Fluoroscopically alignable cutter assembly and method of using the same

• US 5,209,749 A
• Filed: 01/22/1992
• Issued: 05/11/1993
• Est. Priority Date: 05/11/1990
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Urology, Inc.
• Inventors: Buelna, Terrence J.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/824,897
• Time in Patent Office: 475 Days
• Field of Search: 606/194, 606/159, 606/45, 606/167, 604/22, 128/656, 128/657, 128/658, 128/654
• US Class Current: 606/45
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00422 Angioplasty
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia

Abstract

A fluoroscopically alignable assembly is set forth. A longitudinally extending element support is extendable into a body cavity. The element, which may be in the nature of a cutting element, is supported by the element support. A radiopaque marker pattern is carried by the support. The pattern is such that by fluoroscopic viewing of the pattern, the user can determine the angular orientation of the element. In accordance with the method of the invention, the element can be aligned in a desired direction by fluoroscopically observing the marker pattern.

Claims

1. A method of aligning an assembly in a selected orientation with respect to tissue defining a body vessel, orifice, conduit, or other body cavity, comprising the steps of:

inserting a longitudinally extending support having a distal end portion, a proximal end portion and a longitudinal axis, into the body cavity, said support carrying an active element in such a manner that rotation of said support about said axis changes the orientation of said element relative to said body cavity, said support having a radiopaque marker pattern, said pattern being such that by fluoroscopic viewing of said pattern a user can determine the orientation of said element relative to said body cavity;

rotating the active element and the marker pattern circumferentially of the axis, the marker pattern exhibiting a different visual characteristic for each angular orientation of the active element relative to the tissue;

during the rotating step observing the different visual characteristics of the marker pattern, including a known visual characteristic associated with a preferred angular disposition of the active element relative to the tissue;

ceasing rotation of the support in response to observation of the known visual characteristic; and

activating said active element when the active element is in the preferred angular disposition.

2. A method as set forth in claim 1, wherein said element extends longitudinally along said support and wherein said marker pattern includes a radiopaque line running along said support generally parallel to said element.

3. A method as set forth in claim 2, wherein said marker pattern further includes at least one radiopaque indicator line on said support laterally removed from said radiopaque line.

4. A method as set forth in claim 2, wherein said marker pattern further includes a plurality of radiopaque indicator lines extending along said support, each laterally removed from said radiopaque line a different distance to allow selective angular alignment of said element within a body conduit.

5. A method as set forth in claim 4, wherein said element extends longitudinally along said support and the method further comprises the step of:

aligning said element longitudinally by observation of said marker pattern.

6. A method as set forth in claim 1, wherein said element is radiopaque.

7. A method recited in claim 1 wherein the rotating step includes the step of rotating the support.

8. A method recited in claim 1 wherein the active element is a cutter and the activating step includes the step of energizing the cutter to cut the tissue and enlarge the body cavity.

9. The method recited in claim 1 wherein the observing step includes the step of fluoroscopically viewing the visual characteristics of the rotating marker pattern.

10. A method of producing a controlled incision at a desired angular orientation with respect to tissue defining a vessel, orifice, conduit, or other body cavity, comprising:

inserting a longitudinally extending support having a distal end portion, a proximal end portion and a longitudinal axis, distal end portion first, into said body cavity, said support carrying a radiopaque marker pattern including a plurality of indicators each having a visual characteristic different than the other indicators and each alignable with respect to the cutting element to indicate a known orientation of the cutting element relative to the body cavity, the marker pattern facilitating visual orientation of said cutting element relative to the body cavity, the marker pattern facilitating visual orientation of said cutting element in a preferred angular disposition relative to said tissue;

rotating the support to move the cutting element circumferentially of the axis, and to bring a different one of the indicators into alignment with the cutting element thereby exhibiting a different visual characteristic for each angular disposition of the element relative to the tissue;

during the rotating step observing the different visual characteristics being exhibited by the marker pattern, including a known visual characteristic associated with a preferred angular disposition of the cutting element relative to the tissue;

ceasing rotation of the cutting element in response to observation of the known visual characteristic; and

activating said cutting element to cut the tissue when the cutting element is in the preferred angular disposition.

11. A method as set forth in claim 10, herein said element extends longitudinally along said support and wherein said marker pattern includes a radiopaque line running along said support generally parallel to said element.

12. A method as set forth in claim 11, wherein said marker pattern further includes at least one radiopaque indicator on said support laterally removed from said radiopaque line.

13. A method as set forth in claim 12, wherein said marker pattern further includes a plurality of radiopaque indicators on said support, each laterally removed from said radiopaque line a different distance to allow selective angular alignment of said element within the body cavity.

14. A method as set forth in claim 10, wherein said cutting element is radiopaque.

15. The method recited in claim 10 wherein the cutting element is an electrosurgical wire and the energizing step includes the step of introducing a radio frequency current to the wire to enlarge the body cavity.

16. A fluoroscopically alignable assembly adapted for insertion into an orifice, vessel, conduit, or other body cavity, comprising:

a support member having an axis extending between a proximal end and a distal end of the support member, at least the distal end being adapted for insertion into the body cavity;

a radiopaque cutting element carried by the support member and movable with the support member such that rotation of the support member about the axis moves the element into different angular orientations with respect to the body cavity, the cutting element having a predetermined width;

a plurality of indicia disposed on the support member and having a fixed relationship with the element, each of the indicia having a width which is not appreciably greater than the width of the cutting element and being individually fluoroscopically viewable as a different pattern associated with a known angular orientation of the cutting element, about the axis, relative to the body cavity; and

means disposed at the proximal end of the support member for rotating the support member to angularly displace the cutting element and the indicia relative to the body cavity.

17. The assembly recited in claim 16 wherein the body cavity is defined by body tissue and the element is adapted to perform a function relative to the tissue at a preferred location disposed generally radially of the axis.

18. The assembly recited in claim 17 wherein the indicia includes at least a pair of radiopaque symbols which form the different patterns in response to rotation of the support member.

19. The assembly recited in claim 18 wherein the cutting element comprises one of the radiopaque symbols.

20. The assembly recited in claim 18 wherein the radiopaque symbols are lines extending along the support member and the patterns differ in the spacing of the lines as the support member is rotated.

21. The assembly recited in claim 18 wherein the indicia include a plurality of lines forming patterns such that a different one of the lines is alignable with the cutting element to indicate the desired orientation of the cutting element relative to the body cavity.

22. The assembly recited in claim 21 wherein the lines extend longitudinally and each of the lines is substantially parallel to the axis of the support member.

23. The assembly recited in claim 16 wherein the cutting element comprises a wire responsive to an electrical signal to cut the tissue along a particular plane.

24. The assembly recited in claim 23 wherein the axis is disposed in the particular plane.

25. A fluoroscopically alignable assembly adapted for operative disposition in a vessel, orifice, conduit or other body cavity, comprising:

an elongate support having a longitudinal axis extending between a distal end portion and a proximal end portion of the support, the support being rotatable about the axis when disposed in the body cavity;

a radiopaque cutting element having a predetermined width, the cutting element being carried by the distal end portion of the support about the axis such that rotation of the support moves the cutting element through a multiplicity of locations within the body cavity, the locations including a particular location associated with a desired angular orientation of the cutting element within the body cavity;

a radiopaque marker pattern, having a fixed relationship with the cutting element, the pattern including a plurality of indicators, each having a predetermined width which is not appreciably greater than the width of the cutting element and having a radiopaque characteristic which is different than the radiopaque characteristic of the other indicators, each indicator having properties for being oriented relative to the cutting element to present a visual characteristic representative of an associated one of the locations;

means disposed at the proximal end portion of the support for rotating the support to achieve the particular visual orientation;

whereby

the cutting element is disposed at the particular location associated with the desired angular relationship between the cutting element and the body cavity.

26. The assembly recited in claim 25 wherein the body cavity is defined by tissue and the cutting element comprises a wire adapted to receive an electrical signal for cutting the tissue.

27. The assembly recited in claim 26 wherein the wire extends longitudinally of the support member in a plane which extends generally radially of the axis.

28. The assembly recited in claim 25 wherein the cutting element extends longitudinally of the support in spaced relationship to the axis of the support.

29. The assembly recited in claim 25 wherein the cutting element forms part of the marker pattern.

30. The assembly recited in claim 25 wherein the indicators are disposed in a different angular relationship and a different longitudinal relationship with the active element.

31. The assembly recited in claim 30 wherein the indicators are disposed circumferentially about of the elongate support.

32. The assembly recited in claim 30 wherein the indicators are disposed in a common plane with the axis of the support.