Steerable stylet
First Claim
1. A steerable stylet for use within a lumen of an intravascular device comprising:
- a stylet assembly having a distal end portion and a proximal end portion, said stylet assembly including;
a stylet wire having a lumen defined therein, said stylet wire having an outer diameter of less than 0.016 inches and a beam strength of at least 0.005 lbf as measured by the ASTM E855-90 3-point bend test; and
a core wire positioned within said lumen of said stylet wire and having a distal end portion of said core wire operably secured to said stylet wire proximate a distal end portion of said stylet wire; and
a handle proximate said proximal end portion of said stylet assembly, said handle including;
a hand-held housing structure operably connected to one of a proximal end portion of said stylet wire and a proximal end portion of said core wire;
an adjustable tensioner mechanism operably connected to the other of said proximal end portion of said stylet wire and said proximal end portion of said core wire to adjust a relative tension force applied between said stylet wire and said core wire; and
a tension limiter operably arranged to limit said tension force applied between said core wire and said stylet wire to a limit force that is less than a breaking stress force of said stylet wire when said stylet assembly is positioned within said lumen of said intravascular device.
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Accused Products
Abstract
A steerable stylet for use within a lumen of an intravascular device includes a stylet assembly and a handle. The stylet assembly has a distal end portion and a proximal end portion and includes a stylet wire having a lumen and a core wire positioned within the lumen with the distal end portion secured to the stylet wire proximate the distal end portion of the stylet wire. The handle includes a hand-held housing structure connected to one of the proximal end portion of the stylet wire or the core wire. In one embodiment, an adjustable tensioner is connected to the other of the proximal end portion of the stylet wire or the core wire to adjust a relative tension force applied between the stylet wire and the core wire. A tension limiter is arranged to limit the tension force to a limit force that is less than a breaking stress force of the stylet wire when the stylet wire is positioned within the lumen of the intravascular device.
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Citations
59 Claims
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1. A steerable stylet for use within a lumen of an intravascular device comprising:
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a stylet assembly having a distal end portion and a proximal end portion, said stylet assembly including;
a stylet wire having a lumen defined therein, said stylet wire having an outer diameter of less than 0.016 inches and a beam strength of at least 0.005 lbf as measured by the ASTM E855-90 3-point bend test; and
a core wire positioned within said lumen of said stylet wire and having a distal end portion of said core wire operably secured to said stylet wire proximate a distal end portion of said stylet wire; and
a handle proximate said proximal end portion of said stylet assembly, said handle including;
a hand-held housing structure operably connected to one of a proximal end portion of said stylet wire and a proximal end portion of said core wire;
an adjustable tensioner mechanism operably connected to the other of said proximal end portion of said stylet wire and said proximal end portion of said core wire to adjust a relative tension force applied between said stylet wire and said core wire; and
a tension limiter operably arranged to limit said tension force applied between said core wire and said stylet wire to a limit force that is less than a breaking stress force of said stylet wire when said stylet assembly is positioned within said lumen of said intravascular device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A steerable stylet for use within a lumen of an intravascular device comprising:
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a stylet wire having a distal end portion, a proximal end portion and a lumen defined in said stylet wire, said stylet wire having an outer diameter of less than 0.016 inches and a beam strength of at least 0.005 lbf as measured by the ASTM E855-90 3-point bend test;
a core wire having a distal end portion and a proximal end portion, said core wire positioned within said lumen of said stylet wire and having said distal end portion of said core wire operably secured to said stylet wire proximate said distal end portion of said stylet wire; and
a handle proximate said proximal end portion of said stylet wire, said handle including a hand-held housing structure having;
means for adjusting a relative tension force applied between said stylet wire and said core wire; and
means for limiting said relative tension force to a limit force that is less than a breaking stress force of said stylet wire when said stylet wire is positioned within said lumen of said intravascular device. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of steering a stylet within a lumen of an intravascular device comprising:
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providing a steerable stylet including;
a stylet assembly having a distal end portion and a proximal end portion, said stylet assembly including a stylet wire having a lumen defined therein, said stylet wire having an outer diameter of less than 0.016 inches and a beam strength of at least 0.005 lbf as measured by the ASTM E855-90 3-point bend test, and a core wire positioned within said lumen of said stylet wire and having a distal end portion of said core wire operably secured to said stylet wire proximate a distal end portion of said stylet wire; and
a handle operably connected to said stylet wire proximate said proximal end portion of said stylet assembly, said handle including a hand-held housing structure, a tension adjuster and a tension limiter;
inserting at least a portion of said stylet assembly into said lumen of said intravascular device; and
selectively deflecting a distal end portion of said intravascular device by using said tension adjuster to adjust a relative tension force applied between said stylet wire and said core wire in such a manner that said tension limiter limits said relative tension force to a limit force that is less than a breaking stress force of said stylet wire. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41)
returning said distal end portion of said intravascular device to at least an original position of said distal end portion of said intravascular device by releasing said relative tension force applied between said stylet wire and said core wire and using said beam strength of said stylet wire to cause said stylet wire to return to a position beyond an original position of said stylet wire.
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38. The method of claim 34 wherein said step of selectively deflecting is repeated at least fifty times without inducing stress or fatigue failure in said stylet wire.
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39. The method of claim 34 wherein said stylet assembly includes a plurality of regions along said distal end portion having differing wall strengths such that the step of selectively deflecting creates a compound curve of said distal end portion.
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40. The method of claim 39 wherein at least two of said plurality of regions are radially offset with respect to each other and the step of selectively deflecting creates curves in at least two different planes.
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41. The method of claim 39 where at least two of said plurality of regions having differing characteristics and the step of selectively deflecting creates curves at two different times.
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42. A steerable stylet for use within a lumen of an intravascular device comprising:
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a stylet assembly having a distal end portion and a proximal end portion, said stylet assembly including;
a stylet wire having a lumen defined therein, said stylet wire having an outer diameter of less than 0.016 inches and a beam strength of at least 0.005 lbf as measured by the ASTM E855-90 3-point bend test, said stylet wire includes a series of at least ten notches defined along at least one distal region of said stylet wire; and
a core wire positioned within said lumen of said stylet wire and having a distal end portion of said core wire operably secured to said stylet wire proximate a distal end portion of said stylet wire; and
a handle proximate said proximal end portion of said stylet assembly, said handle including a hand-held housing structure having means for adjusting a relative tension force applied between said stylet wire and said core wire. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. A steerable stylet for use within a lumen of an intravascular device comprising:
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a stylet assembly having a distal end portion and a proximal end portion, said stylet assembly including;
a stylet wire having a lumen defined therein, said stylet wire having an outer diameter of less than 0.016 inches and a beam strength of at least 0.005 lbf as measured by the ASTM E855-90 3-point bend test, said stylet wire includes a series of means for altering a material characteristic of a wall of said stylet wire located along a portion of said stylet wire; and
a core wire positioned within said lumen of said stylet wire and having a distal end portion of said core wire operably secured to said stylet wire proximate a distal end portion of said stylet wire; and
a handle proximate said proximal end portion of said stylet assembly, said handle including a hand-held housing structure having means for adjusting a relative tension force applied between said stylet wire and said core wire. - View Dependent Claims (55, 56, 57, 58, 59)
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Specification