Methods and apparatus for treating the interior of a blood vessel

• US 20050113798A1
• Filed: 08/19/2004
• Published: 05/26/2005
• Est. Priority Date: 07/21/2000
• Status: Abandoned Application

• Current Assignee: Veinrx Inc.
• Original Assignee: Veinrx Inc.
• Inventors: Jahrmarkt, Scott L., Slater, Charles R., Lary, Banning G., Bales, Thomas O., Naglreiter, Brett E.
• Application Number:
  US10/922,123
• Publication Number:
  US 20050113798A1
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• 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 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• 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

Methods and apparatus for treating the interior of a blood vessel include a variety of catheter designs, methods and apparatus for occluding a blood vessel, methods and apparatus for locating an occlusion device, methods and apparatus for locating a treating device at the site of blood vessel tributaries, and methods and apparatus for dispensing treating agent.

Claims

1. An apparatus for treating the interior of a blood vessel, comprising:

a first catheter having a proximal end and a distal end with a plurality of spaced apart perforations therebetween;

an occlusion device coupled to the distal end of said first catheter;

means for deploying the occlusion device; and

means for dispensing a treating agent through said perforations proximal of said occlusion device.

2. The apparatus according to claim 1, further comprising

a second catheter movable within said first catheter, said second catheter having at least one perforation adapted to align sequentially with said plurality of spaced apart perforations as said second catheter is moved through said first catheter, said second catheter adapted to receive a treating agent and dispense the treating agent through said at least one perforation.

3. The apparatus according to claim 2, further comprising:

an atraumatic tip coupled to the occlusion device.

4. The apparatus according to claim 2, wherein:

said occlusion device is one of a balloon, a sponge, an umbrella, and a sealant dispenser.

5. The apparatus according to claim 4, wherein:

said occlusion device is an inflatable balloon.

6. The apparatus according to claim 1, wherein:

said perforations are dimensioned to prevent passage of treating fluid until a predetermined fluid pressure is reached.

7. The apparatus according to claim 6, further comprising:

a coaxial cylindrical baffle located within said first catheter and defining an annular space between it and said first catheter.

8. The apparatus according to claim 1, further comprising:

an inflation catheter substantially coaxial with and extending through said first catheter, wherein

said occlusion device and inflatable balloon is coupled to said inflation catheter.

9. The apparatus according to claim 1, wherein:

said means for deploying includes a first lumen in said first catheter, and

said means for dispensing includes a second lumen in said first catheter.

10. The apparatus according to claim 9, wherein:

said first lumen and said second lumen are coaxial.

11. The apparatus according to claim 9, wherein:

said means for dispensing includes said second lumen and a third lumen in said catheter, said second and third lumena being coupled at their distal ends.

12. The apparatus according to claim 9, wherein:

said first lumen is longer than said second lumen.

13. The apparatus according to claim 1, wherein:

said perforations each have substantially the same diameter.

14. The apparatus according to claim 1, wherein:

at least some of said perforations have different diameters.

15. The apparatus according to claim 1, wherein:

said perforations are evenly spaced.

16. The apparatus according to claim 1, wherein:

at least some of said perforations are variably spaced.

17. The apparatus according to claim 1, wherein;

at least some of said perforations are provided in spaced apart groups.

18. The apparatus according to claim 17, wherein:

said groups are evenly spaced.

19. The apparatus according to claim 17, wherein:

at least some of said groups are variably spaced.

20. The apparatus according to claim 17, wherein:

each of said groups contains the same number of perforations.

21. The apparatus according to claim 17, wherein:

at least some of said groups contain different numbers of perforations.

22. A method for treating the interior of a blood vessel, said method comprising:

delivering an apparatus into the blood vessel, the apparatus comprising

a first catheter having a proximal end and a distal end with a plurality of spaced apart perforations therebetween,

an occlusion device coupled to the distal end of the first catheter, and

deployment means for deploying said occlusion device;

deploying the occlusion device; and

dispensing a treating agent through the perforations in the first catheter proximal the occlusion device while maintaining the first catheter stationary.

23. The method according to claim 22, wherein:

the apparatus further comprises

a second catheter movable within the first catheter, the second catheter having at least one perforation adapted to align sequentially with the plurality of spaced apart perforations as the second catheter is moved through the first catheter, the second catheter adapted to receive a treating agent and dispense the treating agent through the at least one perforation, and said method further comprises

withdrawing the second catheter through the first catheter while dispensing treating fluid and maintaining the first catheter stationary.

24. An apparatus for treating the interior of the blood vessel, comprising:

a catheter having a proximal end and a distal end;

a deployment control member having a proximal end and a distal end and being movable through said catheter;

an occlusion device coupled to said distal end of said deployment control member, said occlusion device being deployed by movement of said deployment control member towards said distal end of said catheter and being recaptured by movement of said deployment control member; and

means for dispensing a treating agent proximal said occlusion device.

25. The apparatus according to claim 24, wherein:

said occlusion device is a sponge.

26. The apparatus according to claim 24, wherein:

said occlusion device includes a plurality of elastic struts covered with a material which effectively occludes the flow of blood.

27. The apparatus according to claim 26, wherein:

said elastic struts are superelastic.

28. The apparatus according to claim 26, wherein:

said material is a membrane.

29. The apparatus according to claim 26, wherein:

said material is fine mesh.

30. The apparatus according to claim 24, wherein:

said occlusion device includes a cone shaped membrane with an inflatable cuff.

31. A method of treating the interior of a blood vessel, comprising:

delivering a catheter through the blood vessel;

dispensing an occlusion agent through the catheter; and

dispensing a treating agent proximal said occlusion agent.

32. The method according to claim 31, wherein:

the occlusion agent is a tissue sealant.

33. The method according to claim 31, wherein:

the occlusion agent is a glue.

34. The method according to claim 31, wherein:

the occlusion agent is butyl-cyanoacrylate.

35. The method according to claim 31, wherein:

the occlusion agent is fibrin solution.

36. The method according to claim 31, further comprising:

applying external pressure to the blood vessel after dispensing the occlusion agent.

37. A method of treating the interior of a blood vessel, comprising:

locating an occlusion site along the blood vessel;

applying pressure to the occlusion site sufficient to block the flow of blood; and

dispensing treating agent in the blood vessel proximal the occlusion site.

38. The method according to claim 37, wherein:

the application of pressure is accomplished with a mechanical device.

39. The method according to claim 38, wherein:

the mechanical device is an inflatable cuff with means for localizing pressure applied external to the occlusion site.

40. The method according to claim 38, wherein:

the mechanical device is a clamp applied external to the occlusion site.

41. The method according to claim 38, wherein:

the mechanical device is a suture applied through a surgical opening.

42. The method according to claim 38, wherein:

the mechanical device is a clamp applied through a surgical opening.

43. The method according to claim 37, wherein:

the application of pressure is accomplished by applying negative pressure from within the blood vessel.

44. An apparatus for treating the interior of a blood vessel, comprising:

a first catheter having a proximal end and a distal end;

an occlusion device coupled to said distal end of said first catheter; and

a second catheter having a proximal end and a distal end, said second catheter being slidably coupled to said first catheter via a monorail coupling, said second catheter being adapted to receive a treating agent and dispense it through a port at said distal end of said second catheter and proximal said occlusion device.

45. An apparatus according to claim 44, further comprising:

a flexible guide wire having a proximal end and a distal end, wherein

said first catheter is slidably coupled to said guide wire via a first monorail coupling, and

said second catheter is slidably coupled to said guide wire via a second monorail coupling.

46. The apparatus according to claim 45, further comprising:

an atraumatic tip coupled to said distal end of said guide wire.

47. The apparatus according to claim 44, wherein:

said second catheter is directly coupled to said first catheter via said monorail coupling.

48. The apparatus according to claim 47, further comprising:

an atraumatic tip coupled to said occlusion device.

49. The apparatus according to claim 44, wherein:

said second catheter is directly coupled to said first catheter via said monorail coupling and said monorail coupling is a clip-on coupling.

50. The apparatus according to claim 49, further comprising:

an atraumatic tip coupled to said occlusion device.

51. The apparatus according to claim 44, wherein:

said occlusion device is selected from the group consisting of a balloon, a sponge, an umbrella, and a sealant dispenser.

52. The apparatus according to claim 51, wherein:

said occlusion device is an inflatable balloon.

53. A method for treating the interior of a blood vessel, comprising:

delivering an apparatus to the interior of the blood vessel, the apparatus comprising;

a first catheter having a proximal end and a distal end,

an occlusion device coupled to the distal end of the first catheter, and

a second catheter having a proximal end and a distal end, the second catheter being slidably coupled to the first catheter via a monorail coupling, the second catheter being adapted to receive a treating agent and dispense it through a port at the distal end of the second catheter;

deploying the occlusion device; and

dispensing the treating agent through the second catheter and proximal the occlusion device while sliding the second catheter away from the occlusion device.

54. A method of treating the interior of the blood vessel, comprising:

locating an occlusion site in the blood vessel;

locating an occlusion device at the occlusion site;

deploying the occlusion device at the occlusion site such that the flow of blood is blocked by the occlusion device; and

dispensing a treating agent proximal the occluding device.

55. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise using ultrasound imaging.

56. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise using palpation.

57. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise using fluoroscopic imaging.

58. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise using magnetic resonance imaging.

59. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise illuminating the inside of the blood vessel.

60. The method according to claim 59, wherein:

said illuminating comprises using an LED.

61. The method according to claim 59, wherein:

said illuminating comprises using a fiber optic element.

62. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise using pressure measurements.

63. The method according to claim 62, wherein:

said pressure measurements comprise deploying a pressure sensor inside the blood vessel, moving the pressure sensor until an increase in pressure is detected and then moving the pressure sensor back until a decrease in pressure is detected.

64. The method according to claim 54, wherein:

said locating the occlusion site and said locating the occlusion device comprise using a wedge catheter.

65. A method of treating the interior of the blood vessel, comprising:

locating a catheter within the blood vessel through a venipuncture;

dispensing a treating agent through a dispensing port in the catheter while withdrawing the catheter from the blood vessel;

locating tributary branches along the blood vessel;

locating the catheter at tributary branches along the blood vessel; and

dispensing an additional amount of treating agent when the catheter passes a tributary branch.

66. The method according to claim 65, wherein:

said locating tributary branches comprises using ultrasound.

67. The method according to claim 65, wherein:

said locating tributary branches comprises using x-radiation.

68. The method according to claim 65, wherein:

said locating tributary branches comprises using trans-illumination.

69. The method according to claim 65, wherein:

said locating tributary branches comprises using magnetic resonance imaging.

70. The method according to claim 65, wherein:

said locating the catheter at tributary branches comprises pre-marking the catheter at the location of the venipuncture when the dispensing port is located at the tributary branches.

71. The method according to claim 65, wherein:

said withdrawing the catheter comprises withdrawing the catheter from the blood vessel with a pull wire, and

said locating the catheter at tributary branches comprises pre-marking the pull wire at the location of the venipuncture when the dispensing port is located at the tributary branches.

72. The method according to claim 65, wherein:

the locations of tributaries are marked on the skin of the patient.

73. The method according to claim 72, wherein:

said locating the catheter comprises using a light source on the catheter.

74. The method according to claim 72, wherein:

said locating the catheter comprises using ultrasound imaging.

75. The method according to claim 72, wherein:

said locating the catheter comprises palpation of the end of the catheter.

76. The method according to claim 72, wherein:

said locating the catheter comprises using a magnetic follower.

77. The method according to claim 72, wherein:

said locating the catheter comprises using a magnetic viewer.

78. The method according to claim 72, wherein:

said locating the catheter comprises using an electromagnetic indicator.

79. The method according to claim 78, wherein:

the electromagnetic indicator provides an audible indication.

80. The method according to claim 65, wherein:

said locating the tributaries and said locating the catheter comprise using ultrasound imaging.

81. The method according to claim 65, wherein:

said locating the tributaries and said locating the catheter comprise using a light source on the catheter.

82. The method according to claim 65, wherein:

said locating the tributaries and said locating the catheter comprise using external illumination.

83. The method according to claim 65, wherein:

said locating the tributaries and said locating the catheter comprise using external IR illumination and an IR viewing device.

84. The method according to claim 65, wherein:

said locating the tributaries and said locating the catheter comprise using real-time imaging selected from the group consisting of x-ray, magnetic resonance, and fluoroscopy.

85. The method according to claim 65, wherein:

said locating the tributaries and said locating the catheter comprise using monitoring fluid pressure at the catheter.

86. A device for treating blood vessels, comprising:

a catheter having a proximal end, a body and a distal end, the body comprising;

a plurality of elution holes;

a lumen adapted to provide a fluid pathway from the proximal end of the catheter to the elution holes; and

a vessel flow blocker located about the distal end of the catheter;

wherein the total fluid resistance of the elution holes is about equal to or greater than the total fluid resistance of the lumen.

87. The device for treating blood vessels as in claim 86, wherein the vessel flow blocker is an expandable balloon.

88. The device for treating blood vessels as in claim 86, wherein the vessel flow blocker is an expandable sponge.

89. The device of claim 86, wherein the total fluid resistance of the elution holes is about 125% or more of the fluid resistance of the lumen.

90. The device of claim 86, wherein the hydraulic diameter of the each elution hole is generally less than about 0.010″

.

91. The device of claim 86, wherein the hydraulic diameter of the each elution hole is generally less than about 0.004″

.

92. The device of claim 86, wherein the elution holes are generally spaced about 1 cm to about 2 cm apart.

93. The device of claim 86, the catheter further comprising an occluder capable of blocking fluid flow through at least one elution hole.

94. The device of claim 93, wherein

the catheter body further comprises a side lumen contiguous with at least one elution hole;

the occluder is a configurable occluder positioned within the side lumen, the occluder having a first configuration capable of resisting flow through at least one elution hole, and a second configuration capable of allowing flow through at least one elution hole affected in the first configuration.

95. The device of claim 94, wherein the occluder comprises a wire.

96. The device of claim 95, wherein the wire comprises at least one narrow portion and at least one enlarged portion.

97. The device of claim 96, wherein the first configuration, one enlarged portion is occluding an elution hole, and wherein the second configuration, the one enlarged portion is not occluding an elution hole.

98. The device of claim 94, wherein the occluder comprises an elastomeric cord.

99. The device of claim 98, wherein the distal end of the elastomeric cord is engaged to the distal end of the side lumen.

100. The device of claim 95, wherein the wire has a polygonal cross sectional shape.

101. The device of claim 100, wherein the wire has a square cross-sectional shape.

102. The device of claim 94, wherein the occluder is coated or treated with a lubricant to facilitate movement within the side lumen.

103. The device of claim 94, wherein the occluder comprises a hollow elastomeric tube.

104. The device of claim 103, wherein the tube is inflated in the first configuration and deflated in the second configuration.

105. The device of claim 94, wherein the occluder comprises at least one covering of the catheter body.

106. The device of claim 105, wherein the coverings comprise elastic coverings.

107. The device of claim 106, wherein the elastic coverings comprises movable openings.

108. A device for treating blood vessels, comprising:

a catheter having a proximal end, a body and a distal end, the body comprising;

at least one elution hole, each elution hole having an inflow opening and an outflow opening;

a lumen adapted to provide a fluid pathway from the proximal end of the catheter to the outflow openings of the elution holes; and

an occluder adapted to block fluid flow through at least one elution hole;

wherein the occluder is adapted to affect fluid flow distal to the inflow opening of the elution holes.

109. The device of claim 108, wherein the occluder is adapted to affect fluid flow between the outflow opening and inflow opening of the elution holes.

110. The device of claim 108, wherein the occluder is adapted to affect fluid flow distal to the outflow opening of the elution holes.

111. The device of claim 108, wherein the occluder is a movable occluder positioned within the side lumen, the movable occluder having a first configuration capable of resisting flow through at least one elution hole, and a second configuration capable of allowing flow through at least one elution hole affected in the first configuration.

112. The device of claim 111, wherein the movable occluder comprises a wire.

113. The device of claim 112, wherein the wire comprises at least one narrow portion and at least one enlarged portion.

114. The device of claim 113, wherein the first configuration, one enlarged portion is occluding an elution hole, and wherein the second configuration, the one enlarged portion is not occluding an elution hole.

115. The device of claim 111, wherein the movable occluder comprises a elastomeric cord.

116. The device of claim 115, wherein the distal end of the elastomeric cord is generally engaged about the distal end of the side lumen.

117. The device of claim 112, wherein the wire has a polygonal cross sectional shape.

118. The device of claim 117, wherein the wire has a square cross-sectional shape.

119. The device of claim 111, wherein the occluder is coated or treated with a lubricant to facilitate movement within the side lumen.

120. The device of claim 111, wherein the occluder comprises a hollow elastomeric tube.

121. The device of claim 120, wherein the tube is inflated in the first configuration and deflated in the second configuration.

122. The device of claim 111, wherein the occluder comprises at least one covering of the catheter body.

123. The device of claim 122, wherein the coverings comprise elastic coverings.

124. The device of claim 123, wherein the elastic coverings comprises movable openings.

125. A method of performing sclerotherapy, comprising:

providing a catheter with an infusion lumen and a plurality of elution holes contiguous with the infusion lumen, the plurality of elution holes have a total fluid resistance generally greater than the total fluid resistance of the infusion lumen;

inserting the catheter into a mammal; and

injecting a sclerosing agent into the infusion lumen.

126. The method of claim 125, wherein the inserting step is performed into a vein of the mammal.

127. The method of claim 126, further comprising raising a portion of the mammal to enhance drainage of the vein.

128. The method of claim 125, further comprising changing the relative position of a portion of the mammal to facilitate migration of fluid injected into the infusion lumen.

129. A method of treating a body lumen, comprising:

providing a catheter with an infusion lumen and a plurality of elution holes contiguous with the infusion lumen, the catheter having a first configuration adapted to resist flow through at least one elution hole and a second configuration adapted to allow flow through at least one elution hole where the catheter is adapted to resist flow in the first configuration;

inserting the catheter into a patient;

providing a pressurized fluid to the infusion lumen of the catheter; and

changing the catheter from the first configuration to the second configuration.