High Flow Rate Dialysis Catheters and Related Methods

• US 20090012481A1
• Filed: 07/02/2008
• Published: 01/08/2009
• Est. Priority Date: 02/24/1998
• Status: Active Grant

• Current Assignee: Navilyst Medical Incorporated (AngioDynamics, Inc.)
• Original Assignee: Navilyst Medical Incorporated (AngioDynamics, Inc.)
• Inventors: Sansoucy, Michael R., DAVEY, Christopher T., McCarthy, Matthew N.
• Granted Patent: US 8,540,663 B2
• Time in Patent Office: Days
• US Class Current: 604/265
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• 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 2025/0293 Catheter, guide wire or the like with means for holding, centering, anchoring or frictionally engaging the device within an artificial lumen, e.g. tube
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• 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

Abstract

High flow rate catheters, and related methods, are useful in dialysis and other procedures. A catheter according to the invention comprises a hub and a generally elongated conduit. The conduit has a substantially continuous and smooth wall. The conduit also defines at least one lumen and has a length extending from a proximal end to a distal end of the conduit. The proximal end is coupled to a hub and the distal end has an opening in communication with the lumen. The conduit has a conical shape which tapers along the length.

Claims

1-46. -46. (canceled)

47. A method for making a catheter, comprising:

extruding a generally elongated conduit comprising an outer wall, the conduit defining at least two lumens, the conduit being formed so that a thickness of the outer wall smoothly increases from a first end to a second end of a transition zone of the conduit and so that a cross-sectional area of each of two of the at least two lumens increases from the first end to the second end of the transition zone.

48. A catheter placement method, comprising:

(a) providing a catheter which comprises a hub and a generally elongated conduit comprising an outer wall, the conduit defining at least two lumens and having a proximal end coupled to the hub and a distal end having an opening in communication with at least one of the lumens, wherein a thickness of the outer wall smoothly increases in a distal to proximal direction over at least a transition zone of the conduit with a concomitant increase in cross-sectional area in a distal to proximal direction of each of two of the at least two lumens over at least the transition zone;

(b) inserting the catheter into a vessel having a breach; and

(c) positioning the catheter within the vessel.

49. The method of claim 48, further comprising:

curving the catheter without restricting flow through the catheter.

50. A catheter, comprising:

a hub; and

a generally elongated conduit having a substantially continuous and smooth wall, the conduit defining at least one lumen and having a length extending from a proximal end to a distal end of the conduit, the proximal end coupled to the hub and the distal end having an opening in communication with at least one of the lumens, the conduit being conical and tapering along the length from the hub to the opening, wherein a thickness of the wall smoothly increases in a distal to proximal direction over at least a transition zone of the conduit with a concomitant increase in cross-sectional area in a distal to proximal direction of each of the at least one lumen over at least the transition zone.

51. The catheter of claim 50, wherein the wall has a greater thickness at the proximal end than at the distal end, wherein the thickness transitions between the proximal end and the distal end.

52. The catheter of claim 50, wherein the at least one lumen increases in cross-sectional area from the distal end to the proximal end.

53. The catheter of claim 50, wherein a surface of the conduit is treated to inhibit association of materials with the conduit.

54. The catheter of claim 53, wherein the surface of the conduit is treated with heparin.

55. A catheter, comprising:

a hub; and

a generally elongated conduit having an outer wall, the conduit defining at least one lumen and having a proximal end coupled to the hub and a distal end having an opening in communication with the at least one lumen, wherein a thickness of the outer wall smoothly increases in a distal to proximal direction over at least a transition zone of the conduit with a concomitant increase in cross-sectional area in a distal to proximal direction of each of the at least one lumen over at least the transition zone.

56. A catheter, comprising:

(a) a hub; and

(b) a flexible, generally elongated extruded conduit including an outer wall and defining at least one lumen, the conduit comprising;

(1) a cylindrical proximal section extending from a proximal end coupled to the hub to a first point and having a constant first cross-sectional area along the length of the proximal section;

(2) a frusto-conical middle section extending from the first point to a second point and having a second cross-sectional area at the second point, wherein the first cross-sectional area is larger than the second cross-sectional area; and

(3) a cylindrical distal section extending from the second point to a distal end and having the second cross-sectional area constantly along the length of the distal section, wherein a thickness of the outer wall smoothly increases in a distal to proximal direction over at least a transition zone of the conduit with a concomitant increase in cross-sectional area in a distal to proximal direction of each of the at least one lumen over at least the transition zone.

57. The catheter of claim 56, wherein the thickness of the wall increases in thickness from the second point to the first point and wherein the cross-sectional area of at least one lumen increases from the second point to the first point.

58. The catheter of claim 56, wherein a surface of the conduit is treated to inhibit association of materials with the conduit.

59. The catheter of claim 58, wherein the surface of the conduit is treated with heparin.

60. The catheter of claim 56, wherein the conduit further comprises at least one cuff.

61. The catheter of claim 56, wherein the conduit further comprises at least one internal divider defining at least two of the lumens.

62. The catheter of claim 61, further comprising:

at least one connecting tube connected to the hub, whereby at least one connecting tube is in communication with at least one of the lumens.

63. The catheter of claim 61, wherein at least one of the internal dividers has a thickness that is greater at the proximal end than at the distal end, wherein the thickness transitions between the proximal end and the distal end.

64. The catheter of claim 61, wherein a first one of the lumens extends from the proximal end to the distal end and a second one of the lumens extends from the proximal end to a point distally beyond the distal end.

65. The catheter of claim 56, wherein at least a portion of the conduit is reinforced.

66. A method for making a catheter comprising:

extruding a generally elongated conduit comprising an outer wall, the conduit defining at least one lumen, the conduit being formed so that a thickness of the outer wall smoothly increases from a first end to a second end of a transition zone of the conduit and so that a cross-sectional area of each of the at least one lumen increases from the first end to the second end of the transition zone.

67. A catheter placement method, comprising:

(a) providing a catheter which comprises a hub and a generally elongated conduit comprising an outer wall, the conduit defining at least one lumen and having a proximal end coupled to the hub and a distal end having an opening in communication with at least one of the lumens, wherein a thickness of the outer wall smoothly increases in a distal to proximal direction over at least a transition zone of the conduit with a concomitant increase in cross-sectional area in a distal to proximal direction of each of the at least one lumen over at least the transition zone;

(b) inserting the catheter into a vessel having a breach; and

(c) positioning the catheter within the vessel.

68. The method of claim 67, further comprising curving the catheter without restricting flow through the catheter.

69. A hub assembly, comprising:

a hub element including a plurality of ports;

a first conduit connected to a first one of the plurality of ports;

a second conduit connected to a second one of the plurality of ports, a third one of the plurality of ports being adapted to receive a proximal end of a catheter;

a first clamp connected to the first conduit;

a second clamp connected to the second conduit;

a first Luer fitting coupled to an opening of the first conduit; and

a second Luer fitting coupled to an opening of the second conduit.