Medical Surgical Instruments

Abstract

The device (20) that fits onto the machine end of the tracheostomy tube (10) includes both an HME and a speaking valve (30). The HME includes two exchange elements (28, 29) at opposite ends of a housing (23) that extends transversely to a coupling (25) for fitting onto the tube. The speaking valve has a cylindrical sleeve (31) that extends in line with the tube, traversing the housing partway along its length. The sleeve is rotatable about its axis and has two openings (36) on opposite sides that are alignable with the exchange elements, allowing gas to flow from the tube through the exchange elements and bypass the speaking valve. When the patient wishes to speak, they twist and rotate the speaking valve, blocking flow to the exchange element and allowing them to breathe through the valve instead.

Description

[Technical field]

[0001] The present invention relates to a medical-surgical instrument adapted to be attached to the machine end of a tracheostomy tube.

[0002] The present invention more particularly relates to devices in the form of combined HME and speaking valves. [Background technology]

[0003] When a patient breathes through a tube inserted into the trachea, such as a tracheostomy tube or an endotracheal tube, the gas flow to the bronchi is not warmed and moistened by passing through the nose. This can cause damage and discomfort to the patient's throat unless the gas is warmed and moistened in some way. This gas can be regulated by a humidifier in the ventilation circuit. However, the most convenient is to use a heat and moisture exchange device (HME). HMEs are small, lightweight devices that contain one or more HME exchange elements. When the patient exhales, the gas passes through the exchange element and releases most of its heat and moisture to the element. When the patient inhales, the gas passes through the exchange element in the opposite direction and absorbs most of the heat and moisture in the exchange element. This gas inhaled by the patient is therefore warmed and moistened. HME devices also help protect the patient from airborne contaminants such as dust and bacteria. These HMEs are low cost and disposable after a single use. They can be connected to a breathing circuit or simply connected to the machine end of a tracheal tube and left open to atmosphere while the patient is breathing naturally. HMEs can be used in conjunction with other breathing devices such as face masks. HMEs are sold by Smiths Medical under the Thermovent trademark (Thermovent is a registered trademark of Smiths Medical) and are also sold by other medical device companies.

[0004] A tracheotomy patient may be conscious and able to speak during tube insertion using a speaking valve connected to the outer mechanical end of the tracheotomy tube. Such a speaking valve has a one-way mechanism that allows the patient to inhale air through the valve but closes to prevent air from being exhaled through the speaking valve. Instead, when the patient exhales, air from the lungs bypasses the tube and flows up through the patient's vocal cords. If the tracheotomy tube has a sealing cuff towards the patient end, this can be deflated when speech is required or a fenestration can be made in the wall of the tube on the mechanical side of the seal to allow air to escape through a fenestration above the cuff. Speaking valves are sold by Smiths Medical under the Orator trademark (Orator is a registered trademark of Smiths Medical) and by other medical device companies.

[0005] Previously, patients could benefit from either a speaking valve or an HME, but not both at the same time. So, if a patient needed to speak, they had to first disconnect the HME and then connect the speaking valve. When they no longer needed to speak, they had to disconnect the speaking valve and reconnect the HME. This repeated disconnection and connection of the tracheostomy tube can be uncomfortable for the patient. Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENT EMBODIMENT It is an object of the present invention to provide an alternative medical-surgical instrument. [Means for solving the problem]

[0007] According to one aspect of the present invention there is provided a medico-surgical instrument of the above kind, characterised in that the instrument includes a housing having both a one-way speaking valve and at least one HME element, the instrument being arranged to allow in one state flow through the HME element to flow preferentially through the speaking valve, and in another state inspiratory flow through the speaking valve to flow preferentially through the HME element.

[0008] The speaking valve preferably has a portion arranged to block passage through the HME element in the other state. This portion of the speaking valve is preferably a cylindrical sleeve angularly displaceable within the housing. The sleeve has an opening aligned with the HME element in the one state. The speaking valve can be mounted in the housing such that the valve can be displaced from the housing by excessive exhalation forces. The device preferably comprises a coupling adapted to be mounted on the machine end of a tracheostomy tube, a transversely extending body portion of the coupling, HME elements at both ends of the body portion, and a cavity aligned with the coupling in which the speaking valve is received so as to be angularly displaceable between the one state and the other state. Alternatively, the device can include a closure means actuable separately from the speaking valve to prevent or allow flow through the or each HME element. The closure means may be pneumatically actuable. The device can include a pneumatic actuator. The closure means may include an inflatable bellows to block flow through the or each HME element.

[0009] According to another aspect of the invention there is provided an assembly of a tracheostomy tube and an instrument according to the above aspect of the invention, wherein the instrument is attached to the machine end of the tracheostomy tube.

[0010] An HME device and assembly of the HME device fitted with a tracheostomy tube according to the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0011] [Figure 1] 1A-1C are perspective views of a combined speaking valve and HME assembly for a tracheostomy tube, with the HME, speaking valve, and tracheostomy tube shown separated prior to use. [Diagram 2] 1 is a side cross-sectional view of a combined speaking valve and HME taken along the axis of a body portion of the HME, the speaking valve being positioned to allow flow to and from the HME element. [Diagram 3] 1 shows a combined speaking valve and HME, where the speaking valve has been displaced to block flow to the HME element. [Figure 4] 1A-1C are plan cross-sectional views of an alternative configuration of a combined speaking valve and HME device, with both ends shown in different positions. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 1-3, there is shown the assembly of a tracheostomy tube 10 and a medical-surgical instrument 20 in the form of a combined speaking valve 30 and HME 22. For clarity, the tracheostomy tube 10 is shown separate from the instrument 20. Prior to assembly for use, the instrument 20 has the speaking valve 30 shown separate from the HME device 22.

[0013] The tracheostomy tube 10 is of a conventional type having a curved shaft 11 having a patient end 12 and a machine end 13. The tube 10 has an inflatable sealing cuff 14 near its patient end 12. The shaft 11 is formed with a plurality of spaced fenestrations or openings 15 above the sealing cuff 14. The tube 10 also includes a conventional coupling 16 attached to its machine end 13 and having a male tapered 15 mm connector surface 17 formed on its outer end.

[0014] The HME device 22 has a generally T-shaped configuration with an outer housing 23. The outer housing 23 has a lateral body portion 24 of tubular shape and circular cross section. The housing 23 also has a coupling in the form of a short sleeve 25 of circular cross section on one side that projects radially outward of the body portion 24. Internally, the sleeve 25 is formed with a female tapered surface at its forward end that is adapted to mate with a connector surface 17 on the coupling 16. The HME device 22 also has a short circular collar 26. The circular collar 26 is aligned with the sleeve 25 and projects a short distance on the opposite side of the body portion 24. An inner surface 27 of the collar 26 is adapted to receive a forward end portion 31 of the speaking valve 30. The outer surfaces of the sleeve 25 and collar 26 form a continuation with a cylindrical surface 3 that extends centrally across the body portion 24. Internally, the cylindrical surface 3 defines a cylindrical cavity 4 (FIGS. 2 and 3). The HME device 22 is completed by two conventional HME elements 28, 29 attached to opposite ends of the body portion 24. The HME elements 28 and 29 are of a conventional type and may be formed by coiled strips of corrugated cardboard that have been treated with hygroscopic salts to enhance their ability to absorb water. Alternatively, the HME elements may be made of treated foam. Alternative HMEs may have only one HME element and be of a different configuration, for example having a cross-section that is non-circular.

[0015] The speaking valve 30 is generally cylindrical in shape with a forward, patient end sleeve portion 31 adapted to close and sealingly fit within the inner wall 27 of the collar 26. The opposite, rearward end of the speaking valve 30 has a circular, short, enlarged head 32. The forward end of the head 32 abuts the outer end of the collar 26. The head 32 is closed by an end face 33 having a plurality of openings 34. The head 32 encloses a flexible flap valve 35 centrally mounted on the inner center of the end face 33. The flap valve 35 is positioned to permit air flow into the valve 30 through the openings 34 and prevent flow in the reverse direction. The construction of the speaking valve 30 does not completely prevent all exhaled air from passing through the valve, but prevents enough flow so that a large portion is diverted for speech. Thus, the speaking valve 30 allows the patient to breathe in through the valve but prevents the patient from breathing out through the valve. The speaking valve 30 is modified by including two side openings 36 in the wall of the forward end portion 31. The two side openings 36 are located diametrically opposite one another. The length of the forward end portion 31 is such that it extends across the width of the side body portion 24 into the cavity 4. The speaking valve 30 can be snap-fit ​​into the housing 23 by virtue of the provision of mating formations on the outside of the forward end portion 31 and on the inside of the housing 23. The engagement of the speaking valve 30 in the housing 23 is arranged to limit the angular displacement of the speaking valve to 90° between a speaking position in which the side openings 36 are blocked and an HME position in which the side openings open onto the HME elements 28 and 29. The head 32 of the speaking valve 30 has an arrow-like marking 37 that can be aligned with one of two different markings, an "S" for speech and an "H" around the collar 26 of the HME housing 23. The speaking valve 30 or the housing 23 may include detents that cooperate with the extreme positions of angular displacement so that the speaking valve clicks out of one extreme position and clicks in to the other extreme position. In this way, manual force must be applied to change the device 20 from one mode or state to the other. The fit of the speaking valve 30 within the housing 23 is preferably strong enough to hold the speaking valve within the housing during normal use, but also allows the speaking valve to pop out of the housing if subjected to excessive expiratory force, such as from coughing.

[0016] The speaking valve may also be provided by another one-way valve instead of a flexible flap valve.

[0017] The speaking valve 30 is angularly displaceable through 90° relative to the HME device 22 from one position or condition in which the side openings 36 in the speaking valve are aligned with the ends of the body portion 24 that house the HME elements 28 and 29. In this position, air can pass from the tracheostomy tube 10 through the HME elements 28 and 29, allowing normal heat and moisture exchange to occur. In this position, most of the exhaled air passing through the speaking valve 30 is blocked by the operation of the flap valve. Also, there is less resistance to flow during inspiration through the HME elements than through the speaking valve 30. Therefore, there is substantially no inhalation flow through the speaking valve. As a result, the inhalation air flows preferentially through the HME elements 28 and 29. As the speaking valve 30 is rotated through 90°, the side openings 36 of the valve move out of alignment with both ends of the body portion 24 to a position where both side openings 36 are blocked by contact with the inner surfaces of the walls of the cavity 26 in the housing 23. In this position, flow from the tracheostomy tube 10 to and from the HME elements 28 and 29 is blocked. It can thus be seen that air preferentially flows through the speaking valve 30.

[0018] There are other devices in which an instrument including both an HME element and a speaking valve can be arranged such that in one state, flow through the HME element can preferentially flow through the speaking valve, and in another state, flow through the speaking valve can preferentially flow through the HME element. These other devices do not necessarily require rotating or otherwise displacing the speaking valve.

[0019] FIG. 4 shows such an instrument 120. It is divided into two parts along the axis of the tracheostomy connector 125. The left side illustrates the HME element 126 being substantially uncovered so that air preferentially flows through it rather than through the speaking valve 130. The right side illustrates the HME element 126 being covered or blocked so that air flows through the speaking valve 130 during inspiration. More specifically, the instrument has a tubular body portion 124 with the HME element 126 attached at both ends. The HME element 126 and the body portion can be circular, but are preferably square or rectangular. Partway along its length a short tracheostomy tube coupling 125 projects outward. On the opposite side of the body portion 124, diametrically opposite the tracheostomy tube coupling 125, is fixed the speaking valve 130. The speaking valve 130 has a flexible flap 131. The flaps 131 flex inwards to allow inspiration, but are biased outwards to seal and prevent (or substantially restrict) flow when the patient exhales. The speaking valve 130 may be a separate part removably attached to the body portion 124, or may be a permanent part thereof. Inside the body portion 124 are closure means in the form of two shutters 141 and 142 located adjacent to and inside the respective HME elements 126. The shutters may be of a variety of different types and may be electrically or mechanically operated. However, in this embodiment they are in the form of two inflatable bellows 141 and 142 connected via a small bore tube 143 to a common small manually compressible actuator. The actuator is in the form of a sphere or bellows, shown in its natural uncompressed state as 144 and in its compressed or actuated state as 144'. The shutter bellows 141 and 142 have a natural compressed state in which both HME elements 126 are uncovered, as shown on the left side of FIG. 4. Thus, as the patient inhales and exhales, air can flow in and out of the device through the element.The HME element 126 is square or rectangular in shape and can easily be covered by such a shutter. The speaking valve 130 is positioned so that when the patient breathes in through the HME element 126, the pressure drop across the device is insufficient to open the speaking valve but allow any significant flow through the valve. When the patient wishes to speak, the patient squeezes the sphere to a compressed state 144', thereby expanding and distending both bellows 141 and 142, substantially blocking flow through the HME element 126.

[0020] The device need not have two HME elements, but may only have one element.

Claims

1. A medical-surgical instrument (20) adapted to be attached to a machine end (13) of a tracheostomy tube (10), said instrument including a one-way speaking valve (30) that allows the flow of inhaled air and prevents the flow of exhaled air, at least one HME element (28, 29) for heat and moisture exchange with air passing through, and a housing (23) that holds the speaking valve (30) and the HME element (28, 29) and is attached to the machine end (13); The housing (23) also comprises a tubular body portion (24), a tubular cylindrical surface (3) extending across the body portion (24), and a cavity (4) which is an internal space of the cylindrical surface (3) and communicates with the inside of the body portion (24); the HME elements (28, 29) are attached to the end of the body portion (24), the speaking valve (30) comprises a head (32) having the one-way valve (35) and a cylindrical sleeve (31) extending from the head (32) and rotatably fitted within the cylindrical surface (3), the cylindrical sleeve (31) blocking a passage connecting the cavity (4) to the inside of the body portion (24); The cylindrical sleeve (31) has an opening (36) that penetrates the cylindrical sleeve (31) in a radial direction, and the speaking valve (30) is rotatable between one state in which the opening (36) is blocked by the inner circumference of the cylindrical surface (3) and another state in which the opening (36) communicates with the HME element (28, 29) side in the main body portion (24); and wherein in said one state, exhaled air flows through said cavity (4) and said cylindrical sleeve (31) to said valve (35) and inhaled air flows through said valve (35) into said cylindrical sleeve (31), and in said other state, exhaled and inhaled air enter and exit through said cavity (4), said cylindrical sleeve (31), said opening (36), said body portion (24) and said HME element (28, 29).

2. An apparatus as described in claim 1, characterized in that the resistance to the flow of inhalation air is less through the HME elements (28, 29) than through the speaking valve (30), and in the other state, inhalation air flows through the HME elements (28, 29) without passing through the speaking valve (30).

3. 3. The device according to claim 1 or 2, characterized in that the speaking valve (30) is mounted in the housing (23) in such a way that the cylindrical sleeve (31) can be ejected out of the cylindrical surface (3) by the force of excessive exhalation.

4. A medical-surgical instrument (120) adapted to be attached to a machine end (13) of a tracheostomy tube (10), said instrument comprising: a one-way speaking valve (130) which allows the flow of inspiratory air and prevents the flow of expiratory air; at least one HME element (126) which exchanges heat and moisture with air passing through; and a tubular body portion (124) which holds the speaking valve (130) and the HME element (126) and which is attached to the machine end (13); the device also includes closure means (141, 142) in said body portion (124) operable separately from said speaking valve (130), said closure means (141, 142) being capable of being in one state closing a passageway from within said body portion (124) to said HME element (126) and in another state opening said passageway; and wherein in said one state, exhaled air flows through said body portion (124) to said speaking valve (130) and inhaled air flows through said speaking valve (130) into said body portion (124), and wherein in said other state, exhaled and inhaled air flows in and out through said body portion (124), said passageway, and said HME element (126).

5. 5. The instrument according to claim 4, characterized in that said closure means (141, 142) are pneumatically actuatable, said instrument comprising a pneumatic actuator (144).

6. 6. The device according to claim 4 or 5, characterized in that the closure means comprises an inflatable bellows (141, 142) for blocking flow through the or each HME element (126).

7. Assembly of a tracheostomy tube (10) and an instrument (20, 120) according to any one of claims 1 to 6, wherein the instrument (20, 120) is attached to the machine end (13) of the tracheostomy tube (10).

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