Continuous ambulatory peritoneal dialysis clamping system

• US 4,473,369 A
• Filed: 01/11/1982
• Issued: 09/25/1984
• Est. Priority Date: 01/11/1982
• Status: Expired due to Fees

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Bellotti, Marc, Lueders, Arthur, Taylor, Larry C., Fitzgerald, James
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US06/338,712
• Time in Patent Office: 988 Days
• Field of Search: 604/905, 604/29, 604/244, 604/283, 604/411, 128/346, 251/7
• US Class Current: 604/244
• 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 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/287 Wedge formed by a slot having varying width, e.g. slide clamps
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A system is provided for connection of a transfer spike on the end of a tube with another tube, in which the connection portions may be ultraviolet sterilized prior to connection. Both the spike and the tube for connection communicate with a housing member having a tubular, collapsible sheath member which is ultraviolet transparent. Also, a clamping system may be provided for closing flow through the system.

Claims

1. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike and catheter coupler, said connector system comprising:

a housing member which includes a tube-like, collapsible sheath member having a collapsible tubular, ultraviolet-transparent, spike-receiving section with a spike-receiving opening at one end, and an integral housing portion at the other end of the spike-receiving section, said housing member also having first and second shoulder formations for carrying means for alternatively retaining a transfer spike in piercing and non-piercing positions relative to a pierceable membrane of the delivery tube installed in said housing member, the first shoulder formation being adjacent the spike-receiving opening and the second shoulder formation being adjacent the housing portion, said housing portion having a tube-receiving opening aligned with said spike-receiving section for receiving said delivery tube closed with the pierceable membrane, and also a transverse slide clamp-receiving slot said slot extending through said housing so as to provide slide clamp-receiving openings at either end; and

a slide clamp cooperatively associated with said housing portion in said clamp-receiving slot, said clamp defining a tube-grasping slot, and being carried and movable within said housing slot between tube-closing and tube opening positions;

whereby the delivery tube may be inserted into said sheath member through said housing end and held in a piercing position by moving said slide clamp to said closing position, and a transfer spike may be inserted into said sheath member at the other end held for ultraviolet treatment, and then thrust into said tube end to pierce the membrane associated therewith and provide a sterile condition.

2. A connector system as in claim 1, in which said means for alternatively retaining a transfer spike in piercing and non-piercing positions relative to the supply of dialysis solution and pierceable membrane is present.

3. A connector system as in claim 2, in which said alternatively retaining means includes:

removable retention casing means having a pair of spaced shoulder-grasping ends fixedly spaced from one another, said ends being adapted to grasp the first and second shoulder formations on the housing member so as to prevent collapsing of the spike-receiving section upon insertion of the spike into the sheath.

4. A connector system as in claim 3, wherein a transfer spike may also be held in piercing position by the retention casing means wherein the retention casing means grasps the first shoulder formation on the sheath member adjacent the housing portion and a third shoulder formation on the transfer spike after advancement of the spike through the membrane.

5. A system as in claim 1, wherein said slide clamp is a member having a head section and two leg sections, and said leg sections define between them a tube-grasping slot adjacent the head section and a tube-receiving opening more remote from said head section.

6. A system as in claim 5, wherein said slide clamp includes a pair of outwardly-extending hook-like stop members at the end of said leg opposite the head section, said hook-like members being adapted to engage the housing sections so as to provide a movement limiting stop.

7. A system as in claim 6, wherein each of said hook-like members include tapering ramp portions at the ends thereof for cooperation with said housing slot in guiding said slide clamp into said housing slot.

8. A system as in claim 5, wherein said clamp includes transverse folding grooves intermediate with the head section and distal end for permitting said clamp to be folded about said lines.

9. A system as in claim 5, wherein the outer surface of each of said slide member legs includes an outwardly tapered portion intermediate with the slide housing slot so as to bias the slide clamp outwardly against the housing and to cooperate in maintaining the clamp in a non-grasping position within said housing.

10. A system as in claim 1, wherein the tube set includes a length of medical tubing, catheter coupling means at one end for connecting the tube set to a patient'"'"'s catheter, and said membrane-piercing transfer spike connected to the other end of said tubing.

11. A system as in claim 10, in combination with a bag of dialysis solution, said bag having a delivery tube, said tube having a pierceable membrane for cooperation with said sheath member and slide clamp for piercing by said transfer spike.

12. The connector system of claim 10 in which said transfer spike is transparent to ultraviolet light.

13. The connector system of claim 12 in which said transfer spike is made of poly(methylpentene).

14. A system as in claim 1, wherein said slide clamp has a head section, two leg sections and a closed foot section, and said leg sections define between them a tube-grasping slot adjacent the head section and a tube-receiving opening more remote from said head section than said foot section.

23. The connector system of claim 3 in which said spaced first and second shoulder formations are of a shape to prevent relative rotation of said tube-like collapsible sheath member with respect to the retention casing means.

24. The connector system of claim 23 in which said retention casing means is proportioned to grasp the first shoulder formation on the sheath member adjacent said housing portion and a third shoulder formation on the transverse spike after advancement of the spike member.

15. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike and a catheter coupler at opposite ends thereof;

said connector comprising a housing member which includes a tube-like, collapsible sheath member having a hollow, accordion-like ultraviolet transparent spike-receiving section having a spike-receiving-opening at one end of said section and an integral housing section at the other end of said spike-receiving-section, said sheath member also having a pair of shoulder formations, the first shoulder formation being adjacent the spike-receiving opening and the second shoulder formation being adjacent the housing, said housing section having a tube-receiving-opening aligned with the spike-receiving section for receiving said delivery tube, and a transverse slide clamp-receiving slot, said slot extending through said housing so as to provide slide clamp-receiving openings at either end;

a slide clamp cooperatively associated with said slot, said clamp having a tube grasping slot and being movable within said housing slot between tube closing and tube opening positions;

removable retention casing means having a pair of spaced, shoulder-grasping ends fixedly spaced from one another, said ends being proportioned to grasp said pair of shoulder formations for positioning said transfer spike in a spaced position relative to a pierceable membrane in said delivery tube positioned in said opening by preventing collapsing of said sheath member;

whereby said delivery tube may be inserted into said sheath through said housing end and held in a piercing position by moving said slide clamp to said grasping position and whereby said transfer spike may be inserted into said sheath at the other end and retained in spaced relation from the pierceable membrane and thereafter thrust toward said tube so as to pierce the membrane associated therewith after removal of the retention casing means.

16. The connector system of claim 15 in which said spaced first and second shoulder formations are of a shape to prevent relative rotation of said tube-like collapsible sheath member with respect to the retention casing means.

17. The connector member of claim 16 in which said retention casing means is proportioned to grasp the first shoulder formation on the sheath member adjacent said housing portion and a third shoulder formation on the transverse spike after advancement of the spike member.

18. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to a supply of dialysis solution through a tube set having a transfer spike and catheter coupler, said connection system comprising:

a housing member which includes a tubular, collapsible sheath member having a collapsible tubular ultraviolet-transparent, spike-receiving section with a spike-receiving opening at one end, an integral housing portion at the other end of the spike-receiving section, said housing portion having a tube-receiving opening aligned with said spike-receiving section for receiving a dialysis solution container delivery tube closed with a pierceable membrane, and also a transverse, clamp-receiving slot;

a slide clamp cooperatively associated with said housing portion in said slot, said clamp defining a tube-grasping slot and carried and movable within said housing slot between delivery tube closing and delivery tube opening positions;

casing means provided for alternatively retaining a transfer spike in piercing and nonpiercing positions relative to the anticipated position of the pierceable membrane, said casing means defining slots at opposed ends thereof, and a pair of first and second shoulder formations defined on the spike-receiving, collapsible sheath member whereby said shoulder formations can fit into the slots of the casing to prevent collapse of the sheath member, and said delivery tube may be inserted into said sheath member through the tube-receiving opening and held in position by moving said slide clamp to said closing position, and also a transfer spike may be inserted into said sheath member at the other end and held spaced from the tube end for ultraviolet treatment, and then thrust into said tube end to pierce the membrane associated therewith.

19. The connector system of claim 18 in which said transfer spike carries a third shoulder formation adapted for fitting in an end slot of said casing, whereby the collapsible, tubular, spike-receiving section may be held in collapsed position with one slot of the casing engaging the first shoulder formation and the other slot of the casing engaging the third shoulder formation of the transfer spike.

20. The connector system of claim 19 in which said slide clamp defines a pair of leg sections connected at one end to a head section, said leg sections defining between them a grasping slot into which the delivery tube of the solution container can be placed to close said tube and to grasp it, said slot also defining a tube-receiving opening more remote from the head section than said grasping slot through which the delivery tube can extend in a manner permitting fluid flow therethrough.

21. The connector system of claim 20 in which said casing comprises a pair of casing halves connected together in hinged relation.

22. The connector system of claim 19 in which said transfer spike is transparent to ultraviolet light.

25. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike and catheter coupler, said connector system comprising:

a housing member which includes a tubular, ultraviolet-transparent, spike-receiving section with a spike-receiving opening at one end, and an integral housing portion at the other end of the spike-receiving section, said housing portion having a tube-receiving opening aligned with said spike-receiving section for receiving said delivery tube closed with a pierceable membrane, and also a transverse slide clamp-receiving slot; and

,

a slide clamp cooperatively associated with said housing portion in said slot, said slide clamp having a head section and two leg sections, and said leg sections defining between them a tube-grasping slot adjacent the head section and a tube-receiving opening more remote from said head section than the slot, said slide clamp further including a pair of outwardly-extending hook-like stop members at the ends of said legs opposite the head section, said hook-like members being adapted to engage the housing section so as to provide a movement limiting stop;

whereby the delivery tube may be inserted into said tubular section through said housing end and held in a piercing position by moving said slide clamp to said closing position, and a transfer spike may be inserted into said spike-receiving section at the other end held for ultraviolet treatment, and then thrust into said tube end to pierce the membrane associated therewith and provide a sterile condition.

26. A system as in claim 25, wherein said tubular, spike-receiving section includes a longitudinally collapsible portion, and said slide clamp has a closed foot section, said hook-like stop members being adjacent the foot section.

27. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike, said connector system comprising:

a housing member which includes a tube-like member having a tubular, ultraviolet-transparent, spike-receiving section with a spike-receiving opening at one end, and an integral housing portion at the other end of the spike-receiving section, said housing portion having a delivery tube-receiving opening aligned with said spike-receiving section for receiving said delivery tube closed with a pierceable membrane, and also a transverse slide clamp-receiving slot; and

,

a slide clamp cooperatively associated with said housing portion in said slot, said clamp defining a tube-grasping slot, and being carried and movable within said housing slot between tube-closing and tube-opening positions, said slide clamp having a head section and two leg sections, and said leg sections defining between them said tube-grasping slot adjacent the head section and a tube-receiving opening more remote from said head section than said tube-grasping slot, wherein the outer surface of said slide member leg sections includes an outwardly-tapered portion adjacent the tube-receiving opening to bias the slide clamp against the housing when in contact therewith for frictionally maintaining the clamp out of tube-closing position within said housing;

whereby the delivery tube may be inserted into said tubular section through said housing end and held in a piercing position by moving said slide clamp to said tube-closing position, and a transfer spike may be inserted into said sheath member at the other end, held for ultraviolet treatment, and then thrust into said delivery tube to pierce the membrane associated therewith and provide a sterile connector.

28. A system as in claim 27, wherein said tubular spike-receiving section includes a collapsible portion, and said slide clamp has a closed foot section, said tube-receiving opening being more remote from said head section than said foot section, said hook-like stop members being at the ends of said legs opposite the head section, adjacent the foot section.

29. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike, said connector system comprising:

a housing member which includes an ultraviolet-transparent, spike-receiving tubular section, with a spike-receiving opening at one end and an integral housing portion at the other end of the spike-receiving tubular section, said tubular section carrying shoulder formation means to be gripped by means for retaining the connector system, said housing portion having a tube-receiving opening aligned with said spike-receiving tubular section for receiving said delivery tube closed with a pierceable membrane, and also a transverse, slide clamp-receiving slot extending through said housing so as to provide slide clamp-receiving openings at either end;

a slide clamp cooperatively associated with said housing portion in said clamp-receiving slot, said clamp defining a tube-grasping slot, and being carried and movable within said clamp-receiving slot between tube-closing and tube opening positions;

whereby the delivery tube may be inserted into said tubular section through said tube-receiving opening and held in a piercing position by moving said slide clamp to said closing position, and a transfer spike may be inserted into said tubular section at the other end held for ultraviolet treatment, and then thrust into said tube end to pierce the membrane associated therewith and provide a sterile condition.

30. The connector system of claim 29 in which at least a portion of said tubular ultraviolet-transparent, spike-receiving tubular section is inwardly tapered.

31. The connector system of claim 30 in which said tubular section defines an inner stop member to limit advance of said delivery tube therein.

32. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike, said connector system comprising:

a housing member which includes an ultraviolet-transparent, spike-receiving tubular section with a spike-receiving opening at one end and an integral housing portion at the other end of the spike-receiving tubular section, said tubular section carrying shoulder formation means to be gripped by means for retaining the connector system, said housing portion having a tube-receiving opening aligned with said spike-receiving tubular section for receiving said delivery tube closed with a pierceable membrane, and also a transverse, slide clamp-receiving slot extending through said housing portion so as to provide slide clamp-receiving openings at either end;

a slide clamp cooperatively associated with said housing portion in said clamp-receiving slot, said slide clamp defining a tube-grasping slot, and being carried and movable within said clamp-receiving slot between tube-closing and tube-opening positions;

the slide clamp defining a tube-receiving opening for retaining said delivery tube in the tube-opening position, outer surfaces of said slide member defining an outwardly tapered portion adjacent said tube-receiving opening to bias the slide clamp against said housing when in engagement with said housing portion for frictionally maintaining the slide clamp in tube-opening position within said housing portion;

whereby the delivery tube may be inserted into said tubular section through said tube-receiving opening and held in a piercing position by moving said slide clamp to said closing position, and a transfer spike may be inserted into said tubular section at the other end held for ultraviolet treatment, and then thrust into said tube end to pierce the membrane associated therewith and provide a sterile condition.

33. The system of claim 32 wherein said slide clamp includes transverse folding grooves spaced from the ends thereof for permitting said clamp to be folded about said lines.

34. The system of claim 33 in which at least a portion of said tubular section is inwardly tapered.

35. The system of claim 34 which carries hook-like stop member means at the end of said slide clamp opposite said head section.

36. The system of claim 35 in which said shoulder formation means defines a shape to prevent relative rotation thereof in retained position.

37. The system of claim 35 in which said tubular spike-receiving member defines an inner stop member to limit advance of said delivery tube therein.

38. A connector system for use in peritoneal dialysis applications and the like to connect a patient'"'"'s catheter to the delivery tube of a supply of dialysis solution through a tube set having a transfer spike, said connector system comprising:

a housing member which includes an ultraviolet-transparent, spike-receiving tubular section with a spike-receiving opening at one end and an integral housing portion at the other end of the spike-receiving tubular section, said tubular section carrying shoulder formation means to be gripped by means for retaining the connector system, said housing portion having a tube-receiving opening aligned with said spike-receiving tubular section for receiving said delivery tube closed with a pierceable membrane, and also a transverse slide clamp-receiving slot extending through said housing portion so as to provide slide clamp-receiving openings at either end;

a slide clamp cooperatively associated with said housing portion in said clamp-receiving slot, said slide clamp defining a tube-grasping slot, and being carried and movable within said clamp-receiving slot between tube-closing and tube-opening positions, at least a portion of said tubular section being inwardly tapered and defining an inner stop member to limit advance of said delivery tube therein;

whereby the delivery tube may be inserted into said tubular section through said tube-receiving opening and held in a piercing position by moving said slide clamp to said closing position, and a transfer spike may be inserted into said tubular section at the other end held for ultraviolet treatment, and then thrust into said tube ends to pierce the membrane associated therewith and provide a sterile connection.

39. The system of claim 38 in which said shoulder formation means defines a shape to prevent relative rotation thereof in retained position.