Sheath sterility preservation filter and seal for suction catheters

• US 5,715,815 A
• Filed: 02/12/1996
• Issued: 02/10/1998
• Est. Priority Date: 03/28/1995
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Ballard Medical Products (Kimberly-Clark Corporation)
• Inventors: Lorenzen, Rick D., Madsen, Edward B.
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/599,665
• Time in Patent Office: 729 Days
• Field of Search: 128/200.26, 128/205.12, 128/207.14, 128/207.15, 128/207.16, 128/911, 128/912, 128/DIG. 26, 128/205.19, 604/280, 604/163, 604/171, 604/281
• US Class Current: 128/207.14
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61M 16/0463 combined with suction tubes, catheters or the like; Outside connections
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• CPC Class Codes: A61M 25/0111 Aseptic insertion devices
• CPC Class Codes: Y10S 128/911 Unilimb inhalation-exhalation breathing tubes
• CPC Class Codes: Y10S 128/912 Connections and closures for tubes delivering fluids to or from the body

Abstract

Filtration and closure barriers are disclosed which prevent passage of gas-carried contamination between the atmosphere and a collapsible sheath, which surrounds a catheter tube, during insertion and/or removal of the catheter tube from the respiratory tract of a medical patient.

Claims

1. A catheter assembly for delivery respiratory therapy by way of aspiration of or delivery of fluids to a respiratory tract of an intubated patient, said catheter assembly comprising:

catheter means adapted for insertion into a respiratory tract of an intubated patient so as to be able to either aspirate the respiratory tract or deliver fluids to the respiratory tract;

a distal fitting slidably joined to said catheter means at one end thereof;

a proximal fitting non-slidably joined to said catheter means at an end opposite to said one end;

sheath means, having a distal end joined in a fluid tight fit to the distal fitting, and a proximal end joined in a fluid tight fit to the proximal fitting, for forming a single enclosed area that concentrically surrounds the catheter means between the distal and proximal fittings, said sheath means being collapsible in an accordion-like fashion when said catheter means is advanced through the distal fitting as the proximal and distal fittings slide toward one another;

means for forming a slidable seal around said catheter means at the distal fitting so as to prevent substantially any fluid from entering or exiting through said means from the enclosed area formed by said sheath means; and

filter means for forming a gas permeable filter at said proximal fitting so as to prevent contaminants from entering or exiting the enclosed area through said filter means, said filter means accommodating the exit of gaseous fluids from the enclosed area as said sheath means collapses by moving the proximal end of the sheath means toward the distal end of the sheath means, and the reentry of gaseous fluids when gas is drawn into the enclosed area as said sheath means unfolds by moving the proximal end of the sheath means away from the distal end of the sheath means, said enclosed area being thereby protected from the passage of contaminating fluids into or out of the enclosed area by the combination of said slidable seal means and said filter means.

2. A catheter assembly for delivering respiratory therapy by way of aspiration of or delivery of fluids to a respiratory tract of an intubated patient, said catheter assembly comprising:

catheter means adapted for insertion into a respiratory tract of an intubated patient so as to be able to either aspirate the respiratory tract or deliver fluids to the respiratory tract;

sheath means for forming a single enclosed area that concentrically surrounds the catheter means along its length, said sheath means having distal and proximal ends and being collapsible in an accordion-like fashion when said catheter means is advanced into the respiratory tract, said single enclosed area being partially evacuated and sealed from the atmosphere so that said sheath means can be substantially fully collapsible without exhausting gas from said enclosed area as said catheter is advanced;

a distal fitting slidably joined to said catheter means at one end thereof, said distal fitting comprising distal collar means that compressively joins said distal end of the sheath means along a substantial length thereof in a substantially flat manner so as to thereby form a hermetic seal which prevents gaseous entry into or exit from said enclosed area at said distal fitting;

a proximal fitting non-slidably joined to said catheter means at an end opposite to said one end, said proximal fitting comprising proximal collar means that compressively joins said proximal end of the sheath means along a substantial length thereof in a substantially flat manner so as to thereby form a hermetic seal which prevents gaseous entry into or exit from said enclosed area at said proximal fitting; and

sealing means for forming a slidable seal around said catheter means at the distal fitting so as to prevent substantially any fluid from entering or exiting through said sealing means from the enclosed area formed by said sheath means, said enclosed area being sealed and protected from passage of contaminating fluids into or out of the enclosed area by the combination of said slidable seal means, said proximal sleeve means and said distal sleeve means.

3. A method of manufacturing a catheter assembly for delivering respiratory therapy by way of aspiration of or delivery of fluids to a respiratory tract of an intubated patient, said method comprising the steps of:

obtaining catheter means adapted for insertion into a respiratory tract of an intubated patient so as to be able to either aspirate the respiratory tract or deliver fluids to the respiratory tract;

slidably joining a distal fitting to said catheter means at one end thereof;

non-slidably joining a proximal fitting to said catheter means at an end opposite to said one end;

providing flexible sheath means having a distal end and a proximal end;

surrounding said catheter means with said sheath means so as to form a single enclosed area that concentrically surrounds the catheter means between the distal and proximal fittings so that said sheath means is collapsible in an accordion-like fashion when said catheter means is advanced through the distal fitting as the proximal and distal fittings are moved toward one another;

partially evacuating said single enclosed area so that said sheath means can be substantially fully collapsed without the need to exhaust gas from said enclosed area as said proximal and distal fittings are moved toward one another;

sealing said sheath means along a substantial length of said proximal end and said distal end so as to thereby form a hermetic seal at each of said proximal and distal ends of said sheath means in order to prevent gaseous entry into or exit from said enclosed area so that said enclosed area is hermetically sealed from the atmosphere so as to prevent contaminants from entering said enclosed area as said proximal and distal fittings are moved toward one another; and

forming a fluid tight fit between the distal end of the sheath means and the distal fitting and between the proximal end of the sheath means and the proximal fitting.