Apparatus and method for the dialysis of blood

• US 5,989,206 A
• Filed: 10/31/1997
• Issued: 11/23/1999
• Est. Priority Date: 10/31/1997
• Status: Expired due to Fees

• Current Assignee: Biolink Corp. (Acacia Capital Corp.), Arrow International Incorporated (Teleflex Incorporated)
• Original Assignee: Biolink Corp. (Acacia Capital Corp.)
• Inventors: Prosl, Frank R., Estabrook, Brian K.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Huseman, Cheryl L.
• Application Number:
  US08/962,164
• Time in Patent Office: 753 Days
• Field of Search: 604/4, 604/5, 604/93, 604/523, 604/264
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/0025 having a collapsible lumen
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0035 characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0273 for introducing catheters into the body
• CPC Class Codes: A61M 25/0028 characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Improved apparatus and method for the dialysis of blood. The improved apparatus comprises a subcutaneous port and catheter assembly comprising a connector portion comprising a subcutaneous port element, and a catheter portion comprising a catheter element. The improved apparatus also comprises a novel percutaneous catheter assembly comprising a catheter portion comprising a catheter element, and a connector portion comprising an extracorporeal connector element.

Claims

1. A subcutaneous port and catheter assembly for use in the dialysis of the blood of a patient, said assembly comprising a connector portion and a catheter portion;

said connector portion comprising a subcutaneous port element adapted for implantation within the body of the patient, said subcutaneous port element comprising an inlet adapted for communication with a percutaneous needle connected to the output port of a dialysis machine, and an outlet adapted for communication with a percutaneous needle connected to the inlet port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said subcutaneous port element and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said subcutaneous port element and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient, said suction line mouth and said return line mouth being disposed different distances from said connector portion.

2. A subcutaneous port and catheter assembly according to claim 1 wherein said catheter element is constructed so that said return line mouth is spaced from said suction line mouth such that said return line mouth is farther from said subcutaneous port element that said suction line mouth.

3. A subcutaneous port and catheter assembly according to claim 1 wherein said catheter element is constructed so that said suction line mouth is spaced from said return line mouth such that said suction line mouth is farther from said subcutaneous port element that said return line mouth.

4. A subcutaneous port and catheter assembly according to claim 3 wherein:

said suction line has a length facilitating the disposition of said suction line mouth in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, and (2) an inferior vena cava portion; and

said return line has a length facilitating the disposition of said return line mouth in a second portion of the vascular system of the patient, the second portion being selected from a group of portions consisting of (1) an internal jugular vein portion, and (2) a superior vena cava portion.

5. A subcutaneous port and catheter assembly according to claim 4 wherein said suction line and said return line enter the vascular system of the patient through different openings.

6. A subcutaneous port and catheter assembly according to claim 4 wherein said return line mouth is disposed adjacent to an inside wall of the vascular system of the patient.

7. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal, end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

said suction line having a length facilitating the disposition of said suction line mouth in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, and (2) an inferior vena cava portion; and

said return line having a length facilitating the disposition of said return line mouth in a second portion of the vascular system of the patient, the second portion being selected from a group of portions consisting of (1) an internal jugular vein portion, and (2) a superior vena cava portion.

8. Apparatus according to claim 7 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

9. Apparatus according to claim 7 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

10. Apparatus according to claim 7 wherein said suction line and said return line enter the vascular system of the patient through different openings.

11. Apparatus according to claim 7 wherein said return line mouth is disposed adjacent to an inside wall of the vascular system of the patient.

12. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

said suction line having a length facilitating the disposition of said suction line mouth in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, (2) an inferior vena cava portion, and (3) a superior vena cava portion; and

said return line having a length facilitating the disposition of said return line mouth in the right ventricle of the heart.

13. Apparatus according to claim 12 wherein said connector portion comprise a subcutaneous port element adapted for implantation within the body of the patient.

14. Apparatus according to claim 12 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

15. Apparatus according to claim 12 wherein said suction line and said return line enter the vascular system of the patient through different openings.

16. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said return line comprises a flange adjacent said return line mouth, and said apparatus further comprises a locking collar for capturing a wall of the vascular system of the patient between said flange and said locking collar.

17. Apparatus according to claim 16 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

18. Apparatus according to claim 16 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

19. Apparatus according to claim 17 wherein said suction line in disposed within said return line.

20. Apparatus according to claim 18 wherein said suction line in disposed within said return line.

21. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said apparatus further comprises a support member interconnecting the distal end of said suction line and an inside wall of the vascular system of the patient so as to position said suction line mouth substantially centrally of the inside wall of the vascular system of the patient.

22. Apparatus according to claim 21 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

23. Apparatus according to claim 21 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

24. Apparatus according to claim 21 wherein said apparatus further comprises a support member interconnecting the distal end of said return line and an inside wall of the vascular system of the patient so as to position said return line mouth substantially centrally of the inside wall of the vascular system of the patient.

25. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of said distal end of said suction line and said distal end of said return line includes a relatively stiff portion to help maintain that line in a selected position within the vascular system of the patient.

26. Apparatus according to claim 25 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

27. Apparatus according to claim 25 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

28. Apparatus according to claim 25 wherein a relatively soft portion is disposed distal to said relatively stiff portion.

29. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of said distal end of said suction line and said distal end of said return line includes projections extending radially therefrom so as to keep that line'"'"'s mouth spaced some distance away from an inside wall of the vascular system of the patient.

30. Apparatus according to claim 29 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

31. Apparatus according to claim 29 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

32. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of the central lumen of said suction line and the central lumen of said return line is gradually diametrically increased in a flared manner, with that central lumen having a maximum diameter at that line'"'"'s distal mouth.

33. Apparatus according to claim 32 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

34. Apparatus according to claim 32 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

35. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of said distal end of said suction line and said distal end of said return line includes at least one side opening adjacent that line'"'"'s mouth whereby fluid may enter that line even if that line'"'"'s mouth should be occluded.

36. Apparatus according to claim 35 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

37. Apparatus according to claim 35 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

38. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said catheter element is constructed so that said suction line mouth is spaced from said return line mouth such that said suction line mouth is further from said connector portion than said return line mouth; and

a sleeve having a first portion disposed around an intermediate portion of said suction line and said distal end of said return line, and a second portion disposed around said suction line distally of said return line, said sleeve second portion being integral with and an extension of said sleeve first portion, said sleeve being made of elastic material such that when said apparatus is not in operation, said sleeve second portion contracts around said suction line and blocks off said return line mouth, and when said apparatus is in operation, said sleeve second portion is opened by outflow from said return line mouth.

39. Apparatus according to claim 38 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

40. Apparatus according to claim 38 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

41. A subcutaneous port and catheter assembly for use in the dialysis of the blood of a patient, said assembly comprising a connector portion and a catheter portion;

said connector portion comprising a subcutaneous port element adapted for implantation within the body of the patient, said subcutaneous port element comprising an inlet adapted for communication with a percutaneous needle connected to the output port of a dialysis machine, and an outlet adapted for communication with a percutaneous needle connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said subcutaneous port element and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said subcutaneous port element and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

said return line being formed out of an elastomeric material such that said return line will collapse down when said apparatus is not in use and expand outward when said apparatus is in use.

42. Apparatus according to claim 41 wherein said suction line and said return line are formed integral with one another.

43. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of the central lumen said suction line and the central lumen of said return line is tapered along its length, with the inner diameter of that line being larger at the proximal end of that line than at the distal end of that line.

44. Apparatus according to claim 43 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

45. Apparatus according to claim 43 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

46. Apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said catheter element comprises a proximal section and a distal section, said proximal section and said distal section being connected together by a coupling element adapted to be positioned at the point where the catheter element enters the vascular system of the patient.

47. Apparatus according to claim 46 wherein said connector portion comprises a subcutaneous port element adapted for implantation within the body of the patient.

48. Apparatus according to claim 46 wherein said connector portion comprises an extracorporeal connector element adapted for attachment against an outside surface of the body of the patient.

49. Apparatus according to claim 47 wherein said coupling element comprises a relatively rigid curved member.

50. Apparatus according to claim 48 wherein said coupling element comprises a relatively rigid curved member.

51. A subcutaneous port and catheter assembly for use in the dialysis of the blood of a patient, said assembly comprising a connector portion and a catheter portion;

said connector portion comprising a subcutaneous port element adapted for implantation within the body of the patient, said subcutaneous port element comprising an inlet adapted for communication with a percutaneous needle connected to the output port of a dialysis machine, and an outlet adapted for communication with a percutaneous needle connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said subcutaneous port element and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said subcutaneous port element and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

at least one of the suction line and the return line incorporating a coiled spring therein such that the line will not kink when the line is subjected to significant bending.

52. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing a subcutaneous port and catheter assembly for use in the dialysis of the blood of a patient, said assembly comprising a connector portion and a catheter portion;

said connector portion comprising a subcutaneous port element adapted for implantation within the body of the patient, said subcutaneous port element comprising an inlet adapted for communication with a percutaneous needle connected to the output port of a dialysis machine, and an outlet adapted for communication with a percutaneous needle connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said subcutaneous port element and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said subcutaneous port element and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient, said suction line mouth and said return line mouth being disposed different distances from said connector portion;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

53. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

said suction line having a length facilitating the disposition of said suction line mouth in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, and (2) an inferior vena cava portion; and

said return line having a length facilitating the disposition of said return line mouth in a second portion of the vascular system of the patient, the second portion being selected from a group of portions consisting of (1) an internal jugular vein portion, and (2) a superior vena cava portion;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient so that said suction line mouth is disposed in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, and (2) an inferior vena cava portion; and

so that said return line is disposed in a second portion of the vascular system of the patient, the second portion being selected from a group of portions consisting of (1) an internal jugular vein portion, and (2) a superior vena cava portion;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

54. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

said suction line having a length facilitating the disposition of said suction line mouth in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, (2) an inferior vena cava portion, and (3) a superior vena cava portion; and

said return line having a length facilitating the disposition of said return line mouth in the right ventricle of the heart;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient so that said suction line mouth is disposed in a first portion of the vascular system of the patient, the first portion being selected from a group of portions consisting of (1) a right atrium portion, (2) an inferior vena cava portion, and (3) a superior vena cava portion; and

so that said return line is disposed in the right ventricle of the heart;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

55. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said return line comprises a flange adjacent said return line mouth, and said apparatus further comprises a locking collar for capturing a wall of the vascular system of the patient between said flange and said locking collar;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

56. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said apparatus further comprises a support member interconnecting the distal end of said suction line and an inside wall of the vascular system of the patient so as to position said suction line mouth substantially centrally of the inside wall of the vascular system of the patient;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

57. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of said distal end of said suction line and said distal end of said return line includes a relatively stiff portion to help maintain that line in a selected position within the vascular system of the patient;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

58. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of said distal end of said suction line and said distal end of said return line includes projections extending radially therefrom so as to keep that line'"'"'s mouth spaced some distance away from an inside wall of the vascular system of the patient;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

59. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of the central lumen of said suction line and the central lumen of said return line is gradually diametrically increased in a flared manner, with that central lumen having a maximum diameter at that line'"'"'s distal mouth;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

60. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of said distal end of said suction line and said distal end of said return line includes at least one side opening adjacent that line'"'"'s mouth whereby fluid may enter that line even if that line'"'"'s mouth should be occluded;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

61. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said catheter element is constructed so that said suction line mouth is spaced from said return line mouth such that said suction line mouth is further from said connector portion than said return line mouth; and

a sleeve having a first portion disposed around an intermediate portion of said suction line and said distal end of said return line, and a second portion disposed around said suction line distally of said return line, said sleeve second portion being integral with and an extension of said sleeve first portion, said sleeve being made of elastic material such that when said apparatus is not in operation, said sleeve second portion contracts around said suction line and blocks off said return line mouth, and when said apparatus is in operation, said sleeve second portion is opened by outflow from said return line mouth;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

62. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing a subcutaneous port and catheter assembly for use in the dialysis of the blood of a patient, said assembly comprising a connector portion and a catheter portion;

said connector portion comprising a subcutaneous port element adapted for implantation within the body of the patient, said subcutaneous port element comprising an inlet adapted for communication with a percutaneous needle connected to the output port of a dialysis machine, and an outlet adapted for communication with a percutaneous needle connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said subcutaneous port element and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said subcutaneous port element and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

said return line being formed out of an elastomeric material, such that said return line will collapse down when said apparatus is not in use and expand outward when said apparatus is in use;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

63. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of an dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein at least one of the central lumen of said suction line and the central lumen of said return line is tapered along its length, with the inner diameter of that line being larger at the proximal end of that line than at the distal end of that line;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

64. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing apparatus for use in the dialysis of the blood of a patient, said apparatus comprising a connector portion and a catheter portion;

said connector portion comprising an inlet adapted for communication with a line connected to the output port of a dialysis machine, and an outlet adapted for communication with a line connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said connector portion and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said connector portion and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition relative to the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

and further wherein said catheter element comprises a proximal section and a distal section, said proximal section and said distal section being connected together by a coupling element adapted to be positioned at the point where the catheter element enters the vascular system of the patient;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.

65. A method according to claim 64 wherein said distal section of said catheter element is connected to said coupling element before said proximal section of said catheter element is connected to said coupling element.

66. A method for effecting the dialysis of blood, the method comprising the steps of:

(1) providing a subcutaneous port and catheter assembly for use in the dialysis of the blood of a patient, said assembly comprising a connector portion and a catheter portion;

said connector portion comprising a subcutaneous port element adapted for implantation within the body of the patient, said subcutaneous port element comprising an inlet adapted for communication with a percutaneous needle connected to the output port of a dialysis machine, and an outlet adapted for communication with a percutaneous needle connected to the input port of a dialysis machine; and

said catheter portion comprising a catheter element comprising;

a suction line having a proximal end and a distal end, said proximal end of said suction line being connected to said subcutaneous port element and in communication with said outlet, and said distal end of said suction line terminating in a suction line mouth; and

a return line having a proximal end and a distal end, said proximal end of said return line being connected to said subcutaneous port element and in communication with said inlet, and said distal end of said return line terminating in a return line mouth;

said suction line and said return line being adapted for disposition within the body of the patient so that said suction line mouth and said return line mouth are both disposed in the vascular system of the patient;

at least one of the suction line and the return line incorporating a coiled spring therein such that the line will not kink when the line is subjected to significant bending;

(2) placing said suction line mouth and said return line mouth in the vascular system of the patient;

(3) connecting said outlet to the input port of a dialysis machine, and connecting said inlet to the output port of a dialysis machine; and

(4) operating the dialysis machine.