CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 1 of 56
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MINNESOTA
`
`VASCULAR SOLUTIONS LLC,
`TELEFLEX INNOVATIONS S.à r.l.,
`ARROW INTERNATIONAL, INC.,
`and TELEFLEX LLC
`
`
`
`v.
`
`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 0:19-cv-01760-PJS-TNL
`
`
`
`DECLARATION OF PETER
`KEITH IN SUPPORT OF
`PLAINTIFFS’ MOTION FOR
`PRELIMINARY INJUNCTION
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Plaintiff,
`
`Defendant.
`
`
`
`
`
`I, Peter Keith, hereby declare and state as follows:
`
`1.
`
`I have been retained by Vascular Solutions LLC, Teleflex Innovations
`
`S.à r.l., Arrow International, Inc., and Teleflex LLC, whom I will refer to collectively in
`
`this declaration as “VSI,” to provide my expert opinions in this matter. I make this
`
`declaration in support of VSI’s Motion for Preliminary Injunction. If called to testify, I
`
`could and would testify to the following facts and opinions.
`
`Personal Background
`
`2.
`
`I summarize my educational background and career history in the following
`
`paragraphs. My curriculum vitae is attached as Exhibit Q to this declaration.
`
`3.
`
`I received a Bachelor of Science degree in mechanical engineering 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
`
`1
`
`
`Page 1
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MINNESOTA
`
`VASCULAR SOLUTIONS LLC,
`TELEFLEX INNOVATIONS S.à r.l.,
`ARROW INTERNATIONAL, INC.,
`and TELEFLEX LLC
`
`
`
`v.
`
`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`No. 0:19-cv-01760-PJS-TNL
`
`
`
`DECLARATION OF PETER
`KEITH IN SUPPORT OF
`PLAINTIFFS’ MOTION FOR
`PRELIMINARY INJUNCTION
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Plaintiff,
`
`Defendant.
`
`
`
`
`
`I, Peter Keith, hereby declare and state as follows:
`
`1.
`
`I have been retained by Vascular Solutions LLC, Teleflex Innovations
`
`S.à r.l., Arrow International, Inc., and Teleflex LLC, whom I will refer to collectively in
`
`this declaration as “VSI,” to provide my expert opinions in this matter. I make this
`
`declaration in support of VSI’s Motion for Preliminary Injunction. If called to testify, I
`
`could and would testify to the following facts and opinions.
`
`Personal Background
`
`2.
`
`I summarize my educational background and career history in the following
`
`paragraphs. My curriculum vitae is attached as Exhibit Q to this declaration.
`
`3.
`
`I received a Bachelor of Science degree in mechanical engineering 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
`
`1
`
`
`Page 1
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 2 of 56
`
`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, particularly
`
`catheter design.
`
`4.
`
`Since 1997, 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, particularly catheters.
`
`5.
`
`In addition to my work as an independent consultant, since 2000 I have
`
`engaged in a number of entrepreneurial ventures in the field of medical devices. 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 orthopedics for extremities such as feet and ankles and treatment of spinal disorders.
`
`In 2006, I co-founded Entellus Medical, a company focused on treatments for chronic
`
`sinusitis. As Chief Technology Officer, I lead the product development and research
`
`teams. Entellus went public in 2015, and was acquired by Stryker in 2018.
`
`6.
`
`Between my work at SCIMED, my independent consulting, and my
`
`entrepreneurial ventures, I have been named as an inventor on over 140 issued U.S.
`
`2
`
`
`Page 2
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 3 of 56
`
`patents, as well as many corresponding patents in foreign countries. Numerous patent
`
`applications on which I am a named inventor are still pending.
`
`Background on the Technology: Coronary Catheters and Heart Disease
`
`7.
`
`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.”
`
`8.
`
`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
`
`occluding. 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.
`
`3
`
`
`Page 3
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 4 of 56
`
`
`
`9.
`
`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 and quality of life. If the lesion 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 reopen the blocked region and re-establish normal or
`
`near 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.
`
`4
`
`
`Page 4
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 5 of 56
`
`
`
`10.
`
`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. 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
`
`
`
`5
`
`
`Page 5
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 6 of 56
`
`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 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.
`
`
`
`6
`
`
`Page 6
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 7 of 56
`
`12. 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 vessel to gain access to the aorta and
`
`the coronary arteries as will be described below (see diagram below—B).
`
`13.
`
`In the following paragraphs, I will describe a typical coronary catheter
`
`treatment procedure. Many variations of the procedure 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.
`
`
`
`7
`
`
`Page 7
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 8 of 56
`
`14.
`
`The treatment of 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. A slitted seal is provided on the back
`
`(proximal) end of the sheath to keep blood from exiting. The sheath 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.
`
`15. Once access is established to the remote artery, a catheter (hollow tube) is
`
`advanced through the slitted seal, the sheath and the aorta into the heart where a
`
`“diagnostic” catheterization procedure is performed. This entails injecting an x-ray
`
`visible contrast solution through the catheter into the main coronary vessels and one or
`
`more of the pumping chambers of the heart. This technique identifies the location of any
`
`blockages or narrowings that may require treatment with angioplasty catheters, as well as
`
`any defects in the valves that separate the chambers of the heart. Sometimes this
`
`diagnostic catheterization procedure is performed as a separate procedure.
`
`8
`
`
`Page 8
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 9 of 56
`
`
`
`16. After the sheath is placed and the diagnostic procedure is complete, in order
`
`to treat the lesion a device called a guide catheter (also called a guiding catheter, or
`
`sometimes just a “guide”) is inserted into the sheath and advanced from the femoral
`
`artery, up the aorta, around the aortic arch, with its tip next to or just into the coronary
`
`ostium of choice (see figure below). A stiffening wire, usually about 0.035 inches in
`
`diameter, is often placed inside the length of the guide catheter to keep some of the distal
`
`curves (described below) straight until the curve of the aortic arch is reached. This wire
`
`is then removed. The primary purpose of the guide catheter is to provide a stable access
`
`9
`
`
`Page 9
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 10 of 56
`
`route for coronary devices and a lumen for delivery of x-ray contrast fluid for visualizing
`
`the vessel and lesion.
`
`
`
`17. Guide catheters are more complex than they may appear. They typically
`
`have multiple layers and multiple regions of flexibility, stiffer at the proximal end and
`
`progressively more flexible towards the distal end. However, it must still be sufficiently
`
`rigid to maintain distal curve and position relative to the ostium. A lubricious liner
`
`extends through the inside of the guide catheter. Embedded in the walls of the guide
`
`catheter is a metallic wire braid which facilitates “torquability” by enhancing the
`
`torsional stiffness (see below—A). Guide catheters also have pre-set curves near the
`
`distal tip, to aid in placement within the aortic arch and into the ostium (see below—B).
`
`There are numerous curve shapes offered by many manufacturers (see below—C). The
`
`combination of stiffness characteristics, torsional characteristics and curve shapes aids in
`
`the ability to successfully intubate the ostium of a particular individual. Every person’s
`
`arch and ostium anatomy is different. Therefore, accessing each ostium can be a
`
`10
`
`
`Page 10
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 11 of 56
`
`challenge—thus the variety of guide catheters available. Guide catheters are also
`
`available in a range of outer diameters, which correspond to the introducer sheath inner
`
`diameters.
`
`
`
`18. A device called a hemostatic valve (also sometimes referred to as a
`
`hemostasis valve, or a Y-connector or Y-adaptor, which includes a hemostatic valve) is
`
`positioned on the proximal end of the guide catheter to prevent bleeding from this
`
`catheter (see figure below). The valve can be temporarily opened when devices are
`
`passed into the guide catheter. A side arm allows for injection of fluids, such as contrast
`
`for periodic x-ray visualization.
`
`
`
`11
`
`
`Page 11
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 12 of 56
`
`19.
`
`Through the guide catheter, a small wire called a guidewire is inserted into
`
`and through the guide catheter, into the coronary vessel and across the lesion. A
`
`guidewire used in coronary applications is typically 0.014 inches in diameter and 175 cm
`
`long. The primary purpose of the guidewire is to cross the lesion and serve as a “track”
`
`over which other catheter devices are guided into the coronary vessel and across the
`
`lesion. Guidewires are also more complex than they first appear. They are formed from
`
`a solid metal core wire, about 0.014 inch diameter, typically made of a springy stainless
`
`steel. Towards the distal end, the core wire diameter is ground down gradually until the
`
`diameter is around 0.001 inch diameter. This diameter transition zone is about 30 cm
`
`long. The proximal part of the guidewire is significantly more rigid than the distal part.
`
`Stated differently, the distal end is significantly more flexible than the proximal end.
`
`This is important, as the distal end needs to safely navigate the fragile coronary vessel,
`
`while the proximal end needs to accurately advance and rotate the distal end within the
`
`confines of the guide catheter. Much of the length of the reduced diameter portion is
`
`covered in a fine wire coil, which maintains the outer diameter of the guidewire at 0.014
`
`inches (see diagram below) while maintaining its flexibility.
`
`12
`
`
`Page 12
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 13 of 56
`
`
`
`20.
`
`To aid in navigating the guidewire through the coronary vasculature, a
`
`small “J” bend is often formed at the distal end (see below), and when the guidewire is
`
`rotated from the proximal end, the J bend is rotated. The combination of careful rotation
`
`and advancement of the guidewire allows it to be steered through the coronary artery and
`
`through the lesion. The tip portion is usually advanced to a position several centimeters
`
`distal to the lesion, to allow for a more rigid portion of the guidewire to be within the
`
`lesion. The positioned guidewire now serves as the track to guide the subsequent dilation
`
`or stent delivery catheter to the lesion.
`
`13
`
`
`Page 13
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 14 of 56
`
`
`
`21. With the guidewire in place across the lesion, a stent delivery catheter can
`
`be advanced over the guidewire to position an unexpanded stent across the lesion.
`
`Somewhat similar to the guidewire, the distal portions of the stent delivery catheter need
`
`to safely navigate within the fragile coronary artery, and therefore its distal portions are
`
`relatively flexible. The proximal portions are relatively rigid to provide for responsive
`
`advancement of the distal portion. Stent delivery catheters are available in different
`
`diameters to deliver an appropriately sized stent to the particular lesion. The stent is
`
`mounted over a dilation balloon, which, when inflated with fluid, expands the stent,
`
`deforming it to a larger diameter scaffold that dilates the lesion from the inside and
`
`maintains the now expanded diameter of the blood vessel. Blood flow to the heart
`
`muscle distal to the lesion is thus restored (see figure below).
`
`14
`
`
`Page 14
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 15 of 56
`
`22. Once the lesion is deemed successfully dilated (with confirmation from x-
`
`ray imaging using contrast injections into the artery), the catheter and guidewire devices
`
`are removed from the patient. Or, other lesions may be subsequently treated with either
`
`the same devices, or different devices, depending on the location and size of the other
`
`
`
`lesions.
`
`23. Numerous variables can impact how easy or difficult it is to treat a
`
`particular patient’s lesion. Many of these variables relate to the anatomical variation of a
`
`particular patient’s aortic or coronary vascular anatomy. For example, if a lesion is
`
`particularly tight (small diameter residual lumen, or heavily calcified), after the lesion is
`
`15
`
`
`Page 15
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 16 of 56
`
`crossed with the guidewire (see below—A) it may be difficult to advance the stent
`
`delivery catheter across the lesion. A tighter lesion will require a higher advancement
`
`force on the stent delivery catheter versus a less tight lesion.
`
`24. When the stent delivery catheter is pushed to cross the lesion, a reactive
`
`force is placed against the curve(s) at the distal end of the guide catheter. If the reactive
`
`force is high enough, it will cause the guide catheter to “back out” or back away from the
`
`ostium (see diagram below—B). Continued advancement of the stent delivery catheter
`
`will move the tip of the guide catheter further away from the ostium, allowing the stent
`
`delivery catheter to buckle. So, there is a limit to how much force can be used to advance
`
`the stent delivery catheter. In some instances, the lesion may be so tight or difficult to
`
`cross that attempted advancement of just the guidewire can cause the guide catheter to
`
`back out. In addition to the characteristics of the lesion, other anatomic variables
`
`influence the tendency toward guide back out, including the aorta anatomy, the tortuosity
`
`of the coronary vessel, calcification in the vessel, etc.
`
`16
`
`
`Page 16
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 17 of 56
`
`
`
`25.
`
`Several device design factors can also impact how readily the guide
`
`catheter will back out, including the stiffness of the distal portion of the guide catheter,
`
`the shape of the distal portion of the guide catheter, the stiffness of the distal region of the
`
`guidewire, the diameter profile of the stent delivery catheter, etc. However, there are
`
`design trade-offs for all of these devices which limit just how much these variables can
`
`be altered. For example, the stiffness of the distal portion of the guide catheter cannot be
`
`so high as to inhibit its ability to be navigated around the aortic arch, or so high as to
`
`potentially damage the aorta or the coronary ostium.
`
`26. One approach that has been tried in the scenario where the guide catheter is
`
`prone to backing out is to “deep seat” the guide catheter, by advancing the tip more
`
`deeply into the coronary vessel (see figure below). While this maneuver can increase the
`
`anchoring force of the guide catheter, it risks causing damage to the proximal portion of
`
`the coronary artery. The high relative stiffness of the distal portion of the guide catheter
`
`17
`
`
`Page 17
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 18 of 56
`
`(compared to, say, the stiffness of the distal portion of a guidewire or stent delivery
`
`catheter) can scrape or dissect the artery, both very serious complications. As a result,
`
`this technique is rarely performed.
`
`
`
`27. Another approach that has been tried incorporates the use of a smaller
`
`diameter and longer guide catheter positioned inside the larger diameter conventionally
`
`positioned guide catheter. The inner guide catheter, being a smaller diameter, and
`
`typically without a pre-set bend on the tip, is more flexible than the larger guide catheter.
`
`Therefore it may be more safely inserted deeper into the coronary artery to a position
`
`closer to the lesion. This is referred to as the “mother and child” approach (see figure
`
`below). Once the inner guide catheter (“child”) is positioned in the coronary artery,
`
`effectively “extending” the guide catheter, a stent delivery catheter is advanced across the
`
`lesion and the lesion is dilated and stented. It should be noted that while the child
`
`18
`
`
`Page 18
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 19 of 56
`
`catheter has a smaller diameter than the larger guide catheter, its inner diameter is still
`
`large enough to allow various stent delivery catheters or other catheter devices to be
`
`advanced within it. Each of the mother and child catheters will require its own
`
`hemostatic valve, which adds time and complexity to the procedure.
`
`
`
`28.
`
`The “mother and child” approach described above is effective at improving
`
`the support required to allow for greater pushing forces to be applied to the stent delivery
`
`catheter and is a much safer approach than the “deep seating” approach described above,
`
`as the “child” catheter is more flexible and less traumatic for advancing down the
`
`coronary artery. However, there are some significant drawbacks. For example, this
`
`approach needs to be used with a specialized long “exchange length” guidewire, as will
`
`now be described. The “child” guide catheter has a fully extending lumen from its distal
`
`end to its proximal end, similar to the “mother” guide catheter. Devices such as guide
`
`catheters and stent delivery angioplasty catheters that have fully extending lumens for
`
`guidewires are called full length “over the wire” catheters. When the “child” catheter is
`
`inserted within the “mother” guide catheter and over the prior positioned guidewire, there
`
`19
`
`
`Page 19
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 20 of 56
`
`needs to be enough length of exposed guidewire proximal of the mother guide catheter to
`
`allow installation of the child catheter into the mother guide, while always having the
`
`ability for the guidewire to be grasped and controlled, either in front of (distal to) the
`
`child catheter, or back of (proximal to) the child catheter. Standard length guidewires
`
`cannot be used in this case because standard guidewires are about 175 cm long while
`
`standard guide catheters (the “mother” catheter in this case) are about 100 cm long (see
`
`figures below). If, for example, 15 cm of the guidewire is inserted into the coronary
`
`artery, only 60 cm of guidewire extends proximally from the mother guide catheter (less
`
`actually, when the length of the hemostatic valve is added in) (see below—A). The child
`
`guide catheter needs to be well over 100 cm to be able to further extend into the coronary
`
`artery, say 110 cm (see below—B). If this child catheter is positioned over the
`
`guidewire, the guidewire may be grasped and stabilized in front of the child guide
`
`catheter, but once the child guide catheter reaches the proximal end of the mother guide
`
`catheter, there is no exposed guidewire to grasp and stabilize any more (see below—C).
`
`If the child guide catheter were to continue to be advanced into the mother guide catheter
`
`without grasping and stabilizing the guidewire, the guidewire is likely to be dragged
`
`along and further inserted into the coronary artery. This is very dangerous, as further
`
`uncontrolled advancement of the guidewire may perforate or otherwise damage the distal
`
`coronary artery that it is within.
`
`
`
`20
`
`
`Page 20
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 21 of 56
`
`
`
`29.
`
`To remedy this concern of loss of control of the guidewire, a longer
`
`guidewire may be used. Longer guidewires exist, called “exchange length” guidewires.
`
`These are typically 300 cm long. If the procedure is planned out ahead of time to involve
`
`the use of the “mother and child” approach, an exchange length guidewire will be used
`
`for the initial crossing of the lesion. Note that if the procedure is converted (vs. pre-
`
`planned) to a “mother and child” approach, the preexisting standard length guidewire will
`
`need to be swapped out for the longer exchange length wire. This is highly undesirable
`
`as the lesion needs to be successfully re-crossed a second time, this time with the
`
`exchange length guidewire, which may be difficult or unsuccessful, time-consuming, and
`
`risky to the patient.
`
`30. A 300 cm long guidewire is more difficult to manage in the operating room
`
`and typically requires the assistance of a second operator, as it must be advanced and
`
`21
`
`
`Page 21
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 22 of 56
`
`steered all within the relatively small confines of the sterile area of the operating table.
`
`Regardless, once the lesion is crossed, there is now about 185 cm of available exposed
`
`guidewire exiting from the mother guide catheter (see figure below—A). Now, when the
`
`child guide catheter is installed over the guidewire, once the distal end of it gets to the
`
`proximal end of the mother guide catheter, there will be exposed wire proximal of the
`
`child guide catheter, which may now be grasped to keep control of the guidewire while
`
`the child guide catheter is inserted through the mother guide catheter and into the
`
`coronary artery (see below—B).
`
`
`
`31. While this “mother and child” approach to improving the backup support
`
`was workable, it never gained much traction. There are many reasons for this. For
`
`example, the substantial challenges posed by the need to use an exchange length
`
`guidewire have limited this technique. Furthermore, the “child” guide catheters used
`
`were still primarily designed as guide catheters, and not optimized for deep vessel
`
`placement. For example, they included braided support and other features which tend to
`
`22
`
`
`Page 22
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 23 of 56
`
`make the distal portions somewhat stiff and not ideal for safe advancement into a
`
`coronary artery.
`
`Background on the Technology: VSI’s GuideLiner Devices
`
`32.
`
`The GuideLiner devices were the first in a new class of devices referred to
`
`as “guide extension catheter” devices, which provided significant benefits over prior
`
`designs. Unlike the “mother-child” devices described above, GuideLiner has a
`
`“monorail” or “rapid exchange” design that allows it to be used with a standard length
`
`guidewire. The term “monorail” and “rapid exchange” primarily refers to an attribute of
`
`the device, wherein the “over the wire” portion of the device is short enough to be
`
`advanced over the exposed portion of a prior placed standard length guidewire (e.g.,
`
`approximately 175 cm for a standard length coronary guidewire). The “monorail” design
`
`for stent delivery angioplasty catheters has been in existence for some time. These
`
`catheters have a total length typically about 135 cm, but the guidewire lumen within them
`
`is typically only about 30 cm long. This is short enough that these devices can be loaded
`
`over a prior placed standard length guidewire. The guidewire has enough exposed length
`
`proximal of the guide catheter to allow for full control of the guidewire during insertion
`
`of the angioplasty device.
`
`33. Over time, VSI has introduced four different versions of its GuideLiner
`
`guide extension catheter, referred to as V1, V2, V3 and XL, with V1 being launched in
`
`2009 and V3 being the most current commercialized model. All four versions are
`
`monorail catheters, in that only the distal portion of the catheter rides over the guidewire
`
`23
`
`
`Page 23
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 24 of 56
`
`when it is positioned.1 The distal “over the wire” portion is between 25 and 40 cm (see
`
`below, version V3 shown—note this image is not to scale), depending on the model,
`
`which is short enough to be used with conventional (standard) length guidewires.
`
`Importantly, because it can be used with conventional length guidewires, use of
`
`GuideLiner can be either pre-planned for the procedure, or used later in the procedure on
`
`an “as needed” basis, without necessitating removal of the already positioned guidewire
`
`and guide catheter.
`
`
`
`34.
`
`In its simplest description, GuideLiner consists of 3 sections or portions:
`
`the distal tubular section, the proximal shaft section, and the side opening section.
`
`35.
`
`The distal tubular section in the V3 version described above is 25 cm long.
`
`It is somewhat longer, up to 40 cm, in other versions. In all versions, the tubular section
`
`has a single lumen that is configured both to ride over the guidewire during
`
`advancement/placement of the catheter, and to allow for subsequent catheter devices such
`
`as stent delivery catheters to be advanced through it. Important features of the distal tube
`
`
`1 I use the term “monorail” or “rapid exchange” to refer to this type of device. However,
`these devices are still sometimes referred to as “mother and child” devices because there
`is a smaller catheter within a larger one. In this declaration, I use the term “mother and
`child” only to refer to a system with a full-length inner catheter lumen.
`
`24
`
`
`Page 24
`
`Teleflex Ex. 2072
`Medtronic v. Teleflex
`
`
`
`CASE 0:19-cv-01760-PJS-TNL Document 77 Filed 10/11/19 Page 25 of 56
`
`include having a reinforcement (e.g., a coil in GuideLiner) to provide for a kink-resistant,
`
`stable, circular lumen as it is advanced into potentially tortuous (curved) vessels. Unlike
`
`standard guide catheters that have braid reinforcement, the coil reinforcement used in
`
`GuideLiner is relatively more flexible so that it can safely be advanced deep into a
`
`coronary artery. As described above, standard guide catheters are relatively rigid in
`
`comparison, and therefore the risk of complications is higher when deep seating a
`
`conventional guide catheter. While smaller guide catheters may be more flexible than
`
`larger guide catheters (as in the “child” guide catheters described in the example above),
`
`GuideLiner is optimized for distal flexibility to aid in its placement in a coronary artery.
`
`The distal tubular section further makes use of a flexibility transition from its proximal
`
`end to its distal end by incorporating polymers of differing rigidity. This further
`
`facilitates the “trackability” of the catheter into coronary vessels. The distal tubular
`
`section further makes use of a lubricious inner liner, a soft atraumatic tip, and a lubricious
`
`external coating. The construction of the distal tubular section allows for it to have a
`
`relatively thin wall thickness. Combined with a relatively “snug” fit of the outer diameter
`
`within the guide catheter, the inner diameter can be relatively large compared to the guide
`
`catheter it is compatible with. This maximizes the number of various catheter devices
`
`that can fit within it and be used in the coronary vessels.
`
`36.
`
`The pr
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
