# US 7,931,596 B2 · Ultrasound interfacing device for tissue imaging > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,931,596 B2 - Document ID: US7931596B2 - Status: Granted - Kind: B2 - Application number: 10/521,045 - Filed: 2003-07-14 - Published: 2005-10-27 - Granted: 2011-04-26 - Earliest claimed: 2003-07-14 - Assignees: iScience Interventional Corporation - Inventors: Daniel Rachlin; Stanley R. Conston - Web page: https://patentgrep.com/patent/US7931596B2 ## CPC - A61B 8/10: Eye inspection - A61B 8/4281: {characterised by sound-transmitting media or devices for coupling the transducer to the tissue} - A61B 8/4422: {related to hygiene or sterilisation} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A device (10) used with high frequency ultrasound provides a replaceable barrier between the ultrasound transducer and the tissues being imaged. The device (10) provides an acoustic pathway of minimal effect on the ultrasound signals, and furthermore provides for a safety barrier between a mechanical scanner and the tissues being imaged. The configuration of the device (10) allows it to function as a standoff for the ultrasound transducer to place the focus of the ultrasound beam at the desired depth of tissue for imaging. In addition, the device (10) may be sterilized and replaced as needed, providing sterile tissue contact surfaces. The device (10) has additional features, which are especially advantageous for diagnosis and surgery of the eye. ## Claims ### Claim 1 An interface device for use with an ultrasound imaging system having a scan head with at least one transducer, the interface device being removably attachable to the scan head, the interface device comprising: a reservoir with a proximal end and a distal end, said proximal end being open and shaped to allow the transducer to be inserted within said reservoir, wherein said proximal end of said reservoir is configured to maintain a fluid tight seal between said reservoir and the scan head, and wherein said distal end of said reservoir is configured to extend past a distal end of the transducer, a scan window located proximate said distal end of said reservoir through which ultrasound energy is transmitted and received, wherein said scan window is formed of a solid, non-flowable hydrogel, a fluid tight seal between said scan window and said distal end of said reservoir, and a fluid acoustic coupling medium located within said reservoir and filling a space between said transducer and said scan window, wherein said solid, non-flowable hydrogel comprises a cross-linked hydrogel and wherein said scan window further comprises a support structure comprising a mesh of filaments embedded in the cross-linked hydrogel. ### Claim 2 (depends on 1) The interface device of claim 1, wherein the interface device is sterile. ### Claim 3 (depends on 2) The interface device of claim 2, wherein the interface device is constructed of materials suitable to be sterilized by ionizing radiation. ### Claim 4 (depends on 1) The interface device of claim 1, wherein said scan window is formed of a material with less than 1 dB/mm signal loss of transmitted and received high frequency ultrasound at a frequency in a range of 50 to 100 MHz. ### Claim 5 (depends on 1) The interface device of claim 1, wherein the scan window comprises a cross-linked hydrogel. ### Claim 6 (depends on 5) The interface device of claim 5, wherein said cross-linked hydrogel comprises a cross-linked polymer with water content greater than or equal to 50% by weight. ### Claim 7 (depends on 5) The interface device of claim 5, wherein said cross-linked hydrogel comprises polyethylene oxide. ### Claim 8 (depends on 5) The interface device of claim 5, wherein said cross-linked hydrogel is formed from polyisocyanate terminated poly(alkylene ether) polyols. ### Claim 9 (depends on 1) The interface device of claim 1, wherein reservoir has an adjustable length for adjusting a distance between the scan window and the transducer. ### Claim 10 (depends on 9) The interface device of claim 9, wherein the distance between said scan window and the transducer is adjustable to position the transducer focus approximately 2 to 6 mm distal to said scan window. ### Claim 11 (depends on 1) The interface device of claim 1, wherein a distal surface of said scan window has a preformed concave curve to approximate a curvature of an eye. ### Claim 12 (depends on 1) The interface device of claim 1, wherein the reservoir comprises a plurality of separate pieces between which said scan window is mechanically secured. ### Claim 13 (depends on 1) The interface device of claim 1, wherein the device incorporates delivery of fluid acoustic coupling material to a distal surface of said scan window. ### Claim 14 (depends on 1) The interface device of claim 1, wherein the interface device is configured to be removably attachable to the scan head of a high frequency ultrasound imaging system operable at a frequency in a range of 50 to 100 MHz. ### Claim 15 (depends on 1) The interface device of claim 1, wherein the device incorporates access for surgical instruments. ### Claim 16 (depends on 1) The interface device of claim 1, wherein the device incorporates a surgical instrument. ### Claim 17 (depends on 1) The interface device of claim 1, wherein the device incorporates a surgical instrument that allows use of the instrument in positional relationship to the scanned image. ### Claim 18 (depends on 1) The interface device of claim 1, wherein said proximal end of said reservoir is configured to allow the transducer to traverse across an intended scan path within said reservoir. ### Claim 19 (depends on 1) The interface device of claim 1, wherein the scan window comprises a cross-linked hydrogel and a mesh support extending across the scan window. ### Claim 20 (depends on 1) The interface device of claim 1, wherein said mesh of filaments is in a crossing pattern embedded in the cross-linked hydrogel. ### Claim 21 An interface device for use with an ultrasound imaging system having a scan head with at least one transducer, the interface device being removably attachable to the scan head, the interface device comprising: a reservoir with a proximal end and a distal end, said proximal end being open and shaped to allow the transducer to be inserted within said reservoir, wherein said proximal end of said reservoir is configured to maintain a fluid tight seal between said reservoir and the scan head, and wherein said distal end of said reservoir is configured to extend past a distal end of the transducer, a scan window located proximate said distal end of said reservoir through which ultrasound energy is transmitted and received, wherein said scan window is formed of a solid, non-flowable hydrogel, a fluid tight seal between said scan window and said distal end of said reservoir, and a fluid acoustic coupling medium located within said reservoir and filling a space between said transducer and said scan window, wherein the reservoir has an adjustable length for adjusting a distance between the scan window and the transducer, and wherein said solid, non-flowable hydrogel comprises a cross-linked hydrogel and wherein said scan window further comprises a support structure comprising a mesh of filaments embedded in the cross-linked hydrogel. ### Claim 22 An interface device for use with an ultrasound imaging system having a scan head with at least one transducer, the interface device being removably attachable to the scan head, the interface device comprising: a reservoir with a proximal end and a distal end, said proximal end being open and shaped to allow the transducer to be inserted within said reservoir, wherein said proximal end of said reservoir is configured to maintain a fluid tight seal between said reservoir and the scan head, and wherein said distal end of said reservoir is configured to extend past a distal end of the transducer, a scan window located proximate said distal end of said reservoir through which ultrasound energy is transmitted and received, wherein said scan window is formed of a hydrogel with a support structure comprising a mesh of filaments embedded in said hydrogel, a fluid tight seal between said scan window and said distal end of said reservoir, a fluid acoustic coupling medium located within said reservoir and filling a space between said transducer and said scan window. ### Claim 23 (depends on 22) The interface device of claim 22, wherein said mesh of filaments is arranged in a crossing pattern. ### Claim 24 (depends on 22) The interface device of claim 22, wherein said reservoir has an adjustable length for adjusting a distance between the scan window and the transducer. ### Claim 25 (depends on 24) The interface device of claim 24, wherein said mesh of filaments is arranged in a crossing pattern.