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`Application No. 14/984,273
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`A detailed listing of all claims that are, or were, in the present application, irrespective of
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`whether the claim(s) remain(s) under examination in the application is presented below. The
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`claims are presented in ascending order and each includes one status identifier. Those claims not
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`cancelled or withdrawn but amended by the current amendment utilize the following notations
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`for amendment: 1. deleted matter is shown by double brackets or strikethrough; and 2. added
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`matter is shown by underlining.
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`Application No. I 4/984,273
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`I.
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`(Cancelled) A system for use with interventional cardiology devices adapted to be
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`insertable into a branch artery, the system comprising:
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`a guide catheter having a continuous lumen extending for a predefined length from a proximal
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`end at a hemostatic valve to a distal end adapted to be placed in the branch artery, the
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`continuous lumen of the guide catheter having a circular cross-sectional inner diameter
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`sized such that interventional cardiology devices are insertable into and through the
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`continuous lumen of the guide catheter~ and
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`a device adapted for use with the guide catheter, including:
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`a flexible tip portion defining a tubular structure and having a circular cross-section and a length
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`that is shorter than the predefined length of the continuous lumen of the guide catheter,
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`the tubular structure having a cross-sectional outer diameter sized to be insertable through
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`the cross-sectional inner diameter of the continuous lumen of the guide catheter and
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`defining a coaxial lumen having a cross-sectional inner diameter through which
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`interventional cardiology devices are insertable; and
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`a substantially rigid portion proximal of and operably connected to, and more rigid along a
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`longitudinal axis than, the flexible tip portion and defining a rail structure without a
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`lumen having a maximal cross-sectional dimension at a proximal portion that is smaller
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`than the cross-sectional outer diameter of the flexible tip portion and having a length that,
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`when combined with the length of the flexible distal tip portion, defines a total length of
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`the device along the longitudinal axis that is longer than the length of the continuous
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`lumen of the guide catheter, such that when at least a distal portion of the flexible tip
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`portion is extended distally of the distal end of the guide catheter, at least a portion of the
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`proximal portion of the substantially rigid portion extends proximally through the
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`Medtronic Exhibit 1510
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`hemostatic valve in common with interventional cardiology devices that are insertable
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`Application No. 14/984,273
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`into the guide catheter.
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`2.
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`(Cancelled) The system of claim 1, wherein the tubular structure includes a distal portion
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`adapted to be extended beyond the distal end of the guide catheter while a proximal portion
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`remains within the lumen of the guide catheter, such that the device assists in resisting axial and
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`shear forces exerted by the interventional cardiology device passed through and beyond the
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`coaxial lumen that would otherwise tend to dislodge the guide catheter from the branch artery.
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`3.
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`(Cancelled) The system of claim 2, wherein the proximal portion of the tubular structure
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`further comprises structure defining a proximal side opening extending for a distance along the
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`longitudinal axis, and accessible from a longitudinal side defined transverse to the longitudinal
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`axis, to receive the interventional cardiology devices into the coaxial lumen while the proximal
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`portion remains within the lumen of the guide catheter.
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`4.
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`(Cancelled) The system of claim 3, wherein the proximal side opening includes structure
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`defining a full circumference portion and structure defining a partially cylindrical portion.
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`5.
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`(Cancelled) The system of claim l, wherein the tubular structure includes a flexible
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`cylindrical distal tip portion and a flexible cylindrical reinforced portion proximal to the flexible
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`distal tip portion.
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`6.
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`(Cancelled) The system of claim 5, wherein the flexible cylindrical reinforced portion is
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`reinforced with metallic elements in a braided or coiled pattern.
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`Application No. 14/984,273
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`7.
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`(Cancelled) The system of claim 2, wherein the flexible cylindrical distal tip portion
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`further comprises a radiopaque marker proximate a distal tip.
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`8.
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`(Cancelled) The system of claim l, wherein the cross-sectional inner diameter of the
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`coaxial lumen of the tubular structure is not more than one French smaller than the cross(cid:173)
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`sectional inner diameter of the guide catheter.
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`9.
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`(Cancelled) The system of claim 1, wherein the substantially rigid portion includes from
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`distal to proximal direction, a cross-sectional shape having a full circumference portion, a
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`hemicylindrical portion and an arcuate portion.
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`10.
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`(Cancelled) The system of claim l, wherein the predefined length of the guide catheter is
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`about 100 cm and the total length of the device is about 125 cm.
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`11.
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`(Cancelled) The system of claim l, further comprising a kit that includes the guide
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`catheter and the device in a common sterile package.
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`12.
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`(Cancelled) A system for use with interventiortal cardiology devices adapted to be
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`insertable into a branch artery, the system comprising:
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`Application No. I 4/984,273
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`a guide catheter having a continuous lumen extending for a predefined length from a proximal
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`end at a hemostatic valve to a distal end adapted to be placed in the branch artery, the
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`continuous lumen of the guide catheter having a circular cross-section and a cross(cid:173)
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`sectional inner diameter sized such that interventional cardiology devices are insertable
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`into and through the continuous lumen of the guide catheter; and
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`a device adapted for use with the guide catheter, including:
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`an elongate structure having an overall length that is longer than the predefined length of the
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`continuous lumen of the guide catheter, the elongate structure including:
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`a flexible tip portion defining a tubular structure and having a circular cross-section that is
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`smaller than the circular cross-section of the continuous lumen of the guide catheter and a
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`length that is shorter than the predefined length of the continuous lumen of the guide
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`catheter, the flexible tip portion having a cross-sectional outer diameter sized to be
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`insertable through.the cross-sectional inner diameter of the continuous lumen of the guide
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`catheter and defining a coaxial lumen having a cross-sectional inner diameter through
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`which interventional cardiology devices are insertable;
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`a reinforced portion proximal to the flexible tip portion; and
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`a substantially rigid portion proximal of, connected to, and more rigid along a longitudinal axis
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`than, the flexible tip portion and defining a rail structure without a lumen having a
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`maximal cross-sectional dimension at a proximal portion that is smaller than the cross(cid:173)
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`sectional outer diameter of the flexible tip portion, such that when at least a distal portion
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`of the flexible tip portion is extended distally of the distal end of the guide catheter with
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`at least proximal portion of the reinforced portion remaining within the continuous lumen
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`of the guide catheter, at least a portion of the proximal portion of the substantially rigid
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`portion extends proximally through the hemostatic valve in common with interventional
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`cardiology devices that are insertable into the guide catheter.
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`Application No. 14/984,273
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`13.
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`(Cancelled) The system of claim 12, wherein, when the distal portion of the flexible tip
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`portion is insertable through the continuous lumen of the guide catheter and beyond the distal
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`end of the guide catheter, the device assists in resisting axial and shear forces exerted by an
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`interventional cardiology device passed through and beyond the coaxial lumen that would
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`otherwise tend to dislodge the guide catheter from the branch artery.
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`14.
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`(Cancelled) The system of claim 12, wherein the substantially rigid portion further
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`includes a partially cylindrical portion defining an opening extending for a distance along a side
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`thereof defined transverse to a longitudinal axis that is adapted to receive an interventional
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`cardiology device passed through continuous lumen of the guide catheter and into the coaxial
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`lumen while the device is inserted into the continuous lumen, the opening extending substantially
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`along at least a portion of a length of the substantially rigid portion.
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`15.
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`(Cancelled) The system of claim 12, wherein, after the device is inserted into the
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`continuous lumen of the guide catheter, the device presents an overall effective length of a
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`coaxial lumen through which an interventional cardiology device may be inserted while utilizing
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`only a single hemostatic valve and without any telescoping structure preassembled prior to the
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`device being inserted into the continuous lumen of the guide catheter.
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`16.
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`(Cancelled) The system of claim 12, the device further comprising a radiopaque marker
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`proximate the distal portion of the flexible tip portion.
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`Application No. I 4/984,273
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`17.
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`(Cancelled) The system of claim 12, wherein the reinforced portion of the device is
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`reinforced with metallic elements in a braided or coiled pattern.
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`18.
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`(Cancelled) The system of claim 12, wherein the cross-sectional inner diameter of the
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`coaxial lumen of the flexible distal portion is not more than one French smaller than the cross(cid:173)
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`sectional inner diameter of the guide catheter.
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`19.
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`(Cancelled) The system of claim 12, wherein the substantially rigid portion includes,
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`from distal to proximal, a cross-sectional shape having a full circumference portion, a
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`hemicylindrical portion and an arcuate portion.
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`20.
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`(Cancelled) The system of claim 12, wherein the elongate structure includes, starting at
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`the distal portion of the flexible distal portion, at least a first portion having a first flexural
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`modulus, a second portion having a second flexural modulus greater than the first flexural
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`modulus, and a third portion having a third flexural modulus greater than the second flexural
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`modulus.
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`21.
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`(Cancelled) The system of claim 20, in which the first flexural modulus is about 13,000
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`PSI plus or minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or minus
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`10,000 PSI, and the third portion flexural modulus is about 49,000 PSI plus or minus 10,000 PSI.
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`22.
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`(Cancelled) The system of claim 20, in which the first portion is about O. I cm in length,
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`the second portion is about three cm in length, and the third portion is about five cm in length.
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`23.
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`(Cancelled) The system of claim 12, wherein the predefined length of the guide catheter
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`is about 100 cm and the total length of the device is about I 25 cm.
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`24.
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`(Cancelled) The system of claim 12, further comprising a kit that includes the guide
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`catheter and the device in a common sterile package.
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`Please add new claims 25-45 as follows:
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`25.
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`<New) A method of forming a device adapted for use with a guide catheter having a
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`lumen, the method comprising:
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`providing a tip segment having a lumen therethrough:
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`providing a reinforced segment having a lumen therethrough, including one or more metallic
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`elements covered with a polymer, and extending from a proximal end portion to a distal
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`end portion, the proximal end portion more rigid or having a flexural modulus greater
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`than the tip segment;
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`providing a substantially rigid segment extending from a proximal end portion to a distal end
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`portion;
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`eccentrically positioning the distal end portion of the substantially rigid segment relative to a
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`longitudinal axis of the proximal end portion of the reinforced segment: and
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`coaxially aligning the distal end portion of the reinforced segment and a proximal end portion of
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`the tip segment,
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`wherein providing the substantially rigid segment. the reinforced segment, and the tip segment
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`includes forming a device length such that when a distal end portion of the tip segment is
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`extended distally of a distal end of the guide catheter, at least part of the proximal end
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`portion of the substantially rigid segment extends proximally of a proximal end of the
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`guide catheter.
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`26.
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`<New) The method of claim 25, further comprising providing a segment defining a side
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`opening and positioning the segment proximal of the proximal end portion of the reinforced
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`segment. the side opening extending for a distance along a longitudinal axis of the segment and
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`accessible from a longitudinal side defined transverse to the longitudinal axis.
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`27.
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`<New) The method of claim 25, wherein providing the substantially rigid segment
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`includes providing one or more relief openings at its distal end portion.
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`28.
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`<New) The method of claim 27, wherein the one or more relief openings include a first
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`relief opening and a second relief opening, the openings spaced apart from one another.
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`29.
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`<New) The method of claim 25, wherein providing the substantially rigid segment
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`includes forming or obtaining a hypotube or a metal rail structure.
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`30.
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`<New) The method of claim 25, wherein providing the substantially rigid segment and
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`the reinforced segment includes, starting at the distal end portion of the reinforced segment and
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`moving proximally toward the proximal end portion of the substantially rigid segment forming
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`or obtaining at least a first device portion having a first flexural modulus and a second device
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`portion having a second flexural modulus. the second flexural modulus greater than the first
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`Application No. 14/984,273
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`flexural modulus.
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`31.
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`<New) The method of claim 25. wherein providing the reinforced segment includes
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`covering one or more braided or coiled metallic elements with the polymer.
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`32.
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`<New) The method of claim 31. wherein a length of the one or more braided or coiled
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`metallic elements is in a range of 20 centimeters to 30 centimeters.
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`33.
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`<New) The method of claim 25. wherein providing the reinforced segment includes
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`forming or obtaining a reinforced segment including a lumen having a uniform inner diameter
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`that is about one French smaller than an inner diameter of the lumen of the guide catheter.
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`34.
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`<New) The method of claim 33, wherein the lumen of the reinforced segment is greater
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`than or equal to 0.056 inches and the lumen of the guide catheter is greater than or equal to 0.070
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`inches.
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`35.
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`<New) The method of claim 25, wherein providing one or both of the reinforced segment
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`and the tip segment includes lining the lumens thereof with polytetrafluoroethylene.
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`36.
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`(New) The method of claim 25. wherein providing the tip segment includes providing an
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`atraumatic bumper formed of a polymer or an elastomeric material.
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`37.
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`<New) The method of claim 36, wherein providing the tip segment includes covering a
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`marker band with the polymer or the elastomeric material.
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`38.
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`<New) A method of forming a device adapted for use with a guide catheter having a
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`lumen, the method comprising:
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`providing a tip segment having a lumen therethrough~
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`providing a reinforced segment including one or more metallic elements covered with a polymer
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`and having a lumen for coaxial alignment with the lumen of the tip portion;
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`providing a substantially rigid segment extending from a proximal end portion to a distal end
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`portion;
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`providing a segment defining a side opening extending for a distance along a longitudinal axis of
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`the device and accessible from a longitudinal side, defined transverse to the longitudinal
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`axis. to receive a balloon catheter or stent; and
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`arranging, in a proximal to distal direction. the substantially rigid segment. the segment defining
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`the side opening. the reinforced segment, and the tip segment.
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`39.
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`<New) The method of claim 38. wherein providing the substantially rigid segment, the
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`segment defining the side opening, and the reinforced segment includes, starting at a distal end
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`portion of the reinforced segment and moving proximally toward the proximal end portion of the
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`substantially rigid segment, forming or obtaining at least a first device portion having a first
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`flexural modulus, a second device portion having a second flexural modulus greater than the first
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`flexural modulus, and a third device portion having a third flexural modulus greater than the
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`second flexural modulus.
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`Application No. 14/984,273
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`40.
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`{New) The method of claim 38, wherein providing the segment defining the side opening
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`includes providing an angled entrance into the lumen of the reinforced segment.
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`41.
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`{New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming an arcuate cross-sectional shape having a length of about 15 centimeters.
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`42.
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`<New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming, in a proximal to distal direction, an arcuate cross-sectional shape and a
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`hemicylindrical cross-sectional shape.
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`43.
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`<New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming a concave track.
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`44.
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`<New) The method of claim 38, wherein providing the segment defining the side opening
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`includes forming a first inclined sidewall. forming a second inclined sidewall. and separating the
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`first inclined sidewall and the second inclined sidewall by a non-inclined region.
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`45.
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`<New) The method of claim 38, wherein providing the substantially rigid segment, the
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`segment defining the side opening, the reinforced segment, and the tip segment includes forming
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`a device cross-sectional size and shape configured to be passed. at least in part. into the lumen of
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`Application No. 14/984,273
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`the guide catheter.
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