HIGHLY TRACKABLE BALLOON CATHETER SYSTEM AND METHOD FOR COLLAPSING AN EXPANDED MEDICAL DEVICE
First Claim
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1. A balloon catheter system configured to recover an expanded device in a patient'"'"'s body lumen, comprising:
- a) a balloon catheter having a proximal end, a distal end, an elongated shaft with an inflation lumen and a device lumen therein, and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen; and
b) a recovery sheath having a single lumen with the balloon catheter elongated shaft slidably disposed therein, and having a proximal end, a distal end, a retracted configuration in which the distal end is located proximal to the balloon, and an advanced configuration in which the distal end is located distal to the balloon catheter, and having a transverse cross sectional profile which decreases from a large profile distal recovery section to smaller profile distal shaft section, and which increases from the distal shaft section to a larger profile midshaft section, and which decreases from the midshaft section to a smaller profile proximal shaft section.
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Abstract
A balloon catheter having a pre-mounted recovery sheath for recovering an expanded device, such as an embolic protection device, in a patient'"'"'s body lumen, and a method of using a balloon catheter system of the invention to recover the expanded device
26 Citations
36 Claims
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1. A balloon catheter system configured to recover an expanded device in a patient'"'"'s body lumen, comprising:
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a) a balloon catheter having a proximal end, a distal end, an elongated shaft with an inflation lumen and a device lumen therein, and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen; and b) a recovery sheath having a single lumen with the balloon catheter elongated shaft slidably disposed therein, and having a proximal end, a distal end, a retracted configuration in which the distal end is located proximal to the balloon, and an advanced configuration in which the distal end is located distal to the balloon catheter, and having a transverse cross sectional profile which decreases from a large profile distal recovery section to smaller profile distal shaft section, and which increases from the distal shaft section to a larger profile midshaft section, and which decreases from the midshaft section to a smaller profile proximal shaft section. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A balloon catheter system configured to recover an expanded device in a patient'"'"'s body lumen, comprising:
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a) a balloon catheter having an elongated shaft with an inflation lumen and a device lumen therein and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen; and b) a recovery sheath having a single lumen with the balloon catheter elongated shaft slidably disposed therein, and having a proximal end, a distal end, a retracted configuration in which the distal end is located proximal to the balloon, and an advanced configuration in which the distal end is located distal to the balloon catheter, and having a distal recovery section with a corrugated wall which unfolds from a radially collapsed configuration to a radially enlarged configuration. - View Dependent Claims (12, 13, 14)
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15. A balloon catheter system configured to recover an expanded device in a patient'"'"'s body lumen, comprising:
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a) a balloon catheter having a proximal end, a distal end, an elongated shaft with an inflation lumen and a device lumen therein, and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen; and b) a recovery sheath having a single lumen with the balloon catheter elongated shaft slidably disposed therein, and having a proximal end, a distal end, a retracted configuration in which the distal end is located proximal to the balloon, and an advanced configuration in which the distal end is located distal to the balloon catheter, the sheath lumen extending from a distal port in the distal end of the sheath to a proximal port at a location at which the recovery sheath transitions from a tubular shape to an open-walled proximal section with a C-shaped inner surface which defines a channel and which is configured to extend only partially around the circumference of the balloon catheter elongated shaft. - View Dependent Claims (16, 17, 18, 19, 20)
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21. A method of using a balloon catheter system to perform a medical procedure and recover an expandable device in a patient'"'"'s body lumen, comprising:
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a) introducing within a patient'"'"'s body lumen a balloon catheter system having a balloon catheter within a lumen of a recovery sheath, the balloon catheter having a proximal end, a distal end, an elongated shaft with an inflation lumen and a device lumen therein, and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen, and the recovery sheath being a single lumen tube with the balloon catheter elongated shaft slidably disposed therein, and having a proximal end, a distal end, a retracted configuration in which the distal end is located proximal to the balloon, and an advanced configuration in which the distal end is located distal to the balloon catheter, and having a transverse cross sectional profile which decreases from a large profile distal recovery section to smaller profile distal shaft section, and which increases from the distal shaft section to a larger profile midshaft section, and which decreases from the midshaft section to a smaller profile proximal shaft section; b) slidably advancing the balloon catheter system within the body lumen over a proximal section of the expandable device having an operative distal end section configured to reversibly radially expand and collapse, to position the balloon at a desired treatment location proximal to the radially expanded operative distal end section of the expandable device; c) inflating the balloon to perform a medical procedure, and deflating the balloon; d) advancing the recovery sheath over the deflated balloon to position the distal end of the sheath distal to the balloon catheter shaft; e) advancing the recovery sheath and balloon catheter together distally to position the operative distal end section of the expandable device within the recovery section of the recovery sheath and thereby radially collapse the operative distal end section; and f) slidably displacing the balloon catheter with the collapsed operative distal end section of the device therein, to reposition or remove the expandable device from the patient'"'"'s body lumen. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. A method of performing a medical procedure with embolic protection, comprising:
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a) introducing within a patient'"'"'s body lumen a balloon catheter system having a balloon catheter within a lumen of a recovery sheath, the balloon catheter having a proximal end, a distal end, an elongated shaft with an inflation lumen and a device lumen therein, and a balloon on a distal shaft section with an interior in fluid communication with the inflation lumen, wherein the recovery sheath is a single lumen tube with the balloon catheter elongated shaft slidably disposed therein, and having a proximal end, a distal end, a retracted configuration in which the distal end is located proximal to the balloon, and an advanced configuration in which the distal end is located distal to the balloon catheter, and having a transverse cross sectional profile which decreases from a large profile distal recovery section to smaller profile distal shaft section, and which increases from the distal shaft section to a larger profile midshaft section, and which decreases from the midshaft section to a smaller profile proximal shaft section; b) slidably advancing the balloon catheter system within the body lumen over a proximal section of an embolic protection device having an operative distal end configured to collect embolic material in a radially expanded configuration, to position the balloon at a desired treatment location proximal to the operative distal end of the embolic protection device; c) inflating the balloon to perform a medical procedure, and deflating the balloon; d) advancing the recovery sheath over the deflated balloon; e) advancing the recovery sheath and balloon catheter together distally to position the operative distal end of the embolic protection device within the recovery section of the recovery sheath and thereby radially collapse the operative distal end of the embolic protection device; and f) slidably displacing the balloon catheter with the collapsed embolic protection device therein to reposition or remove the embolic protection device from the patient'"'"'s body lumen.
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Specification