`Garrison et al.
`
`USOO642.5916B1
`(10) Patent No.:
`US 6,425,916 B1
`(45) Date of Patent:
`Jul. 30, 2002
`
`(54) METHODS AND DEVICES FOR
`IMPLANTING CARDIAC VALVES
`
`* cited by examiner
`
`(76) Inventors: Michi E. Garrison, 212 Roosevelt
`Blvd., Half Moon Bay, CA (US) 94019;
`Hanson S. Gifford, III, 3180 Woodside
`Rd., Woodside, CA (US) 94.062;
`Frederick G. St. Goar, 2 Frederick Ct.,
`Menlo Park, CA (US) 94025
`
`(*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days
`
`Primary Examiner-David H. Willse
`(57)
`ABSTRACT
`
`The valve implantation System has a valve displacer for
`displacing and holding the native valve leaflets open in a first
`aspect of the invention. A replacement valve may be
`attached to the valve displacer before or after introduction
`and may be positioned independent of the valve displacer. In
`(21) Appl. No.: 09/248,911
`another aspect of the invention, the valve displacer and valve
`(22) Filed:
`Feb. 10, 1999
`are in a collapsed condition during introduction and are
`(51) Int. Cl."
`expanded to deploy the valve displacer and valve. The valve
`A61F 2/24
`3. S.C.I.G.I.G.I.s. is a tissue valve mounted to an expandable support structure.
`623/904
`The Support Structure may have protrusions for engaging the
`(58) Field of Search ............................... 623/126, 1.24,
`Valve displacer or barbS for anchoring the valve displacer to
`623/2.11, 2.1, FOR 101, 2.12–2.19, 2.42,
`the heart or blood vessel. A temporary valve mechanism may
`904, 2.38
`be used to provide temporary valve functions during and
`after deployment of the valve displacer.
`
`(56)
`
`EP
`
`References Cited
`FOREIGN PATENT DOCUMENTS
`O850607 A1 * 7/1998 ........ 623/FOR 101
`
`
`
`16 Claims, 23 Drawing Sheets
`
`32
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 1 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 1 of 23
`
`US 6,425,916 B1
`
`
`
`FIG. 1A
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 2 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 2 of 23
`
`US 6,425,916 B1
`
`
`
`FIG. 1B
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 3 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 3 of 23
`
`US 6,425,916 B1
`
`
`
`FIG. 2
`
`9
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 4 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 4 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 5 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 5 of 23
`
`US 6,425,916 B1
`
`
`
`co
`H
`L
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 6 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 6 of 23
`
`US 6,425,916 B1
`
`
`
`2O
`
`32
`
`6
`
`
`
`
`
`(NXNE
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 7 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 7 of 23
`
`US 6,425,916 B1
`
`38
`
`100
`
`102
`
`FIG. 29
`
`FIG. 30
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 8 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 8 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 9 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 9 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 10 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 10 Of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 11 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 11 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 12 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 12 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 13 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`
`
`13 of 23 Sheet
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 14 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 14 of 23
`
`US 6,425,916 B1
`
`
`
`ZZ "9 I
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 15 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 15 Of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 16 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 16 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 17 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 17 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 18 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 18 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 19 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 19 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 20 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 20 Of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 21 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 21 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 22 of 30
`
`
`
`U.S. Patent
`
`Jul. 30, 2002
`
`Sheet 22 of 23
`
`US 6,425,916 B1
`
`01. l. ,
`
`
`
`
`
`
`
`Ol. i.
`
`0 || ||
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 23 of 30
`
`
`
`US. Patent
`
`Jul. 30, 2002
`
`Sheet 23 of 23
`
`US 6,425,916 B1
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 24 of 30
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 24 of 30
`
`
`
`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 congential or
`acquired valve disease. Congenital abnormalities can be
`tolerated for years only to develop into life-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 insufficiency, 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 increased 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 lengthy recovery time. These drawbacks to con
`ventional open-chest Surgery prevent Some patients from
`undergoing a valve implantation procedure even though a
`new cardiac valve is needed.
`U.S. Pat. Nos. 5,370,685, 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 thoracotomy. 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.
`SUMMARY OF THE INVENTION
`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
`Sternotomy 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
`U.
`In a first aspect of the invention, a valve displacer is used
`to hold the native valve leaflets open so that the native valve
`
`5
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,425,916 B1
`
`2
`does not need to be removed. The valve displacer is pref
`erably introduced into the patient in a collapsed condition
`and expanded to displace and hold the leaflets open. The
`Valve displacer may either be expanded with an expansion
`mechanism, Such as a balloon, or may be Self-expanding. In
`a preferred embodiment, the valve displacer 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.
`In another aspect of the invention, the valve is also
`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 valve may be coupled
`to the valve displacer or may be positioned independent
`from the valve displacer 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 displacer but may also be integrated with the valve
`displacer during introduction and deployment. In a preferred
`embodiment, the valve has protrusions which engage open
`ings in the valve displacer. In another embodiment, the valve
`has sharp elements or barbS which either pierce the native
`Valve tissue or engage the Sides of the openings in the valve
`displacer.
`In yet another aspect of the present invention, the valve
`and valve displacer 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
`displacer 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 displacer. 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
`inflated and deflated as necessary to permit downstream flow
`and prevent retrograde flow. Although it is preferred to
`implant the cardiac valve while the patient'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 by 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. 1A introduced through
`a femoral vein.
`FIG.2 shows the system of FIG. 1 with a sheath retracted
`to expose the cardiac valve, a valve displacer and a tempo
`rary valve mechanism.
`FIG. 3 shows the valve displacer positioned between the
`native valve leaflets prior to expansion.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 25 of 30
`
`
`
`3
`FIG. 4 shows the valve displacer expanded by a first
`expansion mechanism
`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 for implanting another
`cardiac valve.
`FIG. 14 is a partial cut-away view of the catheter of FIG.
`13 with the valve contained in a chamber.
`FIG. 15 is a cross-sectional view of the catheter along line
`B-B of FIG. 13.
`FIG. 16 shows another System for implanting a cardiac
`valve.
`FIG. 17 shows the system of FIG.16 with a distal portion
`of the 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
`removed.
`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 displacer positioned between the native
`leaflets.
`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 condition.
`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 displacer and the valve.
`FIG. 33 shows sutures being pulled to invert the valve.
`FIG. 34 shows the valve being stored in a preservative
`Solution.
`FIG. 35 shows the valve inverted and in the expanded
`condition.
`
`1O
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,425,916 B1
`
`4
`FIG. 36 shows the valve and valve displacer in the
`collapsed condition before being attached to one another.
`FIG. 37 shows the valve and valve displacer attached to
`one another and mounted to the delivery catheter.
`FIG. 38 shows the valve and the valve displacer in the
`expanded condition.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`Referring to FIGS. 1A, 1B 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 displacer 8. 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. 1A and 1B show the sheath 10 extending around the
`cardiac valve 6 and valve displacer 8 and FIG. 2 shows the
`sheath 10 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. 1A and
`2) or femoral vein (FIG. 1B). FIG. 1B shows introduction of
`the catheter 2 through the femoral vein, into the right atrium,
`through the intraatrial Septum and into the left atrium to
`access the mitral valve. The peripheral vessel is preferably
`a femoral vessel but may also be the internal jugular vein,
`Subclavian 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-chest 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 8 is expanded within the native valve
`to hold the native cardiac valve leaflets 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
`8 and cardiac valve 6 may be integrated into a single
`Structure and delivered together rather than Separately. Thus,
`all features of any valve displacer described herein may also
`form part of any of the cardiac valves described herein
`without 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 8
`forms a number of longitudinal slots 12 which form open
`ings 14 in the valve displacer 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, 18 of the
`valve displacer 8 flare outwardly to form a circumferential
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 26 of 30
`
`
`
`US 6,425,916 B1
`
`15
`
`40
`
`45
`
`S
`receSS 24 at a central Section 22. The native leaflets 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 flared 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
`25
`ference of the valve 6. The first and Second elongate mem
`bers 28, 30 are attached to one another at windings 31 which
`forms three posts 32 extending from the Support Structure
`26.
`The support structure 26 has a protrusion 34, preferably
`three, extending outwardly to form an interrupted lip around
`an end 35 of the support structure 26. The protrusions 34
`engage the openings 14 in the valve displacer 8 as shown in
`FIG. 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 loops31 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
`stentless 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 Structure 26
`before the procedure. Although it is preferred to provide a
`tissue valve for the valve portion 38, the valve portion 38
`may also be made of a flexible, synthetic material. For
`example, the valve portion 38 may be made of polyurethane
`similar to the valves described in “A Tricuspid Polyurethane
`Heart Valve as Alternative to Mechanical Prostheses or
`Bioprostheses,” by Lo et al., Trans Am Society of Artificial
`Internal Organs, 1988; 34: pgsvalve displacer 839-844, and
`“Evaluation of Explanted Polyurethane Trileaflet Cardiac
`Valve Prostheses,” 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 and/or 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 8 to provide time for accurate posi
`tioning and deployment of the valve 6. The temporary valve
`
`35
`
`50
`
`55
`
`60
`
`65
`
`6
`mechanism 40 is preferably a balloon 44 coupled to an
`inflation mechanism 47 controlled by a control system 42.
`The control system 42 senses the patients heartbeat to time
`balloon inflation and deflation to permit and prevent flow in
`the same manner as the native valve. Similar Systems for
`synchronizing 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. 5,817,001, 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.
`The catheter 4 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 deflates 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 heartbeating. If the patient's heart is stopped and
`the patient is Supported by a bypass System during the valve
`implantation procedure, the temporary valve mechanism 40
`and/or balloon 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 members 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
`inflation fluid is delivered from Sources of inflation fluid 58,
`60, respectively. The balloon 50 expands greater at the ends
`to form the flared ends 16, 18 of the valve displacer 8.
`The delivery catheter 4 includes a first 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 hemostasis 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 of the 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
`
`Edwards Lifesciences Corporation, et al. Exhibit 1010, p. 27 of 30
`
`
`
`7
`Published PCT Application WO97/32623 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 adhesions
`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 adhesions. 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 fluoroscopy,
`intravascular 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 percutaneously 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
`the guidewire 72 to the ascending aorta with the sheath 10
`covering the first 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.
`The 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 deflating the balloon 44 at appropriate times to
`permit and block flow in the same manner as the native
`valve. The balloon 45 may also be inflated and deflated to
`provide pumping assistance to the patient's heart during the
`procedure. Although the above-described method is per
`formed with the patient's heartbeating, the procedure may
`also be performed on a stopped heart with the patient
`Supported by a bypass System.
`The second catheter 64 is then advanced until the valve 6
`is positioned adjacent the valve displacer 8. Although FIG.
`5 shows the first catheter 62 extending into the left ventricle,
`the first catheter 62 may also be designed to be withdrawn
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`US 6,425,916 B1
`
`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 protrusions 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 cardiac
`valve 6 described above, however, the cardiac valve 6A is
`Self-expanding and, therefore, does not require an indepen
`dent expansion 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 26A may 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 8.
`The cardiac valve 6A is contained within an outer wall 74
`of the delivery catheter 4A. The cardiac valve 6A 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 element 80 engages the posts 82 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 guidewire 72. Referring to the
`cross-sectional view of FIG. 15, the catheter 4A 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 47, 29 which are
`controlled by the control system 42 described in c