United States Patent 1191
`Block et al.
`
`lllllllllllllllllllllllllllllllllllllllllllllllllllHllllllllllllllllllllll
`USOO5554185A
`[11] Patent Number :
`[45] Date of Patent:
`
`5,554,185
`Sep. 10, 1996
`
`[54] INFLATABLE PROSTHETIC
`CARDIOVASCULAR VALVE FOR
`PERCUTANEOUS TRANSLUMINAL
`IMPLANTATION OF SAME
`
`[76] Inventors: Peter C. Block, 3510 SW. Sherwood
`PL, Portland, Oreg. 97201; W. Earl
`Anderson, 230 E. 38th Ave, Eugene,
`Oreg. 97405-4714; David G. Atteridge,
`18235 SW. Barcelona Way, Beaverton,
`Oreg. 97007
`
`{211 App]. No.: 276,663
`[22] Filed:
`Jul. 18, 1994
`[51] Int. Cl.6
`[52] US. Cl.
`
`[58] Field of Search
`
`A61F 2/24
`623/2; 623/12; 623/900;
`606/195
`.. 623/2, 12, 900;
`606/195
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`?vo?lqwo?ln.
`50.1.5.7.8.
`
`1163277 7508921
`344444
`
`9.42030
`750470
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`27959 95
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`
`
`
`
`444 11/1994 Kusuhara 3/1995 Povcnik et al. FOREIGN PATENT DOCUMENTS
`
`7/1977 Germany.
`2700531
`91/17720 11/1991 mm.
`93/01768 2/1993 WIPO.
`
`Primary Examiner—Paul B. Prebilic
`Attorney,
`Agent, or Firm-Stetina Brunda Buyan; Raymond
`Sun
`[ 7]
`5
`
`ABSTRACT
`
`An in?atable prosthetic cardiovascular valve which is con
`structed so as to be initially deployable in a de?ated “col
`lapsed” con?guration wherein the valve may be passed
`through the lumen of a cardiovascular catheter and subse
`“operative” con?guration so as to
`quently in?ated to an
`perform its intended valving function at its intended site of
`implantation within the cardiovascular system. The in?ated
`h 58 mw 6 mm
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`
`NORRED EXHIBIT 2217 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`Medtronic Corevalve, LLC
`v. Troy R. Norred, LLC
`Case IPR2014-00111
`
`

`
`US, Patent
`
`Sep. 10, 1996
`
`Sheet 1 of 3
`
`5,554,185
`
`NORRED EXHIBIT 2217 - Page 2
`
`

`
`US. Patent
`
`Sep. 10, 1996
`
`Sheet 2 of 3
`
`5,554,185
`
`NORRED EXHIBIT 2217 - Page 3
`
`

`
`US. Patent
`
`Sep. 10, 1996
`
`Sheet 3 of 3
`
`5,554,185
`
`NORRED EXHIBIT 2217 - Page 4
`
`

`
`5,554,185
`
`1
`INFLATABLE PROSTHETIC
`CARDIOVASCULAR VALVE FOR
`PERCUTANEOUS TRANSLUMINAL
`IMPLANTATION OF SAME
`
`FIELD OF THE INVENTION
`
`The present invention pertains generally to medical equip
`ment, and more particularly a catheter-introducible pros
`thetic valve which may be implanted into a mammalian
`heart or elsewhere in the cardiovascular system to augment
`or replace a malfunctioning endogenous valve.
`
`10
`
`2
`body to facilitate attachment of, and/or to maintain operative
`positioning of, the valve lea?ets.
`In accordance with a second split or linear embodiment of
`the invention, there is provided a collapsible prosthetic
`cardiovascular valve comprising an in?atable valve body
`having a split or separation formed therein and one or more
`occluder members (e.g., pliable lea?ets) affixed thereto.
`When de?ated, the valve body may be separated at its split
`or separation and extended into an elongate linear de?ated
`con?guration. When in?ated, the valve body assumes a
`function annular or circular con?guration. The in?atable
`valve body may be inherently biased to assume said annular
`or circular con?guration upon in?ation thereof, or may be
`provided with one or more tether lines or other guide
`members useable to guide or pull the valve body into the
`desired annular con?guration as in?ation of the valve body
`is accomplished.
`Although the prosthetic cardiovascular valves of the
`present invention may incorporate various numbers of indi
`vidual valve lea?ets, a preferred embodiment of the valve
`incorporates three (3) valve lea?ets, each having three (3)
`inboard edges which meet along a tre-foil margin within the
`annular central passageway of the in?atable valve body.
`Although the collapsible cardiovascular valves of the
`present invention may be in?ated by various means, one
`preferred embodiment of the invention employs a detachable
`in?ation tube which is initially connected to the valve, and
`which may be subsequently severed from the valve and
`removed following in?ation thereof.
`The in?atable cardiovascular valves of the present inven
`tion may be in?ated with any suitable in?ation ?uid. In some
`embodiments, the valve may be initially in?ated with mate
`rial(s) which will react or otherwise undergo gelation or
`solidi?cation within the valve body, thereby resulting in a
`gel-?lled or solid-?lled valve.
`The collapsible cardiovascular valves of the present
`invention may be speci?cally sized and con?gured for
`implantation at various sites or locations within the cardio
`vascular anatomy. In particular, collapsible valves of the
`present invention may be sized or con?gured to replace or
`augment any natural heart valve, including the mitral and
`aortic valves of the human heart. Similarly, collapsible
`cardiovascular valves of the present invention may be sized
`and con?gured for implantation in veins of the extremities to
`replace or augment absent or malfunctioning venous valves.
`In instances when the valves of the present invention are
`utilized to replace or augment the aortic valve of the heart,
`the positioning and location of the prosthetic valve of the
`present invention will be such that the prosthetic valve does
`not interfere with blood ?ow into the coronary circulation.
`Further in accordance with the invention, there are pro
`vided apparatus and methods for percutaneous transluminal
`insertion and utilization of the collapsible/in?atable cardio
`vascular valves of the above~described character.
`Further objects and advantages of the invention will
`become apparent to those skilled in the art upon reading and
`understanding of the following detailed description and the
`accompanying drawings.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`BACKGROUND OF THE INVENTION
`
`The prior art has included numerous surgically implant
`able prosthetic valves which may be utilized to replace
`malfunctioning heart valves, such as the aortic valve and the
`mitral valve. Some of the prosthetic heart valves of the prior
`art are umechanical” valves of non-biological origin. Others
`are “biological” valves wherein all or a portion of the valve
`consists of harvested mammalian (e.g., porcine) tissue
`which has been preserved by way of a chemical ?xation
`process.
`Although surgically implantable prosthetic heart valves
`have become widely used in clinical practice, their implan
`tation involves a major cardiothoracic surgical procedure
`wherein the patient must be placed on full cardiopulmonary
`bypass for a signi?cant period of time. As a result, patients
`who have severe complications of their valvular disease or
`who are otherwise severely ill or elderly may be unable to
`undergo the rigors of such major cardiothoracic surgical
`procedure and are, thus, unable to receive the bene?ts of a
`surgically implanted prosthetic cardiovascular valve.
`A number of prior investigators have proposed various
`“collapsible” cardiovascular valves and other cardiovascular
`apparatus (e.g., embolus traps) which may be collapsed and
`inserted into the mammalian vasculature through the lumen
`of a tubular catheter or introducer. Examples of collapsible
`cardiovascular valves and related apparatus are found in
`US. Pat. Nos. 3,671,979; 4,056,854; 4,592,340; 4,727,873;
`4,817,600; 4,960,424; 4,994,077; 5,163,953; and 5,207,695,
`as well as the following foreign patents and/or patent
`publications WO9l/ 17720; DT 2700-531 and WO93/0l7 68.
`Although various collapsible, catheter deployable, heart
`valves and/or other cardiovascular apparatus may have been
`proposed in the prior art, there remains a need for further
`re?nement and development of such devices so as to arrive
`at a clinically useful prosthetic cardiovascular valve which
`may be implanted, through the lumen of a cardiovascular
`catheter, without the need for major cardiothoracic surgery.
`
`SUMMARY OF THE INVENTION
`
`Broadly stated, the present invention comprises an in?at~
`able prosthetic cardiovascular valve which, when in a
`de?ated state, is sufficiently collapsible to be passed through
`the lumen of a tubular cardiovascular catheter and which,
`when subsequently in?ated, will assume a fully functional
`operative cardiovascular valve con?guration.
`In accordance with a ?rst integral or annular embodiment
`of the invention, there is provided a collapsible prosthetic
`cardiovascular valve comprising an annular in?atable toroi
`dal valve body and one or more occluder members (e.g.,
`pliable lea?ets) a?ixed thereto. A plurality of legs or strut
`members may extend from one side of the toroidal valve
`
`20
`
`25
`
`35
`
`45
`
`50
`
`55
`
`FIG. 1 is a perspective view of a catheter-introducible
`cardiovascular valve of the present invention having an
`in?atable toroidal support structure.
`FIG. 1a is a perspective view of the in?atable toroidal
`support structure portion of the catheter-introducible cardio
`vascular valve of FIG. 1.
`
`65
`
`NORRED EXHIBIT 2217 - Page 5
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`

`
`5,554,185
`
`3
`FIG. 1b is a cut away plan view of the portion of the
`in?atable toroidal support structure shown in FIG. 1a.
`FIG. 10 is a perspective view of the prosthetic valve of
`FIG. 1 illustrating anchoring members provided thereon.
`FIG. 2 is a perspective view of an alternative “split”
`embodiment of a catheter-introducible prosthetic valve of
`the present invention.
`FIG. 3 is a cross-sectional diagram of a human heart
`having an in?atable prosthetic valve of the present invention
`implanted adjacent the endogenous aortic valve.
`FIG. 3a is an enlarged view of region AV of FIG. 3.
`FIGS. 4a—4c provide a step-by-step diagram of a method
`by which the prosthetic valve of FIG. 1 may be inserted,
`in?ated and implanted in the body of a human being or other
`mammal.
`FIGS. Sa-Sd are a step-by-step diagram of a method by
`which the prosthetic cardiovascular valve of FIG. 2 may be
`inserted, in?ated and implanted in the body of a human
`being or other mammal.
`
`20
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`The detailed description set forth below in connection
`with the appended drawings is intended merely as a descrip
`tion of the presently preferred embodiments of the inven
`tion, and is not intended to represent the only form in which
`the present invention may be constructed or utilized. The
`description sets forth the functions and sequence of steps for
`construction and implementation of the invention in con
`nection with the illustrated embodiments. It is to be under
`stood, however, that the same or equivalent functions and
`sequences may be accomplished by di?erent embodiments
`that are also intended to be encompassed within the spirit
`and scope of the invention.
`
`25
`
`30
`
`I. CONSTRUCTION OF INFLATABLE
`CARDIOVASCULAR VALVES OF THE
`PRESENT INVENTION
`
`With reference to FIGS. 1, 1a and 1b, there is shown a ?rst
`embodiment of a prosthetic cardiovascular valve 10 of the
`present invention comprising an in?atable support body 12
`having one or more pliable valve lea?ets 14 mounted
`thereon. The lea?ets 14 are con?gured and constructed so as
`to move, in response to hemodynamic movement of the
`blood, between a) an “open” con?guration wherein blood
`may ?ow through the valve in a ?rst direction A and, b) a
`“closed” con?guration whereby blood is prevented from
`back ?owing through the valve in a second direction B.
`In the embodiment shown in FIGS. 1, 1a and 1b, the
`in?atable stent or support body 12 of the valve 10 comprises
`an in?atable annular ring or toroid 16 having a plurality of
`in?atable legs or struts 18 extending therefrom. An in?ation
`tube 20 is initially attached to an in?ation port 17 on the
`in?atable body 12 of the valve 10 to permit infusion of
`in?ation ?uid into the inner cavity 24 of the in?atable
`support body 12. Such in?ation tube 20 preferably com
`prises a pliable, elongate tube having a hollow lumen 22
`extending longitudinally therethrough.
`The distal end of the in?ation tube 20 may be detachable
`from the in?atable body 12 of valve 10 such that, after the
`valve 10 has been fully in?ated, the in?ation tube 20 may be
`volitionally detached from the valve 10 and subsequently
`extracted and removed.
`
`50
`
`55
`
`60
`
`65
`
`4
`In embodiments wherein the in?ation tube 20 is detach
`able from the valve 10, a sealing element 21 such as a check
`valve or sphincter like elastic ring may be disposed within
`or adjacent the in?ation port 17 or other location where the
`in?ation tube 20 separates or disconnects from the valve 10,
`so as to result in closure of the in?ation port 17 or residual
`portion of tube lumen 22, thereby preventing leakage or
`seepage of the in?ation material or ?uid from the inner
`cavity 24 of the valve 10.
`The valve lea?ets 14 may be formed of any material(s)
`suitable for performing the lea?et function, including thin
`membranes or sheets of pliable synthetic or biological
`material capable of ?exing back and forth between the
`above-described “open” and “closed” con?gurations in
`response to hemodynarnic movement of the blood against
`the lea?ets 14, yet su?iciently resistant to extension that
`lea?et(s) perform their intended function.
`As such, the lea?ets 14 are preferably constructed and
`con?gured to mimic the function of the lea?ets or cusps of
`a healthy endogenous cardiovascular valve. Synthetic leaf
`lets 14 may be formed of elastomeric materials such as
`polyurethane, silicone, rubbers, etc. suitably modi?ed to
`provide limited extensibility. Biological lea?ets 14 may be
`formed of chemically ?xed mammalian valvular tissue or
`other biological tissue (e.g., pericardium) which is suffi
`ciently thin and pliable to perform the desired valving
`function of the lea?ets 14.
`Although the lea?ets may vary in number and con?gu
`ration, the presently preferred embodiments shown in the
`drawings utilize three (3) separate lea?ets 14 having corre
`spondingly con?gured inboard edges 15 which, when in
`their closed position, interact or meet with one another in a
`tre-foil margin as shown.
`The valve lea?ets 14 may be mounted on or attached to
`the in?atable support body 12 by any suitable means,
`including suturing or adhesive. For example, in some
`embodiments the material of which the lea?ets 14 are
`formed may be wrapped around portions of the in?atable
`body 12 and subsequently sutured in place to hold such
`biological lea?et material on the in?atable support body 12.
`In other embodiments wherein biological or synthetic mate
`rial is employed, it may be desirable to apply quantities of
`adhesive to affix the lea?ets 14 to the in?atable support body
`12. Also, in some embodiments, the lea?ets 14 may be
`formed of synthetic material integral with the in?atable
`support body 12.
`The presently preferred embodiments of the invention
`include an integral or annular embodiment (FIGS. 1 and 1a)
`as well as a split or linear embodiment (FIGS. 2 and 2a).
`In the integral or annular embodiment of the valve 10
`(FIGS. 1 and 1a) the in?atable valve support body 12 is in
`the form of a continuous ring or annulus which, when
`de?ated, may be compressed or compacted into a su?iciently
`small space to pass through a catheter lumen of approxi
`mately 4—7 mm in diameter. Thereafter, the valve support
`body 12 may be in?ated to cause the valve to assume the
`operative annular or ringlike structure shown in FIG. 1.
`In the alternative linear or “split” embodiment of the
`valve 10a shown in FIG. 2, a division or closed split 23 is
`formed vertically through one of the strut members 18a, as
`shown. In such embodiment, the valve 10a may be de?ated
`to a ?accid state and subsequently extended into an elongate
`outstretched con?guration whereby a ?rst end 11a of the
`split 23 is situated at one longitudinal end of the valve 10a
`and the opposite or second end 11b of the split 23 is situated
`at the opposite end of the valve 10a, as illustrated in FIG. 5b.
`
`NORRED EXHIBIT 2217 - Page 6
`
`

`
`5,554,185
`
`5
`Optionally, in the “split” embodiment shown in FIG. 2,
`one or more pull line(s) or tether(s) 40 may be attached to
`the valve 10a to facilitate movement of the valve 10a from
`its de?ated linearly extended and compact con?guration
`(FIG. 5b) to its generally circular in?ated operative con?gu—
`ration (FIG. 50'). The tether(s) 40 may initially extend
`separately from and alongside the in?ation tube 20a or may
`be contained within one or more tether guides or passage~
`ways associated with or formed within the in?ation tube
`20a. Speci?cally, in the embodiment shown in FIG. 2, a
`separate tether guide lumen 44 extends longitudinally
`through the inflation tube 22a, which is incorporated with
`the ?rst end member of split support strut 18a, and into that
`?rst end strut member 18a where it terminates distally in a
`tether entry apertures formed in the face of the split portion
`11a, opposite the points on corresponding split portion 11b
`where the distal ends of tethers 40 is connected to the second
`portion 11b of the split support strut 18a. From this con
`neetion, tethers 40 pass into tether entry apertures formed in
`the corresponding split portion 11b and extend proximally
`through tether guide lumen 44 of in?ation tube 20a. The
`proximal ends of the tethers 40 emerge out of and/or apart
`from the proximal end of the in?ation tube 20a so as to be
`grasped and retracted by the operator. As such, retraction of
`the tethers 40 in the proximal direction (arrow C) will guide
`or pull the second split portion 11b of the split support strut
`18a into juxtaposition with the ?rst split portion 11a thereof.
`The connection or attachment of the distal ends of tethers
`40 to the second split portion 11b of the split valve support
`body 120 may be a releasable connection whereby the distal
`ends of tethers 40 may be released and pulled away from the
`valve 10a simultaneously or separate from detachment of
`the in?ation tube 22a from the valve body 12a. The releas
`able or tearable connection of the distal ends of the tethers
`40 to the second portion 11b of the split support strut 18a
`may be speci?cally constructed such that the amount of
`tension required to tear or separate the tethers 40 from the
`valve 10a can only be exerted when the valve 10a is
`properly anchored in its desired position within the mam‘
`malian body.
`The valve 10, 10a of the present invention may be
`implanted at many di?’erent desired locations in the mam
`malian cardiovascular system. For example, the valves 10,
`10a may be implanted adjacent to or in replacement of a
`malfunctioning heart valve, as shown in the illustration of
`the human heart shown in FIG. 3. The anatomical structure
`and major blood vessels of the heart are labeled on FIG. 3
`in accordance with the following legend:
`
`PV
`PA
`RPA
`LPA
`SVC
`IVC
`A0
`RA
`RV
`LA
`LV
`AV
`MV
`TrV
`PuV
`
`Pulmonary Veins
`Pulmonary Artery
`Right Pulmonary Artery
`Left Pulmonary Artery
`Superior Vena Cava
`Inferior Vena Cava
`Aorta
`Right Atrium
`Right Ventricle
`Left Atrium
`Left ventricle
`Aortic Valve Position
`Mitral Valve Position
`Tricuspid Valve
`Pulmonic Valve
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`In embodiments where the valve 10, 10a is implanted in
`the aortic position on the out?ow side of the endogenous
`aortic valve, (see FIG. 3) it will be appreciated that the valve
`10, 10a must be carefully positioned so as not to impede or
`
`65
`
`6
`block blood?ow into the coronary ostia. Additionally, it will
`be appreciated that the valves 10, 10a of the present inven
`tion may be useful in various peripheral, extracardiac loca
`tions, such as in the veins of the lower extremities as
`replacements and/or augmentations for absent or malfunc
`tioning endogenous venous valves.
`II. INFLATION OF THE CARDIOVASCULAR
`VALVES OF THE PRESENT INVENTION
`
`The in?atable cardiovascular valve 10, and in particular
`the in?atable support body 12 of the valve 10 may be
`in?ated by any suitable in?ation ?uid or substance.
`In some embodiments and applications, it may be desir
`able to in?ate the support body 12 with a gas or liquid (e.g.,
`carbon dioxide or saline solution) which may subsequently
`be extracted or removed from the valve body 12 if it is
`subsequently desired to de?ate the valve 10.
`In other embodiments and applications, it may be desir
`able to in?ate the valve 10 with a ?uid which subsequently
`gels or solidi?es within the in?ation space 24 of the valve
`support body 12, thereby minimizing any likelihood that the
`in?ation substance would inadvertently leak or seep from
`the implanted valve 10. For example, one or two component
`elastomer-forming chemical reactants may be initially
`instilled into the in?ation space 24 of the support body 12
`through in?ation tube 20 while in a liquid state, and subse
`quently allowed to gel or solidify within the in?ation space
`24 of the valve support body 12 so as to result in a gelatinous
`or solidi?ed (e.g., elastomeric or rigid) ?lling material
`within the in?ation space 24 of the in?ated valve 10.
`In embodiments wherein the valve 10 is in?ated with
`?owable liquid or gaseous in?ation ?uid(s), it may be
`possible to subsequently de?ate and remove the valve, while
`in embodiments wherein gelling or solidifying in?ation
`materials are employed, subsequent de?ation and removal of
`the valve may be rendered non-feasible. Accordingly, the
`selection of the type of in?ation material to be employed
`may depend on whether it is desirable to subsequently
`de?ate the valve.
`Alternatively, a two stage in?ation technique may be
`utilized whereby an initial temporary liquid or gaseous
`in?ation ?uid is initially utilized to in?ate the valve, but is
`subsequently replaced by a more permanent solidifying or
`gelling in?ation substance. This two-staged in?ation tech
`nique would permit the valve to be de?ated and/or manipu
`lated as needed during the implantation and af?xation pro
`cesses, but would subsequently allow the valve to become
`permanently in?ated and con?gured after the proper posi
`tioning and a?ixation of the valve has been achieved. In
`accordance with this aspect of the invention, a bioacceptable
`or biologically inert temporary in?ation ?uid (e.g., 0.9
`percent NaCl solution) may be initially passed into the valve
`10 to effect in?ation thereof. After the valve 10 has been
`appropriately positioned and af?xed in its desired operative
`location, an escape opening may be formed in the body of
`the valve by puncture thereof, or by other suitable means,
`and a more permanent in?ation substance, such as a material
`which will subsequently gel or solidify, may be passed into
`the valve 10, thereby displacing the temporary in?ation ?uid
`out of the escape aperture, and allowing the valve to become
`?lled with a more permanent non-escaping in?ation mate
`rial.
`
`I
`
`III. INSERTION AND POSITIONING OF THE
`INFLATABLE VALVES OF THE PRESENT
`INVENTION
`
`The in?atable cardiovascular valve 10 of the present
`invention may be inserted, deployed and implanted at their
`
`NORRED EXHIBIT 2217 - Page 7
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`

`
`5,554,185
`
`7
`intended anatomical locations, by any suitable means.
`
`a) A Preferred Method of Implanting an Annular
`In?atable Valve of the First Embodiment
`
`8
`minal catheter implantation technique illustrated in FIGS.
`Sa-Sd.
`As shown, an elongate guide catheter 30a having a hollow
`lumen 32a extending longitudinally therethrough is initially
`inserted into the vasculature by a known percutaneous
`insertion technique and is subsequently advanced to a posi
`tion whereat the distal tip of the catheter 30a is positioned
`adjacent the intended site of implantation of the valve 10a.
`The de?ated, linearly extended, valve 10a is initially
`mounted on or in an introducer member 34a, such as a
`pliable cardiovascular guidewire or elongate tube having a
`linear slot for receiving and/or accommodating all or a
`portion of the de?ated valve 10a.
`The in?ation tube 20a and optional manipulation tether 40
`may be initially extended alongside the introducer 34a.
`The introducer 34a having the de?ated, linearly extended,
`valve 10a positioned thereon is then inserted into the lumen
`32a of the pre-positioned guide catheter 30a and advanced
`therethrough until the distal end of the introducer 34a having
`the de?ated valve 10a mounted thereon has emerged from
`the distal opening of the guide catheter lumen 32a.
`In?ation ?uid is then passed through in?ation tube 20a
`and into the valve 10a. The act of in?ation of the valve 10a,
`and/or other physical manipulation means, is employed to
`separate the valve 10a from the introducer 34a, thereby
`permitting the introducer 34a to be proximally extracted and
`removed as shown in FIG. 5b.
`As the valve 5b is being in?ated, the manipulation tethers
`40 may be pulled or otherwise manipulated by the operator
`so as to draw the distal or second end 11a of the linearly
`extended valve into juxtaposition with the proximal or ?rst
`end 11b thereof. After having been placed in juxtaposition,
`the opposing surfaces of split 23 are held, a?ixed or locked
`together in the closure process, thereby creating the desired
`annular con?guration of the in?ated valve.
`After the valve 10a has been fully in?ated, the in?ation
`tube 20a and the optional manipulation tethers 40 may be
`detached, proximally withdrawn and removed as shown in
`FIG. 5d.
`The in?ated valve 10a may be affixed in its desired
`position by way of mechanical ?xation apparatus (e.g., pins,
`hooks, etc. . . . ) or adhesive as described above with respect
`to the valve 10 constructed in accordance with the ?rst
`embodiment.
`After the in?ated valve 10a has been adequately a?‘ixed in
`its intended operative location, the guide catheter 30a may
`be withdrawn and removed, thereby leaving the in?ated
`operatively con?gured valve 10a at its desired site of
`implantation within the heart or vasculature.
`Although the invention has been described herein with
`speci?c reference to presently preferred embodiments
`thereof, it will be appreciated by those skilled in the art that
`various additions, modi?cations, deletions and alterations
`may be made to such preferred embodiments without depart
`ing from the spirit and scope of the invention. Accordingly,
`it is intended that all reasonably foreseeable additions,
`deletions, alterations and modi?cations be included within
`the scope of the invention as de?ned in the following claims.
`What is claimed is:
`1. An in?atable cardiovascular valve initially deployable
`in a collapsed de?ated con?guration and subsequently in?at
`able to a non-collapsed operative con?guration, said valve
`comprising:
`a) an in?atable valve support body which, when fully
`in?ated, comprises a generally armular ring de?ning a
`central passageway through which blood may ?ow;
`
`NORRED EXHIBIT 2217 - Page 8
`
`FIGS. 4a—4c provide a stepwise illustration of a presently
`preferred method for percutaneous transluminal catheter
`introduction of the “integral” or annular ?rst embodiment of
`the in?atable valve 10 of the present invention.
`As shown, a tubular cardiovascular guiding catheter 30
`having a hollow lumen 32 extending longitudinally there
`through is initially inserted, by a standard percutaneous
`introduction technique, into a blood vessel (e. g., the femoral
`artery). The catheter 30 is advanced through the vasculature
`until the distal tip of the catheter 30 is positioned adjacent
`the intended site for implantation of the valve 10.
`The valve 10 is initially deployed in its de?ated compact
`con?guration and is mounted or attached on an introducer
`member 34, such as a bendable cardiovascular guidewire or
`elongate tubular member having an annular slot near the
`distal end to hold or accommodate the de?ated valve 10
`therein. The elongate in?ation tube 20 attached to the
`de?ated valve 10 is deployed within or alongside the intro
`ducer member 34. The introducer member 34 having the
`de?ated valve 10 mounted thereon is then inserted into and
`advanced through the lumen 32 of the pre-positioned guide
`catheter 30.
`After the distal end of the introducer member 34 having
`the de?ated valve 10 mounted thereon has emerged from the
`distal luminal opening of the guide catheter 30, a quantity of
`in?ation ?uid is injected or infused through the in?ation tube
`20 and into the in?atable body 12 of the valve 10. The
`in?ating valve 10 is, by virtue of its in?ation or by other
`mechanical or manipulative means, separated from the intro
`ducer member 34, thereby allowing the introducer member
`34 to be proximally retracted and removed as shown in FIG.
`4b.
`After the valve 10 has been fully in?ated, the in?ation
`tube 20 may be detached, proximally retracted and removed,
`as shown in FIG. 4c.
`The in?ated, operatively con?gured valve 10 (FIG. 40)
`may subsequently be held in its desired position within the
`heart or blood vessel by way of engagement members (for
`example, pins 19 shown in FIG. 10, hooks, or other con
`ventional engagement mechanisms) protruding from the
`valve 10 or by application of one or more physiologically
`compatible adhesives (e.g., polyurethane adhesive).
`In other embodiments and applications, surfaces of valve
`10 which contact the receptive body may be provided with,
`coated, or infused with a suitable biologic element (e.g., a
`biologically compatible tissue graft or cellular matter
`obtained from an autologous or otherwise genetically com
`patible source) such that the aforementioned surfaces on
`valve 10 will become biologically assimilated within the
`local tissue and thereby ?x the valve 10 as an implant.
`After the in?ated valve 10 has been adhesively, mechani~
`cally or frictionally engaged in its desired implanted loca
`tion, the catheter 30 may be removed, thereby leaving the
`in?ated, operatively con?gured valve 10 in its desired
`implanted position within the heart or vasculature.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`b.) A Preferred Method of Implanting a Linear
`In?atable Valve of the Second Embodiment
`
`The linear in?atable valve 10a of the second embodiment
`of the present invention may be implanted by the translu
`
`

`
`5,554,185
`
`b) at least one lea?et occluder attached to said in?atable
`valve support body and con?gured to move back and
`forth between:
`i. an open position wherein blood may ?ow in a ?rst
`direction through said central passageway; and
`ii. a closed position whereby blood is prevented from
`back?owinq through said central passageway in a
`second direction, said second direction being oppo~
`site said ?rst direction;
`c) an in?ation port formed on said in?atable valve support
`body to facilitate in?ation thereof; and
`d) at least one pin protruding outwardly from said valve
`and con?gured to engage said adjacent anatomical
`structure when said in?atable valve body is in?ated.
`2. The prosthetic cardiovascular valve of claim 1 wherein
`said at least one pin member comprises:
`a series of pin members positioned around said annular
`ring so as to penetrate and engage surrounding ana
`tomical tissue when said valve is in?ated.
`3. An in?atable cardiovascular valve initially deployable
`in a collapsed de?ated con?guration and subsequently in?at
`able to a non-collapsed operative con?guration, said valve
`comprising:
`a) an in?atable valve support body which, when fully
`in?ated, comprises a generally annular ring de?ning a
`central passageway through which blood may ?ow;
`b) at least one lea?et occluder attached to said in?atable
`valve support body and con?gured to move back and
`forth between:
`i. an open position wherein blood may ?ow in a ?rst
`direction through said central passageway; and
`ii. a closed position whereby blood is prevented from
`back?owing through said central passageway in a
`second direction, said second direction being oppo
`site said ?rst direction;
`e) an in?ation port formed on said in?atable valve support
`body to facilitate in?ation thereof; and
`d) a gelatinous in?ation substance disposed within said
`in?atable valve body in suf?cient quantity to maintain
`said valve body in said in?ated operative con?guration.
`4. An in?atable cardiovascular valve initially deployable
`in a collapsed de?ated con?guration and subsequently in?at
`able to a non-collapsed operative con?guration, said valve
`comprising:
`a) an in?atable valve support body which, when fully
`in?ated, comprises a generally a