Inflation and monitoring assembly for a pressure cuff of an endotracheal tube
An assembly structured to inflate a retaining or pressure cuff associated with an artificial airway tube and concurrently monitor pressure therein. A pump assembly is structured to force fluid flow to the retaining cuff, for inflation, through a pressure chamber within a casing of the assemblies. An indicator member is observable through a casing window and is variably positionable dependent on and indicative of existing pressure within the retaining cuff. Existing pressure within the pressure chamber is substantially equivalent to that within the retaining cuff and is thereby indicative of pressure within the retaining cuff. A junction may be disposed in removable interconnecting relation between the casing and an inflation lumen and be structured to prevent reconnection there between.
The present application is a continuation-in-part application of previously filed, now pending application having Ser. No. 12/661,103, filed on Mar. 10, 2010 incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION1. Field of the Invention
This invention is directed to an assembly structured to inflate and continuously monitor pressure within a retaining cuff associated with an endotracheal tube and/or tracheostomy tube including a casing having a pump assembly operative to inflate the retaining cuff. An indicator assembly is readily observable and variably positioned on the casing in response to the existing pressure of the cuff. The casing may be alternately structured for fixed or removable securement to an inflating lumen communicating with the cuff. Moreover, when removably secured the casing may be further structured to prevent reconnection to the lumen, once disconnection from the lumen has occurred. The casing includes a relief valve assembly to avoid over pressurization of the cuff.
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 re-positioned, 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 re-use of the device is prevented to avoid cross-contamination of infection from patient to patient.
SUMMARY OF THE INVENTIONThe present invention is directed to an assembly structured to inflate and monitor the pressure within a retaining or pressure cuff of the type associated with an artificial airway tube such as, 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 in the form of a plunger movably connected to the casing 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, the 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, where the forced fluid flow travels to the retaining cuff. The cuff is thereby inflated and pressurized. While a preferred embodiment of the present invention comprises the pump assembly structured as an integrated and/or permanent part of the casing, it is noted that the removable pump assembly, having similar operative and structural characteristics as the plunger, etc., 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. As a result of the existing pressure within the pressure chamber being 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, which as set forth above, is the equivalent of the pressure within the cuff.
More specifically, the indicator member can be accurately described as being “variably positioned” within the casing dependent on and indicative 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 in both the pressure chamber and 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.
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.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTAs 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 the type associated with an endotracheal tube.
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 proximal 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 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 a 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 operative with 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
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,
Claims
1. An assembly structured to inflate and monitor pressure within a retaining cuff, said assembly comprising:
- a casing including an interior pressure chamber disposed in fluid communication with the retaining cuff; said pressure chamber including a multi-chamber construction comprising at least a first chamber and a second chamber,
- a plunger connected to said casing and movable within said first chamber between an extended position and a compressed position,
- said plunger structured to force fluid flow to the retainer cuff sequentially through said first chamber and said second chamber,
- a valve assembly disposed in fluid regulating relation between said first chamber and said plunger,
- a fluid channel disposed in direct fluid communication with said second chamber and structured to deliver fluid flow to the retaining cuff,
- an indicator assembly movably disposed within said second chamber in exposed, fluid communication with said fluid channel, said indicator assembly including an indicator member, said indicator member variably positionable on said casing dependent on and indicative of existing pressure within at least said second chamber, and
- said second chamber and fluid channel disposed in fluid communication with the retaining cuff, wherein said existing pressure within said second chamber is substantially equivalent to the pressure within the retaining cuff.
2. An assembly as recited in claim 1 wherein said indicator assembly further comprises a reaction member movably disposed in fluid communication within said second chamber and in driving relation to said indicator member; said variable positioning of said indicator member being dependent on disposition of said reaction member and existing pressure within said second chamber being exerted on said reaction member.
3. An assembly as recited in claim 2 wherein said reaction member is connected to said indicator member and movable therewith within said second chamber, said casing including a window disposed in visually accessible relation to said variably positionable indicator member.
4. An assembly as recited in claim 2 wherein said indicator assembly further comprises a biasing structure disposed in biasing engagement with said reaction member; said reaction member biasingly mounted in normally opposing relation to said existing pressure within said second chamber.
5. An assembly as recited in claim 4 wherein said reaction member and said biasing structure are disposed within said second chamber in physically segregated relation to said first chamber.
6. An assembly as recited in claim 5 wherein said reaction member includes a hollow interior, said biasing structure disposed within said hollow interior, said reaction member movable between an outwardly extended orientation and a compressed orientation; a vent structure fluidly interconnecting said hollow interior of said reaction member to an exterior of said casing, said vent structure disposed and structured to regulate fluid flow into and out of hollow interior upon movement of said reaction member between said extended orientation and said compressed orientation.
7. An assembly as recited in claim 1 said valve assembly comprising a first valve member and a second valve member cooperatively disposed and structured to regulate fluid flow from an exterior of said casing into at least said first chamber, through an interior of said plunger.
8. An assembly as recited in claim 7 wherein said first and second valve members each comprise a one way valve structure concurrently operable in interconnecting relation between said plunger interior and said first chamber; said first and second valve members alternately disposed in an open position and a closed position to regulate fluid flow from an exterior of said casing into said first chamber, through said interior of said plunger.
9. An assembly as recited in claim 1 further comprising a relief valve assembly operably accessible from an exterior of said casing and disposed in regulating relation to pressure within said pressure chamber; a shield assembly movably mounted on said casing and disposable in access restricting relation to said relief valve assembly.
10. An assembly as recited in claim 9 said shield assembly including an activating portion deformable into activating relation with said relief valve assembly; said shield assembly selectively disposable between a closed, valve shielding position and an open valve activating position.
11. An assembly as recited in claim 1 further comprising a retaining assembly connected to said casing and disposable into and out of retaining relation to said plunger.
12. An assembly as recited in claim 11 said retaining assembly including at least one retaining member, said one retaining member including one end disposable into and out of retaining engagement with said plunger.
13. An assembly as recited in claim 12 wherein said one retaining member is movable relative to said casing and into and out of retaining engagement with said plunger.
14. An assembly as recited in claim 13 wherein said one retaining member is pivotally connected to said casing and normally biased into said retaining engagement with said plunger.
15. An assembly as recited in claim 11 wherein said retaining assembly comprises two substantially oppositely disposed elongated retaining members each including one end disposable into and out of retaining engagement with said plunger; each of said retaining members manually positionable towards and away from said casing and into and out of retaining engagement with said plunger.
16. An assembly as recited in claim 1 further comprising a connection assembly disposed in interconnecting relation between said casing and an inflation lumen of the retaining cuff; said connection assembly disposable between a connect orientation and a disconnect orientation.
17. An assembly as recited in claim 16 wherein said retaining assembly comprises a retaining member and a gripping structure movably disposed relative to one another and to an entry port of said casing; said retaining member disposed in receiving relation to a connector of the retaining cuff and movable relative to said gripping structure upon receipt of the connecting member.
18. An assembly as recited in claim 17 wherein said gripping structure is disposed to extend outwardly through said receiving port in entry obstructing relation thereto upon removal of the connector member associated with the retaining cuff.
19. An assembly structured to inflate and monitor pressure within a retaining cuff, said assembly comprising:
- a casing including an interior pressure chamber disposed in fluid communication with the retaining cuff;
- a plunger movably connected to said casing and disposed and structured to force fluid flow to the retainer cuff through said pressure chamber,
- at least one pressure relief valve accessible from an exterior of said casing and structured to regulate pressure within said pressure chamber;
- a shield assembly mounted on said casing and movable between a closed, valve shielding position and an open, valve activating position;
- said shield assembly including an activating portion positionable into activating engagement with said pressure relief valve when in said open, valve activating position, and
- an indicator assembly movably disposed within said pressure chamber and including an indicator member observable and variably positionable on said casing, dependent on and indicative of existing pressure within said pressure chamber.
20. An assembly structured to inflate and monitor pressure within a retaining cuff, said assembly comprising:
- a casing including an interior pressure chamber disposed in fluid communication with the retaining cuff;
- said casing comprising an integrated pump assembly including a plunger, said plunger movable within said pressure chamber between an extended position and a compressed position and structured to force fluid flow to the retainer cuff through said pressure chamber,
- a valve assembly disposed in fluid regulating relation between said pressure chamber and said plunger, and
- an indicator assembly movably disposed within said pressure chamber and including an indicator member, said indicator member observable and variably positionable on said casing dependent on and indicative of existing pressure within said pressure chamber.
21. A single-use assembly structured to introduce fluid into a medical device, said single-use assembly comprising:
- a casing including an interior pressure chamber disposed in fluid communication with the medical device and an entry port connectable to the medical device;
- a connection assembly structured for a single use of said casing and disposed adjacent said entry port in interconnecting relation between said casing and the medical device; said connection assembly disposable between a connect orientation and a disconnect orientation, and
- said disconnect orientation at least partially defined by at least a portion of said connection assembly disposed in obstructing relation to a reconnection of a medical device to said entry port.
22. An assembly as recited in claim 21 further comprising a connection assembly disposed in interconnecting relation between said casing and an inflation lumen of the retaining cuff; said connection assembly disposable between a connect orientation and a disconnect orientation.
23. An assembly as recited in claim 21 wherein said retaining assembly comprises a retaining member and a gripping structure movably disposed relative to one another and to said entry port of said casing; said retaining member disposed in receiving relation to a connector of the medical device and movable relative to said gripping structure upon receipt of the connecting member.
24. An assembly as recited in claim 23 wherein said gripping structure is disposed to extend outwardly through said entry port in entry obstructing relation thereto upon removal of the connector member associated with the medical device.
25. An assembly structured to inflate and monitor pressure within a retaining cuff, said assembly comprising:
- a casing including an interior pressure chamber disposed in fluid communication with the retaining cuff and an entry port connectable to an inflation lumen of the retaining cuff;
- said casing comprising an integrated pump assembly movable within said pressure chamber and structured to force fluid flow to the retainer cuff through said pressure chamber,
- a valve assembly disposed in fluid regulating relation between said pressure chamber and said pump assembly,
- a retaining assembly including at least one retaining member movably connected to said casing and disposable into and out of retaining relation to said plunger, said one retaining member manually positionable out of retaining engagement with said plunger, and
- an indicator assembly movably disposed within said pressure chamber and including an indicator member, said indicator member observable and variably positionable on said casing dependent on and indicative of existing pressure within said pressure chamber.
26. An assembly structured to inflate and monitor pressure within a retaining cuff, said assembly comprising:
- a casing including an interior pressure chamber disposed in fluid communication with the retaining cuff; said pressure chamber including a multi-chamber construction comprising at least a first chamber and a second chamber,
- said casing including an integrated plunger movably connected to said casing within said pressure chamber and structured to force fluid flow to the retainer cuff sequentially through said first chamber and said second chamber,
- an indicator assembly movably disposed within said pressure chamber and including an indicator member observable and variably positionable on said casing dependent on and indicative of existing pressure within at least said second chamber, and
- a reaction member movably disposed in fluid communication within said second chamber in physically segregated relation to said first chamber and in driving relation to said indicator member; said variable positioning of said indicator member being dependent on disposition of said reaction member and existing pressure within said second chamber being exerted on said reaction member.
Type: Application
Filed: Aug 20, 2010
Publication Date: Sep 15, 2011
Inventors: Stephen Jay Lowenstein (Englewood Cliffs, NJ), Nathan E. Winters (Merrimack, NH), Michael R. Cole (Stratham, NH), Klaus D. Lessnau (New York, NY), Keith Rubin (Fort Lauderdale, FL), James M. Sellers (Portsmouth, NH)
Application Number: 12/806,810
International Classification: A61M 16/04 (20060101);