`
`Background of the Invention
`
`This invention relates to 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
`
`10
`
`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
`
`15
`
`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 therefore the primary object of the present invention to provide an
`
`aortic valve that can be placed nonsurgically.
`
`20
`
`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.
`
`25
`
`aforesaid which functions without removal of the native aortic valve.
`
`Still another object of the present invention is to provide an aortic valve as
`
`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
`
`3O
`
`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.
`
`(Docket 2895)
`
`NORRED EXHIBIT 2048 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`
`v. Troy R. Norred, MD.
`Case |PR2014-00110
`
`
`
`-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
`
`10
`
`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
`
`15
`
`device nonsurgically eliminates the need for a bypass pump or stemotomy 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 of illustration and example, a now preferred embodiment of this
`
`20
`
`invention.
`
`Brief Deseriptien 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.
`
`25
`
`Fig. 2 is a diagrammatic view of Fig.
`
`1 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
`
`3O
`
`place and the catheter removed.
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`NORRED EXHIBIT 2048 - Page 2
`
`
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`-3-
`
`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
`
`Fig
`
`Fig
`
`. 8 is the umbrella aortic valve of Fig. 5 in an open position.
`
`. 9 is a plan view of the umbrella aortic valve of Fig. 7.
`
`. 10 is a diagrammatic view of a cone-shaped aortic valve in a closed
`
`Fig.
`
`Fig.
`
`Fig.
`
`Fig.
`
`11 is a plan view of the cone-shaped valve of Fig. 9.
`
`12 is the cone—shaped valve of Fig. 9 in an open position.
`
`13 is a plan view of the cone—shaped valve of Fig. 11.
`
`14 is a diagrammatic view of another cone-shaped aortic valve in a
`
`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.
`
`Fig.
`
`18 is a diagrammatic view of a cadaver/porcine incorporated valve and
`
`Fig.
`
`19 is a plan view of the cadaver/porcine valve of Fig. 18.
`
`10
`
`15
`
`position.
`
`closed position.
`
`stent system.
`
`NORRED EXHIBIT 2048 - Page 3
`
`
`
`-4-
`
`Description of the Preferred Embodiment
`
`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 system 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
`
`10
`
`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
`
`15
`
`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
`
`20
`
`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).
`
`25
`
`fermoral vein would be accessed and cannulated to guide a balloon catheter into the left
`
`Simultaneously with placement of the valve/stent combination 36,
`
`the
`
`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
`
`NORRED EXHIBIT 2048 - Page 4
`
`
`
`-5-
`
`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 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
`
`10
`
`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
`
`15
`
`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
`
`20
`
`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
`
`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
`
`25
`
`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,
`
`NORRED EXHIBIT 2048 - Page 5
`
`
`
`—6-
`
`without 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 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 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
`
`10
`
`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 biocompatible, 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
`
`15
`
`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,
`
`20
`
`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 valve
`
`30. Generally, any rounded shape, such as a rounded cone or hemi—ellipse, will produce
`
`25
`
`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
`
`3O
`
`left ventricle the blood from the left ventricle may be expelled unimpeded into the aorta (Figs.
`
`NORRED EXHIBIT 2048 - Page 6
`
`
`
`-7-
`
`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
`
`10
`
`to the base 70. The 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
`
`15
`
`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
`
`20
`
`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
`
`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
`
`25
`
`on ring 72 and tips 76 separate to allow blood to flow through 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
`
`30
`
`of base 70 is made of a pliable biocompatible material which seals against the root of the
`
`NORRED EXHIBIT 2048 - Page 7
`
`
`
`~8-
`
`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
`
`intraluminal connecting rods 58 within the 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.
`
`10
`
`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 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
`
`15
`
`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
`
`20
`
`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).
`
`25
`
`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 softer biocompatible materials to better seal the valve 82 when in the closed
`
`position (Figs. l4-15), and reduce regurgitation.
`
`NORRED EXHIBIT 2048 - Page 8
`
`
`
`-9-
`
`Other valvular designs which may prove valuable to this technique include
`
`the usage of biological tissue incorporated valves, such as cadaver/porcine vales, placed
`
`within a percutaneously stented system the benefits of favorable flow and hematologic
`
`characteristics (see Figs. 18 and 19). Cadaver/porcine valve 100 is retained in a base ring
`
`102. Ring 102 is made of a pliable biocompatible 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 100 is placed such that rods 104 are positioned
`
`between the right and left coronary ostia tangentially along the sinus of valsalva.
`
`10
`
`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 valves.
`
`NORRED EXHIBIT 2048 - Page 9
`
`
`
`-10-
`
`Qlaims
`
`Having 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 flow through a channel of an aorta
`
`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 flow therethrough; and
`
`means for mounting said membrane relative to said body member between a first
`
`position wherein said membrane precludes a blood flow past said body member
`
`10
`
`and a second position wherein said membrane allows a blood flow past said body
`
`member.
`
`2. An aortic valve as claimed in claim 1 wherein said membrane extends
`
`across the aortic channel at said first membrane position and extends generally along the
`
`15
`
`aortic channel at said second membrane position.
`
`3. The aortic valve as claimed in claim 1 wherein said mounting means
`
`comprises a plurality of frame members each having a first end hingedly secured to said body
`
`and a free end extending from said body wherein said frame members move with said
`
`20
`
`membrane between said first and second positions.
`
`4. The aortic valve as claimed in claim 3 further comprising a means for
`
`stopping said frame members at said first position.
`
`25
`
`5. The aortic valve as claimed in claim 1 wherein said mounting means is
`
`responsive to changes in blood pressure in the aorta whereby to move said membrane
`
`between said first and second positions.
`
`NORRED EXHIBIT 2048 - Page 10
`
`
`
`-11-
`
`6. The aortic valve as claimed in claim 5 wherein said membrane 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 higher than the blood pressure in the aorta.
`
`7. The aortic valve as claimed in claim 5 wherein said membrane moves to
`
`said first position in response to diastolic filling of the left ventricle and the blood pressure in
`
`the aorta is higher than the blood pressure in the left ventricle resulting in a reverse flow of
`
`blood from the aorta to the left ventricle which is stopped by said membrane.
`
`10
`
`8. 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 said aortic wall to allow blood flow therearound at said membrane second position.
`
`9. The aortic valve as claimed in claim 1 wherein said body member is
`
`15
`
`generally ring—shaped having a circumference adapted to seat about an inner circumference of
`
`the aortic wall surrounding the aortic channel, said ring having an aperture for blood flow
`
`therethrough.
`
`10. The aortic valve as claimed in claim 9 wherein said membrane is
`
`20
`
`generally funnel-shaped having a base opening secured to an inner circumference of said ring-
`
`shaped body member and a free end having an aperture therein whereby said aperture in said
`
`free end of said membrane is open to allow blood to flow though said membrane from said
`
`membrane base opening to said aperture in said free end of said membrane at said membrane
`
`second position.
`
`25
`
`NORRED EXHIBIT 2048 - Page 11
`
`
`
`-12-
`
`11. The aortic valve as claimed in claim 9 wherein said membrane is
`
`generally funnel-shaped having a base opening secured to an inner circumference of said ring-
`
`shaped body member and a free end having an aperture therein whereby said aperture in said
`
`free end of said membrane is closed to preclude blood from flowing though said membrane
`
`from said aperture in said free end of said membrane to said membrane base opening at said
`
`membrane first position.
`
`12. The aortic valve as claimed in claim 10 wherein said membrane is
`
`generally funnel-shaped having a base opening secured to an inner circumference of said ring-
`
`10
`
`shaped body member and a free end having an aperture therein whereby said aperture in said
`
`free end of said membrane is closed to preclude blood from flowing though said membrane
`
`from said aperture in said free end of said membrane to said membrane base opening at said
`
`membrane first position.
`
`15
`
`13. The aortic valve as claimed in claim 1 further comprising means for
`
`maintaining said body member within the aortic channel.
`
`NORRED EXHIBIT 2048 - Page 12
`
`
`
`-13-
`
`14. An aortic valve for regulating blood flow through a channel of an aorta
`
`upon placement therein, said valve comprising:
`
`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 therethrough; and
`
`means for mounting said membrane to said body member 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 position wherein said membrane
`
`is positioned relative to the body member to allow a blood flow therearound.
`
`15. The aortic valve as claimed in claim 14 wherein said means for
`
`mounting comprises at least two ribs each having a first end hingedly secured to said body
`
`member and a free end extending from said body wherein said ribs move with said membrane
`
`between said first and second positions.
`
`10
`
`15
`
`16. The aortic valve as claimed in claim 14 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
`
`20
`
`membrane at said second position.
`
`17. The aortic valve as claimed in claim 14 wherein said membrane
`
`contacts the wall of the aortic channel in said first position and seals said membrane against
`
`the aortic channel wall to reduce a blood flow therearound.
`
`25
`
`18. The aortic valve as claimed in claim 14 further comprising means for
`
`maintaining said body member in the aorta.
`
`NORRED EXHIBIT 2048 - Page 13
`
`
`
`-14-
`
`19. An aortic valve for regulating a blood flow through an aortic channel
`
`upon placement therein, said valve comprising:
`
`a ring member having a circumference 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 ends, said membrane made of a
`
`material resistant to a fluid flow therethrough; and
`
`means for mounting said first end of said membrane about said ring aperture with said
`
`second end displaced therefrom, said means moving said second membrane end
`
`between an open position to allow a blood flow therethrough and a second closed
`
`10
`
`position to preclude a blood flow therethrough.
`
`20. The aortic valve as claimed in claim 19 wherein said mounting means
`
`comprises at least one arm having a first end hingedly secured to said ring member and a free
`
`end spaced therefrom, said first end of said arm secured to said first end of said membrane,
`
`15
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`said free end of said arm secured to said second end of said membrane, and wherein said arm
`
`moves with said membrane between said first and second positions.
`
`21. The aortic valve as claimed in claim 19 wherein said arm extends
`
`generally along a path of said blood flow when in said open position, and generally traverse to
`
`20
`
`said blood flow when in said closed position.
`
`22. The aortic valve as claimed in claim 19 further comprising means for
`
`maintaining said ring member in said seat about the aortic wall.
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`NORRED EXHIBIT 2048 - Page 14
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`
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`-15-
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`23. An aortic valve for controlling a blood flow through an aortic channel
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`upon placement therein, said valve comprising:
`
`a tissue valve having an interior member and circumference;
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`a ring member secured to said tissue valve along said tissue valve circumference and
`
`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 wall;
`
`and
`
`means for moving said tissue valve interior member between a first closed position and
`
`a second open position.
`
`24. The aortic valve as claimed in claim 23 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.
`
`25. The aortic valve as claimed in claim 24 wherein said tissue valve
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`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.
`
`26. The aortic valve as claimed in claim 24 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
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`ventricle.
`
`27. The aortic valve as claimed in claim 23 wherein said ring contacts the
`
`wall of the aortic channel and seals said ring against the aortic channel wall to reduce blood
`
`flow therearound.
`
`10
`
`15
`
`20
`
`25
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`NORRED EXHIBIT 2048 - Page 15
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`
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`-16-
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`Abstract of the Disclosure
`
`An aortic heart valve which is adapted to be placed percutaneously without
`
`the need for open-heart surgery is placed by a catheter and held in place with a stent system.
`
`The stent system is expanded in the ascending aorta to anchor the valve in the aortic channel
`
`5
`
`above the native aortic valve.
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`NORRED EXHIBIT 2048 - Page 16
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`
`
`PCT
`
`POWER OF ATTORNEY
`
`”or an international application filed under the Patent Cooperation Treaty
`
`(PCT Rule 90.4)
`
`The undersigned applicant(s) (Names should be indicated as they appear in the reques)‘.
`
`NORRED, TROY R.
`
`hereby appoints (appoint) the following person as:
`Name and address
`(Family namefollowed by given name.‘for a legal entity, full official dcsigna'bn. The address must include postal code and name ofcountry.)
`
`E]
`
`common representative
`
`agent
`
`Troy R. Norred
`
`CHASE, D. A. N.; YAKIMO, JR., Michael; DERUSSEAU, Ginnie C.; KERNELL, James J.; BRADLEY, Sean T.
`all of CHASE & YAKIMO, LC.
`4400 College Boulevard, Suite 130
`Overland Park, Kansas 66211
`United States of America
`
`to represent the undersigned before
`
`E all the competent lntemational Authorities
`
`E]
`
`C]
`
`the lntemational Searching Authority only
`
`the International Preliminary Examining Authority only
`
`in connection with the international application identified below:
`
`Tm" ”f the “WWW: PERCUTANEOUS AORTIC VALVE REPLACEMENT
`
`Applicant's or agent's file reference: 2895
`
`International application number (if already available):
`
`filed with the following Office US
`and to make or receive payments on behalf of the undersigned.
`
`as receiving Office
`
`Signature of the applicant(s)(where there are several applicants. each ofthem must sign; next to each signature, indicate the name ofthe person signing
`and the capacity in which the person signs, ifsuch capacity is not obvious/ram reading the request or this power):
`
`
`
`Form PCT/Model of power of attorney (for a given international application)(July 1992)
`
`NORRED EXHIBIT 2048 - Page 17
`
`