System for detecting fluid changes and sensoring devices therefor

• US 8,295,920 B2
• Filed: 10/25/2004
• Issued: 10/23/2012
• Est. Priority Date: 10/24/2003
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Bouton, Chad E., Ruggeri, Felicia R., Harpham, R. Reade, Held, Jeffrey R.
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): IP, JASON M
• Application Number:
  US10/576,333
• Publication Number:
  US 20070123770A1
• Time in Patent Office: 2,920 Days
• Field of Search: 600/307, 600/398, 600/407, 600/473, 600/475, 600/476, 600/477
• US Class Current: 600/547
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0507 using microwaves or terahertz waves
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4878 Evaluating oedema
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

A sensor device for detecting a change fluid level within body tissue comprising a housing with bridge segments connecting at intersections arranged to circumscribe an opening. Further, antenna elements are partially seated within the housing at intersections of bridge segments, comprise a generally planar antenna mounted to a substrate material at a base of the planar antenna, and an electrical shield surrounding the substrate. Also, an outer surface of the planar antenna faces away from the substrate. The antenna elements comprise at least first and second antenna element pairs having transmitting and receiving antenna elements and a bridging segment. A high sensitivity zone is formed between the transmitting antenna and receiving antenna. The antenna element pairs are spaced to create an area of reduced sensitivity between the high sensitivity zones, and the space is set so that the sensor is insensitive to fluid changes of a predetermined volume.

Claims

1. A sensor device for detecting a change in the level of fluid within tissue of a body, the sensor device comprising:

a housing having a plurality of bridge segments, the bridge segments connecting at intersections and being arranged to circumscribe an opening defined by the housing; and

a plurality of antenna elements at least partially seated within the housing at intersections of the bridge segments, each of the plurality of antenna elements comprising a generally planar antenna mounted to a substrate material at a base of the planar antenna, an outer surface of the planar antenna facing away from the substrate, each of the plurality of antenna elements further comprising an electrical shield surrounding the substrate,

wherein the each of the plurality of antenna elements comprises at least a first antenna element pair and a second antenna element pair, the first antenna element pair comprising a first transmitting antenna element, a first receiving antenna element, and a first bridging segment, the second antenna element pair comprising a second transmitting antenna element, a second receiving antenna element and a second bridging segment,

wherein a first high sensitivity zone is formed between the first transmitting antenna element and the first receiving antenna element and a second high sensitivity zone is formed between the second transmitting antenna element and the second receiving antenna element

wherein the first antenna element pair and the second antenna element pair are spaced from each other to create an area of reduced sensitivity between the first high sensitivity zone and the second high sensitivity zone,

wherein the space between the first antenna element pair and the second antenna element pair is set so that the sensor is insensitive to fluid changes of a predetermined volume within the area of reduced sensitivity.

2. The sensor device of claim 1 further comprising an RF cable assembly for each of the antenna elements, each of the RF cable assemblies at one end thereof comprising a connector and at the other end thereof being electrically connected to the antenna element corresponding thereto.

3. The sensor device of claim 1 further comprising at least one flexible circuit board assembly for transmission of energy to and from the antenna elements.

4. The sensor device of claim 3 wherein the flexible circuit board comprises at least one splitter such that electromagnetic energy can be transmitted to at least two of the plurality of antenna elements using a single transmission trace within the flexible circuit board.

5. The sensor device of claim 3 wherein the flexible circuit board comprises at least one combiner such that electromagnetic energy can be received from at least two of the plurality of antenna elements and carried by a single transmission trace within the flexible circuit board.

6. The sensor device of claim 1 further comprising an attachment mechanism to operably attach the sensor device to the tissue of the body, the attachment mechanism comprising:

an adhesive portion defining a cutout region generally coextensive with the opening of the housing, the adhesive portion having one side thereof coated with a first adhesive adapted to removably attach to the tissue and an opposite side thereof coated with a second adhesive adapted to attach to a bottom surface of the housing.

7. The sensor device of claim 6 wherein the attachment mechanism further comprises a release band affixed to a perimeter of the adhesive portion.

8. The sensor device of claim 7 wherein the first adhesive provides less adhesion than the second adhesive.

9. The sensor device of claim 1 wherein the electrical shield comprises a rearward section adjacent a rearward side of the substrate, side shields encompassing sides of the substrate and a forward section adjacent a forward side of the substrate and extending inward from the side shields, a margin being maintained between the planar antenna and the forward section.

10. The sensor device of claim 1 wherein the plurality of antenna elements emit electromagnetic energy in the range of approximately 300 MHz to approximately 30 GHz.

11. A sensor for detecting a change in the level of fluid within tissue of a body, comprising:

a first antenna pair comprising a first transmitting antenna element and a first receiving antenna element, the first transmitting antenna element being spaced from and connected to the first receiving antenna element by a first bridging segment; and

at least a second antenna pair comprising a second transmitting antenna element and a second receiving antenna element, the second transmitting antenna element being spaced from and connected to the second receiving antenna element by a second bridging segment,

the first antenna pair and the second antenna pair being placed in spaced connection by a first spacing segment and a second spacing segment so that an open area is defined by the first antenna pair, the second antenna pair, the first spacing segment and the second spacing segment,

wherein the first spacing segment connects a housing section of the first transmitting antenna element to a housing section of the second transmitting antenna element and the second spacing segment connects a housing section of the first receiving antenna element to a housing section of the second receiving antenna element,

wherein the first spacing segment and the second spacing segment space the first antenna pair and the second antenna pair to create an area of reduced sensitivity between a first high sensitivity zone and a second high sensitivity zone,

wherein the space between the first antenna pair and the second antenna pair is set so that the sensor is insensitive to fluid changes of a predetermined volume within the area of reduced sensitivity.

12. The sensor of claim 11 wherein each of the transmitting and receiving antenna elements is surrounded by the respective housing section, each of the transmitting and receiving antenna elements comprising a substrate mounted within the respective housing section and a generally planar antenna element mounted to the substrate.

13. The sensor device of claim 11 wherein a first area of higher sensitivity is defined by an area between the first transmitting antenna element and the first receiving antenna element and a second area of higher sensitivity is defined by an area between the second transmitting antenna element and the second receiving antenna element.

14. The sensor device of claim 11 further comprising an RF cable assembly for each of the antenna elements, each of the RF cable assemblies at one end thereof comprising a connector and at the other end thereof being electrically connected to the antenna element corresponding thereto.

15. The sensor device of claim 11 further comprising at least one flexible circuit board assembly for transmission of energy to and from the antenna elements.

16. The sensor device of claim 15 wherein the flexible circuit board comprises at least one splitter such that electromagnetic energy can be transmitted to the first transmitting antenna element and the second transmitting antenna element using a single transmission trace within the flexible circuit board.

17. The sensor device of claim 15 wherein the flexible circuit board comprises at least one combiner such that electromagnetic energy can be received from the first receiving antenna element and the second receiving antenna element and carried by a single transmission trace within the flexible circuit board.

18. The sensor of claim 11 further comprising an attachment mechanism to operably attach the sensor to the tissue of the body, the attachment mechanism comprising:

an adhesive portion defining a cutout region generally coextensive with the open area, the adhesive portion having one side thereof coated with a first adhesive adapted to removably attach to the tissue and an opposite side thereof coated with a second adhesive adapted to attach to the sensor.

19. The sensor of claim 18 wherein the attachment mechanism further comprises a release band affixed to a perimeter of the adhesive portion, the release band being generally free of adhesive.