United States Patent [191
`Pavcnik et al.
`
`US005397351A
`5,397,351
`[11] Patent Number:
`[45] Date of Patent: Mar. 14, 1995
`
`[54] PROSTHETIC VALVE FOR
`PERCUTANEOUS INSERTION
`
`Inventors: Dusan Pavcnik, Klanec #15, Nova
`Gorica, Slovenija, 65000,
`Yugoslavia; Sidney Wallace, 3324
`Pittsburg, Houston, Tex. 77005;
`Kenneth C. Wright, 1802 Haver,
`Houston, Tex. 77006
`Appl. No.: 699,195
`Filed:
`May 13, 1991
`
`Int. Cl.6 ......................... .. A61F 2/02; A61F 2/24
`US. Cl. ........................................ .. 623/11; 623/2;
`623/3; 623/1; 623/900
`Field of Search .................... .. 623/ 1, l1, 2, 3, 900
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`[21]
`[22]
`[51]
`[52]
`
`[53]
`[56]
`
`3,130,419 4/1964 Edwards ............................... .. 623/ 2
`3,143,742 8/1964 Cromie .................................. .. 623/ 2
`3,571,815 3/1971 Somyk .
`3,574,865 4/1971 Hamaker .
`3,626,518 12/ 1971 Leibinsohn .
`3,911,502 10/1975 Boretos .
`4,580,568 4/ 1986 Gianturco .
`4,648,383 3/1987 Angelchik .
`
`OTHER PUBLICATIONS
`Gregorio Rabago, A Worldwide Overview of Valve Usage,
`Chapter 1 of Heart Valve Replacement: Current Status
`and Future Trends, Futura Publishing Company, Inc.,
`Mount Kisko, N.Y. (G. Rabago, D. Cooley ed. 1987)
`(citing Hufnagel C. A. Harvey W. P. Rabil P. J. M0
`
`Dermott R. F.: Surgical Correction of Aortic Insuf?
`ciency, Surgery, 35:67.3, 1954).
`Cary W. Akins, Mortimer J. Buckley, Wm. M. Daggett,
`W. Gerald Austen, Alan D. Hilgenberg, and Marshall
`L. Jacobs, Ten-Year Follow-Up of the Starr-Edwards
`Prosthesis, Chapter 10 of Heart Valve Replacement: Cur
`rent Status and Future Trends, Futura Publishing Com
`pany, Inc., Mount Kisko, N.Y. (G. Rabago, D. Cooley
`ed. 1987).
`David J. Mehlman, Radiographic and Cineradiographic
`Evaluation of Heart Valve Prostheses, Chapter 11 of
`Heart Valve Replacement: Current Status and Future
`Trends, Futura Publishing Company, Inc., Mount
`Kisko, N.Y. (G. Rabago, D. Cooley ed. 1987).
`Primary Examiner-David Isabella
`Assistant Examiner—Debra S. Brittingham
`Attorney, Agent, or Firm-Woodard, Emhardt,
`Naughton, Moriarty & McNett
`[57]
`ABSTRACT
`A prosthetic valve comprises a poppet, a seat and a
`restraining element. The poppet, seat and restraining
`element include an insertion form for percutaneously
`inserting into a ?uid passageway within a living body
`and an operational form for operating within the ?uid
`passageway. The valve is self-expanding so that upon
`insertion the valve automatically assumes the opera
`tional form. In the operational form the poppet is mov
`ably restrained between the valve seat and restraining
`element. The poppet seals against the valve seat to pre
`vent ?uid ?ow through the valve and unseats from the
`valve seat to permit ?uid ?ow through the valve.
`
`16 Claims, 6 Drawing Sheets
`
`10
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`NORRED EXHIBIT 2215 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`Medtronic Corevalve, LLC
`v. Troy R. Norred, LLC
`Case IPR2014-00111
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`1
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`5,397,351
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`PROSTHETIC VALVE FOR PERCUTANEOUS
`INSERTION
`
`5
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`10
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`20
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`30
`
`BACKGROUND OF THE INVENTION
`This invention relates to prosthetic valves which
`might ?nd application as prosthetic aortic valves for
`percutaneous insertion and placement within a ?uid
`passageway of a living body.
`One example of a prosthetic valve is that of an aortic
`heart valve controlling blood ?ow from the heart
`within the human body. Occasionally valve failure will
`occur as a result of disease, wherein a heart valve be
`comes incompetent. During the pumping action of the
`heart, blood either regurgitates or leaks back across the
`incompetent valve against the normal direction of blood
`?ow. This type of valve failure results in a decrease in
`heart pumping ef?ciency, the heart having to work
`harder to pump the required blood ?ow. Therefore,
`prosthetic valves have been developed and are manu
`factured which replace diseased or incompetent natural
`valves of the heart.
`Replacement of heart valves with prosthetic valves
`within the human body was perhaps ?rst documented
`by Hufnagel in 1954. Hufnagel C. A. Harvey W. P.
`25
`Rabil P. J. McDermott R. F.: Surgical Correction of
`Aortic Insuf?ciency, Surgery, 35:673, 1954. Since then
`numerous prosthetic valves have been developed, in
`cluding both mechanical and biological heart valves.
`Mechanical heart valves are generally of two designs,
`either a ball-in-cage valve or a disc valve. One example
`of a mechanical heart valve is that of Boretos, US. Pat.
`No. 3,911,502, which describes a composite heart valve
`poppet for use with ball-in-cage arti?cial heart valves.
`The poppet includes a core of rigid material covered by
`35
`an elastomer jacket. Leibinsohn, US. Pat. No.
`3,626,518, discloses an arti?cial cardiac valve having
`characteristics of both a ball valve and a disc valve for
`improved streamlined blood ?ow and reduced turbu
`lence. Hamaker, US. Pat. No. 3,574,865, discloses a
`prosthetic sutureless heart valve, the heart valve fasten
`ing to the heart via a two-piece snap ring. Somyk, US.
`Pat. No. 3,857,815, discloses a suture ring for a heart
`valve, wherein a cylindrical collar extends radially from
`the valve to facilitate attachment.
`45
`With regard to currently available prosthetic valves,
`the physician/patient must weigh the advantages and
`disadvantages of each type of prosthetic valve. How
`ever, no choice currently exists regarding the installa
`tion and placement of the prosthetic heart valve. Cur
`rently, installation of prosthetic valves requires general
`anesthesia and open-heart surgery. As a result, the re
`cipient of the prosthetic valve is subjected to the inher
`ent risk of mortality associated with surgery. Therefore,
`a major factor when deciding whether to replace a
`valve and choosing the type of prosthetic valve is the
`mortality risk associated with the surgery. Further
`more, because biological valves have a limited useful
`life and thrombosis can lead to obstruction of the me
`chanical valve, repeat surgeries may be required to
`maintain the valve which further increase the mortality
`risk to the patient.
`A need therefore exists for a prosthetic heart valve
`which does not require surgery for installation and
`placement and, therefore, avoids the mortality risk asso
`ciated with surgery. Such a valve would provide treat
`ment for an incompetent valve and the aortic regurgita
`tion resulting therefrom without requiring general anes
`
`40
`
`55
`
`60
`
`65
`
`2
`thesia and open-heart surgery. Ideally, such a valve
`would be placed in a ?uid passageway via transcatheter
`techniques, similar to that currently used for the instal
`lation and placement of endovascular stents.
`
`SUMMARY OF THE INVENTION
`A prosthetic valve for percutaneous insertion and
`placement within a ?uid passageway of a living body
`according to one embodiment of the present invention
`includes a valve seat, a restraining element, and a pop
`pet. The valve assembly includes a ?rst insertion form
`for percutaneous insertion into the passageway. The
`valve assembly includes a second larger operational
`form for operation within the passageway, wherein the
`valve seat has means for sealing against the passageway
`and an opening for sealing engagement with the poppet
`and the restraining element has means for restraining
`passage of the poppet therethrough while permitting
`?uid ?ow therethrough. The poppet is movably re
`strained within the passageway between the valve seat
`and the restraining element, wherein the poppet seals
`against the opening in the valve seat to prevent fluid
`?ow therethrough and the poppet unseats from the
`valve seat to permit ?uid ?ow therethrough.
`The invention also involves a method for inserting a
`deformable prosthetic valve within a ?uid passageway
`of a living body. The method includes the steps of plac
`ing a deformable aortic prosthetic valve assembly
`within a distal end of a ?rst sheath, wherein the valve
`includes a ?rst insertion form and a second larger opera
`tional form and the ?rst sheath encompasses the valve
`when the valve is in the ?rst smaller insertion form,
`locating the distal end of the ?rst sheath in the passage
`way, and placing the valve in the passageway by re
`moving the ?rst sheath from the passageway while
`holding the valve in place.
`One object of the present invention is to provide an
`improved method and apparatus for a prosthetic heart
`valve.
`Another object of the present invention is to provide
`a prosthetic heart valve which does not require open
`heart surgery and general anesthesia for installation and
`placement.
`Another object of the present invention is to provide
`a prosthetic heart valve which can be percutaneously
`inserted and placed within a ?uid passageway of a liv
`ing body.
`Related objects and advantages of the present inven
`tion will become apparent from the following descrip
`tion.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a perspective view of a prosthetic valve
`according to one embodiment of the present invention.
`FIG. 2 is a side cross-sectional view of the prosthetic
`valve of FIG. 1 collapsed within a distal end of a sheath
`for insertion into a passageway.
`FIG. 3 is a side cross-sectional view of the prosthetic
`valve of FIG. 1 partially deployed.
`FIG. 4 is a side cross-sectional view of the prosthetic
`valve of FIG. 1 fully deployed within the passageway.
`FIG. 5 is a side cross-sectional view of the prosthetic
`valve of FIG. 1 with a balloon collapsed within a distal
`end of a sheath for insertion into the passageway.
`FIG. 6 is a side cross-sectional view of a prosthetic
`valve according to a second embodiment of the present
`invention.
`'
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`5
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`20
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`3
`DESCRIPTION OF THE PREFERRED
`EMBODIMENT
`For the purposes of promoting an understanding of
`the principles of the invention, reference will now be
`made to the embodiments illustrated in the drawings
`and speci?c language will be used to describe the same.
`It will nevertheless be understood that no limitation of
`the scope of the invention is thereby intended, such
`alterations and further modi?cations in the illustrated
`device, and such further applications of the principles of
`the invention as illustrated therein being contemplated
`as would normally occur to one skilled in the art to
`which the invention relates.
`Referring now to FIG. 1, a prosthetic valve 10 is
`shown in its operational form. Valve 10 includes a
`smaller insertion form in addition to its operational
`form, wherein the valve collapses to its smaller form for
`installation. Valve 10 is a ball-in-cage type valve includ
`ing a restraining element, comprising a cage 12, at
`tached to a valve seat, comprising a ring 14. Means for
`?xedly disposing the restraining element relative to the
`valve seat is provided by a length of stainless steel tub
`ing 16.
`Restrained within the valve is a movable poppet com
`prising a balloon 18. Balloon 18 translates between a
`sealing position seated against ring 14 and an open posi
`tion restrained within cage 12. Cage 12 allows ?uid to
`pass therethrough while restraining balloon 18 from
`migrating when in the open position.
`Valve 10 is elastically compressible, wherein cage 12
`and ring 14 resiliently compress into their respective
`smaller installation forms and, upon placement within a
`?uid passageway, automatically self-expand into their
`operational forms. In accompanying FIGS. 1-4, valve
`10 assumes its smaller shape by cage 12 collapsing radi
`ally inward and ring 14 collapsing longitudinally for
`insertion into a ?uid passageway. Tubing 16 is not re
`quired to be compressible as its operational form has a
`40
`sufficiently small cross-section to allow for transca
`theter percutaneous installation and placement. Cage 12
`includes a self-expanding stent 20 in its construction for
`supporting the ?uid passageway open to allow for
`travel of balloon 18 therein. Stent 20 comprises a wire
`formed into a closed zig-zag con?guration including an
`endless series of straight wire sections 22 joined by a
`plurality of bends 24 to form the stent. Preferably, the
`stent 20 is a Gianturco self-expanding stent as described
`in US. Pat. No. 4,580,586, which description is incorpo
`rated herein by reference.
`Attached to bends 24 at one end of stent 20 are four
`lengths of ?at, ?exible stainless steel wire 26. Wires 26
`loop across stent 20 to form a restraining element 28 of
`valve 10 for preventing passage of balloon 18 there
`through. The number of wires attached to bends 24 can
`vary; however, four to six lengths of wire are provided
`for optimum performance of the valve. Fewer wires
`may not adequately restrain balloon 18 within valve 10,
`while greater numbers of wires may promote thrombo
`sis. Soldering provides an effective attachment mecha
`nism of wires 26 to bends 24 of stent 20, with welding
`and other attachment means known in the art also being
`contemplated.
`Also contemplated is a restraining element 28 formed
`by a single ?exible wire wherein the wire is bent into a
`zig-zag shape having straight sections and bends. The
`bends of the single ?exible wire attach to stent 20 with
`
`5,397,351
`4
`the straight sections looping across the end of the stent
`similar to the lengths of ?exible wire 26.
`In the preferred embodiment a number of hooks or
`barbs 30 are attached to cage 12. More than one barb
`may be provided depending on the size of the ?lter and
`the corresponding ?uid ?ow resistance which is reacted
`by the passageway via the attaching hooks. Because the
`passageway is typically tissue (although prosthetic pas
`sageways are envisioned), the ?uid force on the ?lter is
`distributed so as not to tear the ?lter from the tissue
`causing migration of the valve. Also assisting placement
`and ?xation of the valve is stent 20. Depending on the
`particular stent design, upon expansion of the cage or
`stent within the ?uid passageway suf?cient resilient
`stress may be stored within the stent to create a combi
`nation pressure/friction effect which tends to keep the
`stent wires 24 in contact with the surrounding tissue.
`Tissue overgrowth may also occur to prevent migration
`of the valve.
`Ring 14 is comprised of two ring-type springs 32 and
`34 covered with a ?ne mesh 36 preferably formed of a
`tightly woven nylon or dacron material. Nylon mesh 36
`provides effective ?uid ?ow blockage so that ?ow
`passes through opening 38 when balloon 18 is unseated.
`Springs 32 and 34 elastically ?ex to create a smaller
`cross-section for ease of insertion. Springs 32 and 34 are
`preferably formed by attaching the ends of an individual
`length of stainless steel wire together. A number of
`barbs 40, similar to barbs 30, are preferably attached at
`various points around spring 32 for stabilization of the
`valve following placement of ring 14.
`Balloon 18 is preferably a detachable in?atable latex
`balloon. Balloon 18 is de?ated for insertion to provide
`the smaller form required for transcatheter percutane
`ous insertion. Once the cage and ring assembly are in
`place within the ?uid passageway, balloon 18 is inserted
`within the valve between ring 14 and cage 12. Balloon
`18 is then ?lled with a material to prevent de?ation of
`the balloon. Balloon 18 includes a simple one-way valve
`43 which allows for in?ation via a needle or similar
`penetrating medium. Once the material has been in
`jected and the needle withdrawn, one-way valve 43
`seals the material within the balloon to maintain the
`balloon’s spherical shape. In the preferred embodiment,
`the material is a silicone rubber which pressurizes the
`balloon to maintain its spherical shape. Other materials
`are also contemplated which harden within balloon 18
`to maintain its shape.
`Referring to FIG. 2, insertion of the valve 10 begins
`by collapsing the cage 12 and ring 14 within a sheath 42,
`such as an 11-12 French Te?on sheath. The sheath is
`then percutaneously inserted into a ?uid passageway
`and the valve is held in place while the sheath is with
`drawn to deploy the valve. Because the valve is self
`expanding, it opens as it exits the sheath. Proper posi
`tioning of the valve can be veri?ed by known tech
`niques, such as radiography.
`Referring again to FIG. 2, valve 10 is depicted in its
`compressed state constrained within sheath 42. Sheath
`42 is shown inserted into ?uid passageway or vessel 44
`above a ventricle 46 of the heart. Also contemplated is
`sheath 42 inserted remote from ventricle 46, wherein
`the sheath is advanced within a ?uid passageway to
`reach ventricle 46; i.e. percutaneous insertion at the
`groin region. Cage 12 is collapsed radially while ring 14
`is collapsed longitudinally or along the longitudinal axis
`of sheath 42. Tubing l6 maintains the spatial relation
`ship of cage 12 to ring 14 and connects the two so that
`
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`5,397,351
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`the cage 12 and ring 14 may be inserted as a unit. Barbs
`102. Element 102 allows ?uid to pass through while
`40 are depicted facing ventricle 46 so that upon release
`restraining poppet 108 in the open position.
`of ring 14, it will attach to aortic walls 48 above the
`In one speci?c example of the valve 10 for placement
`ventricle, thus stabilizing the ?lter within vessel 44 and
`in dogs, the cage was constructed ranging from 2.5 to
`preventing migration of the valve during deployment of 5
`3.5 cm. in diameter. The outside diameter of the ring
`cage 12. Wire segments 26 deform longitudinally as
`ranged from 2.4 to 3.4 cm., varying in 2 mm. incre
`well to accommodate stent 20 in its collapsed form.
`ments. After induction of general anesthesia, the right
`Referring now to FIG. 3, ring 14 is depicted in its
`common carotid artery was surgically isolated and an
`operational form deployed and attached to aortic wall
`11-12 French Te?on sheath was introduced. This
`48.‘ Barbs 40 attach ring 14 to wall 48 while cage 12
`sheath was advanced into the ascending aorta under
`remains compressed within sheath 42. Ring 14 is deliv
`?uoroscopic monitoring. With the animal in the left
`ered from sheath 42 using a pusher catheter (not shown)
`lateral position, an aortogram was performed to deter
`slidable within sheath 42, wherein the pusher catheter
`mine the diameter of the sinus Valsalva and ascending
`holds the valve in correct placement as the sheath is
`aorta and to select the proper size of the prosthetic
`withdrawn. Once ring 14 is deployed, the cage 12 is
`valve. Following the aortogram, the tip of the delivery
`deployed from sheath 42 to complete placement of
`sheath was positioned in the posterior non coronary
`valve 10.
`cusp. A small amount of contrast material was hand
`Referring now to FIG. 4, both cage 12 and ring 14 are
`injected to check the position of the sheath and was
`shown deployed with tubing 16 connecting the two.
`marked by placement of a needle in the overlying skin.
`However, cage 12 and ring 14 need not be connected to
`20
`The prosthetic valve was then delivered through the
`provide an operable prosthetic valve because barbs 30
`sheath using a pusher catheter. As the ring exited the
`and stent 20 can ?x the cage and barbs 40 can locate ring
`sheath, it opened and was anchored against the annulus
`14 to maintain the integrity of valve 10 within passage
`by the barbs.
`way 44. Tubing 16, however, provides an added mea
`After a determination was made con?rming the
`sure of safety should either cage 12 or ring 14 loosen
`valve’s position, the entire device was extruded into the
`from their respective vessels.
`aorta. The ring was placed below the ostia of the coro
`The next step is deployment of the balloon. Referring
`nary arteries in such a way that the cusps of the aortic
`to FIG. 5, the balloon 18 is placed at the tip of a narrow
`valve were compressed. This created a huge regurgita
`gauge catheter 50, such as a S-French high-?ow cathe
`tion and an appropriate animal model for evaluating the
`ter. Catheter 50 contains tube 52 within pusher sheath
`device. The detachable balloon was then placed into the
`54. The catheter 50 is inserted in the ?uid passageway
`cage. After in?ation with a predetermined volume of
`44 through the cage 12 and ring 14, and the balloon is
`silicone, the balloon was detached from its delivery
`deployed from the catheter 50 similar to the deploy
`system. The position of the ring and the competency of
`ment of the ring and cage. Catheter 50 is also insertable
`the valve were tested by injecting contrast media di
`remote from the placed cage and ring, wherein the
`rectly above the cage.
`catheter is advanced within a ?uid passageway through
`While the invention has been illustrated and de
`the cage and ring to deploy the balloon. After place
`scribed in detail in the drawings and foregoing descrip
`ment, the balloon is ?lled with liquid silicone rubber
`tion, the same is to be considered as illustrative and not
`through tube 52 and then detached from the needle,
`restrictive in character, it being understood that only
`catheter 54 holding in?ated balloon 18 in place as tube
`40
`the preferred embodiment has been shown and de
`52 is withdrawn.
`scribed and that all changes and modi?cations that
`Migration of cage 12 relative to ring 14 is potentially
`come within the spirit of the invention are desired to be
`detrimental as excess travel of balloon 18 can result.
`protected.
`Among other risks, the excess travel may reduce pump
`What is claimed is:
`ing ef?ciency as the response time of the valve will
`45
`1. A prosthetic aortic valve assembly for percutane
`increase; i.e., valve 10 will take increased amounts of
`ous insertion and placement within a ?uid passageway
`time to open and close. Further, if cage 12 migrates
`of a living body, comprising:
`from ring 14, the balloon may become trapped while
`translating within the vessel. Should the balloon be
`a valve seat;
`a restraining element;
`come trapped, it will result in an incompetent valve,
`thus grossly reducing the heart’s pumping capacity and
`a Poppet;
`efficiency.
`said valve assembly having a ?rst insertion form for
`percutaneous insertion into the passageway, said
`Alternative embodiments are also envisioned which
`?rst insertion form including a compressed valve
`minimize these risks. Referring to FIG. 6, one such
`seat, a compressed restraining element, and a com
`embodiment depicts a valve 100 comprising a restrain
`pressed poppet; and
`ing element 102 connected via tubing 104 to seat 106.
`Restraining element 102 comprises a ring-type spring
`each element of said valve assembly expanding to a
`second larger operational form after the assembly
`109 having attached across it wire segments 110 to
`is placed within the passageway, said valve seat
`prevent travel of poppet 108 past element 102. The
`opening in spring 109 is sized sufficiently large to permit
`having means for sealing against the passageway
`?uid ?ow therethrough when restraining element 102
`and an opening for sealing engagement with said
`poppet, said restraining element having means for
`restrains poppet 108. Seat 106 is similar to ring 14in that
`restraining passage of said poppet therethrough
`it provides a sealing interface for poppet 108. Rather
`while permitting ?uid ?ow therethrough, said pop
`than balloon 18 traversing substantially within a cage, as
`within valve 10, poppet 108 traverses within vessel 107
`pet movably restrained between said valve seat and
`between element 102 and seat 106. Poppet 108 translates
`said restraining element, said poppet being mov
`between a sealing position seated against seat 106 to an
`able to seal against said opening in said valve seat to
`open position restrained from passing through element
`prevent ?uid ?ow therethrough and said poppet
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`5,397,351
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`8
`being movable to unseat from said valve seat to
`ing said valve to said passageway upon placement
`permit ?uid ?ow therethrough.
`therein.
`2. The prosthetic valve of claim 1 further comprising
`10. The prosthetic valve of claim 9 wherein said stent
`means for ?xedly disposing said restraining element
`includes a ?exible wire formed into a closed zig-zag
`con?guration, the wire including an endless series of
`relative to said valve seat.
`straight sections and a plurality of bends, the straight
`3. The prosthetic valve of claim 1 wherein said seat
`sections joined by the bends to form the stent and the
`includes a number of ?rst barbs for attaching said valve
`bends de?ning ends of said stent.
`to the passageway upon placement therein.
`11. The prosthetic valve of claim 10 wherein said
`4. The prosthetic valve of claim 1 wherein said re
`?exible ring includes:
`straining element includes a number of second barbs for
`a ?rst smaller diameter circular spring having a ?rst
`attaching said valve to the passageway upon placement
`smaller diameter opening less than the expanded
`therein.
`diameter of the poppet;
`5. A prosthetic aortic valve assembly for percutane
`a concentric second larger diameter circular spring
`ous insertion and placement within a ?uid passageway
`having a second larger diameter adapted to engage
`of a living body, comprising:
`the passageway; and
`a valve seat;
`a ?exible membrane attached between said circular
`a restraining element;
`springs and sealing ?uid from ?owing through said
`a poppet including an in?atable balloon, said balloon
`valve when said balloon is seated against said ring
`assuming the ?rst insertion form when de?ated and
`preventing ?uid ?ow through said ?rst smaller
`the second operational form when in?ated;
`diameter opening.
`means for ?xedly disposing said restraining element
`12. The prosthetic valve of claim 11 wherein said
`relative to said valve seat;
`balloon further includes a one-way valve for in?ation,
`said valve assembly having a ?rst insertion form, said
`said valve containing ?uid within said balloon after
`?rst insertion form including a compressed valve
`in?ation.
`seat, a compressed restraining element, and a com
`13. The prosthetic valve of claim 12 wherein said
`pressed poppet for percutaneous insertion into the
`balloon is in?ated with liquid silicone rubber after
`passageway; and
`placement within the passageway.
`said valve assembly expanding to a second larger
`14. A prosthetic aortic valve assembly for percutane
`operational form after the assembly is placed
`ous insertion and placement within a ?uid passageway
`of a living body, comprising:
`within the passageway, said valve seat having
`means for sealing against the passageway and an
`a valve seat;
`opening for sealing engagement with said poppet,
`a restraining element;
`said restraining element having means for restrain
`a poppet including an in?atable balloon, said balloon
`assuming the ?rst insertion form when de?ated and
`ing passage of said poppet there through while
`the second operational form when in?ated;
`permitting ?uid ?ow there through, said poppet
`said valve assembly having a ?rst insertion form, said
`movably restrained between said valve seat and
`?rst insertion form including a compressed valve
`said restraining element, said poppet being mov
`seat, a compressed restraining element, and a com
`able to seal against said opening in said valve seat to
`pressed poppet for percutaneous insertion into the
`prevent ?uid ?ow there through and said poppet
`passageway; and
`being movable to unseat from said valve seat to
`said valve assembly expanding to a second larger
`permit ?uid ?ow therethrough.
`operational form after the assembly is placed
`6. The prosthetic valve of claim 5 wherein:
`within the passageway, said valve seat having
`said seat includes a ?exible ring;
`means for sealing against the passageway and an
`said restraining element includes a ?exible cage; and
`opening for sealing engagement with said poppet,
`wherein said ring and cage are resiliently compress
`said restraining element having means for restrain
`ible for insertion into the passageway in the ?rst
`ing passage of said poppet there through while
`insertion form and for self-expansion against the
`permitting ?uid ?ow there through, said poppet
`passageway to operate in the passageway in the
`movably restrained between said valve seat and
`second operational form.
`said restraining element, said poppet being mov
`7. The prosthetic valve of claim 6 wherein said cage
`able to seal against said opening in said valve seat to
`includes a ?exible self-expanding stent with ?exible
`prevent ?uid ?ow there through and said poppet
`wire segments looped across an end of said stent and
`being movable to unseat from said valve seat to
`attached thereto, said cage being adapted to support
`permit ?uid ?ow therethrough.
`said passageway in open condition and said wire seg
`15. The prosthetic valve of claim 14 wherein said
`ments being adapted to restrain movement of said bal
`balloon further includes a one-way valve for in?ation,
`loon through the passageway.
`said valve containing ?uid within said balloon after
`8. The prosthetic valve of claim 7 wherein said ?exi
`in?ation.
`ble ring includes a number of ?rst barbs for attaching
`16. The prosthetic valve of claim 15 wherein said
`said valve to the passageway upon placement therein.
`balloon is in?ated with liquid silicone rubber after
`9. The prosthetic valve of claim 8 wherein said ?exi
`placement within the passageway.
`ble cage includes a number of second barbs for attach
`* i * * *
`
`25
`
`45
`
`50
`
`55
`
`60
`
`65
`
`NORRED EXHIBIT 2215 - Page 11
`
`