Marking system and method for medical devices

• US 6,605,049 B1
• Filed: 12/21/2000
• Issued: 08/12/2003
• Est. Priority Date: 12/21/2000
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Wagner, Arno, Cornish, Wayne E., Richardson, Mark T.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/748,305
• Time in Patent Office: 964 Days
• Field of Search: 600/585, 600/433-435, 600/459, 600/562-568, 600/576, 600/581, 600/101, 600/114, 128/897, 604/19, 604/93.01, 604/96.01, 604/164.01, 604/164.11, 604/164.18, 606/1, 606/106, 606/108, 606/119, 606/129, 606/139, 606/160, 606/167, 606/170, 606/184, 606/185, 606/186, 606/205, 606/222, 814/88, 811/771, 81D/IG.5
• US Class Current: 600/585
• CPC Class Codes: A61B 90/92 coded with colour
• 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 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

The invention is directed to a system and method of encoded markings on the body of medical devices such as guide-wires having limited surface for markings. The markings include indicators of characteristics, such as the design family, the size, and other pertinent specifications. The marking system of the invention comprise an spatially ordered series of marks on the surface of the device, with each mark corresponding to an information or data category. Each mark is coded with a value of the code property which is correlated with and expresses a particular data element within the data category and pertinent to the marked device specimen. The code property value may then be inspected or “read” by the device user to evaluate the data element and obtain information regarding the marked device specimen.

Claims

1. A method of marking a specimen of a guide wire having limited surface area to express information about the specimen, comprising:

selecting a plurality of information categories representative of data pertinent to the guide wire;

providing a distinct marking element on the surface of the specimen at a proximal end only corresponding to each information category;

determining a code property for each marking element which is expressible in a plurality of distinct code property values;

determining, for each category, a plurality of data elements, each data element having a data value pertinent to the respective category;

assigning, for each category, a distinct code property value to each data element in the category;

selecting, for each category, one of the plurality of data elements of the respective category, which represents information regarding the specimen; and

for each marking element, expressing on the respective marking element the code property value assigned to the selected data element of the corresponding category.

2. The method of claim 1 wherein each marking element is disposed on the surface of the specimen in a spatial pattern.

3. The method of claim 2, wherein the step of providing a distinct marking element on the surface includes disposing the elements in a generally linear spatial order corresponding to the category sequence order.

4. The method of claim 3, further comprising the step of compiling and providing a reference aid including at least one of:

a) information regarding correlation between the marking element spatial order and the corresponding category sequence order; and

b) information regarding correlation between the assigned code property values and the corresponding data elements for each category.

5. The method of claim 3, wherein the step of providing a distinct marking element corresponding to each category includes that the spatial order of the marking elements is characterized by disposing the marking elements in a generally linear array on the surface.

6. The method of claim 3, wherein the code properties include visibly distinct colors.

7. The method of claim 6, wherein the specimen includes a generally round elongated proximal segment having a longitudinal axis and marking elements comprising a plurality of bands are disposed longitudinally on the surface.

8. The method of claim 7, wherein marking elements are disposed on the proximal segment of the guide wire specimen.

9. The method of claim 8, wherein the step of selecting a plurality of categories of data includes selecting at least a category representative of guide wire distal segment diameter.

10. The method of claim 8, wherein the step of selecting a plurality of categories of data includes selecting at least two categories representative of different digital values of a multi-digit expression of a guide wire property.

11. The method of claim 1, wherein the step of selecting one of the plurality of data elements for each category includes determining the one of the plurality of data elements which is most representative of the specimen.

12. A marked device specimen of a class of guide wires, the specimen being marked to express information about the specimen, the specimen having a body surface, the specimen comprising:

a) a plurality of distinct marks disposed on the body surface of the guide wire in a particular sequence, with each of the marks representative of one of a plurality of selected data categories pertinent to the device class, wherein the distinct marks are disposed only at the proximal end of the guide wire; and

b) each of the marks displaying a selected code property value, which is assigned to represent a data element value pertinent to the specimen.

13. The marked device specimen of claim 12, wherein the particular sequence of the marks is characterized by a generally linear array on the body surface.

14. The marked device specimen of claim 12, wherein the selected code property value includes a visibly distinct color.

15. The marked device specimen of claim 14, wherein:

a) the body includes a generally rounded elongate proximal segment having a longitudinal axis; and

a) the marks comprise a plurality of bands disposed on the rounded elongate proximal segment and extending substantially around the circumference of the rounded elongate proximal segment.

16. The marked device specimen of claim 15, wherein the marking bands are spaced apart along the longitudinal axis of the rounded elongate proximal segment.

17. The marked device specimen of claim 15, wherein at least one of the marks is representative of a category of guide wire design type.

18. The marked device specimen of claim 15, wherein at least one of marks is representative of a category of guide wire distal segment diameter.

19. The marked device specimen of claim 15, wherein at least two of the plurality of marks are representative of different digital values of a multi-digit expression of a guide wire property.