WO2011080731A1

WO2011080731A1 - Corrugated balloon catheter and methods of use thereof

Info

Publication number: WO2011080731A1
Application number: PCT/IL2010/000001
Authority: WO
Inventors: Eran Harari; Doron Besser
Original assignee: Angioslide Ltd.
Priority date: 2010-01-03
Filing date: 2010-01-03
Publication date: 2011-07-07

Abstract

A catheter system includes an outer conduit and an inner conduit movably disposed therein. The inner conduit is suitable for passage over a guide-wire and includes at least one movable part. The proximal end of the inner conduit is angled and pierces the wall of the outer conduit. The catheter includes an inflatable balloon having a proximal margin attached to the distal tip of the outer conduit and a distal margin attached to the portion of the inner conduit extending beyond the distal tip of the outer conduit. The balloon has at least one corrugated portion. The catheter includes means for axially moving the inner conduit within the outer conduit, means for introducing expansion fluid into the balloon and means for permitting axial movement of the inner conduit within the outer conduit, unhindered by the passage of the angled proximal part of the inner conduit through the outer conduit.

Description

CORRUGATED BALLOON CATHETER AND METHODS OF USE THEREOF

FIELD OF THE INVENTION

This invention relates in general to the fields of medical balloon catheters and more particularly to systems and catheters having inflatable intussusceptible corrugated balloons and methods of their construction and use.

BACKGROUND OF THE INVENTION

Catheters are used in various interventional procedures for delivering therapeutic means to a treated site (e.g., body organ or passageway such as blood vessels). In many cases, a catheter with a small distal inflatable balloon is guided to the treated site. Once the balloon is in place it is inflated by the operator for affixing it in place, for expanding a blocked vessel, for placing treatment means (e.g., stent) and/or for delivering surgical tools (e.g. knives, drills etc.) to a desired site. In addition, catheter systems have also been designed and used for retrieval of objects such as stents from body passageways.

Two basic types of catheter have been developed for intravascular use: over-the-wire

(OTW) catheters and rapid-exchange (RE) catheters.

OTW catheter systems are characterized by the presence of a full-length guide-wire, such that when the catheter is in its in situ working position, said guide-wire passes through the entire length of a lumen formed in, or externally attached to, the catheter. OTW systems have several operational advantages which are related to the use of a full length guide-wire, including good stiffness and pushability, features which are important when maneuvering balloon catheters along tortuous and/or partially occluded blood vessels.

U.S. Patent No. 6,039,721 to Johnson et al. describes a balloon catheter system comprising two concentrically-arranged conduits, with a balloon connected between the distal regions thereof. The catheter system permits both expansion/deflation of the balloon and alteration in the length of the balloon when in situ, such that the balloon may be moved between extended and intussuscepted conformations. The catheter system is constructed in order that it may be use for two main purposes: firstly, treatment (i.e. expansion) of different- length stenosed portions of blood vessels with a single balloon and secondly, the delivery of either stents or medication to intravascular lesions, wherein the stent or medication is contained within the distally-intussuscepted portion of the balloon. When used for multiple, differing-length lesion expansion, the balloon is inserted into blood vessel in a collapsed, shortened, intussuscepted conformation, and is advanced until it comes to rest in the region of the shortest lesion to be treated. The balloon is then inflated and the lesion treated (i.e. expanded). Following deflation of the balloon, the distal end of the catheter system is moved such that the balloon becomes positioned in the region of the next—shortest lesion to be treated. The effective length of the balloon is then increased by moving the inner conduit in relation to the proximal conduit, following which the balloon is again inflated and the lesion treated. In this way, a series of different length stenoses, in order from the shortest to the longest, may be treated using a single balloon. When used for stent delivery, the stent is pre-loaded into a proximal annular space formed as a result of balloon intussusception. The balloon is then moved to the desired site and the stent delivered by means of moving the inner conduit distally (in relation to the outer tube), thereby "unpeeling" the stent from the catheter.

WO 2000/38776 discloses a dual-conduit balloon catheter system similar in basic design to that described above in relation to U.S. Pat. number 6,039,721. This catheter system is intended for use in a vibratory mode in order to break through total occlusions of the vascular lumen. In order to fulfill this aim, the outer conduit has a variable stiffness along its length, while the inner conduit. In addition, the inner conduit while being intrinsically relatively flexible is stiffened by the presence of axial tensioning wires. These conduit design features are used in order to permit optimal translation of vibratory movements of the proximal end of the inner conduit into corresponding vibration of the distal tip thereof.

Rapid exchange ("monorail") catheters typically comprise a relatively short guide- wire lumen provided in a distal section thereof, and a proximal guide-wire exit port located between the catheter's distal and proximal ends. This arrangement allows exchange of the catheter over a relatively short guide-wire, in a manner which is simple to perform and which can be carried out by a single operator. Rapid exchange catheters have been extensively described in the art, for example, U.S. Patent numbers 4,762,129, 4,748,982 and EP0380873.

Rapid exchange catheters are commonly used in Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures, in which obstructed blood vessels are typically dilated by a distal balloon mounted on the catheter's distal end. A stent is often placed at the vessel's dilation zone to prevent reoccurrences of obstruction therein. The dilation balloon is typically inflated via an inflation lumen which extends longitudinally inside the catheter's shaft between the dilation balloon and the catheter's proximal end.

The guide-wire lumen passes within a smaller section of the catheter's shaft length and it is accessed via a lateral port situated on the catheter's shaft. This arrangement, wherein the guide-wire tube is affixed to the catheter's shaft at the location of its lateral port, usually prevents designers from developing new rapid exchange catheter implementations which requires manipulating its inner shaft. For example, extending or shortening the catheter's length during procedures may be advantageously exploited by physicians to distally extend the length of the catheter into a new site after or during its placement in the patient's artery, for example in order to assist with the passage of tortuous vessels or small diameter stenoses, or to allow in-situ manipulation of an inflated balloon at the distal end of the catheter.

Published international patent application, publication No. WO 2005/102184 discloses a catheter having a Tollable expandable element. Published international patent applications, publication Nos. WO 2007/004221 , WO 2007/042935, WO 2008/004238 and WO 2008/004239, all five published international applications are incorporated herein by reference in their entirety for all purposes, disclose various types of catheters and catheter systems having intussuscepting balloon-like inflatable members which may be used, inter alia, to treat plaque by balloon inflation while efficiently and safely collecting plaque debris and other particulate matter from the lumen of pathologically-involved blood vessels and to remove such particles and particulate matter from the blood vessel.

A problem frequently encountered in the use of inflatable balloons to treat atheromatous plaque in blood vessels is that inflation of the balloon against the wall of the blood vessel may sometimes cause some damage to the blood vessel wall in the region of contact between the balloon and the blood vessel walls. Physicians are therefore usually reluctant to use balloons longer that the length necessary for treating most of the plaque. However, when the intussuscepting balloons as disclosed, inter alia, in WO 2005/102184 and WO 2007/004221 are used for treating plaque (by expanding the balloon placed inside the plaque region or by other methods) and for trapping and internalizing debris particles or secretions and fluids from inside a treated blood vessel, one would like to increase the capacity of the balloon to trap and include debris particles in it's intussuscepted (invaginated) state without increasing the length of the balloon above the length that is recommended by the physician for the purpose of safe plaque treatment.

International patent applications PCT/IL2009/000667 and PCT/IL2009/000668 commonly assigned to the assignee of the present application and incorporated herein by reference in their entirety for all purposes, disclose various types of over the wire (OVT) catheters having stepped and corrugated types of intussuscepting balloons, respectively.

Another concern which may be encountered in the use of intussuscepting balloons, such as, for example, the balloons disclosed in WO 2005/102184 and WO 2007/004221 is that in balloons in which it is desired to have the distal part of the balloon intussuscept, it is important to ensure that the distal end of the balloon (the end attached to the inner tube of the catheter) collapses preferentially at a lower pulling force than the force required to collapse the proximal end of the balloon (the end of the balloon attached to the outer tube of the catheter) to ensure proper intussuscepting of the distal end of the balloon. (The proximal and distal ends of the balloon are defined as described in WO 2005/102184 and WO 2007/004221 ).

SUMMARY OF THE INVENTION

There is therefore provided, in accordance with an embodiment of the catheters of the present application, a rapid exchange balloon catheter. The catheter includes an outer conduit and an inner conduit disposed within said outer conduit and suitable for total or partial passage over a guide-wire. The inner conduit includes at least one movable part movably disposed within the lumen of the outer conduit. The inner conduit includes an angled portion piercing the wall of the outer conduit and a distal end of the inner conduit extends beyond the distal end of the outer conduit. The catheter also includes a corrugated inflatable balloon having a proximal margin sealingly attached to the outer surface of the distal end of the outer conduit and a distal margin sealingly attached to the outer surface of the portion of the inner conduit that extends beyond the distal end of the outer conduit. The corrugated balloon has at least one corrugated portion. The catheter also includes means for axially moving at least one movable part of the inner conduit within the outer conduit. The catheter also includes means for the introduction of an expansion fluid into the space formed between the inner surface of the outer conduit and the outer surface of the inner conduit and into the lumen of the balloon and for the removal of the fluid from the space and from the balloon. The catheter also includes means for permitting unhindered axial movement of the at least one movable part of the inner conduit within the outer conduit, such that the movement is not hindered by the passage of the angled portion of the inner conduit through the outer conduit.

Furthermore, in accordance with an embodiment of the catheter, the means for axially moving the at least one movable part of the inner conduit include one or more elongated moving members, the distal end(s) thereof being attached to the at least one movable part of the inner conduit, and the proximal end(s) thereof extending beyond the proximal end of the outer conduit.

Furthermore, in accordance with an embodiment of the catheter, the distal portion of the corrugated balloon is capable of intussuscepting upon proximal movement of the at least one movable part of the inner conduit in relation to the outer conduit.

Furthermore, in accordance with an embodiment of the catheter, the catheter also includes means for reducing pressure changes within the space within the catheter upon axial movement of the at least one movable part of the inner conduit in relation to the outer conduit.

Furthermore, in accordance with an embodiment of the catheter, the means for reducing pressure changes include a piston-like member slidably disposed within the proximal end of the outer conduit. The piston-like member is connected to the means for axially moving, such that upon operation of the means for axially moving, the piston-like member is caused to move either distally or proximally, changing the volume of the outer conduit.

Furthermore, in accordance with an embodiment of the catheter, the means for permitting unhindered axial movement include a sealing sleeve sealingly attached to the angled portion of the inner conduit and slidably fitted around the outer conduit, such that the angled portion of the inner conduit passes firstly through an elongated aperture in the wall of the outer conduit, and secondly through a tightly sealed aperture in the sealing sleeve, such that upon axial movement of the at least one movable part of the inner conduit, the sealing sleeve is capable of preventing leaking of inflation fluid through the elongated aperture.

Furthermore, in accordance with an embodiment of the catheter, the means for permitting unhindered axial movement of the inner conduit is provided by a two-part inner conduit construction. A first proximal part of the two-part inner conduit includes a non-movable inner tube including the angled portion, and a second distal part of the two- part inner conduit includes a slidable internal tube disposed within the non-movable inner tube.

Furthermore, in accordance with an embodiment of the catheter, the means for permitting unhindered axial movement of the inner conduit is provided by a two-part inner conduit construction. A first proximal part of the two-part inner conduit includes a non-movable inner tube including the angled portion, and a second distal part of the two- part inner conduit includes a slidable internal tube disposed over the non-movable inner tube.

Furthermore, in accordance with an embodiment of the catheter, the means for permitting unhindered axial movement of the inner conduit is provided by a two-part inner conduit construction. The two-part inner conduit includes a non-movable inner tube including the angled portion and a slidable intermediate tube movably disposed between the non movable inner tube and the outer conduit. The intermediate tube has a longitudinal opening on its side through which the angled portion passes. The distal end of the intermediate tube is the portion of the inner conduit that extends beyond the distal end of the outer conduit, and the proximal end of the intermediate tube sealingly passes through and extends beyond the proximal end of the outer conduit such that the means for axially moving comprises the proximal end of the intermediate tube.

Furthermore, in accordance with an embodiment of the catheter, the means for permitting unhindered axial movement of the inner conduit is provided by a three-part inner conduit construction. The three-part inner conduit includes a first non-movable hollow tube including the angled portion at its proximal portion and having a distal end, a second non-movable hollow inner tube having a proximal end and a distal end, the second inner tube is sealingly disposed within the distal end of the first non-movable inner tube, and a third slidable inner tube slidably disposed over the distal end of the second non- movable hollow tube. The third slidable inner tube has a distal end extending beyond the distal end of the outer conduit and the distal margin of the corrugated balloon is attached to the outer surface of the portion of the distal end of the third inner tube extending beyond the distal end of the outer conduit.

Furthermore, in accordance with an embodiment of the catheter, the outer conduit includes a lateral opening therein. The means for permitting unhindered axial movement includes a sealing sleeve internally disposed within the outer conduit and attached to the angled portion of the inner conduit. The sealing sleeve is sealingly fitted within the outer conduit such that the angled portion of the inner conduit passes firstly through the wall of the sealing sleeve and secondly through the lateral opening of the outer conduit, such that upon axial movement of the inner conduit and the sealing sleeve, the sealing sleeve is capable of preventing leaking of inflation fluid through the lateral opening.

Furthermore, in accordance with an embodiment of the catheter, the corrugated balloon is characterized by having, in its inflated state, a shape which is capable of guiding the intussuscepting of the distal and/or proximal portion(s) thereof upon proximal movement of the at least one movable part of the inner conduit in relation to the outer conduit. Furthermore, in accordance with an embodiment of the catheter, the corrugated balloon is characterized by having, in its inflated state, a distal taper with a rounded distal extremity.

Furthermore, in accordance with an embodiment of the catheter, the inner and outer conduits are characterized by their ability to withstand axially directed forces in the range of between 1 and 30 Newton without undergoing deformation.

Furthermore, in accordance with an embodiment of the catheter, the inflatable balloon includes a substantially cylindrical middle portion flanked by a distally extending portion and a proximally extending portion, wherein the diameter of the distally extending portion diminishes in the distal direction and the diameter of the proximally extending portion diminishes in the proximal direction.

Furthermore, in accordance with an embodiment of the catheter, the balloon is selected from a balloon with at least part of the middle portion is corrugated, a balloon with at least part of the distally extending portion is corrugated, and a balloon wherein at least part of the middle portion and at least part of the distally extending portion is corrugated.

Furthermore, in accordance with an embodiment of the catheter, at least part of the distally extending portion is corrugated such that the force required for causing collapse of the distal portion of the balloon is substantially smaller than the force required to cause collapse of the proximal portion of the balloon.

Furthermore, in accordance with an embodiment of the catheter, at least part of the distally extending portion and at least the distal part of the middle portion are corrugated such that the force required for causing collapse of the distal end of the balloon is substantially smaller than the force required to cause collapse of the proximal end of the balloon.

Furthermore, in accordance with an embodiment of the catheter, the wall thickness of the balloon is non-uniform along the length of the balloon.

Furthermore, in accordance with an embodiment of the catheter, the wall thickness of the proximal part of the balloon is greater than the wall thickness of the distal part of the balloon. Furthermore, in accordance with an embodiment of the catheter, the corrugations of the at least one corrugated portion of the balloon have a cross-sectional shape selected from the group consisting of symmetrical triangular corrugations, non-symmetrical triangular corrugations, curved corrugations, sawtooth like corrugations, symmetrical rounded corrugations, non-symmetrical partly rounded corrugations, and any combinations thereof.

Furthermore, in accordance with an embodiment of the catheter, the corrugations of the at least one corrugated portion of the balloon are arranged intermittently such that corrugated and non-corrugated portions alternate along the at least one corrugated portion.

Furthermore, in accordance with an embodiment of the catheter, the inflatable balloon has a distal portion selected from a dome-like portion, a truncated dome-like portion, a conical portion, a frusto-conical portion, a corrugated dome-like portion, a corrugated conical portion, a corrugated frusto-conical portion, and a corrugated truncated dome- like portion.

Furthermore, in accordance with an embodiment of the catheter, the at least one corrugated portion of the inflatable balloon increases the surface area of the balloon for improving retention of debris or particulate material trapped within the balloon after intussuscepting of the balloon.

Furthermore, in accordance with an embodiment of the catheter, the at least one corrugated portion of the inflatable balloon increases the probability of collapse of the distal portion of the balloon upon proximal moving of the at least one movable part of the inner conduit as compared to the probability of collapse of a distal portion of a similarly shaped balloon having no corrugated portion.

Furthermore, in accordance with an embodiment of the catheter, the at least one corrugated portion of the inflatable balloon is configured to be internally disposed within the space formed in the intussuscepted balloon, after the intussuscepting of the balloon is completed, such that no corrugated portion is presented on the external surface of the fully intussuscepted balloon.

There is also provided in accordance with an embodiment of the method(s) of the present application, a method of constructing an intussusceptible corrugated balloon rapid exchange catheter. The method comprising the steps of providing a catheter having an outer conduit and an inner conduit disposed within the outer conduit and suitable for total or partial passage over a guide-wire, the inner conduit includes at least one movable part movably disposed within the lumen of the outer conduit. The inner conduit includes an angled portion piercing the wall of the outer conduit and the distal end of the inner conduit extends beyond the distal end of the outer conduit, providing a corrugated inflatable balloon having a proximal margin and a distal margin, the corrugated balloon has at least one corrugated portion and sealingly attaching the proximal margin of the corrugated balloon to the outer surface of the distal end of the outer conduit and sealingly attaching the distal margin of the corrugated balloon to the outer surface of the portion of the inner conduit that extends beyond the distal end of the outer conduit such that the lumen of the corrugated balloon is in fluidic communication with the space defined between the outer conduit and the inner conduit. The attaching is performed such that at least one of the distal end and the proximal end of the corrugated balloon is capable of intussuscepting upon proximal movement of the movable part of the inner conduit in relation to the outer conduit.

There is also provided, in accordance with an embodiment of the method(s) of the present application, a method for collecting debris from an internal passage of a mammalian subject. The method includes the steps of:

a) inserting a rapid exchange balloon catheter into the internal passage, and advancing the catheter until the distal end thereof has reached a site at which it is desired to collect debris. The rapid exchange balloon catheter includes an outer conduit, an inner conduit disposed within the outer conduit and suitable for total or partial passage over a guide- wire. The inner conduit comprises at least one movable part movably disposed within the lumen of the outer conduit. The inner conduit includes an angled portion piercing the wall of the outer conduit and a distal end of the inner conduit extends beyond the distal end of the outer conduit,a corrugated inflatable balloon having a proximal margin sealingly attached to the outer surface of the distal end of the outer conduit, and a distal margin sealingly attached to the outer surface of the portion of the inner conduit that extends beyond the distal end of the outer conduit, the corrugated balloon has at least one corrugated portion, means for axially moving the at least one movable part of the inner conduit within the outer conduit, means for the introduction of an expansion fluid into the space formed between the inner surface of the outer conduit and the outer surface of the inner conduit and therefrom into the lumen of the balloon and for the removal of the fluid from the space, and means for permitting unhindered axial movement of the at least one movable part of the inner conduit within the outer conduit, such that the movement is not hindered by the passage of the angled portion of the inner conduit through the outer conduit.

b) inflating the corrugated balloon with expansion fluid.

c) pulling the at least one movable part of the inner conduit in a proximal direction, such that the distal and/or proximal end(s) of the balloon intussuscept(s).

d) deflating the balloon, to form at least one cavity into which the debris is collected and entrapped, and

e) removing the balloon catheter from the internal passage of the subject, together with the entrapped debris.

Furthermore, in accordance with an embodiment of the method, the internal passage is a blood vessel.

There is also provided, in accordance with an embodiment of the method(s) of the present application, a method for collecting debris resulting from treatment of a diseased portion of an internal passage of a mammalian subject. The method cincludes the steps of:

a) inserting a rapid exchange balloon catheter into the internal passage. The rapid exchange balloon catheter includes an outer conduit. The catheter also includes an inner conduit disposed within the outer conduit and suitable for total or partial passage over a guide-wire. The inner conduit includess at least one movable part movably disposed within the lumen of the outer conduit. The inner conduit includes an angled portion piercing the wall of the outer conduit and a distal end of the inner conduit which extends beyond the distal end of the outer conduit. The catheter also includes a corrugated inflatable balloon having a proximal margin sealingly attached to the outer surface of the distal end of the outer conduit, and a distal margin sealingly attached to the outer surface of the portion of the inner conduit that extends beyond the distal end of the outer conduit. The corrugated balloon has at least one corrugated portion. The cathetrer also includes means for axially moving the at least one movable part of the inner conduit within the outer conduit, means for the introduction of an expansion fluid into the space formed between the inner surface of the outer conduit and the outer surface of the inner conduit and therefrom into the lumen of the balloon and for the removal of the fluid from the space, and means for permitting unhindered axial movement of the at least one movable part of the inner conduit within the outer conduit, such that the movement is not hindered by the passage of the angled portion of the inner conduit through the outer conduit. The step of inserting also includes advancing the catheter to position the balloon within at least part of the diseased portion.

b) inflating the balloon with expansion fluid to treat at least part of the diseased portion such that at least some of the debris formed during the inflating is attached to the at least one corrugated portion of the balloon.

c) pulling the at least one movable part of the inner conduit of the balloon catheter in a proximal direction, such that one or more of the distal end and proximal end of the balloon intussuscept.

d) deflating the balloon, to form one or more cavities into which debris is collected and entrapped, wherein at least part of the corrugated portion is disposed within at least one cavity of the one or more cavities, and

Furthermore, in accordance with an embodiment of the method, the internal passage is a blood vessel and the diseased portion includes an atheromatous plaque.

There is also provided, in accordance with an embodiment of the method(s) of the present application, a method for collecting debris from an internal passage of a mammalian subject. The method comprising the steps of,

inserting a corrugated balloon catheter including a balloon having at least one corrugated portion as defined hereinabove into the internal passage, and advancing the catheter until the distal end thereof has reached a site at which it is desired to collect debris,

inflating the corrugated balloon with expansion fluid, pulling the at least one movable part of the inner conduit of the catheter in a proximal direction, for collapsing the distal end of the corrugated balloon to form a cavity within the balloon into which debris is collected and entrapped,

deflating the intussuscepted corrugated balloon, and

removing the deflated corrugated balloon catheter from the internal passage of the subject, together with the entrapped debris.

Furthermore, in accordance with an embodiment of the method, the step of pulling includes pulling the at least one movable part of the inner conduit in a proximal direction to form the cavity, such that all of the corrugated portions of the balloon are disposed within the cavity to enhance retention of the debris.

Furthermore, in accordance with an embodiment of the method, the catheter includes a mechanism for reducing pressure changes within the catheter when the at least one movable part of the inner conduit is moved proximally within the outer conduit while the balloon is inflated and the fluid port is closed. The step of pulling includes pulling the at least one movable part of the inner conduit in a proximal direction, for collapsing the distal end of the corrugated balloon to form a cavity within the balloon into which debris is collected and entrapped without inducing substantial pressure changes within the lumen of the balloon during the intussuscepting of the corrugated balloon.

Finally, in accordance with an embodiment of the method, the internal passage is a diseased blood vessel and the step of inflating includes inflating the corrugated balloon while the balloon is disposed near or within an atheromatous plaque of the blood vessel. The inflating is performed such that at least part of the corrugated portion of the at least one corrugated portion of the balloon is pushed against the plaque and wherein at least some debris from the plaque adheres to the corrugated portion and is internalized within the cavity formed in the step of pulling.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings, in which like components are designated by like reference numerals, wherein:

Figs. 1A to 1C are schematic cross sectional views illustrating a rapid exchange catheter having a corrugated balloon in which the distal section of the inner tube includes an internal slidable tube according to an embodiment of the catheters of the present application;

Figs. I D and I E are schematic cross sectional views illustrating parts of two additional embodiments of rapid exchange catheters having different balloon shapes and usable for different types of balloon manipulations and balloon infolding during use thereof;

Fig. I F is a cross sectional view illustrating a part of an additional embodiment of a rapid exchange catheter having a piston-like member for preventing pressure changes within the catheter during retraction of a slidable tube of the catheter;

Figs. 2A - 2C are longitudinal section views of part of a rapid exchange catheter according to another embodiment of the rapid exchange catheter of the present application in which the diameter of the distal portion of the inner tube is adapted to receive an internal slidable tube;

Fig. 3 is a cross sectional view illustrating a rapid exchange catheter in which an external slidable tube slide over the distal portion of the inner tube, in accordance with yet another embodiment of the catheter of the present application;

Fig. 4 is a cross sectional view illustrating a rapid exchange catheter in which the diameter of the distal portion of the inner tube is adapted to be received within an external slidable tube according to yet another embodiment of the catheter of the present application;

Fig. 5 is a cross sectional view illustrating a rapid exchange catheter in which the distal part of the inner tube includes a fixed inner tube on which an external slidable tube is mounted, according to yet another embodiment of the catheter of the present application; Figs. 6A - 6C are schematic cross sectional views illustrating a rapid exchange catheter having having an inner tube which is encompassed by a slidable intermediate tube, according to yet another embodiment of the catheter of the present application;

Figs. 7 A to 7B are schematic cross sectional views illustrating a rapid exchange catheter having a movable inner tube attached to an external slidable sealing sleeve, in accordance with yet another embodiment of the catheter of the present application;

Fig. 7C is a schematic cross sectional view illustrating part of a rapid exchange catheter having a movable inner tube attached to an internal slidable sealing sleeve, in accordance with still another embodiment of the catheter of the present application;

Fig. 8A is a schematic side view diagram illustrating a corrugated inflatable sleeve-like element usable as an intussusceptible balloon in a balloon catheter in accordance with an embodiment of the balloons of the present application;

Fig. 8B is a schematic cross section of the corrugated balloon of Fig. 8A, taken along the lines VIII-VIII;

Figs. 9-12 are schematic side view diagrams illustrating different types of corrugated inflatable intussusceptible balloons, in accordance with additional embodiments of the balloon of the present application;

Figs. 13-15 are schematic cross-sectional diagrams illustrating different types of corrugated inflatable intussusceptible balloons having different types of corrugations, in accordance with further additional embodiments of the balloon of the present application;

Figs. 16-19 are schematic cross-sectional diagrams illustrating additional different types of corrugated inflatable intussusceptible balloons having different types of corrugated balloon regions and/or different balloon wall thickness at different portions of the balloon, and/or multiple different types of folds on the same balloon, in accordance with yet further additional embodiments of the balloon of the present application;

Fig. 20-21 are schematic cross-sectional diagrams illustrating additional types of corrugated inflatable intussusceptible balloons having partially corrugated middle balloon portions and/or corrugated side portions, suitable for use in the rapid exchange catheters in accordance with yet additional embodiments of the corrugated balloon of the present application; Figs. 22-25 are schematic cross-sectional diagrams illustrating parts of corrugated balloons having different additional types of folds or corrugation shapes and/or having multiple corrugated portions interspersed with non-corrugated portions, in accordance with additional embodiments of corrugated balloons of the present application;

Fig. 26 is a schematic cross sectional diagram illustrating part of the wall of a corrugated balloon having alternating types of differently shaped corrugations, in accordance with an embodiment of the corrugated balloons of the present application; and

Figs. 27A-27B are schematic cross-sectional diagrams illustrating parts of a rapid exchange catheter system including a corrugated intussusceptible inflatable balloon and a pressure regulating mechanism in accordance with other embodiments of the catheter systems of the present application.

DETAILED DESCRIPTION OF THE INVENTION

Notation Used Throughout

The following notation is used throughout this document.

Term Definition

PEBA Polyether block amides

CA Cyanoacrylate

mm millimeter

OVT Over the wire

PE Polyethylene

PET Polyethylene terephthalate

RE Rapid exchange

It is noted that the terms "corrugated balloon" and "concertina-like balloon" (in the single as well as the plural forms) are interchangeably used herein to indicate a balloon or an inflatable element having multiple folds or corrugations formed at least in a part or a portion thereof. The folds or corrugations may be symmetrical or non-symmetrical and may be of any desired shape such as but not limited to folds having triangular, or rounded, or curved, or sawtooth like cross-sectional shape or any other suitable cross- sectional shape.

It is also noted that in the following description and in the claims of the present application, the terms "distal" and "proximal" are defined as follows: the catheter side or end which is inserted into the body first is referred to as the distal side or distal end and the trailing side or end of the catheters part of which remains outside the body after insertion of the catheter is referred to as the proximal side. For example, in the balloon catheter 10 of Fig. 1A, the fluid port 17 is disposed on the proximal side of the catheter 10 and the attachment point 2a is disposed near the distal side or distal end of the catheter 10.

Similarly, when referring to sides, parts or portions of the corrugated balloons (or sleeve-like elements) of the catheters of the present application, the term distal refers to a part, end or portion of the balloon (or sleeve-like element) which is inserted first into the body when the balloon catheter is operated. For example, the corrugated balloon 22 of Figs. 8A-8B has a middle portion 10A, a proximal side portion 10B and a distal side portion IOC. Reference is now made to Fig. 3 which is a schematic cross-sectional diagram illustrating a catheter system including the inflatable corrugated intussusceptible balloon of Fig. 1 , in accordance with an embodiment of the catheter systems of the present application.

In the following description, the terms "conduit" and "tube" are used interchangeably throughout the application wherein a conduit may include multiple tubes in various relationship thereof. For example, a conduit may include two or three tubes of different diameters wherein one of the tubes may be movably or fixedly disposed within one or more of the other tubes. However, it is noted that the term conduit may also be used to define a single tube ( for example, the inner conduits of the catheters 70 and 70a of Figs 7A and 7C, respectively, are comprised of a single inner tube 74, as disclosed in detail hereinafter). Thus, as defined herein, the term "conduit" may also refer to a component comprising one or more parts or tubes in different moving or fixed relationships therebetween.

Furthermore, the term "outer conduit" may be used to define the hollow shaft of the catheters of the present application (such as, but not limited to, the hollow shafts 6, 63 and 76 of Figs. 1 A, 6A and 7A, respectively).

The present invention provides rapid exchange catheter implementations in which the length of a distal portion of the catheter and the shape and/or volume of its distal balloon may be manipulated during procedures carried out therewith. The catheters have a corrugated balloon that has at least one corrugated portion (some embodiments of the catheters have balloons with several corrugated portions). The corrugated portion(s) provides several advantages over the use of non-corrugated balloons of similar dimensions.

A first advantage is the increasing of the surface area of the balloon which is available for trapping and retaining debris resulting from treatment of a treated site, such as, but not limited to, debris resulting from treating an atherosclerotic plaque in coronary or other blood vessels. The corrugated portion(s) of the balloons of the present application have larger surface area as compared to non-corrugated balloons having the same diameter and length used in similar catheters (such as the smooth balloons of the RE catheters disclosed in WO 2007/042935). The increased surface area advantageously increases the area available for attachment and trapping of such harmful debris. To the best of applicants' knowledge, the use of a corrugated balloon for the purpose of providing increased surface area for attachment and entrapment of debris is a novel feature and has not been disclosed in the art. Furthermore, The specific geometry of the corrugated portion of the balloons disclosed herein may provide a conveyor belt-like effect that carries particles and debris trapped within the corrugations initially disposed on the outside surface of the balloon and during the intussuscepting of the balloon moves these particles and debris into the internal cavity produced in the balloon as the formerely external corrugated surface is internalized within the cavity formed in the balloon

Another advantage of the novel corrugated balloons disclosed herein is the providing of better control of the folding or intussuscepting of the balloons of the RE catheters during operation of the catheter. This novel feature is based on the reduction of the longitudinal force required for causing the collapse of a corrugated balloon portion as compared to a non-corrugated portion. Furthermore, by changing the position of the corrugated portion(s) along the length of the corrugated balloon it is possible to implement preferential collapse of the balloon in either the distal portion of the balloon (which is the preferred embodiment) or in the proximal portion of the balloon as desired in response to longitudinal forces exerted on the balloon, as disclosed in detail hereinafter. In accordance with other embodiments of the catheters it is possible to provide balloons which collapse both in the distal and proximal portions thereof in response to longitudinal forces exerted on the balloon, as disclosed in detail hereinafter. To the best of applicants' knowledge, the use of a corrugated balloon for the purpose of enabling preferential collapse of a selected portion (either proximal portion or the distal portion) of the balloon during application of a longitudinal pulling force on the balloon is a novel feature and has not been previously disclosed in the art of interventional catheters.

An additional advantage of the corrugated balloons disclosed herein is that the corrugation also reduces the trauma to the blood vessel wall when the balloon is used in a tortuous (banded) blood vessel since the corrugation of the balloon reduces the inflated balloon bending stiffness. When the corrugated balloon is placed within a tortuous blood vessel and the balloon is inflated to its nominal inflation pressure, the tendency of the balloon to straighten (and potentially damage the blood vessel) is reduced due to the presence of the corrugations.

In general, the rapid exchange catheter of the invention comprises an outer catheter shaft and an inner tube provided therein, wherein the lumen of the inner tube may be accessed via a lateral port provided on the catheter's shaft. In some of the preferred embodiments of the catheter described herein the inner tube of the catheter is affixed to the catheter's outer shaft and the catheter's length and its balloon are manipulated by a unique construction of the inner tube. In these constructions the catheter's inner tube may comprise a slidable distal tube that may be moved by the operator, distally or proximally relative to the catheter's outer shaft, by an elongated moving member attached thereto. Alternatively, the inner tube may be disposed within the lumen of a slidable intermediate tube which may be moved by the operator distally or proximally relative to the catheter's shaft.

In further embodiments of the invention a unique catheter construction is developed in order to provide a movable inner tube affixed to a slidable sealing sleeve which allows the operator to move the inner tube distally or proximally relative to the catheter's outer shaft and thereby manipulate its length and balloon.

Figs. 1 A-1C are schematic cross sectional views illustrating a rapid exchange catheter having a corrugated balloon in which the distal section of the inner tube includes an internal slidable tube according to an embodiment of the catheters of the present application .

Turning to Fig. 1A, the catheter 10 includes a hollow outer shaft 6 having an inner tube 14 installed therein, and a slidable internal tube 13 disposed within the inner tube 14 such that the slidable internal tube 13 protrudes distally via the distal opening of the inner tube 14. In this construction, the inner lumens of the inner tube 14 and the slidable internal tube 13 are in communication, providing a continuous inner lumen ending at the distal opening of the slidable internal tube 13. The catheter 10 includes a corrugated balloon 11a. The Proximal end of the balloon 11a is attached to the hollow outer shaft 6 at proximal attachment points 2b provided around the outer surface of a distal portion of the shaft 6, and the distal end of the balloon 11a is attached to the slidable internal tube 13 at distal attachment points 2a provided around the outer surface of a distal portion of the slidable internal tube 13. The corrugated balloon 11a includes a corrugated cylindrical portion 11c, a conical non-corrugated distal portion lid and a conical non-corrugated proximal portion lie.

The lumen of inner tube 14 may be accessed via a lateral port 12 provided on hollow outer shaft 6, between the distal and proximal ends thereof. A guide-wire 5 (or any other suitable accessories, instruments or devices for diagnosis or treatment, as is known in the art) may be inserted via lateral port 12, advanced along the inner lumens of the inner tube 14 and the slidable internal tube 13, and may exit the inner lumen of the slidable internal tube 13 through a distal opening thereof. The slidable internal tube 13 is adapted to fit into the inner tube 14 and its diameter is preferably smaller than the diameter of the inner tube 14 such that it seals the distal opening of the inner tube 14 while still permitting distal and/or proximal sliding longitudinal movements of the slidable internal tube 13 within the inner tube 14.

The catheter 10 includes an elongated moving member 18. The elongated moving member 18 is implemented as a rod or wire made from stainless steel or any other suitable strong material. The distal end portion of the moving member 18 is attached to the slidable internal tube 13, allowing the operator to move the slidable internal tube 13 distally or proximally relative to the catheter's outer shaft 6 by pushing or pulling the proximal end of moving member 18. Further sealing of the distal opening of the inner tube 14 may be (optionally) achieved by an annular gasket 4 attached to the surface of the distal end of inner tube 14 such that a distal portion of the gasket 4 is pressed against an annular portion of the outer surface of the slidable internal tube 13.

The proximal portion of the hollow shaft 6 includes a fluid port 17 usable for inflating or deflating the corrugated balloon 11a by flowing an inflation fluid into or out of the fluid port 17 (such as, for example, by attaching an indeflator device to the fluid port 17 as is known in the art and using the indeflator device to inject or withdraw fluid through the fluid port, respectively). The catheter 10 also includes an optional over-pressure (discharge) valve 16 installed in a discharge valve outlet 15, and an aperture 19 for sealingly moving the member 18 distally or proximally therethrough. The moving member 18 passes through and is sealingly disposed within the aperture 19, such that it may be moved proximally and distally within the shaft 6. During a typical procedure catheter 10 is inserted into a body treatment site in which the corrugated balloon 11a may be inflated by an inflation fluid (entry of the inflation fluid is schematically designated by arrows 7a in Fig 1 A) flowing through inflation fluid port 17 under pressure, for effecting dilatation or other procedures in the treatment site and/or for anchoring the balloon 11a therein. The pressurized fluids pass through the hollow interior of hollow shaft 6 and reach the interior of the balloon 11a via a distal opening of the shaft 6. In its inflated state, shown in Fig. IB, the hollow interior of shaft 6 and the internal space of balloon 11a are filled with pressurized inflation fluid. The distal opening of the inner tube 14 is sealed by the slidable internal tube 13 and (optionally) by the gasket 4, preventing leakage of pressurized inflation fluid into the inner tube 14. The pressure of the inflation fluid inside the system presses the gasket 4 and improves the sealing provided by gasket 4. On the other hand, when the pressure of the inflation fluid is reduced, the gasket's grip on the outer surface of slidable internal tube 13 is diminished which makes it easier for the slidable internal tube 13 to slide within the gasket 4.

Turning to Fig. I B, in operation, the catheter 10 may be inserted into the body and advanced to the target to be treated. For example, the catheter 10 may be inserted into a blood vessel and placed within an atherosclerotic region to be treated (region not shown). The balloon 11a may then be inserted into the occluded region and inflated to treat the occlusion as is known in the art. When the balloon 11a is inflated and expanded, the corrugated region or part thereof may come into contact with the plaque of the stenosed blood vessel wall and some of the plaque debris which may have formed during the expansion may adhere to the external surface of the corrugated portion 11c. As the surface area of the corrugated portion is larger than the surface of a similar balloon having similar dimensions and a smooth (non-corrugated) portion, the corrugated balloon 11a is advantageously configured for collecting adhering and entrapping such debris, and may collect and retain more debris than a smooth walled balloon of equivalent dimensions.

The requisite procedure is typically carried out in the inflated state of the balloon 11a. In using the catheter 10 for such procedures the operator may manipulate the catheter length and the shape and volume of the balloon 11a by pulling the moving member 18, thereby moving the slidable internal tube 13 proximally further into the inner tube 14, as demonstrated by arrows 8a. As a result, the distal end of the balloon 11a collapses and folds internally, as illustrated in Fig. 1 C, which increases the pressure of the inflation fluid. Whenever the pressure of the inflation fluid inside the hollow interior of hollow outer shaft 6 and in balloon 11a exceeds a predetermined threshold value, a slender passage of the over-pressure valve 16 is expanded to allow portions of inflation fluid to exit via discharge valve outlet 15 reducing the pressure of inflation fluid below the threshold value.

It is noted that the use of the over-pressure valve 16 and the discharge valve outlet 15 constitutes merely one possible, exemplary means of pressure reduction, and that other means for preventing a substantial pressure change within the catheter 10 and the balloon 11a may also be used as is disclosed in detail hereinafter.

The Hollow outer shaft 6 is preferably made from a polymer based or metallic material, such as stainless steel 316, nitinol, nylon®, and the like and it may be manufactured utilizing conventional methods, such as extrusion and laser cutting, or any other manufacturing method known in the art. The diameter of the hollow interior of hollow shaft 6 is generally in the range of 1 -2 mm (millimeter), preferably about 1.2 mm, and the diameter of the inflation fluid port 17 is generally in the range of 2-6 mm, preferably about 3 mm. The diameter of discharge valve outlet 15 is generally in the range of 2-6 mm, preferably about 3 mm, and the entire length of the hollow shaft 6 is generally in the range of 500-2000 mm, preferably about 1200 mm.

The inner tube 14 is preferably made from a flexible polymer or metallic material, such as PEBAX ®, nylon®, stainless steel, nitinol, or any other suitable material, and may be manufactured utilizing conventional methods, such as extrusion and laser cutting. The diameter of the inner lumen of the inner tube 14 is generally in the range of 0.3-1 mm, preferably about 0.8 mm, and its entire length is generally in the range of 100-300 mm, preferably about 120 mm. The slidable internal tube 13 is preferably made from a flexible polymer or metallic type of material, such as pebax, nylon, stainless or nitinol, and it may be manufactured utilizing conventional methods, such as PEBAX®, nylon®, stainless steel, nitinol and the like. The diameter of inner lumen of the slidable internal tube 13 is generally in the range of 0.3-1 mm, preferably about 0.5 mm, and its entire length is generally in the range of 30-150 mm, preferably about 70 mm. However, the typical dimensions of the various parts of the catheter disclosed herein and the materials used for constructing them are given by way of example only, are not obligatory, and may vary substantially depending, inter alia, on the particular medical application of the catheter, the type and size of the treated bodily passage or blood vessel being treated and other engineering, manufacturing and operating considerations.

In view of the axially-directed stretching and buckling forces exerted on the inner and outer tubes during elongation and shortening of the balloon, the tubes need to be constructed such that they are able to withstand axially-directed forces in the range of between 1 and 30 Newton without undergoing deformation. In order to achieve this aim, the conduits may be constructed of a braided material or reinforced material (made by using any suitable reinforcing method known in the art) or of materials having a defined molecular orientation. The approximate maximum forces that the inner and outer tubes need to withstand (for two difference size ranges of balloon) are as follows:

For 2-4 mm balloons, the tubing should withstand up to 500g ; polymer tubing made of nylon or pebax reinforced during the manufacturing process may be used.

For 4-6 mm (or larger) balloons, the tubing should withstand forces up to 2 kg. In this case it will be necessary to use a braided tube (polymer tube with metal mesh reinforcement) or a tube reinforced by any other suitable tube reinforcing methods known in the art.

Exemplary results for a representative study of the forces generated during balloon folding for a smooth non-corrugated balloon are given in detail in WO 2007/042935 and are therefore not be discussed in detail herein.

Corrugated Balloon 11a is preferably a type of non-compliant or semi-compliant or low-compliant balloon. It may be manufactured utilizing conventional methods known in the balloon catheter industry from a biocompatible polymer type of material such as nylon 12, PET, PEBAX®, PA12 PEBAX®, PEBA, Nylon® 11 (PA1 1 ) and the like. The length of the balloon 11a length is generally in the range of 3-350 mm, preferably about 15-50 mm, and its diameter is generally in the range of 2 to 12 mm, preferably about 3 to 5 mm. However, these dimensions are exemplary only, are not meant to be limiting and other different dimensions may be used in making the catheters disclosed herein depending, inter alia, on the particular application, the materials used and other technical and medical considerations.

The proximal and distal ends of the balloon 1 la are preferably sealingly attached to the outer surfaces of the hollow shaft 6 and the slidable internal tube 13, at circumferential attachment points 2b and 2a respectively, by utilizing a low profile type of adhesion such as thermo bonding, UV adhesives or a cyanoacrylate (CA) based adhesive (such as, for example, the cyanoacrylate adhesive manufactured by Locktite Corporation, USA), however, any other attaching method known in the art may be used. Preferably, but not obligatorily, the balloon should have a burst pressure within the range of 6-24 atmospheres.

The materials and design of the corrugated balloons disclosed herein, such as but not limited, the position, number and type of the corrugated portion(s) of the balloon, the shape of the distal taper and the relationship between the distal and the proximal taper, may assist the balloon to fold smoothly and with relatively low pulling forces. Balloon configurations and designs for smooth non-corrugated balloons where disclosed in details in WO 2007/042935 and are therefore not disclosed in details herein, such configurations and designs may also be used in the corrugated balloons of the present application where relevant.

For example, a tapered balloon with a round (smooth or corrugated) ending may be used allowing a relatively low retracting force, when compared to standard tapered balloon or a balloon with a round ending. In an embodiment, the balloon has a proximal taper cone shaped with a 15 - 17 degree angle, and a 15 degree round cone distal taper, having a radius of about 0.5 mm at the junction of the taper and the neck. The corrugated portion 11c may have corrugations having a triangular cross-section (see also similar corrugations of the balloon illustrated in Fig. 8B).

The moving member 18 may be manufactured from a metal wire or tube, such as Stainless steel, Nitinol , and/or from a polymer, having a diameter generally in the range of 0.2-2 mm, preferably about 0.5 mm, and length generally in the range of 50-150 mm, preferably about 100 mm. The distal portion of moving member 18 is attached to the distal portion of slidable internal tube 13 by any suitable attaching method such as but not limited to gluing bonding embedding and the like. Most preferably, the distal portion of the moving member 18 may be embedded into the wall of internal tube 13 thereby enhancing its rigidity and the grip provided therewith. The aperture 19 is adapted to allow conveniently moving the moving member 18 therethrough while providing suitable sealing of the hollow interior of hollow shaft 6, thereby preventing leakage of inflation fluid therefrom. It is noted that the moving member 18 may be a single member or several members, such as but not limited to several wires (not shown).

In operation, the inflation fluid is preferably a saline or a saline mixed with radio- opaque solution in different ratios. A syringe pump, or other suitable inflation pumps or indeflator devices, as commonly used in the field, may be used for introducing the inflation fluid into the system. The pressure in the system in its various states typically varies between low pressure (vacuum) and up to 25 atmospheres.

While different types of over-pressure (discharge) valves may be employed, overpressure valve 16 is preferably implemented by an annular element having an axial slender passage passing therein. In such implementation over-pressure valve 16 is manufactured from an elastomer type of material, such as PVC by an injection molding process. Its outer diameter is generally in the range of 2-6 mm, preferably about 4 mm, and its slender passage is designed to expand whenever a pressure gradient of about 4 bar evolves between its ends.

Optionally, in accordance with an embodiment of the rapid exchange catheter, a piston-like member 18c is attached to the moving member 18 (or formed as a contiguous part thereof). An elongated cylindrical potion 6b is formed in the proximal part of the hollow shaft 6. The piston-like member 18c is movably disposed within the cylindrical portion 6b as illustrated in Fig. IF. The piston-like member 18c allows for a syringe like action of the moving member 18 when the member 18 is retracted proximally, causing the piston-like member 18c to retract proximally within the cylindrical portion 6b allowing the accommodating of a sufficient amount of inflation fluid ejected from the inflated balloon 11a during retraction of the piston-like member 18c. This accommodation of inflation fluid in the space created by the proximal moving of the piston-like member 18c prevents substantial pressure increase in the catheter and in the balloon 11a during retraction of the member 18. Turning to Fig. 1 C, when the balloon 11a is in the inflated state and the member 18 is pulled proximally, balloon 11a fold as its distal end collapses and invaginates internally within the balloon 11a forming a distal cavity 3a defined by the inwardly folded distal portions of the balloon 11a. The volume encompassed by the cavity 3a may be enlarged by (partially or entirely) deflating the balloon 11a in this folded state. Such partial or full deflation of the balloon 11a may result in filling the enlarged cavity 3a with samples and/or debris from the treatment site.

It is noted that when the distal portion lid of the balloon 11a collapses and the balloon 11a folds, the portion lid and at least part of the corrugated portion 11c are internalized such that their formerly externally facing walls now form part of the walls defining the internal cavity 3a. Therefore, any debris that was attached or adhered to the surface of corrugated portion 11c will be entrapped in the cavity 3a of the inflated balloon 11a and (after deflation of the balloon) the deflated balloon 11a.

Different distal balloons may be designed to provide various balloon manipulations as disclosed hereinafter and illustrated in the drawing figures. For example, in balloon lib illustrated in Fig. I E, a proximal portion of the balloon collapses and folds inwardly in response to movement of slidable internal tube 13 proximally, thereby forming a proximal cavity 3b. Such a result may be achieved by using a balloon which has higher resistance to folding at its proximal tapered end relative to its distal tapered end. This may be achieved, inter alia, by using a balloon having different angles at its distal and proximal tapers wherein a steeper taper facilitates folding of the proximal tapering end, or by using a balloon having a distal portion with thicker walls and a proximal portion with thinner walls, or by using a balloon having a corrugated proximal portion and a non-corrugated distal portion(and/or central portion) wherein the proximal corrugated portion preferentially collapses during the application of a longitudinal pulling force. It is noted that a combination of any or of all of the above means for achieving preferential collapse of the proximal potion of the balloon may be used in accordance with an embodiment of the catheter of the present application.

Similarly, in accordance with another embodiment of the catheter of the present application, using a balloon which has higher resistance to folding at its distal tapered end relative to its proximal tapered end will ensure ( or increase the probability of) preferential collapse of the distal end of the balloon. This may be achieved, inter alia, by using a balloon having a steeper taper of the distal tapering end, or by using a balloon having a proximal portion with thicker walls and a distal portion with thinner walls, or by using a balloon having a corrugated distal portion and a non-corrugated proximal portion(and/or central portion) wherein the distal corrugated portion preferentially collapses during the application of a longitudinal pulling force. It is noted that a combination of any or of all of the above means for achieving preferential collapse of the distal potion of the balloon may be used in accordance with an embodiment of the catheter of the present application. Various different examples of such balloons with preferential collapse of a selected end are disclosed in more detail hereinafter.

Turning to Fig. I D, in balloon llab both, both proximal and distal portions of the balloon are folded in response to movement of slidable internal tube 13 proximally, thereby forming a proximal cavity 3 b and a distal cavity 3a. This result may be obtained for example, by using a balloon llab with a symmetric shape - namely, the balloon having the same taper at its distal and proximal sides. Alternatively or additionally, the wall thickness of the proximal portion and the distal portion may be made smaller than the wall thickness of the middle (generally cylindrical) portion with the result of collapse and folding of both proximal and distal ends of the balloon and the formation of both a distal and proximal cavities (such as, for example, the cavities 3a and 3b, respectively)- this may be achieved by suitably modifying the wall thickness of the different corrugated and/or non-corrugated portions of the corrugated balloons described in the present application, depending, inter alia on the specific structure, shape and dimensions of the specific balloon being used.

Thus, any suitable combination of modifications of any desired portion of the corrugated balloons described herein may be used to select either preferential distal collapse (which is the preferred embodiment) or preferential proximal collapse, or both proximal and distal collapse. Such modifications may include changing the wall thickness of any selected portion (or portions) of the balloon relative to the wall thickness of other potion(s) of the balloon, changing the steepness of taper of one of the proximal and distal portion of the balloon relative to the steepness of the taper of the remaining portion, and changing one or more parameter of the corrugated portion of the balloon. Such one or more parameter may include, but are not limited to, the position of the corrugated portion on the balloon, the length of the corrugated portion and/or the type and/or cross-sectional shape of the corrugated portion, the number of the corrugated portions of the balloon, and the like. If there are more than one corrugated portions in the balloon a suitable modification of one or more of the parameters of the corrugated portions relative to the other, or relative to the same parameter of a non-corrugated portion of the same balloon may also be used to achieve a desired preference for collapse of a selected portion of the balloon (distal or proximal) or to achieve collapse of both proximal and distal portions of the balloon.

The procedure for using the balloon catheter(s) of the present application may be briefly described as follows:

1) Inserting of catheter into the body via peripheral blood vessel by use of standard rapid exchange methods, as are well known in the art (a guide-wire may be used for the insertion, such as for example the guide-wire 5 of Fig. 1 A) until the balloon reaches the target area to be treated.

2) Inflating the balloon by injecting inflation fluid via fluid port 17 and the inner lumen of outer shaft 6, as demonstrated by fluid inflation arrows 7a in Fig. 1A. The pressure inside balloon 11 may be in general about 1-25 Atmospheres, preferably about 6 Atmospheres. The inflating of the balloon may already constitute treatment of the target region, such as in the case where the balloon (in the non-inflated state is disposed within a stenosed target region and the inflation of the balloon expands the balloon causing compaction and/or opening of the occluded region. In this state, with the balloon catheter 10 inflated and firmly anchored at the treatment site, the inner lumens of inner tube 14 and of slidable internal tube 13 may now be utilized for operating at the treated site with different interventional tools (not shown) inserted through the lateral port 12 into the lumen of the inner tube 14 and the slidable internal tube, as may be required. It is noted that while the corrugated portion 11c of the corrugated balloon 11a may be placed within the region of the plaque or atheromatous occlusion and may used to treat the plaque by pushing the plaque towards the walls of the blood vessel (not shown) to open a larger passage within the atheromatous portion of the blood vessel, other different treatment methods are also possible, in which the corrugated portion 11c is not used as a plaque treating or plaque pushing means, but is used as an anchoring portion of the corrugated balloon 11a enabling firm anchoring of the catheter 10 to the walls of the blood vessel which in turn allows other different plaque treating devices (not shown) to be inserted into the lumen of the inner tube 14 (after withdrawal of the guide-wire 5 , or alternatively without withdrawal of the guide-wire if the device(s) are included in the guide-wire) for treating the plaque. In such alternative treatment methods, the balloon is typically positioned within the blood vessel at a site proximal to the position of the plaque or occluded region, and treatment is performed by an additional treating device (such as, but not limited to, a rotablator burr, a mechanical cutting device, a laser device such as an excimer laser or other laser for performing ELCA or other types of laser based atherectomies, a radiofrequency angioplasty device, an ultrasonic ablator device, and the like) inserted into the lumen of the inner tube 14. However, some procedures (for example angioplasty) may be completed, or may be near completion, once the balloon 11a reaches its fully inflated state.

3) If required, a sample or other liquid or solid matter (for example fluids, secretions, and/or debris) may be collected from the treatment site, by pulling the moving member 18 proximally to retract the slidable internal tube 13 proximally, as demonstrated by arrow 8a in Fig. IB. During retraction of slidable internal tube 13 by the operator, the distal end of balloon 11a collapses and its outer surface portions are folded inwardly over the distal end of slidable internal tube 13 and thereafter over itself as further portions of the balloon collapse, as illustrated in Fig. 1C.

4) Retraction of slidable internal tube 13 and the resulting inward folding of balloon 11a shorten the overall length of inflated balloon 11a which actually reduces the volume of inflated balloon 11a. Consequently, the pressure of the inflating fluids increases, resulting in a considerable pressure increase in balloon 11 and inner lumen of outer shaft 6. Whenever the pressure in balloon 11a and in the inner lumen of outer shaft 6 reaches a certain set-point (e.g., 5-20 atmospheres) inflation fluids are discharged via over-pressure valve 16, as shown by arrows 7b in Fig. I B, such that the pressure in balloon 11a and inner lumen of outer shaft 6 remains within a predetermined pressure range (e.g., 5-20 atmospheres, but other pressure threshold values are possible). Another exemplary option for preventing substantial pressure increase within the catheter during intussuscepting of the balloon 11a in the catheter embodiment illustrated in Fig. IF, is by proximally pulling the piston-like member 18c of the member 18 so it acts similar to a syringe action and accommodates the inflation fluid ejected from the balloon during the proximal pulling of the member 18, as disclosed in detail hereinabove with respect to Fig. IF. During this step, the operator may determine via a graduated scale (not shown) provided on moving member 18 (or on the piston-like member 18c) the amount of length of inner tube 14 that has been retracted and in this way determine when to stop the retraction of inner tube 14.

5) Subsequently, the balloon 11a is deflated by withdrawal of inflation fluids via fluid port 17. As a result, the pressure inside balloon 11a and inner lumen of outer tube 6 is substantially decreased, and the balloon 11a is deflated. The reduction in the volume of balloon 1 la results in enlargement of distal cavity 3a.

6) The operator may then retract balloon catheter 10 proximally such that portion of fluid/secretion and debris confined within proximal cavity 3a are withdrawn with the balloon catheter 10 (not shown in the figures). The debris, objects or samples collected may be easily collected when the entire length of balloon catheter 10 is ejected from the body of the treated subject, by pushing the inner tube 14 distally and unfolding the folded portions of balloon 11a, thus restoring the deflated state of balloon 11a (shown in Fig. 1A).

Figs. 2A - 2C are longitudinal section views of part of a rapid exchange catheter according to another embodiment of the rapid exchange catheter of the present application in which the diameter of the distal portion of the inner tube is adapted to receive an internal slidable tube.

In rapid exchange catheter 20 includes an inner tube 24a having a non-uniform cross- section. The diameter of a distal portion 24b of the inner tube 24a is adapted to receive an internal slidable tube 13. In this embodiment, the diameter of the distal portion 24b of the inner tube 24a is larger than the diameter of the proximal portion thereof. The internal slidable tube 13 is configured to tightly fit into the proximal portion 24b to seal its distal opening and prevent leakage of inflation fluid thereinto. Alternatively or additionally, sealing may be achieved by a gasket 4 attached to the distal portion 24b of inner tube 24a such that a distal portion of the gasket 4 is pressed against an annular portion of the outer surface of slidable internal tube 13. The internal slidable tube 13 and the proximal portion of inner tube 24a may be manufactured to have lumens having the same inner diameter, thereby forming a substantially uniform inner passage therealong, particularly when internal slidable tube 13 is advanced all the way into the distal portion 24b.

The structure and geometrical dimensions of the components of catheter 20 are much the same as those components designated by the same reference numerals which were described above with reference to Figs. 1A to 1 C. In addition, the construction of the catheter tubes such that they are able to withstand the axially-directed stretching and buckling forces in this, and in all subsequent embodiments, are as described hereinabove, in connection with the first-described embodiment.

While the balloon 11a of Fig. 1A has a corrugated middle portion 11c a proximal non-corrugated conical portion lie and a distal non-corrugated portion lid, the balloon llf of Figs 2A-2C has a distal corrugated portion llh (including the distal conical portion and part of the middle cylindrical portion of the balloon llf) and a proximal non- corrugated portion llg (including the proximal part of the cylindrical middle portion of the balloon and the proximal conical portion of the balloon).

The balloon llf may be inflated by inflation fluid (7a) introduced via the inflation fluid port 17, and the length of the catheter 20 and the shape and volume of balloon llf may be manipulated by moving the member 18 distally or proximally, as illustrated in Figs. 2A to 2C. It is noted, that different balloons may be used to provide various balloon folding configurations as exemplified in Figs. 1A-1 C, I D and IE.

The operation of the catheter 20 is similar to the operation of the catheter 10 as disclosed in detail hereinabove. Briefly, after insertion of the catheter into the body ( preferably using a guide-wire, such as, for example, the guide-wire 5 disclosed in Fig. 1 A), the balloon llf maybe positioned at or near the target to be treated and the balloon may be inflated with inflation fluid through the fluid port 17. After or during treatment of the target region (by using either the balloon llf as the treating part or any other treating device(s) or instrument(s) inserted through the lateral port 12 or by using both the balloon llf and one or more treating and/or diagnostic devices or instruments as disclosed in detail hereinabove for the catheter 10), the balloon llf is inflated as disclosed hereinabove. The part of the corrugated portion which is in contact with the target may thus efficiently trap some debris (not shown) which may adhere thereto during and/or after inflation of the balloon llf.

When the moving member 18 is pulled proximally, the internal slidable tube 13 attached thereto slides proximally within the portion 24b of the inner tube 24a causing the inflated balloon llf to intussuscept forming a cavity 3a and internalizing at least part of the distal corrugated portion llh with some of the debris (not shown) adhering thereto into the cavity 3a. Additionally, the corrugations of the distal corrugated portion llh may assist the preferential collapsing of the distal portion of the balloon llf by reducing the longitudinal force required to initiate the collapsing of the distal portion relative to the force required to initiate the collapse of the proximal portion of the balloon llf.

The inner tube 24a may be manufactured by an extrusion and laser cutting process from a plastomeric or metallic type of material, preferably from nylon, PET or stainless steel, as disclosed in detail hereinabove. The diameter of the distal portion of inner tube 24a is generally in the range of 0.3-2 mm, preferably about 0.5 mm, and the diameter of slidable internal tube 13 is adapted to provide tight fitting and the necessary sealing of distal opening of inner tube 24a when the internal tube is inserted therein. However, other different dimensions may also be used depending inter alia, on the, length and wall thickness of the inner tube 24a and of the internal slidable tube 13, the particular medical application and on engineering and other manufacturing considerations.

It is noted that while in the embodiments of the catheters illustrated in Figs 1A and

Fig 2A, the slidable tube 13 is inserted into the distal part of the inner tubes 14 and 24a , respectively and slides therewithin, this is not obligatory and the catheters of the present application may be constructed such that the slidable tube 13 slides over the inner tube 14 by suitably modifying the diameters of these components.

Reference is now made to Fig. 3 which is a cross sectional view illustrating a rapid exchange catheter in which an external slidable tube slide over the distal portion of the inner tube, in accordance with yet another embodiment of the catheter of the present application. In the catheter 30, an external slidable tube 13a is sealingly and slidably fitted over the distal end of an inner tube 14. The inner diameter of the external slidable tube 13a is only slightly larger than the outer diameter of the inner tube 14 to ensure smooth sliding and a sufficient sealing to prevent leaking of inflation fluid under pressure. In this embodiment the distal end of balloon Hi is attached to the external slidable tube 13a at distal attachment points 2a provided around the outer surface of a distal portion of the external slidable tube 13a. The diameter of the external slidable tube 13a is made slightly larger than the diameter of inner tube 14. The external slidable tube 13a is designed to tightly fit over the outer surface of the proximal section of inner tube 14 and to thereby seal its distal opening and prevent leakage of inflation fluid thereinto. The balloon Hi of the catheter 30 is similar to the balloon 11a of catheter 10 except that the distal end of the balloon Hi is adapted to accommodate the larger outer diameter of the external slidable tube 13a. Alternatively or additionally, sealing may be achieved by gasket 4a attached to the proximal end portion of external slidable tube 13a such that a proximal portion thereof is pressed against an annular portion of the outer surface of inner tube 14.

Using such external slidable tube 13a in catheter 30 permits the attachment of a relatively short moving member 18a to the proximal portion of the slidable tube 13a. Alternatively or additionally, the distal portion of the moving member 18a may be embedded into the wall of external slidable tube 13a along its longitudinal length, thereby enhancing its rigidity and the grip provided therewith.

The structure, geometrical dimensions of elements of catheter 30 designated by the same numerals, and the method of manipulating its length and balloon volume and shape, are much the same as those elements and manipulating method which were previously described hereinabove and therefore, for the sake of brevity, the elements will not be further discussed at this point. External slidable tube 13a may be manufactured from the same material and using similar methods as described for the inner slidable tube 13 hereinabove. In a practical typical example, the diameter of external slidable tube 13a may be in the range of 0.3-2 mm, preferably about 0.8 mm. However, other different larger or smaller diameters may be used, depending inter alia, on the, length and wall thickness of the inner tube 14 and of the internal slidable tube 13a, the particular medical application and on engineering and other manufacturing considerations.

Reference is now made to Fig. 4 which is a cross sectional view illustrating a rapid exchange catheter in which the diameter of the distal portion of the inner tube is adapted to be received within an external slidable tube according to yet another embodiment of the catheter of the present application. In the catheter 40, the diameter of the distal portion 44b of inner tube 44a is adapted to be received in an external slidable tube 13a. In this embodiment, the distal end of balloon 11a is attached to the slidable external tube 13a at distal attachment points 2a provided around the outer surface of a distal portion of the slidable external tube 13a. The diameter of distal portion 44b of inner tube 44a is made relatively smaller than the diameter of the proximal portion thereof. The external slidable tube 13a is designed to tightly fit over proximal portion 44b and thereby seal its distal opening and prevent leakage of inflation fluid thereinto. Alternatively or additionally, sealing may be achieved by gasket 4b attached to the proximal end of External slidable tube 13a such that a proximal portion thereof is pressed against an annular portion of the distal portion 44b of inner tube 44a.

The external slidable tube 13a of catheter 40 also allows attachment of a relatively short moving member 18a to the proximal portion of the slidable tube 13a. Alternatively or additionally, the distal portion of the moving member 18a may be embedded into the wall of external slidable tube 13a along its longitudinal length, thereby enhancing its rigidity and the grip provided therewith.

The structure, geometrical dimensions of elements of catheter 40 designated by the same numerals, and the method of manipulating of its length and balloon's volume and shape, are much the same as those elements and the manipulating method which were previously described hereinabove and therefore will not be further discussed here. Inner tube 44a may be manufactured by an extrusion and laser cutting process from a plastomeric or metallic type of material, preferably from nylon or stainless steel. The diameter of the distal portion 44b of inner tube 44a is generally in the range of 0.3-2 mm, preferably about 0.5 mm, and the diameter of external slidable tube 13a is adapted to provide tight fitting and the necessary sealing of distal opening of inner tube 44a when the external tube is mounted thereover. However, other different larger or smaller diameters may be used, depending inter alia, on the, length and wall thickness of the inner tube 44 and of the internal slidable tube 13a, the particular medical application and on engineering and other manufacturing considerations.

Fig. 5 is a cross sectional view illustrating a rapid exchange catheter in which the distal part of the inner tube includes a fixed inner tube on which an external slidable tube is mounted, according to yet another embodiment of the catheter of the present application. In The catheter 50, an external slidable tube 13a is slidably mounted over an inner tube 54b protruding distally through a distal opening of fixed inner tube 54a of catheter 50. In this embodiment, the distal end of balloon 11a is attached to the slidable external tube 13a at distal attachment points 2a provided around the outer surface of a distal portion of the slidable external tube 13a. A proximal end portion of the inner tube 54b is fitted into the distal opening of the fixed inner tube 54a, such that it seals the distal opening and most of its longitudinal length protrudes distally therefrom into the hollow interior of the hollow shaft 6. The diameter of external slidable tube 13a is adapted to tightly fit over the external surface of inner tube 54b, sealing its distal opening while allowing it to be easily moved distally or proximally thereon by the operator.

A sealant 4c (such as, but not limited to, a silicon based sealant or the like) may be applied to the proximal end of inner tube 54b in order to provide enhanced sealing of the distal opening of fixed inner tube 54a. Sealing of the distal opening of inner tube 54b may be achieved by an annular gasket 4 attached to the proximal end of external slidable tube 13a such that a proximal portion thereof is pressed against an annular portion of the outer surface of inner tube 54b.

The gasket 4 can be made of a flexible material such as silicone or polyurethane. Alternatively, the gasket 4 may be implemented by an added lubricant such as mineral oil or silicone oil which improves the sliding between the tubes. The sealing may be further increased by increasing the pressure in the balloon.

It should be noted that tubes 13a and 54a may be fixed tubes such that tube 54a is fixed to the shaft 6 and tube 13a is fixed to the distal neck of balloon 11a, such that tube 54b can slide into both tubes.

The structure, geometrical dimensions of elements of catheter 50 designated by the same numerals, and the method of manipulating of its length and balloon's volume and shape, are much the same to those elements and manipulating method which were previously described hereinabove and therefore will not be discussed here, for the sake of brevity. Fixed inner tube 54a and external slidable tube 13a may be manufactured by an extrusion and laser cutting process from a plastomeric or metallic type of material, preferably from nylon or flexible metal. Their diameters are adapted to provide tight fitting and the necessary sealing of distal openings of fixed inner tube 54a and of inner tube 54b.

Reference is now made to Figs. 6A to 6C which are schematic cross sectional views illustrating a rapid exchange catheter having an inner tube which is encompassed by a slidable intermediate tube, according to yet another embodiment of the catheter of the present application. In the catheter 60 (Fig. 6A), the inner tube 64 of catheter 60 is encompassed in a slidable intermediate tube 33b. In this embodiment, the distal end of balloon 11a is attached to the slidable intermediate tube 33b at distal attachment points 2a provided around the outer surface of a distal portion of the slidable intermediate tube 33b. A longitudinal opening 38 is provided on an upper side of slidable intermediate tube 33b. The inner tube 64 protrudes upwardly through the longitudinal opening 38 towards the upper side of the hollow shaft 6 at the location in which it is affixed thereto and provide an access to its lumen via lateral port 12.

During a procedure, the balloon 11a may be inflated by pressurized fluid (designated by arrows 7a in Fig. 6A) provided via inflation fluid port 17. As illustrated in Fig. 6B, pressurized inflation fluid passes through the hollow interior of hollow shaft 63 into the internal space of balloon 11a. The catheter and its balloon in the inflated state are illustrated in Fig. 6B. The proximal portion of intermediate tube 33b between longitudinal opening 38 and the proximal end of intermediate tube 33b may be sealed by a sealant 66 in order to prevent entry of inflation fluids thereinto. Whenever the pressure in balloon 11a and hollow interior of hollow shaft 63 is greater than a predetermined threshold value, a portion of the inflation fluids is discharged via over-pressure valve 16 installed in a valve outlet 15.

The proximal portion of intermediate tube 33b protrudes proximally via proximal opening 65 provided at the proximal end of shaft 63. Proximal opening 65 is designed to conveniently allow the sliding of intermediate tube 33b therethrough while providing suitable sealing thereof and preventing leakage of inflation fluid therefrom. Manipulation of the catheter length and its balloon shape and volume are performed by sliding the intermediate tube 33b proximally or distally relative to the catheter shaft.

For example, after inflating the balloon 11a, the operator may pull the proximal portion of intermediate tube 33b (in the direction represented by arrow 8a in Fig. 6B), causing the distal portion of balloon 11a to collapse and fold inwardly forming the cavity 3a, as illustrated in Fig. 6C. The longitudinal opening 38 is constructed to allow the sliding of the intermediate tube 33b proximally into a state in which the attachment point 2a reaches the distal end of the shaft 63, and on the other hand, to allow sufficient distal sliding of intermediate tube 33b in order to enable stretching the full length of balloon 11a.

The intermediate tube 33b may be manufactured by extrusion or laser cutting processes, from a plastomer or metallic type of material such as nylon, Teflon, or flexible stainless steel. The diameters of inner tube 64 and of intermediate tube 33b are adapted to allow insertion of inner tube into the lumen of intermediate tube 33b while providing suitable sealing thereof and preventing leakage of inflation fluids thereinto. For example, the intermediate tube 33b may have an inner diameter of about 0.8 mm and the outer diameter of inner tube 64 may be of about 0.78 mm. The intermediate tube 33b may be manufactured by an extrusion process in which the ID (internal diameter) has an appropriate tolerance to fit over the outer diameter of inner tube 64. The inner tube 64 and the intermediate tube 33b are assembled together such that lateral port 12 is located in the longitudinal opening 38 of intermediate tube 33b. Thereafter the tubes 64 and 33b may be inserted into the hollow shaft 63 and the lateral port 12 may be attached to hollow shaft 63.

It should be noted that intermediate tube 33b is not necessarily a complete tube.

While the distal portion of intermediate tube 33b should be of a tubular shape, its proximal portion may have other cross-sectional shapes such as, but not limited to a semilunar shape. Alternatively, the proximal portion of intermediate tube 33b may be implemented by a wire attached to its distal portion and exiting the catheter 60 via the proximal opening 65.

Reference is now made to Figs 7A to 7B are schematic cross sectional views illustrating a rapid exchange catheter having a movable inner tube attached to an external slidable sealing sleeve, in accordance with yet another embodiment of the catheter of the present application. In the catheter 70, an inner tube 74 is made movable by attaching it to an externak slidable sealing sleeve 79. In this embodiment, the distal end of the balloon 11a is attached to the inner tube 74 at distal attachment points 2a provided around the outer surface of a distal portion of the inner tube 74. The structure, geometrical dimensions of elements of catheter 70 designated by the same numerals, and the method of manipulating its length and balloon's volume and shape, are much the same as those elements and manipulating method which were previously described hereinabove and therefore will not be further discussed herein, for the sake of brevity.

The catheter 70 includes a hollow outer shaft 76 having an over-pressure valve 16 and the discharge valve outlet 15 which are constructed and operative as disclosed hereinabove for the outer shaft 6 of the catheter 10 of Fig. 1 A. A fluid port 27 is disposed at the proximal part of the shaft 76, and is constructed and operative as disclosed for the fluid port 17 of Fig. 1 A.

As with previous embodiments of the catheters of the present application, the inner tube 74 is disposed in the hollow interior of a catheter's hollow outer shaft 76 and an angled portion 37 thereof (or, alternatively, a curved portion thereof) comprising a lateral port 12 protrudes outwardly therefrom. A lateral opening 9 is provided on the hollow outer shaft 76 from which the angled portion 37 of the inner tube 74 protrudes outwardly from the hollow shaft 76. The lateral opening 9 is sealed by an external sealing sleeve 79 mounted over an outer surface of the hollow outer shaft 76. The sealing sleeve 79 is tightly fits over the outer surface of the hollow outer shaft 76 and seals lateral opening 9 and the attachment area between the sealing sleeve 79 and the angled portion 37 of the inner tube 74 protruding therefrom. Moreover, the sealing sleeve 79 is also made slidable to allow its movements distally and proximally within the limits imposed by the lateral opening 9.

In this way a movable inner tube 74 is obtained. The operator may inflate (designated by arrows 7a in Fig. 7A) balloon 11a and move the inner tube distally or proximally by sliding the sealing sleeve 79 over the hollow shaft 76. Additionally or alternatively, a moving member 48 may be attached to the inner tube 74. The displacement rod 48 may be attached to a proximal portion of inner tube 74 and a proximal portion thereof can be made accessible to the operator via a proximal opening 75 provided at the proximal end of hollow shaft 76. The proximal opening 75 is designed to allow conveniently sliding moving member 48 therethrough while providing suitable sealing thereof and preventing leakage of inflation fluid therefrom. The lateral opening 9 is adjusted to allow moving of inner tube 74 proximally into a state in which attachment point 2a reaches the distal end of hollow shaft 76, and on the other hand, to allow sufficient distal movement of the inner tube 74 in order to enable stretching of the balloon 11a to its fullest length.

The sealing sleeve 79 can be manufactured by an extrusion and laser cutting process from a plastomer or metallic type of material, preferably from nylon® , flexible stainless steel and the like. The sealing and attachment of the sealing sleeve 79 and the angled portion 37 of the inner tube 74 is preferably performed by bonding these parts together by thermo-bonding or any other adhesive method such that they can slide together. The diameter of the sealing sleeve 79 is adjusted according to the geometrical dimensions of hollow shaft 76. For example, if the outer diameter of the hollow shaft is about 1.2 mm then the diameter of the sealing sleeve may have an internal diameter of about 1.22 mm. However, these values are given by way of example only, and other different larger or smaller diameters may be used, depending inter alia, on the length and wall thickness of the hollow outer shaft 76 and of the external sealing sleeve 79, the particular medical application and on engineering and other manufacturing considerations.

In the catheter 70a, an internal sealing sleeve 77 is installed within the hollow interior of a hollow shaft 76A. In this implementation, the inner sealing sleeve 77 is pressed against the inner wall of the hollow shaft 76A near the region of a lateral opening 9a formed in the hollow shaft 76A, providing suitable sealing of the lateral opening 9a. As in catheter 70 illustrated in Fig. 7A, an angled portion 37 of an inner tube 74 protrudes outwardly via the internal sealing sleeve 77 and may be accessed by the operator via a lateral port 12 (for insertion of a guidewire and/or other instrument(s) as required). The sealing and attachment of the internal sealing sleeve 77 and the angled portion 37 of the inner tube 74 may be obtained using the same means described above with reference to catheter 70.

The internal sealing sleeve 77 may be manufactured by an extrusion and laser cutting process from a plastomeric or metallic type of material, preferably from nylon® or flexible stainless steel, and the like. The sealing and attachment of internal sealing sleeve 77 and the angled portion 37 of the inner tube 74 is preferably obtained in a similar manner as was explained hereinabove. The diameter of the sealing sleeve 77 is adjusted according to the geometrical dimensions of hollow shaft 76a. For example, if the inner diameter of the hollow shaft 76a is about 1.0 mm then the outer diameter of the inner sealing sleeve 77 may be about 0.98 mm. However, these values are given by way of example only, and other different larger or smaller diameters may be used, depending inter alia, on the length and wall thickness of the hollow outer shaft 76a and of the sealing sleeve 77, the particular medical application and on engineering and other manufacturing considerations.

All of the above mentioned parameters and dimensions are given by way of example only, and may be changed in accordance with the differing requirements of the various embodiments of the present invention. Thus, the above mentioned parameters should not be construed as limiting the scope of the present invention in any way. In addition, it is to be appreciated that the different tubes, balloons, shafts, and other members, described hereinabove may be constructed in different shapes (e.g. having oval, square etc. form in plan view) and sizes and from different materials than those exemplified in the preceding description.

It should be noted that the different balloon catheter embodiments of the invention which were described hereinabove may be implemented with different types of balloons enabling folding of the proximal portion of the balloon, the distal portion of the balloon, or both proximal and distal portions of the balloon, as was exemplified hereinabove with reference to Figs. ID and IE.

Furthermore, it should be noted that the different balloon catheter embodiments of the invention which were described hereinabove may be used for delivering a stent mounted on the balloon, and placing the stent in the treatment site as commonly performed in standard stent procedures.

It is still further noted that the shapes of the exemplary corrugated balloons disclosed hereinabove are not obligatory to practicing the catheter and that many other types and shapes of corrugated balloons may be used in constructing the catheters of the invention as is disclosed in detail hereinafter. Reference is now made to Figs. 8A -8B. Fig. 8A is a schematic side view diagram illustrating a corrugated inflatable balloon usable as an intussusceptible balloon in a balloon catheter in accordance with an embodiment of the balloons of the present application. Fig. 8B is a schematic cross section of the corrugated balloon of Fig. 8A, taken along the lines VIII-VIII.

It is noted that while for the sake of clarity of illustration Figs. 8A-8B and 9-19 illustrate only the sleeve-like elements 22, 34, 35, 36, 37, 41, 45, 47, 51, 61, 71 and 80 usable for implementing the balloon catheters having corrugated inflatable intussuscepting balloons of the present application, all the sleeve-like elements 22, 34, 35, 36, 37, 41, 45, 47, 51, 61, 71 and 80 may be assembled into such catheters in the same way(s) in which the balloon 11a of Fig. 1 is assembled into the balloon catheter 10 of Fig. 1. It is further noted that in view of the above, all the sleeve-like elements disclosed herein and illustrated in the drawing figures are also referred to in the application as balloons and the terms "balloon" and "sleeve-like element" in their singular and plural forms are interchangeably used throughout the specification.

The balloon 22 has a middle portion 10A and two side portions 10B and IOC. The side portion 10B is also referred to as the proximal side portion 10B and the side portion IOC is referred to as the distal side portion IOC. A portion 10D of the wall of the middle portion 10A is corrugated or folded in a concertina-like or accordion- like structure. The shape of the corrugations of the portion 10D may be generally triangular and symmetrical as may be seen in the cross-sectional view of Fig. 8B. The middle portion 10A is the portion that has the largest diameter of the portions 10A, 10B and IOC. The middle portion also includes a curving portion 10E. The proximal side portion 10B includes a cylindrical portion 10F, a frusto-conical portion 10G and a terminal cylindrical portion 10H. The cylindrical portion 10H is the proximal margin of the balloon 22. The distal side portion IOC includes a truncated dome-like portion 101 and a terminal cylindrical portion 10 J. The cylindrical portion 10J is the distal margin of the balloon 22. The diameter of the terminal cylindrical portion 10H is larger than the diameter of the terminal cylindrical portion 10J.

Preferably the balloon 22 (or any of the other corrugated balloons disclosed in the present application) is made from Nylon® or another suitable biocompatible material, as is known in the art, such as, but not limited to, PET, PA12 (for example Grilamid L25, L55 and the like), PA1 1, Polyether block amides (PEBA), such as for example, PEBAX^® 7233, 7033, 6333), various types of Grilflex^® (such as, for example, ELG 6260), and the like. However, any other suitable biocompatible material known in the art and suitable for fabrication of catheter balloons may be used in implementing the balloons of the present application.

The balloon 22 may be suitably attached to any of the catheters 10, 20, 30, 40, 50, 60, 70 and 70a as disclosed in detail hereinabove and hereinafter. For example, if the balloon 22 is used with the catheter 10 of Fig. 1 A (instead of the balloon 11a), the attachment of the balloon 22 to the outer hollow shaft 6 and to the slidable internal tube 13 may be implemented using any suitable sealing attachment method known in the art, including but not limited to heat bonding, welding, ultrasonic welding, gluing, or any other method known in the art and capable of producing a sealed attachment capable of withstanding the pressures required for operating the inflatable expandable balloon(s) of the present application.

It is noted that as explained hereinabove for the balloons 11a, llf and Hi, the corrugated form of the balloon 22 advantageously assists the proper folding of the balloon 22 because the corrugated shape results in reducing the force required for initiating the internal folding of the distal end of the balloon 22. In general, the corrugated portion(s) of the corrugated inflatable balloons disclosed in the present application increase the probability of collapse of the corrugated portion of the balloon upon applying an axial longitudinally directed force in the proximal direction on the balloon as compared to the probability of collapse of the non-corrugated portion of the balloon.

Furthermore, the corrugations of the portion 10D of the balloon 22, increase the surface area of the part of the balloon 22 which is in contact with the wall of the blood vessel (or any other target tissue to be treated) when the balloon 22 is in the inflated state, and thus advantageously increases the surface area onto which debris and other particular matter released from the treated tissue (such as, for example, debris associated with a compacted and or disrupted atheroma or plaque) may adhere and may result in advantageously increasing the amount of debris and/or plaque particulate material that is carried into and trapped within the cavity (not shown in Fig. 8A) internally formed within the balloon 22 after the intussuscepting of the balloon 22.

The balloon 22 (and any of the other corrugated balloons disclosed in the present application) is preferably a non-compliant or semi-compliant balloon which may be manufactured using conventional methods known in the balloon catheter industry (such as, for example, pressure induced thermoforming - by forming the balloon shape using a suitably corrugated mold and a cylindrical tube made from a thermoplastic material which is shaped within the heated mold by suitable application of pressure). The balloon 22 may be made from a non-compliance type of material such as PEBAX^® or Nylon® (preferably Nylon 12), but any other suitable material known in the art may also be used. The length of the balloon 22is generally in the range of 10-60 mm, preferably about 20 mm, but other different lengths may also be used. The diameter of the corrugated portion 10D of the balloon 22 may vary between 2.0 mm to 5 mm for coronary artery applications, but may be significantly larger for use in larger blood vessels. Preferably (but not obligatorily), the balloon 22 should have a burst pressure within the range of 12-20 atmospheres. The proximal and distal edges of the balloon 22 such as the cylindrical portions 10H and 10J, respectively, of the balloon 22, are preferably sealingly attached to the catheter components of the catheters disclosed hereinabove, by using heat bonding, or a UV or thermo bonding type of adhesive such as commonly used in the art.

Thus, the advantages of the corrugated balloons described herein are providing facilitated balloon folding and intussuscepting by reducing the force required for folding of the corrugated portion of the balloon and the providing of an increased surface area (relative to a non-corrugated balloon) of the corrugated portion which may substantially assist the adherence and inclusion of debris particles within the intussuscepted corrugated balloon.

It is noted that while the corrugated balloons 11a, llf, Hi and 22 are shown by way of example, they are not intended to limiting in any way. Rather, many other different types of corrugated balloons may be advantageously implemented in the catheters of the present application.

Reference is now made to Figs. 9-12 which are schematic side view diagrams illustrating different types of corrugated inflatable intussusceptible balloons usable in the catheters and systems of the present application, in accordance with additional embodiments of the balloon of the present application.

Turning to Fig. 9, the corrugated balloon 34 includes contiguous portions 34H, 34G, 34F, 34E, 34D, 341 and 34J. The cylindrical portion 34H is shorter than the cylindrical portion 10H (of Fig. 2). The frusto-conical portion 34G is longitudinally shorter than the frusto-conical portion 10G (of Fig. 8A) and therefore has a steeper cone angle. The cylindrical portion 34F is longer than the cylindrical portion 10F (of Fig. 8A). The portions 34D, 341 and 34J are similar in shape to the corresponding portions 10D, 101 and 10J, respectively, of Fig. 8A. As seen in the inset of Fig. 9, the corrugations 34N have a symmetrical triangular shape, in accordance with an embodiment of the balloons of the present application.

Turning to Fig. 10, the corrugated balloon 35 includes contiguous portions 35H, 35G, 35E, 35D, 351 and 35J. The cylindrical portion 35H is similar in length to the cylindrical portion 10H (of Fig. 8A). The frusto-conical portion 35G is similar to the frusto-conical portion 10G (of Fig. 8A) However, it is noted that the frusto-conical portion 35G is contiguous with the portion 35E (without a cylindrical portion between them as in the balloon 22 of Fig. 8A). The portions 35D, 351 and 35J are similar in shape to the corresponding portions 10D, 101 and 10J, respectively, of Fig. 8 A. As seen in the inset of Fig. 10, the corrugations 35N have a symmetrical rounded shape, in accordance with another embodiment of the balloons of the present application.

Turning to Fig. 1 1 the corrugated balloon 36 includes contiguous portions 36H, 36G, 36F, 36E, 36D, 361 and 36J. The cylindrical portion 36H is shorter than the cylindrical portion 10H (of Fig. 8A). The portion 36G is shaped like a truncated dome (having a convex shape) and is longitudinally shorter than the frusto-conical portion 10G (of Fig. 8A). The cylindrical portion 36F is shorter than the cylindrical portion 10F (of Fig. 8A). The portions 36D, 361 and 36J are similar in shape to the corresponding portions 34D, 341 and 34J respectively, of Fig. 9.

Turning to Fig. 12 the corrugated balloon 37 includes contiguous portions 37H, 37G, 37F, 37E, 37D, 371 and 37J. The cylindrical portion 37H is shorter than the cylindrical portion 10H (of Fig. 8). The portion 36G has a tapered shape (having a concave shape) and is longitudinally shorter than the frusto-conical portion 10G (of Fig. 8 A). The cylindrical portion 37F is shorter than the cylindrical portion 10F (of Fig. 8A). The portions 37D, 371 and 37J are similar in shape to the corresponding portions 34D, 341 and 34J, respectively, of Fig. 9.

It may thus be seen that the dimensions and shapes of the different portions of the balloons of the present application may be varied, including the shape and number of the corrugations included in the corrugated portion of the balloon. Such variations may depend on and may be used in different applications of the catheters (including the use for treatment of different blood vessels and/or other types of body-passage of varying sizes and dimensions.

Reference is now made to Figs. 13-15 which are schematic cross-sectional diagrams illustrating different types of corrugated inflatable intussusceptible balloons having different types of corrugations, in accordance with further additional embodiments of the balloon of the present application.

Turning to Fig. 13, the corrugated balloon 41 includes contiguous portions 40H, 40G, 40F, 40D, 401 and 40J. The portions 40H, 40G, 40F, 401 and 40J are similar the corresponding portions 10H, 10G, 10F, 101 and 10J (of Fig. 8A), respectively. However, the number and shape of the corrugations 40N of the portion 40D are different then those of the corresponding portion 10D (of Fig. 8A). Each of the corrugations 40N is wider than the corrugations 10N (i.e, the length L2 of each of the corrugations 40N is longer than the length LI of the corrugations 10N of Fig. 8A)

Turning to Fig. 14, the corrugated balloon 45 includes contiguous portions 45H, 45G, 45F, 45D, 451 and 45J. The portions 45H, 45G, 45F, 451 and 45J are similar the corresponding portions 10H, 10G, 10F, 101 and 10J (of Fig. 8A), respectively. However, the shape (and possibly the number) of the corrugations 45N of the portion 45D are different then those of the corresponding portion 10D (of Fig. 8A). Each of the corrugations 45N is formed such that it has a sawtooth-like cross-sectional shape with the direction of the sawtooth shape arranged as illustrated in Fig. 14.

Turning to Fig. 15, the corrugated balloon 47 includes contiguous portions 47H, 47G, 47F, 47D, 471 and 47J. The portions 47H, 47G, 47F, 471 and 47J are similar the corresponding portions 10H, 10G, 10F, 101 and 10J (of Fig. 8A), respectively. However, the shape (and possibly the number) of the corrugations 47N of the portion 47D are different then those of the corresponding portion 10D (of Fig. 8A). Each of the corrugations 47N is formed such that it has a sawtooth-like cross-sectional shape with the direction of the sawtooth shape reversed in comparison to the direction of the sawtooth shapes formed on the portion 45D of the balloon 45 (of Fig. 14), as illustrated in Fig. 15.

Reference is now made to Fig. 16-19 which are schematic cross-sectional diagrams illustrating additional different types of folded or corrugated inflatable intususseptable balloons having different types of corrugated balloon regions and/or different balloon wall thickness at different portions of the balloon, and/or multiple different types of folds on the same balloon, in accordance with yet further additional embodiments of the balloon of the present application.

Turning to Fig. 16, the corrugated balloon 51 includes a middle potion 50A, a proximal side portion 50B and a distal side portion 50C. The proximal side portion 50B comprises contiguous portions 50H, 50G and 50F. The middle portion 50A comprises contiguous portions 50M and 50D. The portion 50M is not corrugated and the portion 50D is corrugated as disclosed hereinabove. The distal side portion 50C comprises a corrugated curved portion 501 which is contiguous with the corrugated portion 50D, and a non-corrugated cylindrical portion 50J.

The portions 50H, 50G, 50F, and 50J are similar the corresponding portions 40H, 40G, 40F, and 40J of the balloon 41 (of Fig. 13), respectively. However, while the truncated dome-like portion 401 of Fig. 13 is not corrugated, the portion 501 has a corrugated dome like shape. This corrugated truncated conical structure may further facilitate the folding and intussuscepting of the balloon 51. The shape and dimensions of the corrugations 50K of the potion 501 may be similar to the shape and dimensions of the corrugations 50N of the portion 50D. However, this is not obligatory and the shape and dimensions of the corrugations 50K of the potion 501 may be different than the shape and dimensions of the corrugations 50N of the portion 50D (such as, but not limited to, the corrugations 50K of the potion 501 being smaller than and/or having a different shape then the corrugations 50N of the portion 50D).

Turning to Fig. 17, the corrugated balloon 61 includes a middle potion 60 A, a proximal side portion 60B and a distal side portion 60C. The corrugated balloon 61 has a non-uniform wall thickness along it's length. The proximal side portion 60B comprises contiguous portions 60H, 60G and 60F. The middle portion 60A comprises contiguous portions 60M and 60D. The portion 60M is not corrugated and the portion 60D is corrugated, as disclosed hereinabove. The distal side portion 60C comprises a truncated dome-like portion 601 which is contiguous with the corrugated portion 60D, and a non- corrugated cylindrical portion 60J.

The portions 60D, 601 and 60J are similar in shape and dimensions the corresponding portions 10D, 101 and 10J of the balloon 22 (of Figs. 8A-8B), respectively. However, the portions 60H, 60G, 60F and 60M have walls which are thicker than the walls of the corresponding portions 10H, 10G, 10F and 10E of the balloon 22 (of Fig.8B). The extra thickness of the walls of the balloon portions 60H, 60G, 60F and 60M of the balloon 61 mechanically reinforce the proximal side portion 60B and the portion 60M and advantageously prevents (or reduces the probability of) the folding of the proximal side of the balloon 61 and ensures that when the balloon is attached to a catheter similar to the catheter 10 of Fig. 1A) and a pulling force is applies to the distal side of the balloon 61 by operating the catheter as disclosed hereinabove, the distal side of the balloon 61 will fold (by collapsing) preferentially at a lower force than the force required to cause folding of the balloon at the thicker walled region of the proximal side portion 60B and the portion 60M.

Turning to Fig. 18, the corrugated balloon 71 includes a middle potion 70A, a proximal side portion 70B and a distal side portion 70C. The proximal side portion 70B comprises contiguous portions 70H, 70G and 70F. The middle portion 70A comprises contiguous portions 70M and 70D. The portion 70M is not corrugated and the portion 70D is corrugated as disclosed hereinabove. The distal side portion 70C comprises a corrugated truncated conical portion 701 which is contiguous with the corrugated portion 70D, and a non-corrugated cylindrical portion 70J.

The portions 70H, 70G, 70F, and 70J are similar the corresponding portions 40H, 40G, 40F, and 40J of the balloon 41 (of Fig. 13), respectively. However, while the portion 401 of Fig. 13 has a non-corrugated truncated dome-like shape, the portion 701 has a corrugated truncated conical shape. As explained hereinabove with regard to the corrugated dome-like portion 501 of the balloon 51, the corrugated structure of the portion 701 may similarly facilitate the folding and intussuscepting of the balloon 71. The shape and dimensions of the corrugations 70K of the potion 701 may be similar to the shape and dimensions of the corrugations 70N of the portion 70D. However, this is not obligatory and the shape and dimensions of the corrugations 70K of the potion 701 may be different than the shape and dimensions of the corrugations 70N of the portion 70D (such as, but not limited to, the corrugations 70K of the potion 501 being smaller than and/or having a different shape then the corrugations 50N of the portion 50D).

Turning to Fig. 19, the corrugated balloon 80 includes a middle potion 80 A, a proximal side portion 80B and a distal side portion 80C. The proximal side portion 80B is identical to the proximal portion 10B (of Fig. 8A) and comprises contiguous portions 80H, 80G and 80F. The distal side portion 80C is identical to the distal portion IOC (of Fig. 8A) and includes the portions 801 and 80J. However, the middle portion 80A comprises portion 80M which is identical to the portion 10E of Fig. 8A, and two contiguous corrugated portions 80D and 80P.

The corrugations of the portion 80D are similar in shape to the symmetrical triangular corrugations 50N of Fig. 16. In contrast, the corrugations of the portion 80P are symmetrical rounded or curved corrugations similar to the corrugations 35N (illustrated in the inset of Fig.10).

It is noted that other embodiments with other mixed types of corrugations are also possible in the balloons (and sleeve-like elements) of the present application. For example, in accordance with an embodiment of the balloons of the present application the middle portion of the balloon may include three contiguous portions (not shown), a first portion with rounded corrugations, a second portion with symmetrical triangular corrugations and a third portion with sawtooth-like corrugations. Thus, many other combinations and sub-combinations of multiple corrugated portions (either contiguous or non-contiguous) with multiple different types of corrugations may be implemented in the balloons and balloon catheters of the present application.

It is noted that while in some of the embodiments of the balloons (and sleeve-like elements) disclosed hereinabove, the corrugated portion(s) occupied most of the longitudinal dimension of the balloon's middle portion (the portion having the largest diameter of all the balloon portions), this is by no means obligatory. Rather, only a part of the middle portion may be corrugated resulting in a partially corrugated middle portion. Similarly, embodiments are possible in which the middle portion of the balloon is completely non-corrugated while the distal portion of the balloon or a part thereof is corrugated.

Reference is now made to Figs. 20-21 which are schematic cross-sectional diagrams illustrating additional types of corrugated inflatable intussusceptible balloons having partially corrugated middle balloon portions and/or corrugated side portions, suitable for use in the rapid exchange catheters in accordance with yet additional embodiments of the corrugated balloon of the present application.

Turning to Fig. 20, the corrugated balloon 140 includes a middle potion 140A, a proximal side portion 140B and a distal side portion 140C. The proximal side portion 140B is identical to the proximal portion 40B (of Fig. 13) and comprises contiguous portions 140H, 140G and 140F. The distal side portion 140C is identical to the distal portion IOC (of Fig. 8A) and includes the portions 1401 and 140J. However, the middle portion 140A comprises a non-corrugated portion 140D and a contiguous corrugated portion 141D. In the specific non-limiting embodiment illustrated in Fig. 20, the non- corrugated portion 140D occupies approximately two thirds of the length of the middle portion 140A, and the corrugated portion 141D occupies approximately a third of the length of the of the middle portion 140A. However, this is not obligatory and other different length relationship between the corrugated portion and the non-corrugated portion of the middle portion 140A are also possible.

Turning to Fig. 21, the corrugated balloon 150 includes a middle potion 150A, a proximal side portion 150B and a distal side portion 150C. The proximal side portion 150B is identical to the proximal portion 40B (of Fig. 13) and comprises contiguous portions 150H, 150G and 150F. The distal side portion 150C is identical to the distal portion 50C (of Fig. 16) and includes a corrugated dome-like portion 1501 and a non- corrugated cylindrical portion 150J similar to the portions 501 and 50J, respectively, of Fig. 16. However, the middle portion 140A comprises a single non-corrugated portion. Thus, while the middle portion 150A does not have an extended surface area as do other corrugated middle portions described herein, the balloon 150 has the advantage of facilitated folding of the distal portion 150C of the balloon 150 during the intussuscepting of the balloon 150 because of the reduced force required to initiate collapse in the distal portion 150C due to the presence of the corrugations of the portion 1501.

Thus, it is noted that in balloon catheters in which at least part of the distal portion is corrugated, the force required for causing collapse of the distal portion of the balloon is substantially smaller than the force required to cause collapse of the proximal portion of the balloon. Similarly for the same mechanical reasons, in balloon catheters in which at least part of the distal portion and at least the distal part of the middle portion are corrugated, the force required for causing collapse of the distal portion of the balloon is substantially smaller than the force required to cause collapse of the proximal portion of the balloon.

It is also noted that while, in embodiments of the catheters which are designed for preferential collapse of the distal end of the balloon, the proximal portion of the balloons are preferably not corrugated (in order to minimize the probability of initial collapse of the proximal portion of the balloon when a proximally pulling force is applied to the balloon), it is possible to construct and use embodiments of balloon catheters including balloons having a corrugated proximal part and balloon catheters having the entire balloon being corrugated (continuously or alternatingly as shown in the example of Fig. 25 hereinbelow). For example, in accordance with other embodiments of the balloon catheters of the present application, if the balloon is made to have a corrugated proximal part or to be corrugated along the entire balloon length, the probability of the proximal collapse of the balloon during applying a force for proximally pulling of the balloon may be substantially reduced by making the walls of the proximal part of the balloon thicker than the walls of the middle and/or distal parts of the same balloon. This will enable the use of such balloons safely and effectively while allowing a greater part of the balloon to be corrugated.

It is further noted that typically (but not obligatorily), the balloon catheters of the present application may have a substantially cylindrical middle portion flanked by a distally extending portion and a proximally extending portion. The diameter of the distally extending portion typically diminishes in the distal direction and the diameter of the proximally extending portion typically diminishes in the proximal direction. The change of the diameter of the distal and/or proximal balloon portions may be gradual (as in a conical shape or dome shape but may also be non-gradual or at least partially non-gradual by diminishing abruptly (as in the form of a step or a step or an abrupt transition between a first cone angle to a steeper cone angle). Additionally the balloons of the present application maybe non-linearly tapered in their proximal and/or distal portions by having outwardly or inwardly curving cross sectional shapes of the proximal and/or distal portions.

Reference is now made to Figs. 22-25 which are schematic cross-sectional diagrams illustrating parts of corrugated balloons having different additional types of folds or corrugation shapes and/or having multiple corrugated portions interspersed with non- corrugated portions, in accordance with additional embodiments of corrugated balloons of the present application.

It is noted that in all of the drawings of Figs. 22-25, the reference numeral P schematically represents the proximal side and the reference numeral D schematically represents the distal side of the balloon ( as oriented when attached to the catheter).

Turning to Fig. 22, the corrugated portion of the balloon 160 (only part of which is illustrated in Fig. 22) includes multiple corrugations 160N. Each one of the multiple corrugations 160N has a straight part 160Q facing towards the proximal side of the balloon 160 and a curved part 160R facing the distal side of the balloon 160.

Turning to Fig. 23, the corrugated portion of the balloon 170 (only part of which is illustrated in Fig. 23) includes multiple corrugations 170N. Each one of the multiple corrugations 170N has a straight part 170Q facing towards the distal side of the balloon 170 and a curved part 170R facing the proximal side of the balloon 170.

Turning to Fig. 24, the corrugated portion of the balloon 180 (only part of which is illustrated in Fig. 24) includes multiple symmetrical corrugations 180N. Each one of the multiple corrugations 180N has a first curved part 180Q facing towards the proximal side of the balloon 180 and a second curved part 180R facing the distal side of the balloon 180.

Turning to Fig. 25, the balloon 190 (only part of which is illustrated in Fig. 25) includes three corrugated portions 190 A, 190B and 190C and non-corrugated portions 190D, 190E and 190F. It is noted that in accordance with embodiments of the corrugated balloons disclosed herein, the balloons may include any practical number of corrugated portions interspersed by non-corrugated portions. Furthermore, while the type, shape and dimensions of the corrugations in the portions 190A, 190B and 190C in the non-limiting example illustrated in Fig. 25 are identical, this is by no means obligatory and in different embodiments of balloons with multiple corrugated portions, each portion may have a different type of corrugation in which one or more parameters of the corrugation's shape, dimensions, may be varied at will.

Moreover, different types and/or sizes and/or shapes of corrugations may be mixed and matched within each corrugated portion of the balloons of the present application.

Turning now to Fig. 26 which is a schematic cross sectional diagram illustrating part of the wall of a corrugated balloon having alternating types of differently shaped corrugations, the wall of the balloon 200 (only part of which is shown in Fig. 26) includes triangular shaped corrugations 200N interspersed with curved corrugations 200R.

Generally, in the mixed corrugation type balloons of the present application, any types and sizes of corrugations may be used mixed and matched as desired. For example, the balloon 200 of Fig. 26 may be modified to have repeated sequences of corrugations having a single triangular corrugation 200N followed by two curved corrugations 200R and this sequence may be repeated along the entire length of the corrugated portion. Furthermore, any desired type of repeating or non-repeating combinations and sequences of two or more different corrugation types may be used in the corrugated balloons of the present application.

It is further noted that the cylindrical portions 10J, 34J, 35J, 36J, 37J, 40J, 45J, 47J, 50J, 60J, 70J, 80J, 140J, and 150J are also referred to as the "distal margins" of the balloons 22, 34, 35, 36, 37, 41, 45, 47, 51, 61, 71, 80, 140, and 150, respectively, throughout the specification and the claims of the present application.

Similarly, it is also noted that the cylindrical portions 10H, 34H, 35H, 36H, 37H,

40H, 45H, 47H, 50H, 60H, 70H, 80H, 140H, and 150H and are also referred to as the "proximal margins" of the balloons 22, 34, 35, 36, 37, 41, 45, 47, 51, 61, 71, 80, 140, and 150, respectively, throughout the specification and the claims of the present application.

It is noted that the side portion(s) of the corrugated balloons of the present application may have cylindrical and/or conical and/or ftusto-conical, and/or rounded truncated dome-like and/or tapering shape(s). The side portion(s) may also have a shape which is a combination of one or more of cylindrical, conical, frusto-conical, dome-like and tapering shapes. These shapes are not intended to be limiting, and other different types of portion shapes may also be used in implementing the corrugated balloons of the present application.

The corrugated balloon catheters of the present application may use sleeve like elements having various different dimensions. Typically (but not obligatorily), the inflated diameter of the corrugated balloon may be in the range of 1.5 - 35 millimeter and the length of the corrugated balloons may be in the range of 5- 300 millimeter, with all possible combinations of balloon length and balloon diameters within these ranges may be used. In accordance with some typical non-limiting examples, a balloon with a length of 15 millimeter may have an inflated diameter of 3 millimeters and a balloon with a length of 250 millimeters may have an inflated diameter of 12 millimeter. The typical (but non- limiting) range of balloon wall thickness is 0.022 - 0.030 millimeter depending, inter alia, on the balloon dimensions and on the application. It will be appreciated by those skilled in the art that the above dimension ranges and ratios of balloon diameter to balloon length are not obligatory and that other different dimensions and ratios extending beyond the above indicated ranges may be used in implementing the catheters, depending, inter alia, on the particular application.

While it is possible for the corrugations to span the entire inflatable length of the balloons, as disclosed herein, typically, in some preferred embodiments only the distal portion of the balloon is corrugated and in some other preferred embodiments, both the distal balloon portion and part of the balloon middle portion are corrugated. Typically, in these embodiments between a fifth (1/5) and a third (1/3) of the total length of the balloon are corrugated. However, shorter or longer portions of the balloon length may be corrugated, depending, inter alia, on the balloon structure and shape, the balloon's wall thickness (and/or on the balloon's wall thickness gradient in balloons with a non-uniform wall thickness), and on the particular application.

Furthermore, in embodiments which are designed for preferential collapse of the proximal portions of the balloon (such as, for example, in a catheter having the balloon lib of Fig IE), typically between a fifth (1/5) and a third (1/3) of the total length of the balloon may be corrugated and preferably the corrugations are placed in the proximal portion(s) of the balloon. However, shorter or longer portions of the balloon length may be corrugated, depending, inter alia, on the balloon structure and shape, the balloon's wall thickness (and/or on the balloon's wall thickness gradient in balloons with a non- uniform wall thickness), and on the particular application.

Returning to Fig. 8A-8B, with respect to the dimensions of the corrugations, the corrugations span a "peak to valley" amplitude L (defined as the difference between the maximal radial distance of the corrugation and the minimal radial distance of the corrugation as measured from the longitudinal axis of the inflated balloon, irrespective of the precise corrugation shape). Typically, the corrugation amplitude L depends on the diameter of the balloon. Preferably, the corrugation amplitude L is in the range of 2.5% - 20% of the inflated balloon diameter. However, other values of the corrugation amplitude L may also be used which are larger or smaller than this range depending, inter alia, on the balloon wall thickness and on the particular shape of the corrugations.

The corrugation pitch P is defined as the distance between adjacent peaks of the corrugations (see Fig. 8B for an indication of P in the particular case of symmetrical triangularly shaped corrugations of the balloon 22), and may depend, inter alia, on the outer diameter of the inflated balloon and on the type and shape of the corrugations.

In accordance with one typical non-limiting example, in a balloon having a length of 15 millimeter and an inflated outer diameter of 3 millimeter, the corrugation pitch P may preferably (but not obligatorily) be in the range of 0.025-1.8 millimeter. In accordance with another typical non-limiting example, in a balloon having a length of 250 millimeter and an inflated outer diameter of 12 millimeter, the corrugation pitch P may preferably (but not obligatorily) be in the range of 0.1-7.2 millimeter. It will be appreciated by those skilled in the art that the above two examples are given by way of example only and are not intended to be limiting, and that other values of the corrugation pitch P which are higher or lower than the corrugation pitch ranges of the above given examples may be used depending, inter alia, on the particular values of the balloon length, balloon diameter, balloon wall thickness, corrugation shape and other design and manufacturing considerations. It is noted that as may be seen in Fig. 2C, after the intussuscepting of the balloon 10, the corrugated portion 10D of the balloon 10 is completely internally disposed within the cavity 41 formed in the intussuscepted balloon 10 such that no corrugated portion or surface is presented on the external surface of the fully intussuscepted balloon 10. This may be advantageous, as such a configuration may assist the withdrawal of the deflated balloon 10 and catheter 30 from within the blood vessel 20 (or from any other bodily cavity in which it was inserted), by ensuring that no corrugations are presented on the outside surface of the deflated intussuscepted balloon 10. However, while this feature of the balloon 10 is preferred, this feature is not obligatory and in some embodiments of the catheters of the present invention, the entire surface of the balloon may be corrugated ( as described in detail hereinafter) or a substantial part of the length of the balloon may be corrugated, such that at least part of the corrugated surface is present on the outer surface of the intussuscepted balloon facing the internal blood vessel 20 after intussuscepting of the balloon and after deflating the balloon.

It should be realized that while the over-pressure valve 16 of Fig. 1 A adequately avoids excessive pressure within the catheter 10 during proximal pulling of the moving member 18, such over-pressure conditions may be resolved by other means. For example, an inflatable member or a compliant member may be attached to the opening of over-pressure valve outlet 16, and in such an implementation the over-pressure valve 16 may be eliminated from the design.

Figs. 27A-27C are schematic cross-sectional diagrams illustrating parts of a rapid exchange catheter system including a corrugated intussusceptible inflatable balloon and a pressure regulating mechanism in accordance with other embodiments of the catheter systems of the present application. Fig. 27A is a schematic cross sectional view of part of a rapid exchange catheter in which the overpressure valve 16 is replaced by a compliant member 9. This arrangement is usable as a pressure adjusting mechanism in accordance with another embodiment of the catheter systems of the present application. The catheter 110 of Fig. 27 A is similar in construction and operation to the catheter 10 of Fig. 1A, except that the over-pressure valve 16 of Fig. 1 A is replaced by a compliant member 9 such as (but not limited to) an inflatable and expandable balloon made from latex or from any other suitable expandable compliant material. The compliant member 9 is sealingly attached to the outlet 15 to seal the outlet 15. In this embodiment, the outlet 15 is in fluidic communication with the lumen of the inflatable balloon 11a. When the balloon 11a of the catheter 110 is intussuscepted while it is in the inflated state (by pulling the moving member 18 proximally), the compliant member 9 may expand to accommodate some of the inflating fluid ejected from the balloon 11a thus relieving some of the over-pressure in the lumen of the balloon 11a.

Moreover, in accordance with yet another embodiment of the catheters of the present application, the hollow outer shaft 6, or portions thereof, may be made inflatable or expandable or compliant, such that over-pressure conditions may be at least partially resolved by the expansion of the hollow outer shaft 6 or of a compliant portion thereof.

Fig. 27 A is a schematic cross sectional view of part of a rapid exchange catheter in which the overpressure valve 16 is replaced by a stopcock and a hydraulic accumulator.

The catheter 120 is similar to the catheter 10 except that in the catheter 120 includes a closable stopcock 42 and a hydraulic accumulator 52, instead of the overpressure valve 15 (of catheter 10). The hydraulic accumulator 52 of the catheter 120 is fluidically connectable to the fluid port 16 via the closable stopcock 42. The stopcock 42 may be closed to fluidically isolate the hydraulic accumulator 52 from the fluid filled space within the hollow shaft 6. The stopcock 42 may also be opened to fluidically connect the hydraulic accumulator 52 to the fluid filled space within the hollow shaft 6.

It is noted that the stopcock 42 is optional and is not obligatory to the operation of the catheter 120. Therefore, in accordance with an alternative embodiment of the catheter 120, the catheter 120 does not include a stopcock and the hydraulic accumulator 52 is directly fluidically connected to the fluid filled space within the hollow shaft 6 by the fluid port 16.

The hydraulic accumulator 52 is designed to accommodate fluid ejected from the balloon 11a during intussuscepting thereof. The structure and operating of hydraulic accumulators is well known in the art, is not the subject of the present application and is therefore not described in detail in the present application.

Briefly, a hydraulic accumulator is designed to accommodate excess fluid while preventing excessive increase in the pressure in a fluidic system to which it is fluidically connected. This may be achieved by several different designs such as but not limited to hydraulic accumulators using a bladder, hydraulic accumulators using a moving piston disposed in a compressible gas chamber, hydraulic accumulators using a chamber with a spring loaded piston therein, and other types of hydraulic accumulators as is well known in the_^art. It is noted that in Fig. 27B, the hydraulic accumulator 52 is represented by the conventional engineering symbol labeled 52 and is not drawn to scale.

When fluid ejected from the balloon 11a of the catheter 120 into the hydraulic accumulator 52, the pressure increases somewhat, but as the volume available within the hydraulic accumulator 52 is relatively large in comparison with the volume of fluid ejected from the balloon 11a during intussuscepting thereof, the pressure increase within the catheter 120 is attenuated and is not large enough to prevent the intussuscepting of the balloon 11a. The dimensions, accommodated volume and other characteristics of the hydraulic accumulator 52, such as the maximal pressure developed in the catheter after the balloon 11a has been fully intussuscepted may be selected depending, inter alia, on the dimensions of the balloon 11a, the volume ejected from the balloon 11a during intussuscepting, the balloon's inflation pressure, and other design considerations.

In operation, an indeflator (not shown) may be fluidically connected to the fluid port 17 of the catheter 120 and the stopcock 42 is closed. The catheter 120 may then be inserted into the body and the balloon 11a is placed at or near the region to be treated as disclosed in detail hereinabove. The balloon 11a may then be inflated by injecting inflation fluid under pressure using the indeflator. After treatment of the target region is performed, the stopcock 42 may be opened and the pulling rod may be pulled proximally to cause intussuscepting of the balloon 11a and disclosed hereinabove. The pressure accumulator 52 will attenuate the pressure increase within the catheter 120 and the intussuscepted balloon 11a as explained hereinabove (and may also cause partial deflation of the balloon 11a due to flowing of some of the fluid ejected from the balloon 11a into the hydraulic accumulator 52. After intussuscepting of the balloon 11a is completed, the balloon may be further deflated through the fluid port 17 by using the inderflator or by disconnecting the indeflator from the fluid port 17. The catheter 120 may then be withdrawn from the body as described hereinabove.

Claims

1. A rapid exchange balloon catheter comprising:

an outer conduit;

an inner conduit disposed within said outer conduit and suitable for total or partial passage over a guide-wire, said inner conduit comprises at least one movable part movably disposed within the lumen of said outer conduit, said inner conduit comprises an angled portion piercing the wall of said outer conduit and a distal end of said inner conduit extends beyond the distal end of said outer conduit;

a corrugated inflatable balloon having a proximal margin sealingly attached to the outer surface of the distal end of said outer conduit, and a distal margin sealingly attached to the outer surface of the portion of said inner conduit that extends beyond the distal end of said outer conduit, said corrugated balloon has at least one corrugated portion;

means for axially moving said at least one movable part of said inner conduit within said outer conduit;

means for the introduction of an expansion fluid into the space formed between the inner surface of said outer conduit and the outer surface of said inner conduit and therefrom into the lumen of said balloon and for the removal of said fluid from said space; and

means for permitting unhindered axial movement of said at least one movable part of said inner conduit within said outer conduit, such that said movement is not hindered by the passage of said angled portion of the inner conduit through said outer conduit.

2. The rapid exchange balloon catheter system according to claim 1, wherein the means for axially moving comprise one or more elongated moving members, the distal end(s) thereof being attached to said at least one movable part of said inner conduit, and the proximal end(s) thereof extending beyond the proximal end of the outer conduit.

3. The rapid exchange balloon catheter system according to claim 1 , wherein the distal portion of said corrugated balloon is capable of intussuscepting upon proximal movement of said at least one movable part of said inner conduit in relation to said outer conduit.

4. The rapid exchange balloon catheter system according to claim 1 , also including means for reducing pressure changes within said space upon axial movement of said at least one movable part of said inner conduit in relation to said outer conduit.

5. The rapid exchange balloon catheter system according to claim 4, wherein said means for reducing pressure changes comprises a piston-like member slidably disposed within the proximal end of the outer conduit, wherein said piston-like member is connected to said means for axially moving, such that upon operation of said means for axially moving said piston-like member is caused to move either distally or proximally, changing the volume of said outer conduit.

6. The rapid exchange catheter according to claim 1 , wherein said means for permitting unhindered axial movement comprise a sealing sleeve sealingly attached to said angled portion of said inner conduit and slidably fitted around said outer conduit, such that said angled portion of said inner conduit passes firstly through an elongated aperture in the wall of said outer conduit, and secondly through a tightly sealed aperture in said sealing sleeve, such that upon axial movement of said at least one movable part of said inner conduit, said sealing sleeve is capable of preventing leaking of inflation fluid through said elongated aperture.

7. The rapid exchange catheter according to claim 1 , wherein said means for permitting unhindered axial movement of the inner conduit is provided by a two-part inner conduit construction, wherein a first proximal part of said two-part inner conduit comprises a non-movable inner tube including said angled portion, and a second distal part of said two-part inner conduit comprises a slidable internal tube disposed within said non- movable inner tube.

8. The rapid exchange catheter according to claim 1 , wherein said means for permitting unhindered axial movement of the inner conduit is provided by a two-part inner conduit construction, wherein a first proximal part of said two-part inner conduit comprises a non-movable inner tube including said angled portion, and a second distal part of said two-part inner conduit comprises a slidable internal tube disposed over said non-movable inner tube.

9. The rapid exchange catheter according to claim 1 , wherein said means for permitting unhindered axial movement of said inner conduit is provided by a two-part inner conduit construction, wherein said two-part inner conduit comprises

a non-movable inner tube including said angled portion, and

a slidable intermediate tube movably disposed between said non movable inner tube and said outer conduit, said intermediate tube has a longitudinal opening on its side through which said angled portion passes, wherein the distal end of said intermediate tube is the portion of said inner conduit that extends beyond the distal end of said outer conduit and wherein the proximal end of said intermediate tube sealingly passes through and extends beyond the proximal end of said outer conduit such that said means for axially moving comprises said proximal end of said intermediate tube.

10. The rapid exchange catheter according to claim 1 , wherein said means for permitting unhindered axial movement of said inner conduit is provided by a three-part inner conduit construction, wherein said three-part inner conduit comprises,

a first non-movable hollow tube including said angled portion at its proximal portion and having a distal end,

a second non-movable hollow inner tube having a proximal end and a distal end, said second inner tube is sealingly disposed within said distal end of said first non- movable inner tube, and

a third slidable inner tube slidably disposed over the distal end of said second non- movable hollow tube, said third slidable inner tube has a distal end extending beyond the distal end of said outer conduit, wherein said distal margin of said corrugated balloon is attached to the outer surface of the portion of said distal end of said third inner tube extending beyond the distal end of said outer conduit.

1 1. The rapid exchange catheter according to claim 1 , wherein said outer conduit includes a lateral opening therein, and wherein said means for permitting unhindered axial movement comprise a sealing sleeve internally disposed within said outer conduit and attached to said angled portion of said inner conduit, said sealing sleeve is sealingly fitted within said outer conduit, such that said angled portion of said inner conduit passes firstly through the wall of said sealing sleeve, and secondly through said lateral opening of said outer conduit, such that upon axial movement of said inner conduit and said sealing sleeve, said sealing sleeve is capable of preventing leaking of inflation fluid through said lateral opening.

12. The rapid exchange balloon catheter system according to claim 1, wherein said corrugated balloon is characterized by having, in its inflated state, a shape which is capable of guiding the intussuscepting of the distal and/or proximal portion(s) thereof upon proximal movement of the at least one movable part of the inner conduit in relation to the outer conduit.

13. The balloon catheter system according to claim 12, wherein the balloon is characterized by having, in its inflated state, a distal taper with a rounded distal extremity.

14. The balloon catheter system according to claim 1, wherein the inner and outer conduits are characterized by their ability to withstand axially directed forces in the range of between 1 and 30 Newton without undergoing deformation.

15. The balloon catheter according to claim 1 wherein said inflatable balloon comprises a substantially cylindrical middle portion flanked by a distally extending portion and a proximally extending portion, wherein the diameter of said distally extending portion diminishes in the distal direction and the diameter of said proximally extending portion diminishes in the proximal direction.

16. The balloon catheter according to claim 15, wherein said balloon is selected from, a balloon wherein at least part of said middle portion is corrugated,

a balloon wherein at least part of said distally extending portion is corrugated, and a balloon wherein at least part of said middle portion and at least part of said distally extending portion are corrugated.

17. The balloon catheter according to claim 16, wherein at least part of said distally extending portion is corrugated such that the force required for causing collapse of the distally extending portion of said balloon is substantially smaller than the force required to cause collapse of the proximally extending portion of said balloon.

18. The balloon catheter according to claim 16, wherein at least part of said distally extending portion and at least the distal part of said middle portion are corrugated such that the force required for causing collapse of the distal end of said balloon is substantially smaller than the force required to cause collapse of the proximal end of said balloon.

19. The balloon catheter according to claim 1 , wherein the wall thickness of said balloon is non-uniform along the length of said balloon.

20. The balloon catheter according to claim 1 wherein the wall thickness of the proximal part of said balloon is greater than the wall thickness of the distal part of said balloon.

21. The balloon catheter according to claim 1 , wherein the corrugations of said at least one corrugated portion of said balloon have a cross-sectional shape selected from the group consisting of symmetrical triangular corrugations, non-symmetrical triangular corrugations, curved corrugations, sawtooth like corrugations, symmetrical rounded corrugations, non-symmetrical partly rounded corrugations, and any combinations thereof.

22. The balloon catheter according to claim 1 , wherein the corrugations of said at least one corrugated portion of said balloon are arranged intermittently such that corrugated and non-corrugated portions alternate along said at least one corrugated portion.

23. The balloon catheter according to claim 1 , wherein said inflatable balloon has a distal portion selected from a dome-like portion, a truncated dome-like portion, a conical portion, a frusto-conical portion, a corrugated dome-like portion, a corrugated conical portion, a corrugated frusto-conical portion, and a corrugated truncated dome-like portion.

24. The balloon catheter according to claim 1 , wherein said at least one corrugated portion of said inflatable balloon increases the surface area of said balloon for improving retention of debris or particulate material trapped within said balloon after intussuscepting of said balloon.

25. The balloon catheter according to claim 1 , wherein said at least one corrugated portion of said inflatable balloon increases the probability of collapse of the distal portion of said balloon upon proximal moving of said al least one movable part of said inner conduit as compared to the probability of collapse of a distal portion of a similarly shaped balloon having no corrugated portion.

26. The balloon catheter according to claim 1 , wherein said at least one corrugated portion of said inflatable balloon is configured to be internally disposed within the space formed in the intussuscepted balloon, after the intussuscepting of said balloon is completed, such that no corrugated portion is presented on the external surface of the fully intussuscepted balloon.

27. A method of constructing an intussusceptible corrugated balloon rapid exchange catheter, the method comprising the steps of:

providing a catheter having an outer conduit and an inner conduit disposed within said outer conduit and suitable for total or partial passage over a guide-wire, said inner conduit comprises at least one movable part movably disposed within the lumen of said outer conduit, said inner conduit comprises an angled portion piercing the wall of said outer conduit wherein the distal end of said inner conduit extends beyond the distal end of said outer conduit;

providing a corrugated inflatable balloon having a proximal margin and a distal margin, said corrugated balloon has at least one corrugated portion; and

sealingly attaching said proximal margin of said corrugated balloon to the outer surface of the distal end of said outer conduit and sealingly attaching said distal margin of said corrugated balloon to the outer surface of the portion of the inner conduit that extends beyond the distal end of said outer conduit such that the lumen of said corrugated balloon is in fluidic communication with the space defined between said outer conduit and said inner conduit, said attaching is performed such that at least one of said distal end and said proximal end of said corrugated balloon is capable of intussuscepting upon proximal movement of said at least one movable part of said inner conduit in relation to said outer conduit.

28. A method for collecting debris from an internal passage of a mammalian subject comprising the steps of:

a) inserting a rapid exchange balloon catheter into said internal passage, and advancing said catheter until the distal end thereof has reached a site, at which it is desired to collect debris, said rapid exchange balloon catheter comprises

an outer conduit,

an inner conduit disposed within said outer conduit and suitable for total or partial passage over a guide-wire, said inner conduit comprises at least one movable part movably disposed within the lumen of said outer conduit, said inner conduit comprises an angled portion piercing the wall of said outer conduit and a distal end of said inner conduit extends beyond the distal end of said outer conduit,

a corrugated inflatable balloon having a proximal margin sealingly attached to the outer surface of the distal end of said outer conduit, and a distal margin sealingly attached to the outer surface of the portion of said inner conduit that extends beyond the distal end of said outer conduit, said corrugated balloon has at least one corrugated portion,

means for axially moving said at least one movable part of said inner conduit within said outer conduit,

means for the introduction of an expansion fluid into the space formed between the inner surface of said outer conduit and the outer surface of said inner conduit and therefrom into the lumen of said balloon and for the removal of said fluid from said space, and

means for permitting unhindered axial movement of said at least one movable part of said inner conduit within said outer conduit, such that said movement is not hindered by the passage of said angled portion of the inner conduit through said outer conduit;

b) inflating said corrugated balloon with expansion fluid;

c) pulling said at least one movable part of said inner conduit in a proximal direction, such that the distal and/or proximal end(s) of said balloon intussuscept(s);

d) deflating said balloon, to form one or more cavities into which said debris is collected and entrapped; and

29. The method according to claim 28, wherein the internal passage is a blood vessel.

30. A method for collecting debris resulting from treatment of a diseased portion of an internal passage of a mammalian subject comprising the steps of:

a) inserting a rapid exchange balloon catheter into said internal passage, said rapid exchange balloon catheter comprises an outer conduit,

means for permitting unhindered axial movement of said at least one movable part of said inner conduit within said outer conduit, such that said movement is not hindered by the passage of said angled portion of the inner conduit through said outer conduit, and

advancing said catheter to position said balloon within at least part of said diseased portion;

b) inflating said balloon with expansion fluid to treat at least part of said diseased portion such that at least some of said debris formed during said inflating is attached to said at least one corrugated portion of said balloon;

c) pulling said at least one movable part of said inner conduit of said balloon catheter in a proximal direction, such that one or more of the distal end and proximal end of said balloon intussuscept;

d) deflating said balloon, to form one or more cavities into which debris is collected and entrapped, wherin at least part of said corrugated portion is disposed within at least one cavity of said one or more cavities; and

31. The method according to claim 30, wherein the internal passage is a blood vessel and said diseased portion comprises an atheromatous plaque.

32. A method for collecting debris from an internal passage of a mammalian subject the method comprising the steps of:

inserting a corrugated balloon catheter comprising a balloon having at least one corrugated portion as defined in claim 1 into said internal passage, and advancing said catheter until the distal end thereof has reached a site at which it is desired to collect debris;

inflating said corrugated balloon with expansion fluid;

pulling said at least one movable part of said inner conduit of said catheter in a proximal direction, for collapsing the distal end of said corrugated balloon to form a cavity within said balloon into which debris is collected and entrapped;

deflating the intussuscepted corrugated balloon; and

33. The method according to claim 32, wherein the internal passage is a blood vessel.

34. The method according to claim 32, wherein said step of pulling comprises pulling said at least one movable part of said inner conduit in a proximal direction to form said cavity, such that all of the corrugated portions of said balloon are disposed within said cavity to enhance retention of said debris.

35. The method according to claim 32, wherein said catheter includes a mechanism for reducing pressure changes within the catheter when said at least one movable part of said inner conduit is moved proximally within said outer conduit while said balloon is inflated and said fluid port is closed, and wherein said step of pulling comprises pulling said at least one movable part of said inner conduit in a proximal direction, for collapsing the distal end of said corrugated balloon to form a cavity within said balloon into which debris is collected and entrapped without inducing substantial pressure changes within the lumen of said balloon during the intussuscepting of said corrugated balloon.

36. The method according to claim 32, wherein said internal passage is a diseased blood vessel and wherein said step of inflating comprises inflating said corrugated balloon while said balloon is disposed near or within an atheromatous plaque of said blood vessel, said inflating is performed such that at least part of the corrugated portion of said at least one corrugated portion of said balloon is pushed against said plaque and wherein at least some debris from said plaque adheres to said corrugated portion and is internalized within said cavity formed in said step of pulling.