BSC USP 8,142,413
`Exhibit 1024
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`Exhibit 31
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`Page 335 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 7 of 32
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`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`‘032 patent, claim 1.
`
`1. A device for use with a
`standard guide catheter, the
`standard 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 a
`branch artery, 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
`lumen to the branch artery, the
`device comprising:
`
`
`
`This is preamble language, which I understand may not
`necessarily limit the scope of the claim. Notwithstanding,
`Boston Scientific’s Guidezilla is for use with a standard
`guide catheter.
`
`“The GUIDEZILLA™ Guide Extension Catheter is
`intended to be used in conjunction with guide catheters to
`access discrete regions of the coronary and/or peripheral
`vasculature, and to facilitate placement of interventional
`devices.” Boston Scientific’s 510(k) Summary (Ex. 21);
`see also Guidezilla Directions for Use at 2 (Ex. 25).
`
` A
`
` standard guide catheter has a continuous lumen that
`extends for a predefined length from a proximal end at a
`hemostatic valve to a distal end adapted to be placed in a
`branch artery, and that has a circular cross-sectional inner
`diameter that is sized such that interventional cardiology
`devices are insertable into and through the lumen to the
`branch artery.
`
`The Guidezilla has a flexible tip portion that defines a
`tubular structure with a circular cross-section, which is the
`blue, tubular structure in the following photographs, and
`the tubular structure in the following drawing:
`
`
`
`
`
`
` a
`
` flexible tip portion defining a
`tubular structure having a circular
`cross-section and a length that is
`shorter than the predefined length
`of the continuous lumen of the
`guide catheter, the tubular
`structure having a cross-sectional
`outer diameter sized 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
`
`
`
`
`
`

`
`Page 336 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 8 of 32
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
`
`
`
`
`
`Guidezilla has “a single lumen distal guide segment.”
`Guidezilla Directions for Use at 2 (Ex. 25).
`
`“GUIDEZILLA consists of . . . a distal guide catheter
`segment through which interventional devices may be
`delivered.” Boston Scientific’s 510(k) Summary (Ex. 21).
`
`The flexible tip portion’s length of 25cm is shorter than the
`100cm length of the continuous lumen of a standard guide
`catheter. The tubular structure has a cross-sectional outer
`diameter sized to be insertable through the cross-sectional
`inner diameter of the continuous lumen of the guide
`catheter, and it defines a coaxial lumen with a cross-
`sectional inner diameter through which interventional
`
`2
`
`
`
`
`
`
`
`

`
`Page 337 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 9 of 32
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`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`cardiology devices are insertable.
`
`“The Guidezilla guide extension catheter is a single lumen
`rapid exchange catheter. . . .” with “a stainless steel
`proximal shaft with a 25cm single lumen distal guide
`segment . . . .” Guidezilla Directions for Use at 2 (Ex. 25).
`
`As the attached photographs depict, Guidezilla’s “stainless
`steel proximal shaft” is substantially rigid, proximal of and
`operably connected to, and more rigid than the flexible tip
`portion, and it is a rail structure without a lumen that has a
`maximal cross-sectional dimension at a proximal portion
`that is smaller than the cross-sectional outer diameter of the
`flexible tip portion. That the Guidezilla’s substantially
`rigid portion does not have a lumen is discussed in more
`detail in my declaration, at ¶¶ 89-103.
`
`
`
`
`
`
`
`3
`
` 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 without a lumen and
`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 along the longitudinal
`axis that is longer than the length
`of the continuous lumen of the
`guide catheter,
`
`

`
`Page 338 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 10 of 32
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
`
`The rigid portion has a length that, when combined with
`the length of the flexible distal tip portion, defines a total
`length that is longer than the length of the continuous
`lumen of the guide catheter.
`
`The following Boston Scientific drawing shows that the
`Guidezilla has a length of 145cm. A standard 6F guide
`catheter is 100cm long.
`
`
`
`
`When the distal end of the flexible tip portion is extended
`distally of the distal end of the guide catheter, at least a
`portion of the proximal portion of the substantially rigid
`portion extends through the hemostatic valve.
`
`“The Boston Scientific GUIDEZILLA™ Guide Extension
`
`
`
`
`
`
`
`such that when at least a distal
`portion of the flexible tip portion is
`extended distally of the distal end
`of the guide catheter, at least a
`portion of the proximal portion of
`the substantially rigid portion
`
`
`
`4
`
`

`
`Page 339 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 11 of 32
`
`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`Catheter acts as an extension to a traditional guide
`extends proximally through the
`catheter.” Boston Scientific’s 510(k) Summary (Ex. 21).
`hemostatic valve in common with
`
`interventional cardiology devices
`The distal end of the Guidezilla extends past the distal end
`that are insertable into the guide
`of the guide catheter: “Under fluoroscopy, advance the
`catheter.
`Guidezilla device up to a maximum of 15cm beyond the
`
`distal tip of the guide catheter and into the desired location
`within the vessel.” Guidezilla Directions for Use at 3 (Ex.
`25).
`
`“Never advance the Guidezilla device more than 15cm
`beyond the tip of the guide catheter.” Guidezilla
`Directions for Use at 2 (Ex. 25).
`
`At the same time, the proximal end of the Guidezilla
`extends from the proximal end of the guide catheter,
`through a hemostasis device. “Open the hemostasis valve
`and advance the Guidezilla device through the hemostasis
`valve and into the guide catheter.” Guidezilla Directions
`for Use at 3 (Ex. 25).
`
`
`
`
`The Guidezilla’s the tubular structure has a distal portion
`that is adapted to be extended beyond the distal end of the
`guide catheter while a proximal portion remains within the
`lumen of the guide catheter.
`
`The following Boston Scientific drawing shows that the
`Guidezilla has a tubular structure that is 25cm in length:
`
`
`
`
`That the tubular structure has a distal portion that is
`adapted to be extended beyond the distal end of the guide
`
`
`
`‘032 patent, claim 2.
`
`2. The device of claim 1 wherein
`the tubular structure includes a
`distal portion adapted to be
`extended beyond the distal end of
`the guide catheter while a proximal
`portion remains within the lumen
`of the guide catheter, such that the
`device assists in resisting axial and
`shear forces exerted by the
`interventional cardiology device
`passed through and beyond the
`coaxial lumen that would
`otherwise tend to dislodge the
`guide catheter from the branch
`artery.
`
`
`
`
`5
`
`

`
`Page 340 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 12 of 32
`
`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`catheter while a proximal portion remains within the lumen
`of the guide catheter can be seen in that the length of the
`tubular structure is 25cm, but not more than 15cm of the
`tubular structure is advanced past the distal tip of the guide
`catheter: “Under fluoroscopy, advance the Guidezilla
`device up to a maximum of 15cm beyond the distal tip of
`the guide catheter and into the desired location within the
`vessel.” Guidezilla Directions for Use at 3 (Ex. 25).
`
`“Never advance the Guidezilla device more than 15cm
`beyond the tip of the guide catheter.” Guidezilla
`Directions for Use at 2 (Ex. 25).
`
`See also above, in the discussion regarding claim 1.
`
`The Guidezilla device assists in resisting axial and shear
`forces exerted by the interventional cardiology device
`passed through and beyond the coaxial lumen, where those
`forces would otherwise tend to dislodge the guide catheter
`from the branch artery.
`
`
`
`
`The proximal portion of the Guidezilla’s tubular structure
`includes a proximal side opening that extends for a distance
`along the device’s longitudinal axis and is accessible from
`a longitudinal side that is transverse to the longitudinal
`axis, so that the opening can receive an interventional
`cardiology device into the coaxial lumen while the
`proximal portion remains within the lumen of the guide
`catheter. This opening is shown in the following
`photograph of the Guidezilla device:
`
`
`
`‘032 patent, claim 3.
`
`3. The device of claim 2 wherein
`the proximal portion of the tubular
`structure further comprises
`structure defining a proximal side
`opening extending for a distance
`along the longitudinal axis, and
`accessible from a longitudinal side
`defined transverse to the
`longitudinal axis, to receive an
`interventional cardiology device
`into the coaxial lumen while the
`proximal portion remains within
`the lumen of the guide catheter.
`
`
`
`
`6
`
`

`
`Page 341 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 13 of 32
`
`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
`
`
`
`
`
`
` Proximal Side Opening
`
`
`
`The Guidezilla device’s proximal side opening includes
`structure defining a full circumference portion and
`structure defining a partially cylindrical portion, as can be
`seen in the photograph below of the Guidezilla device:
`
`
`
`‘032 patent, claim 4.
`
`4. The device of claim 3 wherein
`the proximal side opening includes
`structure defining a full
`circumference portion and
`structure defining a partially
`cylindrical portion.
`
`
`
`
`7
`
`

`
`Page 342 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 14 of 32
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
` Full Circumference Partially Cylindrical
` Portion Portion
`
`
`
`
`
`
`
`8
`
`
`
`
`
`

`
`Page 343 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 15 of 32
`
`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`‘032 patent, claim 5.
`
`5. The device of claim 2 wherein
`the flexible cylindrical distal tip
`portion further comprises a
`radiopaque marker proximate a
`distal tip.
`
`
`
`
`Guidezilla has two radiopaque markers located in the
`tubular structure.
`
`“The guide catheter segment incorporates two radiopaque
`marker bands to aid in positioning the device during the
`procedure.” Boston Scientific’s 510(k) Summary (Ex. 21).
`
`“The Guidezilla device has two platinum-iridium marker
`bands, which enable visibility while using standard
`fluoroscopic methods. The distal marker band is located 2
`mm from the distal tip. The proximal marker band is
`located 3 mm distal to the opening of the guide segment.”
`Guidezilla Directions for Use at 2 (Ex. 25).
`
`One of Guidezilla’s radiopaque markers is positioned in the
`device’s flexible cylindrical distal tip portion, proximate a
`distal tip. The distal marker can be seen in the following
`photograph of the Guidezilla device:
`
`
`
`
`
` Radiopaque Marker
`
`
`
`
`
`
`
`9
`
`

`
`Page 344 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 16 of 32
`
`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`‘032 patent, claim 6.
`
`6. The device 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.
`
`
`
`
`The Guidezilla device’s tubular structure has a flexible
`cylindrical distal tip portion, and a flexible cylindrical
`reinforced portion that is proximal to the flexible distal tip
`portion, as can be seen in the following photograph:
`
`
`
` Flexible Cylindrical Flexible Cylindrical
` Distal Tip Portion Reinforced Portion
`
`
`
`
`
`
`
`
`The Guidezilla device’s flexible cylindrical reinforced
`portion is reinforced with metallic elements in a braided
`pattern, as can be seen in the following photograph:
`
`
`
`‘032 patent, claim 7.
`
`7. The device of claim 6 wherein
`the flexible cylindrical reinforced
`portion is reinforced with metallic
`elements in a braided or coiled
`pattern.
`
`
`
`
`10
`
`

`
`Page 345 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 17 of 32
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`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
`
`
`
`
`
`
`
`
` Metallic Elements
`
`The cross-sectional inner diameter of the Guidezilla’s
`coaxial lumen of the tubular structure is one French smaller
`than the cross-sectional inner diameter of the standard 6F
`guide catheter.
`
`“The Guidezilla device is delivered through a guide
`catheter resulting in an inner diameter that is approximately
`1 French size smaller than the guide catheter.” Guidezilla
`Directions for Use at 2 (Ex. 25).
`
`“GUIDEZILLA is a 5F catheter compatible with a 6F
`guide catheter.” Boston Scientific’s 510(k) Summary (Ex.
`21).
`
`“Guide Extension Catheter (5-in-6).” Guidezilla Directions
`for Use at 2 (Ex. 25).
`
`
`‘032 patent, claim 8.
`
`8. The device 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-
`sectional inner diameter of the
`guide catheter.
`
`
`
`See above, in the discussion of claim 1.
`
`‘032 patent, claim 11.
`
`11. A device for use with a
`
`
`
`11
`
`

`
`Page 346 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 18 of 32
`
`
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,048,032, Claims 1-8, 11-17, and 19
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`standard guide catheter, the
`standard 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 a
`branch artery, the continuous
`lumen of the guide catheter having
`a circular cross-section and a
`cross-sectional inner diameter
`sized such that intervent