Catheter for removing emboli from saphenous vein grafts and native coronary arteries

• US 6,682,505 B2
• Filed: 07/19/2001
• Issued: 01/27/2004
• Est. Priority Date: 03/12/1999
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Arteria Medical Science, Inc. (W.L. Gore and Associates)
• Inventors: Hogendijk, Michael, Bates, Mark C., Boucher, Ryan P.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/909,729
• Publication Number:
  US 20020107479A1
• Time in Patent Office: 922 Days
• Field of Search: 604/96.01, 604/915-920, 606/191-194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• 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 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00871 polymeric
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 1/84 : Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/1015 : having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1077 : having a system for expelling the air out of the balloon before inflation and use
• 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 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 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Methods and apparatus are provided for removing emboli generated during a surgical procedure comprising a catheter having proximal and distal ends, a lumen extending therethrough, an occlusive member affixed to the distal end, and at least one blood intake port disposed in a lateral surface of the catheter. The occlusive member preferably is disposed in a treatment vessel, and the blood intake port, when uncovered, permits a portion of the antegrade flow from a host vessel to be diverted into the lumen of the catheter. A pressure differential caused by the blood intake from the host vessel establishes a venturi-effect suitable for manipulating flow in the treatment vessel. The flow characteristics may be manipulated via the intake port to direct emboli into the lumen of the catheter for subsequent removal.

Claims

1. Apparatus for removing emboli from a blood vessel, the apparatus comprising:

a catheter having a proximal end, a distal end, a blood outlet port at the proximal end, a distal inlet port at the distal end, a lateral surface, and a lumen extending between the proximal and distal ends;

an occlusive member affixed to the distal end of the catheter at a location proximal of the distal inlet port; and

at least one intake port disposed in the lateral surface proximal to the occlusive member, the blood intake port configured to induce venturi-assisted retrograde flow in a treatment vessel so that blood entering the lumen flows from the distal inlet port to the blood outlet port.

2. The apparatus of claim 1 wherein the occlusive member is inflatable and includes a tapered surface that communicates with the lumen.

3. The apparatus of claim 2 wherein the occlusive member is adapted to be disposed within the ostium of a treatment vessel.

4. The apparatus of claim 2 wherein the occlusive member further serves as an inflatable cuff.

5. The apparatus of claim 1 wherein the occlusive member comprises a self-expanding woven mesh having contracted a state suitable for transluminal insertion and an expanded state suitable for occluding antegrade flow in a treatment vessel.

6. The apparatus of claim 5 wherein the occlusive member has a rounded configuration and an internal lip.

7. The apparatus of claim 5 wherein the occlusive member comprises a plurality of split ends coated with an elastomeric coating.

8. The apparatus of claim 1 further comprising:

a piston disposed for longitudinal motion within the catheter; and

a flexible sheath affixed at a distal location to the piston and affixed at a proximal location to the catheter, so that proximally retracting the piston within the catheter causes the flexible sheath to form a balloon-shaped occlusive member.

9. The apparatus of claim 1 wherein the blood intake port has edges having variable angle configurations.

10. The apparatus of claim 1 wherein the blood intake port is disposed at an angle with respect to the catheter body.

11. The apparatus of claim 1 wherein the blood intake port has a pattern selected to enhance blood flow into the blood intake ports.

12. The apparatus of claim 1 wherein the catheter further comprises at least one deployable section, the deployable section having an expandable state wherein the proximal edges of the blood intake ports are raised with respect to the catheter body.

13. The apparatus of claim 1 wherein the blood intake port is circular.

14. The apparatus of claim 1 wherein the blood intake port is a slot.

15. The apparatus of claim 1 wherein the catheter further comprises a flexing member that separates a distal catheter section comprising the distal occlusive member and a proximal section comprising the blood intake port.

16. The apparatus of claim 15 further comprising a shape memory member having an expanded state suitable for bending the flexing member to form a substantially acute angle between the proximal and distal sections.

17. The apparatus of claim 1 further comprising:

an outer sheath; and

a hood, the hood being provided in a contracted state within the outer sheath and having an expanded state suitable for guiding blood flow into the blood intake port.

18. A method for removing emboli during a medical procedure and manipulating flow characteristics in a treatment vessel, the method comprising:

providing apparatus comprising a catheter having a proximal end, a distal end, a blood outlet port at the proximal end, an inlet port at the distal end, a lumen extending therethrough, an occlusive member affixed to the distal end at a location proximal of the distal end, and at least one blood intake port disposed in a lateral surface of the catheter;

positioning the distal end of the catheter in a host vessel so that the inlet port extends in at least an ostium of the treatment vessel proximal to a stenosis; and

deploying the occlusive member to prevent communication between the host and treatment vessels, such that a distal portion of the lumen communicates with flow in the treatment vessel; and

flowing blood into the intake port so as to induce retrograde flow in the treatment vessel and cause blood entering the lumen through the inlet port to flow to the blood outlet port.

19. The method of claim 18 wherein deploying the occlusive member further comprises:

providing a piston capable of longitudinally moving within the lumen of the catheter, and further providing a flexible sheath that is affixed at a distal location to the piston and affixed at a proximal location to the catheter; and

proximally retracting the piston within the catheter to compress air within the sheath to form a balloon-shaped occlusive member.

20. The method of claim 18 wherein flowing blood into the intake port further comprises controlling fluid flow from a host vessel into the lumen of the catheter via the blood intake port.

21. The method of claim 20 wherein flowing blood into the intake port further comprises inducing venturi-assisted retrograde flow in the treatment vessel.

22. The method of claim 20 further comprising performing a medical procedure to treat a lesion in the treatment vessel.

23. The method of claim 22 further comprising directing emboli generated during the medical procedure into the lumen of the catheter.

24. The method of claim 22 wherein controlling fluid flow into the lumen further comprises:

providing an inner sheath having at least one opening within the catheter; and

actuating the inner sheath to allow the opening to overlap a selected amount with the intake port.

25. The method of claim 24 wherein actuating the inner sheath comprises rotating the inner sheath within the catheter relative to its longitudinal axis.

26. The method of claim 24 wherein actuating the inner sheath comprises longitudinally sliding the inner sheath within the catheter.

27. The method of claim 20 wherein controlling fluid flow into the lumen further comprises:

providing a flexing member positioned proximal to the occlusive member, the blood intake port positioned proximal to the flexing member, and a shape memory member that is initially retracted;

deploying the shape memory member to flex the flexing member to provide a substantially acute angle between the occlusive member and the intake port; and

deploying the occlusive member proximal to a stenosis in a treatment vessel to anchor the distal end of the catheter.

28. The method of claim 27 further comprising proximally retracting a tensioning member affixed to a distal point within the lumen to bend the flexing member to increase the substantially acute angle.