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
  • A61M16/0475—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
  • A61M16/04—Tracheal tubes
  • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
  • A61M16/049—Mouthpieces
  • A61M16/0493—Mouthpieces with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
• • 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

Definitions

• the invention is directed to endotracheal tubes as used to ventilate comatose patients and those in respiratory failure. More specifically, the invention is directed to an endotracheal tube wherein at least the portion of the body of the tube that is in contact with an orally intubated patient's teeth is bite- resistant.
• the present invention is useful because it prevents the collapsing or damaging of the endotracheal tube during voluntary or involuntary teeth clenching or biting by an intubated patient.
• bite protectors suffer from several deficiencies. The most serious of these deficiencies results from the fact that many bite protectors are not integral to the endotracheal tube. These separable bite protectors often must be mounted onto the endotracheal tube by medical staff in a separate procedure following intubation. Placement of separable bite protectors is often cumbersome and exposes the medical staff to the risk of bite injury and the patient to possible periods of restricted gas flow while the bite protector is retrieved and mounted. Accordingly, there is a need for a bite protector that is integral to the endotracheal tube and, therefore, does not require a separate fitting procedure. Further, separable bite protectors are often bulky and slide freely back and forth along the endotracheal tube causing trauma to the patient's oral cavity.
• bite protector that is not slideably mounted.
• Many separable and non-separable bite protectors have deficiencies resulting from the materials from which they were manufactured.
• Some bite protectors are constructed of materials which, while fairly resistant to collapse, are permanently deformed when bitten, making it necessary to replace either the bite protector or the endotracheal tube or both following forceful teeth clenching.
• Other bite protectors are constructed of materials which are so rigid that they expose the patient to the risk of tooth breakage during forceful voluntary or involuntary teeth clenching.
• a bite protector that is constructed of a material which is sufficiently resistant to collapse or bite damage, but which is not substantially permanently deformed or damaging to the patient's teeth with forceful teeth clenching.
• bite protectors are a separately stocked item from the endotrachael tubes.
• a bite protector is not an item that is universally available.
• it may need to be searched down. It would be of great benefit if each endotrachael tube had an integral bite protector. Accordingly, it is an object of the present invention to provide a solution to that need.
• the present invention is directed to a bite-resistant endotracheal tube having a bite protector that is integral to the endotracheal tube and, therefore, does not require a separate fitting procedure.
• the present invention comprises a length of tubing having a proximal end for receiving and transmitting a flow of air or gas; a distal end of suitable size and length for insertion into the trachea of a patient and delivery of the flow of air and/or gas; and an intermediate bite-resistant portion operatively connecting the proximal and distal ends and forming a tubular passageway therebetween.
• the polymeric materials used to construct the proximal end and the intermediate bite-resistant portion are made from the same bite-resistant material.
• the polymeric materials used to construct the proximal end and the intermediate bite-resistant portion have different structural and functional properties.
• the proximal or machine-end of the tube is constructed of a polymeric material that is sufficiently soft to permit cleavage of a segment of the endotracheal tube to, thereby, reduce dead space and maximize patient ventilation.
• the intermediate bite-resistant portion is constructed of a second, bite-resistant polymeric material which is heterogenous to that used in the proximal end and is sufficiently rigid to cause the intermediate portion to be substantially resistant to collapse or puncture due to biting action.
• the distal end has a tip beveled at an angle acute to the central axis of the tubing to, thereby, form a long wall side and a short wall side.
• the proximal end, the intermediate bite-resistant portion, and the distal end are operatively attached to one another along the length of the endotracheal tube for transmission of air and/or gas.
• the present invention is also directed to a bite-resistant endotracheal tube having a bite-resistant portion constructed of a polymeric material which is "substantially homogeneous."
• a polymeric material which is substantially homogeneous is defined as a polymeric material that either lacks reinforcements or is reinforced by primarily fibrous reinforcement materials, rather than by metal or similar rigid reinforcement materials.
• At least one advantage of an endotracheal tube lacking metal or similar rigid reinforcements is that, if the endotracheal tube were to become damaged during forceful teeth clenching, there is no risk to the patient of oral trauma caused by exposed rigid reinforcement materials.
• the present invention is further directed to an endotracheal tube having a bite-resistant portion constructed of a material which is sufficiently resilient to cause the intermediate portion to retain a substantially round cross-sectional area, and not permanently deform with forceful teeth clenching.
• Figure 1 shows an elevational view of an endotracheal tube made in accordance with this invention.
• Figure 2 shows a cross-sectional view of one embodiment of an endotracheal tube made in accordance with this invention, wherein the second polymeric material is designated with hatch marks and comprises only the intermediate portion of the endotracheal tube.
• Figure 3 shows a cross-sectional view of a rigid junction fitting to which at least a portion of an endotracheal tube is mounted.
• Figure 4 shows both an elevational view (Figure 4A) and a cross- sectional view (Figure 4B) of an endotrahceal tube comprising a balloon cuff apparatus.
• the present invention is directed to an endotracheal tube having an integral bite protector wherein at least that portion of the body of the tube that is in contact with an orally intubated patient's teeth is bite-resistant. More specifically, the present invention is directed to a bite-resistant endotracheal tube comprising: a length of tubing having a proximal end, the proximal end for receiving a flow of air or gas and transmitting the air or gas, a distal end of suitable size and length for insertion into a trachea of a patient, the distal end for delivery of the air or gas, and an intermediate portion operatively connecting the proximal end to the distal end and forming a tubular passageway therebetween, the proximal end being constructed of a first polymeric material which is sufficiently soft to permit cleavage of a segment of the proximal end; the intermediate portion being constructed of a second polymeric material which is heterogenous to the first material and of sufficient rigidity to cause the intermediate portion to be substantially resistant to collapse or
• the endotracheal tube of the present invention has several embodiments.
• the present invention is directed to a bite-resistant endotracheal tube 10 comprising a length of tubing 12 having a proximal end 14 for receiving gas or air flow and transmitting that air or gas; a distal end 16 of suitable size and length for insertion into the trachea of a patient, the distal end 16 for delivery of the air or gas; and an intermediate portion 18 operatively connecting the proximal end 14 to the distal end 16 and forming a tubular passageway 20 therebetween.
• the proximal end 14 comprises at least that portion of the endotracheal tube 10 that extends outwardly from an orally intubated patient's mouth.
• the proximal end 14 is constructed of a first polymeric material 22 which is sufficiently soft to permit cleavage of a segment of the proximal end 14.
• the intermediate portion 18 is constructed of a second polymeric material 24 which is heterogenous to the first polymeric material 22 and of sufficient rigidity to cause the intermediate portion 18 to be substantially resistant to collapse or puncture due to biting action.
• the intermediate portion 18 comprises at least the portion of the endotracheal tube 10 which is in contact with an intubated patient's teeth.
• the distal end 16 has a beveled tip 26 that is mitered, preferably at an angle acute to the central axis of the endotracheal tube 10, to form a long wall side 28 and a short wall side 30.
• the proximal end 14, the intermediate portion 18, and the distal end 16 are operatively attached to one another along the length of tubing for transmission of the air or gas.
• Each of the polymeric materials forming the body of the endotracheal tube 10 should be biocompatible, that is non-toxic, waterproof, hypoallergenic, heat stable at body temperature, and saliva/sputum stable.
• the polymeric materials forming the body of the endotracheal tube 10 must be sterihzable. A preferred method of sterilization is by ethylene oxide gas treatment. It is important that any polymeric materials forming the body of the endotracheal tube 10 be able to withstand the pressures that current endotracheal tubes withstand e.g., 100-120 cm H 2 O pressure. It is also important that materials forming the body of the endotracheal tube be flexible at body temperature.
• the polymeric materials forming the body of the endotracheal tube 10 have some flexibility at body temperature and a hardness within a durometer rating range of at least 50-90 on the Shore A scale. In order to prevent the clogging of the endotracheal tube 10 with thick bodily secretions, it is also important that the materials forming the body of the endotracheal tube 10 are capable of being coated with a non-stick surfactant. It is also preferred that the polymeric materials forming the body of the endotracheal tube 10 be translucent to the tubular passageway 20 to be viewed for obstructions. It is preferred that the materials forming the body of the endotracheal tube 10 be low in cost and the tube itself be easy to manufacture.
• the proximal end 14 and the intermediate portion 18 of the present invention are constructed of materials that differ both structurally and functionally. Because it is important that excess tubing extending outward from the mouth of an orally intubated patient be cleaved, in order to reduce dead space and maximize patient ventilation, the proximal end 14 is constructed of a first polymeric material 22 that is sufficiently soft to permit shortening by cleavage e.g., with scissors. Accordingly, in the present invention, it is preferred that the first polymeric material 22 be comprised of standard medical grade silicone. Typically, the first polymeric material 22 is approximately 90% by weight dimethyl silicone and 10% by weight inert silica.
• the intermediate portion 18 is constructed of a second polymeric material 24 that is sufficiently rigid to cause the intermediate portion 18 to be substantially resistant to collapse or puncture due to biting action, as shown in Figure 2, wherein in one embodiment the second polymeric material 24 is designated with hatch marks and comprises only the intermediate portion 18 of the endotracheal tube 10. Also, in the broadest aspect of the invention, the second polymeric material 24 is "substantially homogeneous.”
• a polymeric material that is substantially homogeneous is defined as a polymeric material that either lacks reinforcing materials or is reinforced by primarily fibrous reinforcement materials, rather than by metal or similar rigid reinforcement materials.
• At least one advantage of an endotracheal tube lacking metal or similar rigid reinforcements is that, if the endotracheal tube were to become damaged during forceful teeth clenching, there is no risk to the patient of oral trauma caused by exposed rigid reinforcement materials.
• Acceptable reinforcement materials include, but are not limited to glass fibers, nylon fibers, and other similar organic and synthetic non-metallic fibers.
• the second polymeric material 24 is sufficiently resilient to cause the intermediate portion 18 to retain a substantially round cross-sectional area following forceful teeth clenching.
• EASTMAN ® TENITE Model No. P5M2Z-012.
• the first polymeric material 22 and the second polymeric material 24 may be joined by chemical adhesives or fusion. This may be accomplished by any adhesion or fusion method commonly used in the art to join polymeric tubing providing that the method employed is biocompatible as defined supra.
• the method employed must withstand sterilization. The preferred method of sterilization is by ethylene oxide gas treatment. The method employed also must be able to withstand pressures within the range of 100-120 cm H 2 O. Further, it is desirable that the junction formed between portions of the tubing be able to be coated with a non- stick surfactant. It is also preferred that the method employed be of low cost and permit the tube itself to be easily manufactured. Suitable fusion techniques include sonic welding/fusion, heat sealing and adhesion.
• the preferred fusion method is heat sealing employing shrink tubing.
• the degree of curvature of the endotracheal tube is preferably integrally pre-formed. Less preferably, the degree of curvature of the endotracheal tube is formed by mitered fusion to form an arcuate formation of the distal and intermediate portions. Alternately, but less preferred, the degree of curvature of the endotracheal tube is formed by mitered fusion to form a rectilinear formation by mitering at 90° angle. Because of anatomical differences between individuals, it is desirable that the endotracheal tube 10 of the present invention be provided in a variety of sizes.
• the polymeric materials forming the proximal end 14, the intermediate portion 18 and the distal end 16 of the present invention may have a variety of inner diameters (I.D.) and outer diameters (O.D.).
• the polymeric materials forming the proximal end 14, the intermediate portion 18, and the distal end 16 of the endotracheal tube 10 will have an I.D. and an O.D. the same as or similar to those cu ⁇ ently used in endotracheal tubes.
• I.D. and O.D. ranges will vary dependent upon the size of individual patients. Standard endotracheal tubes I.D. and O.D. ranges are: for newborns, 3.0 mm I.D.
• the wall thickness of an adult endotracheal tube is about 2.5 mm. These diameters are not critical, but are representative.
• the endotracheal tube 10 has an I.D. of 8.0 mm and an O.D. of 11.0 mm.
• the polymeric materials forming the proximal end 14, the intermediate portion 18 and the distal end 16 have the same I.D. and O.D.
• the tubing of the intermediate portion have a different thickness (difference between OD and ID) than the tubing of the proximal end or the distal end. In some instances, the thickness of the intermediate portion is greater than the thickness of the proximal and/or distal end or both.
• endotracheal tube 10 of the present invention be constructed in a variety of lengths, those lengths being the same as or similar to those cu ⁇ ently used in endotracheal tubes. Accordingly, the endotracheal tube 10 of the present invention may have a variety of lengths. Ordinarily, endotracheal tube 10 length is measured from the beveled tip 26 along the long wall side 28 toward the proximal end 14. Typically, endotracheal tube 10 lengths will vary dependent upon the size of individual patients.
• Standard endotracheal tube sizes for children are: for newborns, about 1 1 - 16 cm.; for four weeks to six months, about 12 - 18 cm; for six months to one year, about 13 - 20 cm; for one year to two years, about 14 -22 cm; for two to four years, about 15 - 24 cm; for four to five and one-half years about 16 - 27 cm; for five and one-half years to seven and one-half years, about 18 - 28 cm; and for adults, about 28 - 35 cm.
• These lengths are not critical, but representative based upon the average size of a child in these age groups.
• the typical endotracheal tube 10 has a length of about 33 cm.
• the intermediate portion 18 encompasses at least that portion of the body of the endotracheal tube 10 which would most likely be in contact with the teeth of an adult intubated patient.
• the region contacting an adult patient's teeth is about 6-8 cm in length and comprises the region of tubing at about 12 to 26 cm from the beveled tip 26 as measured along the long wall side 28.
• the distal end 16 and intermediate portion 18 are constructed of the second polymeric material 24.
• the distal end 16 is formed of a third polymeric material 32 e.g., medical grade polyurethane.
• the third polymeric material 32 must be biocompatible, as defined supra, sterihzable, and able to withstand pressures in the range of 100-120 cm H 2 O. Further, it is important that the third polymeric material 32 be capable of being coated with a non-stick surfactant. More preferably, both the proximal end 14 and the distal end 16 are formed of the first polymeric material 22.
• the endotracheal tube 10 has a rigid junction fitting 34, which operatively connects the endotracheal tube 10 to a mechanical source of suction or a source of controlled mechanical ventilation, as shown in Figure 3.
• the rigid junction fitting 34 has a cylindrical upper portion 36, which provides a connection to a mechanical source of suction or a source of controlled mechanical ventilation.
• the rigid junction fitting 34 also has a cylindrical lower portion 38 attached to the proximal end 14 of the endotracheal tube 10, the cylindrical upper portion 36 having a first outer diameter 40 and the cylindrical lower portion 38 having a second outer diameter 42 smaller than the first outer diameter 40.
• the endotracheal tube 10 has a Murphy's eye 44 to provide adequate airflow to the left bronchi should the endotracheal tube be placed into the right bronchi.
• the Murphy's eye 44 preferably is located inwardly from the beveled tip 26 along the long wall side 28.
• the endotracheal tube 10 has an inflatable balloon cuff apparatus 46 for preventing displacement of the endotracheal tube 10 once properly inserted into the trachea of a patient and for forming a seal between the endotracheal tube 10 and the trachea, as shown in Figures 4 A and 4B.
• the inflatable balloon cuff apparatus 46 comprises inlet means 48 for gas introduction; a channel 50 for ca ⁇ ying gas or air flow, the channel 50 having an entrance port 52 and an exit port 54, the entrance port 52 engaging the channel 50 at the entrance port 52; and an expandable membrane 56 having a top portion 58 and a bottom portion 60, the top portion 58 and bottom portion 60, engaging the endotracheal tube and forming a lumen 62 between the endotracheal tube 10 and the expandable membrane 56, wherein the exit port 54 opens into the lumen 62.
• the inflatable balloon cuff apparatus 46 is located along the distal end 16 of the endotracheal tube 10 as near as possible to the beveled tip 26 without covering the distal opening or the Murphy's eye 44.
• the channel 50 may be provided as a shaft tube extending longitudinally along the endotracheal tube 10 within the polymeric materials forming the endotracheal tube 10.
• the channel 50 may also be provided as a length of tubing extending through the tubular passageway 20 of the endotracheal tube 10.
• the endotrachael tube of the present invention with a natural bend or arc conforming in part to the arc defined by the mouth and the trachea.
• a natural bend or arc facilitates insertion of the endotrachael tube in a patient without need of a stylette to bend the otherwise straight tube to accommodate the natural bends between the mouth and trachea of the patient.
• the bend or arc co ⁇ esponds to the arc of a circle having a radius in the range of about 12 to 72 inches.
• the length of the endotracheal tube 10 has indicia thereon to permit medical staff to detennine the depth to which the endotracheal tube 10 has been inserted into a patient's trachea.
• the material or materials selected for construction of the endotrachael tube are autoclavable and thus, capable of being reused. This embodiment is particularly useful in underdeveloped countries where currency and supply shortages substantially preclude a continuous supply of disposable items.
• a suitable autoclavable material is TYGON ® .
• Other autoclavable materials are commercially available under the tradenames CHEMFLUOR ® FEP and KORVEX ® FEP from Norton Performance Plastics Corporation, Wayne, New Jersey, USA, and EASTMAN TENITE ® from the Huntsman Corporation, Houston, Texas, USA.

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• Health & Medical Sciences (AREA)
• Pulmonology (AREA)
• Emergency Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Otolaryngology (AREA)
• Materials For Medical Uses (AREA)
• Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

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• 2000
  • 2000-11-06 JP JP2001536216A patent/JP2003513713A/ja active Pending
  • 2000-11-06 AU AU14649/01A patent/AU777271B2/en not_active Ceased
  • 2000-11-06 EP EP00976945A patent/EP1229946A2/de not_active Withdrawn
  • 2000-11-06 WO PCT/US2000/030453 patent/WO2001034221A2/en not_active Application Discontinuation

Non-Patent Citations (1)

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