Hemodialysis

• US 4,892,518 A
• Filed: 12/04/1987
• Issued: 01/09/1990
• Est. Priority Date: 12/04/1987
• Status: Expired due to Fees

• Current Assignee: Biocontrol Technology Inc. (Touchpoint Group Holdings, Inc.)
• Original Assignee: Biocontrol Technology Inc. (Touchpoint Group Holdings, Inc.)
• Inventors: Maytin, Orlando, Norman, Robert D., Cupp, James R., Purdy, David L.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Daley, Kathleen A.
• Application Number:
  US07/128,890
• Time in Patent Office: 767 Days
• Field of Search: 604/4, 604/5, 604/93, 604/175, 604/181, 604/183, 604/247, 604/256, 604/27, 604/36, 604/43, 604/9, 137/493, 137/855
• US Class Current: 604/288.02
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: Y10T 137/7891 Flap or reed

Abstract

Hemodialysis port assembly including a port and a catheter assembly. The port includes an inlet septum subtended by an inlet plenum and an outlet septum subtended by an outlet plenum. The catheter assembly includes an inlet channel connected to the inlet plenum and an outlet channel connected to the outlet plenum. The port and catheter assembly are completely implanted in the chest of a patient with the port subcutaneous and the end of the catheter assembly remote from the port injected into the subclavian vein. The blood flow in this vein is in the direction away from the end of the catheter assembly. Near this remote end the catheter assembly or the inlet channel terminates in an inlet valve and the outlet channel terminates in an outlet valve. Each of these valves is essentially a flapper on which the blood is incident in a generally perpendicular direction so that its flow is substantially unimpeded. The outlet valve is spaced a small but effective distance from the inlet valve in the downstream direction of the flow to toxified blood through the outlet channel. In practice of this invention, the detoxified blood from an artificial kidney is supplied to the vein through a hypodermic needle which penetrates the inlet septum, the inlet plenum, the inlet channel and the inlet valve and toxified blood is supplied from the vein to the artificial kidney through the outlet valve, the outlet channel, the outlet plenum and an outlet needle which penetrates the outlet septum. The spacing of the outlet valve from the inlet valve suppresses short-circuit flow of detoxified blood from the inlet branch to the outlet branch.

Claims

1. A hemodialysis port assembly including a port structured for complete subcutaneous implantation in a patient, septum means in said port, an inlet hypodermic needle and an outlet hypodermic needle to penetrate said septum means, said port assembly also including a catheter assembly connected to said septum means, said catheter assembly to be implanted in said patient with its distal end injected into a blood vessel of said patient, said catheter assembly including a first channel, to to connected to said inlet needle to pass detoxified blood from said inlet needle to said blood vessel, and a second channel conducting fluid separately from said first channel, to be connected to said outlet needle, to pass toxified blood from said blood vessel to said outlet needle, said first channel and said second channel being structured in said catheter so as to permit both said channels to be injected into a common blood vessel in transmission communication with the blood in said blood vessel, and valve means connected to each said channel for gating the flow of detoxified blood into said blood vessel and toxified blood out of said blood vessel.

2. The hemodialysis port assembly of claim 1 wherein the separate channel means includes means for substantially suppressing circulation of detoxified blood in a short circuit including said inlet needle, said first channel, said second channel, and said outlet needle.

3. The hemodialysis port assembly of claim 1 characterized by that the cross-sectional area of the first channel through which the detoxified blood or fluid is conducted is substantially equal to the cross-sectional area of the second channel through which the toxified blood or fluid is conducted.

4. The hemodialysis port assembly of claim 1 characterized by that the cross-sectional area of the first channel through which the detoxified blood is conducted and the cross-sectional area of the second channel through which the toxified blood is conducted are of relatively large magnitude to preclude the development of relatively large pressure heads in said first channel or said second channel to drive said detoxified or toxified blood respectively through said first channel or said second channel respectively and resulting destruction of detoxified or toxified blood cells respectively.

10. The hemodialysis port assembly of claim 1 wherein the first and second channels each terminates in a flapper valve having a flapper mounted pivotally at the distal end of its associated channel, each said flapper being mounted in its associated channel in a position such that blood or other fluid which is to flow into or out of the associated channel, as the case may be, is incident on the flapper generally perpendicularly to its surface and will exert pressure to pivot said each associated flapper from a standby closed position out of the path of the flowing blood or other fluid so that the flow is substantially unimpeded, the pivotal mounting said each flapper being resilient so that on the relaxation of the associated said pressure, said each flapper returns to the standby closed position.

5. A hemodialysis port assembly including a port assembly structured for complete subcutaneous implantation in a patient, said port assembly including an inlet septum and an inlet plenum in communication with said inlet septum, said inlet septum to be penetrated by an inlet hypodermic needle for the delivery of detoxified blood to said inlet plenum, said port assembly also including an outlet septum and an outlet plenum in communication with said outlet septum, said outlet plenum to be penetrated by an outlet hypodermic needle for transmission of said patient'"'"'s toxified blood from said outlet plenum, a catheter assembly to be implanted in said patient, said catheter assembly including an inlet to be connected between said inlet plenum and a blood vessel of said patient with its distal end to be injected in said blood vessel for transmission of detoxified blood from said inlet plenum to said blood vessel, and an outlet channel, separate from said inlet channel, to be connected between said outlet plenum and said blood vessel with its distal end also to be injected in said blood vessel for transmission of toxified blood from said blood vessel to said outlet plenum, and valve means connected to each said channel for gating the flow of detoxified blood from said inlet channel into said blood vessel and toxified blood from said blood vessel into said outlet channel.

13. The hemodialysis port assembly of claim 5 characterized by valve means including an inlet valve terminating the distal end of the inlet channel and an outlet valve terminating the distal end of the outlet channel, said inlet valve when open to conduct detoxified blood to the blood vessel and said outlet valve when open to conduct toxified blood from the blood vessel, each said valve having a flapper, the surface of each said flapper being generally perpendicular to the axis of its associated channel, each said flapper being pivotally mounted to set its associated valve in closed position in the absence of flow of blood or other fluid and to be pivoted to the open position under the force of the flow of blood or other fluid and to return resiliently to the closed position on relaxation of said force.

6. A hemodialysis port assembly including a port and a catheter assembly connected to said port, said port and catheter assembly being structured for complete implantation in a patient with said port implanted subcutaneously and said catheter assembly implanted between said port and the vascular system of said patient, said port including an inlet septum and an inlet plenum connected to said inlet plenum, and an outlet septum and an outlet plenum connected to said outlet septum, said inlet septum to be penetrated by an inlet hypodermic needle for delivery of detoxified blood to said inlet plenum and said outlet septum to be penetrated by an outlet hypodermic needle for transmission of toxified blood from said outlet septum, said catheter assembly including an inlet channel connected to said inlet septum and to be connected to said vascular system for transmission of detoxified blood from said inlet plenum to said vascular system, and an outlet channel separate from said inlet channel connected to said outlet plenum and to be connected to said vascular system for transmission of toxified blood from said vascular system to said outlet plenum, said inlet channel and said outlet channel being combined into a physically integral unit capable of being inserted into a common blood vessel of the patient'"'"'s vascular system, and valve means in said inlet channel and said outlet channel actuable to permit the flow of detoxified blood to the vascular system or toxified blood from the vascular system.

7. The hemodialysis port assembly of claim 6 wherein the catheter assembly includes means for substantially suppressing circulation of detoxified blood in the short circuit including said inlet septum, said inlet channel, said outlet channel and said outlet septum.

8. The hemodialysis port assembly of claim 6 wherein, to suppress substantially circulation of blood in the short circuit including the inlet plenum, the inlet channel, the outlet channel and the outlet plenum, the outlet valve is spaced from the inlet valve along the catheter with the outlet valve more remote from the distal end of the catheter.

9. The hemodialysis port assembly of claim 6 wherein at least the outlet valve is a two-way valve.

11. A hemodialysis port assembly including a port structure for complete subcutaneous implantation in a patient, septum means in said port structure, an inlet hypodermic needle and an outlet hypodermic needle to penetrate said septum means, said hemodialysis port assembly also including a catheter assembly connected to said septum means, said catheter assembly to be implanted in said patient connected to the vascular system of said patient, said catheter assembly including an inlet channel, to be connected to said inlet needle, to pass detoxified blood from said inlet needle to said vascular system, and an outlet channel separate from said inlet channel, to be connected to said outlet needle, to pass toxified blood from said vascular system to said outlet needle, one of said channels extending beyond the distal end of said other channel a predetermined distance, a first flapper valve connected to the distal end of said inlet channel, said first valve having a flapper for closing and opening said valve, the surface of said flapper being generally perpendicular to the axis of said channel, and a second flapper valve connected to the distal end of said outlet channel, said second valve having a flapper for closing and opening said second valve, the surface of said flapper being generally perpendicular to the axis of said outlet channel, the said distance being of such length that short-circuit flow between said inlet channel and said outlet channel is suppressed.

12. The hemodialysis port assembly of claim 11 wherein the one channel whose distal end extends beyond the end of the other channel is the inlet channel and the other channel is the outlet channel.

14. The method of conducting hemodialysis on a patinet with an artificial kidney and a hemodialysis port assembly including a port and a catheter assembly having separate inlet and outlet branches connected to said port and with inlet and outlet hypodermic needles;

the said method comprising;

implanting said hemodialysis port assembly in said patient with said port implanted subcutaneously in a region of the patient'"'"'s body which is accessible to said needles and said catheter assembly implanted connected to said port and to a blood vessel of said patient at a place upstream with respect to the normal flow of the blood of said patient through said blood vessel, both said inlet and said outlet branches being connected to said blood vessel, inserting the outlet needle in said port and transmitting the toxified blood from said patient through an outlet opening in said outlet branch and said outlet needle transmitting toxified blood into said artificial kidney, said toxified blood being transmitted in the direction opposite to the direction of the direction of normal flow of blood through said blood vessel, detoxifying said toxified blood derived from said outlet needle in said artificial kidney, inserting said inlet needle into said port and through said inlet needle and said inlet branch supplying detoxified blood from said artificial kidney to said blood vessel through an inlet opening in said inlet branch, said detoxified blood as it is supplied being transmitted in the same direction as the normal flow of blood through said blood vessel, said outlet opening in said outlet branch being displaced along said catheter assembly from said inlet opening in said inlet branch an effective distance along said catheter assembly to suppress substantially the circulation of blood undesirably through the short circuit including said inlet needle, said inlet branch, said outlet branch and said outlet needle.

15. The method of claim 14 wherein the port is implanted subcutaneously in the chest and the channel means is inserted in the subclavian vein.

16. The method of claim 14 practiced with a catheter assembly whose inlet and outlet branches each has a valve near its distal end, each said valve being closed in the standby condition of said hemodialysis port assembly;

the said method including, in the transmission of the toxified blood to the blood vessel through the outlet branch, causing the pressure of the toxified blood to open the associated valve and, in the transmission of the detoxified blood from the blood vessel through the outlet branch, causing the pressure of the detoxified blood to open the associated valve.

17. The method of conducting hemodialysis on a patient with an artificial kidney and a hemodialysis port assembly including a port having an inlet septum and an inlet plenum, an outlet septum and an outlet plenum and a catheter having an inlet conductor and an outlet conductor, each conductor having a valve at its distal end, each said valve being closed in standby condition of said hemodialysis port assembly, the said method including implanting said hemodialysis port assembly in said patient with said port implanted subcutaneously with said septums accessible to injection of hypodermic needles and said conductors injected together in a blood vessel of said patient, and circulating blood through said port assembly with the toxified blood of said patient flowing into said artificial kidney from said blood vessel through its associated valve, said toxified blood opening said valve under its pressure and through said outlet conductor, said outlet plenum and said outlet septum, and detoxified blood flowing from said kidney into said blood vessel through said inlet septum, said inlet plenum, said inlet conductor and its associated valve, opening said inlet valve, said toxified blood opening, said last-named valve under its pressure.