BITE-RESISTANT ENDOTRACHEAL TUBE

Abstract: An endotracheal tube (10) having an integral bite protector portion (18) wherein at least this portion of the body of the tube is adaptable to be in contact with a user's teeth. This portion being made of a bite resistant polymeric material with sufficient rigidity to prevent collapse, puncture or permanent deformity due to clenching by a user. The portion does not require reinforcing materials or only uses fibrous reinforcing materials, and does not use metallic materials for reinforcement.

Description: BITE-RESISTANT ENDOTRACHEAL TUBE BACKGROUND OF THE INVENTION A. Field of the Invention 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. B. Background The endotracheal tubes that are currently used to ventilate comatose patients and those patients in respiratory failure are often difficult for medical staff to insert and uncomfortable for patients to retain. The discomfort patients experience following intubation causes many patients to voluntarily or involuntarily clench their teeth on the endotracheal tube. This clenching action can have life-threatening side effects. When an intubated patient clenches his or her teeth on an endotracheal tube, the tube is compressed and gas flow is restricted. Additionally, the clenching action may puncture the endotracheal tube producing a leak in the tube, which adversely affects patient ventilation. For that reason, a variety of "bite protectors" were developed to prevent endotracheal tube compression and damage caused by teeth clenching. However, currently available 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. Accordingly, there is a need for a 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. Accordingly, there is a need for 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. On most hospital units, bite protectors are a separately stocked item from the endotrachael tubes. Moreover, in many hospital units where intubation is not a common occurrence, a bite protector is not an item that is universally available. Thus, when a bite protector is needed on such a unit during an emergency intubation, 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. SUMMARY OF THE INVENTION Accordingly, 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. In one embodiment, the polymeric materials used to construct the proximal end and the intermediate bite-resistant portion are made from the same bite-resistant material. In another embodiment, 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." In the present invention, 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. An advantage of an endotracheal tube constructed in this manner is that, unlike endotracheal tubes or bite protectors that permanently deform, the endotracheal tube of the present invention does not have to be replaced following forceful teeth clenching. BRIEF DESCRIPTION OF THE DRAWINGS 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. DETAILED DESCRIPTION OF THE INVENTION 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 puncture due to biting action; and the distal end having a beveled tip forming a short wall side and a long wall side, the proximal end, the intermediate portion, and the distal end being operatively attached to one another along the length of tubing for transmission of the air or gas. The endotracheal tube of the present invention has several embodiments. In its broadest aspect, as seen in Figure 1, 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. In addition, 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. Preferably, 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. In one aspect, 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. Additionally, 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. Further, 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. An advantage of an endotracheal tube constructed in this manner is that, unlike endotracheal tubes or bite protectors that permanently deform, the endotracheal tube 10 of the present invention does not have to be replaced following forceful teeth clenching. Suitable materials include those made of fluorinated ethylene propylene copolymers, such as are commercially available under the tradenames CHEMFLUOR ® FEP and KORVEX ® FEP from Norton Performance Plastics Corporation, Wayne, New Jersey, USA. Other suitable materials include those made of polypropylene random copolymers, including those commercially available under the tradename EASTMAN ® TENITE from the Huntsman Corporation, Houston, Texas, USA, such as EASTMAN ® TENITE Model No. P5M2Z-012. In one embodiment, 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. In addition, 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. Accordingly, 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.). Optimally, 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 cuπently used in endotracheal tubes. Typically, 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. and 4.2 - 4.3 mm O.D.; for four weeks to six months, 3.5 mm I.D. and 4.8 mm O.D.; for six months to one year, 4.0 mm I.D. and 5.5m- 5.6 mm O.D.; for one year to two years, 4.5 mm I.D. and 6.1 mm O.D.; for two to four years, 5.0 mm I.D. and 6.8 mm O.D.; for four to five and one-half years, 5.5 - 5.6 mm I.D. and 7.4 - 7.5 mm O.D.; for five and one-half years to seven and one-half years, 6.0 mm I.D. and 8.1 - 8.2 mm O.D.; and for adults, 6.5 - 9.5 mm I.D. and 11 mm O.D. Typically, the wall thickness of an adult endotracheal tube is about 2.5 mm. These diameters are not critical, but are representative. In the prefeπed embodiment, as constructed for an adult patient, the endotracheal tube 10 has an I.D. of 8.0 mm and an O.D. of 11.0 mm. In the prefeπed embodiment, 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. It is also within the scope of the present invention that 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. To further accommodate anatomical differences between individuals, it is important that the endotracheal tube 10 of the present invention be constructed in a variety of lengths, those lengths being the same as or similar to those cuπently 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. For an average 150 kg adult of average height, the typical endotracheal tube 10 has a length of about 33 cm. In one embodiment of the present invention, 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. Typically, 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. In another embodiment of the present invention, the distal end 16 and intermediate portion 18 are constructed of the second polymeric material 24. In yet another embodiment, 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. In a preferred embodiment of the invention, 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. In one embodiment, 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. In a prefeπed embodiment, 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 caπying 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. Preferably 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. Alternatively, the channel 50 may also be provided as a length of tubing extending through the tubular passageway 20 of the endotracheal tube 10. It is particularly convenient to provide 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. The presence of 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. Typically, the bend or arc coπesponds to the arc of a circle having a radius in the range of about 12 to 72 inches. In yet another embodiment, 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. In another embodiment of the present invention, 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. While the invention has been described in connection with several prefeπed embodiments, it will be understood that it is not intended that the present invention be limited to the particular embodiments described. On the contrary, the present invention is intended to cover the various alternative and equivalent constructions covered within the spirit and scope of the claims.

Claims: CLAIMS We claim: 1. 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 said proximal end to said distal end and forming a tubular passageway therebetween; said proximal end being constructed of a first polymeric material which is sufficiently soft to permit cleavage of a segment of said proximal end; said intermediate portion being constructed of a second polymeric material which is heterogenous to said first material and of sufficient rigidity to cause said intermediate portion to be substantially resistant to collapse or puncture due to biting action; said distal end having a beveled tip forming a short wall side and a long wall side; and said proximal end, said intermediate portion, and said distal end being operatively attached to one another along said length of tubing for transmission of said air or gas. 2. The endotracheal tube of claim 1, wherein both said proximal end and said distal end are constructed of said first polymeric material. 3 The endotracheal tube of claim 1 , wherein both said distal end and said intermediate portion are constructed of said second polymeric material. 4. The endotracheal tube of claim 1, wherein said distal end is constructed of a third polymeric material that differs from both said first polymeric material and said second polymeric material. 5. The endotracheal tube of claim 1, 2, 3 or 4, wherein said first polymeric material is comprised of medical grade silicone plastic. 6. The endotracheal tube of claim 1 , 2, 3 or 4, wherein said first polymeric material is approximately 90% by weight dimethyl silicone and 10% by weight inert silica. 7. The endotracheal tube of claim 1, 2, 3 or 4, wherein said second polymeric material is a fluorinated ethylene propylene copolymer. 8. The endotracheal tube of claim 7, wherein said fluorinated ethylene propylene copolymer is CHEMFLUOR ® FEP or KORVEX ® FEP. 9. The endotracheal tube of claim 1, 2, 3 or 4, wherein said first and second polymeric materials are attached by heat sealing using shrink tubing. 10. The endotracheal tube of claim 1, 2, 3 or 4, further comprising a rigid junction fitting, said junction fitting having: a cylindrical upper portion providing a connection to a mechanical source of suction or a source of controlled mechanical ventilation; and a cylindrical lower portion connected to said proximal end of said tubing, said cylindrical upper portion having a first outer diameter and said cylindrical lower portion having a second outer diameter smaller than said first outer diameter. 11. The endotracheal tube of claim 1, 2, 3 or 4, further comprising a Murphy's eye, said Murphy's eye being located inwardly from said distal end along said long wall side. 12. The endotracheal tube of claim 1, 2, 3 or 4, further comprising an inflatable balloon cuff apparatus circumventing the outer diameter of said distal end and having inlet means for gas introduction. 13. A bite-resistant endotracheal tube comprising: a length of tubing having a proximal end, said proximal end for receiving a flow of air or gas and transmitting said air or gas, a distal end of suitable size and length for insertion into a trachea of a patient, said distal end for delivery of said air or gas, and an intermediate portion operatively connecting said proximal end to said distal end and forming a tubular passageway therebetween; said proximal end being constructed of a first polymeric material which is sufficiently soft to permit cleavage of a segment of said proximal end; said intermediate portion being constructed of a second polymeric material which is substantially resistant to collapse or puncture due to biting action and is substantially homogeneous; said distal end having a beveled tip forming a short wall side and a long wall side; said proximal end, said intermediate portion, and said distal end being operatively attached to one another along said length of tubing for transmission of said air or gas. 14. The endotracheal tube of claim 13, wherein both said proximal end and said distal end are constructed of said first polymeric material. 15. The endotracheal tube of claim 13, wherein both said distal end and said intermediate portion are constructed of said second polymeric material. 16. The endotracheal tube of claim 13, wherein said distal end is constructed of a third polymeric material that differs from both said first polymeric material and said second polymeric material. 17. The endotracheal tube of claim 13, 14, 15 or 16, wherein said first polymeric material is comprised of medical grade silicone plastic. 18. The endotracheal tube of claim 13, 14, 15 or 16, wherein said first polymeric material is approximately 90% by weight dimethyl silicone and 10% by weight inert silica. 19. The endotracheal tube of claim 13, 14, 15 or 16, wherein said second polymeric material is a fluorinated ethylene propylene copolymer. 20. The endotracheal tube of claim 19, wherein said fluorinated ethylene propylene copolymer is CHEMFLUOR ® FEP or KORVEX ® FEP. 21. The endotracheal tube of claim 13, 14, 15 or 16, wherein said first and second materials are attached by heat sealing using shrink tubing. 22. The endotracheal tube of claim 13, 14, 15 or 16, further comprising a rigid junction fitting, said junction fitting having: a cylindrical upper portion providing a connection to a mechanical source of suction or a source of controlled mechanical ventilation; and a cylindrical lower portion connected to said proximal end of said tubing, said cylindrical upper portion having a first outer diameter and said cylindrical lower portion having a second outer diameter smaller than said first outer diameter. 23. The endotracheal tube of claim 13, 14, 15 or 16, further comprising a Murphy's eye, said Murphy's eye being located inwardly from said distal end along said long wall side. 24. The endotracheal tube of claim 13, 14, 15 or 16, further comprising an inflatable balloon cuff apparatus circumventing the outer diameter of said distal end and having inlet means for gas introduction. 25. An improved bite-resistant endotracheal tube having a proximal end for receiving a flow of air or gas and transmitting said air or gas, said proximal end being constructed of a first polymeric material, a distal end of suitable size and length for insertion into a trachea of a patient, said distal end for delivery of said air or gas, and an intermediate portion operatively connecting said proximal end to said distal end and forming a tubular passageway therebetween, the improvement comprising: said intermediate portion being constructed of a second polymeric material which is substantially resistant to collapse or puncture due to biting action, substantially homogeneous, and sufficiently resilient to retain a substantially round cross-sectional area following forceful biting action, wherein said intermediate portion encompasses at least that portion of said endotracheal tube that is in contact with an intubated patient's teeth. 26. The endotrachael tube of claim 1, having a bend or arc of sufficient radius to facilitate insertion without a stylette. 27. The endotrachael tube of claim 1 that is autoclavable.

Inventors: EVANS JONATHAN GARETH WESTON, TODD CHRISTINA MICHELLE, EVANS, JONATHAN, GARETH, WESTON, TODD, CHRISTINA, MICHELLE
Applicants: EVANS JONATHAN GARETH WESTON, TODD CHRISTINA MICHELLE, EVANS, JONATHAN, GARETH, WESTON, TODD, CHRISTINA, MICHELLE
Application year: 2000
Main classification: A61M
IPC codes: A61L31, A61M16