Catheter for emboli containment

• US 6,270,477 B1
• Filed: 03/06/1997
• Issued: 08/07/2001
• Est. Priority Date: 05/20/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Ha, Hung V., Patel, Mukund R., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US08/813,023
• Time in Patent Office: 1,615 Days
• Field of Search: 604/280, 604/282, 604/264, 604/96, 604/532, 604/523-27, 604/101, 604/103, 604/103.06, 606/192-196
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1045 : for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 : having radio-opaque markers in the region of the balloon
• 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 2025/1093 : having particular tip characteristics
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• 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 25/0075 : Valve means
• 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
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/1018 : Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: B29C 55/04 : uniaxial, e.g. oblique

Abstract

Disclosed herein is a catheter for use in an emboli containment system. In one embodiment, the catheter has a tubular body with a metallic braid construction. Two lumen extend through the tubular body, the lumen being in a side-by-side configuration. One of the lumen functions as an inflation lumen, and is in fluid communication with an inflatable balloon mounted on the distal end of the catheter. The second lumen is adapted to receive other therapeutic catheters which comprise the emboli containment system.

Claims

1. A catheter adapted for use in the vasculature of a patient, comprising:

an elongate body having a distal section and a proximal section, said body having a substantially continuous cross-sectional profile of not greater than about 0.135 inches; and

an occlusive device mounted on the distal section of said body, said occlusive device comprising an occlusion balloon coupled thereto and having an activated state for embolic containment and a deactivated state having a lower cross-sectional profile not substantially greater than said cross-sectional profile of said body;

said body comprising;

an inner structure defining a main lumen for slidably accommodating other vascular catheters and the like, said main lumen having a diameter of about 0.05 inches to about 0.12 inches and having a side wall, said side wall characterized by an absence of perforations therethrough;

stiffener material arranged over said inner structure;

an outer peripheral structure surrounding said inner structure and said stiffener material; and

an elongate hollow structure defining a secondary lumen for passing inflation media to said occlusive balloon to activate said balloon, said elongate hollow structure inserted within said outer perimeter structure and over said stiffener material so as to be in side-by-side arrangement with said inner structure to provide additional stiffening thereto, all of said structures being bonded together to form said body, said secondary lumen having a major axis and a minor axis;

said secondary lumen having a proximal section and a distal section, said proximal section having a substantially tubular cross-sectional profile of about 0.008 inches to about 0.018 inches and said distal section having a lower non-circular, substantially oval cross-sectional profile in the vicinity of and proximal to said occlusive device, wherein a ratio of the secondary lumen major axis to the secondary lumen minor axis in the distal section of said catheter is greater than a ratio of the secondary lumen major axis to the secondary lumen minor axis in the proximal section of said catheter, and whereby said catheter has a substantially continuous cross-sectional profile.

2. The catheter of claim 1, wherein said inner structure, said outer peripheral structure and said elongate hollow structure each comprise an elongate tube.

3. The catheter of claim 1, wherein said main lumen and said secondary lumen are arranged in a side-by-side arrangement such that the cross-sectional profile of said catheter is substantially tear-drop shaped.

4. The catheter of claim 1, wherein the cross-sectional profile of said catheter body has an eccentricity represented by said secondary lumen.

5. The catheter of claim 1 additionally comprising an inflation port in the proximal section of the body, the inflation port being in fluid communication with the secondary lumen.

6. The catheter of claim 1 additionally comprising a lubricous liner within the main lumen.

7. The catheter of claim 1, wherein the stiffener material comprises a metallic member.

8. The catheter of claim 7, wherein the metallic member comprises a fine wire having a diameter of about 0.0005 inches to about 0.005 inches.

9. The catheter of claim 7, wherein the metallic member comprises a flat ribbon having a thickness of about 0.0005 inches to about 0.005 inches.

10. The catheter of claim 1, wherein a perimeter of the secondary lumen remains constant along the length of the secondary lumen.

11. The catheter of claim 1, wherein the secondary lumen ratio in the distal section is greater than one.

12. The catheter of claim 1, wherein the secondary lumen additionally comprises a transition section between the proximal section and the distal section, and the secondary lumen ratio in the transition section is greater than the secondary lumen ratio in the proximal section, but less than the secondary lumen ratio in the distal section.

13. A catheter, comprising:

an elongate body having a distal section and a proximal section, said body having a substantially continuous cross-sectional profile; and

an occlusion device mounted on the distal section of said body, said occlusion device comprising an occlusive balloon coupled thereto;

said body comprising;

an inner structure defining a main lumen for accommodating other vascular catheters and the like;

stiffener material arranged over said inner structure;

an outer perimeter structure surrounding said inner structure and said stiffener material;

an elongate hollow structure defining a secondary lumen for passing inflation media to said occlusive balloon to activate said balloon;

said secondary lumen having a proximal section and a distal section, said proximal section having a substantially tubular cross-sectional profile and said distal section having a lower cross-sectional profile in the vicinity of and proximal to said occlusion device, whereby said catheter has a substantially continuous cross-sectional profile; and

wherein a ratio of a major axis of the secondary lumen to a minor axis of the secondary lumen in the distal section is greater than a ratio of a major axis of the secondary lumen to a minor axis of the secondary lumen in the proximal section.

14. The catheter of claim 13 additionally comprising an inflation port in the proximal section of the body, the inflation port being in fluid communication with the secondary lumen.

15. The catheter of claim 13 additionally comprising an aspiration port in the proximal section of the body, the aspiration port being in fluid communication with the main lumen.

16. The catheter of claim 13, wherein the balloon is formed of a block copolymer of styrene-ethylene-butylene-styrene.

17. The catheter of claim 13, wherein the stiffener material comprises a metallic member.

18. The catheter of claim 17, wherein the metallic member comprises a metal selected from the group consisting of stainless steel, nitinol, platinum, gold, ELGILOY, and combinations thereof.

19. The catheter of claim 17, wherein the metallic member comprises a metallic braid.

20. The catheter of claim 17, wherein the metallic member comprises a metallic coil.

21. The catheter of claim 13, wherein a cross-sectional profile of the inner structure remains substantially constant along the length of the body.

22. The catheter of claim 13, wherein the secondary lumen has a non-circular, substantially oval-shaped cross-sectional profile in the vicinity of said occlusion device.

23. The catheter of claim 22, wherein the main lumen is not perforated.

24. A catheter, comprising:

an elongate body having a distal section and a proximal section; and

an occlusive device mounted on the distal section of said body, said occlusive device having an activated state for embolic containment and a lower profile deactivated state;

said body comprising;

an inner lumen for slidably accommodating other vascular catheters and the like;

a secondary lumen for passing inflation media to said occlusive device to activate said device, said secondary lumen having a major axis and a minor axis, said inner lumen and secondary lumen being disposed in a side-by-side arrangement;

said secondary lumen having a proximal section and a distal section, said proximal section having a substantially tubular cross-sectional profile and said distal section having a lower cross-sectional profile in the vicinity of said occlusive device, wherein the secondary lumen major axis is greater than the secondary lumen minor axis in the distal section.

25. The catheter of claim 24, wherein the occlusive device comprises a balloon.

26. The catheter of claim 24, wherein the occlusive device comprises a filter.

27. The catheter of claim 24, wherein the occlusive device comprises a braid.

28. The catheter of claim 24, wherein the secondary lumen is adapted to pass activation media for activating said occlusive device.

29. The catheter of claim 28, wherein the activation media comprises inflation fluid.

30. The catheter of claim 28, wherein the activation media comprises a pull wire.

31. The catheter of claim 24, wherein the main lumen is adapted to receive two or more separate catheters which are slidably disposed therein.

32. The catheter of claim 24, wherein the distal section of the body is more flexible than the proximal section of the body.

33. The catheter of claim 24 additionally comprising a lubricous liner within the main lumen.

34. The catheter of claim 33, wherein the lubricous liner is comprised of polytetrafouoroethylene.

35. The catheter of claim 24, wherein the body has an outer surface having a hydrophilic coating.

36. The catheter of claim 24, wherein the body has an outer surface having a hydrophobic coating.

37. The catheter of claim 24, wherein a perimeter of the secondary lumen remains constant along the length of the secondary lumen.

38. The catheter of claim 37, wherein the main lumen is not perforated.

39. The catheter of claim 24, wherein the secondary lumen has a non-circular, substantially oval-shaped cross-sectional profile in the vicinity of said occlusion device.

40. The catheter of claim 24, wherein a ratio of the secondary lumen major axis to the secondary lumen minor axis in the distal section is greater than 1.

41. The catheter of claim 24, wherein the secondary lumen additionally comprises a transition section between the proximal section and the distal section, and a ratio of the major axis to the minor axis in the transition section is greater than the ratio in the proximal section, but less than the ratio in the distal section.

42. The catheter of claim 41, wherein the ratio in the proximal section is about 1.

43. A catheter, comprising:

an elongate body having a distal section and a proximal section, said body having a substantially continuous eccentric cross-sectional profile; and

an occlusion device mounted on the distal section of said body;

said body comprising;

an inner structure defining a main lumen having a relatively large cross-sectional profile; and

an elongate hollow structure defining a secondary lumen, wherein the perimeter of the secondary lumen is substantially constant along substantially the entire length of said secondary lumen, said secondary lumen having a first cross-sectional profile in said proximal section of said body and a differently-shaped, second cross-sectional profile in said distal section of said body in the vicinity of said occlusion device;

said structures arranged so as to be in a side-by-side arrangement such that said elongate hollow structure provides a stiffener for said inner structure.

44. The catheter of claim 43, wherein the cross-sectional profile of said body is substantially tear-drop shaped.

45. The catheter of claim 43, wherein said body has a cross-sectional profile which is dominated by a tubular cross-sectional profile, represented by said main lumen.

46. The catheter of claim 43, wherein the occlusive device comprises a balloon.

47. The catheter of claim 43, wherein the occlusive device comprises a filter.

48. The catheter of claim 43, wherein the occlusive device comprises a braid.

49. The catheter of claim 43 in combination with a second catheter, the second catheter including a second elongate body having proximal and distal ends and having a therapeutic device disposed on the distal end, and the second catheter is adapted to be slidably movable within the main lumen.

50. The catheter of claim 43, wherein the main lumen is adapted to receive two or more separate catheters which are slidably disposed therein.

51. The catheter of claim 43, wherein the first cross-sectional profile is substantially circular and the second cross-sectional profile is non-circular and substantially oval-shaped.

52. The catheter of claim 51, wherein the secondary lumen has a major axis and a minor axis, and a ratio of the major axis to the minor axis at the second cross-sectional profile is greater than the ratio at the first cross-sectional profile.

53. The catheter of claim 43, wherein a first side of said hollow structure is adjacent said inner structure and a second side of said hollow structure is opposite said first side, and a distance between the first and second sides is greater in the proximal section of said body than in the vicinity of said occlusive device.

54. The catheter of claim 43, wherein the distal section of the body is more flexible than the proximal section of the body.