PERCUTANEOUS AORTIC VALVE REPLACEMENT
`
`Background of the Invention
`
`This invention relates to artificial aortic heart
`
`valves
`
`and,
`
`in 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 trileaflet aortic valve normally
`
`will not
`
`become
`
`stenotic until
`
`the
`
`seventh decade
`
`of
`
`a
`
`person's
`
`life unless
`
`infectious 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 person ages
`
`and becomes
`
`symptomatic with aortic stenosis, he is less 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.
`
`(Docket 27
`
`45
`
`)
`
`NORRED EXHIBIT 2044 - Page 1
`Medtronic Inc. Medtronic Vascular Inc.
`7
`l
`l
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, MD.
`CaselPR2014~00110
`
`!
`
`
`
`Background of the Invention
`
`This invention relates to artificial aortic heart
`
`valves
`
`and,
`
`in 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 trileaflet aortic valve normally
`
`will not
`
`become
`
`stenotic until
`
`the
`
`seventh decade
`
`of
`
`a
`
`person's
`
`life unless
`
`infectious 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 person ages
`
`and becomes
`
`symptomatic with aortic stenosis, he is less 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.
`
`(Docket 27
`
`45
`
`)
`
`NORRED EXHIBIT 2044 - Page 1
`Medtronic Inc. Medtronic Vascular Inc.
`7
`l
`l
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, MD.
`CaselPR2014~00110
`
`!
`
`
`
`It is therefore 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
`
`of
`
`the
`
`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
`
`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
`
`regurgitation of a native aortic valve.
`
`Yet
`
`another
`
`important
`
`object
`
`of
`
`the
`
`present
`
`invention.
`
`is to provide an aortic valve as aforesaid. which
`
`increases
`
`the
`
`effective
`
`aortic
`
`valve orifice area while
`
`minimizing 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.
`
`NORRED EXHIBIT 2044 - Page 2
`
`
`
`Yet
`
`another
`
`important
`
`object
`
`of
`
`the
`
`present
`
`invention is to :provide an aortic valve as aforesaid. which
`
`reduces
`
`long—term ventricular
`
`and
`
`aortic
`
`sequelae
`
`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
`
`nonsurgically so as to minimize 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 hemodynamic 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 need for a bypass pump
`
`or sternotomy and the associated postoperative risks.
`
`These
`
`and other objects
`
`and advantages of
`
`this
`
`invention will become apparent
`
`from the following description
`
`NORRED EXHIBIT 2044 - Page 3
`
`
`
`taken in connection with the accompanying drawings, wherein is
`
`set forth by way of
`
`illustration and example,
`
`a now preferred
`
`embodiment of this invention.
`
`Brief Description of the Drawings
`
`Fig.
`
`l
`
`is
`
`a diagrammatic
`
`sectional view of
`
`a
`
`catheter containing aortic valve and stents of
`
`the present
`
`invention in the descending portion of an aorta.
`
`Fig.
`
`2
`
`is a diagrammatic view of Fig.
`
`l 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 inflation 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.
`
`of Fig. 5.
`
`Fig.
`
`7 is a plan view of the umbrella aortic valve
`
`Fig.
`
`8
`
`is the umbrella aortic valve of Fig.
`
`5
`
`in
`
`an open position.
`
`NORRED EXHIBIT 2044 - Page 4
`
`
`
`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.
`
`12
`
`is the cone-shaped valve of Fig.
`
`9
`
`in an
`
`open position.
`
`Fig. 13 is a plan view of the cone—shaped valve of
`
`Fig. 11.
`
`Fig.
`
`14
`
`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. 13.
`
`Fig. 16 is the cone—shaped aortic valve of Fig. 13
`
`in an open position.
`
`Fig. 17 is a plan view of the cone—shaped valve of
`
`Fig. 15.
`
`NORRED EXHIBIT 2044 - Page 5
`
`
`
`D
`
`ri
`
`i n
`
`f
`
`h Pr f rr
`
`Emb
`
`im n
`
`Turning more particularly to the drawings, Fig.
`
`1
`
`illustrates
`
`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
`
`surrounded by a wire mesh tube or stent 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 scaffolding.
`
`The
`
`stent
`
`systen1 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).
`
`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
`
`NORRED EXHIBIT 2044 - Page 6
`
`
`
`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
`
`combination 36,
`
`the
`
`fermoral vein would
`
`be
`
`accessed and
`
`cannulated 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 echocardiography (ICE) or fluoroscopy, which are
`
`known in the art.
`
`Use of
`
`this valve/stent combination 36 precludes
`
`removal of
`
`the native aortic valve
`
`34.
`
`The
`
`focus would
`
`NORRED EXHIBIT 2044 - Page 7
`
`
`
`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
`
`Er—YSGG
`
`percutaneous laser to decalcify the valve and repeat balloon
`
`aortic valvuloplasty.
`
`If
`
`this is not effective then high
`
`frequency ultrasound percutaneously applied to the aortic
`
`valve may be necessary.
`
`These
`
`techniques have been shown
`
`to be highly
`
`effective at producing debulking and preventing restenosis and
`
`increasing the effective aortic valve orifice area.
`
`However,
`
`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
`
`NORRED EXHIBIT 2044 - Page 8
`
`
`
`of the native aortic valve and pneumatically sealed together.
`
`Then expandable and retractable biotomes may be percutaneously
`
`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 mechanism
`
`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 effective orifice area.
`
`Because the
`
`artificial valve is not anchored or dependent upon the native
`
`valve
`
`for
`
`its
`
`function,
`
`this
`
`technique
`
`could be
`
`easily
`
`reapplied,
`
`if
`
`the native valve were
`
`to restenose, without
`
`comprising the artificial valve.
`
`A tremendous advantage of
`
`this procedure would be its independence frmn 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 connecting
`
`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. Hinges 61 permit ribs 60 to move between
`
`NORRED EXHIBIT 2044 - Page 9
`
`
`
`-10,
`
`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 radially from an perpendicular
`
`to body 52. Hinges 61 permit 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 tfiocompatible,
`
`flexible material
`
`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.
`
`However,
`
`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 flow
`
`characteristics of the native aortic valve in the aorta around
`
`NORRED EXHIBIT 2044 - Page 10
`
`
`
`-11-
`
`valve 30.
`
`Generally,
`
`any rounded shape,
`
`such as
`
`ea
`
`rounded
`
`cone or hemi—ellipse, will produce satisfactory laminar flow.
`
`Generally, umbrella—shaped valve 30 is placed in a
`
`position 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 flow from the aorta
`
`into the left ventricle or
`
`regurgitate.
`
`This backflow 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
`
`percutaneously.
`
`Conical valve
`
`66 consists of
`
`two
`
`to 32
`
`interconnected. plates or
`
`fingers
`
`68
`
`and a generally ring-
`
`shaped base 70 and a ring 72 secured to the base 70.
`
`The
`
`NORRED EXHIBIT 2044 - Page 11
`
`
`
`-12-
`
`fingers 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 conically—shaped
`
`fabric 75 membrane 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 of
`
`stainless 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
`
`regurgitation.
`
`It should be understood that if the number of
`
`fingers is increased, contact with the adjacent fingers may be
`
`along the entire length of the finger 68.
`
`If contact is along
`
`the entire side length of each adjacent
`
`finger when conical
`
`valve 66 is in the closed position,
`
`a membrane 75 may not be
`
`necessary to jprevent
`
`regurgitation.
`
`To minimize components
`
`and to aid in miniaturizing the device
`
`for delivery,
`
`the
`
`number
`
`of
`
`fingers
`
`68 may
`
`be
`
`reduced
`
`to
`
`two
`
`to
`
`four
`
`interconnecting fingers 68.
`
`During systole valve 66 expands or opens as shown
`
`in Figs. 12~13 to allow blood ejected from the left ventricle
`
`to flow through the center of valve 66.
`
`Fingers 68 pivot on
`
`ring 72 and tips 76 separate to allow blood to flow through
`
`NORRED EXHIBIT 2044 - Page 12
`
`
`
`-13-
`
`the center of valve 66.
`
`Membrane
`
`75 prevents fingers from
`
`overextending 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 biocompatible 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 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
`
`intraluminal
`
`connecting rods
`
`58 within lthe
`
`ascending aorta as with umbrella valve 30 (see Fig. 4).
`
`Conical valve 66 centralizes the blood ejection
`
`jet
`
`from the left ventricle providing improved laminar
`
`flow
`
`characteristics through the valve 66 and minimizes hematologic
`
`sequelae.
`
`Referring to Figs. 14—17, a third embodiment of an
`
`artificial
`
`aortic
`
`valve
`
`is
`
`shown which may
`
`be
`
`placed
`
`percutaneously.
`
`Trihedral valve 82
`
`is similar
`
`in structure
`
`and operation to conical valve 66
`
`(Figs. 10-13).
`
`Arms 84 are
`
`NORRED EXHIBIT 2044 - Page 13
`
`
`
`-14-
`
`hingedly 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 distole, back flow of blood from the aorta
`
`to the left ventricle causes valve 82
`
`to close preventing
`
`regurgitation (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
`
`tangentially along the sinus of valsalva.
`
`In this embodiment,
`
`as
`
`in the
`
`conical valve
`
`66,
`
`there
`
`are
`
`no
`
`interluminal
`
`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
`
`biocompatible material such as plastic.
`
`Crescent—shaped pads
`
`90 may be constructed of stainless steel for durability or of
`
`NORRED EXHIBIT 2044 - Page 15
`
`
`
`-15-
`
`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
`
`cadaver/porcine
`
`incorporated valves placed within a percutaneously stented
`
`system the
`
`benefits
`
`of
`
`favorable
`
`flow and
`
`hematologic
`
`characteristics.
`
`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—
`
`term sequelae of pressure overload would. be met with this
`
`system of percutaneously delivered aortic valve/s.
`
`NORRED EXHIBIT 2044 - Page 15
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pa. S
`
`NORRED EXHIBIT 2044 - Page 20
`
`
`
`
`
`NORRED EXHIBIT 2044 - Page 21
`
`
`
`
`
`
`
`
`
`
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
