WO2010048729A1 - Multiple-chambered balloon catheter for flaring installed stents - Google Patents

Multiple-chambered balloon catheter for flaring installed stents Download PDF

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Publication number
WO2010048729A1
WO2010048729A1 PCT/CA2009/001577 CA2009001577W WO2010048729A1 WO 2010048729 A1 WO2010048729 A1 WO 2010048729A1 CA 2009001577 W CA2009001577 W CA 2009001577W WO 2010048729 A1 WO2010048729 A1 WO 2010048729A1
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WO
WIPO (PCT)
Prior art keywords
chamber
balloon
stent
chambered
catheter
Prior art date
Application number
PCT/CA2009/001577
Other languages
French (fr)
Inventor
Alexei John Marko
Amir Miller
Original Assignee
Neovasc Inc.
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 Neovasc Inc. filed Critical Neovasc Inc.
Publication of WO2010048729A1 publication Critical patent/WO2010048729A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821—Ostial stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments

Definitions

  • the presently disclosed subject matter generally relates to vascular catheters and stents. More particularly, this subject matter relates to devices and methods for flaring the openings of and for shaping installed vascular stents.
  • Exemplary embodiments of the presently disclosed subject matter relate to multiple- chambered balloon catheters configured to releasably engage and shape stents previously installed in subjects, kits comprising multiple-chambered balloon catheters, methods for production of multiple-chambered balloon catheters, and methods for the use of multiple- chambered balloon catheters to releasably engage and shape previously installed vascular stents.
  • One exemplary embodiment relates to a multiple-chambered balloon catheter configured for controllable and manipulable delivery through a subject's vascular system to and through a stent previously installed in a selected vessel.
  • the multiple-chambered balloon catheter comprises a catheter shaft provided with a distal tip suitably configured for navigating vascular systems, and is further provided with at least two chambered balloons sealably engaged with the catheter shaft wherein the first balloon is positioned approximate the distal tip of the catheter shaft, and the at least second balloon is positioned adjacent the first balloon.
  • At least two reference markers are provided on the catheter shaft underlying at least one of balloons. Alternatively, at least two reference markers are provided on the catheter shaft portions underlying each of the balloons.
  • the first balloon approximate the distal tip of the catheter shaft is configured as a semi-compliant pressure controlled balloon of the sort commonly used in the art to secure or anchor a stent in a vessel
  • the second balloon positioned on the catheter shaft proximal to the first balloon is configured as a somewhat more compliant volumetrically controlled balloon that may be controllably inflated to flare the end of an installed stent.
  • a semi-compliant pressure controlled balloon is inflated using a relatively high pressure, and the diameter of inflation corresponds in a known way to the pressure of the fluid that is inserted into the balloon.
  • the inflation of a volumetrically controlled balloon is controlled by the volume of fluid that is inserted in the balloon at a relatively low pressure, with the diameter of inflation corresponding in a known way to the volume of fluid that is inserted.
  • At least one of the first and second balloons is constructed so as to minimize the existence or size of any gap between the shoulders of the balloons when inflated; in other words, at least one of the first and second balloons is constructed so as to have a "squared-off ' or “teardrop” appearance when inflated, and thereby to tightly abut the other balloon(s) of the multiple-chambered balloon catheter and maximize the working length thereof. More preferably, if only one of the first and second balloons is configured so as to have a "squared- off or "teardrop” appearance when inflated, it is the volumetrically controlled balloon that is so configured.
  • the first balloon approximate the distal tip of the catheter shaft is configured as a volumetrically controlled balloon
  • the second balloon positioned on the catheter shaft proximal to the first balloon is configured as a pressure controlled balloon
  • the first balloon approximate the distal tip of the catheter shaft is configured as a volumetrically controlled balloon
  • the at least second balloon positioned on the catheter shaft proximal to the first balloon is configured as a volumetrically controlled balloon.
  • Another exemplary embodiment relates methods for the use of multiple-chambered balloon catheters according to the presently disclosed subject matter, to flaring at least one end of a previously installed stent.
  • the methods optionally include the use of differently configured multiple-chamber balloon catheters to enable controllable and manipulable flaring of: (a) proximal ends of previously installed stents, (b) distal ends of previously installed stents, and (c) both proximal ends and distal ends of previously installed stents.
  • the methods further optionally include the use of certain multiple-chamber balloon catheters to restore and shape previously installed stents that may have partially collapsed in situ.
  • the methods and devices of the presently disclosed subject matter enable post-installation manipulation, shaping and contouring of stents in situ. BRIEF DESCRIPTION OF THE DRAWINGS
  • Fig. 1 is a partially cross-sectional side view of an exemplary embodiment of a multiple- chambered balloon catheter of the presently disclosed subject matter comprising a catheter shaft having a distal end provided with a first compartment configured for anchoring the catheter in a stent, and a second compartment configured for flaring an end of the stent, and a proximal end provided with two external channels;
  • Fig. 2 is a is a perspective view of the distal end of the catheter showing the expanded configuration of the first compartment and the second compartment;
  • Fig. 3 is a cross-sectional side view of the embodiment shown in Figures 1 and 2;
  • Fig. 4 is a side view showing a prior art stent installed into an ostium and partially protruding into the aorta with an exemplary balloon catheter of the presently disclosed subject matter being guided through the stent with a guide wire;
  • Fig. 5 is a side view showing the exemplary balloon catheter of Figures 1 - 4 being deployed into the installed prior art stent;
  • Fig. 6 is a side view showing the inflation of the first compartment at the distal end of the exemplary balloon catheter in order to anchor the distal end of the stent and the balloon catheter in the ostium;
  • Fig. 7 is a side view showing the subsequent inflation of the second compartment of the exemplary balloon catheter to flare the end of the stent extending into the aorta while the inflated first compartment is anchoring the stent in the ostium;
  • Fig. 8 is a cross-sectional side view showing another exemplary embodiment of the balloon catheter of the presently disclosed subject matter, wherein the first compartment approximate the distal end of the catheter is configured for flaring an end of an installed prior art stent, and the second compartment is configured for anchoring the catheter in the stent;
  • Fig. 9 is a side view showing the insertion of the exemplary balloon catheter of Figure 8 being guided through the stent with a guide wire;
  • Fig. 10 is a side view showing the exemplary balloon catheter of Figure 8 being deployed into the installed prior art stent;
  • Fig. 11 is a side view showing the second compartment of the exemplary balloon catheter of Figure 8 deployed to anchor the catheter and the stent into the ostium;
  • Fig. 12 is a side view showing the first compartment of the exemplary balloon catheter of Figure 8 deployed to flare the end of the stent extending into the aorta, while the second compartment anchors the stent into the ostium;
  • Fig. 13 is a cross-sectional side view showing a further exemplary embodiment of the balloon catheter of the presently disclosed subject matter having two adjacent inflatable compartments approximate the distal end of the catheter, wherein: (a) each compartment is configured for flaring an end of an installed stent, and (b) the compartments are controllably manipulable for concurrently flaring the opposite ends of an installed coronary stent;
  • Fig. 14 is a side view showing a constricture in an installed stent of the sort that may be opened by controllable manipulation of the embodiment of Figure 11;
  • Fig 15 is a side view showing a stent installed such that one end extends into the aorta and its other end installed at the juncture of a minor vessel with the vessel into which the stent is installed: (a) before, and (b) after deployment and manipulation of the exemplary balloon catheter of Figure 13 to flare the opposite ends of the stent.
  • Exemplary embodiments of the presently disclosed subject matter relate to multiple- chambered balloon catheters configured to releasably engage and shape installed stents, kits comprising multiple-chambered balloon catheters, methods for production of multiple- chambered balloon catheters, and methods of use of multiple-chambered balloon catheters for engaging and shaping installed vascular stents.
  • the multiple- chambered balloon catheter is configured for locating and engaging a stent deployed at a minor vessel's ostium, and to flare the section of that stent that is protruding into a major vessel (e.g., the aorta).
  • This exemplary balloon catheter generally comprises a catheter shaft having a distal tip configured for slidingly communicating with a guide wire therethrough, and is provided with at least two inflatable chambers.
  • the first chamber encompasses the catheter shaft and has a first end engaged approximate the distal tip of the catheter shaft and the second end of the first chamber engaged toward the proximal end of the catheter shaft.
  • the second chamber is engaged at its first end with the catheter shaft approximate the second end of the first chamber, while the second end of the second chamber is engaged with the catheter shaft toward the proximal end of the catheter shaft.
  • the first chamber approximate the distal tip of the catheter shaft is configured as a semi-compliant pressure controlled balloon of the sort commonly used in the art to secure or anchor a stent in a vessel
  • the second chamber positioned on the catheter shaft proximal to the first chamber is configured as a somewhat more compliant volumetrically controlled balloon that may be controllably inflated to flare the end of an installed stent.
  • a semi-compliant pressure controlled balloon is inflated using a relatively high pressure, and the diameter of inflation corresponds in a known way to the pressure of the fluid that is inserted into the balloon.
  • the inflation of a volumetrically controlled balloon is controlled by the volume of fluid that is inserted in the balloon at a relatively low pressure, with the diameter of inflation corresponding in a known way to the volume of fluid that is inserted.
  • the two chambers are assembled coaxially and controlled via two separate lumens, as best seen in Figure 3.
  • At least one of the first and second balloons is constructed so as to minimize the existence or size of any gap between the shoulders of the balloons when inflated; in other words, at least one of the first and second balloons is constructed so as to have a "squared-off ' appearance when inflated, and thereby to tightly abut the other balloon(s) of the a multiple- chambered balloon catheter.
  • Two marker bands are imbedded in the catheter shaft underneath or near the first balloon's shoulders. It is optional to instead or additionally imbed a pair of marker bands into the catheter shaft underneath or near the second balloon's shoulders.
  • An exemplary method for the use of the multiple-chambered balloon catheter shown in Figures 1 - 7 comprises the following steps.
  • an operator inserts the multiple-chambered balloon catheter into a major blood vessel about a previously installed guide wire, and manipulably delivers the catheter to and then in through the installed stent, after which the first chamber is positioned within the stent using the markers imbedded into the catheter shaft as references points; see Figures 3 - 5.
  • the operator then inflates the first balloon about the distal end of the catheter to anchor the entire catheter system to the stent and to secure the stent to the vessel (see Figure 6) and to prevent the stent from collapsing or deformation during the stage 2 manipulations of the multiple-chambered balloon catheter.
  • the operator controllably inflates the second chamber whereby its dimensional and mechanical properties flare the protruding area of the stent adjacent to the ostium thereby securing the stent in place; see Figure 7.
  • any portion of the second chamber that is inflated inside the stent portion contained by the minor vessel will conform to the main body of the "jailed" stent and will concurrently “balloon” out into the aortal junction, thus further facilitating the flaring of the stent end.
  • This exemplary multiple-chambered balloon catheter generally comprises a catheter shaft having a distal tip configured for slidingly communicating with a guide wire therethrough, and is provided with at least two inflatable chambers.
  • the first chamber encompasses the catheter shaft and has a first end engaged approximate the distal tip of the catheter shaft and the second end of the first chamber engaged toward the proximal end of the catheter shaft.
  • the second chamber is engaged at its first end with the catheter shaft approximate the second end of the first chamber, while the second end of the second chamber is engaged with the catheter shaft toward the proximal end of the catheter shaft.
  • the first chamber approximate the distal tip of the catheter shaft is configured as a volumetrically controlled balloon that may be controllably inflated to flare the end of an installed stent
  • the second chamber is configured as a a semi- compliant pressure controlled balloon.
  • the two chambers are assembled coaxially and controlled via two separate lumens, as best seen in Figure 8.
  • Two marker bands are imbedded in the catheter shaft underneath or near the second balloon's shoulders. It is optional to instead or additionally imbed a pair of marker bands into the catheter shaft underneath or near the first balloon's shoulders.
  • An exemplary method for the use of the multiple-chambered balloon catheter shown in Figures 8 - 12 comprises the following steps.
  • an operator inserts the multiple-chambered balloon catheter into a minor blood vessel about a previously installed guide wire, and manipulably delivers the catheter to and through the installed stent until the markers embedded into the catheter shaft underlying the second chamber are positioned within the stent; see Figure 10.
  • the operator then inflates the second balloon to anchor the entire catheter system to the stent and to secure the stent to the vessel ( Figure 11 ) and to prevent the stent from collapsing or deforming during the stage 2 manipulations of the multiple-chambered balloon catheter.
  • the operator controllably inflates the first chamber, whereby its dimensional and mechanical properties flare the protruding area of the stent adjacent to the ostium, thereby securing the stent in place at the juncture of the major and minor blood vessels; see Figure 12.
  • Any portion of the first chamber that is inflated inside the stent portion contained by the minor vessel will conform to the main body of the "jailed" stent and will concurrently “balloon" out into the aortal junction, thus further facilitating the flaring of the stent end.
  • This exemplary balloon catheter generally comprises a catheter shaft having a distal tip configured for slidingly communicating with a guide wire therethrough.
  • the catheter shaft is provided with two adjacent chambers assembled coaxially and sealingly engaged with the catheter shaft.
  • Each chamber is communicable and controllably manipulable via a separate lumen.
  • the first chamber and second chamber are both configured as volumetrically controlled balloons.
  • Two marker bands are imbedded in the catheter shaft underneath or near the shoulders of the first balloon (i.e. the balloon adjacent the distal tip of the catheter shaft). It is optional but preferable to additionally imbed a pair of marker bands into the catheter shaft underneath or near the first balloon's shoulders.
  • Exemplary methods for the use of the multiple-chambered balloon catheter shown in Figure 13 generally relate to flaring the ends of installed stents, as well as to shaping and to expanding and/or re-shaping the bodies of installed stents, and/or preventing deformation of a stent during manipulations to reposition an installed stent and flaring one or both ends.
  • the exemplary multiple-chambered balloon catheter of Figure 13 is introduced into and through an installed stent as previously described, after which one of the first and second chambers is inflated to secure the catheter and the stent within the containing vessel. Then the other chamber is controllably inflated and manipulated to affect the expansion and re-shaping of the body of the stent.
  • This method is particularly useful for re-shaping and/or re-structuring recoiled installed stent such as one shown in Figure 14.
  • Other exemplary methods for the use of the multiple- chambered balloon catheter shown in Figure 13 generally relate to flaring the ends of stents installed approximate to side branches leading into or away form vessels wherein the stent is installed; see Figures 15(a) and 15(b).

Abstract

Multiple-chambered balloon catheters configured to releasably engage and shape stents previously installed in subjects, kits comprising multiple-chambered balloon catheters, methods for production of multiple-chambered balloon catheters, and methods for the use of multiple- chambered balloon catheters to releasably engage and shape previously installed vascular stents are provided. The multiple-chambered balloon catheter comprises a catheter shaft provided with a distal tip suitably configured for navigating vascular systems, and is further provided with at least two chambered balloons sealably engaged with the catheter shaft wherein the first balloon is positioned approximate the distal tip of the catheter shaft, and the at least second balloon is positioned adjacent the first balloon. At least two reference markers are provided on the catheter shaft underlying at least one of balloons.

Description

MULTIPLE-CHAMBERED BALLOON CATHETER FOR FLARING INSTALLED STENTS
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Patent Application No. 61/109,384 filed 29 October 2009, priority from the filing date of which is claimed under 35 U.S.C. § 119, and which is hereby fully incorporated by reference.
TECHNICAL FIELD
The presently disclosed subject matter generally relates to vascular catheters and stents. More particularly, this subject matter relates to devices and methods for flaring the openings of and for shaping installed vascular stents.
BACKGROUND
Installation of stents into vascular systems has become a common practice for the treatment of stenosis in blood vessels that clinically impact the unrestricted flow of blood to and from the heart. While stent implantation provides many benefits for cardiovascular care, a number of significant problems have become associated with their use. For example, it is known that restenosis is common occurrence as a result of the stents' partial or complete collapse over extended periods of time. Restenosis may also arise as a consequence of the body's inflammatory responses to the presence of foreign materials (i.e. stents) in the vascular system that results in tissue proliferation about and into the stents. Other problems occur because installed stents may not confirm to and fully engage the vessel walls wherein they are installed. Further problems are associated with improper installation of stents into target sites, with the result that one end may protrude from a minor blood vessel into a major vessel and create an inline obstruction for blood flow. Furthermore, such protrusions may cause extreme difficulties for re-entry into the vessel for further treatments, i.e. by re-insertion of catheter guide wires (AKA re- wiring). Yet other problems are caused by the migration of stents downstream from their installation sites as a consequence of the physical forces of blood flow. SUMMARY
This summary is not an extensive overview intended to delineate the scope of the subject matter that is described and claimed herein. The summary presents aspects of the subject matter in a simplified form to provide a basic understanding thereof, as a prelude to the detailed description that is presented below.
Exemplary embodiments of the presently disclosed subject matter relate to multiple- chambered balloon catheters configured to releasably engage and shape stents previously installed in subjects, kits comprising multiple-chambered balloon catheters, methods for production of multiple-chambered balloon catheters, and methods for the use of multiple- chambered balloon catheters to releasably engage and shape previously installed vascular stents.
One exemplary embodiment relates to a multiple-chambered balloon catheter configured for controllable and manipulable delivery through a subject's vascular system to and through a stent previously installed in a selected vessel. The multiple-chambered balloon catheter comprises a catheter shaft provided with a distal tip suitably configured for navigating vascular systems, and is further provided with at least two chambered balloons sealably engaged with the catheter shaft wherein the first balloon is positioned approximate the distal tip of the catheter shaft, and the at least second balloon is positioned adjacent the first balloon. At least two reference markers are provided on the catheter shaft underlying at least one of balloons. Alternatively, at least two reference markers are provided on the catheter shaft portions underlying each of the balloons.
According to one aspect, the first balloon approximate the distal tip of the catheter shaft is configured as a semi-compliant pressure controlled balloon of the sort commonly used in the art to secure or anchor a stent in a vessel, and the second balloon positioned on the catheter shaft proximal to the first balloon is configured as a somewhat more compliant volumetrically controlled balloon that may be controllably inflated to flare the end of an installed stent. Typically, a semi-compliant pressure controlled balloon is inflated using a relatively high pressure, and the diameter of inflation corresponds in a known way to the pressure of the fluid that is inserted into the balloon. The inflation of a volumetrically controlled balloon is controlled by the volume of fluid that is inserted in the balloon at a relatively low pressure, with the diameter of inflation corresponding in a known way to the volume of fluid that is inserted.
Preferably, at least one of the first and second balloons is constructed so as to minimize the existence or size of any gap between the shoulders of the balloons when inflated; in other words, at least one of the first and second balloons is constructed so as to have a "squared-off ' or "teardrop" appearance when inflated, and thereby to tightly abut the other balloon(s) of the multiple-chambered balloon catheter and maximize the working length thereof. More preferably, if only one of the first and second balloons is configured so as to have a "squared- off or "teardrop" appearance when inflated, it is the volumetrically controlled balloon that is so configured.
According to another aspect, the first balloon approximate the distal tip of the catheter shaft is configured as a volumetrically controlled balloon, and the second balloon positioned on the catheter shaft proximal to the first balloon is configured as a pressure controlled balloon.
According to a further aspect, the first balloon approximate the distal tip of the catheter shaft is configured as a volumetrically controlled balloon, and the at least second balloon positioned on the catheter shaft proximal to the first balloon is configured as a volumetrically controlled balloon.
Another exemplary embodiment relates methods for the use of multiple-chambered balloon catheters according to the presently disclosed subject matter, to flaring at least one end of a previously installed stent. The methods optionally include the use of differently configured multiple-chamber balloon catheters to enable controllable and manipulable flaring of: (a) proximal ends of previously installed stents, (b) distal ends of previously installed stents, and (c) both proximal ends and distal ends of previously installed stents. The methods further optionally include the use of certain multiple-chamber balloon catheters to restore and shape previously installed stents that may have partially collapsed in situ. The methods and devices of the presently disclosed subject matter enable post-installation manipulation, shaping and contouring of stents in situ. BRIEF DESCRIPTION OF THE DRAWINGS
For a fuller understanding of the nature and advantages of the disclosed subject matter, as well as the preferred mode of use thereof, reference should be made to the detailed description, read in conjunction with the accompanying drawings. In the drawings, like reference numerals designate like or similar parts or steps.
Fig. 1 is a partially cross-sectional side view of an exemplary embodiment of a multiple- chambered balloon catheter of the presently disclosed subject matter comprising a catheter shaft having a distal end provided with a first compartment configured for anchoring the catheter in a stent, and a second compartment configured for flaring an end of the stent, and a proximal end provided with two external channels;
Fig. 2 is a is a perspective view of the distal end of the catheter showing the expanded configuration of the first compartment and the second compartment;
Fig. 3 is a cross-sectional side view of the embodiment shown in Figures 1 and 2;
Fig. 4 is a side view showing a prior art stent installed into an ostium and partially protruding into the aorta with an exemplary balloon catheter of the presently disclosed subject matter being guided through the stent with a guide wire;
Fig. 5 is a side view showing the exemplary balloon catheter of Figures 1 - 4 being deployed into the installed prior art stent;
Fig. 6 is a side view showing the inflation of the first compartment at the distal end of the exemplary balloon catheter in order to anchor the distal end of the stent and the balloon catheter in the ostium;
Fig. 7 is a side view showing the subsequent inflation of the second compartment of the exemplary balloon catheter to flare the end of the stent extending into the aorta while the inflated first compartment is anchoring the stent in the ostium;
Fig. 8 is a cross-sectional side view showing another exemplary embodiment of the balloon catheter of the presently disclosed subject matter, wherein the first compartment approximate the distal end of the catheter is configured for flaring an end of an installed prior art stent, and the second compartment is configured for anchoring the catheter in the stent;
Fig. 9 is a side view showing the insertion of the exemplary balloon catheter of Figure 8 being guided through the stent with a guide wire;
Fig. 10 is a side view showing the exemplary balloon catheter of Figure 8 being deployed into the installed prior art stent;
Fig. 11 is a side view showing the second compartment of the exemplary balloon catheter of Figure 8 deployed to anchor the catheter and the stent into the ostium;
Fig. 12 is a side view showing the first compartment of the exemplary balloon catheter of Figure 8 deployed to flare the end of the stent extending into the aorta, while the second compartment anchors the stent into the ostium;
Fig. 13 is a cross-sectional side view showing a further exemplary embodiment of the balloon catheter of the presently disclosed subject matter having two adjacent inflatable compartments approximate the distal end of the catheter, wherein: (a) each compartment is configured for flaring an end of an installed stent, and (b) the compartments are controllably manipulable for concurrently flaring the opposite ends of an installed coronary stent;
Fig. 14 is a side view showing a constricture in an installed stent of the sort that may be opened by controllable manipulation of the embodiment of Figure 11; and,
Fig 15 is a side view showing a stent installed such that one end extends into the aorta and its other end installed at the juncture of a minor vessel with the vessel into which the stent is installed: (a) before, and (b) after deployment and manipulation of the exemplary balloon catheter of Figure 13 to flare the opposite ends of the stent.
DETAILED DESCRIPTION
Exemplary embodiments of the presently disclosed subject matter relate to multiple- chambered balloon catheters configured to releasably engage and shape installed stents, kits comprising multiple-chambered balloon catheters, methods for production of multiple- chambered balloon catheters, and methods of use of multiple-chambered balloon catheters for engaging and shaping installed vascular stents.
An exemplary embodiment of a multiple-chambered balloon catheter according to the presently disclosed subject matter is illustrated in accompanying Figures 1 - 7. The multiple- chambered balloon catheter is configured for locating and engaging a stent deployed at a minor vessel's ostium, and to flare the section of that stent that is protruding into a major vessel (e.g., the aorta). This exemplary balloon catheter generally comprises a catheter shaft having a distal tip configured for slidingly communicating with a guide wire therethrough, and is provided with at least two inflatable chambers. The first chamber encompasses the catheter shaft and has a first end engaged approximate the distal tip of the catheter shaft and the second end of the first chamber engaged toward the proximal end of the catheter shaft. The second chamber is engaged at its first end with the catheter shaft approximate the second end of the first chamber, while the second end of the second chamber is engaged with the catheter shaft toward the proximal end of the catheter shaft. In this exemplary embodiment, the first chamber approximate the distal tip of the catheter shaft is configured as a semi-compliant pressure controlled balloon of the sort commonly used in the art to secure or anchor a stent in a vessel, and the second chamber positioned on the catheter shaft proximal to the first chamber is configured as a somewhat more compliant volumetrically controlled balloon that may be controllably inflated to flare the end of an installed stent. As is known in the art, a semi-compliant pressure controlled balloon is inflated using a relatively high pressure, and the diameter of inflation corresponds in a known way to the pressure of the fluid that is inserted into the balloon. The inflation of a volumetrically controlled balloon is controlled by the volume of fluid that is inserted in the balloon at a relatively low pressure, with the diameter of inflation corresponding in a known way to the volume of fluid that is inserted. The two chambers are assembled coaxially and controlled via two separate lumens, as best seen in Figure 3.
At least one of the first and second balloons is constructed so as to minimize the existence or size of any gap between the shoulders of the balloons when inflated; in other words, at least one of the first and second balloons is constructed so as to have a "squared-off ' appearance when inflated, and thereby to tightly abut the other balloon(s) of the a multiple- chambered balloon catheter. Two marker bands are imbedded in the catheter shaft underneath or near the first balloon's shoulders. It is optional to instead or additionally imbed a pair of marker bands into the catheter shaft underneath or near the second balloon's shoulders.
An exemplary method for the use of the multiple-chambered balloon catheter shown in Figures 1 - 7 comprises the following steps. In the 1st stage of the procedure, an operator inserts the multiple-chambered balloon catheter into a major blood vessel about a previously installed guide wire, and manipulably delivers the catheter to and then in through the installed stent, after which the first chamber is positioned within the stent using the markers imbedded into the catheter shaft as references points; see Figures 3 - 5. The operator then inflates the first balloon about the distal end of the catheter to anchor the entire catheter system to the stent and to secure the stent to the vessel (see Figure 6) and to prevent the stent from collapsing or deformation during the stage 2 manipulations of the multiple-chambered balloon catheter. During the 2n stage of the procedure, the operator controllably inflates the second chamber whereby its dimensional and mechanical properties flare the protruding area of the stent adjacent to the ostium thereby securing the stent in place; see Figure 7. Any portion of the second chamber that is inflated inside the stent portion contained by the minor vessel will conform to the main body of the "jailed" stent and will concurrently "balloon" out into the aortal junction, thus further facilitating the flaring of the stent end.
Another exemplary embodiment of a multiple-chambered balloon catheter according to the presently disclosed subject matter is illustrated in accompanying Figures 8 - 12. This exemplary multiple-chambered balloon catheter generally comprises a catheter shaft having a distal tip configured for slidingly communicating with a guide wire therethrough, and is provided with at least two inflatable chambers. The first chamber encompasses the catheter shaft and has a first end engaged approximate the distal tip of the catheter shaft and the second end of the first chamber engaged toward the proximal end of the catheter shaft. The second chamber is engaged at its first end with the catheter shaft approximate the second end of the first chamber, while the second end of the second chamber is engaged with the catheter shaft toward the proximal end of the catheter shaft. In this exemplary embodiment, the first chamber approximate the distal tip of the catheter shaft is configured as a volumetrically controlled balloon that may be controllably inflated to flare the end of an installed stent, and the second chamber is configured as a a semi- compliant pressure controlled balloon. The two chambers are assembled coaxially and controlled via two separate lumens, as best seen in Figure 8. Two marker bands are imbedded in the catheter shaft underneath or near the second balloon's shoulders. It is optional to instead or additionally imbed a pair of marker bands into the catheter shaft underneath or near the first balloon's shoulders.
An exemplary method for the use of the multiple-chambered balloon catheter shown in Figures 8 - 12 comprises the following steps. In the 1st stage of the procedure, an operator inserts the multiple-chambered balloon catheter into a minor blood vessel about a previously installed guide wire, and manipulably delivers the catheter to and through the installed stent until the markers embedded into the catheter shaft underlying the second chamber are positioned within the stent; see Figure 10. The operator then inflates the second balloon to anchor the entire catheter system to the stent and to secure the stent to the vessel (Figure 11 ) and to prevent the stent from collapsing or deforming during the stage 2 manipulations of the multiple-chambered balloon catheter. During the 2nd stage of the procedure, the operator controllably inflates the first chamber, whereby its dimensional and mechanical properties flare the protruding area of the stent adjacent to the ostium, thereby securing the stent in place at the juncture of the major and minor blood vessels; see Figure 12. Any portion of the first chamber that is inflated inside the stent portion contained by the minor vessel will conform to the main body of the "jailed" stent and will concurrently "balloon" out into the aortal junction, thus further facilitating the flaring of the stent end.
Another exemplary embodiment of a multiple-chambered balloon catheter according to the presently disclosed subject matter is illustrated in accompanying Figure 13. This exemplary balloon catheter generally comprises a catheter shaft having a distal tip configured for slidingly communicating with a guide wire therethrough. The catheter shaft is provided with two adjacent chambers assembled coaxially and sealingly engaged with the catheter shaft. Each chamber is communicable and controllably manipulable via a separate lumen. In this exemplary embodiment, the first chamber and second chamber are both configured as volumetrically controlled balloons. Two marker bands are imbedded in the catheter shaft underneath or near the shoulders of the first balloon (i.e. the balloon adjacent the distal tip of the catheter shaft). It is optional but preferable to additionally imbed a pair of marker bands into the catheter shaft underneath or near the first balloon's shoulders. Exemplary methods for the use of the multiple-chambered balloon catheter shown in Figure 13 generally relate to flaring the ends of installed stents, as well as to shaping and to expanding and/or re-shaping the bodies of installed stents, and/or preventing deformation of a stent during manipulations to reposition an installed stent and flaring one or both ends. The exemplary multiple-chambered balloon catheter of Figure 13 is introduced into and through an installed stent as previously described, after which one of the first and second chambers is inflated to secure the catheter and the stent within the containing vessel. Then the other chamber is controllably inflated and manipulated to affect the expansion and re-shaping of the body of the stent. This method is particularly useful for re-shaping and/or re-structuring recoiled installed stent such as one shown in Figure 14. Other exemplary methods for the use of the multiple- chambered balloon catheter shown in Figure 13 generally relate to flaring the ends of stents installed approximate to side branches leading into or away form vessels wherein the stent is installed; see Figures 15(a) and 15(b).
The present description is of the best presently contemplated mode of carrying out the subject matter disclosed and claimed herein. The description is made for the purpose of illustrating the general principles of the subject matter and not be taken in a limiting sense; the claimed subject matter can find utility in a variety of implementations without departing from the scope and spirit of the invention made, as will be apparent to those of skill in the art from an understanding of the principles that underlie the invention.

Claims

What is claimed is:
1. A multiple-chambered balloon catheter configured for releasably engaging and modifying the shape of an installed stent, the balloon catheter comprising:
a catheter shaft provided with a distal tip, said catheter shaft configured for communication therethrough with a guidewire within for manipulation through a subject's vascular system;
at least a first controllably inflatable chamber sealingly engaged with the catheter shaft approximate the distal tip; and
at least a second controllably inflatable chamber sealingly engaged with the catheter shaft, wherein a portion of the catheter shaft underlying at least one of the first and second chambers is provided with at least two reference markers.
2. A multiple-chambered balloon catheter according to claim 1, wherein the at least first chamber is configured as a semi-compliant pressure controlled balloon.
3. A multiple-chambered balloon catheter according to claim 1, wherein the at least second chamber is configured as a volumetrically controlled balloon.
4. A multiple-chambered balloon catheter according to claim 3, wherein the at least second chamber is a volumetrically controlled balloon having a squared-off or teardrop configuration when inflated.
5. A multiple-chambered balloon catheter according to claim 1, wherein the at least first chamber is configured as a volumetrically controlled balloon.
6. A multiple-chambered balloon catheter according to claim 5, wherein the at least first chamber is a volumetrically controlled balloon having a squared-off or teardrop configuration when inflated.
7. A multiple-chambered balloon catheter according to claim 1, wherein the at least second chamber is configured as a semi-compliant pressure controlled balloon.
8. A multiple-chambered balloon catheter according to claim 1, wherein the at least first chamber and the at least second chamber are configured volumetrically controlled balloons.
9. A multiple-chambered balloon catheter according to claim 1, wherein at least two reference markers are provided on a portion of the catheter shaft underlying the first chamber, and a further at least two reference markers are provided on a portion of the catheter shaft underlying the second chamber.
10. A kit comprising the multiple-chambered balloon catheter of claim 1.
11. A method for flaring an end of an installed stent, the method comprising the steps of:
inserting the multiple-chambered balloon stent of claim 1 into the vascular system of a subject about a guide wire provided therefor;
controllably manipulating and delivering the multiple-chambered balloon catheter to a stent installed a selected vessel within the vascular system of the subject;
positioning the first chamber of the multiple-chambered balloon catheter within the stent using the at least two markers on the catheter shaft as reference points;
controllably inflating the first chamber to releasably engage the stent, and further controllably inflating the first chamber to secure the stent to the selected vessel;
controllably inflating the second chamber to engage the stent, further controllably inflating the second chamber to engage and extend therefrom an end of said stent, and further controllably inflating the second chamber to flare said end of said stent;
controllably deflating the first chamber and the second chamber; and,
controllably removing said multiple-chambered balloon catheter from within the vascular system of the subject.
PCT/CA2009/001577 2008-10-29 2009-10-29 Multiple-chambered balloon catheter for flaring installed stents WO2010048729A1 (en)

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US61/109,384 2008-10-29

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9358042B2 (en) 2013-03-13 2016-06-07 The Spectranetics Corporation Expandable member for perforation occlusion
US10449336B2 (en) 2015-08-11 2019-10-22 The Spectranetics Corporation Temporary occlusions balloon devices and methods for preventing blood flow through a vascular perforation
US10499892B2 (en) 2015-08-11 2019-12-10 The Spectranetics Corporation Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation

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US20040260378A1 (en) * 2003-06-17 2004-12-23 Medtronic Ave Method and system for treating an ostium of a side-branch vessel
US20070073388A1 (en) * 2005-08-22 2007-03-29 Krolik Jeffrey A Flared stents and apparatus and methods for delivering them

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Publication number Priority date Publication date Assignee Title
JP2003052835A (en) * 2001-08-21 2003-02-25 Kazumi Ono Urethra stent and balloon-tip catheter for curing dysuria
US20040260378A1 (en) * 2003-06-17 2004-12-23 Medtronic Ave Method and system for treating an ostium of a side-branch vessel
US20070073388A1 (en) * 2005-08-22 2007-03-29 Krolik Jeffrey A Flared stents and apparatus and methods for delivering them

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9358042B2 (en) 2013-03-13 2016-06-07 The Spectranetics Corporation Expandable member for perforation occlusion
US10932785B2 (en) 2013-03-13 2021-03-02 Spectranetics Llc Expandable member for perforation occlusion
US10449336B2 (en) 2015-08-11 2019-10-22 The Spectranetics Corporation Temporary occlusions balloon devices and methods for preventing blood flow through a vascular perforation
US10499892B2 (en) 2015-08-11 2019-12-10 The Spectranetics Corporation Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation

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