CN-121985911-A - Device for volumetric ultrasound scanning

Abstract

An apparatus for acoustically coupling energy from one or more ultrasound arrays for application to medical treatment during an ultrasound imaging procedure, and an ultrasound imaging and medical instrument guide system connected to the apparatus for ultrasound data acquisition.

Inventors

• Adam Dixon
• ZACHARY LEONARD
• PAUL HIRAM
• Frank William moldin
• Robert Ricoeur
• Nathan Sander
• Alexis Na'en
• Liang andong

Assignees

• 利万纳医疗股份有限公司

Dates

Publication Date

20260505

Application Date

20240902

Priority Date

20230921

Claims (20)

1. 1. An acoustic coupling article comprising: A structural member configured to be removably attached to an ultrasound probe, the ultrasound probe comprising at least one ultrasound transducer array; wherein the acoustic coupling article comprises one or more layers of acoustically transmissive material capable of conforming to a surface of a receiver and the at least one ultrasound transducer array simultaneously; Wherein the one or more acoustically transmissive materials are substantially rigid, and wherein the one or more acoustically transmissive materials are capable of restricting movement of the at least one ultrasound transducer array in at least one direction and/or dimension, and Wherein a non-aqueous mobile phase is distributed over a surface of the acoustic coupling article, and wherein the non-aqueous mobile phase provides acoustic coupling between the at least one ultrasonic transducer array and the surface of the acoustic coupling article.
2. 2. The acoustic coupling article of claim 1, wherein the acoustic coupling article has a total thickness of between 0.05cm and 10 cm.
3. 3. The acoustic coupling article of claim 1, wherein the one or more acoustically transmissive materials have a shore hardness greater than shore OOO 5, an acoustic velocity between 900m/s and 2100m/s, and an acoustic impedance less than 3 MRayl.
4. 4. The acoustic coupling article of claim 1, further comprising a mechanical retention feature comprising one or more of a groove, ridge, clip, hole, or thread that removably mates with the ultrasound probe.
5. 5. The acoustic coupling article of claim 1, further comprising a fluid-tight seal positioned at an engagement surface of the acoustic coupling article and the ultrasonic probe, the seal comprising a gasket, an O-ring, or a sealant, and a structural element comprising a groove, a mating surface, or an alignment feature.
6. 6. The acoustic coupling artefact of claim 1, wherein the acoustic coupling artefact is included in or attached to the ultrasound probe for volumetric ultrasound imaging.
7. 7. The acoustic coupling article of claim 1, wherein a surface of the acoustic coupling article is substantially flat, thereby providing a translational or rotational linear or planar path for the at least one ultrasonic transducer array.
8. 8. The acoustic coupling article of claim 1, wherein a surface of the acoustic coupling article is curved, wherein curvature provides a concave, convex, curvilinear, nonlinear, or non-planar translational path for the at least one ultrasonic transducer array.
9. 9. The acoustic coupling article of claim 1, wherein the one or more acoustically transmissive materials comprise a thermoplastic material selected from one or more of polymethylpentene (polymethylpentene), crosslinked polystyrene-divinylbenzene (cross-linked polystyrene and divinylbenzene), polypropylene (polypropylene), polyether block amide (polyether block amide), polyester (polyethylene), polyethylene terephthalate (polyethylene terephthalate), nylon (nylon), and polyimide (polyimide).
10. 10. The acoustic coupling article of claim 1, wherein the one or more acoustically transmissive materials comprise a thermoplastic, polyurethane, cured silicone rubber material, or a combination thereof, and have an acoustic velocity between 900m/s and 2100 m/s.
11. 11. The acoustic coupling article of claim 1, wherein a surface of an outermost acoustically transmissive material of the layer of one or more acoustically transmissive materials is treated with a surface coating to increase hydrophilicity, wettability, lubricity, or a combination thereof of the surface.
12. 12. The acoustic coupling article of claim 1, wherein an outermost acoustically transmissive material of the layer of one or more acoustically transmissive materials is a malleable composition that is capable of being deformed, thermoformed, or molded into a shape and substantially retains the shape without significant deformation over a period of one year.
13. 13. The acoustic coupling article of claim 1, wherein an outermost acoustically transmissive material of the layer of one or more acoustically transmissive materials provides a protective barrier layer configured to shield an inner layer of the layer of one or more acoustically transmissive materials from environmental degradation, wherein the protective barrier layer comprises a material that is resistant to one or more of moisture, ultraviolet radiation, chemical exposure, or mechanical damage.
14. 14. The acoustic coupling article of claim 1, wherein the non-aqueous mobile phase comprises a synthetic lubricant, a silicon-based lubricant, a petroleum-based lubricant, or a combination thereof.
15. 15. The acoustic coupling article of claim 1, wherein the non-aqueous mobile phase is applied substantially uniformly to a surface of one or more layers of the one or more layers of acoustically transmissive material in contact with the one or more ultrasound transducer arrays.
16. 16. The acoustic coupling article of claim 1, wherein the non-aqueous mobile phase is impregnated into one or more of the layers of the one or more acoustically transmissive materials, and wherein the non-aqueous mobile phase is released in response to a compressive or contact force.
17. 17. The acoustic coupling article of claim 1, further comprising a porous material impregnated with the non-aqueous mobile phase, wherein the impregnated porous material is applied such that the porous material continuously contacts the surface of the ultrasound probe and at least one non-imaging surface of the at least one ultrasound transducer array, including during translation or rotation of the at least one ultrasound transducer array.
18. 18. An ultrasound imaging and medical instrument guidance system, comprising: An acoustic coupling article for conveying ultrasonic energy from at least one ultrasonic probe to a receiving body; the at least one ultrasound probe comprising at least one ultrasound transducer array; One or more computer processors for processing acquired data received from the at least one ultrasonic transducer array, and one or more displays for displaying the acquired data as images, and A non-transitory computer memory comprising instructions that cause the system to translate or rotate the at least one ultrasound transducer array along a surface of the acoustically coupled article to acquire the data at a plurality of spatial locations.
19. 19. The system of claim 18, wherein the instructions further cause the system to generate a three-dimensional image based on volumetric ultrasound data.
20. 20. The system of claim 18, wherein the instructions further cause the system to detect and report a condition indicating that the ultrasound imaging and medical instrument guidance system requires a maintenance event.

Description

Device for volumetric ultrasound scanning Cross Reference to Related Applications The present application relies on and claims priority and benefit from the disclosure of U.S. application Ser. No.18/371,027 filed at 21 at 2023, 9, and relies on and claims priority from the disclosure of U.S. application Ser. No.63/408,490 filed at 21 at 2022, 9. The present application also relies on and claims priority and benefit from the disclosure of U.S. application Ser. No.63/536,181 filed on 1 month 9 of 2023. The disclosures of the above applications are incorporated herein by reference in their entirety. Statement regarding federally sponsored research The present invention was completed under government support under contract No.75A50121C00035 awarded by HHS/ASPR/BARDA. The government has certain rights in this invention. Technical Field The present invention relates to ultrasound imaging for medical purposes. More particularly, the present invention describes an apparatus that may be used to acoustically couple an ultrasound transducer to a scanning interface, and an imaging system that interfaces with the apparatus for ultrasound data acquisition. Background Ultrasound scanning can be used in medical imaging to detect and diagnose pathologies in soft tissue or bone anatomy. The ultrasound image data may be acquired as individual two-dimensional frames, a sequence of two-dimensional frames (e.g., a time sequence), individual three-dimensional volumes, a sequence of three-dimensional volumes, or some combination thereof. Various embodiments of three-dimensional image data acquisition are commonly referred to as volumetric imaging. Methods of acquiring volumetric ultrasound data typically include electronically or mechanically redirecting energy from an ultrasound array in order to transmit and receive information covering an anatomical volume of interest. Volumetric ultrasound scanning systems produced by different manufacturers may integrate ultrasound imaging arrays having different formats. These arrays include "1D" arrays having a single row of multiple transmit/receive elements, "1.25D" and "1.5D" arrays having two to three rows of multiple transmit/receive elements and electronically configured to generate images along the array centerline, or "2D" arrays containing multiple rows of multiple transmit/receive elements and electronically configured to transmit/receive at any point within the volume, including off-centerline locations. The 2D array itself is capable of directly producing volumetric data, but has significant electrical complexity, is costly, and typically covers only a limited range of volumes. Accordingly, improvements in the art are needed. Manufacturers who develop volumetric scanners using 1D arrays, 1.25D arrays, or 1.5D arrays (which can only generate 2D ultrasound images when fixed in a desired spatial position) most often employ techniques such as mechanical translation and/or rotation arrays to acquire volumetric data sets. In this method, a single 2D image generated by the array at each unique spatial location is recorded and stored in hardware memory as a subcomponent of the total volume dataset. The method accommodates volume scanning over a large area while maintaining relatively low electrical complexity. In order to acoustically couple energy from the ultrasound array into the patient tissue while the array is mechanically translated and/or rotated, one of several prior art methods is typically employed: (1) The ultrasound array is directly coupled to the patient tissue through an acoustic gel that spreads along the tissue surface. This approach has lower complexity and lower cost, but maintaining optimal coupling and geometric accuracy is challenging as the array translates along complex tissue surfaces. (2) The ultrasound array is coupled to a rigid acoustically transmissive material (e.g., a plastic lens) via a thin fluid layer by embedding it into a fluid-filled chamber enclosed on one end by the rigid acoustically transmissive material. The rigid acoustically transmissive material is then coupled directly to the patient tissue via the acoustic gel. The method has moderate complexity, is non-modular (the sealed fluid chamber and rigid material remain fixed during the lifetime of the probe), and provides repeatable image quality and geometric accuracy, as the array does not translate directly along the surface of the tissue, and the path of travel is defined by the inner surface of the rigid material by design. However, coupling via fluid-filled chambers is not generally applicable to large surface areas for standard volumetric imaging applications due to increased weight and challenging maintainability. Furthermore, the rigid structure of plastic lenses limits its ability to accommodate irregularly shaped anatomy, which limits the volume scan to use with only relatively soft anatomy, such as the abdomen or breast. (3) The ultrasound array is coupled to a disposable, consumable