Patent Application
20120255555
1. Field of the Invention
This invention is directed to an assembly structured to inflate and continuously monitor pressure within an inflatable cuff, such as a retaining cuff for an endotracheal tube and/or tracheostomy tube. A casing and a pump assembly are collectively operative to inflate the cuff and monitor existing pressure therein. The casing may be alternately structured for fixed or removable securement to either or both the pump assembly and an inflating lumen communicating with the cuff. Moreover, when removably secured the casing may be prevented from being reconnected to the pump assembly and/or the lumen, once disconnection has occurred.
2. Description of the Related Art
The use of endotracheal tubes is well known in the medical profession. In practice, the tube is inserted through the mouth, nose or tracheotomy of the patient into the trachea and is structured, when properly positioned, to facilitate ventilation from a ventilator or the like.
As conventionally used, the endotracheal tube and/or tracheostomy tube includes a coupling structure at the proximal or outer end thereof which connects the lumen of the endotracheal and/or tracheostomy tube to the source of ventilation. The endotracheal and/or tracheostomy tube commonly includes an inflatable, pressure or retaining cuff which is generally disposed in surrounding relation to the distal end of the tube. In use, the cuff is inflated and thereby serves to secure or stabilize the position of the tube as it expands radially outward into confronting relation to the walls of the trachea. As a result, the inflated cuff serves to stabilize the position of the endotracheal tube and also establishes a seal within the trachea. As conventionally structured, a conduit is associated with the tube and includes an interior, inflating lumen used to inflate the cuff when the endotracheal tube is properly positioned within the trachea. Dependent on the structure and use of the endotracheal tube, the inflating line or conduit may be integrally formed on or within the primary wall of the tube itself. As such, the cuff is manually inflated by an appropriate inflation assembly such as, but not limited to, a separate, removable syringe connected in fluid communication with the inflating lumen. Moreover, the cuff is inflated to a pressure which accomplishes the above noted seal with the interior of the trachea, as well as effect the aforementioned stabilization of the endotracheal and/or tracheostomy tube.
The importance of under inflation, over inflation and/or excessive pressurization of the retaining cuff is well recognized, due to the potential of resulting injury and/or trauma to the patient. Accordingly, when the pressure within the cuff is too low, the sealing function thereof cannot be fully achieved resulting in possible leakage of saliva, air, etc. into the trachea. However, an over pressurization of the cuff may result in reduced blood flow to tracheal tissue, tracheal ischemic conditions, and cause ulcers, bleeding and tracheal stenosis or tracheomalacia after removal of the tube, which can lead to the need for tracheal repair surgery or even a tracheal transplant. Accordingly, it is important to maintain the inner pressure of the cuff, depended on its structure and design, within predetermined ranges in order to affect both the above noted fluid seal with the trachea as well as stabilization of the endotracheal tube within the trachea.
Known attempts to overcome problems of the type set forth above have resulted in the provision of various types of pressure gauges or other pressure monitoring devices connected in fluid communication with the inflating lumen and with the pressure or retaining cuff itself. However, many of these known or conventional attempts to accurately monitor cuff pressure have resulted in less than accurate or satisfactory results. Accordingly, while known monitoring devices may be at least minimally effective for their intended function, they have been found to be relatively bulky, cumbersome, costly, and/or less than efficient. Indeed, because of these factors, monitoring devices are often not available at the bed side and ET cuff pressure monitoring is often inadequately addressed, both initially as well as after the patient is intubated. Moreover, even if a one time, initial pressure identification is achieved, such is inadequate because the pressure can change over time, such as when the patient is moved or the endotracheal tube is repositioned, or when ventilation settings are adjusted. As a result, there is a need in the medical profession for an assembly structured to properly inflate and continuously monitor the pressure within a retaining or pressure cuff of an endotracheal and/or tracheostomy tube. Further, the inflating and monitoring functions of a proposed monitoring assembly should preferably be carried out by a single unit which may be incorporated within the endotracheal tube assembly or alternatively may be connected thereto. As such, the monitoring of the pressure within the retaining cuff should be effectively accomplished by a mere visual observation of the preferred assembly, without requiring repeated attachment and removal of a pressure monitor and/or inflating device. In addition, such a preferred monitoring and inflating assembly should be easily operable, and in certain preferred embodiments may be structured to be used as a single use device, which is not integrated into the endotracheal tube, but readily connectable to an inflation lumen of the tube and subsequently detachable there from, but further wherein reconnection of the monitoring assembly is prevented so that reuse of the device is prevented to avoid cross-contamination of infection from patient to patient.
Further, in addition to its applicability within the pressure cuff associated with an endotracheal tube, it is also recognized that such a structure would be highly beneficial for use within a variety of different medical devices, including the pressure cuffs, often referred to as balloons or bladders, used in balloon kyphoplasty, balloon sinuplasty, coronary or vascular balloon angioplasty and/or the delivery of stents, balloon esophageal dilation, and the dilation of strictures and sphincters, balloon dilatation of the nephrostomytract, and/or Swan Ganz catheters, among other medical devices.
The present invention is directed to an assembly structured to inflate and monitor the pressure within a retaining or pressure cuff, such as of the type associated with an artificial airway tube including for example, but not limited to, an endotracheal and/or a tracheostomy tube. In typical fashion, the retaining or pressure cuff is connected to or associated with the distal end of the endotracheal tube and is radially expanded, such as by inflation and pressurization. When inflated the cuff serves to retain the associated tube in an intended position within the trachea of a patient and form a seal therewith. It is emphasized that while the structural and operative features of the assembly of the present invention are applicable for use with a retaining/pressure cuff, associated with the aforementioned artificial airway tube(s), it is not intended to be limited to such use. More specifically, the inflation and monitoring assembly of the present invention can be used to perform the intended and described functions when operatively associated with retaining or pressure cuffs used for a plurality of other purposes.
Accordingly, the assembly of the present invention is structured to efficiently inflate the retaining or pressure cuff so as to orient it in a retaining, sealing position within the trachea. During and subsequent to inflation, the assembly of the present invention is structured to monitor the existing pressure within the cuff in order to avoid under inflation, over inflation and/or over pressurization thereof. More specifically, the assembly of the present invention comprises a casing which is connected to the inflating lumen of the endotracheal tube, leading to the retaining cuff, by means of a connection assembly. In at least one preferred embodiment of the present invention, the connection assembly is structured to selectively assume a connect orientation or a disconnect orientation. When in the connect orientation the connection assembly is disposed or oriented to connect to the inflating lumen and establish and maintain fluid flow between the casing of the assembly and the interior of the retaining cuff. However, when in the disconnect orientation, the connection assembly is structured to allow disconnection and removal of the casing from the inflation lumen and further structured to prevent reconnection therebetween. Therefore, at least one preferred embodiment of the present invention comprises a single-use inflation and monitoring assembly. As a result, once the casing of the assembly is disconnected from the inflating lumen, it is not reusable at least to the extent of being reconnected to the inflating lumen. However, structural modifications of the connection assembly may be included in an additional preferred embodiment, wherein the inflation and monitoring assembly of the present invention may be fixedly and/or permanently connected to the inflation lumen and be used therewith as an integrated unit.
Additional structural and operative features associated with the inflation and monitoring assembly of the present invention include the existence of a pressure chamber on the interior of the casing. In addition, a pump assembly preferably, but not exclusively, in the form of a plunger is connected to the casing and movable between and outwardly extended position and an inwardly directed, compressed position. Therefore, the pump assembly of the present invention is structured for selective manipulation to direct fluid flow from an exterior of the casing into the pressure chamber and therefrom through a remainder of the casing and into the inflating lumen attached to the casing.
A valve assembly is operatively disposed in flow regulating relation between the pump assembly and the interior of the pressure chamber. The valve assembly includes a first valve structure serving to regulate fluid flow from an exterior of the casing into the interior of the pump plunger, as the plunger is drawn or forced into the outwardly extended position. In contrast, a second valve structure of the valve assembly is structured to regulate fluid flow from the interior of the plunger into the interior of the pressure chamber. The inward movement of the plunger into a compressed position forces air or fluid flow through the pressure chamber and predetermined remaining portions of the casing, through the connection assembly and into the inflating lumen, through which the forced fluid flow travels to the retaining cuff. The cuff is thereby inflated and pressurized.
One preferred embodiment of the present invention comprises the pump assembly structured as an integrated and/or permanent part of the casing. However, it should be noted that a source of air or other fluid used to pressurize or inflate the retaining cuff may be removably attached to the casing of the monitoring assembly. Such a source of pressurizing and/or inflating fluid may comprise, but is not limited to, a pump assembly which may or may not have similar operative and/or structural characteristics as the plunger described herein. Accordingly, a removable pump assembly or other source of inflating fluid can be removably connected to the casing without departing from the spirit and scope of the present invention.
The assembly of the present invention further includes an indicator assembly comprising an indicator member movably connected to and variably positioned within the casing. The indicator assembly is disposed in direct fluid communication with the interior of the pressure chamber and as a result the position of the indicator member is directly influenced by the existing pressure within the pressure chamber. Moreover, due to the establishment of fluid communication between the interior of the pressure chamber and the interior of the retaining cuff, the existing pressure in the pressure chamber and the retaining cuff will be substantially equivalent. In that the existing pressure within the pressure chamber is exerted on the indicator member, the indicator member is “variably positioned” within the casing dependent on the magnitude of the existing pressure within the pressure chamber. Due to the fact that the existing pressure within the pressure chamber is equivalent to the pressure within the retaining cuff, the variable positioning of the indicator member will be dependent on and indicative of the existing pressure within the retaining cuff.
Other operative and structural features include a window disposed on the casing to facilitate the visual observation of at least a portion of the indicator member. As a result, personnel may easily and efficiently monitor the pressure within the cuff by visually determining the position of the indicator member within the casing. Moreover, the portion of the indicator member viewable through the window may include informative alpha/numeric indicia, color coding, etc. which provides the observer with a clear and easily determinable visual indication as to an acceptable or non-acceptable pressure level within the retaining cuff. In addition, in order to further facilitate the visual observation of the pressure reading, the window may incorporate a magnifying lens or similar structure to make viewing easier. Yet additional embodiments of the present invention may include an LED or other appropriate digital readout, as well as an audible and/or visual warning in the event of an over inflation condition of the cuff. Also, the inflation and monitoring assembly may be structured to facilitate locating and/or using it when in a darkened room. Such features may include, but are not limited to, the illumination or “glowing” of the casing and/or other components of the assembly when it is used or stored in a darkened area.
Additional structural and operative features of the inflation and monitoring assembly of the present invention include a pressure relief valve assembly including at least one relief valve mounted on the casing in an exteriorly accessible location. Further, the pressure relief valve is disposed in direct fluid communication with the interior of the pressure chamber and in regulating relation to fluid flow vented from the pressure chamber to an exterior of the casing. As a result, the selective manipulation of the relief valve will cause a “bleeding” or venting of air or fluid from within the pressure chamber to the exterior of the casing. As a result the pressure within both the pressure chamber and the retaining cuff may be reduced when it is determined that such pressure is excessive. In addition, the structuring of the relief valve may be tapered or otherwise appropriately structured to provide for a gradual bleeding or release of pressure from within the pressure chamber.
In order to avoid inadvertent venting or release of the pressure within the pressure chamber and retaining cuff, alternately structured embodiments of the inflating and monitoring assembly of the present invention include a restricting assembly or shield assembly. Each of these assemblies is selectively positionable on the casing, so as to restrict inadvertent access to the pressure relief valve. In addition, the restricting assembly is structured to removably lock or otherwise restrictively engage the plunger of the pump assembly in order to restrict its movement and intended operation. In contrast, the shield assembly is movably mounted on the casing and selectively disposable between a closed, valve shielding position and an open, valve activating position relative to the relief valve. In addition, the shield assembly includes an activating portion deformable or otherwise disposable into activating relation and/or engagement with the pressure relief valve, when the shield assembly is in the open, valve activating position.
It should be noted that in the above described embodiments of the present invention the pump assembly defining the source of inflating fluid is generally represented as being permanently or fixedly attached to the casing. However, in at least one embodiment a source of fluid used to pressurize and inflate the retaining cuff may be removably attached to the casing of the monitoring assembly. In addition, the removable source of pressurizing or inflating air or other fluid may comprise, but is not limited to, a pump assembly which may be similarly operative to direct air into and through the casing for purposes of inflating or pressurizing the retaining cuff. Also, in this additional preferred embodiment the casing includes an adaptor assembly structured to define a single use connection between the casing and the inflating lumen associated with the retaining cuff.
It is emphasized that while this preferred embodiment is described in detail as establishing a single use connection with an inflating lumen for a retaining cuff, this embodiment could be used for the establishment of a single use connection between different medical devices. By way of example only, the adaptor assembly could be an effective in defining a single use connection between different but cooperatively structured medical devices especially, but not limited to, where one of the devices includes a luer type connector, as should be apparent from the following detailed description.
The additional preferred embodiment of the present invention includes an adaptor assembly structured to define a single use connection between the casing and the inflating lumen for the retaining cuff. Moreover, the adaptor assembly includes a housing which may be removably or fixedly connected to the casing. In addition, the outlet port connector of the casing is received within the interior of the adaptor in cooperative relation with a restrictor. The restrictor is movable within the interior of the adaptor and in cooperative relation with the outlet port connector of the casing and in receiving relation to a connector associated with the inflating lumen and retaining cuff. Cooperative structuring between the restrictor and the adaptor serve to facilitate the movement of the restrictor between a receiving position, an operative position and an inoperative position. Therefore, the restrictor may be forced to move from the receiving position into the operative position a sufficient force to accomplish the connection of the inflating lumen connector and the outlet port connector. The directed force may be exerted on the restrictor by a forced movement or positioning of the connector of the inflating lumen 15. As set forth above, once the restrictor is in the operative position, the inflating lumen connector will or can be disposed in sealing or mating engagement with the outlet port connector. The aforementioned path of fluid flow is thereby established between the inflating lumen, the interior of the casing and eventually the retaining cuff.
Additional structural and operative features associated with the adaptor assembly include the provision of an orienting assembly connected to or mounted on the adaptor as well as portions of the restrictor. More specifically, the orienting assembly includes a track structure which preferably includes a curved and/or angular configuration and may include curved and/or angular ramp portions. In addition, the orienting assembly includes at least one but preferably a plurality of orienting members connected to the restrictor and extending at least partially outward there from. The one or more orienting members may be formed of a flexible material having sufficient resiliency to be normally biased into engagement with the track structure.
In addition, the adaptor assembly includes the provision of a retaining structure 430 which may include a plurality of independent and/or spaced apart recesses or other appropriately configured grooves or recesses. The retaining structure may be a part of the track structure and as such may be disposed in communicating relation with an appropriately configured track segment which facilitates the movement of the restrictor form the operative position into the inoperative position. Therefore, upon release of the directed force on the restrictor by the inflating lumen connector, the one or more orienting members travel along the track segment(s) until they engage or are at least partially disposed in a retained relation with the retaining structure.
When so positioned, the orienting members will be substantially fixed within or relative to the retaining structure. As a result, when the restrictor is in the inoperative position, it is disposed in obstructing relation to the inflating lumen connector, thereby preventing or restricting the positioning of the restrictor by the connector into the operative position. Moreover, the obstructing position of the restrictor will restrict the inflating lumen connector from entering the adaptor housing to a position where the connector can establish the aforementioned path of fluid flow with the outlet port connector of the casing. Therefore, the adaptor assembly including the provision of the retaining structure and the interaction thereof with the orienting assembly will define a single use connection between the retaining cuff and the inflating lumen. However, it is again emphasized that the adaptor assembly including the provision of the retaining structure and the interaction thereof with the orienting assembly could be effective in defining a single use connection between different but cooperatively structured medical devices especially, but not limited to, where one of the devices includes a luer type connector.
Other features associated with the restrictor include it being color coded so as to provide a clear indication that the adaptor assembly is in fact a single use device. Such color coding may also be used independently of or in combination with appropriate indicia to provide a further visual indication that the adaptor assembly has been previously used and/or is no longer usable.
As set forth above, at least one embodiment of the adaptor assembly is structured to establish a single use connection of the removal fluid source with the casing. Accordingly, additional structural and operative features of the adaptor assembly may include a retaining structure disposed within the housing in engageable relation with the restrictor. The retaining structure is cooperatively structured with the restrictor so as to fixedly maintain the restrictor in the aforementioned inoperative position. Moreover, the inoperative position may be more specifically defined by the retractor being fixed in an obstructing position relative to the discharge portion of the removable fluid source. This obstructing position will prevent connection of the discharge portion of the fluid source and the outlet port of the casing, thereby preventing the establishment of the aforementioned path of fluid flow. The obstructing position of the restrictor being fixed will also prevent the pump assembly from forcing movement of the restrictor into the aforementioned operative position within the housing.
These and other objects, features and advantages of the present invention will become clearer when the drawings as well as the detailed description are taken into consideration.
For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:
Like reference numerals refer to like parts throughout the several views of the drawings.
As shown in the accompanying drawings, the present invention is directed to an inflation and pressure monitoring assembly generally indicated as 10. The assembly 10 structured to inflate and monitor the pressure within a retaining cuff or pressure cuff of a medical device, including in the preferred embodiment the type associated with an endotracheal tube. It is understood, however, that the pressure cuff, often referred to as a balloon in some devices, could be included as part of medical devices used in balloon kyphoplasty, balloon sinuplasty, coronary or vascular balloon angioplasty and/or the delivery of stents, balloon esophageal dilation, and the dilation of strictures and sphincters, balloon dilatation of the nephrostomytract, and/or Swan Ganz catheters, among other medical devices.
More specifically, the assembly 10 includes a generally elongated casing 12 having a distal end generally indicated as 14 structured to be interconnected to an inflation lumen 15, which will be described in greater detail hereinafter, by means of a connection assembly 17. The connection assembly 17 is accessible through a receiving port 14′ associated with the distal end 14 of the casing 12, and will be described hereinafter with primary reference to
With primary reference to FIGS. 1C and 2-4, the casing 12 includes an at least partially hollow interior more specifically defined by a pressure chamber 16. A pump assembly generally indicated as 18 is preferably in the form of a plunger 20 having an outer end 20′ and an elongated stem or barrel portion. The pump assembly 18 and specifically including the plunger 20 includes a hollow interior 24 extending along substantially the entire length or at least a majority of the length of the plunger 20. The plunger 20 is movably connected to the casing 12 and is selectively disposed between an inwardly directed compressed position as represented in
In order to regulate fluid flow to the retainer cuff and maintain a predetermined, acceptable pressure level therein, a valve assembly 28 is associated with the pump 18 and specifically the plunger 20. The valve assembly 28 is disposed in fluid regulating, interconnecting relation between the pressure chamber 16 and the interior 24 of the plunger 20. As such, the valve assembly 28 is disposed and structured to regulate fluid flow from an exterior of the casing 12 into the interior 24 of the plunger 20 and therefrom into the pressure chamber 16. More specifically, the valve assembly 28 includes a first valve structure 30 and a second valve structure 32 both structured in the form of one-way valves. In at least one preferred embodiment of the present invention, the first one-way valve structure 30 and the second one-way valve structure 32 are integrally or fixedly attached and cooperatively operational so as to regulate fluid flow from the exterior of the casing 12, into the pressure chamber 16 and therefrom into the inflation lumen 15 and into the retaining cuff associated with the endotracheal tube.
In operation, when in the compressed position of
Therefore, the air or other fluid forced into the pressure chamber 16 will pass into a delivery channel 40 having an entrance 42 communicating directly with the interior of the pressure chamber 16. An exit or delivery end of the channel 40 is designated as 44, wherein an end most channel segment 44′ will deliver a forced fluid flow through the connecting assembly 17 directly to the connecting collar 80 of the hub 82, of the inflating lumen 15. The end channel segment 44′ is passes through the connecting assembly 17 and is disposed in fluid communication with the connecting collar 80 through the receiving port 14′ associated with the distal end 14 of the casing 12. As set forth above, the distal end 14 may be removably connected to the inflating lumen 15, as primarily represented in
Therefore, it should be apparent that a forced fluid flow from the interior of the plunger 20 into the pressure chamber 16 will serve to deliver a predetermined quantity of air or other inflating fluid through the pressure chamber 16 and into and along the length of the channel 40. Such fluid flow will continue to pass through the exit end 44 and channel segment 44′ of the channel 40 and exit from the casing 12 through the receiving port 14′. Therefore the pressure chamber 16 and the interior of the retaining or pressure cuff will normally be maintained in fluid communication with one another. As a result the “existing pressure” within the pressure chamber 16 will be the same as the pressure within the inflated retainer cuff, as long as the casing 12 is operatively connected to the inflating lumen 15.
While at least one preferred embodiment of the present invention comprises the pump assembly 18 structured as an integrated and/or permanent part of the casing 12, it is noted that the a removable pump assembly, having similar operative and structural characteristics such as, but not limited to, a removably connected syringe type assembly, can be removably connected to the casing 12 without departing from the spirit and scope of the present invention.
Another feature of at least one preferred embodiment of the present invention is the provision of an indicator assembly generally indicated as 50 represented in different stages of operation in
Therefore, as a result of the forces concurrently exerted on the indicator member 52 by the biasing member 54 and the existing pressure within the pressure chamber 16, the indicator member 52 is “variably positioned” within the interior of the casing. The biasing force exerted on the indicator member 52 by the biasing member 54 and may be predetermined and as such relatively constant or at least predictable. Accordingly, the movement of the indicator member 52 and its variable position within the casing 12 is directly dependent on the magnitude of the existing pressure within the pressure chamber 16 and the resulting variable force exerted on the indicator member 52. Additional structural and operative features of the indicator assembly 50 include the aforementioned interconnecting member in the form of the bladder 56, formed of a flexible material. The bladder 56 includes an open end 56′ disposed and dimensioned to establish direct fluid communication with the interior of the pressure chamber 16. The opposite end or other appropriate portion as at 56″ is connected to or is otherwise disposed in confronting, driving relation to a corresponding portion of the indicator member 52. Any existing pressure within the pressure chamber 16 will result in a proportional force being exerted on the flexible material bladder 56 and transferred to the indicator member 52 and against the biasing force exerted on the indicator member 52 by the biasing member 54. Therefore, the existing pressure within the pressure chamber 16 will exert a variable force on the bladder 56 and thereby on the indicator member 52 and against the biasing member 54, depending on the magnitude of this existing force.
With primary reference to
More specifically,
Accordingly, it is again emphasized that the existing pressure within the pressure chamber 16 will be substantially equivalent to the existing pressure within the retaining cuff associated with the endotracheal tube when it is inflated. This is due to the open line of fluid communication between the pressure chamber 16 and the interior of the retainer cuff once inflated and when the pump assembly 18 specifically including the plunger 20 is in its compressed position as represented in
Additional features associated with the indicator assembly 50 preferably include the provision of indicating indicia 53 present on the exterior surface 52′ of the indicator member 52. Further, the casing 12 includes a window or like structure 58 which facilitates a visual observation of the exterior surface 52′ of the indicator member 52 as well as the indicating indicia disposed thereon. Such indicating indicia 53 may be in the form of a color coded segment or segments on the exterior surface 52′ and/or any type of other appropriate markings which are disposed and structured to facilitate a clear visual indication of an adequate or proper pressure within the pressure chamber 16 and accordingly within the retaining cuff. By way of example only, a color coded portion may exist on the exterior surface 52′ which will provide an individual, having visual access to the window 58, with a clear indication that at least the minimum or adequate amount of pressure exists within the retainer cuff. Such color coding may include a “red” surface area segment which will quickly inform an observer that the retainer cuff may be over inflated or include excess pressure on the interior thereof.
In addition, a magnifying lens or other magnifying structure may be included in or as part of the window 58, in order to further facilitate the visual observation of the indicating indicia 53 on the surface 52′. Yet additional embodiments of the present invention may include an LED or other appropriate digital readout, as well as an audible and/or visual warning, associated with the exterior of the casing 12, such as in the vicinity of the window 58, in the event of an over inflation condition of the cuff.
In order to properly inflate, monitor and if necessary regulate the existing pressure within the pressure chamber 16 and accordingly within the retainer cuff, at least one preferred embodiment of the present invention includes a pressure relief assembly generally indicated as 60, as represented in
The provision of a pressure relief assembly 60 may be necessary and/or desirable to maintain an adequate control of the existing pressure within the pressure chamber 16. However, care must be taken to avoid or prevent any inadvertent venting of the existing pressure within the pressure chamber 16. Accordingly, at least one preferred embodiment of the present invention includes a restricting assembly generally indicated as 70. The restricting assembly 70 includes a finger manipulated slide structure 72 movable along the exterior of the casing 12, such as along the one or more rails 74.
With primary reference to
As also noted in
With primary reference to
Although not specifically represented, the gripping structure 92 is associated with an appropriate biasing structure, which is disposed to bias the gripping structure 92 in a direction towards the connecting port 14′. Further, the retaining member 90, while being initially disposed adjacent to and/or extending outwardly from the port 14′, is movable on or relative to the gripping structure 92 in direction away from the port 14, as the collar 80 passes through the port 14′ and engages the retaining member 90. Accordingly, a comparison of
With primary reference to
As a result, it will be impossible or extremely difficult for the casing 12 to be reconnected to the hub 82 or collar 80 of the inflating lumen 15 once it has been disconnected there from, due at least in part to the fact that the collar 80 will not be able to be inserted back through the receiving or connecting port 14′ into engagement with the male connector 43. It should be apparent therefore, that in the embodiment of
In addition to the above, at least one embodiment of the connection assembly 17 comprises the retaining member 90 and the gripping member 92 being of different, contrasting colors thereby clearly indicating whether the assembly 10 and the casing 12 is in the connect orientation and ready for us or in the disconnect orientation and has already been used. More specifically, as represented in
As set forth above, the embodiment represented in
With primary reference to
Structural features of the connection assembly 117 further provide for the removal or disconnection of the hub 180 from the connection assembly 117 as represented in
As represented in
More specifically, the structure of
As best represented in
Although not specifically represented, the fluid connection between the first and second chambers 300 and 302 respectively is disposed within the casing 112 and establishes fluid communication there between. Upon reciprocal movement of the plunger 120 between the extended position of
With further reference to
Moreover, the reaction member 312 is connected to or considered a part of the indicator 312′ which is visually observable through a window 158 formed on the exterior of the casing 112. Accordingly, viewing of the exterior of the casing in the area disclosed in
Other structural features associated with the indicator assembly 110 include the hollow interior 316 as well as the reaction member 312 itself being physically isolated from the first chamber 300, such as by partition structure 333 in order to better provide an accurate response by substantially equivocating the pressure within the second chamber 302 to the pressure within the retaining cuff. However, the indictor assembly 310 further includes a vent structure 320 disposed in fluid communication between the interior 316 of the reaction member 312 and an exterior of the casing 112, as represented at 320′. Vent structure 320 is disposed and structured to regulate fluid flow into and out of the hollow interior 316 as the reaction member 312 moves with and against the biasing force of the biasing structure 314. More specifically, a build up of the pressure within the second chamber 302 will force the reaction member 312 into a compressed orientation thereby forcing fluid from within the hollow interior 316 out through the vent 320. Movement of the reaction member 312 in the opposite, outwardly extended position, upon absence of significant pressure within the chamber 302 will allow air or fluid to be drawn into the interior 316 through the vent structure 320.
With further reference to the embodiments of
Yet additional structural and operative features included in the additional preferred embodiment of
In addition, each of the retaining members 352 include a free end portion 352′ which are cooperatively structured with correspondingly disposed parts of the plunger head 120′, as at 120″. When the one or more retaining members 352 are in the orientation represented in
With primary reference to
As also set forth above, the connecting portion 217 is intended to be of a single use construction. Upon the inward forced movement of the retaining member 90 it is removed from its retaining relation to the outermost end 92′ of the gripping structure 92. The inward forced travel of the retaining member 90 is caused by the insertion thereof of the collar 80, as described in detail with reference to
As described in detail with the above noted embodiments, a source of inflating air or fluid used to inflate and pressurize the retaining cuff may take a variety of forms such as, but not limited to a syringe or like pump assembly. It is also indicated the pump assembly or source of inflating fluid may or may not be fixedly attached to the remainder of the inflating and monitoring assembly. Accordingly, the present invention includes an additional preferred embodiment, represented in
As such, the inflating and monitoring assembly 360 includes a casing 362 having at least one pressure chamber 364. The pressure chamber 362 is disposed in fluid communication with a pump assembly or source of inflating fluid, which may be removably or fixedly connected to an inlet portion 366 of the casing 362. More specifically in the embodiment of
Somewhat similar to the operative and structural features of at least some of the preferred embodiments of
An additional structural modification is represented in
In addition, an outlet port of the casing 362 may be in the form of a male luer type connector 374 including an interior lumen 376. As set forth in greater detail hereinafter the connector structure 374 and the interior lumen 376 may at least partially define a path of fluid flow of the cuff inflating air. More specifically, the inflating air passes from the pressure chamber 364 into a connecting collar or connector 80 associated with the inflating lumen 15 and hub 82. As clearly represented in the embodiment of
Further with regard to the embodiments of
Another structural and operative feature of the additional preferred embodiment of
Additional features of the adaptor assembly 400 include a restrictor 412 movable within the interior of the adaptor housing 406. As such the restrictor 412 preferably, but not necessarily, at least partially surrounds the outlet port connector 374 and is disposed in at least partially receiving relation to the 80 as clearly represented. Cooperative structuring between the restrictor 412 and the adaptor housing 406, including interior portions thereof, serve to facilitate the movement of the restrictor 412 between a receiving position; as represented in
Additional structural and operative features associated with the adaptor assembly 412 include the provision of an orienting assembly connected to or mounted on both interior portions of the adaptor housing 406 and portions of the restrictor 412. More specifically, the orienting assembly includes a track structure generally indicated as 420 formed on interior wall surfaces of the housing 406 or other appropriate portions thereof. The track structure 420 preferably includes a curved and/or angular configuration and may include a curved and/or angular ramp member 422. In addition, the orienting assembly includes at least one but preferably a plurality of orienting members 424 connected to a remainder of the restrictor assembly 412 and extending at least partially outwardly there from. Additionally, in at least one structural modification or additional embodiment, the orienting assembly includes one or more orienting members 424. The orienting members 424 preferably, but not necessarily, are formed of a flexible material having sufficient resiliency to be normally biased outwardly from the remainder of the restrictor 412 into engagement with the track structure 420.
The one or more orienting members 424 will be disposed into movable engagement with at least a portion of the track structure 420 and will “follow” the curved or angular path of the portion of the track structure 420 which the orienting members 424 engage. As such, a forced positioning of the restrictor 412 by an inward and/or axial movement 413 of the connector 80 (or relative axial movement therebetween) will result in the axial travel of the restrictor 412 from the receiving position to the operative position and a concurrent predetermined reorientation of the restrictor 412. Such a predetermined reorientation of the restrictor 412 concurrently to its axial movement within the interior of the housing 406 is caused by the movable interaction between and the “following” of the one or more orienting members 424 along the track assembly 420. As clearly indicated, the connection of the orienting members 424 with the remainder of the restrictor 412 will result in a corresponding “reorientation” of the remainder of the restrictor 412 as it is forced from the receiving position into the operative position. Moreover, it is to be noted that the disposition of the track structure 420 extends about and along potions of the interior surface of the adaptor housing 406. This disposition as well as the curved and/or angular configuration of at least portions of track assembly 420 and/or the provision of one or more ramps 422 will cause a rotation and/or a “rotational reorientation” of the restrictor 412 within the interior of the housing 406, concurrently to its travel from the receiving position to the operative position. Such a rotational reorientation is further due to the interaction of the one or more orienting members 424 with the track structure 420.
As also represented in
Additional structural features which may be associated with one or more preferred embodiments of the adaptor assembly 400 include the provision of a retaining structure 430. The retaining structure 430 is also preferably formed on the interior of the housing 406. The retaining structure 430 may comprise a plurality of independent and/or spaced apart recesses or alternatively an annular, semi-annular or other appropriately configured groove or recess, as represented in at least
When so positioned, the structured disposition or inherent outward biasing feature of the orienting members 424 will cause the distal ends 424′ thereof to be substantially fixed within or relative to the retaining structure 430. Therefore, when the restrictor 412 is in the inoperative position, it is disposed in obstructing relation to the connector 80, thereby preventing or restricting the forced positioning of the restrictor 412 by the connector 80 into the operative position. Moreover, the obstructing position of the restrictor 412 will restrict the connector 80 from entering the adaptor housing 406 to a position where the connector 80 can establish the aforementioned path of fluid flow with the outlet port or male connector 374. Therefore, the adaptor assembly 400 of the present invention, through the provision of the retaining structure 430 and the interaction thereof with the one or more orienting members 424 can be said to define a single use connection between the retaining cuff via the connector 80 of the inflating lumen 15.
However, it is again emphasized that the adaptor assembly 400 including the provision of the retaining structure 430 and the interaction thereof with the orienting assembly, as described herein, could be effective in defining a single use connection between different but cooperatively structured medical devices especially, but not limited to, where one of the devices includes a luer type connector.
As represented in
Since many modifications, variations and changes in detail can be made to the described preferred embodiment of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.
Now that the invention has been described,
The present application is a continuation-in-part application of previously filed, now pending application having Ser. No. 13/005,359, filed on Jan. 12, 2011, which is a continuation-in-part application of previously filed, now pending application having Ser. No. 12/806,810, filed on Aug. 20, 2010, which is a continuation-in-part application of previously filed, now pending application having Ser. No. 12/661,103, filed on Mar. 10, 2010 all of which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13005359 | Jan 2011 | US |
| Child | 13421288 | US | |
| Parent | 12806810 | Aug 2010 | US |
| Child | 13005359 | US | |
| Parent | 12661103 | Mar 2010 | US |
| Child | 12806810 | US |
