Method and device utilizing medicament delivery protocols

Inventors

Saint, Sean

Assignees

Tandem Diabetes Care Inc

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Publication Number

US-12226608-B2

Patent

Publication Date

2025-02-18

Expiration Date


Abstract

A method of infusing liquid medicaments including insulin via an insulin pump, includes identifying an insulin delivery protocol associated with ingestion of carbohydrates wherein the insulin delivery protocol is likely to lead to a postprandial drop in blood glucose to a level below a basal level, then proposing at least one alternative insulin delivery protocol to inhibit the postprandial drop in blood glucose by delivering a metered amount of insulin that is appropriate to facilitate the metabolism of the carbohydrates without the postprandial blood glucose level drop. The invention further includes querying the patient as to whether to apply the alternative insulin delivery protocol, receiving instructions from the patient in response to the query, and applying the alternative insulin delivery protocol following receiving instructions from the patient to apply the alternative insulin delivery protocol.

Core Innovation

The disclosure relates to an ambulatory infusion pump for treatment of diabetes. The pump includes a reservoir configured to contain a medicament and a pumping mechanism configured to deliver the medicament from the reservoir to a user. The pump further includes a memory configured to store one or more medicament delivery protocols.

A processor is configured to determine a type of medicament contained in the reservoir. The processor modifies one of the stored medicament delivery protocols to an alternate medicament delivery protocol based on the determined medicament type, and then causes the pumping mechanism to deliver the medicament according to the alternate medicament delivery protocol.

The control approach addresses a carbohydrate-associated insulin delivery protocol that is likely to cause an undesirable postprandial blood glucose drop below a basal blood glucose level. The disclosure proposes an alternative delivery protocol that adjusts delivery to better match insulin activity timing to carbohydrate metabolism, including reshaped or extended bolus profiles.

The disclosed approach includes delivery protocol adaptation for different insulin types and insulin action time modifiers, including situations involving ultra-rapid acting insulin and slowed gastric emptying associated with pramlintide or GLP-1 agonist therapy, as well as modifiers such as hyaluronidase. The system can track insulin activity using dual hormone and separate compartments, and it can optionally adjust the protocol based on modifier dosing or thresholds to avoid the undesirable glucose drop.

Claims Coverage

The partial content identifies two independent claims, an ambulatory infusion pump and an ambulatory infusion pump system, with the same core processor-based protocol modification architecture. Across the dependent claim set, the coverage includes quantitative and condition-based refinements that adjust an alternate medicament delivery protocol to avoid an undesirable blood glucose drop.

Processor determines medicament type and modifies protocol to alternate protocol based on medicament type

An ambulatory infusion pump includes a reservoir for a medicament, a pumping mechanism for delivery, a memory storing one or more medicament delivery protocols, and a processor configured to determine a type of medicament contained in the reservoir and to modify a medicament delivery protocol to an alternate medicament delivery protocol based on the type, then cause the pumping mechanism to deliver the medicament according to the alternate medicament delivery protocol.

Ambulatory infusion pump system delivers medicament using alternate protocol selected based on medicament type

An ambulatory infusion pump system includes an ambulatory infusion pump with a reservoir and pumping mechanism, a memory storing one or more medicament delivery protocols, and a processor configured to determine a type of medicament contained in the reservoir, modify a medicament delivery protocol to an alternate medicament delivery protocol based on the type, and cause the pumping mechanism to deliver the medicament according to the alternate medicament delivery protocol.

Overall, the claims cover an ambulatory infusion pump architecture where the processor determines the medicament type in the reservoir and selects or creates an alternate medicament delivery protocol for delivery. Dependent claim coverage further specifies that the alternate protocol can be adjusted by a modified delivery volume, including using stored ratios, and that modification can be triggered to avoid an undesirable drop in blood glucose, including automatic modification by the processor.

Stated Advantages

Avoiding an undesirable drop in blood glucose when delivering the medicament according to the protocol.

Documented Applications

Insulin delivery protocol adaptation for carbohydrate-associated insulin delivery to prevent an undesirable postprandial blood glucose drop below basal blood glucose level.

Use with insulin types and insulin action time modifiers, including scenarios involving ultra-rapid acting insulin and slowed gastric emptying associated with pramlintide or GLP-1 agonist therapy, and scenarios involving hyaluronidase.

Tracking insulin activity using dual hormone and separate compartments, with optional protocol adjustment based on modifier dosing or thresholds.

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