Systems for treating a hollow anatomical structure

• US 7,963,961 B2
• Filed: 10/25/2010
• Issued: 06/21/2011
• Est. Priority Date: 07/21/2005
• Status: Active Grant

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Inventors: Thompson, Russell Blake, Esch, Brady David, Dhaka, Vijay Kumar, Sander, Fiona Maria
• Primary Examiner(s): Dvorak; Linda C
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US12/911,633
• Publication Number:
  US 20110034922A1
• Time in Patent Office: 239 Days
• Field of Search: 606 27- 50, 128/898
• US Class Current: 606/32
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• 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 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers

Abstract

A working end of a catheter includes at least one therapeutic element, such as a resistive heating element, usable to deliver energy for ligating, or reducing the diameter of, a hollow anatomical structure. In certain examples, the catheter includes a lumen to accommodate a guide wire or to allow fluid delivery. In certain embodiments, a balloon is inflated to place resistive element(s) into apposition with a hollow anatomical structure and to occlude the structure. Indexing devices and methods are also disclosed for successively treating portions of the hollow anatomical structure. In certain examples, marks along the catheter shaft provide visual verification to the physician of the relative position of the therapeutic element of the catheter. Embodiments of indexing devices may include pairs of rings and/or hinged arms that move a catheter a desired indexed position between successive treatments.

Claims

1. An apparatus for use in treating a hollow anatomical structure (HAS), the apparatus comprising:

an elongate member having a distal section and a proximal section, the elongate member being sized for insertion into a HAS;

a heating element located on the elongate member and having a first length;

wherein the heating element has a distal section and a proximal section and is configured to apply energy along a length of the HAS in consecutive treatment segments of the HAS;

a plurality of index markings marked on the elongate member;

wherein the index markings are configured to be movably indexed in a distal to proximal direction via movement of the elongate member in the distal to proximal direction to sequentially position the heating element axially along the length of the HAS;

at least one final marking distinct from the index markings and marked on the elongate member that indicates a final distance from said final marking to the proximal section of the heating element; and

a warning section marked on the elongate member, the warning section comprising a distinct marking different from the plurality of index markings and the at least one final marking;

wherein consecutive index markings are spaced apart by a second length, the second length being less than the first length to ensure overlap of consecutive treated segments of the HAS when the heating element is moved in the distal to proximal direction along the HAS.

2. The apparatus of claim 1, wherein the warning section is located on the elongate member proximal of the at least one final marking.

3. The apparatus of claim 1, wherein the warning section is between the plurality of index markings and the at least one final marking.

4. The apparatus of claim 3, wherein the warning section extends along the elongate member from one index marking to one final marking to form a prominent and highly visible section of the catheter.

5. An apparatus for treating a hollow anatomical structure (HAS), the apparatus comprising:

an elongate member having a distal section and a proximal section;

a heating element on the elongate member and having a distal section and a proximal section;

wherein the heating element has a first length;

a plurality of index markings marked on the elongate member;

wherein consecutive index markings are spaced apart by a second length, the second length being less than the first length to allow for overlap of consecutive treated segments of the HAS;

at least one final marking marked on the elongate member that is distinct from the index markings and spaced proximally from the proximal section of the heating element to indicate a final treatment position of the heating element; and

a warning section marked on the elongate member, wherein the warning section comprises a distinct marking different from the plurality of index markings and the at least one final marking.

6. The apparatus of claim 5, wherein the warning section is located on the elongate member proximal of the at least one final marking.

7. The apparatus of claim 5, wherein the warning section is between the plurality of index markings and the at least one final marking.

8. The apparatus of claim 5, wherein the at least one final marking is configured for use with an introducer sheath such that the final marking indicates a final treatment position of the heating element relative to the sheath, the final marking configured to become visible outside the introducer sheath during pull-back of the elongate member, the final marking configured to indicate that further heating of the heating element after the final marking is visible may cause the heating element to heat while it is at least partly within the introducer sheath.

9. The apparatus of claim 5, wherein the at least one final marking comprises first and second final markings, the first final marking configured to specify a longer introducer sheath for use with the elongate member and the second final marking configured to specify a shorter introducer sheath for use with the elongate member, each of the first and second final markings allowing the heating element to avoid heating inside the respective specified introducer sheath.

10. The apparatus of claim 9, wherein the first final marking is configured to specify the longer introducer sheath by indicating the length of the longer introducer sheath and the second final marking is configured to specify the shorter introducer sheath by indicating the length of the shorter introducer sheath.

11. The apparatus of claim 10 wherein each respective final marking indicates the length of the longer and shorter introducer sheaths numerically.

12. The apparatus of claim 9, wherein:

the first final marking is marked on the catheter at a distance from the distal-most end of the elongate member, the distance comprising at least the length of the heating element plus the length of the longer introducer sheath; and

the second final marking is marked on the catheter at a distance from the distal-most end of the elongate member, the distance comprising at least the length of the heating element plus the length of the shorter introducer sheath.

13. The apparatus of claim 5, wherein the index markings, the final marking, and the warning section have visually distinct appearances.

14. The apparatus of claim 5, wherein the heating element comprises an electrically driven heating element, a resistive element, an electrode, a laser, a fluid-conducting heat exchanger, or a chemical reaction chamber.

15. An apparatus for treating a hollow anatomical structure (HAS), the apparatus comprising:

an elongate member having a distal section and a proximal section;

a heating element located on the elongate member and having a distal section, a proximal section, and a first length;

a plurality of index markings marked on the elongate member, consecutive index markings being spaced apart by a second length that is less than or approximately equal to the first length;

at least one final marking distinct from the index markings and marked on the elongate member to indicate a final distance from said final marking to the proximal section of the heating element; and

a warning section marked on the elongate member, the warning section comprising a distinct marking different from the plurality of index markings and the at least one final marking.

16. The apparatus of claim 15, further comprising:

an introducer sheath having a distal sheath tip configured for insertion into the HAS, a proximal sheath opening, and a sheath length;

the elongate member configured for insertion into the HAS through the introducer sheath; and

the plurality of index markings configured to become visible sequentially outside the introducer sheath as the elongate member is pulled back between sequential heat treatments to the HAS.

17. The system of claim 16, wherein the at least one final marking is configured to become visible outside the introducer sheath after the plurality of index markings have already become visible and to indicate that heating after further pullback will occur with the heating element near or partly inside the introducer sheath.

18. The apparatus of claim 15, wherein the warning section is located on the elongate member proximal of the at least one final marking.

19. The apparatus of claim 15, wherein the warning section is between the plurality of index markings and the at least one final marking.

20. The apparatus of claim 15, further configured to provide simplified, procedure-specific guidance during a medical procedure, wherein the plurality of index markings are preconfigured to correspond to effective treatment lengths, allowing the user to refer only to the markings on the elongate member to perform an effective procedure.