STERILE DISPOSABLE MEDICAMENT ADMINISTRATION SYSTEM

• US 3,650,093 A
• Filed: 01/08/1970
• Issued: 03/21/1972
• Est. Priority Date: 01/08/1970
• Status: Expired due to Term

• Current Assignee: David Rosenberg
• Original Assignee: David Rosenberg
• Inventors: Rosenberg, David
• Primary Examiner(s): Hart, Charles N.
• Application Number:
  US05/001,499
• Time in Patent Office: 803 Days
• Field of Search: 55/35,97,159,96,171 128/214,214.2
• US Class Current: 96/6
• CPC Class Codes: A61M 1/63 with means for emptying the suction container, e.g. by interrupting suction
• CPC Class Codes: A61M 1/67 Containers incorporating a piston-type member to create suction, e.g. syringes cupping glasses A61M1/08; with a flexible member creating suction A61M1/68
• CPC Class Codes: A61M 2205/7527 liquophilic, hydrophilic
• CPC Class Codes: A61M 2205/7536 allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: A61M 5/38 using hydrophilic or hydrophobic filters
• CPC Class Codes: A61M 5/385 using hydrophobic filters

Abstract

A medicament administration system is provided that can be used once, and then discarded, and that can be used in conjunction with a syringe pump without danger of an embolism, comprising a twin valve T-connector, an air eliminator, and an administering means such as a needle for connection to a patient. A syringe can also be included as an integral part of the system and an administration system combining the syringe is a preferred embodiment. All interconnected components are sterile, and disposable. Another optional but preferred feature is an air spring or cushion that absorbs peak pressures arising from pumping action of the syringe plunger, and that is associated with the air eliminator at its upstream side. A visual flow indicator can also be included as a component.

Claims

1. A sterile disposable fluid administration system that is especially designed for use with a syringe having a plunger adapted to be reciprocated by a syringe pump drive, and a syringe pump, and that prevents administration of air into a patient, comprising, in combination and in series, a twin valve Tconnector for attachment to a supply reservoir;

an air eliminator comprising a housing having liquid-and gas-impervious exterior walls defining a chamber within the housing, of which chamber a first wall comprises a first filter material that is wetted by a liquid to be passed through the housing but when so wetted will not pass a gas, and a second wall opposite the first comprises a second filter material that is not wetted by the liquid but will pass a gas entering the chamber, said second filter material being sufficiently closely spaced from the first filter material that gas will reach and pass through the second filter material in any position of the separator, an inlet in the housing for delivering to the chamber between the two opposite filter materials a fluid comprising a gas and liquid, a liquid outlet in the housing on the other side of the first wall of the chamber, so that liquid entering the chamber must pass through the first filter to reach a liquid outlet, and a gas outlet in the housing on the other side of the second wall of the chamber, so that all gas entering the chamber must pass through the second filter material to reach the gas outlet; and

a delivery means;

all interconnected by fluid delivery tubing, in an air- and liquidtight manner.

2. A disposable fluid administration system in accordance with claim 1, wherein the liquid-wetted and the liquid-repellent materIals of the air eliminator have an average pore size less than about 0.3 micron.

3. A disposable fluid administration system in accordance with claim 1, wherein the housing and associated parts of the air eliminator are made of plastic.

4. A disposable fluid administration system in accordance with claim 1, in which the liquid-wetted and liquid-repellent filter materials of the air eliminator are at opposite sides of the chamber.

5. A disposable fluid administration system in accordance with claim 1, wherein the space between the liquid-wetted and liquid-repellent walls is less than 5 mm.

6. A disposable fluid administration system in accordance with claim 1, wherein the filter materials are each microporous.

7. A disposable fluid administration system in accordance with claim 1, in which the air eliminator housing is in three parts, comprising an annulus defining the chamber walls between the liquid-wetted and liquid-repellent filter materials, and having the fluid inlet in one wall thereof, the annulus being intermediate and attached in a fluid tight seal to two outer portions, in one of which is disposed the gas outlet, the liquid-repellent filter material being disposed across the line of flow between the chamber and the gas outlet, and in the other of which is disposed the liquid outlet, the liquid-wetted material being disposed across the line of flow between the chamber and the liquid outlet, so that all fluid entering the chamber must pass through one of the filter materials to reach an outlet.

8. A disposable fluid administration system in accordance with claim 1, in which the air eliminator housing is in two parts, in one of which is disposed the liquid-repellent filter material, across the line of flow between the chamber and the gas outlet, and in the other of which is disposed the liquid-wetted filter, across the line of flow between the chamber and the liquid outlet, so that all fluid entering the chamber must pass through one of the filter materials to reach an outlet.

9. A disposable fluid administration system in accordance with claim 1, wherein the housing has at least one surface facing the filter material that is channeled for fluid flow towards the outlet from the filter material.

10. A disposable fluid administration system in accordance with claim 9 wherein the channels are in the form of an intersecting grid of grooves extending generally crosswise and generally lengthwise of the housing portion.

11. A sterile disposable administration system in accordance with claim 1 that is especially designed for use with a syringe pump and that prevents administration of air into a patient, comprising, in combination and in series, a twin valve T-connector for attachment to a supply reservoir, a syringe having a plunger adapted to be reciprocated by a pump drive, an air eliminator, and a delivery means, all interconnected by fluid delivery tubing, in an air- and liquid-tight manner.

12. A disposable fluid administration system in accordance with claim 11 comprising an air spring associated with and on the upstream side of the air eliminator.

13. A disposable fluid administration system in accordance with claim 1 comprising a visual flow indicator on the upstream side of the T-connector.

14. A sterile disposable fluid administration system that is especially designed for use with a syringe having a plunger adapted to be reciprocated by a syringe pump drive, and that prevents administration of air into a patient comprising, in combination and in series, a twin valve T-connector for attachment to a supply reservoir;

an air eliminator;

an air spring associated with and on the upstream side of the air eliminator; and

a delivery means;

all interconnected by fluid delivery tubing, in an air- and liquid-tight manner.

15. A disposable fluid administration system in accordance with claim 14, wherein the air spring comprises a chamber, and an inlet communicating the chamber with the upstream side of the air eliminator, both dimensioned To absorb at least in part pressure surges created by pumping action of the syringe.

16. A disposable fluid administration system in accordance with claim 15 wherein the chamber walls are of transparent or translucent material.

17. A disposable fluid administration system in accordance with claim 16 wherein the chamber walls are provided with a visual scale correlating fluid advance in the chamber with fluid pressure.

18. A disposable fluid administration system in accordance with claim 2, including a syringe attached to the T-connector.

19. A disposable fluid administration system in accordance with claim 14, wherein the air spring comprises a chamber, and an inlet communicating the chamber with the upstream side of the air eliminator, both dimensioned to absorb at least in part pressure surges created by pumping action of the syringe.

20. A disposable fluid administration system in accordance with claim 19, wherein the chamber walls are of transparent or translucent material.

21. A disposable fluid administration system in accordance with claim 20, wherein the chamber walls are provided with a visual scale correlating fluid advance in the chamber with fluid pressure.

22. A disposable fluid administration system in accordance with claim 14, comprising a visual flow indicator on the upstream side of the T-connector.

23. A sterile disposable fluid administration system that is especially designed for use with a syringe having a plunger adapted to be reciprocated by a syringe pump drive, and that prevents administration of air into a patient comprising, in combination and in series, a twin valve-T-connector for attachment to a supply reservoir having a coupling body (formed) of plastic material (and as one unit) having three interconnected passages therethrough, check valves in two of said passages controlling flow of fluid therethrough in a single direction;

the check valve in at least one of said passages having retaining means at an outer peripheral portion thereof, a fitting insert in each valve-containing passage, comprising a plastic material which is either the same as or compatible with the plastic material of the coupling body, the fitting insert extending into the said passage from the outside of the coupling body, and having a central passage therethrough for passage of fluid into and out from the T-connector, said valve-retaining means being retained by the fitting insert against the coupling body and a peripheral portion of the fitting insert closely abutting an inner wall of the passage, and being integrated with the plastic material of the coupling body, obliterating any seam therebetween at that portion, and forming a leaktight barrier, the fitting insert thus retaining the valve in the coupling body in a permanent leaktight fit;

the other check valve being fixed in the other passage in a leaktight seal between the retaining means and either the coupling body of a like insert;

the passage that does not include a check valve being adapted to be attached to a syringe having a plunger adapted to be reciprocated by a pump drive;

an air eliminator attached to one of the passages including a check valve, the two check valves together controlling flow of fluid through the system in a direction from the syringe on the pumping stroke of the plunger, towards the air eliminator; and

a delivery means on the downstream side of the air eliminator;

all interconnected by fluid delivery tubing in an air- and liquid-tight manner.

24. A disposable fluid administration system in accordance with claim 23, wherein the coupling body is made of plastic in a T-configuration in one piece, and the passages are interconnected at a central portion of the body. (the twin valve T-connector comprises a coupling housing having in at least one valve-containing passage a fitting retaining the valve in the passage and having a passage therethrough connecting with the coupling housing passage at the inner end and the connection means at the outer end.)

25. A dispOsable fluid administration system in accordance with claim 24, wherein both the coupling body and inserts are formed of the same plastic material. (the fittings are secured to the coupling housing and the coupling housing is in one piece.)

26. A disposable fluid administration system in accordance with claim 23, in which the twin valves are duckbill valves.

27. A disposable fluid administration system in accordance with claim 23, in which the passage for delivery of fluid is in alignment with the passage to which the syringe is attached, and the passage connected to the fluid supply is at right angles to said passage.

28. A disposable fluid administration system in accordance with claim 23, in which the interior volume of the coupling body between the valves is less than 1 cc.

29. A disposable fluid administration system in accordance with claim 23, in which the coupling body is formed of molded plastic.

30. A disposable fluid administration system in accordance with claim 23, in which the coupling body is made of a relatively rigid plastic.

31. A disposable fluid administration system in accordance with claim 23, in which the check valve is associated with a resilient foam spring to ensure a leak-tight seal when the valve is closed.

32. A disposable fluid administration system in accordance with claim 23, including a syringe attached to the T-connector.

33. A disposable fluid administration system in accordance with claim 23, including an air spring associated with and on the upstream side of the air eliminator.

34. A disposable fluid administration system in accordance with claim 33, wherein the air spring comprises a chamber, and an inlet communicating the chamber with the upstream side of the air eliminator, both dimensioned to absorb at least in part pressure surges created by pumping action of the syringe.

35. A disposable fluid administration system in accordance with claim 34 wherein the chamber walls are of transparent or translucent material.

36. A disposable fluid administration system in accordance with claim 34 wherein the chamber walls are provided with a visual scale correlating fluid advance in the chamber with fluid pressure.

37. A disposable fluid administration system in accordance with claim 23 comprising a visual flow indicator on the upstream side of the T-connector.

38. A sterile disposable fluid administration system that is especially designed for use with a syringe having a plunger adapted to be reciprocated by a syringe pump drive, and that prevents administration of air into a patient, comprising, in combination and in series, a twin valve T-connector having a coupling body of plastic material having three interconnected passages therein;

check valves in two of said passages controlling flow of fluid therethrough in a single direction, said check valves each comprising a valve member of rubbery material having retaining means thereon held in a fixed position in its passage in a leaktight seal and moveable in a flex action movement at a peripheral portion thereof to engage a valve seat or like valve member in a relatively leaktight seal so as to close the passage and to crack open in a flex action movement with respect to the fixed portion away from the valve seat or like valve member, said valve member presenting a surface exposed and responsive to fluid pressure on each side thereof and being responsive to a fluid pressure on one side tending to bias the valve member against the valve seat or like valve member in a leaktight seal therewith and thus prevent flow from that side, and being responsive to fluid pressure on the other side to move away from the valve seat or like valve member and thus permit flow from that side at the crack-open pressure and thereafter;

a fitting insert in each valve-containing passage of a plastic material which is the same as or compatible with the plastic material of the coupling body, the fitting insert extending into the said passage from the outside of the coupliNg body, and having a central passage therethrough for passage of fluid into and out from the T-connector, each fitting insert engaging the valve in its passage so as to capture the retaining means on the valve between the body and the insert, and having a peripheral sidewall abutting the sidewalls of the passage and being bonded with the material of the coupling body forming a leaktight barrier, the fitting insert thus retaining the valve in the coupling body in a permanent leaktight fit, the passage that does not include a check valve being adapted to be attached to a syringe having a plunger adapted to be reciprocated by a pump drive, an air eliminator attached to one of the passages including a check valve, the two check valves together controlling flow of fluids through the system in a direction from the syringe on the pumping stroke of the plunger towards the air eliminator and a delivery means on the downstream side of the air eliminator, all interconnected by fluid delivery tubing in an air- and liquid-tight manner.

39. A disposable fluid administration system in accordance with claim 38 including a syringe attached to the T-connector.

40. A disposable fluid administration system in accordance with claim 38 including an air spring associated with and on the upstream side of the air eliminator.

41. A disposable fluid administration system in accordance with claim 40 wherein the air spring comprises a chamber and an inlet communicating the chamber with the upstream side of the air eliminator, both dimensioned to absorb at least in part pressure surges created by the pumping action of the syringe.

42. A disposable fluid administration system in accordance with claim 40 wherein the chamber walls are of transparent or translucent material.

43. A disposable fluid administration system in accordance with claim 41 wherein the chamber walls are provided with a visual scale correlating fluid advance in the chamber with fluid pressure.

44. A disposable fluid administration system in accordance with claim 42 comprising a visual flow indicator on the upstream side of the T-connector.