Balloon catheter apparatus and method

• US 6,626,861 B1
• Filed: 10/04/2000
• Issued: 09/30/2003
• Est. Priority Date: 04/22/1998
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Hart, Charles C., Myers, Richard L., Chi-Sing, Eduardo, Vandenbroek, Frans
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Han, Mark K
• Application Number:
  US09/403,860
• Time in Patent Office: 1,091 Days
• Field of Search: 606/198, 604/96.01, 604/97.01, 604/99.01, 604/101.01, 604/101.02, 604/103, 604/103-1-1, 604/103.05, 604/103-7-1, 604/103.13, 604/104
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 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 surgical device for cleaning and removing obstructing material from within a vascular conduit or other bodily passageway. The device comprises a balloon catheter having an independently operable outer woven sleeve having a plurality of mesh openings. The woven sleeve surrounds the radially expandable and contractible balloon. In one embodiment, the outer woven sleeve is configured into a predetermined shape through manipulation of the catheter and used to maintain the inflated balloon within that predetermined configuration. In another embodiment, the woven sleeve is radially expanded by the inflated balloon such that the woven mesh is driven into the vascular conduit. The woven sleeve may be used to abrade the surface of the vascular conduit and increase the flow passage or alternatively as traction for various other surgical procedures within the vascular conduit.

Claims

1. A surgical device for controlling the expansion and shape of a body conduit, said surgical device comprising:

an outer tube having a longitudinal axis extending between a proximal end and a distal end;

an inner member extending coaxially within said outer tube, said inner member longitudinally slidable within said outer tube and configured such that a longitudinal passageway is created between said inner member and said outer tube for passage of a fluid therethrough;

a balloon disposed coaxially about said inner member, said balloon having a proximal balloon end connected to said distal end of said outer tube and a distal balloon end connected to said inner member to define an annular balloon chamber in fluid connection with said longitudinal passageway, said balloon having properties for inflating and deflating in response to the fluid passing through the longitudinal passageway; and

an outer sleeve surrounding said balloon, said sleeve having a proximal sleeve end connected to said distal end of said outer tube and a distal sleeve end connected to the distal end of said inner member such that said outer sleeve is radially expandable and collapsible independent of said balloon through movement of the inner member relative to the outer tube.

2. The balloon catheter as recited in claim 1 wherein said inner member is longitudinally movable within said outer tube such that said outer sleeve may be radially expanded into a predetermined configuration and said balloon, upon inflation, is limited to the predetermined configuration by said outer sleeve.

3. A balloon catheter for enlarging a flow passage within a vascular conduit, said balloon catheter comprising:

a catheter tube having a longitudinal axis extending between a proximal end and a distal end;

an inner member extending coaxially within said catheter tube, said inner member being longitudinally slidable within said catheter tube and being configured such that a longitudinal passageway is created between said inner member and said catheter tube for passage of a fluid therethrough;

a balloon disposed coaxially about said inner member, said balloon having a proximal balloon end connected to said distal end of said catheter tube and a distal balloon end connected to said inner member to define an annular balloon chamber in fluid connection with said longitudinal passageway, said balloon having properties for inflating and deflating in response to the fluid passing through the longitudinal passageway; and

an outer sleeve disposed about said balloon, said sleeve having a proximal sleeve end connected to said distal end of said catheter tube and a distal sleeve end connected to said inner member such that said outer sleeve is radially expandable and collapsible independent of said balloon through movement of the inner member relative to the catheter tube.

4. The balloon catheter as recited in claim 3 wherein said balloon is distensible.

5. The balloon catheter as recited in claim 3 wherein said inner member is longitudinally movable within said catheter tube such that said outer sleeve may be radially expanded into a predetermined configuration and said balloon, upon inflation, is limited to the predetermined configuration by said outer sleeve.

6. The balloon catheter as recited in claim 5 wherein the predetermined configuration of the outer sleeve is one of a plurality of predetermined configurations, each associated with one of a plurality of predetermined positions of the inner member relative to the catheter tube.

7. The balloon catheter as recited in claim 5 wherein each of said predetermined configurations is associated with one of a plurality of different shapes.

8. The balloon catheter as recited in claim 7 wherein at least one of the unique shapes comprises a pair of spaced apart annular chambers.

9. The balloon catheter as recited in claim 8 wherein said outer sleeve comprises a reduced radius portion between said spaced apart annular sections.

10. The balloon catheter as recited in claim 5 wherein said predetermined configuration comprises a pair of spaced apart annular chambers.

11. The balloon catheter as recited in claim 3 wherein, said fluid is a first fluid, and said inner member comprises an axial passageway for passage of a second fluid.

12. The balloon catheter as recited in claim 3 wherein said outer sleeve comprises a tubular woven mesh.

13. The balloon catheter as recited in claim 12 wherein said woven mesh comprises a plurality of interlaced filaments.

14. A balloon catheter for enlarging a flow passage in a body conduit, said catheter comprising:

a catheter tube having a longitudinal axis extending between a proximal end and a distal end;

an inner tubular member disposed coaxially within said catheter tube, said inner tubular member being longitudinally slidable within said catheter tube and configured to provide a longitudinal passageway between said inner tubular member and said catheter tube for passage of a fluid therethrough;

a balloon disposed coaxially about said inner tubular member, said balloon having a proximal balloon end connected to said distal end of said catheter tube and a distal balloon end connected to said inner tubular member to define an annular balloon chamber; and

an outer sleeve surrounding said balloon, said sleeve having a proximal sleeve end connected to said distal end of said catheter tube and a distal sleeve end connected to said inner member such that said outer sleeve is radially expandable and collapsible independent of said balloon through movement of the inner member relative to the catheter tube.

15. The balloon catheter as recited in claim 14 wherein said inner tubular member comprises a longitudinal passageway in fluid connection with said annular balloon chamber for fluidly inflating and deflating said balloon.

16. The balloon catheter as recited in claim 15 said balloon is distensible.

17. The balloon catheter as recited in claim 15 wherein said inner tubular member is longitudinally movable relative to said catheter tube such that said outer sleeve may be radially expanded into a predetermined configuration and said balloon, upon inflation, being limited to said predetermined configuration by said outer sleeve.

18. The balloon catheter as recited in claim 17 wherein the predetermined configuration of the outer sleeve is one of a plurality of predetermined configurations, each associated with one of a plurality of predetermined positions of the inner member relative to the catheter tube.

19. The balloon catheter as recited in claim 18 wherein each of said predetermined configurations is associated with one of a plurality of different shapes.

20. The balloon catheter as recited in claim 14 wherein said outer sleeve comprises a mesh of woven filaments.

21. A surgical device for cleaning and removing obstructions from a vascular conduit, said surgical device comprising:

a catheter having a longitudinal axis extending between a proximal end and a distal end;

an inflatable and deflatable balloon, coaxial with said catheter and coupled to said catheter adjacent said distal end of said catheter; and

an outer tubular sleeve surrounding said balloon and having a sleeve proximal end and a sleeve distal end, said sleeve being radially expandable independent of said balloon and having an irregular outer surface for contacting said vascular conduit; and

at least one of said sleeve proximal end and said sleeve distal end being coupled to said catheter.

22. The surgical device as recited in claim 21 wherein said catheter further comprises an opening at said distal end and wherein said opening is in fluid connection with said balloon for passing a fluid through said catheter to inflate and deflate said balloon.

23. The surgical device as recited in claim 22 wherein the fluid is a first fluid and said catheter further comprises a second longitudinal passageway for passage of a second fluid through said catheter, said second longitudinal passageway being in fluid connection with a second opening for dispensing of said second fluid exteriorly of said balloon.

24. The surgical device as recited in claim 23 wherein said fluid is a lysing agent.

25. The surgical device as recited in claim 21 wherein said proximal sleeve end is attached to the distal end of said catheter.

26. The surgical device as recited in claim 21 wherein said proximal sleeve end is attached to the catheter proximally of the distal end and said distal sleeve end is longitudinally movable relative to said catheter distal end.

27. The surgical device as recited in claim 21 wherein said outer tubular sleeve comprises a woven filament mesh.

28. The surgical device as recited in claim 21 wherein said balloon is formed of a distensible material.

29. A balloon catheter for enlarging a flow passage within a vascular conduit, said balloon catheter comprising:

a catheter tube having a longitudinal axis extending between a proximal end and a distal end;

an inner member extending co-axially within said catheter tube, said inner member being longitudinally slidable within said catheter tube;

a balloon disposed co-axially about said inner member, said balloon having a proximal balloon end connected to said distal end of said catheter tube and a distal balloon end connected to said inner member to define at least one annular balloon chamber having properties for inflating and deflating in response to a fluid passing through the catheter tube; and

an outer sleeve disposed about said balloon, said sleeve having a proximal sleeve end connected to said distal end of said catheter tube and a distal sleeve end connected to said inner member, the outer sleeve being radially expandable independent of said balloon through movement of the inner member relative to the catheter tube to a predetermined configuration including a pair of spaced-apart annular chambers.

30. A method for using a balloon catheter to enlarge a flow passage within a body conduit, said method comprising the steps of:

providing a catheter having an inflatable balloon and an expandable outer mesh sleeve disposed about said balloon;

inserting said catheter into the vascular conduit;

expanding the mesh into contact with the vascular conduit;

independently of the expanding step, inflating the balloon into contact with the expanded mesh sleeve;

deflating the balloon;

contracting the mesh sleeve; and

removing the balloon catheter from the vascular conduit.

31. The method of enlarging the body conduit as recited in claim 30, and further comprising the step of radially expanding the woven mesh sleeve into a predetermined configuration prior to the step of inflating said balloon, such that when inflated, the balloon is limited to the predetermined configuration of the mesh sleeve.

32. The method of enlarging a vascular conduit as recited in claim 31, and further comprising the step of moving said balloon catheter within said vascular conduit after said step of inflating such that said woven mesh sleeve is expanded against the vascular conduit and abrades said vascular conduit.

33. The method of enlarging a vascular conduit as recited in claim 31, and further comprising the step of infusing a lysing agent adjacent said woven mesh sleeve when said balloon catheter is in said vascular conduit.

34. The method of enlarging the body conduit as recited in claim 32, wherein:

the expanding step includes the step of expanding the sleeve to a predetermined configuration; and

the inflating step includes a step of limiting the shape of the balloon to the predetermined configuration of the mesh sleeve.

35. A method for removing an obstruction from a vascular conduit comprising the steps of:

providing a balloon catheter having a radially expandable woven mesh sleeve disposed about a distensible balloon and a pair of coaxial tubular shafts comprising an inner shaft and an outer shaft, wherein said inner shaft is coupled to a distal end of the mesh sleeve and said outer shaft is coupled to a proximal end of said mesh sleeve such that movement of said inner shaft relative to said outer shaft expands and collapses said woven mesh sleeve;

inserting the balloon catheter into the vascular conduit;

directing the catheter along the vascular conduit until the mesh sleeve is disposed adjacent the obstruction;

moving the inner shaft relative to the outer shaft to enlarge said mesh sleeve into a predetermined configuration;

inflating said balloon to expand the balloon to the predetermined configuration of the woven mesh sleeve;

moving the catheter with the mesh sleeve against the obstruction to remove at least a portion of the obstruction from the vascular conduit;

deflating the balloon to collapse the balloon within the vascular conduit;

moving the inner shaft relative to the outer shaft to collapse said woven mesh sleeve; and

removing the balloon catheter from the vascular conduit.

36. The method for removing an obstruction as recited in claim 35, further comprising the step of infusing a liquid into said vascular conduit adjacent said woven mesh sleeve.

37. A method for cleaning a flow passage within an artificial graft conduit comprising the steps of:

providing a balloon catheter having an inflatable inner balloon and a coaxial woven mesh sleeve surrounding said balloon, said inner balloon being inflatable to expand said mesh sleeve against said vascular graft;

placing the balloon catheter within said artificial vascular graft conduit;

expanding the mesh sleeve into contact with the vascular graft;

independently of the expanding step, inflating the balloon into contact with the mesh sleeve;

deflating the balloon to facilitate the independent collapse of the mesh sleeve; and

removing the balloon catheter from the artificial graft conduit.

38. The method for cleaning a flow path within an artificial graft conduit as recited in claim 37, further comprising the step of moving the expanded mesh sleeve within the vascular graft conduit.

39. The method for cleaning a flow path within an artificial graft conduit as recited in claim 37, further comprising the step of infusing a lysing agent within the vascular graft conduit.