SELF-PRESSURIZING FLUID DELIVERY SYSTEMS AND DEVICES AND METHODS OF USING THE SAME

Self-pressurizing fluid deliver systems and devices and methods of using the same. An exemplary pressurized sterile fluid storage bag system referenced herein includes a foam cavity formed from a rigid, non-conforming material and an elastic, conforming material and containing a resilient open cell or closed cell foam with capabilities to restore form when compressed, an air valve, a fluid cavity formed from said elastic, conforming material on one side and a material which may be rigid and non-conforming or elastic and conforming, and a fluid valve.

PRIORITY

The present application is related to, and claims the priority benefit of, U.S. Provisional Patent Application Ser. No. 62/923,114, filed Oct. 18, 2019, the contents of which are incorporated herein directly and by reference in their entirety.

BACKGROUND

Field of the Invention

The present disclosure relates generally to devices, such as packages and bags, for dispensing sterilized fluids in a medical setting. Specifically, the present disclosure relates to devices and systems configured to and capable of pressurizing interior components to force fluid contents to an ejection port.

Background Art

In many surgical, medical diagnostic, and therapeutic procedures, physicians or medical personnel inject patients with a pressurized, sterile fluid. Some examples of these procedures include wound irrigation, cancer treatment through chemotherapy drugs, rehydration through saline administration, and fluoroscopy procedures.

The simplest form of pressurizing fluid is by using the force of gravity. Such is the method in hanging a sterile fluid bag from an intravenous (IV) pole, which is the most common pressurized fluid delivery system. This system typically involves three components: a sterile fluid bag, a length of tubing, and a fluid delivery port. The sterile fluid bag is connected directly to the length of tubing, which is then connected to the fluid delivery port. The sterile fluid bag is hung at an elevation higher than its fluid delivery port such that the force of gravity establishes a pressurized system. Though this method is simple to achieve, it has several disadvantages. The primary concern for this design is the lack of a constant pressure gradient. As fluid flows to the delivery site, the mass of fluid in the bag decreases, thereby decreasing the force of gravity which pressurizes the system. This results in a gradual decrease in pressure and a corresponding decrease in the amount of fluid delivered, such that in many cases the sterile fluid bag may not fully drain to its desired site. Because of this concern, the bag must repeatedly be raised to higher elevations during a single use, which is quite inconvenient.

Due to the increasing specificity and accuracy required of minimally invasive percutaneous procedures, there exists a need to develop a more sophisticated system to deliver sterile, pressurized fluid to medical instruments or patients. Recent innovations related to pressurizing sterile fluid in a single system have been made, with most of these innovations involving an exterior source for achieving the force required to pressurize the fluid. Such is the case in U.S. Pat. No. 5,810,202, for example. That invention involves an interior, fluid containing bag and an exterior, air filled bag. A hand actuated pressure source inflates the exterior bag which establishes a uniform compressive force on the interior bag. An ejection port then allows the pressurized fluid to be released. Though this has the potential to be more consistent in its pressure gradient, the pressure must still be constantly maintained as the interior bag size will decrease as fluid is released.

Similarly, U.S. Pat. No. 5,163,909, U.S. Pat. No. 8,992,489, and U.S. Pat. No. 3,949,753 pressurize fluid via a dual cavity system and an external power source. However, these innovations involve pressurized gas which can be expensive and potentially dangerous. U.S. Patent Application Publication No. 2003/0135159 discloses devices that pressurize fluid through its own air intake system, but this device's inclusion of many small parts and an electrical system is expensive in comparison to existing technologies.

The present disclosure includes disclosure of devices and systems to apply the restoring expansion force of resilient foam to pressurize the system. This concept has been explored in existing innovations, such as U.S. Pat. No. 3,871,377, which discloses a device that utilizes the expansive force of foam as a suction force to evacuate waste fluids from surgical sights. Perhaps the most similar concept to the present invention is U.S. Pat. No. 5,176,641, which discloses the utilization of the restorative force of foam to pressurize liquid within the same cavity. However, this device is implant exclusive and implies direct contact of sterile liquid to a foam, which can result in undesirable or unforeseen fluid-foam interactions. Additionally, the force required to compress the foam is achieved through fluid injection, which can prove difficult for the end-user and has the potential of retrograde flow and splash back of fluid during loading.

BRIEF SUMMARY

Systems of the present disclosure can comprise several elements. One such elements is a fluid cavity of a bag which can be created by sealing the perimeter of an elastic, fluid impermeable material (which henceforth be referred to as the “dividing barrier”) to the perimeter of another fluid impermeable material which may be rigid and nonconforming or elastic and conforming (which will henceforth be referred to as the “fluid barrier”). The sizing of this cavity may vary with respect to the amount of fluid necessary for the medical procedure and is therefore unspecified herein.

The fluid cavity is airtight aside from an additional element of systems of the present disclosure, namely the fluid valve port. This port passes through fluid barrier to allow flow of fluid both into and out of the fluid cavity. The fluid valve port is to feature a mechanism which allows for air locking. In its preferred embodiment, the fluid valve port mechanism will be adjustable such that the pressure can be changed to fit user preference. This can be achieved through varying the diameter of the fluid valve port. The fluid valve port is also designed such that it can be connected to tubing as well.

On the other side of the dividing barrier is an additional element of systems of the present disclosure, namely the foam cavity. This cavity is formed by sealing the perimeter of a rigid, nonconforming material (which will henceforth be referred to as the “foam insert”) to the perimeter of the dividing barrier. The foam cavity is to be filled with resilient, close cell or open cell foam. It is essential that the foam has characteristics such that it may return to its original form (or close to its original form) after being compressed. The specifications of the foam may vary depending on the amount of fluid pressure necessary and is therefore unspecified at this time.

The foam cavity is airtight aside from an additional component of systems of the present disclosure, namely the air valve port. This port passes through foam insert to allow flow of air both into and out of the foam cavity. The air valve port is to feature a mechanism which allows for air locking. In its preferred embodiment, the air valve port mechanism will be adjustable such that the allowance of air passage can be changed to fit user preference. This can be achieved through varying the diameter of the air valve port. The air valve port is designed such that it may connect to tubing to assist with air removal from the foam cavity.

Devices and systems of the present disclosure can be used as follows. The air valve port is to be opened to allow air to exit from the foam cavity. The foam is then compressed completely and such that there is minimal airspace in the foam cavity. The air valve port is then closed such that no air may flow into the foam cavity. The fluid valve port can be opened to allow sterile, medical fluid to be loaded into the fluid cavity. The system is designed such that there is minimal likelihood of retrograde flow or splash back during fluid loading. The compression of the foam followed by the locking of the air valve not only pressurizes the system, but also creates space for the fluid cavity to be filled. Once the foam cavity is compressed, sterile medical fluid can be loaded into its cavity with essentially no resistive force.

The fluid valve port can be closed, and the pressurized system is now ready for use. Prior to its use, the user may elect to connect various instruments or tubing to the fluid valve port. Opening of the air valve port results in air inflow to the foam cavity. This results in foam expansion, which is the driving force of the pressurized outflow of liquid. The rigidity of the foam insert disallows stretching, and as a result the force of the expanding foam pushes against the dividing barrier. Due to its elasticity, the dividing barrier stretches in the direction of the fluid cavity. The compressive force on the fluid cavity decreases its internal volume, creating pressure. Subsequent opening of the fluid valve port results in release of pressurized fluid contents. The systems of the present disclosure are designed such that the size of the fluid cavity continues to decrease even as fluid contents are released from the system, due to the continuous expansion of the foam. This results in a constant pressure gradient which does not have to be adjusted during use.

The present disclosure includes disclosure of a pressurized sterile fluid storage bag system, the system comprising a foam cavity formed from a rigid, non-conforming material and an elastic, conforming material and containing a resilient open cell or closed cell foam with capabilities to restore form when compressed, an air valve, a fluid cavity formed from said elastic, conforming material on one side and a material which may be rigid and non-conforming or elastic and conforming, and a fluid valve.

In at least one exemplary embodiment, the system further comprises a common seam to seal the perimeter of all cavity forming materials, such that said fluid cavity is adjacent to said foam cavity with the elastic, conforming material separating the two. In at least one exemplary embodiment, the said foam cavity is shaped such that the foam insert is not compressed when said air valve is open. In at least one exemplary embodiment, said foam cavity can be compressed in a matter which compresses its foam contents. In at least one exemplary embodiment, said rigid, nonconforming material forming said foam cavity does not stretch during expansion of foam insert contents.

In at least one exemplary embodiment, said air valve passes through the rigid, nonconforming material used to create said foam cavity and allows air passage between the ambient and the internal air space of said foam cavity. In at least one exemplary embodiment, said air valve features a locking mechanism which allows for complete air locking to fully disallow or permit passage of air between ambient and internal air space of said foam cavity. In at least one exemplary embodiment, said air valve features a locking mechanism which allows the user to adjust the diameter of air exit hole.

In at least one exemplary embodiment, said elastic, nonconforming material acts as the dividing barrier between said foam cavity and said fluid cavity. In at least one exemplary embodiment, said elastic, nonconforming material is able to stretch during expansion of said foam insert. In at least one exemplary embodiment, said fluid cavity is air tight and compresses in internal volume during expansion of said foam insert. In at least one exemplary embodiment, said fluid valve passes through the rigid, nonconforming material or elastic, conforming material used to form the outer surface of said fluid cavity and allows for fluid passage between the ambient and internal space of said fluid cavity.

In at least one exemplary embodiment, said fluid valve features a luer lock on its exterior portion to allow for connection to tubing or various instruments. In at least one exemplary embodiment, said fluid valve features a locking mechanism which allows for complete air locking to fully disallow or permit passage of fluid between the ambient and internal space of said fluid cavity. In at least one exemplary embodiment, said fluid valve features a locking mechanism which allows the user to adjust the diameter of the fluid exit hole. In at least one exemplary embodiment, said materials used to form both said fluid cavity and said foam cavity may share a common perimeter heat sealed seam.

In at least one exemplary embodiment, an exemplary system of the present disclosure is used in connection with a method, the method comprising the steps of opening the air valve and compressing the open cell or closed cell foam within the foam cavity, closing the air valve after compressing the open cell or closed cell foam, opening the fluid valve and introducing fluid into the fluid cavity, and closing the fluid valve after introducing fluid into the fluid cavity.

In at least one exemplary embodiment, the method further comprises the step of connecting tubing to the fluid valve and to a patient such that the fluid from the fluid cavity can pass through the fluid valve, into the tubing, and into the patient.

In at least one exemplary embodiment, the method further comprises the steps of opening the air valve to allow air to enter the foam cavity, allowing the open cell or closed cell foam to expand and exert pressure against the fluid cavity, and opening the fluid valve to allow the fluid to exit the fluid cavity due to the pressure exerted against the fluid cavity by the expanded open cell or closed cell foam.

In at least one exemplary embodiment of a pressurized sterile fluid storage bag system of the present disclosure, the system comprises a foam cavity formed from a rigid, non-conforming material and an elastic, conforming material and containing a resilient foam with capabilities to restore form when compressed, an air valve in communication with the foam cavity, a fluid cavity formed from said elastic, conforming material on one side and a material which may be rigid and non-conforming or elastic and conforming, and a fluid valve in communication with the fluid cavity, wherein when the resilient foam is compressed within the foam cavity and fluid is present within the fluid cavity, opening the air valve causes air to enter the foam cavity causing the resilient foam to expand and exert pressure against the elastic, conforming material, causing the fluid to exit the fluid cavity when the fluid valve is opened.

As such, an overview of the features, functions and/or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described and some of these non-discussed features (as well as discussed features) are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and/or configuration. Furthermore, wherever feasible and convenient, like reference numerals are used in the figures and the description to refer to the same or like parts or steps. The figures are in a simplified form and not to precise scale.

DETAILED DESCRIPTION

For the purpose of explanation, the terms “front”, “back”, “left”, “right”, “upper”, “lower”, “top”, “bottom”, and similar terms shall correspond to the device as positioned in the specified figures. The device may assume alternate orientations and sizings other than those shown. It is understood that the device characterized in the attached drawings and described thereafter are exemplary orientations of the innovative concepts defined in the claims section of this patent. Hence, the specific characteristics shown are not to be considered limiting unless explicitly stated.

With reference to the figures, the present disclosure includes disclosure of embodiments of a storage bag system100and methods of using the same. As shown inFIG.1, an isometric view of an exemplary storage bag of the present disclosure is shown comprising a foam insert1, whereby foam insert1is made of (comprises) a rigid, non-conforming material, so that said material resists bending or otherwise changing from its native configuration under pressure. A foam insertion2, as shown inFIG.1, is positioned adjacent to, or relatively adjacent to, said foam insert1, noting that not all embodiments of storage bags100of the present disclosure require a foam insert1, as discussed in further detail. The size of the encapsulating foam insert1can be slightly larger or smaller than or the same size as than a corresponding foam insertion2, configured such that it can be sealed on a relative perimeter3of storage bag system100in embodiments that utilize such a sealing element. In general, foam insert1must be sized and shaped, compressed or not, to fit within a space defined within storage bag system100.

FIG.1also shows an air valve4and a corresponding air locking mechanism5, whereby air valve4is in communication with an interior space (referred to herein as foam cavity6, noted below) within storage bag system100so that, for example, air can be released from within storage bag system100, and so that air can enter storage bag system100from its outside environment or another source of air. Air locking mechanism5is therefore configured to control the movement of air in and out of storage bag system100, such that if space (foam cavity6) within storage bag system100is under less pressure than its environment, opening air locking mechanism5would allow air from the outside to enter the inside of storage bag system100, and should the space (foam cavity6) within storage bag system100be at a higher pressure than its environment, opening air locking mechanism5would allow air from inside storage bag system100to escape.

FIG.2shows a cross-sectional side view of an exemplary storage bag system100in its pressurized configuration. As shown therein, a foam cavity6, configured to encapsulate foam insertion2, is directly adjacent to fluid cavity8, with the dividing barrier7separating foam cavity6from fluid cavity8. Dividing barrier7, which is to be made of an elastic or otherwise conforming material, is positioned between foam cavity6and fluid cavity8. Storage bag system100materials used to form an overall shape may share a common seam9, such as shown inFIG.2.

An air valve10(also referred to herein as air valve4) is shown with its air locking mechanism11(also referred to herein as air locking mechanism5) in its closed position to prevent air inflow to the foam cavity6.FIG.2also shows a fluid valve12with its fluid locking mechanism13in its closed position to prevent fluid flow out of the fluid cavity8. Fluid valve12is in communication with an interior space (referred to herein as fluid cavity8) within storage bag system100so that, for example, fluid can be released from within storage bag system100, and so that fluid can enter storage bag system100as desired. Fluid locking mechanism13is therefore configured to control the movement of fluid in and out of storage bag system100, such that if fluid is to be transferred into fluid cavity8, fluid locking mechanism13can be opened to allow said transfer and closed when said transfer is complete. Should it be desired to allow fluid from within fluid cavity8to flow out of fluid cavity8, fluid locking mechanism13can be opened to allow said fluid flow to occur.

FIG.3shows a cross-sectional view of an exemplary storage bag system100in its pressurized configuration, whereby air from inside foam cavity14(also referred to herein as foam cavity6) has been removed, such as by way of compression of storage bag system100and/or via some sort of vacuum so to compress foam insert15within said foam cavity14. Foam cavity14is shown with minimal airspace and filled with foam insert15. Foam insert15may be open-cell or closed-cell foam, and of variable porosity, so that said foam insert15can be compressed, such as shown inFIG.3, and ultimately uncompressed, as shown inFIG.4, the latter of which being or close to being a native state of foam insert15.

Foam characteristics are dependent on force necessary to pressurize fluid within fluid cavity17. Foam cavity14is separated from the fluid cavity17(also referred to herein as fluid cavity8) by way of a dividing barrier16(also referred to herein as dividing barrier7), which is to be made of an elastic, conforming material. Fluid cavity17is shown full of sterile liquid, and is closed from the ambient (outside environment) by the fluid barrier18, which is to be made of a material that may be elastic and conforming or rigid and non-conforming. Fluid valve22(also referred to herein as fluid valve12) allows for passage of fluid out of fluid cavity17.FIG.3shows fluid locking mechanism23of fluid valve22in its locked position, with the exit/opening of fluid valve22fully covered/closed.

FIG.3also shows an air valve21(also referred to herein as air valves4and10) in a closed configuration, by way of closing an air locking mechanism21(also referred to herein as air locking mechanisms5and11), so that air cannot enter foam cavity14. A common seam19is also shown around a relative perimeter of storage bag system100.

FIG.4shows a cross-sectional view of an exemplary storage bag system100in its unpressurized configuration, whereby air is permitted to enter foam cavity25(also referred to herein as foam cavities6and14) by way of air valve28(also referred to herein as air valves10and21). As shown inFIG.4, fluid valve29(also referred to herein as fluid valves12and22) and air valve28(also referred to herein as air valves4,10, and21) are in their open position, so that air is permitted to enter foam cavity25(also referred to herein as foam cavities6and14), and so that fluid from within fluid cavity26(also referred to herein as fluid cavities8or17) is permitted to exit the bag, such as to be introduced into a patient intravenously, for example. Foam insert24(also referred to herein as foam inserts1and15) is shown in its uncompressed state inFIG.4due to air being allowed to enter foam cavity25and foam insert24so that foam insert24is permitted to expand, by way of air valve28being open. Foam cavity25is shown with residual air also due to air valve28being in its open configuration. Dividing barrier27(also referred to herein as dividing barriers7and16) is shown compressing fluid cavity26, such that there is no or little residual fluid content left in fluid cavity26.

FIG.5shows a cross-sectional view of an air valve33(also referred to herein as air valves4,10,21, and28) and portions of a storage bag system100, with air valve33shown in its closed configuration (such as by way of air locking mechanism32, also referred to herein as air locking mechanisms5,11, and20). Air valve33is shown as being in communication with foam cavity31(also referred to herein as foam cavities6,14, and25), passing through fluid barrier30(also referred to herein as fluid barrier18). When closed, air locking mechanism32prevents air to flow from the outside environment, through air valve opening34, into air valve33, and into foam cavity31to allow foam insert1,15,24to expand and apply pressure on dividing barrier7,16,27, to cause fluid from fluid cavity8,17,26to exit fluid valve12,22,29. Air valve33, in various embodiments, can be configured as having a relatively low profile, such as shown inFIG.5, such that air flow through portions of air valve33is relatively perpendicular to air flow from foam cavity31into air valve33.

FIG.6shows a cross-sectional view of a fluid valve37(also referred to herein as fluid valves12,22, and29) and portions of a storage bag system100, with fluid valve37shown in its closed configuration (such as by way of fluid locking mechanism38, also referred to herein as fluid locking mechanisms13and23). Fluid valve37is shown as being in communication with fluid cavity35(also referred to herein as fluid cavities8,17, and26), passing through fluid barrier36(also referred to herein as fluid barriers18and30). When closed, fluid locking mechanism38prevents fluid to flow from inside fluid cavity35, through fluid valve opening40, into fluid valve37, and out of fluid valve37. Fluid valve37, in various embodiments, can be configured as having a relatively low profile, such as shown inFIG.6, such that fluid flow through portions of fluid valve37is relatively perpendicular to fluid flow from fluid cavity35into fluid valve37. Locking mechanism38closes off the fluid valve37such that fluid may not flow through ambient opening40of fluid valve37. A luer lock39on an outer edge of fluid valve37allows for tubing or other instruments to be fluidly connected to fluid valve37.

While various embodiments of systems and devices and methods of using the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof.

Further, in describing representative embodiments, the present disclosure may have presented a method and/or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.

Reference List