Infection-preventing catheter arrangement

• US 5,433,705 A
• Filed: 04/30/1993
• Issued: 07/18/1995
• Est. Priority Date: 11/02/1990
• Status: Expired due to Fees

• Current Assignee: Marion Giebel, Palm, Ulo, Willehad Boemke
• Original Assignee: Marion Giebel, Palm, Ulo, Willehad Boemke
• Inventors: Palm, Ulo, Boemke, Willehad, Giebel, Marion
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/055,189
• Time in Patent Office: 809 Days
• Field of Search: 604/264-265, 604/280, 604/27, 604/35, 604/36, 604/82-91, 604/93, 623/1, 623/11, 623/12
• US Class Current: 604/82
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• 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 39/162 with antiseptic agent incorporated within the connector

Abstract

Anti-infection catheter arrangement comprising a catheter which has a rigid or flexible catheter tube with a connection piece at the distal end, characterized by a filling and suction device which can be attached to the connection piece and one or more active principle reservoirs with a total volume equal to the capacity of the catheter, possibly in addition the volume of intermediate pieces, in particular a three-way valve. This volume is entirely filled and at least one of the active principle reservoirs is filled with a substance containing at least an antibiotic agent or a chemotherapeutic agent or an antiviral agent, preferably aminoglycoside, in particular gentamycin, in at least a minimal effective concentration.

Claims

1. An infection-preventing catheter arrangement comprising

a catheter tube having a rear end;

a connection piece furnished at the rear end of the catheter tube and forming an intermediate piece;

a filling and suction device connectable to the connection piece, wherein the filling and suction device includes an active-agent reservoir with a total volume of from about a catheter filling volume to the catheter filling volume plus a volume of any intermediate pieces wherein this total volume of the active-agent reservoir is completely filled with a substance, and wherein the substance contains an agent selected from the group consisting of antibiotic agents, chemotherapeutic agents, antiviral agents and mixtures thereof in at least a minimum active concentration.

2. The infection-preventing catheter arrangement according to claim 1, wherein the antibiotic agent is aminoglycoside.

3. The infection-preventing catheter arrangement according to claim 2, wherein the antibiotic agent is gentamycin.

4. The infection-preventing catheter arrangement according to claim 1, wherein the connection piece is a three-way valve disposed between the catheter tube and the filling and suction device, and wherein the total volume of the active-agent reservoir is equal to from about the catheter filling volume to the catheter filling volume plus a volume of the three-way valve.

5. The infection-preventing catheter arrangement according to claim 1, wherein the catheter tube is rigid.

6. The infection-preventing catheter arrangement according to claim 1, wherein the catheter tube is flexible.

7. The infection-preventing catheter arrangement according to claim 1, wherein the agent is present in a highest possible active concentration.

8. The infection-preventing catheter arrangement according to claim 1, wherein the substance further contains at least one proteolytic enzyme.

9. The infection-preventing catheter arrangement according to claim 1, wherein the substance further contains an antimycotic agent.

10. The infection-preventing catheter arrangement according to claim 1, wherein the substance further contains an anticoagulant.

11. The infection-preventing catheter arrangement according to claim 1, wherein the filling and suction device is formed capable of suctioning at least the volume of the active-agent reservoir.

12. The infection-preventing catheter arrangement according to claim 1, wherein the filling and suction device is formed of plastic;

wherein the plastic is transparent;

further comprising

a plunger disposed in the filling and suction device, wherein the filling and suction device is furnished with a scaling corresponding to a shifting length of the plunger;

a catheter formed essentially of a biocompatible material.

13. The infection-preventing catheter arrangement according to claim 1, wherein the filling and suction device is formed as a closed system;

and

wherein the filling and suction device exhibits a removable protective cap.

14. The infection-preventing catheter arrangement according to claim 1, further comprising

a separate sterile packaging unit furnished for and containing the filling and suction device;

and

a sterile,separately packed closure cap attachable to the filling and suction device.

15. The infection-preventing catheter arrangement according to claim 1, wherein the active-agent reservoir comprises a first active-agent reservoir and a second active-agent reservoir, wherein the filling and suction device exhibits essentially a cylindrical shape, and wherein the first active-agent reservoir and the second active agent reservoir are disposed sequentially in axial direction of the catheter arrangement.

16. The infection-preventing catheter arrangement according to claim 15 further comprising

a membrane, wherein the first active-agent reservoir is separated from the second active-agent reservoir by the membrane, and wherein the first active-agent reservoir is disposed on the catheter side and contains a proteolytic enzyme.

17. The infection-preventing catheter arrangement according to claim 16, wherein the first active-agent reservoir exhibits a tip closed with a membrane, wherein said tip mates with the connection piece.

18. The infection-preventing catheter arrangement according to claim 17, further comprising

a plunger disposed shiftable inside the first active-agent reservoir and the second active-agent reservoir, wherein a shifting path of the plunger corresponds at least to an axial length of the first active-agent reservoir and of the second active-agent reservoir, and wherein the plunger sealingly closes with a wall of the first active-agent reservoir and of the second active-agent reservoir, and wherein a connection between the filling and suction device and the mating tip is formed as a Luer closure.

19. The infection-preventing catheter arrangement according to claim 1, wherein the catheter is an indwelling catheter, and wherein the catheter is made of polyurethane, and wherein the catheter includes a tube tip, and wherein the tube tip exhibits means for closing an opening of the catheter tube.

20. The infection-preventing catheter arrangement according to claim 19, further comprising

lamellae disposed in the catheter tube, which lamellae are movable like a swinging door in two directions,based on the injection pressure and the suction action, respectively.

21. An infection-preventing catheter arrangement with a catheter, which exhibits a rigid or flexible catheter tube with a connection piece comprising a three-way valve furnished at the rear end of the catheter tube,

wherein a filling and suction device (27) is connectable to the connection piece (32), wherein the filling and suction device (27) includes at least one active-agent reservoir (3, 4) with a total volume corresponding to from about a catheter filling volume to the catheter filling volume plus the volume of any connection piece, wherein this total volume is completely filled, and wherein at least one active-agent reservoir (3, 4) is filled with a substance, containing a first active agent selected from the group of one antibiotic agent, antiviral agent, andmixtures thereof, present in at least a minimum active concentration.

22. The infection-preventing catheter arrangement according to claim 21, further comprising a three-way valve, wherein a connection between the filling and suction device (27) and the three-way valve is formed as a Luer closure (6);

wherein the filling and suction device (27) comprises essentially plastic;

wherein the filling and suction device (27) exhibits a scaling corresponding to a shifting path of a plunger (5 or, respectively 5'"'"');

wherein the catheter (25) is formed essentially of a biocompatible material, in particular polyurethane, wherein the catheter (25) is an indwelling catheter, wherein the catheter (25) includes a tube tip (36), and wherein the tube tip (36) exhibits means for closing an opening of the catheter tube;

further comprising lamellae (37) disposed in the catheter tube, which lamellae (37) are movable like a swinging door in two directions, based on an injection pressure or, respectively, a suction action,

wherein the filling and suction device (27) is a closed system.

23. The infection-preventing catheter arrangement according to claim 21, wherein the agent is present in a highest possible active concentration;

wherein the substance further contains at least a second active agent of the group consisting of one proteolytic enzyme, capable of suctioning at least the total volume; and

further comprising

a second active-agent reservoir (4);

wherein the device (27) exhibits essentially a cylindrical shape, and wherein the active-agent reservoirs (3 and

     4) are disposed sequentially in axial direction of the catheter arrangement;

wherein the first active-agent reservoir (3) is disposed on a side of the catheter and contains the second active agent and wherein the second active-agent reservoir (4) is disposed neighboring to the first active-agent reservoir and contains the first active agent;

wherein the first active-agent reservoir (3) is separated from the second active-agent reservoir (4) by a membrane (22);

wherein the first active-agent reservoir (3) exhibits a tip closed with a membrane (8), where the tip mates with the connection piece (32);

wherein the catheter further comprises a plunger (5 or, respectively 5'"'"'), shiftable inside the first active-agent reservoir (3) and the second active-agent reservoir (4), wherein a shifting path of the plunger (5 or, respectively, 5'"'"'), corresponds at least to an axial length of the first active-agent reservoir (3) plus the second active-agent reservoir (4), and wherein the plunger (5 or, respectively, 5'"'"') sealingly closes with a wall of the first active-agent reservoir (3) and of the second active-agent reservoir (4).

24. The infection-preventing catheter arrangement according to claim 23, wherein the proteolytic enzyme is protease.

25. The infection-preventing catheter arrangement according to claim 24, wherein the protease is alpha-chymotrypsin.

26. The infection-preventing catheter arrangement according to claim 21, wherein the antibiotic agent is aminoglycoiside.

27. The infection-preventing catheter arrangement according to claim 26, wherein the aminoglycoside is a gentamycin.

29. The infection-preventing catheter arrangement according to claim 23, wherein the anticoagulant is heparin.

30. The infection-preventing catheter arrangement according to claim 22, where the closed system is formed as a kit including

a removable protective cap,

a separate sterile packaging unit containing the filling and suction device, and

a sterile, separately packed closure cap (21) attachable to the filling and suction device (27).

28. A method for preventing infection in catheter operation comprising

employing a catheter tube having a rear end and having a connection piece furnished at the rear end of the catheter tube;

employing a filling and suction device including an active-agent reservoir with a total volume of from about a catheter tube filling volume to the catheter tube filling volume plus the volume of the connection piece and connectable to the connection piece, wherein the active-agent reservoir of the filling and suction device is completely filled with a solution containing an agent selected from the group consisting of antibiotic agents, chemotherapeutic agents, antiviral agents and mixtures thereof in at least a minimum active concentration;

maintaining the catheter tube with the solution when an agent to be supplied to a patient is absent;

suctioning at least the solution from the catheter tube, before an infusion of the agent begins.