CA2585639A1 - Catheter assembly with plaque cutting balloon - Google Patents

Catheter assembly with plaque cutting balloon Download PDF

Info

Publication number
CA2585639A1
CA2585639A1 CA002585639A CA2585639A CA2585639A1 CA 2585639 A1 CA2585639 A1 CA 2585639A1 CA 002585639 A CA002585639 A CA 002585639A CA 2585639 A CA2585639 A CA 2585639A CA 2585639 A1 CA2585639 A1 CA 2585639A1
Authority
CA
Canada
Prior art keywords
balloon
cutters
catheter assembly
balloon catheter
vessel
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.)
Granted
Application number
CA002585639A
Other languages
French (fr)
Other versions
CA2585639C (en
Inventor
Jeffry S. Melsheimer
David G. Burton
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.)
Cook Medical Technologies LLC
Original Assignee
Cook Incorporated
Jeffry S. Melsheimer
David G. Burton
Cook Medical Technologies Llc
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 Cook Incorporated, Jeffry S. Melsheimer, David G. Burton, Cook Medical Technologies Llc filed Critical Cook Incorporated
Publication of CA2585639A1 publication Critical patent/CA2585639A1/en
Application granted granted Critical
Publication of CA2585639C publication Critical patent/CA2585639C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61M25/1027—Making of balloon catheters
    • 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
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61B2017/22051—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 an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • 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
    • A61B2017/22051—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 an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—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 an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1038—Wrapping or folding devices for use with balloon catheters

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Abstract

A balloon catheter assembly comprises an elongate catheter shaft having a proximal portion and a distal portion, and an inflatable balloon secured to the shaft distal portion. A plurality of cutters are arranged along an outer surface of the balloon. The cutters are shielded by folds of the balloon when the balloon is uninflated, and are arranged and configured to facilitate breakdown of a vascular restriction when said balloon is inflated. Preferably, the cutters are arranged in at least three generally parallel longitudinal rows along the balloon outer surface, and there are at least three longitudinally-aligned cutters in each row. Preferably, the cutters are formed of the same or a similar base composition as the balloon, and are bonded to the balloon outer surface.

Claims (20)

1. ~A balloon catheter assembly, comprising:
an elongate catheter shaft having a proximal portion and a distal portion;
an inflatable balloon secured to said distal portion of said catheter shaft;
and a plurality of cutters disposed along an outer surface of the balloon, said cutters being shielded by folds of the balloon when said balloon is in an uninflated condition, and being arranged and configured to facilitate breakdown of a vascular restriction when said balloon is in an inflated condition, said cutters being fixedly engaged with said outer surface of said balloon.
2. ~The balloon catheter assembly of claim 1, wherein at least some of said cutters are disposed in respective generally parallel longitudinal rows along said balloon outer surface.
3. ~The balloon catheter assembly of claim 2, wherein said cutters are disposed in at least three generally parallel longitudinal rows along said balloon outer surface.
4. ~The balloon catheter assembly of claim 2, wherein said cutters are disposed in four generally parallel longitudinal rows along said balloon outer surface, said rows being spaced at substantially 90 degree intervals along said outer surface.
5.~The balloon catheter assembly of claim 3, wherein each row includes at least three longitudinally-aligned cutters.
6. ~The balloon catheter assembly of claim 5, wherein said cutters are substantially equally spaced along said row.
7. ~The balloon catheter assembly of claim 3, wherein said cutters include a base portion in fixed engagement with said balloon outer surface.
8. ~The balloon catheter assembly of claim 7, wherein said base portion comprises two base segments engaged with said balloon outer surface, said cutters further comprising a respective converging body portion extending radially from each of said base segments, said respective converging body portions configured and aligned to meet to define a cutting edge.
9. The balloon catheter assembly of claim 8, wherein said cutting edges have an elongated cutting surface and have a curved surface at an axial edge of said cutting surface.
10. The balloon catheter assembly of claim 3, wherein said balloon comprises a polymer, said polymer selected from the group consisting of polyamides, polyethylene terephthalate, polyether block amides, and blends of the foregoing.
11. The balloon catheter assembly of claim 1, wherein said elongate catheter has a lumen longitudinally extending therein, an interior space of said balloon being in fluid communication with said lumen for receiving an inflation fluid therefrom.
12. The balloon catheter assembly of claim 3, wherein said cutters are formed from the same polymer as the balloon, and said cutters are heat bonded to said balloon outer surface.
13. The balloon catheter assembly of claim 4, wherein said balloon comprises a polymer selected from the group consisting of polyamides, polyethylene terephthalate, polyether block amides, and blends of the foregoing, and said cutter comprises a polymer capable of fixed engagement with the outer surface of said balloon by heat bonding, each of said cutter rows including at least three longitudinally-aligned cutters substantially equally spaced along said row.
14. The balloon catheter assembly of claim 3, wherein said balloon comprises a noncompliant balloon having a generally cylindrical configuration upon inflation.
15. A method for breaking down a restriction in a blood vessel of a patient, comprising:
providing a balloon catheter assembly for insertion into said vessel, said balloon catheter assembly comprising an elongate catheter shaft and an inflatable balloon secured to a distal portion of said catheter shaft, said balloon having a plurality of cutters fixedly disposed in respective generally parallel longitudinal rows along an outer surface of said balloon, said cutters being shielded by folds of the balloon when said balloon is in an uninflated condition, and being arranged and configured to facilitate a breakdown of said restriction when said balloon is in an inflated condition;
inserting the distal end of the balloon catheter assembly into said vessel, and advancing the assembly in the vessel with the balloon in an uninflated condition until said uninflated balloon reaches said restriction;
inflating the balloon such that said cutters penetrate said restriction;
deflating said balloon; and withdrawing said balloon catheter assembly from said vessel.
16. The method of claim 15, wherein said cutters are disposed in at least three generally parallel longitudinal rows along said balloon outer surface, each of said rows comprising at least three cutters, said rows being spaced at substantially equal intervals along said outer surface.
17. The method of claim 15, wherein said inflating and deflating steps are repeated at least one additional time prior to withdrawing the balloon catheter assembly from the vessel.
18. The method of claim 17, wherein said assembly is rotated prior to said at least one additional step of inflating and deflating.
19. The method of claim 15, wherein said assembly is inserted into the vessel utilizing the Seldinger technique.
20. The method of claim 15, wherein said balloon and said cutters are formed from a polymer, and said cutters are heat bonded to said balloon outer surface.
CA2585639A 2004-12-30 2005-12-28 Catheter assembly with plaque cutting balloon Active CA2585639C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US64077904P 2004-12-30 2004-12-30
US60/640,779 2004-12-30
PCT/US2005/047054 WO2006073933A2 (en) 2004-12-30 2005-12-28 Catheter assembly with plaque cutting balloon

Publications (2)

Publication Number Publication Date
CA2585639A1 true CA2585639A1 (en) 2006-07-13
CA2585639C CA2585639C (en) 2012-12-04

Family

ID=36293386

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2585639A Active CA2585639C (en) 2004-12-30 2005-12-28 Catheter assembly with plaque cutting balloon

Country Status (9)

Country Link
US (1) US7303572B2 (en)
EP (1) EP1830915B1 (en)
JP (1) JP4940398B2 (en)
AT (1) ATE413204T1 (en)
AU (1) AU2005323017B2 (en)
CA (1) CA2585639C (en)
DE (1) DE602005010906D1 (en)
DK (1) DK1830915T3 (en)
WO (1) WO2006073933A2 (en)

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WO2006073933A3 (en) 2006-09-08
CA2585639C (en) 2012-12-04
AU2005323017A1 (en) 2006-07-13
JP2008526312A (en) 2008-07-24
DK1830915T3 (en) 2009-02-16
EP1830915A2 (en) 2007-09-12
DE602005010906D1 (en) 2008-12-18
JP4940398B2 (en) 2012-05-30
US7303572B2 (en) 2007-12-04
EP1830915B1 (en) 2008-11-05
ATE413204T1 (en) 2008-11-15
AU2005323017B2 (en) 2010-12-02
US20060149308A1 (en) 2006-07-06
WO2006073933A2 (en) 2006-07-13

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