Claims
- 1. A portable force resistance meter for determining a catheter resistance value comprising:
an aperture for receiving a catheter distal end; a deflection lever for moving said catheter distal end a quantifiable distance; a load cell linked to said deflection lever for determining a beam stiffness value for said catheter distal end; a microprocessor for converting said beam stiffness value into a force resistance value using the quantifiable distance and the length of the catheter distal end; and a display unit.
- 2. A method of determining the outward radial force of a helical guide section comprising the steps of:
(a) securing a helical guide section in a force measuring device; (b) fixing each end of the helical guide section in said force measuring device; (c) pulling the ends of the helical guide section apart; (d) measuring the force required to pull the helical guide section apart while tracking the linear displacement of the helical guide section during the pull; (e) measuring the corresponding radial displacement of the guide section while the guide section is being pulled; and (f) determining the radial force of the guide section from the measured axial force, the measured linear displacement and the measured radial displacement.
- 3. A method of determining the outward radial force of a catheter over a helical guide section comprising the steps of:
(a) measuring the beam stiffness of a catheter; (b) measuring the beam stiffness of a helical guide section; (c) measuring the axial force required to elongated a helical guide section to one half the helical guide section unconstrained diameter; and (d) determining Peff.
- 4. The method of claim 2, wherein said force measuring device is a portable hand held device.
- 5. A method of matching a catheter to a guidewire for a medical procedure requiring precision radial positioning comprising the steps of:
(a) determining a lumen diameter of a body lumen to be treated; (b) selecting a catheter to be used in said body lumen; (c) choosing the effective length of said catheter; (d) measuring a catheter resistance value of said catheter over said effective length; and (e) matching a guidewire having a compressible guide section to said catheter resistance value to ensure said guidewire has sufficient outward radial force when compressed to deflect said catheter into said lumen wall.
- 6. The method of claim 5, wherein step (d) further comprises measuring the beam stiffness in a portable force measuring device and converting the beam stiffness of said catheter into said catheter resistance value.
- 7. An apparatus for shape setting a wire with a curved three dimensional guide section, said apparatus comprising:
a mandrel having a temperature stable core, at least one screw thread having spaced apart roots capable of mechanically receiving a wire; and at least one retaining device for securing said wire within said spaced apart roots and preventing said wire from slipping or shifting.
- 8. The apparatus of claim 7, wherein said mandrel has a minor diameter between 0.5 and 20 mm.
- 9. The apparatus of claim 7, wherein said mandrel has a non-uniform minor diameter.
- 10. The apparatus of claim 7, wherein said mandrel has a uniform linear geometry.
- 11. The apparatus of claim 7, wherein said mandrel has a non-uniform linear geometry.
- 12. The apparatus of claim 7, wherein the mandrel has a plurality of cross section geometries.
- 13. The apparatus of claim 7, wherein said cross sectional geometries are any combination of regular and irregular shapes.
- 14. The apparatus of claim 7, wherein the distance between said roots is between 0.026 mm and 12.7 mm.
- 15. The apparatus of claim 7, wherein the distance between said roots is preferably between 1 mm and 6 mm.
- 16. The apparatus of claim 7, wherein said mandrel is hollow.
- 17. The apparatus of claim 7, wherein said mandrel is made of brass.
- 18. The apparatus of claim 7, wherein said mandrel is made of any form of steel.
- 19. The apparatus of claim 7, wherein said mandrel is made of a ceramic material.
- 20. The apparatus of claim 7, wherein the retaining device is a clip.
- 21. The apparatus of claim 7, wherein the retaining device is a tube slidably fit over said mandrel.
- 22. A system for shape setting a guidewire comprising:
a rotatable chuck; a mandrel having at least one screw thread engraved along at least a portion of said mandrel axial length; at least one spring tension arm for providing tension to a core wire as said core wire is wrapped around a mandrel; and a heating element for heating said core wire to a shape setting temperature.
- 23. The system of claim 22, wherein said rotatable chuck is mounted on a lathe.
- 24. The system of claim 22, further comprising an automated operation of the core wire winding and heating process through a series of stepper motors .
- 25. The system of claim 22, wherein said spring tension arm is a restraining means for securing said core wire about said mandrel.
- 26. The system of claim 24, wherein the automated operation is handled by a computer.
- 27. A method of manufacturing a guidewire with a curved three dimensional guide section comprising the steps of:
(a) wrapping a core wire around a mandrel; (b) securing the core wire about the mandrel; (c) heating the mandrel assembly to a temperature between 300 degrees C. and 800 degrees C.; (d) stopping the heating; (e) cooling the mandrel assembly to room temperature; and (f) unwrapping the core wire from the mandrel.
- 28. The method of manufacturing a guidewire as in claim 27, further comprising the steps of:
(g) coating the core wire with a biocompatible material; (h) attaching a filament wire to the core wire; and (i) providing an atraumatic tip at the distal end.
- 29. The method of claim 27, wherein step (a) comprises a core wire composed at least partially of a shape memory material.
- 30. The method of claim 27, wherein step (a) comprises a core wire composed at least partially of a shape memory alloy.
- 31. The method of claim 27, wherein step (a) comprises a core wire composed of nickel-titanium.
- 32. The method of claim 27, wherein step (a) comprises a core wire composed of stainless steel with a shape memory material laminate coating.
- 33. The method of claim 27, wherein step (a) comprises a core wire composed of a stainless steel and shape memory sandwich.
- 34. The method of claim 27, wherein step (a) comprises a core wire composed of at least one wire within a shape memory material matrix, said shape memory matrix being formed in particular to operate as a guidewire.
- 35. The method of claim 27, wherein step (a) further comprises a core wire having a diameter between 0.0005″ and 0.020″.
- 36. The method of claim 27, wherein the mandrel further comprises a fixed channel for providing a predetermined shape setting.
- 37. The method of claim 36, further comprising a mandrel minor diameter between 0.5 mm and 20 mm.
- 38. The method of claim 37, wherein the mandrel preferably comprises a mandrel diameter of 1 to 6 mm.
- 39. The method of claim 27, wherein step (a) further comprises ensuring the core wire is wound such that there is no slack in the wire coils.
- 40. The method of claim 27, wherein step (b) further comprises a means for securing the wire about the mandrel to assure the core wire does not unravel or slip.
- 41. The method of claim 27, wherein step (c) further comprises heating the mandrel assembly to a temperature between 450 and 550 degrees C.
- 42. The method of claim 41, wherein the mandrel assembly remains at temperature from 1 to 10 minutes.
- 43. The method of claim 27, wherein step (e) further comprises quenching the mandrel assembly.
- 44. The method of claim 28, wherein step (g) is omitted.
- 45. The method of claim 28, wherein step (h) is omitted.
- 46. The method of claim 28, wherein step (i) is omitted.
- 47. The method of claim 28, wherein step (g) further comprises coating the core wire with a laminate material for reducing the guidewire coefficient of friction.
- 48. The method of claim 28, wherein step (i) further comprises attaching an atraumatic element to said core wire.
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a division from U.S. patent application Ser. No. 09/417,228 (Attorney Docket No. 017903-000580) filed Oct. 13, 1999, which is a continuation-in-part of application Ser. No. 09/289,850 (Attorney Docket No. 017903-000560) filed Apr. 12, 1999, which claimed the benefit of provisional application no. 60/081,631; (Attorney Docket No. 17903-000520), and No. 60/081,614 (Attorney Docket No. 017903-000510) both filed Apr. 13, 1998, and No. 60/103,447 (Attorney Docket No. 017903-000530) filed Oct. 7, 1998; a continuation-in-part of application Ser. No. 08/966,001 (Attorney Docket No. 017903-000500) filed Nov. 7, 1997; of application Ser. No. 09/290,510 (Attorney Docket No. 017903-000550) filed on Apr. 12, 1999, which claimed the benefit of provisional application Nos. 60/081,631; 60/081,614; and 60/103,447; and a continuation-in-part of application Ser. No. 09/389,772 (Attorney Docket No. 017903-001010) filed on Sep. 3, 1999; of which claimed the benefit of provisional application No. 60/099,079 (Attorney Docket No. 017903-001000) filed on Sep. 4, 1998. The full disclosures of each of these prior regular and provisional applications are incorporated herein by reference.
Provisional Applications (7)
|
Number |
Date |
Country |
|
60081631 |
Apr 1998 |
US |
|
60081614 |
Apr 1998 |
US |
|
60103447 |
Oct 1998 |
US |
|
60081631 |
Apr 1998 |
US |
|
60081614 |
Apr 1998 |
US |
|
60103447 |
Oct 1998 |
US |
|
60099079 |
Sep 1998 |
US |
Divisions (1)
|
Number |
Date |
Country |
Parent |
09417228 |
Oct 1999 |
US |
Child |
10057708 |
Jan 2002 |
US |
Continuation in Parts (4)
|
Number |
Date |
Country |
Parent |
09289850 |
Apr 1999 |
US |
Child |
09417228 |
Oct 1999 |
US |
Parent |
08966001 |
Nov 1997 |
US |
Child |
09417228 |
Oct 1999 |
US |
Parent |
09290510 |
Apr 1999 |
US |
Child |
09417228 |
Oct 1999 |
US |
Parent |
09389772 |
Sep 1999 |
US |
Child |
09417228 |
Oct 1999 |
US |