WO2015109229A1 - Medical tube apparatus - Google Patents

Medical tube apparatus Download PDF

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Publication number
WO2015109229A1
WO2015109229A1 PCT/US2015/011818 US2015011818W WO2015109229A1 WO 2015109229 A1 WO2015109229 A1 WO 2015109229A1 US 2015011818 W US2015011818 W US 2015011818W WO 2015109229 A1 WO2015109229 A1 WO 2015109229A1
Authority
WO
WIPO (PCT)
Prior art keywords
passageway
connection fitting
hub connection
endotracheal tube
port
Prior art date
Application number
PCT/US2015/011818
Other languages
French (fr)
Inventor
Scott P. GERAGHTY
Dennis M. WERGER
Original Assignee
Monitoring For Life, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Monitoring For Life, Llc filed Critical Monitoring For Life, Llc
Publication of WO2015109229A1 publication Critical patent/WO2015109229A1/en
Priority to US15/136,587 priority Critical patent/US10112024B2/en
Priority to US16/173,739 priority patent/US11219728B2/en
Priority to US17/572,158 priority patent/US20220126044A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0486—Multi-lumen tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
    • A61B2562/221—Arrangements of sensors with cables or leads, e.g. cable harnesses
    • A61B2562/224—Cables for conducting fluids therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0484—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids at the distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/105—Filters
    • A61M16/106—Filters in a path
    • A61M16/1065—Filters in a path in the expiratory path
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes

Definitions

  • This disclosure relates generally to the field of medical devices, and more specifically to a medical tube apparatus and, in certain embodiments, an endotracheal tube apparatus to be used on a human body.
  • Pulmonary ventilation is achieved through insufflation (e.g. manual or automated) of a person's lungs by causing air or oxygen to flow in and out of a person's lungs, generally when natural breathing has stopped or is otherwise inadequate.
  • intubation or entubation
  • tracheal intubation in which a flexible plastic tube is inserted into the trachea (windpipe) of a person to provide or maintain an open airway, and to serve as a conduit through which to administer certain drugs via a drug delivery port.
  • Tracheal intubation is often performed in critically injured or anesthetized patients to facilitate pulmonary ventilation and to prevent the possibility of asphyxiation or airway obstruction.
  • Tracheal intubation is most often orotracheal, or endotracheal, in which an endotracheal tube is passed through the mouth and vocal apparatus of a person and into the trachea.
  • a laryngoscope may be used to bring the vocal cords and larynx into view prior to inserting the endotracheal tube.
  • the tube may then be inserted in the trachea through the vocal cords to the point that an inflation cuff surrounding a distal end portion of the tube rests just below the vocal cords.
  • a bag valve mask is squeezed adjacent a proximal end of the tube to pass air and/or oxygen to the lungs.
  • a stethoscope may then be used by medical personnel to listen for breathing sounds to ensure proper placement of the tube.
  • endotracheal intubation must be performed away from a clinic and in the field, particularly during a trauma and other emergency situations.
  • a laryngoscope or a stethoscope it may not be possible to use a laryngoscope or a stethoscope to ensure proper placement of the endotracheal tube in the trachea, in which case the endotracheal tube may enter the esophagus.
  • the endotracheal tube in addition to a drug delivery port and a cuff inflation port, the endotracheal tube generally includes a sampling port, provided as part of an adapter, to sample gases of the person being intubated. More particularly, the sampling port may be a carbon dioxide sampling port which is connectable to a carbon dioxide analyzer/monitor (e.g. a capnograph).
  • a carbon dioxide analyzer/monitor e.g. a capnograph
  • the drug delivery port and the cuff inflation port include tubing which is spliced from the outside into a sidewall of the endotracheal tube.
  • the ports may be damaged during use, such as being severed by the person's teeth in response to a seizure.
  • the spliced ports may become compressed between the person's mouth and the endotracheal tube, and not function as intended. What is needed is a tube apparatus, particularly an endotracheal tube apparatus which incorporates various ports which are less susceptible to damage during use of the endotracheal tube.
  • the present disclosure provided a medical device comprising a tube apparatus including a tube and a hub connection fitting; the tube insertable into a patient; the hub connection fitting connectable to the tube; a central passageway extending through the hub connection fitting and longitudinally with the tube; a plurality of ports joined with the hub connection fitting, the plurality of ports comprising at least a first port and a second port; wherein the first port is operable with a first port passageway, wherein the first port passageway extends through the hub connection fitting and longitudinally with the tube; and wherein the second port is operable with a second port passageway, wherein the second port passageway extends through the hub connection fitting and longitudinally with the tube.
  • the passageways for the ports are contained in the tube and the hub connection fitting, thus inhibiting a risk that the ports may become damaged.
  • the present disclosure also provides a medical device comprising an endotracheal tube apparatus including an endotracheal tube and a hub connection fitting; the endotracheal tube insertable into a trachea of a patient; the hub connection fitting connectable to the endotracheal tube; a ventilation passageway extending through the hub connection fitting and along a length of the endotracheal tube; and a plurality of ports joined with the hub connection fitting.
  • the plurality of ports may comprise at least at least one fluid sampling port and at least one drug delivery port; wherein the fluid sampling port is operable with a fluid sampling passageway, wherein the fluid sampling passageway extends through the hub connection fitting and through a fluid sampling lumen of the endotracheal tube and wherein the drug delivery port is operable with a drug delivery passageway, wherein the drug delivery passageway extends through the hub connection fitting and through a drug delivery lumen of the endotracheal tube.
  • the plurality of ports may further comprise at least one cuff inflation port or an additional drug delivery port.
  • the present disclosure also provides a medical device comprising an endotracheal tube apparatus including an endotracheal tube and a hub connection fitting; the endotracheal tube insertable into a trachea of a patient; the hub connection fitting connectable to the endotracheal tube; a ventilation passageway extending through the hub connection fitting and along a length of the endotracheal tube; a plurality of ports joined with the hub connection fitting, the plurality of ports comprising at least one fluid sampling port, at least one drug delivery port, and at least one cuff inflation port; wherein the fluid sampling port is operable with a fluid sampling passageway, wherein the fluid sampling passageway extends through the hub connection fitting and through a fluid sampling lumen of the endotracheal tube; wherein the drug delivery port is operable with a drug delivery passageway, wherein the drug delivery passageway extends through the hub connection fitting and through a drug delivery lumen of the endotracheal tube; and wherein the cuff inflation port in operable with
  • the present disclosure also provides a method of forming a medical device comprising providing an elongated tube comprising a plurality of lumens; providing a hub connection fitting including a plurality of male connectors; connecting the hub connection fitting and the tube such that each male connector of the plurality of male connectors is inserted into and occupies a different lumen of the plurality of lumens of the tube; wherein the plurality of lumens comprise at least a central lumen; a first secondary lumen and a second secondary lumen; wherein, upon connecting the hub connection fitting and the tube, a central passageway is formed which extends through the hub connection fitting and longitudinally through the central lumen of the tube; a first port passageway is formed which extends through the hub connection fitting and longitudinally through the first secondary lumen of the tube; and a second port passageway is formed which extends through the hub connection fitting and longitudinally through the second secondary lumen of the tube.
  • FIG. 1 shows a medical device comprising a tube apparatus, and more particularly an endotracheal tube apparatus according to the present disclosure
  • FIG. 1A is an enlarged view of a distal end of the endotracheal tube apparatus of FIG. 1;
  • FIG. IB is an enlarged view of an alternative embodiment of the distal end of the endotracheal tube apparatus of FIG. 1;
  • FIG. 2 is an exploded cross-sectional view of the endotracheal tube apparatus of FIG. 1;
  • FIG. 2A is an alternative embodiment of the exploded cross-sectional view of the endotracheal tube apparatus of FIG. 1;
  • FIG. 3 is a perspective cross-sectional view of a hub connection fitting of the endotracheal tube apparatus of FIG. 1;
  • FIG. 4 is a top view of the hub connection fitting of the endotracheal tube apparatus of FIG. 1;
  • FIG. 5 is a bottom view of the hub connection fitting of the endotracheal tube apparatus of FIG. 1;
  • FIG. 6 shows an alternative embodiment of medical device according to the present disclosure which may be used in conjunction with other devices as shown.
  • FIG. 7 is a tube apparatus according to the present disclosure including a light.
  • a medical device 10 comprising a tube apparatus 20, and more particularly an endotracheal tube apparatus 20 of a medical (respiratory) system 2 according to the present disclosure. While a remainder of the disclosure may refer to the tube apparatus as being an endotracheal tube apparatus 20, it should be understood that the present disclosure is not limited to an endotracheal tube apparatus 20, and the present tube apparatus may have other medical applications, as well as non-medical applications, other than that of endotracheal tube apparatus 20.
  • the endotracheal tube apparatus 20 comprises a flexible, elongated, hollow endotracheal tube 30, which may be extruded (thermoplastic) tubing having a constant profile along its length, to be inserted into the trachea of a human host, such as a patient.
  • exemplary thermoplastic polymer compositions may include plasticized polyvinyl chloride and thermoplastic elastomers.
  • the endotracheal tube 30 may have a length in a range of 7.5 cm to 50 cm (centimeters); and more particularly in a range of 17 cm to 23 cm.
  • endotracheal tube 30 is cylindrical, with a constant diameter, however in other embodiments endotracheal tube 30 may not necessarily be cylindrical. Endotracheal tube 30 may be translucent, and more particularly transparent.
  • an elastomer may be characterized as a material that has an elongation at 23°C of at least 100%, and which, after being stretched to twice its original length and being held at such for one minute, may recover in a range of 50% to 100% within one minute after release from the stress. More particularly, the elastomer may recover in a range of 75% to 100% within one minute after release from the stress, and even more particularly recover in a range of 90% to 100% within one minute after release from the stress.
  • the elastomer may be comprised of any polymer, including natural or synthetic polymers, and thermoplastic or thermoset polymers. Thus, the elastomer may be either a natural or synthetic elastomer.
  • the elastomer may comprise, essentially consist of or consist of natural or synthetic rubber.
  • Endotracheal tube 30 has an outer cylindrical side wall 32 having an outer surface 34 an inner surface 36.
  • the endotracheal tube 30 may have an outer diameter OD in a range of 5 mm to 15 mm, and more particularly in a range of 9 mm to 13 mm.
  • the thickness of the outer cylindrical side wall 32 may be in a range from 0.75 mm to 3 mm and more particularly in a range of 1 mm to 2 mm. While endotracheal tube apparatus 20 may be described herein for oral intubation, apparatus 20 may also be used for nasal intubation.
  • Endotracheal tube 30 includes a centrally disposed primary ventilation passageway 38, in the form of a lumen, which extends along the length of the endotracheal tube 30 from a proximal end opening 40 of the endotracheal tube 30 to a distal end opening 42 of the endotracheal tube 30.
  • the ventilation passageway 38 shares a common longitudinal (center) axis 41 with the endotracheal tube 30.
  • Ventilation passageway 38 may be understood as the primary passageway for tracheal intubation and subsequent use of a respirator means 200, such as a bag valve mask or a mechanical ventilator connected to endotracheal tube apparatus 20 to provide mechanical ventilation/respiration to the patient.
  • the maximum inner diameter ID of the ventilation passageway 38 may be in a range of 3 mm to 13 mm, and more particularly in a range of 7 mm to 11 mm.
  • endotracheal tube 30 includes a plurality of secondary passageways 44, 46 and 48, all provided by lumens, which have (semi) cylindrical side walls 54, 56 and 58 which are formed unitary (i.e. formed as a single piece monolithic) with the outer cylindrical side wall 32, with the cylindrical side walls 54, 56 and 58. While all the secondary passageways 44, 46 and 48 are shown to have the same cross-sectional profile (circular) and size, they may have different sizes.
  • the secondary passageways 44, 46 and 48 may be arranged 90 degrees apart from one another on the outer cylindrical side wall 32 and extend parallel with ventilation passageway 38 in endotracheal tube 30. As shown, all of the passageways 38, 44, 46 and 48 have a different longitudinal axis (i.e. none of the passageways 38, 44, 46 and 48 are coaxial), and the axis of passageways 44, 46 and 48 are parallel with the axis of ventilation passageway 38. Cylindrical side walls 54, 56 and 58 may have a thickness in a range from 0.5 mm to 2 mm and more particularly in a range of 0.75 mm to 1.5 mm.
  • the secondary passageways As shown in FIG 1A, in certain embodiments the secondary passageways
  • the secondary passageways 44, 46 and 48 may not be formed within the outer cylindrical side wall 32, but rather adjacent thereto, as placing the secondary passageways 44, 46 and 48 within the confines of the outer cylindrical side wall 32 may locally weaken the outer cylindrical side wall 32. Furthermore, as the proximal end of the endotracheal tube 30 seals with a hub connection fitting 70 as further described herein, maintaining the thickness of outer cylindrical side wall 32 uniformly around the passageway 38 may provide a more stable seal. In such case, as shown, the secondary passageways 44, 46, 48 and the inner walls thereof 54, 56, 58 thereof will narrow the ventilation passageway 38 in certain locations along the length of the ventilation passageway 38 in the form of a semi-circular/semi- cylindrical protuberance into the ventilation passageway 38.
  • one or more of the secondary passageways 44, 46 and 48 may reduce the thickness of the outer cylindrical side wall 32 (shown at location 32a) to no less than 60% (and preferably no less that 70% and more preferably no less than 80% and even more preferably no less than 90%) of the thickness of the outer cylinder side wall 32 adjacent to the secondary passageways 44, 46 and 48 (shown at location 32b) located between the secondary passageways 46 and 48.
  • secondary passageway 44 is a fluid sampling passageway in fluid communication with a fluid sampling port 24 of the endotracheal tube apparatus 20, while secondary passageway 46 is a drug delivery passageway in fluid communication with a drug delivery port 26 and secondary passageway 48 is a cuff inflation passageway in fluid communication with a cuff inflation port 28.
  • the overall inner diameter and radius of the secondary passageways 44, 46, 48 is smaller than the overall inner diameter and radius of the primary passageway 38, and in a range of 10%-50% of the inner diameter and radius of the primary passageway 38 and more particularly in a range of 20 -40 of the inner diameter and radius of the primary passageway 38, such as 25-35% of the inner diameter and radius of the primary passageway 38.
  • endotracheal apparatus 20 further comprises hub connection fitting 70 that operatively connects the endotracheal tube 30 to respirator means 200.
  • the hub connection fitting 70 comprises a body 72 having a proximal (cylindrical male connector) body portion 74 and a distal (cylindrical male connector) body portion 76 separated by an intermediate/middle body portion 78.
  • Hub connection fitting 70 further comprises a primary ventilation passageway 80 which extends through the proximal connector portion 74, middle body portion 78 and distal connector portion 76. Ventilation passageway 80 is to provide fluid communication between ventilation passageway 38 of endotracheal tube 30 and respirator means 200.
  • the outer diameter of the proximal cylindrical male connector portion 74 of the hub connection fitting 70 is dimensioned to be inserted into a passageway 202 of a respirator tube 204 of respirator means 200 and interference (frictionally) fit with the inside diameter of the sidewall 206 thereof.
  • the respirator tube 204 is to contact against annular lip/shoulder 82 of intermediate portion 78.
  • hub connection fitting 70 includes three secondary passageways 94, 96 and 98 arranged to connect and provide fluid communication with passageways 44, 46 and 48 of endotracheal tube 30.
  • secondary passageway 94 defines a portion of the fluid (exhaled gas(es) from the patient) sampling passageway in fluid communication with fluid sampling port 24 of the endotracheal tube apparatus 20, while secondary passageway 96 defines a portion of the drug delivery passageway in fluid communication with drug delivery port 26 and secondary passage 98 defines a portion of the cuff inflation passageway in fluid communication with cuff inflation port 28.
  • the secondary passageways 94, 96 and 98 are shown to have an L-shape including a 90 degree bend/angle A.
  • angle A is shown at 90 degrees, the shape and/or angle may be different in other embodiments.
  • angle A may be in a range of 10 degrees to 170 (e.g. 20 degrees to 160 degrees, 30 degrees to 150 degrees, 45 degrees to 135 degrees, 30 degrees to 90 degrees, 90 degrees to 160 degrees, 45 degrees to 90 degrees, 90 degrees to 135 degrees) relative to the longitudinal axis, with an acute angle A being towards the distal body portion 76 and an obtuse angle A being towards the proximal body portion 74.
  • angle A is at 135 degrees.
  • each passageway 94, 96 and 98 is defined by a distal cylindrical male connector portion 104, 106, 108 of the hub connection fitting 70 which is dimensioned to be inserted into passageways 44, 46 and 48, respectively, of endotracheal tube 30 and interference (frictionally) fit with the inside diameter of the side walls 54, 56 and 58, respectively.
  • the hub connection fitting 70 includes a fluid sampling passageway connector 104 which connects to the fluid sampling passageway 44 of the endotracheal tube 30; a drug delivery passageway connector 106 which connects to the drug delivery passageway 46 of the endotracheal tube 30; and a cuff inflation connector 108 which connects to the cuff inflation passageway 48 of the endotracheal tube 30.
  • the endotracheal tube 30 is to contact and butt against annular lip/shoulder 84 of distal connector portion 76. In the foregoing manner, all of the passageways may be sealed between endotracheal tube 30 and hub connection fitting 70 with a fluid (air) tight seal, i.e. a hermetic seal.
  • each passageway 94, 96 and 98 defined by a distal cylindrical male connector portion 104, 106, 108 may be adhesively bonded with the inside diameter of the side walls 54, 56 and 58, respectively, and the endotracheal tube 30 in contact against annular lip/shoulder 84 of distal connector portion 76 may also be adhesively bonded with an adhesive.
  • each passageway 94, 96 and 98 defined by a distal cylindrical male connector portion 104, 106, 108 may be also be welded with the inside diameter of the side walls 54, 56 and 58, respectively, and proximal end of the endotracheal tube 30 in contact against annular lip/shoulder 84 of distal connector portion 76 may also be welded thereto.
  • a thin membrane e.g. an adhesive bonding tape strip
  • an annular ring 90 may overlie distal body portion 76 and be at least one of interference fit, adhesive bonded and welded thereto.
  • annular ring 90 may be provided as part of the body 72 of hub connection fitting 70, i.e. as a single piece. As shown, a recess 92 is now formed at the distal end of distal connector portion 76 into which endotracheal tube 30 may be located and at least one of interference fit, adhesive bonded and welded thereto. It should be understood that any combination of interference fits, adhesive bonding and welding may be used for any of the connections alone or in conjunction with another joining method.
  • each passageway 94, 96, 98 includes a counter-bore 114, 116, 118.
  • Counter-bore 114 is configured to receive the distal end portion of (extruded) tubing 124 in fluid communication with the fluid sampling port 24.
  • Counter-bore 116 is configured to receive the distal end portion of (extruded) tubing 126 in fluid communication with the drug delivery port 26.
  • Counter-bore 118 (on the backside of the structure, same type of counter-bore as 114 and 116) is configured to receive the distal end portion of (extruded) tubing 128 in fluid communication with the cuff inflation port 28.
  • the distal end portion of tubing 124, 126, 128 may be interference fit with counter-bore 114, 116, 118.
  • the distal end portion of tubing 124, 126, 128 may be adhesive bonded with counter-bore 114, 116, 118 with an adhesive and/or the distal end portion of tubing 124, 126, 128 may be welded with counter-bore 114, 116, 118.
  • the extruded tubing 124 in fluid communication with the fluid sampling port 24 includes a passageway (lumen) 134 which forms part of the fluid sampling passageway which extends through hub connection fitting 70 (as passageway 94) and endotracheal tube 30 (as passageway 44).
  • the proximal end of tubing 124 is connected to fluid sampling port 24, which comprises a filter 142 and fluid sampling port threaded connector 144, which connects fluid sampling port to an analyzing/monitoring apparatus 300.
  • fluid sampling port 24 may be a carbon dioxide sampling port
  • analyzing/monitoring apparatus 300 may be a carbon dioxide analyzer/monitor (e.g. a capnograph).
  • Filter 142 may be particularly suited to separate liquids (e.g. saliva) from the gases (e.g. carbon dioxide) exhaled by the patient, such that the gases therein may be analyzed by a gas analyzer, such as a capnograph, which may detect a presence of carbon dioxide therein.
  • fluid sampling port 24 may be a sampling port which provides a liquid (e.g. saliva) sample for analysis, with or without a gas sample for analysis.
  • fluid sampling port 24 may include colorimetric paper to detect a presence of carbon dioxide in the fluid sample exhaled from the patient.
  • the colorimetric paper e.g. KangarooTM C0 2 colorimetric paper from Covidien
  • the colorimetric paper e.g. KangarooTM C0 2 colorimetric paper from Covidien
  • gases exhaled by the patient may enter passageway 44 of endotracheal tube 30 at the distal end opening 42 of endotracheal tube 30, and thereafter flow through passageway 94 of hub connection fitting 70 and passageway 134 of extruded tubing 124, and thereafter through fluid sampling port threaded connector 144 and into analyzing/monitoring apparatus 300.
  • the passageway for the fluid sampling port 24 may be closer positioned to obtain a carbon dioxide sample from the patient than known sampling ports which terminate at a proximal end of the endotracheal tube apparatus 20, and more particularly within adapter 70.
  • passageway 94 also opens into ventilation passageway 80 and is in fluid communication therewith such that a fluid sample may be drawn from the patient by respirator means 200.
  • Extruded tubing 126 in fluid communication with the drug delivery port 26 includes a passageway (lumen) 136 which forms part of the drug delivery passageway which extends through hub connection fitting 70 (as passageway 96) and endotracheal tube 30 (as passageway 46).
  • a drug delivery port 26 which comprises a drug delivery port connector 146, which may be particularly suited to a drug delivery device, such as a syringe (not shown).
  • passageway 96 is not in fluid communication with ventilation passageway 80.
  • Extruded tubing 128 in fluid communication with the cuff inflation port 28 includes a passageway (lumen) 138 which forms part of the cuff inflation passageway which extends through hub connection fitting 70 (as passageway 98) and endotracheal tube 30 (as passageway 48).
  • a passageway (lumen) 138 which forms part of the cuff inflation passageway which extends through hub connection fitting 70 (as passageway 98) and endotracheal tube 30 (as passageway 48).
  • the proximal end of tubing 128 is connected to cuff inflation port 28, which comprises a cuff inflation port connector 148, which connects with an inflation means (not shown).
  • a proximal end of passageway 98 is not in fluid communication with ventilation passageway 80.
  • the distal end of the passageway 98 is occluded in a known manner and an aperture is formed in a distal end portion of the outer wall 32 to the passageway 98, such that the passageway 98 is in fluid communication with inflation cuff 49.
  • each of the fluid sampling port 24, drug delivery port 26 and cuff inflation port 28 connect to the endotracheal tube apparatus 20 via the hub connection fitting 70, which remains outside the patient during intubation.
  • the fluid sampling port 24, drug delivery port 26 and cuff inflation port 28 are not subject to damage during use, such as being severed by the person's teeth in response to a seizure.
  • the medical device 10 disclosed herein is an endotracheal tube apparatus 20, it should be understood that the medical device 10 is not necessarily limited to that of an endotracheal tube apparatus 20, and such may provide uses in minimally invasive surgery, as well as more specific applications such as gastrointestinal and cardiology, and any other use where multi-lumen tube/tubing in combination with the hub connection fitting may be utilized. Furthermore, it should be understood that the multi-lumen tube/tubing and hub connection fitting are not limited to one primary (central) passageway and three secondary passageways, and that any feasible number of passageways may be utilized, such as up to 20 secondary passageways.
  • a medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used or medical inspection, diagnosis and/or treatment where one or more inspection, diagnostic and/ or treatment devices are passed through a passageway of the medical device 10.
  • Devices which pass through the passageways may include devices for grasping, suturing, stapling, chemically bonding and/or removal of tissue, and/or for removal of foreign bodies, gas, tissue or liquid sampling; and/or for insertion of inspection/diagnosis devices, treatment devices, a suction device, a camera or other viewing device and/or a light for viewing.
  • Devices may include catheters, snares, staplers, and forceps.
  • a lighting apparatus 160 may be incorporated in endotracheal tube apparatus 20.
  • lighting apparatus 160 may comprise a lighting device 164, particularly a light source, such as a light- emitting diode, positioned within one of secondary passageways 44, 46 or 48 to emit light from the distal end opening 42 of endotracheal tube 30.
  • Lighting device 164 may be electrically connectable to a battery 168 by an electrical conductor 166.
  • battery 168 may be located in one of counter-bores 114, 116, 118 of hub connection fitting 70.
  • the battery 168 may be positioned out of electrical contact with electrical connector 166 to inhibit the lighting apparatus 160 from powering prior to desired use.
  • a removable non-conductive liner 170 with a pull tab 172 may be initially positioned between the electrical conductor 166 and the battery 168.
  • the electrical conductor 166 may be removed from hub connection fitting 70 by simply pulling on pull tab 172, which may establish electrical contact between battery 168 and electrical conductor 166 to power and light lighting device 164.
  • battery 168 may also be pushed further into the counter-bore 114, 116 or 118 to establish electrical contact with electrical conductor 166.
  • a medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used in pulmonary applications involving inspection, diagnosis and/or treatment where one or more devices are passed through each passageway to perform procedures in the lungs, such as lung resection or biopsy sample (tissue) extraction.
  • a medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used in gastrointestinal applications involving inspection, diagnosis and/or treatment where one or more devices are passed through each passageway to perform procedures in the gastrointestinal tract. Such procedures may involve the esophagus, stomach, intestines such as the duodenum, and the colon. Specific procedures may include gastric bypass or other stomach reduction.
  • a medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used in cardiology for the insertion of pacing leads or other diagnostic electrical leads.
  • multiple surgical related devices can be inserted through the tube 30 and a hub connection fitting 70 to the procedure site, which each device using a separate lumen of the tube 30 and a hub connection fitting 70 to improve control, safety and/or efficacy of the surgical devices.
  • the tube 30 and a hub connection fitting 70 may both have appropriately sized passageways for such applications, which may be larger or smaller than the passageways required for use as an endotracheal tube apparatus.
  • the tube 30 and a hub connection fitting 70 may be provided in kits with multiple quantities, sizes and angle of the passageways through the hub connection fitting 70.
  • the number of passageways is only limited by the outside dimensions of the tube and required internal dimensions of the passageways.

Abstract

The present disclosure provides a medical device comprising an endotracheal tube apparatus including an endotracheal tube and a hub connection fitting; the endotracheal tube insertable into a trachea of a patient; the hub connection fitting connectable to the endotracheal tube; a ventilation passageway extending through the hub connection fitting and along a length of the endotracheal tube; and a plurality of ports joined with the hub connection fitting, the plurality of ports comprising at least at least one fluid sampling port and at least one drug delivery port.

Description

MEDICAL TUBE APPARATUS
CROSS-REFERNCE TO RELATED APPLICATONS
This application claims the benefit of U.S. Provisional Patent Application Serial No. 61/928,685 filed January 17, 2014, the entire disclosure of which is incorporated herein by reference.
FIELD
This disclosure relates generally to the field of medical devices, and more specifically to a medical tube apparatus and, in certain embodiments, an endotracheal tube apparatus to be used on a human body.
BACKGROUND
Artificial respiration involves assisting or stimulating a person's natural respiration, a metabolic process referring to an exchange of gases within the body by pulmonary ventilation, external respiration and internal respiration. Pulmonary ventilation is achieved through insufflation (e.g. manual or automated) of a person's lungs by causing air or oxygen to flow in and out of a person's lungs, generally when natural breathing has stopped or is otherwise inadequate.
One method of pulmonary ventilation involves intubation, or entubation, which pertains to the insertion of a tube generally into an external orifice of the body. One particular method of intubation is tracheal intubation, in which a flexible plastic tube is inserted into the trachea (windpipe) of a person to provide or maintain an open airway, and to serve as a conduit through which to administer certain drugs via a drug delivery port. Tracheal intubation is often performed in critically injured or anesthetized patients to facilitate pulmonary ventilation and to prevent the possibility of asphyxiation or airway obstruction. Tracheal intubation is most often orotracheal, or endotracheal, in which an endotracheal tube is passed through the mouth and vocal apparatus of a person and into the trachea.
During an endotracheal intubation, the person's mouth is opened and the endotracheal tube is inserted down the throat. To better ensure the endotracheal tube is properly positioned, a laryngoscope may be used to bring the vocal cords and larynx into view prior to inserting the endotracheal tube. The tube may then be inserted in the trachea through the vocal cords to the point that an inflation cuff surrounding a distal end portion of the tube rests just below the vocal cords.
Finally, after an inflation cuff is inflated to inhibit leakage, a bag valve mask is squeezed adjacent a proximal end of the tube to pass air and/or oxygen to the lungs. A stethoscope may then be used by medical personnel to listen for breathing sounds to ensure proper placement of the tube.
Often endotracheal intubation must be performed away from a clinic and in the field, particularly during a trauma and other emergency situations. Unfortunately, under such adverse conditions, it may not be possible to use a laryngoscope or a stethoscope to ensure proper placement of the endotracheal tube in the trachea, in which case the endotracheal tube may enter the esophagus.
As a result, in addition to a drug delivery port and a cuff inflation port, the endotracheal tube generally includes a sampling port, provided as part of an adapter, to sample gases of the person being intubated. More particularly, the sampling port may be a carbon dioxide sampling port which is connectable to a carbon dioxide analyzer/monitor (e.g. a capnograph).
With current devices prior to the present disclosure, the drug delivery port and the cuff inflation port include tubing which is spliced from the outside into a sidewall of the endotracheal tube. Unfortunately, because the spliced tubing are located between the endotracheal tube and the person's mouth during use, the ports may be damaged during use, such as being severed by the person's teeth in response to a seizure. Also, the spliced ports may become compressed between the person's mouth and the endotracheal tube, and not function as intended. What is needed is a tube apparatus, particularly an endotracheal tube apparatus which incorporates various ports which are less susceptible to damage during use of the endotracheal tube.
SUMMARY
The present disclosure provided a medical device comprising a tube apparatus including a tube and a hub connection fitting; the tube insertable into a patient; the hub connection fitting connectable to the tube; a central passageway extending through the hub connection fitting and longitudinally with the tube; a plurality of ports joined with the hub connection fitting, the plurality of ports comprising at least a first port and a second port; wherein the first port is operable with a first port passageway, wherein the first port passageway extends through the hub connection fitting and longitudinally with the tube; and wherein the second port is operable with a second port passageway, wherein the second port passageway extends through the hub connection fitting and longitudinally with the tube.
With the tube apparatus, the passageways for the ports are contained in the tube and the hub connection fitting, thus inhibiting a risk that the ports may become damaged.
In certain embodiments, the present disclosure also provides a medical device comprising an endotracheal tube apparatus including an endotracheal tube and a hub connection fitting; the endotracheal tube insertable into a trachea of a patient; the hub connection fitting connectable to the endotracheal tube; a ventilation passageway extending through the hub connection fitting and along a length of the endotracheal tube; and a plurality of ports joined with the hub connection fitting. The plurality of ports may comprise at least at least one fluid sampling port and at least one drug delivery port; wherein the fluid sampling port is operable with a fluid sampling passageway, wherein the fluid sampling passageway extends through the hub connection fitting and through a fluid sampling lumen of the endotracheal tube and wherein the drug delivery port is operable with a drug delivery passageway, wherein the drug delivery passageway extends through the hub connection fitting and through a drug delivery lumen of the endotracheal tube. In certain embodiments, the plurality of ports may further comprise at least one cuff inflation port or an additional drug delivery port.
In certain embodiments, the present disclosure also provides a medical device comprising an endotracheal tube apparatus including an endotracheal tube and a hub connection fitting; the endotracheal tube insertable into a trachea of a patient; the hub connection fitting connectable to the endotracheal tube; a ventilation passageway extending through the hub connection fitting and along a length of the endotracheal tube; a plurality of ports joined with the hub connection fitting, the plurality of ports comprising at least one fluid sampling port, at least one drug delivery port, and at least one cuff inflation port; wherein the fluid sampling port is operable with a fluid sampling passageway, wherein the fluid sampling passageway extends through the hub connection fitting and through a fluid sampling lumen of the endotracheal tube; wherein the drug delivery port is operable with a drug delivery passageway, wherein the drug delivery passageway extends through the hub connection fitting and through a drug delivery lumen of the endotracheal tube; and wherein the cuff inflation port in operable with a cuff inflation passageway, wherein the cuff inflation passageway extends through the hub connection fitting and through a cuff inflation lumen of the endotracheal tube.
In certain embodiments, the present disclosure also provides a method of forming a medical device comprising providing an elongated tube comprising a plurality of lumens; providing a hub connection fitting including a plurality of male connectors; connecting the hub connection fitting and the tube such that each male connector of the plurality of male connectors is inserted into and occupies a different lumen of the plurality of lumens of the tube; wherein the plurality of lumens comprise at least a central lumen; a first secondary lumen and a second secondary lumen; wherein, upon connecting the hub connection fitting and the tube, a central passageway is formed which extends through the hub connection fitting and longitudinally through the central lumen of the tube; a first port passageway is formed which extends through the hub connection fitting and longitudinally through the first secondary lumen of the tube; and a second port passageway is formed which extends through the hub connection fitting and longitudinally through the second secondary lumen of the tube.
FIGURES
The above-mentioned and other features of this disclosure, and the manner of attaining them, will become more apparent and better understood by reference to the following description of embodiments described herein taken in conjunction with the accompanying drawings, wherein:
FIG. 1 shows a medical device comprising a tube apparatus, and more particularly an endotracheal tube apparatus according to the present disclosure; FIG. 1A is an enlarged view of a distal end of the endotracheal tube apparatus of FIG. 1;
FIG. IB is an enlarged view of an alternative embodiment of the distal end of the endotracheal tube apparatus of FIG. 1;
FIG. 2 is an exploded cross-sectional view of the endotracheal tube apparatus of FIG. 1;
FIG. 2A is an alternative embodiment of the exploded cross-sectional view of the endotracheal tube apparatus of FIG. 1;
FIG. 3 is a perspective cross-sectional view of a hub connection fitting of the endotracheal tube apparatus of FIG. 1;
FIG. 4 is a top view of the hub connection fitting of the endotracheal tube apparatus of FIG. 1;
FIG. 5 is a bottom view of the hub connection fitting of the endotracheal tube apparatus of FIG. 1;
FIG. 6 shows an alternative embodiment of medical device according to the present disclosure which may be used in conjunction with other devices as shown; and
FIG. 7 is a tube apparatus according to the present disclosure including a light.
DETAILED DESCRIPTION
It may be appreciated that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention(s) herein may be capable of other embodiments and of being practiced or being carried out in various ways. Also, it may be appreciated that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting as such may be understood by one of skill in the art. Furthermore, throughout the present description, like reference numerals and letters indicate corresponding structure throughout the several views, and such corresponding structure need not be separately discussed. Furthermore, any particular feature(s) of a particular exemplary embodiment may be equally applied to any other exemplary embodiment(s) of this specification as suitable. In other words, features between the various exemplary embodiments described herein are interchangeable as suitable, and not exclusive.
Referring now to FIGS. 1-5, there is shown a medical device 10 comprising a tube apparatus 20, and more particularly an endotracheal tube apparatus 20 of a medical (respiratory) system 2 according to the present disclosure. While a remainder of the disclosure may refer to the tube apparatus as being an endotracheal tube apparatus 20, it should be understood that the present disclosure is not limited to an endotracheal tube apparatus 20, and the present tube apparatus may have other medical applications, as well as non-medical applications, other than that of endotracheal tube apparatus 20.
As shown, the endotracheal tube apparatus 20 comprises a flexible, elongated, hollow endotracheal tube 30, which may be extruded (thermoplastic) tubing having a constant profile along its length, to be inserted into the trachea of a human host, such as a patient. Exemplary thermoplastic polymer compositions may include plasticized polyvinyl chloride and thermoplastic elastomers. As such, in certain embodiments, the endotracheal tube 30 may have a length in a range of 7.5 cm to 50 cm (centimeters); and more particularly in a range of 17 cm to 23 cm. As shown, endotracheal tube 30 is cylindrical, with a constant diameter, however in other embodiments endotracheal tube 30 may not necessarily be cylindrical. Endotracheal tube 30 may be translucent, and more particularly transparent.
As used herein, an elastomer may be characterized as a material that has an elongation at 23°C of at least 100%, and which, after being stretched to twice its original length and being held at such for one minute, may recover in a range of 50% to 100% within one minute after release from the stress. More particularly, the elastomer may recover in a range of 75% to 100% within one minute after release from the stress, and even more particularly recover in a range of 90% to 100% within one minute after release from the stress. The elastomer may be comprised of any polymer, including natural or synthetic polymers, and thermoplastic or thermoset polymers. Thus, the elastomer may be either a natural or synthetic elastomer. The elastomer may comprise, essentially consist of or consist of natural or synthetic rubber.
Endotracheal tube 30 has an outer cylindrical side wall 32 having an outer surface 34 an inner surface 36. In certain embodiments, the endotracheal tube 30 may have an outer diameter OD in a range of 5 mm to 15 mm, and more particularly in a range of 9 mm to 13 mm. The thickness of the outer cylindrical side wall 32 may be in a range from 0.75 mm to 3 mm and more particularly in a range of 1 mm to 2 mm. While endotracheal tube apparatus 20 may be described herein for oral intubation, apparatus 20 may also be used for nasal intubation.
Endotracheal tube 30 includes a centrally disposed primary ventilation passageway 38, in the form of a lumen, which extends along the length of the endotracheal tube 30 from a proximal end opening 40 of the endotracheal tube 30 to a distal end opening 42 of the endotracheal tube 30. As shown, the ventilation passageway 38 shares a common longitudinal (center) axis 41 with the endotracheal tube 30. Ventilation passageway 38 may be understood as the primary passageway for tracheal intubation and subsequent use of a respirator means 200, such as a bag valve mask or a mechanical ventilator connected to endotracheal tube apparatus 20 to provide mechanical ventilation/respiration to the patient. The maximum inner diameter ID of the ventilation passageway 38 may be in a range of 3 mm to 13 mm, and more particularly in a range of 7 mm to 11 mm.
In addition, endotracheal tube 30 includes a plurality of secondary passageways 44, 46 and 48, all provided by lumens, which have (semi) cylindrical side walls 54, 56 and 58 which are formed unitary (i.e. formed as a single piece monolithic) with the outer cylindrical side wall 32, with the cylindrical side walls 54, 56 and 58. While all the secondary passageways 44, 46 and 48 are shown to have the same cross-sectional profile (circular) and size, they may have different sizes.
As shown, the secondary passageways 44, 46 and 48 may be arranged 90 degrees apart from one another on the outer cylindrical side wall 32 and extend parallel with ventilation passageway 38 in endotracheal tube 30. As shown, all of the passageways 38, 44, 46 and 48 have a different longitudinal axis (i.e. none of the passageways 38, 44, 46 and 48 are coaxial), and the axis of passageways 44, 46 and 48 are parallel with the axis of ventilation passageway 38. Cylindrical side walls 54, 56 and 58 may have a thickness in a range from 0.5 mm to 2 mm and more particularly in a range of 0.75 mm to 1.5 mm.
As shown in FIG 1A, in certain embodiments the secondary passageways
44, 46 and 48 may not be formed within the outer cylindrical side wall 32, but rather adjacent thereto, as placing the secondary passageways 44, 46 and 48 within the confines of the outer cylindrical side wall 32 may locally weaken the outer cylindrical side wall 32. Furthermore, as the proximal end of the endotracheal tube 30 seals with a hub connection fitting 70 as further described herein, maintaining the thickness of outer cylindrical side wall 32 uniformly around the passageway 38 may provide a more stable seal. In such case, as shown, the secondary passageways 44, 46, 48 and the inner walls thereof 54, 56, 58 thereof will narrow the ventilation passageway 38 in certain locations along the length of the ventilation passageway 38 in the form of a semi-circular/semi- cylindrical protuberance into the ventilation passageway 38.
However, in certain embodiments, as shown in FIG. IB, one or more of the secondary passageways 44, 46 and 48 may reduce the thickness of the outer cylindrical side wall 32 (shown at location 32a) to no less than 60% (and preferably no less that 70% and more preferably no less than 80% and even more preferably no less than 90%) of the thickness of the outer cylinder side wall 32 adjacent to the secondary passageways 44, 46 and 48 (shown at location 32b) located between the secondary passageways 46 and 48.
As explained in greater detail below, secondary passageway 44 is a fluid sampling passageway in fluid communication with a fluid sampling port 24 of the endotracheal tube apparatus 20, while secondary passageway 46 is a drug delivery passageway in fluid communication with a drug delivery port 26 and secondary passageway 48 is a cuff inflation passageway in fluid communication with a cuff inflation port 28. As shown, the overall inner diameter and radius of the secondary passageways 44, 46, 48 is smaller than the overall inner diameter and radius of the primary passageway 38, and in a range of 10%-50% of the inner diameter and radius of the primary passageway 38 and more particularly in a range of 20 -40 of the inner diameter and radius of the primary passageway 38, such as 25-35% of the inner diameter and radius of the primary passageway 38.
In addition to endotracheal tube 30, endotracheal apparatus 20 further comprises hub connection fitting 70 that operatively connects the endotracheal tube 30 to respirator means 200. The hub connection fitting 70 comprises a body 72 having a proximal (cylindrical male connector) body portion 74 and a distal (cylindrical male connector) body portion 76 separated by an intermediate/middle body portion 78. Hub connection fitting 70 further comprises a primary ventilation passageway 80 which extends through the proximal connector portion 74, middle body portion 78 and distal connector portion 76. Ventilation passageway 80 is to provide fluid communication between ventilation passageway 38 of endotracheal tube 30 and respirator means 200.
The outer diameter of the proximal cylindrical male connector portion 74 of the hub connection fitting 70 is dimensioned to be inserted into a passageway 202 of a respirator tube 204 of respirator means 200 and interference (frictionally) fit with the inside diameter of the sidewall 206 thereof. The respirator tube 204 is to contact against annular lip/shoulder 82 of intermediate portion 78.
In addition to ventilation passageway 80, hub connection fitting 70 includes three secondary passageways 94, 96 and 98 arranged to connect and provide fluid communication with passageways 44, 46 and 48 of endotracheal tube 30. As such, secondary passageway 94 defines a portion of the fluid (exhaled gas(es) from the patient) sampling passageway in fluid communication with fluid sampling port 24 of the endotracheal tube apparatus 20, while secondary passageway 96 defines a portion of the drug delivery passageway in fluid communication with drug delivery port 26 and secondary passage 98 defines a portion of the cuff inflation passageway in fluid communication with cuff inflation port 28. As shown, the secondary passageways 94, 96 and 98 are shown to have an L-shape including a 90 degree bend/angle A. However, while angle A is shown at 90 degrees, the shape and/or angle may be different in other embodiments. For example, angle A may be in a range of 10 degrees to 170 (e.g. 20 degrees to 160 degrees, 30 degrees to 150 degrees, 45 degrees to 135 degrees, 30 degrees to 90 degrees, 90 degrees to 160 degrees, 45 degrees to 90 degrees, 90 degrees to 135 degrees) relative to the longitudinal axis, with an acute angle A being towards the distal body portion 76 and an obtuse angle A being towards the proximal body portion 74. For example, as shown in phantom, angle A is at 135 degrees.
As shown, the distal end of each passageway 94, 96 and 98 is defined by a distal cylindrical male connector portion 104, 106, 108 of the hub connection fitting 70 which is dimensioned to be inserted into passageways 44, 46 and 48, respectively, of endotracheal tube 30 and interference (frictionally) fit with the inside diameter of the side walls 54, 56 and 58, respectively. Thus, the hub connection fitting 70 includes a fluid sampling passageway connector 104 which connects to the fluid sampling passageway 44 of the endotracheal tube 30; a drug delivery passageway connector 106 which connects to the drug delivery passageway 46 of the endotracheal tube 30; and a cuff inflation connector 108 which connects to the cuff inflation passageway 48 of the endotracheal tube 30. Further, the endotracheal tube 30 is to contact and butt against annular lip/shoulder 84 of distal connector portion 76. In the foregoing manner, all of the passageways may be sealed between endotracheal tube 30 and hub connection fitting 70 with a fluid (air) tight seal, i.e. a hermetic seal. In certain alternative embodiments, the distal end of each passageway 94, 96 and 98 defined by a distal cylindrical male connector portion 104, 106, 108 may be adhesively bonded with the inside diameter of the side walls 54, 56 and 58, respectively, and the endotracheal tube 30 in contact against annular lip/shoulder 84 of distal connector portion 76 may also be adhesively bonded with an adhesive.
In certain embodiments, the distal end of each passageway 94, 96 and 98 defined by a distal cylindrical male connector portion 104, 106, 108 may be also be welded with the inside diameter of the side walls 54, 56 and 58, respectively, and proximal end of the endotracheal tube 30 in contact against annular lip/shoulder 84 of distal connector portion 76 may also be welded thereto. A thin membrane (e.g. an adhesive bonding tape strip) may also overly the butt joint around the diameter thereof. Alternatively, as shown in FIG. 2A, an annular ring 90 may overlie distal body portion 76 and be at least one of interference fit, adhesive bonded and welded thereto. Alternatively, annular ring 90 may be provided as part of the body 72 of hub connection fitting 70, i.e. as a single piece. As shown, a recess 92 is now formed at the distal end of distal connector portion 76 into which endotracheal tube 30 may be located and at least one of interference fit, adhesive bonded and welded thereto. It should be understood that any combination of interference fits, adhesive bonding and welding may be used for any of the connections alone or in conjunction with another joining method.
The proximal end of each passageway 94, 96, 98 includes a counter-bore 114, 116, 118. Counter-bore 114 is configured to receive the distal end portion of (extruded) tubing 124 in fluid communication with the fluid sampling port 24. Counter-bore 116 is configured to receive the distal end portion of (extruded) tubing 126 in fluid communication with the drug delivery port 26. Counter-bore 118 (on the backside of the structure, same type of counter-bore as 114 and 116) is configured to receive the distal end portion of (extruded) tubing 128 in fluid communication with the cuff inflation port 28. In order to join the two components together, the distal end portion of tubing 124, 126, 128 may be interference fit with counter-bore 114, 116, 118. Alternatively, or in conjunction with the interference fit, the distal end portion of tubing 124, 126, 128 may be adhesive bonded with counter-bore 114, 116, 118 with an adhesive and/or the distal end portion of tubing 124, 126, 128 may be welded with counter-bore 114, 116, 118.
As shown, the extruded tubing 124 in fluid communication with the fluid sampling port 24 includes a passageway (lumen) 134 which forms part of the fluid sampling passageway which extends through hub connection fitting 70 (as passageway 94) and endotracheal tube 30 (as passageway 44). As shown, the proximal end of tubing 124 is connected to fluid sampling port 24, which comprises a filter 142 and fluid sampling port threaded connector 144, which connects fluid sampling port to an analyzing/monitoring apparatus 300. More particularly, fluid sampling port 24 may be a carbon dioxide sampling port, and analyzing/monitoring apparatus 300 may be a carbon dioxide analyzer/monitor (e.g. a capnograph). Filter 142 may be particularly suited to separate liquids (e.g. saliva) from the gases (e.g. carbon dioxide) exhaled by the patient, such that the gases therein may be analyzed by a gas analyzer, such as a capnograph, which may detect a presence of carbon dioxide therein. In other embodiments, fluid sampling port 24 may be a sampling port which provides a liquid (e.g. saliva) sample for analysis, with or without a gas sample for analysis. In certain embodiments, fluid sampling port 24 may include colorimetric paper to detect a presence of carbon dioxide in the fluid sample exhaled from the patient. The colorimetric paper (e.g. Kangaroo™ C02 colorimetric paper from Covidien) may be wrapped around filter 142.
With use of endotracheal tube apparatus 20, gases exhaled by the patient may enter passageway 44 of endotracheal tube 30 at the distal end opening 42 of endotracheal tube 30, and thereafter flow through passageway 94 of hub connection fitting 70 and passageway 134 of extruded tubing 124, and thereafter through fluid sampling port threaded connector 144 and into analyzing/monitoring apparatus 300. In the foregoing manner, the passageway for the fluid sampling port 24 may be closer positioned to obtain a carbon dioxide sample from the patient than known sampling ports which terminate at a proximal end of the endotracheal tube apparatus 20, and more particularly within adapter 70. As shown, passageway 94 also opens into ventilation passageway 80 and is in fluid communication therewith such that a fluid sample may be drawn from the patient by respirator means 200.
Extruded tubing 126 in fluid communication with the drug delivery port 26 includes a passageway (lumen) 136 which forms part of the drug delivery passageway which extends through hub connection fitting 70 (as passageway 96) and endotracheal tube 30 (as passageway 46). As shown, the proximal end of tubing 126 is connected to a drug delivery port 26, which comprises a drug delivery port connector 146, which may be particularly suited to a drug delivery device, such as a syringe (not shown). As shown, unlike passageway 94, passageway 96 is not in fluid communication with ventilation passageway 80.
Extruded tubing 128 in fluid communication with the cuff inflation port 28 includes a passageway (lumen) 138 which forms part of the cuff inflation passageway which extends through hub connection fitting 70 (as passageway 98) and endotracheal tube 30 (as passageway 48). As shown, the proximal end of tubing 128 is connected to cuff inflation port 28, which comprises a cuff inflation port connector 148, which connects with an inflation means (not shown). As shown, unlike passageway 94, a proximal end of passageway 98 is not in fluid communication with ventilation passageway 80. Also unlike the other passageways, the distal end of the passageway 98 is occluded in a known manner and an aperture is formed in a distal end portion of the outer wall 32 to the passageway 98, such that the passageway 98 is in fluid communication with inflation cuff 49.
In the foregoing manner, each of the fluid sampling port 24, drug delivery port 26 and cuff inflation port 28 connect to the endotracheal tube apparatus 20 via the hub connection fitting 70, which remains outside the patient during intubation. As a result, because none of the fluid sampling port 24, drug delivery port 26 and cuff inflation port 28 are located between the endotracheal tube 30 and the person's mouth during use, the fluid sampling port 24, drug delivery port 26 and cuff inflation port 28 are not subject to damage during use, such as being severed by the person's teeth in response to a seizure. Also, there is no possibility of the fluid sampling port 24, drug delivery port 26 or the cuff inflation port 28 compressed between the person's mouth and the endotracheal tube 30 during use of endotracheal tube apparatus 20 and not operating as intended.
While the medical device 10 disclosed herein is an endotracheal tube apparatus 20, it should be understood that the medical device 10 is not necessarily limited to that of an endotracheal tube apparatus 20, and such may provide uses in minimally invasive surgery, as well as more specific applications such as gastrointestinal and cardiology, and any other use where multi-lumen tube/tubing in combination with the hub connection fitting may be utilized. Furthermore, it should be understood that the multi-lumen tube/tubing and hub connection fitting are not limited to one primary (central) passageway and three secondary passageways, and that any feasible number of passageways may be utilized, such as up to 20 secondary passageways.
Referring to FIG. 6, a medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used or medical inspection, diagnosis and/or treatment where one or more inspection, diagnostic and/ or treatment devices are passed through a passageway of the medical device 10. Devices which pass through the passageways may include devices for grasping, suturing, stapling, chemically bonding and/or removal of tissue, and/or for removal of foreign bodies, gas, tissue or liquid sampling; and/or for insertion of inspection/diagnosis devices, treatment devices, a suction device, a camera or other viewing device and/or a light for viewing. Devices may include catheters, snares, staplers, and forceps.
For example, as shown in FIG. 7, a lighting apparatus 160 may be incorporated in endotracheal tube apparatus 20. As shown, lighting apparatus 160 may comprise a lighting device 164, particularly a light source, such as a light- emitting diode, positioned within one of secondary passageways 44, 46 or 48 to emit light from the distal end opening 42 of endotracheal tube 30. Lighting device 164 may be electrically connectable to a battery 168 by an electrical conductor 166. As shown, battery 168 may be located in one of counter-bores 114, 116, 118 of hub connection fitting 70.
When endotracheal tube apparatus 20 is provided by the manufacturer, the battery 168 may be positioned out of electrical contact with electrical connector 166 to inhibit the lighting apparatus 160 from powering prior to desired use. In such regard, a removable non-conductive liner 170 with a pull tab 172 may be initially positioned between the electrical conductor 166 and the battery 168.
Thereafter, when endotracheal tube apparatus 20 is to be used, the electrical conductor 166 may be removed from hub connection fitting 70 by simply pulling on pull tab 172, which may establish electrical contact between battery 168 and electrical conductor 166 to power and light lighting device 164. Alternatively, or in addition to the use of non-conductive liner 170, battery 168 may also be pushed further into the counter-bore 114, 116 or 118 to establish electrical contact with electrical conductor 166.
A medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used in pulmonary applications involving inspection, diagnosis and/or treatment where one or more devices are passed through each passageway to perform procedures in the lungs, such as lung resection or biopsy sample (tissue) extraction. A medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used in gastrointestinal applications involving inspection, diagnosis and/or treatment where one or more devices are passed through each passageway to perform procedures in the gastrointestinal tract. Such procedures may involve the esophagus, stomach, intestines such as the duodenum, and the colon. Specific procedures may include gastric bypass or other stomach reduction.
A medical device 10 comprising a tube 30 and a hub connection fitting 70 as disclosed herein may be used in cardiology for the insertion of pacing leads or other diagnostic electrical leads.
For minimally invasive surgery, multiple surgical related devices can be inserted through the tube 30 and a hub connection fitting 70 to the procedure site, which each device using a separate lumen of the tube 30 and a hub connection fitting 70 to improve control, safety and/or efficacy of the surgical devices.
In the foregoing applications, it should be understood that the tube 30 and a hub connection fitting 70 may both have appropriately sized passageways for such applications, which may be larger or smaller than the passageways required for use as an endotracheal tube apparatus. As such, the tube 30 and a hub connection fitting 70 may be provided in kits with multiple quantities, sizes and angle of the passageways through the hub connection fitting 70. The number of passageways is only limited by the outside dimensions of the tube and required internal dimensions of the passageways.
While a preferred embodiment of the present invention(s) has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention(s) and the scope of the appended claims. The scope of the invention(s) should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents. Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention(s) which the applicant is entitled to claim, or the only manner(s) in which the invention(s) may be claimed, or that all recited features are necessary.

Claims

What is claimed is:
1. A medical device comprising:
an endotracheal tube apparatus including an endotracheal tube and a hub connection fitting;
the endotracheal tube insertable into a trachea of a patient;
the hub connection fitting connectable to the endotracheal tube;
a ventilation passageway extending through the hub connection fitting and along a length of the endotracheal tube;
a plurality of ports joined with the hub connection fitting, the plurality of ports comprising at least at least one fluid sampling port and at least one drug delivery port;
wherein the fluid sampling port is operable with a fluid sampling passageway, wherein the fluid sampling passageway extends through the hub connection fitting and through a fluid sampling lumen of the endotracheal tube; and
wherein the drug delivery port is operable with a drug delivery passageway, wherein the drug delivery passageway extends through the hub connection fitting and through a drug delivery lumen of the endotracheal tube.
2. The device of claim 1 wherein:
the fluid sampling passageway extends through a fluid sampling port tubing segment which connects the fluid sampling port to the hub connection fitting; and
the drug delivery passageway extends through a drug delivery port tubing segment which connects the drug delivery port to the hub connection fitting.
3. The device of claim 2 wherein:
the fluid sampling port tubing segment is located in a first counterbore of the hub connection fitting; and
the drug delivery port tubing segment is located in a second counterbore of the hub connection fitting.
4. The device of claim 2 wherein:
at least one of the fluid sampling port tubing segment and the drug delivery port tubing segment is at least one of interference fit, adhesively bonded and welded to the hub connection fitting.
5. The device of claim 1 wherein:
the fluid sampling port includes a fluid sampling port connector to connect the fluid sampling port to an analyzer to detect a presence of carbon dioxide gas in a fluid sample comprising one or more gases exhales from the patient.
6. The device of claim 1 wherein:
the hub connection fitting comprises
a fluid sampling passageway connector which connects with the fluid sampling passageway of the endotracheal tube; and
a drug delivery passageway connector which connects with the drug delivery passageway of the endotracheal tube.
7. The device of claim 6 wherein:
the fluid sampling passageway connector comprises a male connector portion which is located in a fluid sampling lumen of the endotracheal tube which provides the fluid sampling passageway of the endotracheal tube; and
the drug delivery passageway connector comprises a male connector portion which is located in a drug delivery lumen of the endotracheal tube which provides the drug delivery passageway of the endotracheal tube.
8. The device of claim 7 wherein:
the fluid sampling passageway connector is at least one of interference fit, adhesively bonded and welded within the fluid sampling lumen of the endotracheal tube; and the drug delivery passageway connector is at least one of interference fit, adhesively bonded and welded within the drug delivery lumen of the endotracheal tube.
9. The device of claim 1 wherein:
the plurality of ports further comprise at least one cuff inflation port; and wherein the cuff inflation port in operable with a cuff inflation passageway, wherein the cuff inflation passageway extends through the hub connection fitting and through a cuff inflation lumen of the endotracheal tube.
10. The device of claim 9 wherein:
the cuff inflation passageway extends through a cuff inflation port tubing segment which connects the cuff inflation port to the hub connection fitting;
11. The device of claim 10 wherein:
the cuff inflation port tubing segment is located in a counterbore of the hub connection fitting.
12. The device of claim 10 wherein:
the cuff inflation port tubing segment is at least one of interference fit, adhesively bonded and welded to the hub connection fitting.
13. The device of claim 9 wherein:
the hub connection fitting comprises a cuff inflation passageway connector which connects with the cuff inflation passageway of the endotracheal tube.
14. The device of claim 13 wherein:
the cuff inflation passageway connector comprises a male connector portion which is located in a cuff inflation lumen of the endotracheal tube which provides the cuff inflation passageway of the endotracheal tube.
15. The device of claim 14 wherein: the cuff inflation passageway is at least one of interference fit, adhesively bonded and welded within the cuff inflation lumen of the endotracheal tube.
16. The device of claim 1 wherein:
the hub connection fitting includes cylindrical connector portion adapted to be inserted into a respirator tube of a respirator means.
17. The device of claim 1 further comprising:
a lighting apparatus
18. The device of claim 17 wherein:
the lighting apparatus comprises a light source and a battery.
19. The device of claim 1 further comprising:
a camera.
20. A method of forming a medical device comprising:
providing an elongated tube comprising a plurality of lumens;
providing a hub connection fitting including a plurality of male connectors;
connecting the hub connection fitting and the tube such that each male connector of the plurality of male connectors is inserted into and occupies a different lumen of the plurality of lumens of the tube;
wherein the plurality of lumens comprise at least a central lumen, a first secondary lumen and a second secondary lumen;
wherein, upon connecting the hub connection fitting and the tube,
a central passageway is formed which extends through the hub connection fitting and longitudinally through the central lumen of the tube; a first port passageway is formed which extends through the hub connection fitting and longitudinally through the first secondary lumen of the tube; and a second port passageway is formed which extends through the hub connection fitting and longitudinally through the second secondary lumen of the tube.
PCT/US2015/011818 2014-01-17 2015-01-16 Medical tube apparatus WO2015109229A1 (en)

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US15/136,587 US10112024B2 (en) 2014-01-17 2016-04-22 Medical tube apparatus
US16/173,739 US11219728B2 (en) 2014-01-17 2018-10-29 Medical tube apparatus
US17/572,158 US20220126044A1 (en) 2014-01-17 2022-01-10 Medical Tube Apparatus

Applications Claiming Priority (2)

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US201461928685P 2014-01-17 2014-01-17
US61/928,685 2014-01-17

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Publication number Priority date Publication date Assignee Title
WO2021248657A1 (en) * 2020-06-12 2021-12-16 上海交通大学医学院附属第九人民医院 Awake tracheal intubation device with gas navigation and visualization
WO2022229912A1 (en) * 2021-04-29 2022-11-03 Fisher & Paykel Healthcare Limited Respiratory device connector with lumen

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US4850371A (en) * 1988-06-13 1989-07-25 Broadhurst John H Novel endotracheal tube and mass spectrometer
US20040215061A1 (en) * 2003-04-28 2004-10-28 Zebadiah Kimmel Visualization stylet for endotracheal intubation
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US20130092171A1 (en) * 2011-10-17 2013-04-18 Nellcor Puritan Bennett Llc Multi-lumen tracheal tube with pressure distribution

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US4669463A (en) * 1984-02-22 1987-06-02 Mcconnell Richard B Endotracheal tube injection site addition
US4850371A (en) * 1988-06-13 1989-07-25 Broadhurst John H Novel endotracheal tube and mass spectrometer
US20040215061A1 (en) * 2003-04-28 2004-10-28 Zebadiah Kimmel Visualization stylet for endotracheal intubation
US7503328B2 (en) * 2005-03-15 2009-03-17 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Mucus slurping endotracheal tube
US20120172664A1 (en) * 2010-12-29 2012-07-05 Nellcor Puritan Bennett Llc Multi-lumen tracheal tube with visualization device
US20130092171A1 (en) * 2011-10-17 2013-04-18 Nellcor Puritan Bennett Llc Multi-lumen tracheal tube with pressure distribution

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021248657A1 (en) * 2020-06-12 2021-12-16 上海交通大学医学院附属第九人民医院 Awake tracheal intubation device with gas navigation and visualization
WO2022229912A1 (en) * 2021-04-29 2022-11-03 Fisher & Paykel Healthcare Limited Respiratory device connector with lumen

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