Ultrasound phantom models, materials, and methods

• US 8,678,831 B2
• Filed: 02/18/2011
• Issued: 03/25/2014
• Est. Priority Date: 02/19/2010
• Status: Active Grant

• Current Assignee: gaumard scientific company, inc
• Original Assignee: gaumard scientific company, inc
• Inventors: Trotta, Thomas Neil, Trotta, Jennifer Anne, Lowe, Siobhain
• Primary Examiner(s): Fernstrom, Kurt
• Application Number:
  US13/031,087
• Publication Number:
  US 20110207103A1
• Time in Patent Office: 1,131 Days
• Field of Search: 434/262, 434/267, 434/268, 434/272, 434/273
• US Class Current: 434/273
• CPC Class Codes: B29C 39/006 Monomers or prepolymers by reaction injection moulding B29C67/246
• CPC Class Codes: B29C 39/021 by casting in several steps
• CPC Class Codes: B29C 39/025 for making multilayered articles
• CPC Class Codes: B29C 39/10 incorporating preformed parts or layers, e.g. casting around inserts or for coating articles coating a surface by casting in general B05D1/30, B29C39/126 takes precedence
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G09B 23/286 for scanning or photography techniques, e.g. X-rays, ultrasonics
• CPC Class Codes: G09B 23/30 Anatomical models G09B23/281 - G09B23/288 take precedence

Abstract

Devices, systems, and methods appropriate for use in medical training that include materials that better mimic natural human tissue are disclosed. In one aspect a polysiloxane mixture for simulating human biological tissue, especially human breast tissue, is disclosed. In another aspect, a method of manufacturing a biological tissue ultrasound phantom is disclosed. In another aspect, a human breast tissue models are disclosed. In some instances, the human breast tissue model includes at least one simulated pathological structure that simulates such pathologies as a cyst, a medullary carcinoma, a ductal carcinoma, an infiltrating scirrhus carcinoma, a lobular carcinoma, and a fibroadenoma.

Claims

1. A method of creating an ultrasound phantom, comprising:

pouring a first silicone layer into a mold;

introducing liquid directly onto the first layer;

pouring a second silicone layer over the first layer and the liquid to encapsulate the liquid directly between the first and second silicone layers.

2. The method of claim 1, wherein the liquid encapsulated within the first and second silicone layers simulates a cyst.

3. The method of claim 2, wherein the liquid encapsulated within the first and second silicone layers has a volume between about 0.1 ml and about 2.5 ml.

4. The method of claim 1, wherein the liquid is introduced into a recess in the first silicone layer.

5. The method of claim 4, further comprising defining the recess in the first silicone layer using an insert mold.

6. The method of claim 1, wherein the step of pouring the second silicone layer is performed prior to curing of the first silicone layer.

7. The method of claim 1, wherein the liquid is water.

8. The method of claim 7, wherein the first and second silicone layers are formed of a silicone gel.

9. The method of claim 8, wherein the mold is shaped to simulate aspects of a human breast.

10. The method of claim 1, further comprising:

introducing liquid onto the second layer; and

pouring a third silicone layer over the second layer and the liquid introduced onto the second layer to encapsulate the liquid between the second and third silicone layers.

11. The method of claim 10, wherein the first silicon layer defines a simulated skin layer.

12. The method of claim 11, wherein the liquid encapsulated within the first and second silicone layers simulates a pathology positioned at a first depth relative to the skin layer and the liquid encapsulated within the second and third silicone layers simulates a pathology positioned at a second depth relative to the skin layer, the second depth being greater than the first depth.

13. The method of claim 1, further comprising positioning a simulated dense mass onto the first silicone layer prior to pouring the second silicone layer.

14. The method of claim 13, wherein the simulated dense mass comprises a silicone material having an increased durometer relative to the first and second silicone layers.

15. A human breast tissue ultrasound model comprising:

a body portion sized and shaped to simulate a human breast, the body portion including;

a first silicone layer;

a second silicone layer; and

a liquid suspended directly between the first and second silicone layers to simulate a first pathology.

16. The human breast tissue model of claim 15, wherein the first pathology is a cyst.

17. The human breast tissue model of claim 16, wherein the first and second silicone layers and the liquid are configured to allow aspiration of the liquid from the body portion.

18. The human breast tissue model of claim 15, wherein the body portion further includes a third silicone layer and a silicone material having an increased hardness relative to the second and third silicone layers positioned between the second and third silicone layers to simulate a second pathology.

19. The human breast tissue model of claim 18, wherein the second pathology is a dense mass.

20. The human breast tissue model of claim 19, wherein the dense mass is configured to allow biopsy of at least a portion of the dense mass from the body portion.

21. The human breast tissue model of claim 19, wherein the first pathology is positioned at a first depth relative to an outer surface of the body portion and the second pathology is positioned at a second depth relative to the outer surface of the body portion, the second depth being greater than the first depth.