BREAST IMPLANT WITH REGIONALIZED ANALYTE SENSORS AND INTERNAL POWER SOURCE

• US 20140296978A1
• Filed: 06/11/2014
• Published: 10/02/2014
• 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.
• Granted Patent: US 9,333,071 B2
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/06 Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 2562/168 Fluid filled sensor housings
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• 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 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• 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: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/57415 of breast

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; a plurality of sensor modules attached to the shell, 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 at least one power source operably attached to the plurality of sensor modules.

Claims

1-112. -112. (canceled)

113. A breast implant comprising:

a shell configured to be substantially filled with a viscous material;

a plurality of projections extending from an external surface of the shell, each of the plurality of projections including a first end surface sealed to the external surface of the shell, the projections forming a plurality of compartments adjacent to the external surface of the shell;

a plurality of sensor modules attached to the shell, each of the sensor modules positioned within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier; and

at least one power source operably attached to the plurality of sensor modules.

114-116. -116. (canceled)

117. 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 sensor data from the second sensor module;

forming an initial record from the first information and the second information;

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 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 an updated record in the 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.

118. The method of claim 117, 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; and

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

119. (canceled)

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

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

receiving, from a remote device, a response signal from the at least one transmission unit attached to the breast implant, the response signal including information from the one or more sensor modules;

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

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

121. The method of claim 120, wherein the detection result for each of the one or more sensor modules includes a positive result, a negative result, or a null result.

122. The method of claim 120, comprising:

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

123. The method of claim 120, 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.

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

sending a signal from at least one transmission unit attached to a 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 east 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; and

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

125. The method of claim 124, wherein the detection result for each of the one or more sensor modules includes a positive result, a negative result, or a null result.

126. The method of claim 124, comprising:

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

127. The method of claim 124, 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.

128. A breast implant comprising:

a shell configured to be substantially filled with a viscous material;

a plurality of projections extending from an external surface of the shell, each of the plurality of projections including a first end surface sealed to the 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, each of the plurality of projections including a second end surface sealed to a surface of the cover, the cover completely enveloping the shell and the plurality of projections;

a plurality of sensor modules attached to the shell, each of the sensor modules positioned within one of the plurality of compartments, wherein each of the plurality of sensor modules includes a unique identifier; and

at least one power source operably attached to the plurality of sensor modules.

129. A breast implant comprising:

a shell configured to be substantially filled with a viscous material, the shell including a barrier layer with a plurality of apertures, the plurality of apertures each including a surface configured to reversibly mate with a region of an outer surface of a sensor module;

a plurality of projections extending from an external surface of the shell, each of the plurality of projections including a first end surface sealed to the 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, each of the plurality of projections including a second end surface sealed to a surface of the cover, the cover completely enveloping the shell and the plurality of projections;

a plurality of sensor modules attached to the shell with the region of an outer surface of each of the sensor modules mated to the surface of one of the plurality of apertures in the barrier layer, each of the sensor modules positioned within one of the plurality of compartments; and

at least one power source operably attached to the plurality of sensor modules.

130. A breast implant comprising:

a shell configured to be substantially filled with a viscous material, the shell including a plurality of cavities in a surface of the shell, the plurality of cavities each including a surface configured to reversibly mate with a region of an outer surface of a sensor module;

a plurality of projections extending from an external surface of the shell, each of the plurality of projections including a first end surface sealed to the 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, each of the plurality of projections including a second end surface sealed to a surface of the cover, the cover completely enveloping the shell and the plurality of projections;

a plurality of sensor modules attached to the shell with the region of an outer surface of each of the sensor modules mated to the surface of one of the plurality of cavities, each of the sensor modules positioned within one of the plurality of compartments; and

at least one power source operably attached to the plurality of sensor modules.