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EP-4736781-A2 - ENDOBRONCHIAL ULTRASOUND IMAGING

EP4736781A2EP 4736781 A2EP4736781 A2EP 4736781A2EP-4736781-A2

Abstract

An endobronchial ultrasound (EBUS) bronchoscope is configured as a single-use (e.g., disposable) device. The bronchoscope includes an insertion tube having a proximal section adjacent the handle and a distal tip. An ultrasound transducer assembly is located at the distal tip. The ultrasound transducer assembly includes an ultrasound transducer array, transmit-and-receive circuitry for the ultrasound transducer array, and a flexible interconnection between the ultrasound transducer array and the transmit-and-receive circuitry. The insertion tube further includes an imaging lumen including one or more power cables and one or more communication wires that extend from the ultrasound transducer assembly through the proximal section and a working channel that is separate from the imaging lumen.

Inventors

  • WATERS, KENDALL R.
  • Galvin, Moira

Assignees

  • Verathon INC.

Dates

Publication Date
20260506
Application Date
20191114

Claims (15)

  1. A bronchoscope, comprising: a handle; and an insertion tube including: an ultrasound transducer assembly located within a distal tip, the ultrasound transducer assembly including: an ultrasound transducer array; an analog front end; and connection lines between the ultrasound transducer array and the analog front end; and at least one power cable and at least one communication wire extending from the ultrasound transducer assembly to a proximal section of the insertion tube.
  2. The bronchoscope of claim 1, comprising an inflatable balloon adjacent to the ultrasound transducer array.
  3. The bronchoscope of claim 1, wherein the insertion tube comprises an inflation lumen including an exit port configured to provide access to an interior of a balloon when the balloon is secured on the distal tip over the ultrasound transducer array.
  4. The bronchoscope of any one of claims 1-3, wherein the insertion tube comprises: a control lumen extending through the proximal section toward the distal tip; and a control cable extending along a length of the control lumen, wherein the control cable is connected to a steering control element located in the handle.
  5. The bronchoscope of any one of claims 1-4, wherein the insertion tube comprises a camera lumen extending along an axial length of the insertion tube, the camera lumen including a camera exit port near the distal tip.
  6. The bronchoscope any one of claims 1-5, comprising a convex lens applied over the ultrasound transducer array.
  7. The bronchoscope of any one of claims 1-5, wherein the ultrasound transducer array includes a curved two-dimensional array.
  8. The bronchoscope of any one of claims 1-6, wherein the ultrasound transducer array includes a microelectromechanical system (MEMS).
  9. The bronchoscope of any one of claims 1-8, wherein the analog front end includes a beamformer.
  10. The bronchoscope of any one of claims 1-9, wherein the analog front end includes a multiplexer.
  11. The bronchoscope of any one of claims 1-10, comprising: a linking interface for removably connecting a first handle segment to a second handle segment, wherein the second handle segment includes an entry port for working lumen, and wherein the linking interface: connects the one or more power cables to a power supply, and connects the one or more communication wires to control logic.
  12. An insertion tube for a bronchoscope, comprising: a proximal section configured to connect to a handle; an ultrasound transducer assembly located within a distal tip, the ultrasound transducer assembly including: an ultrasound transducer array; an analog front end; and a flexible interconnection between the ultrasound transducer array and the analog front end; at least one power cable and at least one communication wire for the ultrasound transducer assembly; and a working channel.
  13. The insertion tube of claim 12, comprising an inflatable balloon secured over the ultrasound transducer array, wherein the insertion tube and balloon are enclosed together in a sterile package.
  14. The insertion tube of claims 12 or 13, wherein the ultrasound transducer array includes a microelectromechanical system (MEMS).
  15. The insertion tube of any one of claims 12-14, comprising: a linking interface for removably connecting a first handle segment to a second handle segment, wherein the second handle segment includes an entry port for working lumen, and wherein the linking interface includes: a power cable interface to connect the one or more power cables to a power supply, and a communication interface to connect the one or more communication wires to control logic.

Description

BACKGROUND OF THE INVENTION Physicians use endobronchial ultrasound (EBUS) techniques to guide lung cancer staging procedures. In particular, physicians use EBUS bronchoscopes to guide transbronchial needle aspiration (TBNA) of lymph nodes. Currently available EBUS bronchoscopes are reusable. Healthcare facilities reprocess EBUS bronchoscopes between uses in different patients to minimize infection risks. A reliable, high-quality reprocessing program requires an infrastructure that involves administration, documentation, inventory control, physical facility maintenance, education, training, risk assessment, and quality assurance. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A is a schematic of an environment in which systems and methods described herein may be implemented;Fig. 1B is a schematic of an endobronchial ultrasound (EBUS) bronchoscope inserted within a patient, according to an implementation described herein;Fig. 2 is a schematic side view of the EBUS bronchoscope of Figs. 1A and 1B;Fig. 3 is a longitudinal cross-sectional view of a distal tip of the EBUS bronchoscope of Fig. 2, according to one implementation;Fig. 4 is a cross-sectional end view of a portion of the EBUS of Fig. 2, according to an implementation described herein;Fig. 5 is an illustration of a distal tip of an EBUS bronchoscope shown with a balloon and a biopsy needle according to one embodiment;Fig. 6 is a side view of an ultrasound transducer array of the distal tip of Fig. 3;Fig. 7 is a top view of the ultrasound transducer array of Fig. 6;Fig. 8 is a block diagram of an application-specific integrated circuit (ASIC) of Fig. 6;Fig. 9 is a side view of an ultrasound transducer array of the EBUS bronchoscope, according to another implementation;Fig. 10 is an illustration of an ultrasound image of a bronchial lymph node from an EBUS bronchoscope, according to an implementation described herein;Fig. 11 is a cross sectional side view of distal tip of an EBUS bronchoscope according to another implementation described herein;Figs. 12A and 12B are block diagrams illustrating functional component of EBUS bronchoscope systems according to implementations described herein; andFig. 13 is a schematic side view of an EBUS bronchoscope with a detachable insertion tube, according to an implementation described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following detailed description refers to the accompanying drawings. The same reference numbers in different drawings may identify the same or similar elements. Implementations described herein relate to an endobronchial ultrasound (EBUS) bronchoscope that can employed as a single-use (e.g., disposable) device. The EBUS bronchoscope may be used, for example, to image bronchial lymph nodes for lung cancer staging and to guide transbronchial needle aspiration (TBNA). The EBUS bronchoscope includes a microelectromechanical system (MEMS)-based ultrasound transducer. The transducer is curved to enable imaging a wider view, compared to a flat array. The transducer is integrated with analog and digital electronics installed within a distal tip of the EBUS bronchoscope. The arrangement requires fewer wires (e.g., compared to a conventional EBUS bronchoscope) and a correspondingly smaller diameter lumen extending through an insertion tube. Fig. 1A illustrates a top view of an exemplary use of EBUS technology by an operator 10 (e.g., a pulmonologist or pulmonary interventionist) for evaluation of the lungs of a patient 12. An interventional suite may include a patient table 14, one or more portable carts 16, a console 20, a display 22, and an EBUS bronchoscope 100. The patient 12 lies supine upon the patient table 14. The operator 10 is generally at one end of the patient table 14 toward the head of the patient 12. One or more assistants 24 may be present. FIG. 1B is a cross-sectional view of the upper body of the patient 12 with a side view of EBUS bronchoscope 100 delivered to the bronchus of the patient 12. EBUS bronchoscope 100 includes a handle 102 connected to an insertion tube 104 that is inserted into the patient and directed to a region of interest. For example, a distal tip 106 of the EBUS bronchoscope 100 may be positioned in proximity to one or more bronchial lymph nodes 24. Fig. 2 is a side view of EBUS bronchoscope 100, including handle 102, insertion tube 104, and distal tip 106. Insertion tube 104 may include a proximal section 202 that connects to handle 102 and a distal section 204 between proximal section 202 and distal tip 106. Handle 102 includes a working channel entry port 206, an injection port 208, and a suction port 212. Working channel entry port 206 may be used for inserting fluids or tools (e.g., a biopsy needle, etc.) into a working channel (e.g., working channel 302, Fig. 3) extending through insertion tube 104 and exiting near distal tip 106. Injection port 208 may be used to insert or extract fluid through a lumen (e.g., inflation lumen 408, Fig. 4) extending t