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Researchers Submit Patent Application, "Medical Ultrasound Scanning with Control over Pressure/Force Exerted by an Ultrasound Probe And/Or a...

May 22, 2014



Researchers Submit Patent Application, "Medical Ultrasound Scanning with Control over Pressure/Force Exerted by an Ultrasound Probe And/Or a Compression/Scanning Assembly", for Approval

By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventors Wang, Shih-Ping (Los Altos, CA); Anderson, Tor C. (Los Gatos, CA); Chen, Jiayu (Palo Alto, CA); Summers, Douglas G. (Palo Alto, CA), filed on December 23, 2013, was made available online on May 8, 2014.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "Volumetric ultrasound scanning usually involves the movement of an ultrasound transducer relative to a tissue sample and the processing of resultant ultrasound echoes to form a data volume representing at least one acoustic property of the tissue sample. Although several examples herein are presented in the particular context of human breast ultrasound, it is to be appreciated that the present teachings are broadly applicable for facilitating ultrasonic scanning of any externally accessible human or animal body part (e.g., abdomen, legs, feet, arms, neck, etc.). Moreover, although several examples herein are presented in the particular context of mechanized scanning (i.e., in which the ultrasound transducer is moved by a robot arm or other automated or semi-automated mechanism), it is to be appreciated that one or more aspects of the present teachings can be advantageously applied in a handheld scanning context.

"Volumetric ultrasound scanning of the breast has been proposed as a complementary modality for breast cancer screening as described, for example, in the commonly assigned US 20031007598A1 published Jan. 9, 2003, which is incorporated by reference herein. The commonly assigned WO 20041030523A2 published Apr. 15, 2004, which is incorporated by reference herein, describes a full-field breast ultrasound (FFBU) scanning apparatus that compresses a breast along planes such as the craniocaudal (CC) plane, the mediolateral oblique (MLO) plane, etc., and ultrasonically scans the breast. One side of an at least partially conformable, substantially taut membrane or film sheet compresses the breast. A transducer translation mechanism maintains an ultrasound transducer in contact with the other side of the film sheet while translating the ultrasound transducer thereacross to scan the breast.

"Other FFBU scanning devices that compress the breast in other directions, such as in generally chestward or 'head-on' directions, are described in one or more of the following commonly assigned applications, each of which is incorporated by reference herein: U.S. Ser. No. 60/565,698 filed Apr. 26, 2004; U.S. Ser. No. 60/577,078 filed Jun. 4, 2004; U.S. Ser. No. 60/629,007 filed Nov. 17, 2004; U.S. Ser. No. 60/702,202 filed Jul. 25, 2005; U.S. Ser. No. 60/713,322 filed Aug. 31, 2005; WO 2005/104729A2 published Nov. 10, 2005; and WO 2005/120357A1 published Dec. 22, 2005.

"Among other useful applications, ultrasound imaging systems can be used to facilitate percutaneous biopsy procedures in which a needle or other fine biopsy instrument is used to extract a tissue sample. More specifically, ultrasound imaging systems can be used to locate a lesion and to assist the radiologist in guiding a biopsy instrument to the lesion. In such applications, it is necessary to keep the biopsy needle positioned within the imaged plane in order for it to remain visible on the ultrasound monitor during the procedure. As used herein, the terms radiologist and physician are used interchangeably and generically to refer to medical professionals that analyze medical images and make clinical determinations therefrom, and/or that perform medical procedures under the at least partial guidance of medical imaging systems, it being understood that such person might be titled differently, or might have differing qualifications, depending on the country or locality of their particular medical environment.

"Percutaneous ultrasound-guided biopsy of the breast is a procedure that can be quickly performed free-handed by a 'skilled' physician, using a hand-held ultrasound imaging system, in an out-patient environment. Because this procedure would take less physician time, it is less expensive than other breast biopsy procedures, such as x-ray guided stereotactic BIOPSY and surgical biopsy. Thus, percutaneous ultrasound-guided biopsy has become a highly popular breast biopsy procedure.

"However, this procedure could become even more popular if it were easier to perform. This is because many physicians may find it difficult to do the free-handed procedure, which requires the physician to hold a hand-held ultrasound transducer in one hand and the biopsy needle in the other hand, while looking at both the display monitor and the patient breast (usually placed three feet apart) and trying to visualize simultaneously the thin biopsy needle (approximately 1 mm in diameter) and the breast lesion in the thin (approximately 1 mm thick) scan plane of the ultrasound imaging system.

"One type of ultrasound-assisted biopsy guide is described in the commonly assigned U.S. Pat. No. 6,695,786, issued Feb. 24, 2004, which is incorporated by reference herein. Although one or more preferred embodiments are herein presented in the particular context of needle biopsy procedures for the breast such as fine needle aspiration biopsy, core-needle biopsy, vacuum-assisted biopsy, and/or other single-cylinder excision alternatives, it is to be appreciated that one or more aspects of the present teachings can be advantageously applied in a variety of different image-guided surgical contexts.

"It would be desirable to facilitate ultrasound scanning of a tissue volume (such as, but not limited to, a breast) in a manner that further improves at least one of image quality, volumetric thoroughness, patient comfort, and overall quickness of the scanning process. It would be further desirable to provide assistance to physicians in performing ultrasound-guided biopsy of the breast. It would be further desirable to provide for ultrasound scanning of a tissue volume in a manner that facilitates at least one of guidance, positioning, and operation of a biopsy instrument. Other issues arise as would be readily apparent to one skilled in the art in view of the present disclosure. It would be further desirable to sense the force or pressure that a compression/scanning assembly exerts on a patient and to use the resulting information to improve imaging."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventors' summary information for this patent application: "In one embodiment, an apparatus and related methods for ultrasonically scanning a tissue sample are provided, the apparatus comprising an ultrasound transducer and a membranous sheet, the membranous sheet compressing the tissue sample, the ultrasound transducer contacting the membranous sheet and ultrasonically scanning the tissue sample therethrough, wherein the membranous sheet has a generally arcuate shape and the ultrasound transducer is movable in a generally arcuate trajectory therealong during the ultrasonic scan. Preferably, the membranous sheet comprises one or more of a fabric and a vented membrane that is at least partially porous to a liquid or gel acoustic coupling agent. Alternatively, the membranous sheet may comprise material available under the trade name Mylar or other non-porous sheet-like material, or may comprise thin, sheet-like versions of solid materials such as 40-mil polycarbonate plastic. The tissue sample is compressed in an at least partially conformal manner toward an underlying anatomical structure during the ultrasonic scan.

"In one particular example, the tissue sample may be a breast of a human patient and the underlying anatomical structure may be the patient's rib cage. In the context of ultrasonic scanning in which a transducer scans the breast through a compressing membranous sheet, it has been found advantageous to compress the breast along a generally arcuate surface, and still more advantageous to have the generally arcuate surface positioned to compress the breast conformally toward the rib cage. Among other advantages, volumetric thoroughness and patient comfort are promoted while maintaining good image quality. Also promoted is an ability to better accommodate a variety of different breast sizes ranging from larger fatty breasts to smaller dense breasts.

"According to another embodiment, an apparatus for facilitating a medical procedure is provided, comprising a membranous sheet compressing a tissue sample, an ultrasound transducer contacting the membranous sheet to ultrasonically scan the tissue sample therethrough, and a biopsy guide operably coupled to the ultrasound transducer for maintaining a biopsy instrument in a scan plane of the ultrasound transducer to facilitate a percutaneous biopsy of a lesion located in the scan plane. The ultrasound transducer is preferably translatable along a scanning trajectory as it scans the tissue sample through the membranous sheet, to provide for volumetric imaging of the tissue sample so that a position of the lesion within the tissue sample can be determined prior to the percutaneous biopsy. In one particular example, the tissue sample is a human breast and the biopsy instrument is a biopsy needle for fine needle aspiration biopsy, core-needle biopsy, or vacuum-assisted biopsy. However, it is to be appreciated that one or more aspects of the present teachings can be advantageously applied for other single-cylinder excision alternatives and in other image-guided surgical contexts.

"For one embodiment, the ultrasound transducer is movably disposed within a housing, and the biopsy guide is coupled to the ultrasound transducer through an opening in the housing. The biopsy guide is thereby movable with the ultrasound transducer and maintainable in the scan plane for many or all transducer positions along the scanning trajectory.

"In one embodiment, the biopsy guide is provided as an addable and removable accessory to the above-described curved-membrane ultrasonic scanning apparatus. For this embodiment, and with particular applicability to the breast, the part of the tissue sample near an apex of the scanning trajectory becomes raised relative to the other parts of the tissue sample, and side entry of the needle or other biopsy instrument into that raised portion of the tissue sample becomes particularly convenient. In other embodiments, the biopsy guide is provided as an addable/removable accessory for ultrasound scanners having planar (i.e., flat, non-curved) compression surfaces that compress the breast in a generally chestward direction. In still other embodiments, the biopsy guide is provided as an addable/removable accessory for dual compression-plate scanning devices. For another preferred embodiment applicable to each of these cases, the biopsy guide is configured such that the biopsy instrument can have different angular orientations within the scan plane, such as by using a multi-link assembly analogous to that described in the commonly assigned U.S. Pat. No. 6,695,786, supra.

"In another embodiment, the apparatus senses pressure or force that a compression/scanning assembly exerts on the patient and uses the results to improve imaging.

BRIEF DESCRIPTION OF THE DRAWINGS

"FIG. 1 illustrates a perspective view of a breast ultrasound scanning apparatus according to an embodiment;

"FIGS. 2-3 illustrate a perspective view of a compression/scanning assembly of the ultrasound scanning apparatus of FIG. 1;

"FIGS. 4-5 illustrate a top view of breast ultrasound scanning according to an embodiment;

"FIGS. 6-7 illustrate an axial cut-away view of breast ultrasound scanning according to an embodiment;

"FIG. 8 illustrates a perspective view of a curved frame and membranous sheet as removed from a compression/scanning assembly according to an embodiment;

"FIG. 9 illustrates a perspective view of an ultrasound transducer, a curved membranous sheet, a rigid frame, and a transducer translation apparatus according to an embodiment;

"FIG. 10 illustrates a perspective view of a flexible curved compression/scanning assembly according to an embodiment;

"FIG. 11 illustrates a perspective view of a compression/scanning assembly and a biopsy attachment according to an embodiment;

"FIG. 12 illustrates a conceptual perspective view of the biopsy guide of FIG. 11 guiding a biopsy instrument into a lesion located in a scan plane of an ultrasound transducer;

"FIG. 13 illustrates a perspective view of a compression/scanning assembly and a biopsy guide attachment according to an embodiment;

"FIG. 14 illustrates a top view of a compression/scanning assembly and a biopsy guide attachment according to an embodiment;

"FIG. 15 illustrates a perspective view of a breast ultrasound scanning apparatus with biopsy guide attachment according to a preferred embodiment;

"FIG. 16 illustrates ultrasound scanning and ultrasound-assisted breast biopsy according to an embodiment;

"FIG. 17 illustrates a locking and actuating support column according to certain embodiments;

"FIG. 18 illustrates a perspective view of a breast ultrasound scanning apparatus according to an alternative embodiment;

"FIG. 19 illustrates a perspective view of a wall mounted breast ultrasound scanning apparatus according to a further alternative embodiment;

"FIG. 20 illustrates a perspective view of a chair or bed-mounted breast ultrasound scanning apparatus according to further alternative embodiments;

"FIG. 21 illustrates a perspective view of an ultrasound transducer with pressure or force sensing elements;

"FIG. 22 illustrates in perspective view a compression scanning assembly with pressure or force sensing elements;

"FIG. 23 is a functional block diagram illustrating an example of using force/pressure sensing results to improve imaging; and

"FIG. 24 illustrates in schematic form motors for driving an ultrasound probe and a compression/scanning assembly."

For additional information on this patent application, see: Wang, Shih-Ping; Anderson, Tor C.; Chen, Jiayu; Summers, Douglas G. Medical Ultrasound Scanning with Control over Pressure/Force Exerted by an Ultrasound Probe And/Or a Compression/Scanning Assembly. Filed December 23, 2013 and posted May 8, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1840&p=37&f=G&l=50&d=PG01&S1=20140501.PD.&OS=PD/20140501&RS=PD/20140501

Keywords for this news article include: Patents.

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