Multi-lumen catheter with separate distal tips

• US 20040167463A1
• Filed: 02/21/2003
• Published: 08/26/2004
• Est. Priority Date: 02/21/2003
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Powers, Kelly B., Evans, John G., Zawacki, John A., Rome, Guy
• Granted Patent: US 7,393,339 B2
• Time in Patent Office: Days
• US Class Current: 604/43
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

A multi-lumen catheter defined by at least two separate tip sections distal to a dividing point includes strategic placement of openings in the tip sections to facilitate fluid flow and minimize typical problems associated with catheters. In a multi-lumen catheter having tip sections with a releasably joined or splittable region, the bond strength between the tip sections is varied along their length such that an increasing separation force is required to separate the tip sections from one another distal to the dividing point. Delivery of a multi-lumen catheter is improved with respect to both sheathed and non-sheathed delivery methods, in which a friction reducing structure is provided on either the catheter, delivery sheath or both to provide a buffer for a sheathed delivery and in which a unique guidewire aperture or additional lumen is provided in at least one of the tip sections for a non-sheathed delivery.

Claims

1. A multi-lumen catheter, comprising:

a catheter body enclosing at least two separate lumens from a proximal end to a dividing point;

a first tip section enclosing a first of said at least two separate lumens distal to said dividing point; and

a second tip section enclosing a second of said at least two separate lumens distal to said dividing point,

wherein said first and second tip sections each comprise an inner surface and an outer surface and an opening in a distal end thereof, and wherein at least one of said tip sections comprises an opening on said inner surface in close proximity to said dividing point.

2. The multi-lumen catheter according to claim 1, wherein said second tip section has a length greater than said first tip section and wherein said opening is positioned on said inner surface of said first tip section in close proximity to said dividing point.

3. The multi-lumen catheter according to claim 2, further comprising a plurality of openings on said inner surface of said first tip section in close proximity to said dividing point.

4. The multi-lumen catheter according to claim 1, wherein said second tip section has a length greater than said first tip section and wherein said opening is positioned on said inner surface of said second tip section at or near said dividing point.

5. The multi-lumen catheter according to claim 4, further comprising a plurality of openings on said inner surface of said second tip section at or near said dividing point.

6. The multi-lumen catheter according to claim 1, further comprising a second dividing point distal to said dividing point, wherein a third tip section and a fourth tip section separate at said second dividing point along said first or second tip section.

7. The multi-lumen catheter according to claim 6, wherein said second tip section has a length greater than said first tip section and wherein said opening is positioned on said inner surface of said first tip section at or near said dividing point.

8. The multi-lumen catheter according to claim 7, further comprising a plurality of openings on said inner surface of said first tip section in close proximity to said dividing point.

9. The multi-lumen catheter according to claim 6, wherein said second tip section has a length greater than said first tip section and wherein said opening is positioned on said inner surface of said second tip section in close proximity to said dividing point.

10. The multi-lumen catheter according to claim 9, further comprising a plurality of openings on said inner surface of said second tip section at or near said dividing point.

11. The multi-lumen catheter according to claim 6, further comprising an opening on an inner surface of said third or fourth tip section in close proximity to said second dividing point.

12. The multi-lumen catheter according to claim 1, wherein the distal end of at least one of said tip sections is beveled.

13. The multi-lumen catheter according to claim 1, wherein said first and second tip sections are splittable along at least a portion of their length distal to said dividing point.

14. The multi-lumen catheter according to claim 1, wherein said catheter body has a cylindrical shape.

15. The multi-lumen catheter according to claim 1, further comprising a friction reducing structure positioned between said catheter and a delivery sheath.

16. The multi-lumen catheter according to claim 15, wherein said friction reducing structure comprises a raised portion on said outer surface of at least one of said tip sections.

17. The multi-lumen catheter according to claim 16, wherein said raised portion is located nearer to the distal end of said at least one of said tip sections than to said dividing point.

18. The multi-lumen catheter according to claim 15, wherein said friction reducing structure comprises a ring of material around at least one of said tip sections.

19. The multi-lumen catheter according to claim 18, wherein said ring is located nearer to the distal end of said at least one of said tip sections than to said dividing point.

20. The multi-lumen catheter according to claim 15, wherein said friction reducing structure comprises an inflatable balloon attached to an inflation lumen, said balloon being positioned on said outer surface of at least one of said tip sections.

21. The multi-lumen catheter according to claim 20, wherein said inflation balloon is located nearer to the distal end of said at least one of said tip sections than to said dividing point.

22. A multi-lumen catheter, comprising:

a catheter body enclosing at least two separate lumens from said proximal end to a dividing point;

a first tip section enclosing a first of said at least two separate lumens distal to said dividing point; and

a second tip section enclosing a second of said at least two separate lumens distal to said dividing point,

wherein at least one of said first and second tip sections comprises a friction reducing structure between said catheter and a delivery sheath.

23. The multi-lumen catheter according to claim 22, wherein said friction reducing structure comprises a raised portion on said outer surface of at least one of said tip sections.

24. The multi-lumen catheter according to claim 23, wherein said raised portion is located nearer to the distal end of said at least one of said tip sections than to said dividing point.

25. The multi-lumen catheter according to claim 22, wherein said friction reducing structure comprises a ring of material around at least one of said tip sections.

26. The multi-lumen catheter according to claim 25, wherein said ring is located nearer to the distal end of said at least one of said tip sections than to said dividing point.

27. The multi-lumen catheter according to claim 22, wherein each of said first and second tip sections comprise a friction reducing structure.

28. The multi-lumen catheter according to claim 27, wherein said friction reducing structure comprises a raised portion on an outer surface of each of said first and second tip sections.

29. The multi-lumen catheter according to claim 27, wherein said friction reducing structure comprises a ring of material around each of said first and second tip sections.

30. The multi-lumen catheter according to claim 27, wherein said friction reducing structure comprises an inflatable material positioned at a distal end of each of said first and second tip sections, wherein said inflatable material is attached to an inflation lumen.

31. The multi-lumen catheter according to claim 27, wherein said friction reducing structure is located nearer to the distal end of said first and second tip sections than to said dividing point.

32. A delivery sheath for delivering a multi-lumen catheter to a body vessel, comprising at least one ridge positioned on an inside surface of said delivery sheath along an entire length thereof.

33. The delivery sheath according to claim 32, further comprising a plurality of ridges positioned on an inside surface of said delivery sheath along an entire length thereof, wherein said plurality of ridges are offset from one another.

34. The delivery sheath according to claim 33, wherein said plurality of ridges are spaced an equidistant arc length from one another.

35. A multi-lumen catheter, comprising:

a catheter body enclosing at least two separate lumens from a proximal end to a dividing point;

at least two tip sections each enclosing at least one of said at least two separate lumens distal to said dividing point;

wherein each of said tip sections comprises an inner surface, the inner surface of one of said tip sections being joined to the inner surface of another of said tip sections over a predetermined length L₁, wherein said joined inner surfaces are separable from one another through the application of a separation force that varies along L₁.

36. The multi-lumen catheter according to claim 35, wherein each of said tip sections comprises at least one opening in a distal end thereof.

37. The multi-lumen catheter according to claim 35, wherein said separation force increases along L₁ from a distal end of said tip sections toward said dividing point.

38. The multi-lumen catheter according to claim 35, wherein said separation force decreases along L₁ from a distal end of said tip sections toward said dividing point.

39. The multi-lumen catheter according to claim 35, wherein said separation force is continuous.

40. The multi-lumen catheter according to claim 35, wherein said separation force is incremental.

41. The multi-lumen catheter according to claim 35, wherein said at least two tip sections comprise a first tip section and a second tip section, said second tip section having a length longer than a length of said first tip section.

42. The multi-lumen catheter according to claim 35, further comprising at least two adjacent fusion zones positioned between said inner surfaces of said tip sections along L₁.

43. The multi-lumen catheter according to claim 42, wherein said fusion zones comprise a plurality of fusion points.

44. The multi-lumen catheter according to claim 43, wherein each of said fusion points comprises a fusion strength, wherein said fusion strength of said fusion points is substantially similar within each fusion zone.

45. The multi-lumen catheter according to claim 44, wherein the fusion strength of said fusion points is different for adjacent fusion zones.

46. The multi-lumen catheter according to claim 45, wherein the fusion strength of said fusion points within a fusion zone increases from a distal end to a proximal end thereof.

47. The multi-lumen catheter according to claim 43, wherein the number of fusion points within a fusion zone is different for adjacent fusion zones.

48. The multi-lumen catheter according to claim 47, wherein the number of said fusion points within a fusion zone increases in adjacent fusion zones along L₁ from a distal end of said tip sections toward said dividing point.

49. The multi-lumen catheter according to claim 43, wherein the size of fusion points within a fusion zone is different for adjacent fusion zones.

50. The multi-lumen catheter according to claim 49, wherein the size of fusion points within a fusion zone increases in adjacent fusion zones along L₁ from a distal end of said tip sections toward said dividing point.

51. The multi-lumen catheter according to claim 42, wherein the surface area is different for said adjacent fusion zones.

52. The multi-lumen catheter according to claim 51, wherein the surface area of each of said adjacent fusion zones increases along L₁ from a distal end of said tip sections toward said dividing point.

53. The multi-lumen catheter according to claim 41, wherein the size of each of said adjacent fusion zones increases along L₁ from a distal end of said tip sections toward said dividing point.

54. The multi-lumen catheter according to claim 53, wherein an unfused section is positioned between said adjacent fusion zones.

55. A method for producing a variable separation force between adjacent inner surfaces of at least two tip sections distal to a dividing point in a split-tip catheter, comprising the step of creating at least two fusion zones between said inner surfaces, each of said fusion zones having a different bond strength.

56. The method according to claim 55, wherein the fusion zone creating step further comprises increasing said bond strength from a distal end of said tip sections toward said dividing point.

57. The method according to claim 55, wherein the fusion zone creating step further comprises applying a pattern of adhesive to at least one of said inner surfaces, each of said fusion zones comprising a unique pattern of adhesive.

58. The method according to claim 57, wherein said unique pattern of adhesive comprises individual points of adhesive.

59. The method according to claim 58, wherein said unique pattern of adhesive within each of said fusion zones comprises a unique number, of individual points of adhesive.

60. The method according to claim 59, wherein the unique number of individual points of adhesive within each of said fusion zones increases from a distal end of said tip sections toward said dividing point.

61. The method according to claim 58, wherein said unique pattern of adhesive within each of said fusion zones comprises a unique size of individual points of adhesive.

62. The method according to claim 61, wherein the unique size of individual points of adhesive within each of said fusion zones increases from a distal end of said tip sections toward said dividing point.

63. The method according to claim 55, wherein the fusion zone creating step further comprises applying different types of adhesive in each of said fusion zones.

64. The method according to claim 63, wherein said bond strength of said types of adhesive increases from a distal end of said tip sections toward said dividing point.

65. The method according to claim 55, wherein the fusion zone creating step further comprises applying a pattern of solvent to at least one of said inner surfaces, each of said fusion zones comprising a unique pattern of solvent.

66. The method according to claim 55, wherein the fusion zone creating step further comprises utilizing a thermal welding technique.

67. The method according to claim 55, wherein the fusion zone creating step further comprises utilizing radio frequency energy.

68. The method according to claim 55, wherein the fusion zone creating step further comprises extruding said catheter with a joining web positioned between said inner surfaces, wherein the surface area of said joining web increases from a distal end of said catheter to a proximal end of said catheter.

69. The method according to claim 55, wherein the fusion zone creating step further comprises the step of twisting said catheter upon formation thereof.

70. The method according to claim 69, wherein the twisting step comprises placing said catheter into at least one twisted mandrel.

71. The method according to claim 70, wherein the twisting step further the step of heating said catheter and mandrel.

72. A multi-lumen catheter, comprising:

a catheter body enclosing at least two separate lumens from a proximal end to a dividing point;

a first tip section enclosing a first of said at least two separate lumens distal to said dividing point and having a first length; and

a second tip section enclosing a second of said at least two separate lumens distal to said dividing point and having a second length, said second length being longer than said first length, wherein said second tip section comprises a proximal portion, a distal portion and a transition region, said transition region connecting said proximal portion to said distal portion, wherein said transition region comprises an aperture connecting an exterior of said second tip section to said second lumen.

73. The multi-lumen catheter according to claim 72, wherein said catheter body has a cylindrical shape.

74. The multi-lumen catheter according to claim 72, wherein said first tip section has a semi-cylindrical shape.

75. The multi-lumen catheter according to claim 72, wherein said proximal portion of said second tip section has a semi-cylindrical shape.

76. The multi-lumen catheter according to claim 75, wherein said distal portion of said second tip section has a cylindrical shape.

77. The multi-lumen catheter according to claim 72, wherein said distal portion of said second tip section has a cross-sectional area that is greater than a cross-sectional area of said proximal portion of said second tip section.

78. The multi-lumen catheter according to claim 72, wherein said distal portion of said second tip section has a cross-sectional area that is less than a cross-sectional area of said proximal portion of said second tip section.

79. The multi-lumen catheter according to claim 72, wherein said distal portion of said second tip section has a cross-sectional area that is substantially equivalent to a cross-sectional area of said proximal portion of said second tip section.

80. The multi-lumen catheter according to claim 72, wherein said second lumen in said distal portion of said second tip section has a cross-sectional area that is greater than a cross-sectional area of said second lumen in said proximal portion of said second tip section.

81. The multi-lumen catheter according to claim 72, wherein said second lumen in said distal portion of said second tip section has a cross-sectional area that is less than a cross-sectional area of said second lumen in said proximal portion of said second tip section.

82. The multi-lumen catheter according to claim 72, wherein said second lumen in said distal portion of said second tip section has a cross-sectional area that is substantially equivalent to a cross-sectional area of said second lumen in said proximal portion of said second tip section.

83. The multi-lumen catheter according to claim 72, wherein said catheter body is straight.

84. The multi-lumen catheter according to claim 72, wherein said catheter body is pre-curved.

85. The multi-lumen catheter according to claim 72, wherein said two separate lumens have a semicircular cross-sectional shape in said catheter body, being divided by a planar septum.

86. The multi-lumen catheter according to claim 85, wherein a cross-sectional area of said two separate lumens is substantially equivalent.

87. The multi-lumen catheter according to claim 72, wherein each of said first and said second tip sections comprise a planar surface along at least a portion of their length, wherein said planar surface of said first tip section is in facing relation to said planar surface of said second tip section.

88. The multi-lumen catheter according to claim 87, wherein each of said planar surfaces of said first and second tip section comprises two edges connecting said planar surface to a semicircular portion, wherein said two edges of each of said planar surfaces are rounded along at least a portion of their length.

89. The multi-lumen catheter according to claim 72, wherein said first tip section comprises at least one opening in a wall thereof.

90. The multi-lumen catheter according to claim 72, wherein said second tip section comprises at least one opening in a wall of said distal portion.

91. The multi-lumen catheter according to claim 72, further comprising a plurality of openings spaced around the circumference of said first tip section.

92. The multi-lumen catheter according to claim 91, wherein said plurality of openings comprise four openings circumferentially offset from one another.

93. The multi-lumen catheter according to claim 91, wherein said plurality of openings comprise four openings longitudinally offset from one another.

94. The multi-lumen catheter according to claim 93, wherein said four openings are spaced longitudinally equidistant from one another.

95. The multi-lumen catheter according to claim 91, wherein said plurality of openings comprise four openings circumferentially and longitudinally offset from one another.

96. The multi-lumen catheter according to claim 95, wherein said first tip section comprises a planar surface, a semicircular surface and two edges connecting said planar surface to said semicircular surface, wherein a first of said four openings is formed in said semicircular surface, wherein a second of said four openings is formed in a first of said two edges, wherein a third of said four openings is formed in a second of said two edges, and wherein a fourth of said four openings is formed in said planar surface.

97. The multi-lumen catheter according to claim 96, wherein said four openings are spaced longitudinally equidistant from one another.

98. The multi-lumen catheter according to claim 97, wherein said first opening is positioned distal to said second opening, wherein said second opening is positioned distal to said third opening, and wherein said third opening is positioned distal to said fourth opening.

99. The multi-lumen catheter according to claim 72, wherein a terminal end of said first tip section is rounded such that a side view thereof reveals a semicircular shape.

100. The multi-lumen catheter according to claim 72, wherein a terminal end of said first tip section is cut perpendicular to a longitudinal axis of said first tip section.

101. The multi-lumen catheter according to claim 72, wherein a terminal end of said second tip section is inwardly beveled in a proximal direction.

102. The multi-lumen catheter according to claim 101, wherein edges of said beveled terminal end are rounded.

103. The multi-lumen catheter according to claim 101, wherein said terminal end of said second tip section is inwardly beveled at an angle having a range between approximately 25°

and 75°

.

104. The multi-lumen catheter according to claim 72, wherein at least a portion of said transition region is positioned at a point distal to a terminal end of said first tip section.

105. The multi-lumen catheter according to claim 72, wherein said transition region comprises a transition shoulder having a positive slope with respect to a longitudinal axis of said second tip section.

106. The multi-lumen catheter according to claim 72, wherein said transition region comprises a transition shoulder that increases in width and height from said proximal portion to said distal end portion.

107. The multi-lumen catheter according to claim 72, wherein said transition region comprises a transition shoulder having an interior wall that defines an open cylindrical space therethrough, said aperture being formed at a distal end of said open cylindrical space.

108. The multi-lumen catheter according to claim 107, wherein said aperture is formed at an angle with respect to a longitudinal axis of said second tip section.

109. The multi-lumen catheter according to claim 107, wherein said aperture is formed parallel to a longitudinal axis of said second tip section.

110. A multi-lumen catheter, comprising:

a catheter body enclosing at least two separate lumens from a proximal end to a dividing point;

a first tip section enclosing a first of said at least two separate lumens distal to said dividing point, said first tip section comprising a first surface and a second surface and having a first opening formed in said first tip section with at least a portion thereof through each of said first and second surfaces; and

a second tip section enclosing a second of said at least two separate lumens distal to said dividing point.

111. The multi-lumen catheter according to claim 110, wherein said second tip section has a length greater than said first tip section.

112. The multi-lumen catheter according to claim 110, wherein said catheter body has a cylindrical shape.

113. The multi-lumen catheter according to claim 110, wherein said first tip section has a semi-cylindrical shape.

114. The multi-lumen catheter according to claim 113, wherein said first surface comprises a planar surface and said second surface comprises a semi-circular surface.

115. The multi-lumen catheter according to claim 114, wherein said semi-circular surface is joined to said planar surface along a first and a second edge, and wherein said first opening is positioned along said first edge.

123. The multi-lumen catheter according to claim 110, wherein a terminal end of said first tip section is rounded such that a side view thereof reveals a semicircular shape.

124. The multi-lumen catheter according to claim 110, wherein a terminal end of said first tip section is cut perpendicular to a longitudinal axis of said first tip section.

125. The multi-lumen catheter according to claim 110, wherein a terminal end of said second tip section is inwardly beveled in a proximal direction.

126. The multi-lumen catheter according to claim 110, wherein edges of said beveled terminal end are rounded.

127. The multi-lumen catheter according to claim 125, wherein said terminal end of said second tip section is inwardly beveled at an angle having a range between approximately 25°

and 75°

.

116. The multi-lumen catheter according to claim 1115, further comprising a second opening formed in said first tip section along said second edge, said second opening being positioned with at least a portion thereof though each of said first and second surfaces.

117. The multi-lumen catheter according to claim 1116, wherein said first and second openings are longitudinally offset from one another.

118. The multi-lumen catheter according to claim 1117, further comprising a third and fourth opening formed in said first tip section.

119. The multi-lumen catheter according to claim 118, wherein said third opening is formed in said semi-circular surface and said fourth opening is formed in said planar surface.

122. The multi-lumen catheter according to claim 118, wherein said third opening is positioned distal to said first opening, wherein said first opening is positioned distal to said second opening, and wherein said second opening is positioned distal to said fourth opening.

120. The multi-lumen catheter according to claim 1119, wherein each of said first, second, third and fourth openings are longitudinally offset from one another.

121. The multi-lumen catheter according to claim 120, wherein each of said first, second, third and fourth openings are spaced longitudinally equidistant from one another.

128. A multi-lumen catheter, comprising:

a catheter body enclosing at least two separate lumens from a proximal end to a dividing point;

a first tip section enclosing a first of said at least two separate lumens distal to said dividing point and having a first length; and

a second tip section enclosing a second of said at least two separate lumens distal to said dividing point and having a second length, said second length being longer than said first length, wherein said second tip section comprises a proximal portion, a distal portion and a transition region, said transition region connecting said proximal portion to said distal portion and comprising a transition shoulder having a positive slope with respect to a longitudinal axis of said second tip section.

129. The multi-lumen catheter according to claim 128, wherein said catheter body has a cylindrical shape.

130. The multi-lumen catheter according to claim 128, wherein said first tip section has a semi-cylindrical shape.

131. The multi-lumen catheter according to claim 128, wherein said proximal portion of said second tip section has a semi-cylindrical shape.

132. The multi-lumen catheter according to claim 131, wherein said distal portion of said second tip section has a cylindrical shape.

133. The multi-lumen catheter according to claim 128, wherein said two separate lumens have a semicircular cross-sectional shape in said catheter body, being divided by a planar septum.

134. The multi-lumen catheter according to claim 133, wherein a cross-sectional area of said two separate lumens is substantially equivalent.

135. The multi-lumen catheter according to claim 128, wherein each of said first and said second tip sections comprise a planar surface along at least a portion of their length, wherein said planar surface of said first tip section is in facing relation with said planar surface of said second tip section.

136. The multi-lumen catheter according to claim 128, wherein said distal portion of said second tip section has a cross-sectional area that is greater than a cross-sectional area of said proximal portion of said second tip section.

137. The multi-lumen catheter according to claim 128, wherein said distal portion of said second tip section has a cross-sectional area that is less than a cross-sectional area of said proximal portion of said second tip section.

138. The multi-lumen catheter according to claim 128, wherein said distal portion of said second tip section has a cross-sectional area that is substantially equivalent to a cross-sectional area of said proximal portion of said second tip section.

139. The multi-lumen catheter according to claim 128, wherein said second lumen in said distal portion of said second tip section has a cross-sectional area that is greater than a cross-sectional area of said second lumen in said proximal portion of said second tip section.

140. The multi-lumen catheter according to claim 128, wherein said second lumen in said distal portion of said second tip section has a cross-sectional area that is less than a cross-sectional area of said second lumen in said proximal portion of said second tip section.

141. The multi-lumen catheter according to claim 128, wherein said second lumen in said distal portion of said second tip section has a cross-sectional area that is substantially equivalent to a cross-sectional area of said second lumen in said proximal portion of said second tip section.