Ultrashield devices and methods for use in ultrasonic procedures

• US 10,206,653 B2
• Filed: 03/31/2017
• Issued: 02/19/2019
• 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:
  US15/476,468
• Publication Number:
  US 20170202538A1
• Time in Patent Office: 690 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 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, wherein the couplant layer comprises a couplant material having a couplant which is able to flow out of the couplant material, wherein either

a) the couplant material comprises a hydrogel and the couplant comprises water which is able to flow out of the hydrogel, or

b) the couplant material comprises a thermoplastic elastomer, a polymer matrix or a collagen material; and

a body contact layer adjacent the couplant layer, the body contact layer comprised of a hydrophilic material having a plurality of openings which allow controlled release of the couplant which is able to flow out of the couplant material 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.

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 the couplant material comprises the thermoplastic elastomer, the polymer matrix or the collagen material and the couplant comprises water.

7. The device of claim 1, wherein the couplant material comprises the thermoplastic elastomer, the polymer matrix or the collagen material and the couplant comprises ultrasonic gel.

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

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

10. The device of claim 9, 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.

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

12. The device of claim 11, wherein the ultrashield has a thickness in a range of 0.1 to 0.3 inches.

13. 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.

14. The device of claim 13, wherein the ultrashield is integral with the probe cover.

15. The device of claim 13, 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.

16. The device of claim 13, further comprising a removable protective pouch extending over the ultrashield, wherein the pouch resists loss of at least a portion of the couplant from the couplant layer.

17. The device of claim 13, further comprising a replenishment mechanism configured to replenish the couplant layer with supplemental couplant.

18. The device of claim 17, wherein at least a portion of the replenishment mechanism is pre-filled with the supplemental couplant.

19. 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.

20. The device of claim 1, wherein the couplant material comprises the hydrogel, wherein the hydrogel has greater than 95% water.

21. 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, wherein the couplant layer comprises a couplant material having a couplant which is able to flow out of the couplant material, wherein either

a) the couplant material comprises a hydrogel and the couplant comprises water which is able to flow out of the hydrogel, or

b) the couplant material comprises a thermoplastic elastomer, a polymer matrix or a collagen material having the couplant; and

a body contact layer adjacent the couplant layer, the body contact layer comprised of a hydrophilic material having a plurality of openings which allow controlled release of the couplant which is able to flow out of the couplant material through the openings to the surface of the body;

moving the ultrasound probe so that the ultrashield glides along the surface of the body so that the couplant 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.

22. The method of claim 21, 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.

23. The method of claim 21, 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.

24. The method of claim 23, 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.

25. The method of claim 21, further comprising replenishing the couplant.

26. The method of claim 25, wherein replenishing the couplant comprises activating a replenishment system.

27. The method of claim 21, wherein the couplant material comprises the hydrogel, wherein the hydrogel has greater than 95% water.