High Cell Density Bioartificial Pancreas Enabled by Implantable Oxygen Generator

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$222,735.00
Award Year:
2013
Program:
SBIR
Phase:
Phase I
Contract:
1R43DK100996-01
Award Id:
n/a
Agency Tracking Number:
R43DK100996
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
DK13-001
Small Business Information
2828 SW Corbett Ave #211A, PORTLAND, OR, 97201-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
78297084
Principal Investigator:
ROBERT CARGILL
(503) 847-9170
bcargill@pacificdt.com
Business Contact:
ROBERT CARGILL
(503) 847-9170
bcargill@pacificdt.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Type 1 diabetes often leads to short-term and long-term complications which impair quality of life. Though many research groups are developing versions of an artificial endocrine pancreas (AP) system, current systems require at least one hormone delivery insertion site and at least one glucose sensor site. This complexity limits commercial viability and potential acceptance by patients. The risk of bacterial colonization and infection from the multiplicity of insertion sites merits reduction of the number of inserted devices. In this project, we propose to create a novel artificial pancreas technology that integrates into a single wearable device the following three elements: (1) an intelligent hormone delivery catheterwhose outer wall contains a multi-site amperometric continuous glucose monitor (CGM), the development of which is funded elsewhere; (2) a wireless sensor module with a transceiver, battery, and data acquisition unit; and (3) a quick connect/disconnect portthat attaches to the sensing catheter and to an insulin delivery tubing connector. This combination device is intended to allow more freedom of movement and increase patient comfort. We prefer the subcutaneous site over the intradermal site for sensing and hormone delivery because of a lower risk for catheter dislodgement. In order to avoid the need for perfusion- and waste fluid compartments, we prefer direct amperometry over microdialysis. In a separate project, we are using solid state design and microfabrication techniques to create the sensing catheter by placing a flat amperometric sensing array on a flexible polyimide substrate which will then be wrapped into a tube. In this application, we propose to develop the unified wearable device that will allow clinical use of the sensing catheter. This three-part device will connect to an insulin delivery line and will include an analog sensor electrical interface and a Bluetooth SMART transceiver. The combination will permit the commercial introduction of an intelligent infusion set that can connect to an insulin-only pump or an insulin/glucagon pump such as the one under development by Tandem Diabetes as funded by JDRF. This pump will likely incorporate a Bluetooth wireless interface capable of communication with our sensor module. We also propose to create an early prototype insertion device and carry out preliminary tests of the system in swine. In these tests, the three-part device with sensing catheter will be inserted subcutaneously into anesthetized pigs in order to allow (1) radiographic assessment of the catheter insertion angle and depth; (2) verification of telemetric data transmission to a remote smart phone receiver; and (3) leak-free delivery of insulin. Pig study costs will largely be covered elsewhere. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: The potential for wide acceptance of artificial pancreas systems is currently limited due in part to the need for multiple device insertion sites for sensor and pump sets. Pacific Diabetes Technologies is developing a dual function catheter in which glucose sensing and hormone delivery capabilities are combined. In this application, we propose to design and create a multi- part structure that will attach to the sensing catheter, transmitsensor data to a remote receiver, and interface with an insulin delivery connector.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government