Angioplasty apparatus facilitating rapid exchanges and method

• US 6,921,411 B2
• Filed: 11/08/2002
• Issued: 07/26/2005
• Est. Priority Date: 04/15/1986
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Yock, Paul G.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US10/290,881
• Publication Number:
  US 20030120301A1
• Time in Patent Office: 991 Days
• Field of Search: 606/194, 606/192, 606/193, 606/103.04, 604/103.04
• US Class Current: 606/194
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus for introduction into the vessel of a patient comprising a guiding catheter adapted to be inserted into the vessel of the patient and a device adapted to be inserted into the guiding catheter. The device includes a flexible elongate member and a sleeve carried by the flexible elongate member near the distal extremity thereof and extending from a region near the distal extremity to a region spaced from the distal extremity of the flexible elongate element. The device also includes a guide wire adapted to extend through the sleeve so that the guide wire extends rearwardly of the sleeve extending alongside of and exteriorally of the flexible elongate element into a region near the proximal extremity of the flexible elongate element.

Claims

1. A method of loading a balloon catheter onto a guidewire in preparation for advancing the catheter within a patient'"'"'s vasculature and into a coronary artery of the patient, comprising:

a) providing an elongated catheter configured for percutaneous introduction into the patient'"'"'s vasculature having

i) a proximal end and a distal end,

ii) an inflation fluid passageway,

iii) an inflatable balloon on the distal portion thereof having an interior in fluid communication with the inflation fluid passageway, and

iv) a guidewire receiving passageway which extends through the interior of the balloon; and

b) loading the catheter onto an elongated guidewire having a proximal end, a distal end, and a flexible distal portion such that the proximal end of the guidewire enters the distal end of the catheter and exits the catheter proximal of the inflatable balloon and at least 10 cm from the distal end of the catheter and a substantial distance from the proximal end of the catheter.

2. A method of loading a balloon catheter onto a guidewire in preparation for advancing the catheter within a patient'"'"'s vasculature and into a coronary artery of the patient, comprising:

a) providing an elongated guidewire having a proximal end, a distal end, and a flexible distal portion and being sufficiently long to be advanced into a coronary artery of a patient;

b) providing an elongated catheter configured for percutaneous introduction into the patient'"'"'s vasculature having

i) a proximal end and a distal end,

ii) an inflation fluid passageway,

iii) an inflatable balloon on the distal portion thereof having an interior in fluid communication with the inflation fluid passageway, and

iv) a guidewire receiving passageway which extends through the interior of the balloon; and

c) loading the catheter onto the guidewire such that the proximal end of the guidewire enters the distal end of the catheter and exits the catheter proximal of the inflatable balloon and at least 10 cm from the distal end of the catheter and a substantial distance from the proximal end of the catheter.

3. A method of loading a balloon catheter onto a guidewire in preparation for advancing a the catheter within a patient'"'"'s vasculature and into a coronary artery of the patient, comprising:

a) providing a guiding catheter having a proximal end and a distal end and having a passageway extending therein;

b) disposing the guiding catheter within a patient'"'"'s vasculature with the proximal end of the guiding catheter extending out of the patient;

c) providing an elongated guidewire having a proximal end, a distal end, and a flexible distal portion and being sufficiently long to be advanced into a coronary artery of the patient;

d) disposing the guidewire within the passageway of the guiding catheter with the proximal end of the guidewire extending out of the proximal end of the guiding catheter;

e) providing an elongated catheter configured for percutaneous introduction into the patient'"'"'s vasculature having

i) a proximal end and a distal end,

ii) an inflation fluid passageway,

iii) an inflatable balloon on the distal portion thereof having an interior in fluid communication with the inflation fluid passageway, and

iv) a guidewire receiving passageway which extends through the interior of the balloon; and

f) loading the catheter onto the guidewire such that the proximal end of the guidewire enters the distal end of the catheter and exits the catheter proximal of the inflatable balloon and at least 10 cm from the distal end of the catheter and a substantial distance from the proximal end of the catheter.

4. A method of performing a procedure within a patient'"'"'s coronary artery, comprising:

a) providing a guiding catheter having a proximal end and a distal end and having a passageway extending therein;

b) disposing the guiding catheter within a patient'"'"'s vasculature with the proximal end of the guiding catheter extending out of the patient;

c) providing an elongated guidewire having a proximal end, a distal end, and a flexible distal portion and being sufficiently long to be advanced into a coronary artery of the patient;

d) disposing the guidewire within the inner passageway of the guiding catheter with the proximal end of the guidewire extending out of the proximal end of the guiding catheter;

e) providing an elongated catheter configured for percutaneous introduction into the patient'"'"'s vasculature having

i) a proximal end and a distal end,

ii) an inflation fluid passageway,

iii) an inflatable balloon on the distal portion thereof having an interior in fluid communication with the inflation fluid passageway, and

iv) a guidewire receiving passageway which extends through the interior of the balloon;

f) loading the catheter onto the guidewire such that the proximal end of the guidewire enters the distal end of the catheter and exits the catheter proximal of the inflatable balloon and at least 10 cm from the distal end of the catheter and a substantial distance from the proximal end of the catheter;

g) advancing the catheter within the patient'"'"'s vasculature such that the distal end of the catheter extends out of the distal end of the guiding catheter and into the patient'"'"'s coronary artery; and

h) withdrawing the catheter from the patient.

5. A method of unloading an elongated balloon catheter off an elongated guidewire having a distal end, a proximal end, and a flexible distal portion with the guidewire proximal end extending outside a patient, wherein the catheter has (i) a proximal end, (ii) a distal end, (iii) an inflation fluid passageway, (iv) an inflatable balloon on the distal portion thereof having an interior in fluid communication with the inflation fluid passageway, and (v) a guidewire receiving passageway which extends through the interior of the inflatable balloon, and wherein at least a portion of the catheter has been advanced into the cardiovascular system of the patient over the guidewire, the method comprising:

a) withdrawing the catheter from the patient'"'"'s cardiovascular system over the guidewire until both (i) a first portion of the guidewire is exposed outside of the patient and distal to the distal end of the catheter and (ii) a second portion of the guidewire extends through the catheter from the distal end of the catheter and exits the catheter proximal of the inflatable balloon, at least 10 cm from the distal end of the catheter, and a substantial distance from the proximal end of the catheter;

b) maintaining the guidewire within the patient'"'"'s cardiovascular system; and

c) unloading the catheter off the guidewire.