REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
`
`AMENDMENTSTO THE CLAIMS
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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 includesonestatus identifier. Those claims not
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`cancelled or withdrawn but amended by the current amendmentutilize the following notations
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`for amendment:
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`1. deleted matter is shown by strikethrough for six or more characters and
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`double brackets for five or fewer characters; and 2. added matter is shown by underlining.
`
`
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
`
`AMENDMENTSTO THE CLAIMS
`
`A detailed listing of all claims that are, or were, in the present application,irrespective of
`
`whether the claim(s) remain(s) under examination in the application is presented below. The
`
`claims are presented in ascending order and each includesonestatus identifier. Those claims not
`
`cancelled or withdrawn but amended by the current amendmentutilize the following notations
`
`for amendment:
`
`1. deleted matter is shown by strikethrough for six or more characters and
`
`double brackets for five or fewer characters; and 2. added matter is shown by underlining.
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`
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP 708)
`
`1.
`
`(Cancelled) A system for use with interventional cardiology devices adapted to be
`
`insertable into a branch artery, the system comprising:
`
`a guide catheter having a continuous lumen extending for a predefined length from a
`
`proximal end at a hemostatic valve to a distal end adapted to be placed in the branchartery, the
`
`continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized
`
`such that interventional cardiology devices are insertable into and through the continuous lumen
`
`of the guide catheter; and
`
`a device adapted for use with the guide catheter, including:
`
`a flexible tip portion defining a tubular structure and having a
`
`circular cross-section and a length that is shorter than the predefined length of the continuous
`
`lumenof the guide catheter, the tubular structure having a cross-sectional outer diametersized to
`
`be insertable through the cross-sectional inner diameter of the continuous lumen of the guide
`
`catheter and defining a coaxial lumen having a cross-sectional inner diameter through which
`
`interventional cardiology devices are insertable; and
`
`a substantially rigid portion proximal of and operably connected to, and more
`
`rigid along a longitudinal axis than, the flexible tip portion and defining a rail_structure withouta
`
`lumen having a maximal cross-sectional dimension at a proximal portion that is smaller than the
`
`cross-sectional outer diameter of the flexible tip portion and having a length that, when
`
`combined with the length of the flexible distal tip portion, defines a total length of the device
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`along the longitudinal axis that is longer than the length of the continuous lumen of the guide
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`catheter, such that whenatleast a distal portion of the flexible tip portion is extended distally of
`
`3
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`
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
`
`the distal end of the guide catheter, at least a portion of the proximal portion of the substantially
`
`rigid portion extends proximally through the hemostatic valve in common with interventional
`
`cardiology devices that are insertable into the guide catheter.
`
`2.
`
`(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 branchartery.
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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
`
`axis, to receive the interventional cardiology devices into the coaxial lumen while the proximal
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`portion remains within the lumen ofthe guide catheter.
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`4,
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`(Cancelled) The system of claim 3, wherein the proximal side opening includes structure
`
`defining a full circumferenceportion andstructure defining a partially cylindrical portion.
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`
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`REISSUE APPLICATIONNO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
`
`5.
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`(Cancelled) The system of claim 1, wherein the tubular structure includes a flexible
`
`cylindrical distal tip portion and a flexible cylindrical reinforced portion proximal to the flexible
`
`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 elementsin a braided or coiled pattern.
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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 proximateadistaltip.
`
`8.
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`(Cancelled) The system of claim 1, wherein the cross-sectional inner diameter of the
`
`coaxial
`
`lumen of the tubular structure is not more than one French smaller than the cross-
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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
`
`distal
`
`to proximal direction, a cross-sectional shape having a full circumference portion, a
`
`hemicylindrical portion and an arcuate portion.
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`10.
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`(Cancelled) The system of claim 1, wherein the predefined length of the guide catheteris
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`about 100 cm andthetotal length of the device is about 125 cm.
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`REISSUE APPLICATION NO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION(MPEP708)
`
`11.
`
`(Cancelled) The system of claim 1, further comprising a kit that includes the guide
`
`catheter and the device in a commonsterile package.
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`12.
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`(Cancelled) A system for use with interventional cardiology devices adapted to be
`
`insertable into a branch artery, the system comprising:
`
`a guide catheter having a continuous lumen extending for a predefined length from a
`
`proximal end at a hemostatic valve to a distal end adapted to be placed in the branchartery, the
`
`continuous lumen ofthe guide catheter having a circular cross-section and a cross-sectional inner
`
`diameter sized such that interventional cardiology devices are insertable into and through the
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`continuous lumenof the guide catheter; and
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`a device adapted for use with the guide catheter, including:
`
`an elongate structure having an overall length that is longer than the predefined
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`length of the continuous lumenofthe guide catheter, the elongate structure including:
`
`a flexible tip portion defining a tubular structure and having a
`
`circular cross-section that is smaller than the circular cross-section of the continuous lumen of
`
`the guide catheter and a length that is shorter than the predefined length of the continuous lumen
`
`of the guide 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 which
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`interventional cardiology devices are insertable;
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`a reinforced portion proximal to the flexible tip portion; and
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`
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`REISSUE APPLICATION NO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP 708)
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`a substantially rigid portion proximal of, connected to, and morerigid along a
`
`longitudinal axis than, the flexible tip portion and defining a rail structure without a lumen
`
`having a maximalcross-sectional dimension at a proximal portion that is smaller than the cross-
`
`sectional outer diameter of the flexible tip portion, such that whenat least a distal portion ofthe
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`flexible tip portion is extended distally of the distal end of the guide catheter with at
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`least
`
`proximal portion of the reinforced portion remaining within the continuous lumen of the guide
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`catheter, at least a portion of the proximal portion of the substantially rigid portion extends
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`proximally through the hemostatic valve in common with interventional cardiology devices that
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`are insertable into the guide catheter.
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`13.
`
`(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
`
`end of the guide catheter, the device assists in resisting axial] and shear forces exerted by an
`
`interventional cardiology device passed through and beyond the coaxial
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`lumen that would
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`otherwise tend to dislodge the guide catheter from the branchartery.
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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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`includesa partially cylindrical portion defining an opening extending for a distance alonga 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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`REISSUE APPLICATION NO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
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`lumen while the device is inserted into the continuous lumen, the opening extending substantially
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`alongat 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
`
`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 maybe 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 lumenofthe guide catheter.
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`16.
`
`(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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`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.|(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-
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`sectional inner diameter of the guide catheter.
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`
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
`
`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 thefirst flexural modulus is about 13,000
`
`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, andthe third portion flexural modulusis 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 0.1 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 andthetotal length of the device is about 125 cm.
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
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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 commonsterile package.
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`Please add new claims 25-55 as follows:
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`25.|(New)_A method, comprising:
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`advancing a distal end of a guide catheter having a lumen through a main blood vessel to
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`an ostium of a coronary artery:
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`advancing a distal end of a guide extension catheter through, and beyond the distal end
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`of, the guide catheter, including advancing a distal end portion of a tubular structure of the guide
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`extension catheter beyond the distal end of the guide catheter while a segment defining a side
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`opening of the guide extension catheter
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`_remains within the guide catheter, the side opening
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`extending for a distance along a longitudinal axis of the guide extension catheter and accessible
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`from a longitudinal side defined transverse to the longitudinal axis, the tubular structure having a
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`cross-sectional
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`inner diameter that_is not more than one French size smaller than a cross-
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`sectional inner diameter of the lumen of the guide catheter;
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`maintaining the distal end portion ofthe tubular structure of the guide extension catheter
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`in position beyondthedistal end ofthe guide catheter; and
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`while maintaining the distal end of the guide extension catheter positioned beyond the
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`
`
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`
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`distalendoftheguidecatheter,advancingaballooncatheterorstentatleastpartiallythroughthe
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`
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`guidecatheterandtheguideextensioncatheterandintothecoronaryartery,includingadvancing
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`10
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`REISSUE APPLICATION NO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP 708)
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`the balloon catheter or stent through a hemostatic valve associated with a proximal end ofthe
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`guide catheter, along a substantially rigid segment of the guide extension catheter, through the
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`side opening, and through the tubularstructure.
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`26.
`
`(New) The method of claim 25, further comprising injecting one or more fluids into the
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`coronary artery via the proximal end of the guide catheter.
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`27.|(New)_The method of claim 25, wherein advancing the distal end of the guide extension
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`catheter through, and beyond the distal end of,
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`the guide catheter includes opening the
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`hemostatic valve and advancing the distal end of the guide extension catheter through the
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`hemostatic valve and into the guide catheter.
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`28.
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`(New) The method of claim 25, wherein advancing the distal end of the guide extension
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`catheter through, and beyond the distal end of, the guide catheter includes advancing the distal
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`end of the guide extension catheter proximal to a location of a lesion to be treated in the coronary
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`artery.
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`29.|(New) The methodofclaim 25, wherein advancingthe distal end of the guide extension
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`catheter through, and beyond the distal end of, the guide catheter _includes manipulating the
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`substantially rigid segment to advance the segment defining the side opening to a position within
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`the lumen ofthe guide catheter.
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`
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`REISSUE APPLICATION NO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP 708)
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`30.
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`(New) The method of claim 25, wherein advancing the distal end of the guide extension
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`catheter through, and beyond the distal end of, the guide catheter includes sealing around the
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`substantially rigid segment with the hemostatic valve associated with the proximal end of the
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`guide catheter.
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`31.
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`(New) The method of claim 25, wherein advancingthe distal end of the guide extension
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`catheter through, and beyond the distal end of,
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`the guide catheter_includes advancing the
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`substantially rigid segment within the lumen of the guide catheter.
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`32.|(New) The method of claim 25, wherein advancing the distal end_of the guide extension
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`catheter through, and beyond the distal end of, the guide catheter includes coaxially aligning the
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`tubular structure of the guide extension catheter with the lumenof the guide catheter.
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`33.
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`(New) The method of claim 25, wherein advancing the distal end of the guide extension
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`catheter through, and beyond the distal end of,
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`the guide catheter includes positioning the
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`segment defining the side opening within the guide catheter for receiving the balloon catheter or
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`stent.
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`34.|(New) The method of claim 25, wherein advancing the distal end of the guide extension
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`catheter through, and beyond the distal end of, the guide catheter includes establishing fluid
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`12
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION(MPEP708)
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`communication between the tubular structure of the guide extension catheter and the lumen of
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`the guide catheter.
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`35.|(New) The method of claim 25, wherein maintaining the distal end of the guide
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`extension catheter through, and beyond the distal end of, the guide catheter includes resisting
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`dislodging of the distal end of the guide catheter from the ostium of the coronary artery when the
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`balloon catheter or stent is at least partially advanced through the guide catheter, through the
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`guide extension catheter, and into the coronary artery.
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`36.
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`(New) The method of claim 25, wherein maintaining the distal end of the guide
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`extension catheter through, and beyond the distal end of, the guide catheter includes using the
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`guide extension catheter to resist axial and shear forces exerted by the balloon catheter or stent
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`when the balloon catheter or stent is advanced at least_partially through the guide catheter,
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`through the guide extension catheter, and into the coronary artery.
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`37.
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`(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
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`partially through the guide catheter, through the guide extension catheter, and into the coronary
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`artery includes advancing a delivery system including the stent into the coronary artery.
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`38.
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`(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
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`partially through the guide catheter, through the guide extension catheter, and into the coronary
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`13
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
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`artery includes advancing one or more interventional devices through a single seal, which is the
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`hemostatic valve associated with the proximal end of the guide catheter.
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`39.
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`(New) The methodof claim 25, wherein, subsequent to advancing the balloon catheter or
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`stent_at
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`least_partially through the hemostatic valve,
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`the method further comprises _at
`
`least
`
`partially sealing around a proximal end portion of the balloon catheter or a delivery system
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`including the stent with the hemostatic valve associated with the proximal end of the guide
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`catheter.
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`40.
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`(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
`
`partially through the side opening includes accessing the side opening of the guide extension
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`catheter within the lumen of the guide catheter.
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`41.|(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
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`partially through the side opening includes advancing the balloon catheter or stent along a
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`concave track of the side opening, the concave track extending for a length of about 20 cm to
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`about 75 cm.
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`42.
`
`(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
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`partially through the side opening includes advancing the balloon catheter or stent through a
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`structure having an arcuate cross-sectional shape.
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`14
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`REISSUE APPLICATION NO.14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP 708)
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`43.
`
`(New) A method, comprising:
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`advancing a distal end of a guide catheter having a lumen through a main blood vessel to
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`an ostium of a coronaryartery;
`
`advancing a distal end of a guide extension catheter through, and beyond the distal end
`
`of, the guide catheter while a segment defining a side opening of the guide extension catheter
`
`and a proximal end of a tubular structure of the guide extension catheter remain within the guide
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`catheter,
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`the side opening extending for a distance along a longitudinal axis of the guide
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`extension catheter and accessible from a longitudinal side defined transverse to the longitudinal
`
`axis, the tubular structure having a cross-sectional inner diameter that is not more than one
`
`French size smaller than a cross-sectional inner diameter of the lumen of the guide catheter: and
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`with the distal end of the guide extension catheter positioned beyond the distal end of the
`
`guide catheter, advancing a treatmentcatheterat least partially through the guide catheter and the
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`guide extension catheter and into the coronary artery, including advancinga distal portion of the
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`treatment catheter through a hemostatic valve associated with a proximal end_of the guide
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`catheter, along a substantially rigid segment of the guide extension catheter, through the side
`
`opening, and through the tubular structure,
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`wherein advancing the treatment catheter _at
`
`least partially through the side opening
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`
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`includesadvancingthetreatmentcatheterthroughastructurehavinganarcuatecross-
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`
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`
`
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`sectional shape extending for a length of 15 cm.
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`15
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
`TO BE GIVEN PRIORITY IN EXAMINATION (MPEP708)
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`44.
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`(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
`
`partially through the side opening includes advancing the balloon catheter or stent through a
`
`structure having a hemicylindrical cross-sectional shape.
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`45.|(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
`
`partially through the side opening includes advancing the balloon catheter or stent_through a
`
`side-openingstructure having at least two inclined slopes.
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`46.|(New) The method of any one of claims 25 or 40-45, wherein advancing the balloon
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`catheter or stent at least partially through the side opening includes advancing the balloon
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`catheter or stent through an opening formed by a material or material combination more rigid
`
`than the distal end portion of the tubular structure.
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`47.|(New) The method of claim 25, wherein advancing the balloon catheter or stent at least
`
`partially through the tubular structure includes advancing the balloon catheter or stent through a
`
`reinforcing braid or coil having a length of 20 to 30 cm.
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`48.
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`(New) The method of claim 25, wherein advancing the balloon catheter or stent though
`
`the side opening and through the tubular structure includes advancing the balloon catheter_or
`
`stent respectively through a first portion of the guide extension catheter having a first flexural
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`REISSUE APPLICATION NO. 14/195,435
`REISSUE APPLICATION
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`modulus and a second portion of the guide extension catheter having a second flexural modulus
`
`less than the first flexural modulus.
`
`49.
`
`(New) The method of any one of claims 25, 33, 37, 40 or 48, wherein advancing the
`
`balloon catheter or stent at
`
`least partially through the side opening includes advancing the
`
`balloon catheter or stent through a side-opening structure having one or moreslits or cuts.
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`50.
`
`(New) The method of claim 49, wherein at least one cut includes two aligned linear cuts
`
`separated by a section of uncutstructure.
`
`51.
`
`(New) A method, comprising:
`
`advancinga distal end of a guide catheter having a lumen through a main blood vessel to
`
`an ostium of a coronary artery;
`
`advancing a distal end of a guide extension catheter through, and beyond the distal end
`
`of, the guide catheter, including advancing a distal end portion of a tubular structure of the guide
`
`extension catheter beyond the distal end of the guide catheter while a segment defining an
`
`arcuate cross-sectional shape of the guide extension catheter remains within the guide catheter,
`
`the arcuate cross-sectional shape extending for a length of at least about 15 cm; and
`
`with the distal end of the guide extension catheter positioned beyond the distal end ofthe
`
`guide catheter, advancing a treatment catheter at least partially through the guide catheter and the
`
`guide extension catheter and into the coronary artery, including advancing a distal portion of the
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`17
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`REISSUE APPLICATION
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`treatment_catheter through a hemostatic valve associated with a proximal end of the guide
`
`catheter, along a substantially rigid segment of the guide extension catheter, along the arcuate
`
`cross-sectional shape, and throughthe tubular structure.
`
`52.
`
`(New) A method, comprising:
`
`advancing a distal end of a guide catheter having a lumen through a main blood vessel to
`
`an ostium of a coronary artery:
`
`advancingadistal end of a guide extension catheter through the guide catheter, including
`
`advancing a distal end portion of a tubularstructure of the guide extension catheter beyond the
`
`distal end of the guide catheter while a segment defining a side opening of the guide extension
`
`catheter remains within the guide catheter, wherein the segment defining the side opening
`
`comprises a portion of the guide extension catheter that is more rigid than the distal end portion
`
`of the tubular structure;
`
`maintaining the distal end portion of the tubular structure of the guide extension catheter
`
`in position beyond the distal end of the guide catheter; and
`
`while maintaining the distal end of the guide extension catheter positioned beyond the
`
`distal end of the guide catheter, advancing a balloon catheter or stent at least partially through the
`
`guide catheter and the guide extension catheter and into the coronary artery, including advancing
`
`the balloon catheter or stent through a hemostatic valve associated with a proximal end ofthe
`
`
`
`
`
`
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`guidecatheter,alongasubstantiallyrigidsegmentoftheguideextensioncatheter,throughthe
`
`
`
`
`
`
`
`
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`side opening, and through the tubular structure.
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`18
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`33,
`
`(New) The method of claim 52, wherein advancing the distal end of the guide extension
`
`catheter through the guide catheter includes positioning the segment defining the side opening
`
`within the guide catheter for receiving the treatment catheter.
`
`54.
`
`(New) The method of claim 52, wherein advancing the treatment _catheter_at_ least
`
`partially through the side opening includes advancing the balloon catheter or the stent along a
`
`concave track of the side opening, the concave track extending for a length of about 20 cm to
`
`about 75 cm.
`
`55.
`
`(New) The method of claim 52, wherein advancing the treatment_catheter_at
`
`least
`
`partially through the side opening includes advancing the treatment catheter through a structure
`
`having an arcuate cross-sectional shape, the arcuate cross-sectional shape extending for a length
`
`of at least about 15 cm.
`
`19
`
`
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