United States Patent [19]
`Fenton, Jr.
`
`[54] SUTURELESS CARDIAC VALVE
`PROSTHESIS, AND DEVICES AND
`METHODS FOR IMPLANTING THEM
`
`[75] Inventor: Paul V. Fenton, Jr., Marblehead, Mass.
`
`[73] Assignee: AXya Medical, Inc., Beverly, Mass.
`
`[21] Appl. No.: 09/072,524
`
`[22]
`
`Filed:
`
`May 4, 1998
`
`[51] Int. Cl.7 ................................ .. A61F 2/24; A61F 2/02
`
`[52] US. Cl. ............................................... .. 623/2; 623/900
`
`[58] Field of Search ................................ .. 623/2, 11, 900,
`623/66, 1
`
`[56]
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`4/1971 Hamaker ................................... .. 623/2
`3,574,865
`8/1996 Hata et al.
`623/2
`5,549,666
`5,578,076 11/1996 Krueger et a1. .... ..
`623/2
`5,693,090 12/1997 Unsworth et a1. ......... ..
`623/2
`5,716,370
`2/1998 Williamson, IV et a1. ..
`606/153
`5,735,894
`4/1998 Krueger et al. ............ ..
`623/2
`5,800,531
`9/1998 Cosgrove et al.
`623/2
`5,871,489
`2/1999 Ovil ...................................... .. 606/148
`
`US006059827A
`[11] Patent Number:
`[45] Date of Patent:
`
`6,059,827
`May 9, 2000
`
`OTHER PUBLICATIONS
`International Search Report of International Application No.
`PCT/US99/08010.
`The History of SulZer Carbomedics, Sulzer Carbomea'ics,
`The Heart Valve Company, 1996.
`The Valve System, Choice Combinations, Deknatel, 1995.
`Primary Examiner—David H. Willse
`Assistant Examiner—Choon P. Koh
`Attorney, Agent, or Firm—McDermott, Will & Emery
`[57]
`ABSTRACT
`
`A prosthetic cardiac valve assembly for sutureless implan
`tation in a patient. The assembly includes a generally
`disk-shaped valve annulus element and one or more gener
`ally disk-shaped retainer elements. The elements are adapted
`for mutual engagement and for engagement With a host
`tissue region so as to ?x a portion of the host tissue betWeen
`them in a sutureless bond. Ultrasonic or thermal energy is
`applied to one or more of the elements to bond them
`together. Either the valve annulus element or the retainer
`element includes a plurality of projections, and the corre
`sponding element includes a corresponding plurality of
`apertures for receiving the projections, thus providing for
`mutual physical engagement. The valve annulus element can
`include a plurality of valve lea?ets Which open and close in
`response to ?uid pressure differentials across them. Various
`insertion devices for the assembly are designed to facilitate
`insertion of the elements in the heart through a relatively
`small incision. The elements can be implanted, assembled
`and bonded together in situ around the host tissue.
`
`15 Claims, 3 Drawing Sheets
`
`NORRED EXHIBIT 2214 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`Medtronic Corevalve, LLC
`v. Troy R. Norred, LLC
`Case IPR2014-00111
`
`

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`U.S. Patent
`
`May 9, 2000
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`Sheet 1 of3
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`6,059,827
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`NORRED EXHIBIT 2214 - Page 2
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`U.S. Patent
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`May 9, 2000
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`U.S. Patent
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`May 9, 2000
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`Sheet 3 0f 3
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`6,059,827
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`1
`SUTURELESS CARDIAC VALVE
`PROSTHESIS, AND DEVICES AND
`METHODS FOR IMPLANTING THEM
`
`FIELD OF THE INVENTION
`
`The invention relates to prosthetic cardiac valves, and
`more particularly to prosthetic cardiac valves Which can be
`implanted in a patient Without sutures.
`
`BACKGROUND OF THE INVENTION
`
`Cardiac valve replacement may be required if the valve is
`prolapsed or otherWise malfunctioning. Replacement of a
`cardiac valve, such as, for example, the mitral or tricuspid
`valve, typically involves the resection of at least a portion of
`the diseased valve, leaving an annulus of host tissue, and the
`implantation of a prosthetic valve Which includes a ?exible
`ring and a plurality of lea?ets mounted Within the ring Which
`are designed to open and close in response to changes in
`?uid pressure across them. The lea?ets may be rotatable
`Within the ring so that they can be oriented properly after the
`prosthesis has been implanted in the heart.
`Prior art cardiac valve prostheses typically include a
`titanium ring and either tWo or three pyrolytic carbon lea?ets
`(tWo if a mitral valve, three if a tricuspid valve). The ring is
`typically covered With a fabric cuff Which promotes endot
`helialiZation of cardiac tissue into the prosthesis.
`The prosthesis is generally secured to the annulus of
`native tissue at the valve site Within the heart With a
`relatively large number of sutures Which must be precisely
`placed and oriented so that the prosthesis does not rotate and
`the movement of the lea?ets is not impeded When the
`prosthesis is in place. In practice, the prosthetic valve is
`secured to the host tissue using sutures attached to the fabric
`cuff surrounding the ring. Generally, relatively long sutures
`are passed through the tissue at the intended valve site and
`carefully laid out to extend through the incision in patient’s
`chest, to points outside the incision. Then, the distal ends of
`the sutures are coupled to the cuff, and ?nally the valve and
`cuff arc “parachuted”, or slid doWn the sutures, into place
`With the orientation of the valve maintained. The sutures
`anchoring the cuff of the prosthesis to the host tissue are then
`tied off.
`Open-heart surgery is complicated, delicate, and con?ned.
`Minimally invasive surgical technologies and techniques are
`favored to minimiZe patient trauma; hoWever, such proce
`dures require a high degree of surgical skill. The implanta
`tion of a prosthetic valve With large numbers of sutures that
`cannot be crossed or otherWise tWisted or misplaced is
`painstaking and dif?cult and prolongs the surgical
`procedure, thereby increasing patient trauma and the risk of
`infection. It Would be an advancement in the art of cardiac
`valve replacement surgery to provide a valve Which can be
`implanted Without sutures.
`
`SUMMARY OF THE INVENTION
`
`According to one aspect of the invention, there is pro
`vided a prosthetic cardiac valve assembly for sutureless
`implantation in a living patient. The assembly comprises a
`valve annulus element and at least one retainer element
`Which are adapted for mutual engagement and engagement
`With one or more sections of host tissue. The valve annulus
`element and retainer element are made of a biocompatible
`material and can be bonded together around the section or
`sections of host tissue upon application of energy to one or
`more of the elements, thereby ?xing the host tissue between
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`them Without sutures. Preferably, the material is a thermo
`plastic material Which is suitable for bonding using ultra
`sonic or thermal Welding techniques.
`The valve annulus element can, but need not, include a
`plurality of valve lea?ets Which are pivotably mounted in the
`valve annulus element for controlling ?uid ?oW through the
`assembly in response to ?uid pressure differentials across
`the lea?ets. In one embodiment, the prosthetic cardiac valve
`assembly is suitable for use as a mitral valve, and the valve
`annulus element includes a pair of valve lea?ets. In another
`embodiment, the assembly is suitable for use as a tricuspid
`valve, and the valve annulus element includes three valve
`lea?ets. The valve lea?ets can be made of living tissue, such
`as porcine tissue, or from a synthetic material. In another
`embodiment, the valve annulus element contains no lea?ets
`and is suitable for use in annuloplastic surgery.
`Either or both of the retainer element and the annulus
`preferably include a plurality of projecting members, and the
`mating part includes a corresponding plurality of apertures
`adapted to receive the projecting members. In this
`embodiment, the valve annulus element is held to the
`retainer element by mechanical engagement of the project
`ing members in corresponding apertures on the mating part.
`In one embodiment, the retainer element is in the form of
`a single-piece, continuous ring; in another embodiment the
`retainer is a multi-piece ring. In still another embodiment the
`assembly includes a pair of retainer elements, the ?rst
`retainer element including a plurality of projecting
`members, and the second retainer element including a cor
`responding plurality of apertures adapted to snugly receive
`the projecting members of the ?rst retainer element. In this
`embodiment, the valve annulus element is held frictionally
`betWeen the ?rst and second retainer elements.
`At least one of the valve annulus element and the retainer
`element includes a tissue anchor for penetrating the host
`tissue and facilitating and maintaining the placement of the
`assembly.
`The tissue-contacting surfaces of the valve annulus ele
`ment and retainer element are preferably adapted to promote
`endothelialiZation of the host tissue into and around the
`supporting ring-like portion of the valve assembly.
`The valve annulus element and the retainer element are
`preferably adapted to be bonded together upon application
`of ultrasonic or thermal energy to one or both of the
`elements.
`According to another aspect of the invention, there is
`provided an insertion device for sutureless implantation of a
`generally disk-shaped cardiac valve prosthesis in a living
`patient. The device comprises a ?at elongated member
`extending along a principal axis betWeen distal and proximal
`ends. The proximal end of the device includes a handle, and
`the distal end includes a plurality of ?ngers that extend at
`least partially in the direction of the principal axis. The
`?ngers are adapted to receive and hold a generally disk
`shaped cardiac valve prosthesis in an orientation having its
`principal plane substantially parallel to the principal axis of
`the device during implantation of the prosthesis.
`According to still another aspect of the invention, there is
`provided a different insertion device for sutureless implan
`tation of a generally disk-shaped cardiac valve prosthesis in
`a living patient. The device comprises a plurality of rigid
`Wires, each Wire including a tissue anchor at a distal end
`thereof for penetrating host tissue. In use the Wires are
`disposed parallel to each other, and each Wire is engageable
`With a portion of the circumference of the prosthesis so that
`the prosthesis is supported by the Wires and is maneuverable
`
`NORRED EXHIBIT 2214 - Page 5
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`6,059,827
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`3
`by and Within the Wires to various positions between and
`including positions transverse to and substantially parallel to
`the Wires. The insertion device includes at least a pair of
`Wires and may include three or more Wires.
`According to still another aspect of the invention, there is
`provided a method of implanting a generally disk-shaped
`cardiac valve prosthesis in a living patient Without using
`sutures. The method comprises the steps of:
`a. Providing a prosthetic cardiac valve assembly, includ
`ing a valve annulus element and at least one retainer
`element, Which elements are adapted for mutual engagement
`With one or more sections of host tissue;
`b. Providing an insertion device for the assembly for
`holding and maneuvering the valve assembly;
`c. Preparing the patient’s chest cavity and heart to receive
`the assembly and the insertion device, Wherein one or more
`sections of host tissue surrounds a valve implant region;
`d. Orienting the valve annulus element of the assembly so
`that its principal plane is substantially parallel to the prin
`cipal axis of the insertion device and inserting the valve
`annulus element into the valve implant region of the
`patient’s heart so that in situ the valve annulus element is
`overlying and in substantial registration With the host tissue,
`and ?xing the valve annulus element to the host tissue With
`the tissue anchor so as to position the valve annulus element
`over the valve implant region;
`e. Orienting the retainer element of the assembly so that
`its principal plane is substantially parallel to the principal
`axis of the insertion device and inserting the retainer element
`into the valve implant region of the patient’s heart so that in
`situ the retainer element is lying under and in substantial
`registration With the host tissue and With the valve annulus
`element, thereby sandWiching the sections of host tissue
`betWeen the retainer element and the valve annulus element,
`and ?xing the retainer element to the host tissue With the
`tissue anchor so as to position the retainer element in
`substantial registration With the valve annulus element over
`the valve implant region;
`f. WithdraWing the insertion device from the patient’s
`heart and chest cavity; and
`g. Applying energy to the assembly to fuse the retainer
`element and the valve annulus element together and ?x the
`sections of host tissue betWeen them.
`In one embodiment, the insertion device comprises a ?at
`elongated member extending along a principal axis betWeen
`distal and proximal ends, the proximal end including a
`handle, and the distal end including a plurality of ?ngers
`extending at their distal ends in the direction of the principal
`axis. The ?ngers of the device are adapted to receive and
`hold a generally disk-shaped cardiac valve prosthesis in an
`orientation such that its principal plane is substantially
`parallel to the principal axis of the device during implanta
`tion of the prosthesis.
`In another embodiment, the insertion device comprises a
`plurality of rigid Wires, each Wire including a tissue anchor
`at a distal end thereof for penetrating host tissue. Each Wire
`is engageable With a portion of the circumference of the
`prosthesis so that the prosthesis is supported by the Wires
`and is maneuverable by and Within the Wires to positions that
`include positions transverse to and substantially parallel to
`the Wires.
`One the assembly is assembled in situ and maintained in
`its desired orientation in the heart, ultrasonic or thermal
`energy can be applied to the assembly to bond the valve
`annulus element and retainer element or elements together
`around the sections of host tissue.
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`According to still another aspect of the invention, there is
`provided a method of implanting a prior art generally
`disk-shaped cardiac valve prosthesis in a living patient. The
`method comprises the steps of:
`a. Providing a prosthetic cardiac valve, including a valve
`annulus element Which is adapted to engage With a corre
`sponding region of host tissue;
`b. Providing an insertion device for holding and maneu
`vering the valve annulus element;
`c. Preparing the patient’s chest cavity and heart to receive
`the valve annulus element and the insertion device, Wherein
`one or more sections of host tissue surrounds a valve implant
`region;
`d. Orienting the valve annulus element parallel to the
`principal axis of the insertion device and inserting the valve
`annulus element into the patient’s heart so that in situ the
`valve annulus element is in substantial registration With the
`host tissue, and attaching the valve annulus element to the
`host tissue; and
`e. WithdraWing the insertion device from the patient’s
`heart and chest cavity.
`The insertion device can be, for example, either of the
`insertion devices described above.
`These and other features of the invention Will be more
`fully appreciated With reference to the folloWing detailed
`description Which is to be read in conjunction With the
`attached draWings.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The invention is further described by the folloWing
`description and ?gures, in Which:
`FIG. 1 is an exploded perspective vieW of a prosthetic
`valve assembly according to one embodiment of the inven
`tion;
`FIG. 2 is an exploded perspective vieW of another
`embodiment of the invention;
`FIG. 3 is a side vieW of the components of a similar
`embodiment to that shoWn in FIG. 2;
`FIG. 4A is an enlarged side vieW of a portion of the
`assembly, in Which the components of the assembly are in
`place in the heart but not assembled together;
`FIG. 4B is an enlarged side vieW of a portion of the
`assembly, in Which the components of the assembly are
`assembled together around a section of host tissue Within the
`heart;
`FIG. 5 is a side vieW of a portion of the heart shoWing
`placement of the valve assembly;
`FIG. 6 is a plan vieW of the valve assembly;
`FIG. 7 is a perspective vieW of an insertion device for the
`valve assembly, Which alloWs the assembly to be inserted
`into the heart through a relatively small incision in the
`patient’s chest;
`FIG. 8A is a side vieW of another insertion device,
`comprising a plurality of Wires Which engage With the valve
`assembly;
`FIG. 8B is a side vieW of the valve assembly and insertion
`Wires of FIG. 8A, in Which the valve assembly is maneu
`vered to be nearly parallel to the insertion Wires; and
`FIG. 8C is a side vieW of the valve assembly and insertion
`Wires of FIGS. 8A and 8B, shoWing implantation of the
`assembly using the insertion Wires.
`Like elements in the respective FIGURES have the same
`reference numbers.
`
`NORRED EXHIBIT 2214 - Page 6
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`6,059,827
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`5
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`The cardiac valve prosthesis of the present invention can
`be implanted and properly oriented in the patient’s heart
`Without sutures and, therefore, Without the difficulties inher
`ent in the use of sutures for valve placement. The prosthetic
`valve of the present invention is an assembly Which can be
`implanted and assembled in situ around one or more
`sections, or an annulus, of host tissue using minimally
`invasive surgical (MIS) techniques. Ultrasonic or thermal
`energy is then applied to one or more of the elements of the
`assembly to bond them together around, and couple them to,
`the host tissue. Application of ultrasonic energy to the
`assembly in situ provides a clean and durable Weld of the
`components Without traumatiZing surrounding tissue and
`eliminates the risk of valve misplacement due to suture
`crossing and entanglement. It also eliminates the require
`ment of suture guides for accurate placement and ?xation of
`the prosthesis.
`One embodiment of the invention is illustrated in FIG. 1.
`According to this embodiment, the cardiac valve prosthesis
`10 includes a valve annulus element 12 and at least one
`retainer element 16 (tWo are shoWn in the embodiment of
`FIG. 1, and one is shoWn in the embodiment of FIGS. 2 and
`3), Which is adapted to engage With the valve annulus
`element 12, as Well as With a corresponding section or
`annulus of host tissue 18 (shoWn in FIGS. 4A, 4B, 5 and
`8C).
`The valve annulus element 12 can include a plurality of
`valve lea?ets 14 Which are pivotably mounted in the valve
`annulus element to control ?uid ?oW through the valve in
`response to ?uid pressure differentials across the valve
`lea?ets. The valve annulus element 12 can include tWo valve
`lea?ets if it is intended for use as a mitral valve prosthesis,
`or three lea?ets if it is intended for use as a tricuspid valve
`prosthesis. The valve lea?ets can be made of a biocompat
`ible synthetic material, such as pyroliZed carbon, Which is
`highly resistant to clot formation, or they can be made of
`living tissue, such as porcine tissue, Which is compatible
`With human tissue, as knoWn in the art, and may have a form
`knoWn in the art.
`In some patients, valve replacement is not necessary. The
`patient’s oWn valve is suitable for use after selected portions
`are resected and an annular element is implanted at the base
`of the valve lea?ets. Such an annular element can be made
`in the form of a valve annulus element 12 or a retainer
`element 16, as shoWn in FIGS. 1, 2 or 3 With no value
`lea?ets.
`FIGS. 2 and 3 illustrate another embodiment of the
`invention, in Which a single retainer element 16 is engage
`able With a ?anged valve annulus element 12. In both
`embodiments, the retainer element 16 includes projections
`20 Which extend toWard a second retainer element 16, as in
`FIG. 1, or toWard a ?ange 22 on the valve annulus element
`12. The retainer element 16 and ?ange 22 include corre
`sponding apertures 24 Which receive the projections 20.
`These structures permit the valve annulus element 12 and
`retainer element(s) 16 to engage With each other in situ,
`capturing one or more sections or an annulus of host tissue
`betWeen them, as detailed more fully beloW. The projections
`20 may also act as energy directors for ultrasonic energy
`applied to the retainer element or valve annulus element
`With an ultrasonic Weld horn and anvil.
`In FIG. 2, the projections 20 are shoWn to be extending
`from the retainer element 16 and adapted for mating engage
`ment With apertures in the ?ange 22. The respective posi
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`tions of projections and apertures can, of course, be reversed
`in other embodiments.
`The retainer element 16 can be in the form of a continuous
`ring Which corresponds to the siZe of the valve annulus
`element, as shoWn in FIG. 3, or it can be in tWo or more
`separate pieces, such as a split ring, as shoWn in FIGS. 1 and
`2. A multi-part ring may be bene?cial in some
`circumstances, as it provides ?exibility of siZing and attach
`ment to the valve annulus element and to discrete or dis
`continuous sections of host tissue. A continuous ring may be
`bene?cial in other circumstances, as it is a single piece and
`is easier to implant and integrate With the valve annulus
`element. The valve annulus element can be in the form of a
`split or multi-section ring as Well, as needed.
`At least one of the valve annulus element 12 and the
`retainer element(s) 16 includes a tissue anchor 26 extending
`outWardly from the circumference of the valve annulus
`element or retainer element. The tissue anchor 26 is a
`barb-like projection Which can pierce the host tissue and
`hold the assembly in place temporarily until it can be
`properly located and oriented in the heart, as detailed more
`fully beloW.
`The valve annulus element 12 and the retainer element(s)
`16 are preferably made of a biocompatible material, pref
`erably a thermoplastic material, Which can be bonded or
`Welded together around one or more sections of host tissue,
`as shoWn in FIGS. 4A and 4B, upon the application of
`energy, such as ultrasonic or thermal energy, to one or both
`of the valve annulus element and the retainer element(s).
`The host tissue can thus be captured and held securely and
`atraumatically Within the valve assembly 10 Without the
`need for sutures.
`In FIG. 4A, retainer elements 16 are engaged With an
`annulus of host tissue 18, and tooth 28 in the loWer retainer
`element 16 penetrates tissue 18 and ?ts Within correspond
`ing recess 30 in the upper opposing retainer element. The
`valve annulus element 12 is sandWiched betWeen the
`retainer elements 16, and projection 20 (shoWn for conve
`nience in shortened form in FIG. 4A) in the loWer retainer
`element extends through a countersunk hole 32 in the valve
`annulus element 12 and through aperture 24 in the upper
`retainer element. The projection 20 includes a head portion
`34 Which extends beyond the top of the aperture 24 When the
`retainer elements are fully assembled around the valve
`annulus element and host tissue. Energy applied to the head
`portion 34 of the projection causes it to melt and ?atten out
`over the aperture, as shoWn in FIG. 4B, thereby anchoring
`the projection in the aperture and Welding the retainer
`elements 16 together around the valve annulus element 12
`and the host tissue annulus 18.
`The valve assembly as implanted is shoWn in FIG. 5. Host
`tissue 18 may form an annulus or discrete portions of an
`annulus, into Which the valve annulus elements is installed,
`as detailed more fully beloW. The retainer element(s) 16 grip
`opposite surfaces of the host tissue sections or annulus so
`that the valve annulus element 12 is held in place betWeen
`them, if the embodiment of FIG. 1 (tWo retainer elements)
`is used. If the embodiment of FIGS. 2 and 3 (one retainer
`element) is used, the retainer element 16 and ?ange 22 of the
`valve annulus element engage opposite surfaces of the host
`tissue to secure the valve annulus element in place.
`FIG. 6 illustrates a plan vieW of the valve assembly. The
`valve lea?ets 14 are freely movable Within the valve annulus
`element 12 in response to ?uid pressure differentials across
`them. Retainer element 16 is held in place, either attached to
`a complementary retainer element or to a complementary
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`NORRED EXHIBIT 2214 - Page 7
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`7
`?ange 22 integral With the valve annulus element, as shown
`in FIGS. 2 and 3. Projections 20 extend through apertures 24
`in the retainer element 16 and head portion 34 is caused to
`?oW plastically With the application of energy to form a
`?attened head over the aperture, thereby Welding the retainer
`elements (or retainer element and ?ange of the valve annulus
`element) to each other around the host tissue.
`FIG. 7 illustrates one embodiment of an insertion device
`36 that can be used to implant the valve assembly (illustrated
`here as a generally disk-shaped tricuspid valve prosthesis) in
`a patient through an incision in the patient’s chest and heart
`Wall. The insertion device of this embodiment comprises a
`?at elongated member 38 extending along a principal axis X
`betWeen distal end 40 and proximal end 42. The proximal
`end 42 includes a handle 44 Which can be shaped, siZed and
`textured as knoWn in the art to facilitate grasping and
`manipulation by a surgeon. The distal end 40 of the device
`includes a plurality of ?ngers 46 Which at their distal ends
`can extend, for example, at least partially in the direction of
`the principal axis X to surround or otherWise receive and
`hold the complete valve assembly or its individual elements,
`namely, the valve annulus element and retainer element(s).
`The valve assembly can ?t easily Within the opening
`betWeen the ?ngers 46 at the end of the insertion device and
`can also be easily released from the device. The insertion
`device maintains the valve assembly or components in an
`orientation in Which the principal planes of the elements of
`the assembly are substantially parallel to the principal axis
`X of the device, so that the elements of the assembly and
`insertion device can be inserted into the patient’s chest
`through a relatively small incision using minimally invasive
`surgical techniques.
`The tissue anchor 26 on the valve assembly assists in
`orientation and location of the device in the heart and
`facilitates removal of the insertion device 36 from the heart
`by piercing the host tissue in the valve implant region and
`holding the valve assembly in place While the insertion
`device is WithdraWn.
`FIGS. 8A—8C illustrate another embodiment of an inser
`tion device 48 for the valve assembly of the invention. This
`insertion device comprises a plurality of rigid Wires 50
`Which can engage With portions of the circumference of the
`retainer element(s) 16 and valve annulus element 12 as
`shoWn in the FIGURES. TWo, three or more Wires can be
`used, depending on available space and the degree of
`maneuverability required. Each of the Wires includes a
`barb-like tissue anchor 52 at a distal end thereof Which can
`penetrate the host tissue 18 and anchor the Wires so that the
`valve annulus element 12 and the retainer element(s) 16 of
`the valve assembly can be parachuted along them into the
`proper location in the heart, as shoWn in FIG. 8C.
`The Wires 50 support the individual components of the
`valve assembly and alloW them each to be oriented in a
`variety of positions, from a position Which is substantially
`perpendicular to the Wires, as shoWn in FIGS. 8A and 8C, to
`a position Which is substantially parallel to the Wires, as
`shoWn in FIG. 8B. If one of the Wires in FIG. 8A is pulled
`in the direction of the arroW 54, the portion of the component
`Which is engaged With that Wire Will be pulled in that
`direction, as shoWn in FIG. 8B, as a result of the friction
`betWeen the Wire and the component. This causes the
`generally disk-shaped component to lie along, or substan
`tially parallel to, the Wires. This orientation alloWs the
`elements to be inserted through a relatively small incision in
`the patient’s chest and heart. Once the elements of the valve
`assembly are inside the heart, the Wires can grasp the host
`tissue 18 With the tissue anchors, and the elements can be
`
`10
`
`15
`
`25
`
`35
`
`45
`
`55
`
`65
`
`6,059,827
`
`8
`oriented as needed in preparation for ?nal assembly and
`implantation in the valve implant region in the heart. The
`elements can then be gently urged along the Wires in the
`direction of arroWs 56 toWard the annulus of host tissue 18.
`A method for sutureless implantation of the valve assem
`bly of the present invention using the insertion devices of the
`invention involves the orientation of the generally disk
`shaped valve annulus element and retainer element(s) so that
`they can pass into the body through a relatively small
`incision in the patient’s chest and heart Walls. Because of the
`geometry of the valve implant region in the heart, and the
`preference for performing open-heart surgery using mini
`mally invasive surgical techniques, it is necessary to insert
`each of the components of the assembly of the invention
`individually, one on each side of the host tissue annulus, and
`assemble them in situ around the host tissue section(s) or
`annulus. As described previously in connection With FIGS.
`4A and 4B, the valve annulus element 12 and one or more
`retainer elements 16 are joined together around an annular or
`partially annular section of host tissue by ultrasonic or
`thermal Welding.
`The method comprises the steps of:
`a. Providing a generally disk-shaped prosthetic cardiac
`valve assembly, including a valve annulus element and at
`least one retainer element adapted for mutual engagement
`With host tissue, Wherein the valve annulus element and
`retainer element are made of a biocompatible material and
`can be bonded together around one or more sections of host
`tissue upon application of energy to the prosthesis, and
`Wherein at least one of the valve annulus element and the
`retainer element includes a tissue anchor for penetrating the
`host tissue;
`b. Providing an insertion device for the assembly for
`holding and maneuvering the assembly;
`c. Preparing the patient’s chest cavity and heart to receive
`the assembly and the insertion device, Wherein one or more
`sections of host tissue surrounds a valve implant region;
`d. Orienting the valve annulus element of the assembly so
`that its principal plane is substantially parallel to the prin
`cipal axis of the insertion device and inserting the valve
`annulus element into the patient’s heart so that in situ the
`valve annulus element is overlying and in substantial reg
`istration With the host tissue, and ?xing the valve annulus
`element to the host tissue With the tissue anchor so as to
`position the valve annulus element over the valve implant
`region;
`e. Orienting the retainer element of the assembly so that
`its principal plane is substantially parallel to the principal
`axis of the insertion device and inserting the retainer element
`into the valve implant region of the patient’s heart so that in
`situ the retainer element is lying under and in substantial
`registration With the sections of host tissue and With the
`valve annulus element, thereby sandWiching the sections of
`host tissue betWeen the retainer element and the valve
`annulus element, and ?xing the retainer element to the host
`tissue With the tissue anchor so as to position the retainer
`element in registration With the valve annulus element over
`the valve implant region;
`f. WithdraWing the insertion device from the patient’s
`heart and chest cavity; and
`g. Applying energy to the assembly to fuse the retainer
`element and the valve annulus element together and ?x the
`host tissue betWeen them.
`The method of the invention can also be used to implant
`a prior art generally disk-shaped cardiac valve prosthesis in
`
`NORRED EXHIBIT 2214 - Page 8
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`6,059,827
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`9
`a patient’s heart. According to the method, a prosthetic
`cardiac valve a valve annulus element Which is adapted to
`engage With a section or sections of host tissue, is provided.
`An insertion device for holding and maneuvering the valve
`annulus element is also provided. The patient’s chest cavity
`and heart are then prepared to receive the valve annulus
`element and the insertion device. Typically, one or more
`sections of host tissue surrounds a valve implant region. The
`valve annulus element is oriented so that its principal plane
`is substantially parallel to the principal aXis of the insertio