(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2001/0039450 A1
`(43) Pub. Date:
`Nov. 8, 2001
`Pavcnik et al.
`
`US 20010039450A1
`
`(54) IMPLANTABLE VASCULAR DEVICE
`
`Related US. Application Data
`
`(63) Non-provisional of provisional application No.
`
`(76) Inventors: Dusan Pavcnik, Portland, OR (US);
`Frederick S. Keller, Portland, OR
`(US); Josef Rosch, Portland, OR (US);
`Thomas A. Osborne, Bloomington, IN
`(US); Brian L. Bates, Bloomington, IN
`(US); John A. Deford, Bloomington,
`IN (US); Christopher G. Dixon,
`Bloomington, IN (US);
`d n A
`Ho?'a, Bloomington, IN (US);
`Raymond B. Leonard II, Bloomington,
`IN (US); Joseph F. Obermiller,
`Bloomington, IN (US)
`
`Correspondence Address;
`Charles W, Angnew
`Patent Agent
`R0, Box 2269
`Bloomington, IN 47402-2269 (Us)
`
`(21) Appl. No.:
`
`09/777,091
`
`(22) Filed:
`
`Feb. 5, 2001
`
`66 GAP
`DD 3mm
`un
`
`0., Ul- dr m cc em
`
`1 I - er w ms mm 6 [U mg
`0 1W0
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`bends and interconnecting sides. The device has both a ?at
`con?guration and a second, folded con?guration Which a
`generally serpentine shape. The device is pushed from a
`delivery catheter into the lumen of a duct or vessel and may
`include one or more barbs for anchoring purposes. A full or
`partial covering of fabric or other ?exible material such as
`DACRON, PTFE, or a collagen-based material such as
`small intestinal submucosa (SIS), may be sutured or
`attached to the frame to form an occlusion device, a stent
`graft, or an implantable, intraluminal valve such as for
`correcting incompetent veins in the loWer legs and feet.
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 1 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 1 0f 14
`
`US 2001/0039450 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 2 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 2 of 14
`
`US 2001/0039450 A1
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 3 of 29
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 3 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 3 0f 14
`
`US 2001/0039450 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 4 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 4 0f 14
`
`US 2001/0039450 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 5 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 5 0f 14
`
`US 2001/0039450 A1
`
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 6 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 6 0f 14
`
`US 2001/0039450 A1
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`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 7 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 7 0f 14
`
`US 2001/0039450 A1
`
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 8 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 8 0f 14
`
`US 2001/0039450 A1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 9 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 9 0f 14
`
`US 2001/0039450 A1
`
`ms
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 10 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 10 0f 14
`
`US 2001/0039450 A1
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 11 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 11 0f 14
`
`US 2001/0039450 A1
`
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`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 12 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 12 0f 14
`
`US 2001/0039450 A1
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 13 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 13 0f 14
`
`US 2001/0039450 A1
`
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`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 14 of 29
`
`

`

`Patent Application Publication
`
`Nov. 8, 2001 Sheet 14 0f 14
`
`US 2001/0039450 A1
`
`/25
`/
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 15 of 29
`
`

`

`US 2001/0039450 A1
`
`Nov. 8, 2001
`
`IMPLANTABLE VASCULAR DEVICE
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`[0001] This application claims priority of provisional
`application Ser. No. 60/180,002, ?led Feb. 3, 2000 and
`regular utility application Ser. No. 09/324,382, ?led Jun. 2,
`1999.
`
`TECHNICAL FIELD
`
`[0002] This invention relates to medical devices, more
`particularly, to intraluminal devices.
`
`BACKGROUND OF THE INVENTION
`[0003] As minimally invasive techniques and instruments
`for placement of intraluminal devices have developed over
`recent years, the number and types of treatment devices have
`proliferated as Well. Stents, stent grafts, occlusion devices,
`arti?cial valves, shunts, etc., have provided successful treat
`ment for a number of conditions that heretofore required
`surgery or lacked an adequate solution altogether. Minimally
`invasive intravascular devices especially have become
`popular With the introduction of coronary stents to the US.
`market in the early 1990s. Coronary and peripheral stents
`have been proven to provide a superior means of maintain
`ing vessel patency. In addition, they have subsequently been
`used as ?lter, occluders, or in conjunction With grafts as a
`repair for abdominal aortic aneurysm, With ?bers or other
`materials as occlusion devices, and as an intraluminal sup
`port for arti?cial valves, among other uses.
`
`[0004] Some of the chief goals in designing stents and
`related devices include providing suf?cient radial strength to
`supply suf?cient force to the vessel and prevent device
`migration. An additional concern in peripheral use, is having
`a stent that is resistant to external compression. Self-expand
`ing stents are superior in this regard to balloon expandable
`stents Which are more popular for coronary use. The chal
`lenge is designing a device that can be delivered intralumi
`nally to the target, While still being capable of adequate
`expansion. Self-expanding stents usually require larger
`struts than balloon expandable stents, thus increasing their
`pro?le. When used With fabric or other coverings that
`require being folded for placement into a delivery catheter,
`the problem is compounded.
`
`[0005] There exists a need to have a basic stent, including
`a fabric or biomaterial covering, that is capable of being
`delivered With a loW pro?le, While still having a suf?cient
`expansion ratio to permit implantation in larger vessels, if
`desired, While being stable, self-centering, and capable of
`conforming to the shape of the vessel. There is a further need
`to have a intraluminal valve that can be deployed in vessels
`to replace or augment incompetent native valves, such as in
`the loWer extremity venous system to treat patients With
`venous valve insuf?ciency. Such a valve should closely
`simulate the normal functioning valve and be capable of
`permanent implantation With excellent biocompatibility.
`
`SUMMARY OF THE INVENTION
`
`[0006] The foregoing problems are solved and a technical
`advance is achieved in an illustrative implantable valve that
`is deployed Within a bodily passage, such as a blood vessel
`or the heart, to regulate or augment the normal ?oW of blood
`
`or other bodily ?uids. The valve includes a covering having
`oppositely facing curvilinear-shaped surfaces (upper and
`loWer) against Which ?uid traveling in a ?rst or second
`direction Within the bodily passage exerts force to at least
`partially open or close the valve. At least one outer edge of
`the covering resiliently engages and exerts force against the
`Wall of the vessel and has arcuate shape that provides at least
`a partial seal against the Wall.
`
`[0007] In one aspect of the invention, the covering com
`prises a plurality of lea?ets, each lea?et having a body
`extending from a Wall-engaging outer edge to a free edge
`Which is cooperable With one or more opposing lea?ets to
`prevent ?oW in one direction, such as retrograde ?oW, While
`at least a portion of the lea?ets having suf?cient ?exibility,
`When in situ to move apart, thereby creating a valve ori?ce
`that permits ?oW in the opposite direction, such as normal
`blood ?oW. The outer edge of each lea?et is adapted to
`engage and resilient exert force against a Wall of the bodily
`passage such that it extends in both a longitudinal and
`circumferential directions along the vessel Wall to at least
`partially seal a portion of the vessel lumen, While the free
`edge of each lea?et traverses the passageWay across the
`diameter of the vessel.
`
`[0008] In another aspect of the invention, the valve
`includes a frame that is covered by a piece of biocompatible
`material, preferably an Extracellular Collagen Matrix
`(ECM) such as small intestinal submucosa (SIS) or another
`type of submucosal-derived tissue. Other potential bioma
`terials include allographs such as harvested native valve
`tissue. The material is slit or otherWise provided With an
`opening along one axis to form tWo triangular valve lea?ets
`over a four-sided frame. In the deployed con?guration, the
`lea?ets are forced open by normal blood ?oW and subse
`quently close together in the presence of back?oW to help
`eliminate re?ux. Other con?gurations include a tWo-lea?et
`valve having an oval or elliptically shaped frame, and valves
`having three or more legs and associated lea?ets, Which
`provide a better distribution of the load exerted by the
`column of ?uid acting on the lea?ets.
`
`[0009] In still another aspect of the invention, the frame of
`the device is modi?ed by placing one or more of the bends
`under tension Which results in the frame assuming a second
`shape that has superior characteristics of placement Within
`the vessel. One method of adjusting the shape includes
`forming the bends in the Wire at an initial angle, e.g., 150°,
`that is larger than the desired ?nal angle, e.g., 90° for a
`four-sided valve, so When the frame is constrained into the
`?nal con?guration, the sides are arcuate and boW outWard
`slightly. The curvature of the sides alloWs the sides to better
`conform to the rounded countours of the vessel Wall When
`the valve is deployed. In devices having a full or partial
`covering of material over the frame, a second method of
`modifying the shape is to use the material to constrain the
`frame in one axis. One such embodiment includes a four
`sided valve With tWo triangular-shaped halves of material,
`such as SIS, Where the material constrains the frame in a
`diamond shape. This puts the bend of the frame under stress
`or tension Which permits better positioning Within the ves
`sel. It also alloWs the diagonal axis of the frame With the slit
`or ori?ce to be adjusted to the optimal length to properly siZe
`the frame for the vessel such that the lea?ets open to alloW
`suf?cient ?oW, but do not open to such a degree that they
`contact the vessel Wall. The potential bene?ts of both adding
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 16 of 29
`
`

`

`US 2001/0039450 A1
`
`Nov. 8, 2001
`
`tension to the bends to bow the sides and constraining the
`frame into a diamond shape using the covering, can be
`combined in a single embodiment or employed separately.
`
`single piece, such as When cut from a sheet of material or
`injection molded, the barbs can be formed as integral
`extensions of the frame.
`
`[0010] In still another aspect of the present invention, the
`device includes a frame that in one embodiment, is formed
`from a single piece of Wire or other material having a
`plurality of sides and bends each interconnecting adjacent
`sides. The bends can be coils, ?llets, or other con?gurations
`to reduce stress and improve fatigue properties. The single
`piece of Wire is preferably joined by an attachment mecha
`nism, such as a piece of cannula and solder, to form a closed
`circumference frame. The device has a ?rst con?guration
`Wherein the sides and bends generally lie Within a single, ?at
`plane. In an embodiment having four equal sides, the frame
`is folded into a second con?guration Where opposite bends
`are brought in closer proximity to one another toWard one
`end of the device, While the other opposite ends are folded
`in closer proximity together toWard the opposite end of the
`device. In the second con?guration, the device becomes a
`self-expanding stent. In a third con?guration, the device is
`compressed into a delivery device, such as a catheter, such
`that the sides are generally beside one another. While the
`preferred embodiment is four-sided, other polygonal shapes
`can be used as Well. The frame can either be formed into a
`generally ?at con?guration, or into the serpentine con?gu
`ration for deployment. Besides rounded Wire, the frame can
`comprise Wires of other cross-sectional shapes (e.g., oval,
`delta, D-shape), or ?at Wire. Additionally, the frame can be
`molded from a polymer or composite material, or formed
`from a bioabsorbable material such as polyglycolic acid and
`materials With similar properties. Another method is to laser
`cut the frame out of a metal tube, such as stainless steel or
`nitinol. Still yet another method is to spot Weld together, or
`otherWise attach, a series of separate struts that become the
`sides of a closed frame. In further alternative embodiments,
`the frame can be left With one or more open gaps that are
`bridged by the material stretched over the remainder of the
`frame. The frame can also be formed integrally With the
`covering, typically as a thickened or strengthened edge
`portion that gives the device sufficient rigidity to alloW it to
`assume the deployed con?guration in the vessel. To prevent
`the frame from radially expanding Within the vessel beyond
`the point Which Would be considered safe or desirable, the
`device can be formed into the serpentine con?guration and
`a circumferentially constraining mechanism, such as a
`tether, strut, sleeve, etc., placed around the device, or built
`into the frame, to expand or unfold during deployment of the
`device to limit its expansion to a given diameter, such as that
`Which is slightly larger than the vessel into Which it is placed
`to alloW anchoring, but not permit the device to exert to great
`a force on the vessel Wall.
`
`[0011] In another aspect of the present invention, one or
`more barbs can be attached to the frame for anchoring the
`device in the lumen of a vessel. The barbs can be extensions
`of the single piece of Wire or other material comprising the
`frame, or they can represent a second piece of material that
`is separately attached to the frame by a separate attachment
`mechanism. An elongated barb can be used to connect
`additional devices With the second and subsequent frames
`attached to the barb in a similar manner. Additional barbs
`can be secured to the device from cannulae placed over the
`frame. In embodiments in Which the frame is formed as a
`
`[0012] In still another aspect of the present invention, a
`covering, Which can be a ?exible synthetic material such as
`DACRON, or expanded polytetra?uorethylene (ePTFE), or
`a natural or collagen-based material, such as an allographic
`tissue (such as valvular material) or a xenographic implant
`(such as SIS), can be attached to the device With sutures or
`other means to partially, completely, or selectively restrict
`?uid ?oW. When the covering extends over the entire
`aperture of the frame, the frame formed into the second
`con?guration functions as an vascular occlusion device that
`once deployed, is capable of almost immediately occluding
`an artery. An arti?cial valve, such as that used in the loWer
`legs and feet to correct incompetent veins, can be made by
`covering half of the frame aperture With a triangular piece of
`material. The arti?cial valve traps retrograde blood How and
`seals the lumen, While normal blood How is permitted to
`travel through the device. In related embodiments, the
`device can be used to form a stent graft for repairing
`damaged or diseased vessels. In a ?rst stent graft embodi
`ment, a pair of covered frames or stent adaptors are used to
`secure a tubular graft prosthesis at either end and seal the
`vessel. Each stent adaptor has an opening through Which the
`graft prosthesis is placed and an elongated barb is attached
`to both frames. In another stent graft embodiment, one or
`more frames in the second con?guration are used inside a
`sleeve to secure the device to a vessel Wall.
`
`BRIEF DESCRIPTION OF THE DRAWING
`
`[0013] FIG. 1 depicts a top vieW of one exemplary
`embodiment of the present invention;
`
`[0014] FIG. 2 depicts a pictorial vieW of the embodiment
`of FIG. 1;
`
`[0015] FIG. 3 depicts a top vieW and enlarged, partial
`cross-sectional vieWs of a second exemplary embodiment of
`the present invention;
`
`[0016] FIG. 4 depicts a side vieW of the embodiment of
`FIG. 3 deployed in a vessel;
`
`[0017] FIG. 5 depicts a enlarged partial vieW of the
`embodiment of FIG. 1;
`
`[0018] FIG. 6 depicts a partially-sectioned side vieW of
`the embodiment of FIG. 1 inside a delivery system;
`
`[0019] FIG. 7 depicts a top vieW of a third embodiment of
`the present invention;
`
`[0020] FIG. 8 depicts a side vieW of the embodiment of
`FIG. 7 deployed in a vessel;
`
`[0021] FIGS. 9-11 depict enlarged partial vieWs of other
`embodiments of the present invention;
`
`[0022] FIG. 12 depicts a top vieW of a fourth embodiment
`of the present invention;
`
`[0023] FIGS. 13-14 depicts side vieWs of the embodiment
`of FIG. 12;
`
`[0024] FIG. 15 depicts a top vieW of a ?fth embodiment
`of the present invention;
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 17 of 29
`
`

`

`US 2001/0039450 A1
`
`Nov. 8, 2001
`
`[0025] FIG. 16 depicts a side vieW of the embodiment of
`FIG. 15;
`
`[0048] FIG. 43 depicts a pictorial vieW a frame embodi
`ment formed into a deployed con?guration;
`
`[0026] FIG. 17 depicts a side vieW of a sixth embodiment
`of the present invention;
`
`[0027] FIG. 18 depicts an enlarged pictorial vieW of a
`seventh embodiment of the present invention;
`
`[0028] FIG. 19 depicts a top vieW of an eighth embodi
`ment of the present invention;
`
`[0029] FIG. 20 depicts a top vieW of a ?rst embodiment
`of a multi-lea?et intraluminal valve of the present invention;
`
`[0030] FIG. 21 depicts a top vieW of a second embodi
`ment of a multi-lea?et intraluminal valve;
`
`[0031] FIG. 21A depicts a partial top vieW of another
`embodiment of lea?ets of the present invention;
`
`[0032] FIG. 21B depicts a top vieW of another embodi
`ment of lea?et of the present invention;
`
`[0033] FIGS. 22-23 depict side vieWs of the embodiment
`of FIG. 21 When deployed in a vessel;
`
`[0034] FIGS. 24-25 depict pictorial vieWs of the embodi
`ments of FIG. 21 When deployed in a vessel;
`
`[0035] FIG. 26-26A depict the method of attaching the
`covering to the embodiment of FIG. 21;
`
`[0036] FIG. 27 depicts a pictorial vieW of the basic valve
`of FIG. 21 upon deployment With an alternative lea?et
`embodiment;
`[0037] FIGS. 28-31 depict top vieWs of selected embodi
`ments of the present invention, made using the method
`shoWn in FIG. 28;
`
`[0038] FIG. 32 depicts a pictorial vieW of an embodiment
`of a stent graft that includes stent adaptors of the present
`invention;
`[0039] FIG. 33 depicts a delivery system for deploying an
`embodiment of the present invention; and
`
`[0040] FIG. 34 depicts a pictorial vieW of the present
`invention having returned to the ?rst con?guration folloW
`ing formation into the second con?guration;
`
`[0041] FIGS. 35-36 depict top vieWs of a three-leg valve
`embodiment of the present invention, before and after being
`constrained;
`[0042] FIG. 37 depicts a pictorial vieW of the embodiment
`of FIG. 35 in the deployed con?guration;
`
`[0043] FIGS. 38-39 depict top vieWs of four-leg valve
`embodiments of the present invention, before and after
`being constrained;
`[0044] FIG. 40 depicts a pictorial vieW of the embodiment
`of FIG. 38 in the deployed con?guration;
`
`[0045] FIG. 41 depicts a top vieW of a frame formed from
`a sheet of material;
`
`[0046] FIG. 41A depicts a detail vieW of the embodiment
`of FIG. 41;
`
`[0047] FIG. 42 depicts a top vieW of a third embodiment
`of an intraluminal valve;
`
`[0049] FIG. 44 depicts a top vieW of an embodiment of
`implantable valve having an integrally formed frame and
`covering;
`[0050] FIG. 45 depicts a cross-sectional vieW taken along
`line 45-45 of FIG. 44;
`
`[0051] FIG. 46 depicts a cross-sectional vieW of a second
`embodiment of valve having an integrally formed frame and
`covering;
`[0052] FIG. 47 depicts a top vieW of an intraluminal valve
`embodiment having an open frame;
`
`[0053] FIGS. 48-49 depict a pictorial vieWs of an intralu
`minal valve embodiments that includes a circumferentially
`constraining mechanism; and
`[0054]
`FIG. 50 depicts a top vieW of the embodiment of
`FIG. 22.
`
`DETAILED DESCRIPTION
`
`[0055] The invention is further illustrated by the folloWing
`(preceding) pictorial embodiments, Which in no Way should
`be construed as further limiting. The present invention
`speci?cally contemplates other embodiments not illustrated
`but intended to be included in the appended claims. FIGS.
`1-11, 18-19 are directed to a basic stent frame; FIGS. 12-14
`are directed to a single-leaf let valve; FIGS. 15-16 are
`directed to an occluder (or ?lter); FIGS. 17 and 32 are
`directed to a stent adaptor for a stent graft, FIGS. 20-27,
`35-40, 42-50 are directed to a multi-leaf valve; and FIGS.
`28-31 are directed to a constrained frame Which can be used
`to form any of the other embodiments.
`
`[0056] FIG. 1 depicts a top vieW of one embodiment of
`the medical device 10 of the present invention comprising a
`frame 11 of resilient material, preferably metal Wire made of
`stainless steel or a superelastic alloy (e.g., nitinol). While
`round Wire is depicted in each of the embodiments shoWn
`herein, other types, e.g., ?at, square, triangular, D-shaped,
`delta-shaped, etc. may be used to form the frame. In the
`illustrative embodiment, the frame comprises a closed cir
`cumference 62 of a single piece 59 of material that is formed
`into a device 10 having a plurality of sides 13 interconnected
`by a series of bends 12. The depicted embodiment includes
`four sides 13 of approximately equal length. Alternative
`embodiments include forming a frame into any polygonal
`shape, for example a pentagon, hexagon, octagon, etc. One
`alternative embodiment is shoWn in FIG. 19 that includes a
`four-sided frame 11 having the general shape of a kite With
`tWo adjacent longer sides 66 and tWo adjacent shorter sides
`67. In the embodiment of FIG. 1, the bends 12 intercon
`necting the sides 13 comprise a coil 14 of approximately one
`and a quarter turns. The coil bend produces superior bending
`fatigue characteristics than that of a simple bend 40, as
`shoWn in FIG. 9, When the frame is formed from stainless
`steel and most other standard materials. The embodiment of
`FIG. 9 may be more appropriate, hoWever, if the frame is
`formed from nitinol (NiTi) or other superelastic alloys, as
`forming certain type of bends, such as coil 14, may actually
`decrease fatigue life of a device of superelastic materials.
`Therefore, the bend 12 should be of a structure that mini
`miZes bending fatigue. Alternative bend 12 embodiments
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 18 of 29
`
`

`

`US 2001/0039450 A1
`
`Nov. 8, 2001
`
`include an outward-projecting ?llet 41 as shown in FIG. 10,
`and an inward-projecting ?llet 42 comprising a series of
`curves 63, as shown in FIG. 11. Fillets are well known in the
`stent art as a means to reduce stresses in bends. By having
`the ?llet extend inward as depicted in FIG. 11, there is less
`potential trauma to the vessel wall.
`
`[0057] When using stainless steel wire, the siZe of the wire
`which should be selected depends on the siZe of device and
`the application. An occlusion device, for example, prefer
`ably uses 0.010“ wire for a 10 mm square frame, while
`0.014“ and 0.016“ wire would be used for 20 mm and 30 mm
`frames, respectively. Wire that is too stiff can damage the
`vessel, not conform well to the vessel wall, and increase the
`pro?le of the device when loaded in the delivery system
`prior to deployment.
`
`[0058] Returning to FIG. 1, the single piece 59 of material
`comprising the frame 11 is formed into the closed circum
`ference 62 by securing the ?rst and second ends 60,61 with
`an attachment mechanism 15 such as a piece of metal
`cannula. The ends 60,61 of the single piece 59 are then
`inserted into the cannula 15 and secured with solder 25, a
`weld, adhesive, or crimping to form the closed frame 11. The
`ends 60,61 of the single piece 59 can be joined directly
`without addition of a cannula 15, such as by soldering,
`welding, or other methods to join ends 61 and 62. Besides
`joining the wire, the frame could be fabricated as a single
`piece of material 59, by stamping or cutting the frame 11
`from another sheet (e.g., with a laser), fabricating from a
`mold, or some similar method of producing a unitary frame.
`
`[0059] The device 10 depicted in FIG. 1 is shown in its
`?rst con?guration 35 whereby all four bends 20,21,22,23
`and each of the sides 13 generally lie within a single ?at
`plane. To resiliently reshape the device 10 into a second
`con?guration 36, shown in FIG. 2, the frame 11 of FIG. 1
`is folded twice, ?rst along one diagonal axis 94 with
`opposite bends 20 and 21 being brought into closer prox
`imity, followed by opposite bends 22 and 23 being folded
`together and brought into closer proximity in the opposite
`direction. The second con?guration 36, depicted in FIG. 2,
`has two opposite bends 20,21 oriented at the ?rst end 68 of
`the device 10, while the other opposite bends 22,23 are
`oriented at the second end 69 of the device 10 and rotated
`approximately 90° with respect to bends 20 and 21 when
`viewed in cross-section. The medical device in the second
`con?guration 36 can be used as a stent 44 to maintain an
`open lumen 34 in a vessel 33, such as a vein, artery, or duct.
`The bending stresses introduced to the frame 11 by the ?rst
`and second folds required to form the device 10 into the
`second con?guration 36, apply force radially outward
`against the vessel wall 70 to hold the device 10 in place and
`prevent vessel closure. Absent any signi?cant plastic defor
`mation occurring during folding and deployment, the device
`in the second con?guration 36 when not with the vessel or
`other constraining means, will at least partially return to the
`?rst con?guration 25, although some deformation can occur
`as depicted in FIG. 34, depending on the material used. It is
`possible to plastically form the stent into this con?guration
`which represents an intermediate condition between the ?rst
`con?guration (which it also can obtain) and the second
`con?guration. It is also possible to plastically deform the
`device 10 into the second con?guration 36, such that it does
`
`not unfold when restraint is removed. This might be par
`ticularly desired if the device is made from nitinol or a
`superelastic alloy.
`[0060] The standard method of deploying the medical
`device 10 in a vessel 33, depicted in FIG. 6, involves
`resiliently forming the frame 11 into a third con?guration 37
`to load into a delivery device 26, such as a catheter. In the
`third con?guration 37 the adjacent sides 13 are generally
`beside each other in close proximity extending generally
`along the same axis. To advance and deploy the device from
`the distal end 28 of the delivery catheter 26, a pusher 27 is
`placed into the catheter lumen 29. When the device 10 is
`fully deployed, it assumes the second con?guration 36
`within the vessel as depicted in FIG. 2. The sides 13 of the
`frame, being made of resilient material, conform to the
`shape of the vessel wall 70 such that when viewed on end,
`the device 10 has a circular appearance when deployed in a
`round vessel. As a result, sides 13 are arcuate or slightly
`bowed out to better conform to the vessel wall.
`
`[0061] A second embodiment of the present invention is
`depicted in FIG. 3 wherein one or more barbs 16 are
`included to anchor the device 10 following deployment. As
`understood, a barb can be a wire, hook, or any structure
`attached to the frame and so con?gured as to be able to
`anchor the device 10 within a lumen. The illustrative
`embodiment includes a ?rst barb 16 with up to three other
`barbs 17,71,72, indicated in dashed lines, representing alter
`native embodiments. As depicted in detail viewA of FIG. 3,
`the barb combination 38 that comprises barbs 17 and 18,
`each barb is an extension of the single piece 59 of material
`of the frame 11 beyond the closed circumference 59. The
`attachment cannula 15 secures and closes the single piece 59
`of material into the frame 11 as previously described, while
`the ?rst and second ends 60,61 thereof, extend from the
`cannula 15, running generally parallel with the side 13 of the
`frame 11 from which they extend, each preferably terminat
`ing around or slightly beyond respective bends 20,23. To
`facilitate anchoring, the distal end 19 of the barb 16 in the
`illustrative embodiment contains a bend or hook.
`
`[0062] Optionally, the tip of the distal end 19 can be
`ground to a sharpened point for better tissue penetration. To
`add a third and fourth barb as shown, a double ended barb
`39 comprising barbs 71 and 72 is attached to the opposite
`side 13 as de?ned by bends 21 and 22. Unlike barb com
`bination 38, the double barb 39, as shown in detail view B
`of FIG. 3, comprises a piece of wire, usually the length of
`barb combination 38, that is separate from the single piece
`59 comprising the main frame 11. It is secured to the frame
`by attachment mechanism 15 using the methods described
`for FIG. 1. FIG. 4 depicts barb 17 (and 18) engaging the
`vessel wall 70 while the device 10 is in the second, deployed
`con?guration 36. While this embodiment describes up to a
`four barb system, more than four can be used.
`
`[0063] FIG. 7 depicts a top view of a third embodiment of
`the present invention in the ?rst con?guration 35 that
`includes a plurality of frames 11 attached in series. In the
`illustrative embodiment, a ?rst frame 30 and second frame
`31 are attached by a barb 16 that is secured to each frame by
`their respective attachment mechanisms 15. The barb 16 can
`be a double-ended barb 39 as shown in FIG. 3 (and detail
`view B) that is separate from the single pieces 59 comprising
`frames 30 and 31, or the barb may represent a long extended
`
`Edwards Lifesciences Corporation, et al. Exhibit 1109, Page 19 of 29
`
`

`

`US 2001/0039450 A1
`
`Nov. 8, 2001
`
`end of the one of the single pieces 59 as shown in detail vieW
`A of FIG. 3. Further frames, such as third frame 32 shown
`in dashed lines, can be added by merely extending the length
`of the barb 16. FIG. 8 depicts a side vieW of the embodiment
`of FIG. 7 in the second con?guration 36 as deployed in a
`vessel 33.
`
`[0064] FIGS. 12-18 depict embodiments of the present
`invention in Which a covering 45 comprising a sheet of
`fabric, collagen (such as small intestinal submucosa), or
`other ?exible material is attached to the frame 11 by means
`of sutures 50, adhesive, heat sealing, “Weaving” together,
`crosslinking, or other knoWn means. FIG. 12 depicts a top
`vieW of a fourth embodiment of the present invention While
`in the ?rst con?guration 35, in Which the covering 45 is a
`partial covering 58, triangular in shape, that extends over
`approximately half of the aperture 56 of the frame 11. When
`formed into the second con?guration 36 as shoWn in FIGS.
`13-14, the device 10 can act as an arti?cial valve 43 such as
`the type used to correct valvular incompetence. FIG. 13
`depicts the valve 43 in the open con?guration 48. In this
`state, the partial covering 58 has been displaced toWard the
`vessel Wall 70 due to positive ?uid pressure or How in a ?rst
`direction 46, e.g., normal venous blood ?oW, t