NORRED EXHIBIT 2210 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00395
`
`

`
`PERCUTANEOUS AORTIC
`
`VALVE
`
`REPLACEMENT
`
`The aortic Valve undergoes a series of changes based upon the initial
`structure at birth and the dynamic stresses, which it has to undergo daily.
`The trileaflet aortic Valve will not become stenotic usually until the 7”‘
`decade unless infectious processes are exposed sooner. The incidence of
`aortic stenosis can reach between 2 to 5 % at these ages. The average
`mortality rate at all ages is 9% /year which also increases as a population
`ages. Coupled with these facts is the likelihood that as a person ages and
`becomes symptomatic with aortic stenosis he is less likely to be an operative
`candidate. The mortality of octogenarians has been reported as high as 20%
`for aortic valve replacement that precludes a reasonable attempt at the
`therapy of choice.
`
`In an attempt to formulate therapy for this class of patients I have designed a
`series of devices which can be placed noninvasively so as to minimize the
`risk to the patient during the procedure. This procedure involves Novell and
`known equipment and techniques.
`
`The first in a line of options involves the placement of an aortic Valve
`incorporated within a stent. This device would be anchored in the ascending
`aorta with further support supplied in branch vessels or descending aorta as
`seen necessary by the stress forces placed upon and calculate before the
`procedure. The valve would be connected to the stents by serially connected
`rods. This placement would displace the forces placed upon the
`artificial/biomechanical/bioprosthetic valve across a large surface area.
`FIGURE 1. There are several variations to the valve design that can be
`utilized using this technique. The first is the umbrella shaped valve, which
`would be placed in a position that was above the native valve, and when it
`collapsed, would seal the opening between the aorta and left ventricle. This
`would also make it ideal for those patients who primarily have aortic
`regurgitation. The hinges can be of several types: (in order to produce as
`much laminar flow characteristics as possible) 1. Stainless steel rods upon
`enveloped within a rubber or plastic polymer that would withstand sheer
`stresses with opening and closing; 2. Rubber and plastic polymer with the
`thickest portion at the bases and the narrowest portions at the center so that it
`folds during systolic contraction of the left ventricle. The tip of the valve
`.-\
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`would be of a semicircular design to permit the much desired laminar flow
`characteristics of the aortic valve. This would decrease the shear stress
`placed upon the aortic root and ascending aorta. The design may also
`incorporate a semi circular configuration opposing the sinus’s of valsalva so
`as to disperse the stress upon the aortic Valve along a larger surface area and
`to maximize the flow characteristics to the coronary arteries. This valve
`would be place within a catheter system, which is standardly available.
`However a steering mechanism and placement mechanism incorporate a
`connection of removable rods which would be quided by a half ball
`configuration may be necessary. The femoral artery would be accessed and
`cannulated. The femoral vein would be accessed and cannulated. Both and
`antegrade and retrograde approach would be used to place the stent/valve
`combination within the right anatomic position. The visualization would
`utilize continuous roentgrarn and ultrasound techniques, which are currently
`available. In this valve model direct connection of the Valve to the aortic
`root would not be utilized unless the direction of the jet from the aortic valve
`made it necessary. The procedure would involve inflation of balloons within
`the aortic valve and ascending aorta to deploy the stents/valve combination.
`If traditional valvuloplasty does not produce significant enough opening of
`the aortic valve and relieve the gradient between the left ventricle and aorta
`then a series of further steps may be required. These would include the
`positioning of the an Er—YSGG percutaneous laser to decalcify the valve
`and repeat balloon aortic valvuloplasty. If not effective then high frequency
`ultrasound percutaneously applied may be necessary. The technique are
`highly effective at producing debulking and stenosis; however, produce
`unwanted aortic regurgitation. This would not be a problem for the
`unattached valve which would work as stated previously for aortic
`regurgitation./_ If the desired result were not seen then two rings would be
`iiontoithe aortic side of the aortic valve and the ventricular side of the
`aortic valve and pneumatically sealed together. Then expandable and
`retractable biotomes would be percutaneously placed for controlled
`dissection of the native aortic valve. There would not be a need for a
`
`percutaneous bypass pump during this procedure.
`
`The second valve design could be best described as a conical design. It
`would be composed of 16 to 32 individual rubber/plastic/metal plates, which
`would be interconnected by resistant fabric. Figure 2 shows how this valve
`would be connected together. It would be placed in direct opposition of the
`native aortic valve. It would expand during systole and collapse during
`diastole.
`It would also be anchored along the aortic root wall with
`
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`connecting rods to the ascending aortic stents. The rods would be placed
`between the right and left coronary ostia. In this design there would not be
`any intraluminal rods within the ascending aorta as with the umbrella design.
`The techniques described above to relieve the aortic stenosis would also be
`applicable to this valve. This valve however may not be the best valve for
`isolated aortic regurgitation given the direct placement of the valve over the
`native valve may impede opening and create an outflow obstruction.
`However given the curved and redundant nature of this valve and the fact
`that it centralizes the ejection jet from the left ventricle it may produce the
`most laminar flow characteristics and least hematologic sequelae. The edges
`may need to have a loose rim of pliable material to help reduce peri—valVular
`leaks.
`
`Other valvular designs which may prove valuable to this technique include
`the usage of cadaver/porcine incorporated valves placed within a
`percutaneously stented system and would have the benefits of favorable flow
`characteristics and hematological characteristics. Also tilted disk/duo disk
`design could be hinge and compacted within a percutaneous system to
`provide reasonable partition between the left ventricle and aorta. However
`these valves have shown to have less favorable hematological sequelae.
`
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`TROY R. NORRED 07/98
`LAURA E. NORRED
`4511 ROYAL LYTHAM PH. 573-443-8301
`
`COLUMBIA, MO 65203
`Pay to the
`orderof
`gjgua
`BankofAmerica./
`
`
`éA_4£,L_,
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`wsmo
`u /‘
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`Date gig? 5 9 02,000
`
`2 4 4 1
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`Afigwa
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` o llars
`
`Bank of America Advantagem
`
`NORRED EXHIBIT 2210 -Page 12
`NORRED EXHIBIT 2210 -Page 12