Method and apparatus for catheter location determination

• US 4,905,698 A
• Filed: 09/13/1988
• Issued: 03/06/1990
• Est. Priority Date: 09/13/1988
• Status: Expired due to Term

• Current Assignee: Smiths Medical MD Incorporated
• Original Assignee: Pharmacia Deltec, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: Whipple, Gary R., Ferragamo, Michael C., Kay, Donald A., Shapiro, Alan R., Strohl, Clair L. Jr.
• Primary Examiner(s): Hanley, John C.
• Application Number:
  US07/243,689
• Time in Patent Office: 539 Days
• Field of Search: 128/737, 128/653, 600/11, 600/13, 600/14, 600/15, 324/219, 324/234, 324/239, 324/220, 324/233
• US Class Current: 600/424
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/062 using magnetic field

Abstract

A method and apparatus (10) for determining accurately the location of the tip (14) of a catheter (16) inside biological tissue is disclosed including a locator (34) having a coil (38) wound axially on a core (36) and a detector (12) in the form of a coil (28) wound on a core (24) removably positionable within catheter (16) adjacent the tip (14). A controller (20) generates AC current to coil (38) to produce an electromagnetic field and compares it with the output voltage developed in coil ( b 28) when the locator (34) comes within close physical proximity to detecetor (12). Locator (34) includes an amber LED indicator (42) which is energized when the locator (34) is behind the detector (12) and the monitored output voltage is in phase with the generated alternating current and includes a red LED indicator (44) which is energized when the locator (34) is beyond the detector (12) and the monitored output voltage is 180° out of phase with the generated alternating current. The controller (20) includes a beeper (48) which provides an audible indicator when energization changes between the indicators (42, 44).

Claims

1. Apparatus for determining the location of a catheter inside biological tissue comprising, in combination:

means for providing an external alternating current magnetic field;

means for providing a first signal representative of the phase of the magnetic field;

means contained in said catheter for developing a second signal when the catheter is in physical proximity to the magnetic field;

means for comparing the phase of the second signal with that of the first signal; and

means for indicating when a predetermined phase relationship exists between the first and second signals.

2. Apparatus for determining the location of a tip of a catheter inside biological tissue comprising, in combination:

means for developing and transmitting an alternating current magnetic field;

means for detecting the alternating current magnetic field and for developing an output voltage when in close physical proximity thereto; and

means for comparing the alternating current of the magnetic field means and the output voltage of the detecting and developing means and for giving indication when the output voltage is in phase with the alternating current, when no output voltage is detected, and when the output voltage is 180°

out of phase with the alternating current, with one of the magnetic field means and the detecting and developing means being removably positionable adjacent the tip of the catheter and the other of the magnetic field means and the detecting and developing means being positionable outside the biological tissue at landmarks consistent with the desired location of the tip of the catheter.

3. The catheter location determining apparatus of claim 2 wherein the comparing and giving means includes at least a first visual indicator positionable with the other of the magnetic field means and the detecting and developing means.

4. The catheter location determining apparatus of claim 3 wherein the comparing and giving means includes a second visual indicator positionable with the other of the magnetic field means and the detecting and developing means, with the first visual indicator providing a visual indication when the output voltage is in phase with the alternating current and the second visual indicator providing a visual indication when the output voltage is 180°

out of phase with the alternating current.

5. The catheter location determining apparatus of claim 4 wherein the comparing and giving means includes means for producing an audible signal when indication changes from the first indicator to the second indicator and from the second indicator to the first indicator.

6. The catheter location determining apparatus of claim 2 wherein the magnetic field means comprises a core of magnetically permeable material and an encircling coil and wherein the detecting and developing means comprises a core of magnetically permeable material and an encircling coil, with the core of the other of the magnetic field means and the detecting and developing means being positionable generally perpendicular to the core removably positionable adjacent the tip of the catheter.

7. The catheter location determining apparatus of claim 6 wherein the detecting and developing means includes first and second amplifiers for amplifying any electrical signal detected by the coil, and switch means for by-passing one of said amplifiers to provide a different operational mode when said one amplifier is by-passed by said switch means.

8. The catheter location determining apparatus of claim 2 wherein the catheter includes a guidewire removably insertable in the catheter, with one of the magnetic field means and the detecting and developing means secured to the guidewire and positionable adjacent the tip of the catheter.

9. The catheter location determining apparatus of claim 2 wherein the magnetic field means is positionable outside the biological tissue and the detecting and developing means is removably positionable adjacent the tip of the catheter.

10. The catheter location determining apparatus of claim 2 including a battery;

means for converting direct current supplied by said battery to alternating current for energizing the magnetic field means; and

means for preventing the supply of direct current to said converting means when said battery is being charged so as to render the apparatus inoperable.

11. Method for determining the location of a tip of a catheter inside biological tissue comprising the steps of:

(a) providing means for developing and transmitting an alternating current magnetic field;

(b) means for detecting the alternating current magnetic field and for developing an output voltage when in close proximity to the magnetic field;

(c) removably positioning one of the magnetic field means and the detecting and developing means adjacent the tip of the catheter for entry into the biological tissue with the catheter;

(d) supplying alternating current to the magnetic field means;

(e) comparing the alternating current and the output voltage;

(f) moving the other of the magnetic field means and the detecting and developing means outside of the biological tissue at landmarks consistent with the desired locations of the tip of the catheter; and

(g) indicating when the output voltage is in phase with the alternating current, when no output voltage is detected, and when the output voltage is 180°

out of phase with the alternating current.

12. The method of claim 11 wherein the indicating step comprises the steps of:

(a) providing a first visual indication when the output voltage is in phase with the alternating current;

(b) providing a second visual indication when the output voltage is 180°

out of phase with the alternating current.

13. The method of claim 12 wherein the indicating step further comprises the step of:

(c) providing an audible signal when indication changes from the first visual indication to the second visual indication and from the second visual indication to the first visual indication.

14. The method of claim 11 wherein the removably positioning step comprises the steps of:

(a) providing a guidewire, with one of the magnetic field means and the detecting and developing means being secured to the guidewire; and

(b) positioning the guidewire within the catheter for entry into the biological tissue with the catheter.

15. The method of claim 11 wherein the removably positioning step comprises the step of removably positioning the detecting and developing means adjacent the tip of the catheter;

and wherein the moving step comprises the step of moving the magnetic field means.

16. The method of claim 15 wherein the indicating step comprises the step of providing an indicator for providing a visual indication with the moving step further comprises the step of moving the indicator with the magnetic field means.