Valued fenestrated tracheotomy tube having outer and inner cannulae

Abstract

An outer cannula has a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer, a first passageway coupling the first port to the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, and a third port between the first and second ports. An inner cannula is configured for insertion into the first passageway via the first port when the wearer desires to be able to exhale through his or her pharynx. The inner cannula includes a fourth port for orienting adjacent the first port, a fifth port for orienting adjacent the second port and a second passageway coupling the fourth port to the fifth port to permit the flow of gases from the fourth port to through the fifth during inhalation by the wearer and prevent the flow of gases from the fifth fourth port during exhalation by the wearer. A valve controls flow through the third port. The valve assumes a first orientation to permit flow from the first fourth port to the second fifth port when the first fourth port is at a higher pressure than the second fifth port, and a second orientation to permit prevent flow from the second fourth port through the third port when the second fifth port is at a higher pressure than the first fourth port.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S Ser. No. 09/398,110 filed Sep. 16, 1999 now abandoned and titled Valved Fenestrated Tracheotomy Tube Having Outer and Inner Cannulae. U.S. Ser. No. 09/398,110 is a continuation-in-part of U.S. Ser. No. 09/360,274 filed Jul. 26, 1999 now abandoned and titled Valved Fenestrated Tracheotomy Tube. U.S. Ser. No. 09/360,274 is a continuation of U.S. Ser. No. 08/996,282 filed Dec. 22, 1997 and titled Valved Fenestrated Tracheotomy Tube, now U.S. Pat. No. 5,957,978. U.S. Ser. No. 09/398,110 and U.S. Ser. No. 09/360,274 are both now abandoned. The disclosures of these prior applications are hereby incorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to improvements in tracheotomy tubes.

BACKGROUND OF THE INVENTION

This invention is directed toward the problem of being unable to produce audible laryngeal voice, and thus, the inability to speak, that confronts individuals whose breathing is provided mechanically by a respirator which is connected to a cuffed tracheotomy tube inserted into the trachea of a wearer below the level of the vocal cords. The cuff on the tracheotomy tube is inflated, for example, with air, so that the cuff seals substantially fluid tight against the wall of the trachea. The purposes of the inflated cuff include: to protect against leakage of saliva and other secretions around the tracheotomy tube and into the lungs; and, to prevent the air being delivered under pressure from the respirator through the tracheotomy tube to the lungs and exhalation from the lungs from escaping around the tracheotomy tube and out through the mouth and nose of the wearer. In other words, the inflated cuff provides a closed mechanical respiratory system that completely bypasses the upper airway above the level of the tracheotomy tube, including the vocal cords. The side effects of this include the elimination of exhaled airflow upward through the vocal cords. Of course, this eliminates voice production and audible speech.

Currently, there are only two available options for individuals being mechanically ventilated via a cuffed tracheotomy tube to produce audible voice and speech with their own vocal cords. The first of these options is described in O. Hessler, M. D., K. Rehder, M. D., and S. W. Karveth, MC, U. S. A., “Tracheostomy Cannula for Speaking During Artificial Respiration,” Anesthesiology, vol. 25, no. 5, pp.719-721 (1964). There is no known commercially available device constructed as described in Hessler, et al.

The second option is a so-called “talking tracheotomy tube,” which is a conventional cuffed tracheotomy tube manufactured with an 8-10 French conduit extending along its length. The distal end of this conduit terminates above the level of the inflated cuff. The proximal end of this conduit is connected to a source of, for example, compressed air. Examples of such a device are manufactured by Sims Portex, Inc., and Bivona Surgical Inc. The wearer of such a device is able to stop and start the flow of compressed air to the distal end of this conduit, thereby enabling the stopping and starting of the flow of air upward through his or her vocal cords, enabling the wearer to produce speech. This speech airflow is completely independent of the respiratory airflow through the tracheotomy tube. Such talking tracheotomy tubes have been available for several years, but are not in widespread use, perhaps owing to numerous mechanical limitations.

A ventilator-dependent patient breathing through cuffed tracheotomy tube is unable to produce audible voice with his or her vocal cords because the cuff of the tracheotomy tube he or she wears prevents exhalations from going around the lower end of the tube and upward through the vocal cords. This situation continues until the wearer's condition improves sufficiently that the cuff on the tracheotomy tube can be deflated so that exhaled air can pass around the tracheotomy tube and up through the wearer's vocal cords, mouth and nose, permitting audible vocal cord vibrations for speech.

The invention alleviates this situation. When coupled to a respirator with its cuff inflated, a valved, cuffed tracheotomy tube system according to the invention directs air on the inhalation cycle of the respirator to the lungs. Exhalations are directed by the valved, cuffed tracheotomy tube system according to the invention to the upper airway, permitting vocal cord vibration and audible laryngeal speech.

DISCLOSURE OF THE INVENTION

According to one aspect of the invention, an outer cannula has a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer, a first passageway coupling the first port to the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, and a third port between the first and second ports. An inner cannula is configured for insertion into the first passageway via the first port when the wearer desires to be able to exhale through his or her pharynx. The inner cannula includes a fourth port for orienting adjacent the first port, a fifth port for orienting adjacent the second port and a second passageway coupling the fourth port to the fifth port to permit the flow of gases from the fourth port to the fifth during inhalation by the wearer exhalation5-6 6-7 illustrate two different configurations of outer cannulae. While the configuration illustrated in FIGS. 1-5 is easier to insert into, and remove from, the trachea of a wearer, the configuration illustrated in FIGS. 6-7 has a more natural shape. That is, the configuration of the trachea and tracheostoma of a wearer is configured rather more like the inverted L configuration of outer cannula 112 and inner cannula 140 and rather less like the curved configuration of outer cannula 12 and inner cannula 40 . According to another aspect of the invention, an outer cannula 212 is provided which is constructed from a thermoplastic resin which has the somewhat more curved configuration of outer cannula 12 when outer cannula 212 is at temperatures somewhat lower than body temperature, illustrated in FIG. 8, but which reverts to the somewhat more inverted L configuration of outer cannula 112 when it is inserted into the trachea of a wearer. See FIG. 9. This characteristic facilitates insertion of the outer cannula 212 into the trachea 218 of a wearer 220, while providing the somewhat more natural inverted L configuration once the outer cannula 212 is inserted. Of course, removal is rendered somewhat more difficult, but such outer cannulae 212 typically reside for extended times in their wearers 220.

In another embodiment constructed according to the invention and illustrated in FIGS. 10-11, a relatively pliable, for example, relatively low-durometer silicone, tracheotomy tube 250 of a somewhat L-shaped configuration is provided with a stylet 252 having a somewhat bullet-shaped remote end 254 for ease of insertion through a tracheostoma 256 into the trachea 258 of a wearer 260. The proximal end 266 of the tracheotomy tube 250 is provided with some means such as, for example, a flange 268, to permit the healthcare worker to hold the proximal end 266 of the tracheotomy tube 250 so that the stylet 252 can be inserted into the open proximal end 266 of the tube 250 and pushed the full length into the tracheotomy tube 250 to cause deflection of the relatively pliable tracheotomy tube 250 from its somewhat L-shaped configuration illustrated in FIG. 10 into a somewhat more curved configuration illustrated in FIG. 11. This configuration facilitates insertion of the tracheotomy tube 250 through the tracheostoma 256 and into the trachea 258 of the wearer 260. Once the tracheotomy tube 250 is in place in the trachea 258 of the wearer 260, the stylet 252 is removed, at which time the tracheotomy tube 250 returns from its somewhat more curved configuration illustrated in FIG. 11 to its somewhat more L-shaped configuration illustrated in FIG. 10.

To remove the tracheotomy tube 250 from the trachea 258 of the wearer 260, the stylet 252 can be reinserted into the tracheotomy tube 250 to return it to its somewhat more curved configuration illustrated in FIG. 11 prior to removing it from the trachea 258 of the wearer 260. If this is done, the tracheotomy tube 250 comes out relatively easily. Alternatively, the tracheotomy tube 250 can be removed while still in its somewhat more L-shaped configuration. Although this requires somewhat more force than if the stylet 252 were used to render the tracheotomy tube 250 somewhat more curved in configuration, the tracheotomy tube 250 still can be removed without excessive effort or damage to the trachea 258 or tracheostoma 256 of the wearer 260. The tracheotomy tube 250 is otherwise configured similarly to tracheotomy tube 112, 140 illustrated in FIGS. 6-7.

While many details of the embodiments illustrated in FIGS. 1-7 are eliminated from the illustrations of FIGS. 8-11 for the purpose of clarity, it is to be understood that practical embodiments of the invention illustrated in FIGS. 8-11 can be provided with, for example, secretion evacuation tubes like tubes 29, 129 illustrated in FIGS. 1-7.

Claims

1. In combination , an outer cannula having a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer and a first passageway coupling the first port to the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, a third port between the first and second ports, and an inner wearer for insertion into the first passageway via the first port when the wearer desires to be able to exhale through the wearer's pharynx, the inner cannula including a fourth port for orienting adjacent the first port, a fifth port for orienting adjacent the second port and a second passageway coupling the fourth port to the fifth port to permit the flow of gases from the fourth port to through the fifth during inhalation by the wearer and preventing the flow of gases from the fifth fourth port during exhalation by the wearer, a valve controlling flow through the third port, the valve assuming a first orientation to permit flow from the first fourth port to the second fifth port when the first fourth port is at a higher pressure than the second fifth port, and a second orientation to permit prevent flow from the second fourth port through the third port when the second fifth port is at a higher pressure than the first fourth port.

2. The apparatus of claim 1 wherein the valve includes a movable member and a seat, the movable member moving away from the seat to permit flow from the fourth port to the fifth port when the fourth port is at a higher pressure than the fifth port, and seating against the seat to impede flow from the fifth port through the fourth port and promote flow from the fifth port through the third port when the fourth port is at a lower pressure than the fifth port.

3. The apparatus of claim 2 wherein the seat is provided in the second passageway.

4. The apparatus of claim 3 including a second seat, the movable member moving toward the second seat to impede flow from the fourth port through the third port when the fourth port is at a higher pressure than the fifth port, and moving away from the second seat to permit flow from the fifth port through the third port when the fourth port is at a lower pressure than the fifth port.

5. The apparatus of claim 4 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

6. The apparatus of claim 3 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

7. The apparatus of claim 2 wherein the seat is provided in the first passageway.

8. The apparatus of claim 4 7 including a second seat, the movable member moving toward the second seat to impede flow from the fourth port through the third port when the fourth port is at a higher pressure that than the fifth port, and moving away from the second seat to permit flow from the fifth second port through the third port when the fourth port is at a lower pressure than the fifth port.

9. The apparatus of claim 8 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

10. The apparatus of claim 7 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

11. The apparatus of claim 2 including a second seat, the movable member moving toward the second seat to impede flow from the fourth port through the third port when the fourth port is at a higher pressure than the fifth port, and moving away from the second seat to permit flow from the fifth second port through the third port when the fourth port is at a lower pressure than the fifth port.

12. The apparatus of claim 11 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

13. The apparatus of claim 2 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

14. The apparatus of claim 1 wherein the valve includes a movable member and a seat, the movable member moving toward the seat to impede flow from the fourth port through the third port when the fourth port is at a higher pressure than the fifth port, and moving away from the seat to permit flow from the fifth port through the third port when the fourth port is at a lower pressure than the fifth port.

15. The apparatus of claim 14 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

16. The apparatus of claim 1 wherein the outer cannula includes an inflatable cuff between the second and third ports and a third passageway for introducing an inflating fluid into the cuff in situ in the trachea of the wearer to impede the flow of fluids between the cuff and the trachea when the cuff is inflated.

17. The apparatus of claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 wherein the outer cannula includes a flexible member for covering the third port.

18. The apparatus of claim 17 wherein the flexible member and the outer cannula including include complementary first and second attachment members, respectively, for attaching the flexible member to the outer cannula, the second attachment member providing an attachment point located within the third port for attachment of the first attachment member to the second attachment member at the attachment point.

19. The apparatus of claim 17 wherein the flexible member comprises a flexible membrane having a slit in it.

20. The apparatus of claim 17 wherein the flexible member comprises a flap for covering the third port.

21. The apparatus of claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or 16 further including a member selectively movable into interfering relationship to the valve, the member preventing the valve from moving to the second orientation.

22. A tracheotomy cannula having a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer and a first passageway between the first port and the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, the cannula including a portion formed from a thermoplastic material having a first, generally curved orientation configuration when said portion is maintained substantially below body temperature and a second, somewhat inverted l-shaped configuration when said portion is warmed substantially to body temperature.

23. A tracheotomy cannula having a first port for orienting outside the neck of a wearer, a second port for orienting within the trachea of the wearer and a first passageway between the first port and the second port to permit the flow of gases from the first port to the second during inhalation by the wearer and from the second port during exhalation by the wearer, the cannula including a portion formed from a first material, and a stylet formed from a second material, the first material being more flexible than the second, the stylet having a generally curved orientation configuration, the tracheotomy cannula having a somewhat inverted l-shaped configuration when the stylet is not inserted into the first passageway and a generally curved orientation configuration when the stylet is inserted into the first passageway.