Method and apparatus for imparting curves in elongated implantable medical instruments
First Claim
1. An elongated medical instrument to be advanced through the body comprising:
- an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment;
the instrument body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment; and
proximal tension applying means coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment and distal tension applying means coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment, the proximal and distal tension applying means separated apart by a relaxed length of the instrument body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying means and transferred to the instrument body proximal segment to stretch it to a tensioned length of the instrument body proximal segment exceeding the relaxed length.
1 Assignment
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Accused Products
Abstract
A medical instrument including a body extending between proximal and distal ends and enclosing an elongated, inelastic, pull wire extending between a pull wire proximal end affixed at a point at or near the proximal end and a pull wire distal end affixed at or near the distal end. The wire extends through a lumen off-set from the instrument axis and through a distal segment of the body that is to be curved for deflection at the distal end. A proximal segment of the instrument axially stretches when tension is applied to increase the length of the proximal segment from a relaxed length. A hand-held tool engages the proximal and distal ends of the proximal segment and manually applies a selective amount of tension that stretches the proximal segment from its relaxed length.
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Citations
45 Claims
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1. An elongated medical instrument to be advanced through the body comprising:
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an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment;
the instrument body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment; and
proximal tension applying means coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment and distal tension applying means coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment, the proximal and distal tension applying means separated apart by a relaxed length of the instrument body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying means and transferred to the instrument body proximal segment to stretch it to a tensioned length of the instrument body proximal segment exceeding the relaxed length. - View Dependent Claims (2, 3, 6, 7, 8)
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4. An elongated medical instrument to be advanced through the body comprising:
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an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment, wherein the instrument body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bonds in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment, wherein the instrument body further comprises an elongated stylet lumen extending from a stylet lumen proximal end opening through the instrument body proximal segment and instrument body distal segment to a stylet distal end, the stylet lumen extending in parallel with and radially offset in a second radial direction from the instrument body distal axis in the instrument body distal segment, whereby a relatively straight stylet wire of a stylet can be inserted through the stylet lumen proximal end opening and advanced distally through a selected proximal portion of the instrument body distal segment to constrain the formation of the curve to the distal portion of the instrument body distal segment, and wherein the instrument body in the instrument body proximal segment has an instrument body diameter and further comprising an enlarged diameter proximal tension applying ring coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment and an enlarged diameter distal tension applying ring coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment, the proximal and distal tension applying rings separated apart by a relaxed length of the instrument body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying rings and transferred to the instrument body proximal segment to stretch it to a tensioned length of the instrument body proximal segment exceeding the relaxed length.
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5. An elongated medical instrument to be advanced through the body comprising:
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an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment; and
the instrument body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment, wherein the instrument body in the instrument body proximal segment has an instrument body diameter and further comprising an enlarged diameter proximal tension applying ring coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment and an enlarged diameter distal tension applying ring coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment, the proximal and distal tension applying rings separated apart by a relaxed length of the instrument body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying rings and transferred to the instrument body proximal segment to stretch it to a tensioned length of the instrument body proximal segment exceeding the relaxed length.
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9. An elongated electrical medical lead to be advanced through the body comprising:
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a lead body extending between a lead body proximal end and a lead body distal end and having a lead body proximal segment and a lead body distal segment, the lead body having a lead body axis extending axially in the lead body distal segment and further comprising an elongated pull wire lumen extending through the lead body proximal segment and lead body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the lead body distal axis in the lead body distal segment;
a proximal connector element at the lead body proximal end;
an electrode at the lead body distal end;
an elongated electrical conductor extending between the proximal connector element and the electrode through and enclosed within the lead body;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical lead to a pull wire distal attachment with the lead body distal segment;
the lead body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the lead body in the lead body distal segment to orient the electrode at a desired site in the body; and
proximal tension applying means coupled to the lead body proximal segment at a proximal site of the lead body proximal segment and distal tension applying means coupled to the lead body proximal segment at a distal site of the lead body proximal segment, the proximal and distal tension applying means separated apart by a relaxed length of the lead body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying means and transferred to the lead body proximal segment to stretch it to a tensioned length of the lead body proximal segment exceeding the relaxed length. - View Dependent Claims (10, 11, 13, 14, 15)
a further proximal connector element at the lead body proximal end;
a further electrode at the lead body distal end; and
wherein the pull wire is formed of a conductive material and is attached to the further proximal connector element and the further electrode and functions as a lead conductor.
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15. The elongated medical lead of claim 9, further comprising:
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a further proximal connector element at the lead body proximal end;
a further electrode at the lead body distal end; and
wherein the pull wire is formed of a conductive material and is attached to the further proximal connector element and the further electrode and functions as a lead conductor.
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12. An elongated electrical medical lead to be advanced through the body comprising:
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a lead body extending between a lead body proximal end and a lead body distal end and having a lead body proximal segment and a lead body distal segment, the lead body having a lead body axis extending axially in the lead body distal segment and further comprising an elongated pull wire lumen extending through the lead body proximal segment and lead body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the lead body distal axis in the lead body distal segment;
a proximal connector element at the lead body proximal end;
an electrode at the lead body distal end;
an elongated electrical conductor extending between the proximal connector element and the electrode through and enclosed within the lead body;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical lead to a pull wire distal attachment with the lead body distal segment; and
the lead body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the lead body in the lead body distal segment to orient the electrode at a desired site in the body, wherein the lead body further comprises an elongated stylet lumen extending from a stylet lumen proximal end opening through the lead body proximal segment and lead body distal segment to a stylet distal end, the stylet lumen extending in parallel with and radially offset in a second radial direction from the lead body distal axis in the lead body distal segment, whereby a relatively straight stylet wire of stylet can be inserted through the stylet lumen proximal end opening and advanced distally through a selected proximal portion of the lead body distal segment to constrain the formation of the curve to the distal portion of the lead body distal segment, wherein the lead body in the lead body proximal segment has a lead body diameter and further comprising an enlarged diameter proximal tension applying ring coupled to the lead body proximal segment at a proximal site of the lead body proximal segment and an enlarged diameter distal tension applying ring coupled to the lead body proximal segment at a distal site of the lead body proximal segment, the proximal and distal tension applying rings separated apart by a relaxed length of the lead body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying rings and transferred to the lead body proximal segment to stretch it to a tensioned length of the lead body proximal segment exceeding the relaxed length.
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16. An elongated electrical medical lead to be advanced through the body comprising:
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a lead body extending between a lead body proximal end and a lead body distal end and having a lead body proximal segment and a lead body distal segment, the lead body having a lead body axis extending axially in the lead body distal segment and further comprising an elongated pull wire lumen extending through the lead body proximal segment and lead body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the lead body distal axis in the lead body distal segment;
a proximal connector element at the lead body proximal end;
an electrode at the lead body distal end;
an elongated electrical conductor extending between the proximal connector element and the electrode through and enclosed within the lead body;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical lead to a pull wire distal attachment with the lead body distal segment; and
the lead body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension applied directly at the instrument body proximal segment, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the lead body in the lead body distal segment to orient the electrode at a desired site in the body, wherein the lead body in the lead body proximal segment has a lead body diameter and further comprising an enlarged diameter proximal tension applying ring coupled to the lead body proximal segment at a proximal site of the lead body proximal segment and an enlarged diameter distal tension applying ring coupled to the lead body proximal segment at a distal site of the lead body proximal segment, the proximal and distal tension applying rings separated apart by the relaxed length of the lead body proximal segment, wherein tension is adapted to be applied axially between the proximal and distal tension applying rings and transferred to the lead body proximal segment to stretch it to the tensioned length of the lead body proximal segment exceeding the relaxed length.
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17. A system for advancing an elongated medical instrument through the body comprising:
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an elongated medical instrument comprising;
an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment; and
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment;
the instrument body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment; and
proximal tension applying means coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment and distal tension applying means coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment, the proximal and distal tension applying means separated apart by a relaxed length of the instrument body proximal segment, tool means for engaging and applying tension axially between the proximal and distal tension applying means to stretch the instrument body proximal section to a tensioned length exceeding the relaxed length. - View Dependent Claims (18, 19, 20, 21, 22, 23)
the instrument body in the instrument body proximal segment has an instrument body diameter;
the proximal tension applying means further comprises an enlarged diameter proximal tension applying ring coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment;
the distal tension applying means further comprises an enlarged diameter distal tension applying ring coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment; and
the tool means is adapted to engage and increase the separation between the proximal and distal tension applying rings to stretch the instrument body proximal segment to the tensioned length.
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21. The system of claim 17, wherein the medical instrument comprises an electrical medical lead.
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22. The system of claim 17, wherein the medical instrument comprises a guide wire.
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23. The system of claim 17, wherein the medical instrument comprises a catheter.
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24. A system for advancing an elongated medical instrument through the body comprising:
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an elongated medical instrument comprising;
an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment; and
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment;
the instrument body proximal segment is tubular having a predetermined segment diameter and is formed of an elastic material capable of being stretched axially under axially applied tension, whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment;
an enlarged diameter proximal tension applying ring coupled to the instrument body proximal segment at a proximal site of the instrument body proximal segment; and
an enlarged diameter distal tension applying ring coupled to the instrument body proximal segment at a distal site of the instrument body proximal segment and separated from the proximal tension applying ring by a relaxed length of the instrument body proximal segment; and
a hand-held tool having a first surface that engages the proximal tension applying ring and a second surface spaced from the first surface that engages the distal tension applying ring and a spanner extending between the first and second surfaces that can be manually adjusted to increase the spacing between the first and second surfaces to axially apply tension to and increase the length of the instrument body proximal segment. - View Dependent Claims (25, 26, 27, 28, 29)
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30. A system for advancing an elongated medical instrument through the body comprising:
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an the elongated medical instrument adapted to be inserted into a pathway of the body, the elongated medical instrument comprising;
an instrument body extending between an instrument body proximal end and an instrument body distal end and having an instrument body proximal segment and an instrument body distal segment, the instrument body having an instrument body axis extending axially in the instrument body distal segment and further comprising an elongated pull wire lumen extending through the instrument body proximal segment and instrument body distal segment, the pull wire lumen extending in parallel with and radially offset in a first radial direction from the instrument body distal axis in the instrument body distal segment;
an inelastic pull wire extending through the pull wire lumen from a pull wire proximal attachment with the elongated medical instrument to a pull wire distal attachment with the instrument body distal segment; and
the instrument body proximal segment is formed of an elastic material capable of being stretched axially under axially applied tension; and
tension applying means operable as the distal end is advanced, for selectively applying axial tension directly at the instrument body proximal section to stretch the instrument body proximal segment whereby the inelastic pull wire bends in the first radial direction and thereby imparts a curve to the instrument body in the instrument body distal segment so as to deflect the distal end to the extent found expedient to advance the distal tip and to position the distal end at a remote site in the body. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
means for selectively restraining the length of the curve imparted in the instrument body distal segment to effect the advancement and positioning of the distal end.
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32. The system of claim 30, wherein the instrument body further comprises an elongated stylet lumen extending from a stylet lumen proximal end opening through the instrument body proximal segment and instrument body distal segment to a stylet distal end, the stylet lumen extending in parallel with and radially offset in a second radial direction from the instrument body distal axis in the instrument body distal segment, and further comprising:
a stylet having a relatively straight stylet wire adapted to be inserted through the stylet lumen proximal end opening and distally through a selected proximal portion of the instrument body distal segment to constrain the formation of the curve to the distal portion of the instrument body distal segment.
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33. The system of claim 32, wherein the tension applying means further comprises a hand-held tool adapted to engage the proximal and distal ends of the proximal segment in its relaxed length and having means responsive to manual manipulation to apply a selective amount of tension that stretches the proximal segment from its relaxed length to a selected tensioned length that forms a curve of desired radius at least a distal portion of the distal segment.
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34. The system of claim 30, wherein the tension applying means further comprises a hand-held tool adapted to engage the proximal and distal ends of the proximal segment in its relaxed length and having means responsive to manual manipulation to apply a selective amount of tension that stretches the proximal segment from its relaxed length to a selected tensioned length that forms a curve of desired radius at least a distal portion of the distal segment.
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35. The system of claim 34, wherein the hand-held tool further comprises a frame that supports a fixed cradle adapted to engage one of the first and second ends of the instrument body proximal segment and supports a shuttle movable along the frame with respect to the fixed cradle, the shuttle adapted to engage the other of the first and second ends of the instrument body proximal segment, whereby the shuttle is manually movable along the frame to axially apply tension to and increase the length of the instrument body proximal segment.
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36. The system of claim 35, wherein the hand-held tool further comprises a movable stop supported by the frame in the path of movement of the movable shutter that is adjustable to limit the maximum spacing that can be made between the first and second surfaces.
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37. The system of claim 35, wherein the hand-held tool further comprises a spring load that limits the maximum tension that can be applied made between the proximal and distal rings.
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38. The system of claim 34, wherein the hand-held tool further comprises first and second elongated spring bands that extend between opposed first and second sides of first and second extension blocks, the first extension block engaging one of the first and second ends of the instrument body proximal segment and the second extension block engaging the other of the first and second ends of the instrument body proximal segment, whereby the first and second extension blocks are spread apart as the elongated spring bands are pressed toward one another to axially apply tension to and increase the length of the instrument body proximal segment.
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39. The system of claim 38, wherein the hand-held tool further comprises third and fourth spring bands extending between opposed third and fourth sides of the first and second extension blocks, whereby the first and second extension blocks are spread apart as the first and second elongated spring bands are pressed toward one another and the third and fourth spring bands are pressed toward one another to axially apply tension to and increase the length of the instrument body proximal segment.
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40. The system of claim 30, wherein the medical instrument comprises an electrical medical lead.
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41. The system of claim 30, wherein the medical instrument comprises a guide wire.
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42. The system of claim 30, wherein the medical instrument comprises a catheter.
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43. An elongated medical instrument, comprising:
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an instrument body having a proximal segment and a distal segment, the proximal segment having a first length extending distally from a proximal end to a distal end and the distal segment extending distally from the distal end of the proximal segment, and the instrument body forming a first lumen extending through the proximal segment and the distal segment;
an elongated member extending through the first lumen of the instrument body;
a first member positioned at the proximal end of the proximal segment; and
a second member positioned at the distal end of the proximal segment and spaced a first length from the first curve imparting member, wherein the proximal segment is advanced from the first length to a second length greater than the first length in response to axial tension being applied to at least one of the first member and the second member, and wherein a selective curvature is applied along the distal segment via the elongated member in response to the proximal segment being advanced to the second length. - View Dependent Claims (44, 45)
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Specification