CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 1 of 805
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`EXHIBIT 23 
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`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 2 of 805
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`Case No. 0:17-cv-01969 (PJS/TNL)
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`
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`QXMédical, LLC,
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`Plaintiff and Counterclaim
`Defendant,
`
`
`v.
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`Vascular Solutions LLC, Teleflex
`Innovations S.à.r.l., and Arrow
`International, Inc.,
`
`Defendants and Counterclaim
`Plaintiffs.
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`EXPERT REPORT OF PETER T. KEITH ON INFRINGEMENT, CLAIM
`COVERAGE, AND LACK OF ACCEPTABLE NONINFRINGING ALTERNATIVES
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`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 3 of 805
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`
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`TABLE OF CONTENTS
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`I. 
`
`II. 
`
`III. 
`IV. 
`
`Introduction ..........................................................................................................................1 
`A. 
`Assignment ..............................................................................................................1 
`B. 
`Summary of Opinions ..............................................................................................2 
`1. 
`Infringement .................................................................................................2 
`2. 
`GuideLiner, TrapLiner, and Guidezilla .......................................................6 
`3. 
`Acceptable noninfringing alternatives .........................................................8 
`Qualifications ...........................................................................................................8 
`C. 
`Compensation ..........................................................................................................9 
`D. 
`Materials Considered ...............................................................................................9 
`E. 
`Background on the Technology of This Case ....................................................................10 
`A. 
`Coronary Catheters and Heart Disease ..................................................................10 
`B. 
`VSI’s GuideLiner Devices .....................................................................................27 
`C. 
`QXMédical’s Boosting Catheter ............................................................................33 
`D. 
`Other Catheters—Guidezilla and TrapLiner ..........................................................36 
`E. 
`Overview of VSI’s Patents .....................................................................................39 
`Legal Standards and Claim Construction ..........................................................................42 
`Opinions on Infringement ..................................................................................................45 
`A. 
`Overview ................................................................................................................45 
`B. 
`The ’032 Patent ......................................................................................................47 
`C. 
`The ’413 Patent ......................................................................................................48 
`D. 
`The ’380 Patent ......................................................................................................53 
`E. 
`The ’760 Patent ......................................................................................................59 
`F. 
`The ’776 Patent ......................................................................................................64 
`G. 
`The ’116 Patent ......................................................................................................66 
`Opinions on GuideLiner, TrapLiner, and Guidezilla .........................................................74 
`V. 
`Lack of Acceptable Noninfringing Alternatives ................................................................76 
`VI. 
`VII.  Conclusion .........................................................................................................................80 
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`TABLE OF APPENDICES
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`Curriculum Vitae ............................................................................................................................ A
`Materials Considered ...................................................................................................................... B
`Description of Laboratory Testing .................................................................................................. C
`Summary of Testing Results ........................................................................................................... D
`Two Point Bend Test – Data Summary and Notes ......................................................................... E
`Two Point Bend Test – Raw Data ................................................................................................... F
`Crush Test – Data Summary and Notes .......................................................................................... G
`Crush Test – Raw Data ................................................................................................................... H
`Claim Charts – Boosting Catheter ................................................................................................... I
`Claim Charts – GuideLiner v1 ......................................................................................................... J
`Claim Charts – GuideLiner v2 ........................................................................................................ K
`Claim Charts – GuideLiner v3 ........................................................................................................ L
`Claim Charts – GuideLiner XL ...................................................................................................... M
`Claim Charts – TrapLiner ............................................................................................................... N
`Claim Charts – Guidezilla I ............................................................................................................ O
`Claim Charts – Guidezilla II ........................................................................................................... P
`Material Property Data – PTFE ...................................................................................................... Q
`Material Property Data – Pebax 6333 ............................................................................................. R
`Summary of Market Data ................................................................................................................ S
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`
`I.
`
`INTRODUCTION
`A.
`
`Assignment
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`
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`My name is Peter T. Keith. I am an engineer, inventor, and independent
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`consultant in the medical device industry. I have over 30 years of experience in research and
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`development of medical devices, and in particular catheters for cardiovascular procedures.
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`I have been retained as an independent expert on behalf of Vascular Solutions
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`LLC, Teleflex Innovations S.à.r.l., and Arrow International, Inc., whom I will refer to
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`collectively in this report as Vascular Solutions or VSI.
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`
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`I have been asked to provide my expert opinions and testimony in the patent
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`dispute between Vascular Solutions and QXMédical, LLC. In particular, I have been asked to
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`analyze whether QXMédical’s Boosting Catheter infringes the following claims of Vascular
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`Solutions’ patents:
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` Claims 3 and 8 of U.S. Patent No. 8,048,032 (the ’032 Patent)
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` Claim 9 of U.S. Patent No. 8,142,413 (the ’413 Patent)
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` Claims 1, 3, and 8 of U.S. Patent No. RE45,380 (the ’380 Patent)
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` Claims 25, 30, 31, 32, and 48 of U.S. Patent No. RE45,760 (the ’760 Patent)
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` Claims 25, 32, 36, 52, and 53 of U.S. Patent No. RE45,776 (the ’776 Patent), and
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` Claims 25, 34, and 53 of U.S. Patent No. RE46,116 (the ’116 Patent).
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`I will refer to these claims throughout this report as the asserted claims.
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`
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`In addition to analyzing whether QXMédical’s Boosting Catheter infringes the
`
`asserted claims, I was asked to analyze whether the asserted claims cover Vascular Solutions’
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`GuideLiner and TrapLiner devices and Boston Scientific Corporation’s Guidezilla devices.
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`
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`Finally, I was asked to analyze whether Terumo’s Heartrail 5-in-6 device or the
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`catheters described in U.S. Patent No. 5,527,292 to Adams et al. (“Adams”), U.S. Patent No.
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`5,290,247 to Crittenden (“Crittenden”), and U.S. Patent No. 5,439,445 to Kontos (“Kontos”)
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`would be acceptable noninfringing alternatives to the Boosting Catheter if made commercially
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`available.
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`This report summarizes the opinion testimony I expect to offer if called to testify
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`at trial. This report is based on the information currently available to me. If additional
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`information becomes available, I reserve the right to supplement and/or amend my analysis and
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`my opinions. In particular, I understand that QXMédical or one of its experts may offer opinions
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`regarding the questions I have analyzed in this report and I reserve the right to review and
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`respond to that testimony.
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`If I am called to testify at trial, at a deposition, or at another hearing or proceeding
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`about this report, I may cite other documents or information similar to what I have specifically
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`identified in this report. I may also use graphics, animations, pictures, demonstrations, and/or
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`other audio/visual aids to explain my analysis and opinions. In particular, I may use product
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`samples of the Boosting Catheter, GuideLiner, Guidezilla, and other related products discussed
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`in this report.
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`B.
`
`Summary of Opinions
`1.
`
`Infringement
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`
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`In order to form my opinions on infringement, I reviewed the Vascular Solutions
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`patents, the asserted claims, and various information produced during discovery in this case,
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`including technical documents and deposition testimony. I personally attended the depositions
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`of QXMédical’s chief technical officer, Fernando Di Caprio. In addition, I manually inspected
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`and performed various laboratory tests on samples of the Boosting Catheter device.
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`Based on my review of these materials relating to the Boosting Catheter, I have
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`formed opinions about whether the Boosting Catheter meets the limitations of each of the
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`asserted claims. For claims to the device itself, I have also reached a conclusion about whether
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`QXMédical infringes the claims by making, using, selling, or offering for sale the Boosting
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`Catheter. For asserted claims covering methods of using the device or systems including the
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`device and a guide catheter, I have not reached an ultimate conclusion about whether QXMédical
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`infringes the claims. Instead, I have reached a conclusion about whether physicians (generally
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`cardiologists) using the Boosting Catheter or combining it with a guide catheter infringe the
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`method and system claims. I have also formed opinions about whether the Boosting Catheter
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`constitutes a material part of the invention of the asserted claims, whether the Boosting Catheter
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`is especially made or adapted for use in the method or system of the asserted claims, and whether
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`the Boosting Catheter is a staple article or commodity of commerce suitable for substantial
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`noninfringing use. I have not formed opinions regarding QXMédical’s knowledge or intent, nor
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`whether QXMédical has induced or contributed to physicians’ infringement. Those questions
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`are beyond the scope of my analysis.
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`
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`The ’032 Patent: It is my opinion that each model of the Boosting Catheter
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`meets the limitations of claim 3 of the ’032 Patent and that the six French Boosting Catheter,
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`Model No. BC57-150, meets the limitations of claim 8 of the ’032 Patent. It is my opinion that
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`QXMédical infringes these claims when it makes, uses, sells, offers for sale, or imports one of
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`these devices in or into the United States.
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`
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`The ’413 Patent: It is my opinion that each model of the Boosting Catheter
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`meets the limitations of claim 9 of the ’413 Patent when used for a coronary vascular procedure
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`with a guidewire, standard guide catheter, and an interventional cardiology device (balloon
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`catheter or stent), and that physicians infringe claim 9 of the ’413 Patent when using the
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`Boosting Catheter when performing such procedures. It is my opinion that the Boosting Catheter
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`constitutes a material part of the method of claim 9 of the ’413 Patent, that the Boosting Catheter
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`is especially made or adapted for use in the method of claim 9 of the ’413 Patent, and that the
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`Boosting Catheter is not a staple article or commodity suitable for substantial noninfringing use.
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`
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`The ’380 Patent: It is my opinion that each model of the Boosting Catheter
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`meets the limitations of claims 1 and 3 of the ’380 Patent when combined with a guide catheter
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`and that the six French Boosting Catheter, Model No. BC57-150, meets the limitations of claim 8
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`of the ’380 Patent when combined with a guide catheter. It is my opinion that physicians
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`infringe claims 1, 3, and 8 of the ’380 Patent when they assemble and use the combinations just
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`described to perform vascular procedures. It is my opinion that each model of the Boosting
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`Catheter constitutes a material part of the systems of claims 1 and 3 of the ’380 Patent, that each
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`model of the Boosting Catheter is especially made or adapted for the systems of claims 1 and 3
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`of the ’380 Patent, and that no model of the Boosting Catheter is a staple article or commodity
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`suitable for substantial noninfringing use. Further, it is my opinion that the six French Boosting
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`Catheter constitutes a material part of the system of claim 8 of the ’380 Patent, that the six
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`French Boosting Catheter is especially made or adapted for use in the system of claim 8 of the
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`’380 Patent, and that the six French Boosting Catheter is not a staple article or commodity
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`suitable for substantial noninfringing use.
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`The ’760 Patent: It is my opinion that the six French model of the Boosting
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`Catheter, Model No. BC57-150, meets the limitations of claims 25, 30, 31, 32, and 48 of the ’760
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`Patent when combined with a guide catheter, and that physicians infringe claims 25, 30, 31, 32,
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`and 48 of the ’760 Patent when they assemble and use the combinations just described to
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`perform vascular procedures. It is my opinion that the six French Boosting Catheter constitutes a
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`material part of the systems of claims 25, 30, 31, 32, and 48 of the ’760 Patent, that the six
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`French Boosting Catheter is especially made or adapted for use in the systems of claims 25, 30,
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`31, 32, and 48 of the ’760 Patent, and that the six French Boosting Catheter is not a staple article
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`or commodity suitable for substantial noninfringing use.
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`The ’776 Patent: It is my opinion that each model of the Boosting Catheter meets
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`the limitations of claims 25, 36, and 52 of the ’776 Patent and that the six French Boosting
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`Catheter, Model No. BC57-150, meets the limitations of claims 32 and 53 of the ’776 Patent. It
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`is my opinion that QXMédical infringes these claims when it makes, uses, sells, offers for sale,
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`or imports one of these devices in or into the United States.
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`
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`The ’116 Patent: It is my opinion that the six French Boosting Catheter, Model
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`No. BC57-150, meets the limitations of claims 25 and 34 of the ’116 Patent when used for a
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`coronary vascular procedure with a guide catheter and a balloon catheter or stent and that each
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`model of the Boosting Catheter meets the limitations of claim 53 of the ’116 Patent in those
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`circumstances. It is my opinion that physicians infringe claims 25, 34, and 53 of the ’116 Patent
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`when performing a procedure as just described. It is my opinion that the six French Boosting
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`Catheter constitutes a material part of the methods of claims 25 and 34 of the ’116 Patent, that
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`the six French Boosting Catheter is especially made or adapted for the methods of claims 25 and
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`34 of the ’116 Patent, and that the six French Boosting Catheter is not a staple article or
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`commodity suitable for substantial noninfringing use. It is my opinion that each model of the
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`Boosting Catheter constitutes a material part of the method of claim 53 of the ’116 Patent, that
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`each model of the Boosting Catheter is especially made or adapted for use in the method of claim
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`53 of the ’116 Patent, and that no model of the Boosting Catheter is a staple article or commodity
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`suitable for substantial noninfringing use.
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`2.
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`GuideLiner, TrapLiner, and Guidezilla
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`Similar to my opinions on infringement, I have formed opinions regarding which
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`of the asserted claims cover VSI’s GuideLiner and TrapLiner catheters and Boston Scientific’s
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`Guidezilla catheters based on my review of the asserted patents and claims, information
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`produced in discovery, and my manual inspection and testing of the products.
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`There are four models of the GuideLiner catheter: the first generation of the
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`device, which I will call Version 1 or V1, the second generation of the device, Version 2 or V2,
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`the third generation of the device, Version 3 or V3, and an extra-long version of the device, XL.
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`Models V1, V2, and V3 come in different sizes, for example five French and six French. Model
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`XL comes in six French size only. In summarizing and explaining my opinions in this report and
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`the attached claim charts, I will use the phrase “all versions” to refer to all four versions of the
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`GuideLiner and the phrase “all sizes” to refer to all sizes of those models. Where appropriate, I
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`will specify which models and sizes I am indicating.
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`Similarly, there are two versions of the Guidezilla catheter: a first generation that
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`I will call Version 1 or V1 and a second generation that I will call Version 2 or V2. Version 1
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`was available in a six French size only; Version 2 is available in several sizes. I will use the
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`same conventions just described to refer to the various versions and sizes of the Guidezilla
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`catheter.
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`The ’032 Patent: It is my opinion that all versions and sizes of the GuideLiner
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`and Guidezilla meet the limitations of claim 3 of the ’032 Patent. It is my opinion that the six
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`French size of each version of the GuideLiner and Guidezilla meets the limitations of claim 8 of
`
`the ’032 Patent.
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`The ’413 Patent: It is my opinion that all versions and sizes of the GuideLiner
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`and Guidezilla meet the limitations of claim 9 of the ’413 Patent when used for a coronary
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`vascular procedure with a guidewire, guide catheter, and interventional cardiology device
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`(balloon catheter or stent).
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`The ’380 Patent: It is my opinion that all versions and sizes of the GuideLiner
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`and Guidezilla meet the limitations of claims 1 and 3 of the ’380 Patent when combined with a
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`guide catheter. It is my opinion that the six French size of each version of the GuideLiner and
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`Guidezilla meets the limitations of claim 8 of the ’380 Patent when combined with a guide
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`catheter.
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`The ’760 Patent: It is my opinion that the six French size of each version of the
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`GuideLiner, Guidezilla, and TrapLiner meets the limitations of claims 25, 30, 31, 32, and 48 of
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`the ’760 Patent when combined with a guide catheter, except that the GuideLiner V2 does not
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`meet the limitations of claim 32 of the ’760 Patent.
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`The ’776 Patent: It is my opinion that all versions and sizes of the GuideLiner,
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`Guidezilla, and TrapLiner catheters meet the limitations of claim 25 of the ’776 Patent and that
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`the six French sizes of those catheters meet the limitations of claim 32 of the ’776 Patent. It is
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`my opinion that all sizes of the GuideLiner V3 and the TrapLiner meet the limitations of claim
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`36 of the ’776 Patent. It is my opinion that all versions and sizes of the GuideLiner, Guidezilla,
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`and TrapLiner except GuideLiner V2 meet the limitations of claim 52 of the ’776 Patent and that
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`the six French sizes of those catheters meet the limitations of claim 53 of the ’776 Patent.
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`The ’116 Patent: It is my opinion that the six French size of each version of the
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`GuideLiner, Guidezilla, and TrapLiner meets the limitations of claims 25 and 34 of the ’116
`
`Patent when used for a coronary vascular procedure with a guide catheter and that all versions
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`and sizes of the GuideLiner, GuideZilla, and TrapLiner meet the limitations of claim 52 of the
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`’116 Patent in those circumstances.
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`3.
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`Acceptable noninfringing alternatives
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`
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`It is my opinion that neither the Heartrail 5-in-6 catheter, Adams, Crittenden, nor
`
`Kontos embodies or describes a device that would be an acceptable noninfringing alternative to
`
`the Boosting Catheter if made commercially available in the United States. Although those
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`devices would not infringe the asserted claims, they each suffer from a number of practical
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`drawbacks that would make them unacceptable alternatives. I describe these drawbacks in
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`greater detail in Part VI below.
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`C.
`
`Qualifications
`
`
`
`I summarize my educational background and career history in the following
`
`paragraphs. My curriculum vitae is attached as Appendix A to this report.
`
`
`
`I received a Bachelor of Science degree with High Distinction from the University
`
`of Minnesota in 1987.
`
`
`
`During my undergraduate training, I began working as an engineering intern in
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`the research and development (R&D) department at SCIMED, which was later acquired by
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`Boston Scientific Corporation. I joined SCIMED full-time after graduation, and I remained with
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`the company until 1996. During this time I rose from engineering intern to full-time R&D
`
`engineer to Director of R&D. Throughout my various roles at SCIMED, the focus of my work
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`was on medical devices in the field of interventional cardiology, and particularly catheter design.
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`
`
`From 1997 through today, I have served as an independent consultant for early
`
`stage medical device companies in the areas of product design and intellectual property
`
`development. Several of my consulting clients have developed successful products that are on
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`the market and in hospitals today. A number of the products have been in the field of
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`interventional cardiology, and particularly catheters.
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`
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`In addition to my work as an independent consultant, I have engaged in a number
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`of entrepreneurial ventures in the field of medical devices since the year 2000. In many of these
`
`ventures, I held chief responsibility for product design and development. Several of these
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`products have been in the area of interventional cardiology. I have also done considerable work
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`outside the area of interventional cardiology, including in treatments for chronic sinusitis,
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`orthopedics for extremities such as feet and ankles, and treatment of spinal disorders.
`
`
`
`Between my work at SCIMED, my independent consulting, and my
`
`entrepreneurial ventures, I have been named as an inventor on over 100 issued U.S. patents, as
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`well as many corresponding patents in foreign countries. Numerous patent applications on
`
`which I am a named inventor are still pending.
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`
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`I have served as an expert witness in three prior patent litigations on behalf of
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`Boston Scientific Corporation, my former employer. These litigations are described briefly in
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`my curriculum vitae, Appendix A. I have not testified as an expert witness by deposition or at
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`trial in the last four years.
`
`D.
`
`Compensation
`
`
`
`I am being compensated at my normal rate of $475 per hour for my time spent
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`preparing this report. I am also being reimbursed for my reasonable expenses associated with
`
`my work on this case. My compensation in no way depends on my conclusions or the outcome
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`of this case.
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`E. Materials Considered
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`
`
`In preparing this report, I have relied on my years of experience and expertise in
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`the relevant technology. I have also reviewed and relied upon the materials listed in Appendix
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`B, as well as all other documents cited in this report and its attachments.
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`II.
`
`BACKGROUND ON THE TECHNOLOGY OF THIS CASE
`A.
`
`Coronary Catheters and Heart Disease
`
`
`
`The technology involved in this case pertains to coronary catheter procedures.
`
`These are procedures for treating conditions in the blood vessels of the heart itself (coronary
`
`arteries). More specifically, this case pertains to a specialized catheter device used in some of the
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`more challenging procedures, called a “guide extension catheter”.
`
`
`
`As the heart is essentially a large muscular pumping organ, it requires a lot of
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`oxygenated blood to sustain itself. This blood circulates within the heart muscle via the coronary
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`arteries (see diagram below). Over time, these blood vessels may become diseased (coronary
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`artery disease, “CAD”) resulting in regions of narrowing or clogging. Starting in the 1970s,
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`advances were made in treating this disease with catheter devices advanced into the coronary
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`arteries from relatively accessible arteries in the leg or arm, e.g., the femoral artery in the leg or
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`the radial artery in the arm.
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`
`
`CAD (also called atherosclerosis or plaque buildup) results in narrowed regions
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`(lesions or stenoses) that can restrict the flow of blood to regions of the heart muscle (see
`
`below—A). Severe lesions can dramatically restrict the blood flow, starving the muscle of
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`oxygen (ischemia), which can create severe chest pain, and significantly limit a patient’s activity
`
`
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`10
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`and quality of life. If the restriction completely blocks the flow of blood (typically from a
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`subsequent blood clot within the lesion), this can lead to a heart attack (myocardial infarction).
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`(See below—B). Severe lesions and complete blockages necessitate some sort of treatment to re-
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`open the blocked region and re-establish normal blood flow. In the case of a complete blockage
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`(myocardial infarction), the patient may die if the blocked vessel is not re-opened quickly, i.e.,
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`within hours of the blockage.
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`The most common treatment for CAD is with catheter devices that dilate the
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`blockage from inside and place a support scaffold (stent) therein. The stent is inserted across the
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`lesion in a collapsed state and then dilated with a balloon-tipped catheter called an angioplasty
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`catheter (see below). It is therefore critical that these catheter devices are able to be positioned
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`within the blockage, and positioned quickly, in order to successfully treat the patient.
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`One of the main pumping chambers of the heart is the left ventricle “LV”. The LV
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`receives the oxygenated blood from the lungs, and pumps it to the body via the aorta. The rest of
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`the blood vessels that oxygenate the body are all branches and sub-branches off of the aorta. The
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`very first branches, near the very beginning of the aorta, are the coronary arteries, the left main
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`coronary artery “LM”, and the right coronary artery “RCA”. The openings of these arteries from
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`the aorta are called ostia (singular: ostium). The LM runs for a short length before it branches
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`into two longer arteries that run the rest of the way down the left and posterior sides of the heart:
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`the left anterior descending “LAD” and left circumflex “LCX”. The RCA extends down the right
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`side of the heart. The RCA, LAD, and LCX are considered the three primary coronary arteries.
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`Each of these arteries, in turn, has numerous side branches, which then further branch ultimately
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`into the capillary beds where the actual transfer of oxygen to heart muscle tissue takes place (see
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`figure below). Most lesions requiring treatment are within these three primary arteries, or
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`occasionally a major branch stemming therefrom.
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`Beyond the coronary arteries, the aorta has numerous branches and sub-branches
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`as it feeds oxygenated blood to the rest of the body (see diagram below—A). The aortic arch is
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`where the aorta turns and heads inferiorly (descending aorta) towards the legs. One of the
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`branches off the aorta that feeds the arm is the right subclavian artery. A sub-branch of this artery
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`is the radial artery near the wrist. Another branch from the aorta is the iliac artery, which further
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`sub-branches into the femoral artery near the groin. The femoral artery and radial arteries are
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`relatively close to the skin surface, and one or the other are typically used as the access vessels to
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`gain access to the aorta and the coronary arteries as will be described below (see diagram
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`below—B).
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`In the following paragraphs, I will describe a typical treatment procedure. Many
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`variations of this exist, but this description of a typical and common procedure will serve to
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`illustrate the issues pertinent to the technology in the case at issue.
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`The treatment of these lesions by catheter techniques involves accessing a remote
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`blood vessel, e.g., the femoral artery, via a needle puncture from the skin into the vessel, known
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`as percutaneous access. A series of devices and maneuvers (called the “Seldinger” technique)
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`results in placement of an introducer sheath into this vessel (see below). The introducer sheath is
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`a relatively short tubular access catheter, approximately 20 cm long. Its purpose is primarily to
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`maintain an access pathway into the femoral artery to facilitate the rest of the procedure.1 These
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`sheaths have a fixed inner diameter of 5, 6, 7, or 8 French. (One French is 0.33mm). A slitted
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`seal is provided on the back (proximal) end of the sheath to keep blood from exiting. The size is
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`chosen by the interventionalist and depends on numerous factors, including the sizes of the
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`planned devices to be inserted through the sheath and used for the coronary lesion.
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`1 In some angioplasty procedures, particularly those targeting sites in the peripheral
`vasculature, physicians use a long guiding sheath in lieu of a guide catheter. These guiding
`sheaths are different from the introducer sheaths I am now discussing.
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