Catheter placement detection system and operator interface

• US 6,780,182 B2
• Filed: 05/23/2002
• Issued: 08/24/2004
• Est. Priority Date: 05/23/2002
• Status: Expired due to Fees

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Adiana, Inc. (Hologic Incorporated)
• Inventors: Kitlas, Kenneth, Dhaka, Vijay, Harrington, Douglas C., Bowman, Brett S.
• Primary Examiner(s): Gibson, Roy D.
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US10/155,462
• Publication Number:
  US 20030220636A1
• Time in Patent Office: 824 Days
• Field of Search: 606/34, 606/41, 606/48, 606/28, 606/31, 606/38, 606/42, 607/101
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure

Abstract

A system for facilitating the placement of a catheter within the human body, in a lumen or vessel such as the fallopian tubes, and controlling the catheter after placement. The system coordinates the operation of treatment electrodes on the catheter with informative displays and prompts to an operator, based on information derived from electrical parameters of position detection electrodes on the catheter.

Claims

1. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the position detection electrodes are arranged circumferentially about the catheter, in circuit with a return electrode also disposed on the catheter; and

the computer system is further programmed to create the display comprising a circular image divided into radial segments, the number radial segments corresponding to the number of position detection electrodes, and associate each radial segment with a position detection electrode, and provide visual indication within the radial segments corresponding to the impedance measured at the associated position detection electrode.

2. The system of claim 1 wherein:

the computer system is further programmed to determine that a position detection electrode is in a first degree of contact with the ovarian pathway, and alter the display accordingly, when the impedance measured at the electrode falls into a first predetermined range and the impedance measured at all electrodes falls within a second predetermined range.

3. The system of claim 2 wherein:

the computer system is further programmed to determine that the detection electrode is in a second degree of contact with the ovarian pathway, and alter the display accordingly to provide an additional visual indication, when the impedance measured at the electrode falls into a first predetermined range and the impedance measured at all electrodes falls within a third predetermined range.

4. The system of claim 3 wherein the first predetermined range is zero to 30 Kohm, the second predetermined range is about 17 Kohm, and the third range is about 4 Kohm.

5. The system of claim 3 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

6. The system of claim 2 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

7. The system of claim 1 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

12. The system of claim 7 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

8. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment seqment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the computer system is programmed to determine that a position detection electrode is in a first degree of contact with the ovarian pathway, and alter the display accordingly, when the impedance measured at the electrode falls into a first predetermined range and the impedance measured at all electrodes falls within a second predetermined range.

9. The system of claim 8 wherein:

the computer system is programmed to determine that the detection electrode is in a second degree of contact with the ovarian pathway, and alter the display accordingly to provide an additional visual indication, when the impedance measured at the electrode falls into a first predetermined range and the impedance measured at all electrodes falls within a third predetermined range.

10. The system of claim 9 wherein the first predetermined range is zero to 30 Kohm, the second predetermined range is about 17 Kohm, and the third range is about 4 Kohm.

11. The system of claim 9 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

13. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment seqment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the treatment segment comprises at least one wounding element and the control box includes treatment means for applying energy to the ovarian pathway through the wounding element, and input means for receiving input from an operator to initiate application of energy;

the computer system is operably connected to the treatment means, and the computer system is further programmed to determine, based on the measured impedance, when the catheter has achieved a predetermined degree of contact with the ovarian pathway, and control operability of the treatment means based on the degree of contact; and

the computer system is further programmed to alter the display to inform an operator when the computer system has determined that the predetermined degree of contact has been lost, provide a visual indication of loss of contact, and interrupt application of energy when the predetermined degree of contact has been lost.

14. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment seqment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the treatment segment comprises at least one wounding element, and the control box includes treatment means for applying energy to the ovarian pathway through the wounding element, and input means for receiving input from an operator to initiate application of energy;

the computer system is operably connected to the treatment means, and the computer system is further programmed to determine, based on the measured impedance, when the catheter has achieved a predetermined degree of contact with the ovarian pathway, and control operability of the treatment means based on the degree of contact; and

the computer system is further programmed operate the treatment means for a predetermined treatment period upon receipt of operator input to initiate application of energy.

15. The system of claim 14, wherein:

the computer system is further programmed to alter the display to inform an operator when the computer system has determined that the predetermined degree of contact has been lost, provide a visual indication of loss of contact, and interrupt application of energy when the predetermined degree of contact has been lost.

16. The system of claim 15, wherein:

the computer system is further programmed, upon determining loss of contact between the catheter and ovarian pathway, to prompt the operator to reposition the catheter and reinitiate application energy for an entire predetermined treatment period.

17. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment seqment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the impedance measuring circuit further comprises;

an oscillator operable to provide an RF or AC impedance detection signal to the position detection electrodes; and

a voltage divider and envelope detector circuit for creating an output impedance signal corresponding to the impedance measured at the position detection electrodes and supplying the impedance signal to the computer system.

18. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the impedance measuring circuit further comprises;

a constant current supply operable to supply a constant current to the position detection electrodes; and

an envelope detector circuit for creating an output impedance signal corresponding to the voltage measured at the position detection electrodes and supplying the impedance signal to the computer system.

19. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway, a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising a plurality of position detection electrodes disposed on the catheter in the proximity of the treatment segment, and arranged circumferentially about the catheter, such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control system and an indicator, said control system being designed to receive input from the impedance detection circuit corresponding to the impedance measured at the electrodes of the array and create an indication of the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the plurality of position detection electrodes are disposed on the catheter at a position proximal to the treatment segment, and the distance between the position detection electrodes and the treatment segment is chosen such that contact between the position detection electrodes and the ovarian pathway indicates that the treatment segment is positioned in a desired portion of the ovarian pathway;

wherein the treatment segment is about 1 to 2 mm in diameter and the distance between the position detection electrodes and the treatment segment is about 1.5 mm.

20. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system cormprising:

a catheter adapted for transcervical introduction into the ovarian pathway, a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising a plurality of position detection electrodes disposed on the catheter in the proximity of the treatment segment, and arranged circumferentially about the catheter, such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the plurality of position detection electrodes are disposed on the catheter at a position proximal to the treatment segment, and the distance between the position detection electrodes and the treatment segment is chosen such that contact between the position detection electrodes and the ovarian pathway indicates that the treatment segment is positioned in a desired portion of the ovarian pathway;

wherein the treatment segment is about 1 to 2 mm in diameter and the distance between the position detection electrodes and the treatment segment is about 1.5 mm.

21. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the position detection electrodes are arranged circumferentially about the catheter, in circuit with a return electrode also disposed on the catheter; and

the computer system is further programmed to create the display comprising an image divided into radial segments, the number radial segments corresponding to the number of position detection electrodes, and associate each radial segment with a position detection electrode, and provide visual indication within the radial segments corresponding to the impedance measured at the associated position detection electrode.

22. The system of claim 21 wherein:

the computer system is further programmed to determine that a position detection electrode is in a first degree of contact with the ovarian pathway, and alter the display accordingly, when the impedance measured at the electrode falls into a first predetermined range and the impedance measured at all electrodes falls within a second predetermined range.

23. The system of claim 22 wherein:

the computer system is further programmed to determine that the detection electrode is in a second degree of contact with the ovarian pathway, and alter the display accordingly to provide an additional visual indication, when the impedance measured at the electrode falls into a first predetermined range and the impedance measured at all electrodes falls within a third predetermined range.

24. The system of claim 23 wherein the first predetermined range is zero to 30 Kohm, the second predetermined range is about 17 Kohm, and the third range is about 4 Kohm.

25. The system of claim 23 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

26. The system of claim 22 wherein:

the position detection electrodes comprise four electrodes disposed circuinferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

27. The system of claim 21 wherein:

the position detection electrodes comprise four electrodes disposed circumferentially around the distal end of the catheter, proximal to the treatment segment; and

the computer system is programmed to create a display comprising a circle divided into four radial segments, and is further programmed to alter the appearance of the four radial segments based on the impedance measured at the four electrodes.

28. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the computer system is programmed to determine that a position detection electrode is in a first degree of contact with the ovarian pathway, and alter the display accordingly, when the impedance measured at the electrode is between zero and 30 Kohm and the impedance values of all electrodes in the array are within 17 Kohm of each other.

29. The system of claim 28 wherein:

the computer system is programmed to determine that the detection electrode is in a second degree of contact with the ovarian pathway, and alter the display accordingly to provide an additional visual indication, when the impedance measured at the electrode is between zero and 30 Kohm and the impedance values of all electrodes in the array are within 4 Kohm of each other.

30. A system for treating the ovarian pathway of a female patient, through transcervical placement of a catheter into the ovarian pathway of the patient, said system comprising:

a catheter adapted for transcervical introduction into the ovarian pathway;

a treatment segment disposed on the distal tip of the catheter;

an impedance detection circuit comprising an array of position detection electrodes disposed on the catheter in the proximity of the treatment segment such that the position electrodes will contact the ovarian pathway upon insertion of the catheter into the ovarian pathway, and an impedance measuring circuit operably connected to the electrodes of the array, said impedance measuring circuit being operable to provide an output corresponding to the impedance of the impedance detection circuit measured at the position detection electrodes;

a control box comprising a computer system and a display screen, said computer system being programmed to receive input from the impedance detection circuit corresponding the impedance measured at the electrodes of the array and create a display indicating the degree of contact between the electrodes and the ovarian pathway based on the measured impedance;

wherein the position detection electrodes are arranged circumferentially about the catheter, in circuit with a return electrode also disposed on the catheter;

the computer system is further programmed to create the display comprising an image divided into radial segments, the number radial segments corresponding to the number of position detection electrodes, and associate each radial segment with a position detection electrode, and provide visual indication within the radial segments corresponding to the impedance measured at the associated position detection electrode; and

the computer system is further programmed to determine that a position detection electrode is in a first degree of contact with the ovarian pathway, and alter the display accordingly, when the impedance measured at the electrode is between zero and 30 Kohm and the impedance values of all electrodes in the array are within 17 Kohm of each other.

31. The system of claim 30 wherein:

the computer system is further programmed to determine that the detection electrode is in a second degree of contact with the ovarian pathway, and alter the display accordingly to provide an additional visual indication, when the impedance measured at the electrode is between zero and 30 Kohm and the impedance values of all electrodes in the array are within 4 Kohm of each other.