Bioimpedance-assisted placement of a medical device

• US 9,415,188 B2
• Filed: 07/31/2014
• Issued: 08/16/2016
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: He, Ding Sheng, Ciavarella, David J., Burnside, Eddie K., Stinger, Kevin W.
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): Sakamoto, Colin T
• Application Number:
  US14/449,061
• Publication Number:
  US 20140343398A1
• Time in Patent Office: 747 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/068 using impedance sensors
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B

Abstract

A system and method for guiding a catheter or other medical device to a desired target destination within the vasculature of a patient via bioimpedance measurements is disclosed. The target destination in one embodiment includes placement of the catheter such that a distal tip thereof is disposed proximate the heart, e.g., the junction of the right atrium and superior vena cava. In one embodiment the method for guiding the catheter comprises introducing the catheter into a vessel of the patient, the catheter defining a lumen through which fluids can be infused into the vasculature of the patient. The catheter is advanced toward a target destination within the vasculature. A first impedance value based on intravascular detection of at least one electrical property related to a first tissue surface of the vessel is calculated to enable determination of the proximity of a distal end of the catheter to the target destination.

Claims

1. A catheter guidance system, comprising:

a catheter for disposal within a vessel of a patient, the catheter defining at least one lumen through which a fluid may be infused into the vessel;

a radiofrequency (RF) source for providing an electrical current;

at least one electrode pair included proximate a distal tip of the catheter to which the electrical current is provided;

a voltage measuring device to measure voltage values across the at least one electrode pair when the electrical current is provided to the electrode pair;

a processor for determining the proximity of the distal tip of the catheter to a target destination, the processor;

calculating a first impedance value based on intravascular detection of at least one electrical property being a measured characteristic of a first tissue surface of the vessel, the at least one electrical property detected across the at least one electrode pair;

calculating a second impedance value based on intravascular detection across the at least one electrode pair of at least one electrical property being a measured characteristic of a second tissue surface of the vessel; and

determining the proximity of the distal end of the catheter to the target destination from a relative variance between the first impedance value and the second impedance value; and

a display for depicting data relating to the first and second impedance values.

2. The catheter guidance system as defined in claim 1, wherein the voltage measuring device is a voltmeter operably connected to the processor, and wherein the system further includes an ammeter to measure the magnitude of the electrical current, the ammeter operably connected to the processor.

3. The catheter guidance system as defined in claim 2, wherein the RF source, the voltmeter, the processor, and the display are included in a console.

4. The catheter guidance system as defined in claim 1, further including a magnetic tracking system for magnetically tracking the catheter within the vessel and an ultrasound imaging system for ultrasonically imaging at least a portion of the vessel.

5. The catheter guidance system as defined in claim 1, wherein the at least one electrode pair is disposed on an outer surface of the catheter proximate the distal tip thereof.

6. The catheter guidance system as defined in claim 1, wherein the electrode pair is included on a stylet removably received in the at least one lumen of the catheter.

7. The catheter guidance system as defined in claim 1, wherein the catheter further includes a diversion component for selectively diverting the electrode pair into physical contact with a tissue surface of the vessel.

8. The catheter guidance system as defined in claim 7, wherein a stylet is disposed within the at least one lumen of the catheter, and wherein the diversion component includes a movable diversion flap disposed on a distal portion of the stylet extending distal to the distal tip of the catheter.

9. The catheter guidance system as defined in claim 7, wherein the diversion component includes a single movable diversion flap disposed proximate the distal tip of the catheter.

10. The catheter guidance system as defined in claim 7, wherein the diversion component includes first and second movable diversion flaps disposed proximate the distal tip of the catheter, each diversion flap operably connected to an actuating wire for selective actuation of the diversion flap by a clinician, the diversion flaps movable to center the distal tip of the catheter in a center region of the vessel.

11. The catheter guidance system as defined in claim 7, wherein the diversion component includes a deployable flap defining a generally triangular shape.

12. The catheter guidance system as defined in claim 1, wherein the first and second impedance values enable a clinician to determine placement of the catheter in one of a vein and an artery.

13. The catheter guidance system as defined in claim 1, wherein the first and second impedance values enable a clinician to identify areas in the vessel where pre-stenoses or early plaque formation are present.