Catheter having a variable length balloon and method of using the same

• US 5,961,536 A
• Filed: 10/14/1997
• Issued: 10/05/1999
• Est. Priority Date: 10/14/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Carlson, John H. II, Harris, Chad G., Mickley, Timothy J., Larson, Christopher R., Mertens, Steven P.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/950,520
• Time in Patent Office: 721 Days
• Field of Search: 606/194, 606/192, 606/108, 606/193, 604/96
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A variable length balloon catheter is provided. The balloon catheter includes a catheter shaft having a distal portion, a balloon and an adjustment device. The balloon is in fluid communication with a distal end of the catheter shaft. The adjustment device includes an outer sleeve and an attachment structure. The outer sleeve is configured to be generally co-axially received over the distal portion of the catheter shaft and includes a distal end configured to restrict inflation proximal the distal end. Further, the outer sleeve is configured such that at least a portion of the outer sleeve is slidable relative to the distal portion of the catheter shaft such that a distal end of the outer sleeve relative to the balloon can be varied. The attachment structure is similarly disposed at the distal portion of the catheter shaft and is configured to selectively secure at least a portion of the outer sleeve to the distal portion of the catheter shaft such that the outer sleeve will not move upon inflation of the balloon.

Claims

1. A balloon catheter assembly including a catheter shaft having a distal portion terminating at a distal end, a balloon fluidly connected to the distal end of the catheter shaft, and an adjustment device disposed along the distal portion of the catheter shaft for adjusting effective balloon inflation length, the adjustment device comprising:

an outer sleeve generally having a distal end co-axially received over the distal portion of the catheter shaft, at least a portion of the outer sleeve being slidable relative to the distal portion of the catheter shaft, the distal end of the outer sleeve being configured to restrict inflation of the balloon proximal the distal end of the outer sleeve; and

attachment means for selectively securing at least a portion of the outer sleeve to the distal portion of the catheter shaft such that the distal end of the outer sleeve is selectively maintained relative to the balloon to define a desired effective balloon inflation length, the attachment means including an enlarged shaft portion proximate the balloon and a locking sleeve generally co-axially received over the outer sleeve, the locking sleeve configured to selectively secure the outer sleeve to the enlarged shaft portion.

2. The adjustment device of claim 1, wherein the distal end of the outer sleeve includes a marker for providing a fluoroscopic indication of balloon positioning.

3. The adjustment device of claim 1, wherein the distal end of the outer sleeve includes a conical ring.

4. The attachment device of claim 1, wherein the distal end of the outer sleeve is configured to be an annular shoulder allowing at least partial inflation of the balloon both proximal and distal of the annular shoulder.

5. The adjustment device of claim 1, further comprising:

markers disposed along a distal portion of the catheter shaft for indicating effective balloon inflation length.

6. The adjustment device of claim 1, wherein the outer sleeve is configured to be adjusted when the balloon is in a deflated state, but cannot be adjusted when the balloon is in an inflated state.

8. The adjustment device of claim 1, wherein the locking sleeve includes a proximal end, an intermediate portion and a distal end, the proximal end of the locking sleeve having a diameter less than an outer diameter of the rib, and the distal end of the locking sleeve having a diameter greater than the diameter of the proximal end of the locking sleeve and approximating the outer diameter of the rib.

9. The adjustment device of claim 8, wherein the intermediate portion of the locking sleeve expands from the proximal end of the locking sleeve to the distal end of the locking sleeve such that the locking sleeve is configured to frictionally secures the outer sleeve to the rib.

7. A balloon catheter assembly including a catheter shaft having a distal portion terminating at a distal end, a balloon fluidly connected to the distal end of the catheter shaft, and an adjustment device disposed along the distal portion of the catheter shaft for adjusting effective balloon inflation length, the adjustment device comprising:

an outer sleeve generally having a distal end co-axially received over the distal portion of the catheter shaft, at least a portion of the outer sleeve being slidable relative to the distal portion of the catheter shaft, the distal end of the outer sleeve being configured to restrict inflation of the balloon proximal the distal end of the outer sleeve; and

attachment means for selectively securing at least a portion of the outer sleeve to the distal portion of the catheter shaft such that the distal end of the outer sleeve is selectively maintained relative to the balloon to define a desired effective balloon inflation length, the attachment means including a rib attached to the distal portion of the catheter shaft proximal the balloon, and a locking sleeve generally co-axially received over the outer sleeve, wherein the locking sleeve is configured to selectively secure the outer sleeve to the rib.

10. The adjustment device of claim 7, wherein the rib is a ring attached to the distal portion of the catheter shaft.

11. The adjustment device of claim 10, wherein the ring includes an inner portion and an outer portion, the outer portion being plastic.

12. The adjustment device of claim 7, wherein the outer sleeve includes a stop collar positioned on a proximal end thereof, the stop collar being configured to prevent the outer sleeve from disengaging the catheter shaft.

13. The adjustment device of claim 12, wherein the stop collar is a rigid body having an inner diameter less than an outer diameter of the rib.

14. The adjustment device of claim 7, wherein the outer sleeve is a relatively flexible body having a relatively rigid distal end such that the outer sleeve permits slight inflation of the balloon proximal the distal end of the outer sleeve.

15. The adjustment device of claim 14, wherein the outer sleeve is defined by a proximal portion and a distal portion, the distal portion having a diameter greater than a diameter of the proximal portion.

16. An improved balloon catheter including a balloon fluidly connected to a distal end of a catheter shaft, the improvement comprising:

an outer sleeve generally co-axially received over a distal portion of the catheter shaft, the outer sleeve including a proximal end, an intermediate portion and a distal end sized to restrict balloon inflation proximal the distal end, and at least a portion of the intermediate portion being slidable relative to the catheter shaft for an adjusting effective balloon inflation length; and

attachment means positioned proximate a distal end of the catheter shaft for selectively securing the distal end of the outer sleeve to the catheter shaft, the attachment means including an enlarged shaft portion proximate the balloon and a locking sleeve generally co-axially received over the outer sleeve, the locking sleeve configured to selectively secure the outer sleeve to the enlarged shaft portion.

17. The improved balloon catheter of claim 16, wherein the distal end of the outer sleeve is configured to be an annular shoulder, allowing at least partial inflation of the balloon both proximal and distal of the annular shoulder.

18. An improved balloon catheter including a balloon fluidly connected to a distal end of a catheter shaft, the improvement comprising:

an outer sleeve generally co-axially received over a distal portion of the catheter shaft, the outer sleeve including a proximal end, an intermediate portion and a distal end sized to restrict balloon inflation proximal the distal end, and at least a portion of the intermediate portion being slidable relative to the catheter shaft for adjusting effective balloon inflation length; and

attachment means positioned proximate a distal end of the catheter shaft for selectively securing the distal end of the outer sleeve to the catheter shaft, the attachment means including a rib attached to the distal portion of the catheter shaft proximal the balloon, and a locking sleeve configured to be generally co-axially received over the outer sleeve and configured to selectively secure the outer sleeve to the rib.

19. The improved balloon catheter of claim 18, wherein the locking sleeve includes a proximal end, an intermediate portion and a distal end, the proximal end of the locking sleeve having a diameter smaller than a diameter of the rib, and the distal end of the locking sleeve having a diameter greater than the diameter of the proximal end of the locking sleeve and approximating the diameter of the rib.

20. The improved balloon catheter of claim 18, wherein the outer sleeve includes a stop collar positioned at the proximal end, the stop collar being configured to prevent the outer sleeve from disengaging the catheter shaft.

21. A method of using a variable length balloon catheter, the method comprising:

providing a catheter shaft including a distal portion, and having a balloon fluidly connected to a distal end thereof;

providing an adjustment device including;

an outer sleeve generally co-axially received over the distal portion of the catheter shaft and including a sleeve distal end for restricting balloon inflation proximal the sleeve distal end;

attachment means for selectively securing the outer sleeve to the distal portion of the catheter shaft, the attachment means including an enlarged shaft portion proximate the balloon, and a locking sleeve generally co-axially received over the outer sleeve, the locking sleeve configured to selectively secure the outer sleeve to the enlarged shaft portion;

determining a desired balloon inflation length;

sliding the outer sleeve along the distal portion of the catheter shaft and a portion of the balloon such that the sleeve distal end defines an effective balloon inflation length approximating the desired balloon inflation length;

securing the outer sleeve to the distal portion of the catheter shaft by sliding the locking sleeve over the outer sleeve and the enlarged shaft portion until the outer sleeve is secured between the locking sleeve and the enlarged shaft portion; and

directing the balloon to a treatment site.

22. The method of claim 21, wherein securing the outer sleeve of the catheter shaft includes securing the outer sleeve proximate a distal end of the catheter shaft.

23. The method of claim 21, wherein the outer sleeve is secured to the distal portion of the catheter shaft such that the outer sleeve cannot be moved upon directing the balloon to the treatment site.

24. The method of claim 21, wherein determining a desired balloon inflation length includes measuring a length of a stent to be delivered to the treatment site.

25. The method of claim 24, further comprising:

securing the stent over the balloon prior to inflation.