`
`\
`
`\
`
`\
`
`\
`
`\
`
`\
`
`\
`
`\
`
`\
`
`\
`
`FIG.1
`
`Medtronic Exhibit 1017
`Medtronic Corevalve v. Colibri Heart Valve
`IPR2020-01454
`Page 00001
`
`
`
`221
`
`
`
`222
`
`223
`
`FIG.2
`
`IPR2020-01454 Page 00002
`
`IPR2020-01454 Page 00002
`
`
`
`\
`
`
`FIG.3A
`FEQSA
`
`IPR2020-01454 Page 00003
`
`IPR2020-01454 Page 00003
`
`
`
`
`
`FIG.3B
`FEGBE _
`
`IPR2020-01454 Page 00004
`
`IPR2020-01454 Page 00004
`
`
`
`
`
`L
`
`FIG.4
`
`IPR2020-01454 Page 00005
`
`IPR2020-01454 Page 00005
`
`
`
`200
`200
`
`FIG.5
`FEG5
`
`IPR2020-01454 Page 00006
`
`IPR2020-01454 Page 00006
`
`
`
`
`
`
`
`
`F!G.6
`
`IPR2020-01454 Page 00007
`
`IPR2020-01454 Page 00007
`
`
`
`FIG. 7
`
`000000000000000000000
`
`IPR2020-01454 Page 00008
`
`
`
`450
`
`
`
`460
`
`400
`
`FIG.8
`
`IPR2020-01454 Page 00009
`
`IPR2020-01454 Page 00009
`
`
`
`---- -- -
`
`- - - - - - -(- - - - - -
`
`—-—~~—._
`
`_.-_——._—-....—-_— w...--——-——
`
`® FOL-A (LOWER.- Bombm)
`
`Fig. 9A
`Fig . 9A
`
`IPR2020-01454 Page 00010
`
`IPR2020-01454 Page 00010
`
`
`
`... I
`vff€YL Bo~Pl.
`l
`( U('PEYl. tO<.if' 'L>F ~,:r.
`1S ~=-~bE='t) 1(:) O't~""l"L .n~) j
`
`'( Lcwm. E-"nGE" oF'" · s~)
`
`r ,·
`_.:p?·
`
`~
`@)W __ FOLa
`l ,
`
`FIG. 9B
`
`_(};) _ f:01-.b
`
`·
`
`IPR2020-01454 Page 00011
`
`
`
`vt'Prn.. . /3o.t.6f"Y2.
`~\ !
`( Uf PE'fl E"t>Cif'" oF ~"1::'"1"°'
`i::oc..bFb "t~ Cl't~-(L .not/ I
`.. ,.
`
`---------,,--------::-------:-----~=-------,_..,...--------:....-:-,--
`. f'At,€ of: Sf1£l?r)
`-~
`I I'
`' ' @)I ',
`
`(. LOWS\ .
`
`I
`
`I
`
`,
`
`"I
`
`.
`
`\
`
`FIG. 9C
`
`/
`
`I
`
`,'
`,.
`
`I
`
`I
`I
`I
`
`I
`
`\
`
`I
`I
`
`I
`
`\
`\
`\
`\
`
`I-'-
`
`I
`I
`I
`
`l
`
`I
`
`/
`
`rl\
`\
`I \
`I~~
`.,_ 1 ·
`\
`,
`'
`. \
`\
`\
`
`I
`I
`I
`
`k
`\
`\
`
`\
`\
`
`I
`
`I
`
`,,.
`
`.
`f
`
`'
`
`..... - /
`:
`Ci) {s°i~f <: 11rp I
`I
`S-H-(+-PE
`!
`.L,~wal. &cit~
`
`IPR2020-01454 Page 00012
`
`
`
`PTO/AIN14 (08-12)
`Approved for use through 01/31/2014. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`109978.10101
`
`Application Number
`
`Title of Invention
`
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1.76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2
`Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`D 37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.)
`Inventor Information:
`
`1
`Inventor
`Legal Name
`
`I Remove I
`
`Prefix Given Name
`
`Middle Name
`
`Family Name
`
`Suffix
`
`Residence Information (Select One) (!) US Residency 0 Non US Residency O Active US Military Service
`I State/Province I
`I Country of Residence i I
`City
`
`Mailing Address of Inventor:
`
`Address 1
`Address 2
`City
`I
`Postal Code
`
`I State/Province
`I Country 1
`I
`I
`All Inventors Must Be Listed - Additional Inventor Information blocks may be
`generated within this form by selecting the Add button.
`
`I
`
`I Add I
`
`Correspondence Information:
`Enter either Customer Number or complete the Correspondence Information section below.
`For further information see 37 CFR 1.33(a).
`
`An Address is being provided for the correspondence Information of this application.
`
`(cid:143)
`
`Customer Number
`
`Email Address
`
`29880
`
`I I Add Email I
`
`I Remove Email I
`
`Application Information:
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF
`MAKING SAME
`Attorney Docket Number 109978.10101
`
`Title of the Invention
`
`I Small Entity Status Claimed ~
`
`Application Type
`
`Nonprovisional
`
`Subject Matter
`Suggested Class (if any)
`Suggested Technology Center (if any)
`
`Utility
`
`1sub Class (if any)
`
`I
`
`Total Number of Drawing Sheets (if any)
`
`12
`
`I Suggested Figure for Publication (if any) I
`
`EFS Web 2.2.3
`
`IPR2020-01454 Page 00013
`
`
`
`PTO/AIN14 (08-12)
`Approved for use through 01/31/2014. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`109978.10101
`
`Application Number
`
`Title of Invention
`
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
`Publication Information:
`D Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. I hereby request that the attached application not be published under
`(cid:143)
`35 U.S.C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`Representative Information:
`
`Representative infonnation should be provided for all practitioners having a power of attorney in the application. Providing
`this information in the Application Data Sheet does not constitute a power of attorney in the application (see 37 CFR 1.32).
`Either enter Customer Number or complete the Representative Name section below. If both sections are completed the customer
`Number will be used for the Representative lnfonnation during processing.
`
`Please Select One:
`
`Customer Number
`
`® Customer Number
`29880
`
`I O US Patent Practitioner 10 Limited Recognition (37 CFR 11.9)
`
`Prior Application Status Pending
`
`Domestic Benefit/National Stage Information:
`This section allows for the applicant to either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate
`National Stage entry from a PCT application. Providing this information in the application data sheet constitutes the
`specific reference required by 35 U.S.C. 119(e) or 120, and 37 CFR 1.78.
`I Remove I
`Filing Date (YYYY-MM-DD)
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Prior Application Status Abandoned
`
`Continuation of
`
`10887688
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`10887688
`
`Continuation in part of
`
`10037266
`
`Additional Domestic Benefit/National Stage Data may be generated within this form
`by selecting the Add button.
`
`2004-07-10
`I Remove I
`Filing Date (YYYY-MM-DD)
`
`2002-01-04
`I Add I
`
`Foreign Priority Information:
`This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is
`not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b)
`and 37 CFR 1.55(a).
`
`Application Number
`
`Country i
`
`Additional Foreign Priority Data may be generated within this form by selecting the
`Add button.
`
`I Remove I
`Filing Date (YYYY-MM-DD)
`Priority Claimed
`0 Yes ® No
`I Add I
`
`EFS Web 2.2.3
`
`IPR2020-01454 Page 00014
`
`
`
`PTO/AIN14 (08-12)
`Approved for use through 01/31/2014. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`109978.10101
`
`Application Number
`
`Title of Invention
`
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
`Authorization to Permit Access:
`
`~ Authorization to Permit Access to the Instant Application by the Participating Offices
`
`If checked, the undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO),
`the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the World Intellectual Property Office (WIPO),
`and any other intellectual property offices in which a foreign application claiming priority to the instant patent application
`is filed access to the instant patent application. See 37 CFR 1.14(c) and (h). This box should not be checked if the applicant
`does not wish the EPO, JPO, KIPO, WIPO, or other intellectual property office in which a foreign application claiming priority
`to the instant patent application is filed to have access to the instant patent application.
`
`In accordance with 37 CFR 1.14(h)(3), access will be provided to a copy of the instant patent application with respect
`to: 1) the instant patent application-as-filed; 2) any foreign application to which the instant patent application
`claims priority under 35 U.S.C. 119(a)-(d) if a copy of the foreign application that satisfies the certified copy requirement of
`37 CFR 1.55 has been filed in the instant patent application; and 3) any U.S. application-as-filed from which benefit is
`sought in the instant patent application.
`
`In accordance with 37 CFR 1.14(c), access may be provided to information concerning the date offiling this Authorization.
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 37 of CFR
`to have an assignment recorded by the Office.
`
`Applicant 1
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`I Remove I
`
`®
`
`Assignee
`
`lo Legal Representative under 35 U.S.C. 117
`lo
`
`Person to whom the inventor is obligated to assign.
`
`0
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
`
`Person who shows sufficient proprietary interest
`
`Name of the Deceased or Legally Incapacitated Inventor : I
`
`If the Assignee is an Organization check here.
`
`~
`
`Organization Name
`
`I COLIBRI HEART VALVE LLC
`
`EFS Web 2.2.3
`
`I
`
`IPR2020-01454 Page 00015
`
`
`
`PTO/AIN14 (08-12)
`Approved for use through 01/31/2014. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`109978.10101
`
`Application Number
`
`Title of Invention
`
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE DEVICE AND METHOD OF MAKING
`SAME
`
`Mailing Address Information:
`
`2150 W. 6th Ave., Unit M
`
`Broomfield
`
`Address 1
`
`Address 2
`
`City
`Country ii us
`
`Phone Number
`
`Email Address
`
`State/Province
`
`Postal Code
`
`Fax Number
`
`co
`80020
`
`Additional Applicant Data may be generated within this form by selecting the Add button.
`
`I Add I
`
`Signature:
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and
`certifications
`
`Remove
`
`Signature
`
`/ Mark L. Yaskanin /
`
`Date (YYYY-MM-DD) 2012-11-13
`
`First Name Mark
`
`I Last Name I Yaskanin
`
`Registration Number
`
`45246
`
`Additional Signature may be generated within this form by selecting the Add button.
`
`I Add I
`
`This collection of information is required by 37 CFR 1.76. 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 1.14. This
`collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data
`sheet form to the US PTO. Time will vary depending upon the individual case. Any comments on the amount of lime 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.
`
`EFS Web 2.2.3
`
`IPR2020-01454 Page 00016
`
`
`
`Privacy Act Statement
`
`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the attached form related to
`a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised that: (1) the general authority for the collection
`of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is
`used by the U.S. Patent and Trademark Office is to process and/or examine your submission related to a patent application or patent. If you do not
`furnish the requested information, the U.S. Patent and Trademark Office may not be able to process and/or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
`
`The information provided by you in this form will be subject to the following routine uses:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act (5 U.S.C. 552)
`and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the Department of Justice to determine
`whether the Freedom of Information Act requires disclosure of these records.
`
`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or
`administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.
`
`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an
`individual, to whom the record pertains, when the individual has requested assistance from the Member with respect to the subject matter of
`the record.
`
`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for the information in
`order to perform a contract. Recipients of information shall be required to comply with the requirements of the Privacy Act of 1974, as
`amended, pursuant to 5 U.S.C. 552a(m).
`
`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records may be disclosed,
`as a routine use, to the International Bureau of the World Intellectual Property Organization, pursuant to the Patent Cooperation Treaty.
`
`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of National Security
`review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
`
`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or his/her designee,
`during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records
`management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the
`GSA regulations governing inspection of records for this purpose, and any other relevant (i.e., GSA or Commerce) directive. Such
`disclosure shall not be used to make determinations about individuals.
`
`A record from this system of records may be disclosed, as a routine use, to the public after either publication of the application pursuan
`to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
`CFR 1.14, as a routine use, to the public if the record was filed in an application which became abandoned or in which the proceedings were
`terminated and which application is referenced by either a published application, an application open to public inspections or an issued
`patent.
`
`9.
`
`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law enforcement agency, if the
`USPTO becomes aware of a violation or potential violation of law or regulation.
`
`EFS Web 2.2.3
`
`IPR2020-01454 Page 00017
`
`
`
`PERCUTANEOUSLY IMPLANTABLE REPLACEMENT HEART VALVE
`
`DEVICE AND METHOD OF MAKING SAME
`
`CONTINUITY INFORMATION
`
`[000 I] The present application 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(cid:173)
`
`in-part application of U.S. Patent Application No. 10/037,266, filed on January 4, 2002 (now
`
`abandoned). Both applications of which 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.
`
`[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.
`
`DNl 31005vl 11/13/12
`
`IPR2020-01454 Page 00018
`
`
`
`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
`
`between the leaflets and the papillary muscles; instead, numerous chordae are present, and
`
`chordae from each papillary muscle attach to both of the valve leaflets.
`
`[0007] When the left ventricular wall relaxes so that the ventricular chamber enlarges and
`
`draws in blood, the leaflets of the mitral valve separate and the valve opens. Oxygenated blood
`
`flows in a downward direction through the valve, to fill the expanding ventricular cavity. Once
`
`the left ventricular cavity has filled, the left ventricle contracts, causing a rapid rise in the left
`
`DNl 31005vl 11/13/12
`
`2
`
`IPR2020-01454 Page 00019
`
`
`
`ventricular cavitary pressure. This causes the mitral valve to close while the aortic valve opens,
`
`allowing the oxygenated blood to be ejected from the left ventricle into the aorta. The chordae
`
`tendineae of the mitral valve prevent the mitral leaflets from prolapsing back into the left atrium
`
`when the left ventricular chamber contracts.
`
`[0008] The three leaflets, chordae tendineae, and papillary muscles of the tricuspid valve
`
`function in a similar manner, in response to the filling of the right ventricle and its subsequent
`
`contraction. The cusps of the aortic valve also respond passively to pressure differentials
`
`between the left ventricle and the aorta. When the left ventricle contracts, the aortic valve cusps
`
`open to allow the flow of oxygenated blood from the left ventricle into the aorta. When the left
`
`ventricle relaxes, the aortic valve cusps reapproximate to prevent the blood which has entered the
`
`aorta from leaking (regurgitating) back into the left ventricle. The pulmonary valve cusps
`
`respond passively in the same manner in response to relaxation and contraction of the right
`
`ventricle in moving de-oxygenated blood into the pulmonary artery and thence to the lungs for
`
`re-oxygenation. Neither of these semilunar valves has associated chordae tendineae or papillary
`
`muscles.
`
`[0009] Problems that can develop with heart valves consist of stenosis, in which a valve
`
`does not open properly, and/or insufficiency, also called regurgitation, in which a valve does not
`
`close properly. In addition to stenosis and insufficiency of heart valves, heart valves may need to
`
`be surgically repaired or replaced due to certain types of bacterial or fungal infections in which
`
`the valve may continue to function normally, but nevertheless harbors an overgrowth of bacteria
`
`(vegetation) on the leaflets of the valve that may embolize and lodge downstream in a vital
`
`artery. If such vegetations are on the valves of the left side (i.e., the systemic circulation side) of
`
`the heart, embolization may occur, resulting in sudden loss of the blood supply to the affected
`
`DNl 31005vl 11/13/12
`
`3
`
`IPR2020-01454 Page 00020
`
`
`
`body organ and immediate malfunction of that organ. The organ most commonly affected by
`
`such embolization is the brain, in which case the patient suffers a stroke. Thus, surgical
`
`replacement of either the mitral or aortic valve (left-sided heart valves) may be necessary for this
`
`problem even though neither stenosis nor insufficiency of either valve is present. Likewise,
`
`bacterial or fungal vegetations on the tricuspid valve may embolize to the lungs resulting in a
`
`lung abscess and therefore, may require replacement of the tricuspid valve even though no
`
`tricuspid valve stenosis or insufficiency is present.
`
`[0010] These problems are treated by surgical repair of valves, although often the valves
`
`are too diseased to repair and must be replaced. If a heart valve must be replaced, there are
`
`currently several options available, and the choice of a particular type of artificial valve depends
`
`on factors such as the location of the valve, the age and other specifics of the patient, and the
`
`surgeon's experiences and preferences. Currently in the United States over 100,000 defective
`
`heart valves are replaced annually, at an approximate cost of $30-50,000 per procedure, and thus
`
`it would be desirable if heart valves could be replaced using minimally invasive techniques and
`
`without having to repeat the procedure within a matter of years due to the lack of durability of
`
`the replacement heart valve. It would be especially advantageous if a defective heart valve could
`
`be removed via an endovascular procedure, that is, a procedure where the invasion into the body
`
`is through a blood vessel such as the femoral artery. The procedure is then carried out
`
`percutaneously and transluminally using the vascular system to convey appropriate devices to the
`
`position in the body wherein it is desired to carry out the desired procedure. An example of such
`
`a procedure would be angioplasty, wherein a catheter carrying a small balloon at its distal end is
`
`manipulated through the body's vessels to a point where there is a blockage in a vessel. The
`
`DNl 31005vl 11/13/12
`
`4
`
`IPR2020-01454 Page 00021
`
`
`
`balloon is expanded to create an opening in the blockage, and then the balloon is deflated and the
`
`catheter and balloon are removed from the vessel.
`
`[0011] Endovascular procedures have substantial benefits both from the standpoint of
`
`health and safety as well as cost. Such procedures require minimal invasion of the human body,
`
`and there is consequently considerable reduction and in some instances even elimination, of the
`
`use of a general anesthesia and much shorter hospital stays.
`
`[0012] Replacement heart valves can be categorized as either artificial mechanical
`
`valves, transplanted valves and tissue valves. Replacement heart valves are designed to optimize
`
`hemodynamic performance,
`
`thrombogenicity and durability. Another factor
`
`taken
`
`into
`
`consideration is the relative ease of surgical implantation.
`
`[0013] Mechanical valves are typically constructed from nonbiological materials such as
`
`plastics, metals and other artificial materials which, while durable, are expensive and prone to
`
`blood clotting which increases the risk of an embolism. Anticoagulants taken to help against
`
`blood clotting can further complicate the patient's health due to increased risks for hemorrhages.
`
`[0014] Transplanted valves are natural valves taken from cadavers. These valves are
`
`typically removed and frozen in liquid nitrogen, and are stored for later use. They are typically
`
`fixed in glutaraldehyde to eliminate antigenicity and are sutured in place, typically with a stent.
`
`[0015] Artificial tissue valves are valves constructed from animal tissue, such as bovine
`
`or porcine tissue. Efforts have also been made at using tissue from the patient for which the
`
`valve will be constructed.
`
`[0016] Most tissue valves are constructed by sewing the leaflets of pig aortic valves to a
`
`stent to hold the leaflets in proper position, or by constructing valve leaflets from the pericardial
`
`sac of cows or pigs and sewing them to a stent. The porcine or bovine tissue is chemically
`
`DNl 31005vl 11/13/12
`
`5
`
`IPR2020-01454 Page 00022
`
`
`
`treated to alleviate any antigenicity. The pericardium is a membrane that surrounds the heart and
`
`isolates it from the rest of the chest wall structures. The pericardium is a thin and very slippery,
`
`which makes it difficult for suturing in a millimetricly precise way. The method of making the
`
`replacement heart valve of the present invention solves this problem through a process that
`
`includes drying and compressing the pericardium using photo-mechanical compression in such a
`
`way that makes it possible to handle and fold the material more easily.
`
`[0017] For example, one prior replacement heart valve requires each sculpted leaflet to
`
`be trimmed in a way that forms an extended flap, which becomes a relatively narrow strand of
`
`tissue near its tip. The tip of each pericardial tissue strand is sutured directly to a papillary
`
`muscle, causing the strand to mimic a chordae tendineae. Each strand extends from the center of
`
`a leaflet in the valve, and each strand is sutured directly to either an anterior and posterior
`
`papillary muscle. This requires each leaflet to be positioned directly over a papillary muscle.
`
`This effectively rotates the leaflets of the valve about 90 degrees as compared to the leaflets of a
`
`native valve. The line of commissure between the leaflets, when they are pressed together during
`
`systole, will bisect ( at a perpendicular angle) an imaginary line that crosses the peaks of the two
`
`papillary muscles, instead of lying roughly along that line as occurs in a native valve.
`
`[0018] A different approach to creating artificial tissue valves is described in U.S. Pat.
`
`No. 5,163,955 to Calvin, et al. and U.S. Pat. Nos. 5,571,174 and 5,653,749 to Love. Using a
`
`cutting die, the pericardial tissue is cut into a carefully defined geometric shape, treated with
`
`glutaraldehyde, then clamped in a sandwich-fashion between two stent components. This creates
`
`a tri-leaflet valve that resembles an aortic or pulmonary valve, having semilunar-type cusps
`
`rather than atrioventricular-type leaflets.
`
`DNl 31005vl 11/13/12
`
`6
`
`IPR2020-01454 Page 00023
`
`
`
`[0019] U.S. Pat. No. 3,671,979 to Moulopoulos describes an endovascularly inserted
`
`conical shaped umbrella-like valve positioned and held in place by an elongated mounting
`
`catheter at a supra-annular site to the aortic valve in a nearby arterial vessel. The conical end
`
`points toward the malfunctioning aortic valve and the umbrella's distal ends open up against the
`
`aorta wall with reverse blood flow, thereby preventing regurgitation.
`
`[0020] U.S. Pat. No. 4,056,854 to Boretos describes an endovascularly inserted, catheter
`
`mounted, supra-annular valve in which the circular frame abuts the wall of the artery and
`
`attached flaps of flexible membrane extend distally in the vasculature. The flaps lie against the
`
`artery wall during forward flow, and close inward towards the central catheter to prevent
`
`regurgitation during reverse blood flow. The Boretos valve was designed to be positioned
`
`against the artery wall during forward flow, as compared to the mid-center position of the
`
`Moulopoulos valve, to reduce the stagnation of blood flow and consequent thrombus and
`
`embolic formation expected from a valve at mid-center position.
`
`[0021] The main advantage of tissue valves is that they do not cause blood clots to form
`
`as readily as do the mechanical valves, and therefore, they do not absolutely require systemic
`
`anticoagulation. The major disadvantage of tissue valves is that they lack the long-term
`
`durability of mechanical valves. Tissue valves have a significant failure rate, usually within ten
`
`years following implantation. One cause of these failures is believed to be the chemical
`
`treatment of the animal tissue that prevents it from being antigenic to the patient. In addition, the
`
`presence of extensive suturing prevents the artificial tissue valve from being anatomically
`
`accurate in comparison to a normal heart valve, even in the aortic valve position.
`
`[0022] A shortcoming of prior artificial tissue valves has been the inability to effectively
`
`simulate the exact anatomy of a native heart valve. Although transplanted human or porcine
`
`DNl 31005vl 11/13/12
`
`7
`
`IPR2020-01454 Page 00024
`
`
`
`aortic valves have the gross appearance of native aortic valves, the fixation process (freezing
`
`with liquid nitrogen, and chemical treatment, respectively) alters the histologic characteristics of
`
`the valve tissue. Porcine and bovine pericardial valves not only require chemical preparation
`
`(usually involving fixation with glutaraldehyde), but the leaflets must be sutured to cloth-covered
`
`stents in order to hold the leaflets in position for proper opening and closing of the valve.
`
`Additionally, the leaflets of most such tissue valves are constructed by cutting or suturing the
`
`tissue material, resulting in leaflets that do not duplicate the form and function of a real valve and
`
`are more susceptible to failure.
`
`SUMMARY OF THE INVENTION
`
`[0023] The present invention is a replacement heart valve device and method of making
`
`same. The replacement heart valve device, in a preferred embodiment, comprises a stent made
`
`of stainless steel or self-expanding nitinol a