On-body injector with segmented basal and bolus ports
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Solution Overview
Problem
Current on-body injectors and injection port systems require frequent administration of therapeutic agents, often leading to adverse effects like bruising and are cumbersome, especially for patients with diabetes who need multiple daily injections, as they necessitate repeated needle insertions and lack flexibility in therapy options based on daily needs or activities.
Innovation Solution
An on-body injector system with a bolus reservoir and a slideable bolus injection needle, along with a button mechanism to advance the needle and deliver a predetermined bolus volume, and a pressurized reservoir with a flow restrictor for basal insulin delivery, allowing for flexible and reduced frequency of injections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple daily injections are administered to maintain medical condition control, then therapeutic effectiveness is improved, but patient convenience deteriorates and adverse effects increase
Solution Approach 1:
The injection system is segmented into two separate ports: a first injection port for basal insulin delivery and a second injection port for bolus insulin delivery. This segmentation allows different injection types to be administered through separate access points, enabling flexible therapy options and reducing the frequency of needle insertions while maintaining therapeutic effectiveness.
Solution Approach 2:
The system employs dynamic injection mechanisms where the bolus injection needle can be advanced into the second injection port upon actuation of a button, allowing on-demand bolus injections. This dynamic capability enables patients to adjust their therapy based on daily needs and activities without requiring multiple predetermined needle insertions.
2Ease of operation
If injection ports are used to reduce needle insertion frequency, then patient convenience is improved, but therapeutic flexibility deteriorates
Solution Approach 1:
The injection device is divided into separate functional compartments with dedicated ports for different injection types (basal and bolus). This segmentation preserves therapeutic flexibility by allowing patients to choose different therapy options based on specific daily needs while maintaining the convenience of reduced needle insertion frequency through the same port system.
Solution Approach 2:
The injection port system is designed with multi-functionality, serving both basal and bolus injection purposes through a single integrated device. The button mechanism enables the bolus injection needle to advance into the second injection port, providing universal access to both injection types while maintaining patient convenience.
3Adaptability or versatility
If a dedicated electronic insulin pump is used to provide flexible therapy options, then therapeutic adaptability is improved, but device complexity and expense increase
Solution Approach 1:
The patent extracts the essential injection functionality from a complex electronic pump system, providing a simplified mechanical solution. The button-actuated mechanism for advancing the bolus injection needle and delivering predetermined bolus volumes eliminates the need for electronic controls, batteries, and complex programming while maintaining therapeutic adaptability through manual operation.
Solution Approach 2:
The system employs simple, inexpensive mechanical components including a button mechanism and a disposable needle assembly that can be advanced and retracted. This approach replaces expensive electronic pump systems with affordable mechanical alternatives that provide sufficient therapeutic adaptability without the complexity and cost of electronic controls.
4Measurement precision
If frequent needle insertions are performed to deliver therapeutic agents, then dosage accuracy is improved, but patient well-being deteriorates due to adverse effects
Solution Approach 1:
The injection system segments the delivery function into separate ports for basal and bolus injections, allowing precise dosage control through dedicated access points. This segmentation enables accurate dosing while reducing the total number of needle insertions required, thereby minimizing adverse effects such as bruising and skin reactions.
Solution Approach 2:
The bolus injection needle is pre-positioned in a retracted state within the injection device, ready to be advanced into the second injection port when needed. This preliminary positioning allows for rapid, accurate bolus delivery without requiring repeated needle insertions, thereby maintaining dosage accuracy while reducing adverse effects from frequent skin punctures.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system enables efficient and flexible delivery of therapeutic agents with reduced frequency of needle insertions, minimizing adverse effects and allowing patients to choose therapy options based on daily needs, enhancing user convenience and reducing the burden of multiple daily injections.
Implementation Method 1
a flow restrictor disposed between the pressurized reservoir and the delivery tube, the flow restrictor being tubing having a length and interior diameter selected to provide a desired pressure drop
Data Source
AI summary
An on-body injector and method of use including an on-body injector for use with an injection device. The on-body injector includes a bolus reservoir; a bolus injection needle in fluid communication with the bolus reservoir, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap between the bolus injection needle tip and the injection port; and a button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port. The button is further operable to advance a plunger through the bolus reservoir to deliver a predetermined bolus volume to the patient through the injection flow path.