Breast implant with regionalized analyte sensors responsive to external power source

• US 9,339,372 B2
• Filed: 06/12/2014
• Issued: 05/17/2016
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Elwha LLC (Intellectual Ventures LLC)
• Original Assignee: Elwha LLC (Intellectual Ventures LLC)
• Inventors: Boyden, Edward S., Della Rocca, Gregory J., Hawkins, Daniel, Hyde, Roderick A., Langer, Robert, Leuthardt, Eric C., Myckatyn, Terence, Parikh, Parag Jitendra, Rivet, Dennis J., Shimony, Joshua S., Smith, Michael A., Sweeney, Elizabeth A., Tegreene, Clarence T.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/302,814
• Publication Number:
  US 20140288647A1
• Time in Patent Office: 705 Days
• Field of Search: 623 7- 8
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/4312 Breast evaluation or disorder diagnosis A61B5/0091 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

Breast implants including sensor modules and related methods are described herein. Breast implants include those with: a shell configured to be substantially filled with a viscous material; a plurality of projections extending from an external surface of the shell, the projections forming a plurality of compartments adjacent to the external surface of the shell; at least one fluid-permeable cover attached to the projections, the cover completely enveloping the shell and the plurality of projections; and a plurality of sensor modules attached to the shell and positioned at a distance from each other, each of the sensor modules oriented to detect one or more analytes in a fluid within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier and is configured to utilize energy transmitted from an external source.

Claims

1. A method of monitoring information from a breast implant, comprising:

receiving first information from a first sensor module attached to a shell of a breast implant within an individual, wherein the first information includes a first unique sensor module identifier and sensor data from the first sensor module;

receiving second information from a second sensor module attached to the shell of the breast implant within the individual, wherein the second information includes a second unique sensor module identifier and the sensor data from the second sensor module;

forming an initial record from the first information and the second information, the initial record including positional information regarding the first sensor module and the second sensor module;

calculating deviation limits regarding the initial record;

setting deviation parameters based on the deviation limits and a predetermined set of standards;

saving the initial record and the deviation parameters in a memory in a computing device;

receiving third information from the first sensor module attached to the shell of the breast implant within the individual, wherein the third information includes the first unique sensor module identifier and the sensor data from the first sensor module;

receiving fourth information from the second sensor module attached to the shell of the breast implant within the individual, wherein the fourth information includes the second unique sensor module identifier and the sensor data from the second sensor module;

updating the initial record with the third information and the fourth information;

saving the updated record in memory in the computing device;

comparing the updated record to the initial record and to the deviation parameters; and

indicating if the updated record is within the deviation parameters of the initial record and the positional information for each of the first sensor module and the second sensor module.

2. The method of claim 1, comprising:

receiving fifth information from the first sensor module attached to the shell of the breast implant within the individual, wherein the fifth information includes the first unique sensor module identifier and the sensor data from the first sensor module;

receiving sixth information from the second sensor module attached to the shell of the breast implant within the individual, wherein the sixth information includes the second unique sensor module identifier and the sensor data from the second sensor module;

updating the initial record with the fifth information and the sixth information;

saving the updated record in the memory in the computing device;

comparing the updated record to the initial record and to the deviation parameters;

indicating if the updated record is within the deviation parameters of the initial record.

3. A method of monitoring information from a breast implant, comprising:

directing, from an ex-vivo device, a non-electrical power source to a breast implant in-vivo;

sending, from a remote device, a query signal to at least one transmission unit attached to the breast implant in vivo, the at least one transmission unit attached to at least two sensor modules;

receiving, from a remote device, a response signal from the at least one transmission unit attached to the breast implant, the response signal including positional information from each of the at least two sensor modules;

processing, in a computing device, the response signal to identify information from the at least two sensor modules;

identifying, for each of the at least two sensor modules, a detection result and a unique identifier; and

initiating a display of the detection result and the unique identifier for at least one of the sensor modules.

4. The method of claim 3, wherein the detection result for each of the at least two sensor modules includes a positive result, a negative result, or a null result.

5. The method of claim 3, comprising:

initiating a graphic display of the breast implant, the graphic display including a position for each of the sensor modules and the detection result for at least one of the sensor modules.

6. A method of monitoring information from a breast implant, comprising:

directing, from an ex-vivo device, a non-electrical power source to a breast implant in vivo;

sending a signal from at least one transmission unit attached to the breast implant in vivo, the signal including information regarding one or more sensor modules configured to detect biological analytes in fluid from biological tissue, the at least one transmission unit attached to the one or more sensor modules;

receiving, at a remote device, the signal from the at least one transmission unit attached to the breast implant;

processing, in a computing device, the signal to identify information from the one or more sensor modules;

identifying, for each of the one or more sensor modules, a detection result and a unique identifier; and

initiating a graphic display of the breast implant, the graphic display including a position for each of the sensor modules and the detection result for at least one of the sensor modules.

7. The method of claim 6, wherein the detection result for each of the one or more sensor modules includes a positive result, a negative result, or a null result.

8. The method of claim 6, comprising:

initiating a display of the detection result and the unique identifier for at least one of the sensor modules.