Device for removal of embolic debris

• US 5,195,955 A
• Filed: 03/13/1990
• Issued: 03/23/1993
• Est. Priority Date: 11/14/1989
• Status: Expired due to Term

• Current Assignee: Don Michael International, LLC
• Original Assignee: T. Anthony Don Michael
• Inventors: Don Michael, T. Anthony
• Primary Examiner(s): Thaler, Michael H.
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US07/492,580
• Time in Patent Office: 1,106 Days
• Field of Search: 604/96-102, 604/103, 604/104, 604/22, 606/7, 606/194.5
• US Class Current: 604/22
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A device for temporarily blocking a blood vessel of a patient during a procedure for removing an obstruction deposited on the blood vessel wall. The device includes: a catheter having a proximal end and a distal end and arranged to be inserted into the blood vessel via the distal end, the catheter having a peripheral wall and being provided with first and second lumens extending from the proximal end, the first lumen extending fully to the distal end of the catheter, a first opening extending from the first lumen to the peripheral wall for communication with the interior of the blood vessel in order to permit blood flow from a point upstream of the obstruction and through the first lumen to the distal end of the catheter, and a second opening extending from the secon lumen to the peripheral wall at a location between the first opening and the distal end of the catheter; and a balloon secured to the periphral wall and having an inflation opening communicating with the second opening. The balloon is configured such that upon being inflated, it expands eccentrically with respect to the longitudinal axis of the catheter in order to urge the catheter toward the blood vessel wall. The balloon catheter may be used with embolic removal device such as ultrasonic probes and suction catheters.

Claims

1. A device for temporarily obstructing a region of a blood vessel of a patient, without imposing any substantial radial force which act to stretch the vessel wall on the blood vessel, during a procedure for removing embolic material deposited on the blood vessel wall, which device allows blood flow through the vessel beyond the region blocked by the device, said device comprising:

a catheter having a proximal end, a distal end and a longitudinal axis intersecting the ends, said catheter being arranged to be inserted into the blood vessel via said distal end, said catheter having a peripheral wall and being provided with first and second lumens extending from said proximal end, said first lumen extending fully to said distal end of said catheter, a first opening extending from said first lumen to said peripheral wall for communication with the interior of the blood vessel in order to permit blood flow from a point upstream of the embolic material and through said first lumen to said distal end of said catheter, and a second opening extending from said second lumen to one side of said peripheral wall at a location between said first opneing and said distal end of said catheter; and

a high compliance volume balloon secured to said peripheral wall, said balloon having an inflation opening surrounding said second opening and located at the one side of said peripheral wall, the compliance of said balloon being such that when said catheter is inserted into the blood vessel and said balloon is being inflated, sid balloon expands eccentrically around and excircling a major portion of said catheter and expands radially to conform substantially to the interior cross section of the blood vessel, without stretching the blood vessel wall, in order to substantially completely block the blood vessel while urging said catheter away from the center of the blood vessel.

2. A device as defined in claim 1 further comprising coupling means connected to said proximal end of said catheter for establishing communication between said lumens and a region outside the patient'"'"'s body when said distal end of said catheter is located witin the blood vessel.

3. A device as defined in claim 2 wherein said coupling means include a passage for introducing air into said second lumen for inflating said balloon.

4. A device as defined in claim 2 wherein said catheter is provided with a plurality of first openings.

5. A device as defined in claim 2 wherein the sapcing between said first opening and said balloon, along the longitudinal axis of said catheter, is greater than the length of the embolic maerial deposit to be removed.

6. A device for temporarily blocking a region of a blood vessel of a patient, without imposing any substantial radial force on the blood vessel, during a procedure for removing embolic material deposited on the blood vessel wall, which device allows blood flow through th vessel beyond the region blocked by the device, said device comprising:

a catheter having a proximal end, a distal end and a longitudinal axis intersecting the ends, said catheter being arranged to be inserted into the blood vessel via said distal end, said catheter having a peripheral wall and being provided with first and second lumens extending from said proximal end, said first lumen extending fully to said distal end of said catheter, a first opening extending from said first lumen to said peripheral wall for communication with the interior of the blood vessel in order to permit blood flow from a point upstream of the embolic material and through said first lumen to said distal end of said catheter, and a second opening extending from said second lumen to said peripheral wall at a location between said first opening and said distal end of said catheter; and

a high compliance volume balloon secured to said peripheral wall, said balloon having an inflation opening communicating with said second opening, said balloon being inflatable into a configuration which is eccentric with respect to the longitudinal axis of said catheter and which substantially completely surrounds said catheter wherein said balloon is constructed to have wall portions with respectively different expansion characteristics such that, upon inflation of said balloon the exterior surface of a side of said balloon which faces one end of said catheter has a concave portion with a tangent surface that is substantially normal to said catheter longitudinal axis.

7. A device as defined in claim 6 wherein said balloon has a wall portion which decreases in thickness in a direction away from said inflation opening.

8. A device for temporarily obstructing a region of a blood vessel of a patient, without imposing any substantial radial force which act to stretch the vessel wall on the blood vessel, during a procedure for removing embolic material deposited on the blood vessel wall, which device allows blood flow through the vessel beyond the region blocked by the device, said device comprising:

a catheter having a proximal end, a distal end and a longitudinal axis intersecting the ends, said catheter being arranged to be inserted into the blood vessel via said distal end, said catheter having a peripheral wall and being provided with first and second lumens extending from said proximal end, said first lumen extending fully to said distal end of said catheter, a first opening extending from said first lumen to said peripheral wall for communication with the interior of the blood vessel in order to permit blood flow from a point upstream of the embolic material and through said first lumen to said distal end of said catheter, and a second opening extending from said second lumen to said peripheral wall at a location between said first opening and said distal end of said catheter; and

a high compliance volume balloon secured to one side of said peripheral wall, said balloon having an inflation opening surrounding said second opening, the compliance of said balloon being such that when said catheter is inserted into the blood vessel and said balloon is being inflated, said balloon expands eccentrically around and encircling a major portion of said catheter and expands radially to conform substantially to the interior cross section of the blood vessel, without stretching the blood vessel wall, in order to substantially completely block the blood vessel while urging said catheter away from the center of the blood vessel,

in combination with an ultrasonic probe for disintegrating embolic material, said probe being structurally independent of, and movable relative to, said catheter and being insertable into the blood vessel adjacent said catheter to a location which is spaced from said balloon along the longitudinal axis of said catheter.

9. A combination as defined in claim 11 further comprising a suction catheter insertable into the blood vessel separately from, and adjacent, said first-recited catheter for removing embolic debris after disintegration of embolic material by said probe.