CA2369312A1 - Balloon anchor wire - Google Patents

Balloon anchor wire Download PDF

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Publication number
CA2369312A1
CA2369312A1 CA002369312A CA2369312A CA2369312A1 CA 2369312 A1 CA2369312 A1 CA 2369312A1 CA 002369312 A CA002369312 A CA 002369312A CA 2369312 A CA2369312 A CA 2369312A CA 2369312 A1 CA2369312 A1 CA 2369312A1
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CA
Canada
Prior art keywords
end portion
ablation
elongate body
anchor device
tissue
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Granted
Application number
CA002369312A
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French (fr)
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CA2369312C (en
Inventor
Alan K. Schaer
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Atrionix Inc
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Individual
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Publication of CA2369312C publication Critical patent/CA2369312C/en
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Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • 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
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A61B2018/00285—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09008—Guide wires having a balloon
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • 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
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2201/00—Properties
    • C08L2201/12—Shape memory

Abstract

The present invention relates to an anchor device comprising an elongated tubular body having an expandable member disposed on its distal end portion. The invention also relates to a system adapted to position and anchor the distal end of an ablation device at a location where a pulmonary vein extend s from the atrium.

Claims (45)

1. A tissue ablation system for ablating a region of tissue at a location where a pulmonary vein extends from an atrium in a patient, comprising:
an anchor device having an elongate body with a proximal end portion and a distal end portion that is adapted to be positioned within the pulmonary vein, and also having an expandable member along the distal end portion adjustable between a radially collapsed condition and a radially expanded condition that is adapted to engage the pulmonary vein; and an ablation device comprising an elongate catheter having a proximal region and a distal region, and an ablation element located along the distal region, wherein the ablation device is adapted to slideably engage and track over the anchor device, such that the ablation element can be ablatively coupled to the region of tissue by advancing the ablation device distally over the anchor device.
2. The tissue ablation system of claim 1, wherein the expandable member is an inflatable balloon.
3. The tissue ablation system of claim 2, wherein the anchor device further comprises an inflation lumen, a pressurizable fluid source and a removable adapter on the proximal end portion of the elongate body, which is adapted to couple the pressurizable fluid source to the inflation lumen.
4. The tissue ablation system of claim 2, wherein the balloon has an outer diameter of from about 0.114" to about 0.122" when inflated.
5. The tissue ablation system of claim 2, wherein the balloon is made from a low density polymer or copolymer.
6. The tissue ablation system of claim 5, wherein the low density polymer or copolymer is selected from the group consisting of polyethylene, polypropylene, polyolefins, PET, nylon, urethane, silicon, and Cflex.
7. The tissue ablation system of claim 1, wherein the anchor device further comprises a shaped distal tip distal to the expandable member.
8. The tissue ablation system of claim 7, wherein the anchor device is configured so as to be torquable and steerable, such that the anchor device may be directed into the pulmonary vein by manipulation of the proximal end portion.
9. The tissue ablation system of claim 1, wherein the elongate body of the anchor device further comprises a polymeric tube.
10. The tissue ablation system of claim 1, wherein the distal end portion of the elongate body of the anchor device is more flexible than the proximal end portion.
11. The tissue ablation system of claim 1, wherein the elongate body of the anchor device further comprises an intermediate region disposed between the distal and proximal end portions, and wherein the proximal end portion has a wall thickness which is greater than a wall thickness of the intermediate region, such that the proximal end portion possess a sufficient push force and kink resistance.
12. The tissue ablation system of claim 1, further comprising a wire within the elongate body, extending proximally from the distal end portion of the elongate body through at least a portion of the elongate body.
13. The tissue ablation system of claim 12, wherein the elongate body further comprises a guidewire passageway and wherein the wire is a guidewire slideably engaged in the guidewire passageway.
14. The tissue ablation system of claim 13, wherein the guidewire passageway has a proximal port along the proximal end portion of the elongate body and a distal port along the distal end portion of the elongate body.
15. The tissue ablation system of claim 13, wherein the guidewire passageway extends only through a portion of the elongate body.
16. The tissue ablation system of claim 1, wherein the ablation element is selected from the group consisting of a microwave ablation element, a cryogenic ablation element, a thermal ablation element, a light-emitting ablation element such as a laser, an ultrasound transducer, and an electrical ablation element such as an RF ablation element.
17. The tissue ablation system of claim 1, wherein the ablation element is adapted to form a linear lesion.
18. The tissue ablation system of claim 1, wherein the ablation element is adapted to form a circumferential lesion.
19. The tissue ablation system of claim 18, wherein the ablation element is adapted to form the circumferential lesion at the location.
20. A positioning system adapted to position and anchor one end of a medical device at a location where a pulmonary vein extends from an atrium, comprising:
a transeptal sheath adapted to be inserted through an atrial septum; and an anchor device having an elongate body with a proximal end portion and a distal end portion that is adapted to be positioned within the pulmonary vein, and also having an expandable member along the distal end portion that is adjustable between a radially collapsed condition and a radially expanded condition that is adapted to engage the pulmonary vein after the distal end portion of the anchor device is advanced through the transeptal sheath and into the pulmonary vein.
21. The positioning system of claim 20, wherein the medical device has a tracking mechanism adapted to slideably engage and track over the anchor device, such that advancing the medical device over the anchor device causes one end of the medical device to be positioned at the location.
22. The positioning system of claim 21, wherein the medical device is a mapping device comprising an electrode adapted to map a region of tissue at the location.
23. The positioning system of claim 21, wherein the medical device is an ablation device comprising an ablation element adapted to ablate a region of tissue at the location.
24. The tissue ablation system of claim 23, wherein the ablation element is selected from the group consisting of a microwave ablation element, a cryogenic ablation element, a thermal ablation element, a light-emitting ablation element such as a laser, an ultrasound transducer, and an electrical ablation element such as an RF ablation element.
25. The positioning system of claim 23, wherein the ablation element is adapted to form a linear lesion.
26. The positioning system of claim 23, wherein the ablation element is adapted to form a circumferential lesion.
27. The positioning system of claim 26, wherein the ablation element is adapted to form the circumferential lesion at the location.
28. The positioning system of claim 20, wherein the expandable member is an inflatable balloon.
29. The positioning system of claim 28, wherein the anchor device further comprises an inflation lumen, a pressurizable fluid source and a removable adapter on the proximal end portion of the elongate body, which is adapted to couple the pressurizable fluid source to the inflation lumen.
30. The positioning system of claim 28, wherein the balloon has an outer diameter of from about 0.114"
to about 0.122" when inflated.
31. The tissue ablation system of claim 28, wherein the balloon is made from a low density polymer or copolymer.
32. The tissue ablation system of claim 31, wherein the low density polymer or copolymer is selected from the group consisting of polyethylene, polypropylene, polyolefins, PET, nylon, urethane, silicon, and Cflex.
33. The positioning system of claim 20, wherein the anchor device further comprises a shaped distal tip distal of the expandable member.
34. The positioning system of claim 33, wherein the anchor device is configured to be torquable and steerable, such that the anchor device may be directed into the pulmonary vein by manipulation of the proximal end portion.
35. The positioning system of claim 20, wherein the elongate body of the anchor device further comprises a polymeric tube.
36. The positioning system of claim 20, wherein the distal end portion of the elongate body is more flexible than the proximal end portion.
37. The positioning system of claim 20, wherein the elongate body of the anchor device further comprises an intermediate region disposed between the distal and proximal end portions, and wherein the proximal end portion has a wall thickness which is greater than a wall thickness of the intermediate region, such that the proximal end portion possess a sufficient push force and kink resistance.
38. The positioning system of claim 20, further comprising a wire within the elongate body, extending proximally from the distal end portion of the elongate body through at least a portion of the elongate body.
39. The positioning system of claim 38, wherein the elongate body further comprises a guidewire passageway and wherein the wire is a guidewire slideably engaged in the guidewire passageway.
40. The positioning system of claim 39, wherein the guidewire passageway has a proximal port along the proximal end portion of the elongate body and a distal port along the distal end portion of the elongate body.
41. The positioning system of claim 39, wherein the guidewire passageway extends only through a portion of the elongate body.
42. A method of ablating a region of tissue at a location where a pulmonary vein extends from an atrium, comprising:
inserting into the atrium an anchor device, which is adapted to be positioned within the pulmonary vein and has an elongate body with a proximal end portion and a distal end portion, and also has an expandable member along the distal end portion adjustable between a radially collapsed condition and a radially expanded condition that is adapted to engage the pulmonary vein;
positioning the anchor device within the pulmonary vein;
anchoring the distal end portion of the anchor device within the pulmonary vein by adjusting the expandable member from the radially collapsed condition to the radially expanded condition;
providing an ablation catheter adapted to slideably engage and track over the anchor device and also having an ablation element adapted to couple to an ablation actuator;
advancing the ablation catheter into the atrium over the anchor device until the ablation element is positioned at the location;
actuating the ablation actuator to energize the ablation element; and ablating the region of tissue with the ablation element.
43. The method of claim 54, wherein prior to inserting the anchor device, the method further comprises inserting a transeptal sheath through an atrial septum that separates a right atrium from the left atrium.
44. The method of claim 55, wherein after inserting a transeptal sheath and prior to inserting the anchor device, the method further comprises:
inserting a guide member having a preshaped distal portion through the transeptal sheath from the right atrium into the left atrium;
positioning the preshaped distal portion of the guide member within the left atrium so that it points toward the pulmonary vein; and inserting the anchor involves inserting the anchor device through the guide member.
45. The method of claim 56, wherein prior to advancing the ablation catheter over the anchor device, the guide member is removed.
CA002369312A 1999-05-11 2000-05-11 Balloon anchor wire Expired - Lifetime CA2369312C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13361099P 1999-05-11 1999-05-11
US60/133,610 1999-05-11
PCT/US2000/013194 WO2000067832A2 (en) 1999-05-11 2000-05-11 Balloon anchor wire

Publications (2)

Publication Number Publication Date
CA2369312A1 true CA2369312A1 (en) 2000-11-16
CA2369312C CA2369312C (en) 2009-11-24

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CA002369312A Expired - Lifetime CA2369312C (en) 1999-05-11 2000-05-11 Balloon anchor wire

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US (2) US6595989B1 (en)
EP (4) EP2289448B1 (en)
AT (1) ATE353001T1 (en)
AU (2) AU770417B2 (en)
CA (1) CA2369312C (en)
DE (1) DE60033232T2 (en)
ES (1) ES2279757T3 (en)
WO (1) WO2000067832A2 (en)

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US7881807B2 (en) 2011-02-01
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EP2289448B1 (en) 2013-03-13
ATE353001T1 (en) 2007-02-15

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