Ultrasound interfacing device for tissue imaging

• US 7,931,596 B2
• Filed: 07/14/2003
• Issued: 04/26/2011
• Est. Priority Date: 07/12/2002
• Status: Expired due to Term

• Current Assignee: Nova Eye Incorporated
• Original Assignee: iScience Interventional Corporation
• Inventors: Rachlin, Daniel, Conston, Stanley R.
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): BOR, HELENE CATHERINE
• Application Number:
  US10/521,045
• Publication Number:
  US 20050240102A1
• Time in Patent Office: 2,843 Days
• Field of Search: 600459-471
• US Class Current: 600/459
• CPC Class Codes: A61B 8/10 Eye inspection
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation

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

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.

2. The interface device of claim 1, wherein the interface device is sterile.

3. The interface device of claim 2, wherein the interface device is constructed of materials suitable to be sterilized by ionizing radiation.

4. 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.

5. The interface device of claim 1, wherein the scan window comprises a cross-linked hydrogel.

6. 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.

7. The interface device of claim 5, wherein said cross-linked hydrogel comprises polyethylene oxide.

8. The interface device of claim 5, wherein said cross-linked hydrogel is formed from polyisocyanate terminated poly(alkylene ether) polyols.

9. The interface device of claim 1, wherein reservoir has an adjustable length for adjusting a distance between the scan window and the transducer.

10. 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.

11. 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.

12. The interface device of claim 1, wherein the reservoir comprises a plurality of separate pieces between which said scan window is mechanically secured.

13. The interface device of claim 1, wherein the device incorporates delivery of fluid acoustic coupling material to a distal surface of said scan window.

14. 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.

15. The interface device of claim 1, wherein the device incorporates access for surgical instruments.

16. The interface device of claim 1, wherein the device incorporates a surgical instrument.

17. 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.

18. 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.

19. The interface device of claim 1, wherein the scan window comprises a cross-linked hydrogel and a mesh support extending across the scan window.

20. The interface device of claim 1, wherein said mesh of filaments is in a crossing pattern embedded in the cross-linked hydrogel.

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.

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.

23. The interface device of claim 22, wherein said mesh of filaments is arranged in a crossing pattern.

24. The interface device of claim 22, wherein said reservoir has an adjustable length for adjusting a distance between the scan window and the transducer.

25. The interface device of claim 24, wherein said mesh of filaments is arranged in a crossing pattern.