No-sepsis urinary drainage catheter

• US 5,417,657 A
• Filed: 10/06/1993
• Issued: 05/23/1995
• Est. Priority Date: 10/06/1993
• Status: Expired due to Fees

• Current Assignee: Carolyn Hauer
• Original Assignee: Carolyn Hauer
• Inventors: Hauer, Carolyn
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): TSOSIE, BRYAN
• Application Number:
  US08/132,719
• Time in Patent Office: 594 Days
• Field of Search: 604/43, 604/96, 604/100, 604/101, 604/102, 604/104, 604/74, 604/265, 604/280, 604/890.1, 606/192
• US Class Current: 604/103.02
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

A no-sepsis urinary catheter, comprising three lumens, each in fluid communication with a drainage tip for receiving urine from the bladder, a retention balloon for retaining the catheter within the bladder, and a microporous bacteriostasis balloon for the diffusion by osmosis of a pharmaceutical agent for the killing and prevention of bacteria growth within and around the bladder to preclude the development of sepsis therein.

Claims

1. A catheter for preventing the development of sepsis in patients as caused by bacteria, said catheter comprising:

an elongated shaft having a proximal end for insertion into a patient'"'"'s bladder and a distal end for pending outside the patient;

means for draining urine from the bladder, said draining means defined by said shaft and in fluid communication with said proximal end and said distal end;

means for the retention of said catheter in the bladder, said retention means juxtaposed below said proximal end;

an inflatable flexible barrier balloon juxtaposed below said retention means for inflating with pharmaceutical agents when said barrier balloon is inserted inside the patient'"'"'s bladder, said barrier balloon fabricated from a flexible porous material that conforms to a portion of the bladder and that allows the diffusion by osmosis of pharmaceutical agents into and around the bladder to prevent sepsis;

said barrier balloon being substantially crescent shaped when inflated, said barrier balloon partially conforming to said retention balloon so that said means for draining urine resides low in the bladder when said barrier balloon is inflated; and

means for inflating said barrier balloon with a pharmaceutical agent defined by said shaft.

2. A catheter according to claim 1, wherein said draining means comprises:

a drainage lumen defined by said elongated shaft, said drainage lumen providing a passageway for fluid communication between said proximal end and said distal end;

a drainage inlet comprising an aperture defined by said shaft at said proximal end above said retention means for receiving urine; and

a drainage outlet comprising an opening defined by said shaft at said distal end in fluid communication with said drainage inlet for discharging urine.

3. A catheter according to claim 1, wherein said retention means comprises an inflatable retention balloon juxtaposed below said proximal end in fluid communication with said distal end.

4. A catheter according to claim 3, said retention means further comprising:

a retention lumen defined by said shaft in fluid communication with said retention balloon; and

a retention inlet comprising an aperture defined by said retention lumen near said distal end for providing a passageway for the injection of fluid or air to inflate said retention balloon.

5. A catheter according to claim 4, said catheter further comprising a means for attaching an injection device to said retention inlet.

6. A catheter according to claim 1, wherein said means for inflating said barrier balloon comprises:

a barrier lumen defined by said shaft in fluid communication with said barrier balloon; and

a barrier inlet aperture defined by said barrier lumen near said distal end, providing a passageway for the injection of a pharmaceutical agent into the balloon for inflating said balloon.

7. A catheter according to claim 1, further comprising a refill indicator means for determining when said barrier balloon requires reloading with a pharmaceutical agent.

8. A catheter according to claim 1, wherein said permeable material is a microporous latex.

9. A catheter for preventing the development of sepsis in the patient as caused by bacteria, said catheter comprising:

an elongated shaft having a proximal end for insertion into a patient'"'"'s bladder and a distal end for pending outside the patient'"'"'s bladder;

a drainage lumen defined by said shaft providing fluid communication between said proximal end and said distal end;

a drainage inlet comprising a drainage opening defined by said drainage lumen at said proximal end for receiving urine from the bladder;

a drainage outlet defined by said drainage lumen in fluid communication with said drainage inlet disposed at said distal end for discharging urine;

means for the retention of said catheter in the bladder, said retention means juxtaposed below said drainage inlet at said proximal end;

an inflatable flexible barrier balloon formed to said shaft for insertion inside the patient'"'"'s bladder, said barrier balloon juxtaposed below said retention means for blocking the passage of bacteria from the urethra into the bladder, said barrier balloon fabricated from a flexible porous material that allows the diffusion by osmosis of a pharmaceutical agent into and around the bladder when said barrier balloon is inserted in said bladder;

means for inflating said barrier balloon with a pharmaceutical agent defined by said shaft; and

a refill indicator means in communication with the contents of said barrier balloon for determining when said barrier balloon rewires reloading with a pharmaceutical agent.

10. A catheter according to claim 9, wherein said retention means comprises:

an inflatable retention balloon juxtaposed below said drainage inlet;

a retention lumen defined by said shaft in fluid communication with said retention balloon;

a retention inlet aperture defined by said retention lumen near said distal end; and

a retention outlet aperture defined by said retention lumen disposed within said retention balloon, said retention outlet in fluid communication with said retention inlet, providing a passageway for the injection of fluid to inflate said retention balloon.

11. A catheter according to claim 10, wherein said retention balloon is fabricated from a non-porous expandable latex.

12. A catheter according to claim 9, wherein said means for inflating said barrier balloon comprises:

a barrier lumen defined by said shaft in fluid communication with said barrier balloon;

a barrier inlet aperture defined by said barrier lumen near said distal end; and

a barrier outlet aperture defined by said barrier lumen disposed within said balloon, said barrier outlet in fluid communication with said barrier inlet as defined by said barrier lumen for providing a passageway for the injection of a pharmaceutical agent into the balloon for inflating said balloon.

13. A catheter according to claim 9, wherein said permeable material is a microporous latex.

14. A catheter according to claim 9, wherein said refill indicator means comprises a litmus strip partially disposed in said barrier balloon and disposed along said shaft.

15. A catheter for preventing the development of sepsis in patients as caused by bacteria, said catheter comprising:

an elongated shaft having a proximal end for insertion into a patient'"'"'s bladder and a distal end for pending outside the patient'"'"'s bladder;

a drainage lumen defined by said shaft, providing fluid communication between said proximal end and said distal end;

a drainage inlet comprising a drainage opening defined by said drainage lumen at said proximal end for receiving urine from the bladder;

a drainage outlet defined by said drainage lumen in fluid communication with said drainage inlet disposed near said distal end for discharging urine;

an inflatable retention balloon juxtaposed below said drainage inlet;

a retention lumen defined by said shaft in fluid communication with said retention balloon;

a retention inlet aperture defined by said retention lumen near said distal end;

a retention outlet aperture defined by said retention lumen disposed in said retention balloon, said retention lumen providing fluid communication between said retention inlet and said retention outlet for providing a passageway for the injection of fluid for inflating said retention balloon;

said retention balloon fabricated from a non-porous, expandable latex;

an inflatable barrier balloon juxtaposed below said retention balloon, said barrier balloon fabricated from a permeable material for the diffusion by osmosis of a pharmaceutical agent;

a barrier lumen defined by said shaft in fluid communication with said barrier balloon;

a barrier inlet aperture defined by said barrier lumen near said distal end;

a barrier outlet aperture defined by said lumen within said barrier balloon such that said barrier lumen provides fluid communication between said barrier inlet and said barrier outlet for the injection of a pharmaceutical agent into the barrier balloon to inflate said barrier balloon; and

a litmus coating disposed longitudinally along said shaft from said barrier balloon to said distal end for determining when said barrier balloon requires reloading of a pharmaceutical agent, wherein said litmus coating changes color upon contact with urine from the bladder.

16. A catheter according to claim 15, further comprising:

a microporous membrane disposed below said barrier balloon, wherein said microporous membrane remains outside the bladder when said catheter is inserted;

a drug delivery chamber defined by a void between said member and said catheter for storing a drug to be delivered;

a drug delivery lumen defined by said shaft in fluid communication with said drug delivery chamber; and

a drug delivery aperture defined by said drug delivery lumen near said distal end for injecting said drug chamber with an antibody for treating the area outside the bladder with an antibody by diffusion through said porous membrane.

17. A catheter according to claim 15, further comprising:

a water pre-filled syringe in fluid communication with said retention inlet for inflating said retention balloon with water after placement of said catheter in the bladder; and

a pharmaceutical agent pre-filled syringe in fluid communication with said barrier inlet for inflating said barrier balloon with the agent after placement of said catheter in the bladder.

18. A catheter according to claim 15, further including:

a securing tab depending from said drainage lumen for securing said catheter to a strap worn on a patient'"'"'s leg; and

a means for securing said tab to the strap to hold said catheter in place.