CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 1 of 805
`
`
`
`EXHIBIT 23 
`
`
`
`
`
`
`
`
`
`
`
`
`Page 1
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 2 of 805
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Case No. 0:17-cv-01969 (PJS/TNL)
`
`
`
`
`
`QXMédical, LLC,
`
`Plaintiff and Counterclaim
`Defendant,
`
`
`v.
`
`Vascular Solutions LLC, Teleflex
`Innovations S.à.r.l., and Arrow
`International, Inc.,
`
`Defendants and Counterclaim
`Plaintiffs.
`
`
`
`
`
`
`
`
`
`EXPERT REPORT OF PETER T. KEITH ON INFRINGEMENT, CLAIM
`COVERAGE, AND LACK OF ACCEPTABLE NONINFRINGING ALTERNATIVES
`
`1
`
`
`
`
`
`
`
`
`Page 2
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 3 of 805
`
`
`
`TABLE OF CONTENTS
`
`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 
`
`
`
`
`
`
`
`i
`
`
`Page 3
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 4 of 805
`
`TABLE OF APPENDICES
`
`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
`
`
`
`
`
`
`
`
`
`
`
`ii
`
`
`Page 4
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 5 of 805
`
`
`I.
`
`INTRODUCTION
`A.
`
`Assignment
`
`
`
`My name is Peter T. Keith. I am an engineer, inventor, and independent
`
`consultant in the medical device industry. I have over 30 years of experience in research and
`
`development of medical devices, and in particular catheters for cardiovascular procedures.
`
`
`
`I have been retained as an independent expert on behalf of Vascular Solutions
`
`LLC, Teleflex Innovations S.à.r.l., and Arrow International, Inc., whom I will refer to
`
`collectively in this report as Vascular Solutions or VSI.
`
`
`
`I have been asked to provide my expert opinions and testimony in the patent
`
`dispute between Vascular Solutions and QXMédical, LLC. In particular, I have been asked to
`
`analyze whether QXMédical’s Boosting Catheter infringes the following claims of Vascular
`
`Solutions’ patents:
`
` Claims 3 and 8 of U.S. Patent No. 8,048,032 (the ’032 Patent)
`
` Claim 9 of U.S. Patent No. 8,142,413 (the ’413 Patent)
`
` Claims 1, 3, and 8 of U.S. Patent No. RE45,380 (the ’380 Patent)
`
` Claims 25, 30, 31, 32, and 48 of U.S. Patent No. RE45,760 (the ’760 Patent)
`
` Claims 25, 32, 36, 52, and 53 of U.S. Patent No. RE45,776 (the ’776 Patent), and
`
` Claims 25, 34, and 53 of U.S. Patent No. RE46,116 (the ’116 Patent).
`
`I will refer to these claims throughout this report as the asserted claims.
`
`
`
`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’
`
`GuideLiner and TrapLiner devices and Boston Scientific Corporation’s Guidezilla devices.
`
`
`
`Finally, I was asked to analyze whether Terumo’s Heartrail 5-in-6 device or the
`
`catheters described in U.S. Patent No. 5,527,292 to Adams et al. (“Adams”), U.S. Patent No.
`
`
`
`1
`
`
`Page 5
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 6 of 805
`
`5,290,247 to Crittenden (“Crittenden”), and U.S. Patent No. 5,439,445 to Kontos (“Kontos”)
`
`would be acceptable noninfringing alternatives to the Boosting Catheter if made commercially
`
`available.
`
`
`
`This report summarizes the opinion testimony I expect to offer if called to testify
`
`at trial. This report is based on the information currently available to me. If additional
`
`information becomes available, I reserve the right to supplement and/or amend my analysis and
`
`my opinions. In particular, I understand that QXMédical or one of its experts may offer opinions
`
`regarding the questions I have analyzed in this report and I reserve the right to review and
`
`respond to that testimony.
`
`
`
`If I am called to testify at trial, at a deposition, or at another hearing or proceeding
`
`about this report, I may cite other documents or information similar to what I have specifically
`
`identified in this report. I may also use graphics, animations, pictures, demonstrations, and/or
`
`other audio/visual aids to explain my analysis and opinions. In particular, I may use product
`
`samples of the Boosting Catheter, GuideLiner, Guidezilla, and other related products discussed
`
`in this report.
`
`B.
`
`Summary of Opinions
`1.
`
`Infringement
`
`
`
`In order to form my opinions on infringement, I reviewed the Vascular Solutions
`
`patents, the asserted claims, and various information produced during discovery in this case,
`
`including technical documents and deposition testimony. I personally attended the depositions
`
`of QXMédical’s chief technical officer, Fernando Di Caprio. In addition, I manually inspected
`
`and performed various laboratory tests on samples of the Boosting Catheter device.
`
`
`
`Based on my review of these materials relating to the Boosting Catheter, I have
`
`formed opinions about whether the Boosting Catheter meets the limitations of each of the
`
`
`
`2
`
`
`Page 6
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 7 of 805
`
`asserted claims. For claims to the device itself, I have also reached a conclusion about whether
`
`QXMédical infringes the claims by making, using, selling, or offering for sale the Boosting
`
`Catheter. For asserted claims covering methods of using the device or systems including the
`
`device and a guide catheter, I have not reached an ultimate conclusion about whether QXMédical
`
`infringes the claims. Instead, I have reached a conclusion about whether physicians (generally
`
`cardiologists) using the Boosting Catheter or combining it with a guide catheter infringe the
`
`method and system claims. I have also formed opinions about whether the Boosting Catheter
`
`constitutes a material part of the invention of the asserted claims, whether the Boosting Catheter
`
`is especially made or adapted for use in the method or system of the asserted claims, and whether
`
`the Boosting Catheter is a staple article or commodity of commerce suitable for substantial
`
`noninfringing use. I have not formed opinions regarding QXMédical’s knowledge or intent, nor
`
`whether QXMédical has induced or contributed to physicians’ infringement. Those questions
`
`are beyond the scope of my analysis.
`
`
`
`The ’032 Patent: It is my opinion that each model of the Boosting Catheter
`
`meets the limitations of claim 3 of the ’032 Patent and that the six French Boosting Catheter,
`
`Model No. BC57-150, meets the limitations of claim 8 of the ’032 Patent. It is my opinion that
`
`QXMédical infringes these claims when it makes, uses, sells, offers for sale, or imports one of
`
`these devices in or into the United States.
`
`
`
`The ’413 Patent: It is my opinion that each model of the Boosting Catheter
`
`meets the limitations of claim 9 of the ’413 Patent when used for a coronary vascular procedure
`
`with a guidewire, standard guide catheter, and an interventional cardiology device (balloon
`
`catheter or stent), and that physicians infringe claim 9 of the ’413 Patent when using the
`
`Boosting Catheter when performing such procedures. It is my opinion that the Boosting Catheter
`
`
`
`3
`
`
`Page 7
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 8 of 805
`
`constitutes a material part of the method of claim 9 of the ’413 Patent, that the Boosting Catheter
`
`is especially made or adapted for use in the method of claim 9 of the ’413 Patent, and that the
`
`Boosting Catheter is not a staple article or commodity suitable for substantial noninfringing use.
`
`
`
`The ’380 Patent: It is my opinion that each model of the Boosting Catheter
`
`meets the limitations of claims 1 and 3 of the ’380 Patent when combined with a guide catheter
`
`and that the six French Boosting Catheter, Model No. BC57-150, meets the limitations of claim 8
`
`of the ’380 Patent when combined with a guide catheter. It is my opinion that physicians
`
`infringe claims 1, 3, and 8 of the ’380 Patent when they assemble and use the combinations just
`
`described to perform vascular procedures. It is my opinion that each model of the Boosting
`
`Catheter constitutes a material part of the systems of claims 1 and 3 of the ’380 Patent, that each
`
`model of the Boosting Catheter is especially made or adapted for the systems of claims 1 and 3
`
`of the ’380 Patent, and that no model of the Boosting Catheter is a staple article or commodity
`
`suitable for substantial noninfringing use. Further, it is my opinion that the six French Boosting
`
`Catheter constitutes a material part of the system of claim 8 of the ’380 Patent, that the six
`
`French Boosting Catheter is especially made or adapted for use in the system of claim 8 of the
`
`’380 Patent, and that the six French Boosting Catheter is not a staple article or commodity
`
`suitable for substantial noninfringing use.
`
`
`
`The ’760 Patent: It is my opinion that the six French model of the Boosting
`
`Catheter, Model No. BC57-150, meets the limitations of claims 25, 30, 31, 32, and 48 of the ’760
`
`Patent when combined with a guide catheter, and that physicians infringe claims 25, 30, 31, 32,
`
`and 48 of the ’760 Patent when they assemble and use the combinations just described to
`
`perform vascular procedures. It is my opinion that the six French Boosting Catheter constitutes a
`
`material part of the systems of claims 25, 30, 31, 32, and 48 of the ’760 Patent, that the six
`
`
`
`4
`
`
`Page 8
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 9 of 805
`
`French Boosting Catheter is especially made or adapted for use in the systems of claims 25, 30,
`
`31, 32, and 48 of the ’760 Patent, and that the six French Boosting Catheter is not a staple article
`
`or commodity suitable for substantial noninfringing use.
`
`
`
`The ’776 Patent: It is my opinion that each model of the Boosting Catheter meets
`
`the limitations of claims 25, 36, and 52 of the ’776 Patent and that the six French Boosting
`
`Catheter, Model No. BC57-150, meets the limitations of claims 32 and 53 of the ’776 Patent. It
`
`is my opinion that QXMédical infringes these claims when it makes, uses, sells, offers for sale,
`
`or imports one of these devices in or into the United States.
`
`
`
`The ’116 Patent: It is my opinion that the six French Boosting Catheter, Model
`
`No. BC57-150, meets the limitations of claims 25 and 34 of the ’116 Patent when used for a
`
`coronary vascular procedure with a guide catheter and a balloon catheter or stent and that each
`
`model of the Boosting Catheter meets the limitations of claim 53 of the ’116 Patent in those
`
`circumstances. It is my opinion that physicians infringe claims 25, 34, and 53 of the ’116 Patent
`
`when performing a procedure as just described. It is my opinion that the six French Boosting
`
`Catheter constitutes a material part of the methods of claims 25 and 34 of the ’116 Patent, that
`
`the six French Boosting Catheter is especially made or adapted for the methods of claims 25 and
`
`34 of the ’116 Patent, and that the six French Boosting Catheter is not a staple article or
`
`commodity suitable for substantial noninfringing use. It is my opinion that each model of the
`
`Boosting Catheter constitutes a material part of the method of claim 53 of the ’116 Patent, that
`
`each model of the Boosting Catheter is especially made or adapted for use in the method of claim
`
`53 of the ’116 Patent, and that no model of the Boosting Catheter is a staple article or commodity
`
`suitable for substantial noninfringing use.
`
`
`
`5
`
`
`Page 9
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 10 of 805
`
`2.
`
`GuideLiner, TrapLiner, and Guidezilla
`
`
`
`Similar to my opinions on infringement, I have formed opinions regarding which
`
`of the asserted claims cover VSI’s GuideLiner and TrapLiner catheters and Boston Scientific’s
`
`Guidezilla catheters based on my review of the asserted patents and claims, information
`
`produced in discovery, and my manual inspection and testing of the products.
`
`
`
`There are four models of the GuideLiner catheter: the first generation of the
`
`device, which I will call Version 1 or V1, the second generation of the device, Version 2 or V2,
`
`the third generation of the device, Version 3 or V3, and an extra-long version of the device, XL.
`
`Models V1, V2, and V3 come in different sizes, for example five French and six French. Model
`
`XL comes in six French size only. In summarizing and explaining my opinions in this report and
`
`the attached claim charts, I will use the phrase “all versions” to refer to all four versions of the
`
`GuideLiner and the phrase “all sizes” to refer to all sizes of those models. Where appropriate, I
`
`will specify which models and sizes I am indicating.
`
`
`
`Similarly, there are two versions of the Guidezilla catheter: a first generation that
`
`I will call Version 1 or V1 and a second generation that I will call Version 2 or V2. Version 1
`
`was available in a six French size only; Version 2 is available in several sizes. I will use the
`
`same conventions just described to refer to the various versions and sizes of the Guidezilla
`
`catheter.
`
`
`
`The ’032 Patent: It is my opinion that all versions and sizes of the GuideLiner
`
`and Guidezilla meet the limitations of claim 3 of the ’032 Patent. It is my opinion that the six
`
`French size of each version of the GuideLiner and Guidezilla meets the limitations of claim 8 of
`
`the ’032 Patent.
`
`
`
`The ’413 Patent: It is my opinion that all versions and sizes of the GuideLiner
`
`and Guidezilla meet the limitations of claim 9 of the ’413 Patent when used for a coronary
`
`
`
`6
`
`
`Page 10
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 11 of 805
`
`vascular procedure with a guidewire, guide catheter, and interventional cardiology device
`
`(balloon catheter or stent).
`
`
`
`The ’380 Patent: It is my opinion that all versions and sizes of the GuideLiner
`
`and Guidezilla meet the limitations of claims 1 and 3 of the ’380 Patent when combined with a
`
`guide catheter. It is my opinion that the six French size of each version of the GuideLiner and
`
`Guidezilla meets the limitations of claim 8 of the ’380 Patent when combined with a guide
`
`catheter.
`
`
`
`The ’760 Patent: It is my opinion that the six French size of each version of the
`
`GuideLiner, Guidezilla, and TrapLiner meets the limitations of claims 25, 30, 31, 32, and 48 of
`
`the ’760 Patent when combined with a guide catheter, except that the GuideLiner V2 does not
`
`meet the limitations of claim 32 of the ’760 Patent.
`
`
`
`The ’776 Patent: It is my opinion that all versions and sizes of the GuideLiner,
`
`Guidezilla, and TrapLiner catheters meet the limitations of claim 25 of the ’776 Patent and that
`
`the six French sizes of those catheters meet the limitations of claim 32 of the ’776 Patent. It is
`
`my opinion that all sizes of the GuideLiner V3 and the TrapLiner meet the limitations of claim
`
`36 of the ’776 Patent. It is my opinion that all versions and sizes of the GuideLiner, Guidezilla,
`
`and TrapLiner except GuideLiner V2 meet the limitations of claim 52 of the ’776 Patent and that
`
`the six French sizes of those catheters meet the limitations of claim 53 of the ’776 Patent.
`
`
`
`The ’116 Patent: It is my opinion that the six French size of each version of the
`
`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
`
`and sizes of the GuideLiner, GuideZilla, and TrapLiner meet the limitations of claim 52 of the
`
`’116 Patent in those circumstances.
`
`
`
`7
`
`
`Page 11
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 12 of 805
`
`3.
`
`Acceptable noninfringing alternatives
`
`
`
`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
`
`devices would not infringe the asserted claims, they each suffer from a number of practical
`
`drawbacks that would make them unacceptable alternatives. I describe these drawbacks in
`
`greater detail in Part VI below.
`
`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
`
`the research and development (R&D) department at SCIMED, which was later acquired by
`
`Boston Scientific Corporation. I joined SCIMED full-time after graduation, and I remained with
`
`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
`
`was on medical devices in the field of interventional cardiology, and particularly catheter design.
`
`
`
`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
`
`the market and in hospitals today. A number of the products have been in the field of
`
`interventional cardiology, and particularly catheters.
`
`
`
`8
`
`
`Page 12
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 13 of 805
`
`
`
`In addition to my work as an independent consultant, I have engaged in a number
`
`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
`
`products have been in the area of interventional cardiology. I have also done considerable work
`
`outside the area of interventional cardiology, including in treatments for chronic sinusitis,
`
`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
`
`well as many corresponding patents in foreign countries. Numerous patent applications on
`
`which I am a named inventor are still pending.
`
`
`
`I have served as an expert witness in three prior patent litigations on behalf of
`
`Boston Scientific Corporation, my former employer. These litigations are described briefly in
`
`my curriculum vitae, Appendix A. I have not testified as an expert witness by deposition or at
`
`trial in the last four years.
`
`D.
`
`Compensation
`
`
`
`I am being compensated at my normal rate of $475 per hour for my time spent
`
`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
`
`of this case.
`
`E. Materials Considered
`
`
`
`In preparing this report, I have relied on my years of experience and expertise in
`
`the relevant technology. I have also reviewed and relied upon the materials listed in Appendix
`
`B, as well as all other documents cited in this report and its attachments.
`
`
`
`9
`
`
`Page 13
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 14 of 805
`
`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
`
`more challenging procedures, called a “guide extension catheter”.
`
`
`
`As the heart is essentially a large muscular pumping organ, it requires a lot of
`
`oxygenated blood to sustain itself. This blood circulates within the heart muscle via the coronary
`
`arteries (see diagram below). Over time, these blood vessels may become diseased (coronary
`
`artery disease, “CAD”) resulting in regions of narrowing or clogging. Starting in the 1970s,
`
`advances were made in treating this disease with catheter devices advanced into the coronary
`
`arteries from relatively accessible arteries in the leg or arm, e.g., the femoral artery in the leg or
`
`the radial artery in the arm.
`
`
`
`CAD (also called atherosclerosis or plaque buildup) results in narrowed regions
`
`(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
`
`oxygen (ischemia), which can create severe chest pain, and significantly limit a patient’s activity
`
`
`
`10
`
`
`Page 14
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 15 of 805
`
`and quality of life. If the restriction completely blocks the flow of blood (typically from a
`
`subsequent blood clot within the lesion), this can lead to a heart attack (myocardial infarction).
`
`(See below—B). Severe lesions and complete blockages necessitate some sort of treatment to re-
`
`open the blocked region and re-establish normal blood flow. In the case of a complete blockage
`
`(myocardial infarction), the patient may die if the blocked vessel is not re-opened quickly, i.e.,
`
`within hours of the blockage.
`
`
`
`The most common treatment for CAD is with catheter devices that dilate the
`
`blockage from inside and place a support scaffold (stent) therein. The stent is inserted across the
`
`lesion in a collapsed state and then dilated with a balloon-tipped catheter called an angioplasty
`
`catheter (see below). It is therefore critical that these catheter devices are able to be positioned
`
`within the blockage, and positioned quickly, in order to successfully treat the patient.
`
`
`
`11
`
`
`Page 15
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 16 of 805
`
`
`
`
`
`One of the main pumping chambers of the heart is the left ventricle “LV”. The LV
`
`receives the oxygenated blood from the lungs, and pumps it to the body via the aorta. The rest of
`
`the blood vessels that oxygenate the body are all branches and sub-branches off of the aorta. The
`
`very first branches, near the very beginning of the aorta, are the coronary arteries, the left main
`
`coronary artery “LM”, and the right coronary artery “RCA”. The openings of these arteries from
`
`the aorta are called ostia (singular: ostium). The LM runs for a short length before it branches
`
`into two longer arteries that run the rest of the way down the left and posterior sides of the heart:
`
`the left anterior descending “LAD” and left circumflex “LCX”. The RCA extends down the right
`
`side of the heart. The RCA, LAD, and LCX are considered the three primary coronary arteries.
`
`Each of these arteries, in turn, has numerous side branches, which then further branch ultimately
`
`into the capillary beds where the actual transfer of oxygen to heart muscle tissue takes place (see
`
`figure below). Most lesions requiring treatment are within these three primary arteries, or
`
`occasionally a major branch stemming therefrom.
`
`
`
`
`
`12
`
`
`Page 16
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 17 of 805
`
`
`
`
`
`Beyond the coronary arteries, the aorta has numerous branches and sub-branches
`
`as it feeds oxygenated blood to the rest of the body (see diagram below—A). The aortic arch is
`
`where the aorta turns and heads inferiorly (descending aorta) towards the legs. One of the
`
`branches off the aorta that feeds the arm is the right subclavian artery. A sub-branch of this artery
`
`is the radial artery near the wrist. Another branch from the aorta is the iliac artery, which further
`
`sub-branches into the femoral artery near the groin. The femoral artery and radial arteries are
`
`relatively close to the skin surface, and one or the other are typically used as the access vessels to
`
`gain access to the aorta and the coronary arteries as will be described below (see diagram
`
`below—B).
`
`
`
`
`
`13
`
`
`Page 17
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 18 of 805
`
`
`
`In the following paragraphs, I will describe a typical treatment procedure. Many
`
`variations of this exist, but this description of a typical and common procedure will serve to
`
`illustrate the issues pertinent to the technology in the case at issue.
`
`
`
`The treatment of these lesions by catheter techniques involves accessing a remote
`
`blood vessel, e.g., the femoral artery, via a needle puncture from the skin into the vessel, known
`
`as percutaneous access. A series of devices and maneuvers (called the “Seldinger” technique)
`
`results in placement of an introducer sheath into this vessel (see below). The introducer sheath is
`
`a relatively short tubular access catheter, approximately 20 cm long. Its purpose is primarily to
`
`maintain an access pathway into the femoral artery to facilitate the rest of the procedure.1 These
`
`sheaths have a fixed inner diameter of 5, 6, 7, or 8 French. (One French is 0.33mm). A slitted
`
`seal is provided on the back (proximal) end of the sheath to keep blood from exiting. The size is
`
`chosen by the interventionalist and depends on numerous factors, including the sizes of the
`
`planned devices to be inserted through the sheath and used for the coronary lesion.
`
`
`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.
`
`
`
`14
`
`
`Page 18
`
`Teleflex Ex. 2056
`Medtronic v. Teleflex
`
`

`

`CASE 0:17-cv-01969-PJS-TNL Document 125-22 Filed 04/10/19 Page 19 of 805
`
`
`
`Once access is established to the remote artery, a catheter (hollow tube) is
`
`advanced through the aorta into the heart where a “diagnostic” catheterization procedure is
`
`performed. This entails injectin