Valued fenestrated tracheotomy tube having outer and inner cannulae
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.
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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 INVENTIONThis invention relates to improvements in tracheotomy tubes.
BACKGROUND OF THE INVENTIONThis 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 INVENTIONAccording 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 and from the fifth port during exhalation by the wearer . A valve control 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.
Illustratively according to the invention, the valve includes a movable member and a seat. The movable member moves 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 seats 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.
Illustratively according to the invention, the seat is provided in the second passageway.
Alternatively illustratively according to the invention, the seat is provided in the first passageway.
Additionally according to the invention, the valve includes a movable member and a seat. The movable member moves 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 moves 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.
Further illustratively according to the invention, 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.
Additionally illustratively according to the invention, the outer cannula includes a flexible member for covering the third port.
Illustratively according to the invention, the flexible member and the outer cannula include complementary first and second attachment members, respectively, for attaching the flexible member to the outer cannula. The second attachment member provides an attachment point located within the third port for attachment of the first attachment member to the second attachment member at the attachment point.
Alternatively illustratively according to the invention, the flexible member comprises a flexible membrane having a slit in it.
Alternatively illustratively according to the invention, the flexible member comprises a flap for covering the third port.
According to another aspect of the invention, a tracheotomy cannula has 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. The cannula includes 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.
According to another aspect of the invention, a tracheotomy cannula has 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 includes a portion formed from a relatively more flexible material. A stylet is formed from a relatively less flexible material. The stylet has a generally curved orientation configuration. The tracheotomy cannula has 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.
The invention may best be understood by referring to the following detailed description and accompanying drawings which illustrate the invention. In the drawings:
Referring now to
The outer cannula 12 includes a pivotally mounted attachment plate 30 adjacent its proximal end 32 to facilitate attachment, for example, by a strap or belt around the neck of the wearer 20. The outer cannula 12 also includes a fenestration 34 which permits the wearer 20 to speak by forcing exhaled gases upward through the fenestration 34 and into the pharynx 24. Speech may then be articulated in accordance with known principles. Although only one such fenestration 34 is illustrated, it should be understood that any number of fenestrations 34 may be provided in the outer cannula 12 for this purpose. The fenestration 34 is covered by a flexible sheet 36 of, for example, a suitable elastomer, which contains a slit 38 for the passage of exhaled gases upward through the pharynx 24. The flexible sheet 36 is provided to prevent the growth of so-called granulation tissue from the trachea 18 into the outer cannula 12 in accordance with known principles. While this covering 36 for the fenestration 34 is the only one illustrated in the drawings, numerous techniques for covering the fenestration 34 are known. See, for example, U.S. Ser. No. 09/360,274 and U.S. Ser. No. 08/996,282.
The speaking tracheotomy tube system 10 also includes an inner cannula 40 which is insertable through the lumen 42 of the outer cannula 12. Inner cannula 40 includes a port 41 at an end thereof which lies adjacent port 21 when inner cannula 40 is inserted into its use orientation within outer cannula 12 and a port 43 which lies adjacent port 23 when inner cannula 40 is inserted into its use orientation within outer cannula 12. Inner cannula 40 also includes a connector 60 portion for connecting the inner cannula 40 to a ventilator 62, illustrated in block form only in
The inner cannula 40 also includes an opening 64 and a cooperating flap 66 adjacent the fenestration 34 of the outer cannula 12. On pressurization of the inner cannula 40, the flap 66 assumes the position illustrated in
The flap 66 can have a plan view somewhat the shape of a ping pong paddle, with the sealing portion of the flap 66 corresponding to the hitting portion of the paddle and the hinge portion of the flap 66 corresponding to the handle of the paddle. In order to reduce the likelihood of eversion of the flap 66 through its seat 70, the flap 66 can be constructed from a stiffer material, such as, for example, a stiffer silicone, or may be molded with a reinforcement to stiffen it, such as, for example, a molded-in X-shaped wire reinforcement or an X-shaped boss on one or the other or both of its major surfaces, or the like. The hinge, or handle of the ping pong paddle, can, for example, be located in a notch provided therefor in the wall of the cannula 40 where it is attached by an appropriate adhesive, or can be inserted into an opening provided therefor in the wall of the cannula 40 where it is attached by an appropriate adhesive, or can be attached to the inner surface of the wall of the cannula 40 by an appropriate adhesive.
Typically, ventilators 62 are provided with mechanisms to measure exhaled gas volume and alarms to indicate when recovered gas volume during exhalation is much less than output gas volume during the pressurization phase of the ventilator 62s' operation. These mechanisms, or at least the alarms of these mechanisms, may have to be disconnected to prevent the alarms from sounding during use of the inner cannula 40 by the wearer 20 during speaking sessions.
The tracheotomy tube system 10 can be quickly converted into a conventional tracheotomy tube by pushing the formed proximal end 80 of a somewhat blade-shaped lock 82 inward. See FIG. 4. Lock 82 is slidable in a channel 84 provided therefor within lumen 68. See FIG. 5. The distal end 86 of lock 82 lies adjacent the inside surface of flap 66. When lock 82 is slid distally in channel 84, its distal end 86 interferes with the opening of flap 66 to its orientation illustrated in FIG. 3. See FIG. 4. This prevents the escape of air upward through opening 64, but provides relatively unrestricted access through lumen 68 to the wearer 20's trachea 18. Alternatively, the tracheotomy tube system 10 can be converted into a conventional tracheotomy tube by removing inner cannula 40 and inserting a non-fenestrated, non-valved conventional inner cannula (not shown) into lumen 42. To provide positive positioning of blade 82 in one or the other of its non-speaking (
In another embodiment of the invention illustrated in
The outer cannula 112 includes a fenestration 134 which permits the wearer 120 to speak by forcing exhaled gases upward through the fenestration 134 and into the pharynx 124. Speech may then be articulated in accordance with known principles. The fenestration 134 is covered by a flexible flap 136 of, for example, a suitable elastomer, which moves upward to the position illustrated in broken lines in
The speaking tracheotomy tube system 110 also includes an inner cannula 140 which is insertable through the lumen 142 of the outer cannula 112. Inner cannula 140 includes a port 141 at an end thereof which lies adjacent port 121 when inner cannula 140 is inserted into its use orientation within outer cannula 112 and a port 143 which lies adjacent port 123 when inner cannula 140 is inserted into outer cannula 112. Inner cannula 140 also includes a connector 160 for connecting the inner cannula 140 to a ventilator 162, illustrated in block form in
The inner cannula 140 also includes an opening 164 and a cooperating flap 166 adjacent the fenestration 134 of the outer cannula 112. On pressurization of the inner cannula 140, the flap 166 swings upward to the position illustrated in
Again, the flap 166 has somewhat the shape of a ping pong paddle in elevation, with the sealing portion of the flap 166 corresponding to the hitting portion of the paddle and the hinge portion of the flap 166 corresponding to the handle of the paddle. In order to reduce the likelihood of eversion of the flap 166 through its opening 164, the flap 166 can be constructed from a stiffer material, such as, for example, a stiffer silicone, or may be molded with a reinforcement to stiffen it, such as, for example, a molded-in X-shaped wire reinforcement or an X-shaped boss on one or the other or both of its major surfaces, or the like. Again, the hinge, or handle of the ping pong paddle, can be located in a notch provided therefor in the wall of the cannula 40 where it is attached by an appropriate adhesive, or inserted into an opening provided therefor in the wall of the cannula 140 where it is attached by an appropriate adhesive, or attached to the inner surface of the wall of the cannula 140 by an appropriate adhesive.
The tracheotomy tube system 110 can be quickly converted into a conventional tracheotomy tube by pushing the formed proximal end 180 of a somewhat blade-shaped lock 182 inward. See FIG. 6. Lock 182 is slidable in a channel 184 provided therefor within lumen 168. The distal end 186 of lock 182 lies adjacent the front surface of flap 166. When lock 182 is slid distally in channel 184, its distal end 186 interferes with the opening of flap 166 to its orientation illustrated in FIG. 7. See FIG. 6. This prevents the escape of air upward through opening 164, but provides relatively unrestricted access through lumen 168 to the wearer 120's trachea 118. Alternatively, the tracheotomy tube system 110 can be converted into a conventional tracheotomy tube by removing inner cannula 140 and inserting a non-fenestrated, non-valved conventional inner cannula (not shown) into lumen 142. To provide positive positioning of blade 182 in one or the other of its non-speaking (
The embodiments of
In another embodiment constructed according to the invention and illustrated in
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
While many details of the embodiments illustrated in
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.
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Type: Grant
Filed: Mar 9, 2006
Date of Patent: May 25, 2010
Assignee: Hansa Medical Products, Inc. (Indianapolis, IN)
Inventor: Eric D. Blom (Indianapolis, IN)
Primary Examiner: Steven O Douglas
Attorney: Barnes & Thornburg LLP
Application Number: 11/373,867
International Classification: A61M 16/00 (20060101); A61M 25/00 (20060101);