EP2306910A1 - Cathéter à ballonet ondulé et ses procédés d utilisation - Google Patents

Cathéter à ballonet ondulé et ses procédés d utilisation

Info

Publication number
EP2306910A1
EP2306910A1 EP09773060A EP09773060A EP2306910A1 EP 2306910 A1 EP2306910 A1 EP 2306910A1 EP 09773060 A EP09773060 A EP 09773060A EP 09773060 A EP09773060 A EP 09773060A EP 2306910 A1 EP2306910 A1 EP 2306910A1
Authority
EP
European Patent Office
Prior art keywords
balloon
corrugated
distal
conduit
corrugations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09773060A
Other languages
German (de)
English (en)
Other versions
EP2306910A4 (fr
Inventor
Eran Harari
Doron Besser
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Angioslide Ltd
Original Assignee
Angioslide Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Angioslide Ltd filed Critical Angioslide Ltd
Publication of EP2306910A1 publication Critical patent/EP2306910A1/fr
Publication of EP2306910A4 publication Critical patent/EP2306910A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A61M25/10182—Injector syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1068—Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1006—Balloons formed between concentric tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves
    • A61M25/10186—One-way valves

Definitions

  • 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 manufacturing and use.
  • 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).
  • 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.
  • treatment means e.g., stent
  • surgical tools e.g. knives, drills etc.
  • catheter systems have also been designed and used for retrieval of objects such as stents from body passageways.
  • OW over-the-wire
  • rapid-exchange catheters Two basic types of catheter have been developed for intravascular use: over-the-wire (OTW) catheters and rapid-exchange 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. Pat. 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.
  • 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).
  • 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.
  • the stent 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. No. 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.
  • the outer conduit has a variable stiffness along its length, while the inner conduit.
  • the inner conduit while being intrinsically relatively flexible is stiffened by the presence of axial tensioning wires.
  • Rapid exchange 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. Pat. Nos. 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 guidewire 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.
  • 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 reliable 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.
  • intussuscepting balloons such as, for example, the balloons disclosed in WO 2005/102184 and WO 2007/004221
  • the proximal and distal ends of the balloon are defined as described in WO 2005/102184 and WO 2007/004221).
  • a balloon catheter the catheter includes an outer conduit and an inner conduit, suitable for passage over a guide wire.
  • the inner conduit is disposed within the lumen of the outer conduit such that the longitudinal axes of the inner and outer conduits are substantially parallel.
  • the inner and outer conduit are positioned such that the distal tip of the inner conduit extends beyond the distal tip of the outer conduit.
  • the inner conduit is capable of being moved along its longitudinal axis in relation to the outer conduit.
  • the catheter also includes an inflatable balloon having a proximal margin attached to the outer surface of the distal tip of the outer conduit and a distal margin attached to the outer surface of the portion of the inner conduit that extends beyond the distal tip of the outer conduit.
  • the inflatable balloon has at least one corrugated portion.
  • the distal end portion of the balloon is capable of intussuscepting upon proximal movement of the inner conduit in relation to the outer conduit.
  • the catheter also includes a fluid port for introducing an inflation 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 removing the inflation fluid from the space and from the lumen.
  • the balloon catheter also includes a pressure adjusting mechanism for preventing substantial pressure changes within the space formed between the inner surface of the outer conduit and the outer surface of the inner conduit and within the lumen of the balloon upon axial movement of the inner conduit in relation to the outer conduit.
  • the pressure adjusting mechanism is selected from, a pressure adjusting mechanism including a syringe-like structure disposed at the proximal end of the balloon catheter, the syringe-like structure includes a barrel and a plunger disposed within said barrel.
  • the plunger co-axially surrounds the proximal end of the inner conduit, and is affixed thereto, an over-pressure outlet in fluidic communication with the lumen of the inflatable balloon and having an opening and a compliant member sealingly attached to the opening for at least partially relieving over-pressure in the lumen, an over-pressure valve outlet in fluidic communication with the lumen of the inflatable balloon and an over-pressure valve disposed within the over-pressure outlet to allow discharging of fluid from the lumen when over-pressure conditions develop in the lumen, and an expandable or inflatable portion of the outer conduit, capable of being inflated when over-pressure conditions occur in the lumen of the balloon to at least partially relieve the over-pressure in said lumen.
  • 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.
  • the balloon is selected from a balloon wherein at least part of the middle portion is corrugated, a balloon wherein at least part of the distal portion is corrugated, and a balloon wherein at least part of the middle portion and at least part of the distal portion is corrugated.
  • At least part of the distal portion of the balloon 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.
  • At least part of the distal portion and at least the distal part of the middle portion are 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.
  • the wall thickness of the balloon is non-uniform along the length of the balloon.
  • the wall thickness of the proximal part of the balloon is greater than the wall thickness of the distal part of the balloon.
  • the corrugations of the corrugated portion(s) 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.
  • the corrugations of thee corrugated portion(s) of said balloon are arranged intermittently such that corrugated and non-corrugated portions alternate along the corrugated portion(s).
  • the inflatable balloon has a distal portion selected from a domelike 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 truncated dome-like portion.
  • the corrugated portion(s) of the inflatable balloon increase the surface area of the balloon for improving retention of debris or particulate material trapped within the balloon after intussuscepting of said balloon.
  • the corrugated portion(s) of the inflatable balloon increase the probability of collapse of the distal portion of the balloon upon proximal moving of the inner conduit as compared to the probability of collapse of the distal portion of a similarly shaped balloon having no corrugated portion(s).
  • 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.
  • a method of manufacturing an intussusceptible corrugated balloon catheter includes the steps of: providing a catheter having an outer conduit and an inner conduit, suitable for passage over a guide wire, the inner conduit is disposed within the lumen of the outer conduit such that the longitudinal axes of the inner and outer conduits are substantially parallel.
  • the inner conduit is positioned such that the distal tip thereof extends beyond the distal tip of the outer conduit.
  • the inner conduit is capable of being moved along its longitudinal axis in relation to the outer conduit.
  • the catheter has an inflation fluid port in fluidic communication with the space formed between the inner surface of the outer conduit and the outer surface of the inner conduit; providing an inflatable corrugated balloon having at least one corrugated portion, said corrugated balloon has a proximal margin and a distal margin; and sealingly attaching said proximal margin of said balloon to the outer surface of the distal end of said outer conduit and sealingly attaching said distal margin of said 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 said space formed between said inner surface of said outer conduit and said outer surface of said inner conduit, said attaching is performed such that the distal end portion of said corrugated balloon is capable of intussuscepting upon proximal movement of said inner conduit in relation to said outer conduit.
  • a method for collecting debris from an internal passage of a mammalian subject includes the steps of: inserting a corrugated balloon catheter including a balloon having at least one corrugated portion into the internal passage and advancing the catheter until the distal tip thereof has reached the site, at which it is desired to collect debris, inflating the corrugated balloon with expansion fluid, pulling the inner conduit of the corrugated balloon catheter in a proximal direction, such that the distal end of the corrugated balloon intussuscepts forming a cavity 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.
  • the internal passage is a blood vessel.
  • the step of pulling includes pulling the inner conduit of the corrugated balloon catheter 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.
  • the catheter includes a mechanism for preventing substantial pressure changes when the inner conduit is moved proximally within the outer conduit while the balloon is inflated and the fluid port is closed and wherein the step of pulling includes pulling the inner conduit of the corrugated balloon catheter in a proximal direction for collapsing the distal end of the corrugated balloon to form a cavity within the balloon into which cavity debris is collected and entrapped without inducing substantial pressure changes within the lumen of the balloon during the intussuscepting.
  • a corrugated element for use in constructing a catheter, the corrugated element includes a sleeve-like element including a first side portion having a first open end with a first diameter, a second side portion having a second open end with a second diameter smaller than the first diameter and a middle portion disposed between the first side portion and the second side portion, at least part of the sleeve-like element is corrugated.
  • At least part of the second side portion is corrugated.
  • the wall thickness of the sleeve-like element is non-uniform along a longitudinal axis of the element.
  • the wall thickness of the first side portion is greater than the wall thickness of the second side portion of the sleeve-like element.
  • the corrugations of the corrugated part of the sleeve-like element 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.
  • the corrugations of the corrugated part of the sleeve-like element are arranged intermittently such that corrugated and non-corrugated portions alternate along the corrugated part of said sleeve-like element.
  • the shape of the second side portion of the sleeve-like element is selected from a dome-like shape, a truncated dome-like shape, a conical shape, a frusto- conical shape, a corrugated dome-like shape, a corrugated conical shape, corrugated frusto-conical shape and a corrugated truncated dome-like shape.
  • Fig. 1 is a schematic side view diagram illustrating a corrugated inflatable sleeve-like usable as an intussusceptible balloon in a balloon catheter in accordance with an embodiment of the balloons of the present application;
  • Fig. 2 is a schematic cross section of the corrugated balloon of Fig. 1, taken along the lines II-II;
  • Fig. 3 is a schematic cross-sectional diagram illustrating a catheter system including the corrugated intussusceptible inflatable balloon of Fig. 1 in accordance with an embodiment of the catheter systems of the present application;
  • Figs. 4-8 are a schematic cross-sectional diagrams illustrating different steps of a method of using a catheter system including the corrugated intussusceptible inflatable balloon of Fig. 1, in accordance with an embodiment of the method of the present application;
  • 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;
  • 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
  • FIGS. 20-21 are schematic cross-sectional diagrams illustrating parts of catheters with different types of corrugated inflatable intussusceptible balloons having partially corrugated middle balloon portions and/or corrugated side portions, 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.
  • Fig. 27 is a schematic cross-sectional diagram illustrating a catheter system including the corrugated intussusceptible inflatable balloon of Fig. 1 having a compliant member usable as a pressure adjusting mechanism in accordance with another embodiment of the catheter systems of the present application.
  • the terras "corrugated balloon” and “concertina-like balloon” 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.
  • 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.
  • the graduated scale 19 is disposed on the proximal side of the catheter 30 and the terminal cylindrical portion 10J is disposed near the distal side or distal end of the catheter 30.
  • 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.
  • the corrugated balloon 10 of Figs. 1-2 has a middle portion 1OA, a proximal side portion 1OB and a distal side portion 1OC.
  • Fig. 1 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. 2 is a schematic cross section of the corrugated balloon of Fig. 1, taken along the lines H-II.
  • the balloon 10 has a middle portion 1OA and two side portions 1OB and 1OC.
  • the side portion 1OB is also referred to as the proximal side portion 1OB and the side portion 1OC is referred to as the distal side portion 1OC.
  • a portion 1OD of the wall of the middle portion 1OA is corrugated or folded in a concertina-like or accordion-like structure. The shape of the corrugations of the portion 1OD may be generally triangular and symmetrical as may be seen in the cross-sectional view of Fig. 2.
  • the middle portion 1OA is the portion that has the largest diameter of the portions HA, 1OB and 1OC.
  • the middle portion also includes a curving portion 1OE.
  • the proximal side portion 1OB includes a cylindrical portion 1OF, a frusto-conical portion 1OG and a terminal cylindrical portion 1OH.
  • the cylindrical portion 1OH is the proximal margin of the balloon 10.
  • the distal side portion 1OC includes a truncated dome-like portion 101 and a terminal cylindrical portion 10J.
  • the cylindrical portion 10J is the distal margin of the balloon 10.
  • the diameter of the terminal cylindrical portion 1OH is larger than the diameter of the terminal cylindrical portion 10J.
  • the balloon 10 is made from Nylon® or another suitable biocompatible material, as is known in the art, such as, but not limited to, PET, PAl 2 (for example Grilamid ® L25, L55 and the like), PAI l, 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.
  • PET for example Grilamid ® L25, L55 and the like
  • PAI l Polyether block amides
  • PEBA Polyether block amides
  • Grilflex ® such as, for example, ELG 6260
  • 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.
  • Fig. 3 is a schematic cross-sectional diagram illustrating a catheter system including the corrugated intussusceptible inflatable balloon of Fig. 1, in accordance with an embodiment of the catheter systems of the present application.
  • the balloon catheter 30 comprises an inner tube 17 slidably positioned inside an outer tube 18.
  • the proximal (i.e., trailing) end of inner tube 17 comprises an entry port 12, which extends outwardly through orifice 29 provided at the proximal end of the outer tube 18.
  • Orifice 29 tightly fits around the outer surface of inner tube 17 without gripping it, thereby allowing proximal and distal movements of inner tube 17 while sealing the inner lumen of outer tube 18.
  • the outer tube 18 may (optionally but not obligatorily) include an over-pressure valve outlet 15 or other suitable pressure adjusting mechanisms constructed and operable to relieve over-pressure as is disclosed in detail hereinafter.
  • the outer conduit 18 of the catheter 30 does not include the over-pressure valve outlet 15 or any other type of pressure adjusting mechanism.
  • a graduated scale 19 may optionally be provided on the outer surface of inner tube 17 as illustrated and described in detail in the above referenced international patent application published as WO 2007/7004221 and as explained hereinafter with reference to Fig. 3 of the present application.
  • the proximal end of outer tube 18 further comprises a fluid port 11 for injecting/removing inflation fluids to/from the inner lumen of outer tube 18, an overpressure valve outlet 15 for discharging inflation fluids whenever over-pressure conditions develop in the inner lumen of outer tube 18, and an inner tube safety lock 14 adapted for gripping the outer surface of inner tube 17, thereby preventing proximal- distal movements thereof relative to outer tube 18.
  • the precise structure and operation of the safety lock 14 is as disclosed in detail in WO 2007/7004221.
  • the over-pressure adjusting mechanism there is no the over-pressure adjusting mechanism and the over-pressure may be resolved by slight expansion of some parts of the catheter (such as but not limited to, the outer conduit 18) if these parts are made of sufficiently compliant material.
  • the pressure inside the lumen of the balloon 10 may increase during the intussuscepting of the balloon, such pressure increase may be safely accommodated by using a balloon 10 capable of safely withstanding the over-pressure resulting from the intussuscepting of the balloon 10.
  • the wall thickness of the balloon 10 may be made sufficiently thick to safely withstand the over-pressure or the balloon 10 may be made from a material having sufficient strength to effectively withstand the over-pressure resulting from the intussuscepting of the balloon 10.
  • a pressure adjusting mechanism may be used in the catheter 30 of Fig. 3.
  • the pressure adjusting mechanism includes an over-pressure valve outlet 15 and an over-pressure valve 16 disposed therein.
  • the over-pressure valve outlet 15 may include an over-pressure valve 16 for sealing the opening of over-pressure valve outlet 15 and for discharging portions of inflating fluids therethrough whenever overpressure conditions are reached in inner lumen of outer tube 18.
  • the over-pressure valve outlet 15 is in fluidic communication with the lumen of the inflatable balloon 10 through the space formed between the inner surface of the outer tube 18 and the outer surface of the inner tube 17, and the over-pressure valve 16 disposed within the over-pressure outlet 15 may allow discharging of fluid from the lumen of the balloon 10 when over-pressure conditions develop in the lumen of the balloon 10 during the intussuscepting of the balloon 10. It should be realized however that such over-pressure conditions may be resolved by other means. For example, an inflatable member may be attached to the opening of over-pressure valve outlet 15, and in such an implementation over-pressure valve 16 may be eliminated. Reference is now made to Fig.
  • FIG. 27 is a schematic cross-sectional diagram illustrating a catheter system including the corrugated intussuscepting inflatable balloon of Fig. 1 and having an additional compliant member usable as a pressure adjusting mechanism in accordance with another embodiment of the catheter systems of the present application.
  • the catheter 39 is similar in construction and operation to the catheter 30 of Fig. 3, except that the over-pressure valve 16 of Fig. 3 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 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 10.
  • the compliant member 9 may expand to accommodate some of the inflating fluid thus relieving some of the over-pressure in the lumen of the balloon 10.
  • the outer tube 18, 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 tube 18 or of a compliant portion thereof.
  • the inner tube safety lock 14 contacts the outer surface of inner tube 17 via a tight orifice provided on the outer surface at the proximal end of outer tube 18. It is noted that the details of construction and operation of the safety lock 14 are fully explained and illustrated in Figs IA and IB of the above referenced International Patent Application published as WO 2007/7004221, and are therefore not disclosed in detail hereinafter. As seen in Fig.
  • the distal (leading) end (distal tip) of the inner tube 17 extends outwardly through the distal opening of outer tube 18.
  • the corrugated balloon 10 (of Figs. 1-2), is attached to the distal ends of outer tube 18 and the inner tube 17.
  • the portion 1OH of the corrugated balloon 10 is attached at a circumferential attachment region 7 to the outer surface near the distal tip of outer tube 18.
  • the portion 10J of the corrugated balloon 10 is attached at circumferential attachment region 6 to the outer surface near the distal tip of inner tube 17, such that it seals the distal opening of the outer tube 18.
  • the attachment of the balloon 10 to the tips of the inner tube 17 and the outer tube 18 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.
  • the catheter may include a pressure adjusting mechanism comprising a syringe-like structure.
  • the syringe-like structure is disposed at the proximal end of the balloon catheter.
  • the syringe-like structure may include a barrel and a plunger disposed within the barrel.
  • the plunger co-axially surrounds the proximal end of the inner conduit 17, and is affixed thereto.
  • 1C of WO 2007/7004221 is positioned at the proximal end of the catheter system, wherein the barrel portion 26 (of Fig. 1C of WO 2007/7004221) of the syringe-like structure is formed by an expanded portion of the outer conduit 18, and wherein the plunger 17a (of Fig. 1C of WO 2007/7004221) of the syringe- like structure co-axially surrounds the proximal end of the inner conduit 17.
  • the barrel portion 26 may also be implemented as a separate member suitably sealingly attached to the outer conduit 18.
  • FIGs. 4-8 are a schematic cross-sectional diagrams illustrating different steps of a method of using a catheter system including the corrugated intussusceptible inflatable balloon of Fig. 1, in accordance with an embodiment of the method of the present application.
  • Figs. 4-8 illustrate the insertion of the balloon catheter 30 to a treatment site, for example a blood vessel 20. It is noted that while the illustrations of the application use the blood vessel 20 as an example of the treated site, this is done by way of exemplary demonstration only, and other body passages may also be treated by the catheters, and catheter systems of the present application. Turning to Fig.
  • FIG. 4 an exemplary interventional procedure using the corrugated balloon catheter 30 of the present application starts as the balloon catheter 30 is guided to the treatment site within the blood vessel 20 (e.g., over the wire).
  • Fig. 4 illustrates over-the- wire insertion, wherein the insertion of the balloon catheter 30 is performed over a guide wire 13. It should be clear, however, that the invention is not limited to one specific insertion method and that other appropriate and practicable catheter insertion methods known in the art (such as, but not limited to, using a guiding catheter) may also be used.
  • the catheter is advanced over the guide wire 13 until the (non-inflated) middle portion 5A is positioned within an atheromatous plaque 23 attached to the inner surface 21 of the blood vessel 20.
  • the operator inflates the corrugated balloon 10 by injecting inflation fluids via fluid port 11 (see Fig. 3) and the inner lumen of outer tube 18.
  • inflation fluids are preferably injected into the corrugated balloon 10 such that the circumferential corrugated sides of the portion 1OA of the corrugated balloon 10 are expanded and pressed against the inner surface 21 of blood vessel 20 and against the plaque 23, as illustrated in Fig. 5.
  • the pressure inside the corrugated balloon 10 in such conditions may be in general about 1-25 Atmospheres, preferably about 6 Atmospheres.
  • the middle portion 1OA of the corrugated balloon 10 is placed within the region of the plaque 23 and is used to treat the plaque 23 by pushing the plaque 23 towards the walls of the blood vessel 20 to open a larger passage within the atheromatous portion of the blood vessel 20
  • the portion 1OA is not used as a plaque treating or plaque pushing means, but is used as an anchoring portion of the corrugated balloon 10 enabling firm anchoring of the catheter 30 to the walls of the blood vessel 20 which in turn allows other different plaque treating devices (not shown in Fig.
  • the portion 1OA of the balloon is typically positioned within the blood vessel 20 at a site proximal to the position of the plaque 23, and plaque 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, Radiofrequency angioplasty device, an ultrasonic ablator device, and the like) inserted into the lumen of the inner tube 17.
  • 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, Radiofrequency angioplasty device, an ultrasonic ablator device, and the like
  • the inner lumen of the inner tube 17 may now be utilized for operating in the treated site with different interventional tools (not shown in Figs 4-8), as may be required. However, some procedures (for example angioplasty) may be completed, or may be near completion, once balloon 10 reaches its fully inflated state.
  • a sample of liquid or solid matter, for example fluids, secretions, and/or debris 25 may be collected and removed from the treatment site by causing the balloon 10 to intussuscept.
  • the inner tube safety lock 14 (see Fig. 3) is pulled out, thereby releasing its grip from inner tube 17.
  • the inner tube 17 is then retracted outwardly (proximally) by the operator as shown by arrow 28 of Fig. 6.
  • the distal portion of balloon 10 collapses and the outer surface portions of the balloon 10 are folded inwardly over the distal tip of inner tube 17 and thereafter over itself as further portions of the balloon collapse, as illustrated in Figs. 6-7.
  • the corrugated form of the balloon 10 advantageously assists the proper folding of the balloon 10 because the corrugated shape results in reducing the force required for initiating the internal folding of the distal end of the balloon.
  • the operator can determine by monitoring the graduated scale 19, the amount of length of the inner tube 17 that has been retracted and in this way the operator may determine when to stop the retraction and restore immobilization (locking) of the inner tube 17 by pushing down the inner tube safety lock 14 (of Fig. 3), as explained in the catheter systems disclosed in detail in WO 2007/7004221.
  • the balloon 10 may have a substantially increase in the pressure during the period in which it is intussuscepted while the fluid port 11 is sealed.
  • Fig. 6 during the retraction of the inner tube 17 in the proximal direction indicated by the arrow 27, the dome-like portion 101 of the balloon 10 inverts starting the intussuscepting of the balloon 10.
  • Fig. 7 during the retraction of during the retraction of the inner tube 17 in the proximal direction indicated by the arrow 27, the additional portions of the balloon 10 continue to intussuscept as illustrated, such that portion 101, and part of the portion 1OD form an internal cavity 41.
  • the internal cavity 41 increases in length and its volume increases until the retraction of the inner tube 17 is stopped and the operator restores immobilization (locking) of the inner tube 17 by pushing down the inner tube safety lock 14 (of Fig. 3), as explained in the catheter systems disclosed in detail in WO 2007/7004221.
  • the fluids contained within the walls of the intussuscepted balloon 10 and may be withdrawn through the open annular passage 33 formed between the inner tube 17 and the outer tube 18.
  • the corrugation of the portion 1OD advantageously assists the intussuscepting of the balloon 10 by reducing the puling force required for the internal folding of the balloon, as compared to the force required for the internal folding of a non-corrugated balloon (having substantially similar dimensions but including no corrugations), such as the balloons disclosed in WO 2007/7004221.
  • corrugated portion(s) of the corrugated inflatable balloons disclosed in the present application increase the probability of collapse of the distal portion of the balloon upon proximal moving of the inner conduit 17 as compared to the probability of collapse of a distal portion of a similarly shaped balloon having no corrugated portion(s).
  • the corrugations of the portion 10D increase the surface area of the part of the balloon 10 which is in contact with the wall of the blood vessel 20 when the balloon 10 is in the inflated state, and thus advantageously increases the surface area onto which the debris 25 and other particular matter released from the compacted and/or disrupted plaque 23 may adhere and may result in advantageously increasing the amount of debris 25 and/or plaque particulate material that is carried into and trapped within the cavity 41 internally formed within the balloon 10 after the intussuscepting of the balloon 10.
  • the balloon 10 is deflated by retracting inflation fluids through the fluid port 11 (of Fig. 3) as explained in detail in WO 2007/7004221.
  • the pressure inside the balloon 10 and in the inner lumen of outer tube 18 is substantially decreased, and the intussuscepted balloon 10 is deflated.
  • the operator may retract (withdraw) the balloon catheter 30 proximally in the direction of the arrow 31 such that the portion of fluid/secretion and the debris 25 confined within the cavity 41 are withdrawn with the balloon catheter 30 outside of the treated body (not shown in the figures).
  • the debris 25, or objects or samples may be easily collected when the entire length of balloon catheter 30 is withdrawn from the body of the treated subject, by pushing the inner tube 17 distally and unfolding the folded portions of balloon 5, thus restoring the deflated state of balloon 10 (shown in Fig. 3).
  • the coiTugated portion 1OD 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.
  • 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.
  • the conduits may be constructed of a braided material or of materials having a defined molecular orientation.
  • the approximate maximum forces that the inner and outer tubes need to withstand are as follows: I) 2.5-4 mm diameter balloons: the tubing should withstand forces of up to 500 gram; polymer tubing made of Nylon or Pebax ® (a thermoplastic polyether block amide polymer) reinforced during the manufacturing process can be used. II) 4-8 mm diameter (or larger) balloons: the tubing should withstand forces up to 2 kilogram. In this case it may be necessary to use a braided tube (polymer tube with metal mesh reinforcement).
  • Example 2 Exemplary results for a representative study of the forces generated during balloon folding are presented in Example 2, of WO 2007/7004221 incorporated herein by reference in its entirety.
  • the outer tube 18 is preferably made from a biocompatible polymer type of material, such as polyurethane or nylon or PET, and may be manufactured using conventional methods, such as extrusion.
  • the diameter of the inner lumen of outer tube 18 is generally in the range of 0.5-2.0 mm (millimeters), preferably about 0.7 mm, and the diameter of the fluid port 11 is generally in the range of 2-6 mm, preferably about 4 mm.
  • the diameter of the over-pressure valve outlet 15 is generally in the range of 1-6 mm, preferably about 4 mm, and the entire length of the outer tube 18 is generally in the range of 100-2000 mm, preferably about 1400 mm.
  • the inner tube 17 is preferably made from a biocompatible polymer type of material, such as polyurethane or Nylon or PET, and it may be manufactured using conventional methods, such as extrusion.
  • the diameter of the inner lumen of inner tube 17 is generally in the range of 0.2-2.0 mm, preferably about 0.5 mm, and its entire length is generally in the range of 100-2000 mm, preferably about 1500 mm.
  • the diameter of the orifice 29 provided at the proximal tip of the outer tube 18 should be adapted to provide appropriate sealing of inner lumen of the outer tube 18 it should also close over the outer surface of the inner tube 17 such that inner tube 17 may be displaced therethrough with relatively low frictional forces.
  • the diameter of the orifice 29 should be 1.0 mm.
  • the balloon 10 is preferably a non-compliant or semi-compliant balloon such as manufactured by Advanced Polymers (Salem, USA) and by Interface Associates (CA).
  • the balloon 10 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 10 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 10 is 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 1OD of the balloon 10 may vary between 2.0 mm to 5 mm for coronary artery applications, but may be significantly larger for use in larger blood vessels.
  • the balloon 10 should have a burst pressure within the range of 12-20 atmospheres.
  • the proximal and distal edges of the balloon 10 such as the cylindrical portions 1OH and 10J, respectively, of the balloon 10, are preferably sealingly attached to the outer surfaces of outer tube 18 and of the inner tube 17 respectively, at circumferential attachment points 7 and 6 respectively, by using, heat bonding, or a UV or thermo bonding type of adhesive such as commonly used in the art.
  • 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.
  • corrugated balloon 10 and the catheter 30 including it are shown by way of example, they are not intended to limiting by any way. Rather, many other different types of corrugated balloons may be advantageously implemented in the catheters of the present application.
  • Figs. 9-12 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.
  • 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 1OH (of Fig. 2).
  • the frusto-conical portion 34G is longitudinally shorter than the frusto-conical portion 1OG (of Fig. 2) and therefore has a steeper cone angle.
  • the cylindrical portion 34F is longer than the cylindrical portion 1OF (of Fig. 2).
  • the portions 34D, 341 and 34J are similar in shape to the corresponding portions 10D, 101 and 1OJ, respectively, of Fig. 2.
  • the corrugations 34N have a symmetrical triangular shape, in accordance with an embodiment of the balloons of the present application.
  • 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 1OH (of Fig. 2).
  • the frusto-conical portion 35G is similar to the frusto-conical portion 1OG (of Fig. 2) 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 10 of Fig. 2).
  • the portions 35D, 351 and 35J are similar in shape to the corresponding portions 10D, 101 and 10J, respectively, of Fig. 2.
  • the corrugations 35N have a symmetrical rounded shape, in accordance with another embodiment of the balloons of the present application.
  • 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 1OH (of Fig. 2).
  • the portion 36G is shaped like a truncated dome (having a convex shape) and is longitudinally shorter than the frusto-conical portion 1OG (of Fig. 2).
  • the cylindrical portion 36F is shorter than the cylindrical portion 1OF (of Fig. 2).
  • the portions 36D, 361 and 36J are similar in shape to the corresponding portions 34D, 341 and 34J respectively, of Fig. 9.
  • the corrugated balloon 37 includes contiguous portions 37H, 37G,
  • the cylindrical portion 37H is shorter than the cylindrical portion 1OH (of Fig. 2).
  • the portion 36G has a tapered shape (having a concave shape) and is longitudinally shorter than the frusto-conical portion 1OG (of Fig. 2).
  • the cylindrical portion 37F is shorter than the cylindrical portion 1OF (of Fig. 2).
  • the portions 37D, 371 and 37J are similar in shape to the corresponding portions 34D, 341 and 34J respectively, of Fig. 9.
  • 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.
  • 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.
  • the corrugated balloon 40 includes contiguous portions 4OH, 4OG, 4OF, 4OD, 401 and 4OJ.
  • the portions 4OH, 4OG, 4OF, 401 and 4OJ are similar the corresponding portions 1OH, 1OG, 1OF, 101 and 10 J (of Fig. 2), respectively.
  • the number and shape of the corrugations 4ON of the portion 4OD are different then those of the corresponding portion 1OD (of Fig. T).
  • Each of the corrugations 4ON is wider than the corrugations ION (i.e, the length L2 of each of the corrugations 4ON is longer than the length Ll of the corrugations ION of Fig. 2)
  • the corrugated balloon 45 includes contiguous portions 45H, 45G, 45F, 45D, 451 and 45 J.
  • the portions 45H, 45G, 45F, 451 and 45 J are similar the corresponding portions 1OH, 1OG, 1OF, 101 and 10J (of Fig. T), respectively.
  • the shape (and possibly the number) of the corrugations 45N of the portion 45D are different then those of the corresponding portion 1OD (of Fig. 2).
  • Each of the corrugations 4ON 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.
  • the corrugated balloon 47 includes contiguous portions 47H, 47G, 47F, 47D, 471 and 47 J.
  • the portions 47H, 47G, 47F, 471 and 47J are similar the corresponding portions 1OH, 1OG, 1OF, 101 and 10J (of Fig. 2), respectively.
  • the shape (and possibly the number) of the corrugations 47N of the portion 47D are different then those of the corresponding portion 1OD (of Fig. 2).
  • Each of the corrugations 4ON 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.
  • Fig. 16-19 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.
  • the corrugated balloon 50 includes a middle potion 5OA, a proximal side portion 5OB and a distal side portion 5OC.
  • the proximal side portion 5OB comprises contiguous portions 5OH, 5OG and 5OF.
  • the middle portion 5OA comprises contiguous portions 5OM and 5OD.
  • the portion 5OM is not corrugated and the portion 5OD is coiTugated as disclosed hereinabove.
  • the distal side portion 5OC comprises a corrugated curved portion 501 which is contiguous with the corrugated portion 50D, and a non-corrugated cylindrical portion 50 J.
  • the portions 5OH, 5OG, 5OF, and 5OJ are similar the corresponding portions 4OH, 4OG, 4OF, and 4OJ of the balloon 40 (of Fig. 13), respectively.
  • the truncated dome-like portion 401 of Fig. 13 is not corrugated, the portion 5OT has a corrugated dome like shape.
  • This corrugated truncated conical structure may further facilitate the folding and intussuscepting of the balloon 50.
  • the shape and dimensions of the corrugations 5OK of the potion 501 may be similar to the shape and dimensions of the corrugations 5ON of the portion 5OD.
  • the shape and dimensions of the corrugations 5OK of the potion 501 may be different than the shape and dimensions of the corrugations 5ON of the portion 5OD (such as, but not limited to, the corrugations 5OK of the potion 501 being smaller than and/or having a different shape then the corrugations 5ON of the portion 50D).
  • the corrugated balloon 60 includes a middle potion 6OA, a proximal side portion 6OB and a distal side portion 6OC.
  • the corrugated balloon 60 has a non-uniform wall thickness along it's length.
  • the proximal side portion 6OB comprises contiguous portions 6OH, 6OG and 6OF.
  • the middle portion 6OA comprises contiguous portions 6OM and 6OD.
  • the portion 6OM is not corrugated and the portion 6OD is corrugated, as disclosed hereinabove.
  • the distal side portion 6OC comprises a truncated dome-like portion 601 which is contiguous with the corrugated portion 6OD, and a non-corrugated cylindrical portion 6OJ.
  • the portions 6OD, 601 and 6OJ are similar in shape and dimensions the corresponding portions 10D, 101 and 10J of the balloon 10 (of Figs. 1-2), respectively.
  • the portions 6OH, 6OG, 6OF and 6OM have walls which are thicker than the walls of the corresponding portions 1OH, 1OG, 1OF and 1OE of the balloon 10 (of Fig.2).
  • the extra thickness of the walls of the balloon portions 6OH, 6OG, 6OF and 6OM of the balloon 60 mechanically reinforce the proximal side portion 6OB and the portion 6OM and advantageously prevents (or reduces the probability of) the folding of the proximal side of the balloon 60 and ensures that when the balloon is attached to a catheter similar to the catheter 30 of Fig.
  • the distal side of the balloon 60 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 6OB and the portion 6OM.
  • the corrugated balloon 70 includes a middle potion 7OA, a proximal side portion 7OB and a distal side portion 7OC.
  • the proximal side portion 7OB comprises contiguous portions 7OH, 7OG and 7OF.
  • the middle portion 7OA comprises contiguous portions 7OM and 7OD.
  • the portion 7OM is not corrugated and the portion 7OD is corrugated as disclosed hereinabove.
  • the distal side portion 7OC comprises a corrugated truncated conical portion 701 which is contiguous with the corrugated portion 7OD, and a non-corrugated cylindrical portion 70 J.
  • the portions 7OH, 7OG, 7OF, and 7OJ are similar the corresponding portions 4OH, 4OG, 4OF, and 4OJ of the balloon 40 (of Fig. 13), respectively.
  • the portion 401 of Fig. 13 has a non-corrugated truncated dome-like shape
  • the portion 701 has a corrugated truncated conical shape.
  • the corrugated structure of the portion 701 may similarly facilitate the folding and intussuscepting of the balloon 70.
  • the shape and dimensions of the corrugations 7OK of the potion 701 may be similar to the shape and dimensions of the corrugations 7ON of the portion 7OD.
  • the shape and dimensions of the corrugations 7OK of the potion 701 may be different than the shape and dimensions of the corrugations 7ON of the portion 7OD (such as, but not limited to, the corrugations 7OK of the potion 501 being smaller than and/or having a different shape then the corrugations 5ON of the portion 50D).
  • the corrugated balloon 80 includes a middle potion 8OA, a proximal side portion 8OB and a distal side portion 8OC.
  • the proximal side portion 8OB is identical to the proximal portion 1OB (of Fig. 2) and comprises contiguous portions 8OH, 8OG and 8OF.
  • the distal side portion 8OC is identical to the distal portion 1OC (of Fig. 2) and includes the portions 801 and 8OJ.
  • the middle portion 8OA comprises portion 8OM which is identical to the portion 1OE of Fig. 2, and two contiguous corrugated portions 8OD and 8OP.
  • the corrugations of the portion 8OD are similar in shape to the symmetrical triangular corrugations 5ON of Fig. 16.
  • the corrugations of the portion 8OP are symmetrical rounded or curved corrugations similar to the corrugations 35N (illustrated in the inset of Fig.10).
  • 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.
  • 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.
  • 20-21 which are schematic cross-sectional diagrams illustrating parts of catheters with different types of corrugated inflatable intussusceptible balloons having partially corrugated middle balloon portions and/or corrugated side portions, in accordance with yet additional embodiments of the corrugated balloon of the present application.
  • 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 4OB (of Fig. 13) and comprises contiguous portions 140H, 140G and 1400F.
  • the distal side portion 140C is identical to the distal portion 1OC (of Fig. 2) and includes the portions 1401 and 140J.
  • the middle portion 140A comprises a non-corrugated portion 140D and a contiguous corrugated portion 141D.
  • 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.
  • 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.
  • 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 4OB (of Fig. 13) and comprises contiguous portions 140H, 140G and 140F.
  • the distal side portion 140C is identical to the distal portion 1OC (of Fig. 2) and includes the portions 1401 and 140J.
  • the middle portion 140A comprises a non-corrugated portion 140D and a contiguous corrugated portion 141D.
  • 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.
  • 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.
  • 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 4OB (of Fig. 13) and comprises contiguous portions 150H, 150G and 150F.
  • the distal side portion 150C is identical to the distal portion 5OC (of Fig. 16) and includes a corrugated dome-like portion 1501 and a non- corrugated cylindrical portion 150J similar to the portions 501 and 5OJ, respectively, of Fig. 16.
  • the middle portion 140A comprises a single non-corrugated portion.
  • 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 the corrugations of the portion 1501.
  • 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.
  • 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.
  • proximal portion of the balloons described herein and illustrated in the drawings are not corrugated (in order to minimize the probability of initial collapse of the proximal portion of the balloon when the inner tube 17 is pulled proximally), it is possible to construct and use embodiments of balloon catheters having balloons having a corrugated proximal part and balloon catheters having the entire balloon being corrugated (continuously or altematingly as shown in the example of Fig. 25 hereinbelow).
  • the balloon catheters of the present application may have a corrugated proximal part or to be corrugated along the entire balloon length.
  • the probability of the proximal collapse of the balloon when the inner tube 17 is pulled proximally 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the balloon 190 (only part of which is illustrated in Fig. 25) includes three corrugated portions 190A, 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.
  • Fig. 26 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.
  • any types and sizes of corrugations may be used mixed and matched as desired.
  • 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.
  • cylindrical portions 10J, 34J, 35J, 36J, 37J, 4OJ, 45J, 47J, 5OJ, 6OJ, 7OJ, 8OJ, 140J, and 150J are also referred to as the "distal margins" of the balloons 10, 34, 35, 36, 37, 40, 45, 47, 50, 60, 70, 80, 140, and 150, respectively, throughout the specification and the claims of the present application.
  • proximal margins of the balloons 10, 34, 35, 36, 37, 40, 45, 47, 50, 60, 70, 80, 140, and 150, respectively, throughout the specification and the claims of the present application.
  • the side portion(s) of the corrugated balloons of the present application may have cylindrical and/or conical and/or frusto-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.
  • 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.
  • 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.
  • the corrugations 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. Returning to Fig.
  • 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).
  • the corrugation amplitude L depends on the diameter of the balloon.
  • the corrugation amplitude L is in the range of 2.5%
  • 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. 2 for an indication of P in the particular case of symmetrical triangularly shaped corrugations of the balloon 10), and may depend, inter alia, on the outer diameter of the inflated balloon and on the type and shape of the corrugations.
  • the corrugation pitch P 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.
  • the corrugated balloons described herein may also be used in the rapid exchange catheters disclosed in Published International Patent applications, Publication Number WO 2007/042935, or in other catheter systems having intussuscepting balloons, such as the catheters disclosed in Published International Patent applications, Publication Numbers. WO2005/102184, WO2007/004221, WO2008/004238 and WO2008/004239.

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Abstract

La présente invention concerne un cathéter à ballonnet comportant un conduit extérieur, un conduit intérieur disposé dans un passage du conduit extérieur. L’extrémité distale du conduit intérieur se prolonge au-delà de l’extrémité distale du conduit extérieur. Le conduit intérieur est capable de se déplacer longitudinalement dans le conduit extérieur. Un ballonnet gonflable présente un bord proximal fixé à la surface extérieure de l’extrémité distale du conduit extérieur, et un bord distal fixé à la surface extérieure de la partie de conduit intérieur se prolongeant au-delà de l’extrémité distale du conduit extérieur. Le ballonnet comprend au moins une partie ondulée. La partie d’extrémité distale du ballonnet est capable d’une invagination lors du déplacement proximal du conduit intérieur dans le conduit extérieur. Le cathéter présente un orifice de fluide pour l’introduction d’un fluide de gonflage dans l’espace formé entre le conduit extérieur et le conduit intérieur et dans la lumière du ballonnet.
EP09773060A 2008-07-02 2009-07-02 Cathéter à ballonet ondulé et ses procédés d utilisation Withdrawn EP2306910A4 (fr)

Applications Claiming Priority (3)

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US7752008P 2008-07-02 2008-07-02
US14384709P 2009-01-12 2009-01-12
PCT/IL2009/000668 WO2010001405A1 (fr) 2008-07-02 2009-07-02 Cathéter à ballonet ondulé et ses procédés d’utilisation

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EP2306910A4 EP2306910A4 (fr) 2011-08-17

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US8556851B2 (en) 2005-07-05 2013-10-15 Angioslide Ltd. Balloon catheter
US9439662B2 (en) 2005-07-05 2016-09-13 Angioslide Ltd. Balloon catheter
US9675780B2 (en) 2010-01-19 2017-06-13 Angioslide Ltd. Balloon catheter system and methods of making and use thereof
WO2012006629A2 (fr) * 2010-07-09 2012-01-12 The Regents Of The University Of California Cathéter urinaire de sécurité
US9345499B2 (en) 2011-05-26 2016-05-24 Covidien Lp Pressure activated foreign body removal system and method of use
US9597171B2 (en) 2012-09-11 2017-03-21 Covidien Lp Retrieval catheter with expandable tip
EP2928537A4 (fr) 2012-12-04 2016-08-03 Angioslide Ltd Cathéter à ballonnet et procédés d'utilisation
WO2014133708A1 (fr) * 2013-02-26 2014-09-04 Cook Medical Technologies Llc Cathéter à ballonnet
US20140277071A1 (en) * 2013-03-12 2014-09-18 Acclarent, Inc. Features to enhance grip of balloon within airway
CN103236346A (zh) * 2013-05-28 2013-08-07 国家电网公司 变压器套管穿线专用工具
EP3154452A1 (fr) * 2014-06-13 2017-04-19 Neuravi Limited Dispositifs d'élimination d'obstructions aiguës des vaisseaux sanguins
US9351747B2 (en) 2014-09-10 2016-05-31 Vascular Solutions, Inc. Capture assembly and method
GB2566690B (en) 2017-09-19 2019-09-11 Strait Access Tech Holdings Pty Ltd Delivery system and method of assembling such
US20220047314A1 (en) * 2020-08-11 2022-02-17 Ethicon, Inc. Tissue dilation and resection systems and methods
CN112145746B (zh) * 2020-11-30 2021-03-23 上海微创医疗器械（集团）有限公司 驱动装置和旋磨设备

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KR101364933B1 (ko) * 2005-07-05 2014-02-19 안지오슬라이드 엘티디. 풍선 카테터 시스템 및 포유류 피험체의 내부 통로로부터 조직파편을 수집하기 위한 방법

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WO2010001405A1 (fr) 2010-01-07
JP2011526530A (ja) 2011-10-13
CA2728773A1 (fr) 2010-01-07
CN102131470A (zh) 2011-07-20
EP2306910A4 (fr) 2011-08-17

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