1. Field of the Invention
This invention relates to the field of fluid carrying tubes and hoses, and more particularly relates to tubes and hoses that are asymmetrical and crush/crimp-resistant, yet exhibit symmetrical resistance to crimping/crushing and bending.
2. Description of the Prior Art
Tubes having strengthening features are known in the art. Many different approaches have been taken to eradicate or lessen the effects of external forces exerted on hoses. For example, helically wrapped rigid structures (e.g. wire) have been used, as have two or more constituent materials having differing hardness or flexibility, otherwise known as the materials' durometer. Stiffening ribs have also been used to provide structural integrity to a tube to reduce the effects of external forces on the constituent fluids within a tube.
Tubes allowing for the flow of a plurality of fluids in a single tube have also been proposed in the past. For example, hemodialysis catheters are routinely provided with two or more passageways or lumens to permit the removal of blood from the patient's body, transportation to a dialysis machine, and return of the treated blood to the body through a second lumen within the same tube.
Numerous attempts have been made in the prior art to optimize the multi-lumen configuration.
In some approaches, such as disclosed in U.S. Pat. Nos. 4,568,329 and 5,053,023, the inflow and outflow lumen themselves are provided side by side in D-shaped form. In other approaches, such as those disclosed in U.S. Pat. Nos. 4,493,696, 5,167,623 and 5,380,276, the inflow and outflow tubes are placed in concentric relation. Other examples of different lumen configurations are disclosed in U.S. Pat. Nos. 5,221,256, 5,364,344, and 5,451,206. U.S. Pat. Nos. 6,814,718 and 7,011,645 disclose other lumen configurations. However, there remains an unmet need for tubes which themselves have an asymmetrical cross-sectional profile, for which the current art does not provide.
Many forms of respiratory therapy involve use of a respirator hose to convey a breathing gas such as air to a patient. For such use, the respirator hose must be light enough to move about easily, but still be strong enough to resist crushing or kinking that would close off flow of the breathing gas. A common practice for strengthening such respirator hoses is to wrap a thin, flexible plastic membrane about a helical or spiral support structure. The spiral support structure is typically formed of a hard metal wire or plastic.
In the provision of pressurized breathing gas provided to patients in the administration of CPAP therapy, it is necessary to convey breathable gas from a source of pressurized breathing gas to a breathing interface worn by the patient. In instances where it is desirable to detect the pressure at the interface and feed that pressure back to a sensor associated with the air supply, a pressure sensing lumen may be used. The simplest way to incorporate a pressure sensing lumen with a breathable gas supply tube is to connect the pressure sensing lumen to the gas supply tube. One way to accomplish this is to provide a multi-lumen tube.
In as much as the breathing gas tube or tubes employed with some CPAP systems make contact with the wearer's face, it is critical to reduce to the greatest extent possible any discomfort experienced by the wearer in areas where the tube contacts the face. One means of doing so is to form the tube with a somewhat flattened skin-facing surface, such as would be realized with a D-shaped cross-sectional profile. Such a configuration has the effect of increasing the contact area between the tube and the skin, which in turn reduces the discomfort perceived by the wearer.
Users of CPAP systems also face the challenges associated with movements during sleep. Such movements create crushing and kinking forces on the tube, which can interfere with, and even completely interrupt, the flow of breathing gas to the wearer. Therefore, it is critical that a tube be as strong as possible, yet light weight enough to be as unobtrusive as possible. These competing needs create an especially difficult challenge in the case of D-shaped breathing gas tubes, due to the asymmetrical cross-sectional profile thereof. The movements create essentially infinitely varying deflections in the tube depending upon the direction of the forces exerted upon the tube (e.g. radial, columnar, bending, etc.). Therefore, if the structural configuration and compositional material used to create the tube is not carefully chosen, the D-shaped tube will be easy to kink and/or crush.
The use of coextruded materials having different durometers is known. For example, U.S. Pat. No. 5,451,206 to Young discloses a triple lumen catheter formed from coextrusion using materials of different durometers, in which an inner septum or dividing wall is formed using a material having a durometer greater than the material which is used to form the outer cylindrical tube. However, not only does the tube of Young have a cylindrical cross-sectional profile, but the third, smaller, lumen, along with the two larger lumen, are bounded in part by the softer outer peripheral wall of the tube. This creates a situation where pressure forces in one lumen may collapse any of the lumens due to the softer wall material used to form each of the lumen. U.S. Pat. No. 5,221,256 to Mahurkar discloses a multi-lumen catheter of cylindrical cross-sectional shape having an internal diametral septum extending along the length thereof. The third lumen of the Mahurkar tube is also bounded by the lower durometer material, allowing for crushing and/or kinking In addition, a rigid septum is more complicated and expensive to incorporate during the extrusion process than simply coextruding a tube out of a single base material, but having differing durometers in the different components of the tube.
What is needed, therefore, is a hose that has substantially equal bending resistance in all directions to reduce the tendency of the hose to crimp.
Therefore, it is a principal object of this invention to provide a tube of the type having an asymmetrical cross-sectional profile/area but which exhibits symmetrical bending and crush resistance, i.e., uniform resistance to bending and/or crushing, regardless of the direction of the bending and/or crushing forces exerted on the tube.
It is also an object of the invention to provide a fluid flow tube, regardless of the number of lumen which it defines, which has an asymmetrical cross-sectional profile/area but which exhibits symmetrical bending and crush resistance.
It is a further object of one embodiment of the invention to provide a flexible fluid flow tube which has a somewhat, or alternatively completely, flattened side adapted to rest against a user's face or other body part which demonstrates omnidirectional rigidity against crushing and kinking forces.
These and other objects are achieved by the configuration and arrangement of component parts of a tube as shown and described herein.
The present invention provides a hose having an asymmetrical cross-section but which exhibits symmetrical bending and crush resistance regardless of the direction of the bending and/or crushing forces exerted on the tube. Such a tube may have an inner strengthening rib which is coextruded with the outer wall of the tube. In at least one embodiment the rib defines at least one additional lumen, and is fabricated of a material having an equal or higher durometer, i.e., equal or higher resistance to deflection and/or indentation than the material out of which the outer wall is fabricated. This arrangement provides a flexible tube body but which will resist kinking and crushing to the greatest extent possible.
This invention is suited to, among many other things, application to tubes used to supply a respirable breathing gas under pressure from a pressure source to a respiratory interface worn by a user. In the preferred embodiment, the breathable gas is adapted to be supplied under pressure at or below the range used for the treatment of sleep disordered breathing. Such pressurized gas creates a pneumatic stent of the upper respiratory tract of a patient, whereby obstructions which may cause snoring, apnea or the like are displaced out of the breathing space. Such apparatus, known as CPAP (continuous positive airway pressure) devices, deliver breathable gas at a predetermined, substantially constant, pressure to achieve the aforementioned stenting. A suitable gas supply apparatus S, as seen in
As used herein “tube” or “tubes” shall mean a hose or hoses made from an extruded material having at least one outer wall and one inner wall which allows for the free flow of a fluid, gas, or mixed phase materials within. A tube may have a plurality of inner walls forming one or more lumen within a tube. A tube may be made from one or a combination of materials selected from polyvinyl chloride (PVC), rubber, tygon, polyurethane, silicon, or any polymers, combinations or derivatives thereof. In at least one embodiment the tube materials are medical grade.
As used herein “asymmetrical” shall mean, only as to the preferred embodiment, a tube having a non-circular cross-sectional area when cut through a plane that is perpendicular to an elongate axis of the tube.
As used herein, the term “flattened” in connection with a fluid-carrying hose shall mean a planar tube wall section, or, if curved, a tube wall section having a radius of curvature that is greater than a radius of curvature of any other aspects of the tube.
The pressure sensor of such device may be coupled with the user breathing interface and provide an output signal indicative of the pressure of the supply of breathing gas at the user breathing interface. A measurement lumen may be resident within the breathing gas tube, which measurement lumen fluidly communicates the user breathing interface with the pressure sensor.
A controller which couples the measurement lumen to the blower controls the output of the breathing gas from the blower. In a preferred embodiment, the controller maintains a pressure of the breathing gas at the user breathing interface to between about 1 cm H2O to about 6 cm H2O. Also in the preferred embodiment, the blower assembly accelerates the breathing gas at about 1.5 l/min/s over a flow rate of about 0 l/min to about 100 l/min. The breathing gas supply tube may have a cross-sectional area in the range of 0.5 mm2 to 2.0 mm2. Other sizes, dimensions and configurations of flow parameters are contemplated to be within the scope of the invention disclosed herein.
The blower includes a blower motor and an impeller. A speed of the motor may be controlled based upon, at least in part, the control signal communicated through the sensing lumen. In this way, the pressure of breathing gas supplied to the user breathing interface may be closely controlled to within predetermined parameters specified for the particular user.
Referring now to the drawings, in a preferred embodiment, the breathing gas tube 10 includes an asymmetrically-shaped outer wall member 20, which defines a hollow interior capable of conveying any type of fluid, and a coextruded inner strengthening rib or partition wall 30. Rib 30 divides tube 10 into first and second flow chambers 40, 50, respectively. Rib 30 has, in the preferred embodiment, an upper wall member 32 and a lower wall section 36 which defines and surrounds a third, pressure sensing, lumen 60. Pressure lumen 60 may have any cross-sectional configuration desirable, the circular cross-section shown being merely exemplary. Alternatively, pressure lumen 60 may be dispensed with without departing from the spirit of the invention. In the event that there is no pressure lumen such as third lumen 60, rib 30 may extend from the upper wall section to the lower wall section as a rib having a constant cross-sectional area, or the cross-sectional area may be varied depending upon the bending-resistance characteristics desired for tube 10. For example, the increased amount of material used to created third lumen 60 causes a commensurate strengthening of the tube 10 in one or more directions.
Chambers 40 and 50 are adapted to convey breathing gas from the blower to the user breathing interface, and are sometimes herein referred to as the “first” and “second” lumens. Third lumen 60 fluidly communicates the above-referenced pressure sensor with a desired location at which pressure (or one or more other parameters) is to be measured, such as within the user breathing interface.
Outer wall 20 may be fabricated from a resinous or polymeric material such as medical grade PVC in the preferred embodiment. In the preferred embodiment, the material out of which external wall 20 is fabricated has a durometer of between 40 Shore A and 70 Shore A, and may be 50 Shore A. Also in the preferred embodiment, rib 30 is also preferably fabricated of medical grade PVC, and preferably has a durometer of between 40 Shore A and 80 Shore A, and may be 70 Shore A.
It is preferred to select the material out of which outer wall 20 and rib 30 are constructed from the same family of materials so that when they are coextruded a secure bond will be formed there between due to the molecular compatibility of the material.
The bond area 25 between upper rib wall 32 and outer wall 20 is preferably formed in the shape of the arch shown in
Bond area 38, where lower section 36 of rib 30 mates with wall 20, is preferably shaped in the manner shown in
Wall 20 is defined by an upper section 27, that is, substantially the portion of wall 20 above reference line R. A lower portion 29 of outer wall 20 is that portion of said wall 20 lying below reference line R. Upper section 27 has a radius of curvature centered about center point C3 of preferably in the range of 0.240 inches, and is substantially bisected by rib 30 in the preferred embodiment.
Lower portion or section 29 of wall 20 has a complex curvature in the preferred embodiment. In one embodiment, a central section, or second wall segment, 31 thereof, which is substantially bisected by lower portion 36 of rib 30, has a radius of curvature of approximately 0.794 inches. On opposed sides of lower wall section 31 are first and third curved wall segments 33, 34. Preferably, the curvature of each of lower section wall segments 33, 34 are similarly shaped, in the preferred embodiment having a radius of curvature of approximately 0.105 inches. First and third curved segments 33, 34 of lower section 29 of outer wall 20 preferably are preferably centered about respective centers C1 and C2.
As stated earlier, rib 30 and outer wall 20 are, preferably, coextruded. However, any other manner of assembling outer wall 20 and inner strengthening rib 30 is contemplated to be within the scope of this invention, including extruding them simultaneously when they are fabricated of material having a single durometer.
The intersection of upper rib wall 32 with lower rib, or partition, section 36 may employ rounded interior corners 70, 71 to facilitate a low friction environment for the fluid passing through chambers 40, 50. Preferably, the radius of corners 70, 71 is in the range of approximately 0.020 inches.
Third lumen 60 preferably has an inner diameter of approximately 0.079 inches. The outer diameter of lower rib section 36 is preferably, but not by way of limitation, approximately in the range of 0.169 inches. The overall height of tube 10 when viewed in the orientation shown in
The upper wall 32 of rib 30 may or may not be fluid-permeable, such that, if the fluid to be conveyed in chambers 40 and 50 is the same, there need be no fluid-tight barrier between them. By constructing upper wall 32 of fluid-permeable material, the fluid in chambers 40 and 50 can intermix. Therefore, if the hose 10 is bent to such an extent that one of chambers 40 or 50 are occluded, there can still be essentially unimpeded fluid flow in the remainder of tube 10. One manner in which to render upper wall 32 fluid-permeable is to create pores therein. Another manner in which to render upper wall 32 fluid-permeable is to otherwise create apertures therein
It is to be understood that the connections between rib 30 and outer wall 20 may take any suitable form. All that is required is that rib 30 and outer wall 20 are attached such that they move together when forces are imposed upon them. The bond between rib 30 and outer tube 20 need not involve penetration into the outer tube wall by rib 30.
In the case of a device for the treatment of snoring, it is preferred that the pressure in the user breathing interface be fed back to the controller to regulate the flow rate and/or pressure of the breathing gas delivered through tube 10. However, third lumen 60 need not be included, such that rib 30 may extend as an elongated wall, having a constant or varying cross-section, disposed substantially across the center, or in any other orientation, within outer wall 20. In many CPAP devices, pressure is sensed not at the user breathing interface, but at or near the blower apparatus. In such apparatus, a sensing, or third, lumen such as lumen 60 may be unnecessary. Nevertheless, it is desirable in many applications to use a hose having a “flattened” side (e.g., D-shaped) such as tube 10, resulting in an asymmetrical cross-section, such that the principals upon which the instant invention are founded apply regardless of whether or not a third lumen is provided.
In general, the invention is directed to a fluid delivery hose or tube which has an asymmetrical cross-section but which exhibits essentially symmetrical bending resistance in all directions. This is accomplished by the selection and arrangement of materials and structural dimensions of the tube 10, the preferred embodiment of which is disclosed herein.
In the preferred embodiment, therefore, the outer hose forms a substantially D-shaped cross-section defined by an upper section 27 which has a substantially constant radius of curvature that extends from the point that wall 20 intersects reference line R on the left side of tube 10 to the point that wall 20 intersects reference line R on the right side of tube 10. In the preferred embodiment, the distance from center C3 to the uppermost point 11 of tube 10 is approximately 0.224 inches. The distance from center C3 to the lowermost point 13 of the lower section 29 of wall 20 is approximately 0.12 inches. The uppermost and lowermost points 11 and 13 correspond to uppermost and lowermost edges 11 and 13 of outer tube 20. In this embodiment, a strengthening rib 30 is interposed between the upper section 27 of wall 20 and the lower section 29 of wall 20. Rib 30 is preferably coextruded with wall 20 and is preferably fabricated out of a material having a durometer that is equal to or higher than the durometer of the material out of which wall 20 is manufactured. It has been determined that configuring the tube 10 in this manner results in a surprising, unexpected result, where the tube exhibits uniform bending moment of inertia balance in all directions. In the preferred embodiment, the combination of the structural shapes of the walls 20 and 30, and/or the disclosed durometer ranges, yields results never before achieved in an asymmetrically shaped tube.
While the invention has been described in its preferred form or embodiment with some degree of particularity, it is understood that this description has been given only by way of example and that numerous changes in the details of construction, fabrication, and use, including the combination of structural arrangement and sizes of features, may be made without departing from the spirit and scope of the invention.
This application is a continuation-in-part of and claims priority to U.S. patent application Ser. No. 29/522,917 filed Apr. 3, 2015 entitled “Breathing Tube;” is a continuation-in-part of and claims priority to U.S. patent application Ser. No. 13/289,178 filed Nov. 4, 2011 entitled “Breathing Apparatus,” which itself claims priority to U.S. Provisional Patent Application Ser. No. 61/410,134 filed Nov. 4, 2010 and U.S. Provisional Patent Application Ser. No. 61/423,195 filed Dec. 15, 2010; is a continuation-in-part of U.S. patent application Ser. No. 13/425,049 filed Mar. 20, 2012 entitled “Breathing Apparatus,” which itself claims priority to U.S. Provisional Patent Application Ser. No. 61/467,760 filed Mar. 25, 2011; and is a continuation-in-part of and claims priority to Ser. No. 13/534,984 filed Jun. 27, 2012 entitled “Replaceable Nasal Interface System,” which itself claims priority to U.S. Provisional Patent Application Ser. No. 61/501,444 filed Jun. 27, 2011, the contents of which are hereby incorporated by reference in their entirety.