System of indicia for a medical device

• US 6,613,002 B1
• Filed: 06/05/2000
• Issued: 09/02/2003
• Est. Priority Date: 06/05/1999
• Status: Expired due to Term

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Hawkins, Melvin Kem, Clark, Tamisha A., Karpiel, John A.
• Primary Examiner(s): Mulcahy, John
• Application Number:
  US09/587,301
• Time in Patent Office: 1,184 Days
• Field of Search: 604/117, 604/528, 604/164.13, 600/104, 600/106, 600/107, 600/117, 600/587, 600/593
• US Class Current: 600/593
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The present invention involves a elongated member, such as a wire guide, that is used with in a endoscopic procedure. In one aspect of the invention, the elongate member includes a first system of indicia comprising a scale reference markings that can include numeric indicia, sequentially increasing markers, etc., located at regular increments (e.g., 1 cm) on the distal portion of the elongate member, that permit measurement of structures within a body passage. In one example, an exchange wire guide having a radiopaque marker on the distal portion is positioned under fluoroscopy at a first location, such as the distal point of a stricture, and the scale reference marking on the wire guide that visible in the viewing region of the endoscope is read. The wire guide is partially withdrawn such that the marker corresponds to a second position (e.g., the proximal point of the stricture) and the new scale reference marking is read. The difference is calculated to determine the length of the structure. In a second aspect of the invention, a second system of indicia are included to aid the endoscopist in maintaining the device in position. These indicia, which may include oblique markings, helical striping, or some other closely spaced markings or pattern, help in the detection of longitudinal movement of the device.

Claims

1. A medical device for measuring an anatomical structure comprising a first reference and a second reference within a body passage during a medical procedure which uses an endoscope, comprising:

an elongate member comprising a wire guide that includes a distal tip, a distal portion, and an indicia pattern, wherein the indicia pattern, which is at least partially located on the distal portion, includes a first system of indicia and a second system of indicia;

wherein the first system of indicia is located at least partially on the distal portion and includes a series of uniquely identifiable scale reference markings comprising at least two different types of markings, the wire guide so configured to be positionable within the endoscope such that when the distal portion is at least partially extended distally from the endoscope during the medical procedure, at least a portion of the first system of indicia is viewable to the operator with the endoscope while the distal portion of the wire guide as viewed with the endoscope is positioned relative to the first reference of the anatomical structure to obtain a first measurement, and at least a portion of the first system of indicia is viewable to the operator with the endoscope while the distal portion of the wire guide as viewed with the endoscope is positioned relative to the second reference of the anatomical structure, such that the anatomical structure within the body passage can be measured by comparing the first measurement to the second measurement;

wherein the second system of indicia includes a pattern of closely spaced markings so configured to readily indicate motion of the wire guide and spaced such that at least a portion thereof will fall within a viewable region located adjacent to an unsheathed portion of the wire guide during the medical procedure, the pattern of closely spaced markings located at least partially between selected ones of the scale reference markings.

2. The device of claim 1 wherein the wire guide includes a fixed reference point located therealong, wherein the first system of indicia includes a series of scale reference markings, each of the scale reference markings uniquely corresponding to a particular distance to the fixed reference point.

3. The device of claim 2 wherein the scale reference markings comprise a sequentially increasing marker series at selected intervals distributed therealong the proximal portion of the wire guide.

4. The device of claim 2 wherein the scale reference markings include a progressively increasing series of markings, each member of the series corresponding to a particular distance to the fixed reference point with each of the members being located at 5 cm increments with respect to any adjacent members of the series.

5. The device of claim 2 wherein the scale reference markings include numerical values identifying the particular distance to the fixed reference point.

6. The device of claim 5 wherein the first system of indicia further includes a plurality of intermediate markings located therebetween selected adjacent scale reference markings.

7. The device of claim 1 wherein the distal portion includes at least one radiopaque marker.

8. The device of claim 7 wherein one of the at least one radiopaque marker includes the distal tip.

9. The device of claim 1 wherein the second system of indicia includes a pluarlity of oblique markings.

10. The device of claim 1 wherein the second system of indicia comprises a series of discrete diagonal lines that at least partially circumscribe the wire guide.

11. The device of claim 10 wherein the second system of indicia comprises at least on helical stripe extending along at least a portion of the wire guide.

12. The device of claim 10 wherein the wire guide further includes an outerlayer, the outer layer including alternating first and second helical striping incorporated thereinto.

13. A medical device for measuring an anatomical structure comprising a first reference and a second reference within a body passage during a medical procedure which uses an endoscope, comprising:

a wire guide that includes a distal tip, a distal portion having at least one radiopaque marker, a proximal portion and a fixed reference point,

wherein the proximal portion includes at least a first system of indicia that includes a plurality of uniquely identifiable scale reference markings comprising at least two different types of markings which are at least partially viewable while the distal portion of the wire guide as viewed with the endoscope is positioned relative to the first reference of the anatomical structure to obtain a first measurement, and the plurality of uniquely identifiable scale reference markings on the proximal portion are at least partially viewable while the distal portion of the wire guide as viewed with the endoscope is positioned relative to the second reference of the anatomical structure to obtain a second measurement, to thereby measure the anatomical structure within the body passage by comparing the first measurement with the second measurement,

wherein the first system of indicia comprises both the uniquely identifiable scale reference markings and a plurality of intermediate markings located between selected ones of the uniquely identifiable scale reference markings,

the wire guide further including a second system of indicia comprising a pattern of markings that permit continuous monitoring of movement of the device by the operator thereof.

14. The device of claim 13 wherein the indicia sufficiently circumscribe the distal portion to assuredly be at least partially viewable within the viewing region at any angular position of the elongate member.

15. The device of claim 13 wherein the scale reference markings comprise a sequentially increasing marker series.

16. The device of claim 15 wherein the sequentially increasing marker series comprises differently numbered bands at least partially circumscribing the wire guide.

17. The device of claim 13 wherein the scale reference markings are located at 5 cm increments relative to the fixed reference point, and the intermediate markings are located at 1 cm increments relative to the fixed reference point.

18. A medical device for measuring an anatomical structure comprising a first reference and a second reference within a body passage, comprising:

a wire guide comprising a distal portion;

a plurality of uniquely identifiable scale reference markings comprising at least two different types of markings distributed along at least a portion of the distal portion, at least a portion of the uniquely identifiable scale reference markings comprising numeric indicia, at least a portion of the uniquely identifiable scale reference markings distributed along the distal portion of the wire guide is viewable to an operator with an endoscope while the distal portion of the wire guide as viewed with the endoscope is positioned relative to the first reference of the anatomical structure to obtain a first measurement, and at least a portion of the uniquely identifiable scale reference markings distributed along the distal portion of the wire guide is viewable to the operator with the endoscope while distal portion of the wire guide as viewed with the endoscope is positioned relative to the second reference of the anatomical structure such that the anatomical structure within the body passage can be measured by comparing the first measurement to the second measurement, and a pattern of markings that permit continuous monitoring of movement of the device by the operator thereof.

19. The device of claim 18 wherein the wire guide comprises a solid core wire with a polymeric outer coating, the numeric indicia imprinted on the outer coating.

20. The device of claim 18 wherein the at least a portion of adjacent ones of the numeric indicia are located at 1 cm intervals with respect to one other.

21. The device of claim 20 wherein the scale reference markings further include a series of a sequentially increasing numbered bands between selected ones of the numeric indicia.

22. The device of claim 18 wherein the distal portion further includes a radiopaque marker.

23. A medical device for measuring an anatomical structure having a first reference and a second reference within a body passage during a medical procedure which uses an endoscope, comprising:

a wire guide comprising a solid inner core and an outer coating, the wire guide including a distal tip, a distal portion that includes at least one radiopaque marker, a proximal portion, and an indicia pattern;

wherein the indicia pattern, which is at least partially located on the proximal portion, includes a first system of indicia that includes a plurality of uniquely identifiable scale reference markings comprising at least two different types of markings and a fixed reference point, the plurality of uniquely identifiable scale reference markings comprising a sequentially increasing marker series located at 5 cm intervals from the fixed reference point, the first system of indicia further including numeric indicia located at 1 cm increments between selected ones of the sequentially increasing marker series;

wherein at least a portion of the first system of indicia is viewable to an operator of the medical device as the wire guide proximal of the distal portion is situated in the endoscope during the medical procedure, when the distal portion of the wire guide extends at least partially beyond the distal end of the endoscope;

wherein at least a portion of the first system of indicia is viewable to an operator of the medical device while the distal portion as viewed with the endoscope is positioned relative to the first reference of the anatomical structure to obtain a first measurement, and at least a portion of the first system of indicia is viewable to an operator of the medical device while the distal portion as viewed with the endoscope is positioned relative to the second reference of the anatomical structure to obtain a second measurement, such that the anatomical structure within the body passage can be measured by comparing the first measurement and the second measurement; and

the indicia pattern further includes a second system of indicia comprising a pattern of markings that permits continuous monitoring of movement of the device by the operator thereof, the pattern of markings extending along at least a portion of the wire guide, including at least a series of discrete diagonal lines that at least partially circumscribe the wire guide, the pattern of markings further including at least one helical stripe.