Systems, apparatus and methods for treating blood vessels

• US 9,878,128 B2
• Filed: 03/12/2014
• Issued: 01/30/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad J., Robinson, David B.
• Primary Examiner(s): Eastwood, David C
• Application Number:
  US14/205,901
• Publication Number:
  US 20140277068A1
• Time in Patent Office: 1,420 Days
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/2256 with means for locating or checking the concrement, e.g. X-ray apparatus, imaging means A61B17/2255 takes precedence
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

A system and method for treating a blood vessel that is at least partially obstructed by an occlusion which divides the lumen into a proximal lumen segment and a distal lumen segment. The system includes an orienting catheter having an orientation element positionable in an intrawall space of the vessel and an occlusion catheter having an occlusion balloon inflatable in the proximal lumen segment so as to isolate a target volume including the intrawall space. The pressure inside the target volume is reduced to a pressure below the pressure of the distal lumen segment so that the intima presses against the orienting element of the orienting catheter. A distal end of a reentry device may be advanced from the orienting catheter through the intima and into the distal lumen segment.

Claims

1. A system for treating a blood vessel including a blood vessel wall defining a blood vessel lumen, the blood vessel lumen being at least partially obstructed by an occlusion, the occlusion dividing the lumen into a proximal lumen segment and a distal lumen segment, the system comprising:

an orienting catheter configured to direct a re-entry device toward the blood vessel lumen, the orienting catheter including an orienting catheter shaft and a guide advanceable longitudinally relative to and along the orienting catheter shaft;

an occlusion catheter comprising an occlusion catheter shaft, a balloon secured to the occlusion catheter shaft, and a first coupling located distal of the balloon on the occlusion catheter shaft, the first coupling configured to engage a complementary second coupling of the guide to form a connection therebetween;

wherein the first coupling and the second coupling have a first configuration in which the first coupling and the second coupling are separated and a second configuration in which the first coupling and the second coupling are engaged to preclude axial movement between the occlusion catheter and the guide;

wherein the balloon includes a proximal end, and wherein the orienting catheter shaft extends along an exterior of the occlusion catheter shaft proximal of the proximal end of the balloon;

the occlusion catheter defining an inflation lumen disposed in fluid communication with an interior of the balloon so that the balloon can be selectively inflated by injecting an inflation fluid through the inflation lumen;

the balloon, when in an inflated state, being sized so as to occlude the blood vessel lumen to isolate a target volume defined by blood vessel tissues;

the occlusion catheter defining an aspiration lumen disposed in fluid communication with a distal port positioned so that fluid can be withdrawn from the target volume and into the aspiration lumen while the first coupling is engaged with the second coupling.

2. The system of claim 1, wherein the guide includes a lumen through which the orienting catheter shaft extends through.

3. The system of claim 2, wherein the lumen of the guide is dimensioned so that the guide is free to slide in proximal and distal axial directions along the orienting catheter shaft.

4. The system of claim 1, wherein the orienting catheter comprises a first inflatable member and a second inflatable member, the first inflatable member extending from the orienting catheter shaft in a first direction, the second inflatable member extending from the orienting catheter shaft in a second direction, the second direction being substantially opposite the first direction.

5. The system of claim 4, wherein the first inflatable member, the second inflatable member, and the orienting catheter shaft are monolithic.

6. The system of claim 4, further comprising a first aperture extending through a wall of the orienting catheter shaft to a lumen extending through the orienting catheter shaft.

7. The system of claim 6, wherein the first aperture is positioned between the first and second inflatable members.

8. The system of claim 7, wherein the first aperture extends away from the lumen of the orienting catheter shaft in a third direction perpendicular to the first and second directions.

9. The system of claim 6, further comprising a re-entry device extendable through the lumen of the orienting catheter shaft.

10. The system of claim 9, wherein the re-entry device is configured to be advanced out through the first aperture into the distal lumen segment.

11. The system of claim 1, wherein the orienting catheter and the occlusion catheter are positionable exterior of and alongside one another while the first coupling is engaged with the complimentary second coupling.

12. A system comprising:

an intravascular catheter including an elongate catheter shaft and a guide advanceable longitudinally relative to and along the elongate catheter shaft of the intravascular catheter;

an occlusion catheter including an elongate catheter shaft, a balloon mounted on a distal region of the elongate catheter shaft of the occlusion catheter, and a first coupling located distal of the balloon on the elongate catheter shaft, the first coupling configured to engage a complementary second coupling of the guide to form a connection therebetween;

wherein the first coupling and the second coupling have a first configuration in which the first coupling and the second coupling are separated and a second configuration in which the first coupling and the second coupling are engaged to preclude axial movement between the occlusion catheter and the guide;

wherein the balloon includes a proximal end, and wherein the elongate catheter shaft of the intravascular catheter extends along an exterior of the elongate catheter shaft of the occlusion catheter proximal of the proximal end of the balloon;

the elongate catheter shaft of the occlusion catheter defining an inflation lumen disposed in fluid communication with an interior of the balloon so that the balloon can be selectively inflated by injecting an inflation fluid through the inflation lumen;

the balloon, when in an inflated state, being sized so as to occlude a blood vessel lumen.

13. The system of claim 12, wherein the elongate catheter shaft of the occlusion catheter defines an aspiration lumen disposed in fluid communication with a distal port of the elongate catheter shaft of the occlusion catheter.

14. The system of claim 12, wherein the guide includes a lumen through which the elongate catheter shaft of the intravascular catheter extends through.

15. The system of claim 14, wherein the lumen of the guide is dimensioned so that the guide is free to slide in proximal and distal axial directions along the elongate catheter shaft of the intravascular catheter.

16. The system of claim 12, wherein the first coupling of the occlusion catheter is a male coupling and the second coupling of the guide is a female coupling configured to mate with the male coupling.

17. A system comprising:

an intravascular catheter including an elongate catheter shaft and a guide advanceable along the elongate catheter shaft of the intravascular catheter;

an occlusion catheter including an elongate catheter shaft, a balloon mounted on a distal region of the elongate catheter shaft of the occlusion catheter, and a first coupling located distal of the balloon on the elongate catheter shaft, the first coupling configured to engage a complementary coupling of the guide to form a connection therebetween;

wherein the first coupling and the second coupling have a first configuration in which the first coupling and the second coupling are separated and a second configuration in which the first coupling and the second coupling are engaged to preclude axial movement between the occlusion catheter and the guide;

wherein the balloon includes a proximal end, and wherein the elongate catheter shaft of the intravascular catheter extends along an exterior of the elongate catheter shaft of the occlusion catheter proximal of the proximal end of the balloon;

the elongate catheter shaft of the occlusion catheter defining an inflation lumen disposed in fluid communication with an interior of the balloon so that the balloon can be selectively inflated by injecting an inflation fluid through the inflation lumen;

the balloon, when in an inflated state, being sized so as to occlude a blood vessel lumen;

wherein the intravascular catheter includes an inflatable balloon mounted on a distal end region of the elongate catheter shaft of the intravascular catheter.