ANCHORED IMPLANTABLE PRESSURE MONITOR

• US 20100174201A1
• Filed: 03/15/2010
• Published: 07/08/2010
• Est. Priority Date: 11/23/2005
• Status: Active Grant

• Current Assignee: Endotronix, Inc.
• Original Assignee: Vital Sensors Holding Company, Inc
• Inventors: Ostermeier, Max Georg, Bodecker, Volker, Niemeyer, Axel, Meyer, Stefan
• Granted Patent: US 7,931,597 B2
• Time in Patent Office: Days
• US Class Current: 600/488
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

An anchored implantable pressure monitor.

Claims

1. An implantable pressure monitor comprising:

a sensor assembly comprising;

a substantially rigid chip including;

a proximal end and a distal end;

pressure sensors exposed on a first surface of the chip in a sensor region of the distal end;

signal processing circuitry receiving pressure-indicative signals from the sensors and producing pressure-indicative output signals; and

a chip electrical connector in the proximal end communicating the output signals;

a substantially rigid substrate that;

is spaced apart from the chip;

faces the first surface of the chip;

is connected to the chip electrical connector in the chip'"'"'s proximal end by a substrate electrical connector;

defines an aperture positioned over the sensor region of the chip'"'"'s distal end, thereby exposing the pressure sensors; and

covers the distal end of the chip except for the sensor region; and

a flexible filler material located throughout space between the chip and the substrate except beneath the aperture, thereby leaving the pressure sensors exposed, such that (a) the flexible filler material connects the chip to the substrate, and (b) the distal end of the chip is connected to the substrate by only the flexible filler material;

a wire that;

extends from the substrate;

is electrically connected to the substrate electrical connector;

communicates the output signals; and

is not connected to the chip;

a biocompatible sheath that encapsulates the sensor assembly and wire and is sufficiently flexible to transmit pressure exerted on the sheath exterior through the sheath;

a pressure-transferring medium extending from the sheath, through the aperture, and to the pressure sensors, thereby transferring pressure exerted on the sheath exterior to the pressure sensors;

an anchor structure that is;

sized and shaped for securing the implantable pressure monitor to an anatomic structure; and

foldable to fit within a delivery catheter lumen; and

a sensor fastener holding the sensor assembly away from the anchor structure.

2. The implantable pressure monitor of claim 1, wherein the sensor fastener comprises a bend or an elbow shape.

3. The implantable pressure monitor of claim 1, wherein the sheath has a curved shape to reduce or eliminate hydrodynamic forces.

4. The implantable pressure monitor of claim 1, wherein the substantially rigid substrate extends distally from the chip to a distal end which comprises a barrier wall protecting a distal end of the chip.

5. The implantable pressure monitor of claim 4, wherein the barrier wall forms an end cap at the distal end of the chip.

6. The implantable pressure monitor of claim 5, wherein the barrier wall extends in a direction substantially perpendicular to a plane of the substrate and to a height such that a top of the barrier wall is at or above a top of the chip.

7. The implantable pressure monitor of claim 4, wherein the substantially rigid substrate further extends distally from the barrier wall to a tapered front portion.

8. The implantable pressure monitor of claim 1, wherein the sheath comprises a one-piece, seamless silicone covering.

9. The implantable pressure monitor of claim 1, wherein the pressure-transferring medium comprises silicone.

10. The implantable pressure monitor of claim 1, wherein the anchor structure comprises resilient arms that spring into an expanded position after release from confinement.

11. The implantable pressure monitor of claim 10, wherein the resilient arms of the anchor structure are arranged as two looped wire elements separated by a distance corresponding to or slightly less than the thickness of a cardiac septum, and the sensor assembly is positioned outside the anchor structure.

12. The implantable pressure monitor of claim 1, wherein the substrate is sufficiently rigid such that it cannot be folded or rolled up.

13. The implantable pressure monitor of claim 1, wherein the substrate is sufficiently rigid to protect the pressure sensors from damage as a consequence of contact with a surgical instrument during implantation and from mechanical damage during use.

14. The implantable pressure monitor of claim 1, wherein the substantially rigid substrate is sufficiently rigid to protect the pressure sensors from damage due to stress and strain due to bending of the monitor during insertion.

15. The implantable pressure monitor of claim 1, wherein the substrate is sufficiently rigid to avoid twisting of the chip due to turbulent blood flow.

16. The implantable pressure monitor of claim 1, wherein the substrate is rigid.

17. The implantable pressure monitor of claim 1, wherein the substrate is mechanically inflexible.

18. The implantable pressure monitor of claim 1, wherein the flexible filler material comprises silicone.

19. The implantable pressure monitor of claim 1, wherein the flexible filler material holds the chip and the substrate together in a fixed relationship.

20. A method of monitoring pressure with an anchored implantable pressure monitor positioned in a space in which pressure is to be monitored such that pressure sensors of the monitor are exposed to the pressure, the method comprising:

conveying power to the monitor, thereby causing the monitor to operate;

receiving from the monitor the pressure-indicative output signals; and

storing the pressure-indicative output signals.