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EP-4281143-B1 - OCCLUSION SENSOR FOR PUMP ASSEMBLY

EP4281143B1EP 4281143 B1EP4281143 B1EP 4281143B1EP-4281143-B1

Inventors

  • TUOHY, JOHN

Dates

Publication Date
20260513
Application Date
20211230

Claims (15)

  1. A medicament delivery system comprising: a reservoir (4) that carries a medicament; a pump (3) connected to the reservoir (4) that draws the medicament out of the reservoir (4) for medication delivery; and an occlusion sensor (49) connected to the reservoir (4) that senses whether an occlusion is present, the reservoir (4) comprising a flexible reservoir, the occlusion sensor (49) comprising a strain gauge, wherein the occlusion sensor (49) does not contact the medicament.
  2. The system according to claim 1, wherein the occlusion sensor (49) does not detect pressure.
  3. The system according to claim 1, wherein the occlusion sensor (49) does not detect current draw.
  4. The system according to claim 1, wherein the occlusion sensor (49) outputs resistance to control electronics (8).
  5. The system according to claim 4, wherein the resistance decays as the medicament exits the reservoir (4) when there is no occlusion.
  6. The system according to claim 4, wherein the occlusion (49) is detected when the resistance of the strain gauge (600) does not decay according to a designated pattern.
  7. The system according to claim 1, wherein as the medicament exits the reservoir (4), a surface of the reservoir (4) compresses, and the occlusion sensor (49) senses changes in forces across the reservoir (4).
  8. The system according to claim 1, wherein as the medicament exits the reservoir (4), tension at a surface of the reservoir (4) reduces.
  9. The system according to claim 8, wherein the tension is measured axially across the reservoir (4).
  10. The system according to claim 1, wherein the occlusion sensor (49) is insensitive to lateral forces across the reservoir (4).
  11. The system according to claim 1, wherein the occlusion sensor (49) is bonded to a mid-section of an outer surface of the reservoir (4).
  12. A method for determining an occlusion (49) in a medicament delivery system, the method comprising: securing an occlusion sensor (49) to an outer surface of a flexible reservoir (4); operating the medicament delivery system for medication delivery; measuring resistance at the outer surface of the flexible reservoir (4); providing resistance output from the occlusion sensor (49) to control electronics (8); and determining whether an occlusion (49) is present based on the resistance output, wherein the reservoir (4) comprises a flexible reservoir, wherein the occlusion sensor (49) comprises a strain gauge, wherein the occlusion sensor (49) does not contact the medicament.
  13. The method of claim 12, further comprising securing the occlusion sensor (49) to a mid-section of the outer surface of the flexible reservoir (4).
  14. The method of claim 12, further comprising measuring axial tension and axial compression at the outer surface of the flexible reservoir (4) to determine resistance.
  15. The method of claim 12, further comprising determining whether the occlusion (49) is present based on a decay of the resistance output.

Description

Field of the Invention The present invention relates to an occlusion sensor in a system comprising a pump assembly to detect an occlusion in the system. Background of the Invention Diabetes is a group of diseases characterized by high levels of blood glucose resulting from the inability of diabetic patients to maintain proper levels of insulin production when required. Diabetes can be dangerous to the affected patient if it is not treated, and it can lead to serious health complications and premature death. However, such complications can be minimized by utilizing one or more treatment options to help control the diabetes and reduce the risk of complications. The treatment options for diabetic patients include specialized diets, oral medications and/or insulin therapy. The main goal of diabetes treatment is to control the diabetic patient's blood glucose or sugar level. However, maintaining proper diabetes management may be complicated because it has to be balanced with the activities of the diabetic patient. Type 1 diabetes (T1D) patients are required to take insulin (e.g., via injections or infusion) to move glucose from the bloodstream because their bodies generally cannot produce insulin. Type 2 diabetes (T2D) patients generally can produce insulin but their bodies cannot use the insulin properly to maintain blood glucose levels within medically acceptable ranges. In contrast to people with T1D, the majority of those with T2D usually do not require daily doses of insulin to survive. Many people are able to manage their condition through a healthy diet and increased physical activity or oral medication. However, if they are unable to regulate their blood glucose levels, they will be prescribed insulin. For example, there are an estimated 6.2 million Type 2 diabetes patients (e.g., in the United States, Western Europe and Canada) taking multiple-daily-injections (MDI) which consist of a 24-hour basal insulin and a short acting rapid insulin that is taken at mealtimes for glycemic management control. For the treatment of Type 1 diabetes (T1D) and sometimes Type 2 diabetes (T2D), there are two principal methods of daily insulin therapy. In the first method, diabetic patients use syringes or insulin pens to self-inject insulin when needed. This method requires a needle stick for each injection, and the diabetic patient may require three to four injections daily. The syringes and insulin pens that are used to inject insulin are relatively simple to use and cost effective. Another effective method for insulin therapy and managing diabetes is infusion therapy or infusion pump therapy in which an insulin pump is used. The insulin pump can provide continuous infusion of insulin to a diabetic patient at varying rates to more closely match the functions and behavior of a properly operating pancreas of a non-diabetic person that produces the required insulin, and the insulin pump can help the diabetic patient maintain his/her blood glucose level within target ranges based on the diabetic patient's individual needs. Infusion pump therapy requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the diabetic patient's skin and through which infusion of insulin takes place. Infusion pump therapy offers the advantages of continuous infusion of insulin, precision dosing, and programmable delivery schedules. In infusion therapy, insulin doses are typically administered at a basal rate and in a bolus dose. When insulin is administered at a basal rate, insulin is delivered continuously over 24 hours to maintain the diabetic patient's blood glucose levels in a consistent range between meals and rest, typically at nighttime. Insulin pumps may also be capable of programming the basal rate of insulin to vary according to the different times of the day and night. In contrast, a bolus dose is typically administered when a diabetic patient consumes a meal, and generally provides a single additional insulin injection to balance the consumed carbohydrates. Insulin pumps may be configured to enable the diabetic patient to program the volume of the bolus dose in accordance with the size or type of the meal that is consumed by the diabetic patient. In addition, insulin pumps may also be configured to enable the diabetic patient to infuse a correctional or supplemental bolus dose of insulin to compensate for a low blood glucose level at the time when the diabetic patient is calculating the bolus dose for a particular meal that is to be consumed. Insulin pumps advantageously deliver insulin over time rather than in single injections, typically resulting in less variation within the blood glucose range that is recommended. In addition, insulin pumps may reduce the number of needle sticks which the diabetic patient must endure, and improve diabetes management to enhance the diabetic patient's quality of life. For example, many of the T2D patients who are prescribed insulin therapy can be