Microchips, Inc.

Massachusetts Institute of Technology

On Demand Therapeutics, Inc.

Boston Scientific Scimed, Inc.

John T Santini, Jr

Michael John Cima

Norman F Sheppard, Jr

Robert Samuel Langer

Scott Albert Uhland

Stephen Jack Herman

Dennis Ausiello

Chung Chang Young

Benjamin F Polito

John M Maloney

Jonathan Robert Coppeta

Charles E Hutchinson

Zouhair Sbiaa

John Anthony Scholl

Kenneth N Horne

Christina M Feakes

James H Prescott

Gregory J R Spooner

Andrew I Poutiatine

Barry Mitchell Yomtov

Mark Staples

Cynthia L Stevenson

Douglas Snell

Achim Göpferich

Naveed Shams

Nolan T Flynn

Amy C Richards

Rebecca S Shawgo

Mark A Staples

An implantable drug delivery device that uses multiple reservoir elements to contain and release doses of active pharmaceutical ingredients. The device includes a first shell element, which has a first enclosed cavity volume and forms a low-permeability barrier. The first shell element is configured to absorb light irradiation from a laser source, the laser irradiation causing a breach in the first shell element. A first active pharmaceutical ingredient is contained in the first enclosed cavity volume and is released when the first shell element is breached. The device also includes a second shell element, which has a second enclosed cavity volume and also forms a low-permeability barrier. A second active pharmaceutical ingredient is contained in the second enclosed cavity volume. The device also includes an envelope element containing the first and second shell elements.

Low-permeability, laser-activated drug delivery device

The present disclosure relates to methods for visualizing the opening of a drug reservoir of an implantable medical device. In particular, the present disclosure provides methods for observing the release or exposure of contents from a drug reservoir of a medical device placed within the vitreous of an eye of a subject. The methods include implanting a drug delivery device within an anatomy of a subject. The drug device includes a plurality of reservoirs, each loaded with a therapeutic agent and a marker. Furthermore, the drug delivery device comprises a plurality of barrier layers for separating the contents of one of the plurality of reservoirs from the anatomy. The method further includes irradiating at least one of the plurality of barrier layers such that at least one of the plurality of reservoirs is breached, thereby triggering release of the therapeutic agent and the marker from the device. By visually detecting release of the marker into the anatomy, release of the therapeutic agent into the anatomy is verified.

Visual indication of rupture of drug reservoir

Electrochemical sensor devices are provided, in various amperometric, potentiometric, and conductometric sensor device configurations. An amperometric sensor device may include a structural body which has at least one reservoir that has at least one opening; a working electrode located within the reservoir; analyte sensor chemistry located within the reservoir and deposited on at least the working electrode; an auxiliary electrode located outside of the reservoir; a reference electrode; at least one reservoir cap closing the opening to isolate the working electrode and analyte sensor chemistry within the reservoir and to prevent an analyte outside of the reservoir from contacting the analyte sensor chemistry; and means for rupturing or displacing the reservoir cap to permit the analyte from outside of the reservoir to contact the analyte sensor chemistry.

Electrochemical biosensors and arrays

A medical device is provided which may include a reservoir which has an opening and contains a sensor; a reservoir cap closing off the opening to isolate the sensor from an environmental component outside the reservoirs, the reservoir cap being impermeable to the environmental component and adapted to selectively undergo a phase change to disintegrate the reservoir cap and thereby expose the sensor to the environmental component. A method of use may include (i) selectively disintegrating a reservoir cap to expose a sensor which is disposed inside a reservoir of a device implanted in a patient, the disintegrating comprising inducing a phase change in the reservoir cap; and (ii) using the sensor to generate an output signal, wherein the output signal is recorded and stored in a writeable computer memory chips, directed to a microprocessor for immediate analysis and processing, or sent to a remote location away from the device.

Medical device with reservoir-based sensors

A method is provided for monitoring the status of a medical device implanted in a patient. The method includes the steps of implanting in a patient a medical device which comprises (i) a substrate in which two or more reservoirs are located, with each covered by a reservoir cap, (ii) a drug or sensor located in the reservoir, (iii) a power source and actuation electronics for disintegrating or permeabilizing the reservoir cap, and (iv) a telemetry system; and then using said telemetry system to wirelessly transmit to a remote controller data about the condition of the power source and/or data about which reservoirs have been or have yet to be activated to release the drug therefrom or to expose the sensor therein.

Method for wirelessly monitoring implanted medical device

Devices, such as medical devices, are provided which include a body portion having at least one reservoir which has two or more openings, the two or more openings being defined in part by a reservoir cap support; reservoir contents, such as a drug formulation or sensor, disposed inside the reservoir; and a reservoir cap which closes off the two or more reservoir openings. The reservoir cap, which can be ruptured, controls release or exposure of the reservoir contents. In one embodiment, the device is an implantable medical device and provides for the controlled release of drug or exposure of a sensor.

Multi-opening reservoir devices for controlled release or exposure of reservoir contents

Methods and systems are provided for delivering drug to the eye. The method and system may include implanting into the eye a device which comprises two or more discrete reservoirs, each reservoir containing a drug; and directing focused light to the implanted device to open a first one of the reservoirs and thereby permit the drug to diffuse from the first reservoir to the patient's eye.

Method and system for drug delivery to the eye

Method and devices are provided for extended and controlled delivery of parathyroid hormone to a patient. The method includes implanting a medical device into the patient, the medical device comprising a substrate, a plurality of reservoirs in the substrate, a release system contained in each of the reservoirs, wherein the release system comprises parathyroid hormone; and controllably releasing a pharmaceutically effective amount of the parathyroid hormone from the reservoirs. The parathyroid hormone can be released intermittently, such as once daily over an extended period (e.g., two months, ten months, or more.). The device can further include reservoirs containing a bone resorption inhibitor or other drug for release. The devices are useful in delivering PTH for the treatment and prevention of bone loss, such as associated with osteoporosis.

Implantable device for controlled, extended delivery of parathyroid hormone

Medical devices, utilizing multiple reservoirs to protect and selectively expose sensors or other reservoir contents, are provided having (i) a reservoir contents destruction mechanism to interrupt the release or exposure of reservoir contents, for example, to deactivate an unneeded sensor and prevent it from negatively impacting other sensors, (ii) a protective covering material layer over the sensor underneath the reservoir cap, which protects the sensor membrane and sensor during reservoir cap disintegration and then is removed, (iii) a device design for containing sensors in shallow, wide reservoir structures to enhance sensor exposure by minimizing molecular diffusion distances, (iv) an implantable sensor unit and a separate drug delivery unit, or (v) combinations thereof.

Medical device for sensing glucose

Microchip devices are provided that include a substrate; a plurality of reservoirs in the substrate, each reservoir defining an internal volume; and a reservoir cap positioned on or in each of the reservoirs bounding the internal volume from an external environment, the reservoir cap being formed of a material that undergoes a phase change upon heating, wherein the internal volume can communicate with the external environment upon heating said reservoir cap to cause said reservoir cap to undergo a phase change and rupture.

Device for controlling exposure of reservoir contents to surroundings

An implantable medical device is provided for use with an external detector to detect an analyte in vivo. In one embodiment, the device consisting essentially of a substrate; a plurality of discrete reservoirs located in the substrate, each reservoir having at least one opening; a reacting component contained in each reservoir; and at least one non-degradable barrier layer covering each reservoir opening, the barrier layer being permeable to an analyte to be detected, wherein the reacting component remains inside the reservoirs and can react with the analyte to be detected, and wherein the device is adapted for implantation into the body of a patient.

Implantable medical device for diagnostic sensing

Implantable medical devices are provided for controlled release of drugs. In one embodiment, the device comprises a support structure; two or more discrete reservoirs provided in spaced positions across at least one surface of the support structure; and a release system loaded in each of the reservoirs, the release system including drug molecules dispersed in a degradable matrix material, wherein release of the drug molecules from the reservoir is controlled by in vivo disintegration of the matrix material. In another embodiment, the device comprises a support structure; two or more discrete reservoirs provided in spaced positions across at least one surface of the support structure; and a release system loaded in each of the reservoirs, the release system including drug molecules dispersed in a non-degradable matrix material, wherein release of the drug molecules from the reservoir is controlled by in vivo diffusion of the drug molecules from the matrix material.

Medical device with controlled reservoir opening

A method is provided for operating a device for the containment and controlled release or exposure of a chemical substance. The method includes (i) providing a device which includes a substrate having a plurality of reservoirs, at least one chemical substance stored in the reservoirs, a plurality of metal reservoir caps, each of which closes an opening of one of said reservoir caps, and power and electrode means for disintegrating each of said reservoir caps; and (ii) disintegrating at least one of said reservoir caps, using said power and electrode means, to expose or release the chemical substance, wherein said disintegration comprises using potentiostatic or galvanostatic control to a voltage potential at said at least one reservoir cap.

Method for operating microchip reservoir device

Reservoir-based medical devices are provided. In one embodiment, the medical device comprises a substrate; at least two discrete, microfabricated reservoirs provided in spaced positions across at least one surface of the substrate; discrete reservoir caps covering the at least two reservoirs; and control circuitry for selectively disintegrating the reservoir caps to open the reservoirs. The reservoirs of the device can include a diagnostic reagent or other molecules useful in medical diagnostics. In one embodiment, the reservoir cap comprises an anode and the control circuitry comprises a cathode and a power source for creating an electric potential between the cathode and the anode. Application of the electric potential causes the reservoir cap to disintegrate, thereby opening the reservoir.

Method of controlled drug delivery from implant device

A method is provided for selectively opening a containment reservoir. The method includes providing a device which comprises a substrate in which at least one reservoir is located and covered by a reservoir cap; and directing laser light to the reservoir cap to cause the reservoir cap to disintegrate or become permeable. The device may be an implantable medical device. The reservoirs may contain a drug for controlled release or a biosensor.

Growing community of inventors

North Chelmsford, MA, United States of America

John T Santini, Jr