Drainage and infusion catheters having a capillary sleeve forming a reservoir for a fluid antimicrobial agent

• US 4,623,329 A
• Filed: 12/15/1983
• Issued: 11/18/1986
• Est. Priority Date: 12/15/1983
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Thompson, Hugh A., Drobish, James L., Spletzer, Eldon G.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Kaechele, Karen L.
• Application Number:
  US06/561,840
• Time in Patent Office: 1,069 Days
• Field of Search: 604/29, 604/27, 604/43, 604/45, 604/265, 604/266, 604/280-284, 604/101, 604/103
• US Class Current: 604/29
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• 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 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202

Abstract

A catheter for drainage of or infusion into a body cavity. The catheter comprises an elongated tubular shaft having a distal end provided with at least one port near the distal end and intended to be located in the body cavity. The catheter has an open proximal end for connection to a drain, suction conduit or infusion line. A sleeve is mounted about the shaft extending along a portion at least of the internal body surface contacting part thereof between its proximal and distal ends. The sleeve forms a substantially concentric fluid reservoir between the drainage tube and the sleeve. Filling means are provided at the proximal end of the shaft for supplying to the reservoir a fluid antimicrobial agent capable of controlled passage through the sleeve by diffusion. The inner surface of the sleeve is provided with a plurality of longitudinally extending capillary channels or grooves providing uniform distribution of the fluid antimicrobial agent within the reservoir and throughout the length of the reservoir.

Claims

1. A catheter for drainage of or infusion into a body cavity, said catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in said body cavity to be treated and an open proximal end adapted to be connected to a drainage or infusion conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, filling means at said proximal end of said shaft for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to one of said shaft and said filling means, and distribution means for distributing said fluid antimicrobial agent within said reservoir about the periphery of said reservoir and for transporting said fluid antimicrobial agent along the length of said reservoir, said distribution means comprising a plurality of capillary grooves formed in the inside surface of said sleeve, said grooves being in parallel side-by-side relationship and extending the length of said sleeve.

2. The catheter of claim 1, wherein said sleeve containing said grooves exhibits a surface contact angle with respect to said fluid antimicrobial agent which will promote distribution of said fluid antimicrobial agent along the length of said sleeve and preferentially hold said fluid antimicrobial agent at the base of said grooves by capillary action.

3. The catheter claimed in claim 1, wherein said capillary grooves formed in said inside surface of said sleeve have a nominal width in the range of from about 0.001 to about 0.010 inch and a depth of from about 0.5 to about 5 times the nominal width.

4. A catheter for drainage of or infusion into a body cavity, said catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in said body cavity to be treated and an open proximal end adapted to be connected to a drainage or infusion conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, filling means at said proximal end of said shaft for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to one of said shaft and said filling means, and distribution means for distributing said fluid antimicrobial agent within said reservoir about the periphery of said reservoir and for transporting said fluid antimicrobial agent along the length of said reservoir, said distribution means comprising a plurality of capillary grooves formed in the exterior surface of said shaft within said reservoir, said last mentioned grooves being in parallel side-by-side relationship and extending the length of said shaft within said reservoir.

5. The catheter of claim 4, wherein said shaft containing said grooves exhibits a surface contact angle with respect to said fluid antimicrobial agent which will promote distribution of said fluid antimicrobial agent along the length of said shaft and preferentially hold said fluid antimicrobial agent at the base of said grooves by capillary action.

6. A catheter for drainage of or infusion into a body cavity, said catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in said body cavity to be treated and an open proximal end adapted to be connected to a drainage or infusion conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, an inlet port at said proximal end of said catheter for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said inlet port being connected by a lumen formed in the wall of said shaft and opening into said reservoir at the distal end thereof, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to said shaft, and distribution means for distributing said fluid antimicrobial agent within said reservoir about the periphery of said reservoir and for transporting said fluid antimicrobial agent along the length of said reservoir, and a one-way valved port in the wall of said tubular shaft located at the proximal end of said reservoir and permitting the flow of said fluid antimicrobial agent from said reservoir into said tubular shaft.

7. A catheter for drainage of or infusion into a body cavity, said catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in said body cavity to be treated and an open proximal end adapted to be connected to a drainage or infusion conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, an inlet port at said proximal end of said catheter for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said inlet port being connected by a lumen formed in the wall of said shaft and opening into said reservoir at the distal end thereof, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to said shaft, distribution means for distributing said fluid antimicrobial agent within said reservoir about the periphery of said reservoir and for transporting said fluid antimicrobial agent along the length of said reservoir, and a one-way valved port in said sleeve located at the proximal end thereof and permitting flow of said fluid antimicrobial agent from said reservoir therethrough.

8. A catheter for drainage of or infusion into a body cavity, said catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in said body cavity to be treated and an open proximal end adapted to be connected to a drainage or infusion conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, an inlet port at said proximal end of said catheter for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said inlet port being connected by a lumen formed in the wall of said shaft and opening into said reservoir at the proximal end thereof, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to one of said shaft and said filling means, and distribution means for distributing said fluid antimicrobial agent within said reservoir about the periphery of said reservoir and for transporting said fluid antimicrobial agent along the length of said reservoir, and a one-way valved port in the wall of said tubular shaft located at the distal end of said reservoir and permitting the flow of said fluid antimicrobial agent from said reservoir into said tubular shaft.

9. A urethral drainage catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in the body cavity to be drained and an open proximal end adapted to be connected to a drainage conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, filling means at the proximal end of said shaft for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to one of said shaft and said filling means, distribution means within said reservoir for distributing said fluid antimicrobial agent about and along the length of said reservoir, said distribution means comprising a plurality of capillary grooves formed in one of the inside surface of said sleeve and the exterior surface of said shaft, said grooves being in parallel side-by-side relationship and extending the length of said reservoir, an inflatable retention balloon on said shaft located between said at least one port of said shaft distal end and said distal end of said sleeve, and a fluid inlet port near said proximal end of said shaft connected to said retention balloon by a lumen formed in the wall of said shaft whereby fluid can be introduced into said retention balloon to inflate said balloon.

10. The catheter of claim 9, wherein said sleeve containing said grooves exhibits a surface contact angle with respect to said fluid antimicrobial agent which will promote distribution of said fluid antimicrobial agent along the length of said sleeve and preferentially hold said fluid antimicrobial agent at the base of said grooves by capillary action.

11. A urethral drainage catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in the body cavity to be drained and an open proximal end adapted to be connected to a drainage conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, an inlet port at the proximal end of said catheter for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said inlet port being connected by a lumen formed in the wall of said shaft opening into said reservoir at the distal end thereof, and including a one-way valved outlet port at the proximal end of said reservoir formed in one of said shaft and said sleeve, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to said shaft, distribution means within said reservoir for distributing said fluid antimicrobial agent about and along the length of said reservoir, an inflatable retention balloon on said shaft located between said at least one port of said shaft distal end and said distal end of said sleeve, and a fluid inlet port near said proximal end of said shaft connected to said retention balloon by a lumen formed in the wall of said shaft whereby fluid can be introduced into said retention balloon to inflate said balloon.

12. A continuous ambulatory peritoneal dialysis catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in the body cavity to be treated and an open proximal end adapted to be connected to a conduit leading to a conventional bag of dialysis fluid, a pair of conventional proximal and distal anchoring cuffs on said catheter, said proximal anchoring cuff being surgically located just under the skin of the patient and said distal anchoring cuff being surgically located deeper in the muscle of the abdominal wall, a sleeve extending about and longitudinally of said shaft from said distal anchoring cuff beneath said proximal anchoring cuff to a position toward said proximal end of said catheter outside said patient'"'"'s body, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, an inlet port at the proximal end of said catheter for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said inlet port being connected by a lumen formed in the wall of said shaft and opening into said reservoir at the distal end thereof, a one-way valved outlet port at the proximal end of said reservoir formed in one of said shaft and said sleeve, and distribution means within said reservoir for distributing said fluid antimicrobial agent about and along the length of said reservoir.

13. A catheter for drainage of or infusion into a body cavity, said catheter comprising an elongated tubular shaft having a distal end with at least one port near said distal end to be located in said body cavity to be treated and an open proximal end adapted to be connected to a drainage or infusion conduit, a sleeve extending about and longitudinally of said shaft from a point near said at least one port toward said proximal end of said shaft, said sleeve forming a concentric reservoir for a fluid antimicrobial agent, said sleeve being permeable to the controlled passage of said fluid antimicrobial agent by diffusion, an inlet port at said proximal end of said catheter connected directly to said reservoir for supplying said fluid antimicrobial agent to said reservoir and for replenishing said fluid antimicrobial agent therein, said sleeve having a distal end sealed to said shaft, said sleeve having a proximal end sealed to said shaft, distribution means for distributing said fluid antimicrobial agent within said reservoir about the periphery of said reservoir and for transporting said fluid antimicrobial agent along the length of said reservoir, and a one-way valved port in the wall of said tubular shaft located at the distal end of said reservoir and permitting the flow of said fluid antimicrobial agent from said reservoir into said tubular shaft.