Bioimpedance-assisted placement of a medical device

• US 8,801,693 B2
• Filed: 10/27/2011
• Issued: 08/12/2014
• 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.
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): SAKAMOTO, COLIN T
• Application Number:
  US13/283,395
• Publication Number:
  US 20120108950A1
• Time in Patent Office: 1,020 Days
• Field of Search: 600/547, 600372-377, 600/381, 604/510
• US Class Current: 604/510
• 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 method for guiding a catheter within a vasculature of a patient, the method comprising:

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;

advancing the catheter toward a target destination within the vasculature;

calculating at least a first impedance value based on intravascular detection of at least one electrical property related to a first tissue surface of the vessel, the at least one electrical property detected across at least one electrode pair associated with the catheter disposed proximate to the first tissue surface;

advancing the catheter so that the electrode pair is proximate a second tissue surface in the vessel;

calculating a second impedance value based on intravascular detection across the at least one electrode pair of at least one electrical property related to 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.

2. The method for guiding a catheter as defined in claim 1, wherein calculating the at least first impedance value is performed by a processor based on detection of the at least one electrical property, the at least one electrode operably connected to the processor, the at least one electrical property including a voltage value across the electrode pair.

3. The method for guiding a catheter as defined in claim 2, wherein calculating the at least first impedance value further comprises:

providing an electrical current to the electrode pair disposed proximate to the first tissue surface;

detecting a voltage value across the electrode pair; and

calculating the at least first impedance value based on the provided electrical current and the detected voltage.

4. The method for guiding as defined in claim 3, further comprising:

establishing physical contact of the electrode pair with the tissue surface before providing the electrical current.

5. The method for guiding as defined in claim 4, further comprising:

depicting data relating to the calculated at least one impedance value on a display for observation by a clinician.

6. The method for guiding as defined in claim 3, wherein calculating the second impedance value based on intravascular detection of at least one electrical property related to the second tissue surface of the vessel further comprises:

providing an electrical current to the electrode pair;

detecting a voltage value across the electrode pair; and

calculating the second impedance value based on the provided electrical current and the detected voltage.

7. The method for guiding as defined in claim 6, wherein the target destination is proximate a junction of the superior vena cava and the right atrium of the heart of the patient, and wherein an impedance drop between the first impedance value and the second impedance value indicates advancement of a distal end of the catheter toward the junction from the superior vena cava.

13. The method for guiding a catheter as defined in claim 1, wherein the first tissue surface is separated from the target destination by a distance greater than zero.

14. The method for guiding a catheter as defined in claim 13, wherein the determination of the proximity of the distal end of the catheter with respect to the target destination is used to locate the catheter distal end in relation to a superior vena cava, a right atrium, or junctures thereof.

15. The method for guiding a catheter as defined in claim 6, wherein measurements of impedance values at a given catheter location, followed by movement of the catheter and subsequent measurement at a new location, is iteratively performed to determine when the catheter has reached the target destination.

16. The method for guiding a catheter as defined in claim 15, wherein a relative variance between sequential iterative measurements is used to determine the proximity of the distal end of the catheter to the target destination.

8. A method for guiding a catheter within a vasculature of a patient, the catheter defining a lumen through which fluids can be infused into the vasculature of the patient, the catheter including at least a first electrode pair disposed on an outer surface thereof, the method comprising:

introducing the catheter into a vessel of the patient;

advancing the catheter toward a target destination within the vasculature;

providing an electrical current to the electrode pair with the electrode pair disposed proximate a first tissue surface;

calculating at least a first impedance value according to the electrical current and a voltage value of the electrode pair at the first tissue surface;

conveying to a user the first impedance value;

further advancing the catheter such that the electrode pair is disposed proximate a second tissue surface;

providing the electrical current to the electrode pair with the electrode pair disposed proximate the second tissue surface;

calculating a second impedance value according to the electrical current and a voltage value of the electrode pair at the second tissue surface; and

comparing the first impedance value with the second impedance value to determine proximity of the distal tip of the catheter to the target destination.

9. The method for guiding as defined in claim 8, further comprising:

storing the first and second impedance values for future use.

10. The method for guiding as defined in claim 8, wherein when the second impedance value is smaller relative to the first impedance value, the clinician can infer the distal tip of the catheter is approaching the right atrium of the heart of the patient.

11. The method for guiding as defined in claim 8, wherein the electrode pair physically touches the first tissue surface and the second tissue surface when the electrical current is provided.

12. The method for guiding as defined in claim 8, wherein at least one electrode of the electrode pair includes at least one extended electrode wire that compliantly engages one of the first tissue surface and the second tissue surface.

17. A method for guiding a catheter within a vasculature of a patient, the method comprising:

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 having at least one electrode pair associated with the catheter;

advancing the catheter toward a target destination within the vasculature;

calculating at least a first impedance value based on intravascular detection of at least one electrical property related to a first tissue surface of the vessel, the at least one electrical property detected across the at least one electrode pair disposed proximate to the first tissue surface;

iteratively performing measurements of impedance values at a given catheter location by the at least one electrode pair disposed proximate the given catheter location, followed by movement of the catheter and subsequent measurement at a new location by the at least one electrode pair disposed proximate the new location; and

determining the proximity of the distal end of the catheter to the target destination from the relative variance between sequential iterative measurements.