Peritoneal dialysis patient connection system

• US 8,986,243 B2
• Filed: 03/15/2012
• Issued: 03/24/2015
• Est. Priority Date: 07/05/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Griswold, William R., Han, William W., Steinhaus, Andrew, Oishi, Hiroshi, Katsuyoshi, Sobue
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US13/421,469
• Publication Number:
  US 20120209168A1
• Time in Patent Office: 1,104 Days
• Field of Search: 604/29, 604533-538, 604/6.08, 604/199, 422/24
• US Class Current: 604/29
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 39/165 Shrouds or protectors for aseptically enclosing the connector
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking

Abstract

Peritoneal dialysis connectors, connector sets, connector systems and methods are disclosed. In an embodiment, a connector includes, a body, a spike located at a first end of the body, a sealing ring sized to seal inside a female connector and located adjacent to the spike end, threads located adjacent to the sealing ring, and at least one barbed ring located adjacent to the threads at a second end of the body. The at least one barbed ring is configured to seal the second end of the body to a tube.

Claims

1. A peritoneal dialysis connector set comprising:

a male connector including

a spike portion having a distal end and a proximal end,

a spike located at the distal end,

a seal apparatus located at the proximal end and fixed to the spike portion, the seal apparatus including an outer surface, and

a first tube connection portion adjacent to the spike portion; and

a female connector including

a second tube connection portion having a tube section and a mouth section, the tube section having a tube end configured to receive a tube, the mouth section having a mouth end configured to receive the spike, the second tube connection portion defining a lumen extending longitudinally between the tube end and the mouth end, and

a shroud including a radial wall and an axial wall, the radial wall extending from the mouth end in a radial direction and the axial wall including an inner surface and extending from the radial wall in an axial direction so as to protect the mouth end from human touch, the radial wall and the axial wall forming an enclosure sized (i) to seal to the seal apparatus of the male connector via the outer surface of the seal apparatus contacting the inner surface of the axial wall of the shroud and (ii) to enable the seal apparatus to remain safely away from the mouth end when the male connector and female connector are mated.

2. The peritoneal dialysis connector set of claim 1, wherein at least one of the spike portion, the first tube connection portion, the second tube connection portion and the shroud are cylindrical.

3. The peritoneal dialysis connector set of claim 2, wherein the shroud of the female connector has a larger diameter than a diameter of the second tube connection portion of the female connector.

4. The peritoneal dialysis connector set of claim 1, wherein one of the first and second tube connection portions is a male port sized to fit sealingly inside a tube.

5. The peritoneal dialysis connector set of claim 1, wherein the male and female connectors are configured to snap-fit together.

6. The peritoneal dialysis connector set of claim 1, wherein the female connector includes a flange, the flange sized and positioned to enable the female connector to be held by a fixture when the male connector is inserted into the female connector.

7. The peritoneal dialysis connector set of claim 6, wherein the shroud is spaced away from the flange a distance sufficient to enable the shroud to extend past an end of the fixture when held by the fixture.

8. The peritoneal dialysis connector set of claim 1, wherein at least one of the male and female connectors is provided initially with a tip protector.

9. The peritoneal dialysis connector set of claim 1, wherein at least one of the male and female connectors is made of a material that can be irradiated for sterilization.

10. The peritoneal dialysis connector set of claim 1, wherein the female connector includes a pierceable diaphragm attached to an end of the shroud.

11. The peritoneal dialysis connector set of claim 1, wherein at least one of the first and second tube connection portions includes at least one barb for sealing to a tube.

12. A peritoneal dialysis connector set comprising:

a male connector including a sealing portion and a spike connector including a spike, the sealing portion fixed to the spike connector and including an outer surface; and

a female connector including

a tube connection portion having a tube section and a mouth section, the tube section having a tube end configured to receive a tube, the mouth section having a mouth end configured to receive the spike connector, the tube connection portion defining a lumen extending longitudinally between the tube end and the mouth end, and

a shroud including a radial wall and an axial wall, the radial wall extending from the mouth end in a radial direction and the axial wall including an inner surface and extending from the radial wall in an axial direction so as to protect the mouth end of the tube connection portion from human touch, the axial wall of the shroud sealing to the sealing portion of the male connector via the outer surface of the sealing portion contacting the inner surface of the axial wall of the shroud, the axial wall extending axially from the radial wall a distance sufficient to preclude the sealing portion of the male connector from contacting the mouth end of the tube connection portion of the female connector.

13. The peritoneal dialysis connector set of claim 12, wherein at least one of the sealing portion, the tube connection portion, and the shroud are cylindrical.

14. The peritoneal dialysis connector set of claim 12, wherein the male connector includes at least one barb for sealing to a tube.

15. The peritoneal dialysis connector set of claim 12, wherein the female connector includes a flange, the shroud spaced away from the flange a distance sufficient to enable a fixture to fit between the shroud and the flange, so that the fixture can hold the female connector.

16. The peritoneal dialysis connector set of claim 12, wherein the male and female connectors are configured to snap-fit together.

17. A peritoneal dialysis connector comprising:

a body including a first end and a second end, the second end of the body having an outer diameter;

a spike located at the first end of the body;

a sealing ring located adjacent to the spike, the sealing ring sized to seal inside a female connector;

threads located adjacent to the sealing ring; and

first and second barbed rings located adjacent to the threads at the second end of the body, the first and second barbed rings spaced apart a distance at least as large as the outer diameter of the body and configured to seal the second end of the body to a tube having a thickness, and

wherein (i) a length of the second end of the body extending from an edge of the second end to the threads is at least two times that of the outer diameter of the second end of the body, and (ii) the first and second barbed rings extend radially away from the body a distance that is less than or equal to the thickness of the tube.

18. The peritoneal dialysis connector of claim 17, wherein the outer diameter of the second end of the body is about 0.25 inch.

19. The peritoneal dialysis connector of claim 17, wherein the first and second barbed rings are sized and configured to provide a resistive force of at least five pounds that a person must overcome to remove the tube from the second end of the body.

20. The peritoneal dialysis connector of claim 17, wherein the first and second barbed rings include a tapered surface extending at an angle of about thirty degrees.

21. The peritoneal dialysis connector of claim 17, wherein the first and second barbed rings are formed integrally with the body.

22. The peritoneal dialysis connector of claim 17, wherein the outer diameter of the second end of the body is 0.22 inch.

23. The peritoneal dialysis connector of claim 17, wherein the second end of the body is cylindrical.

24. A peritoneal dialysis connector set comprising:

a port connector including

a tube connection portion having a tube section and a mouth section, and

a port; and

a spike connector including (i) a spike portion including a spike and (ii) a sealing portion located adjacent to the spike portion, the sealing portion fixed to the spike connector and including an outer surface, the sealing portion configured to snap-fit to the port of the port connector,

wherein the tube connection portion defines a lumen extending longitudinally between a tube end of the tube section and a mouth end of the mouth section, the tube end configured to receive a tube and the mouth end configured to receive the spike portion, and wherein the port includes a radial wall and an axial wall, the radial wall extending from the mouth end in a radial direction and the axial wall including an inner surface and extending from the radial wall in an axial direction so as to protect the mouth end from human touch, the axial wall of the port sealing to the sealing portion of the spike connector via the outer surface of the sealing portion contacting the inner surface of the axial wall.

25. The peritoneal dialysis connector set of claim 24, wherein the port includes an inwardly projecting ring that snap-fits into a groove in the sealing portion of the spike connector.

26. The peritoneal dialysis connector set of claim 24, wherein the sealing portion of the spike connector includes an outwardly projecting ring that snap-fits into a groove in an inner surface of a wall of the port.

27. The peritoneal dialysis connector set of claim 24, the port including an undercut feature sized to snap-fit to an annular groove of the sealing portion of the spike connector.

28. The peritoneal dialysis connector set of claim 27, wherein the annular groove of the spike connector is formed between two annular rings projecting from a body of the spike connector.

29. The peritoneal dialysis connector set of claim 24, wherein the spike connector includes a tube connection portion located adjacent to the spike portion.

30. The peritoneal dialysis connector set of claim 24, wherein the port includes a cylindrical wall configured to fit over the sealing portion of the spike connector.

31. The peritoneal dialysis connector set of claim 24, wherein the snap-fit configuration is structured so as to provide a resistance that can be overcome manually or via a connection/disconnection device.