Method of peritoneal dialysis involving ultraviolet radiation of dialysis apparatus

• US 4,475,900 A
• Filed: 06/05/1981
• Issued: 10/09/1984
• Est. Priority Date: 06/05/1981
• Status: Expired due to Term

• Current Assignee: Jack W. Moncrief, Robert P. Popovich
• Original Assignee: Jack W. Moncrief, Robert P. Popovich
• Inventors: Popovich, Robert P., Moncrief, Jack W.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/270,800
• Time in Patent Office: 1,222 Days
• Field of Search: 128/213, 128/213 A, 128/214, 128/247, 128/214.2, 250/455.1, 422/24, 604/28, 604/29, 604/905
• US Class Current: 604/28
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/287 Dialysates therefor
• CPC Class Codes: A61M 2039/167 with energizing means, e.g. light, vibration, electricity
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: B29C 66/001 Joining in special atmospheres
• CPC Class Codes: B29C 66/5221 for forming coaxial connections, i.e. the tubular articles to be joined forming a zero angle relative to each other
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

The incidence of peritonitis is reduced in continuous ambulatory peritoneal dialysis by irradiating the peritoneum access tube connection with ultraviolet (UV) radiation so as to have an antimicrobial effect on the fluid flow path defined thereby prior to draining and infusion of dialysis fluid therethrough. The apparatus for effecting UV irradiation of the dialysis fluid flow path includes a housing for enclosing the tube connection. Contained inside the housing is a source of UV radiation for irradiating the tube connection. A UV radiation source control circuit establishes the irradiation cycle based on time of exposure. A UV radiation intensity measuring circuit may also be used to maintain UV source output until a predetermined cumulative UV exposure has been attained.

Claims

1. A method of exchanging spent dialysis fluid for fresh dialysis fluid in the peritoneal cavity of a patient undergoing peritoneal dialysis treatment, wherein an indwelling catheter is surgically implanted in the peritoneal cavity of the patient and extends through the abdominal wall of the patient, said catheter connected to an access tube, said access tube having a connector attached to the external end of said access tube with a removable cap thereon, comprising the steps of:

(a) closing the access tube at a point adjacent the access tube connector;

(b) removing the cap from the access tube connector;

(c) connecting fluid drainage apparatus to the access tube, the drainage apparatus including an empty container, a container outlet tube, an inlet tube connector adapted for connection to the access tube connector, and closure means on the container inlet tube adjacent the container inlet tube connector;

(d) irradiating a potential contamination zone between the closure means on the access tube and the closure means on the container inlet tube with ultraviolet light to kill microbes in said zone;

(e) opening the closure means on the access tube and the closure means on the inlet tube and effecting drainage of dialysis fluid from the patient'"'"'s peritoneal cavity;

(f) closing the closure means on the access tube and the closure means on the container inlet tube;

(g) disconnecting the fluid drainage apparatus from the access tube;

(h) connecting fluid infusion apparatus to the access tube, the infusion apparatus including a container of fresh dialysis fluid, a container outlet tube, a container outlet tube connector adapted for connection to the access tube connector, and a closure means on the container outlet tube adjacent the outlet tube connector;

(i) irradiating a potential contamination zone between the closure means on the access tube and the closure means on the container outlet tube with ultraviolet light to kill microbes in said zone;

(j) opening the closure means on the access tube and the closure means on the container outlet tube and effecting an infusion of fresh dialysis fluid into the patient'"'"'s peritoneal cavity;

(k) closing the closure means on the access tube after infusion of the fresh dialysis fluid; and

(l) disconnecting the fluid infusion apparatus and placing the cap on the access tube connector.

2. The method of claim 1 in which during said drainage of dialysis solution from the patient'"'"'s peritoneal cavity, the potential contamination zone between the closure means and the access tube and the closure tube and the container inlet tube is irradiated with ultraviolet light to kill microbes in said zone.

3. The method of claim 1 in which during said infusion of fresh dialysis solution into the patient'"'"'s peritoneal cavity, the potential contamination zone between the closure means and the access tube and the closure means on the container inlet tube is irradiated with ultraviolet light to kill microbes in said zone.

4. The method of claim 1, further comprising:

irradiating the cap with ultraviolet light after said cap has been placed on said access tube connector to kill microbes.

5. A method of peritoneal dialysis therapy of a patient having an indwelling catheter surgically implanted in his peritoneal cavity, said catheter extending through the abdominal wall said catheter connected to an access tube, said access tube having a connector at its external end with a removable cap, comprising the steps of:

(a) closing the access tube at a point adjacent the access tube connector;

(b) removing the cap from the access tube'"'"'s external end connector coupling;

(c) connecting fluid drainage and infusion apparatus to said access tube, the apparatus including a first container filled with fresh dialysis fluid, a second empty container, a first tubing segment with a connector adapted for connection to the access tube'"'"'s external end connector, a branch tubing segment interconnecting said containers with said first tubing segment, and a closure member on said first tubing segment adjacent said first tubing segment connector;

(d) irradiating a potential contamination zone between the closure member on the access tube and the closure member on the first tubing segment of the fluid drainage and infusion apparatus with ultraviolet radiation to kill microbes;

(e) opening the closure member on the access tube and the closure member on the first tubing segment of the fluid drainage and infusion apparatus;

(f) draining spent dialysate fluid from the patient'"'"'s peritoneal cavity into said second empty container;

(g) infusing fresh dialysis fluid from said first container into the patient'"'"'s peritoneal cavity;

(h) closing the closure means on the access tube following infusion of fresh dialysis fluid;

(i) disconnecting the fluid drainage and infusion apparatus from the access tube; and

(j) placing a cap on the access tube connector to seal the same.

6. The method of claim 5 in which, during the draining of spent dialysate fluid, the potential contamination zone between the closure member on the access tube and the closure member on the first tubing segment of the fluid drainage and infusion apparatus is irradiated with ultraviolet radiation to kill microbes.

7. The method of claim 5 in which, during said infusion of fresh dialysis solution, the potential contamination zone between the closure member of the access tube and the closure member on the first tubing segment is irradiated with ultraviolet radiation to kill microbes.

8. The method of claim 5, comprising the further step of:

irradiating said cap with ultraviolet radiation to kill microbes after said cap has been placed on said access tube connector.

9. A method of performing peritoneal dialysis upon a patient having an implanted catheter with a first connector member at the end thereof which comprises the steps of:

connecting a first tubing segment at one end to said first connector while said first tubing segment is closed at a point between its ends;

connecting a second tubing segment to the other end of said first tubing segment while said second tubing segment is closed at a point between its ends, said second tubing segment being connected at one end to a third, branched tubing segment, which in turn communicates with a first container filled with a peritoneal dialysis solution at the end of one branch, and a second, empty container at the end of the other branch;

irradiating with ultraviolet radiation the area of said first and second tubing segments positioned between the point of closure, to kill microbes present;

opening the closed portions of said first and second tubing segments, and draining spent peritoneal dialysis solution from the peritoneal cavity of the patient into the second container of the branched tubing segment;

closing the filled, second container;

opening the filled, first container;

passing fresh peritoneal dialysis solution to the patient;

temporarily closing the second tubing segment at a point intermediate its ends;

removing the branched tubing segment from its connection with the second tubing segment; and

closing the free end of said second tubing segment.

10. The method of claim 9 in which, during the draining of said spent peritoneal dialysis solution, the area of the first and second tubing segments positioned between the points of closure are irradiated with ultraviolet radiation to kill microbes present.

11. The method of claim 9 in which the area of said first and second tubing segments between the points of closing intermediate the ends is continuously irradiated with the ultraviolet light as peritoneal dialysis solution is drained from the peritoneal cavity into the second container, and fresh solution passed from the first container into the peritoneal cavity of the patient.

12. A method of draining spent peritoneal dialysis solution from, and adding fresh peritoneal dialysis solution to, the peritoneal cavity of a patient being treated by continuous ambulatory peritoneal dialysis in a manner that decreases the likelihood of transmitting microbial contamination to the peritoneal cavity of the patient, the method comprising the steps of:

(a) connecting a first container filled with fresh peritoneal dialysis solution to a conduit in flow communication with the patient'"'"'s peritoneal cavity;

(b) connecting to said conduit a second container which is empty and adapted to receive spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity;

(c) flowing spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity into said empty container via said conduit while simultaneously exposing at least a portion of said conduit to a sufficient quantity of ultraviolet radiation of a predetermined wavelength so that an antimicrobial effect is obtained on said portion of said conduit;

(d) preventing further communication of spent dialysis solution between said empty container and the patient'"'"'s peritoneal cavity;

(e) flowing fresh peritoneal dialysis solution from said first container into the patients'"'"'s peritoneal cavity via said conduit while simultaneously exposing at least a portion of said conduit to a sufficient quantity of ultraviolet radiation of a predetermined wavelength so that an antimicrobial effect is obtained on said portion of said conduit; and

(f) disconnecting said first and second containers from said conduit and said patient'"'"'s peritoneal cavity.

13. A method of performing peritoneal dialysis by draining spent peritoneal dialysis solution from, and adding fresh peritoneal dialysis solution to, the peritoneal cavity of a patient being treated by peritoneal dialysis manner that decreases the likelihood of transmitting microbial contamination to the peritoneal cavity of the patient, the method comprising the steps of:

(a) connecting a first container filled with fresh peritoneal dialysis solution to a first connection port of a conduit in communication with the patient'"'"'s peritoneal cavity;

(b) connecting a second container which is empty and adapted to receive spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity to a second connection port of said conduit;

(c) flowing spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity into said empty container via said conduit while simultaneously exposing at least a portion of said conduit including said first connection port to a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained on said portion of said conduit;

(d) closing the pathway of access of said spent dialysis solution to said empty container;

(e) flowing fresh peritoneal dialysis solution from the first container into the patient'"'"'s peritoneal cavity via said conduit.

14. The method of claim 13 in which said portion of the conduit is also exposed to ultraviolet radiation during the step of flowing said fresh peritoneal dialysis solution from the first container into the patient'"'"'s peritoneal cavity.

15. A method of performing peritoneal dialysis by draining spent peritoneal dialysis solution from, and adding fresh peritoneal dialysis solution to, the peritoneal cavity of a patient being treated by peritoneal dialysis in a manner that decreases the likelihood of transmitting microbial contamination to the peritoneal cavity in the patient, comprising the steps of:

(a) connecting an access port of a first container filled with fresh peritoneal dialysis solution to a first connection port of a conduit in communication with the patient'"'"'s peritoneal cavity, said access port and first connection port being both sealed at their inner ends to prevent migration of bacteria inwardly;

(b) exposing said first connection port and first access port to a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained thereon;

(c) opening the seals between said access port and connection port to allow peritoneal dialysis solution to flow from the first container to the patient'"'"'s peritoneal cavity;

(d) connecting a second container filled with fresh peritoneal dialysis solution to a second connection port of a conduit in communication with the patient'"'"'s peritoneal cavity, said second access port and connection port being each sealed against migration of bacteria inwardly beyond a predetermined area, said predetermined area being spaced and sealed from the first access port and connection port;

(e) flowing spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity through said first connection port and access port into said empty container while simultaneously exposing at least said connection port and access port to a sufficient quantity of ultraviolet radiation that an antimicrobial effect is obtained thereon;

(f) closing at least said first connection port and

(g) opening the seal between said second connection port and said second access port to flow fresh peritoneal dialysis solution from the second container into the patient'"'"'s peritoneal cavity via said conduit.

16. A method of peritoneal dialysis therapy of a patient having a peritoneum access tube extending through the adominal wall, for establishing a fluid flow path to the peritoneal cavity, comprising the steps of:

connecting a container of fresh dialysis fluid to said peritoneum access tube;

irradiating the connection junction between the container and the access tube with a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained at said connection junction;

infusing the fresh dialysis fluid into the patient;

allowing the dialysis fluid to remain within the patient'"'"'s peritoneal cavity for the residence time period;

draining the dialysis fluid from the patient'"'"'s peritoneal cavity after the residence time period;

irradiating the connection junction between the container and the access tube as dialysis solution is drained from the patient'"'"'s pertoneal cavity; and

disconnecting said container from said access tube.

17. A method of peritoneal dialysis therapy of a patient having an indwelling catheter implanted in his peritoneal cavity and extending through his abdomen, said catheter interconnected with an access tube, comprising the steps of:

connecting an empty container to the access tube;

irradiating a potential contamination zone between the indwelling catheter and said empty container, including at least aportion of the access tube, with a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained in said potential contamination zone;

draining dialysis fluid from the patient'"'"'s peritoneal cavity and into the empty container through the access tube;

irradiating the connection junction between the container and the access tube as dialysis solution is drained from the patient'"'"'s peritoneal cavity;

disconnecting the now-filled said empty container;

connecting a source of fresh dialysis fluid to the peritoneum access tube; and

infusing said dialysis fluid into the patient'"'"'s peritoneal cavity through the access tube.

18. A method of peritoneal dialysis therapy of a patient having an indwelling catheter implanted in his peritoneal cavity and extending through his abdomen, said catheter interconnected with an access tube, comprising the steps of:

connecting an empty container to the access tube;

irradiating a potential contamination zone between the indwelling catheter and said empty container, including at least a portion of the access tube, with a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained in said potential contamination zone;

draining dialysis fluid from the patient'"'"'s peritoneal cavity and into the enpty container through the access tube;

disconnecting the now-filled said empty container;

connecting a source of fresh dialysis fluid to the peritoneum access tube;

infusing said dialysis fluid into the patient'"'"'s peritoneal cavity through the access tube; and

irradiating with ultraviolet radiation a potential contamination zone between the indwelling catheter and empty container, to provide an antimicrobial effect after connection of the source of fresh dialysis solution to the peritoneal access tube, said irradiation continuing during the infustion of said dialysis fluid into the patient'"'"'s peritoneal cavity through the access tube.

19. A method of peritoneal dialysis therapy of a patient, comprising the steps of:

establishing a fluid flow path to the peritoneal cavity of the patient;

connecting a container of fresh dialysis fluid to said fluid flow path;

irradiating the connection junction between the container and the fluid flow path with a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained on said connection junction;

infusing said dialysis fluid into the patient'"'"'s pertioneal cavity through the fluid flow path;

allowing the dialysis fluid to remain within the patient'"'"'s peritoneal cavity for a residence time period;

draining the dialysis fluid from the patient'"'"'s peritioneal cavity after the residence time period; and

irradiating during said draining step the connection junction between the container and the fluid flow path with a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained on said connection junction.

20. A method of performing peritoneal dialysis on a patient by adding fresh peritoneal dialysis solution to the peritoneal cavity of a patient in a manner that decreases the likelihood of transmitting microbial contamination to the peritoneal cavity of the patient, the method comprising the steps of:

connecting a first container filled with fresh peritoneal dialysis solution, and a second container which is empty, to a conduit in flow communication with the patient'"'"'s peritoneal cavity;

exposing at least the connection junction between the conduit and the containers to a sufficient guantity of ultraviolet radiation so that an antimicrobial effect is obtained at said connection junction;

flowing fresh peritoneal dialysis solution from the first container into the patient'"'"'s peritoneal cavity via said conduit;

thereafter draining spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity via said conduit into said empty container; and

exposing said connection junction of said conduit and containers to a sufficient quantity of ultraviolet radiation while spent peritoneal dialysis solution flows from the patient'"'"'s peritoneal cavity into said empty container.