NORRED EXHIBIT 2324 - Page 1
`Medtronic, Inc., Medtronic Vascular,
`Inc., & Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case No. IPR2014-00395
`
`

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`U.S. Patent
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`Ju|.30, 2002
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`Sheet 1 of 23
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`US 6,425,916 B1
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`FIG.
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`‘IA
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`NORRED EXHIBIT 2324 - Page 2
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`U.S. Patent
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`Jul. 30, 2002
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`Sheet 2 of 23
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`US 6,425,916 B1
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`FIG. 1B
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`NORRED EXHIBIT 2324 - Page 3
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`U.S. Patent
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`Jul. 30, 2002
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`Sheet 3 of 23
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`US 6,425,916 B1
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`U.S. Patent
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`Jul. 30, 2002
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`Sheet 4 of 23
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`Us 6,425,916 B1
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`NORRED EXHIBIT 2324 - Page 5
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`U.S. Patent
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`JuI.30, 2002
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`Sheet 5 of 23
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`Us 6,425,916 B1
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`FIG.5
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`NORRED EXHIBIT 2324 - Page 6
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`U.S. Patent
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`Jul. 30,2002
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`Sheet 6 of 23
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`US 6,425,916 B1
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`NORRED EXHIBIT 2324 - Page 7
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`U.S. Patent
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`Jul. 30, 2002
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`Sheet 7 of 23
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`US 6,425,916 B1
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`32
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`NORRED EXHIBIT 2324 - Page 8
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`U.S. Patent
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`Jul. 30, 2002
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`NORRED EXHIBIT 2324 - Page 9
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`U.S. Patent
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`Jul._ 30, 2002
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`Sheet 9 of 23
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`US 6,425,916 B1
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`NORRED EXHIBIT 2324 - Page 10
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`U.S. Patent
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`Jul. 30, 2002
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`Sheet 10 of 23
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`US 6,425,916 B1
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`FIG.
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`NORRED EXHIBIT 2324 - Page 11
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`Sheet 11 of 23
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`Sheet 14 of 23
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`Shect19 of 23
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`Sheet 22 of 23
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`US 6,425,916 B1
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`1
`METHODS AND DEVICES FOR
`IMPLANTING CARDIAC VALVES
`
`BACKGROUND OF THE INVENTION
`
`The present invention is directed to methods and devices
`for implanting replacement cardiac valves. Replacement
`cardiac valves are implanted when the patient’s native valve
`exhibits abnormal anatomy and function due to congentiat or
`acquired valve disease. Congenital abnormalities can be
`tolerated for years only to develop into lit'e-threatening
`problems later. Acquired valve disease may result
`from
`various causes such as rheumatic fever, degenerative disor-
`ders of the valve tissue, and bacterial or fungal infections.
`Valve dysfunction can be classified as either stenosis, in
`which the valve does not open properly, or irisu tficicncy, in
`which the valve does not close properly. Stenosis and
`insufficiency can occur at the same time and both abnor-
`malities increase the workload on the heart
`in pumping
`blood through the body. The ability of the heart to function
`with the ittcrcascd workload is a major factor in determining
`whether the valve should be replaced.
`When the valve must be replaced using conventional
`methods, the patient must undergo an invasive, traumatic
`surgical procedure. The patient’s chest
`is opened with a
`median sternotomy or major thoracotomy to provide direct
`access to the heart through the large opening in the chest.
`The heart
`is then stopped and the patient
`is placed on
`cardiopulmonary bypass using catheters and cannulae
`inserted directly into the heart and great vessels. The heart,
`or a great vessel leading to the heart. is then cut open to
`access and remove the malfunctioning valve. After remov-
`ing the valve, the replacement valve is then sewn into place.
`After the new valve has been implanted, the chest is then
`closed and the patient is weaned off cardiopulmonary bypass
`support.
`The conventional open -chest surgery described above is
`problematic in that
`it
`is highly invasive,
`traumatic and
`requires a lengtlty recovery time. These drawbacks to con-
`vcntional open-chest surgery prevent some patients from
`undergoing a valve implantation procedure even though a
`new cardiac valve is needed.
`U.S. Pat. Nos. 5,370,635, 5,411,552 and 5,718,725, which
`are hereby incorporated by reference, describe devices and
`methods for implanting a new cardiac valve without requir-
`ing a median sternotomy or major
`thoraootomy. Such
`devices and methods reduce the pain, trauma and recovery
`time as compared to conventional open-chest surgery.
`An object of the present invention is to provide additional
`devices and methods which reduce the trauma associated
`with conventional open-chest methods and devices for
`implanting cardiac valves.
`SU M MARY O1-'
`
`'l'l-lli IN Vl:'.N'l'l(JN
`
`In accordance with the object of the invention, a system
`and method for implanting a cardiac valve is provided which
`does not require a median sternotomy or major thoracotomy.
`The devices and methods of the present
`invention are
`preferably carried out by passing the valve through a blood
`vessel, preferably the femoral artery, so that
`the median
`stcrnotomy or major
`thoracotomy is not
`required.
`Alternatively,
`the systems of the present
`invention also
`permit introduction of the valve through a small incision
`between the patient's ribs without cutting the ribs or ster-
`num.
`
`In a first aspect of the invention, a valve displace: is used
`to hold the native valve leaflets open so that the native valve
`
`2
`does not need to be removed. The valve displaoer is pref-
`erably introduced into the patient in a collapsed condition
`and expanded to displace and hold the leaflets open. The
`valve displaccr may either be expanded with an expansion
`mechanism, such as a balloon, or may he self-expanding. In
`a preferred erltboditncnt, the valve displaccr has a first end,
`a second end and a central section between the first and
`second ends. The first and second ends are preferably flared
`outwardly to form a circumferential recess around the cen-
`tral portion. The native leaflets are trapped within the recess
`when the valve displacer is deployed.
`the valve is also
`In another aspect of the invention,
`introduced into the patient
`in a collapsed condition and
`expanded within the patient. The valve may either be
`expanded with an expansion mechanism, such as a balloon,
`or may be self-expanding. The cardiac valvt: may be coupled
`to the valve displaccr or may be positioned independent
`from the valve displaccr while still substantially performing
`the functions of the native valve. For instance, a replacement
`aortic valve may be positioned in the ascending or descend-
`ing aorta to substantially perform the functions of the native
`aortic valve.
`
`The cardiac valve is preferably delivered separate from
`the valve displaccr but may also be integrated with the valve
`displaccr during introduction and deployment. In a preferred
`embodiment, the valve has protrusions which engage open-
`ings in the valve displaccr. In another embodiment, the valve
`has sharp elements or barbs which either pierce the native
`valve tissue or engage the sides ofthe openings in the valve
`displaccr.
`in yet another aspect of the present invention, the valve
`and valve displaccr are preferably introduced into the patient
`with a catheter system.
`In a preferred system,
`the valve
`displacer is mounted to a first catheter and the valve is
`mounted to a second catheter which passes through and is
`slidably coupled to the first catheter. Alternatively, the valve
`displaccr and valve may be mounted to a single catheter. The
`term catheter as used herein refers to any catheter, trocar or
`similar device for introducing medical devices into a patient.
`In still another aspect of the present invention, the valve
`delivery catheter has a temporary valve mechanism which
`provides temporary valve functions after deployment of the
`valve displaccr. The temporary valve mechanism prevents
`regurgitation while the native valve is held open and before
`deployment of the replacement cardiac valve. The tempo-
`rary valve mechanism is preferably a balloon which is
`inllated and deflated as necessary to permit dotvnslream [low
`and prevent retrograde flow. Although it
`is preferred to
`implant the cardiac valve while the paticnt"s heart is beating,
`the devices and methods of the present invention may also
`be used with the patient’s heart stopped and the patient
`supported hy a bypass system.
`These and other advantages and aspects of the invention
`will become evident from the following description of the
`preferred embodiments and claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1A shows a system for implanting a cardiac valve.
`FIG. 1B shows the system of FIG. 1Aintroduct.-it through
`a femoral vein.
`
`10
`
`15
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`30
`
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`FIG. 2 shows the system of FIG. 1 with a sheath retracted
`to expose the cardiac valve, a valve displaccr and a tempo-
`rary valve mechanism.
`F] G. 3 shows the valve displaccr positioned between the
`native valve leaflets prior to expansion.
`
`NORRED EXHIBIT 2324 - Page 25
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`US 6,425,916 B1.
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`first
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`3
`FIG. 4 shows the valve displacer expanded by a
`expansion trtechttnism
`FIG. 5 shows the valve expanded by a second expansion
`mechanism into engagement with the valve displacer.
`FIG. 6 shows the valve displacer and valve implanted in
`the native valve position.
`FIG. 7 shows the valve displacer in the collapsed position.
`FIG. 8 shows the valve displacer in the expanded position.
`FIG. 9 shows the valve and valve displacer in the
`expanded position.
`FIG. 10 shows the valve in a collapsed condition.
`FIG. 11 is a plan view of the valve showing the leaflets.
`FIG. 12 is a cross-sectional view of the catheter along line
`A—A of FIG. 5.
`
`FIG. 13 shows another system [or implanting another
`cardiac valve.
`
`FIG. 14 is a partial cut-away view ofthe catheter of FIG.
`13 with the valve contained in a chamber.
`
`FIG. 15 is a cross-sectional view of the catheter along line
`B—l3 of FIG. 13.
`
`FIG. 16 shows another system for implanting a cardiac
`valve.
`
`‘If!
`
`FIG. 17 showsthc system of FIG. 16 with a distal portion -'
`of tlte valve displacer extending, from the catheter.
`FIG. 18 shows the valve displacer fully deployed to hold
`the native leaflets open.
`FIG. 19 shows the valve partially expanded with the
`catheter manipulated so that
`the valve engages the valve
`displacer.
`FIG. 20 shows the valve fully deployed and the catheter
`retnoved.
`
`FIG. 21 is a partial cut-away view of the catheter of FIGS.
`16-19.
`
`FIG. 22 is a cross-sectional view of the catheter along line
`C—C of FIG. 16.
`FIG. 23 shows another system for implanting a cardiac
`valve with the valve displaeer positioned between the native
`leaflets.
`
`50
`
`FIG. 24 shows the valve displacer expanded.
`FIG. 25 shows the valve partially deployed within the
`valve displacer.
`FIG. 26 shows the valve fully deployed within the valve
`displacer.
`FIG. 27 shows the valve displacer holding the native
`leaflets open with the valve deployed in the ascending aorta.
`FIG. 28 shows the valve displacer holding the native
`leaflets open with the valve deployed in the descending
`aorta.
`FIG. 29 shows the cardiac valve of FIGS. 23-28 in the
`collapsed contlition.
`J1 JI.
`FIG. 30 shows the cardiac valve of FIGS. 23-28 in the --
`expanded condition.
`FIG. 31 shows another system for delivering a cardiac
`valve with the delivery catheter passing through a trocar in
`the ascending aorta.
`FIG. 32 shows an expansion mechanism expanding the
`valve displaecr and the valve.
`FIG. 33 shows sutures being pulled to invert the valve.
`FIG. 34 shows the valve being stored in a preservative
`solution.
`
`(:0
`
`FIG. 35 shows the valve inverted and in the expanded
`condition.
`
`4
`in the
`FIG. 36 shows the valve and valve displace:
`collapsed condition before being attached to one another.
`FIG. 37 shows the valve and valve displaccr attached to
`one another and mounted to the delivery catheter.
`FIG. 38 shows the valve and the valve displacer in the
`expanded condition.
`I)ESCRlP'I'ION (IF THE l’REFERRF.D
`EMBODIMENTS
`
`Referring to FIGS. IA. IB and 2 a system for implanting
`a replacement cardiac valve is shown. The present invention
`is described in connection with implantation of a replace-
`ment aortic valve but
`is applicable to any other cardiac
`valve. The system 2 includes a delivery catheter 4, a cardiac
`valve 6 and a valve displaccr 3. A protective sheath 10
`covers the delivery catheter 4, cardiac valve 6 and valve
`displacer 8 during introduction to prevent contact between
`the blood vessel and the cardiac valve 6 and valve displacer
`8. FIGS. IA and 1B show the sheath 10 extending around the
`cardiac valve ti and valve displaccr 8 and FIG. 2 shows the
`sheath ll} retracted to expose the cardiac valve 6 and valve
`displacer 8.
`The cardiac valve 6 is preferably introduced through a
`peripheral vessel such as the femoral artery (FIGS. IA and
`2) or femoral vein (FIG. 1B). FIG. 1B shows introduction of
`the catheter2 through the femoral vein, into the right atrium,
`through the intraatrial septum and into the left atrium to
`access the rnitral valve. The peripheral vessel is preferably
`a femoral vessel but may also he the internal jugular vein,
`sttbelavian artery, axillary artery, abdominal aorta, descend-
`ing aorta or any other suitable blood vessel. As will be
`explained below, the delivery catheter 4 may be introduced
`by surgical cutdown or percutaneously using the Seldinger
`technique. An advantage of passing the catheter 4 through a
`peripheral vessel is reduced trauma to the patient as com-
`pared to the conventional open—chcst procedure described
`above. Although it is preferred to deliver the cardiac valve
`6 through a peripheral vessel, the cardiac valve 6 may also
`be introduced directly into the ascending aorta through a
`small incision between ribs. The system 2 of the present
`invention is small enough to deliver between the patient's
`ribs so that the advantages of the present invention over
`conventional open-chest surgery are provided even when
`introducing the catheter through an incision in the chest.
`The valve displacer ti is expanded within the native valve
`to hold the native cardiac valve Ieallets 6 open. An advan-
`tage of the system 2 and method of the present invention is
`that
`the native valve does not need to be removed. The
`replacement cardiac valves described herein may, of course,
`also be used when removing the native valve rather than
`using the valve displacer 8. Furthermore, the valve displacer
`3 and cardiac valve 6 may be integrated into a single
`structure and delivered together rather than separately. Thus,
`all features of any valve displaoer described herein may also
`form part of any of the cardiac valves described herein
`withottt departing from the scope of the invention.
`The valve displacer 8 is shown in the collapsed condition
`in FIGS. 3 and 7 and in the expanded condition in FIGS. 4
`and 8. When in the collapsed position, the valve displacer 3
`forms a number of longitudinal SIOLS 12 which form open-
`ings 14 in the valve displace: 8 when in the expanded
`condition. The valve displacer 8 is substantially cylindrical
`in the collapsed condition to facilitate introduction into the
`patient.
`Referring to FIG. 8, first and second ends 16, 13 of the
`valve displacer 8 flare outwardly to form :1 circumferential
`
`NORRED EXHIBIT 2324 - Page 26
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`US 6,425,916 B1
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`5
`recess 24 at a central section 22. The native leallets are
`trapped in the recess 24 when the valve displacer 8 is
`deployed. The first end 16 has three extensions 20 extending
`from the central section 22. The valve displacer 8 may be
`made of any suitable material and preferred materials
`include stainless steel, nitinol, kevlar. titanium, nylon and
`composites thereof. The valve displacer 8 may also be
`coated with an antithrombogenic coating. The valve dis-
`placer 8 is preferably formed from a solid hypotube by
`etching or micromachining, machining from a solid
`material, or welding wire elements together. Although it is
`preferred to provide the llared ends 16, 18,
`the valve
`displacer 8 may have any other suitable shape which holds
`the leaflets open. The valve displacer 8 may also have a
`fabric cover 17 which can trap calcium fragments which
`might break free from the valve when the valve displacer is
`deployed. The cover 17 is preferably made of a polyesther
`knit material. such as dacron, but may be made of any other
`suitable material.
`The cardiac valve 6 has an expandable support structure
`26 which moves from the collapsed position of FIGS. 4 and
`10 to the expanded position of FIGS. 5 and 9. The support
`structure 26 is preferably formed with first and second
`elongate members 28, 30 which are wound to form windings
`31, preferably about 12-18 windings 31, around the circum-
`ference of the valve 6. The first and second elongate mem-
`bers 28, 3|) are attached to one another at windings 31 which
`forms three posts 32 extending from the support structttre
`26.
`
`The support structure 26 has a protrusion 34, preferably
`three, extending outwardly to fonrt an interrupted lip around
`an end 35 of the suppon structure 26. The protnisions 34
`engage the openings 14 in the valve displacer 8 as shown in
`FEG. 9 to secure the cardiac valve 6 to the valve displacer 8.
`The protrusions 34 are preferably formed by a coil 36
`wrapped around the loops 31 in the elongate member 30. As
`will be described below, the support structure 26 may also
`have barbs to secure the cardiac valve 6 to the valve
`displacer 8 or to the blood vessel wall. The cardiac valve 6
`may also engage the valve displacer 8 with any other
`suitable connection.
`
`The posts 32 support a valve portion 38 which performs
`the functions of the patient’s malfunctioning native valve.
`Referring to FIGS. 10 and 11,
`the valve portion 38 is
`preferably a stentless tissue valve such as a tri-leaflet 39
`stcntless porcine valve. The valve portion 38 has a base 41
`which is secured to the support structure 26 with sutures (not
`shown). The valve portion 38 may be stored separately from
`support structure 26 and attached to the support structttre 26
`before the procedure. Although it is preferred to provide a
`tissue valve for the valve portion 38, the valve portion 33
`may also be made of a flexible, synthetic material. For
`example, the valve portion 33 may be made of polyurethane
`similar to the valves described in "ATrict1.spid Polyurethane
`Ilearl Valve as Alternative to Mechanical Prostheses or
`Bioprostheses," by In et al., Trans Am Society of Artificial
`Internal Organs, 1988; 34: pgsvalve displacer 839-844, and
`"Evaluation of Explanted Polyurethane Trileatlet Cardiac
`Valve l’rostheses," Journal Thoracic Cardiovascular
`Surgery, 1988; 94‘. pgs 419-429.
`Referring to FIGS. 2-4, the delivery catheter 4 has a
`temporary valve mechanism 40 which provides temporary
`valve functions during andior after deployment of the valve
`displacer 8. The temporary valve mechanism 40 ensures
`proper blood flow regulation when the leaflets are held open
`by the valve displacer 3 to provide time for accurate posi-
`tioning and deployment of the valve 6. The temporary valve
`
`6
`mechanism 40 is preferably a balloon 44 coupled to an
`inflation mechanism 4'? controlled by a control system 42.
`The control system 42 senses the patient’s heartbeat to time
`balloon inllalion and deflation to permit and prevent llow in
`the same manner as the native valve. Similar systems for
`synchronizitlg inflation and deflation of a balloon with the
`patient’s heartbeat are known in balloon pump technology
`and are described in U.S. Pat. Nos. 5,8] 7,001, 5,413,549 and
`5,254,097 which are hereby incorporated by reference. The
`balloon 44 is preferably inflated with a gas for quick
`inflation and deflation. The temporary valve mechanism 40
`is preferably the balloon 44 but may also be a passive
`mechanical valve which automatically opens and closes due
`to blood flow forces.
`
`'1:
`
`10
`
`The catheter4 may also include an elongate balloon 45 to
`help pump blood through the patient’s body like a blood
`pump. The balloon 45 is also coupled to an inflation mecha-
`nism 49 controlled by the control system 42 which inflates
`and deflate-s the balloon 45 to provide pumping assistance to
`the patient ‘s heart. Balloon pump technology is described in
`the above-mentioned patents. The elongate balloon 45 may
`be replaced by any other suitable blood pump, such as a
`centrifugal pump having an impeller, without departing from
`the scope of the invention.
`The temporary valve mechanism 40 and balloon 45 are, of
`course, only necessary when implanting the valve with the
`patient’s heart beating. If the patient’s heart is stopped and
`the patient is supported by a bypass system during the valve
`implantation procedure, the temporary valve mccltattism 40
`andfor balloort 45 may be used after the procedure for
`emergency valve functions or pumping assistance. The
`balloon 44 is preferably positioned in the ascending or
`descending aorta and the balloon 45 is preferably positioned
`in the descending aorta.
`Referring to FIGS. 3-6. the delivery catheter 4 also has
`first and second expandable metnbcrs 46, 48 which deploy
`the valve displacer 8 and cardiac valve 6. respectively. The
`expandable members 46, 48 are preferably balloons 50, 52
`but may also be mechanically actuated devices. The balloons
`50, 52 are coupled to inflation lumens 54, 56 through which
`inllation fluid is delivered from sources ofinflatinn fluid 58,
`60, respectively. The balloon 50 expands greater at the ends
`to form the llared ends 16. 18 of the valve displacer 8.
`The delivery catheter 4 includes a flrst catheter 62, which
`carries the valve displacer 8, and a second catheter 64, which
`carries the cardiac valve 6. Referring to FIGS. 2 and 12, the
`second catheter 64 has a passageway 66 which receives the
`first catheter 62. A heniostasis valve 68 permits slidable
`movement between the first and second catheters 62, 64. The
`first catheter 62 has lumen 54 for inflating balloon 50 and the
`second catheter 64- has lumen 48 for inflating balloon 52.
`The second catheter 64 also has a lumen 51 for inflating
`balloon 44 and a lumen 53 for inflating balloon 45. The first
`catheter 62 also has a main lumen 70 which receives a
`guidewire 72.
`The slidable connection between the first and second
`catheters 62, 64 permits introduction of the first catheter 62
`over the guidewire 72 with the second catheter 64 being
`advanced over the first catheter 62 after the valve displacer
`8 is in the ascending aorta. In this manner, the first catheter
`62 may be advanced more easily over the guidewire 72 and
`through the patient’s vasculature, such as around the aortic
`arch, as compared to a single, multichannel catheter having
`' all features ofthc first and second catheters 62, 64-. The first
`and second catheters 62, 64 may be wire-reinforced (not
`shown) catheters constructed in the manner described in
`
`50
`
`60
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`NORRED EXHIBIT 2324 - Page 27
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`

`
`US 6,425,916 B1
`
`It]
`
`7
`Published l’Cl‘Applicalion W0 9752623 entitled “Cannula
`and Method of Manufacture and Use” which is hereby
`incorporated by reference.
`A method of implanting a cardiac valve 6 in accordance
`with the present invention is now described in connection
`with FIGS. 1-6. Although the method is described in con-
`nection with the system described above, the method may be
`practiced with other suitable devices, including the devices
`and systems described below, without departing from the
`scope of the invention. Furthermore, the method is described
`in connection with replacing the aortic valve, however, the
`method may also be applied to other other cardiac valves
`such as the mitral. tricuspid and pulmonary valves.
`Before implanting the cardiac valve 6, it may be desirable
`to perform valvuloplasty to break up pathologic adhesions
`between the native valve leaflets. Breaking up adltesions
`ensures that the valve displacer 8 expands fully to provide a
`large blood flow path. Valvuloplasty is preferably performed
`with a balloon which is inflated to open the leaflets and break
`the adhcsions. The native cardiac valve and annulus are also
`sized to determine the proper size valve displacer 8 and
`cardiac valve 6. Sizing may be carried out using lluoroscopy,
`intravaseular ultrasound or with any other suitable device
`during or after the valvuloplasty. Size parameters to consider
`include the cross-sectional profile through the valve,
`the '
`length and size of the valve leaflets and position of the
`coronary ostia.
`The delivery catheter 4 is preferably introduced into the
`patient by surgical cutdown in the femoral artery but may
`also be introduced pcrcutaneously using the Seldinger tech-
`nique. As mentioned above, the delivery catheter 4 may also
`be introduced into any other suitable vessel or through a
`small incision in the chest.The first and second catheters 62,
`64 are advanced into the artery through the cutdown a short
`distance. The guidewire 72 is then advanced ahead of the
`first and second catheters 62, 64 up the descending aorta,
`around the aortic arch, into the ascending aorta and across
`the aortic valve. The first catheter 62 is then advanced over
`
`31]
`
`"as an
`
`the guidcwirc 72 to the ascending aorta with the sheath 10
`covering the lirst catheter 62 to prevent contact between the
`valve displacer 8 and the blood vessel or native valve. The
`second catheter 64 is then advanced over the first catheter 62
`to position the cardiac valve 6 in the ascending aorta. The
`sheath 10 also prevents contact between the cardiac valve 6
`and vessel wall when advancing the second catheter 64. The
`sheath 10 is then retracted as shown in FIG. 2 to expose the
`valve displacer 8 and the cardiac valve 6.
`The valve displacer 8 is then introduced between the
`valve leaflets as shown in FIG. 3 and the balloon 50 is
`inflated to expand the valve displacer as shown in FIG. 4.
`Tile valve displacer 8 holds the native valve leaflets open so
`that the native valve does not have to be removed. When the
`valve displacer 8 has been deployed, the temporary valve
`mechanism 40 provides temporary valve functions by inflat-
`ing and dellating the balloon 44 at appropriate times to
`permit and block llow in the same manner as the native
`valve. The balloon 45 may also be inllated and dellatcd to
`provide pumping assistance to the patient‘s heart during the
`procedure. Although the above—described method is per-
`formed with the patio-nt's' heart beating, the procedure may
`also he performed on a stripped heart with the patient
`Sttpptirlctl by :I
`lwypai-as system.
`The second catheter 64 is then advttnccrl until the valve 6
`is positioned adjacent the valve displacer 8. Although FIG.
`5 shows the lirst catheter 62 extending into the left ventricle,
`the lirst catheter 1'12 may also be designed to be withdrawn
`
`45
`
`Ml
`
`8
`into the passageway 66 of the second catheter 64 so that the
`first catheter 62 does not extend beyond the second catheter
`64. The balloon 52 is then partially inflated so that the distal
`end of the valve 6 having the protnisions 34 expands. The
`second catheter 64 is then manipulated until the protrusions
`34 engage the openings 14 in the valve displacer 8. The
`balloon 52 is then inflated further to expand the rest of the
`support structure 26. The catheters 62, 64 are then removed
`leaving the cardiac valve 6 in place.
`Referring to FIGS. 13 and 14, another system 2A for
`implanting a cardiac valve 6A is shown wherein the same or
`similar reference numbers refer to the same or similar
`structures. The cardiac valve 6A is similar to the cardirlc
`valve 6 described above, however, the cardiac valve 6A is
`self-expanding and, therefore. does not rcqu ire an indepen-
`dent cxpansion mechanism. The support structure 26A is
`made of a resilient material to naturally bias the support
`structure 26A to the expanded position. The support struc-
`ture 26/trnay be made of any suitable material and preferred
`materials are stainless steel or shape-memory alloys such as
`nitinol. Delivery catheter 4A has the expandable member 46,
`which is preferably the balloon 50, for expanding the valve
`displacer S.
`The cardiac valve GA is contained within an outer wall 74
`of the delivery catheter 4A. The cardiac valve (IA is
`advanced out of a chamber 76 in the delivery catheter 4A by
`advancing a rod 78 having a pusher element 80 attached
`thereto. The pusher e1ement80 engages the posts 32 on the
`cardiac valve 6A to move the cardiac valve 6A out of the
`chamber 76. The rod 78 has threaded connections 80, 82
`with a
`tip 84 and the pusher element 80 to facilitate
`assembling the delivery catheter 4A and loading the cardiac
`valve 6A in the chamber 76. The rod 78 has a guidewire
`lumen 86 for receiving the guidcwire 72. Referring to the
`cross-sectional view of FIG. 15, the catheter 4-A has a first
`lumen 88 coupled to the balloon 50, a second lumen 90
`coupled to the balloon 44 and a third lumen 91 coupled to
`the balloon 45. The second and third lumens 88, 90 are
`coupled to the inflation mechanisms 4'7, 29 which are
`controlled by the control system 42 described in connection
`with FIGS. 1 and 2. The system 2/\ preferably includes the
`sheath 10 which prevents contact between the blood vessel
`and the valve displacer 3 when the catheter 4A is advanced
`through the blood vessel.
`The cardiac valve 6/\ is implanted in substantially the
`same manner as the cardiac valve 6 and the discussion of
`implantation of the cardiac valve 6 is also applicable here.
`The delivery catheter 4A may be introduced in any manner
`described herein and FIG. 13 shows the catheter 4/\ extend-
`ing through the fcrnoral artery with the valve displacer 8
`positioned between the valve leaflets prior to expansion. The
`valve displacer 8 is expanded in the manner explained above
`to hold the leaflets open. After the valve displacer 8 has been
`expanded.
`the catheter 4A is retraccd a predetermined
`amount so that the protrusions 34 are exposed outside the
`distal end of the catheter 4A. The catheter 4A may then be
`manipulated as necessary so that the protrusions 34 engage
`the openings 14 in the valve displacer 8. The valve GA
`preferably remains coupled to the catheter 4A while the
`protrusions 34 are exposed for manipulation of the valve 6/\
`until the valve 6A engages the valve displacer 8. After the
`valve 6A has engaged the valve displacer 8. the rod 78 is
`then advanced far enough to completely release the cardiac
`valve 6A.
`
`Referring to FIGS. I6-22. another system 4B ihr implant-
`ing thc cardiac valve 4A is shown wherein the same or
`similar reference numbers refer to the same or similar
`
`
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`NORRED EXHIBIT 2324 - Page 28
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`

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`US 6,425,916 B1
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`10
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`-
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`30
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`4|]
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`9
`structure. The system has the self—cxpun(.ling cardiac valve
`4A described above. The valve displacer 8B is similar to the
`valve displacer 8 described above, however. the valve dis-
`placer 8B is also self—expanrling and, therefore, does not
`require an independent expatrsiotl mechanism. The valve
`displacer BB is made of a resilient material to naturally bias
`the valve displacer SB to the expanded position. Tltc valve
`displacer SB may be made of any suitable material and
`preferred materials are stainless steel and shape-memory
`alloys such as nitinol.
`The valve displacer 8B and cardiac valve 6A are con-
`tained within an outer wall 74 of the delivery catheter 48 as
`shown in FIG. 21. 'll1e valve displacer 8B and cardiac valve
`4A are advanced out of a chamber 7613 in the delivery
`catheter 4B by advancing a rod 7813 having first and second
`pusher elements SOB, 31B attached thereto. The rod 7813 has
`threaded connections 7913. 82B. and 83B with the tip 84 and
`the Iirst and second pusher elemcnts SOB, SIB to facilitate
`assembling catheter 4B and loading the valve displacer 8B
`and cardiac valve GA in the chamber '?'6B. The rod 7813 has
`the guidewire lumen 86 for receiving the guidewire 72 (FIG.
`14). Referring to FIG. 16 and the cross-sectional view of
`FIG. 22. the catheter 4B has a lumen 90 coupled to the
`balloon 44 which serves as the temporary valve me