Linearly angled face arranged ultrasound elements

Abstract

A transducer for an endobronchial ultrasound sampling device can include a substrate, a plurality of electrode rails, and a plurality of ultrasound elements. The plurality of electrode rails can be disposed on the substrate. Each electrode rail of the plurality of electrode rails can be independently electrically connected. The plurality of ultrasound elements can be spaced from a proximal portion of the transducer to a distal portion of the transducer. Each element of the plurality of ultrasound elements can be coupled to an electrode rail of the plurality of electrode rails and angled relative to the substrate such as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

Description

LINEARLY ARRANGED ULTRASOUND ELEMENTSCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority, under 35 U.S.C. Section 119(e), to Christopher Lee, U.S. Patent Application Serial Number 63 / 503,093, entitled “LINEARLY ARRANGED ULTRASOUND ELEMENTS,” filed on May 18, 2023 (Attorney Docket No. 5409.860PRV), and to Vignesh Mandalapa Bhoopathy et al., U.S. Patent Application Serial Number 63 / 581,814, entitled “LINEARLY ARRANGED ULTRASOUND ELEMENTS,” filed on September 11, 2023 (Attorney Docket No.5409.860PV2), each of which is hereby incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] Examples described herein generally relate to ultrasound devices. More specifically, the examples described herein generally relate to linearly arranged ultrasound elements.BACKGROUND

[0003] Conventional endoscopes can be used in a variety of clinical procedures, including, for example, illuminating, imaging, detecting and diagnosing one or more disease states, providing fluid delivery (e.g., saline or other preparations via a fluid channel) toward an anatomical region, providing passage (e.g., via a working channel) of one or more therapeutic devices for sampling or treating an anatomical region, providing suction passageways for collecting fluids (e.g., saline or other preparations), and the like. Such anatomical regions can include the gastrointestinal tract (e.g., esophagus, stomach, duodenum, pancreaticobiliary duct, intestines, colon, and the like), renal area (e.g., kidney(s), ureter, bladder, urethra), other internal organs (e.g., reproductive systems, sinus cavities, submucosal regions, respiratory tract), and the like.SUMMARY

[0004] The inventors of the present disclosure have recognized the limits of the field of view of a transducer on a sampling device. For example, transducers for sampling devices typically have a limited field of view, making it difficult for medical providers to obtain samples from target tissue near the insertion limits of the sampling device. Thus, the inventors have developed a sampling device that includes a transducer designed to extend the field of view of the transducer beyond a distal edge of the sampling device.

[0005] In examples, an endobronchial ultrasound sampling device can include an elongated member extending along a longitudinal axis between a proximal section and a distal section. The elongated member can define a lumen extending from the proximal section into the distal section. The elongated member can include a medical instrument egress, and a transducer. The medical instrument egress can be configured to direct a medical instrument from the lumen and into a tissue of a patient. The transducer can be attached to the distal section of the elongated member and can include a plurality of ultrasound elements. The plurality of ultrasound elements can be spaced from a proximal portion of the transducer to a distal portion of the transducer. Each element of the plurality of ultrasound elements can be angled relative to the longitudinal axis of the elongated member such as to extend a field of view of the transducer distal to the distal section of the elongated member. In this way, the distalmost boundary of the field of view is extended distally, as compared to if the ultrasound elements were arranged normal to the longitudinal axis, thereby enabling a medical instrument being advanced distally at an acute angle relative to the longitudinal axis and through the field of view of the transducer to penetrate deeper into the tissue before extending beyond the distalmost field of view boundary.

[0006] In examples, a transducer for an endobronchial ultrasound sampling device can include a substrate, a plurality of electrode rails, and a plurality of ultrasound elements. The plurality of electrode rails can be disposed on the substrate. Each electrode rail of the plurality of electrode rails can be independently electrically connected. The plurality of ultrasound elements can be spaced from a proximal portion of the transducer to a distal portion of the transducer. Each element of the plurality of ultrasound elements can be coupledto an electrode rail of the plurality of electrode rails and angled relative to the substrate such as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

[0007] In examples, a method for reprocessing a sampling device can include obtaining a sampling device, sterilizing the sampling device, and storing the sampling device.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Various examples are illustrated in the figures of the accompanying drawings. Such examples are demonstrative and not intended to be exhaustive or exclusive examples of the present subject matter.

[0009] FIG. 1 illustrates a schematic diagram of an example of an endobronchial ultrasound sampling device system.

[0010] FIG. 2 illustrates a schematic diagram of an example of an imaging and control system of an endobronchial ultrasound sampling device.

[0011] FIG. 3 illustrates a cross-sectional view of a portion of an example bronchoscope.

[0012] FIG. 4 illustrates a portion of an example of an ultrasound array of elements.

[0013] FIG. 5 illustrates an example of an ultrasound array of elements.

[0014] FIG. 6 illustrates an example of an ultrasound array of elements.

[0015] FIG. 7 illustrates a side view of an example of a sampling device.

[0016] FIG. 8 illustrates a cutaway view of a port in an example actuator of an example sampling device.

[0017] FIG. 9 illustrates a block diagram illustrating an example of a method for reprocessing a bronchoscope.DETAILED DESCRIPTION

[0018] The field of view for endobronchial ultrasound sampling devices can be primarily a byproduct of the geometric properties of the arrays of ultrasound transducer elements in such ultrasound sampling devices. For example, an array in which ultrasound transducer elements are distributed linearly and oriented parallel may result in a substantially rectangular field ofview. Such an arrangement is typically referred to as a linear array. In contrast, an array in which the ultrasound transducer elements are distributed along a convexly curved surface and each oriented perpendicular to the convexly curved surface (e.g., such that the direction of individual elements diverges away from adjacent elements) will result in a field of view that spreads out to increase a field of view of the ultrasound. Such an arrangement is typically referred to as a curved array (or a curvilinear array).

[0019] In some clinical settings, the geometric properties associated with a linear array may be desirable over those of a curved array despite the field of view associated with the curved array being greater than that of a linear array. For example, some EBUS biopsy sampling devices include a ramp through which a biopsy needle may be extended into a field of view (FOV) of an ultrasound transducer. Typically, the ramp is located proximally from the US transducer and bends and directs the biopsy needle into the FOV along a needle path axis that diverges away from the longitudinal axis of the EBUS device at an acute angle. Depending on the depth that a target nodule or target tissue resides in relation to an airway from which the biopsy is to be collected, it may not be possible to collect a sample while the target nodule (e.g., a solitary pulmonary nodule or “SPN”) remains within the FOV because the needle may exit the distal FOV boundary before reaching the target depth. Accordingly, the FOV associated with a curved array may be desirable over that of a linear array - predominantly because the curved geometric properties of a curved array results in the distalmost FOV boundary being more distal relative to the needle exit. However, the geometric properties of curved arrays may severely limit the ability of an EBUS biopsy sampling device from reaching into narrow airways in the lung periphery. Therefore, there is a clinical need for real-time US imaging techniques that mitigate the above challenges.

[0020] FIG. 1 is a schematic diagram of an endoscopy system 100 that can include an imaging and control system 102 and an endobronchial ultrasound sampling arrangement including an endoscope 104 and a sampling device 136 that is attachable to the endoscope 104 and which includes a distal end 144 that extends from the distal end of the endoscope 104 via a distal working channel port. The system of FIG. 1 is an illustrative example of an endoscopy systemsuitable for use with the systems, devices and methods described herein, such as a bronchoscope with linearly arranged ultrasound elements.

[0021] The endoscope 104 can be insertable into an anatomical region for imaging 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 anatomical region. The endoscope 104 can interface or connect to imaging and control system 102. The endoscope 104 is described in the present example as being a bronchoscope, though other types of endoscopes contemplated for use with the features and teachings of the present disclosure. The imaging and control system 102 can include a control unit 106, a display unit 108, an input unit 110, a light source 112, a fluid source 114, and a suction pump 116.

[0022] The imaging and control system 102 can include various ports for coupling with the endoscopy system 100. For example, the control unit 106 can include a data input / output port for receiving data from and communicating data to the endoscope 104. The light source 112 can include an output port for transmitting light to the endoscope 104, such as via a fiber optic link. The fluid source 114 can include a port for transmitting fluid to the endoscope 104. The fluid source 114 can include, for example, a pump and a tank of fluid or can be connected to an external tank, vessel, or storage unit. The suction pump 116 can include a port used to draw a vacuum from the endoscope 104 to generate suction, such as for withdrawing fluid from the anatomical region into which the endoscope 104 is inserted. The display unit 108 and the input unit 110 can be used by an operator of the endoscopy system 100 to control functions of the endoscopy system 100 and view output of the endoscope 104. The control unit 106 can additionally be used to generate signals or other outputs from treating the anatomical region into which the endoscope 104 is inserted. In examples, the control unit 106 can generate electrical output, acoustic output, fluid output, or the like for treating the anatomical region with, for example, cauterizing, cutting, freezing, or the like.

[0023] The endoscope 104 can include an insertion section 118, a functional section 120, and a handle section 122, which can be coupled to a cable section 124 and a coupler section 126. The insertion section 118 can extend distally from the handle section 122, and the cable section 124 can extendproximally from the handle section 122. The insertion section 118 can be elongated and include a bending section, and a distal end to which the functional section 120 can be attached. The bending section can be controllable (e.g., by a steering control 128 on the handle section 122) to maneuver the distal end through tortuous anatomical passageways (e.g., stomach, duodenum, kidney, ureter, trachea, lungs, or the like). The insertion section 118 can also include one or more working channels (e.g., an internal lumen) that can be elongated and can support the insertion of one or more therapeutic tools of the functional section 120, such as a bronchoscope. The working channel can extend between the handle section 122 and the functional section 120. Additional functionalities, such as fluid passages, guide wires, and pull wires, can also be provided by the insertion section 118 (e.g., via suction or irrigation passageways, or the like).

[0024] A coupler section 126 can be connected to the control unit 106 to connect to the endoscope 104 to multiple features of the control unit 106, such as the input unit 110, the light source 112, the fluid source 114, and the suction pump 116.

[0025] The handle section 122 can include the steering control 128 as well as the port 130. The steering control 128 can be a knob, lever, or other actuation mechanism or the like, which can be used to navigate the endoscope 104 within the patient. The steering control 128 can be connected to a pull wire, or other actuation mechanisms, extending through the insertion section 118. The port 130, as well as other ports, such as a port 132 can be configured to couple various electrical cables, guide wires, auxiliary scopes, tissue collection devices, fluid tubes, and the like to the handle section 122, such as for coupling with the insertion section 118. The examples shown in FIG. 1 and FIG. 2 are examples of endoscopes 104.

[0026] According to examples, the imaging and control system 102 can be provided on a mobile platform (e.g., a cart 134) with shelves for housing the light source 112, the suction pump 116, an image processing unit 202 (FIG. 2), or the like. Alternatively, components of the imaging and control system 102, shown in FIG. 1 and FIG. 2, can be provided directly on the endoscope 104 to make the endoscope “self-contained.”

[0027] The functional section 120 can include components for treating and diagnosing the anatomy of a patient. The functional section 120 can includean imaging device, an illumination device, and an elevator. The functional section 120 can further include optically enhanced biological matter and tissue collection and retrieval devices as are described herein. For example, the functional section 120 can include one or more electrodes conductively connected to the handle section 122 and functionally connected to the imaging and control system 102 to analyze biological matter in contact with the electrodes based on comparative biological data stored in the imaging and control system 102.

[0028] As shown in FIG. 1, a sampling device 136 can extend from a distal end of the functional section (e.g., the insertion section 118 or the cable section 124) of the endoscope 104. The sampling device 136 can be configured to be attached to the port 132 such that the sampling device 136 extends through a working channel of the endoscope 104 and out the distal end of the endoscope 104. The sampling device 136 can include an actuator 138, an instrument actuator 142, and a distal end 144. The actuator 138 can be configured to extend the sampling device 136 beyond a distal end of the endoscope 104 such as to navigate the sampling device 136 to the target area within the patient. The actuator can slide along a housing 140 of the sampling device 136. The housing 140 can include indicia, which can indicate an amount of extension of the sampling device 136 beyond a distal end of the endoscope 104. The instrument actuator 142 can be configured to extend an instrument from the sampling device 136 to obtain a sample of tissue from the patient. A distal end 144 of the sampling device 136 can include a transducer (or other imaging device) and an instrument configured to obtain a sample of tissue from the patient. The sampling device 136 will be discussed in more detail herein.

[0029] FIG. 2 is a schematic diagram of the endoscopy system 100 of FIG. 1 including the imaging and control system 102 and the endobronchial ultrasound arrangement, which includes an endoscope and a sampling device 136 extendable via a distal working channel port of the endoscope. FIG. 2 schematically illustrates components of the imaging and control system 102 coupled to the endoscope 104. The imaging and control system 102 can include the control unit 106, which can include or be coupled to an image processing unit 202, a treatment generator 206, and a drive unit 208, as well as the light source 112, the input unit 110, and the display unit 108. The control unit 106 caninclude, or can be in communication with, an endoscope, a surgical instrument, and an endoscopy system, 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 the inclusion of optically enhanced materials and components. The control unit 106 can be configured to activate a camera to view target tissues distal of the endoscopy system. Likewise, the control unit 106 can be configured to activate the light source 112 to shine a light on the surgical instrument, which can include select components configured to reflect light in a particular manner, such as tissue cutters being enhanced with reflective particles.

[0030] The coupler section 126 can be connected to the control unit 106 to connect to the endoscope 104 to multiple features of the control unit 106, such as the image processing unit 202, the treatment generator 206, or the like. In examples, the port 130 can be used to insert another instrument or device, such as a daughter scope or auxiliary scope, or a sampling needle, biopsy needle, ablation instrument, scalpel, or the like, into the endoscope 104. Such instruments and devices can be independently connected to the control unit 106 via the cable section 124. In examples, the port 132 can be used to connect the coupler section 126 to various inputs and outputs, such as video, air, light and electric.

[0031] The image processing unit 202, the ultrasound image processing unit 204, and the light source 112 can each interface with the endoscope 104 (e.g., at the functional section 120) or the sampling device 136 by wired or wireless electrical connections. The imaging and control system 102 can accordingly illuminate an anatomical region, collect signals representing the anatomical region, process signals representing the anatomical region, and display images representing the anatomical region on the display unit 108. The ultrasound image processing unit 204 can be configured to receive ultrasonic signals from either of the endoscope 104 or the sampling device 136, which can be converted into ultrasonic images and transmitted to the display unit 108 or any other component of the endoscopy system 100. The imaging and control system 102 can include the light source 112 to illuminate the anatomical region using light of a desired spectrum (e.g., broadband white light, narrow-band imaging using preferred electromagnetic wavelengths, and the like). Theimaging and control system 102 can connect (e.g., via an endoscope connector) to the endoscope 104 for signal transmission (e.g., light output from the light source, video signals from the imaging system in the distal end, diagnostic and sensor signals from a diagnostic device, and the like).

[0032] The fluid source 114 (shown in FIG. 1) can be in communication with control unit 106 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 the like) and connectors (barb fittings, fluid seals, valves, and the like). The imaging and control system 102 can also include a drive unit 208, which can include a motorized drive for advancing a distal section of endoscope 104.

[0033] FIG. 3 illustrates a cross-sectional view of a portion of an example of an endobronchial ultrasound sampling device (e.g., the endoscope 14 (FIG. 1)). For example, FIG. 3 shows an elongated member 300 (e.g., the functional section 30) of the endobronchial ultrasound sampling device. The elongated member 300 can be configured to be inserted into a patient to obtain one or more samples or images or complete a medical procedure. In examples, the elongated member 300 can be configured to be inserted into the airways within the lungs of a patient to obtain samples of nodules within the lung tissue of the patient. The elongated member 300 can include a proximal section 302 and a distal section 304. The elongated member 300 can extend along a longitudinal axis 306 between the proximal section 302 and the distal section 304. The elongated member 300 can define a lumen 308 extending from the proximal section 302 into the distal section 304. The elongated member 300 can also include a medical instrument egress 310 and a transducer 312.

[0034] The medical instrument egress 310 can be configured to direct a medical instrument 320 from the lumen 308 and into a tissue 314 of the patient. In examples, the medical instrument egress 310 can direct the medical instrument 320 from the lumen 308 and out of a side of the elongated member 300 at a pre-determined angle (angle 311). The angle 311 can be an angle relative to the longitudinal axis 306 of the elongated member 300. In examples, the angle 311 of the medical instrument egress 310 can alter a trajectory 332 of the medical instrument 320 extending from the elongated member 300 via the medical instrument egress 310.

[0035] As discussed herein, the transducer 312 can be configured to transmit and capture ultrasound signals to capture an ultrasonic image of the tissue of the patient as the medical instrument 320 extends into the tissue of the patient. The transducer 312 can be attached to the distal section 304 of the elongated member 300 and can include a plurality of ultrasound elements (e.g., elements 330). The transducer 312 can extend between a proximal portion 316 and a distal portion 318. The transducer 312 can include a field of view 340, which can be configured to capture the medical instrument 320 as the medical instrument 320 extends from the medical instrument egress 310 along the trajectory 332.

[0036] The transducer 312 can include a plurality of elements (such as elements 330) that can be configured to emit and capture ultrasound signals. The elements 330 can be spaced from the proximal portion 316 to the distal portion 318 of the transducer 312. Each element of the elements 330 can be angled relative to the longitudinal axis 306 of the elongated member 300 such as to extend the field of view 340 of the transducer 312 distal to the distal section 304 of the elongated member 300.

[0037] As shown in FIG. 3, the field of view 340 is shifted distally as compared to a field of view 341 of an example sampling device where the elements 330 are not angled relative to the longitudinal axis 306. As shown in FIG. 3, the field of view 340 extending distally makes it so that more of the trajectory 332 of the medical instrument 320 is within the field of view 340 of the transducer 312 such that the transducer 312 can capture the medical instrument 320 as the medical instrument 320 extends into the tissue of the patient. Such an extension of the field of view 340 can increase a distance within the tissue of the patient that the sampling device (such as endoscope 14) can capture, extract, sample, or remove tissue of the patient.

[0038] FIG. 4 illustrates a portion of the transducer 312 installed on the elongated member 300. As shown in FIG. 4, each element of the plurality of elements 330 can be angled such that a normal vector 402 of each element of the elements 330 can be parallel to other elements of the elements 330. As such, each element can transmit an ultrasonic signal 404 and can capture the ultrasonic signal 404 as it reflects off the tissue (e.g., the tissue 314 (FIG. 3)) of the patient to generate the ultrasonic image. The ultrasonic signal 404 of each of theelements 330 can overlap with the ultrasonic signal 404 of the other elements of the elements 330. Thus, each element of the elements 330 can produce the ultrasonic signal 404 at different frequencies such as to decrease an interference between the overlapping signals (such as the ultrasonic signal 404) of the other elements of the elements 330.

[0039] Angling the elements 330 can extend the field of view 340 (FIG. 3) of the transducer 312 beyond a distal edge 319 of the transducer 312 such as to capture more of the trajectory 332 (FIG. 3) of the medical instrument 320 (FIG. 3) extending from the medical instrument egress 310 and into the tissue 314 of the patient. The increased trajectory 332 captured by the transducer 312 can increase a distance from the medical instrument egress 310 where the target tissue of the patient can be sampled by the sampling device (e.g., the endoscope 14 (FIG. 1)).

[0040] As shown in FIG. 4, each of the elements 330 can be angled around 30 degrees relative to the longitudinal axis 306 (FIG. 3) of the elongated member 300. In examples, each of the elements 330 can be angled between 25 and 40 degrees relative to the longitudinal axis 306 of the elongated member 300. In examples, each of the elements 330 can be angled between 10 and 70 degrees relative to the longitudinal axis 306 of the elongated member 300. In examples, the elements of the elements 330 can be angled at any angle relative to the longitudinal axis 306 of the elongated member 300 such as to maximize an image quality captured by the elements 330 as the medical instrument 320 extends into the tissue of the patient.

[0041] The inventors of the present disclosure have recognized that an array of configurations for the elements 330 can achieve varying clarity and quality of the ultrasonic images. As such, various examples of angles of the elements 330 can be included. For example, As shown in FIG. 4, each of the normal vectors 402 of the elements 330 can be parallel. In examples, the normal vectors 402 can be angled relative to one another. For example, a most proximal element of the elements 330 can be more upright than the elements 330 attached toward a distal portion (such as distal portion 318) of the transducer 312. In examples, the normal vector 402 of each element of the elements 330 can be offset from one another such that none of the normal vectors of the elements 330 are parallel. In examples, the array of elements 330 can include one moreelement of the elements 330 that includes the normal vector 402 that is not parallel to the other normal vectors 402 of the elements 330.

[0042] FIGS. 5 and 6 will be discussed together below. FIG. 5 illustrates an example of an ultrasound array of the elements 330. FIG. 6 illustrates another example of the ultrasound array of the elements 330. As shown in FIGS. 5 and 6, the transducer 312 can include a substrate 502, a plurality of electrode rails (rails 504), and the plurality of ultrasound elements (such as elements 330).

[0043] The substrate 502 can be configured to hold the transducer 312 together in a configuration such that the transducer 312 can function as designed. For example, the substrate 502 can be configured to electronically isolate components of the transducer 312 from other components of the transducer 312 and electronically connect components of the transducer 312 to other components of the transducer 312. The substrate 502 can include lead zirconate titanate (PZT), polyvinylidene fluoride, lead metaniobate, quartz and Rochelle salt, ceramic composites, other piezocomposites, other piezoelectric materials, or any combination thereof, or the like.

[0044] The rails 504 can be disposed on the substrate 502 such that each rail of the rails 504 is independently electrically connected. Thus, each rail of the rails 504 can be electrified independently from other rails of the rails 504. The independent electrical connectivity of the rails 504 can help control the transducer 312 such as to provide more custom imaging by providing a more predictable image with less interference.

[0045] The elements 330 can be spaced from a proximal portion 316 (FIG. 3) of the transducer 312 to a distal portion 318 (FIG. 3) of the transducer 312. Each element of the elements 330 can be coupled to any rail of the rails 504. Thus, as each respective rail of the rails 504 is electrified, the elements 330 coupled to the respective rail of the rails 504 can receive power to transmit an ultrasonic signal (such as the ultrasonic signal 404 (FIG. 4)). The endoscopy system 10 (FIG. 1) can be programmed to fire each of the rails 504 at different frequencies to control the electrification of the elements 330 coupled to the respective rails such as to improve the ultrasonic image captured by the transducer 312.

[0046] Each element of the elements 330 can also be angled relative to the substrate 502 such as to extend the field of view 340 (FIG. 3) of thetransducer 312 distally beyond a distal edge 319 of the transducer 312. As discussed herein, angling the elements 330 can extend the field of view 340 of the transducer 312 beyond a distal edge 319 of the transducer 312 such as to capture more of the trajectory 332 of the medical instrument 320 extending from the medical instrument egress 310 and into the tissue of the patient. The increased trajectory 332 captured by the transducer 312 can increase a distance from the medical instrument egress 310 that target tissue of the patient can be sampled by the sampling device (e.g., the endoscope 14 (FIG. 1)).

[0047] As shown in FIGS. 5 and 6, each element of the elements 330 can include a plurality of drums (drums 510). Each drum of the drums 510 can be laterally spaced (e.g., across the medical instrument 320 and perpendicular to the longitudinal axis 306 of the elongated member 300) from other drums of the drums 510. Each drum of the drums 510 can include a diameter 512. As shown in FIG. 5, the diameter 512 of each drum of the drums 510 can be common such that each of the drums 510 has the same diameter 512. As shown in FIG. 6, one or more drums of the drums 510 can include varying diameter 512, such as multiple variations of the diameter 512 of the drums 510. The diameter 512 of the drums 510 can affect the frequency of the ultrasonic signal 404 transmitted by the elements 330. As such, the ultrasonic signal 404 of the elements 330 can be adjusted by altering the diameter 512 of the drums 510. For example, increasing the diameter 512 can decrease the frequency of the ultrasonic signal 404 transmitted. Thus, decreasing the diameter 512 can increase the frequency of the ultrasonic signal 404 transmitted by the elements 330.

[0048] As shown in the examples of FIGS. 1-6, the endoscopy system (e.g., the endoscopy system 10 or the elongated member 300) can be inserted directly within the patient. In other examples, the elongated member 300 can be inserted into a patient using a sampling device 700. FIG. 7 is a side view of the sampling device 700, according to at least one example of the present disclosure. The sampling device 700 can operate in conjunction with an insertion device 730 (only a portion is shown in FIG. 7), such as an endoscope or a bronchoscope. As previously described, the insertion device 730 can include an insertion conduit that is insertable into a body via an orifice or other opening. In examples, the insertion device 730 can receive the elongated instrument 702 (e.g., the elongated member 300 (FIG. 3)), and the elongated instrument 702 can beextended through the insertion conduit to the desired location. For example, the elongated instrument 702 may be inserted through a working channel of a bronchoscope and extended from a port on the distal end of the bronchoscope. In this way, the elongated instrument 702 may be extended further into a bronchial structure than the bronchoscope due to the elongated instrument 702 having a smaller outer diameter than the bronchoscope. The elongated instrument 702 can be a sampling probe that can include an imaging probe (which may be integrated into a distal tip of the elongated instrument) and a sampling needle within a flexible lumened catheter. The elongated instrument 702 can be insertable via the insertion device 730 to procure a tissue sample at a desired location within a body. The elongated instrument 702 also can include a stylet that can be removably insertable into or through the needle, as further described below.

[0049] The sampling device 700 herein described can be coupled to the insertion device 730 using a coupling 706 at a distal end 708 of the sampling device 700. The elongated instrument 702, which can be manipulated by the sampling device 700, can extend through the coupling 706 and can be inserted into the insertion conduit of the insertion device 730. The elongated instrument 702 can be secured to an actuator 712 that is movably coupled to a housing 714. The actuator 712 can be moved along the housing 714 between a proximal end 710 and the distal end 708 of the sampling device 700 (which corresponds with proximal and distal ends of the housing 714) to extend and retract the elongated instrument 702 relative to the insertion device 730. Movement of the actuator 712 along the housing 714 in distal and proximal directions may cause the elongated instrument 702 to be extended distally from a port at the distal end of the insertion device 730 or retracted into the port, respectively. Anti-buckling devices can be received within the housing 714 to provide lateral support to the elongated instrument 702 as the actuator 712 moves the elongated instrument 702 through the housing 714.

[0050] In examples, the flexible lumened catheter of the elongated instrument 702 can be secured to the actuator 712 while the needle can be received into the flexible lumened catheter via the actuator 712. In some embodiments, a proximal port 716 can be configured to receive and secure an imaging probe such as, for example, a radial Endobronchial Ultrasound (EBUS) probe configured to generate real-time ultrasound images of tissue surroundingthe distal end of the elongated instrument 702. A needle inlet guide tube 718 can be configured to receive and engage a needle actuator 720 to which the sampling needle can be secured. The needle inlet guide tube 718 and the needle actuator 720 can be movably coupled at an orientation interface 722. The orientation interface 722 can be configured to maintain an orientation of the needle actuator 720 relative to the needle inlet guide tube 718 to control an orientation of the sampling needle, as further described below. The needle actuator 720 can removably receive an end cap 724 that can be coupled with the stylet and used to releasably secure the stylet within the sampling needle. Depending on the location of target tissue within the patient’s anatomy, the stylet may be used to prevent the sampling needle from collecting non-targeted tissue. For example, in a scenario in which the operator is targeting tissue several millimeters or centimeters beyond an airway wall, the operator may leave the stylet fully inserted in the sampling needle while the sampling needle is advance through non-target tissue. Then, when the operator sees on the real-time images generated by the imaging probe that the needle have reached or nearly reached the target tissue, the stylet may be withdrawn to permit target tissue to enter the sampling needle core. The needle actuator also can include a release mechanism 726 that an operator can positively engage to permit advancing the sampling needle into a sampling position, as also further described below.

[0051] FIG. 8 is a cutaway view of the port 716 in the actuator 712 of the sampling device 700, according to at least one example of the present disclosure. The sampling device 700 can include an imaging probe 748 (e.g., the elongated member 300 (FIG. 3). The proximal port 716 of the actuator 712 can be configured to receive the imaging probe 748 and direct the imaging probe 748 into a first lumen 744 of a flexible lumened catheter 740. The flexible lumened catheter 740 can include a proximal end 742 that can be coupled to the actuator 712. In examples, the flexible lumened catheter 740 can define a second lumen 746 configured to receive a sampling needle 750. The second lumen flexible lumened catheter 740 can extend into the first lumen 744 and can be configured to keep the sampling needle 750 away from the imaging probe 748 In other examples, the flexible lumened catheter 740 can define only a single lumen configured to receive the sampling needle 750 and a distal end of the elongated instrument 702 may include an imaging element (e.g., linear ultrasoundtransducer) integrated into the distal tip thereof adjacent to a ramp (of a side exit port) that is configured to directed the sampling needle 750 into a field of view of the imaging element. The sampling needle 750, as further described below, can be coupled with and controlled by the needle actuator 720.

[0052] The sampling needle 750 can extend between a base 752 (FIG. 4) and a tip 754. The sampling needle 750 can also include a lumen 751. The lumen 751 can be used to extract a sample from the patient. The needle actuator 720 can be slidably mounted on the needle inlet guide tube 718 (which can be also further described below). In examples, the sampling needle 750 can extend from the needle actuator 720 through the needle inlet guide tube 718 and into the second lumen 746 of the flexible lumened catheter 740, through which the sampling needle 750 can be extended into a body to collect a sample. The needle inlet guide tube 718 can also be joined with the actuator 712. Accordingly, when the needle inlet guide tube 718 and the imaging probe 748 are secured to the actuator 712, movement of the actuator 712 along the housing 714 can advance the elongated instrument 702 as well as the imaging probe 748 and sampling needle 750 contained therein.

[0053] FIG. 9 illustrates a schematic view of an example method 900. The method 900 can be a method of reprocessing a bronchoscope (e.g., the endoscope 14, the elongated member 300, or the like). More specific examples of the method 900 are discussed below. The steps or operations of the method 900 are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. The method 900 as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operations discussed in the method 900 can be attributable to a single actor, device, or system could be considered a separate standalone process or method.

[0054] The reprocessing method 900 for the above-described treatment instrument (e.g., the endoscope 14 or another bronchoscope) will be described with reference to FIG. 9. The treatment instrument (e.g., the endoscope 14 or another bronchoscope) described above can be disposed of after one use, or can be repeatedly used, for example, a plurality of times. In the case of aconfiguration that is repeatedly used a plurality of times, for example, the reprocessing method 900 shown in FIG. 9 can be relevant.

[0055] An operator can collect the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) after it has been used for treatment and transport it to a factory or the like (Step SI). At this time, the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) can be transported in a dedicated container to prevent contamination from the treatment instrument (e.g., the endoscope 14 or another bronchoscope).

[0056] Then, the operator can clean and sterilize the collected and transported used treatment instrument (e.g., the endoscope 14 or another bronchoscope) (Step S2). Specifically, in cleaning the treatment instrument (e.g., the endoscope 14 or another bronchoscope), deposits adhering to the exterior of the functional section 30 can be removed by using a brush or the like. After that, to remove pathogenic microorganisms and the like derived from blood, body fluid, etc., the functional section 30 can be cleaned using a cleaning solution of isopropanol-containing cleaning agent, proteolytic enzyme detergent, and alcohol. The cleaning liquid is not limited to the cleaning liquid described above, and other cleaning liquids may be used. Further, in the sterilization of the treatment instrument (e.g., the endoscope 14 or another bronchoscope), to sterilize the pathogenic microorganisms and the like adhering to the functional section 30, any of high-pressure steam sterilization, ethylene oxide gas sterilization, gamma ray sterilization, hydrogen peroxide and hydrogen peroxide low-temperature sterilization can be used. The functional section 30 can be disassembled by actuating the clips or securing features to decouple the coupler and the housing.

[0057] The operator can perform an acceptance check of the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) (Step S3). In detail, the operator can check whether the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) has significant defects or whether the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) exceeds a maximum number of reprocessing.

[0058] Next, the operator can disassemble the used treatment instrument (e.g., the endoscope 14 or another bronchoscope) (Step S4). Can disassemble thefunctional section 30 by removing the housing from the coupler and removing all of the components from within the coupler and the housing.

[0059] After the step S4, some parts are replaced (Step S5). For example, any of the components of the functional section 30, or any of the components within the coupler or the housing can be replaced during step S4.

[0060] After step S5, the operator can assemble a new treatment instrument (e.g., the endoscope 14 or another bronchoscope (Step S6). In some examples, Step S6 can include adding an identifier to indicate the device has been modified from its original condition, such as a adding a label or other marking to designate the device as reprocessed, refurbished or remanufactured.

[0061] After step S6, the operator can inspect and test the newly formed treatment instrument (e.g., the endoscope 14 or another bronchoscope) (step S7). Specifically, the operator who remanufactures verifies that the newly formed treatment instrument (e.g., the endoscope 14 or another bronchoscope) has the same effectiveness and safety as the original product by various functional tests.

[0062] After Step S7, the operator sequentially performs a sterilization and storage (Step S8), and shipping (Step S9) of the new treatment instrument (e.g., the endoscope 14 or another bronchoscope). In the Step S8, a sterilization treatment can use a sterilizing gas such as ethylene oxide gas or propylene oxide gas is applied to the new treatment instrument (e.g., the endoscope 14 or another bronchoscope), and the device is stored in a storage container until use.

[0063] Steps SI to S9 described above are executed to achieve reprocessing of the treatment instrument (e.g., the endoscope 14 or another bronchoscope). Any of steps S1-S9 can be completed by one or more parties in any order of the steps. Moreover, steps S1-S9 are exemplary steps, which are not an all-inclusive list of steps that can be performed by an operator to refurbish, remanufacture, or replenish the medical instrument (e.g., the endoscope 14 or another bronchoscope).

[0064] The above discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below is included to provide further information about the present patent application.

[0065] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0066] Example 1 is an endobronchial ultrasound sampling device comprising: an elongated member extending along a longitudinal axis between a proximal section and a distal section, the elongated member defining a lumen extending from the proximal section into the distal section, the elongated member including: a medical instrument egress configured to direct a medical instrument from the lumen and into a tissue of a patient; and a transducer attached to the distal section of the elongated member, the transducer including: a plurality of ultrasound elements spaced from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements angled relative to the longitudinal axis of the elongated member such as to extend a field of view of the transducer distal to the distal section of the elongated member.

[0067] In Example 2, the subject matter of Example 1 optionally includes wherein a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

[0068] In Example 3, the subject matter of Example 2 optionally includes wherein each element of the plurality of ultrasound elements is angled between twenty five and forty degrees relative to the longitudinal axis of the elongated member.

[0069] In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein each element of the plurality of ultrasound elements is angled thirty degrees relative to the longitudinal axis of the elongated member.

[0070] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the medical instrument egress is configured to guide the medical instrument from the lumen and out of a side of the elongated member at a pre-determined angle.

[0071] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include wherein the medical instrument is a sampling needle configured to capture a sample of at least a portion of the tissue of the patient.

[0072] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include wherein each element of the plurality of ultrasound elements comprises a plurality of drums, each drum of the plurality of drums is laterally spaced from other drums of the plurality of drums.

[0073] In Example 8, the subject matter of Example 7 optionally includes wherein each drum of the plurality of drums includes a common diameter.

[0074] In Example 9, the subject matter of any one or more of Examples 7-8 optionally include wherein the plurality of drums includes varying diameters.

[0075] Example 10 is a transducer for an endobronchial ultrasound sampling device, the transducer comprising: a substrate; a plurality of electrode rails disposed on the substrate, each electrode rail of the plurality of electrode rails is independently electrically connected; a plurality of ultrasound elements spaced from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements coupled to an electrode rail of the plurality of electrode rails and angled relative to the substrate such as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

[0076] In Example 11, the subject matter of Example 10 optionally includes wherein a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

[0077] In Example 12, the subject matter of Example 11 optionally includes wherein each element of the plurality of ultrasound elements is angled between twenty five and forty degrees relative to a longitudinal axis of the transducer.

[0078] In Example 13, the subject matter of any one or more of Examples 11-12 optionally include wherein each element of the plurality of ultrasound elements is angled thirty degrees relative to a longitudinal axis of the transducer.

[0079] In Example 14, the subject matter of any one or more of Examples 10-13 optionally include wherein each element of the plurality of ultrasound elements comprises a plurality of drums, each drum of the plurality of drums is laterally spaced from other drums of the plurality of drums.

[0080] In Example 15, the subject matter of Example 14 optionally includes wherein each drum of the plurality of drums includes a common diameter.

[0081] In Example 16, the subject matter of any one or more of Examples 14-15 optionally include wherein the plurality of drums includes varying diameters.

[0082] Example 17 is a method for reprocessing a sampling device, the method comprising: obtaining the sampling device of Example 1; sterilizing the sampling device; and storing the sampling device.

[0083] In Example 18, the subject matter of Example 17 optionally includes removing the medical instrument from the lumen of the elongated member; removing the transducer; sanitizing the medical instrument, elongated member, and the transducer; and packaging the medical instrument, elongated member, and the transducer.

[0084] In Example 19, the subject matter of Example 18 optionally includes testing the transducer to ensure the transducer is outputting ultrasonic signals within an expected range; and reinstalling the transducer onto the elongated member on condition that the transducer is outputting ultrasonic signals within the expected range.

[0085] In Example 20, the subject matter of any one or more of Examples 18-19 optionally include marking the elongated member to indicate the elongated member has been reprocessed; logging the elongated member to track a number of times the elongated member has been reprocessed; and disposing or recycling one or more components of the elongated member after the elongated member has been reprocessed more than a set limit.

[0086] Example is 21, an apparatus, system, or method including any element 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 embodiments that may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements in addition to those shown or described.However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors alsocontemplate 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] All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.

[0089] 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 the appended claims, 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, 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 the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0090] The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5). Similarly, numerical ranges recited herein byendpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1- 1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1-4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”

[0091] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other examples may be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is to allow the reader to quickly ascertain the nature of the technical disclosure and 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 may 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 may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the examples should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0092] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0093] Preferably, the invention described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. The device may also be sterilized using any other technique known in the art, including but limited to beta or gamma radiation, ethylene oxide, or steam.

Claims

CLAIMS1. An endobronchial ultrasound sampling device comprising: an elongated member extending along a longitudinal axis between a proximal section and a distal section, the elongated member defining a lumen extending from the proximal section into the distal section, the elongated member including: a medical instrument egress configured to direct a medical instrument from the lumen and into a tissue of a patient; and a transducer attached to the distal section of the elongated member, the transducer including: a plurality of ultrasound elements spaced from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements angled relative to the longitudinal axis of the elongated member such as to extend a field of view of the transducer distal to the distal section of the elongated member.

2. The sampling device of claim 1, wherein a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

3. The sampling device of claim 2, wherein each element of the plurality of ultrasound elements is angled between 25 and 40 degrees relative to the longitudinal axis of the elongated member.

4. The sampling device of claim 2, wherein each element of the plurality of ultrasound elements is angled 30 degrees relative to the longitudinal axis of the elongated member.

5. The sampling device of claim 1, wherein the medical instrument egress is configured to guide the medical instrument from the lumen and out of a side of the elongated member at a pre-determined angle.

6. The sampling device of claim 1, wherein the medical instrument is a sampling needle configured to capture a sample of at least a portion of the tissue of the patient.

7. The sampling device of claim 1, wherein each element of the plurality of ultrasound elements comprises a plurality of drums, each drum of the plurality of drums is laterally spaced from other drums of the plurality of drums.

8. The sampling device of claim 7, wherein each drum of the plurality of drums includes a common diameter.

9. The sampling device of claim 7, wherein the plurality of drums includes varying diameters.

10. A transducer for an endobronchial ultrasound sampling device, the transducer comprising: a substrate; a plurality of electrode rails disposed on the substrate, each electrode rail of the plurality of electrode rails is independently electrically connected; a plurality of ultrasound elements spaced from a proximal portion of the transducer to a distal portion of the transducer, each element of the plurality of ultrasound elements coupled to an electrode rail of the plurality of electrode rails and angled relative to the substrate such as to extend a field of view of the transducer distally beyond a distal edge of the transducer.

11. The transducer of claim 10, wherein a normal vector of each element of the plurality of ultrasound elements is parallel to other elements of the plurality of ultrasound elements.

12. The transducer of claim 11, wherein each element of the plurality of ultrasound elements is angled between 25 and 40 degrees relative to a longitudinal axis of the transducer.

13. The transducer of claim 11, wherein each element of the plurality of ultrasound elements is angled 30 degrees relative to a longitudinal axis of the transducer.

14. The transducer of claim 10, wherein each element of the plurality of ultrasound elements comprises a plurality of drums, each drum of the plurality of drums is laterally spaced from other drums of the plurality of drums.

15. The transducer of claim 14, wherein each drum of the plurality of drums includes a common diameter.

16. The transducer of claim 14, wherein the plurality of drums includes varying diameters.

17. A method for reprocessing a sampling device, the method comprising: obtaining the sampling device of claim 1; sterilizing the sampling device; and storing the sampling device.

18. The method of claim 17, comprising: removing the medical instrument from the lumen of the elongated member; removing the transducer; sanitizing the medical instrument, elongated member, and the transducer; and packaging the medical instrument, elongated member, and the transducer.

19. The method of claim 18, comprising:testing the transducer to ensure the transducer is outputting ultrasonic signals within an expected range; and reinstalling the transducer onto the elongated member on condition that the transducer is outputting ultrasonic signals within the expected range.

20. The method of claim 18, comprising: marking the elongated member to indicate the elongated member has been reprocessed; logging the elongated member to track a number of times the elongated member has been reprocessed; and disposing or recycling one or more components of the elongated member after the elongated member has been reprocessed more than a set limit.

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