Systems for treating a hollow anatomical structure

• US 8,043,285 B2
• Filed: 11/19/2010
• Issued: 10/25/2011
• 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
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US12/950,697
• Publication Number:
  US 20110054456A1
• Time in Patent Office: 340 Days
• Field of Search: 606 27- 50, 128/898, 604117-118
• 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 and configured for insertion into a HAS through either one of at least two introducer sheaths, a shorter introducer sheath having a shorter sheath length and a longer introducer sheath having a longer sheath length;

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

wherein the heating element has a distal end and a proximal end 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 by moving the elongate member in the distal to proximal direction to sequentially position the heating element axially along the length of the HAS;

wherein consecutive index markings are spaced apart by an index length, the index length being less than the heating length and configured to provide overlap of consecutive treated segments of the HAS when the heating element is moved in the distal to proximal direction along the HAS; and

at least two final markings marked on the elongate member such that no markings similar to the final or index markings are located between the distal-most final marking and the heating element, each of the at least two final markings being marked so as to be visually distinct and different from the plurality of index markings, each of said final markings being spaced proximally from the proximal end of the heating length by at least the shorter sheath length;

wherein a first final marking of the at least two final markings indicates a first distance from said first final marking to the proximal end of the heating element, the first distance comprising the longer sheath length and a first safety zone distance on the elongate member; and

wherein a second final marking of the at least two final markings indicates a second distance from said second final marking to the proximal end of the heating element, the second distance comprising the shorter sheath length and a second safety zone distance on the elongate member.

2. The apparatus of claim 1, wherein each of the at least two final markings includes an alphanumeric marking that indicates the sheath length of introducer sheath to be used with the final marking.

3. The apparatus of claim 1, wherein the plurality of index markings comprises a most distal index marking and the at least two final markings comprises a most proximal final marking wherein the most distal index marking and the most proximal final marking are spaced apart by the index length.

4. The apparatus of claim 1, wherein the at least two final markings are spaced apart by a distance less than either of the heating or index lengths.

5. The apparatus of claim 1, wherein each final marking distinguishes the length of one of the two introducer sheaths and further indicates a final treatment position of the heating element within the HAS.

6. The apparatus of claim 1, wherein each final marking specifies one of the two introducer sheaths by numerically indicating one of the two introducer sheaths.

7. The apparatus of claim 1, wherein the index markings comprise a sequential series of markings.

8. The apparatus of claim 1, wherein the first safety zone and the second safety zone each have the same length.

9. The apparatus of claim 1, wherein the first safety zone and the second safety zone each have a different length.

10. A catheter for use in treating a hollow anatomical structure (HAS), the catheter comprising:

an elongate shaft having a distal section and a proximal section, the elongate shaft being sized for insertion into a HAS, the elongate shaft being configured to be introduced into the HAS through any one of a plurality of introducer sheaths, the plurality of introducer sheaths having different lengths;

a heating element located on the elongate shaft and having an element 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;

a series of tick marks marked on the elongate shaft;

wherein the series of tick marks are configured to be moved in a distal to proximal direction via movement of the elongate shaft in the distal to proximal direction to position the heating element axially along the length of the HAS;

wherein consecutive tick marks are spaced apart by a movement length; and

a plurality of final markings marked on the elongate member spaced apart from the proximal section of the element length and distinguishable and different from the series of tick marks, the plurality of final markings located between the series of tick marks and the heating element such that no markings similar to the final markings or series of tick marks are located between the distal-most final marking and the heating element, and none of tick marks in the series of tick marks being among the plurality of final markings;

wherein each of the plurality of final markings indicates an approximate sheath length of one of the plurality of introducer sheaths, the sheath length corresponding approximately to the distance from said final marking to the proximal end of the heating element.

11. The catheter of claim 10, wherein each final marking includes an associated alphanumeric marking that corresponds to the approximate sheath length of one of the plurality of introducer sheaths.

12. The catheter of claim 10, wherein the series of tick marks comprises a most distal tick mark and the plurality of final markings comprises a most proximal final marking wherein the most distal tick mark and the most proximal final marking are spaced apart by the movement length.

13. The catheter of claim 10, wherein the plurality of final markings are spaced apart by less than either of the element or movement lengths.

14. The catheter of claim 10, further configured as an apparatus to improve safety and efficacy of segmental vein ablation, the movement length being less than the element length such that each time the elongate shaft is withdrawn in the proximal direction by the movement length to position the heating element for the next energy application, the distal section of the heating element is configured to remain partly within the portion of the HAS that has previously been heated by the heating element, thereby avoiding any gaps in treatment along the length of the HAS.

15. The catheter of claim 10, wherein the plurality of introducer sheaths each have a length selected from a group consisting of 7, 11, or 15 centimeters and each of the plurality of final markings indicates one of those lengths.

16. A system comprising the catheter of claim 10 and at least one introducer sheath of the plurality of introducer sheaths.

17. An apparatus comprising:

an elongate member having a distal section and a proximal section, the elongate member being sized and configured to be introduced into the body through an introducer sheath;

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

a plurality of index markings marked on the elongate member for use in positioning the heating element within a hollow anatomical structure (HAS);

wherein consecutive index markings are spaced apart by an indexing length, the indexing length being less than the treating length and thereby configured to provide overlap; and

at least one final marking marked on the elongate member and spaced from the proximal section of the treating length such that no markings similar to the final or index markings are located between the distal-most final marking and the heating element, the final marking configured to indicate a final treatment position of the heating element within the HAS;

wherein the final marking is distinct and different from the plurality of index markings and comprises an indication of at least the length of the introducer sheath and a safety zone.

18. The apparatus of claim 17, wherein the final marking includes an associated alphanumeric marking that corresponds to the length of the introducer sheath.

19. The apparatus of claim 17, further comprising a plurality of final markings, wherein the plurality of index markings comprises a most distal index marking and the plurality of final markings comprises a most proximal final marking wherein the most distal index marking and the most proximal final marking are spaced apart by the indexing length.

20. The apparatus of claim 19, wherein each of the plurality of final markings is spaced apart a distance less than either of the treating or indexing lengths.

21. A system comprising the apparatus of claim 17 and the introducer sheath, the introducer sheath having a distal end for insertion and a proximal end with a reference, the sheath configured to allow the elongate member to be introduced into the interior of a vein, to allow adjustment of the elongate member to align one of the index markings with the reference, and to allow the elongate member to be pulled back out of the sheath by indexed increments as the vein is treated.

22. The system of claim 21, wherein when in the vein, the introducer sheath is further configured to obscure the final marking until the final treatment position of the heating element has been reached but thereafter allowing the final marking to be visible, thereby aiding a user in determining when to stop heating the heating element.