BSC USP 8,048,032
`Exhibit 1027
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`Page 351 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 23 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
`modulus greater than the second
`flexural modulus.
`
`
`
`
`
` First Flexural Modulus Second Flexural Modulus
`
`
`
`
`
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`
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` Third Flexural Modulus
`
`
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`
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`17
`
`

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`CASE 0:13-cv-01172-JRT-SER Document 12-9 Filed 06/10/13 Page 24 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
`
`
`
`
` Fourth Flexural Modulus
`
`
`
`
`
`
`
`18
`
`
`
`
`
`
`
`

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`Exhibit 39
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`

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`Page 450 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 48 of 81
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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. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`‘413 patent, claim 1.
`
`1. A method of providing backup
`support for an interventional
`cardiology device for use in the
`coronary vasculature, the
`interventional cardiology device
`being adapted to be passed through
`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, the method comprising:
`
`
`
`This is preamble language, which I understand may not
`necessarily limit the scope of the claim. Notwithstanding,
`Boston Scientific’s Guidezilla is used to provide backup
`support for an interventional cardiology device for use in
`the coronary vasculature, where the interventional
`cardiology device is passed through a standard guide
`catheter that has a continuous lumen that extends from a
`proximal end at a hemostatic valve to a distal end that is
`placed in a branch artery.
`
`That Boston Scientific instructs users to use the Guidezilla
`in a manner that meets all steps of this claim 1 is clear from
`the Boston Scientific Directions for Use (Ex. 25). Excerpts
`from these Directions for Use are included below, but, for
`clarity, and because these Directions for Use show that
`Boston Scientific instructs users to use the Guidezilla in a
`manner that meets all steps of claim 1, the “Delivery
`Procedure” portion of the Directions for Use are
`reproduced here, as follows:
`
`“Delivery Procedure
`“Deliver the Guidezilla device according to the following
`steps:
`“1. Secure the previously inserted guidewire and backload
`the distal tip of the Guidezilla device onto the guidewire
`and advance until the device is just proximal to the
`hemostasis valve.
`“2. Open the hemostasis valve and advance the Guidezilla
`device through the hemostasis valve and into the guide
`catheter.
`“3. 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.
`. . . .
`“4. Using fluoroscopy, confirm the desired position of the
`Guidezilla device in the vessel.
`“5. If performing an interventional procedure, backload the
`interventional device over the guidewire and advance the
`device through the guide catheter and Guidezilla device
`into the desired vascular space.
`
`
`
`
`
`

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`Page 451 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 49 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`“Note: Use caution when advancing the interventional
`device into the distal guide segment.
`“6. Tighten the Y-adaptor hemostasis valve securely on the
`proximal shaft of the Guidezilla device to prevent back-
`bleeding.
`“7. Perform the catheterization procedure. After completing
`the procedure, remove the Guidezilla device prior to
`removing the guide catheter from the vessel.”
`Guidezilla Directions for Use at 3 (Ex. 25).
`
`“Other items required but not provided: Guide catheter
`with an inner diameter large enough to accommodate the
`Guidezilla™ device.” Guidezilla Directions for Use at 3
`(Ex. 25).
`
`“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.
`
`To use the Guidezilla, a standard guide catheter is inserted
`into a first artery over a guidewire. Boston Scientific’s
`documents confirm that a guidewire is used with the
`catheter (see above) and Guidezilla.
`
`“Never advance the Guidezilla device into a vessel without
`a leading guidewire. . . .” Guidezilla Directions for Use at
`2 (Ex. 25).
`
`“Other items required but not provided: . . . Guidewire with
`diameter < 0.014 in (0.36 mm).” Guidezilla Directions for
`Use at 3 (Ex. 25).
`
`2
`
`inserting the standard guide
`catheter into a first artery over a
`guidewire, the standard guide
`catheter having a distal end;
`
`
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`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 50 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`positioning the distal end of the
`standard guide catheter in a branch
`artery that branches off from the
`first artery;
`
`
`To use the Guidezilla, the distal end of the standard guide
`catheter is positioned in a branch artery that branches off
`from the first artery.
`
`“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.”
`Guidezilla Directions for Use at 2 (Ex. 25).
`
`Boston Scientific documents instruct the user to insert the
`flexible tip portion of the Guidezilla coaxial guide catheter
`into the continuous lumen of the standard guide catheter.
`
`“Delivery Procedure
`“Deliver the Guidezilla device according to the following
`steps:
`“1. Secure the previously inserted guidewire and backload
`the distal tip of the Guidezilla device onto the guidewire
`and advance until the device is just proximal to the
`hemostasis valve. . . .”
`
`Guidezilla Directions for Use at 3 (Ex. 25).
`
`Guidezilla has a flexible tip portion with a tubular structure
`and a circular cross-section and a length that is shorter than
`the predefined length of the continuous lumen of the
`standard guide catheter. That 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 diagram below:
`
`
`
`
`
`
`3
`
`
`
`inserting a flexible tip portion of a
`coaxial guide catheter 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
`standard guide catheter, into the
`continuous lumen of the standard
`guide catheter, and,
`
`
`
`
`
`

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`Page 453 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 51 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
`
`
`
`
`
`Guidezilla has a tubular structure. It has “a single lumen
`distal guide segment.” Guidezilla Directions for Use at 2.
`“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 is shorter than the length of
`the continuous lumen of the guide catheter. The following
`Boston Scientific drawing shows that the Guidezilla has a
`tubular structure that is 25cm in length:
`
`4
`
`
`
`
`
`
`
`
`
`

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`Page 454 of 483
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`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 52 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
` standard 6F guide catheter length is 100cm. 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 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).
`
`Guidezilla has a substantially rigid portion that is proximal
`of, operably connected to, and more rigid along a
`longitudinal axis than the flexible tip portion. This is the
`“stainless steel proximal shaft” of the Guidezilla device.
`Guidezilla Directions for Use at 2 (Ex. 25).
`
`As the attached photographs depict, this “stainless steel
`proximal shaft” is substantially rigid, defines a rail
`structure without a lumen, and 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.
`
` A
`
`
`
`
`
`further inserting a substantially
`rigid portion that is proximal of,
`operably connected to, and more
`rigid along a longitudinal axis than
`the flexible tip portion, into the
`continuous lumen of the standard
`guide catheter, the substantially
`rigid portion 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
`
`
`
`5
`
`

`
`Page 455 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 53 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`guide 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 145cm, longer than the standard 100cm length
`of the continuous lumen of the guide catheter.
`
`When the distal end of the flexible tip portion is extended
`distally of the distal end of the guide catheter, at least a
`
`6
`
`
`
`
`
`

`
`Page 456 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 54 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`portion of the proximal portion of the substantially rigid
`portion extends through the hemostatic valve.
`
`“The Boston Scientific GUIDEZILLA™ Guide Extension
`Catheter acts as an extension to a traditional guide
`catheter.” Boston Scientific’s 510(k) Summary (Ex. 21).
`
`The distal end of the Guidezilla extends past the distal end
`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).
`
`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).
`
`This substantially rigid portion of the Guidezilla device is
`inserted into the continuous lumen of the standard guide
`catheter, as noted above from the Directions for Use, which
`instruct the user to insert the Guidezilla device into the
`guide catheter “until the device is just proximal to the
`hemostasis valve.” Guidezilla Directions for Use at 3 (Ex.
`25).
`
` A
`
` distal portion of the Guidezilla’s flexible tip portion is
`advanced distally beyond the distal end of the standard
`guide catheter and into the second artery, such that the
`distal portion extends into the second artery and such that at
`least a portion of the proximal portion of the substantially
`rigid portion extends proximally through the hemostatic
`valve.
`
`“Delivery Procedure
`
`7
`
`
`
`
`
`
`
`advancing a distal portion of the
`flexible tip portion distally beyond
`the distal end of the standard guide
`catheter and into the second artery
`such that the distal portion extends
`into the second artery and such
`that at least a portion of the
`proximal portion of the
`substantially rigid portion extends
`proximally through the hemostatic
`valve; and
`
`

`
`Page 457 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 55 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`“Deliver the Guidezilla device according to the following
`steps:
`. . . .
`“2. Open the hemostasis valve and advance the Guidezilla
`device through the hemostasis valve and into the guide
`catheter.
`“3. 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.
`. . . .
`“6. Tighten the Y-adaptor hemostasis valve securely on the
`proximal shaft of the Guidezilla device to prevent back-
`bleeding.”
`Guidezilla Directions for Use at 3 (Ex. 25).
`
`Boston Scientific’s documents instruct the user to insert the
`interventional cardiology device into and through the
`continuous lumen of the standard guide catheter, alongside
`the substantially rigid portion, and to advance the
`interventional cardiology device through and beyond a
`lumen of the flexible tip portion into contact with or past a
`lesion in the second artery.
`
`“Delivery Procedure
`“Deliver the Guidezilla device according to the following
`steps:
`. . . .
`“5. If performing an interventional procedure, backload the
`interventional device over the guidewire and advance the
`device through the guide catheter and Guidezilla device
`into the desired vascular space.
`“Note: Use caution when advancing the interventional
`device into the distal guide segment.”
`Guidezilla Directions for Use at 3 (Ex. 25).
`
`
`inserting the interventional
`cardiology device into and through
`the continuous lumen of the
`standard guide catheter alongside
`of the substantially rigid portion
`and advancing the interventional
`cardiology device through and
`beyond a lumen of the flexible tip
`portion into contact with or past a
`lesion in the second artery.
`
`
`
`
`
`
`In use, the Guidezilla’s distal portion remains seated in the
`second artery as a force is applied to a proximal portion of
`the Guidezilla in response to an opposing backward force
`exerted by the interventional cardiology device as the
`interventional cardiology device is advanced. Boston
`
`‘413 patent, claim 2.
`
`2. The method as claimed in claim
`1, further comprising applying a
`force to a proximal portion of the
`coaxial guide catheter such that the
`distal portion of the coaxial guide
`
`
`
`8
`
`

`
`Page 458 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 56 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`Scientific’s documents indicate that this use is intended.
`catheter remains seated in the
`“The Boston Scientific GUIDEZILLA™ Guide Extension
`second artery in response to an
`Catheter acts as an extension to a traditional guide
`opposing backward force exerted
`catheter.” Boston Scientific’s 510(k) Summary (Ex. 21).
`by the interventional cardiology
`
`device as the interventional
`“Under fluoroscopy, advance the Guidezilla device up to a
`cardiology device is advanced.
`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.
`
`“Never advance the Guidezilla device more than 15cm
`beyond the tip of the guide catheter.” Guidezilla Directions
`for Use at 2 (Ex. 25).
`
`
`
`
`The substantially rigid portion of the Guidezilla is selected
`so that it comprises a cylindrical portion and a partially
`cylindrical portion defining an opening along a side
`thereof, as can be seen in the photograph below of the
`Guidezilla device:
`
`
`
` Cylindrical Partially Cylindrical
` Portion Portion
`
`
`
`‘413 patent, claim 4.
`
`4. The method as claimed in claim
`1, further comprising selecting the
`substantially rigid portion of the
`coaxial guide catheter such that it
`comprises a cylindrical portion
`and a partially cylindrical portion
`defining an opening along a side
`thereof.
`
`
`
`
`9
`
`

`
`Page 459 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 57 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`
`
`
`
`
`In use, the Guidezilla uses a Y-adapter. “6. Tighten the Y-
`adaptor hemostasis valve securely on the proximal shaft of
`the Guidezilla device to prevent back-bleeding.”
`Guidezilla Directions for Use at 3 (Ex. 25).
`
`The physician injects a fluid through the Y-adapter into the
`standard guide catheter. For example, a physician will
`inject a contrast dye through the Y-adaptor when using
`Guidezilla in order to visualize the vessel under
`fluoroscopy.
`
`
`
`
`Boston Scientific’s documents instruct the user to extend a
`distal portion of the tubular structure beyond the distal end
`of the standard guide catheter while a proximal portion
`remains within the lumen of the standard 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 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
`
`‘413 patent, claim 5.
`
`5. The method as claimed in claim
`1, further comprising selecting the
`standard guide catheter to further
`comprise a Y-adapter and the
`method further comprising
`injecting a fluid through the Y-
`adapter into the standard guide
`catheter.
`
`
`‘413 patent, claim 7.
`
`7. The method as claimed in claim
`1, further comprising extending a
`distal portion of the tubular
`structure beyond the distal end of
`the standard guide catheter while a
`proximal portion remains within
`the lumen of the standard guide
`catheter, such that the coaxial
`guide catheter 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
`standard catheter from the branch
`artery.
`
`
`
`
`10
`
`

`
`Page 460 of 483
`
`CASE 0:13-cv-01172-JRT-SER Document 12-11 Filed 06/10/13 Page 58 of 81
`
`PLAINTIFF VASCULAR SOLUTIONS, INC.’S CLAIM CHART
`Comparison of Boston Scientific’s GUIDEZILLA Guide Extension Catheter
`to U.S. Patent No. 8,142,413, Claims 1, 2, 4, 5, and 7-13
`Claim Language
`GUIDEZILLA Guide Extension Catheter
`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).
`
`By having the distal portion of the Guidezilla’s tubular
`structure extend beyond the distal end of the standard guide
`catheter while a proximal portion remains within the lumen
`of the standard guide catheter, the Guidezilla 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 standard catheter from the branch artery.
`
`
`
`
`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).
`
`One of Guidezilla’s radiopaque marker is positioned in the
`device’s flexible cylindrical distal tip portion proximat