11111111111111111111111111111111111)1!1J111101°11!111611A111111111111111111111111110111111
`
`(19) United States
`(12) Patent Application Publication
`Nitzan et al. (cid:9)
`
`(10) Pub. No.: US 2009/0093876 Al
`Apr. 9, 2009
`(43) Pub. Date: (cid:9)
`
`(54) RECOIL INHIBITOR FOR PROSTHETIC (cid:9)
`VALVE
`
`(75) Inventors:
`
`Yacov Nitzan, Hertzelia (IL);
`Benjamin Spenser, Moshav
`Bat-Shlomo (IL); Yaron Keidar,
`Haifa (IL); Tamir Levi, Moshav
`Ein HaEmek (IL); Melissa Denton,
`Irvine, CA (US)
`
`Correspondence Address:
`KLARQUIST SPARKMAN, LLP
`121 SW SALMON STREET, SUITE 1600
`PORTLAND, OR 97204 (US)
`
`(73) Assignee:
`
`Edwards Lifesciences
`Corporation
`
`(21) Appl. No.:
`
`12/202,131
`
`(22) Filed:
`
`Aug. 29, 2008
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/969,522, filed on Aug.
`31, 2007.
`
`Publication Classification
`
`(51) Int. Cl.
`A61F 2/24 (cid:9)
`(52) U.S. Cl. (cid:9)
`
`(2006.01)
`
` 623/2.11
`
`(57) (cid:9)
`
`ABSTRACT
`
`A valve loading apparatus is provided for loading a crimped
`prosthetic valve into a lumen of a delivery system. The valve
`recoil adapter can counteract recoil of a compressed pros-
`thetic valve, and maintain the valve at its desired crimp diam-
`eter. An integrated bioprosthesis/delivery system is provided
`for delivering a bioprosthesis to a target area within a body
`lumen is provided. The delivery system includes a valve
`covering member and a compressing member, which com-
`presses the valve covering member to surround, hold, and/or
`compress the valve during delivery to the target area.
`
`118
`
`114 (cid:9)
`
`100 112
`
`300 302 120 (cid:9)
`
`108
`
`110 116
`
`D1
`
`Page 1 of 19
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`(cid:9)
`(cid:9)
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`

`Patent Application Publication (cid:9)
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`Apr. 9, 2009 Sheet 1 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`FIG. 1A
`
`114
`,____-----___Th
`100 112
`
`119 (cid:9)
`
`108
`
`/ 110 116
`
`FIG. 1B
`
`D1
`
`Page 2 of 19
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`

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`Patent Application Publication (cid:9)
`
`Apr. 9, 2009 Sheet 2 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`200
`
`202
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`206
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`210
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`le‘%04
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`304
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`D1
`FIG. 3A
`
`312
`
`310
`
`304
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`FIG. 3B
`
`302
`
`Page 3 of 19
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`(cid:9)
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`

`Patent Application Publication
`
`OT Jo £ WIN
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`TV 9L8£600/600Z SR
`
`118 (cid:9)
`
`114 (cid:9)
`108
`100 (cid:9) 112 300 302 120 /
`
`110 116
`
`114
`
`FIG. 4A
`
`112 412
`
`100 402 412 410406
`
`FIG. 46
`
`112
`
`414412 410
`
`Page 4 of 19
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`

`

`Patent Application Publication (cid:9)
`
`Apr. 9, 2009 Sheet 4 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`116 110 (cid:9)
`
`A — ?
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`r_.--k-Th
`100 402
`1 (cid:9)
`404 4 6
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`(cid:9))
`
`FIG. 5A
`
`114
`
`110
`
`FIG. 5B
`
`402 116 412 (cid:9)
`
`t-
`
`FIG. 5C (cid:9)
`
`412
`
`110
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`112
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`412
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`• MI
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`112
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`406
`
`406
`
`FIG. 5D (cid:9)
`
`412
`
`112
`
`Page 5 of 19
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`

`

`Patent Application Publication (cid:9)
`
`Apr. 9, 2009 Sheet 5 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`602 (cid:9)
`110
`
`114
`
`100 402
`
`408
`r----1`—Th
`404 406
`
`. (cid:9)PAIEW:..IP:111:111111MIKIIIKIIIK,WIErl. Mr
`
`ii
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`II
`FIG. 6
`
`710
`\ lb. 702
`
`704
`
`J
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`
`
`112 404
`
`700
`/706
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`114
`
`FIG. 7A
`702
`704
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`700
`/ 706
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`1
`FIG. 7B 16 112
`
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`lot o
`
`FIG. 7C
`
`709
`
`Page 6 of 19
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`

`

`Patent Application Publication (cid:9)
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`Apr. 9, 2009 Sheet 6 of 10 (cid:9)
`
`US 2009/0093876 Al
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`Page 7 of 19
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`

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`Patent Application Publication (cid:9)
`
`Apr. 9, 2009 Sheet 7 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`702
`
`704 204
`
`200
`
`FIG. 8E
`
`FIG. 8F
`
`Page 8 of 19
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`

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`Patent Application Publication (cid:9)
`
`Apr. 9, 2009 Sheet 8 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`716 708 714 702 (cid:9)
`
`
`190 704
`
`700
`/
`
`802
`
`112
`116 712 704
`
`100
`
`FIG. 8H
`
`Page 9 of 19
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`(cid:9)
`

`

`Patent Application Publication (cid:9)
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`Apr. 9, 2009 Sheet 9 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`1010
`
`1002
`
`1016
`
`1014
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`1012 1018
`FIG. 9
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`FIG. 10
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`s (cid:9)
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`I
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`1106
`1105 (cid:9)
`1014
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`FIG. 11A
`
`1102
`\ 1106 114 1010
`
`702 (cid:9)
`
`1016
`
`F1
`
`1010 1014 10121108 (cid:9) FIG. 11B
`
`Page 10 of 19
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`(cid:9)
`

`

`Patent Application Publication (cid:9)
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`Apr. 9, 2009 Sheet 10 of 10 (cid:9)
`
`US 2009/0093876 Al
`
`1207
`
`1209-
`1210
`1211. --
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`FIG. 12
`
`Page 11 of 19
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`

`

`US 2009/0093876 Al (cid:9)
`
`Apr. 9, 2009
`
`1
`
`RECOIL INHIBITOR FOR PROSTHETIC
`VALVE
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`[0001] This application claims priority to commonly
`assigned U.S. provisional patent application No. 60/969,522
`filed Aug. 31, 2007, which is hereby incorporated by refer-
`ence in its entirety.
`
`FIELD
`
`[0002] The invention relates generally to delivery catheters
`and, more particularly, to a method and device for preparing
`a stented prosthetic valve for delivery into a patient's body.
`
`BACKGROUND
`
`[0003] A variety of prosthetic valves have been developed
`for replacing defective native valves, such as an aortic heart
`valve, in a human body. Prosthetic valves typically include a
`valve structure mounted on a stent which is delivered to a
`treatment site via a percutaneous catheterization technique. A
`stent is a generally cylindrical prosthesis introduced into a
`lumen of a body vessel via a catheterization technique. Stents
`may be self-expanding or balloon expandable. Balloon-ex-
`pandable stents are typically crimped from an initial large
`diameter to a smaller diameter prior to advancement to a
`treatment site in the body. Before crimping, a balloon expand-
`able stent is typically placed over an expandable balloon on a
`catheter shaft.
`[0004] To properly position a balloon expandable stent on a
`delivery catheter over the expandable balloon, the stent must
`be smoothly and evenly crimped to closely conform to the
`overall profile of the catheter and the unexpanded balloon.
`[0005] Despite the most careful and firm crimping, physi-
`cal properties of the material used in manufacturing stents
`(some stainless steels, tantalum, platinum or platinum alloys,
`CoCr, MP35N or shape memory alloys such as NitinolTM)
`allow a certain amount of "recoil" of the stent. That is, the
`stent tends to slightly open up from its crimped diameter once
`the crimping force has been removed. In some instances, the
`stent diameter has been shown to increase about 15% from its
`crimped diameter.
`[0006] The enlarged recoil diameter increases the overall
`profile of the underlying catheter and balloon. Thus, since the
`stented prosthetic valve is configured to be delivered percu-
`taneously, in a less invasive procedure, a smaller device is
`beneficial.
`
`SUMMARY
`
`[0007]
`In one embodiment, a valve recoil inhibitor adapter
`is provided which may be attached onto a loader or delivery
`system component. The valve recoil adapter counteracts the
`stent recoil and maintains the overall valve frame and device
`at its desired crimp diameter.
`[0008]
`In another embodiment, a prosthesis assembly,
`including a bioprosthesis and a balloon catheter, is inserted
`into or covered with an over tube, which maintains the bio-
`prosthesis in substantially a delivery diameter and prevents
`the bioprosthesis from recoiling.
`[0009]
`In another embodiment, an integrated bioprosthesis/
`delivery system for delivering a bioprosthesis to a target area
`within a body lumen is provided. The delivery system
`includes a moveable cover and a slit tube, where the moveable
`
`cover is positioned over the slit tube in a telescoping arrange-
`ment. The delivery system encapsulates, holds, and delivers
`the bioprosthesis to the target area.
`[0010]
`In one embodiment, a valve loading apparatus for
`loading a crimped prosthetic valve into a lumen of a delivery
`system is provided. The valve loading apparatus comprises a
`first portion, a second portion, and a transitional portion. The
`first portion is configured to receive a crimped prosthetic
`valve. The second portion is configured to be coupled to a
`distal end of the delivery system. The apparatus has an open-
`ing that passes through the first, second, and transitional
`portions. The opening has a first diameter at the first portion
`and a second diameter at the second portion, with the first
`diameter being larger than the second diameter. The transi-
`tional portion has a transitional diameter that varies from the
`first diameter to the second diameter. When the crimped valve
`is passed through the opening of the loading apparatus and
`into the lumen of the delivery system, the crimped valve is
`radially compressed from a larger diameter to a smaller diam-
`eter.
`[0011]
`In a specific implementation, the second portion has
`a third diameter section. The third diameter is larger than the
`second diameter. The transition from the second diameter to
`the third diameter forms a lip, and the lip is configured to abut
`the distal end of the delivery system.
`[0012]
`In another specific implementation, the valve load-
`ing apparatus further comprises a first clamp portion and a
`second clamp portion, with the first and second clamp por-
`tions being separable from one another. The first clamp por-
`tion forms a part of each of the first, second, and transitional
`portions, and the second clamp portion forms the remainder
`of the first, second, and transitional portions. In another spe-
`cific implementation, the valve loading apparatus further
`comprises a pushing member. The pushing member com-
`prises a handle portion and one or more extending portions,
`with the extending portions having a hollow central area and
`being sized to extend into the opening of the valve loading
`apparatus to urge the crimped prosthetic valve through the
`opening of the valve loading apparatus. In another specific
`implementation, the extending portions of the pushing mem-
`ber comprise two or more annularly spaced finger members.
`[0013]
`In another embodiment, a method of loading a
`crimped prosthetic valve into a lumen of a delivery system is
`provided. The method comprises crimping a prosthetic valve
`on a balloon member of a balloon catheter. The method fur-
`ther comprises providing a loading apparatus, the loading
`apparatus having a first section and a second section. The first
`section has a first diameter and the second section has a
`second diameter. The second diameter is smaller than the first
`diameter. The method further comprises introducing the
`crimped prosthetic valve into the first section, wherein at the
`time of introduction into the first section, the crimped pros-
`thetic valve has a diameter greater than the second diameter.
`The method further comprises passing the crimped prosthetic
`valve through the second section and into the lumen of the
`delivery system. The crimped prosthetic valve exits the sec-
`ond section with the crimped prosthetic valve having a diam-
`eter that is equal to or less than the second diameter.
`[0014]
`In a specific implementation, the method further
`comprises coupling the second section of the loading appa-
`ratus to a distal end of the delivery system. In another specific
`implementation, the method further comprises passing the
`balloon member through an introducer sheath prior to prior to
`crimping the prosthetic valve on the balloon member. In
`
`Page 12 of 19
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`

`US 2009/0093876 Al (cid:9)
`
`Apr. 9, 2009
`
`2
`
`another specific implementation, the act of passing the
`crimped prosthetic valve through the second section further
`comprises providing a pushing member; and using the push-
`ing member to apply a force to the crimped prosthetic valve to
`push the crimped prosthetic valve through the second section
`of the loading apparatus.
`[0015] In another embodiment, an apparatus for delivering
`a prosthetic valve through the vasculature of a patient is
`provided. The apparatus comprises a main catheter, a balloon
`catheter, a valve covering member, and a compressing mem-
`ber. The main catheter comprises a distal section. The balloon
`catheter comprises an elongated shaft and a balloon member
`connected to a distal end portion of the shaft, with the balloon
`member having an external surface configured to receive a
`crimped prosthetic valve. The valve covering member
`extends from the distal section of the main catheter and over
`at least a portion of the balloon member. The valve covering
`member is compressible to apply a compressive force to the
`prosthetic valve when the prosthetic is crimped on the balloon
`member. The compressing member is configured to compress
`at least a portion of the valve covering member.
`[0016] In specific implementations, the compressing mem-
`ber comprises a nose piece, the nose piece being disposed
`distal to the balloon member and being configured to receive
`at least a portion of a distal end of the valve covering member.
`In other specific implementations, the nose piece is coupled to
`a distal end of the balloon member. In other specific imple-
`mentations, the portion of the distal end of the valve covering
`member that is received by the nose piece has a smaller inner
`diameter than a portion of the valve covering member that is
`not received by the nose piece. In other specific implementa-
`tions, the portion of the distal end of the valve covering
`member that is received by the nose piece comprises at least
`one slit or notch.
`[0017] In other specific implementations, the compressing
`member comprises an outer covering member. The outer
`covering member has an elongated shaft and is movable lon-
`gitudinally relative to the valve covering member. The outer
`covering member is configured to have a smaller inner diam-
`eter than an outer diameter of the valve covering member,
`such that when the outer covering member extends over the
`valve covering member, the valve covering member is com-
`pressed to a smaller inner diameter. In other specific imple-
`mentations, the valve covering member is adhered to the
`distal section of the elongated shaft of the main catheter. In
`other specific implementations, the valve covering member is
`integrally formed with the distal section of the elongated shaft
`of the main catheter.
`[0018] In another embodiment, a method of loading a
`crimped prosthetic valve into a lumen of a delivery system is
`provided. The method comprises providing a main catheter
`with an elongated shaft; providing a balloon catheter with an
`elongated shaft and a balloon member disposed at a distal end
`of the elongated shaft; crimping a prosthetic valve on the
`balloon member; providing a valve covering member, the
`valve covering member being configured to extend at least
`from a distal end of the main catheter to a distal end of the
`balloon member, the valve covering member having at least
`one slit or notch at a distal portion of the valve covering
`member; covering the crimped prosthetic valve with the valve
`covering member; crimping at least a portion of the valve
`covering member to a smaller profile, the portion of the valve
`covering member that is crimped covering at least a portion of
`the crimped prosthetic valve during the act of crimping; pro-
`
`viding an outer covering member, the outer covering member
`having an elongated shaft; and moving the outer covering
`member to extend over the portion of the valve covering
`member that covers the crimped prosthetic valve, the outer
`covering member being sized to apply a compressive force to
`the valve covering member. In specific implementations, at
`least a part of the act of moving the outer covering member
`over the valve covering member occurs while the valve cov-
`ering member is loaded into a crimping device.
`[0019] The foregoing and other features and advantages of
`the invention will become more apparent from the following
`detailed description, which proceeds with reference to the
`accompanying figures.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0020] FIG. 1A illustrates an exemplary embodiment of a
`balloon expandable prosthetic heart valve.
`[0021] FIG. 1B is a simplified side view of a balloon
`expandable prosthetic heart valve delivery system that is con-
`figured to support and deliver the balloon expandable pros-
`thetic heart valve in FIG. 1A to a target area inside a patient's
`body.
`[0022] FIG. 2 is an illustration of a crimping device used to
`mount a bioprosthesis to a balloon catheter.
`[0023] FIG. 3A is a illustration of a valve recoil inhibitor in
`accordance with an embodiment disclosed herein.
`[0024] FIGS. 3B and 3C are exemplary illustrations of a
`valve recoil inhibitor positioned on a delivery system in
`accordance with an embodiment disclosed herein.
`[0025] FIGS. 4A and 4B are illustrations of an embodiment
`disclosed herein.
`[0026] FIGS. 5A-5D are illustrations of an embodiment
`disclosed herein.
`[0027] FIG. 6 is a illustration of an embodiment disclosed
`herein.
`[0028] FIGS. 7A and 7B are side views of an integrated
`bioprosthesis/delivery system loading system in accordance
`with an embodiment disclosed herein.
`[0029] FIG. 7C is a cross sectional view of the integrated
`bioprosthesis/delivery system loading system of FIG. 7A in
`accordance with an embodiment disclosed herein.
`[0030] FIGS. 8A-8G show an exemplary process for load-
`ing a prosthesis assembly into delivery system in accordance
`with an embodiment disclosed herein.
`[0031] FIG. 8H is a cross sectional view of an integrated
`bioprosthesis/delivery system in accordance with an embodi-
`ment disclosed herein.
`[0032] FIG. 9 is an illustration of a loading tool in accor-
`dance with an embodiment disclosed herein.
`[0033] FIG. 10 is an illustration of a loading tool in accor-
`dance with an embodiment disclosed herein.
`[0034] FIG. 11A is an illustration of a loading tool in accor-
`dance with an embodiment disclosed herein.
`[0035] FIG. 11B is an illustration of a loading tool and an
`integrated bioprosthesis/delivery system in accordance with
`an embodiment disclosed herein.
`[0036] FIG. 12 is an illustration of a loading tool in accor-
`dance with an embodiment disclosed herein.
`
`DETAILED DESCRIPTION
`
`[0037] The following description is exemplary in nature
`and is not intended to limit the scope, applicability, or con-
`figuration of the invention in any way. Various changes to the
`
`Page 13 of 19
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`

`US 2009/0093876 Al (cid:9)
`
`Apr. 9, 2009
`
`3
`
`described embodiment may be made in the function and
`arrangement of the elements described herein without depart-
`ing from the scope of the invention.
`[0038] FIG. 1A illustrates an exemplary embodiment of a
`balloon expandable prosthetic heart valve 100 (hereinafter,
`"bioprosthesis 100"). Bioprosthesis 100 includes an implant-
`able structure 102 (also referred to herein as a stent or support
`frame), a flexible membrane 104, and a membrane support
`106. Implantable structure 102 is expandable from a first
`reduced diameter to a second enlarged diameter, and has a
`flow path along a longitudinal axis. Implantable structure 102
`generally may be a tubular framework, such as a stent as
`shown in the illustrated example, which primarily anchors
`bioprosthesis 100 within or adjacent the annulus of the defec-
`tive valve in the heart. Implantable structure 102 provides
`stability and helps prevent bioprosthesis 100 from migrating
`after it has been implanted.
`[0039] Flexible membrane 104 is positionable in the flow
`path for permitting flow in a first direction, and substantially
`resisting flow in a second direction. In one preferred configu-
`ration, the flexible membrane can be formed from tissue, such
`as, for example, bovine pericardial tissue, or a suitable bio-
`compatible, synthetic material such as those described in U.S.
`Pat. No. 6,730,118, which is incorporated herein by refer-
`ence. Membrane support 106 is positionable in the flow path
`and affixed, such as by suture, to implantable structure 102.
`Membrane support 106 can comprise a fabric skirt that sur-
`rounds the lower portion of the membrane 104 to reinforce the
`connection between the membrane 104 and the frame 102.
`[0040] Prior to implantation, bioprosthesis 100 is carefully
`mounted and crimped onto a catheter assembly (delivery
`assembly) 108 (hereinafter, "assembly 108"), which can
`include a delivery catheter 110 and a balloon catheter with an
`elongated shaft 116 and a balloon member 112 (FIG. 1B). The
`balloon catheter can have an inner lumen that is in fluid
`communication with the balloon member 112 and a fluid
`pressurizing device (not shown). During inflation of the bal-
`loon member 112, fluid passes from the fluid pressurizing
`device to the balloon member 112 and the balloon member is
`inflated with a controlled volume of fluid (e.g., saline/con-
`trast).
`[0041] Delivery catheter 110 can be used to deliver and
`deploy the appropriate size bioprosthesis 100. Delivery cath-
`eter 110 can be a guide catheter or flex catheter that is con-
`figured to be selectively steerable or bendable to assist the
`surgeon in guiding the delivery assembly 108 through the
`patient's vasculature. In one embodiment, delivery catheter
`110 advances bioprosthesis 100 through a sheath over a
`guidewire and tracks bioprosthesis 100 through the aortic
`arch. Delivery catheter 110 also aids in crossing, and posi-
`tioning bioprosthesis 100 within the native valve. Delivery
`catheter 110 can include a tapered nose cone 118 mounted at
`the distal end of a respective catheter shaft 119, which allows
`assembly 108 to cross the native valve easily. In one exem-
`plary operation, bioprosthesis 100 and assembly 108 are
`inserted into the femoral artery and delivered to the site of the
`native stenotic aortic valve. Bioprosthesis 100 is positioned
`and deployed across the stenotic native valve. The balloon
`delivery system is then removed. An exemplary bioprosthesis
`100 designed for transfemoral implantation in patients with
`severe aortic stenosis (AS) is the SAPIEN transcatheter heart
`valve model 9000TFX available from Edwards Lifesciences
`Corporation, Irvine, Calif, the assignee of the present inven-
`tion. An exemplary catheter assembly 108 designed to deliver
`
`bioprosthesis 100 is the RETROFLEX II catheter assembly
`also available from Edwards Lifesciences Corporation, Irv-
`ine, Calif The bioprosthesis can be implanted in a retrograde
`approach where the bioprosthesis, mounted in a crimped state
`at the distal end of a delivery apparatus, is introduced into the
`body via the femoral artery and advanced through the aortic
`arch to the heart, as further described in U.S. Patent Publica-
`tion No. 2008/0065011, which is incorporated herein by ref-
`erence.
`[0042] Although the operation described above is a per-
`formed with an elongate catheter in a percutaneous trans-
`femoral procedure, it should be understood that the present
`invention may also be used with a shorter catheter assembly in
`a minimally-invasive surgical transapical procedure for treat-
`ing a defective aortic valve. In the transapical procedure, the
`bioprosthesis is preferably advanced into the heart through a
`small incision formed between two ribs and through an inci-
`sion formed in the apex of the heart. Although the transapical
`procedure is generally considered a more invasive approach
`as compared with the percutaneous transfemoral procedure,
`the direct line of access used in the transapical procedure
`provides the physician with greater degree of control during
`advancement and deployment of the bioprosthesis.
`[0043] With reference now to FIG. 2, a crimping device 200
`is illustrated which may be used to mount bioprosthesis 100 to
`the catheter assembly 108. In one embodiment, crimping
`device 200 is a single-use non-patient contacting, compres-
`sion device that symmetrically reduces the overall diameter
`of bioprosthesis 100 from its expanded size to its collapsed
`(mounted) size, effectively mounting bioprosthesis 100 to its
`delivery balloon catheter 112. Crimping device 200 includes
`a housing 202 and a compression mechanism 204. Compres-
`sion mechanism 204 is closed by means of a handle 206
`located on housing 202. Crimping device 200 is also
`equipped with two measuring gauges: a crimp gauge 208 to
`verify that the bioprosthesis/balloon assembly has been suit-
`ably collapsed, and a balloon gauge 210 to verify the biopro s-
`thesi s/balloon assembly catheter diameter when inflated. Fur-
`ther details relating to a crimping device can be found in U.S.
`Patent Publication No. 2007/0056346, which is incorporated
`herein by reference.
`[0044] As mentioned above, despite the most careful and
`firm crimping of bioprosthesis 100 and balloon catheter 112
`to closely conform to the overall desired profile of the catheter
`unexpanded balloon 112 and underlying inflatable tube com-
`ponents, there is a certain amount of "recoil" of implantable
`structure 102 (hereinafter, "stent 102") or a tendency of stent
`102 to slightly open from a desired hypothetical minimum
`crimped diameter. This tendency of stent 102 to open or recoil
`slightly when crimped on balloon catheter 112 has been char-
`acterized as "recoil." The actual minimum diameter achiev-
`able for fully crimped stent 102 on balloon catheter 112 is
`referred to as delivery diameter Dl (FIG. 1B).
`[0045] In a first embodiment shown in FIGS. 3A-3C, a
`valve recoil adapter 300 is illustrated which may be used to
`counteract stent recoil by compressing a crimped valve to the
`delivery diameter Dl of bioprosthesis 100 as it is inserted into
`a delivery device. Valve recoil adapter 300 includes a first
`portion with a large open end 304 and second portion with a
`crimp diameter portion 302. A frusto-conical transitional por-
`tion 305 extends between the first and second portions. Crimp
`diameter portion 302 may be variably sized to any desired
`delivery diameter.
`
`Page 14 of 19
`
`

`

`US 2009/0093876 Al (cid:9)
`
`Apr. 9, 2009
`
`4
`
`[0046] In operation, as shown in FIGS. 3A, 3B and 3C, after
`crimping bioprosthesis 100 onto balloon catheter 112 to form
`a prosthesis assembly 114 (using, for example, crimping
`device 200), prosthesis assembly 114 is inserted into large
`open end 304 of valve recoil adapter 300 until it can be force
`fit into crimp diameter portion 302. The crimp diameter por-
`tion 302 counter acts any recoil that stent 102 on prosthesis
`assembly 114 has experienced after crimping by radially
`compressing prosthesis assembly 114 back to its desired
`delivery diameter Dl. In the absence of valve recoil adapter
`300, the delivery diameter Dl is dependent on random recoil
`that the material experiences after the crimping process.
`Valve recoil adapter 300 allows the practitioner to control the
`delivery diameter Dl of prosthesis assembly 114.
`[0047] Referring to FIG. 3B, in one embodiment, valve
`recoil adapter 300 can be configured for use with another
`delivery system, i.e., loader device 310. For the purposes of
`this application, the term "delivery system" refers to any
`apparatus or structure that has a lumen or other opening into
`which a prosthesis assembly can be received and includes, for
`example, a catheter, a loader device, and an introducer sheath.
`Loader device 310 has a lumen into which a prosthesis assem-
`bly can be loaded. Loader device 310 can be attached to an
`introducer sheath (not shown) by clips 312. The distal end of
`the introducer sheath is inserted into a patient's vessel (e.g.,
`the femoral artery) over a guide wire and receives a delivery
`assembly, which is inserted through the introducer sheath and
`into the vessel, as known in the art. Valve recoil adapter 300 is
`desirably configured to extend into the lumen of the loader
`device 310 and attach to a proximal end of loader device 310.
`The method of attachment could include, for example, screw-
`ing threaded portions together, clipping, snap fit, etc. Typi-
`cally, the introducer sheath is long enough to extend through
`the portion of the delivery path having the smallest diameter.
`As the prosthesis assembly 114 is inserted through the recoil
`adapter 300, it is compressed to diameter Dl for insertion
`through the loader 310 and introducer sheath. Accordingly,
`the overall cross-sectional profile of the introducer sheath can
`be reduced to minimize trauma to the patient.
`[0048] Referring to FIG. 3C, in another embodiment, valve
`recoil adapter 300 can be configured for use with a delivery
`catheter 110. Delivery catheter 110 can be configured to
`receive the prosthesis assembly 114 within an enlarged por-
`tion 120 of catheter 110. Valve recoil adapter 300 can be
`secured to enlarged portion 120 between the prosthesis
`assembly 114 and the enlarged portion 120. Portion 302 desir-
`ably extends into enlarged portion 120. If desired, portion 302
`can be secured to the enlarged portion 120 by configuring the
`recoil adapter 300 and enlarged portion 120 with mating
`threaded portions or sizing portion 302 so it fits tightly into
`the enlarged portion 120.
`[0049] After the valve 100 is crimped onto balloon member
`112, the prosthesis assembly 114 is moved longitudinally
`relative to the delivery catheter 110, such as by retracting
`shaft 116, to position the prosthesis assembly 114 within the
`enlarged portion 120. Since valve recoil adapter 300 is posi-
`tioned between the prosthesis assembly 114 and the enlarged
`portion 120, the prosthesis assembly 114 must pass through
`valve recoil adapter 300 before entering the enlarged portion
`120 of the delivery catheter 110. As the prosthesis assembly
`114 passes through the crimp diameter portion 302, the outer
`diameter of crimped valve 100 is maintained at (or reduced
`to) the inner diameter of the crimp diameter portion 302.
`Once the prosthesis assembly 114 is positioned within the
`
`enlarged portion 120, the valve recoil adapter 300 is removed
`from the assembly. If desired, nose cone 118 can have a
`hollow section which can be moved proximally to cover the
`distal end portion of the balloon member 112 and/or valve
`100.
`[0050] If it is desirable to remove the valve recoil adapter
`300 from the delivery assembly, such as in the embodiment
`shown in FIG. 3C, it may be desirable to form the valve recoil
`adapter in two or more pieces. For example, valve recoil
`adapter 300 can be formed so that it is split in half longitudi-
`nally, with those two halves being configured to fit together to
`form a single part. The two (or more) parts can attach to one
`another by various mechanical means, such as by a snap-fit
`connection. Alternatively, valve recoil adapter 300 can form
`its cone (or funnel) shape by having a single piece of material
`that is rolled up into a cone shape. Thus, upon unraveling, the
`valve recoil adapter 300 can be removed from the assembly.
`[0051] Referring now to FIGS. 4A-B, in a second embodi-
`ment the elongated shaft 116 of the balloon catheter may be
`inserted through an elongated shaft of catheter 110 with tip
`mobility, such as Edwards' RETROFLEX II catheter avail-
`able from Edwards Lifesciences Corporation. Bioprosthesis
`100 may be crimped on balloon member 112 using crimping
`device 200 (FIG. 2) to form prosthesis assembly 114 having,
`for example, a delivery diameter Dl (FIG. 1B).
`[0052] As shown in FIG. 4A, prosthesis assembly 114 can
`be inserted or covered with over tube 402, which substantially
`maintains prosthesis assembly 114 at delivery diameter Dl
`and prevents stent 102 from recoiling. Another function of
`over tube 402 is to provide protection to the blood vessel from
`the bare stent of bioprosthesis 100.
`[0053] Over tube 402 can be secured at its proximal end to
`the inner surface of delivery catheter 110. At its distal end,
`over tube 402 can be temporarily attached to a tip 406. Tip 406
`also can be mounted on (or otherwise attached to) a distal end
`of balloon member 112. Alternatively, tip 406 can have a
`separate elongated shaft and can be moveable in the longitu-
`dinal direction independently of the elongated shaft of the
`balloon member.
`[0054] Tip 406 can have a smaller diameter than the diam-
`eter of the elongated shaft of the delivery catheter 110. In
`addition, tip 406 can have extending portions 410, which are
`configured to capture and hold a distal portion 412 of over
`tube 402. Over tube 402 is desirably formed of a material that
`can be compressed to a smaller diameter at its distal end, so
`that the distal portion 412 can be inserted and held within the
`extending portions 410. Accordingly, as shown in FIG. 4A,
`when the distal portion 412 of over tube 402 is secured at a
`smaller diameter by tip 406, an inward pressure (a compres-
`sive force) is applied by the over tube 402 to prosthesis
`assembly 114, which reduces and/or maintains the diameter
`of the prosthesis assembly at the desired delivery diameter.
`[0055] When the prosthesis assembly 114 is in position for
`deployment at the treatment site, over tube 402 can be