Methods and systems for treating ischemia

• US 20030023230A1
• Filed: 06/26/2002
• Published: 01/30/2003
• Est. Priority Date: 02/03/1998
• Status: Abandoned Application

• Current Assignee: Salient Interventional Systems Incorporated
• Original Assignee: Salient Interventional Systems Incorporated
• Inventors: Bolduc, Lee R., Lewis, Brian Douglas
• Application Number:
  US10/186,245
• Publication Number:
  US 20030023230A1
• Time in Patent Office: Days
• US Class Current: 604/537
• 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 perfusion device for perfusing an oxygenated medium into a patient'"'"'s cerebral vasculature, comprising:

a catheter shaft having a distal portion, the distal portion having a length of at least 10 cm from the distal end, the distal portion also having a maximum outer dimension of no more than 3.2 mm;

a perfusion lumen extending through the shaft, the perfusion lumen having a cross-sectional area of 0.77 mm squared to 7.1 mm squared over the distal portion of the shaft; and

at least one fluid outlet coupled to the lumen for delivering an oxygenated medium into the cerebral vasculature.

2. The perfusion device of claim 1, wherein:

the catheter shaft has a maximum outer dimension of no more than 2.4 mm along the distal portion.

3. The perfusion device of claim 1, wherein:

the catheter shaft has a maximum outer dimension of no more than 2.0 mm along the distal portion.

4. The perfusion device of claim 1, wherein:

the distal portion of the catheter shaft is at least 15 cm long.

5. The perfusion device of claim 1, wherein:

the cross-sectional area of the perfusion lumen is at least 1.0 mm squared over the distal portion.

6. The perfusion device of claim 1, wherein:

the cross-sectional area of the perfusion lumen is at least 1.5 mm squared over the distal portion.

7. The perfusion device of claim 1, wherein:

the cross-sectional area of the perfusion lumen is at least 2.0 mm squared over the distal portion.

8. The perfusion device of claim 1, wherein:

the cross-sectional area of the perfusion lumen is at least 4.0 mm squared over the distal portion.

9. The perfusion device of claim 1, further comprising:

a pressure transducer positioned along the distal portion of the catheter shaft.

10. The perfusion device of claim 1, further comprising:

a balloon attached to the catheter shaft.

11. The perfusion device of claim 1, wherein:

the catheter shaft includes only the perfusion lumen and no other lumens.

12. A balloon catheter which is configured to be advanced through another catheter, the balloon catheter comprising:

only one lumen and a balloon, the balloon being coupled to the lumen for inflating the balloon, the balloon catheter having no other lumens and having no structure, guidewire lumen or distal opening for guiding the catheter along a guidewire.

13. The balloon catheter of claim 12, wherein the balloon catheter has a tapered shaft.

14. The balloon catheter of claim 13, wherein the catheter has a maximum outer dimension of no more than 1.6 mm excluding the balloon along a length of 5 cm from a distal end.

15. The balloon catheter of claim 12, wherein a stent is mounted on the balloon.

16. A catheter for accessing the cerebral vasculature, comprising:

a shaft having a proximal end, a distal end, a proximal portion and a distal portion, the distal portion extending for a length of at least 5 cm from the distal end and the proximal portion extending for a length of at least 75 cm; and

a lumen extending through the shaft, the lumen having a cross-sectional area of 0.45 to 2.3 mm² along the distal portion and a cross-sectional area of 2.0-7.6 mm² along the proximal portion.

17. The catheter of claim 16, wherein the distal portion extends for at least 10 cm from the distal end.

18. The catheter of claim 16, wherein the lumen has a cross-sectional area of 2.8-5.6 mm² along the proximal portion.

19. The catheter of claim 16, wherein the lumen has a cross-sectional area of 0.62-1.7 mm² along the distal portion.

20. The catheter of claim 16, wherein the lumen is surrounded by a wall having a wall thickness, the wall thickness being no more than 0.20 mm.

21. The catheter of claim 16, wherein the lumen is surrounded by a wall having a wall thickness, the wall thickness being no more than 0.15 mm.

22. The catheter of claim 16, wherein the lumen has a circular cross-sectional shape and a diameter of 0.76-1.7 mm along the distal portion;

and the shaft has an outer diameter along the distal portion of no more than 0.40 mm larger than the diameter of the lumen.

23. The catheter of claim 16, wherein the proximal portion of the shaft extends for at least 100 cm.

24. The catheter of claim 16, wherein the shaft has an intermediate section between the proximal and distal sections, and the intermediate section has a cross-sectional area smaller than the proximal section and larger than the distal section.

25. The catheter of claim 24, wherein the intermediate section has a length of at least 15 cm.

26. The catheter of claim 25, wherein the intermediate section is tapered and has a length of at least 20 cm.