Medtronic, Inc.

Scott A Sarkinen

Scott L Kalpin

Brad Jacobsen

Steven L Hartmann

Andrew Bzostek

Bradley A Jascob

Matthew W Koenig

Peter J Borowitz

Keith Alan Miesel

James Martin Haase

Irfan Z Ali

Ronald L Mezera

Christian Peclat

Jason J Hoendervoogt

Timothy J Denison

Charles Randall Rogers

Earle Timothy Roberts

William J Mitchell

Nicholas R Whitehead

Patrick S Leong

Touby Austin Drew

Venkat R Gaddam

Todd A Kallmyer

Erik J Peterson

Mark R Bilitz

Steven R Christenson

Donald L Villalta

Emem D Akpan

Darrin T Schauble

Christopher Ambri

Jacob A Otterstetter

Naveed Alam

Douglas E Hentges

Naresh Lakshman Raman

Mark E Dunlap

Alex O Espe

Cindy Konen

A medicament delivery system configured to reduce the risk of inadvertently injecting medicament directly into a patient during a refill procedure via an external refilling apparatus. The medicament delivery system may include an implantable medical pump having a refillable medicament reservoir accessible via an access port, wherein the refillable medicament reservoir includes a flexible diaphragm having a nonlinear spring rate configured to create a relative vacuum within a medicament chamber when medicament is expelled from the medicament chamber beyond a predefined threshold, so as to spontaneously draw a quantity of medicament into the medicament chamber during the refill procedure to reestablish the predefined threshold, thereby confirming proper placement of a portion of the external refilling apparatus into the access port.

Needle insertion responsive system

Reservoir volume of implantable infusion devices may be determined using a volume sensor that provides a signal representative of a distance between the volume sensor and a movable wall of the reservoir. The volume sensor may be a light-based or sound-based sensor, and may be located outside of the reservoir.

Reservoir volume sensing

A total dose of a therapeutic agent to be delivered to a patient by an infusion device over a total period of time is automatically divided into a plurality of unit doses to be delivered to the patient over a plurality of unit periods of time. The infusion device is automatically programmed to deliver one of the unit doses of the therapeutic agent to the patient over its respective unit period of time, after which the one unit dose is delivered, and a determination is made of whether an error occurred in delivering the one unit dose to the patient. Delivery of the total dose of the therapeutic agent to the patient may include iteratively automatically programming the infusion device to deliver successive unit doses upon determining that no error occurred in delivering a previous unit dose to the patient. Accordingly, the risk of improperly dosing the patient with the therapeutic agent in an event of a software or hardware anomaly within the infusion device is prevented or reduced.

Detecting and responding to software and hardware anomalies in a fluid delivery system

A support tool for a supply assembly delivers a functional fluid to an implantable medical device. The supply assembly defines a supply axis. The support tool includes a support member defining an opening. The opening has a support axis, and the opening is configured to receive the supply assembly. The support member includes a three dimensionally contoured nesting surface that conforms to a corresponding three dimensionally contoured surface of the supply assembly. The corresponding surface of the supply assembly nests against the nesting surface to support the supply assembly such that the supply axis remains substantially fixed relative to and aligned with the support axis.

Method and apparatus for guiding an external needle to an implantable device

An implantable infusion device includes a pump, a charge storage unit, and a charging circuit configured to supply current to the charge storage unit from a battery in preparation for actuating the pump. The implantable infusion device also includes a pump actuator circuit configured to actuate the pump using energy from the charge storage unit, and a voltage boost circuit configured to provide a boosted battery voltage generated from the battery. The charging circuit is configured to supply current to the charge storage unit from the voltage boost circuit instead of directly from the battery in response to (i) a comparison of a voltage of the battery with a predetermined threshold and (ii) a comparison of a voltage of the charge storage unit with the voltage of the battery.

Implantable infusion device having voltage boost circuit and selection circuit to alternately connect battery with charging circuit

Systems, devices and methods employing coded magnetic fields or transfer of encryption key information via proximity telemetry are described. The systems, methods and devices help prevent or reduce unintended or unintentional distance telemetry communication between an external medical device and an implantable medical device.

Proximity signature for secure communication with implantable medical device

Transdermal insertion of a transcutaneous filling apparatus, for the purpose of filling a fill chamber of an implanted therapy delivery device, is monitored by measuring each impedance between pairs of electrodes of a needle of the apparatus, and comparing each to a threshold impedance; the electrodes, preferably at least three in number, are isolated and spaced apart from one another along a length of the needle. A confirmation signal is generated when at least one of the measured impedances is greater than the threshold impedance, and another is less than the threshold, the condition indicating that one of the electrodes is located within a non-conductive septum, through which the apparatus must pass to access the fill chamber. A detection circuit, which may be located in a housing of the apparatus that is attached to a proximal end of the needle, measures and compares the impedances.

Filling methods and apparatus for implanted medical therapy delivery devices

A support tool or a supply assembly that delivers a functional fluid to a patient includes an antenna array for receiving or sensing a navigation field. The navigation field can be generated from a localizer. The localizer can be incorporated or included in an implanted device.

A system to generate a navigation field relative to an implanted device is disclosed. The system can include a small and/or thin localizer array positioned in the implanted device. A power management scheme and circuits can be provided to conserve and resource power in the implanted device.

A method of detecting a fault condition within an implantable medical pump comprises delivering therapeutic fluid using a medical pump comprising an actuation mechanism configured to be energized to provide a pump stroke, detecting a property associated with energizing the actuation mechanism, and determining whether the property associated with energizing the actuation mechanism indicates that a fault condition exists with the medical pump.

Implantable medical pump diagnostics

A system can include an implantable device, an instrument, a display device and a processor. The implantable device can include a port and a localizer for generating a navigation field. The instrument can include a tracking device for sensing the navigation field. The processor can be operably coupled to the tracking and display devices and operable to determine a real-time location of the instrument relative to the port and a trajectory of the instrument relative to an insertion axis of the port. The processor system can be operable to cause the display device to graphically render the instrument as a plurality of two or three-dimensional rings positioned around an axis coincident with the determined trajectory and in spaced relation to each other along the axis. A first ring of the plurality of rings can be positioned at the determined instrument location relative to a graphical representation of the port location.

Systems for detecting needle insertion into a port chamber of an implantable medical device include a pressure sensor. The system detects characteristic pressure profiles associated with needle insertion into the port chamber through a septum and may generate a sensory cue to a clinician that proper needle placement has been achieved. Methods for detecting needle insertion into a port chamber of an implantable medical device includes detecting characteristic pressure profiles associated with needle insertion into the port chamber through a septum.

Detecting needle entry into a port of an infusion device

A medical device system comprises a reservoir configured to store a therapeutic fluid and a medical pump configured to deliver the therapeutic fluid from the reservoir to a patient. The system also comprises a sensor that can detect a characteristic associated with the pump and a processor to determine if the characteristic detected indicates the reservoir is empty or near empty. The characteristic may comprise a characteristic of a noise made by an actuator within the pump at the end of a pump stroke.

Detecting empty medical pump reservoir

Detection of end of stroke for an electromagnetic pump may be performed using, for example, a calculated first flux derivative. Further, inductance of a coil that can be energized to produce a pump stroke may be calculated (e.g., the pump may include an actuator moveable in response to the energization of the coil). For example, the inductance may be calculated as a function of sense coil current and source electrical potential when the actuator is not moving for use in determining position of the actuator.

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Greenfield, MN, United States of America

Scott A Sarkinen