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WO-2026096669-A1 - SYSTEM AND METHOD FOR MONITORING ANALYTES WITHIN BLOOD, BODILY FLUIDS, OR TISSUE OF A PATIENT

WO2026096669A1WO 2026096669 A1WO2026096669 A1WO 2026096669A1WO-2026096669-A1

Abstract

An analyte sensing system (210) includes a sensor assembly (216) and a sensor (214). The sensor assembly (216) includes an energy source (228) that generates energy. The sensor (214) includes (i) an energy guide (218) that receives the energy from the energy source (228), (ii) a sheath (220) coupled to the energy guide (218) near a guide distal end (218D), the sheath (220) being substantially cylindrical-shaped to define at least a portion of a reaction chamber (222) therewithin that extends distally away from the guide distal end (218D), the sheath (220) being oxygen permeable and analyte impermeable, (iii) a sensing polymer (224) positioned near the guide distal end (218D) of the energy guide (218), the energy guide (218) guiding the energy from the energy source (228) toward the sensing polymer (224), the sensing polymer (224) being configured to sense one of oxygen and the analyte, the sensing polymer (224) defining a chamber proximal end (222P) of the reaction chamber (222), and (iv) a transduction matrix (226) retained substantially within the reaction chamber (222). The oxygen and the analyte follow different diffusion paths within the transduction matrix (226).

Inventors

  • CONNER, JACOB D.
  • BARTHOLOMEUSZ, DANIEL A.
  • TICHENOR, John F.

Assignees

  • CLOVERSENSE, LLC

Dates

Publication Date
20260507
Application Date
20251029
Priority Date
20241029

Claims (20)

  1. 1 . An analyte sensing system for sensing an analyte within blood, bodily fluid, or tissue of a patient, the analyte sensing system comprising: a sensor assembly including an energy source that generates energy; and a sensor including (i) an energy guide that receives the energy from the energy source, the energy guide including a guide distal end (ii) a sheath that is coupled to the energy guide near the guide distal end, the sheath being substantially cylindrical-shaped to define at least a portion of a reaction chamber therewithin that extends distally away from the guide distal end, the sheath being oxygen permeable, and the sheath being impermeable to the analyte being sensed, the sheath having a sheath distal end, (iii) a sensing polymer that is positioned near the guide distal end of the energy guide, the energy guide guiding the energy from the energy source toward the sensing polymer, the sensing polymer being configured to sense one of oxygen and the analyte, the sensing polymer defining a chamber proximal end of the reaction chamber, and (iv) a transduction matrix that is retained substantially within the reaction chamber; wherein the oxygen that permeates through the sheath and into the transduction matrix that is retained within the reaction chamber follows a first diffusion path within the transduction matrix; and wherein the analyte permeates into the transduction matrix that is retained within the reaction chamber through the sheath distal end, the analyte following a second diffusion path within the transduction matrix that is different than the first diffusion path.
  2. 2. The analyte sensing system of claim 1 wherein the sensing polymer is coated onto the guide distal end of the energy guide.
  3. 3. The analyte sensing system of claim 1 wherein the sensing polymer is hydrophobic; and wherein the transduction matrix is hydrophilic.
  4. 4. The analyte sensing system of claim 1 wherein the sensing polymer is an oxygen sensing polymer that is configured to sense the oxygen within the transduction matrix.
  5. 5. The analyte sensing system of claim 1 wherein the sensing polymer is configured to directly sense the analyte within the transduction matrix.
  6. 6. The analyte sensing system of claim 1 wherein the sheath is formed via one of a three-dimensional extrusion technique and a three-dimensional molding technique.
  7. 7. The analyte sensing system of claim 1 wherein the sheath has a concentric unibody design.
  8. 8. The analyte sensing system of claim 1 wherein the substantially cylindrical shape of the sheath defines a chamber diameter of the reaction chamber, the chamber diameter being between approximately 100 nanometers and 500 micrometers.
  9. 9. The analyte sensing system of claim 1 wherein the sheath is formed from one or more of fluorinated ethylene propylene (FEP), paraformaldehyde (PFA), polytetrafluoroethylene (PTFE), polyimide, polyether block amide (PEBA), polyvinylchloride (PVC), polydimethylsiloxane, polyurethane, polyethylene, polycarbonate, poly(1 -trimethylsilyl-1 -propyne) (PTMSP), ethylene vinyl alcohol (EVOH), sulfonated tetrafluoroethylene-based fluoropolymer-copolymer, and modified cellulose.
  10. 10. The analyte sensing system of claim 9 wherein the sheath is formed at least partially from fluorinated ethylene propylene (FEP).
  11. 11 . The analyte sensing system of claim 1 wherein the transduction matrix is comprised of a hydrogel and one or more enzymes that are configured to react with the oxygen and the analyte; and wherein a reaction between the one or more enzymes with the oxygen and the analyte consumes at least a portion of the oxygen and the analyte that is present within the transduction matrix.
  12. 12. The analyte sensing system of claim 11 wherein the transduction matrix further includes a catalyst that is configured to initiate the reaction between the oxygen and the analyte.
  13. 13. The analyte sensing system of claim 1 wherein the sheath has a wall thickness that impacts the permeability of the sheath to oxygen; and wherein the wall thickness of the sheath is between approximately 10 micrometers and 400 micrometers.
  14. 14. The analyte sensing system of claim 1 wherein the sheath has a wall thickness that impacts the permeability of the sheath to oxygen; and wherein the wall thickness of the sheath is less than approximately 1 micrometer.
  15. 15. The analyte sensing system of claim 1 wherein the sheath has an oxygen permeability of between approximately five (cm 3 mm/ m 2 .day. bar)/mm and 60,000 (cm 3 mm/ m 2 .day. bar)/mm.
  16. 16. The analyte sensing system of claim 1 wherein the sensor further includes a buffer layer that is positioned about the energy guide, the buffer layer being formed from one or more polymeric materials.
  17. 17. The analyte sensing system of claim 1 wherein the energy source is a light source that generates light energy; and wherein the energy guide is an optical fiber.
  18. 18. The analyte sensing system of claim 1 wherein the sensor is a first sensor channel; and wherein the analyte sensing system further includes a second sensing channel that includes (i) a second energy guide that receives the energy from the energy source, the second energy guide including a second guide distal end, (ii) a second sheath that is coupled to the second energy guide near the second guide distal end, the second sheath defining at least a portion of a second reaction chamber, the second sheath being oxygen permeable, and the second sheath being impermeable to the analyte being sensed, (iii) a second sensing polymer that is positioned near the second guide distal end of the second energy guide, the second energy guide guiding the energy from the energy source toward the second sensing polymer, the second sensing polymer being configured to sense one of the oxygen and the analyte, and (iv) a second transduction matrix that is retained substantially within the second reaction chamber.
  19. 19. The analyte sensing system of claim 18 wherein the reaction chamber further includes a chamber distal end; wherein the second reaction chamber includes a second chamber proximal end and a second chamber distal end; and wherein at least one of (i) the chamber proximal end is staggered relative to the second chamber proximal end, and (ii) the chamber distal end is staggered relative to the second chamber distal end.
  20. 20. The analyte sensing system of claim 19 wherein both of (i) the chamber proximal end is staggered relative to the second chamber proximal end, and (ii) the chamber distal end is staggered relative to the second chamber distal end.

Description

Attorney Docket No. 30302.01.1. PCT SYSTEM AND METHOD FOR MONITORING ANALYTES WITHIN BLOOD, BODILY FLUIDS, OR TISSUE OF A PATIENT RELATED APPLICATIONS [0001] This Application is related to and claims priority from U.S. Patent Application Serial No. 18/930,288 filed on October 29, 2024, and entitled “SYSTEM AND METHOD FOR MONITORING ANALYTES WITHIN BLOOD, BODILY FLUIDS, OR TISSUE OF A PATIENT,” and on U.S. Patent Application Serial No. 18/975,411 , filed on December 10, 2024, and entitled “SYSTEM AND METHOD FOR MONITORING ANALYTES WITHIN BLOOD, BODILY FLUIDS, OR TISSUE OF A PATIENT”, the contents of which are incorporated in their entirety herein by reference. BACKGROUND [0002] Diabetes is an increasingly relevant health issue for millions of people throughout the world. The International Diabetes Federation (IDF) estimates that there were 537 million adults (aged 20-79) living with diabetes in 2021 , and this number is expected to increase to 642 million by 2040. The IDF also reports that the prevalence of diabetes is growing globally, with the highest increase witnessed in low- and middleincome countries. [0003] Factors such as aging, obesity, and unhealthy lifestyles have been found to contribute to the prevalence of diabetes, with obesity being a known major factor contributing to diabetes. According to the World Health Organization (WHO), in 2022, the number of obese individuals worldwide exceeded one billion, including 650 million adults, 340 million adolescents, and 39 million children. This number continues to grow. If things continue as they are, the WHO predicts that by 2025, around 167 million people, both adults and children, will experience worsening health problems due to their weight issues. [0004] Due to the increase in the prevalence of diabetes in the global population, there has been a corresponding increase in the prescription of a medical device known as a Continuous Glucose Monitor (CGM) to help diabetics monitor and indirectly or directly control blood glucose levels. In particular, the use of CGM devices is projected to grow at a compound annual growth rate (CAGR) of 7.19% from 2024 to 2030. [0005] Unfortunately, trust in CGM use among diabetics has not significantly improved over the last decade due to limitations of the sensor accuracy. In particular, lack of trust in CGM devices is due, at least in part, to evidence that these CGM devices are subject to sporadic, unpredictable, large errors. For example, the FDA Manufacturer and User Facility Device Experience (MAUDE) was established as a surveillance tool for monitoring case reports of problems and safety issues with such devices. A text analysis of reports to the FDA MAUDE database since 2015 reveals over 25,000 complaints of CGM sensor inaccuracy in comparison to more accurate Blood Glucose Monitor (BGM) readings, with many instances directly leading to serious outcomes. Approximately 55 percent of reported differences between concurrent CGM and BGM readings show differences of 100 mg/dl or more. For the year 2022, CGM devices had a total of 281 ,963 adverse events with 268,310 malfunctions, 13,644 injuries, and nine deaths (as the manufacturer comments on each event, the total number of records was 583,321 ). [0006] Some currently available CGM devices utilize hydrogen peroxide probes for sensing the level of glucose within the blood of a patient. However, hydrogen peroxide probes encounter significant challenges due to electrochemical interference in complex matrices like the body. This interference causes errors in measurements by oxidizing other electroactive constituents along with hydrogen peroxide, leading to variable and positive net errors. Additionally, hydrogen peroxide can react undesirably with surrounding tissue and degrade the enzyme needed for sensor operation. Even with glucose oxidase coupled to a transducer, issues persist if oxygen is not in excess, particularly in subcutaneous tissue where oxygen levels fluctuate. These problems necessitate addressing background oxygen variations for accurate measurements. Despite efforts to stabilize electrodes and minimize electroactive interference, challenges remain. Alternative optical methods are desirable, especially in oxygen-scarce environments, but they also require addressing selective oxygen sensing issues. [0007] Further, electrochemical sensors, including those used in CGM devices, face several challenges when deployed within the body. Some of the common issues include (i) low limit of detection (achieving a low level of detection is crucial for detecting low concentrations of analytes, which is often required for early disease diagnosis), (ii) nonspecific adsorption (suppressing the non-specific adsorption of interfering species is necessary to avoid false readings and maintain sensor accuracy), (iii) reproducibility and stability (ensuring consistent performance over time and in different conditions is challenging especially in the complex environment of