US20120209375A1

Movatterモバイル変換

Info

Publication number: US20120209375A1
Application number: US13/370,215
Authority: US
Inventors: Gilbert Madrid; Matthew T. Winston; Sam Sok; Thanh Huy Le; Tri D. Tran; Kim Le
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2011-02-11
Filing date: 2012-02-09
Publication date: 2012-08-16
Also published as: CN106214290B; CN106214290A; EP2673037A2; US11717403B2; EP2673037A4; EP3834879A1; EP2921198A3; CN110522989A; US12350150B2; CA3069744A1; US10327897B2; EP4282384A3; US20230329863A1; CN103476451B; US20190298518A1; EP3566738A1; US20160206425A1; CA3069744C; WO2012109595A3; WO2012109595A2

Abstract

A delivery system for stabilizing a catheter shaft across an aortic arch can include one or more stabilizing members configured to fix or stabilize the position of the catheter relative to the aortic arch of a patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application No. 61/442,044, which was filed on Feb. 11, 2011, and is incorporated herein.

FIELD

The present disclosure is directed to apparatuses and methods that can be used in the treatment of heart valve disease, including balloon valvuloplasty and the delivery of transcatheter heart valves.

BACKGROUND

Heart valve disease is a serious problem that involves the malfunction of one or more valves of the heart. The malfunction can manifest itself in a variety of manners. For example, valve stenosis is the calcification or narrowing of a native heart valve. As a result, the native heart valve is not able to completely open and blood flow through the native valve is impeded or restricted. Another example of heart valve disease is valve insufficiency. Valve insufficiency is the failure of a native heart valve to close properly to prevent leaking, or backflow, of blood through the valve.

Various methods have been developed to treat heart valve disease. Some of these methods require a balloon member that is expanded within the native heart valve. For example, a balloon member can be used in a valvuloplasty procedure where the balloon member is positioned within the native heart valve and expanded to increase the opening size (i.e., flow area) of the native heart valve and thereby improve blood flow. Another procedure that can be performed is a valve replacement, in which a native heart valve is replaced by a prosthetic heart valve. The implantation of a prosthetic heart valve in the heart can also involve the expansion of a balloon member in the valve annulus. For example, the balloon member can be used to increase the size of the native valve prior to implantation of the prosthetic valve and/or it can be used to expand and deploy the prosthetic heart valve itself. In some procedures, the prosthetic heart valve can comprise a self-expanding device that is capable of expanding within the annulus upon being released from a constrained state.

The effectiveness of such procedures is contingent, at least in part, upon the position of the balloon member and/or prosthetic device within the native heart valve during expansion of balloon member and/or prosthetic device. However, delivering and maintaining the position of the balloon member and/or prosthetic device within the annulus of a native heart valve during these procedures can be challenging due to various environmental conditions in the surrounding area, including, for example, blood flow, pressure changes, and movement of the heart and related vessels of the patient.

SUMMARY

In some embodiments, a delivery system is provided for stabilizing a catheter shaft near a treatment location within a patient's body. The system can include a catheter shaft having a distal end portion and a tension member coupled to the catheter shaft at a first area adjacent to the distal end portion and to the delivery system at second area that is proximal to the distal end portion of the catheter shaft. By adjusting the tension in the tension member, the catheter shaft can be caused to flex between the first and second areas. In some implementations, the second area is a location on the catheter shaft proximal to the first area, and the tension member is fixedly coupled at the first area and moveably coupled at the second area so that tension between the first and second areas can be adjusted. In other implementations, the system includes an outer shaft that generally surrounds at least a portion of the catheter shaft, the second area comprising a location at a distal portion of the outer shaft and the amount of tension in the tension member can be adjusted by moving the first and second areas relative to one another.

In other embodiments, a delivery system includes a catheter shaft having a distal end portion and at least one expansion member positioned proximal to the distal end portion. The at least one expansion member is moveable between a collapsed state and an expanded state and in its expanded state, the at least one expansion member is configured to stabilize the catheter shaft by contacting a wall of the aortic arch and substantially fixing the position of a portion of the catheter shaft relative to the aortic arch. In some implementations, the expansion member is a single balloon member that is expandable along an outer surface of the catheter shaft. In other implementations, the at least one expansion member includes three balloon members that are expandable along an outer surface of the catheter shaft, and, when in their expanded state, the three balloon members generally surround the catheter shaft.

In another embodiment, a system includes a catheter shaft having a distal end portion that has an increased stiffness relative to rest of the catheter shaft. At least one pull wire extends from the distal end portion of the catheter shaft to a proximal portion, with the pull wire being configured to cause the distal end portion to flex so that a first portion contacts the inner wall of the aortic arch and a second portion contacts the outer wall of the aortic arch to wedge the catheter shaft within the aortic arch. In some implementations, the distal end portion comprises a plurality of locking sections, with the locking sections being moveable between an unlocked state in which the locking sections are moveable relative to one another and a locked state in which the locking sections are fixed relative to one another, the locked state being achieved by pulling on the pull wire. In other implementations, the locking sections comprise interlocking tubes that have respective chamfered proximal portions that are sized to be received into a distal opening of an adjacent interlocking tube.

In some implementations, the system includes one or more stability members, and the catheter shaft comprises one or more lumens that extends along the length the catheter shaft to receive the one or more stability members. The one or more stability members can include a plurality of wires. In other implementations, the one or more stability members comprise a generally flat strip.

In some implementations, the distal end portion can have increased stiffness relative to rest of the catheter shaft by having a slotted tube embedded in the catheter shaft. In other implementations, the catheter shaft can include a coiled member embedded in the catheter shaft.

In another embodiment, a system includes a catheter shaft having a distal end portion sized to extend from the descending aorta, through the aortic arch, and into the ascending aorta of the patient. The catheter shaft can include at least a first articulating area and a second articulating area. At least one pull wire can extend from the distal end portion of the catheter shaft to a proximal portion, with the pull wire being configured to cause the first articulating portion to bend toward an outer wall of the aortic arch and the second articulating portion to bend toward an inner wall of the aortic arch. The opposing bending directions of the first and second articulating portions cause a first portion of the catheter shaft to contact the inner wall of the aortic arch and a second portion of the catheter shaft to contact the outer wall of the aortic arch to wedge the catheter shaft within the aortic arch.

In another embodiment, a system includes a catheter shaft having a distal end portion sized to extend from the descending aorta, through the aortic arch, and into the ascending aorta of the patient. The catheter shaft has at least a first bend area and a second bend area that allow for a higher amount of bending than at other areas of the catheter shaft with the first and second bend areas being spaced apart from one another. At least one pull wire extends from the distal end portion of the elongate shaft to a proximal portion, with the pull wire being configured to cause the catheter shaft to bend at the first and second bend points to cause the catheter shaft to wedge within the aortic arch.

In other embodiments, the systems described herein can further include an expansion device configured to extend from the distal end portion of the catheter shaft, with the expansion device comprising a balloon member for expanding a prosthetic device or performing a valvuloplasty procedure. In some implementations, the expansion device includes an inner expandable member and a plurality of outer expandable members. The plurality of outer expandable members at least partially surround the inner expandable member and when the expandable member is in the expanded configuration, gaps between adjacent outer expandable members provide perfusion passageways across the expansion device. In other embodiments, the systems described herein can further include a self-expanding prosthetic device configured to extend from the distal end portion of the catheter shaft.

In another embodiment, a method of stabilizing a catheter shaft near a treatment location within a patient's body is provided. The method includes delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, with the catheter shaft having a tension member coupled to the elongate shaft at a first area at or adjacent to the distal end portion of the catheter shaft and at a second area proximal to the distal end portion of the catheter shaft. Tension is adjusted in the tension member to cause the tension member to move into contact with an inner wall of the aortic arch and to cause a portion of the catheter shaft to flex and move into contact with an opposing outer wall of the aortic arch, thereby wedging the catheter shaft and tension member within the aortic arch. In some implementations, a pull wire is pulled to increase tension in the tension member, with the pull wire extending from the distal end portion to a proximal end of the catheter shaft.

In another embodiment, a method is provided that includes delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, with the catheter shaft having a tension member coupled to the catheter shaft at a first area at or adjacent to the distal end portion of the catheter shaft and at a second area at a distal end portion of an outer shaft that at least partially surrounds the catheter shaft. The catheter shaft is moved relative to the outer shaft to adjust the tension of the tension member, causing the tension member to move into contact with an inner wall of the aortic arch and causing a portion of the catheter shaft to flex and move into contact with an opposing outer wall of the aortic arch, thereby wedging the catheter shaft and tension member within the aortic arch.

In another embodiment, a method is provided that includes delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient. At least one expansion member is expanded, causing the at least one expansion member to extend from an outer surface of the catheter shaft at a location proximal to the distal end portion, with the at least one expansion member expanding to contact at least an inner wall of the aortic arch to substantially fix the position of a portion of the catheter relative to the aortic arch. In some implementations, the at least one expansion member comprises a single balloon member that is expandable along an outer surface of the catheter shaft. The at least one expansion member can include three balloon members that are expandable along an outer surface of the catheter shaft, and, when in their expanded state, the three balloon members generally surround the catheter shaft.

In another embodiment, a method can include delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, with the distal end portion having increased stiffness relative to rest of the elongate shaft. At least one pull wire that extends from the distal end portion of the elongate shaft to a proximal portion can be pulled to flex the distal end portion so that a first portion of the catheter shaft contacts the inner wall of the aortic arch and a second portion of the catheter shaft contacts the outer wall of the aortic arch to wedge the catheter shaft within the aortic arch. In some implementations, the distal end portion includes a plurality of locking sections and the act of pulling on the at least one pull wire causes the locking sections to transition from an unlocked state in which the locking sections are moveable relative to one another and a locked state in which the locking sections are fixed relative to one another. In some implementations, the locking sections comprise interlocking tubes that have respective chamfered proximal portions that are sized to be received into a distal opening of an adjacent interlocking tube.

In another embodiment, a method is provided that includes delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, with the catheter shaft having at least a first articulating area and a second articulating area and with the first articulating area being proximal to the second articulating area. At least one pull wire that extends from the distal end portion of the catheter shaft to a proximal portion is pulled to cause the first articulating portion to bend toward an outer wall of the aortic arch and the second articulating portion to bend toward an inner wall of the aortic arch. The opposing bending directions of the first and second articulating portions causes a first proximal portion of the catheter shaft to contact the inner wall of the aortic arch and a second distal portion of the catheter shaft to contact the outer wall of the aortic arch to wedge the catheter shaft within the aortic arch.

In another embodiment, a method is provided that includes delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, with the catheter shaft having at least a first bend area and a second bend area that allow for a higher amount of bending than at other areas of the catheter shaft and with the first and second bend areas being spaced apart from one another. At least one pull wire that extends from the distal end portion of the catheter shaft to a proximal portion is pulled to cause the elongate shaft to bend at the first and second bend points to cause the elongate shaft to wedge within the aortic arch. The positioning of the bend points causes a first proximal portion of the catheter shaft to contact the outer wall of the aortic arch and a second distal portion of the catheter shaft to contact the inner wall of the aortic arch to wedge the catheter shaft within the aortic arch. In some implementations, an expansion device that extends from the distal end portion of the catheter shaft is expanded. The expansion device can comprise a balloon member for expanding a prosthetic device or performing a valvuloplasty procedure. In some implementations, the expansion device can include an inner expandable member and a plurality of outer expandable members, with the plurality of outer expandable members at least partially surrounding the inner expandable member and the expanding of the expansion device providing gaps between adjacent outer expandable members to provide perfusion passageways across the expansion device. In other implementations, the methods described herein can include releasing a self-expanding prosthetic device from a sheath that extends from the distal end portion of the catheter shaft.

In other embodiments, the method includes delivering a distal end portion of a catheter shaft through the descending aorta and across the aortic arch of the patient, with the catheter shaft having at least one lumen extending from the distal end portion to a portion of the catheter shaft external to the patient's body. At least one stability member can be inserted through the at least one lumen to cause the distal end portion of the catheter shaft to move into contact with an outer wall of the aortic arch and generally fix or immobilize the catheter shaft relative to the aortic arch. In some implementations, the at least one lumen includes a plurality of lumens and the at least one stability member includes a plurality of stability members, and the plurality of stability members are inserted into respect ones of the plurality of lumens. In some implementations, the method includes expanding an expansion device that extends from the distal end portion of the catheter shaft, the expansion device comprising a balloon member for expanding a prosthetic device or performing a valvuloplasty procedure. The expansion device can include an inner expandable member and a plurality of outer expandable members, with the plurality of outer expandable members at least partially surrounding the inner expandable member and the expanding of the expansion device providing gaps between adjacent outer expandable members to provide perfusion passageways across the expansion device.

In another embodiment, an apparatus for delivering a prosthetic valve through the vasculature of a patient is provided. The apparatus includes a main catheter comprising an elongated shaft and a balloon catheter having an elongated shaft with at least one opening extending through a side surface of the shaft and a balloon member connected to a distal end portion of the shaft. The shaft of the balloon catheter can be capable of moving longitudinally within the shaft of the main catheter. The balloon catheter can include a perfusion lumen extending through at least a portion of the balloon catheter, with the lumen configured to permit blood to pass through the lumen when the balloon member is in an expanded state, the blood passing through the opening in the shaft of the balloon catheter.

In other specific implementations, at least a portion of the balloon catheter under the balloon member (e.g., in the mounting area of the prosthetic valve) can include a collapsible portion that is moveable between a collapsed state which reduces a diameter of the lumen and an expanded state that increases the diameter of the lumen. In other specific implementations, the lumen can include a plurality of separate passageways extending between a proximal end and a distal end of the balloon member.

In another embodiment, a method for delivering an expandable member through the vasculature of a patient is provided. The method can include the acts of providing an expandable member at a distal end of an elongate shaft, the expandable member having a distal end and a proximal end, the expandable member comprising an inner expandable member and a plurality of outer expandable members at least partially surrounding the inner expandable member; delivering the expandable member to a treatment site; expanding the inner expandable member in a passageway of the body of the patient; expanding the plurality of outer expandable members in the passageway; and permitting blood to pass through a plurality gaps formed between an inner surface of the passageway and the inner and outer expandable members.

In other specific implementations, the method can also include the acts of providing a prosthetic device, positioning the prosthetic device on the expandable member, and deploying the prosthetic device within the passageway by the acts of expanding the inner and outer expandable members.

In other specific implementations, the act of expanding the inner expandable member can be performed independently of the act of expanding the outer expandable members. In other specific implementations, the inner expandable member can include a first inner balloon member that has a first diameter and a second inner balloon member that has a second diameter. The first diameter can be smaller than the second diameter and the first and second balloon members can be substantially coaxial with one another. The act of expanding the inner expandable member can comprise first expanding the first inner balloon member and then expanding the second inner balloon member. In other specific implementations, the act of expanding the outer expandable members can comprise expanding one or more of the outer expandable members before expanding the other of the outer expandable members.

The foregoing and other objects, 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

FIG. 1 illustrates a delivery system with an expansion device located along a distal end portion.

FIG. 2A illustrates a partial cross-sectional view of a portion of a delivery system, shown with an expansion device in an expanded configuration.

FIG. 2B illustrates a close-up view of the delivery system ofFIG. 2A.

FIG. 3 illustrates a view of an expansion device of a delivery system, shown in an expanded configuration.

FIG. 4 illustrates an end view of an expansion device of a delivery system, shown in an expanded configuration within an annulus.

FIG. 5A illustrates a view of an expansion device of a delivery system, shown in an expanded configuration.

FIG. 5B illustrates a cross-sectional view taken alongline5B-5B ofFIG. 5A.

FIG. 6 illustrates a cross-sectional view of an alternative expansion device of a delivery system.

FIG. 7 illustrates a cross-sectional view of an expansion device, shown in a collapsed state and positioned within an annulus with a prosthetic device mounted thereon.

FIG. 8 illustrates a cross-sectional view of the expansion device ofFIG. 7, shown in a partially expanded state.

FIG. 9 illustrates a cross-sectional view of the expansion device ofFIG. 7, shown in a fully expanded state.

FIG. 10 illustrates a cross-sectional view of the expansion device ofFIG. 7, shown in an expanded state, with some outer balloon members deflated.

FIG. 11 illustrates a cross-sectional view of an expansion device, shown in a collapsed state and positioned within an annulus with a prosthetic device mounted thereon.

FIG. 12 illustrates a cross-sectional view of the expansion device ofFIG. 11, shown in a partially expanded state.

FIG. 13 illustrates a cross-sectional view of the expansion device ofFIG. 11, shown in a fully expanded state.

FIG. 14 illustrates a partial cross-sectional view of an expansion device with a prosthetic device mounted thereon.

FIG. 15 illustrates an expansion device shown in an expanded state with one or more blood perfusion passageways between a distal and proximal end of the expansion device.

FIG. 16 illustrates an expansion device shown in an expanded state with one or more blood perfusion passageways between a distal and proximal end of the expansion device.

FIG. 17 illustrates an expansion device shown in an expanded state with one or more blood perfusion passageways between a distal and proximal end of the expansion device.

FIG. 18A illustrates a side view of an expansion device with an inner balloon member and a plurality of separate outer balloon members, shown in a collapsed configuration.

FIG. 18B illustrates a side view of an expansion device ofFIG. 18A, shown in an expanded configuration.

FIG. 19A illustrates a side view of an expansion device with an inner balloon member and an outer balloon member surrounding the inner balloon member, shown in a collapsed configuration.

FIG. 19B illustrates a side view of an expansion device ofFIG. 19A, shown in a partially expanded configuration.

FIG. 19C illustrates a side view of an expansion device ofFIG. 19A, shown in an expanded configuration.

FIG. 20 illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens.

FIG. 21 illustrates a partial cross-sectional view of the delivery system ofFIG. 20, shown with an expansion device in an expanded configuration.

FIG. 22 illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens and a collapsible portion.

FIG. 23 illustrates a side view of an expansion device with an inner balloon member and one or more perfusion lumens.

FIG. 24 illustrates a side view of an expansion device with an inner balloon member and one or more perfusion lumens.

FIG. 25A illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens.

FIG. 25B illustrates a cross-sectional view of the delivery system ofFIG. 25A taken alongline25B-25B.

FIG. 26A illustrates a partial cross-sectional view of a delivery system with one or more perfusion lumens.

FIG. 26B illustrates a cross-sectional view of the delivery system ofFIG. 26A taken alongline26B-26B.

FIG. 27 illustrates a delivery system and a method and apparatus for securing a prosthetic device to a distal end of the delivery system.

FIG. 28 illustrates a delivery system and a method and apparatus for securing a prosthetic device to a distal end of the delivery system.

FIG. 29 illustrates a delivery system and a method and apparatus for securing a prosthetic device to a distal end of the delivery system.

FIG. 30 illustrates a delivery system and a method and apparatus for securing a prosthetic device to a distal end of the delivery system.

FIG. 31 illustrates a delivery system and a method and apparatus for securing a prosthetic device to a distal end of the delivery system.

FIG. 32 illustrates an expansion device with a mechanical inner expansion device and a plurality of outer balloon members, shown in a non-expanded (collapsed) configuration.

FIG. 33 illustrates an expansion device with a mechanical inner expandable member and a plurality of outer balloon member, shown in a partially expanded configuration.

FIG. 34 illustrates an expansion device with a mechanical inner expandable member and a plurality of outer balloon member, shown in an expanded configuration.

FIG. 35 illustrates an embodiment of the expansion device ofFIG. 32 with the outer balloon members and the majority of the struts removed for clarity, shown in a non-expanded (collapsed) configuration.

FIG. 36 illustrates an embodiment of the expansion device ofFIG. 32 with the outer balloon members and the majority of the struts removed for clarity, shown in an expanded configuration.

FIG. 37 illustrates an embodiment of the expansion device ofFIG. 32 with majority of the outer balloon members and struts removed for clarity, shown in an expanded configuration.

FIG. 38A illustrates a method of delivering a prosthetic device in a collapsed configuration to a treatment location within a native aortic valve annulus.

FIG. 38B illustrates a method of deploying the prosthetic device ofFIG. 38A within the native aortic valve annulus using the expansion device ofFIG. 3.

FIG. 38C illustrates the prosthetic device ofFIG. 38A in a deployed state within the native aortic valve annulus.

FIG. 39 is a schematic view a calcified native aortic valve annulus.

FIG. 40 illustrates a prosthetic heart valve mounted on an expansion device.

FIG. 41 illustrates another embodiment of a prosthetic heart valve mounted on an expansion device.

FIG. 42 illustrates an embodiment of an expansion device with a plurality of outer balloon members that have a shorter working length.

FIG. 43A is a cross-sectional view taken alongline43A-43A ofFIG. 42.

FIG. 43B is a cross-sectional view taken alongline43B-43B ofFIG. 42.

FIG. 44 illustrates a prosthetic heart valve mounted on the expansion device shown inFIG. 42.

FIG. 45 illustrates another embodiment of a prosthetic heart valve mounted on an expansion device.

FIG. 46 illustrates another embodiment of an expansion device with portions of the outer balloon members attached to an outer surface of the inner balloon member.

FIG. 47A illustrates another embodiment of an expansion device with tail portions coupled and/or fused together.

FIG. 47B illustrates another embodiment of an expansion device with tail portions fused together.

FIGS. 48A and 48B illustrate another embodiment an expansion device with tail portions fused together.

FIG. 49 illustrates an embodiment of an expansion device formed from a single balloon member.

FIG. 50A is a cross-sectional view taken alongline50A-50A ofFIG. 49.

FIG. 50B is a cross-sectional view taken alongline50B-50B ofFIG. 49.

FIG. 51 illustrates a catheter shaft that utilizes a stabilization member to provide improved stability within an aortic arch of a patient.

FIG. 52 illustrates another catheter shaft that utilizes a stabilization member to provide improved stability within an aortic arch of a patient.

FIG. 53 illustrates a catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 54 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIGS. 55A and 55B illustrate views of a delivery system that utilizes a plurality of expansion members to provide improved stability within an aortic arch of a patient.

FIGS. 56A and 56B illustrate views of a delivery system that utilizes an expansion member to provide improved stability within an aortic arch of a patient.

FIG. 57 illustrates a catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 58 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 59 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 60 illustrates a tube member that can be coupled to a catheter shaft to provide improved stability within an aortic arch of a patient.

FIG. 61 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 62 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 63 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 64 illustrates another catheter shaft that provides improved stability within an aortic arch of a patient.

FIG. 65 illustrates a catheter shaft having multiple lumens for receiving stability members to provide improved stability within an aortic arch of a patient.

FIG. 66 illustrates a catheter shaft having a single lumen for receiving a stability member to provide improved stability within an aortic arch of a patient.

DETAILED DESCRIPTION

The following description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Various changes to the described embodiment may be made in the function and arrangement of the elements described herein without departing from the scope of the invention.

As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “associated” generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed.

Moreover, for the sake of simplicity, the attached figures may not show the various ways (readily discernable, based on this disclosure, by one of ordinary skill in the art) in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses. Additionally, the description sometimes uses terms such as “produce” and “provide” to describe the disclosed method. These terms are high-level abstractions of the actual operations that can be performed. The actual operations that correspond to these terms can vary depending on the particular implementation and are, based on this disclosure, readily discernible by one of ordinary skill in the art.

FIG. 1 shows adelivery apparatus10 adapted to deliver a prosthetic heart valve12 (e.g., a prosthetic aortic valve) to a heart.Apparatus10 generally includes asteerable guide catheter14, and aballoon catheter16 extending through theguide catheter14.Balloon catheter16 can comprise multiple lumens to independently deliver fluid to one or more regions of an expansion device, as described in more detail below. The guide catheter can also be referred to as a flex catheter or a main catheter. As shown inFIGS. 38A-38C and described in more detail below,prosthetic valve12 can be configured for deployment within an aortic annulus of a patient.

Guide catheter

14 can include ahandle portion20 and an elongated guide tube, or shaft,22 extending fromhandle portion20.Balloon catheter16 can include aproximal portion24

adjacent handle portion

20 and anelongated shaft26 that extends fromproximal portion24 and throughhandle portion20 and guidetube22.Handle portion20 can include aside arm27 having an internal passage which fluidly communicates with the one or more lumens defined by thehandle portion20. An expansion device28 (e.g., a plurality of inflatable balloons) can be mounted at the distal end ofballoon catheter16. InFIG. 1,prosthetic valve12 is mounted on theexpansion device28 and is shown in a crimped state, providingprosthetic valve12 with a reduced diameter for delivery to the heart via the patient's vasculature. It should be understood thatexpansion device28 can be configured for delivery to a treatment location without a prosthetic heart valve mounted thereon, either for off-expansion device delivery of the prosthetic valve to a treatment location (as discussed below) or for use of the expansion device in a valvuloplasty procedure.

Although the illustrated embodiments discussed herein refer to the prosthetic heart valve as being crimped or mounted on the expansion device for delivery to the treatment location, it should be understood that the prosthetic heart valve can be crimped or mounted at a location different from the location of expansion device (e.g., distal or proximal to expansion device) and repositioned over the expansion device at some time before expanding the expansion device and deploying the prosthetic valve. This off-expansion device/off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the expansion device. The lower profile permits the physician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient's vasculature to the treatment location. The lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient's vasculature which are particularly narrow, such as the iliac artery.

Anose piece32 can be mounted at the distal end of thedelivery apparatus10 to facilitate advancement of thedelivery apparatus10 through the patient's vasculature to the implantation site. In some instances, it may be useful to havenose piece32 connected to a separate elongated shaft so thatnose piece32 can move independently of other elements ofdelivery apparatus10.

Nose piece

32 can be formed of a variety of materials, including various plastic materials. Alternatively,nose piece32 can comprise an inflatable balloon member. When inflated,nose piece32 can generally form a cone shape, such as is shown inFIG. 1. The inflation ofnose piece32, whennose piece32 comprises a balloon member, can be achieved by having a lumen extend from a proximal end of the delivery apparatus tonose piece32. A fluid pressurizing device can be in fluid contact with the lumen, andnose piece32 can be inflated and deflated by the fluid pressurizing device.Nose piece32 can be inflated to help tracknose piece32 through the vasculature of a patient and/or to provide a surface against whichprosthetic valve12 can abut, which can help maintain the position ofprosthetic valve12 on the delivery apparatus until deployment at the treatment site. In other embodiments, discussed in more detail below,nose piece32 can have one or more lumens to provide blood perfusion throughnose piece32.

As shown inFIGS. 2A and 2B, in the illustratedconfiguration balloon catheter16 can further include an inner shaft34 (FIG. 2B) that extends fromproximal portion24 and extends coaxially throughouter shaft26 andexpansion device28.Expansion device28 can be supported on a distal end portion ofinner shaft34 that extends outwardly fromouter shaft26 with aproximal end portion36 of the expansion device secured to the distal end of outer shaft26 (e.g., with a suitable adhesive). The outer diameter ofinner shaft34 is sized such that an annular space is defined between the inner and outer shafts along the entire length of the outer shaft.Proximal portion24 of the balloon catheter can be formed with afluid passageway38 that is fluidly connectable to a fluid source (e.g., a saline source) for inflating the expansion device.Fluid passageway38 is in fluid communication with the annular space betweeninner shaft34 andouter shaft26 such that fluid from the fluid source can flow throughfluid passageway38, through the space between the shafts, and intoexpansion device28 to inflate the same and deployprosthetic valve12.

Proximal portion

24 also defines aninner lumen40 that is in communication with alumen42 ofinner shaft34. The

lumens

40,42 in the illustrated embodiment can be sized to receive the shaft of a nose catheter, if desired.Inner shaft34 andouter shaft26 of theballoon catheter16 can be formed from any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®).

Shafts

26,34 can have longitudinal sections formed from different materials in order to vary the flexibility of the shafts along their lengths.Inner shaft34 can have an inner liner or layer formed of Teflon® to minimize sliding friction with a nose catheter shaft.

Expansion device

28 can comprise a plurality of balloon members, including, for example, aninner balloon member50 and a plurality ofouter balloon members52, as shown inFIGS. 2A and 2B. As shown more clearly inFIGS. 3 and 4, the plurality ofouter balloon members52 desirably at least partially surroundinner balloon member50. Theouter balloon members52 can be angularly spaced at substantially equal intervals around the outer surface of theinner balloon member50, as shown.

Eachouter balloon member52 also preferably extends axially along anouter surface54 ofinner balloon member50.Outer balloon members52 can comprise a mainouter surface53 that is configured to receive and urge against a prosthetic valve (i.e., to radially expand the prosthetic heart valve) and/or configured to urge against an inner surface of a passageway (i.e., during a valvuloplasty procedure). In addition, eachouter balloon member52 can comprise one or morenarrowed sections55 located distal and/or proximal to the mainouter surface53.

As best seen inFIG. 3,outer balloon members52 are preferably fixed at aproximal end56 and at thedistal end58 of theinner balloon member50. The proximal and distal ends56,58 ofouter balloon members52 can be fixed to the inner balloon member, theouter shaft26, or other structure near the proximal and distal ends56,58. If theouter balloon members52 comprise narrowedsections55, a portion of the narrowedsections55 that is closest to the proximal and distal ends56,58 can be the portion of the outer balloon member that is fixed to the inner balloon member, the outer shaft or the other related structure.

Outer balloon members

52 can also be fixed to theouter surface54 ofinner balloon member50 at positions intermediate to the proximal or distal ends56,58; however, eachouter balloon member52 is desirably fixed only at the proximal and distal ends56,58 so that a portion ofouter balloon members52 between the proximal and distal ends56,58 can freely move relative to theouter surface54 of theinner balloon member50. By not fixing theouter balloon members52 to theouter surface54 ofinner balloon member50,outer balloon members52 can freely move along theouter surface54. This freedom of movement allows theouter balloon members52 to achieve a lower profile when compressed because they are able to self-align and/or move into gaps in the compressed profile ofexpansion device28.

As shown inFIG. 4, whenexpansion device28 is inflated (expanded) in an annulus61 (or other similar orifice or passageway in the body), one ormore gaps60 are preferably provided between at least two adjacentouter balloon members52. Preferably, eachouter balloon member52 is spaced apart from an adjacentouter balloon members52 so that a side (outer) surface62 of a firstouter balloon member52 does not contact a facingside surface62 of an adjacentouter balloon member52. Thus, one ormore gaps60 can permit blood perfusion through the body passageway between the distal and proximal ends56,58 ofexpansion device28 whenexpansion device28 in an expanded configuration.

It should be understood that the number and size ofouter balloon members52 can vary. For example, if the final desired expanded inner diameter of a prosthetic device is about 23 mm, the expanded diameter of the expansion device can be configured in a variety of ways to achieve this expansion. For example,inner balloon member50 can have an expanded diameter of about 15 mm and seven outer balloon members (FIG. 4) can have an expanded diameter of about 4 mm each. Thus, the final expanded diameter of the expansion device is about 23 mm—the same diameter as the desired inner diameter of the expanded prosthetic device. In another example,inner balloon member50 can have an expanded diameter that is about 17 mm. If the prosthetic device should be expanded to about 23 mm (as described in the previous example), the expanded diameters ofouter balloon members52 should be smaller than in the previous example. In this case, for example, the expanded diameters ofouter balloon members52 can be about 3 mm to achieve the same diameter of expansion as in the previous example (i.e., 23 mm).

In some embodiments, there are at least five outer balloon members. By providing at least five outer balloon members, the outer profile of the expansion device can approximate a circle in cross section. More preferably, there are at least seven outer balloon members as shown inFIG. 4 to provide a rounder cross-sectional profile with the outer profile of the expansion device. As described in more detail below, it can be particularly desirable to approximate a circular cross section when expanding a prosthetic heart valve using the expansion devices disclosed herein.

FIG. 5A illustrates another embodiment of anexpansion device28 comprising aninner balloon member50 and a plurality ofouter balloon members52.FIG. 5B illustrates a cross-sectional view of theexpansion device28, which shows that this embodiment includes eightouter balloon members52. As discussed above, theouter balloon members52 are preferably not fixed to theinner balloon member50 between theproximal end56 anddistal end58 of theexpansion device28. Eachouter balloon member52 can be secured at its respective proximal or distal ends to the proximal and distal ends respectively of the inner balloon member. If desired,outer balloon members52 can taper to a smaller diameter (as shown inFIG. 5A) or have narrowed sections (as shown inFIG. 3) at the proximal and distal ends56,58.

Referring toFIG. 6, a cross-sectional view of another embodiment is provided. In the embodiment shown inFIG. 6, anexpansion device70 comprises a plurality ofinner balloon members72 and a plurality ofouter balloon members74. Ashaft76 of the balloon catheter can extend through the expansion device betweeninner balloon members72.

Multipleinner balloon members72 can be used to create a balloon assembly that is capable of achieving various shapes. For example, threeinner balloon members72 can be used to create an expanded shape that is generally tri-lobular in cross section (as shown inFIG. 6). A tri-lobular shape can be useful, for example, when expanding prosthetic valves into portions of the aortic valve and/or aortic root. Alternatively, the inner balloon members and outer balloon members can be selected so that the expanded shape of the expansion device is substantially circular in cross section, as in the embodiments described above. Of course, if desired, in the embodiments described above with a single inner balloon member, the sizes (i.e., expanded diameters) of the outer balloon members can be varied to form a cross section that is a shape other than circular (e.g., tri-lobular, oval).

In each of the embodiments herein, the balloon members of an expansion device can be expanded (inflated) simultaneously or they can be inflated individually (e.g., sequentially or in one or more stages). Preferably, each inner balloon member is fluidly separate or distinct from each outer balloon member. Similarly, each outer balloon member can be fluidly separate or distinct from the other outer balloon members. By separately expanding at least some of the balloon members, the passageway in which the expansion device expands can be partially or completely occluded for a shorter period of time. For example,FIGS. 7-13 illustrate various stages of expansion of an expansion device that can be configured to expand a prosthetic device, such as a prosthetic heart valve, or to perform a valvuloplasty procedure.

In addition, as described in more detail herein, the sequential and/or alternate expansion of members is not limited to outer balloon members. In various embodiments, inner and outer members (balloon or mechanical) can be sequentially expanded and/or collapsed. For example, a first inner balloon can be expanded and then one or more outer balloons can be expanded. Alternatively, the outer member(s) can be expanded and then the inner member can be expanded.

Referring toFIG. 7, an expansion device is shown in a collapsed configuration with aprosthetic device86 crimped thereon. The expansion device comprises aninner balloon member82 and a plurality ofouter balloon members84 in a deflated configuration and carried on aninner shaft81. Sevenouter balloon members84 are shown, but as discussed above, in some embodiments, the number of outer balloon members can be fewer or greater.Prosthetic device86 is crimped onto the collapsed expansion device. As discussed above, eachouter balloon member84 preferably has a portion (e.g., a central longitudinal or axial portion) that is freely floating or movable relative to theballoon member82, which allowsouter balloon members84 to be collapsed to a lower profile shape. To deploy (expand) theprosthetic device86, the expansion device andprosthetic device86 can be moved to the treatment site (e.g., a body passageway or orifice) where the prosthetic device will be expanded. The treatment site can be, for example, anative valve annulus80, as shown inFIGS. 7-8. As can be seen inFIG. 7, when the expansion device is completely collapsed with the prosthetic valve positioned thereon, blood can pass through the annulus in the space between the outer surface of the crimpedprosthetic device86 and the inner surface of theannulus80.

Referring toFIG. 8, a first stage of deployment can comprise partially expanding the expansion device by expandinginner balloon member82 to its expanded configuration. The expansion ofinner balloon member82 causesprosthetic device86 to partially expand, as shown inFIG. 8. Thus,inner balloon member82 can be expanded whileouter balloon members84 remain in their collapsed configuration. To facilitate the independent and/or separate expansion of the inner balloon member and outer balloon members, separate lumen can be provided. In some embodiments, the separate lumen can be in a side-by-side configuration; however, it should be understood that other configurations are possible.

Inner balloon member

82 preferably expands to a size sufficient to maintain a frictional force onprosthetic device86. If desired,prosthetic device86 can be repositioned as necessary by moving the expansion device (e.g., by movinginner shaft81 in a proximal or distal direction). The frictional force onprosthetic device86 can help maintain the position of theprosthetic device86 on the expansion device.

As shown inFIG. 8, because the partially expanded expansion device andprosthetic device86 have an outer diameter that is less that the inner diameter of the annulus, blood is still able to pass through the annulus in the space between the outer surface of the partially expandedprosthetic device86 and the inner surface of theannulus80.

Referring toFIG. 9, the expansion device is shown in a further expanded configuration (e.g., a fully expanded configuration) withinner balloon member82 in an expanded state andouter balloon members84 in an expanded state. The full expansion of the expansion device also expandsprosthetic device86 to its fully deployed state. As seen inFIG. 9, and as discussed above with respect toFIG. 4,gaps60 are present betweeninner balloon member82 andouter balloon members84, and betweenannulus80 andinner balloon member82. These gaps permit blood to pass between the proximal and distal ends ofprosthetic device86 when the expansion device is in a fully expanded condition.

Accordingly, as shown inFIGS. 7-9, the expansion device can expand a prosthetic device while permitting blood perfusion between proximal and distal ends of the expansion device. Moreover, the expansion device can be expanded in stages to maximize blood flow during deployment of a prosthetic device (or during a valvuloplasty procedure). Also, becauseinner balloon member82 can be fully expanded when the prosthetic device is in a partially expanded configuration, the size and shape of the partially expanded expansion device is predictable. In contrast, although a conventional balloon member can be partially expanded during expansion of a delivery device, the shape of the conventional balloon member is generally unpredictable during expansion because balloon members do not tend to conform to predictable shapes until full expansion of the balloon member is achieved.

In some embodiments,outer balloon members84 can be expanded beforeinner balloon member82 is expanded. Preferably, when expandingouter balloon members84 first,outer balloon members84 can be collectively expanded to a size sufficient to maintain a frictional force onprosthetic device86 to achieve the same repositionability as described above with respect to the embodiment whereinner balloon member82 is expanded first.

In another embodiment,outer balloon members84 can be separately expanded relative to one another. Thus, as shown inFIG. 10,inner balloon member82 can be expanded to partially expand theprosthetic device86, and thenouter balloon members84 can be expanded in stages. For example, as shown inFIG. 10, alternatingouter balloon members84 are shown in an expanded state. In this manner,gaps60 that are present betweeninner balloon member82 andannulus80 are larger than those described above inFIG. 9, and greater blood perfusion is possible throughgaps60.

The configuration shown inFIG. 10 can be illustrative of a deployment stage of aprosthetic device86 or it can be illustrative of the collapsing of the expansion device after deployment ofprosthetic device86. That is, the deflatedouter balloon members84 shown inFIG. 10 can be in an intermediate stage and subsequently inflated to assist in the expansion ofprosthetic device86. Alternatively, the configuration shown inFIG. 10 can be illustrative of a selective collapsing (deflation) of one or moreouter balloon members84 after theprosthetic device86 is fully deployed. Thus, the expansion device can quickly reduce its profile to allow for increased blood perfusion prior to being completely deflated or collapsed.

After expansion of the expansion device (e.g., to expand a prosthetic device or perform valvuloplasty), the expansion device can also be deflated or collapsed in stages. For example, the outer balloons can be deflated prior to deflation of the inner balloon(s). In this manner, blood can be permitted to pass between the proximal and distal ends of the expansion device in the areas adjacent to the deflated balloon members and the urgency to deflate the remaining expanded balloon members can be lessened.

In another embodiment, an expansion device can comprise a multi-diameter inner balloon assembly comprised of a plurality of coaxially arranged inner balloon members configured such that the inner balloon members can be expanded to different diameters. For example,FIG. 11 illustrates anexpansion device100 with a prosthetic device102 (e.g., a prosthetic valve) crimped thereon.Expansion device100 can comprise a firstinner balloon member104 and a secondinner balloon member106. First and second

inner balloon members

104,106 are preferably coaxial. In the illustrated embodiment, first and

second balloon members

104,106 can both be carried on aninner shaft107. In a manner similar to that described above, a plurality ofouter balloon members108 can at least partially surround the first and second

inner balloon members

104,106.

Firstinner balloon member104 and secondinner balloon member106 preferably have different diameters so that theexpansion device100 can inflate to a plurality of predictable, increasing diameters. For example, firstinner balloon member104 can have a smaller inflated diameter than secondinner balloon member106. Thus, as shown inFIG. 12, whenexpansion device100 is inflated (expanded) to a first configuration, in which firstinner balloon member104 is fully inflated andouter balloon members108 are fully inflated, the total inflated diameter (profile) of the expansion device is less than that of an inner diameter of anannulus110. However, as shown inFIG. 13, whenexpansion device100 is inflated (expanded) to a second configuration, in which secondinner balloon member106 is fully inflated andouter balloon members108 are fully inflated, the total inflated diameter (profile) of the expansion device is substantially the same as the inner diameter of theannulus110.

Thus, the expansion device can be inflated (expanded) in stages characterized by predictable, increasing diameters. That is, the expansion of the expansion device can include an intermediate stage (FIG. 12) between the deflated stage (FIG. 11) and the fully expanded stage (FIG. 13). As shown inFIG. 12, in this intermediate stage theexpansion device100 is only partially expanded and blood can more easily pass between the proximal and distal ends ofexpansion device100. Preferably, first and second inner balloon members are concentric and coaxial so that they can expand in a predictable and uniform manner relative to the prosthetic device. In addition, as in other embodiments, it should be understood that even in the fully expanded stage (FIG. 13), blood is able to pass between proximal and distal ends ofexpansion device100 by passing through the gaps (spaces)109 present between adjacentouter balloon members108.

As noted above, an inner member can be inflated before one or more outer members, or one or more outer members can be inflated before the inner member. By expanding the outer members first, gaps (e.g., passageways) can be formed between adjacent outer balloon members early in the expansion procedure. These gaps between adjacent outer balloons can be maintained as the inner member is expanded. In this manner, the gaps in the expansion device are present as the expansion device moves from a partially expanded state to a fully expanded state and blood can be allowed to flow across the device throughout the expansion procedure.

In another embodiment, the expansion device can comprise aninner balloon member127 and a plurality ofouter balloon members128 at least partially surroundinginner balloon member127.Outer balloon members128 can be oriented relative to aprosthetic device120 to increase perfusion between distal and proximal ends ofprosthetic device120. For example, as shown inFIG. 14, aprosthetic device120 can comprise aframe member122 and a plurality ofleaflets124 coupled toframe member122.Adjacent leaflets124 form a plurality ofcommissures126. As shown inFIG. 14,prosthetic device120 can be mounted on the expansion device so thatouter balloon members128 are not aligned with (or spaced away from) thecommissures126. By positioning theouter balloon members128 so that they are not located at the area ofcommissure126, maximum blood perfusion between proximal and distal ends of theprosthetic device120 can be achieved by taking advantage of blood flow through theprosthetic device120 itself.

Although the balloon members described above can be formed in various cross-sectional shapes (e.g., round, tri-lobular, oval, etc.), they are preferably substantially round in cross section. When subjected to high pressure inflation, as is required to expand a prosthetic device, balloon members have a tendency to “round out,” regardless of their pre-set shape. For example, although it possible to heat-set a balloon to have an oval cross section, during high pressure inflation that oval shape will tend to inflate to a substantially round, cross-sectional shape. Thus, an advantage of the embodiments described above is that each balloon member (e.g., inner and outer balloon members) can be configured to be round in cross section, yet the overall profile of the expansion device in cross section is more complex and includes gaps for blood perfusion. Therefore, even when subjected to high pressure expansion, the final shape of the expansion device is substantially the same as its preset shape since each balloon has a pre-set shape having a substantially circular cross-sectional profile. In contrast, balloon members having a non-circular cross-sectional profile may distort upon high pressure expansion and the final shape of the balloon member may not be as expected.

In another embodiment, other expansion devices are provided that prevent and/or minimize distortion of a balloon member when it undergoes high pressure expansion. Referring toFIG. 15, anexpansion device150 with a plurality of projections is disclosed.Expansion device150 comprises amain body152 and a plurality ofprojections154 that extend radially frommain body152 and circumferentially around the main body.Projections154 definegrooves156 alone theexpansion device150 to allow blood to pass from aproximal end158 to adistal end160 of the expansion device.Projections154 preferably define bothlongitudinal grooves162 andcircumferential grooves164.Longitudinal grooves162 extend in a substantially longitudinal direction betweenproximal end158 anddistal end160, whilecircumferential grooves164 extend in a circumferential direction aroundexpansion device150. Preferably,longitudinal grooves162 extend substantially the length of theexpansion device150 andcircumferential grooves164 extend substantially around the circumference of themain body152; however, as long aslongitudinal grooves162 andcircumferential grooves164 collectively form a one or more passageways between the proximal and

distal ends

158,160 ofexpansion device150 whenexpansion device150 is in an expanded configuration in an orifice or passageway of the body,expansion device150 can effectively permit blood to pass between the two ends158,160.

As noted above, balloon members have a tendency to distort towards a rounded cross-sectional configuration when subjected to high pressures. Thecircumferential grooves164 function to minimize the deleterious effects of the inflation pressure. Specifically, becausecircumferential grooves164 preferably extend around the circumference ofexpansion device150, at those locations the expansion device can achieve a circular cross section when inflated to minimize distortion ofexpansion device150 at other locations along the length of the balloon member. In other words, by allowing portions of theexpansion device150 at grooves to achieve a circular cross section, the distortive forces at other locations along the longitudinal axis ofexpansion device150 are prevented or at least minimized.

Thus,expansion device150 can have a plurality of circular cross-sectional areas extending along the length ofexpansion device150. In particular, such circular cross-sectional areas can be at the locations of the one or more circumferential grooves. In addition, because expansion device has projections and grooves formed between the projections, the expansion device desirably has a plurality of different cross-sectional shapes/sizes along the length ofexpansion device150. For example, the cross section at a circumferential groove can be circular and of a certain size (diameter), while the cross section at other locations can be non-circular and larger in size than the cross section of the circumferential groove.

FIG. 16 illustrates another embodiment of anexpansion device150. The expansion device ofFIG. 16 comprisesfewer projections154 than that ofFIG. 15. In addition, theprojections154 ofFIG. 16 are rounded or tapered along the circumferential direction. Theserounded portions166 can reduce the likelihood of “blow-out” of the non-circular sections. As inFIG. 15,longitudinal grooves162 extend in a substantially longitudinal direction betweenproximal end158 anddistal end160, whilecircumferential grooves164 extend in a circumferential direction aroundexpansion device150.

Although each of theexpansion devices150 shown inFIGS. 15 and 16 have projections that are uniformly distributed in a grid-like manner, it should be understood that the projections can be non-uniformly spaced along the main body ofexpansion device150.

In another embodiment, anexpansion device170 is provided. As shown inFIG. 17,expansion device170 comprises aninner balloon member172 and an outer balloon member (or projection)174 that extends from aproximal end176 to adistal end178 ofexpansion device170.Outer balloon member174 extends fromproximal end176 todistal end178 by wrapping around the main body ofinner balloon member172 one or more times. Preferably,outer balloon member174 wraps aroundinner balloon member172 in the substantially helical manner shown inFIG. 17. Thus, wheninner balloon member172 andouter balloon member174 are expanded, blood can perfuse between the proximal and

distal ends

176,178 through apassageway180 formed between adjacent radially projecting portions of theouter balloon member174. If theouter balloon member174 extends around a surface of theinner balloon member172 in a substantially helical configuration, the resulting passageway will also be substantially helical in shape.

Outer balloon member

174 is preferably coupled toinner balloon member172 so as to maintain the helical shape whenouter balloon member174 is expanded. However, it may be preferable to leave portions of outer balloon member free (unattached to inner balloon member172) so thatexpansion device170 can have a smaller reduced profile when the balloon members are deflated. In other words, as described above with respect to the embodiment shown inFIG. 3, theouter balloon member174 can self-align by moving into gaps in the compressed profile of theexpansion device170.

As discussed above, balloon members preferably have a round cross section to prevent or reduce the chance of distortion of the balloon member when inflated. Other shapes, however, may be advantageous. For example,FIGS. 18A and 18B illustrate anexpansion device190 similar to that shown inFIGS. 3 and 4, except that theinner balloon member192 is peanut- or dog bone-shaped. That is,inner balloon member192 has a wider radius at portions near theproximal end194 anddistal end196 than at a center portion. A plurality ofouter balloon members198 extends substantially the length of theinner balloon member192. The outer balloon members can be configured in an identical or substantially similar manner as the outer balloon members of other embodiments. For example, as described above with respect toFIGS. 3 and 4,outer balloon members198 can be attached to theinner balloon member192 at the proximal and

distal ends

194,196 such that a central area of each outer balloon member between the proximal and

distal ends

194,196 is left unattached to the inner balloon member.

As discussed above and shown, for example, inFIG. 4, outer balloon members can be configured to provide gaps for perfusion of blood between adjacent balloon members. The use of an inner balloon member that is shaped as shown inFIGS. 18A and 18B can be advantageous when used in combination with a plurality of outer balloon members because it can allow for even more flow between the proximal and distal ends of the expansion device. In particular, becauseouter balloon member198 is preferably unattached at a central region, an inner surface ofouter balloon members198 can be spaced apart from theinner balloon member192 when expanded, definingadditional gaps199 between theouter balloon member198 and theinner balloon member192. Theseadditional gaps199 can further facilitate blood flow between the proximal and

distal ends

194,196.

Moreover, the dog bone-shape of theinner balloon member192 can help to stabilize the prosthetic valve on the expansion device during the expansion procedure. That is, the prosthetic valve can be mounted on the prosthetic valve between the proximal and

distal ends

194,196 so that at least a portion of the two bulbous or radially enlarged regions (i.e., the wide portions of the dog bone-shaped inner balloon member) extend beyond the proximal and distal ends, respectively, of the prosthetic device.

FIGS. 19A-19C illustrate another embodiment of an expansion device. Theexpansion device190 ofFIGS. 19A-19C is similar to that shown inFIGS. 18A and 18B, except that instead of a plurality of outer balloon members, there is a singleouter balloon member198 that surrounds theinner balloon member192. As in the embodiment, ofFIGS. 18A and 18B, theinner balloon member192 can be expanded to stabilize or secure the prosthetic device on the inner balloon member192 (FIG. 19B). Then, by expanding theouter balloon member198, the prosthetic device can be fully deployed within an annulus (FIG. 19C). While the embodiment ofFIGS. 19A-19C includes the dog bone-shapedinner balloon member192, it does not provide forgaps199 as shown inFIGS. 18A-18B since theouter balloon member198 fully surroundsinner balloon member192 in this embodiment.

In other embodiments, other techniques, devices, and methods can be used to increase blood perfusion between proximal and distal ends of an expansion device mounted at the distal end of a delivery device.FIG. 20 illustrates a perfusion device, or catheter assembly,200 that includes an inner tube, or catheter,202 with alumen204 passing therethrough. Aballoon member206 can extend over a portion of theinner tube202 and a prosthetic device208 (e.g., a prosthetic valve) can be crimped onto theballoon member206. An outer tube, sheath, or catheter,210 (sheath) can extend along at least a portion ofinner tube202. Anose cone212 can be provided at a distal end ofinner tube202.Balloon member206 can comprise a conventional inflatable balloon or one of the expansion devices described herein.

Lumen

204 can be configured to receive a guide wire (not shown). After the prosthetic device is advanced to a deployment position for expansion in the body, the guide wire can be removed from the lumen204 (or at least removed from the distal end of the lumen) and blood can be allowed to perfuse between adistal end216 and aproximal end214 ofballoon member206. Referring toFIG. 20, blood can flow in the direction ofarrows218 throughnose cone212 andlumen204. To facilitate blood flow out oflumen204, one ormore openings220 can be provided ininner tube202. Also, ifouter tube210 is positioned overinner tube202,outer tube210 can also comprise a plurality ofopenings222. Preferably, theopenings222 inouter tube210 can be aligned or positioned adjacent toopenings220 ininner tube202 to facilitate blood flow out of the lumen at theproximal end214 ofballoon member206.

FIG. 21 illustrates an expanded configuration of theperfusion device200 ofFIG. 20. As shown inFIG. 21,balloon member206 can be expanded to deployprosthetic device208. During the expansion ofballoon member206, blood flow between the distal and proximal ends of theballoon member206 can be restricted byballoon member206. However, by providing an internal passageway (lumen204) through which blood can flow, the restriction of blood flow through the passageway can be reduced. In addition, ifperfusion device200 is used with the inner and outer balloon member configurations disclosed in other embodiments, blood perfusion can be further increased.

In a modification ofperfusion device200, as shown inFIG. 22,inner tube202 can comprise a collapsible member orcollapsible portion226. Thus, as shown inFIG. 22, thecollapsible member226 can receive a crimpedprosthetic device208 and achieve a lower profile by collapsing to a smaller diameter when theprosthetic device208 is crimped thereon. Since blood perfusion through thelumen204 is primarily required when theballoon member206 is in an expanded configuration (FIG. 21), the narrowedlumen204 ofcollapsible member226 when the prosthetic device is in a collapsed (crimped) configuration (FIG. 22) does not significantly restrict blood flow.

When the compressive force on thecollapsible member226 is removed by expanding theballoon member206, thecollapsible member226 desirably returns to a larger diameter configuration (such as is shown inFIG. 21). Conventional tubing material may not recover sufficiently to allow for sufficient blood flow through the lumen. In addition, conventional tubing may kink, break, or otherwise fail when crushed (collapsed) by the force of the crimped prosthetic valve or when later expanded by the inward force applied by theballoon member206 during inflation. Accordingly,collapsible member226 is preferably formed of a resilient material, such as Nitinol. In a preferred embodiment,collapsible member226 comprises a braid formed of Nitinol.

As discussed above, a perfusion lumen can be used in combination with the multi-balloon expansion devices described herein. For example,FIGS. 23 and 24 illustrateexpansion devices250 that include aninner balloon member252 and a plurality ofouter balloon members254, and which are used in combination with aperfusion lumen256 of aninner tube258.Perfusion lumen256 extends between proximal and distal ends ofexpansion device250.Expansion devices250 ofFIGS. 23 and 24 are substantially the same, except thatinner balloon member252 ofFIG. 24 has a shape that is substantially peanut-shaped or dogbone-shaped, as described above with regard toFIGS. 18A and 18B. It should be understood thatexpansion devices250 can take the form of any expansion devices discussed herein, andlumen256 can be configured to allow the passage of blood between proximal and distal ends of expansion device as described in any of the embodiments herein.

In other embodiments, the perfusion passageway between proximal and distal ends of the expansion device can comprise one or more lumens. For example, as shown inFIGS. 25A and 25B, a perfusion device, or catheter assembly,300 comprises atube302 that has asingle lumen304 for blood perfusion between adistal end308 andproximal end306 of anexpansion device310. Anopening312 in thetube302 permits blood to flow from thelumen304. Perfusion of blood throughlumen304 can be achieved in the manner identical to or substantially similar to that described above with respect toFIGS. 20 and 21.

In another embodiment shown inFIGS. 26A and 26B, a perfusion device, or catheter assembly,320 comprises a tube, or catheter,322 that hasmultiple lumens324 for blood perfusion between aproximal end326 anddistal end328 of anexpansion device330. One ormore openings332 in thetube322 permit blood to flow outwardly from the one ormore lumens324. Desirably,tube322 is formed with at least oneopening332 in fluid communication with each lumen. Again, perfusion of blood throughlumens324 can be achieved in the manner identical to or substantially similar to that described above with respect toFIGS. 20 and 21. However, because there aremultiple lumens324 for blood perfusion, it may be more desirable to includemultiple openings332 that can be aligned with the respective openings in an outer shaft (not shown).

The above embodiments disclose methods for deploying expansion devices in an orifice or passageway of the body. By providing mechanisms for allowing and/or increasing blood perfusion between the expansion devices, a physician can have additional time to deploy (or collapse) the expansion device and the risk of significant adverse effects due to blood occlusion through the orifice or passageway can be reduced.

Additional embodiments are disclosed for securing a prosthetic device to a distal end portion of a delivery device.FIG. 27 illustrates an apparatus and device for releasably securing the prosthetic device using a release wire. Adelivery apparatus400 comprises an inner tube, or catheter,402 and an outer tube, or catheter,404 (sheath). Aballoon member406 andnose cone408 are positioned at a distal end ofinner tube402. Aprosthetic device410 can be secured to the inner tube via one or more tethers (e.g., wires)412 that extend into respective openings on theprosthetic device410. Eachtether412 passes through an opening on theprosthetic device410, and one ormore release wires414 are passed through an opening orloop416 at the end of arespective tether412 to secure theprosthetic device410 to the inner tube. Therelease wires414 can be coupled toouter tube404 and the retraction (proximal movement) ofouter tube404 relative toinner tube402 can causerelease wires414 to be removed fromopenings416 oftethers412, allowing theloops416 to be pulled through their respective openings onprosthetic device410 and thereby releasingprosthetic device410 from the connection formed bytethers412 and releasewires414. Alternatively,release wires414 can extend proximally to a handle (not shown) and be moved or released independently ofouter tube404. In the illustrated embodiment,prosthetic device410 comprises a stented prosthetic heart valve. The leaflets of the prosthetic valve are omitted for clarity in the figures.

In another embodiment shown inFIG. 28,delivery apparatus400 comprises hookingmembers420 that extend from a distal end ofinner tube402. Hookingmembers420 are preferably biased outwards so that a distal end of each hookingmember420 is held against anopening421 inprosthetic device410. To release theprosthetic device410,outer tube404 can be moved distally relative toinner tube402 and the hooking members, thereby forcing outwardly-biased hookingmembers420 inward as the outer tube passes over the hooking members. As theoutward tube404 moves over the hookingmembers420, the hookingmembers420 are compressed to the inner diameter of the outer tube, thereby moving the hookingmembers420 radially inward and out of engagement withopenings421. Thus, the inward force applied to the hookingmembers420 byouter tube404 releasesprosthetic device420 from hookingmembers420.

In other embodiments, the prosthetic device can be secured to the delivery apparatus from both ends to provide further maneuverability of the prosthetic valve after it has been expanded.FIG. 29 schematically (in partial cross section) illustrates aballoon member450 that has a plurality of securingmembers452 for securing aprosthetic device454 to theballoon member450. Securingmembers452 can comprise holding flaps that extend distally and proximally, respectively, from theballoon member450. Holding flaps can be formed integral with theballoon member450 or they can be separate members that are coupled (glued, stitched, etc.) to theballoon member450. Asballoon member450 deflates, securingmembers452 pull away fromprosthetic device454, thereby releasingprosthetic valve454 from securingmembers452.

FIG. 30 illustrates an embodiment in which a prosthetic device (e.g., a prosthetic heart valve) is coupled to adelivery apparatus500 at both proximal and distal ends. A hooking member502 (as discussed above) can be used to secure a proximal end of aprosthetic device504, while one ormore sutures506 can extend from a proximal end ofdelivery apparatus500 to a distal end ofprosthetic device504. For example, sutures506 can extend through aninner tube508 from the proximal end ofdelivery apparatus500 and outwardly throughopenings505 in anose cone510 positioned at a distal end ofapparatus500.Sutures506 can extend fromopenings505 and loop over and around (or through) a distal portion ofprosthetic device504. The free end of the sutures can then extend back throughinner tube508 to the proximal end ofdelivery apparatus500. From the proximal end ofdelivery apparatus500,sutures506 can be released to release the distal end ofprosthetic device504.

To maintain tension on the distal end ofprosthetic device504, aspring member512 can be coupled to each end of thesutures506 that secureprosthetic device504. For example, if threesutures506 are used to secure the distal end of the prosthetic device504 (as shown inFIG. 27), after thesutures506 loop through the prosthetic device, six ends of thesutures506 can be secured to a proximal end of delivery apparatus500 (e.g., at spring member512).

FIG. 31 illustrates an embodiment in which a prosthetic device (e.g., a prosthetic heart valve) is coupled to adelivery apparatus600 at both proximal and distal ends of aprosthetic device604 using sutures. As shown inFIG. 31, a first set ofsutures602acan extend through aninner tube606 from the proximal end of the delivery apparatus and outopenings609 in anose cone610 positioned at a distal end ofdelivery apparatus600. Similarly, a second set ofsutures602bcan extend out ofinner tube608 at an area proximal to the prosthetic valve and secure the proximal end ofprosthetic device604.

Sutures

602aand602bcan be coupled toprosthetic device604 any known manner, including for example, using the loops discussed above.

The above structures and methods for hooking or otherwise securing a prosthetic device to a portion of the delivery apparatus can be particularly useful in combination with the multi-stage expansion mechanisms described herein. As a prosthetic device is partially expanded, the forces applied by the balloon member on the prosthetic device can vary and be less predictable than the forces under full expansion, and therefore, the balloon member may not adequately secure or grip the prosthetic valve as it is being expanded to its functional size. Thus, when partially expanding a balloon member or providing a system for expansion of a prosthetic valve in stages, securing mechanism such as those described above can be particularly useful because such securing mechanisms can maintain the prosthetic valve at a fixed position relative to the balloon member to ensure predictable and even expansion of the prosthetic valve. Moreover, such securing mechanism can maintain the prosthetic valve at a fixed position relative to the delivery apparatus after the prosthetic valve is partially expanded to allow the physician to adjust the position of the prosthetic valve (e.g., proximally or distally) within the body lumen relative to the deployment site.

Although many of the embodiments disclosed herein have been described with reference to expanding a prosthetic device, such as a prosthetic heart valve, within an orifice or passageway of the body, it should be understood that the expansion devices and perfusion devices disclosed herein can also be used to perform a valvuloplasty procedure. That is, the expansion of the balloon member(s) can be done without a prosthetic device crimped thereon in a valvuloplasty procedure. The same advantages of blood perfusion described above with respect to an implantation procedure will be present in a valvuloplasty procedure, where no prosthetic device is involved.

Additionally, it should be understood that the expansion device need not comprise all balloon members and, alternatively, can comprise mechanical expansion devices. For example, a mechanical expanding member with an open-frame configuration can comprise the central expanding member around which multiple outer balloon members are positioned.

FIGS. 32-37 disclose an illustrated embodiment of an expansion device (expandable basket)700 with an open-frame configuration. Expansion device700 can comprise a plurality of longitudinally-extending, circumferentially-spacedstruts702 terminating and joined together at opposite ends of the expansion device. As shown inFIG. 32, for example, struts702 can extend between the distal member (cup)704 and proximal member (cup)706 of the expansion device700.Struts702 can be formed of a variety of materials and in a variety of shapes, as long as the shape and structure is sufficiently strong to cause expansion of a prosthetic device, as described in more detail below. For example, eachstrut702 can be formed of a tubular structure of elastic material, such as stiff plastic or metal. In addition, the expansion device700 can be formed of a variety of number ofstruts702, so long as the struts are of sufficient number, strength, and/or shape so as to provide sufficient force to surfaces and/or contact points of the prosthetic device to expand the device as described herein.

In operation, distal and

proximal members

704,706 can move relative to one another to either expand (by moving closer together) or collapse (by moving further apart) the expansion device700. The relative movement of the distal and

proximal members

704,706 can be achieved, for example, by translating acentral screw mechanism710 that extends between each member and to which each of the member is threadably connected. Referring toFIGS. 35-37, a method of expanding the expansion device700 is shown. For convenience, in each of these figures only asingle strut702 is shown. In addition, inFIGS. 35 and 36 the balloon members are removed for clarity.FIG. 35 illustrates the mechanical portion (i.e., strut702) of expansion device700 in a collapsed configuration.FIG. 36 illustratesstrut702 in an expanded configuration, where the two cups (distal and proximal members)704,706 have moved closer together forcingstrut702 to expand radially. The relative movement of

cups

704,706 can be achieved, for example, by rotation ofcentral screw mechanism710. Alternatively, cups704,706 can be moved closer together (to radially expand struts702) or further apart (to radially collapse struts702) using other mechanisms, such as by pulling or pushing on wires or rods attached to one or both of

cups

704,706.

FIG. 37 illustratesstrut702 in a fully expanded configuration with an outer balloon member extending along at least a portion of the surface ofstrut702. The other struts and outer balloon members have been removed for clarity.Strut702 is shown in an expanded configuration with theouter balloon member708 also expanded. The sequence of expansion can vary. For example, the inner members (struts702) can be expanded and then theouter balloon members708 can be expanded, or, alternatively, theouter balloon members708 can be expanded before the expansion of the inner members (struts702). Also, as shown inFIG. 37, acatheter711 can extend distally from the proximal end of the expansion device.Outer balloon members708 can be expanded by fluid delivered through a lumen withincatheter711.

A plurality ofouter balloon members708 can be coupled to thestruts702. Eachouter balloon member708 is desirably coupled to at least onestrut702 so that it can maintain its position relative to thestruts702. The plurality ofstruts702 can each have an outer surface that defines a supporting surface for supporting at least oneouter balloon member708. The width of the supporting surface of each strut can vary. For example, if only onestrut702 supports eachouter balloon member708, the strut and the supporting surface can have a greater width. However, ifmultiple struts702 support a singleouter balloon member708, the width of the strut and support surface can be smaller. Eachstrut702 in the annular array can be laterally deformable to radially expand or radially contract the annular array ofstruts702, and the supporting surfaces defined by them.

In operation, struts702 can function similar to the inner balloon members disclosed herein. That is, struts702 have a collapsed configuration (FIG. 32) and an expanded configuration (FIG. 33).FIG. 33 illustrates thestruts702 in an expanded configuration with outer balloon members remaining in a collapsed configuration. When expansion device700 is expanded, the supporting surfaces of thestruts702 will push theouter balloon members708 radially outwards against a prosthetic device (not shown) mounted thereon.

As discussed in other embodiments, the expansion device can be expanded in stages such as a first stage where only thestruts702 are expanded (to partially expand the prosthetic device) and a second stage where thestruts702 andouter balloon members708 are expanded (to fully expand the prosthetic device). In addition,outer balloon members708 are preferably expandable independent of the mechanical components (e.g., struts) of expansion device700. Thus, for example,outer balloon members708 can be expanded when thestruts702 of expansion device700 are in a collapsed state (FIG. 32) or a completely expanded state (FIG. 33). Because outer balloon members are independently expandable,outer balloon members708 can be expanded either before or after the expansion ofstruts702. That is, as described in other embodiments herein, the sequence of expansion of the inner member (struts702) and outer members (outer balloon member708) can vary.

Expansion device700 can be particularly advantageous in delivering prosthetic heart valves because themechanical struts702 provide significant expansion while at the same time allowing blood to pass around adjacent outer balloons and through the largely hollow internal portion of expansion device700. Referring toFIGS. 36 and 37, for example, it can be seen that the internal area (i.e., the area beneath the outer balloon members708) of expansion device700 is mostly empty space which allows for significant blood perfusion through that portion of expansion device700. In contrast, when the inner member is a balloon member, the inner balloon member occupies a large portion of the inner area of the expansion device and prevents blood perfusion through that portion of the expansion device. Expansion device700 is also particularly advantageous because it combines the perfusion capabilities of a mechanical expansion member (e.g., struts702) with the high pressure expansion strength associated with balloon expansions members.

FIGS. 38A-38C illustrate a method of deploying a prosthetic heart valve within a native aortic annulus. Referring toFIG. 38A, adelivery device720 is shown delivering aprosthetic heart valve722 in a collapsed configuration.Delivery device720 can deliverprosthetic valve722 to the treatment location using known procedures. For example, the prosthetic device can comprise a SAPIEN Transcatheter Heart Valve (THV) available from Edwards Lifesciences LLC and the prosthetic valve can be delivered either through a transfemoral or transapical approach.

Prosthetic valve

722 can be mounted on anexpansion device724, which can be, for example, an expansion device of the type described herein with reference toFIG. 3.Prosthetic valve722 is maneuvered within a nativeaortic valve annulus726 for deployment usingdelivery device720. Referring toFIG. 38B,expansion device724 is expanded by inflating the inner balloon member and the outer balloon members of theexpansion device724. As illustrated by arrows B, blood can flow between theproximal end728 anddistal end730 ofexpansion device724 through the perfusion pathways provided by thegaps734 in theexpansion device724 as described and shown herein (e.g.,FIG. 4). Afterprosthetic device722 is deployed within the nativeaortic annulus726,expansion device724 can be collapsed (deflated) and removed from the aortic annulus (FIG. 38C).

As discussed above, the number and size of outer balloon members (e.g.,balloon members52 inFIG. 3) can vary. When the expansion device is used to expand a prosthetic heart valve (e.g., as shown inFIG. 40), the expansion device desirably expands to outer profile that engages with and expands the prosthetic heart valve to a shape that conforms to the anatomy of the native annulus. Thus, for example, when expanding a prosthetic heart valve within the annulus of a native aortic valve, it can be desirable to expand the prosthetic heart valve into a generally round cross-sectional shape.

Generally, an expansion device can achieve a rounder outer profile by increasing the number ofouter balloon members52. However, a larger number ofouter balloon members52 will generally result smaller gaps being formed between adjacent outer balloon members, which can reduce the total flow area across the expansion device. Accordingly, in some embodiments, an expansion device has outer balloon members of a particular orientation and size so that the expansion device is capable of expanding a prosthetic heart valve to a generally round cross-sectional shape while providing a large enough flow area across the expansion device to permit a sufficient amount of blood perfusion between the proximal and distal ends of the expansion device.

In some embodiments, when the expansion device is in its expanded configuration, it can be desirable to provide an amount of flow area across the expansion device that is substantially equal to or greater than an effective orifice area (EOA) of the native valve that is being replaced by the prosthetic heart valve. In this manner, the same amount of blood perfusion across the native annulus can be achieved with the expansion device in an expanded state within the native annulus as was possible before the expansion device was positioned within the native annulus.

As noted above, calcification of a native aortic valve can significantly reduce the size of the orifice.FIG. 39 is a schematic view of a calcified nativeaortic valve800 during ventricular systole (e.g., in an open state). As seen inFIG. 39, because of calcification of nativeaortic valve800, the three

native leaflets

802,804,806 cannot fully open, which results in a reducedEOA808 for nativeaortic valve800. The EOA of a calcified aortic valve is generally estimated to be between about 0.5 cm²and 0.7 cm². For example, the EOA for a native aortic valve annulus having a diameter of about 23 mm the EOA is estimated to be about 0.56 cm²and the EOA for a native aortic valve annulus having a diameter of about 26 mm is estimated to be about 0.65 cm².

FIG. 40 illustrates anexpansion device810 that is similar toexpansion device28 shown inFIG. 4.Expansion device810 has aninner balloon member812 and sevenouter balloon members814. Aprosthetic heart valve816 can be mounted on the outer surfaces ofouter balloon members814. As seen inFIG. 40, the sevenouter balloon members814 are of sufficient number and size that, upon expansion ofexpansion device810,outer balloon members814 urge againstprosthetic heart valve816 and expand it to a generally round cross-sectional shape.Gaps818 are formed between adjacentouter balloon members814 to provide a total flow area that is equal to or exceeds the flow area of the EOA of the calcified nativeaortic valve800 shown inFIG. 39.

Accordingly, for a 23 mm prosthetic heart valve, a total flow area provided between theouter balloon members814 is equal to or greater than about 0.56 cm². For a 26 mm prosthetic heart valve, a total flow area provided between theouter balloon members814 is equal to or greater than about 0.65 cm². For native aortic valves of any size, the total area of gaps at any location along the length ofexpansion device810 is preferably greater than 0.7 cm²to ensure that the flow area equals or exceeds the flow area of the EOA of the calcified native aortic valve. Thus, by providing a total area for blood perfusion that is greater than 0.7 cm², a patient's blood flow condition will not be made worse during delivery of a prosthetic heart valve mounted onexpansion device810.

Table 1 below illustrates estimated total flow areas achieved by expansion devices that have seven outer balloon members. It should be understood that an outer diameter of an expansion device generally corresponds to the size of the prosthetic heart valve being expanded by the expansion device.

TABLE 1

			Total flow area
Prosthetic		Outer	between gaps
heart	Inner balloon	balloon	adjacent outer	EOA of
valve size	member	members	balloon	calcified native
(diameter)	(diameter)	(diameter)	members	aortic valve

23 mm	11 mm	6 mm	1.2 cm²	0.56cm²
26 mm	13 mm	6 mm	1.8 cm²	0.65 cm²

As shown in Table 1 above, the total flow area of 23 mm and 26 mm prosthetic heart valves can be about twice that of the EOA of a calcified aortic annulus (e.g., 1.2>2(0.56) and 1.8>2(0.65)). Thus, in some embodiments, a total flow area of an expansion device can be greater than about twice the flow area of an EOA of a calcified valve.

For a prosthetic heart valve that has a desired expanded size of about 23 mm, the inner balloon member preferably has a diameter that is between about 10 and 12 mm (more preferably about 11 mm) and the outer balloon members preferably have a diameter that is between about 5 and 7 mm (more preferably about 6 mm). For a prosthetic heart valve that has a desired expanded size of about 26 mm, the inner balloon member preferably has a diameter that is between about 12 and 14 mm (more preferably about 13 mm) and the outer balloon members preferably have a diameter that is between about 5 and 7 mm (more preferably about 6 mm).

Other size expansion devices can be utilized while still providing the desired flow areas described above. For example, prosthetic heart valves can be provided with diameters smaller than the 23 mm and 26 mm prosthetic heart valves shown in Table 1, such as 20 mm, and with diameters larger than the 23 mm and 26 mm prosthetic heart valves shown in Table 1, such as 29 mm. For each size expansion device, the inner balloon member and outer balloon members are preferably sized to provide a desired amount perfusion across the expansion device. For example, in some embodiments, each expansion device can be sized to provide an amount of flow area that is greater than about 0.7 cm²and/or an amount greater than or equal to the EOA of the calcified valve.

In addition, in some embodiments,expansion device810, like the other expansion devices described herein, can be used for valvuloplasty procedures. In such procedures, the expansion devices can be configured to provide an outer diameter that can be used to achieve the desired amount of perfusion across the expansion device during a valvuloplasty procedure. The outer diameter of the expansion devices can be generally the same as the size of the prosthetic heart valves described above. Alternatively, in some embodiments, it may be desirable to provide expansion devices that expand to an outer diameter that is smaller than those used for prosthetic heart valve expansion. For example, expansion devices that expand to an outer diameter of about 16 mm or 17 mm can be provided. Of course, if desired, such smaller size expansion devices could also be used to expand similarly sized prosthetic heart valves.

FIG. 41 illustrates another embodiment of anexpansion device830 configured to expand aprosthetic heart valve832 within a native annulus. As in other embodiments described herein, aninner balloon member834 is surrounded by a plurality ofouter balloon members836. One or more ofouter balloon members836 can comprise enlarged portions at one or both ends of the mountedprosthetic heart valve832. For clarity,expansion device830 is illustrated inFIG. 41 with only twoouter balloon members836; however, it should be understood that the number of outer balloon members can be the same as disclosed in other embodiments, such as the seven balloon embodiment shown inFIG. 4 or the eight balloon embodiment shown inFIGS. 5A and 5B.

One or moreouter balloon members836 can have a proximalenlarged portion838 and a distalenlarged portion840. For example, each of theouter balloon members836 can have

enlarged portions

838,840. Alternatively, fewer than all ofouter balloon members836 can have

enlarged portions

838,840, since as few as oneouter balloon members836 with

enlarged portions

838,840 can help to retainprosthetic heart valve832 onexpansion device830.

The distance between proximal and distal

enlarged portions

838,840 can be large enough to receive the length of a crimped and/or expandedprosthetic heart valve832 therebetween. In this manner, outer balloon members can have a peanut- or dumbbell-like shape that can help maintainprosthetic heart valve832 on the generally flat, central portion ofouter balloon members836 between the two

enlarged portions

838,840. Whenexpansion device830 is collapsed, the additional material associated with

enlarged portions

838,840 can help retainprosthetic heart valve832 in a crimped configuration (not shown) onexpansion device830. When expansion device is fully expanded (FIG. 41),

enlarged portions

838,840 are located adjacent the two ends ofprosthetic heart valve832, thereby restricting movement ofprosthetic heart valve832 relative toouter balloon members836.

FIGS. 42-44 illustrate another embodiment of anexpansion device850.Expansion device850 also comprises aninner balloon member852 and a plurality ofouter balloon members854 as described in other embodiments herein. However, the portion ofouter balloon members854 that comes into contact with the valve has a length BL. Balloon length BL can also be referred to as the “working length” or “working portion” of the balloon since it is the portion of the balloon that contacts and urges against a prosthetic heart valve causing the prosthetic heart valve to expand.

In some embodiments, the working length BL of at least some ofouter balloon members854 is shorter than the length VL of the prosthetic heart valve. By reducing the working length BL of the outer balloon member, greater blood perfusion can be achieved acrossexpansion device850. That is, the distance that blood must flow through the gaps in the outer balloon members is shortened, increasing the rate of blood flow acrossexpansion device850.

FIGS. 43A is a cross-sectional view taken along a working portion of outer balloon members854 (i.e., a portion that urges against and expands the prosthetic heart valve).FIG. 43B is a cross-sectional view taken along a non-working portion of outer balloon members854 (i.e., a portion that includes reduced-profile tail portions that do not urge against and expand the prosthetic heart valve). Higher rates of blood flow can be achieved acrossexpansion device850 in the area of the reduced-profile tail portions (i.e., the non-working portions of the outer balloon members) because there are larger gaps or openings between adjacentouter balloon members854 in that area as shown inFIG. 43B.

FIG. 44 illustrates a prosthetic heart valve856 expanded on the shorter,outer balloon members854. As described above, blood can pass more easily through the shorter passageways provided by the gaps between adjacentouter balloon members854, thereby permitting a greater amount of blood to perfuse acrossexpansion device850.

FIG. 45 illustrates another embodiment of anexpansion device860.Expansion device860 also comprises aninner balloon member862 and a plurality ofouter balloon members864 as described in other embodiments herein. However, at least some of theouter balloon members864 have a working length BL that is shorter than the length of the valve VL. As described in the previous embodiment, by reducing the working length BL of an outer balloon member, greater blood perfusion can be achieved across the expansion device.

In addition to having one or moreouter balloon members864 that have a working length BL that is less than the length VL of aprosthetic heart valve866 mounted onexpansion device860, adjacentouter balloon members864 can be staggered longitudinally so that they are not aligned with one another along the length ofinner balloon member862. Thus, for example, someouter balloon members864 can be shifted towards aproximal end867 ofprosthetic heart valve866 so that they are not positioned directly underprosthetic heart valve866 at itsdistal end869. Otherouter balloon members864 can be shifted toward thedistal end869 ofprosthetic heart valve866 so that they are not positioned directly underprosthetic heart valve866 at itsproximal end867. In some embodiments,outer balloon members864 can be alternately staggered, as shown inFIG. 45, so that adjacentouter balloon members864 alternate from being shifted toward one side ofproximal heart valve866 to the other.

By providing the staggered and/or alternating arrangements described above, blood perfusion acrossexpansion device860 can be increased. In addition, such a staggered arrangement can reduce the collapsed profile ofexpansion device860 because less balloon material is required to produce a balloon with a shorter working length.

FIG. 46 illustrates another embodiment of anexpansion device870.Expansion device870 also comprises aninner balloon member872 and a plurality ofouter balloon members874 as described in other embodiments herein.FIG. 46 is a cross-sectional view ofexpansion device870 taken along a longitudinal centerline of the expansion device and showing only two of the plurality ofouter balloon members874.

Eachouter balloon member874 has atail portion876 that extends from a proximal or distal end of eachouter balloon member874. Thetail portions876 are preferably attached to a portion ofinner balloon member872 to achieve better control ofouter balloon members874 as they collapse and expand. Thus, for example,tail portions876 can be fused or otherwise coupled toinner balloon member872 at connection points878. By attachingtail portions876 as close as possible to the body ofinner balloon member872, movement ofouter balloon members874 relative toinner balloon member872 can be restricted, providing a consistent expansion device.

In addition to fusing and/orcoupling tail portions876 ofouter balloon members874 toinner balloon member872 as shown inFIG. 46, in some embodiments, adjacentouter balloon members874 can be fused and/or fixedly coupled to one another to further control the movement ofouter balloon members874 relative to each other andinner balloon member872.

The coupling of adjacent outer balloon members to one another and/or to the inner balloon member can be achieved by coupling the balloon material together.FIGS. 47A and 47B illustrate embodiments of coupled tail portions.FIG. 47A illustrates a cross-sectional view of a tail portion of anexpansion device880 that comprises aninner balloon member882 and a plurality ofouter balloon members884. Each outer balloon member is secured to an adjacent outer balloon member and to the inner balloon member.

In the embodiment shown inFIG. 47B, instead of simply coupling the tail portions together, the tail portions shown inFIG. 47A can be fused together to form anintegrated expansion device890 with a plurality of lumens (i.e., oneinner balloon lumen892 and seven outer balloon lumen894). Fusing the tail portions together in this manner can provide for better control of expansion device by reducing movement between adjacent balloon members. In addition, by fusing each of the tail portions together, a diameter of that area of the expansion device can be reduced from a first larger diameter φ1 (FIG. 47A) to a second smaller diameter φ2 (FIG. 47B) due to the use of shared wall sections between adjacent, fused balloon members. Accordingly, not only can the relative movement of balloon members be reduced and/or controlled by fusing adjacent balloon members together as described above, but the profile of the expansion device can be further reduced.

FIGS. 48A and 48B illustrate a method for fusing tail portions ofexpansion member890 by pre-shaping the tails ofouter balloon members894 into a segment or shape that can facilitate fusing of adjacent tail portions. For example, to facilitate the fusing process, it can be desirable to pre-shape the tails into wedge-shaped portions so that each outer balloon members can be fused to the outer balloon members that are adjacent to it as shown inFIG. 48B. The tail portions can then be fused together by placing the pre-shaped tail portions into a fixed, hot metal die.

FIGS. 49,50A, and50B illustrate another embodiment of an expansion device900. Expansion device900 comprises aninner balloon member902 and a plurality ofouter balloon members904.Inner balloon member902 andouter balloon members904 can be constructed by fusing portions of a single balloon. Thus, for example, as shown inFIG. 49, a single balloon can be pinched and/or fused along a plurality oflines906 to provide the plurality ofouter balloon members904.

Becauselines906 do not extend the full length of the expansion device900, a cross section taken alongline50A-50A reveals only asingle lumen909 at aproximal end908 of expansion device900. Similarly, if a cross section were taken near adistal end910 of expansion device900 it would also show only a single lumen. As a result of the fusing of portions of expansion device900 alonglines906,lumen909 splits into a plurality of lumen between theproximal end908 anddistal end910 of expansion device900. The plurality of lumens include a central lumen defined byinner balloon member902 and a plurality of lumens that are defined byouter balloon members904.FIG. 50B is a cross-sectional view taken alongline50B-50B inFIG. 49, showing howlumen909 splits into aninner lumen912 and a plurality ofouter lumen914. Because all lumen are in fluid communication with one another, when an inflation fluid is delivered intolumen909, the inflation fluid simultaneously moves intoinner lumen912 andouter lumens914.

The expansion devices described herein can provide uniform radial expansion of a valve annulus during a valvuloplasty procedure and uniform radial expansion of a prosthetic valve in a valve replacement procedure. Also, it should be note that such expansion devices can be used in stand-alone valvuloplasty procedures, as well as in valvuloplasty procedures performed in preparation of a valve replacement procedure. For example, the expansion device can be used to perform a valvuloplasty procedure and then used to expand a prosthetic device in the same annulus. The expansion devices described herein can allow blood to flow across and/or through the expansion device, which can allow the device to be expanded for a longer duration of time and can reduce the need to pace the heart during a procedure where the expansion device is expanded in an annulus.

The expansion devices described herein can radially expand a prosthetic valve to a shape that is generally circular in cross section by expanding an inner, central expandable member and one or more outer expandable members. Conventional multiple balloon expansion devices are not capable of performing such uniform circular expansion while also providing for sufficient blood perfusion across the expansion member. For example, a three balloon device with the three balloon members positioned side-by-side may provide passageways for blood perfusion, but it will expand to a shape that is tri-lobular in cross section—not circular. The expansion devices described herein are capable of expanding to a shape that is substantially circular in cross section, while allowing sufficient blood to pass through the device. In addition, the sequential or staged expansion of the expansion devices described herein can permit a substantially circular deployment of a prosthetic valve at each stage of deployment.

The methods and apparatuses provided herein also include securement and stabilizing means for securing prosthetic devices during deployment of the prosthetic valve in a native aortic valve annulus. Because of the substantial pressures present in the left ventricle, securement and stabilizing devices, such shown inFIGS. 18A-19C andFIGS. 27-31, can be useful to maintain the prosthetic valve in position on the expansion device.

Various systems and methods are also provided for providing improved stability of the catheter itself during a valvuloplasty or prosthetic valve implantation procedure. The following embodiments provide enhanced stability of a catheter to improve the accuracy with which a balloon member and/or prosthetic device is delivered and/or positioned within an annulus of a native heart valve.

FIG. 51 illustrates adelivery catheter shaft1000 with itsdistal end1002 positioned adjacent a nativeaortic valve1004.Catheter shaft1000 is shown in a retrograde approach (i.e., against the direction of blood flow). Such an approach can be achieved, for example, by inserting thecatheter shaft1000 into the femoral artery of the patient and tracking the delivery catheter, through thedescending aorta1006, over the aortic arch, and into theascending aorta1010. As used herein, unless explicitly stated otherwise, the term aortic arch refers to the portions of the anatomy between the ascending aorta and the descending aorta, and also generally include portions of both the ascending aorta and the descending aorta. The terms inner wall or inner area refer to areas of the aortic arch that are generally at or near the inside portion of the curvature of the aortic arch, while the terms outer wall or outer area refer to areas of the aortic arch that are generally on the outer portion of the curvature of the aortic arch.

Astability member1012 is coupled to adistal area1014 and aproximal area1016 oncatheter shaft1000.Stability member1012 can comprise a pull wire that is fixedly coupled atdistal area1014 and movably coupled atproximal area1016. Thus, by applying tension to the pull wire (e.g., from a distal end of the delivery catheter), an operator can causecatheter shaft1000 to flex or bend between distal and

proximal areas

1014,1016. The pull wire can comprise any suitable material, including for example, a round wire or flat ribbon.

As the pull wire is tightened, the pull wire is moved into contact with aninner area1018 of the aortic arch (as shown by arrow1020), whilecatheter shaft1000 is pushed into contact with anouter area1022 of the aortic arch (as shown by arrow1024). Thus, the flexing ofcatheter shaft1000 caused by thestability member1012 can effectively wedge the flexing portion ofcatheter shaft1000 within the aortic arch.

The amount of force (e.g., fixation) exerted on the aortic arch bycatheter shaft1000 can vary depending on the location where the pull wire is coupled to the distal and

proximal areas

1014,1016. Accordingly, the fixation forces can be adjusted by moving these coupling areas either proximally or distally along thecatheter shaft1000.

By flexingcatheter shaft1000 across the aortic arch in the manner shown inFIG. 51, a stable platform can be provided for performing valvuloplasty and/or implanting a prosthetic device. For example, a balloon catheter (with or without a prosthetic device) can extend beyonddistal end1004 until it is positioned within the nativeaortic valve1004. The greater the distance betweendistal area1014 anddistal end1002, the greater the stability provided to the balloon catheter (or other device extending from distal end1002). Once positioned within the native aortic valve, a balloon member of the balloon catheter can be expanded to perform a valvuloplasty procedure and/or to expand a prosthetic device within the annulus of nativeaortic valve1004.

The balloon member can comprise a conventional balloon member, with the stability shaft functioning to improve the positioning accuracy of the balloon member by reducing movement of the catheter shaft within the aortic arch. Alternatively, the balloon member can comprise a balloon member that allows blood to perfuse across the balloon member when expanded, including, for example, the perfusion devices described elsewhere herein. By combining a perfusion balloon member with a stability member, the position of the delivery system can be remain substantially steady while the balloon member(s) are inflated or being inflated within the native aortic valve. Thus, the stability shaft and perfusion balloons can help offset the environmental forces that can destabilize the delivery catheter, such as the flow of blood directed across the aortic valve and the balloon member during ventricular systole.

FIG. 52 illustrates anotherstability device1030. In this embodiment,catheter shaft1000 can be coaxially mounted with anouter shaft1032.Stability device1030 can comprise a tension member (or wire) coupled to adistal area1034 of thecatheter shaft1000 and adistal area1036 ofouter shaft1032. Relative movement ofcatheter shaft1000 andouter shaft1032 alters the tension caused bystability device1030, causingcatheter shaft1000 to flex and wedge itself within the aortic arch. Thus, in a manner similar to that shown inFIG. 51 and described above, ascatheter shaft1000 extends away from thedistal area1036 ofouter shaft1032, the tension member is forced intoinner area1018 of the aortic arch (i.e., in the direction of arrow1020) andcatheter shaft1000 is pushed to anouter area1022 of the aortic arch (i.e., in the direction of arrow1024). As tension member contacts theinner area1018 andcatheter shaft1000 contacts theouter area1022,catheter1000 andouter shaft1032 are wedged or generally fixed within the aortic arch to provide a stable platform for delivery of various catheters of device from thedistal end1002 ofcatheter shaft1000.

The tension member of thestability device1030 can be a wire, polymer, nitinol metal band, cloth, stainless steel, or other suitable material capable of providing sufficient strength to wedge thecatheter shaft1000 in the manner described above. Preferably, the tensioning member is also selected so that can maintain atraumatic contact with the aortic arch during actuation of thestability device1030.

FIG. 53 illustrates anothercatheter shaft1040 that comprises astability portion1042.Stability portion1042 is formed to be substantially stiffer than the rest ofcatheter shaft1040.Stability portion1042 can be flexed into the curvature shown inFIG. 53 (e.g., tracking the curvature of the aortic arch) and its stiffness can maintain it in that position.Stability portion1042 can be pre-tensioned into the curvature shown inFIG. 53. Alternatively, stability portion can be articulated so that it can be forced into the curvature shown inFIG. 53 by applying a tensioning force via a pull wire. However, in view of the stiffness of thestability portion1042, the pull wire should be of sufficient size and strength to overcome the stiffness of thestability portion1042. In addition, when positioned for balloon deployment within the aortic annulus, thestability portion1042 preferably extends a sufficient distance into the descending aorta to provide the desired stability. In some embodiments, thestability portion1042 extends at least 10 cm into the descending aorta, more preferably at least 12 cm and, even more preferably, at least 15 cm.

AlthoughFIG. 53 is shown withcatheter shaft1040 spaced apart from the walls of the aortic arch, it should be understood that portions ofcatheter shaft1040 can be brought into contact with the walls of the aortic arch (and neighboring portions of the descending aorta). For example,catheter shaft1040 can be flexed so that a proximal portion ofcatheter shaft1040 contacts theinner area1018 and a distal portion ofcatheter shaft1040 contacts theouter area1022, thereby further stabilizingcatheter shaft1040 by creating the wedging effect described herein.

FIG. 53 illustrates aprosthetic device1044 mounted on aballoon catheter1046 that extends fromcatheter shaft1040. Although this embodiment illustrates balloon expansion of a prosthetic device, it should be understood that the stability device embodiments described herein, like those described elsewhere, can be configured for balloon deployment of a prosthetic device, balloon deployment only (e.g., a valvuloplasty procedure), and/or for use with other prosthetic devices (e.g., self-expanding prosthetic devices).

FIG. 54 illustrates acatheter shaft1050 that comprises a plurality offlexible locking sections1052 that allow thecatheter shaft1050 to articulate and bend to conform to the aortic arch. The lockingsections1052 can flex and bend to allow thecatheter shaft1050 to negotiate the anatomy. One or more pull wires (not shown) can be coupled to thedistal end1054 of the catheter shaft. Once tension is applied to the pull wire, lockingsections1052 engage and lock together, stabilizingcatheter shaft1050 by maintaining it in the desired curvature.

Lockingsections1052 can comprise any structures suitable for providing flexing (to allow delivery ofcatheter1050 through the anatomy) until tension is applied. In one embodiment, lockingsections1052 comprise a plurality of interlocking tubes with their proximal sides chamfered so that they can be received in the distal portion of an adjacent tube. As tension is applied to the interlocking tubes, each tube is partly received into a portion of an adjacent tube and the chamfered ends cause the tubes to lock together with the desired curvature. When the tension is released, the tubes can separate again, thereby allowing the lockingsections1052 to flex as the catheter shaft is withdrawn from the vasculature of the patient. The interlocking tubes can be formed of metal, polymers, or other suitable materials.

Again, althoughFIG. 53 is shown withcatheter shaft1050 spaced apart from the walls of the aortic arch, it should be understood that portions ofcatheter shaft1050 can be brought into contact with the walls of the aortic arch (and neighboring portions of the descending aorta) towedge catheter shaft1050 between opposing walls of the aortic arch as described herein.

FIGS. 55A-56B illustrate embodiments of catheter shafts that comprise one or more expansion devices (e.g., balloon members) positioned to stabilize the catheter shafts in and/or about the aortic arch.FIG. 55 illustrates a stabilizingdevice1060 that comprises a plurality ofballoon members1062 that at least partially surround acatheter shaft1064. One or more lumens can extend the length ofcatheter shaft1064 to deliver fluid toballoon members1062.

Balloon members

1062 can expand to contact the inner walls of the aortic arch and/or thedescending aorta1006. Thus, as shown inFIG. 55A, the balloon members can expand to contact the inner and

outer areas

1018,1022 of the aortic arch, thereby bracing or wedging thecatheter shaft1064 within the aortic arch.Balloon members1062 can be formed in any way that allows for their expansion as shown inFIG. 55A. In one embodiment,balloon members1062 can be positioned within cut-outs or slots provided in an outer surface ofcatheter shaft1064. By providing balloon members in such recesses, the profile of the balloon members relative to an outer diameter ofcatheter shaft1064 can be reduced.

FIG. 55B illustrates a cross-sectional view of stabilizingdevice1060. As shown inFIG. 55B,balloon members1062 can be formed with generally the same size. Alternatively, the size (e.g., diameter) ofballoon members1062 can vary. Thus, for example, a balloon member positioned adjacentinner area1018 of aortic arch may be larger than a balloon member positioned adjacentouter area1022 of aortic arch. By varying the size of balloon member, the required amount of bending or flexing ofcatheter shaft1064 can be adjusted.

As shown inFIG. 55B, one ormore gaps1066 can be provided betweenadjacent balloon members1062.Such gaps1066 can improve blood perfusion across stabilizingdevice1060. In other embodiments,balloon members1062 can be shaped to provide even greater amounts of blood perfusion betweenadjacent balloon members1062.

In addition to balloon members, expansion members can comprise mechanical expansion devices. For example, similar to the open frame configurations shown inFIGS. 32-37, mechanical linkages or struts can alternatively, or additionally, be used to fix the catheter shaft relative to the aortic arch. Because of their generally open frame construction, such configurations can allow for greater blood perfusion across the expansion member.

FIG. 56A illustrates another embodiment of a stabilizingdevice1070. Stabilizingdevice1070 comprises asingle balloon member1072 that expands to stabilizecatheter shaft1074. Asballoon member1072 expands,balloon member1072 contacts theinner area1018 of the aortic arch and, at the same time, pushescatheter shaft1074 towards theouter area1022 of the aortic arch, thereby wedgingcatheter shaft1074 within the aortic arch.Gaps1076 can be provided between thecatheter shaft1074 andballoon member1072 to allow for blood perfusion. As described above, theballoon member1072 can be constructed in various manners and the shape ofballoon member1072 can be varied to improve stability and/or to increase the areas of blood perfusion acrossballoon member1072.

FIG. 57 illustrates another catheter shaft that is configured to be stabilized within the aortic arch to improve positioning of a balloon catheter or other similar delivery devices.Catheter shaft1080 is a flexible catheter shaft formed with at least two articulating areas to form a generally “question-mark”-like shape. A first articulatingarea1082 is formed at a proximal position oncatheter shaft1080 and the second articulatingarea1084 is formed at a distal position oncatheter shaft1080. First and second articulating

areas

1082,1084 are configured to allow bending of thecatheter shaft1080 in opposite directions at those locations.

Articulating

areas

1082,1084 can be formed by providing selective laser cuts along the shaft. The laser cuts in articulatingarea1082 are different from those in articulatingarea1084 to allow for bending (i.e., articulation) of the shaft in opposite directions. A pull wire can extend from adistal end1086 ofcatheter shaft1080 to a proximal end (not shown). By pulling on the pull wire, a tension is applied to thecatheter shaft1080, causing the shaft to bend at articulating

areas

1082,1084. As shown inFIG. 57, first articulatingarea1082 is configured so that the shaft bends towards theouter area1022 of the aortic arch and second articulatingarea1084 is configured so that the shaft bends towards theinner area1018 of the aortic arch.

As tension is applied by the pull wire, a portion ofcatheter shaft1080 proximal to the first articulatingarea1082 is moved toward aninner area1008 of the aortic arch or descending aorta (i.e., in the direction of arrow1086). As the first articulatingarea1082 bends away from theinner area1008, another portion ofcatheter shaft1080 moves toward theouter area1022 of the aortic arch or descending aorta (i.e., in the direction of arrow1088).

Because the first and second articulating

areas

1082,1084 bend in opposite directions as shown inFIG. 57, when tension is applied tocatheter shaft1080, it moves into contact with opposing walls of the aortic arch or descending aorta. The contact of thecatheter shaft1080 with opposing walls of the aortic arch or descending aorta cause the catheter shaft to be wedged in place, thereby providing stability to any device (e.g., a balloon catheter) deployed therefrom.

First and second articular regions are preferably formed of materials that not only articulate, but that also become stiff when articulating. Thus, for example, articulating

areas

1082,1084 can comprise selective laser cuts at one or more locations that allow compression of thecatheter shaft1080 in these regions and also allow the shaft to be locked when the pull wire is tensioned.

FIG. 58 illustrates another catheter shaft1100 that is configured to provide additional stability of the catheter across the aortic arch. Catheter shaft1100 comprises at least two

flex points

1102 and1104. These flex points (shown schematically inFIG. 58) are areas or portions of catheter shaft1100 that are adapted to allow for a greater amount of flexing or bending in the vicinity of

flex points

1102,1104. In one embodiment, flex points1102,1104 can comprise cut-out portions of an inner portion of catheter shaft1100 that allow catheter shaft1100 to flex a greater amount at those areas. Such cut-out portions can be formed, for example, by laser cutting small slits, notches, etc., along the inner portion of catheter shaft1100.

Catheter shaft1100 can comprise a pull wire extending along catheter shaft1100 and fixed in the vicinity ofdistal end1106. By applying tension to pull wire, catheter shaft1100 will flex as shown inFIG. 58. By providing

flex points

1102,1104, catheter shaft1100 will bend or flex a greater amount at those areas, causing catheter shaft1100 to move adjacent an outer wall of the aortic arch or descending aorta as shown byarrow1108. The movement of catheter shaft1100 towards the outer wall of the aortic arch or descending aorta, the portion of catheter shaft1100 between

flex points

1102,1104 is directed towards theinner area1018 of the aortic arch (i.e., in the direction of arrow1110). As seen inFIG. 58, the portion of catheter shaft1100 between

flex points

1102,1104 may bend or flex; however, the provision of

flex points

1102,1104 allow for greater flexing at

flex points

1102,1104 than at the portion of catheter shaft1100 that is between

flex points

1102,1104.

As shown inFIG. 58,flex point1104 is preferably provided at the area of catheter shaft1100 that contacts theinner area1008 of the aortic arch. Thus, catheter shaft1100 can bend or flex a greater amount at or around the point that it contacts theinner area1008 of the aortic arch (i.e., in the direction of arrow1112), allowing shaft1100 to wedge and stabilize itself between opposing walls of the aortic arch.

FIG. 59 illustrates another embodiment of acatheter shaft1040 that comprises astability portion1042 that is formed with atube member1090 having a plurality of cuts (e.g., gaps or openings along the length oftube member1090 that are either preformed or otherwise cut into the tube) to provide improved flexibility oftube member1090.Tube member1090 can be embedded in, or otherwise coupled to, the distal end of thecatheter shaft1040.Stability portion1042 can be, for example, a Nitinol tube that is laser cut to allow for a predetermined amount of flexing in the distal end ofcatheter shaft1040. Ascatheter shaft1040 moves through the aortic arch of the patient,stability portion1042 can be flexed in the manner shown inFIG. 59 (e.g., tracking the curvature of the aortic arch). The increased stiffness ofcatheter shaft1040 can help maintaincatheter shaft1040 in a desired position within the aortic arch. In addition, thestability portion1042 can be configured to resist bending so that it provides a springback force (e.g., a force generally opposite the direction of the bending) thereby wedging ofcatheter shaft1040 within the aortic arch as described elsewhere herein.

In this embodiment, and in others, one or more pull wires can be provided along the length ofcatheter shaft1040. For example, a pull ring can be provided at the distal end ofcatheter shaft1040 and one or more pull wires can be coupled to the pull ring. In some embodiments, two pull wires can be coupled to the pull ring at different locations (e.g., at opposite sides of the pull ring) and extend along the length ofcatheter shaft1040. The application of force to the pull wires (e.g., via an external handle) can impart a desired amount of flexing to the portion ofcatheter shaft1040 within the aortic arch. Also, the flexing ofcatheter shaft1040 can effectively wedge the flexing portion ofcatheter shaft1040 within the aortic arch as described elsewhere herein.

FIG. 60 illustrates atube member1090 with a plurality of cuts that extend along the length of the tube member. The spacing of cuts intube member1090 can vary. The cuts can be separate and distinct from one another, providing, for example, a “slotted” tube member as shown inFIG. 60. Alternatively, the plurality of cuts can be continuous or otherwise interconnected along the length oftube member1090.

In some embodiments, cuts can be spaced from the distal and proximal ends of thetube member1090. For example, at the distal end, a first cut can be spaced a distance L_Dfrom the distal end, and at the proximal end, a first cut can be spaced a distance L_Pfrom the proximal end. As shown inFIG. 60, L_Dcan be less than L_P. In addition, the spacing between adjacent cuts in the tube can be selected to provide a desired curvature ofcatheter shaft1040. In some embodiments, cuts nearer the distal end can be spaced closer together to accommodate a greater degree of flexing at the distal end and to provide increased stiffness further away from the distal end oftube member1090. For example, lengths L₁, L₂, L₃, and L₄depict distances between adjacent cuts along the length oftube member1090, and the distances between adjacent cuts increases along length oftube member1090 so that length L₁is less than length L₂, L₂is less than length L₃, and L₃is less than length L₄. In addition, althoughFIG. 60 depicts the cuts as having the same general size and shape, it should be understood that the size and shape of individual cuts can vary to provide the desired amount of flexibility and/or stiffness along the length oftube member1090.

FIG. 61 illustrates another embodiment utilizing a tube member. In this embodiment,tube member1090 is embedded in (or otherwise coupled to)balloon catheter1046.Tube member1090 can be formed in the same general manner as described above with respect to the tube member shownFIGS. 59 and 60. Balloon catheter1046 (withtube member1090 embedded therein) is moveable relative tocatheter shaft1040. For convenience,catheter shaft1040 is illustrated inFIG. 61 with a portion removed to more clearly showballoon catheter1046. One or more pull members can be provided onballoon catheter1046 to facilitate flexing ofballoon catheter1046 within the aortic arch.Tube member1090 stabilizes balloon catheter by increasing the stiffness ofballoon catheter1046 and/or by causingballoon catheter1046 to flex withincatheter shaft1040, thereby pushingcatheter shaft1040 towards the other wall of the aortic arch and wedgingcatheter shaft1040 within the aortic arch as described elsewhere herein.

FIG. 62 illustrates another embodiment of acatheter shaft1040 that comprises astability portion1042. In this embodiment, stability portion comprises a coil member embedded in (or otherwise coupled) the distal end of thecatheter shaft1040 to provide greater stiffness tocatheter shaft1040.Stability portion1042 can be, for example, a Nitinol coil that is configured to allow a predetermined amount of flexing in the distal end ofcatheter shaft1040. The stiffness of the coil member can vary along its length by varying the distance between adjacent turns of the coil. Thus,catheter shaft1040 can be stabilized within the aortic arch by increasing the stiffness ofcatheter shaft1040 and/or by causingcatheter shaft1040 wedge itself within the aortic arch as described elsewhere herein.

As described elsewhere herein, apull ring1092 can be provided at the distal end ofcatheter shaft1040. Pull

wires

1094,1096 can be coupled to pullring1092 at different locations (e.g., at opposite sides of the pull ring) and can extend along the length ofcatheter shaft1040. The application of force (e.g., in the direction of arrows F₁and F₂as illustrated inFIG. 62) to the

pull wires

1094,1096 via anexternal handle1098 can cause a desired amount of flexing ofcatheter shaft1040 within the aortic arch. Pull

wires

1094,1096 can be independently and/or collectively pulled to alter the amount of flexing ofcatheter shaft1040.

FIGS. 63 and 64 illustrates another embodiment in which one ormore stability members2000 are delivered through one ormore lumens2002 incatheter shaft1040. As shown inFIG. 64, lumen(s)2002 can extend the length ofcatheter shaft1040 to allow for introduction of thestability member2000 intocatheter shaft1040 from outside of the patient's body. Asstability members2000 are introduced intocatheter shaft1040 and move across the bend of the aortic arch, stability members exert a force generally opposite their bending direction (e.g., a springback force). This springback force can increase the stability ofcatheter shaft1040 by pushingcatheter shaft1040 against the outer walls of the aortic arch. Thus, as shown inFIG. 63, the insertion ofstability member2000 intolumen2002 causescatheter shaft1040 to stiffen and move towards the outer wall of the aortic arch, thereby wedging or generally fixing the distal end ofcatheter shaft1040 within the aortic arch to provide a more stable platform for delivery of various catheters of device from the distal end ofcatheter shaft1040.

FIG. 65 illustrates an embodiment with a plurality oflumens2002 configured to receive a plurality ofstability members2000.Stability members2000 can comprise wires, such as Nitinol wires, that can be advanced throughrespective lumens2002 alongcatheter shaft1040 until the wires reach the distal end ofcatheter shaft1040, causing the distal end of catheter shaft to stiffen within the aortic arch as discussed above. AlthoughFIG. 65 illustrates stability members as being generally round in cross section, it should be understood that stability members can comprise other shapes, including, for example, generally flat members (e.g., strips) that extend through correspondingly-shaped lumens. In addition, althoughFIG. 65 illustrates six lumens, it should be understood that more or less than six lumens can be provided.

FIG. 66 illustrates another embodiment, in which asingle lumen2002 is provided for receiving astability member2000. For example,FIG. 66 illustratesstability member2000 configured as a generally flat strip, such as a Nitinol strip.Lumen2002 extends along the length ofcatheter shaft1040, as shown inFIG. 64, to allow for introduction of thesingle stability member2000 intocatheter shaft1040 from outside of the patient's body. Although the single lumen embodiment illustrates thestability member2000 as a generally flat strip, it should be understood that members of other shapes can be utilized, including, for example, the generally round cross-sectional members described in the multi-lumen embodiment.

FIGS. 65 and 66 also illustrate another lumen for receiving one or more pull wires. It should be understood that additional lumen can be provided incatheter shaft1040, if additional pull wires are desired.

In operation, stability member(s)2000 can be introduced into lumen(s)2002 ofcatheter shaft1040 after the distal end ofcatheter shaft1040 is positioned within the aortic arch. After advancing stability member(s)2000 through the lumen(s)2002, the springback force caused by the bending ofstability members2000 causescatheter shaft1040 to contact one or more portions of the outer wall of the aortic arch, thereby wedging or otherwise generally fixingcatheter shaft1040 within the aortic arch to provide a more stable platform for delivery of various catheters of device from the distal end ofcatheter shaft1040, such as aprosthetic device1044 on aballoon catheter1046.

Although the detailed description generally describes the deployment of a prosthetic valve within the aortic annulus, it should be understood that the expansion devices described herein can be used to expand other prosthetic valves or stents in other areas of the body, including, for example, the delivery of a bare stent in the coronary artery. In addition, the expansion devices described herein can also be used in other medical procedures where an annulus or passageway of the cardiovascular system is to be enlarged, either with or without the deployment of a stent or other prosthetic member. For example, the expansion devices described herein can be used in angioplasty procedures, including for example, coronary artery dilation procedures. Similarly, the methods and systems disclosed herein for providing improved stability to a catheter in the vicinity of a heart valve can be generally applicable in other areas of the body. For example, the stability systems and methods illustrated inFIGS. 51-66 can be useful to stabilize a catheter in connection with other medical procedures that involve a bending or curving region similar to that of the aortic arch.

In addition, one of ordinary skill in the art would understand that specific features of the various embodiments can be combined in other manners, unless those features are directly contradictory to each other. For example, a stiffer distal end portion (as shown, for example, inFIG. 53) can be combined with articulating portions or bend areas (as shown, for example, inFIGS. 57 and 58) to increase the stability of the distal end portion of a catheter shaft by providing a stiffer distal end portion that can be more easily wedged or otherwise fixed in place relative to a patient's aortic arch.

In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.