1. Field of the Invention
The present invention relates to a ventilation device which either provides a patient with partial breathing assistance or does all the breathing for the patient.
2. Description of the Related Art
These units for supplying breathing gas are usually based on a certain air flow concept, which influences the breathing gas and changes the influence of the breathing gas on the device in the desired manner.
In many cases, a blower motor serves as the gas source. This makes the device independent of other, stationary gas sources. The ambient air is drawn through a filter, arrives in the blower housing, and, for preparation with oxygen and/or moisture, is administered to the patient. In the devices according to the state of the art, furthermore, a clumsy and unattractive method is used to connect the humidifier to the basic unit. This also increases the size of the unit unnecessarily. The filling of the humidifiers also has a direct influence on the geometries and air supply properties of the device.
In many cases, the most effective way of influencing the amount of sound and noise produced is to isolate the blower from the rest of the device. In most devices, this idea is realized in a cumbersome, complicated, and inadequate manner.
The design embodiments and variants explained in detail below can be used alternatively or supplementally with respect to each other. In particular, each individual inventive idea can be realized independently of each of the other inventive ideas. A combined realization, however, leads to additional advantages, which have positive effects on the construction, size, ease of use, safety, and noise generation of the unit and thus positive effects on the entire system.
To supplement the following explanations, various additional explanations will be found directly in the drawings. The disclosure content of the present patent application comprises, in particular, both the written explanations of the drawings and also the design variants illustrated in the drawings but not explained in the following text.
The task of the invention is to provide a device which is suitable for CPAP, bi-level, APAP, titration, home, emergency, and hospital ventilation by either invasive or noninvasive means.
The air present in the atmosphere is drawn in by a blower integrated into the unit. The air thus passes through at least one filter, which separates the particles present in the air.
The air then arrives in a semi-enclosed sound-damping box, which is located inside a device for supplying breathing gas and which has a high-pressure area and low-pressure area.
Another embodiment provides a structure consisting of at least two modules. If central modules are present, the outer modules are fastened to them by screws and thus clamp them in position. This design can be realized by means of latching elements and/or screws, which pass through all of the modules.
Damping materials between the modules can be easily clamped and held in place by tongue-and-groove profiles.
Because at least one area and/or one side of the box is open, air could freely escape from the box through this opening. This is prevented by a simple seal of foam material. The foam fulfills the functions of sealing the sound-damping box, of damping the sound, and also of at least partially supporting the sound-damping box. The sealing action can be achieved simply by the application of pressure, by clamping, by adhesive bonding, and/or by screwing the box onto the foam. A seal is preferably provided both in the low-pressure area and in the high-pressure area of the sound-damping box.
The sound-damping box is thus characterized by simpler and lower-cost construction.
An opening is also provided in the box for the cable coming from a blower. The box is preferably formed by the cooperation between two modules.
The air flow can proceed between or in these modules and therefore proceeds in at least two planes, preferably three planes: the intake or low-pressure plane, the blower plane, and the discharge or high-pressure plane.
The functions are thus divided vertically into the individual planes. A “plane” is defined here as a long, flat, elongated space.
The air flow planes can be connected to each other by channels/structures. The channels/structures are preferably essentially perpendicular to the planes and can project far into the next plane or into at least one plane which bridges the next plane.
The air flow path is also intentionally laid out so that the direction of air flow is diverted at least twice by 80°±10°, once from vertical to horizontal and once from horizontal to vertical. This diversion of the air helps considerably to minimize the production of noise.
In an especially preferred embodiment, this effect is linked with another possibility of sound damping and/or is integrated into the sound-damping box. First, the previously mentioned diversions, preferably of 90° or 180°, of which there should be as many as possible, are used to deflect the air onto baffle plates, which thus at least partially absorb the sound; second, as many alternations as possible between cross-sectional constrictions and cross-sectional expansions in the form of channels, openings, and/or exit areas between openings and baffle plates are used.
In an especially preferred embodiment, this baffle plate can also be provided with a special sound-damping surface and/or lined with various materials.
Second, as many alternations as possible between cross-sectional constrictions and cross-sectional expansions in the form of channels, openings, and/or exit areas between openings and baffle plates are integrated into the sound box.
To achieve a further reduction in the amount of sound produced, an alternation between air-conducting and sound-damping areas is provided. The air-conducting and sound-damping areas are defined by openings, which result from the geometries of other components of the sound-damping box: screw channels, the blower, the external boundaries of the box, the blower mounting, the intake connectors, the intake filter, the discharge opening, etc.
Because the existing geometries of integral components of the sound-damping box are used to form the air flow guides and sound-damping areas, the volume can be kept relatively small.
For example, when screw channels are provided inside the planes, the air flow is adapted aerodynamically in such a way that the number of flow separations, which can lead to noise, is reduced to a minimum.
In a preferred embodiment, the blower is located as close to the center of the sound-damping box as possible. This offers optimum conditions over the widest possible area for influencing the sound produced by the blower and of damping it with respect to the outside.
In a preferred embodiment, the blower and the blower mounting are located within a central plane, the blower preferably being suspended from above. This plane is itself surrounded by sound-damping material. In addition to the preferred method of suspending the blower from above by means of elastomeric material, however, it is also possible to support it from underneath and/or from above with the help of springs, elastomeric material, and/or foam to ensure that the blower is effectively isolated from the box.
In addition to its suspension, the blower has another connection to the sound box in the form of at least one hose. This connection, however, is selected with respect to form and material so that the blower is isolated from the sound-damping box.
The preferred method of mounting the blower is to suspend it by means of elastomeric hangers in such a way that it has freedom of movement in three dimensions.
Thus, with the concept presented here, the blower is thus isolated from the equipment housing in at least one way and preferably in two: The sound-damping box is isolated by being mounted on foam and sealing material and also by the use of an elastomeric hose to conduct the air from the sound-damping box to a component permanently connected to the housing.
In addition to or in place of the measures described above, the blower can be isolated from the sound-damping box by means of the mounting methods cited above and by means of at least one elastomeric tube for conducting the air. Together with the elastomeric hangers, of which at least two are provided, this tube then serves not only to isolate the sound but also to support the blower.
The elastomeric tubes are connected to their mating parts by folding in the ends and pushing them over the mating profiles of the other parts to which they are to be joined.
The box can be fabricated of any desired material, preferably of plastic or metal.
The elastomers used to support/suspend the blower should have viscoelastic properties and thus have energy-absorbing properties in addition to their elastic properties. This makes a key contribution to the reduction of the transmission of sounds and vibrations. As previously explained, the blower can be supported from underneath or preferably from above.
Through proper selection of the material and design of the suspension and support elements, the blower can be installed quickly and easily in the sound-damping box.
Installation is made possible by the integration of a guide element and a shoulder/undercut on each of the hangers. During the installation process, the tip of the hanger makes it easy to guide it through a suitable bore; the blower then engages with the undercut and can be detached only by partially destroying the mounting.
At the same time, the hangers seal the bores and thus also seal off the two adjacent planes from each other. A suspended mounting also offers the advantage that considerable relative movement is possible.
These movements are limited to the desired extent by additional elements, at least some of which are attached to the base of the hangers and around them. These deflection limiters prevent, for example, the blower from contacting the walls of individual modules of the sound-damping box.
As previously explained, a preferred support can consist of at least one elastomeric mounting element and at least one tubular air channel or tubular isolating hose, which can also consist of elastomeric material or of rubber-like material.
The selection of the design and material of the mounting elements largely determines the quality of the sound isolation.
After the air has entered the unit through the intake and after the sound has been reduced by the sound-damping box, the air arrives in the stationary housing shell part of the unit.
To guarantee that the patient is provided with gas under the best possible conditions in terms of respiratory physiology during the treatment, it can be helpful to use a humidifier. When desired, this unit can be connected to the previously described components, preferably downstream from them.
To ensure that the humidifier is positioned precisely and that it is integrated optimally into the base unit, the three possible directions in which the humidifier can move are limited by various elements of the base unit.
The first dimension is limited by the facing contact planes, namely, the bottom plane of the humidifier and an upward-facing, also horizontal plane of the base unit.
The second dimension is limited by the presence of at least one round element, preferably two round elements, both of which can be components of the humidifier or of the base unit. To prevent the humidifier from tipping as it is being inserted into the base unit, the humidifier is provided with guide rails.
In a preferred embodiment, the round elements consist of a tubular connecting piece of the air flow guide system, an air inlet, and a self-limiting heating rod, designed to produce an electrical connection, which projects into the bottom part of the humidifier, is immersed in water, and is responsible for heating the water in the filled humidifier.
The isolating element between the sound-damping box and the base unit serves simultaneously as sealing material for the connection between the air intake and the humidifier. The humidifier has at least one centering element, preferably designed as a rail, to prevent it from tipping as the cover cap is being introduced into the base unit. The base unit has guide slots.
The third dimension is limited by the insertion of a connecting element through the base unit and through the humidifier. The connecting element connects the air flow to the humidifier at one end and to the patient hose at the other end. The air pathways thus created are not parallel. In particular, the inlet to the humidifier and the outlet from it are arranged at an angle of preferably 80°±10° to each other.
To maintain a high level of moisture in the air, various air flow pathways are conceivable. The air is conducted through the unit to the bottom part of the humidifier, from which it rises vertically upward through an air-carrying profile. It then mixes as desired with the highly humidified air of the humidifier and carries a portion of the humidity back into an additional profile, which guides the air vertically downward. The humid air then passes through the connecting element and thus finally reaches the breathing hose and the patient.
The air flow guide profiles can consist of two separate, adjacent pipes (
In an especially preferred embodiment, the air enters and leaves through a centrally installed pipe with an implemented wall to separate the inlet from the outlet.
The air introduced into the humidifier first strikes a baffle plate. In conjunction with a separating plane and a mushroom-shaped hood, the air is thus diverted directly onto the surface of the water to ensure that the air absorbs a large amount of moisture.
These elements are seated in the upper part of the humidifier. The separating plane prevents a short-circuit from forming between the incoming and outgoing air, which would prevent the air from becoming humidified.
The incoming and outgoing air profiles should be as close to the center as possible to prevent any possible intrusion of water into the openings, especially into the opening of the incoming air channel. In addition, the tilt and height of the opening has an effect on the likelihood that water will be able to enter the openings, especially when the unit is resting at an angle, which would thus affect the rebound behavior of the air flow.
In conjunction with the separating plane of the upper part and the air flow guide profiles of the humidifier, it is also advisable to provide measures to prevent the top part from being twisted on the bottom part.
In addition to the previously described elements, the top part of the humidifier has additional inventive elements, which improve the air flow guidance, safety, and ease of use of the unit for supplying breathing gas.
It is advantageous that the mushroom-shaped hood over the air flow guide openings prevents the intrusion of water into the unit when the humidifier is being filled.
The mushroom-shaped hood or collar is arranged so that it is concentric with respect to the inlet/outlet tube in the top part to prevent spray water from entering the tubes, especially from entering the inlet. The collar of the outlet is not as tall, so that, when the unit is resting at an angle and the humidifier tank is full, the positive pressure built up in the unit cannot cause water to enter the air outlet and pass via the air discharge line into the hose. In addition, the collar guides the air directly onto the surface of the water.
On the side which guides the air inward, the mushroom-shaped hood is provided with a larger collar than it is on the side which guides the air outward, both to prevent water from entering the unit and to prevent water from escaping when the unit is resting at an angle.
The humidifying space is sealed off by the top part and a seal. In a preferred embodiment, the seal is designed as an O-ring. In this case, the standard radial sealing method is not used; instead, an axial seal is used with the help of a circumferential shoulder on the top part (shoulder on the inside) and another shoulder on the bottom part (shoulder on the outside). The top part is dimensioned so that it is easy for the user to upend it over the bottom part. The sealing element is therefore not squeezed in the radial direction but rather remains on the actual axial sealing surface. The ring-shaped sealing element acts as an assembly aid for the user and prevents the sealing element from being pushed out of its radial position.
When the humidifier is detached from the unit, it is kept closed by a bayonet joint. When the humidifier is mounted on the unit, the top part of the humidifier cannot be untwisted from the humidifier nor twisted onto the humidifier. This is provided according to the invention to minimize the likelihood that water could enter the unit during the process of filling the humidifier. Such entry could occur by mistakenly pouring water into the profiles while the bottom part of the humidifier is open. This safety measure to prevent the top part of the housing from being taken off is realized by a positive connection with the ventilator.
So that the humidifier can be filled while it is installed on the unit, a stopper is provided on the top part. According to the invention, this can be operated with only one hand, which significantly improves the ease of use in comparison with previous types of closure. This is achieved through the use of a pretensioned element, which, when operated (opened), automatically allows the stopper to flip into the fully open position.
The opened state of the stopper is free of tension; in the closed state; the stopper is under tension. For this purpose, slight pressure is exerted on the lever-like stopper to overcome both the pretensioning force and the sealing force.
In some groups of patients, namely, those who do not complain of dryness of the mouth or of the airways, the use of a humidifier can be omitted. So that the unit can be opened and used even without the humidifier, a dummy humidifier is used, which is inserted into the base unit in the same way as described above.
If a dummy humidifier is used, the heating rod is not necessary and is replaced by a blind connection, which closes off the opening in the unit and protects the electrical contacts for the heating rod from environmental influences.
The connectors for connecting to the air outlet and the heating rod of the base unit are also designed as parallel connections. The first dimension is again limited by the facing horizontal planes, i.e., the bottom of the dummy humidifier and the upward-facing, horizontal surface of the base unit.
The second dimension is inhibited by the connection of least one, preferably two round elements to the base unit. The third dimension is inhibited by the introduction of a connecting element through the basic unit into the dummy humidifier.
The stopper also serves to reduce the mask sound, because the stopper has a relatively large space for expansion, in which, in a preferred embodiment, additional cross-sectional constrictions and expansions and sound-damping materials can be installed.
To reduce the mask sound even more, the size of the stopper can be increased and provided with several such elements. The stopper has at least one centering element, preferably designed as a rail, to prevent the cap from tipping as it is being introduced into the base unit. The base unit has guide slots.
The isolating element has an additional function, namely, that of a seal with a sealing bead for the air intake of the humidifier or dummy humidifier.
Until now it has not been possible to detach the hose quickly from the unit with only one hand. By means of the connecting element mentioned above, however, a standard ventilator hose can be attached to the unit easily, quickly, and with only one hand.
This element has a Bernoulli compensator. With the help of a constriction, this element simulates the behavior of the breathing hose, especially the resistance of the breathing hose, so that, after the pressure has become reduced in the constriction, it is equivalent to the pressure at the mask of the patient. This eliminates the need for a pressure-measuring hose leading to the patient.
The pressure present in the constriction of the connecting element is conducted through an opening in the connecting element, preferably a slot, and via a pressure-measuring connecting piece leading to a pressure sensor positioned in the unit.
The pressure-measuring channel is located in the same place regardless of which of the two different elements (humidifier or dummy humidifier) is present. The two elements do not have any relevant effect on the measurement, because the measuring site is located as far away as possible from them, at the outlet of the unit. The geometries present in the area of the connecting element are identical.
The connecting element has at least one seal, preferably two O-rings, which, with respect to the flow of gas, are upstream and downstream of the pressure opening. One seals off the unit from the outside and the other seals off the pressure measurement connecting piece from the interior of the unit, because pressure gradients near the Bernoulli element can short-circuit the air flows and thus interfere with the possibility of a correct measurement.
The opening which produces the connection between the pressure space in the area of the constriction and the pressure sensor in the unit is preferably at the top, because otherwise condensate would probably accumulate in the circumferential groove and could affect the pressure measurement.
In another preferred embodiment of the connecting element, an anti-twist device which cooperates with the base unit is attached to the element. The anti-twist device makes it easy to join the element to the mating component and is preferably designed as a triangle. The tip pointing in the joining direction serves simultaneously as a centering/positioning element for the connecting element.
The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of the disclosure. For a better understanding of the invention, its operating advantages, specific objects attained by its use, reference should be had to the drawing and descriptive matter in which there are illustrated and described preferred embodiments of the invention.
In the drawing:
To prevent the patient's airways from drying out, it is has been found advisable to humidify the breathing air, especially during long phases of ventilation. These humidifications of the breathing air can also be realized in other applications. To humidify the air, adaptable breathing air humidifiers (9) are usually used, which are installed in the air pathway between the ventilator and the patient. The breathing air humidifier consists of a top part (11) and a bottom part (12). The breathing air humidifier has at least one water filling port, which is in the area of the top part (11).
In addition, an oxygen feed valve can be adapted to supply the user with an increased amount of oxygen along with the breathing gas.
At the end facing away from the ventilator, the connecting hose can be connected to a patient interface, which can be designed as a nasal mask. A hood can be used to hold the mask in position on the patient's head. On the side facing the connecting hose, the breathing mask has a connector piece.
The top part (11) has a curved edge, which can be seen especially clearly in
In the area of the receptacle for the breathing air humidifier (9), it is possible as an alternative, as shown in
The cover (14) serves not only an air guidance function but also a pneumatic function. Because air is conducted through the interior of the cover (14), a sound-damping function is achieved. When installed, the breathing air humidifier also helps to reduce the noise level.
The receptacle (15) for the breathing air humidifier, as shown in
By giving the receptacle for the breathing air humidifier a rounded form, which is not, however, symmetrical, and by providing the breathing air humidifier with a complementary shape, the direction and/or arrangement of the breathing air humidifier in the unit is defined. The breathing air humidifier is inserted with an exact fit into the receptacle provided specifically for the breathing air humidifier. As a result, a high degree of functional integration is achieved. Faulty installation is thus prevented. The breathing air humidifier cannot be twisted out of place in the unit.
The air outlet (17) from the unit and the power supply (18) for the breathing air humidifier are located in the receptacle (15) for the breathing air humidifier. A pressure-measuring connector (19) can also be seen. In the forward area of the unit, there is an opening (16), which serves to accept the connecting element (4).
Because of the way in which the pressure-measuring connector (19) is arranged, the pressure is therefore measured in the unit, but downstream (in the direction of air flow) of the humidifier. Any pressure losses in the area of the humidifier will therefore not affect the pressure measurement.
In the bottom part (12) of the breathing air humidifier, as shown in
The humidifier is held in place on the unit by means of plug-and-socket connections. That is, the air inlet (21) of the breathing air humidifier plugs into the air outlet (18) of the unit, and the power supply (20) of the breathing air humidifier plugs into the power supply (17) in the unit.
The humidifier can be adapted to the unit and made ready to operate in two steps. The humidifier is first guided horizontally onto the support surface of the unit, where the mating areas of the humidifier and of the unit define the proper joining direction. At least partial engagement between the mating areas, i.e., between the air inlet (21) and the power supply (20) of the breathing air humidifier with the air outlet (17) and the power supply (18) of the unit, holds the humidifier in position. Second, the humidifier is held and locked in its final position by the insertion and/or placement of the connecting element (4) into the opening (16) in the unit.
Two guide aids (57, 58) are also provided on the humidifier to ensure easy and secure installation. These guides engage with the two guide aides on the unit (55, 56).
The connecting element fulfills at least two of the following functions:
1. it holds the humidifier on the unit;
2. it forms an airtight passage between the humidifier and the hose;
3. it fastens the hose to the unit and/or humidifier;
4. it serves as a measuring site;
5. it puts the device into operation;
6. its air-conducting parts also partially hold the humidifier in place.
The air conduit (31) is divided in two by a continuous partition wall (35) and is open at the top. One part, serving as an air intake line (33), conducts the air coming from the unit into the top part (11) of the humidifier. After arriving in the entrance area, the air strikes the baffle plate (39), which is subject essentially to unhumidified air, and is conducted by at least one air guide structure (37) into the humidification space (41). The air guide structure (37) prevents essentially unhumidified air from being conducted directly to the air outlet (22). The structure fits into a recess (59) in the humidifier outlet and simultaneously serves as an anti-twist device for the top part of the humidifier.
The air which has become humidified during operation is now conducted by at least one air guide structure (37) to an area of the baffle plate (38), which is subjected essentially to humidified air. When the humidifier is assembled, a circumferential collar (40) is located above the upper end of the air conduit (31), serving a cap-like function. In cooperation with the air guide structure (37), which rests on the partition wall (35) with a sealing effect, the collar defines the path of the air through the humidifier. The collar (40) overlaps the upper edge of the air conduit (31). This overlap prevents water from surging into the air inlet and into the unit or into the air outlet and to the patient.
The air is guided through the humidifier essentially by vertical pipes, which are located essentially in the center of the humidifier. The opening is always located above the surface of the water.
According to the embodiment shown in
In general, an essential design feature of the breathing air humidifier is to be seen in that, in the interior of the humidifier, chimney-like structures are provided to supply the air to be humidified and to carry away the humidified breathing air. The connections leading to the outside are all located in a lower area of the unit. This structure makes it possible to integrate the breathing air humidifier into the ventilator and avoids the need to fasten the breathing air humidifier onto the outside surface of the ventilator by means of a flange.
To prevent the top part (11) from being opened while the humidifier is attached, the opening (60) at the edge of the top part matches the shape of the housing, so that it is impossible to turn the top part (11), because at least a certain part of the opening (60) is designed to engage positively with the equipment housing.
In the top part (11), it is possible to see the water filling port (36), which can be accessed by way of the stopper (10).
As shown in
As shown in
The angle of the operating surface defines and directs the force applied by the user preferably in such a way that even a weak but accurately applied force is sufficient to cause the stopper to open the filling port.
The stopper is preferably made of a slightly elastic material; even more preferably, it is made of a rubber-like material. The circumferential groove (61) makes it possible to install the stopper easily on the top part (11).
In the ready-to-operate state, the top part of the humidifier cannot be removed. As a result, the goal is achieved that the humidifier cannot be filled in the wrong way, i.e., by improperly removing the top part.
The seal between the top part of the humidifier and the bottom part is provided by, for example, an O-ring. The seal is preferably axial, with radial guidance. It is also preferable to insert O-ring seals, which are guided radially but seal in the axial direction, in the area of the base unit.
It is especially preferable to use lip seals wherever pressures of more than 4 mbars can occur in the area of the humidifier and/or of the base unit. The applied gas pressure pushes the lip seal with a sealing action against sealing surfaces, which are located, for example, in the area between the top part and the bottom part of the humidifier.
By means of at least one air-deflecting structure (53), the air is deflected at least once from a horizontal plane into a vertical plane and preferably again into a different horizontal plane. The air is preferably subjected to a two-fold change of planes.
For example, the air-conducting and sound-damping structures alternate at least once in the sound-damping box (45).
The flat, horizontal, sound-damping areas are located above or below the receptacle for the blower (47). So that the modules can be placed neatly on top of each other, guide posts (68) are integrated into the box, which also conceal the screw channels.
The blower is attached by soft, elastomeric elements (54), which preferably have both elastic and damping properties. The blower is attached from above. The blower is supported from above. Because of the way it is attached, the blower is suspended with freedom to move in 3 dimensions. At least two sound-damping structures are provided in the area of the blower. The blower is mounted in the center of the unit, as far away as possible from the walls of the outer housing and/or surrounded by air-conducting components and/or surrounded by sound-conducting components.
To facilitate the installation of the damping material (63), the damping material is preferably provided with at least two openings, and the associated surfaces of the top part of the unit are provided with markings in the area which will face the damping material (63).
The lateral webs (92, 93) have, on the outside, a latching profile, which can be gripped from behind by an adapter (94). The adapter (94) has mounting sidepieces (95, 96), which engage in the retaining profile. The sidepieces are carried by a central element (97) of the adapter (94). One end of the central element can be plugged into the sealing element (91). A stop plate (98) is provided to ensure that the adapter (94) is positioned precisely.
A connector (99) of the adapter (94) facing away from the sealing element (91) is used to accept a pressure-measuring hose (not shown), which establishes a connection with the pressure sensor itself. In particular, the pressure sensor is to be located in the area of the control circuit board of the unit.
While specific embodiments of the invention have been shown and described in detail to illustrate the inventive principles, it will be understood that the invention may be embodied otherwise without departing from such principles.
Number | Date | Country | Kind |
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10 2005 036 611.2 | Aug 2005 | DE | national |
10 2006 014 751.0 | Mar 2006 | DE | national |
The present application is a Divisional application of U.S. patent application Ser. No. 13/028,969, filed Feb. 16, 2011, which was a Divisional application of U.S. patent application Ser. No. 11/496,062, filed Jul. 29, 2006, which claims priority of DE 10 2005 036 611.2, filed Aug. 1, 2005, and DE 10 2006 014 751.0, filed Mar. 28, 2006, the priority of these applications is hereby claimed and these applications are incorporated herein by reference.
Number | Date | Country | |
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Parent | 13028969 | Feb 2011 | US |
Child | 14166322 | US | |
Parent | 11496062 | Jul 2006 | US |
Child | 13028969 | US |