Medtronic, Inc.

Medtronic, in

Scott L Kalpin

Scott A Sarkinen

Steven L Hartmann

Andrew Bzostek

Brad Jacobsen

Bradley A Jascob

Matthew W Koenig

Peter J Borowitz

Keith Alan Miesel

Irfan Z Ali

William J Mitchell

Jason J Hoendervoogt

Michael D Baudino

Earle Timothy Roberts

Patrick S Leong

Timothy J Denison

James Martin Haase

Charles Randall Rogers

Todd A Kallmyer

Cynthia R Nelson Konen

Lucien Bell Solefack

Andrew M Bzostek

A method includes receiving data regarding a catheter being used with the infusion device. The catheter has a lumen operably coupled to a reservoir of the infusion device and is configured to deliver fluid from the infusion device to a target location of a patient. The method further includes infusing fluid from the reservoir into the lumen of the catheter at a first rate and monitoring pressure via a pressure sensor in communication with the lumen of the catheter. Monitoring the pressure includes acquiring pressure data from the pressure sensor at a first frequency. The method also includes (i) determining whether the monitored pressure exceeds a first threshold, wherein the first threshold is based on the data regarding the catheter; and (ii) decreasing the rate at which the fluid is delivered from the reservoir into the catheter if the monitored pressure is determined to exceed the threshold.

Limiting pressure in an implanted catheter

The present invention includes systems and methods for detecting fluid flow into or out of a port chamber or a reservoir of an implantable medical device utilizing a pressure sensor and calculating the fluid status of the reservoir. The system detects characteristic pressure profiles associated with fluid flowing into the medical device, out of the medical device, and also whether one or both of the port chamber or reservoir are substantially empty or substantially full. In addition, the present invention may generate a sensory cue to a clinician to indicate the fluid status.

Pressure based refill status monitor for implantable pumps

Unexpected changes in the volume of therapeutic fluid in the reservoir of a fluid delivery device are detected based on changes in the pressure of the reservoir measured over a period of time by a pressure sensor. Additionally, an ambulatory reservoir fluid volume gauge is provided to indicate an actual volume of therapeutic fluid in a fluid delivery device reservoir. The actual volume of therapeutic fluid in the reservoir indicated by the ambulatory reservoir fluid volume gauge is determined based on changes in the pressure in the reservoir measured over a period of time by a pressure sensor.

Volume monitoring for implantable fluid delivery devices

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

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

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 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.

A method for determining status of an implanted catheter includes acquiring raw pressure data from a pressure sensor of in an implantable infusion device. The pressure sensor is in communication with a lumen of the catheter operably coupled to the infusion device. The catheter has a delivery region, in communication with the lumen, intended to be positioned in a fluid-filled target location of a patient. The method further includes filtering the raw pressure data to remove the DC component, leaving the AC component within a relevant physiological frequency range; rectifying the AC component to produce a rectified pressure signal; calculating a mean magnitude of the rectified signal; and determining whether the mean magnitude is below a predetermined threshold. If the mean magnitude is below the threshold, the catheter is determined to be in a state other than a normal state.

Devices and methods for detecting catheter complications

A system includes (i) a needle for insertion into a port of an implantable infusion device, and (ii) a receiver apparatus having a port location signal receiver module capable of receiving a signal from the implantable infusion device regarding spatial orientation of the port. The system further includes a processor operably coupled to the receiver apparatus and capable of determining the orientation of the needle relative to the port based on the received signal. The system also includes a display operably coupled to the processor. The processor is configured to cause the display to graphically render trajectory of the needle relative to the port. The port is graphically rendered as a target structure having a reference area. The needle is graphically rendered as an object moveable relative to the target structure. Occupation of the reference area by the object indicates trajectory alignment of the port and the needle.

Needle to port trajectory indicator

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 number of parameters related to the operation of a fluid delivery device are determined based on a pressure within the device sensed using a pressure sensor. In one example, the volume of therapeutic fluid added to or removed from a reservoir of a fluid delivery device is determined based on a sensed pressure of the reservoir. In another example, the volume of therapeutic fluid added to or removed from the reservoir is determined based on a sensed pressure of a refill port assembly of the device. In another example, an initial temperature of the reservoir as a therapeutic fluid is removed from the reservoir is estimated based on a sensed pressure within the device. In another example, a temperature of a therapeutic fluid added to the reservoir is estimated based on a sensed pressure within the device.

Reservoir monitoring for implantable fluid delivery devices

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.

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Harris, MN, United States of America

Scott L Kalpin