “self-contained.”

[0035] Figure 2 is a schematic diagram of the bronchoscope system 104 including the imaging and control system 106 of Figure 1. The control unit 120 can include or can be coupled to an image processing unit 204, a treatment generator 206, and a drive unit 208, as well as the light source 114, the input unit 112, and the output unit 110. The control unit 120 can include, or can be in communication with, a surgical instrument, which can include a device configured to engage tissue and collect and store a portion of that tissue and through which imaging equipment (e.g., a camera) can view target tissue via inclusion of optically enhanced materials and components. The control unit 120 can be configured to activate a camera to view target tissue distal of the bronchoscope system 104 and the bronchoscope 100. Likewise, the control unit 120 can be configured to activate the light source unit 114 to shine light on the surgicalinstrument, which can include select components that are configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles. The light source 114 can be controlled to illuminate a target site using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like).

[0036] The coupler section 200 can be connected to the control unit 120 to connect the bronchoscope 100 to multiple features of the control unit 120, such as the image processing unit 204 and the treatment generator 206. In examples, the port 40 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, into the bronchoscope 100. Such instruments and devices can be independently connected to the control unit 120 via the cable section 126.

[0037] The image processing unit 204 and light source 114 can each interface with the bronchoscope 100 by wired or wireless electrical connections. The imaging and control system 106 can accordingly illuminate a target site, collect signals representing the target site, process signals representing the target site, and display images representing the target site on the display unit 110. The imaging and control system 106 can connect (e.g., via an endoscope connector) to the bronchoscope 100 for signal transmission (e.g., light output from a light source, video signals from an imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).

[0038] The fluid source 116 can be in communication with the control unit 120 and can include one or more sources of air, saline, or other fluids, as well as associated fluid pathways (e.g., air channels, irrigation channels, suction channels) and connectors (barb fittings, fluid seals, valves and the like). The fluid source 116 can be utilized as an activation energy source for a biasing device or a pressure-applying device of features discussed herein. The imaging and control system 106 can also include the drive unit 208, which can include a motorized drive for advancing a distal section of bronchoscope 100.

[0039] The end effector 102 can include a first member 300 (Figure 3A) coupled at a distal end 302 of the insertion section 122. The first member 300 can include a lumen port 304 from which a resection element 400 (Figure 4) can extend that can be used to resect tissue from a target site. In particular, the resection element 400 can include acutting portion 402 that can be used to resect tissue from a target. Furthermore, the resection element 400 can include an inner lumen 404, which can be coupled to a suction source (not shown). Tissue resected from a target by the cutting portion 402 can be withdrawn from a target site via a suction that is applied at the inner lumen 404 by the suction source. The end effector 102 can include a ramp 406 that can guide the resection element 400 away from the end effector 102 and towards a target.

[0040] Returning attention Figure 3A, the first member 300 can include a camera / illuminating feature 308, which is capable of assisting navigation of the end effector 102 through anatomy of a patient to a target site. Examples of cameras that can be used for the camera / illuminating feature 308 can include a Complimentary Metal-Oxide Semiconductor (CMOS) camera or a charge-coupled device (CCD) camera. Examples for the illuminating feature can include a fiber optic, light emitting diodes, or any other type of illumination device capable of illuminating a field of view being viewed by the camera / illuminating feature 308.

[0041] The first member can be rotatably coupled with a second member 306 via a hinge 310. The hinge 310 can allow for rotation of the first member 300 relative to the second member 306 and rotation of the second member 306 relative to the first member 300. Examples of the hinge 310 can include a barrel hinge or any type of hinge having a pin, knuckle, and a leaf or similar structure that can allow for rotation of the first member 300 relative to the second member 306 and vice versa.

[0042] The hinge 310 can include a biasing means 312, which can provide for passive articulation of the end effector 102 between the positions shown in Figures 3A and 3B. Passive articulation may occur as a result of exterior forces being applied against one or both of the first member 300 and the second member 306. The hinge 310 can include a pin 500 (Figure 5) about which the biasing means 312 can be disposed where a first portion 502 of the biasing means 312 can abut against the first member 300 while a second portion 504 of the biasing means 312 can abut against the second member 306 thereby biasing the end effector 102 into the position of Figure 3A. The biasing means 312 can be a torsion spring or any other type of biasing mechanism capable of biasing opposing members about a pivot point, such as the hinge pin 500. The hinge pin 500 can pass through a knuckle 506. The hinge pin 500 and the hinge knuckle 506 can rotate relative to each other. Thus, when the biasing means 312 biasesthe end effector 102 such that the first member 300 rotates relative to the second member 306, the hinge knuckle 506 can rotate relative to the hinge pin 500 thereby allowing the end effector 102 to have the configurations shown in Figures 3A and 3B.

[0043] The hinge 310 allows for repositioning of the end effector 102 within an airway 600 when a practitioner is attempting to remove a sample from a target 602 within a target site 604. The target 602 can correspond to suspicious tissue, which can be cancerous and a practitioner may desire to remove a sample of the suspicious tissue for testing. The target site 604 can correspond to an anatomy of a patient, such as a lung. A practitioner may desire to remove a portion of the target 602 with the end effector 102. The practitioner can position the end effector 102 within the airway 600 as shown in Figure 6A where a surface 606 of the first member 300 abuts an airway wall surface 608 while a surface 610 of the second member 306 abuts the airway wall surface 608.

[0044] In Figure 6A, a resection element (similar to the resection element 400 but not shown for ease of discussion) that extends from the lumen port 304 has a resection element trajectory 612. As may be seen within a field of view 614 in Figure 6A, the resection element trajectory 612 does not intersect or overlap with the target 602. Thus, when the practitioner extends the resection element 400 from the lumen port 304, the resection element 400 will not be able to resect a portion of the target 602 for testing. Instead, healthy tissue may be resected from the target site 604, which can lead to erroneous results as mentioned above.

[0045] A practitioner can pivot the end effector 102 in a direction Y where the second member 306 can rotate relative to the first member 300 about the hinge 310 such that the end effector assembly has the orientation shown in Figure 6B. A practitioner can move a handle 124 (Figure 1) of the bronchoscope 100 such that the second member surface 610 abuts the airway wall surface 608 as shown in Figure 6B, thereby passively rotating the second member 306 relative to the first member 300 about the hinge 310 by virtue of a force imparted at the handle 124 and translated about the hinge 310. Alternatively, the bronchoscope 100 can include a guidewire that extends from the second member 306 to the handle 124 where a practitioner can pull on the guidewire along a direction A to rotate the second member 306 relative to the first member 300 about the hinge 310 in the direction Y in an active manner. Moreover, agap 616 can be created between the first member surface 606 and the airwall 608. When the end effector 102 has the orientation shown in Figure 6B, a resection element trajectory 618 intersects / overlaps with the target 602. Thus, when a practitioner maneuvers a resection element along the resection element trajectory 618, the resection element will contact the target 602 and can be used to remove a tissue sample from the target 602 for testing.

[0046] In order to create the field of view 614, the end effector can include a sensor 700 that can have an array that can convert electrical signals into ultrasound signals and convert reflected ultrasound signals into electrical signals. The converted electrical signals can be sent to an imaging engine described above to image the target 602 and create the field of view 614 for display on the display unit 110. Thus, the sensor 700 can be used to create the field of view 614.

[0047] The sensor 700 can be an ultrasound sensor, such as a piezoelectric micromachined ultrasonic transducer (PMUT), a capacitive micromachined ultrasonic transducer (CMUT), or a polymer-based CMUT. When the sensor 700 is a PMUT, the sensor can include a flexible substrate, an ultrasound transducer array, mixed-signal integrated circuits (IC), and capacitors. The flexible substrate can be a laminated structure having a cover layer, an electrical insulating layer, electrically conductive features, and adhesives. The electrical insulating layer can be made of polyimide having a thickness of about 12 µm. The electrically conductive features can be etched from copper foils having a thickness of about 5 µm, vapor deposited copper having a thickness in a range between about 2 µm and about 4 µm thick, vapor deposited nickel having a thickness in a range between about 2 µm and about 4 µm thick or vapor deposited gold having a thickness of about 0.5 µm. The flexible substrate can include electrical contacts such as pads for die attachment of components for the mixed-signal ICs and capacitors. The ultrasound transducer array can include an array of 64 elements where each element includes at least one PMUT. The PMUTs can have a resonant frequency between about 5 MHz and about 40 MHz. The PMUTs can also have a resonant frequency of about 9.0 MHz.

[0048] When the sensor 700 is a CMUT, the sensor 700 can be formed with a silicon substrate where a cavity can be formed in the silicon substrate. A thin layer can be suspended over the cavity and function as a membrane where a metalized layer canact as an electrode. When an AC signal is applied across the electrode, ultrasonic waves can be produced in the target site 604 and in particular in the field of view 614. The ultrasonic waves can be used to determine a location of the target 602 within the target site 604 and the field of view 614.

[0049] By virtue of the second member 306 being rotatable relative to the first member 300 about the hinge 310, a field of view created by the sensor 700 is adjustable. For example, a practitioner may desire to view a target 702 with the end effector assembly 102. However, as may be seen in Figure 7, the target 702 is outside of the field of view 614. Thus, a practitioner can rotate the second member 306 relative to the first member 300 about the hinge 310 along the direction Y to create a field of view 800. The target 702 is in the field of view 800 such that a practitioner can see the target 702 via the output unit 110 and remove tissue from the target 702 with a resection element.

[0050] With particular reference to Figure 9, in some instances, when a practitioner positions the end effector 102 within the airway 600, a gap 900 may exist between the second member surface 610 and the airway wall surface 608 that can create an airgap 902. The airgap 902 can create poor imaging of the target 602 and the target site 604, as discussed above. A practitioner can rotate the first member 300 relative to the second member 306 along a direction X into the orientation of Figure 6B where the airgap 902 is eliminated. Accordingly, the sensor 700 can sense ultrasonic signals that can be used to accurately image the target site 604 and the target 602 within the field of view 614.

[0051] The end effector 102 can include electromagnetic elements that can be used to track a trajectory of the resection element 400 within the fields of view 614 and 800. In a first example, the first member 300 can include an electromagnetic (EM) sensor 704 and the second member 306 can include an EM sensor 706. Each of the EM sensors 704 and 706 can have lead wires that extend into the insertion section 122 and to a power source at the bronchoscope system 104. In addition, the EM sensors 704 and 706 can each have coil elements that can function as solenoids in order to determine a trajectory of the resection element 400 within the target site 604.

[0052] A location of the EM sensor 704 can be fixed relative to the sensor 700 and a location of the EM sensor 706 can be fixed relative to a location of the ramp 406. Afirst angular position between the EM sensor 704 and the EM sensor 706 can be calibrated in a resting position, such as when the end effector 102 has the position in Figure 7. As the angular position changes from the first angular position to a second angular position, such as when the first member 300 rotates relative to the second member 306 and the end effector 102 has the position in Figure 8, the difference between the angular positions, which can be determined from the EM sensors 704 and 706, can be used to determine a resection trajectory 802.

[0053] While two EM sensors, the EM sensors 704 and 706 are shown in Figure 7, in alternatives, the end effector 102 can include more than two EM sensors. In particular, the second member 306 can include two EM sensors, such as EM sensors 1000 and 1002, as shown in Figure 10. The sensors 1000 and 1002 can have the same functionality as the EM sensors 704 and 706 as discussed above.

[0054] In further examples, the second member 306 can include a camera 1100 located at a distal tip 1102 of the second member 306 as shown in Figures 11 and 12. An illumination feature 1104 and associated circuitry 1106 can also be disposed at the second member distal tip 1102. The illumination feature 1104 can be a fiber optic, a light emitting diode, or any other type of illuminating device capable of illuminating a field of view being viewed by the camera 1100. By placing the camera 1100 at the second member distal tip 1102, an overall diameter of the end effector 102 can be reduced.

[0055] While the sensor 700 is shown as being substantially flat, in alternatives, the sensor 700 can have a curved configuration in order to increase a field of view. Furthermore, a length of the second member 306 can be variable along with a length of the sensor 700 in order to increase a field of view or decrease a field of view.

[0056] Now making reference to Figure 13, a method 1300 for positioning a device having a first member and a second member rotatably coupled with the first member at a target site to view a target is shown. The first member can define a lumen that can be configured to position a resection element within the target site. The second member can include an ultrasound transducer, which can be used to create a field of view for the target site. During an operation 1302, the first member can be positioned in a first position against a first surface at the target site. Furthermore, during an operation 1304, the second member can be positioned in a second position against a second surface thatis adjacent the first surface. The second surface can be non-planar with the first surface. While the operation 1304 is described as occurring after the operation 1302, the operation 1304 can be performed before the operation 1302 or contemporaneously with the operation 1302.

[0057] As an example of the method 1300, and referred to herein as the “example,” reference is now made to Figure 6A. During the operation 1302, the first member 300 is moved into a first position within the airway 600 where the first member surface 606 is against the airway wall surface 608. During the operation 1304, the second member 306 is moved into a second position within the airway 600, where the second member 610 is against the airwall wall surface 609, which is non-planar with the airwall surface 608.

[0058] Returning to Figure 13 and the method 1300, after the first and second members are positioned in the operations 1302 and 1304, an operation 1306 is performed where an ultrasound transducer of the second member can create a field of view for a target site. The field of view can include a target within the target site. Once the field of view is created, a trajectory of an element within the field of view is determined in an operation 1308. Returning to the example and Figure 6A, during the operation 1306, the sensor 700 can create the field of view 614 for the target site 604 that can include the target 602. Moreover, the resection element trajectory 612 of the resection element 400 can be determined during the operation 1308 as described above.

[0059] Turning attention back to Figure 13 and the method 1300, after the trajectory of the element is determined in the operation 1308, an operation 1310 is performed where a determination is made if the resection element comes into contact with the target at the target site based on the determined trajectory. The resection element can come into contact with the target when the resection element extends from the device. This determination can be made by mapping the trajectory through the target site and, if the trajectory overlaps the target, a determination can be made that the resection element comes into contact with the target. Alternatively, if the trajectory does not overlap the target when the resection element extends from the device, then a determination can be made that the resection element does not come into contact with the target.

[0060] Referring back to the example and Figure 6A, the EM sensors 704 and 706 determine that, based on the first position of the first member 300 in Figure 6A, when the resection element 400 extends from the end effector 102 via the lumen port 304, the resection element 400 will extend through the target site 604 along the resection element trajectory 612. As can be seen, the resection element trajectory 612 does not overlap with the target 602. Thus, during the operation 1310, a determination is made that the resection element will not come into contact with the target 602.

[0061] Returning to Figure 13 and the method 1300, the first member is adjusted from the first position to a third position against the surface when a determination is made that the resection element will bypass the target based on the determined trajectory in an operation 1312. In the example, during the operation 1312, the first member 300 is rotated about the hinge 310 along the direction X into the position shown in Figure 6B. In the third position, the first element 300 can be rotated such that the gap 616 exists between the first member surface 606 and the airwall surface 608. In the third position, the resection element trajectory 618 determined by the EM sensors 704 and 706 overlaps the target 602 such that the resection element 400 will come into contact with the target 602 when the resection element 400 extends from the end effector 192 and the lumen port 304.

[0062] Having described various aspects and features of the inventive subject matter, the following numbered examples are provided as illustrative embodiments:

[0063] Example 1 is a medical device comprising: a handle; an elongate member extending from the handle; an end effector assembly at a distal end of the elongate member, the end effector assembly comprising: a first member coupled at the elongate member distal end, the first member defining a lumen configured to position a resection element at an angle; and a second member rotatably coupled with the first member, the second member rotatable between a first position relative to the first member and a second position relative to the first member, the second member having an ultrasonic transducer configured to create a first field of view in the first position and a second field of view in the second position where the first member is configured to position the resection element at the angle in the first field of view in the first position and positions the resection element at the angle in the second field of view in the second position.

[0064] In Example 2, the subject matter of Example 1 includes, wherein a hinge rotatably couples the first member with the second member.

[0065] In Example 3, the subject matter of Examples 1–2 includes, wherein the second member comprises an electromagnetic coil element.

[0066] In Example 4, the subject matter of Examples 1–3 includes, wherein the first member comprises an electromagnetic coil element.

[0067] In Example 5, the subject matter of Examples 1–4 includes, wherein the first member lumen defines a ramp at an opening of the first member lumen where the ramp is configured to direct the resection element at the angle, and wherein the angle is an acute angle with respect to a longitudinal axis of the first member.

[0068] In Example 6, the subject matter of Examples 1–5 includes, wherein the first member includes a camera located at a distal end of the first member.

[0069] In Example 7, the subject matter of Examples 1–6 includes, wherein the second member includes a camera located at a distal end of the second member.

[0070] In Example 8, the subject matter of Examples 1–7 includes, wherein the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer.

[0071] In Example 9, the subject matter of Examples 1–8 includes, wherein the ultrasonic transducer is a capacitive micromachined ultrasonic transducer.

[0072] Example 10 is a method of positioning a device having a first member and a second member rotatably coupled with the first member, the first member defining a lumen configured to position a resection element at an angle and the second member having an ultrasonic transducer, the method comprising: positioning the first member in a first position against a first surface; positioning the second member in a second position against a second surface adjacent the first surface, the first surface being non- planar with the second surface; creating a field of view for a target site with the ultrasonic transducer, the field of view including a target within the target site; determining a trajectory of the resection element within the field of view; determining if the resection element comes into contact with the target based on the determined trajectory; and adjusting the first member from the first position to a third position against the first surface when a determination is made that the resection element will bypass the target based on the determined trajectory.

[0073] In Example 11, the subject matter of Example 10 includes, wherein the first member is positioned against the first surface such that the first member is flush against the first surface in the first position.

[0074] In Example 12, the subject matter of Example 11 includes, wherein the second member is positioned against the second surface such that the second member is flush against the second surface in the second position.

[0075] In Example 13, the subject matter of Examples 10–12 includes, wherein the first member is positioned against the first surface such that an airgap exists between the first member and the first surface in the third position.

[0076] In Example 14, the subject matter of Examples 10–13 includes, wherein a hinge rotatably couples the first member with the second member.

[0077] In Example 15, the subject matter of Examples 10–14 includes, wherein the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer.

[0078] In Example 16, the subject matter of Examples 10–15 includes, wherein the ultrasonic transducer is a capacitive micromachined ultrasonic transducer.

[0079] Example 17 is a medical device for obtaining a sample of a target while imaging the target via ultrasound, the medical device comprising: a handle; an elongate member extending from the handle and including a lumen through which a resection tool is advanceable; an end effector assembly at a distal end of the elongate member, the end effector assembly comprising: a first member coupled at the elongate member distal end, the first member defining a side exit ramp configured to receive the resection tool from the lumen and to direct the resection tool into the target at an acute angle with respect to a longitudinal axis of the first member; and a second member rotatably coupled with the first member, the second member rotatable between a first position relative to the first member and a second position relative to the first member, the second member having an ultrasonic transducer configured to generate an ultrasound field of view that includes, the target and the resection tool while the sample is being obtained, wherein rotation of the second member between the first position and the second position causes a needle trajectory extending from the side exit ramp to traverse across a portion of the field of view.

[0080] In Example 18, the subject matter of Example 17 includes, wherein the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer.

[0081] In Example 19, the subject matter of Examples 17–18 includes, wherein the ultrasonic transducer is a capacitive micromachined ultrasonic transducer.

[0082] In Example 20, the subject matter of Examples 1–19 includes, wherein the second member includes a camera located at a distal end of the second member.

[0083] Example 21 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1–20.

[0084] Example 22 is an apparatus comprising means to implement of any of Examples 1–20.

[0085] Example 23 is a system to implement of any of Examples 1–20.

[0086] Example 24 is a method to implement of any of Examples 1–20.

[0087] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific examples in which the invention can be practiced. These examples are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0088] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in thefollowing claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0089] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other examples can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description as examples or examples, with each claim standing on its own as a separate example, and it is contemplated that such examples can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

WHAT IS CLAIMED IS:

1. A medical device comprising: a handle; an elongate member extending from the handle; an end effector assembly at a distal end of the elongate member, the end effector assembly comprising: a first member coupled at the elongate member distal end, the first member defining a lumen configured to position a resection element at an angle; and a second member rotatably coupled with the first member, the second member rotatable between a first position relative to the first member and a second position relative to the first member, the second member having an ultrasonic transducer configured to create a first field of view in the first position and a second field of view in the second position where the first member is configured to position the resection element at the angle in the first field of view in the first position and positions the resection element at the angle in the second field of view in the second position.

2. The medical device of claim 1, wherein a hinge rotatably couples the first member with the second member.

3. The medical device of claim 1, wherein the second member comprises an electromagnetic coil element.

4. The medical device of claim 1, wherein the first member comprises an electromagnetic coil element.

5. The medical device of claim 1, wherein the first member lumen defines a ramp at an opening of the first member lumen where the ramp is configured to direct the resection element at the angle, and wherein the angle is an acute angle with respect to a longitudinal axis of the first member.

6. The medical device of claim 1, wherein the first member includes a camera located at a distal end of the first member.

7. The medical device of claim 1, wherein the second member includes a camera located at a distal end of the second member.

8. The medical device of claim 1, wherein the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer.

9. The medical device of claim 1, wherein the ultrasonic transducer is a capacitive micromachined ultrasonic transducer.

10. A method of positioning a device having a first member and a second member rotatably coupled with the first member, the first member defining a lumen configured to position a resection element at an angle and the second member having an ultrasonic transducer, the method comprising: positioning the first member in a first position against a first surface; positioning the second member in a second position against a second surface adjacent the first surface, the first surface being non-planar with the second surface; creating a field of view for a target site with the ultrasonic transducer, the field of view including a target within the target site; determining a trajectory of the resection element within the field of view; determining if the resection element comes into contact with the target based on the determined trajectory; and adjusting the first member from the first position to a third position against the first surface when a determination is made that the resection element will bypass the target based on the determined trajectory.

11. The method of claim 10, wherein the first member is positioned against the first surface such that the first member is flush against the first surface in the first position.

12. The method of claim 11, wherein the second member is positioned against the second surface such that the second member is flush against the second surface in the second position.

13. The method of claim 10, wherein the first member is positioned against the first surface such that an airgap exists between the first member and the first surface in the third position.

14. The method of claim 10, wherein a hinge rotatably couples the first member with the second member.

15. The method of claim 10, wherein the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer.

16. The method of claim 10, wherein the ultrasonic transducer is a capacitive micromachined ultrasonic transducer.

17. A medical device for obtaining a sample of a target while imaging the target via ultrasound, the medical device comprising: a handle; an elongate member extending from the handle and including a lumen through which a resection tool is advanceable; an end effector assembly at a distal end of the elongate member, the end effector assembly comprising: a first member coupled at the elongate member distal end, the first member defining a side exit ramp configured to receive the resection tool from the lumen and to direct the resection tool into the target at an acute angle with respect to a longitudinal axis of the first member; and a second member rotatably coupled with the first member, the second member rotatable between a first position relative to the first member and a second position relative to the first member, the second member having an ultrasonic transducer configured to generate an ultrasound field of view thatincludes the target and the resection tool while the sample is being obtained, wherein rotation of the second member between the first position and the second position causes a needle trajectory extending from the side exit ramp to traverse across a portion of the field of view.

18. The medical device of claim 17, wherein the ultrasonic transducer is a piezoelectric micromachined ultrasonic transducer.

19. The medical device of claim 17, wherein the ultrasonic transducer is a capacitive micromachined ultrasonic transducer.

20. The medical device of claim 1, wherein the second member includes a camera located at a distal end of the second member.

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