Method and apparatus for continuous peritoneal cascade dialysis and hemofiltration (CPCD/H)

• US 5,980,481 A
• Filed: 05/08/1997
• Issued: 11/09/1999
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: Transvivo, Inc.
• Original Assignee: Transvivo, Inc.
• Inventors: Gorsuch, Reynolds G.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): SADULA, JENNIFER R
• Application Number:
  US08/853,051
• Time in Patent Office: 915 Days
• Field of Search: 604/28, 604/29, 604/49, 604/4, 604/5, 604/266, 210/321.6, 210/321.71, 210/321.62
• US Class Current: 604/28
• CPC Class Codes: A61M 1/1625 Dialyser of the outside perfusion type, i.e. blood flow outside hollow membrane fibres or tubes
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 1/3673 Anticoagulant coating, e.g. Heparin coating
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2209/088 on the body
• CPC Class Codes: B01D 2313/23 Specific membrane protectors, e.g. sleeves or screens
• CPC Class Codes: B01D 2313/243 Pumps
• CPC Class Codes: B01D 61/28 Apparatus therefor
• CPC Class Codes: B01D 63/02 Hollow fibre modules
• CPC Class Codes: B01D 63/084 at least one flow duct intersecting the membranes

Abstract

A continuous peritoneal dialysis is carried out by providing a dialyzer element having a filter membrane for being exposed within the peritoneal cavity and an interior dialysate passageway, the membrane having pores sufficient to allow diffusion of blood toxins, implanting the dialyzer element in the peritoneal cavity of a patient, infusing a transfer fluid into the patient'"'"'s peritoneal cavity and continuously supplying substantially fresh dialysate fluid into interior dialysate passageway of the dialyzer element, directing the fluid along the passageway whereby it is exposed to the transfer fluid by diffusion through the membrane and whereby toxins from said transfer fluid are diffused into the dialysate in the dialyzer element to form toxic dialysate fluid, and continuously removing the toxic dialysate from said dialyzer element.

Claims

1. A method for carrying out continuous peritoneal dialysis comprising:

providing a dialyzer element comprising a filter membrane for being exposed to fluid within said peritoneal cavity, said membrane having an interior dialysate passageway, and pores sufficient to allow diffusion of blood and plasma toxins therethrough,

implanting said dialyzer element in the peritoneal cavity of a patient whereby the exterior surface of said filter membrane is exposed to peritoneal cavity fluid,

infusing a transfer fluid into the patient'"'"'s peritoneal cavity and allowing said transfer fluid to dwell in said peritoneal cavity for a period of time whereby blood and plasma toxins from peritoneal vasculative are diffused through the peritoneal membrane into said transfer fluid and exposing the transfer fluid to the exterior of the filter membrane,

continuously supplying substantially fresh dialysate fluid into said interior dialysate passageway of said dialyzer element and directing said dialysate fluid along said dialysate passageway, diffusing blood and plasma toxins in said transfer fluid through said membrane into said dialysate fluid in said interior dialyzer passageway to form toxic dialysate fluid therein, and continuously removing said toxic dialysate fluid from said dialyzer element.

2. A method of claim 1 wherein the rate of supplying fresh dialysate fluid and removing toxic dialysate fluid provides a dwell time of dialysate fluid within said dialyzer element sufficient to substantially equilibrate the concentration of diffusible toxins between the dialysate fluid in the dialyzer element and the transfer fluid.

3. A method of claim 2 wherein said rate of supplying and removing dialysate fluid in said dialyzer element is between about 5 ml and about 50 ml per minute.

4. A method of claim 1 comprising providing a dialyzer element having a filter membrane comprising a plurality of elongated hollow microporous fibers.

5. A method of claim 4 comprising providing a dialyzer element having a porous guard secured around the exterior of said element and forming a protective envelope for said hollow fibers.

6. A method of claim 1 including providing a multilumen tube having a first conduit connected to an inlet for said dialyzer element and a second conduit connected to an outlet for said dialyzer element and pumping said dialysate fluid to and from said dialyzer element along first and second conduits, respectively.

7. A method of claim 1 including providing one or more bacteria filters cooperating with said dialyzer element and passing said fresh dialysate fluid through one or more of said bacteria filters and/or passing toxic dialysate fluid removed from said dialyzer element through one or more of said bacteria filters.

8. A method of claim 1 including regenerating toxic dialysate fluid to form substantially fresh dialysate fluid therefrom and using said regenerated dialysate for supplying substantially fresh dialysate fluid to said dialyzer element.

9. A method of claim 1 wherein said toxic dialysate fluid removed from said dialyzer element is directed to a drain bag.

10. A method of claim 1 comprising selectively removing blood and plasma toxins having a molecular weight between 10⁵ and 10³ daltons from said transfer fluid by providing said filter membrane having a pore size selected to allow passage of toxins having a selected molecular weight between 10⁵ and 10³ daltons therethrough.

11. A method of claim 1 wherein the transfer fluid infused into the patient'"'"'s peritoneal cavity is allowed to dwell therein for a time sufficient to become substantially equilibrated with blood toxins present in the surrounding peritoneal membrane vasculature prior to starting to continuously supply fresh dialysate fluid into the dialyzer element.

12. A method of claim 11 wherein the rate of supplying fresh dialysate fluid and removing toxic dialysate fluid provides a dwell time of dialysate fluid within said dialyzer element sufficient to substantially equilibrate the concentration of diffusible toxins between the dialysate fluid in the dialyzer element and the transfer fluid.

13. A method of carrying out continuous intraperitoneal dialysis comprising:

implanting a dialyzer element comprising a filter membrane having an exterior surface for being exposed to fluid within said peritoneal cavity, said membrane having an interior dialysate passageway and pores sufficient to allow diffusion of blood toxins therethrough, an inlet for directing dialysate fluid into said dialyzer element and an outlet for directing dialysate fluid from said dialyzer element, a tube having a first conduit connected to said inlet and a second conduit connected to said outlet and one or more pumps cooperating with said tube for pumping dialysate fluid in and/or out of said dialyzer element into the peritoneal cavity of a patient whereby the exterior surface of said filter membrane is exposed to peritoneal cavity fluid,

continuously supplying fresh dialysate fluid through the dialysate passageway whereby it is exposed to the interior filter membrane surface,

diffusing toxins from the peritoneal cavity fluid through said filter membrane into said dialysate fluid, and

continuously removing the toxic dialysate fluid from said dialyzer element.

14. A method of claim 13 including infusing a transfer fluid into the peritoneal cavity of a patient and allowing the transfer fluid to dwell in the peritoneal cavity for a time sufficient to become substantially equilibrated with blood toxins present in the surrounding peritoneal membrane vasculature prior to starting to continuously supply fresh dialysate fluid to the dialyzer element.

15. A method of claim 14 wherein the rate of supplying fresh dialysate fluid and removing toxic dialysate fluid provides a dwell time of dialysate fluid within said dialyzer element sufficient to substantially equilibrate the concentration of diffusible toxins between the dialysate fluid in the dialyzer element and the transfer fluid.