ANTI-FOULING SLEEVE FOR INDWELLING CATHETERS

• US 20140378792A1
• Filed: 06/24/2014
• Published: 12/25/2014
• Est. Priority Date: 06/24/2013
• Status: Abandoned Application

• Current Assignee: Innovital LLC
• Original Assignee: Innovital LLC
• Inventors: Krimsky, William S., Yasar, Murat, Hiemenz, Gregory J., Shah, Amit Navin
• Application Number:
  US14/313,921
• Publication Number:
  US 20140378792A1
• Time in Patent Office: Days
• US Class Current: 600/310
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/0833 Measuring rate of oxygen consumption
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2/232 layered or coated
• CPC Class Codes: A61M 16/0427 with removable and re-insertable liner tubes, e.g. for cleaning
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/0484 at the distal end
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/584 : having a color code
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2230/435 : partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity

Abstract

An anti-fouling sleeve for an endotracheal tube, a method of placement, and the tools for placement. The anti-fouling sleeve occupies the entire length of endotracheal tube, and can be installed permanently or made removable and disposable. The sleeve may be instrumented with sensors and/or a UV light source to reduce and potentially eliminate biofilm formation. Once placed inside the endotracheal tube the sleeve expands to conform to the inner diameter of the tube. After use, any accumulated biofilm on the inner portion of the sleeve is removed leaving the inner portion of the endotracheal tube essentially sterile.

Claims

1. An inner sleeve adapted for placement on an inner wall of an indwelling catheter for avoiding secretion and biofilm build-up on surfaces of said catheter, said inner sleeve comprising a flexible tubular liner configured for insertion inside said indwelling catheter and having an open distal end and a proximal end, a length between said proximal and distal ends configured for insertion into said indwelling catheter, and an enlarged section at said proximal end that limits insertion into said indwelling catheter.

2. The inner sleeve according to claim 1, wherein said indwelling catheter has a side vent hole, and said inner sleeve comprises a surface feature for alignment with said side vent hole to ensure full insertion.

3. The inner sleeve according to claim 1, wherein said inner sleeve is formed of a biocompatible material.

4. The inner sleeve according to claim 3, wherein said inner sleeve is formed of a braided mesh.

5. The inner sleeve according to claim 1, wherein said inner sleeve is formed with a score line to allow disassembly in a predetermined fashion.

6. The inner sleeve according to claim 5, wherein said disassembly occurs to facilitate extraction of said inner sleeve from said catheter.

7. The inner sleeve according to claim 6, wherein said disassembly occurs at a predetermined tensile force.

8. The inner sleeve according to claim 5, wherein said disassembly occurs to facilitate laboratory or microbiological analysis or antimicrobial targeting.

9. The inner sleeve according to claim 5, wherein said score line runs helically down said inner sleeve.

10. The inner sleeve according to claim 1, wherein said inner sleeve is formed of an expandable material.

11. The inner sleeve according to claim 1, wherein the enlarged section at said proximal end is funnel-shaped.

12. The inner sleeve according to claim 1, wherein said sleeve imparts a radial preload to said catheter.

13. The inner sleeve according to claim 1, further comprising a biocidal coating on said sleeve.

14. The inner sleeve of claim 1, wherein said sleeve covers the entire interior wall of the indwelling catheter.

15. The inner sleeve of claim 1, wherein said sleeve is disposable.

16. The inner sleeve of claim 1, wherein the sleeve material is flexible, biocompatible and conformable.

17. The inner sleeve of claim 15, wherein said sleeve comprises plastic.

18. The inner sleeve of claim 1, wherein said sleeve material comprises of nickel-titanium alloys.

39. The tool for placing the inner sleeve of claim 1 by the method of claim 38.

40. The tool of claim 39, wherein said tool can expand and contract in radial direction.

41. The tool of claim 40, wherein said expansion and contraction is achieved due to an applied perpendicular force.

43. The inner sleeve according to claim 3, wherein said inner sleeve is formed of a woven biocompatible material.

44. The inner sleeve according to claim 1, wherein said inner sleeve further comprises a helical structural element to cause said inner sleeve to contract in diameter when tensioned.

45. The inner sleeve according to claim 1, further comprising an external timer to indicate the length of time since placement of the inner sleeve.

46. The inner sleeve according to claim 1, further comprising a feature or plurality of features to interface with an insertion tool, extraction tool, or suction catheter.

47. The inner sleeve according to claim 1, further comprising a fiber optic cable in optical communication with a light source, wherein the light source emits UV radiation at an antimicrobial wavelength within a range of 170 nm to 300 nm.

19. An inner sleeve adapted for placement on an inner wall of an indwelling catheter for avoiding secretion and biofilm build-up on surfaces of said catheter, said inner sleeve comprising a flexible tubular liner configured for insertion inside said indwelling catheter and having an open distal end and a proximal end, a length between said proximal and distal ends configured for insertion into said indwelling catheter, said inner sleeve further comprising a sensor.

20. The inner sleeve of claim 19, further comprising a cable embedded in said flexible tubular liner.

21. The inner sleeve of claim 20, wherein said sensor is connected to said cable and is selected from among a group comprising temperature, pressure, humidity, pH, tissue oxygen, flow rate, O2 and CO2, and light sensors.

22. The inner sleeve of claim 20, wherein said cable is a fiber optic cable to transmit light.

23. The inner sleeve of claim 22, further comprising a light source in optical communication with said at least one fiber optic cable.

24. The inner sleeve of claim 23, wherein the light source is a source of ultraviolet light.

25. The inner sleeve of claim 24, wherein the light source emits UV radiation at an antimicrobial wavelength within a range of 170 nm to 300 nm.

26. The inner sleeve of claim 23, wherein the light source comprises an LED.

27. The inner sleeve of claim 26, wherein the light source comprises an ultraviolet LED.

28. The inner sleeve of claim 22, wherein said sleeve has a fiber optic opening and the light is radiated on said indwelling catheter through said opening.

29. The inner sleeve of claim 19, further comprising a processor to record measurements from said sensors.

30. The inner sleeve of claim 20, further comprising a processor to record measurements from said sensors, said at least one cable extending from said at least one sensor to said processor, wherein measured data are transmitted from said sensors to said processor through said cables.

31. The inner sleeve of claim 19, wherein said sleeve has a braided structure.

32. The inner sleeve of claim 19, wherein the at least one sensor includes a sensor for sensing accumulation on the inner sleeve or indwelling catheter

33. The inner sleeve of claim 32, wherein the sensor optically senses accumulation on the inner sleeve or indwelling catheter.

34. The inner sleeve of claim 32, wherein the sensor comprises a timer for estimating accumulation by passage of time.

35. The inner sleeve of claim 32, wherein the sensor electrically senses accumulation on the inner sleeve or indwelling catheter.

36. The inner sleeve of claim 32, wherein the sensor is non electrical.

37. The inner sleeve of claim 36, wherein the sensor is chemically or photochemically reactive.

38. A method of placing an inner sleeve on an indwelling catheter, comprising the step of:

deploying said sleeve on the inner surface of said indwelling catheter.

42. The method of claim 38, further comprising applying a twisting motion to the inner sleeve.