IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`In Re the Application of:
`
`P ANIA GU A et al.
`
`Application No.: Not Yet Assigned
`
`Filed: Filed Herewith
`
`Atty. File No.: 109978.10113
`
`For: METHOD OF CONTROLLED
`RELEASE OF A
`PERCUTANEOUS
`REPLACEMENT HEART VAL VE
`(as amended herein)
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria Virginia 22313-14 5 0
`
`Dear Sir:
`
`Confirmation No.: Not Yet Assigned
`
`Group Art Unit: Not Yet Assigned
`
`Examiner: Not Yet Assigned
`
`PRELIMINARY AMENDMENT
`
`(Filed Electronically)
`
`Certificate ofEFS-Web Transmission
`I hereby certify that this correspondence is being electronically
`transmitted to the U.S. Patent And Trademark Office on
`15 April 2014
`Typed or printed name of person signing this certificate:
`Carol Donahue
`Signature:
`/ Carol Donahue/
`
`Prior to the initial review of the above-identified patent application by the Examiner,
`
`please enter the following Preliminary Amendment.
`
`Please amend the above-entitled patent application as follows:
`
`Amendments To The Specification begin on page 2 of this paper.
`
`Amendments To The Claims begin on page 6 of this paper.
`
`Amendments To The Drawings begin on page 13 of this paper.
`
`Remarks begin on page 14 of this paper.
`
`Attachments begin after page 16 of this paper.
`
`Applicants believe no additional fees are due for this submission. However, please credit
`
`any over payment or debit any under payment to Deposit Account No. 50-1943.
`
`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 1 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`AMENDMENTS TO THE SPECIFICATION
`
`Please amend the following paragraphs as noted. A marked up and a clean Specification
`
`are in the Attachments to the Preliminary Amendment.
`
`Please amend the Title as follows:
`
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE
`
`AND METHOD OF MAKING SAME
`
`METHOD OF CONTROLLED RELEASE OF A PERCUTANEOUS REPLACEMENT
`
`HEART VALVE
`
`[0001] The present application is a continuation application of U.S. Patent Application No.
`
`13/675,665 filed on November 13, 2012, which is a continuation application of U.S. Patent
`
`Application No. 10/887,688 filed on July 10, 2004, now U.S. Patent No. 8,308,797, which is a
`
`continuation-in-part application of U.S. Patent Application No. 10/037,266, filed on January 4,
`
`2002 (now abandoned).
`
`[[Both]] All of the foregoing applications of 1tvhich are incorporated
`
`herein by reference in their entireties.
`
`[0025] The present invention also comprises a method of making a replacement heart valve
`
`device. In order to make the valve, the pericardium starting material is isolated and all the fat
`
`tissue and extra fibers are removed. The biological membrane material is cleaned by mechanical
`
`separation of unwanted layers using hydromechanical force means. Once the pericardium is
`
`completely clean, the material is dried in order to make it easier to handle and fold. Preferably,
`2
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`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 2 of 2039
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`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`this drying is done by exposmg the biocompatible membrane material to photomechanical
`
`compression to remove all lipids from the pericardium or other biocompatible membrane
`
`material and to cause protein denaturalization, transforming the material into a stronger and more
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`homogeneous surface. The valve is formed by taking a flat sheet of the material and folding in
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`such a way that forms a three-leaflet or other number of leaflet valve. Then it is placed in a
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`sequence of solutions, one of isopropyl alcohol of about 70-100%, one of ethanol of about 70-
`
`100%, one of glycerol and one of gluteraldehyde glutaraldehyde, preferably at a concentration of
`
`about 0.07-25% for approximately 36 hours. The material is dried in order to make it easier to
`
`handle and fold. Preferably this drying is done by exposing the biocompatible membrane
`
`material to light and then mechanically compressing the material to cause protein denaturation.
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`This results in material that is stronger and more homogeneous. The valve is formed by taking a
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`flat sheet of bovine or procine porcine pericardium and folding it in such a way that forms a
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`three-leaflet valve. The valve can also be made in the same manner from fresh, cryopreserved or
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`glutaraldehyde fixed allografts or xenografts or synthetic non-biological, non- thrombogenic
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`material. The folding of the pericardium material to create the cusps or leaflets reduces the
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`extent of suturing otherwise required, and resembles the natural form and function of the valve
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`leaflets. The cleaning, pressing and drying technique used to create the valve material makes the
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`folding more practicable. The valve is rehydrated after being formed. The method of the present
`
`invention also greatly reduces the risk of tearing of the cusps or leaflets, since they are formed by
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`folding a single uncut portion of material forming the valve rather than being attached by
`
`suturing.
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`ACTIVE 25389134
`
`3
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 3 of 2039
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`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`[0040] The stent used in a preferred embodiment of the present invention is fabricated from a
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`"shaped memory" alloy, nitinol, which is composed of nickel and titanium. Nitinol wire is first
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`fashioned into the desired shape for the device and then the device is heat annealed. A
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`meshwork of nitinol wire of approximately 0.008 inch gauge is formed into a tubular structure
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`with a minimum central diameter of 20 [[min]] mm to make the stent. Away from its central
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`portion, the tubular structure flares markedly at both ends in a trumpet-like configuration. The
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`maximum diameter of the flared ends of the stent is approximately 50 mm. The purpose of the
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`stent is to maintain a semi-rigid patent channel through the diseased cardiac valve following its
`
`implantation.
`
`[0045] The present invention also comprises a method of making a replacement heart valve
`
`device. In order to make the valve, the biocompatible tissue material is isolated and all the fat
`
`tissue and extra fibers are removed. Cleaning is preferably accomplished by using a
`
`hydromechanical force-based cleaning device to separate tissue layers and hydration with
`
`distilled water to remove unwanted layers. Once the pericardium is completely clean, it is
`
`subjected to photo-mechanical compression, then the valve is formed and placed in sequential
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`solutions of isopropyl alcohol of about 70-100%, ethanol of about 70-100%.,_glycerol and
`
`glutaraldehyde preferably at a concentration of about 0.07-25% for about 36 hours, respectively.
`
`The material is preferably photomechanically compressed to remove lipids and produce protein
`
`coagulation to make the surface smoother and more compact and biocompatible, decreasing the
`
`molecular distance of collagen fibers. The exposure to light and mechanical compression cause
`
`protein denaturation making the material stronger and more homogeneous and biocompatible.
`
`Gas sterilization can also be used to sterilize the tissue membrane material. The valve is formed
`4
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`ACTIVE 25389134
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 4 of 2039
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`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`by taking a flat sheet of the material and folding it in such a way that forms a three-leaflet or
`
`desired number of leaflet valve as shown in FIGS. 3A and 3B and/or FIGS. 9A, 9B and 9C. The
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`folding of the pericardium material to create the cusps or leaflets reduces the extent of suturing
`
`otherwise required, and resembles the natural form and function of the valve leaflets.
`
`It also
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`greatly reduces the risk of tearing of the cusps or leaflets, since they are integral to the valve
`
`rather than being attached by suturing.
`
`ACTIVE 25389134
`
`5
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 5 of 2039
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`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions, and listings, of claims m the
`
`application:
`
`Listing of Claims:
`
`1.-33. (Cancelled)
`
`34.
`
`(New) A method of controlled release of a percutaneous replacement heart valve
`
`in a patient where a bioprosthetic heart valve is indicated, comprising:
`
`providing a replacement heart valve device and a delivery and implantation system:
`
`the replacement heart valve device including:
`
`a stent member that is collapsible, expandable and configured for
`
`percutaneous delivery; and
`
`a valve attached to the stent member, the valve including two to four
`
`individual leaflets;
`
`the delivery and implantation system including:
`
`a pusher member and a moveable sheath, wherein the pusher member
`
`includes a lumen for receiving a guide wire, wherein the moveable sheath
`
`includes a lumen configured for receiving the pusher member, and
`
`wherein the replacement heart valve device is collapsed onto the pusher
`
`member to reside in a collapsed configuration on the pusher member and
`
`is restrained in a collapsed configuration by the moveable sheath;
`
`ACTIVE 25389134
`
`6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 6 of 2039
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`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`after the providing step, advancing the delivery and implantation system over the guide
`
`wire within the patient to position the replacement heart valve device for deployment within the
`
`patient;
`
`after the advancing step, partially deploying the replacement heart valve device within
`
`the patient by pushing out the pusher member from the moveable sheath to expose a portion of
`
`the replacement heart valve device; and
`
`after the partially deploying step, recovering the portion of the replacement heart valve
`
`device within the moveable sheath that was exposed in order to address a problem with the
`
`position of the replacement heart valve device within the patient.
`
`35. (New) The method of Claim 34, wherein the advancing step is done transluminally.
`
`36. (New) The method of Claim 34, wherein the stent member is self-expanding.
`
`37. (New) The method of Claim 36, wherein the stent member comprises nitinol.
`
`38. (New) The method of Claim 34, wherein the stent member includes a tubular
`
`structure away from its central portion that flares at both ends in a trumpet-like configuration.
`
`39.
`
`(New) A method of controlled release of a percutaneous replacement heart valve
`
`in a patient where a bioprosthetic heart valve is indicated, comprising:
`
`providing a replacement heart valve device and a delivery and implantation system:
`
`the replacement heart valve device including:
`7
`
`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 7 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`a stent member that is collapsible, expandable and configured for
`
`percutaneous delivery; and
`
`a valve attached to the stent member, the valve including two to four
`
`individual leaflets;
`
`the delivery and implantation system including:
`
`a pusher member and a moveable sheath, wherein the pusher member
`
`includes a lumen for receiving a guide wire, wherein the moveable sheath
`
`includes a lumen configured for receiving the pusher member, and
`
`wherein the replacement heart valve device is collapsed onto the pusher
`
`member to reside in a collapsed configuration on the pusher member and
`
`is restrained in a collapsed configuration by the moveable sheath;
`
`after the providing step, advancing the delivery and implantation system over the guide
`
`wire within the patient to position the replacement heart valve device for deployment within the
`
`patient;
`
`after the advancing step, partially deploying the replacement heart valve device within
`
`the patient by retracting the moveable sheath to expose a portion of the replacement heart valve
`
`device; and
`
`after the partially deploying step, recovering the portion of the replacement heart valve
`
`device within the moveable sheath that was exposed in order to address a problem with the
`
`position of the replacement heart valve device within the patient.
`
`40. (New) The method of Claim 39, wherein the advancing step is done transluminally.
`
`ACTIVE 25389134
`
`8
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 8 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`41. (New) The method of Claim 39, wherein the stent member is self-expanding.
`
`42. (New) The method of Claim 41, wherein the stent member comprises nitinol.
`
`43. (New) The method of Claim 39, wherein the stent member includes a tubular
`
`structure away from its central portion that flares at both ends in a trumpet-like configuration.
`
`44.
`
`(New) A method of controlled release of a percutaneous replacement heart valve
`
`in a patient where a bioprosthetic heart valve is indicated, comprising:
`
`providing a replacement heart valve device and a delivery and implantation system:
`
`the replacement heart valve device including:
`
`a stent member that is collapsible, expandable and configured for
`
`percutaneous delivery; and
`
`a valve attached to the stent member, the valve including two to four
`
`individual leaflets;
`
`the delivery and implantation system including:
`
`a flexible hollow tube catheter and a moveable sheath, wherein the flexible
`
`hollow tube catheter includes a lumen for receiving a guide wire, wherein
`
`the moveable sheath includes a lumen configured for receiving the flexible
`
`hollow tube catheter, and wherein the replacement heart valve device is
`
`collapsed onto the flexible hollow tube catheter to reside in a collapsed
`
`configuration on the flexible hollow tube catheter and is restrained in a
`
`collapsed configuration by the moveable sheath;
`9
`
`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 9 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`after the providing step, advancing the delivery and implantation system over the guide
`
`wire within the patient to position the replacement heart valve device for deployment within the
`
`patient;
`
`after the advancing step, partially deploying the replacement heart valve device within
`
`the patient by pushing out the flexible hollow tube catheter from the moveable sheath to expose a
`
`portion of the replacement heart valve device; and
`
`after the partially deploying step, recovering the portion of the replacement heart valve
`
`device within the moveable sheath that was exposed in order to address a problem with the
`
`position of the replacement heart valve device within the patient.
`
`45. (New) The method of Claim 44, wherein the advancing step is done transluminally.
`
`46. (New) The method of Claim 44, wherein the stent member is self-expanding.
`
`47. (New) The method of Claim 46, wherein the stent member comprises nitinol.
`
`48. (New) The method of Claim 44, wherein the stent member includes a tubular
`
`structure away from its central portion that flares at both ends in a trumpet-like configuration.
`
`49.
`
`(New) A method of controlled release of a percutaneous replacement heart valve
`
`in a patient where a bioprosthetic heart valve is indicated, comprising:
`
`providing a replacement heart valve device and a delivery and implantation system:
`
`the replacement heart valve device including:
`10
`
`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 10 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`a stent member that is collapsible, expandable and configured for
`
`percutaneous delivery; and
`
`a valve attached to the stent member, the valve including two to four
`
`individual leaflets;
`
`the delivery and implantation system including:
`
`a flexible hollow tube catheter and a moveable sheath, wherein the flexible
`
`hollow tube catheter includes a lumen for receiving a guide wire, wherein
`
`the moveable sheath includes a lumen configured for receiving the flexible
`
`hollow tube catheter, and wherein the replacement heart valve device is
`
`collapsed onto the flexible hollow tube catheter to reside in a collapsed
`
`configuration on the flexible hollow tube catheter and is restrained in a
`
`collapsed configuration by the moveable sheath;
`
`after the providing step, advancing the delivery and implantation system over the guide
`
`wire within the patient to position the replacement heart valve device for deployment within the
`
`patient;
`
`after the advancing step, partially deploying the replacement heart valve device within
`
`the patient by retracting the moveable sheath to expose a portion of the replacement heart valve
`
`device; and
`
`after the partially deploying step, recovering the portion of the replacement heart valve
`
`device within the moveable sheath that was exposed in order to address a problem with the
`
`position of the replacement heart valve device within the patient.
`
`50. (New) The method of Claim 49, wherein the advancing step is done transluminally.
`11
`
`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 11 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`51. (New) The method of Claim 49, wherein the stent member is self-expanding.
`
`52. (New) The method of Claim 51, wherein the stent member comprises nitinol.
`
`53. (New) The method of Claim 49, wherein the stent member includes a tubular
`
`structure away from its central portion that flares at both ends in a trumpet-like configuration.
`
`ACTIVE 25389134
`
`12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 12 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`AMENDMENTS TO THE DRAWINGS
`
`The attached sheets of drawings include replacement Figures 9A-9C. Please replace
`
`Figures 9A-9C currently on file with the attached replacement drawings. Applicants believe no
`
`new matter has been added with submittal of replacement drawings 9A-9C.
`
`ACTIVE 25389134
`
`13
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 13 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`REMARKS
`
`Applicants request that this Preliminary Amendment be entered and the claims presented
`
`herein be examined in this application.
`
`Several typographical errors have been corrected in the amendments to the specification
`
`noted herein. In addition, the title has been amended to better reflect the claims as presented
`
`herein. Applicants believe no new matter has been added with submittal of replacement
`
`drawings 9 A-9C.
`
`Claims 1-33 have been cancelled and new Claims 34-53 have been added. Applicants
`
`believe that support for all claims presented herein is provided in the first application in the
`
`priority chain, namely, U.S. Pat. App. No. 10/037,266 filed on January 4, 2002. Applicants are
`
`providing the following information to assist the examiner with assessing support for the claims
`
`as presented herein. It is noted that other locations in the application may also provide support.
`
`Citations below note the location for claim limitation support within U.S. Pat. App. No.
`
`10/037,266 filed on January 4, 2002 (with paragraph numbering provided below matching that
`
`within U.S. Pat. App. Pub. No. 2003/0130729 that corresponds to U.S. Pat. App. No. 10/037,266
`
`filed on January 4, 2002).
`
`34.
`
`(New) A method of controlled release of a percutaneous replacement heart valve
`
`in a patient where a bioprosthetic heart valve is indicated, comprising: (US 2003/0130729 ,i,i 57,
`
`58 and 63)
`
`providing a replacement heart valve device and a delivery and implantation system: (US
`
`2003/0130729 ,i 57)
`
`the replacement heart valve device including:
`14
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`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 14 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`a stent member that is collapsible, expandable and configured for
`
`percutaneous delivery; (US 2003/0130729 ,i 37) and
`
`a valve attached to the stent member, the valve including two to four
`
`individual leaflets; (US 2003/0130729 ,i 37)
`
`the delivery and implantation system including:
`
`a pusher member and a moveable sheath, wherein the pusher member
`
`includes a lumen for receiving a guide wire, wherein the moveable sheath
`
`includes a lumen configured for receiving the pusher member, and
`
`wherein the replacement heart valve device is collapsed onto the pusher
`
`member to reside in a collapsed configuration on the pusher member and
`
`is restrained in a collapsed configuration by the moveable sheath; (US
`
`2003/0130729 Fig. 8 and ,i,i 57-58)
`
`after the providing step, advancing the delivery and implantation system over the guide
`
`wire within the patient to position the replacement heart valve device for deployment within the
`
`patient; (US 2003/0130729 ,i,i 57-58)
`
`after the advancing step, partially deploying the replacement heart valve device within
`
`the patient by pushing out the pusher member from the moveable sheath to expose a portion of
`
`the replacement heart valve device; and (US 2003/0130729 ,i 57)
`
`after the partially deploying step, recovering the portion of the replacement heart valve
`
`device within the moveable sheath that was exposed in order to address a problem with the
`
`position of the replacement heart valve device within the patient. (US 2003/0130729 ,i 57)
`
`ACTIVE 25389134
`
`15
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 15 of 2039
`
`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`With regard to the claims depending from Claim 34, support for the claim limitations is
`
`provided as follows:
`
`Claim 35 (" ... transluminally"): (US 2003/0130729 ,i 57)
`
`Claim 36 (" ... self-expanding"): (US 2003/0130729 ,i 40)
`
`Claim 37 (" ... nitinol"): (US 2003/0130729 ,i 40)
`
`Claim 38 (" ... trumpet-like configuration"): (US 2003/0130729 ,i 42)
`
`Support for the other independent and dependent claims is found in locations as noted
`
`above, with "flexible hollow tube catheter" (for claims including this limitation) at least
`
`disclosed in Paragraph 58 of US 2003/0130729.
`
`In the event that the Examiner has any questions regarding this Preliminary Amendment,
`
`the Examiner is invited to contact the below-named attorney at (303) 446-3852.
`
`Respectfully submitted,
`
`FOX ROTHSCHILD LLP
`
`/ Mark L. Y askanin /
`Mark L. Y askanin
`Registration No. 45,246
`Customer No. 29880
`Phone: (303) 446-3852
`Facsimile: (303) 292-1300
`
`Dated: April 15, 2014
`
`ACTIVE 25389134
`
`16
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 16 of 2039
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`

`

`Preliminary Amendment
`Filed on April 15, 2014
`
`MARKED UP SPECIFICATION
`
`ACTIVE 25389134
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 17 of 2039
`
`

`

`PERCUTANEOUSLY Il\4PLANTABLE REPLACE1\4ENT HEART VALVE
`
`DEVICE AND 1\4ETHOD OF 1\4A.KING SA1\4E
`
`METHOD OF CONTROLLED RELEASE OF A PERCUTANEOUS
`
`REPLACEMENT HEART VAL VE
`
`CONTINUITY INFORMATION
`
`[0001] The present application is a continuation application of U.S. Patent Application
`
`No. 13/675,665 filed on November 13, 2012, which is a continuation application of U.S. Patent
`
`Application No. 10/887,688 filed on July 10, 2004, now U.S. Patent No. 8,308,797, which is a
`
`continuation-in-part application of U.S. Patent Application No. 10/037,266, filed on January 4,
`
`2002 (now abandoned).
`
`[[Both]] All of the foregoing applications of 1tvhich are incorporated
`
`herein by reference in their entireties.
`
`BACKGROUND OF THE INVENTION
`
`[0002] Field of the Invention
`
`The present invention is in the field of heart valve replacement. More specifically, the
`
`present invention is directed to a method of making a percutaneously implantable replacement
`
`heart valve.
`
`[0003] 2. Description of Related Art
`
`There have been numerous efforts in the field of heart valve replacement to improve both
`
`the durability and effectiveness of replacement heart valves as well as the ease of implantation.
`
`A brief description of heart valves and heart function follows to provide relevant background for
`
`the present invention.
`
`25410868
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 18 of 2039
`
`

`

`[0004] There are four valves in the heart that serve to direct the flow of blood through the
`
`two sides of the heart in a forward direction. On the left (systemic) side of the heart are: 1) the
`
`mitral valve, located between the left atrium and the left ventricle, and 2) the aortic valve,
`
`located between the left ventricle and the aorta. These two valves direct oxygenated blood
`
`coming from the lungs through the left side of the heart into the aorta for distribution to the body.
`
`On the right (pulmonary) side of the heart are: 1) the tricuspid valve, located between the right
`
`atrium and the right ventricle, and 2) the pulmonary valve, located between the right ventricle
`
`and the pulmonary artery. These two valves direct de-oxygenated blood coming from the body
`
`through the right side of the heart into the pulmonary artery for distribution to the lungs, where it
`
`again becomes re-oxygenated to begin the circuit anew.
`
`[0005] Heart valves are passive structures that simply open and close in response to
`
`differential pressures on either side of the particular valve. They consist of moveable "leaflets"
`
`that are designed simply to open and close in response to differential pressures on either side of
`
`the valve's leaflets. The mitral valve has two leaflets and the tricuspid valve has three. The
`
`aortic and pulmonary valves are referred to as "semilunar valves" because of the unique
`
`appearance of their leaflets, which are more aptly termed "cusps" and are shaped somewhat like
`
`a half-moon. The aortic and pulmonary valves each have three cusps.
`
`[0006] In general, the components of heart valves include the valve annulus, which will
`
`remain as a roughly circular open ring after the leaflets of a diseased or damaged valve have
`
`been removed; leaflets or cusps; papillary muscles which are attached at their bases to the
`
`interior surface of the left or right ventricular wall; and multiple chordae tendineae, which couple
`
`the valve leaflets or cusps to the papillary muscles. There is no one-to-one chordal connection
`
`25410868
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 19 of 2039
`
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`between the leaflets and the papillary muscles; instead, numerous chordae are present, and
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`chordae from each papillary muscle attach to both of the valve leaflets.
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`[0007] When the left ventricular wall relaxes so that the ventricular chamber enlarges and
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`draws in blood, the leaflets of the mitral valve separate and the valve opens. Oxygenated blood
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`flows in a downward direction through the valve, to fill the expanding ventricular cavity. Once
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`the left ventricular cavity has filled, the left ventricle contracts, causing a rapid rise in the left
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`ventricular cavitary pressure. This causes the mitral valve to close while the aortic valve opens,
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`allowing the oxygenated blood to be ejected from the left ventricle into the aorta. The chordae
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`tendineae of the mitral valve prevent the mitral leaflets from prolapsing back into the left atrium
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`when the left ventricular chamber contracts.
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`[0008] The three leaflets, chordae tendineae, and papillary muscles of the tricuspid valve
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`function in a similar manner, in response to the filling of the right ventricle and its subsequent
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`contraction. The cusps of the aortic valve also respond passively to pressure differentials
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`between the left ventricle and the aorta. When the left ventricle contracts, the aortic valve cusps
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`open to allow the flow of oxygenated blood from the left ventricle into the aorta. When the left
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`ventricle relaxes, the aortic valve cusps reapproximate to prevent the blood which has entered the
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`aorta from leaking (regurgitating) back into the left ventricle. The pulmonary valve cusps
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`respond passively in the same manner in response to relaxation and contraction of the right
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`ventricle in moving de-oxygenated blood into the pulmonary artery and thence to the lungs for
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`re-oxygenation. Neither of these semilunar valves has associated chordae tendineae or papillary
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`muscles.
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`[0009] Problems that can develop with heart valves consist of stenosis, in which a valve
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`does not open properly, and/or insufficiency, also called regurgitation, in which a valve does not
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 20 of 2039
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`close properly. In addition to stenosis and insufficiency of heart valves, heart valves may need to
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`be surgically repaired or replaced due to certain types of bacterial or fungal infections in which
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`the valve may continue to function normally, but nevertheless harbors an overgrowth of bacteria
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`(vegetation) on the leaflets of the valve that may embolize and lodge downstream in a vital
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`artery. If such vegetations are on the valves of the left side (i.e., the systemic circulation side) of
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`the heart, embolization may occur, resulting in sudden loss of the blood supply to the affected
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`body organ and immediate malfunction of that organ. The organ most commonly affected by
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`such embolization is the brain, in which case the patient suffers a stroke. Thus, surgical
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`replacement of either the mitral or aortic valve (left-sided heart valves) may be necessary for this
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`problem even though neither stenosis nor insufficiency of either valve is present. Likewise,
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`bacterial or fungal vegetations on the tricuspid valve may embolize to the lungs resulting in a
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`lung abscess and therefore, may require replacement of the tricuspid valve even though no
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`tricuspid valve stenosis or insufficiency is present.
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`[0010] These problems are treated by surgical repair of valves, although often the valves
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`are too diseased to repair and must be replaced. If a heart valve must be replaced, there are
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`currently several options available, and the choice of a particular type of artificial valve depends
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`on factors such as the location of the valve, the age and other specifics of the patient, and the
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`surgeon's experiences and preferences. Currently in the United States over 100,000 defective
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`heart valves are replaced annually, at an approximate cost of $30-50,000 per procedure, and thus
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`it would be desirable if heart valves could be replaced using minimally invasive techniques and
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`without having to repeat the procedure within a matter of years due to the lack of durability of
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`the replacement heart valve. It would be especially advantageous if a defective heart valve could
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`be removed via an endovascular procedure, that is, a procedure where the invasion into the body
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`Edwards Lifesciences Corporation, et al. Exhibit 1011, p. 21 of 2039
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`is through a blood vessel such as the femoral artery. The procedure is then carried out
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`percutaneously and transluminally using the vascular system to convey appropriate devices to the
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`position in the body wherein it is desired to carry out the desired procedure. An example of such
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`a procedure would be angioplasty, wherein a catheter carrying a small balloon at its distal end is
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`manipulated through the body's vessels to a point where there is a blockage in a vessel. The
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`balloon is expanded to create an opening in the blockage, and then the balloon is deflated and the
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`catheter and balloon are removed from the vessel.
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`[0011] Endovascular procedures have substantial benefits both from the standpoint of
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`health and safety as well as cost. Such procedures require minimal invasion of the human body,
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`and there is consequently considerable reduction and in some instances even elimination, of the
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`use of a general anesthesia and much shorter hospital stays.
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`[0012] Replacement heart valves can be categorized as either artificial mechanical
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`valves, transplanted valves and tissue valves. Replacement heart valves are designed to optimize
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`hemodynamic performance,
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`thrombogenicity and durability. Another factor
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`taken
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`into
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`consideration is the relative ease of surgical implantation.
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`[0013] Mechanical valves are typically constructed from nonbiological materials such as
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`plastics, metals and other artificial materials which, while durable, are expensive and prone to
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`blood clotting which increases the risk of an embolism. Anticoagulants taken to help against
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`blood clotting can further complicate the patient's health due to increased risks for hemorrhages.
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`[0014] Transplanted valves are natural valves taken from cadavers. These valves are
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`typically removed and frozen in liquid nitrogen, and are stored for later use. They are typically
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`fixed in glutaraldehyde to eliminate antigenicity and are sutured in place, typically with a stent.
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