Ultrashield devices and methods for use in ultrasonic procedures

• US 10,064,599 B2
• Filed: 10/24/2016
• Issued: 09/04/2018
• Est. Priority Date: 11/09/2015
• Status: Active Grant

• Current Assignee: Cal TENN Innovation Incorporated
• Original Assignee: Healthcare Evolution LLC
• Inventors: Desai, Siddharth, Jones, Jerry
• Primary Examiner(s): Gillman, Amelie R
• Application Number:
  US15/332,571
• Publication Number:
  US 20170128042A1
• Time in Patent Office: 680 Days
• Field of Search: None
• 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
• CPC Class Codes: A61B 8/4444 related to the probe
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects

Abstract

Devices and method are provided for ultrasound transmission without the need for external couplants, such as gels, which are typically used in conventional ultrasound procedures. In particular, ultrashields are provided for use with ultrasound probes, wherein the ultrashields have specialized layers to provide an uninterrupted pathway of acoustic conductance from the probe to the surface of the body throughout the procedure while introducing minimal to no attenuation of ultrasound wave transmission. In addition, combinations of ultrashields and probe covers are provided to provide additional features such as a microbial barrier.

Claims

1. A device comprising an ultrashield for coupling with at least a faceplate of an ultrasound probe for ultrasound transmission through a surface of a body, the ultrashield comprising:

a probe contact layer couplable with the faceplate so as to isolate the faceplate from gel and liquid;

an intermediate couplant layer adjacent the probe contact layer, wherein the couplant layer comprises a hydrogel holding water which is able to flow out of the hydrogel; and

a body contact layer adjacent the couplant layer and opposite the probe contact layer, the body contact layer having a plurality of openings which allow controlled release of the water from the couplant layer through the openings to the surface of the body so that the water facilitates movement of the body contact layer across the surface of the body without application of gel to an external surface of the body contact layer,

wherein the probe contact layer, intermediate couplant layer and body contact layer are stacked and adhered together to form a single multi-layered sheet, and

wherein the ultrashield provides ultrasound wave transmission from the faceplate of the ultrasound probe to the surface of the body.

2. The device of claim 1, wherein the body contact layer has a coefficient of friction less than 0.84.

3. The device of claim 1, wherein the body contact layer has a coefficient of friction less than or equal to 0.5.

4. The device of claim 3, wherein the body contact layer has a coefficient of friction less than or equal to 0.1.

5. The device of claim 1, wherein the body contact layer comprises polyester or polyvinylidene fluoride.

6. The device of claim 1, wherein each opening is in a range of 0.5-5 microns.

7. The device of claim 1, wherein the body contact layer is sufficiently flexible to allow compression of the couplant layer.

8. The device of claim 7, wherein the body contact layer is sufficiently stretchable to move axially so as to conform to the surface of the body as the probe glides thereover.

9. The device of claim 1, wherein the ultrashield has a thickness in a range of 0.1 to 0.3 inches.

10. The device of claim 9, wherein the thickness of the ultrashield in a range of 0.110 to 0.220 inches.

11. The device of claim 1, wherein the ultrashield creates an uninterrupted pathway of acoustic conductance from the faceplate of the probe to the surface of the body without externally applied couplant to the probe or the surface of the body when the probe is applied to the surface of the body for ultrasound imaging therethrough.

12. The device of claim 1, wherein the couplant layer has a thickness in a range of approximately 0.060 to 0.150 inches.

13. The device of claim 1, wherein the couplant layer has a durometer between 10-20 Shore A-2.

14. The device of claim 1, wherein the body contact layer has a thickness in a range of approximately 0.010 to 0.070 inches.

15. The device of claim 1, wherein the probe contact layer has a thickness of less than or equal to 0.060 inches.

16. The device of claim 1, wherein the ultrashield is sized and configured so that at least a portion of its exterior edge is able to flexibly wrap onto the ultrasound probe beyond the faceplate to couple the ultrashield with the ultrasound probe.

17. The device of claim 1, wherein the probe contact layer comprises a flexible film forming at least one side wall configured to bend and wrap onto the ultrasound probe to couple the ultrashield with at ultrasound probe.

18. The device of claim 17, wherein the probe contact layer comprises a rigid layer residing along a portion of the probe contact layer configured to cover the faceplate while the at least one side wall of flexible film bends and wraps onto the ultrasound probe to couple the ultrashield with the ultrasound probe.

19. The device of claim 1, the ultrashield further comprises an adhesive arranged to removably adhere the ultrashield to the ultrasound probe.

20. The device of claim 1, wherein the device comprises packaging layers sized and configured to encase the ultrashield, wherein the packaging layers are comprised of a material which reduces water vapor transmission or loss of water from the ultrashield.

21. The device of claim 1, wherein the ultrashield is configured to conform to the ultrasound probe so as to allow use within a body cavity.

22. The device of claim 1, wherein the hydrogel has greater than 95% water.

23. The device of claim 1, wherein the body contact layer is hydrophilic.

24. A method of transmitting ultrasound through a surface of a body with an ultrasound probe, the method comprising:

covering a faceplate of the ultrasound probe with an ultrashield so that the faceplate is isolated from gel and liquid, wherein the ultrashield comprises

a probe contact layer couplable with the faceplate,

an intermediate couplant layer comprising a hydrogel holding water, and

a body contact layer adjacent the couplant layer and opposite the probe contact layer, the body contact layer having a plurality of openings which allow controlled release of the water from the couplant layer through the openings to the surface of the body so that the water facilitates movement of the body contact layer across the surface of the body without application of gel to an external surface of the body contact layer;

wherein the probe contact layer, intermediate couplant layer and body contact layer are stacked and adhered together to form a single multi-layered sheet;

moving the ultrasound probe so that the ultrashield glides along the surface of the body so that the water is released from the couplant layer through the openings to the surface of the body creating an uninterrupted pathway of acoustic conductance from the faceplate of the probe to the surface of the body; and

transmitting ultrasound through the surface of the body with the faceplate of the ultrasound probe.

25. The method of claim 24, wherein covering the faceplate comprises adhering the probe contact layer to the faceplate of the ultrasound probe.

26. The method of claim 24, wherein the ultrashield is carried by a probe cover, and wherein covering the faceplate comprises covering the faceplate with the probe cover so that the ultrashield covers the faceplate of the ultrasound probe.

27. The method of claim 26, wherein the ultrashield is covered by a protective pouch, the method further comprising removing the protective pouch prior to contacting the ultrashield to the surface of the body.

28. The method of claim 24, further comprising replenishing the water.

29. The method of claim 24, further comprising generating an image with the transmitted ultrasound.

30. The method of claim 24, wherein covering comprises wrapping at least a portion of an exterior edge of the ultrashield onto the ultrasound probe beyond the faceplate.

31. The method of claim 30, wherein the probe contact layer comprises a flexible film forming at least one side wall, and wherein wrapping at least the portion of the exterior edge of the ultrashield onto the ultrasound probe beyond the faceplate comprises bending and wrapping the at least one side wall onto the ultrasound probe, and further comprising adhering the at least one sidewall to the ultrasound probe beyond the faceplate.

32. The method of claim 24, further comprising removing the ultrashield from packaging prior to the covering step, wherein the packaging includes packaging layers sized and configured to encase the ultrashield, and wherein the packaging layers are comprised of a material which reduces water vapor transmission or loss of couplant water from the ultrashield.

33. The method of claim 24, wherein the hydrogel has greater than 95% water.

34. The method of claim 24, wherein the body contact layer is hydrophilic.