PTO/SB/05 (07-06)
`Approved for use through 01/31/2007. OMS 0651-0032
`U.S. Patent and Trademark Office. U.S. DEPARTMENT OF COMMERCE
`u d
`n ert e
`h p aoerwork Reduction Act of 1995 no persons are reauired to resPOnd to a collection of information unless it displays a valid OMB control number.
`
`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`(Only for new nonprovisional applications under 37 CFR 1.53(b))
`
`Attorney Docket No.
`
`10012-710.401
`
`First Inventor
`
`Title
`
`Amr SALAHIEH et al.
`
`Everting Heart Valve
`
`Express Mail Label No. FILED VIA EFS
`
`APPLICATION ELEMENTS
`See MPEP chapter 600 concerning utility patent application contents.
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria VA 22313-1450
`
`'
`
`"'
`
`..1
`
`2.0
`
`1.0 Fee Transmittal Form (e.g., PTO/SBI17)
`(Submit an original and a duplicate for fee processing)
`Applicant claims small entity status.
`See 37 CFR 1.27.
`(Total Pages
`3.0 Specification
`29
`Both the claims and abstract must start on a new page
`(Forinfonnation on the preferred arrangement, see MPEP 60B.01(a))
`[Total Sheets
`40 Drawing(s) (35 U.S. C. 113)
`63
`
`5. Oath or Declaration
`
`[Total Sheets
`
`4
`
`a. fZj Newly executed (original or copy)
`0or continuation/divisional with Box 18 completed)
`
`b.
`
`A copy from a prior application (37 CFR 1.63(d))
`
`i.
`
`DELETION OF INVENTOR(S)
`Signed statement attached deleting inventor(s)
`name in the prior application, see 37 CFR
`1.63(d)(2) and 1.33(b).
`
`6.0 Application Data Sheet. See 37 CFR 1. 76
`
`7.0 CD-ROM or CD-R in duplicate, large table or
`cr5puter Program (Appendix)
`Landscape Table on CD
`
`8. Nucleotide and/or Amino Acid Sequence Submission
`(if applicable, items a. -c. are required)
`Computer Readable Form (CRF)
`a. 0
`b.
`Specification Sequence Listing on:
`
`0
`CD-ROM or CD-R (2 copies); or
`i.
`ii.O Paper
`
`l
`
`I
`l
`
`ACCOMPANYING APPLICATION PARTS
`
`9. 0
`
`Assignment Papers (cover sheet & document(s))
`
`Name of Assignee
`
`10. 0
`
`37 CFR 3.73(b) Statement
`(when there is an assignee)
`
`OPowerof
`Attorney
`
`11. 0
`
`English Translation Document (if applicable)
`
`12. 0
`
`lnfo~tion Disclosure Statement (PTO/SB/08 or PT0-1449)
`Copies of citations attached
`
`13. 0
`
`Preliminary Amendment
`
`14. 0 Return Receipt Postcard (MPEP 503)
`(Should be specifically itemized)
`
`15. 0 Certified Copy of Priority Document(s)
`(if foreign priority is claimed)
`
`16. 0 Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`Applicant must attach form PTO/SB/35 or equivalent.
`
`17. 0 Other: Communication reOrder of Inventors
`
`Statements verifying identity of above copies
`c. 0
`18. If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below and in the first sentence of the
`specification following the title, or in an Application Data Sheet under 37 CFR 1. 76:
`D Divisional
`Examiner Ann M. S!;;HILLINGER
`
`0
`
`Continuation-in-part (CIP)
`
`of prior application No :1.2/.269,:U3. ...............
`
`Art Unit: 3774
`
`0
`
`Continuation
`
`Prior application information:
`
`[{] The address associated with Customer Number: I
`
`66854
`
`I OR D Correspondence address below
`
`19. CORRESPONDENCE ADDRESS
`
`Name
`
`Address
`
`City
`
`Country
`
`Signature
`
`Name
`(Print/Type)
`
`I State I
`1 Telephone J
`
`~;---
`THOMAS M. ZLOGAR
`
`1 Zip Code
`I Email
`1 Date JUNE 26, 2009
`Registration No. I
`(Attornev/Aoent\ 55•760
`
`This collection of information is required by 37 CFR 1.53(b). The information is required to obtain or retain a benefit by the public which is to file (and by the
`USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.11 and 1.14. This collection is estimated to take 12 minutes to
`complete, including gathering, preparing, and submitting the completed application form to the USPTO. Time will vary depending upon the individual case. Any
`comments on the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer,
`U.S. Patent and Trademark Office, U.S. Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED
`FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, ca/11-800-PT0-9199 and select option 2.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 1 of 442
`
`

`

`FILED VIA EFS ON JUNE 26, 2009
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Confirmation No.:
`
`Appl. No.
`
`Applicant
`
`Filing Date
`
`Title
`
`Group Art Unit
`
`Examiner
`
`Docket No.
`
`Arnr SALAHIEH et al.
`
`June 26, 2009 (herewith)
`
`Everting Heart Valve
`
`10012-710.401
`
`Customer No.
`
`66854
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313
`Sir:
`
`COMMUNICATION REORDER OF INVENTORS
`
`This communication accompanies a new application, which is a divisional of U.S.
`Application No. 12/269,213, which in tum is a continuation ofUS Application No. 10/870,340.
`In that application, a petition was filed and granted, changing the order of inventors as follows:
`
`Arnr SALAHIEH,
`Ulrich R. HAUG,
`Hans. F. VALENCIA,
`Robert A. GESHLIDER,
`Torn SAUL,
`Dwight P. MOREJOHN and
`Kenneth J. MICHLITSCH.
`
`Copies of the granted petition and the corrected filing receipt are attached. It is requested
`that the subject divisional application herein retain the same order of inventors.
`
`Respectfully submitted,
`
`~b
`
`Thomas Zlogar, Reg. No. 55,760
`
`Date: June 26, 2009
`
`By:
`
`SHAY GLENN LLP
`2755 Campus Drive, Suite 210
`San Mateo, CA 94403
`Telephone: 650.212.1700
`Facsimile: 650.212.7562
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 2 of 442
`
`

`

`

`

`

`

`.., ~i
`
`' . -1
`
`.-·
`
`** SMALL ENTITY**
`
`Title
`
`Everting heart valve
`
`Preliminary Class
`623
`
`Page 2 of3
`
`PROTECTING YOUR INVENTION OUTSIDE THE UNITED STATES
`
`Since the rights granted by a U.S. patent extend only throughout the territory of the United States and have no
`effect in a foreign country, an inventor who wishes patent protection in another country must apply for a patent in
`a specific country or in regional patent offices. Applicants may wish to consider the filing of an international
`application under the Patent Cooperation Treaty (PCT). An international (PCT) application generally has the same
`effect as a regular national patent appllcatic;m in each PCT -member country. The PCT process simplifies the
`filing of patent applications on the same invention in member countries, but does not result in a grant of '1an
`international patent'' and does. not eliminate the need of applicants to file additional documents and fees in
`countries where patent protection is desired.
`
`Almost every country has its own patent law, and a person desiring a patent in a particular country must make an
`application for patent in that country in accordance with its particular laws. Since the laws of many countries differ
`in various respects from the patent law of the United States, applicants are advised to seek guidance from
`specific foreign countries to ensure that patent rights are not lost prematurely.
`
`Applicants also are advised that in the case of inventions made in the United States, the Dire~or of the USPTO
`must issue a license before applicants can apply for a patent in a foreign country. The filing of a U.S. patent
`application serves as a request for a foreign filing license. The application's filing receipt contains further
`information and guidance as to the status of applicant's license for foreign filing.
`
`Applicants may wish to consult the USPTO booklet, "General Information Concerning Patents" (specificaUy, the
`section entitled "Treaties and Foreign Patents") for more information on timeframes and deadlines for filing foreign
`patent applications. The guide is available either by contacting the USPTO Contact Center at 800-786-9199, or it
`. can be viewed on the USPTO website at http://www.uspto.gov/web/offices/pac/doc/general/index.html.
`
`For information on preventing theft of your intellectual property (patents, trademarks and copyrights), you may
`wish to consult the U.S. Government website, http://www.stopfakes.gov. Part of a Department of Commerce
`initiative, this website Includes self-help "toolkits" giving innovators guidance on how to protect intellectual
`. property in specific countries such as China, Korea and Mexico. For. questions regarding patent enforcement
`issues, applicants may call the U;S. Government hotline at 1-866-999-HALT (1-866-999-4158).
`
`LICENSE FOR FOREIGN FILING UNDER
`Title 35, United States Code, Section 184
`Title 37, Code of Federal Regulations, 5.11 & 5.15
`
`GRANTED
`
`The applicant has been granted a license under 35 U.S.C. 184, if the phrase "IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED" followed by a date appears on this form. Such licenses are issued in all applications where
`the conditions for issuance of a license have been met, regardless of whether or not a license may be required as
`set forth in 37 CFR 5.15. The scope and limitations of this license are set forth in 37 CFR 5.15(a) unless an earlier
`license has been issued under 37 CFR 5.15(b). The license is subject to revocation upon written notification. The
`date indicated is the effective date of the license, unless an earlier license of similar scope has been granted
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 5 of 442
`
`

`

`'·'
`
`'··
`
`under 37 CFR 5.13 or 5.14.
`
`Page 3 of3
`
`This license is to be retained by the licensee and may be used at any time on or after the effective date thereof
`unless it is revoked. This license is automatically transferred to any related applications(s) filed under 37 CFR
`1.53(d). This license is not retroactive.
`
`The grant of a license does not in any way lessen the responsibility of a licensee for the security of the subject
`matter as imposed by any Government contract or the provisions of existing laws relating to espionage and the
`national security or the export of technical data. Licensees should apprise themselves of current regulations
`especially with respect to certain countries, of other agencies, particularly the Office of Defense Trade Controls,
`Department of State (with respect to Arms, Munitions and Implements of War (22 CFR 121-128)); the Bureau of
`Industry and Security, Department of Commerce (15 CFR parts 730-774); the Office of Foreign Assets Control,
`Department of Treasury (31 CFR Parts 500+) and the Department of Energy.
`
`NOT GRANTED
`
`No license und~r 35 U.S.C. 184 has been granted at this time, if the phrase ''IF REQUIRED, FOREIGN FILING
`LICENSE GRANTED"'DOES NOT appear on this form. Applicant may still petition for a license under 37 CFR
`5.12, if a license is desired before the expiration of 6 months from the filing date of the application. If 6 months
`has lapsed from the filing date of this application and the licensee has not received any indication of a secrecy
`order under 35 U.S.C. 181, the licensee may foreign file the application pursuant to 37 CFR 5.15(b).
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 6 of 442
`
`

`

`

`

`Attorney Docket No. 10012-710.401
`
`EVERTING HEART VALVE
`
`CROSS-REFERENCE TO RELATED APPLICATION
`
`[0001]
`
`This application is a divisional of pending U.S. Application No. 12/269,213, filed
`
`November 12, 2008; which application is a continuation of pending U.S. Application No. 10/870,340,
`
`filed June 16, 2004, entitled "Everting Heart Valve", the disclosures of which are incorporated by
`
`reference in their entirety.
`
`BACKGROUND OF THE INVENTION
`
`[0002]
`
`The present invention relates to methods and apparatus for endovascularly replacing a heart
`
`valve. More particularly, the present invention relates to methods and apparatus for endovascularly
`
`replacing a heart valve with a replacement valve and an expandable and retrievable anchor. The
`
`replacement valve preferably is not connected to the expandable anchor and may be wrapped about an
`
`end of the anchor, for example, by everting during endovascular deployment.
`
`[0003] Heart valve surgery is used to repair or replace diseased heart valves. Valve surgery is an open-
`
`heart procedure conducted under general anesthesia. An incision is made through the patient's sternum
`
`(sternotomy), and the patient's heart is stopped while blood flow is rerouted through a heart-lung bypass
`
`machine.
`
`[0004] Valve replacement may be indicated when there is a narrowing of the native heart valve,
`
`commonly referred to as stenosis, or when the native valve leaks or regurgitates. When replacing the
`
`valve, the native valve is excised and replaced with either a biologic or a mechanical valve. Mechanical
`
`valves require lifelong anticoagulant medication to prevent blood clot formation, and clicking of the valve
`
`often may be heard through the chest. Biologic tissue valves typically do not require such medication.
`
`Tissue valves may be obtained from cadavers or may be porcine or bovine, and are commonly attached to
`
`synthetic rings that are secured to the patient's heart.
`
`[0005] Valve replacement surgery is a highly invasive operation with significant concomitant risk.
`
`Risks include bleeding, infection, stroke, heart attack, arrhythmia, renal failure, adverse reactions to the
`
`anesthesia medications, as well as sudden death. 2-5% of patients die during surgery.
`
`[0006]
`
`Post-surgery, patients temporarily may be confused due to emboli and other factors associated
`
`with the heart-lung machine. The first 2-3 days following surgery are spent in an intensive care unit
`
`where heart functions can be closely monitored. The average hospital stay is between I to 2 weeks, with
`
`several more weeks to months required for complete recovery.
`
`[0007]
`
`In recent years, advancements in minimally invasive surgery and interventional cardiology have
`
`encouraged some investigators to pursue percutaneous replacement of the aortic heart valve. See, e.g.,
`
`-2 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 8 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`U.S. Patent No. 6,168,614. In many of these procedures, the replacement valve is deployed across the
`
`native diseased valve to permanently hold the valve open, thereby alleviating a need to excise the native
`
`valve and to position the replacement valve in place of the native valve.
`
`[0008]
`
`In the endovascular aortic valve replacement procedure, accurate placement of aortic valves
`
`relative to coronary ostia and the mitral valve is critical. Standard self-expanding systems have very poor
`
`accuracy in deployment, however. Often the proximal end of the stent is not released from the delivery
`
`system until accurate placement is verified by fluoroscopy, and the stent typically jumps once released. It
`
`is therefore often impossible to know where the ends of the stent will be with respect to the native valve,
`
`the coronary ostia and the mitral valve.
`
`[0009] Also, visualization of the way the new valve is functioning prior to final deployment is very
`
`desirable. Visualization prior to final and irreversible deployment cannot be done with standard self(cid:173)
`
`expanding systems, however, and the replacement valve is often not fully functional before final
`
`deployment.
`
`[0010] Another drawback of prior art self-expanding replacement heart valve systems is their lack of
`
`radial strength. In order for self-expanding systems to be easily delivered through a delivery sheath, the
`
`metal needs to flex and bend inside the delivery catheter without being plastically deformed. In arterial
`
`stents, this is not a challenge, and there are many commercial arterial stent systems that apply adequate
`
`radial force against the vessel wall and yet can collapse to a small enough of a diameter to fit inside a
`
`delivery catheter without plastic deformation. However when the stent has a valve fastened inside it, as is
`
`the case in aortic valve replacement, the anchoring of the stent to vessel walls is significantly challenged
`
`during diastole. The force to hold back arterial pressure and prevent blood from going back inside the
`
`ventricle during diastole will be directly transferred to the stent/vessel wall interface. Therefore, the
`
`amount of radial force required to keep the self-expanding stent/valve in contact with the vessel wall and
`
`not sliding will be much higher than in stents that do not have valves inside of them. Moreover, a self(cid:173)
`
`expanding stent without sufficient radial force will end up dilating and contracting with each heartbeat,
`
`thereby distorting the valve, affecting its function and possibly migrating and dislodging completely.
`
`Simply increasing strut thickness of the self-expanding stent is not a practical solution as it runs the risk
`
`of larger profile and/or plastic deformation of the self-expanding stent.
`
`[0011]
`
`In view of drawbacks associated with previously known techniques for endovascularly
`
`replacing a heart valve, it would be desirable to provide methods and apparatus that overcome those
`
`drawbacks.
`
`-3 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 9 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`SUMMARY OF THE INVENTION
`
`[0012] One aspect of the present invention provides apparatus for endovascularly replacing a patient's
`
`heart valve, the apparatus including: a replacement valve; and an expandable anchor, wherein the
`
`replacement valve and expandable anchor are configured for endovascular delivery to the vicinity of the
`
`heart valve, and wherein at least a portion of the replacement valve is configured to evert about the anchor
`
`during endovascular deployment.
`
`[0013] Another aspect of the invention provides a method for endovascularly replacing a patient's
`
`heart valve. In some embodiments the method includes the steps of: endovascularly delivering a
`
`replacement valve and an expandable anchor to a vicinity of the heart valve; everting at least a portion of
`
`the replacement valve about the anchor; and expanding the anchor to a deployed configuration.
`
`[0014] Yet another aspect of the invention provides apparatus for endovascularly replacing a patient's
`
`heart valve including: an anchor comprising a lip region and a skirt region; and a replacement valve,
`
`wherein at least a portion of the replacement valve is configured to evert about the anchor during
`
`endovascular deployment, and wherein the lip region and skirt region are configured for percutaneous
`
`expansion to engage the patient's heart valve.
`
`[0015]
`
`Still another aspect of the present invention provides a method for endovascularly replacing a
`
`patient's heart valve, the method including: endovascularly delivering a replacement valve and an
`
`expandable anchor to a vicinity of the heart valve, endovascularly wrapping at least a portion of the
`
`replacement valve about the anchor, and expanding the anchor to a deployed configuration.
`
`[0016] Another aspect of the present invention provides apparatus for endovascularly replacing a
`
`patient's heart valve, the apparatus including: a replacement valve, and an expandable anchor, wherein
`
`the replacement valve and the anchor are configured for endovascular delivery to a vicinity of the
`
`patient's heart valve, and wherein at least a portion of the replacement valve is wrapped about an end of
`
`the anchor in a deployed configuration.
`
`INCORPORATION BY REFERENCE
`
`[0017] All publications and patent applications mentioned in this specification are herein incorporated
`
`by reference to the same extent as if each individual publication or patent application was specifically and
`
`individually indicated to be incorporated by reference.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0018]
`
`The novel features of the invention are set forth with particularity in the appended claims. A
`
`better understanding of the features and advantages of the present invention will be obtained by reference
`
`to the following detailed description that sets forth illustrative embodiments, in which the principles of
`
`the invention are utilized, and the accompanying drawings of which:
`
`-4 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 10 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`[0019]
`
`Figures lA-B are elevational views of a replacement heart valve and anchor according to one
`
`embodiment of the invention.
`
`[0020]
`
`Figures 2A-B are sectional views of the anchor and valve of Figures 1.
`
`[0021]
`
`Figures 3A-B show delivery and deployment of a replacement heart valve and anchor, such as
`
`the anchor and valve of Figures 1 and 2.
`
`[0022]
`
`Figures 4A-F also show delivery and deployment of a replacement heart valve and anchor, such
`
`as the anchor and valve of Figures 1 and 2.
`
`[0023]
`
`[0024]
`
`Figures 5A-F show the use of a replacement heart valve and anchor to replace an aortic valve.
`
`Figures 6A-F show the use of a replacement heart valve and anchor with a positive registration
`
`feature to replace an aortic valve.
`
`[0025]
`
`Figure 7 shows the use of a replacement heart valve and anchor with an alternative positive
`
`registration feature to replace an aortic valve.
`
`[0026]
`
`Figures SA-C show another embodiment of a replacement heart valve and anchor according to
`
`the invention.
`
`[0027]
`
`Figures 9A-H show delivery and deployment of the replacement heart valve and anchor of
`
`Figures 8.
`
`[0028]
`
`Figure 10 is a cross-sectional drawing ofthe delivery system used with the method and
`
`apparatus of Figures 8 and 9.
`
`[0029]
`
`Figures llA-C show alternative locks for use with replacement heart valves and anchors of this
`
`invention.
`
`[0030]
`
`Figures 12A-C show a vessel wall engaging lock for use with replacement heart valves and
`
`anchors of this invention.
`
`[0031]
`
`[0032]
`
`[0033]
`
`[0034]
`
`[0035]
`
`[0036]
`
`[0037]
`
`Figure 13 demonstrates paravalvular leaking around a replacement heart valve and anchor.
`
`Figure 14 shows a seal for use with a replacement heart valve and anchor of this invention.
`
`Figures 15A-E show alternative arrangements of seals on a replacement heart valve and anchor.
`
`Figures 16A-C show alternative seal designs for use with replacement heart valves and anchors.
`
`Figures 17 show an alternative anchor lock embodiment in an unlocked configuration.
`
`Figures 18A-B show the anchor Jock of Figure 17 in a locked configuration.
`
`Figure 19 shows an alternative anchor deployment tool attachment and release mechanism for
`
`use with the invention.
`
`[0038]
`
`Figure 20 shows the attachment and release mechanism of Figure 19 in the process of being
`
`released.
`[0039]
`
`Figure 21 shows the attachment and release mechanism of Figures 19 and 20 in a released
`
`condition.
`
`- 5 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 11 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`[0040]
`
`Figure 22 shows an alternative embodiment of a replacement heart valve and anchor and a
`
`deployment tool according to the invention in an undeployed configuration.
`
`(0041]
`
`Figure 23 shows the replacement heart valve and anchor of Figure 22 in a partially deployed
`
`configuration.
`
`(0042]
`
`Figure 24 shows the replacement heart valve and anchor of Figures 22 and 23 in a more fully
`
`deployed configuration but with the deployment tool still attached.
`
`[0043]
`
`Figure 25 shows yet another embodiment of the delivery and deployment apparatus of the
`
`invention in use with a replacement heart valve and anchor.
`
`[0044]
`
`Figure 26 shows the delivery and deployment apparatus of Figure 25 in the process of
`
`deploying a replacement heart valve and anchor.
`
`[0045]
`
`Figure 27 shows an embodiment of the invention employing seals at the interface of the
`
`replacement heart valve and anchor and the patient's tissue.
`
`(0046]
`
`Figure 28 is a longitudinal cross-sectional view of the seal shown in Figure 27 in compressed
`
`form.
`
`[0047]
`
`Figure 29 is a transverse cross-sectional view of the seal shown in Figure 28.
`
`[0048]
`
`Figure 30 is a longitudinal cross-sectional view of the seal shown in Figure 27 in expanded
`
`form.
`
`(0049]
`
`Figure 31 is a transverse cross-sectional view of the seal shown in Figure 30.
`
`[0050]
`
`Figure 32 shows yet another embodiment of the replacement heart valve and anchor of this
`
`invention in an undeployed configuration.
`
`[0051]
`
`Figure 33 shows the replacement heart valve and anchor of Figure 32 in a deployed
`
`configuration.
`
`[0052]
`
`Figure 34 shows the replacement heart valve and anchor of Figures 32 and 33 deployed in a
`
`patient's heart valve.
`
`[0053]
`
`Figures 35A-H show yet another embodiment of a replacement heart valve, anchor and
`
`deployment system according to this invention.
`
`(0054]
`
`Figures 36A-E show more detail of the anchor of the embodiment shown in Figures 35A-H.
`
`[0055]
`
`Figures 37A-B show other embodiments of the replacement heart valve and anchor of the
`
`invention.
`
`[0056]
`
`Figures 38A-C illustrate a method for endovascularly replacing a patient's diseased heart valve.
`
`(0057]
`
`Figures 39A-G are side views, partially in section, as well as an isometric view, illustrating a
`
`method for endovascularly replacing a patient's diseased heart valve with an embodiment of the present
`
`invention comprising a replacement valve that is not connected to the expandable anchor, the replacement
`
`valve wrapped about the anchor, illustratively by everting during deployment.
`
`-6of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 12 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`[0058)
`
`Figures 40A-D are side views, partially in section, illustrating a method for endovascularly
`
`replacing a patient's diseased heart valve with another everting embodiment of the present invention.
`
`[0059)
`
`Figures 41A-E are side views, partially in section, illustrating a method for endovascularly
`
`replacing a patient's diseased heart valve with yet another everting embodiment ofthe present invention,
`
`wherein the replacement valve and the anchor are telescoped relative to one another during endovascular
`
`delivery.
`
`[0060]
`
`Figures 42A-B are side-sectional views of alternative everting apparatus comprising everting
`
`valve leaflets.
`
`[0061]
`
`Figures 43A-B, are side-sectional views of further alternative everting apparatus comprising a
`
`locking mechanism coupled to the everting segment.
`
`[0062]
`
`Figures 44A-B are side-sectional views of telescoping embodiments of the present invention
`
`comprising U-shaped valve frames.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0063] While preferred embodiments of the present invention have been shown and described herein, it
`
`will be obvious to those skilled in the art that such embodiments are provided by way of example only.
`
`Numerous variations, changes, and substitutions will now occur to those skilled in the art without
`
`departing from the invention. It should be understood that various alternatives to the embodiments of the
`
`invention described herein may be employed in practicing the invention. For example, for the two-part
`
`locking mechanisms described hereinafter, it will be apparent that the locations of the male and female
`
`elements may be reversed. It is intended that the following claims define the scope of the invention and
`
`that methods and structures within the scope of these claims and their equivalents be covered thereby.
`
`[0064] With reference now to Figures 1-4, a first embodiment of replacement heart valve apparatus in
`
`accordance with the present invention is described, including a method of actively foreshortening and
`
`expanding the apparatus from a delivery configuration and to a deployed configuration. Apparatus I 0
`
`comprises replacement valve 20 disposed within and coupled to anchor 30. Figures I schematically
`
`illustrate individual cells of anchor 30 of apparatus I 0, and should be viewed as if the cylindrical anchor
`
`has been cut open and laid flat. Figures 2 schematically illustrate a detail portion of apparatus I 0 in side(cid:173)
`
`section.
`
`[0065) Anchor 30 has a lip region 32, a skirt region 34 and a body region 36. First, second and third
`
`posts 3 Sa, 3 8b and 3 8c, respectively, are coupled to skirt region 34 and extend within lumen 3I of anchor
`
`30. Posts 38 preferably are spaced 120° apart from one another about the circumference of anchor 30.
`
`[0066] Anchor 30 preferably is fabricated by using self-expanding patterns (laser cut or chemically
`
`milled), braids and materials, such as a stainless steel, nickel-titanium ("Nitinol") or cobalt chromium, but
`
`-7 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 13 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`alternatively may be fabricated using balloon-expandable patterns where the anchor is designed to
`
`plastically deform to its final shape by means of balloon expansion. Replacement valve 20 is preferably
`
`made from biologic tissues, e.g. porcine valve leaflets or bovine or equine pericardium tissues or human
`
`cadaver tissue. Alternatively, it can be made from tissue engineered materials (such as extracellular
`
`matrix material from Small Intestinal Submucosa (SIS)) or may be prosthetic and made from an
`
`elastomeric polymer or silicone, Nitinol or stainless steel mesh or pattern (sputtered, chemically milled or
`
`laser cut). The leaflet may also be made of a composite of the elastomeric or silicone materials and metal
`
`alloys or other fibers such Kevlar or carbon. Annular base 22 of replacement valve 20 preferably is
`
`coupled to skirt region 34 of anchor 30, while commissures 24 of replacement valve leaflets 26 are
`
`coupled to and supported by posts 38.
`
`[0067] Anchor 30 may be actuated using external non-hydraulic or non-pneumatic force to actively
`
`foreshorten in order to increase its radial strength. As shown below, the proximal and distal end regions
`
`of anchor 30 may be actuated independently. The anchor and valve may be placed and expanded in order
`
`to visualize their location with respect to the native valve and other anatomical features and to visualize
`
`operation of the valve. The anchor and valve may thereafter be repositioned and even retrieved into the
`
`delivery sheath or catheter. The apparatus may be delivered to the vicinity of the patient's aortic valve in
`
`a retrograde approach in a catheter having a diameter no more than 23 french, preferably no more than 21
`
`french, more preferably no more than 19 french, or more preferably no more than 17 french. Upon
`
`deployment the anchor and replacement valve capture the native valve leaflets and positively lock to
`
`maintain configuration and position.
`
`[0068] A deployment tool is used to actuate, reposition, lock and/or retrieve anchor 30. In order to
`
`avoid delivery of anchor 30 on a balloon for balloon expansion, a non-hydraulic or non-pneumatic anchor
`
`actuator is used. In this embodiment, the actuator is a deployment tool that includes distal region control
`
`wires 50, control rods or tubes 60 and proximal region control wires 62. Locks 40 include posts or arms
`
`38 preferably with male interlocking elements 44 extending from skirt region 34 and mating female
`
`interlocking elements 42 in lip region 32. Male interlocking elements 44 have eyelets 45. Control wires
`
`50 pass from a delivery system for apparatus 10 through female interlocking elements 42, through eyelets
`
`45 of male interlocking elements 44, and back through female interlocking elements 42, such that a
`
`double strand of wire 50 passes through each female interlocking element 42 for manipulation by a
`
`medical practitioner external to the patient to actuate and control the anchor by changing the anchor's
`
`shape. Control wires 50 may comprise, for example, strands of suture.
`
`[0069]
`
`Tubes 60 are reversibly coupled to apparatus 10 and may be used in conjunction with wires 50
`
`to actuate anchor 30, e.g., to foreshorten and lock apparatus 10 in the fully deployed configuration. Tubes
`
`60 also facilitate repositioning and retrieval of apparatus 10, as described hereinafter. For example,
`
`- 8 of29-
`
`FILED VIA EFS
`
`Edwards Lifesciences Corporation, et al. Exhibit 1102, Page 14 of 442
`
`

`

`Attorney Docket No. 10012-710.401
`
`anchor 30 may be foreshortened and radially expanded by applying a distally directed force on tubes 60
`
`while proximally retracting wires 50. As seen in Figures 3, control wires 62 pass through interior lumens
`
`61 oftubes 60. This ensures that tubes 60 are aligned properly with apparatus 10 during deployment and
`
`foreshortening. Control wires 62 can also actuate anchor 60; proximally directed forces on control wires
`
`62