Systems and devices for coupling ultrasound energy to a body

• US 10,413,757 B2
• Filed: 01/23/2015
• Issued: 09/17/2019
• Est. Priority Date: 08/29/2012
• Status: Active Grant

• Current Assignee: Cerevast Medical, Inc.
• Original Assignee: Cerevast Medical, Inc.
• Inventors: Sato, Tomokazu, Tyler, William J., Lamb, Philip, Wetmore, Daniel Z., Chang, Han-Ting, Goldwasser, Isy
• Primary Examiner(s): Pehlke, Carolyn A
• Application Number:
  US14/603,671
• Publication Number:
  US 20150135840A1
• Time in Patent Office: 1,698 Days
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61H 2201/1607 Holding means therefor
• CPC Class Codes: A61H 2201/169 Physical characteristics of the surface, e.g. material, relief, texture or indicia
• CPC Class Codes: A61H 2205/02 Head
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 2007/0021 Neural system treatment
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: G01N 29/28 providing acoustic coupling , e.g. water impedance matching G10K11/02

Abstract

Methods and systems for coupling ultrasound to the body, including to the head, are disclosed. The system is optionally configured to transmit ultrasound energy for transcranial ultrasound neuromodulation. Couplant assemblies are described that incorporate a semi-solid component that interfaces directly to the user'"'"'s body and face of the ultrasound transducer. These couplant assemblies can be shaped, molded, or otherwise machined and, in some embodiments, contain one or more liquid, gel, or other non-solid component in an enclosed reservoir of the couplant assembly. Beneficial embodiments of ultrasound coupling assemblies described herein include those that conform to the contour of the user'"'"'s body (e.g. the user'"'"'s head for transcranial applications) and can easily be removed without leaving a messy residue. By having solid materials physically contacting the body, no residue is left that requires cleanup.

Claims

1. A system for coupling ultrasound energy to a subject, the system comprising:

a couplant assembly having a proximal surface shaped to contact an ultrasound transducer and a distal surface, the couplant assembly including a conformable solid couplant material between the proximal and distal surfaces, wherein the conformable solid couplant material has a Shore D durometer hardness value of less than 60 D, wherein the conformable solid couplant material includes a first surface and a second surface, wherein the proximal surface of the couplant assembly comprises the first surface of the conformable solid couplant material, wherein the distal surface of the couplant assembly comprises the second surface of the conformable solid couplant material, wherein the first surface of the conformable solid couplant material is configured to physically contact the ultrasound transducer, wherein the second surface of the conformable solid couplant material is capable of deflecting at least partially in response to contact with skin or hair of the subject when placed on the subject in order to couple the ultrasound transducer in contact with the proximal surface to the subject, and wherein the conformable solid couplant material fully contains an enclosed reservoir that contains a liquid or gel material, the couplant assembly comprising;

a housing containing one or more structures of the couplant assembly, the housing comprising;

a chassis; and

a retaining ring dimensioned to attach to the chassis to hold the conformable solid couplant material, wherein the housing is configured to hold the proximal surface of the couplant assembly in contact with the ultrasound transducer.

2. The system of claim 1, wherein the couplant assembly comprises a deformable coupling structure that is deformable to conform to a contour of a head of the subject when placed in contact with the head of the subject.

3. The system of claim 1, wherein the conformable solid couplant material comprises a gel.

4. The system of claim 1, wherein the conformable solid couplant material comprises silicone.

5. The system of claim 1, wherein the couplant assembly comprises one or more stiffening assembly components made of a material that is harder than the conformable solid couplant material.

6. The system of claim 1, wherein the couplant assembly is reusable.

7. The system of claim 6, wherein the housing is configured to hold the ultrasound transducer when the couplant assembly is placed on the subject and when the couplant assembly is removed from the subject.

8. The system of claim 7, wherein the couplant assembly is configured to be removeably attached to the ultrasound transducer.

9. The system of claim 1, wherein the distal surface includes a conformable solid couplant material having an internal adhesion strength greater than the adhesion strength between the distal surface and the scalp, skin, or hair of the subject when the distal surface is pressed against the subject.

10. The system of claim 1, wherein the couplant assembly further comprises at least one first material held in contact with at least one second material to provide rigidity to the couplant assembly, a rigidity characteristic of the first material being higher than a rigidity characteristic of the second material.

11. The system of claim 1, wherein the conformable solid couplant material comprises a gel composed of physically crosslinked polymers, chemically crosslinked polymers, or a combination thereof.

12. The system of claim 11 wherein the gel comprises small molecules.

13. The system of claim 1, wherein the conformable solid couplant material comprises a gel prepared from one of i) naturally occurring polymers, (ii) synthetic polymers, and iii) synthetic monomers.

14. The system of claim 1, wherein the conformable solid couplant material comprises a gel prepared from naturally occurring polymers comprising one or more of collagen, gelatin, hyaluronic acid, fibrin, alginate, agarose, and chitosan and wherein the naturally occurring polymers are formed and shaped by addition of crosslinkers to add structural stiffness thereto.

15. The system of claim 1, wherein the conformable solid couplant material comprises a gel prepared from synthetic polymers comprising one or more of homo- or co-polymers of acids, amides, alcohols, PEGs, and amine.

16. The system of claim 1, wherein the conformable solid couplant material comprises a gel prepared from synthetic monomers comprising one or more of mono-, di-, tri- and multi-functional acrylates, methacrylates, vinyls, amines, alcohol, carboxylic acids, epoxides, andydrides, and isocyantes.

17. The system of claim 1, wherein the enclosed reservoir is completely enclosed by the conformable solid couplant material.