NORRED EXHIBIT 2230 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00395
`
`

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`U.S. Patent
`
`Nov. 19, 2002
`
`Sheet 1 of 7
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`US 6,482,228 B1
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`NORRED EXHIBIT 2230 - Page 2
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`U.S. Patent
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`Nov. 19, 2002
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`Sheet 2 of 7
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`US 6,482,228 B1
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`NORRED EXHIBIT 2230 - Page 3
`NORRED EXHIBIT 2230 - Page 3
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`U.S. Patent
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`Nov. 19, 2002
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`Sheet 3 of 7
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`US 6,482,228 131
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`mt._ ,
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`U.S. Patent
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`Nov. 19, 2002
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`Sheet 4 of 7
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`US 6,482,228 B1
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`U.S. Patent
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`Nov. 19,2002
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`Sheet 5 of 7
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`US 6,482,228 B1
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`NORRED EXHIBIT 2230 - Page 6
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`U.S. Patent
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`Nov. 19, 2002
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`Sheet 6 of 7
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`US 6,482,228 B1
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`?5LO0D FLOW
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`U.S. Patent
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`Nov. 19, 2002
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`Sheet 7 0l'7
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`US 6,482,228 B1.
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`US 6,482,228 Bl
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`1
`PERCUTAN E() US A0 RTI C VALVE
`RICI’I.ACI<“.I\/I ICNT
`
`BAC.‘KGROUND OF TI~lI33 INVENTION
`
`.10
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`20
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`in
`This invention relates to aortic heart valves and,
`particular, to a percutaneous aortic heart valve that is placed
`by a catheter or other means and held in place with a stent
`system without the need for surgery.
`The aortic valve undergoes a series of changes based upon
`the initial structure at birth and the normal dynamic daily
`stresses. The trileallet aortic valve normally will not become
`stenotic until the seventh decade of a person’s life unless
`in liectious processes are introduced earlier. The incidence of
`aortic stenosis can reach between two and nine percent of the
`people in this age range. The average mortality rate at all
`ages is nine percent
`a year which also increases as a
`population ages. Coupled with these facts is the likelihood
`that as a per.son ages and becomes symptomatic with aortic
`stenosis, he is
`likely to be an operative candidate due to
`being physically unable to withstand the stresses of surgery.
`The mortality of octogenarians has been reported as high as
`20% for aortic valve replacement which can preclude a
`reasonable attempt at the therapy of choice, e.g., surgical
`replacement of the aortic valve using the traditional method
`of open heart surgery.
`It is tlierefore the primary object of the present invention
`to provide an aortic valve that can be placed nonsurgically.
`Another object of the present invention as aforesaid is to
`provide an aortic valve which may be anchored in the
`ascending aorta by a stent system.
`Yet another important object ofthe present invention is to
`provide an aortic valve as aforesaid which may be placed
`percutaneously.
`Still another object of the present invention is to provide I
`an aortic valve as aforesaid which functions without removal
`of the native aortic valve.
`Another important object of the present invention is to
`provide an aortic valve as aforesaid which reduces regurgi-
`tation ol a native aortic valve.
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`40
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`2
`need for a bypass pump or sternotoniy and the associated
`postoperative risks.
`These and other objects and advantages of this invention
`will become apparent from the following description taken
`in connection with the accompanying drawings, wherein is
`set forth by way ofillustration and example, a now preferred
`embodiment of this invention.
`
`IIRIEF IJESCRIPTION OF TIIIT. DRAWINGS
`
`FIG. I is a diagrammatic sectional view of a catheter
`containing aortic valve and stcnts of the present invention in
`the descending portion of an aorta.
`FIG. 2 is a diagrammatic view of FIG. I with the catheter
`advanced to the ascending portion of the aorta.
`FIG. 3 is a diagrammatic view of FIG. 2 with the aortic
`valve and stents being deployed into the aorta and the stents
`being expanded by intlation of a balloon.
`FIG. 4 is a diagrammatic view of FIG. 3 with the stents
`expended and in place and the catheter removed.
`FIG. 5 is a diagrammatic view of FIG. 4 showing the
`relationship between the placement of the stent system and
`valve to the aortic valve and left ventricle.
`
`FIG. 6 is an umbrella aortic valve in a closed position.
`FIG. 7 is a plan view of the umbrella aortic valve of FIG.
`
`5.
`
`FIG. 8 is the umbrella aortic valve of FIG. 5 in an open
`position.
`FIG. 9 is a plan view of the umbrella aortic valve of FIG.
`
`7.
`
`FIG. 10 is a diagrammatic view of a cone~shaped aortic
`valve in a closed position.
`FIG. 11 is a plan view of the cone-shaped valve of FIG.
`10.
`
`FIG. 12 is the cone-shaped valve of FIG. 10 in an open
`position.
`FIG. I3 is a plan view of the cone~shaped valve of FIG.
`12.
`
`FIG. I4 is a diagrammatic view of another cone-shaped
`aortic valve in a closed position.
`FIG. 15 is a plan view of the cone-shaped valve of FIG.
`14.
`
`Yet another important object of the present invention is to
`provide an aortic valve as aforesaid which increases the
`elliective aortic valve orillce area while minimivjng the
`resultant aortic regurgitation.
`Still another important object of the present invention is
`to provide an aortic valve as aforesaid which reduces left
`ventricle energy expenditure from aortic regurgitation.
`Yet another important object of the present invention is to
`provide an aortic valve as aforesaid which reduces long-term
`ventricular and aortic sequelac from pressure overload
`caused by aortic regurgitation.
`Another important object of the present invention is to
`provide an aortic valve as aforesaid which can be placed
`nonsurgically so as to minimize the health risk to a patient
`during the procedure.
`These and other objects and advantages of this invention
`are achieved by an artificial biomechanical aortic valve
`integrated with a stent system, which may be placed non-
`surgically so as to rninimi/.c the risk to the patient during the
`procedure. The aortic valve is anchored in the ascending
`aorta with further support supplied in branch vessels or
`descending aorta as necessary due to the stress forces placed
`on the artificial valve by the normal hemodynainic pressures
`in the aorta. The valve is connected to the stent system by
`serially connected rods. Because of the relatively large
`surface area of the stent system, this design displaces the
`forces placed upon the artificial valve across this large
`surface area. Placing the device nonsurgically eliminates the
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`45
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`FIG. 16 is the cone-shaped aortic valve of FIG. .14 in an
`open position.
`FIG. 17 is a plan view of the cone-shaped valve of FIG.
`I6.
`
`FIG. 18 is a diagrammatic view of a cadaver/porcine
`incorporated valve and stent system.
`FIG.
`I9 is a plan view of the cadaver/porcine valve of
`FIG. 18.
`
`Dl3SCRIl"l'ION OF TIIF. l’RllFllRl{l_lI')
`EMBODIMENT
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`illus-
`I
`Turning more particularly to the drawings, FIG.
`trates a sectional diagrammatic view of a cannular catheter
`20 in the descending portion 22 of aorta 24. Cannular
`catheter 20 contains a balloon catheter 26 which is sur-
`rounded by a wire mesh tube or stem system 28 connected
`to artificial valve 30.
`
`The stent system 28 is made up of a small slotted stainless
`steel tube or series of interconnected rods which form an
`expandable cylindrical lattice or scallolding. The stent sys-
`tem 28 is initially collapsed to a small diameter around an
`angioplasty balloon 29 so that it and valve 30 may be guided
`into place using an antegrade approach through the fermoral
`artery (not shown) to the ascending aorta 32 (FIG. 2).
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`Once cannular catheter 20 is located in ascending aorta 32
`above native aortic valve 34,
`the balloon catheter 26 is
`deployed (FIG. 3) to place the valve/stent combination 36 in
`the correct anatomical position so that valve 30 is above
`aortic valve 34 (FIG. 4) and below coronary arteries 38 so
`that the openings to coronary arteries 38 are unobstructed.
`When the valve/stent combination 36 is correctly placed, the
`balloon 29 is inflated to expand the stent scaffolding 28 and
`force the stent system 28 against the inner walls of ascending
`aorta 32 to anchor valve 30 in place. After balloon 29 is
`deflated and balloon catheter 26 is removed, the stent 28
`remains locked in place. The stent lattice 28 may extend into
`descending aorta 32 or branch vessels (not shown) to further
`support and secure valve 30 in place.
`Once the valve and stent combination 36 is in place, the
`balloon 29 is deflated and balloon catheter 26 is retracted
`into cannular catheter 20. Both catheters 26 and 20 are
`removed from aorta 24 through the fermoral artery (not
`shown).
`Simultaneously with placement of the valve/stent combi-
`nation 36, the fcrmoral vein would be accessed and cannu-
`lated to guide a balloon catheter into the left ventricle using
`a retrograde approach to perform a valvoplasty by inflating
`the balloon within the aortic valve. The purpose of the
`valvoplasty is to force the aortic valve open to relieve the
`pressure gradient between the left ventricle 40 (FIG. 5) and
`aorta 24. Visualization to place the catheters within the aorta
`24 and left ventricle 40 would be accomplished using
`continuous roentgenogram and ultrasound techniques, such
`as intracardiac echoeardiography (ICE) or
`fluoroseopy,
`which are known in the art.
`
`Use of this valve/stent combination 36 precI11des removal
`of the native aortic valve 34. The focus would instead be
`upon debulking of the native aortic valve 34. The main
`purpose is abolition of the resting gradient. The techniques
`employed would attempt to achieve a large effective aortic
`valve area regardless of the functioning of the native aortic
`valve 34 post-procedure because an artificial aortic valve 30
`designed to prevent aortic regurgitation would be in place.
`Aortic valve 30 is designed not to hinder the ejection of
`blood from the left ventricle, and to minimize the aortic
`regurgitant volume. The techniques used to debulk the
`native aortic valve may include positioning of an I31‘-YSGG
`percutaneous laser to decalcify the valve and repeat balloon
`aortic valvuloplasty. If this is not effective then high fre-
`quency ultrasound pereutaneously applied to the aortic Valve
`may be necessary.
`These techniques have been shown to be highly elfective
`at producing debulking and preventing restenosis and
`increasing the effective aortic valve orifice area. Ilowever,
`they produce tremendous aortic regurgitation. This would
`not be a problem for the unattached valve 30 which would
`work as disclosed below for aortic regurgitation.
`If these techniques do not produce the desired result of
`increasing the effective aortic valve orifice area then a host
`of options are still available. For example, two rings may be
`guided onto both the aortic and ventricular sides of the
`native aortic valve and pneumatically sealed together. Then
`expandable and retractable biotomes may be pereutaneously
`placed for controlled dissection of the native aortic valve.
`The biotomes may be used for primary resection without
`stabilizing rings, but there would need to be a stabilization
`mechanism for the native aortic valve. Another such mecha-
`nism could employ the use of a micro screw into the native
`valve, which would act as an anchor to guide a biotome onto
`the native valve. Then the biotomes would take small snips
`in a controlled fashion off of the native Valve. This would
`gradually increase the eflective orifice area. Because the
`artificial valve is not anchored or dependent upon the native
`valve for
`its function,
`this technique could be easily
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`I0
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`15
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`30
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`45
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`50
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`S5
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`60
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`if the native valve were to restenose, without
`reapplied,
`comprising the artificial valve. A tremendous advantage of
`this procedure would be its independence from a need for a
`percutaneous bypass pump.
`Referring to FIGS. 6-9, an inverted generally umbrella-
`shaped valve 30 is shown. Umbrella valve 30 has a generally
`pear or bulb-shaped main body 52 and a neck 54 which
`extends from the body. Extending from neck 54 is connect-
`ing rod 56 which secures stent struts 58 to umbrella valve 30.
`Frame members or ribs 60 extend radially from and are
`hingedly attached to body 52. llinges 61 permit ribs 60 to
`move between a folded position (FIGS. 6-7) where the ribs
`extend generally parallel
`to neck 54, and an unfolded
`position (FIGS. 8-9) where the ribs extend generally radi-
`ally from an perpendicular to body 52. llinges 61 prevent
`ribs 60 from overextending when unfolded. A generally
`circular canopy 62 is secured to the lower sides of each of
`the frame members 60 and the lower side 64 of body 52.
`Canopy 62 may be made of a biocompatible, flexible mate-
`rial such as an elastomeric sheet or a Dacron® reinforced
`polymer, for example. Frame members 60 may be made of
`stainless steel or a plastic polymer that is able to withstand
`the shear stresses during folding of valve 30.
`In FIGS. 6-9 frame members 60 are shown generally
`straight.
`Ilowever,
`frame members 60 may be curved
`inwardly toward neck 54 when valve 30 is in the folded or
`collapsed position (FIG. 6) and generally tangentially to the
`inner wall of the aorta and toward the stent system 28 (FIG.
`4) when valve 30 is in the unfolded position (FIG. 8).
`Additionally, canopy 62 may extend beyond the ends of
`frame members 60 to help reduce or eliminate peri-valvular
`leaks by sealing the valve against the inner wall of the aorta.
`The end 64 of valve body 52 is generally hemispherical
`which permits the desired laminar blood llow characteristics
`of the native aortic valve in the aorta around valve 30.
`Generally, any rounded shape, such as a rounded cone or
`hemi-ellipse, will produce satisfactory laminar llow.
`Generally, umbrella-shaped valve 30 is placed in a posi-
`tion above the native aortic valve and below the openings of
`the coronary arteries 28 (FIG. 4). The structure of valve 30
`collapses to a folded (FIG. 6) position wherein the ribs
`extend along the neck such that the canopy does not traverse
`the aortic channel. Thus, during systolic contraction of the
`left ventricle the blood from the left ventricle may be
`expelled unimpeded into the aorta (FIGS. 6~7) as the valve
`is folded. During diastolic filling of the left ventricle, the
`pressure in the aorta becomes greater than the pressure in the
`left ventricle and the blood attempts to llow from the aorta
`into the left ventricle or regurgitate. This baeldlow is caught
`in the canopy 62 which causes valve structure 30 to unfold
`(FIGS. 8-9) and prevents aortic regurgitation as the opening
`between the aorta 24 and the left ventricle is sealed. At this
`position ribs 60 extend radially and generally perpendicular
`from body 52.
`Referring to FIGS. 10-13 a second embodiment of an
`artificial aortic valve is shown which may be placed pereu-
`taneously. Conical valve 66 consists of two to 32 intercon-
`nected plates or fingers 68 and a generally ring-shaped base
`70 and a ring 72 secured to the base 70. The lingers 68 are
`generally wedge or bowling pin-shaped and are hingedly
`secured together by ring 72 extending through the base 74 of
`each finger 68 and interconnected by a biocompatible,
`durable, flexible generally eonically-shaped fabric 75 me1n—
`brane secured to the inside surfaces 69 of the fingers. The
`fingers 68 extend generally radially inwardly and away from
`the base 70. Fingers 68 may be constructed ofstainless steel,
`plastic or other biocompatible material.
`In the closed position (FIGS. 10-11), the tops 76 of the
`fingers contact each adjacent fingertip 76 to prevent regur-
`gitation. It should be understood that if the number of fingers
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`is increased, contact with the adjacent tliigers may be along
`the entire length of the finger 68. If contact is along the entire
`side length ofeach adjacent finger when conical valve 66 is
`in the closed position, a membrane 75 may not be necessary
`to prevent regurgitation. To minimize components and to aid
`in miniaturizing the device for delivery,
`the number of
`tliigers 68 may be re(luced to two to four interconnecting
`fingers 68.
`During systole valve 66 expands or opens as shown in
`FIGS. 1%13 to allow blood ejected from the left ventricle
`to llo\v through the center of valve 66. Fingers 68 pivot on
`ring 72 and tips 76 separate to allow blood to tlow through
`the center of valve 66. Membrane 75 prevents lingers from
`overexteiidiiig to block coronary arteries 38 (FIG. 4).
`Valve 66 and the combined stent 28 is guided into position
`as shown in FIGS. 1-4, and placed over the native aortic
`valve 34. Base 70 is seated against the root of the aortic
`valve 34 next
`to the inner wall of the aorta 24 below
`coronary arteries 38. The rim 78 of base 70 is made of a
`pliable biocompatiblc material which seals against the root
`of the native aortic valve 34 to reduce peri-valvular leaks.
`Valve 66 is anchored along the root of the aortic valve with
`connecting rods 80 which are connected to the ascending
`aortic stents 28 (see FIG. 4). Valve 66 is placed such that
`rods 80 are positioned between the right and left coronary
`ostia tangentially along the sinus of valsalva.
`In this
`embodiment, there are no iiitralumiiial coiuiectiiig rods 58
`within the ascending aorta as \vitli umbrella valve 30 (see
`FIG. 4).
`Conical valve 66 centralizcs the blood ejection jet from
`the left ventricle providing improved Ianiinar tlow charac-
`teristics through the valve 66 and minimizes hematologic
`sequelae.
`third embodiment of an
`Referring to FIGS. 14-17, a
`artificial aortic valve is shown which may be placed percu-
`taneously. Trihedral valve 82 is similar in structure and
`operation to conical valve 66 (FIGS. 10~13). Arms 84 are
`liingedly attached to ring 86 of base 88 and extend upwardly
`and radially inwardly from base 88 to generally form a
`trihedron or cone. Each rod 84 has a crescent-shaped pad 90
`at
`its free end. A cone-shaped membrane 92 of fibrous
`polymer is secured to each arm 84 and base 88 (not shown
`in FIG. 14).
`During diastole, back tlow of blood from the aorta to the
`left ventricle causes valve 82 to close preventing regurgita-
`tion (FIGS. 14—15). During systole, blood is ejected from the
`left ventricle to force valve 82 open and allow blood to flow
`into the ascending aorta through the center of valve 82.
`Valve 82 is anchored along the aortic valve root wall with
`connecting rods (not shown; see connecting rods 80, FIG.
`10) which are connected to ascending aortic stents 28 (FIG.
`4). Valve 82 is placed so that
`the connecting rods are
`positioned between the right and left coronary ostia tangen-
`tially along the sinus of valsalva. In this embodiment, as in
`the conical valve 66, there are no interluininal connecting
`rods 58 within the ascending aorta as with umbrella valve 30
`(see FIG. 4).
`Base 88 of valve 82 is constructed as disclosed above for
`base 70 of conical valve 62. Arms 84 may be constructed of
`stainless steel or other structural biocoinpatible material
`such as plastic. Crescent—shaped pads 90 may be constiucted
`of stainless steel for durability or of softer biocompatible
`materials to better seal the valve 82 when in the closed
`position (FIGS. 14-15), and reduce regurgitation.
`Other valvular designs which may prove valuable to this
`technique include the usage of biological tissue incorporated
`valves, such as cadaver/porcine valves, placed within a
`percutaneously stented system the benefits of favorable llow
`and hematologic characteristics (see FIGS. 18 and 19).
`
`an
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`St.)
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`Cadaver/porcine valve 100 is retained in a base ring 102.
`Ring 102 is made of a pliable biocoinpatible material which
`seals against the root of the native aortic valve 34 (see FIG.
`4) to reduce peri-valvular leaks. Valve 100 is anchored along
`the root of the aortic valve with connecting rods 104 which
`are connected to the ascending aortic stents 28 shown in
`FIG. 4. Valve 10() is placed such that rods 104 are positioned
`between the right and left coronary ostia tangentially along
`the sinus of valsalva.
`The central themes involve increasing the effective aortic
`valve orifice area while minimizing the resultant aortic
`regurgitation. Thus,
`the goals in reducing left ventricular
`energy expenditure and its resultant long-teriii sequclae of
`pressure overload would be met with this system of percu-
`taneously delivered aortic valves.
`Ilaving thus described the invention, what is claimed as
`new and desired to be secured by Letters Patent is:
`1. An aortic valve for regulating blood tlo\v through a
`chamiel of an aorta, the channel surrounded by an aortic
`wall, upon placement therein, said valve comprising:
`a body member having a configuration adapted to fit
`within a channel of an aorta;
`a membrane made of a material impervious to an aortic
`blood tlow, said membrane having a first membrane
`position precluding a blood tlow through the aorta and
`a second position for allowing a blood tlow through the
`aorta; and
`a plurality of frame members with said membrane
`mounted thereto, each frame member having a first end
`pivotally secured to said body member and a second
`end, said frame members pivotally responsive to a
`condition within the aorta between a first position
`wherein said membrane at said first frame member
`position is at said first membrane position and a said
`second frame member position wherein said membrane
`is at said second membrane position.
`2. An aortic valve as claimed in claim 1 wherein said
`membrane extends across the aortic channel to block a blood
`tlow at said first membrane position and extends generally
`along the aortic channel to allow a blood tlow through the
`aorta at said second membrane position.
`3. The aortic valve as claimed in claim 1 further coiii-
`prising means for stopping pivotal movement ofsaid second
`end of said frame members into contact with the aorta wall.
`4. The aortic valve as claimed in claim 1 wherein said
`condition within the aorta is a change in blood pressure in
`the aorta.
`5. The aortic valve as claimed in claim 1 wherein said
`frame members and membrane move to said second posi-
`tions in response to systolic ejection of blood from the left
`ventricle in which the blood pressure in the left ventricle is
`higher than the blood pressure in the aorta.
`6. The aortic valve as claimed in claim 1 wherein said
`frame member and membrane move to said first position in
`response to diastolic filling ofthe left ventricle and the blood
`pressure in the aorta is higher than the blood pressure in the
`left ventricle resulting in a reverse tlow of blood from the
`aorta to the left ventricle which is stopped by said membrane
`at said first position.
`7. An aortic valve as claimed in claim 1 wherein said body
`member has an exterior configuration to present a space
`between said body member exterior configuration and the
`aortic wall to allow blood tlow tlierearouiid at said incin-
`braiie second position.
`8. The aortic valve as claimed in claim 1 wherein said
`body member comprises a base presenting an edge adapted
`to seat about the aortic wall surrounding the aortic channel;
`an aperture in said base for blood flow tlieretlirougli;
`a ring surrounding said aperture, said first end of said
`frame members pivotally mounted to said ring with
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`said membrane mounted thereto, said second ends of
`said frame members being in contact at said first frame
`member position to cause said membrane to span said
`base aperture and preclude a blood flow past said
`second frame member ends and said membrane, said
`frame members pivotable about said ring to a second
`position wherein said second frame member ends are
`displaced one from the other to allow a blood flow
`through the aperture and past said membrane.
`9. The aortic valve as claimed in claim 8 wherein said
`membrane presents a base opening secured about said
`aperture and a free end having an aperture therein, said
`aperture in said free end of said membrane at said second
`frame and membrane positions is open to allow blood to
`flow though said membrane between said membrane base
`opening and said aperture in said free end of said membrane
`at said membrane second position.
`10. The aortic valve as claimed in claim 9 wherein said
`membrane free end aperture is closed at said first frame
`membrane and member positions to preclude blood from
`flowing though said membrane at said membrane first posi-
`tion.
`11. The aortic valve as claimed in claim 1 further com—
`prising means for maintaining said body member within the
`aortic channel.
`
`.12. An aortic valve for regulating blood flow through a
`channel of an aorta upon placement
`therein, said valve
`COII]pf1SlUg§
`
`a body member having a configuration adapted to fit
`within a channel of an aorta to allow passage of a blood
`flow therearound;
`a membrane for traversing the aortic channel to preclude
`blood flow thcrethrough; and
`at least two ribs for attachment of said membrane thereto,
`each rib having a first end hingedly attached to said
`body member and a free end extending from said body
`member, wherein said at least two ribs are responsive
`to a change in pressure in the aorta for movement
`between a first position wherein said membrane is
`unfolded so as to traverse the aortic channel and
`preclude a blood flow therethrough and a second col-
`lapsed position wherein said membrane is positioned
`relative to the aorta channel
`to allow a blood flow
`therearound.
`13. The aortic valve as claimed in claim 12 wherein said
`at least two ribs extend radially from said body so as to
`traverse the aortic channel at a first rib position, said first rib
`position corresponding to unfold said membrane at said first
`position, and wherein said ribs extend generally along said
`aortic channel at a second rib position to collapse said
`membrane at said second position.
`14. The aortic valve as claimed in claim 13 wherein said
`membrane presents an edge adapted for contact about a wall
`of the aortic channel in said first position, said contact seats
`said membrane edge against
`the aortic channel
`\vall
`to
`reduce a blood flow therearound.
`15. The aortic valve as claimed in claim 12 further
`comprising means for maintaining said body member at a
`selected position in the aorta.
`16. An aortic valve for regulating a blood flow through an
`aortic channel surrounded by an aortic wall upon placement
`therein, said valve comprising:
`
`8
`a ring member having a circurnferenee adapted to seat
`about an aortic wall surrounding an aortic channel, said
`ring including an aperture for blood flow therethrough;
`a membrane having first and second spaced—apart open
`ends, said membrane made of a material resistant to a
`fluid flow tlieretlirougli; and
`means for mounting said first open end of said membrane
`about said ring aperture with said second open end
`displaced therefrom, said means moving said mem-
`brane second end between a first open position to allow
`a blood flow thcrethrough and a second closed position
`to preclude a blood flow tlierethrough.
`17. The aortic valve as claimed in claim [6 wherein said
`mounting means compris s at least one aim having a first
`end liingedly secured to said ring member and a free end
`spaced therefrom, said first end of said at
`least one arm
`secured to said first end of said membrane, said free end of
`said at least one arm secured to said second end of said
`membrane, said at least one arm responsive to a blood flow
`within the channel
`for movement with said membrane
`between said first open and second closed positions.
`18. The aortic valve as claimed in claim 17 wherein said
`at least one arm extends generally along a path ofsaid blood
`flow at said first open position, and generally traverses a
`blood flow path when at said second closed position.
`19. The aortic valve as claimed in claim 16 further
`comprising means for maintaining said ring member in said
`seat about the aortic wall.
`20. An aortic valve for controlling a blood flow through
`an aortic channel upon placement therein, said valve coin-
`prising:
`a tissue valve having an interior member made of a tissue
`material and presenting an opening movable between
`open and closed positions;
`a ring member surrounding said tissue valve, said ring
`member having an outer circumference adapted to seat
`said ring member about an aortic wall surrounding an
`aortic channel;
`means for maintaining said ring member in said seated
`position about the aortic \vall,
`said tissue valve interior member responsive to changes of
`conditions within the aorta for movement of said open-
`ing between a first closed position and a second open
`position.
`21. The aortic valve as claimed in claim 20 wherein said
`tissue valve interior member is responsive to changes in
`blood pressure in the aorta whereby to move said tissue
`valve between said first and second positions.
`22. The aortic valve as claimed in claim 21 wherein said
`tissue valve interior member moves to said second position
`in response to systolic ejection of blood from the left
`ventricle in which the blood pressure in the left ventricle is
`greater than the blood pressure in the aortic channel.
`23. The aortic valve as claimed in claim 21 wherein said
`tissue valve interior member moves to said first position in
`response to diastolic filling of the left ventricle whereby the
`blood pressure in the aortic channel is greater than the blood
`pressure in the left ventricle.
`24. The aortic valve as claimed in claim 20 wherein said
`ring member contacts the wall of the aortic channel and seals
`said ring against the aortic channel wall to reduce blood flow
`therearound.
`
`NORRED EXHIBIT 2230 - Page 12
`NORRED EXHIBIT 2230 - Page 12
`
`

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`CERTIFICATE ()F C()RRECTI()N
`
`PA'I‘EN'’l‘‘NO.
`I.)A'l‘I;ZD
`INVl3N"I‘()R(S)
`
`: 6,482,228 B‘!
`: November 19, 2002
`1 Troy R. Norred
`
`Page ‘I of ‘l
`
`It is certified that error appears in the above—identified patent and that said Letters Patent is
`hereby corrected as shown below:
`
`
`Column 7
`
`Lines 15 and 21, delete “though” and substitute ~— through —-.
`
`Signed and Sealed this
`
`Fourth Day of March, 2003
`
`JAMES E. ROGAN
`Dirrzclor of/he United .S‘mIe.s Patent and '1'radenzur/c Office
`
`NORRED Exhibit 2230 - Page 13
`NORRED Exhibit 2230 - Page 13