Methods and systems for treating ischemia

• US 6,295,990 B1
• Filed: 05/14/1999
• Issued: 10/02/2001
• Est. Priority Date: 02/03/1998
• Status: Expired due to Fees

• Current Assignee: Salient Interventional Systems Incorporated
• Original Assignee: Salient Interventional Systems Incorporated
• Inventors: Bolduc, Lee R., Lewis, Brian Douglas
• Primary Examiner(s): Nguyen, Dinh X.
• Application Number:
  US09/311,903
• Time in Patent Office: 872 Days
• Field of Search: 128/898, 604/4, 604/7, 604/8, 604/48, 604/49-53, 604/96, 604/102
• US Class Current: 128/898
• CPC Class Codes: A61B 17/22 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 dilators A61M29/00
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/22038 with a guide wire
• 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 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Methods for treating total and partial occlusions employ a perfusion conduit which is penetrated through the occlusive material. Oxygenated blood or other medium is then perfused through the conduit in a controlled manner, preferably at a controlled pressure below the arterial pressure, to maintain oxygenation and relieve ischemia in tissue distal to the occlusion. In another aspect, interventional devices, such as stents or balloon catheters, are passed through the perfusion catheter to remove obstructions. Optionally, the occlusion may be treated while perfusion is maintained, typically by introducing a thrombolytic or other agent into the occlusive material using the perfusion conduit or by employing mechanical means to remove the obstruction. Such methods are particularly suitable for treating acute stroke to prevent damage to the cerebral tissue.

Claims

1. A method of treating an obstruction in a patient'"'"'s cerebral vasculature, comprising the steps of:

providing a perfusion device having a perfusion lumen and at least one outlet fluidly coupled to the perfusion lumen;

advancing the perfusion device through a patient'"'"'s cerebral vasculature to an obstruction in the cerebral vasculature;

directing the distal end of the perfusion device through the obstruction so that the at least one outlet is on a distal side of the obstruction;

delivering an oxygenated medium through the perfusion lumen;

passing an obstruction removal device through the perfusion lumen;

withdrawing the distal end of the perfusion device through the obstruction; and

removing the obstruction with the obstruction removal device.

2. The method of claim 1, wherein the passing step is carried out with the obstruction removal device having a balloon;

and the removing step is carried out by positioning the balloon in the obstruction and inflating the balloon to displace the obstruction.

3. The method of claim 1, further comprising the step of:

positioning the obstruction removal device inside the perfusion lumen during the withdrawing step so that the obstruction removal device is exposed during the withdrawing step.

4. The method of claim 1, wherein the providing step is carried out with the perfusion lumen having a cross-sectional area of at least 0.45 mm² along a length of at least 5 cm from a distal end.

5. The method of claim 4, wherein the providing step is carried out with the perfusion device having a maximum cross-sectional dimension of 3.0 mm along a length of at least 5 cm from the distal end.

6. The method of claim 1, wherein the passing step is carried out with the obstruction removal device having a stent mounted on a balloon;

and the removing step is carried out by positioning the stent in the obstruction and inflating the balloon to expand the stent and displace the obstruction.

7. A method for treating an obstruction in a cerebral artery, comprising the steps of:

providing a first catheter and a second catheter each having a lumen;

advancing the first catheter to the obstruction in the cerebral artery;

infusing an oxygenated medium through the lumen of the first catheter to a position downstream of an obstruction in the cerebral artery;

passing the second catheter through the lumen of the first catheter to the obstruction; and

removing the obstruction with at least one of the first and second catheters.

8. The method of claim 7, wherein the providing step is carried out with the first catheter having a tapered shape.

9. The method of claim 7, wherein the providing step is carried out with the second catheter being a stent catheter, the stent catheter having a stent mounted to a balloon, the balloon begin coupled to a balloon inflation lumen.

10. The method of claim 7, wherein the providing step is carried out with the lumen of the first catheter having a cross-sectional area of at least 0.45 mm² and a maximum, cross-sectional dimension of no more than 3 mm along a distal portion, the lumen of the second catheter having a cross-sectional area of at least 0.19 mm² along the distal portion of the first and second catheters, the distal portion having a length of at least 5 cm.

11. The method of claim 7, wherein the providing step is carried out with the first catheter having only one lumen.

12. The method of claim 7, wherein the providing step is carried out with the lumen of the first catheter having a cross-sectional area of at least 0.45 mm² along a distal portion extending 5 cm from a distal end.