Blood sampling device

Abstract

A blood sampling patch comprises at least one lancet 7 and one or more conduits or vias form flow channels 5 in comminication with a blood collection region. Flow to the blood collection region takes

Description

The field of the invention is blood sampling devices of the type know as patches administered to the skin and methods of their use. Background Lancets are small, sharp medical devices used to puncture the skin to obtain a small blood sample, typically from a fingertip. They are commonly used in point-of-care settings like blood glucose monitoring for diabetics or for other rapid diagnostic tests. The lancet quickly pricks the skin, allowing a drop of blood to be drawn for analysis. After use, the lancet is typically discarded to maintain hygiene and prevent cross-contamination. This method is minimally invasive, easy to perform, and causes little discomfort to the patient. Devices using the lancet include: 1. Blood Glucose Monitoring • Device: Point-of-care device (e.g., glucometer) • Purpose: Measures blood glucose levels, commonly used by diabetics. 2. Hemoglobin • Device: Point-of-care device (e.g., handheld hemoglobin meters) or benchtop device • Purpose: Measures hemoglobin concentration to assess for anemia or other blood disorders. 3. Hemoglobin Ale (HbAlc) • Device: Point-of-care device or laboratory instrument • Purpose: Provides average blood glucose levels over the past 2-3 months, important in diabetes management. 4. Lipid Profile (Cholesterol, HDL, LDL, Triglycerides) • Device: Point-of-care device or laboratory instrument • Purpose: Measures cholesterol levels for assessing cardiovascular health. 5. Prothrombin Time / Intemational Normalized Ratio (PT / INR) • Device: Point-of-care device • Purpose: Measures blood clotting time, used in patients on anticoagulants like warfarin. 6. C-Reactive Protein (CRP) • Device: Point-of-care device or laboratory instrument • Purpose: Detects inflammation in the body, used to assess infections or inflammatory conditions. 7. Blood Gas Analysis (Lactate, pH) • Device: Point-of-care device or benchtop device • Purpose: Measures blood pH and lactate levels, used in critical care or sports medicine. 8. COVID-19 Antibody Test • Device: Point-of-care device • Purpose: Detects antibodies against SARS-CoV-2 to assess prior infection or immune response. 9. Complete Blood Count (CBC) - limited version • Device: Benchtop device or laboratory instrument • Purpose: Assesses red and white blood cells, hemoglobin, and platelets, but lancet samples usually limit this to a few parameters. 10. Electrolytes (Sodium, Potassium, Chloride) • Device: Laboratory instrument or benchtop device • Purpose: Measures key electrolytes for hydration, kidney, and heart function monitoring. 11. Creatinine • Device: Point-of-care device or laboratory instrument • Purpose: Assesses kidney function by measuring creatinine levels. 12. Bilirubin • Device: Benchtop device or laboratory instrument • Purpose: Measures bilirubin levels, typically used for diagnosing liver function or jaundice, especially in newborns. 13. HIV Rapid Test • Device: Point-of-care device • Purpose: Detects HIV antibodies in the blood for rapid screening. 14. Malaria Rapid Diagnostic Test (RDT) • Device: Point-of-care device • Purpose: Detects malaria antigens for quick diagnosis. 15. Lead Screening • Device: Point-of-care device or laboratory instrument • Purpose: Measures lead levels, typically used for screening in children. 16. Thyroid-Stimulating Hormone (TSH) • Device: Laboratory instrument • Purpose: Assesses thyroid function, although lancet samples are rarely used for this without lab processing. 17. Uric Acid • Device: Point-of-care device or laboratory instrument • Purpose: Monitors uric acid levels, often used in patients with gout. 18. Blood Typing (ABO and Rh) • Device: Point-of-care device or laboratory instrument • Purpose: Determines blood type for transfusions or prenatal care. These tests are limited by the small sample size provided by a lancet, so some more complex tests often require a venous blood sample for more extensive analysis. Lateral flow tests (LFTs) are a type of point-of-care diagnostic tool that use a small sample, often from a finger prick, to quickly and easily measure various analytes in the blood. They operate on the principle of immunoassay, where specific antibodies or antigens interact with the target analyte, producing a visible result. How Lateral Flow Tests Work: 1. Sample Collection: A small drop of blood from a finger prick is placed on the test strip. 2. Flow and Interaction: The blood flows along the test strip by capillary action, passing through various zones that contain reagents. o Conjugate Pad: Contains labeled antibodies (usually gold nanoparticles or colored beads) that bind to the target analyte in the blood sample. o Test Line: Contains immobilized antibodies that capture the analyte-conjugate complex, producing a visible colored line. o Control Line: Confirms that the test has functioned correctly, by showing a separate color band regardless of the result. 3. Result Visualization: If the analyte is present, the test line will show a visible result (e.g., a colored line), indicating a positive result. Advantages for Measuring Multiple Analytes with Small Blood Samples: • Low Sample Volume: LFTs require only a small volume of blood, making them ideal for fingerprick samples. This makes the process minimally invasive. • Rapid Results: Results are typically available within minutes, making it ideal for point-of-care testing or home use. • Portability: LFTs are small, easy to transport, and can be used in resource-limited settings. • Multiplexing Capabilities: Newer lateral flow devices are capable of measuring multiple analytes simultaneously from a single blood sample. o Multiplexed Test Strips: Some LFTs incorporate multiple test lines, each targeting a different analyte (e.g., simultaneous testing for HIV and Hepatitis B antibodies). o Combination Tests: Certain devices integrate several assays into one strip, such as measuring multiple markers for cardiovascular disease or infectious diseases. Examples of Analytes Measured by Lateral Flow Tests: • Infectious Diseases: o HIV and Hepatitis antibodies o Malaria antigens o COVID-19 antibodies and antigens • Chronic Disease Monitoring: o Hemoglobin Ale (HbAlc) for diabetes management o C-reactive protein (CRP) for inflammation • Cardiac Markers: o Troponin for heart attack diagnosis o D-dimer for blood clot detection • Pregnancy Tests: o Human chorionic gonadotropin (hCG) • Drug and Alcohol Screening: o Presence of drugs or alcohol metabolites Ongoing Developments: • Increased Sensitivity: Advances in antibody production and nanotechnology (e.g., use of gold nanoparticles) have made LFTs more sensitive, allowing detection of even small amounts of analytes. • Quantitative LFTs: While traditional LFTs are typically qualitative (positive / negative results), newer devices are capable of quantitative results, using smartphone apps or portable readers to analyze the intensity of the test line and provide an exact measurement. • Multiplex Platforms: Platforms like biochip or microarray-based LFTs allow multiple analytes (e.g., cytokines, hormones, or cancer markers) to be tested from a single blood drop. Impact of LFTs on Blood Testing: Lateral flow tests are revolutionizing the way many blood-based tests are performed, especially in settings where quick results and minimal invasiveness are needed. As more analytes can be tested using small blood samples, these tests are expanding access to healthcare, reducing the need for laboratory visits, and enabling personalized, on-the-spot diagnostics. Despite the growing use of lateral flow tests (LFTs) and other point-of-care devices that rely on finger prick blood sampling, the method itself presents several key barriers and challenges: 1. User Discomfort and Fear of Needles • Pain and Anxiety: While finger pricks are less invasive than venous blood draws, many people still find them uncomfortable or painful. Even mild discomfort can discourage individuals from regularly testing, especially for chronic conditions like diabetes that require frequent monitoring. • Needle Phobia: Some people experience severe anxiety or fear of needles, even with a small lancet, which can be a deterrent to using finger-prick tests. This psychological barrier can limit adoption, especially for self-testing. 2. Sample Quality and Variability • Inconsistent Blood Volumes: The amount of blood obtained from a finger prick can be variable, which can affect test accuracy. Insufficient blood samples can lead to inaccurate or failed tests, requiring multiple attempts. • Hemolysis Risk: Finger pricks can cause hemolysis (mpture of red blood cells), which can interfere with the accuracy of certain tests. This is a particular issue for tests measuring blood components like hemoglobin or electrolytes. • Capillary vs. Venous Blood Differences: Blood obtained from finger pricks is capillary blood, which differs in composition from venous blood. This can affect the accuracy of certain measurements, as capillary blood may have different levels of glucose, oxygen, or other analytes compared to venous blood. 3. Limited Sample Volume • Restricted Test Types: Finger pricks yield a small volume of blood, which limits the number of tests that can be performed from a single sample. While LFTs and other point-of-care devices are designed for low-volume samples, more comprehensive testing or tests requiring multiple analytes often require larger volumes, making venous blood draws necessary. • Dilution with Tissue Fluid: The small blood sample from a finger prick can be contaminated with tissue fluids, particularly if too much pressure is applied when squeezing the finger. This can dilute the blood sample and impact test results. 4. User Technique and Variability • Improper Collection: Self-administering a finger prick requires some level of skill. Improper technique—such as not cleaning the site properly, squeezing the finger too much, or not puncturing the skin deeply enough—can lead to poor sample quality or contamination. This can cause false results or the need for repeat testing. • Inconsistent Test Results: Variability in how the blood is collected or how the test is performed can result in inconsistent or unreliable results, reducing trust in the testing process. 5. Risk of Infection and Contamination • Infection Risk: Although the risk is low, improper hygiene or technique when using lancets can introduce bacteria into the puncture site, leading to infection. • Contamination Concerns: Cross-contamination between samples is also a concern, especially when finger-prick tests are performed in community settings or by individuals without proper training in sterile procedures. 6. Challenges with Repeated Testing • Skin Damage: For people who require frequent blood testing (e.g., diabetics), repeated finger pricks can cause skin irritation, calluses, and damage to the fingertips. This not only causes discomfort but can also reduce the quality of future blood samples. • Non-compliance: The need for regular, painful finger pricks can lead to non-compliance, where individuals avoid or delay testing, particularly for chronic disease management. 7. Environmental and Usability Factors • Environmental Constraints: Finger-prick testing requires sterile conditions, proper waste disposal of lancets, and a stable environment for the test to be accurate. In low-resource or home settings, these factors may not be met, leading to erroneous results. • Storage and Shelf Life: Some LFTs require precise storage conditions, like specific temperature ranges, which may not be feasible for patients in non-clinical settings. This can affect the reliability of the test results. 8. Psychological Barriers and Adoption • Perception of Accuracy: Many individuals perceive laboratory-based venous blood tests to be more accurate and reliable than finger-prick-based point-of-care tests. This perception can act as a barrier to wider adoption of self-testing methods. • Awareness and Training: Not all patients are aware of or confident in using point-of-care devices, particularly older adults or those unfamiliar with digital health tools. This lack of training or confidence can reduce uptake and proper usage of finger-prick testing. While finger-prick blood sampling is an essential tool for point-of-care diagnostics and lateral flow tests, it remains a key barrier due to discomfort, variability in sample quality, user errors, and the limited volume of blood obtained. These challenges can impede the adoption and effectiveness of point-of-care testing, particularly for chronic conditions or in low-resource settings where proper training and consistent technique are crucial for accurate results. Several approaches have been developed to draw blood using finger prick or skin-prickling techniques, aiming to reduce pain, improve ease of use, and increase sample quality. Each method has its pros and cons, which influence its suitability for different use cases. 1. Traditional Lancet • How it works: A single-use lancet pricks the skin, usually on the fingertip, to create a small puncture and draw a drop of blood. The blood is then collected directly or using a capillary tube or strip. • Pros: o Widely available and low cost: Easily accessible and affordable, especially for home testing. o Simple to use: Does not require advanced skills or technology. o Minimal blood volume required: Ideal for tests needing a small sample, such as glucose monitoring. • Cons: o Pain and discomfort: Some users find the pricking process uncomfortable or painful, especially with frequent use. o Risk of inconsistent blood volume: The amount of blood drawn can vary depending on the technique, leading to errors in test results. o Manual operation: Requires user control, which can lead to user errors such as pricking too deep or not deep enough. 2. Automatic Lancing Devices • How it works: Automatic lancing devices control the depth and speed of the needle prick. These devices have adjustable settings to optimize blood flow and minimize pain. • Pros: o Precision: Depth and speed are controlled, leading to more consistent blood volume and less tissue damage. o Less pain: The automated pricking reduces the sharpness of pain by using a fast, controlled motion. o Reusability: Some devices are reusable with replaceable lancet heads, which can reduce waste and costs. • Cons: o Higher cost: More expensive than manual lancets. o Bulky: Some devices are bulkier, making them less convenient for travel or frequent use. o Not completely pain-free: Though better controlled, the procedure still involves some discomfort. 3. Laser Lancing Devices • How it works: Laser-based lancing devices use a focused laser beam to perforate the skin, creating a small hole through which blood is drawn. • Pros: o Minimal pain: The laser can cause less pain and discomfort compared to traditional lancets. o Precise: Controlled depth reduces the risk of going too deep or not deep enough. o Reduced tissue damage: Less mechanical damage to the skin compared to needle pricks. • Cons: o Expensive: Laser lancing devices are significantly more expensive than traditional lancets. o Limited availability: Not widely available, with fewer manufacturers and products on the market. o Requires power: Typically battery-powered or chargeable, adding a layer of complexity. 4. Vacuum-Assisted Devices (e.g., Tasso Device) • How it works: A small vacuum-assisted device is placed on the skin (usually the upper arm) and uses micro-needles or microlancets to puncture the skin. A gentle vacuum then draws the blood into a collection tube. • Pros: o Painless or nearly painless: The use of microneedles and a gentle vacuum minimizes pain. o Self-contained: No need for user control or complex handling, reducing the chance of user error. o Sufficient sample size: Can collect more blood than a traditional finger prick, enabling more types of tests. • Cons: o Expensive: Vacuum-assisted devices are pricier compared to lancets. o Larger size: These devices can be bulkier than a simple lancet or finger prick tool. o Longer time: Blood collection takes slightly longer compared to a traditional prick. 5. Microneedle Arrays • How it works: Microneedles are tiny, minimally invasive needles that penetrate the upper layers of the skin. These needles allow blood to flow through the microchannels they create or collect fluid for testing. • Pros: o Virtually painless: The microneedles are so small that they don’t reach nerve endings, greatly reducing pain. o Minimally invasive: Causes less tissue damage compared to traditional pricking. o Potential for multiplex testing: Can simultaneously test multiple analytes from interstitial fluid or blood. • Cons: o Limited blood volume: Only a small amount of blood or fluid is drawn, which can limit the range of tests. o Higher cost: Microneedle devices tend to be more expensive and are still in development for widespread use. o Limited commercial availability: Not yet widely available for mainstream consumer use. 6. Patch-Based Microfluidic Devices • How it works: These wearable patches use tiny microneedles or microfluidic channels to collect blood or interstitial fluid without significant discomfort. The patches can be worn for a longer period to collect continuous or one-time samples. • Pros: o Painless: Microneedles used in these patches generally avoid pain due to their size. o Continuous monitoring: Can potentially allow for real-time blood glucose or other analyte monitoring without multiple pricks. o User-friendly: No active pricking involved, which improves patient compliance. • Cons: o Limited blood volume: Only a small amount of blood or fluid can be collected, limiting some types of tests. o Expensive: The technology is still new, so the costs are relatively high. o Technical complexity: Requires careful design and manufacturing, limiting its current availability and reliability. 7. Blood Sample Collection Cards (e.g., Dried Blood Spot Cards) • How it works: A finger prick is used to deposit a drop of blood on a specialized card that dries the sample. The card can then be sent to a laboratory for analysis. • Pros: o Simple and portable: Can be done anywhere, and the card is easy to store and transport. o Minimal blood needed: Only a small drop of blood is required, making it suitable for finger-prick samples. o Long storage: Dried blood samples can be stored for a long time and transported easily. • Cons: o Laboratory processing required: The sample needs to be sent to a lab, so it is not suitable for rapid point-of-care results. o Accuracy limitations: There can be variability in sample quality and accuracy, depending on how the blood dries and is collected. There is therefore a significant advantage to having a lancing device that addresses or overcomes the aforementioned issues and allows sufficient blood volume to be drawn for immediate analysis using a point of care device or a benchtop instrument. Description of Invention This invention describes a method and device for collecting blood samples by lancing the skin using a traditional lancing device in a patch form, which may be augmented with mixing to enhance blood flow to the point of measurement without causing patient discomfort and without user intervention being required, other than to assemble the sensor into the reader or meter, and applying the patch to the skin. This technique, device and method applies to all the tests mentioned in the earlier introductory section. It is preferable to draw blood using a traditional lancing device as this is well established in the art as being able to draw the requisite volume of blood for point of care analysis. However instead of using a pen like lancing device the lancing pin, described as the component that pierces the skin and leads to the flow of blood to the outer surface of the skin, the lancet is incorporated in a flat patch that may be applied to the skin such as the legs, abdomen, or arms. A time controlled vibratory unit of suitable amplitude may be applied to cause the lancet tip to pierce the skin, leading to the flow of blood through conduits within the patch, by capillary diffusion or facilitated using the vibrational forces applied to the patch. Furthermore, the blood sample will travel to the detection region by capillary flow, and once again a vibrational energy source may be used to facilitate this movement, prevent the build-up of air bubbles, and provide a consistent volume of sample for analysis. One or more lancing components will be present allowing for more than one sample to be detected, and therefore time-based measurements to be made. The data may then be transferred via any of the well-known data communication means such as radio frequency, blue tooth and also hard-wired connections, to a smart device or reader where an algorithm may be used to display the data in the desired manner. Furthermore, the data may be used to provide artificial intelligence (AI) based algorithms to predict an event in near time or in the long term based on patterns identified from one or more reading taken from the subjects. The AI may be driven by data from the single user standalone, or be evaluated in conjunction with or relative to data derived for other subjects, where there may be common denominators such as ethnicity, age, gender, body mass etc. The present invention relates to a system and method for monitoring analytes or metabolites present in the blood, capturing readings before and after an activity, and using these data points to provide insights into the patient’s condition. It further enables the prediction of future events. An example is given: Blood glucose monitoring is essential for individuals managing diabetes and for others interested in tracking their metabolic health. Traditionally, blood glucose readings are taken at various times, including fasting (before meals) and postprandial (after meals), to assess how food intake affects glucose levels. However, these readings are often interpreted in isolation and do not provide comprehensive insights into an individual’s insulin sensitivity or allow for future predictions of glucose levels based on dietary choices. This invention provides a method that integrates pre- and post-meal glucose readings into a system capable of analyzing insulin sensitivity over time. Furthermore, the system uses these data points in conjunction with meal composition to predict future glucose responses, providing personalized insights for users on how specific foods impact their glucose levels. Further elaboration on data processing: The invention is a Predictive Monitoring System that captures two or more key data points: for example a glucose reading taken before a meal (baseline or fasting glucose) and a glucose reading taken approximately 90 minutes after the meal (postprandial peak). These data points are processed through an algorithm that analyzes the individual's insulin sensitivity, predicts future glucose levels based on dietary intake, and provides personalized recommendations. 1. Pre-Meal and Post-Meal Glucose Data Capture: The system relies on blood glucose readings captured by the device at a minimum of two critical time points: • Pre-Meal Glucose Reading: Taken before the individual eats, this reading serves as a baseline for assessing how the meal will affect glucose levels. • Post-Meal Glucose Reading (90-Minute Mark): This second reading is taken approximately 90 minutes after the meal, a time aimed to capture the peak glucose response after food intake. This time frame is ideal for assessing how efficiently the body processes glucose and whether there is a spike indicating insulin resistance. • Alternatively rather than measuring the peak post-prandial glucose level the rate of rise within the first 90 minutes, preferably between baseline and 30 to 90 minutes, may also be used to predict the post-prandial peak and subsequent fluctuations. 2. Analysis of Insulin Sensitivity: The system uses the difference between pre-meal and post-meal glucose readings to calculate insulin sensitivity. • Low Insulin Sensitivity (Insulin Resistance): If there is a significant spike in post-meal glucose, it indicates that insulin is less effective at transporting glucose into the cells, suggesting insulin resistance. • High Insulin Sensitivity: A smaller increase in post-meal glucose levels suggests effective insulin response, meaning glucose is processed efficiently, indicating good insulin sensitivity. • Adaptation Over Time: The system tracks changes over multiple meals and days to detect trends in insulin sensitivity, which may fluctuate based on factors such as stress, sleep, exercise, or changes in diet. 3. Meal Composition Logging: The user logs detailed information about the meal they consumed, including the macronutrient breakdown (carbohydrates, fats, and proteins), fiber content, portion sizes, and glycemic index (GI) of the food. This information is stored in the system’s database and linked to glucose data points, allowing the algorithm to understand the user’s unique metabolic response to different types of food. 4. Predictive Algorithm for Future Glucose Levels: The invention includes a machine learning-based algorithm that learns from the individual’s glucose patterns and meal data to predict future glucose responses based on what they plan to eat. The algorithm uses key factors such as: • The individual’s historical glucose responses to similar meals. • Insulin sensitivity patterns derived from previous meal responses. • The glycemic load of the food being consumed. • The timing of meals and any exercise or other metabolic influencers. Based on these factors, the system can predict how an upcoming meal will affect glucose levels and whether it is likely to cause a significant glucose spike. It can also provide real-time recommendations, such as suggesting a smaller portion size, adding fiber, or incorporating physical activity to mitigate potential glucose spikes. 5. Feedback and Personalized Recommendations: After processing the glucose data and meal composition, the system provides users with personalized insights into their insulin sensitivity and recommendations for future meal planning. This feedback may include: • Optimized meal suggestions to maintain balanced glucose levels. • Predicted glucose spikes based on upcoming meals and advice on how to minimize them (e.g., altering meal composition). • Insights into time-of-day variations in insulin sensitivity, allowing the user to adjust meal timing for optimal glucose control. • Behavioral guidance, such as the effects of post-meal walks or light exercise on reducing glucose spikes. 6. Real-Time Alerts and Continuous Learning: As the system gathers more data from the user’s daily routine, it refines its predictions through a continuous learning process. Over time, the system can alert users if a particular meal is likely to cause a high glucose spike based on past responses and suggest pre-emptive actions (e.g., modifying meal composition or timing insulin doses). 7. Integration with Health Platforms: The invention can be integrated with health apps and platforms to track physical activity, sleep, and other metabolic factors that influence glucose control. Additionally, it could share data with healthcare providers, offering them insights into the patient’s insulin sensitivity trends and enabling better treatment adjustments. The Predictive Glucose Monitoring System described in this invention offers a novel approach to understanding and managing insulin sensitivity using simple pre- and post-meal glucose readings. By capturing and analyzing these two key data points, the system provides actionable insights into an individual’s glucose metabolism. Moreover, it predicts future glucose responses based on meal composition, empowering users to make informed dietary choices and manage their glucose levels more effectively. This invention offers great potential to enhance diabetes management, promote metabolic health, and improve long-term health outcomes for individuals at risk of insulin resistance or type 2 diabetes. The above principle is applied to multiple analytes as indicated below: The table indicates how two-point measurements of different blood analytes can be used to predict outcomes, along with the activities between the two readings that facilitate such predictions: Analyte Time of 1st Measurement Time of 2nd Measurement Activity Between Readings Predicted Outcome Glucose Before a meal (fasting) Approx. 90 minutes post-meal Eating a meal (carbohydrate-rich meal) Insulin sensitivity, risk of hyperglycemia, metabolic response Cortisol Early morning (upon waking) Late evening (before sleep) Normal daily activities Cortisol rhythm, stress response, potential adrenal dysfunction Analyte Time of 1st Measurement Time of 2nd Measurement Activity Between Readings Predicted Outcome Triglycerides Before a meal (fasting) 4 hours post-meal High-fat meal Lipid metabolism efficiency, risk of hypertriglyceridemia Insulin Fasting (before meal) 1-2 hours postmeal Consuming a meal Insulin resistance, pancreatic beta-cell function C-reactive Protein (CRP) Baseline (no inflammation) After physical stress or infection onset Physical exercise or onset of illness Inflammatory response, risk of chronic inflammation Lactate Rest (preexercise) After exercise Physical exercise (moderate to intense) Muscle oxygenation, fitness level, lactic acidosis risk Thyroid-Stimulating Hormone (TSH) Early morning (baseline) 24 hours after administration of T3 / T4 Administration of thyroid hormone Thyroid function, thyroid medication adjustment C-Peptide Before a meal (fasting) 90 minutes postmeal Eating a meal (stimulates insulin release) Endogenous insulin production, pancreatic function Ketones Morning (before eating) 2-3 hours after fasting or high-fat meal Intermittent fasting or ketogenic diet Ketosis status, fat metabolism, diabetes management Growth Hormone (GH) Pre-exercise (fasting) Post-exercise (1 hour after) Resistance training or high-intensity exercise Growth hormone release, anabolic response, fitness level Blood Urea Nitrogen (BUN) Pre-exercise (baseline) Post-exercise Intense exercise or high-protein intake Protein metabolism, kidney function, dehydration status Key Considerations: • Activity Between Readings: The activity between the two measurements is designed to provoke a physiological response that can be measured and interpreted. • Predicted Outcome: The two-point measurements help assess the body’s response to a stimulus, such as a meal, exercise, or medication. This can provide insight into various conditions like insulin sensitivity, metabolic health, inflammatory responses, or fitness levels. • The response can also be used to determine the future health of the patient and provide guidance to prevent a serious event or the onset of a disease condition. The presentation of the data may be in formats that are easy to interpret, and the algorithms may automatically provide alerts for high-risk cases. • This can equally be applied to patients to enable them to be released home early and managed in the home setting rather than occupy hospital beds, and alerts may be sent such that interventions can be administered for high-risk cases. Below is a further tabulation outlining how two-point measurements of specific blood analytes or physiological metrics can be used for cardiovascular and stroke risk prediction, along with the activities between the readings that facilitate these predictions: Analyte / Metric Time of 1st Measurement Time of 2nd Measurement Activity Between Readings Predicted Outcome LDL Cholesterol Fasting (morning) 4 hours post high-fat meal Consuming a high-fat meal Atherogenic lipid response, plaque formation risk HDL Cholesterol Fasting (morning) After exercise (1-2 hours) Moderate to vigorous exercise Cardioprotective HDL response, improvement in lipid metabolism Triglycerides Fasting (morning) 4 hours post high-fat meal High-fat meal Postprandial hyperlipidemia, cardiovascular disease risk C-Reactive Protein (CRP) Baseline (morning) After physical or psychological stress Physical stress or inflammation Chronic inflammation risk, atherosclerosis progression Homocysteine Fasting (baseline) After methionine challenge Methionine challenge test (dietary or supplement intake) Risk of endothelial dysfunction, stroke, and cardiovascular disease Blood Viscosity Fasting (baseline) Post-exercise or dehydration Exercise or dehydration Blood flow resistance, risk of thrombus or stroke Oxidized LDL Fasting (morning) After 4-6 hours of high-fat meal High-fat meal Oxidative stress, risk of atherosclerosis and cardiovascular events Key Considerations: • Activity Between Readings: These activities are chosen to provoke specific cardiovascular and metabolic responses, providing a more dynamic understanding of risk factors. • Predicted Outcome: By measuring the body’s response to stress, dietary changes, or exercise, these analytes and metrics can predict risks for hypertension, atherosclerosis, heart attack, stroke, and other cardiovascular conditions. • The device is designed to achieve the blood samples using a lancet and sensor attached to the skin in a manner that is currently not utilised, and enhances patient comfort, as well as compliance through an element of automation. The device and algorithms collectively are intended to provide a powerful tool for point of care monitoring, at a level not previously achieved, with a radical impact on healthcare delivery. Note also that the tables above provide the second time point for the second sample measurement as an estimated time, and these time points may be varied and optimised through AI. Drawings The invention is described in more detail with reference to the drawings wherein: -Figure 1 shows a flow diagram of the functionality of a sensing and sampling device; Figure 2 shows a cross-section of a blood sampling and sensing patch consisting of a first upper substrate 1, a lancet substrate 12, lancet substrate supporting pillars which also act as capillary diffusion enhancing pillars 2, a vibration module and / or vibration inducing control means 20, skin support pillar 4, conduit or blood flow vias 5, sensor detector region 6, lancet 7, support structures which double up as blood flow capillary diffusion enhancing component 8, sensor substrate 9, sensor connection means 10 to reader / meter, Reader / detector 11. Supporting pillars or flange 3 provide support and transmission of vibrational force between the upper substrate 1 and lancet substrate 12. Figure 3 is a plan view of the device shown in Figure 2, including a lancet substrate 12 upper-side 16 containing vias 5 for blood flow. The support structures / capillary diffusion enhancing pillars 2 are not shown in this illustration. Figure 4 is an enlarged cross-sectional side view of a blood transport path showing the additional feature of a blood flow path 13 in relation to a user’s skin 14. Figure 5 is another plan view of the under-side 17 of the lancet substrate 12, depicting the support structures 8 and 15, shown as different dimensions, e.g., rectangular and cylindrical or conical. Figure 6 is a plan view of patch under-side 17 with peripheral adhesive 18 and measuring device securing means 19. Figure 7 shows a longitudinal cross-section depiction of the upper substrate 1 containing the actuating or vibration inducing element 20, a power supply 24, and data communication means 25, a side arm 21 and hinged underside 22 to the side arm, and support structure / diffusion enhancing structure 3. Figure 8 shows another longitudinal cross-section of the lancet substrate 12, with vias 5, lancet 7, support structures / capillary diffusion enhancing structures 8 and 2, peripheral adhesive 18, and flanged section 24 which is designed to slot into the flanged section 21 and 22 shown in figure 7. This is referred to as the disposable component. Figure 9 show another longitudinal cross-section depiction of the upper substrate 1 containing a sensing meter and / or reader 27, a non-contact sensing element 26, a side arm 21 and hinged underside 22 to the side arm, and support structure / capillary diffusion enhancing structure 3. This is referred to as the nondisposable component. Figure 10 shows another longitudinal cross-section depiction of a series of meters / readers 27, nondisposable components 28, sensor strips 23, and disposable components 29. Figure 11 shows a plan view of figure 10, depicting a central reader 30, rather than multiple readers, and data and electrical connectivity lines 31 and data and electrical connectivity ports 32, and the disposable component 29, and non-disposable component 28 (shown as a second layer hence shown as an offset). Figure 12 is a layered plan view of the system showing the reader 27, reader securing strap or layer 33, the sensor strip 9 (and 23) and the disposable component 28 and non-disposable component 29; the offset intended to depict the layered assembly. Figure 1 shows a schematic flow chart of the various steps this device or system is intended to undertake as part of the sampling, processing, data presentation and predictions. The first step involves the application of a lancing device to the skin, which is integrated with a sensor and reader, though equally the lancing component and sensor housed within the first upper substrate 1, may be independently applied to the skin and removed and connected to a reader which may be a point of care device or a benchtop instrument, the key being that the blood should not clot prior to the connection of the sensor to the reader. Normal clotting time could be as little as 3 minutes or up to 10 minutes depending on temperature and other factors, or this may be prolonged to hours by coating the patch areas where the blood is drawn and flows through, using an anticoagulant such as heparin or EDTA. The lancet insertion into the skin may be initiated and effected either manually by slowly and gently depressing the top of the patch or by pressing a button that initiates a vibratory action with increasing amplitude to gradually ease the needle into the skin, causing the lancet to pierce the skin, or automatically based on a pre-program, or it may be remotely triggered. The blood will flow by capillary diffusion through to the sensing region / detector. The lancing may be from a single source or could be conducted in more than one location and the blood drawn to the same sensor or two different sensors, for the purpose of accuracy or verification respectively. A single first measurement may be taken and reported as a point in time measurement. Subsequent measurements may be taken and also reported as a point in time measurements or combined and using an algorithm a prediction may be made. The prediction may take in to account resting state or an activity. For example, first reading pre-meal time, and second reading 90 minutes post meal time, to measure blood glucose, which can then be used to predict future glucose fluctuations, or insulin sensitivity, or the presence of diabetes or pre-diabetes. Similarly blood cholesterol levels may be measured at rest to determine baseline levels, and also the elevation or reduction caused by certain activities such as long term exercise or change in diet. Similarly other blood markers such as lactic acid could be used to predict the onset or a cardiac arrest, as can the measurement of cardiac troponin. These measurements may be made and predictions all derived near-instantaneously and the results shared with the subject / patient, or a third party or used to create an alert or an alarm such that appropriate interventions may be administered. Figure 2 is a cross-section view of blood sampling and sensing patch consisting of a first upper substrate 1, a lancet substrate 12, lancet substrate supporting pillars / blood capillary diffusion enhancing structures 2, a vibration module and / or vibration inducing control means 20, skin support pillar 4, conduit or blood flow vias 5, sensor detector region 6, lancet 7, blood flow capillary diffusion enhancing component 8, sensor substrate 9, sensor connection means 10 to reader / meter, Reader / detector 11. The sensor will reside between the upper substrate 1, and the lancet substrate 12, a gap between the sensor (such as a glucose strip sensor for example) and the upper substrate lis designed to allow potential flow of excess blood volume around the sensor, although the gap may be minimal, sufficient to create a capillary effect thus allowing the blood to accumulate at a consistent and pre-determined volume (in the range of microlitres) the detection area 6. It will be appreciated that the location of these areas is for illustration purposes only and may by in different configurations, designed to achieve optimal blood flow to the sensing / detector region. Supporting pillars / flanges 3 (shown as dotted lines at the opposite end) provide support between the upper substrate 1 and lancet substrate 12 and also act to transmit force to the lancet to cause it to penetrate the skin. The lancet supporting pillar 2 provide support between the sensor strip 9 and the lancet substrate 12, such that the sensor strip 9 slots into the gap, and these can also double up as blood capillary diffusion enhancing structures which may be tens to hundreds of microns in height, and tens to hundreds of microns in diameter. The vias 5 will allow the blood to flow from the skin to the sensor detector region 6. The reader or meter 11 may have Bluetooth connectivity or other communication means to transmit data to the cloud and therefore a dashboard that can be remotely accessed or to an app on a smart device. The skin support pillar 4 has a dual purpose, firstly to anchor the device to the skin to prevent lateral stretching of the skin when the lancet is inserted, and secondly to act as a decoy in that these pillars are intended to have a level of sharpness to them which will prevent them from piercing the skin but provide a sensation on the skin that will detract from any pain associated with the insertion of the lancet into the skin. Properties of the lancet may include but not be limited to the following: Lancets come in a variety of shapes, sizes, and designs to suit different blood collection needs, levels of comfort, and user preferences. The following are common lancet shapes and sizes that could be used: Lancet Shapes 1. Straight Lancets o Description: These are simple, straight lancets, often used with lancing devices. They have a straight, pointed needle or blade. 2. T-shaped Lancets o Description: Lancets with a "T" shape handle for easy grip and control. The short top part serves as a handle, and the needle extends from the center. 3. Twist Lancets o Description: Lancets with a protective cap that twists off to expose the needle. These are commonly used with automatic lancing devices. 4. Round Lancets o Description: Some lancets have a round base, making them easier to handle and providing a more comfortable grip. 5. Flat Lancets o Description: Flat-shaped lancets are easier to store and may be used with specific devices for precision. 6. Safety Lancets o Description: These are single-use lancets with built-in protective features that shield the needle after use, reducing the risk of accidental pricks and contamination. Lancet Sizes (Gauge and Length) The size of a lancet is typically described in terms of: • Gauge: The diameter of the needle. The higher the gauge number, the thinner the needle. • Length: The depth to which the needle can penetrate the skin. Common Lancet Gauges 1. 21 Gauge o Needle Thickness: Thicker needle (approximately 0.82 mm in diameter). o Use: For individuals with thicker or calloused skin, or when a larger blood sample is needed. 2. 23 Gauge o Needle Thickness: Slightly thinner than 21 gauge (about 0.64 mm in diameter). 3. 26 Gauge o Needle Thickness: Thin needle (about 0.45 mm in diameter). 4. 28-30 Gauge o Needle Thickness: Very thin needle (approximately 0.36 mm to 0.30 mm in diameter). 5. 31-33 Gauge o Needle Thickness: Ultra-thin needle (about 0.25 mm in diameter or smaller). o Use: For extremely sensitive skin or individuals who experience pain with thicker lancets. Common Lancet Lengths (Penetration Depth) 1. 1.0 to 1.5 mm o Use: Shallow penetration, typically for children or individuals with thin skin. o Pros: Minimal pain and discomfort. o Cons: May not produce enough blood in adults or individuals with thick skin. 2. 1.8 to 2.0 mm o Use: General-purpose lancet depth for routine glucose or cholesterol testing. o Pros: Works well for most users, draws sufficient blood. o Cons: Mild discomfort, may cause pain for people with very sensitive skin. 3. 2.2 to 2.4 mm o Use: For individuals with thicker or calloused skin, or when a larger blood sample is required. o Pros: Ensures an adequate blood sample. o Cons: Can cause more discomfort or pain compared to shorter lancets. 4. 3.0 mm or more o Use: Designed for individuals with very thick skin, or for specific tests that require a larger blood volume. o Pros: Quickly produces a large blood sample. o Cons: More painful, not suitable for sensitive skin or frequent use. Lancet Selection Based on Use Case • Frequent Testing (e.g., diabetics): Thin lancets (30-33 gauge) with shallow penetration depth (1.5-2.0 mm) to minimize discomfort during frequent use. • Occasional Testing: Medium gauge lancets (26-28 gauge) with moderate depth (1.8-2.2 mm), balancing blood volume and comfort. • Thick or Calloused Skin: Thicker lancets (21-23 gauge) with deeper penetration (2.4-3.0 mm) to ensure enough blood is drawn. The lancet will be adhered or secured to the lancet substrate 12 and this may be achieved by one of the following means: 1. Adhesive Bonding • Method: A strong adhesive (e.g., epoxy, cyanoacrylate) is applied to secure the lancet directly to the substrate. • How it works: The lancet's base is bonded to the thin substrate, keeping the overall height minimal. • Pros: o Low cost and simple to apply. o Suitable for mass production. o Adds minimal height to the assembly. • Cons: o Permanent attachment (not reusable). o Potential for adhesive degradation over time. o May not provide strong enough fixation for repeated use or high-force applications. 2. Mechanical Clamping • Method: A tiny clamp or press-fit mechanism is used to hold the lancet in place on the substrate. • How it works: The substrate has a small groove or slot, and the lancet is held in place by the clamp, keeping it secure without exceeding the height limit. • Pros: o Non-permanent, easy to replace the lancet. o Secure attachment without adhesives. • Cons: o May be difficult to design clamps that fit within the height constraints. o Can be complex for small-scale or precision devices. 3. Ultrasonic Welding • Method: The lancet is welded to the substrate using ultrasonic vibrations to fuse the materials together. • How it works: The high-frequency vibrations create heat through friction, bonding the lancet to the substrate without additional material. • Pros: o Permanent and strong bond. o No additional adhesives or fasteners required. o Keeps overall height minimal. • Cons: o Requires specialized equipment. o Not suitable for all materials. o Permanent bond, limiting flexibility for adjustments or replacement. 4. Snap-Fit Design • Method: The substrate and lancet are designed with interlocking features that snap together. • How it works: The substrate has a small depression or notch that aligns with a protrusion or ridge on the base of the lancet. Once inserted, the lancet "snaps" into place. • Pros: o Easy assembly and replacement. o No need for adhesives or tools. o Adds minimal height. • Cons: o May require precise manufacturing tolerances. o Snap-fit joints can weaken over time or under repeated use. 5. Heat Staking • Method: Heat is applied to the base of the lancet or a plastic pin to deform it, securing it in place on the substrate. • How it works: A part of the lancet or the substrate is slightly melted and then reshaped to form a "rivet" that holds the lancet in place. • Pros: o Permanent, strong connection. o Minimal height added to the assembly. o Works well with plastics or thermoplastic materials. • Cons: o Permanent attachment. o Requires precise heat control to avoid damaging the substrate or lancet. 6. Press-Fit into Pre-Formed Hole or Groove • Method: The substrate has a pre-formed hole or groove where the lancet base is press-fitted. • How it works: The lancet is inserted into a tight-fitting cavity in the substrate, holding it securely through friction. • Pros: o Secure and simple. o No adhesives or fasteners needed. o Allows for replacement if needed. • Cons: o The substrate must have enough thickness to hold the press-fit. o Tolerances need to be tight for a secure fit. 7. Magnetic Attachment • Method: Small, thin magnets are used to hold the lancet to the substrate. • How it works: A magnetic base on the lancet and a corresponding magnet or magnetic material in the substrate allow the lancet to be held in place. • Pros: o Allows for easy removal and replacement of the lancet. o Adds minimal height. o No adhesives or mechanical fasteners required. • Cons: o Requires a magnetic material or magnet on the substrate. o May not be strong enough for high-force applications. o Limited to lightweight lancets. 8. Low-Profile Screws orPins • Method: Small screws or pins secure the lancet to the substrate without exceeding the height constraint. • How it works: The lancet is placed on the substrate, and low-profile screws or press-in pins hold it in place. • Pros: o Secure and reliable attachment. o Allows for disassembly if needed. • Cons: o May add slight height to the assembly depending on screw or pin head. o Requires holes or threaded inserts in the substrate. 9. Double-Sided Adhesive Tape • Method: Thin, double-sided adhesive tape is used to stick the lancet to the substrate. • How it works: A piece of strong, double-sided tape is placed between the lancet base and the substrate, holding the lancet in place without adding significant thickness. • Pros: o Minimal height added. o Easy to apply and remove. • Cons: o Less durable than permanent adhesives or mechanical fasteners. o Tape can lose adhesive strength over time. 10. Conductive or Flexible Epoxy • Method: A specialized flexible or conductive epoxy is applied to secure the lancet to the substrate. • How it works: The epoxy cures to form a strong bond while maintaining some flexibility, which could be useful for substrates that bend or experience vibration. • Pros: o Strong, durable bond. o Can allow for electrical conductivity if needed (e.g., for certain biosensors). • Cons: o Requires curing time. o Permanent bond, not suitable for removable lancets. The following is a list of materials that can be used as a substrate to secure a lancet, with thicknesses of less than 5 mm, and which are relatively rigid: 1. Acrylic (PMMA) • Description: A clear, lightweight, and rigid plastic material. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o Good rigidity and durability. o Easy to machine and laser-cut. o Transparent, allowing for easy visual inspection. • Cons: o Brittle and prone to cracking under stress. o Scratches easily. 2. Polycarbonate (PC) • Description: A tough, transparent plastic with high impact resistance. • Thickness: Available in sheets less than 5 mm thick. • Pros: o Stronger and more impact-resistant than acrylic. o Can be used in applications where some transparency is required. • Cons: o More expensive than acrylic. o Can be prone to scratches, though less so than acrylic. 3. ABS (Acrylonitrile Butadiene Styrene) • Description: A strong, lightweight plastic often used in injection molding. • Thickness: Commonly available in sheets around 1-5 mm. • Pros: o High rigidity and impact resistance. o Easy to mold and machine. o Good thermal stability. • Cons: o Not UV resistant, may degrade with prolonged exposure to sunlight. 4. Aluminum • Description: A lightweight, rigid metal material. • Thickness: Thin aluminum sheets (e.g., 1-5 mm) are widely available. • Pros: o Lightweight and corrosion-resistant. o Strong and highly rigid, suitable for precise applications. o Good thermal and electrical conductivity. • Cons: o Requires specialized tools for machining or bending. o Can be more expensive compared to plastics. 5. Stainless Steel • Description: A strong and corrosion-resistant metal. • Thickness: Available in very thin sheets, typically starting at 1 mm. • Pros: o Extremely strong and rigid, even in thin sections. o Corrosion-resistant and suitable for medical applications. • Cons: o Heavier than other materials like aluminum or plastics. o More expensive and difficult to machine. 6. FR-4 (Fiberglass Reinforced Epoxy) • Description: A composite material made from woven glass fiber and epoxy resin, commonly used in printed circuit boards (PCBs). • Thickness: Typically available in thin sheets from 1 mm to 5 mm. • Pros: o Highly rigid and heat resistant. o Excellent dielectric properties (good for electronic applications). o Lightweight and durable. • Cons: o Difficult to cut and machine without proper tools. o Can be brittle under extreme stress. 7. Polyethylene Terephthalate Glycol (PETG) • Description: A transparent, flexible, and impact-resistant thermoplastic. • Thickness: Available in thin sheets (typically 1-5 mm). • Pros: o Good impact resistance and durability. o Easy to thermoform and mold. o More flexible than acrylic and polycarbonate, but still relatively rigid. • Cons: o Prone to scratching. o Not as rigid as polycarbonate or aluminum. 8. Delrin (Acetal) • Description: A high-strength, rigid plastic with good dimensional stability. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o Excellent wear resistance and rigidity. o Low friction, ideal for applications involving moving parts. o Easy to machine and form. • Cons: o Less impact-resistant than polycarbonate. o More expensive than standard plastics like ABS or PETG. 9. Glass-Filled Nylon • Description: A composite plastic material reinforced with glass fibers. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o Very strong and stiff, even in thin sections. o Good chemical resistance and dimensional stability. • Cons: o Can be brittle compared to unfilled nylons. o More difficult to machine and shape than standard nylon. 10. Phenolic Resin (Bakelite) • Description: A rigid thermosetting plastic with good electrical insulating properties. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o High rigidity and heat resistance. o Good electrical insulator. • Cons: o Brittle and prone to cracking under mechanical stress. o Difficult to machine and process. 11. High-Density Polyethylene (HDPE) • Description: A lightweight and durable plastic material. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o Resistant to chemicals and moisture. o Easy to machine and fabricate. o Flexible but still rigid enough for many applications. • Cons: o Lower rigidity compared to other plastics like polycarbonate or ABS. o Less heat-resistant. 12. Polystyrene (HIPS) • Description: High-impact polystyrene (HIPS) is a rigid, lightweight plastic. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o Easy to cut, shape, and bond with adhesives. o Cost-effective and readily available. • Cons: o Brittle compared to other plastics like PETG or polycarbonate. o Not suitable for high-impact or high-stress applications. 13. Titanium • Description: A strong, lightweight, and corrosion-resistant metal. • Thickness: Available in thin sheets (1-3 mm). • Pros: o High strength-to-weight ratio. o Biocompatible and corrosion-resistant. o Extremely durable even in thin sections. • Cons: o Expensive. o Requires specialized tools for machining and processing. 14. POM (Polyoxymethylene, Acetal) • Description: A rigid, high-performance plastic with good wear resistance. • Thickness: Available in thin sheets, typically 1-5 mm. • Pros: o High mechanical strength and stiffness. o Low friction and good dimensional stability. • Cons: o Limited UV resistance. o More expensive than standard plastics. These materials may also be used to construct the supporting pillars and structures indicated above. Below is described a list of connection mechanisms that may be used to secure a test strip 9 (e.g., glucose test strip, lateral flow strip) to a reader or meter 11, via the connection compartment 10: 1. Pin Contacts • Description: Metal pins on the reader / meter make direct contact with conductive traces on the test strip. • How it works: When the test strip is inserted into the reader, the conductive contacts on the strip align with the metal pins, forming an electrical connection. • Pros: o Reliable electrical connection. o Easy to align and use. o Simple, low-cost design. • Cons: o Pins may wear out over time with repeated use. o Requires precise alignment between the strip and the reader. 2. Spring-Loaded Contacts • Description: The test strip is secured by spring-loaded pins or contacts in the reader. • How it works: When the strip is inserted, spring-loaded contacts press against the conductive areas of the strip, ensuring a firm connection. • Pros: o Provides consistent pressure and good contact. o Can accommodate slight variations in strip thickness. • Cons: o Can wear out over time. o Spring tension may decrease after prolonged use. 3. Clip or Snap-Fit Mechanism • Description: A clip or snap-fit mechanism secures the test strip into place mechanically. • How it works: The test strip is inserted into a slot, and the clip or snap-fit locks it in place. Electrical contacts are made automatically upon insertion. • Pros: o Simple and secure. o Easy to insert and remove strips. o Good for quick, repeatable testing. • Cons: o Mechanical wear can loosen the fit over time. o Requires precise manufacturing for consistent performance. 4. Slot-and-Guide System • Description: A precisely sized slot or groove guides the test strip into the reader and holds it in place. • How it works: The user slides the test strip into a slot, ensuring proper alignment with the reader's contacts or sensors. • Pros: o Ensures precise alignment. o Simple, low-cost solution. • Cons: o Mechanical friction can cause wear on the strip or reader. o May not handle variations in strip thickness or shape well. 5. Lever or Locking Mechanism • Description: A lever or locking mechanism is used to secure the test strip in place after it is inserted. • How it works: The test strip is placed into the reader, and a lever or locking tab is moved into position to hold the strip securely. • Pros: o Very secure once locked in place. o Reduces risk of accidental disconnection. • Cons: o Adds mechanical complexity. o Requires user interaction to engage / disengage the lock. 6. Magnetic Attachment • Description: Magnets are used to secure the test strip to the reader. • How it works: The test strip contains a small ferromagnetic material or magnet, which is attracted to magnets embedded in the reader. • Pros: o Easy to attach and remove strips. o No mechanical wear on the strip or reader. • Cons: o May not provide a strong enough connection for all applications. o Requires ferromagnetic materials, adding complexity to strip design. 7. Adhesive Attachment • Description: Adhesive or a tacky surface secures the test strip to the reader temporarily. • How it works: The test strip sticks to an adhesive surface in the reader, holding it in place while readings are taken. • Pros: o Simple and easy to use. o Suitable for disposable strips. • Cons: o Adhesive can wear out over time. o Not ideal for repeated use or long-term applications. 8. Pressure-Fit or Compression Fit • Description: The test strip is secured by pressing it into a slot where friction holds it in place. • How it works: The strip is inserted into a slot that is slightly narrower than the strip, causing friction to hold the strip securely in position. • Pros: o Simple and requires no additional parts. o Easy to insert and remove. • Cons: o May wear down the strip or slot over time. o Can lead to inconsistent alignment if the fit loosens. 9. Electromagnetic Induction • Description: Electromagnetic coupling (inductive charging or sensing) is used to transmit data or power from the test strip to the reader without direct contact. • How it works: The reader induces an electrical signal or power into the test strip through magnetic fields, eliminating the need for direct physical contact. • Pros: o No wear on the contacts. o Reliable for high-throughput testing. • Cons: o Complex and expensive to implement. o May be sensitive to misalignment or interference. 10. ZIF (Zero Insertion Force) Connectors • Description: A ZIF connector uses a locking lever to secure the test strip without requiring any insertion force. • How it works: The user places the test strip into the ZIF socket, and a lever is moved to lock the strip in place, ensuring good contact with the reader's pins. • Pros: o Prevents wear and tear on the strip and reader contacts. o Very secure connection. • Cons: o Mechanically complex. o Requires the user to operate the locking mechanism. 11. Conductive Elastomer Contacts • Description: Conductive elastomers (rubbery materials with embedded conductive particles) are used to form a contact with the test strip. • How it works: The elastomer is compressed between the test strip and the reader, forming a reliable electrical connection. • Pros: o Good electrical contact without rigid metal pins. o Flexible and adaptable to small variations in strip thickness. • Cons: o Elastomer can wear out over time. o More costly compared to standard pin contacts. 12. C-clamp or Sliding Latch • Description: A sliding mechanism or C-clamp holds the strip tightly in place during testing. • How it works: After inserting the strip, a sliding latch or clamp is engaged to secure the strip in the reader. • Pros: o Very secure, good for use in rugged environments. o Prevents accidental disconnection during testing. • Cons: o More complex and requires user interaction. o Adds bulk to the reader. Figure 3 is a plan view of the lancet substrate 12 upper-side 16 containing vias 5 for blood flow. This illustration does not indicate the structural support pillars described in figure 2, in order to highlight that multiple vias may be present to encourage the capillary diffusion effect to draw the blood to the sensor / detector region. To achieve optimal capillary diffusion of blood through sections formed by two plates such as in this case by the lancet substrate 12 and the upper substrate 1 and vias 5 (small holes or channels), several factors need to be considered, including the thickness of the plates, the diameter of the vias, and the properties of the blood. Here are some guidelines to achieve effective capillary diffusion: 1. Plate Thickness • Optimal Thickness: Typically, for capillary action, the distance between the plates (i.e., the thickness) should be small to ensure efficient capillary rise. A common range for effective capillary action is 0.1 to 1 mm. • Why: Capillary action is more pronounced in narrower gaps, as the surface tension of the liquid creates a more significant rise in thinner spaces. 2. Via Diameter • Optimal Diameter: The diameter of the vias should be small to facilitate capillary action but not so small that they become clogged or impede flow. The ideal diameter for effective capillary diffusion is typically between 0.5 mm and 2 mm. • Why: Smaller vias promote capillary rise by increasing the surface-to-volume ratio and improving the contact between the blood and the channel walls. However, if too small, the vias may become blocked by particulate matter in the blood or become too narrow to allow adequate flow. 3. Material and Surface Characteristics • Hydrophilicity: The materials used for the plates and vias should have hydrophilic properties to promote capillary action. Surface treatment or coating can be used to enhance hydrophilicity if necessary. • Why: Hydrophilic surfaces attract water (and blood), improving the capillary action and ensuring the blood diffuses effectively through the vias. 4. Channel Design • Channel Shape: The shape of the channels (vias) can influence capillary flow. Channels that are too deep or too wide may not support efficient capillary action. Shallow, narrow channels are often more effective. • Why: Shallow channels improve the capillary rise due to increased surface tension effects relative to the channel depth. Figure 4 is an expanded view of blood transport path showing in addition to the features shown in figure 2, the skin 14, and blood flow patch 13. The support structures 8 between the lancet substrate 12 and the skin 14 will also follow the principles described in figure 3 with respect to the via dimensions and thicknesses for optimising capillary diffusion of blood. Figure 5 is a plan view of the under-side 17 of the lancet substrate 12, depicting the support structures 8 and 15, shown as different dimensions, e.g., rectangular and cylindrical or conical. These are interspersed between the vias. The vias are not shown here. The dispersion and pattern of dispersion shall be uniform so as to promote capillary diffusion. These structures act to enhance surface area of contact as well as providing mechanical support. Figure 6 is a plan view of patch under-side 17 with peripheral adhesive 18 and measuring device securing means 19. The aim is to secure the patch to the skin without impeding the regions where blood is intended to be drawn from. Furthermore, the adhesion is preferably at the periphery of the regions surrounding the area of skin where the lancet pierces the skin to allow the blood to flow out toward the capillary diffusion enhancing structures and the thin gaps between the skin and the vias, rather than having a single spot from which blood must then find its way through a narrow cavity to the sensor / detector. The device securing component may be an adhesive layer that allows the reader / meter to be releasably secured to the adhesive during use, or it may be a pocket in which the reader / meter is contained, or a combination of the two. The reader is releasably secured to the patch at the point of use and similarly the vibration module and control means 20 is also releasably secured to the rest of the patch / the lancet substrate layer of the patch, the latter being a disposable element. Securing a patch or device to the skin requires adhesives that are both effective in maintaining adhesion and gentle on the skin. The following is a list of the various types of adhesives that could be used for this system (peripheral adhesive 18 and device securing means 19): 1. Acrylic Adhesives • Description: Made from acrylic resins, these adhesives provide strong adhesion and good resistance to moisture and UV light. • Pros: o Durable and long-lasting adhesion. o Good resistance to water and sweat. • Cons: o Can be more irritating to sensitive skin. o May be harder to remove. 2. Silicone Adhesives • Description: Silicone-based adhesives are known for their flexibility and gentle adhesion. • Pros: o Non-irritating and suitable for sensitive skin. o Easy to remove and less likely to leave residue. • Cons: o May not adhere as strongly as acrylics. o Can be more expensive. 3. Hydrocolloid Adhesives • Description: Made from a gel-like material that absorbs moisture, these adhesives create a cushioning effect. • Pros: o Ideal for moist environments and wounds. o Provides a protective barrier and reduces friction. • Cons: o Can become less adhesive when saturated. o May need frequent changes. 4. Pressure-Sensitive Adhesives (PSAs) • Description: PSAs stick to surfaces with light pressure and do not require heat or solvents to activate. • Pros: o Easy to apply and remove. o Provides a strong, immediate bond. • Cons: o Adhesive strength can degrade over time or with moisture exposure. 5. Medical-Grade Adhesives • Description: Specifically formulated for medical use, these adhesives are designed to be safe for prolonged skin contact. • Pros: o Biocompatible and designed for sensitive skin. o Generally resistant to moisture and sweat. • Cons: o Can be more costly. o Specific formulations may be needed for different applications. 6. Rubber Adhesives • Description: Made from natural or synthetic rubber, these adhesives offer good tack and adhesion. • Pros: o Provides good initial adhesion. o Often cost-effective. • Cons: o May cause irritation or allergic reactions. o Less flexible and more difficult to remove. 7. Polyurethane Adhesives • Description: Known for their flexibility and durability, these adhesives are used in various medical applications. • Pros: o Provides a strong, flexible bond. o Resistant to moisture and chemicals. • Cons: o Can be difficult to remove. o May cause skin irritation in some cases. 8. Hot-Melt Adhesives • Description: Thermoplastic adhesives that are melted and applied in a liquid state and then solidify upon cooling. • Pros: o Fast curing time. o Provides a strong bond. • Cons: o Can be uncomfortable due to heat during application, o Not as flexible as other adhesives. 9. Water-Based Adhesives • Description: Adhesives that use water as the primary solvent, making them generally gentler on the skin. • Pros: o Less likely to irritate the skin. o Easier to clean up and remove. • Cons: o Adhesion strength may be less compared to solvent-based adhesives. o Can be affected by moisture and sweat. 10. Biodegradable Adhesives • Description: Made from natural or sustainable materials that break down over time. • Pros: o Environmentally friendly. o Suitable for short-term applications. • Cons: o Typically, less durable and may not last as long. o Can be more expensive. Figure 7 is a longitudinal cross-section depiction of the upper substrate 1 containing the actuating or vibration inducing element 20, a power supply 24, and data communication means 25, a side arm 21 and hinged underside flange 22 to the side arm, and support structure 3. This may be a complete standalone component or may be integrated with a reader or meter for direct readings, whereby the reader may be positioned directly on the upper substrate, above the vibration inducing element 20. Vibration is described here as a method for aiding a lancet to pierce the skin and is intended to refer to the application of rapid, oscillating or repetitive motion to the lancet or surrounding mechanism to reduce skin resistance and improve the comfort and efficiency of the puncture process. This technique can involve various mechanical, electrical, or pneumatic mechanisms that cause the lancet to oscillate or vibrate at different frequencies, amplitudes, or patterns to achieve the desired effect. Broad Mechanisms that could be used for Vibration-Aided Skin Piercing: 1. Mechanical Oscillation: o The lancet or its housing is subjected to high-frequency back-and-forth motion, reducing the force required to puncture the skin and minimizing discomfort by distracting nerve signals. 2. Rotational Vibration: o The lancet or surrounding components rotate at high speeds, creating a combination of rotational and percussive forces that help the lancet break through the skin more smoothly. 3. Piezoelectric Vibration: o Utilizing piezoelectric materials that generate oscillatory motion when subjected to electrical current, this method allows the lancet to move at a precise frequency, improving penetration efficiency with minimal pressure. 4. Pneumatic Vibration: o Compressed air or gas is used to create rapid pulses or vibrations, enabling the lancet to oscillate in place and reduce the effort needed to pierce the skin. 5. Electromagnetic Vibration: o Electromagnetic forces drive the movement of the lancet in a controlled oscillatory motion, offering precise vibration control to facilitate skin puncture. 6. Haptic Feedback or Tactile Vibration: o Low-frequency vibrations are applied to the skin surrounding the puncture site to desensitize nerves, making the insertion of the lancet less noticeable and reducing pain perception. 7. Ultrasonic Vibration: o Ultrasonic waves are employed to vibrate the lancet or surrounding surface at extremely high frequencies, allowing for minimal friction and faster penetration of the skin. 8. Manual application of force: It may be that an alarm alerts the user to press down on the upper substrate layer housing, thus manually inducing the piercing of the skin, and this may be repeated several times, in the form of a low frequency vibration to ensure the lancet has pierced the skin and also allowed blood to flow to the sensor / detector. It will be appreciated that the switching on of the vibration inducing element may suffice for the purposes of initiating the first reading. In the case of a reader there will be a switch that will also need to be activated at the same time to switch on the reader or to notify it that there is a sample of blood that will be soon reaching the sensor. This switch may be a separate switch configured with the reader or it may be that the vibration motion acts to switch on the reader. Alternatively the feedback may come from the reader which switches on at a pre-determined time and thus causes the vibration motor to also switch on and thus lead to the removal of a blood sample and subsequent measurement. Figure 8 is a longitudinal cross-section of the lancet substrate 12, with vias 5, lancet 7, support structures / capillary diffusion enhancing structures 8 and 2, peripheral adhesive 18, and flanges peripheral section 24 which is designed to slot into the flanged section 21 and 22 shown in figure 7. For the purposes of this invention Figure 7 will be referred to as the non-disposable component and Figure 8 as the disposable component. The disposable component may be supplied with or without the sensor 23. The sensor is defined here broadly as follows: In diagnostic testing, glucose strips and lateral flow sensors (strips) are widely used for point-of-care testing. These strips are typically plugged into a reader, a device that interprets the results based on various sensing methods. While some strips themselves contain sensing elements, others may function as carriers of reagents, chemicals, or proteins, which interact with the sample (e.g., blood) but rely on the reader for sensing, sometimes through non-contact methods. Glucose Strips and Lateral Flow Strips Plugging into a Reader When a strip is plugged into a reader, the design of the strip and the reader interface is key to proper function. This can be done in various ways depending on the sensing method: 1. Direct Electrical Contact with a Reader: o How It Works: ■ In glucose test strips, the sensing element (e.g., an electrochemical sensor) is embedded within the strip. When blood is applied to the strip, a chemical reaction takes place, such as glucose oxidation. This reaction generates an electrical signal (such as current or voltage), which is measured by the reader. ■ Conductive electrodes on the strip are designed to align with contacts in the reader. When the strip is inserted, these electrodes form a circuit with the reader, allowing it to measure the electrical signal generated by the chemical reaction. o Examples: ■ Glucose Test Strips: Contain enzymes (e.g., glucose oxidase) that react with glucose in the blood, generating an electrical signal that the reader interprets to give a blood glucose level. ■ Lateral Flow Test Strips with Embedded Electrodes: Some lateral flow tests (e.g., for drugs or proteins) have conductive elements to measure specific reactions electrically. 2. Optical Sensing with Reader: o How It Works: ■ In lateral flow tests, the strip may not itself be the sensing element but rather a medium for a biochemical reaction, such as antigen-antibody interactions. The reader can detect these interactions by measuring changes in the optical properties (e.g., color intensity) of the strip. ■ The strip is inserted into an optical reader, which uses light (e.g., LED or laser) to illuminate the strip, and a detector (such as a photodiode or camera) measures the reflected or transmitted light. The change in light intensity or color is correlated with the presence or quantity of the analyte. o Examples: ■ Pregnancy Tests (hCG): A lateral flow strip shows a color change based on the presence of human chorionic gonadotropin (hCG) in urine or blood, detected optically by the reader. ■ Drug Screening: Lateral flow tests for drugs or specific proteins often involve colorimetric changes that can be quantified by an optical reader. 3. Capacitive or Inductive Sensing with Reader: o How It Works: ■ Some test strips, especially for advanced diagnostic platforms, may rely on changes in capacitance or inductance. When blood or another sample interacts with the strip, it may alter the dielectric properties of a material in the strip. The reader measures these changes to determine the concentration of the target molecule. ■ The reader may not require direct contact with the strip but instead detects changes in capacitance (for capacitive sensing) or magnetic fields (for inductive sensing) through a non-contact method. o Examples: ■ Capacitive Blood Analysis: The strip may contain layers of conductive material that change capacitance when exposed to blood, and this change is detected by the reader. Strips Without Sensing Elements (Carrier Strips) In some cases, the strip itself is not the sensing element but instead contains a chemical or reagent that reacts with the blood sample. The sensing is performed by the reader using non-contact methods. These strips are often used to immobilize a sample, facilitate a reaction, or trigger a colorimetric or other physical change, which is then detected externally. Non-Contact Sensing Methods for Strips Non-contact sensing methods allow the reader to detect and analyze the sample on the strip without needing direct physical contact. These methods can be advantageous because they avoid wear and tear on the strip, prevent contamination, and can often allow faster readings. Here are some of the most common non-contact sensing methods: 1. Optical Sensing (Spectrophotometry, Fluorescence, or Absorbance) o How It Works: ■ A light source in the reader illuminates the strip, and a detector (like a photodiode, camera, or spectrometer) measures the reflected, transmitted, or emitted light from the sample. ■ Based on the intensity or wavelength of the light, the reader can detect the presence or concentration of a specific substance. o Examples: ■ Colorimetric Detection: Detects color changes (e.g., glucose levels, pH changes) based on the chemical reaction between the strip’s reagent and the blood. ■ Fluorescence: In some lateral flow tests, fluorescent markers are used, and the reader detects the fluorescence emitted by these markers. 2. Infrared (IR) Sensing o How It Works: ■ Infrared light is emitted by the reader and is absorbed or reflected by specific molecules in the sample (e.g., glucose or proteins). The reader measures the IR light's absorption or reflection pattern, which correlates with the concentration of the analyte. o Examples: ■ Glucose Measurement: IR spectroscopy can be used to measure glucose in blood non-invasively. 3. Capacitive Sensing o How It Works: ■ Capacitive sensors detect changes in the dielectric properties of the strip when exposed to blood or other fluids. As blood interacts with the strip, the capacitance changes, which can be measured by the reader without physical contact. o Examples: ■ Blood Coagulation Tests: Detect changes in the sample's properties when it solidifies or reacts. 4. Electromagnetic Induction Sensing o How It Works: ■ The reader generates an electromagnetic field and detects how the strip's material, or the blood interacting with it, affects this field. This method can measure changes in electrical impedance or magnetic properties. o Examples: ■ Biosensing Strips with Metallic Nanoparticles: Some lateral flow strips use metallic nanoparticles, and their interaction with blood alters electromagnetic signals detected by the reader. 5. Radiofrequency (RF) Sensing o How It Works: ■ RF sensors can detect changes in the dielectric properties of a sample as it interacts with the strip. This non-contact sensing method is based on how the sample absorbs or reflects RF signals. o Examples: ■ Hydration and Electrolyte Monitoring: RF sensing has been explored for monitoring hydration levels and electrolyte imbalances in fluids on strips. 6. Thermal Sensing o How It Works: ■ Changes in temperature due to a reaction (e.g., exothermic or endothermic reactions) between the sample and a reagent on the strip can be detected by thermal sensors in the reader. o Examples: ■ Enzyme-Based Strips: Enzymatic reactions can release or absorb heat, which can be detected by the reader to quantify analytes such as glucose. Strips such as glucose test strips and lateral flow sensors can either contain embedded sensing elements, like electrodes or conductive traces, or simply serve as carriers for reactions between reagents and the blood. Readers can measure the result of these interactions using direct contact methods (e.g., electrical connections) or non-contact sensing methods like optical, infrared, capacitive, or electromagnetic induction sensing. The choice of method depends on the type of strip, the nature of the sample, and the sensitivity required for the measurement. Figure 9 illustrates s longitudinal cross-section depiction of the upper substrate 1 containing a sensing meter and / or reader 27, a non-contact sensing element 26, a side arm 21 and hinged underside 22 to the side arm, and support structure 3. The non-contact sensing element is intended to describe sensing that occurs without the sensor having to make direct contact with the sensing element, though there may well be a window or surface of the non-sensing element with which the sensor makes intimate contact to avoid any interference from air bubble / air or other matter. Its position is also intended to be as close as possible to the source of blood sampling to minimise the distance of travel required for the blood sample so as to minimise the volume of blood required. It will be apparent that this may be in conjunction with the device depicted in figure 7, and the reader / detector element may be positioned adjacent to or above the vibrational element (in which case the device securing means 19 will be redundant). The non-contact sensing element may be constructed from one or more of the following: 1. Optical Sensors • Materials: o Photodiodes: Silicon (Si), Gallium Arsenide (GaAs) o Phototransistors: Silicon (Si) o Light-emitting diodes (LEDs): Gallium Nitride (GaN), Gallium Arsenide (GaAs) o Lenses: Glass, Quartz, Polymers (e.g., PMMA) 2. Infrared (IR) Sensors • Materials: o Thermopile Detectors: Bismuth / Antimony (Bi / Sb) alloys, Silicon (Si) o Pyroelectric Detectors: Lithium Tantalate (LiTaOs), Barium Titanate (BaTiOs) o IR LEDs and Photodiodes: Silicon (Si), Gallium Arsenide (GaAs) 3. Capacitive Sensors • Materials: o Electrodes: Copper (Cu), Aluminum (Al), Indium Tin Oxide (ITO) o Dielectrics: Polymers (e.g., Polyimide, PDMS), Ceramics (e.g., Silicon Dioxide) 4. Electromagnetic Induction Sensors • Materials: o Coils: Copper (Cu), Aluminum (Al) o Core Materials: Ferrite, Iron (Fe) 5. Radiofrequency (RF) Sensors • Materials: o Antennas: Copper (Cu), Silver (Ag), Aluminum (Al) o Substrates: Polyimide, FR4 (fiberglass-epoxy laminate) 6. Ultrasonic Sensors • Materials: o Piezoelectric Crystals: Quartz (SiCh), Lead Zirconate Titanate (PZT), Polyvinylidene Fluoride (PVDF) o Housing: Stainless Steel, Polymers (e.g., Polycarbonate) 7. Thermal Sensors • Materials: o Thermocouples: Nickel-Chromium (NiCr), Platinum (Pt), Constantan (CuNi alloy) o Thermistors: Metal Oxides (e.g., Manganese, Nickel, Cobalt oxides) 8. Fluorescent Sensors • Materials: o Fluorophores: Organic Dyes (e.g., Rhodamine, Fluorescein), Quantum Dots (CdSe, ZnS) o Encapsulants: Silicon Dioxide (SiO?), Polymers (e.g., Polyethylene glycol) 9. Magnetoresistive Sensors • Materials: o Sensing Elements: Permalloy (Nickel-Iron alloy), Cobalt (Co) o Substrates: Silicon (Si), Glass 10. Surface Acoustic Wave (SAW) Sensors • Materials: o Piezoelectric Substrates: Quartz (SiO?), Lithium Niobate (LiNbOs), Zinc Oxide (ZnO) o Interdigitated Electrodes: Gold (Au), Aluminum (Al) Figure 10 is a longitudinal cross-section depiction of a series of meters / readers 27, non-disposable components 28, sensor strips 23, and disposable components 29, which is a further embodiment of the invention whereby multiple sensors with multiple readers, for the same or different analytes to be measured, may be incorporated as a single patch. Figure 11 is a plan view of figure 10, depicting a central reader 30, rather than multiple readers, and data and electrical connectivity lines 31 and data and electrical connectivity ports 32, and the disposable component 29, and non-disposable component 28. Figure 12 is a layered plan view of a further embodiment of the system showing the reader 27, reader securing strap or layer 33, the sensor strip 9 (and 23) integrated / slotted into the disposable component 28 and attached to the non-disposable component 29. The sensor strip was depicted in Figure 2 as 9, and subsequently also depicted as 23, and constitutes the same principle of a sensor but shown in different configurations, with one sensing directly and the other acting as a blood reservoir / collection chamber. This figure depicts a system that has four separate components: The reader, the disposable component, the non-disposable component and the sensor which is also disposable. In the event a non-contact sensing mechanism is utilised, the function of this strip is to act as the collector or blood deposition chamber, and where the strip undertakes a sensing function the strip acts as a blood deposition chamber as well as sensing chamber. The disposable sensor or blood collection strip may be either a separate strip / component, or it may be integrated to the disposable component. The sensing section is slotted into the disposable component whist the connecting tail region would be connected into the reader / meter where the strip directly makes a sensing measurement. The readers may be slotted into pockets and strapped around the arm or thigh or abdomen for example, or it may be adhered to the skin as described earlier. The user would apply the sensor into the disposable component and attached to the nondisposable component and then slot into the reader and apply to the skin using a band or the peripheral adhesive. This invention relates to a multi-functional blood sampling and analysis system that integrates a lancetbased blood collection mechanism with an adjacent sensor for immediate diagnostic analysis. The system is designed to operate in both manual and automated modes, allowing the user to trigger the lancet either manually or through an automated activation mechanism. This flexibility provides users with more control over blood sampling while also enabling automated, consistent, and minimally invasive operation when needed. The core innovation lies in the Integrated Blood Sampling and Sensing Unit, where a lancet is used to puncture the skin, and blood is immediately captured by a sensor that is positioned adjacent to the sampling site. The proximity of the sensor ensures that the sample is analyzed quickly, without the need for complex or delayed transfer processes, which improves the efficiency of point-of-care testing. The invention also features a Modular Blood Sampling and Sensor System, in which the sensor patch can either remain directly connected to a reader for immediate analysis or be removed and applied to a separate reader device at a later time. This modularity allows for greater flexibility in sample handling, making it adaptable for both on-site, real-time diagnostics or deferred, laboratory-based analysis. A key aspect of this invention is the Detachable Sensor Patch, which can be easily removed from the skin after blood collection. The sensor patch can then be attached to a reader for data analysis, making the system highly versatile for different testing environments. For real-time analysis, the sensor can also function as part of a Direct-Connect Sensor-Reader System, transmitting data to the reader instantly for immediate feedback on the user's health metrics. Furthermore, the Automated or Manual Lancet Deployment Mechanism allows for blood collection to be initiated either by the user manually or through a pre-programmed, automated activation system. This ensures a customizable user experience while maintaining precision in blood sampling. This Portable Blood Sampling and Diagnostic Device is designed for ease of use in point-of-care settings or even home-based health monitoring, offering real-time data and insights with minimal discomfort to the user. The invention streamlines the process of blood sampling, analysis, and result transmission, providing an efficient and flexible solution for diagnostics across various healthcare settings. In summary, this invention combines a versatile blood sampling method with adjacent sensor-based analysis, offering both real-time and modular diagnostic options, making it suitable for a range of medical and personal health monitoring applications. A key feature of this invention is its ability to capture and analyze blood samples at one or more time points, and—significantly—at two time points with an intervention occurring between the measurements. This unique approach allows for advanced predictive digital health monitoring and management. The term intervention is used broadly to encompass a wide range of activities or clinical procedures designed to provoke the body into revealing its underlying physiological or pathological state. These interventions can include: • Dietary interventions, such as the consumption of a meal to observe the body's metabolic response (e.g., blood glucose levels before and after eating). • Physical exercise, to assess cardiovascular, respiratory, or metabolic responses (e.g., changes in heart rate, blood pressure, or lactate levels). • Pharmacological treatments, where medication is administered to evaluate drug efficacy, side effects, or metabolic clearance (e.g., changes in liver enzyme activity or drug metabolites). • Stress tests, where the patient undergoes controlled psychological or physical stress to monitor cortisol or blood pressure variations. • Fasting periods or postprandial measurements, to study changes in lipid profiles, glucose metabolism, or hormone regulation. • Sleep interventions, where measurements are taken before and after sleep or rest periods to study circadian rhythms or recovery states (e.g., melatonin or cortisol levels). The system allows for blood measurements at multiple time points, which can reveal patterns and trends in physiological response to these interventions. For example, in a glucose monitoring scenario, a reading before and 90 minutes after a meal can provide insights into insulin sensitivity and glucose metabolism. This type of two-point analysis is essential for understanding not only the body’s immediate reaction but also its ability to return to a baseline state, a key marker of metabolic health and predictive of future outcomes. By leveraging the Multi-Mode Lancet Activation System and Integrated Blood Sampling and Sensing Unit, the invention makes it easy to capture these measurements with minimal patient discomfort. This enables frequent and repeatable measurements over time, which is critical for longitudinal monitoring in digital health management. The system's ability to measure biomarkers at different time points, and in response to specific interventions, provides healthcare professionals with a powerful tool to predict health outcomes and manage chronic conditions. For example, monitoring cardiovascular responses before and after exercise or a stress test can offer early insights into cardiovascular disease risk. Similarly, observing the inflammatory response before and after a physical stressor may help identify chronic inflammation and predict conditions such as atherosclerosis or autoimmune disorders. In addition, this invention facilitates personalized digital health monitoring by integrating predictive algorithms into the sensor-reader system. By analyzing trends in multiple biomarker levels over time, the system can help predict future health events, such as the risk of diabetes, cardiovascular incidents, or metabolic syndromes. This data-driven approach to healthcare enables proactive management and preventive interventions, tailored to the individual’s unique physiological profile. In conclusion, the invention not only improves the flexibility and efficiency of blood sampling and analysis but also introduces a sophisticated mechanism for predictive digital health monitoring, allowing for continuous, personalized, and data-driven healthcare management. The broad application of interventions enhances the system's ability to assess underlying disease states, making it an invaluable tool for both clinical and personal health environments. As well as the attributes claimed, other attributes of the invention include:- In a method of operating a blood sampling device, a) providing a device which includes a skin-mounted patch, the patch including at least one lancet and separate plural capillary channels suitable for transporting blood induced by the or each lancet and an analyte sensor in communication with the channels arranged in use to receive blood via said channels to enable detection and measurement; and a vibration module operable to cause said lancet and or patch or skin to vibrate, and b) operating the device to receive blood and using the device to output an indication of one or more analytes to be measured. That method may further comprise taking measurements at multiple time points to monitor changes in analyte levels. The measurements may be taken before and after an intervention selected from: meal consumption, exercise, medication administration, or stress test. The intervention may be a meal consumption, and then the analyte may be may be glucose. The method may include transmitting sensor data to a remote device for analysis. The method may include predicting future health events based on analysis of temporal changes in analyte levels. The method may include providing personalized recommendations based on the analysis of blood samples. The vibration mechanism may be activated automatically at predetermined times. The method may include using artificial intelligence to analyse patterns in multiple readings from the user. The method may include comparing the user's data with population data having common denominators including: ethnicity, age, gender, or body mass. It will be appreciated that the numerous features described above and / or illustrated herein are set forth by way of example and are not intended to limit the scope of the invention. Numerous alternatives, variations, modifications, additions, and omissions, to those examples will be apparent to a skilled person in the relevant art. It is envisaged that features from different embodiments may be brought together, without adding to the scope of the invention. In addition, the order of any features in the form of method steps or sequences in the description, claims and / or drawings herein is not intended to require that order of performance unless a particular order is necessary for technical reasons. Multiple features in a single claim herein may be so combined in that claim for, for example, fiscal, not technical reasons and so such combined features are not necessarily intended to form a whole inseparable technical concept. Thereby, in the claims set forth, it is intended that claim features may be exchanged between, or extracted from, claims containing other features without broadening the scope of the invention, or causing a so-called intermediate generalisation.

Claims

25Claims1. A skin-mounted blood sampling device comprising: at least one lancet configured to pierce the skin for obtaining whole blood at a respective puncture site; one or more capillary channels in fluid communication with the or each lancet puncture site, said channels being dimensioned to promote capillary transport of said blood, and a collection region arranged to receive and retain the blood transported via said channels for either (i) in situ analysis or (ii) subsequent removal for analysis in a separate reader.

2. The device of claim 1, further comprising a vibration module configured to (i) reduce the penetration force of the lancet during insertion and / or (ii) facilitate transport of blood through the channels after insertion.

3. The device of claim 2, wherein the vibration module operates at a frequency of 20-200 Hz and at an amplitude sufficient to reduce lancet insertion force by at least 30 %.

4. The device of any preceding claim, wherein the lancet has a gauge of 27-33 and a penetration depth of 0.5-2.0 mm with a bevelled tip.

5. The device of any preceding claim, wherein the capillary channels are 0.1-2.0 mm in diameter and include an anticoagulant coating selected from heparin or EDTA.

6. The device of any preceding claim, further comprising a disposable patch component containing the lancet, channels and collection region, and a reusable module containing power and electronics.

7. The device of any preceding claim, wherein the collection region comprises an analyte sensor selected from: an electrochemical sensor; an optical sensor; a fluorescence-based sensor; or a capacitive volume sensor.

8. The device of claim 7, wherein the analyte sensor comprises a multiplexed sensor array configured to detect two or more analytes simultaneously from a single blood sample.

9. The device of any preceding claim, further comprising a reader configured to receive data from the analyte sensor via one or more of: spring-loaded pins, zero-insertion-force connectors, or optical coupling interfaces.

10. The device of any preceding claim, wherein said channels further comprise micro-pillars or other microstructures to enhance capillary flow and reduce air bubble formation.

11. The device of any preceding claim, further comprising skin anchors or blunt-tipped stabilising pillars positionable to contact the skin and reduce lateral stretch during lancet insertion.

12. The device of any preceding claim, wherein the patch includes a peripheral adhesive layer configured to adhere the patch to the skin.

13. The device of any preceding claim, further comprising a clot detection circuit, occlusion detection system, or sample volume detection mechanism.22 09 2514. The device of any preceding claim, wherein the device is configured to be re-used with a replaceable lancet cartridge and a replaceable sensor element.

15. The device of any preceding claim, further comprising a calibration element selected from onboard reference sensors or optically readable indicia such as a QR code.

16. The device of any preceding claim, further comprising a breathable peripheral material or a sterile barrier surrounding the puncture site.

17. The device of any preceding claim, wherein the capillary channels are defined between an upper substrate and a lancet substrate spaced 0.1-1 mm apart to enhance capillary flow.

18. The device of any preceding claim, wherein the analyte sensor is configured for noncontact optical or infrared detection of analytes from the blood sample.

19. The device of any preceding claim, wherein the blood sample volume delivered to the collection region is at least 5 pL.

20. The device of any preceding claim, wherein the patch comprises a plurality of lancets and collection regions configured to collect sequential blood samples at different times from different sites on the skin.

21. A method of operating a blood sampling device comprising:(a) providing a skin-mounted patch having at least one lancet, one or more capillary channels, and a collection region,(b) inserting the lancet to obtain blood,(c) collecting blood into the channels and conveying the blood to the collection region via capillary flow, and(d) generating a measurement of an analyte from the collected blood either in situ or after removal of the collection region to a separate reader.

22. The method of claim 21, further comprising actuating a vibration module to reduce the penetration force of the lancet and / or enhance transport of blood through the channels.

23. The method of claim 21 or 22, further comprising taking a first measurement before a physiological intervention and a second measurement after the intervention, and determining a physiological response based on the difference between the two measurements.

24. The method of claim 23, wherein the intervention is selected from: consuming a meal, performing exercise, administering a medication, undergoing a stress test, or sleeping.

25. The method of any of claims 21-24, further comprising transmitting the measurement data to a remote device or cloud platform and processing the data using an algorithm to predict a future physiological state or health event, optionally by comparing the user’s data with population data having common denominators including ethnicity, age, gender, or body mass.T +44(0)30 0300 2000A

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