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.,
`
`
`
`
`
`
`
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`
`
`No. 0:19-cv-01760-PJS-TNL
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`
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`DECLARATION OF PETER
`KEITH IN SUPPORT OF
`PLAINTIFFS’ MOTION FOR
`PRELIMINARY INJUNCTION
`
`
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`)
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`
`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
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`1
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`Page 1
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`Medtronic Exhibit 1082
`
`
`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
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`Corporation. I joined SCIMED full-time after graduation, and I remained with the
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`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
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`considerable work outside the area of interventional cardiology, including in treatments
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`for orthopedics for extremities such as feet and ankles and treatment of spinal disorders.
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`In 2006, I co-founded Entellus Medical, a company focused on treatments for chronic
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`sinusitis. As Chief Technology Officer, I lead the product development and research
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`teams. Entellus went public in 2015, and was acquired by Stryker in 2018.
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`6.
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`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.
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`patents, as well as many corresponding patents in foreign countries. Numerous patent
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`applications on which I am a named inventor are still pending.
`
`Background on the Technology: Coronary Catheters and Heart Disease
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`7.
`
`The technology involved in this case pertains to coronary catheter
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`procedures. These are procedures for treating conditions in the blood vessels of the heart
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`itself (coronary arteries). More specifically, this case pertains to a specialized catheter
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`device used in some of the more challenging procedures, called a “guide extension
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`catheter.”
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`8.
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`As the heart is essentially a large, muscular, pumping organ, it requires a lot
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`of oxygenated blood to sustain itself. This blood circulates within the heart muscle via
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`the coronary arteries (see diagram below). Over time, these blood vessels may become
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`diseased (coronary artery disease, “CAD”) resulting in regions of narrowing or
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`occluding. Starting in the 1970s, advances were made in treating this disease with
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`catheter devices advanced into the coronary arteries from relatively accessible arteries in
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`the leg or arm, e.g., the femoral artery in the leg or the radial artery in the arm.
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`9.
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`CAD (also called atherosclerosis or plaque buildup) results in narrowed
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`regions (lesions or stenoses) that can restrict the flow of blood to regions of the heart
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`muscle (see below—A). Severe lesions can dramatically restrict the blood flow, starving
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`the muscle of oxygen (ischemia), which can create severe chest pain and significantly
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`limit a patient’s activity and quality of life. If the lesion completely blocks the flow of
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`blood (typically from a subsequent blood clot within the lesion), this can lead to a heart
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`attack (myocardial infarction). (See below—B). Severe lesions and complete blockages
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`necessitate some sort of treatment to reopen the blocked region and re-establish normal or
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`near normal blood flow. In the case of a complete blockage (myocardial infarction), the
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`patient may die if the blocked vessel is not re-opened quickly, i.e., within hours of the
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`blockage.
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`10.
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`The most common treatment for CAD is with catheter devices that dilate
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`the blockage from inside and place a support scaffold (stent) therein. The stent is inserted
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`across the lesion in a collapsed state and then dilated with a balloon-tipped catheter called
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`an angioplasty catheter (see below). It is therefore critical that these catheter devices are
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`able to be positioned within the blockage, and positioned quickly, in order to successfully
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`treat the patient.
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`11. One of the main pumping chambers of the heart is the left ventricle “LV.”
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`The LV receives the oxygenated blood from the lungs and pumps it to the body via the
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`
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`aorta. The rest of the blood vessels that oxygenate the body are all branches and sub-
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`branches off of the aorta. The very first branches near the beginning of the aorta are the
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`coronary arteries, the left main coronary artery “LM,” and the right coronary artery
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`“RCA.” The openings of these arteries from the aorta are called ostia (singular: ostium).
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`The LM runs for a short length before it branches into two longer arteries that run the rest
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`of the way down the left and posterior sides of the heart: the left anterior descending
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`“LAD” and left circumflex “LCX.” The RCA extends down the right side of the heart.
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`The RCA, LAD, and LCX are considered the three primary coronary arteries. Each of
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`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
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`place (see figure below). Most lesions requiring treatment are within these three primary
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`arteries, or occasionally a major branch stemming therefrom.
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`12. Beyond the coronary arteries, the aorta has numerous branches and sub-
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`branches as it feeds oxygenated blood to the rest of the body (see diagram below—A).
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`The aortic arch is where the aorta turns and heads inferiorly (descending aorta) towards
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`the legs. One of the branches off the aorta that feeds the arm is the right subclavian
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`artery. A sub-branch of this artery is the radial artery near the wrist. Another branch
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`from the aorta is the iliac artery, which further sub-branches into the femoral artery near
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`the groin. The femoral artery and radial arteries are relatively close to the skin surface,
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`and one or the other are typically used as the access vessel to gain access to the aorta and
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`the coronary arteries as will be described below (see diagram below—B).
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`13.
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`In the following paragraphs, I will describe a typical coronary catheter
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`treatment procedure. Many variations of the procedure exist, but this description of a
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`typical and common procedure will serve to illustrate the issues pertinent to the
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`technology in the case at issue.
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`14.
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`The treatment of 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,
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`known as percutaneous access. A series of devices and maneuvers (called the
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`“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
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`20 cm long. Its purpose is primarily to maintain an access pathway into the femoral
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`artery to facilitate the rest of the procedure. A slitted seal is provided on the back
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`(proximal) end of the sheath to keep blood from exiting. The sheath size is chosen by the
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`interventionalist and depends on numerous factors, including the sizes of the planned
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`devices to be inserted through the sheath and used for the coronary lesion.
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`15. Once access is established to the remote artery, a catheter (hollow tube) is
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`advanced through the slitted seal, the sheath and the aorta into the heart where a
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`“diagnostic” catheterization procedure is performed. This entails injecting an x-ray
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`visible contrast solution through the catheter into the main coronary vessels and one or
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`more of the pumping chambers of the heart. This technique identifies the location of any
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`blockages or narrowings that may require treatment with angioplasty catheters, as well as
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`any defects in the valves that separate the chambers of the heart. Sometimes this
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`diagnostic catheterization procedure is performed as a separate procedure.
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`16. After the sheath is placed and the diagnostic procedure is complete, in order
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`to treat the lesion a device called a guide catheter (also called a guiding catheter, or
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`sometimes just a “guide”) is inserted into the sheath and advanced from the femoral
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`artery, up the aorta, around the aortic arch, with its tip next to or just into the coronary
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`ostium of choice (see figure below). A stiffening wire, usually about 0.035 inches in
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`diameter, is often placed inside the length of the guide catheter to keep some of the distal
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`curves (described below) straight until the curve of the aortic arch is reached. This wire
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`is then removed. The primary purpose of the guide catheter is to provide a stable access
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`route for coronary devices and a lumen for delivery of x-ray contrast fluid for visualizing
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`the vessel and lesion.
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`
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`17. Guide catheters are more complex than they may appear. They typically
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`have multiple layers and multiple regions of flexibility, stiffer at the proximal end and
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`progressively more flexible towards the distal end. However, it must still be sufficiently
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`rigid to maintain distal curve and position relative to the ostium. A lubricious liner
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`extends through the inside of the guide catheter. Embedded in the walls of the guide
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`catheter is a metallic wire braid which facilitates “torquability” by enhancing the
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`torsional stiffness (see below—A). Guide catheters also have pre-set curves near the
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`distal tip, to aid in placement within the aortic arch and into the ostium (see below—B).
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`There are numerous curve shapes offered by many manufacturers (see below—C). The
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`combination of stiffness characteristics, torsional characteristics and curve shapes aids in
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`the ability to successfully intubate the ostium of a particular individual. Every person’s
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`arch and ostium anatomy is different. Therefore, accessing each ostium can be a
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`challenge—thus the variety of guide catheters available. Guide catheters are also
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`available in a range of outer diameters, which correspond to the introducer sheath inner
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`diameters.
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`
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`18. A device called a hemostatic valve (also sometimes referred to as a
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`hemostasis valve, or a Y-connector or Y-adaptor, which includes a hemostatic valve) is
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`positioned on the proximal end of the guide catheter to prevent bleeding from this
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`catheter (see figure below). The valve can be temporarily opened when devices are
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`passed into the guide catheter. A side arm allows for injection of fluids, such as contrast
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`for periodic x-ray visualization.
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`19.
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`Through the guide catheter, a small wire called a guidewire is inserted into
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`and through the guide catheter, into the coronary vessel and across the lesion. A
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`guidewire used in coronary applications is typically 0.014 inches in diameter and 175 cm
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`long. The primary purpose of the guidewire is to cross the lesion and serve as a “track”
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`over which other catheter devices are guided into the coronary vessel and across the
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`lesion. Guidewires are also more complex than they first appear. They are formed from
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`a solid metal core wire, about 0.014 inch diameter, typically made of a springy stainless
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`steel. Towards the distal end, the core wire diameter is ground down gradually until the
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`diameter is around 0.001 inch diameter. This diameter transition zone is about 30 cm
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`long. The proximal part of the guidewire is significantly more rigid than the distal part.
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`Stated differently, the distal end is significantly more flexible than the proximal end.
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`This is important, as the distal end needs to safely navigate the fragile coronary vessel,
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`while the proximal end needs to accurately advance and rotate the distal end within the
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`confines of the guide catheter. Much of the length of the reduced diameter portion is
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`covered in a fine wire coil, which maintains the outer diameter of the guidewire at 0.014
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`inches (see diagram below) while maintaining its flexibility.
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`20.
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`To aid in navigating the guidewire through the coronary vasculature, a
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`small “J” bend is often formed at the distal end (see below), and when the guidewire is
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`rotated from the proximal end, the J bend is rotated. The combination of careful rotation
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`and advancement of the guidewire allows it to be steered through the coronary artery and
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`through the lesion. The tip portion is usually advanced to a position several centimeters
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`distal to the lesion, to allow for a more rigid portion of the guidewire to be within the
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`lesion. The positioned guidewire now serves as the track to guide the subsequent dilation
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`or stent delivery catheter to the lesion.
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`21. With the guidewire in place across the lesion, a stent delivery catheter can
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`be advanced over the guidewire to position an unexpanded stent across the lesion.
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`Somewhat similar to the guidewire, the distal portions of the stent delivery catheter need
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`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
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`maintains the now expanded diameter of the blood vessel. Blood flow to the heart
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`muscle distal to the lesion is thus restored (see figure below).
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`22. Once the lesion is deemed successfully dilated (with confirmation from x-
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`ray imaging using contrast injections into the artery), the catheter and guidewire devices
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`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
`
`
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`lesions.
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`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
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`crossed with the guidewire (see below—A) it may be difficult to advance the stent
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`delivery catheter across the lesion. A tighter lesion will require a higher advancement
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`force on the stent delivery catheter versus a less tight lesion.
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`24. When the stent delivery catheter is pushed to cross the lesion, a reactive
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`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.
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`25.
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`Several device design factors can also impact how readily the guide
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`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
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`(compared to, say, the stiffness of the distal portion of a guidewire or stent delivery
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`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
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`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
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`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.
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`29.
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`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
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`steered all within the relatively small confines of the sterile area of the operating table.
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`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
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`Medtronic Exhibit 1082
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`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.
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`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
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`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
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`23
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`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
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`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.
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`It is somewhat longer, up to 40 cm, in other versions. In all versions, the tubular section
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`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.
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`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),
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`GuideLiner is optimized for distal flexibility to aid in its placement in a coronary artery.
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`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
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`section further makes use of a lubricious inner liner, a soft atraumatic tip, and a lubricious
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`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
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`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 proximal shaft section is formed of a metallic rod. Being formed of
`
`stainless steel, it is able to be both small in its cross-sectional dimensions and
`
`substantially rigid, allowing for positive advancement of the GuideLiner catheter down
`
`the guide catheter and into the coronary vessel. Once in the vessel, the proximal shaft
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`Medtronic Exhibit 1082
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`section also maintains a stable position of the distal tubular section within the coronary
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`vessel, while other devices such as a stent delivery catheter are advanced across the
`
`stenosis. It is important for the proximal shaft to be small in its cross-sectional
`
`dimensions so as not to dimensionally interfere with the other devices that will be
`
`advanced alongside it in the guide catheter. Thus, a stiff metal such as stainless steel is
`
`suitable. The height dimension of the proximal shaft is further reduced by fabricating it
`
`out of a flattened ribbon. The combination of the relatively more rigid proximal shaft
`
`with the relatively more flexible distal portion of the distal tube optimizes the pushability
`
`responsiveness of GuideLiner with the trackability of the distal tube.
`
`37.
`
`The side opening section is the part or region of the catheter where the
`
`proximal shaft is joined to the distal tube, and where the opening into the lumen of the
`
`distal tube is formed. An important consideration for this section of GuideLiner is to
`
`have a secure connection between the two portions, wherein potential for kinking and
`
`deformation of this section are minimized. A side opening section that is more rigid than
`
`the tubular section helps to achieve this. Another important consideration is to have the
`
`side opening be angled or beveled relative to the axis of the catheter. This helps to
`
`facilitate smooth introduction of the subsequent coronary devices into the lumen of the
`
`distal tube. The newest model of GuideLiner, GuideLiner V3, also includes non-inclined
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`regions of the side opening in between two angled portions. These non-inclined regions,
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`along with the angled portions, serve to further facilitate smooth entry of the subsequent
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`coronary devices into the lumen of the distal tube and reduce or inhibit wire wrap (i.e.,
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`wrapping of the guidewire near the opening into the lumen of the distal tube).
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`Medtronic Exhibit
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