ULTRASHIELD DEVICES AND METHODS FOR USE IN ULTRASONIC PROCEDURES

• US 20170128042A1
• Filed: 10/24/2016
• Published: 05/11/2017
• 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
• Granted Patent: US 10,064,599 B2
• Time in Patent Office: Days
• 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 for coupling with at least a faceplate of an ultrasound probe for ultrasound transmission through a surface of a body, the device comprising:

an ultrashield comprising a couplant layer having a couplant, and a body contact layer adjacent the couplant layer, the body contact layer having a plurality of openings which allow controlled release of the couplant from the couplant layer through the openings to the surface of the body,

wherein the ultrashield provides ultrasound wave transmission from the faceplate of the ultrasound probe to the surface of the body with minimal to no attenuation.

2. The device of claim 1, wherein the body contact layer has a low coefficient of friction so as to glide over the surface of the body with minimal friction.

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

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

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

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

7. The device of claim 1, wherein the couplant comprises water.

8. The device of claim 1, wherein the couplant layer comprises ultrasonic gel.

9. The device of claim 1, wherein the couplant layer comprises a hydrogel.

10. The device of claim 1, wherein the couplant layer comprises a thermoplastic elastomer, a polymer matrix or a collagen material.

11. The device of claim 1, wherein the couplant layer comprises a pouch filled with the couplant.

12. The device of claim 11, wherein the couplant is selected from the group consisting of water, silicone oil, silicone gel, propylene glycol, glycerin, a corrosion inhibitor, carboxy polymethylene, cellulose, amino alcohol, a surfactant, a preservative, and combinations thereof.

13. The device of claim 1, wherein each opening is in the range of up to 10 microns.

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

15. The device of claim 14, 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.

16. The device of claim 1, further comprising a probe contact layer configured to mate with the couplant layer and adhere to the ultrasound probe.

17. The device of claim 1, further comprising a probe cover having at least a bottom surface configured to cover the faceplate of the ultrasound probe, wherein the ultrashield is disposed along the bottom surface so that the bottom surface and ultrashield provide ultrasound wave transmission from the faceplate of the ultrasound probe to the surface of the body with minimal to no attenuation.

18. The device of claim 17, wherein the ultrashield is integral with the probe cover.

19. The device of claim 17, wherein the ultrashield further comprises a probe contact layer configured to mate with the couplant layer and adhere to the bottom surface of the probe cover.

20. The device of claim 17, further comprising a removable protective pouch extending over the ultrashield, wherein the pouch resists loss of couplant from the couplant layer.

21. The device of claim 17, further comprising a replenishment mechanism configured to replenish the couplant layer with couplant.

22. The device of claim 21, wherein at least a portion of the replenishment mechanism is pre-filled with couplant.

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

24. 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.

25. 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, wherein the ultrashield comprises a couplant layer having a couplant, and a body contact layer adjacent the couplant layer, the body contact layer having a plurality of openings which allow controlled release of the couplant from the couplant layer through the openings to the surface of the body;

contacting the ultrashield to the surface of the body so that 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; and

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

26. The method of claim 25, wherein the ultrashield comprises a probe contact layer adjacent to the couplant layer, and wherein covering the faceplate comprises adhering the probe contact layer to the faceplate of the ultrasound probe.

27. The method of claim 25, 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.

28. The method of claim 27, 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.

29. The method of claim 25, further comprising replenishing the couplant.

30. The method of claim 29, wherein replenishing the couplant comprises activating a replenishment system.

31. The method of claim 25, wherein transmitting ultrasound comprises imaging through the surface of the body.