Tissue perfusion sensor and placement device
Inventors
Pierskalla, Irvin T. • Winger, Kent R.
Assignees
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Publication Number
US-12115001-B2
Publication Date
2024-10-15
Expiration Date
Abstract
A physiologic sensor for measuring the partial pressure of carbon dioxide is provided. The sensor includes a generally C-shaped in cross-section sensor cover, the sensor cover defining an opening on an underside thereof; a membrane body housed within the opening, the membrane comprising an amorphous fluoroplastic, the membrane including a first end and a second end and defines a chamber therewithin; a sensor body for coupling the membrane to the sensor cover; two or more electrodes positioned within the membrane chamber; and a substantially electrolyte-free liquid contained within the membrane chamber and in contact with the two or more electrodes.
Core Innovation
The invention provides a sensor system for measuring partial pressure of carbon dioxide (pCO2) in tissue, including buccal tissue of a subject. The sensor includes a generally C-shaped in cross-section sensor cover defining an opening bounded on a top by an underside of the sensor cover and bounded on a distal end by a lip, with a membrane body housed within the opening.
The membrane body comprises a first amorphous fluoroplastic and forms an enclosed chamber including a first end and a second closed end situated against the lip. The enclosed chamber contains a substantially electrolyte-free liquid in contact with two or more electrodes extending from the first end and positioned within the enclosed chamber.
The sensor placement device is configured to facilitate placement of the sensor in a subject, with a U-shaped portion configured to fold tissue over the membrane body. The U-shaped portion resides in a plane that is offset from another plane in which the sensor resides when the sensor is coupled to the sensor placement device, and the lip shields the membrane from end-tidal carbon dioxide.
Claims Coverage
The document includes four independent claims directed to a sensor system, a sensor placement device, and methods for determining pCO2 in tissue or buccal tissue. Across these claims, the core inventive features include a generally C-shaped cover with a lip, an amorphous fluoroplastic membrane forming an enclosed chamber with substantially electrolyte-free liquid and electrodes, and an offset-plane U-shaped tissue-folding placement device that enables contact without air gaps and with a pressure limit.
Generally C-shaped sensor cover with lip-bounded opening
A generally C-shaped in cross-section sensor cover defining an opening bounded on a top by an underside of the sensor cover and bounded on a distal end by a lip.
Amorphous fluoroplastic membrane forming enclosed, substantially electrolyte-free liquid chamber
A membrane body housed within the opening, the membrane body comprising a first amorphous fluoroplastic, the membrane body forming an enclosed chamber including a first end and a second closed end situated against the lip; a substantially electrolyte-free liquid contained within the enclosed chamber and in contact with the two or more electrodes.
Two or more electrodes within the enclosed chamber
Two or more electrodes extending from the first end and positioned within the enclosed chamber, with the substantially electrolyte-free liquid in contact with the electrodes.
Offset-plane U-shaped sensor placement configured to fold tissue
A sensor placement device comprising a U-shaped portion configured to fold tissue over the membrane body of the sensor, wherein the U-shaped portion resides in a plane that is offset from another plane in which the sensor resides when the sensor is coupled to the sensor placement device.
At least 40 to 50% membrane contact with buccal tissue
A sensor placement device configured to position the membrane body against buccal tissue of a subject such that at least 40 to 50% of the membrane body contacts the buccal tissue.
Sensor placement without air gaps and without pressure in excess of 25 mm Hg
Placing the sensor proximate to buccal tissue of a subject without air gaps and without applying pressure in excess of 25 mm Hg.
Measuring pCO2 in buccal tissue using the fluoroplastic sensor and placement constraints
Measuring, using the sensor, the pCO2 in the buccal tissue using the sensor placement device to place the sensor proximate to buccal tissue without air gaps and without applying pressure in excess of 25 mm Hg, wherein the U-shaped portion resides in a plane that is offset from another plane in which the sensor resides.
Across the independent claims, the claimed subject matter centers on a CO2 tissue/buccal sensor using a generally C-shaped cover with a lip-bounded opening and an amorphous fluoroplastic membrane that forms an enclosed chamber with substantially electrolyte-free liquid contacting electrodes. The placement device and method emphasize offset-plane positioning with a U-shaped surface that folds buccal tissue over the membrane to achieve quantified tissue contact and to avoid air gaps while limiting pressure to not exceed 25 mm Hg, enabling measuring pCO2 in buccal tissue.
Stated Advantages
Resists carboxylic acid ingress while enabling rapid CO2 transport (as stated in the described material).
Avoids silicone contamination-driven pCO2 errors by using amorphous fluoroplastics instead of silicone membranes (as described).
Shields the membrane from end-tidal carbon dioxide using the lip feature of the generally C-shaped sensor cover.
Documented Applications
Measuring partial pressure of carbon dioxide (pCO2) in tissue, including determining pCO2 in buccal tissue of a subject by placing a sensor proximate to buccal tissue.
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