Flow Interface Device and Method of Use Thereof for Use in a Wound Irrigation Device

Abstract

A perfusion system, method, and interface device. The interface device includes a receiving portion configured to provide a sealed connection with a container interface of a solution container, and the receiving portion further includes a spike interface therein. The spike interface includes a first fluid path that provides fluid communication between the solution container and the perfusion device via the interface device.

Description

Technical Field

[0001] The present disclosure generally relates to devices for performing wound irrigation, particularly flow interface devices, and wound irrigation devices that use flow interface devices. relates to.

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 366,588, filed Jun. 17, 2022, entitled "FLOW INTERFACE APPARATUS USABLE WITH WOUND IRRIGATION DEVICE AND METHODS OF USE THEREOF", which is hereby incorporated by reference in its entirety.

Background Art

[0003] Irrigation is an accepted method for assisting in the prevention of surgical site infection (SSI) and / or for performing flushing or dilution during a patient's treatment. In the case of open procedures, irrigation is generally performed in one of two ways. Namely, manually (e.g., injecting the irrigation fluid directly, adding the irrigation fluid via a bulb-type syringe or device, or squeezing the irrigation device manually to add the irrigation fluid), or pulsatile lavage (e.g., the electrical pumping of the irrigation fluid with increased pressure and flow rate), or gravity lavage (e.g., the irrigation fluid is supplied from a container held or placed at a position higher than the irrigation site). Irrigation may also be applicable to open and / or closed procedures used in cystoscopy, transurethral procedures (e.g., TUR), general procedures, and arthroscopic surgical procedures. To provide improvements in the versatility, safety, and efficiency of irrigation, flushing, and / or washing systems (which may be pump-operated or gravity systems), and also to provide improvements in the overall efficiency and safety of irrigation and / or flushing systems, devices, and methods, the present disclosure describes aspects and improvements.

Summary of the Invention

[0004] The following presents a simplified summary of one or more aspects of the invention in order to provide a basic understanding of such aspects. This summary is not an extensive overview of all contemplated aspects, nor is it intended to identify key or critical elements of all aspects or to delineate the scope of any or all aspects. Its purpose is to present some concepts of one or more aspects in a simplified form as an introduction to the more detailed description that follows.

[0005] In some aspects, the technology described herein relates to an interface device that can be used with a solution container and an infusion (e.g., a washing device) and / or a flushing system, the interface device comprising a receptacle configured to provide a sealed connection with a container interface of the solution container, the receptacle further comprising a spike interface therein, the spike interface including a first fluid path that provides fluid communication between the solution container and an infusion device via the interface device.

[0006] In some aspects, the technology described herein relates to an interface device, the spike interface having a tip configured to pierce a portion of the solution container, and the first fluid path being configured to provide fluid communication with the solution container when the solution container is pierced.

[0007] In some aspects, the technology described herein relates to an interface device, the spike interface including a second fluid path, and the second fluid path (e.g., an air path) being configured to provide fluid communication to the atmosphere outside the solution container via a vent to the solution container when the solution container is pierced by the spike interface.

[0008] In some aspects, the technology described herein relates to an interface device, the vent further including at least one of a one-way valve, a membrane, or a sterile filter.

[0009] In some aspects, the technology described herein relates to an interface device, the interface device being configured to be attached to a container interface of a solution container.

[0010] In some aspects, the technology described herein relates to an interface device, the receiving portion further including an engaging thread configured to engage in a threaded manner with a threaded container engagement provision of the container interface, when the interface device is rotated relative to the solution container, the threaded engagement between the engaging thread and the threaded container engagement provision causes the spike interface to pierce the solution container at the container interface.

[0011] In some aspects, the technology described herein relates to an interface device, further comprising a perfusion port configured to interface with the solution container and provide fluid communication from the solution container to a perfusion device connector.

[0012] In some aspects, the technology described herein relates to an interface device, the perfusion device connector being a perfusion device spike, the perfusion device connector being configured to provide fluid communication from the solution container to the perfusion device connector and the perfusion device when the perfusion device spike is pushed into the perfusion port.

[0013] In some aspects, the technology described herein relates to an interface device, the perfusion port further including a perfusion port seal, the perfusion port seal being configured to be pierced by the perfusion device spike when the perfusion device spike is pushed into the perfusion port.

[0014] In some aspects, the technology described herein relates to a cleaning device and an interface device, the cleaning device including a nozzle and a pump in fluid communication with the nozzle, the pump supplying a pressurized flow of a cleaning solution supplied from a solution container, the cleaning device and the interface device. The interface device is a receiving part configured to provide a sealed connection with the container interface of the solution container, and includes a receiving part further including a spike interface therein. The spike interface includes a first fluid path that provides fluid communication between the solution container and the cleaning device via the interface device.

[0015] In some embodiments, the technology described herein relates to a cleaning device and an interface device, the spike interface has a tip configured to puncture a part of the solution container, and the first fluid path is configured to provide fluid communication with the solution container when the solution container is punctured.

[0016] In some embodiments, the technology described herein relates to a cleaning device and an interface device, the spike interface includes a second fluid path, and the second fluid path is configured to provide fluid communication to the atmosphere outside the solution container through a vent to the solution container when the solution container is punctured by the spike interface.

[0017] In some embodiments, the technology described herein relates to a cleaning device and an interface device, and the vent further includes at least one of a one-way valve, a membrane, or a sterile filter.

[0018] In some embodiments, the technology described herein relates to a cleaning device and an interface device, and the interface device is configured to be attached to the container interface of the solution container.

[0019] In some embodiments, the technology described herein relates to a cleaning device and an interface device, and the receiving part further includes an engaging thread configured to engage threadedly with the threaded container engagement provision of the container interface. When the interface device is rotated relative to the solution container, the spike interface pierces the solution container at the container interface by means of a screw engagement between the engagement thread and the threaded container engagement provision.

[0020] In some aspects, the technology described herein relates to a cleaning device and an interface device, and further comprises a cleaning port configured to interfacially connect with a solution container and provide fluid communication from the solution container to a cleaning device connector.

[0021] In some aspects, the technology described herein relates to a cleaning device and an interface device, wherein the cleaning device connector is a cleaning spike, and is configured to provide fluid communication from the solution container to the cleaning device connector and the cleaning device when the cleaning spike is pushed into the cleaning port.

[0022] In some aspects, the technology described herein relates to a cleaning device and an interface device, wherein the cleaning port further includes a cleaning port seal configured to be pierced by the cleaning spike when the cleaning spike is pushed into the cleaning port.

[0023] In some aspects, the technology described herein relates to a method of providing a fluid path from a solution container to an infusion device, which includes connecting a receiving portion of the interface device to the solution container by piercing a portion of the solution container with a spike interface of the interface device, and establishing a fluid connection between the solution container and the infusion device via the interface device by piercing a portion of the solution container with the spike interface.

[0024] In some aspects, the technology described herein relates to a method, wherein the receiving portion further has an engagement thread, and the solution container further has a threaded container engagement provision, The method further comprises threadedly engaging the engagement threads of the receiving portion with a threaded container engagement provision to provide a seal interface between the interface device and the solution container.

[0025] These and other aspects of the invention will be more fully understood upon reading the following detailed description.

Brief Description of the Drawings

[0026]

Figure 1

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DETAILED DESCRIPTION OF THE INVENTION

[0027] The detailed description set forth below in connection with the appended drawings is intended as a description of various configurations and is not intended to represent the only configuration in which the concepts described herein can be implemented. The detailed description includes specific details for the purpose of providing a thorough understanding of the various concepts. However, it will be apparent to those skilled in the art that these concepts may be practiced without these specific details. In some instances, well-known components are shown in simplified form to avoid obscuring such concepts.

[0028] [I. TERMINOLOGY] Throughout this disclosure, the term "substantially" or "approximately" may be used as a modifier to a geometric relationship between elements or to the shape of an element or component. The term "substantially" or "approximately" is not limited to specific variations and may cover any variation understood by one of ordinary skill in the art to be an acceptable variation, but some examples are shown below. In one example, the term "substantially" or "approximately" may include a variation of less than 10% of the dimension of an article or component. In another example, the term "substantially" or "approximately" may include a variation of less than 5% of the dimension of an article or component. If the term "substantially" or "approximately" is used to define an angular relationship between one element and another element, a non-limiting example of the term "substantially" or "approximately" may include a variation of 5 degrees or less. These examples are not intended to be limiting and may be increased or decreased based on an understanding of acceptable limits by one of ordinary skill in the relevant art.

[0029] For purposes of this disclosure, directional terms are generally expressed in relation to a standard frame of reference when the systems and devices described herein are installed in the orientation in which they are used. Further, to provide context for this disclosure, a general overview of the identified deficiencies of various systems, an example implementation of this disclosure, and the advantages provided by this disclosure are described below. Further details of the example implementation of this disclosure are described in detail with reference to the following figures.

[0030] The terms "a," "an," "the," etc. are not intended to refer to only a single entity and include general classes for which a particular example may be used for illustrative purposes. The terms "a," "an," and "the" may be used interchangeably with the term "at least one." The phrases "at least one of" following a list and "including at least one of" refer to any one of the items in the list and any combination of two or more of the items in the list.

[0031] In the present disclosure, among other numerical values, the terms first, second, third, and fourth may be used. It is understood that, unless otherwise specified, these terms are used only in a relative sense. In particular, in some aspects, certain components may be present in interchangeable and / or identical multiples (e.g., pairs). For these components, the designations first, second, third, and / or fourth may be applied to the components only as a matter of convenience in the description of one or more aspects of the present disclosure.

[0032] The term lavage as used throughout the present disclosure may include, but is not limited to, pulsed lavage, pulsatile jet lavage, or irrigation. However, the term lavage is not intended to be limited to a particular type of irrigation or flushing mechanism or system. For example, the term lavage may include, by way of several non-limiting examples, flushing or irrigation systems and devices typically used in open and / or closed procedures used in cystoscopy, transurethral procedures (e.g., TUR), general procedures, and arthroscopic surgical procedures. Accordingly, the terms lavage, irrigation, and / or flushing may be used interchangeably throughout the present disclosure. In one example, the term lavage may include a device, system, or method that provides either a constant flow or a pulsed flow of a solution to irrigate and dislodge contaminants and / or necrotic tissue from a wound and / or to flush or dilute body fluids or substances.

[0033] [II. Summary] For context, this summary describes aspects of the disclosure and advantages provided by the disclosure. This summary and the detailed description that follows are presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the forms described. Numerous modifications are possible in light of the above teachings, including combinations of the above aspects. Some such modifications are discussed, and others will be understood by those skilled in the art. The various aspects are selected and described in order to best explain the principles of the disclosure and the various aspects as applied to the particular use contemplated. Of course, the scope of the disclosure is not limited to the examples or aspects described herein and may be employed by those skilled in the art in any number of applications and equivalent devices. Rather, the scope is intended to be defined by the claims appended hereto.

[0034] As will be described in further detail below, aspects of the present disclosure relate to an improved cleaning system, an interface device for the cleaning system, and a cleaning method using the system and the interface. The interface described below provides several advantages such as improving the versatility and efficiency of the cleaning system, improving the use safety of the cleaning system, and / or eliminating or reducing the risk of contamination when using a solution in the cleaning system. As one advantage, the interface device described below enables a cleaning system that is not normally compatible with non-cleaning or manual solution containers to be effectively used with such containers, and also improves ease of use and / or safety. FIGS. 1 and 2 show a solution container 100, which may be, for example, a container that is not normally compatible with a cleaning system and / or a container that is not sold for use with a cleaning system or device 300 together with the cleaning system. As will be described in further detail below, the interface device 200 may include a threaded engagement surface for threadedly engaging the interface device 200 to the solution container 100. The interface device 200 may include a hidden or partially covered spike interface that is configured to pierce the membrane of the solution container 100 and provide a fluid path to the cleaning device 300 when the threaded engagement surface is threadedly engaged with the corresponding threads of the solution container 100. The combination of the threaded engagement surface and the partially covered spike interface improves the reliability and safety of the system by ensuring that a technician or physician receives tactile feedback indicating that the interface device 200 is securely connected to the solution container 100. Further, since the spike interface is surrounded or at least partially covered by the outer wall of the interface device 200, the risk of injury to a technician or physician by the spike interface is reduced, which may be particularly important in a hospital or other high-pressure environment.

[0035] Other features and advantages will be described in connection with the drawings in the following detailed examples.

[0036] [III. Detailed Examples] FIG. 1 shows an example of an interface device 200 according to an aspect of the present disclosure. The interface device 200 may include a grippable surface or a tactile surface 202. As shown in FIGS. 1 and 2, the interface device 200 may be configured to engage with a solution container 100. The solution container 100 may include, for example, a container interface 102, which may include a membrane or a breakable seal 108, a container seal surface and / or a container engagement surface 106, and a threaded container engagement provision 104 (engagement functional portion 104). Further, the solution container 100 may include, for example, a housing 110 configured to contain a liquid cleaning solution. The housing 110 and / or the container interface 102 may be formed from flexible or semi-flexible plastic, or other synthetic or semi-synthetic materials known in the art (e.g., polyethylene, polyethylene terephthalate (PET), polystyrene, polyvinyl chloride (PVC)). In one example, the solution container 100 may be blow-molded from flexible or semi-flexible plastic, or other synthetic or semi-synthetic materials known in the art (e.g., polyethylene, polyethylene terephthalate (PET), polystyrene, polyvinyl chloride (PVC)). In a more specific example, the solution container 100 may be blow-molded from polypropylene.

[0037] Although only one example of the solution container 100 is shown, it should be noted that the solution containers that can be used in the aspects of the present disclosure may be, for example, known related solution containers commercially available. Therefore, some elements such as the container interface 102 may vary. As will be described later, the interface device 200 is fully envisioned to be modified and / or changed to be usable with various container types and container interfaces, including commercially available containers. An example of a commercially available container is a packaged premixed PVP-I solution sold under the name BD Surgiphor (trademark) of a sterile wound irrigation system from Becton Dickinson.

[0038] As shown in FIGS. 1 and 2, the disclosed interface device 200 can be used with a cleaning device 300. After the interface device 200 is attached to the container 100 via the container interface 102, a fluid path can be provided to one or more fluid conduits 306 of the cleaning device 300. The cleaning device 300 may include one or more pumps (not shown) that increase the velocity and / or flow rate of fluid supplied from the container 100 to the cleaning device 300 via the interface device 200. As shown in FIGS. 2A through 2D, an example of the cleaning device 300 may include a trigger 312, a body 310, and a nozzle 308. The cleaning device 300 may be configured to supply a pulsed or steady flow of pressurized fluid from the nozzle 308 when the trigger 312 is depressed or held down. FIGS. 2B through 2D relate to aspects of the present disclosure and show an example of the step of connecting the cleaning device 300 to the solution container 100 via the interface device 200. By screwing the interface device 200 into the solution container 100 and tightening until the interface device 200 is fully seated in the solution container 100, the interface device 200 can be attached to the solution container 100. As shown in FIGS. 2B through 2D, the cleaning port 230 may have a removable cap or other seal portion 211. When the removable cap or seal portion is removed (e.g., twisted off), the cleaning spike 307 can be attached to the cleaning port 230 by pushing and / or twisting the cleaning spike 307 into the cleaning port 230. When the interface device 200 is attached to the solution container 100 and the cleaning spike 307 is fully attached into the cleaning port 230, the solution from the solution container 100 may be dispensed through the cleaning device (e.g., cleaning device 300).

[0039] In one example implementation, the cleaning device 300 may be a commercially available cleaning device such as, for example, the Simpulse (trademark) SOLO cleaning device sold by Becton, Dickinson and Company. In another example, the cleaning device 300 may be the Simpulse VariCare (trademark) suction cleaner sold by Becton, Dickinson and Company. Other examples of cleaning devices that may be used in the present disclosure are the Pulsavac Plus (trademark) and / or Pulsavac Plus AC (trademark) wound debridement systems sold by Zimmer Biomet, and / or the InterPulse (trademark) pulse cleaning system sold by Stryker. Although one specific example of a cleaning device is shown and additional examples are provided above, it should be noted that the cleaning device that may be used in the aspects of the present disclosure may be any known related device that may be, for example, commercially available. Thus, some elements such as the body 310 and / or one or more fluid conduits 306 may vary without departing from the scope of the present disclosure. For example, the cleaning device may have a remote or separate pump, and the handpiece may have a configuration different from the gun-type device shown in FIGS. 2A through 2D.

[0040] In one example, a plurality of solution containers 100 and / or a single solution container 100 may be connected to at least one solution container 100 and / or another solution container, or to a line set having a plurality of fluid paths that enable dispensing of fluid from or to the solution containers. The another solution container may contain other solutions. For example, as shown in FIG. 2E, one or more solution containers (e.g., 100a, 100b, and / or 100c) may be connected to either a Y-type or “bladder-type” tube set used for flushing and / or irrigation (e.g., open and / or closed procedures used in cystoscopy, transurethral procedures (e.g., TUR), general procedures, and arthroscopic surgical procedures). For example, one or more solution containers may be connected to a first flushing spike 307a and / or a second flushing spike 307b of the tube set via one or more interface devices 200 (e.g., 200a). The user may then dispense any of the fluid mixtures from two solution containers connected to the first flushing spike 307a and / or the second flushing spike 307b, and / or remove fluid from the patient into one or more of containers 100a, 100b, and / or 100c. The flow of fluid into or out of each container 100a, 100b, and / or 100c (and / or any other container connected to any one or combination of the first flushing spike 307a, the second flushing spike 307b in the first line set 350, and / or the first flushing spike 407a, the second flushing spike 407b, the third flushing spike 407c, and / or the fourth flushing spike 407d in the exemplary second line set 450) can be controlled by one or the other via a series of tube clamps or valves 313a and / or 313b. At the proximal end of the tube, the tube may be in fluid communication with a catheter or other irrigation or flushing device 314 and / or 414. Although the irrigation device or flushing device is not specifically shown in FIG. 2E, note that any one or combination of known cleaning devices including the devices discussed herein, and / or any flushing device or irrigation device, may be at the distal end of the tube as indicated by reference numeral 314.

[0041] In another example, one or more solution containers may be connected to the first cleaning spike 407a, and / or the second cleaning spike 407b, and / or the third cleaning spike 407c, and / or the fourth cleaning spike 407d of the tubing set via one or more interface devices 200 (e.g., 200b and / or 200c). The user may then dispense a fluid mixture from any one, combination, or all of the containers, and / or remove fluid from the patient towards any one, combination, or all of the containers connected to the first cleaning spike 407a, and / or the second cleaning spike 407b, and / or the third cleaning spike 307, and / or the fourth cleaning spike 407d. Also, the flow from one or the other, or to one or the other, may be controlled via a series of tube clamps or valves 313a and / or 313b. At the proximal end of the tubing, the tubing may be in fluid communication with a cleaning device (e.g., the cleaning device 300 of FIGS. 2A - 2D), an irrigation device, or a flushing device (e.g., a catheter). Although the cleaning device, irrigation device, and / or flushing device are not specifically shown, note that their location or connection point is indicated by reference numeral 400 in FIG. 2E. As will be explained below, the interface device 200 is fully envisioned to be modified and / or changed to enable use with various cleaning devices, irrigation devices, and / or flushing devices.

[0042] Figures 3 and 4 illustrate an example of an interface device 200 according to an aspect of the present disclosure. The interface device 200 may include, for example, a grippable surface or a tactile surface 202. The tactile surface 202 may include a series of radially spaced recesses, which, for example, enable a user to easily grip the interface device 200 even when wearing gloves. Further, for example, when the gloves of a technician or a doctor are wet or otherwise covered with a material that may reduce the coefficient of friction between the user's gloves and the interface device 200, the tactile surface 202 can provide an extra grip. Although a series of recesses or valleys are shown in FIG. 1, it should be noted that any surface irregularities or patterns that can improve the user's grip on the interface device 200 may be provided. Some exemplary alternatives include ribs, grooves, dots, and / or a roughened surface.

[0043] The interface device 200 may further include a container interface receiving portion 205. The container receiving portion 205 may include a radially inner wall having a thread 204 configured to threadedly engage with the threaded container engagement provision 104 of the solution container 100 (FIG. 1). In some examples, the interface receiving portion 205 of the interface device 200 may include a child lock type or an anti-opening lock within the thread. For example, the anti-opening lock may require a twisting operation and a second operation by another technician or user. For example, the second operation may be the application of squeezing and / or pressing to a button or buttons, which, in combination with the twisting operation, causes the threads of the solution container 100 to engage and enables removal. In the foregoing example, when the second operation is not performed, the interface device 200 can simply rotate the solution container (i.e., without engaging the thread 204) and / or lock it from rotation. This feature can prevent accidental or unintended removal of the interface device 200 from the solution container 100.

[0044] As shown in the exemplary cross-sectional views of the interface device 200 of FIGS. 4 to 6, the container interface receiving portion 205 may have a spike interface 208 therein. The spike interface 208 may extend, for example, from the inner wall 222 of the interface device 200. The spike interface 208 may taper to a reduced cross-sectional point and / or may have a pointed tip (e.g., as shown in FIGS. 4 and 6). The point or pointed tip may be dimensioned or otherwise configured to pierce the membrane or pierceable section (pierceable cross-sectional area) of the solution container when the interface device 200 (e.g., shown in FIGS. 2A to 2D) is screwed into or otherwise attached to the solution container. The spike interface 208 may include one or more fluid conduits, and the one or more fluid conduits are configured to provide fluid communication to the solution container 100 when the interface device 200 is attached to the container interface 102 of the solution container 100. The spike interface 208 may include a fluid passage 207 that supplies fluid (e.g., a cleaning solution contained in the solution container) to one or more fluid conduits 306 of the cleaning device 300. The arrow 206 in FIG. 5 represents an example of the fluid path of the cleaning solution supplied from the container 100 (FIG. 1), through the interface device 200, to the cleaning device 300 (FIGS. 2A to 2D).

[0045] The spike interface 208 may further include a vent passage 209. The vent passage can supply air or gas to the solution container 100, for example, to equalize the pressure in the solution container 100 when the cleaning solution is removed from the container 100 via the fluid passage 207. In one example implementation, the vent passage may include, for example, a one-way valve or a vent 210 having a membrane such as a hydrophobic membrane 212. In one example implementation, the hydrophobic membrane 212 allows air to move freely into and / or out of the solution container 100 while preventing the liquid solution from passing therethrough, and thus enables the pressure in the solution container to equalize when the solution is removed from the solution container 100 by the cleaning device. In some examples, the vent passage may have, for example, a filter or other membrane, and the filter or other membrane may be a sterile filter or membrane at the opening of the hydrophobic membrane to prevent contaminants from entering the solution container. The arrow 266 in FIG. 5 shows an example of the fluid air / gas flow through the vent passage 209 and the hydrophobic membrane 212 (for example, when the interface device 200 is attached to the solution container 100).

[0046] The interface device 200 may further include an end face 223, which can provide a surface transition, for example, from the threaded portion 204 of the interface device 200 to the non-threaded radial surface and / or the blind wall 225. The end face 223 and / or the blind wall can provide a mechanical stop point when the interface device 200 engages the solution container 100 in a threaded manner. The mechanical stop point provided by the end face 223 and / or the blind wall 225 has the additional advantage of indicating to the user that the interface device 200 is properly attached to the solution container 100 and that the spike interface 208 has completely penetrated the membrane or pierceable section of the solution container 100. In some examples, the end face 223 may include, for example, an additional feedback mechanism or device. For example, the blind wall may have an elastic or semi-elastic secondary wall or other protrusion that provides a tactile or audible "click" when the interface device 200 is fully engaged with the solution container 100.

[0047] By engaging any one or a combination of the thread 204, the spike interface 208, and / or the blind wall 225 or the end face 223, a seal can be formed between the solution container 100 and the interface device 200, ensuring that the cleaning solution does not leak from the interface and / or the container. For example, to attach the interface device 200 to the solution container, the user can align the receiving portion 205 with the container interface 102 of the solution container 100 and press and twist the interface device 200 against the container interface 102 while gripping the grippable surface or the tactile surface 202 of the solution container 100 and the interface device 200. When the threaded container engagement provision 104 and the mating thread 204 are threadedly engaged and the spike interface 208 punctures the membrane or the pierceable portion 108 of the solution container 100, the user can continue to twist the interface device with respect to the solution container 100. Also, when the container interface 102 reaches the bottom against the end face 223 and / or the blind wall 225 of the interface device 200, the user can continue to twist the interface device until resistance is felt. The increase in resistance felt by the user when the container interface 102 reaches the bottom against the end face 223 and / or the blind wall 225 of the interface device 200 gives an indication that the interface device 200 is fully attached and a seal with the solution container 100 is established.

[0048] As an alternative to the foregoing aspect, the user may align the spike interface 208 with the membrane or pierceable portion 108 of the solution container and use the spike interface 208 to pierce the membrane or pierceable portion 108 before the threaded container engagement provision 104 and the receiving thread 204 are threadedly engaged. After the membrane or pierceable portion 108 has been pierced by the spike interface 208, the user may engage the threaded container engagement provision 104 and the receiving thread 204 and twist the interface device 200 relative to the solution container 100 until resistance is felt as the container interface 102 reaches the bottom against the end face 223 and / or the blind wall 225 of the interface device 200. Similar to the above aspect, the increase in resistance felt by the user as the container interface 102 reaches the bottom against the end face 223 and / or the blind wall 225 of the interface device 200 provides an indication that the interface device 200 is fully attached and a seal with the solution container 100 has been established.

[0049] In one example that can be used in the foregoing example, the interface device 200 may include, for example, a protective seal 280. The protective seal can further prevent contamination of the spike interface 208 and / or protect the user from accidentally contacting and being injured by the spike interface 208. In one example, the protective seal 280 can be removable before attaching the interface device 200 to the solution container 100 and / or can be configured to break or pierce when the user attaches the interface device 200 to the solution container 100 using the method described above, and may be a polymer film or foil. In another example, the spike interface 208 may be covered with a spike sheath (not shown) until activation or use. As another alternative, the interface device 200 may incorporate a retractable spike interface 208 that is simply exposed when the interface device 200 is screwed into the solution container 100. In the foregoing example, when the interface device 200 is not in use, the spike interface 208 remains hidden. When the interface device 200 is screwed into the container interface 102 of the solution container 100, the spike interface 208 is simply exposed. In the foregoing example, the interface device 200 may include a split polymer material 281 that covers the spike interface 208, and when the interface device 200 is screwed into the container interface 102 of the solution container 100, the polymer material splits to expose the spike interface 208. The foregoing split polymer material may be an elastic material configured to retain its original shape, and thus, when the interface device 200 is removed from the container interface 102, is configured to cover the spike interface 208 again. In one example, the split polymer material 281 may be, for example, silicone or other material that maintains or returns to its original shape while providing the flexibility necessary for the spike interface 208 to pierce the material. In one example, the split polymer material 281 may be formed of, for example, semi-rigid silicone.The foregoing examples provide improved safety to the user both before the interface device 200 is attached and after the interface device 200 is removed.

[0050] Either the protective seal 280 or the split polymer material 281 may be coated or treated with, and / or include, an antibacterial agent, for example. This can further reduce the likelihood of contamination of the solution or solution path and help maintain the sterility of the cleaning solution.

[0051] As shown in FIG. 6, in one example aspect of the present disclosure, the interface device 200 may include a check valve or one-way valve 299. The check valve or one-way valve may include any known valve, membrane, or combination thereof. The check valve 299 can, for example, allow flow only in the direction of arrow 298, thereby preventing potential contaminants in the cleaning device 300 and / or one or more fluid conduits 306 from being drawn back into the solution container 100 due to a pressure differential in the pump between the cleaning device 300 and the solution container 100. Since the check valve 299 is incorporated into the interface device 200, the risk of contamination of the cleaning solution is further reduced and / or completely eliminated.

[0052] As shown in FIG. 6, the interface device 200 may further include a cleaning port 230. The cleaning port 230 may have, for example, a channel or fluid path 231 that is in fluid communication with the fluid passage 207. As shown in FIG. 3(6), the fluid passage may have, for example, a cleaning port seal 234. The cleaning port seal 234 may be, for example, a foil or film seal and / or may be formed as part of the interface device 200, and may be configured to be broken by the pointed tip 311 of the cleaning spike 307 of the cleaning device (e.g., the cleaning device 300 of FIGS. 2A-2D) or otherwise have an opening formed therein. The inner diameter of the channel or fluid path 231 may be dimensioned, for example, to be slightly smaller than or equal to at least a portion of the cleaning spike, thus forming a sealing fit with the cleaning spike 307. In addition, the area surrounding the cleaning port 230 and / or the channel or fluid path 231 may be formed of, for example, a flexible or semi-flexible material. Any one or combination of the foregoing features may allow a liquid-impermeable seal to be formed between the interface device 200 and the cleaning spike 307 when the cleaning spike 307 is pushed into the cleaning port 230. When preparing the cleaning device 300 for use, the user may push the cleaning spike 307 into the cleaning port 230. This may break the cleaning port seal 234 or otherwise open the fluid path between the cleaning spike 307 and the fluid passage 207 of the interface device 200. Thus, when the cleaning spike 307 is attached to the interface device 200 and the solution container 100 is connected to the interface device 200, the cleaning solution can be pumped from the solution container 100 to the cleaning device 300.

[0053] In addition to preventing contamination of the interface device 200, the cleaning port seal 234 can further provide improved usability and efficiency and reduce waste or accidents of the cleaning fluid. Typically, technicians and medical staff are accustomed to suspending fluid on an IV pole and then directly attaching the cleaning spike 307 of the cleaning device 300 to the bag containing the solution. Thus, if the cleaning port seal 234 is absent and the technician suspends the solution container 100, to which the interface device 200 has already been attached, on the IV pole, the cleaning fluid will flow out of the solution container 100 through the channel or fluid path 231. The cleaning port seal 234 enables the technician to use the solution container 100 with the interface device 200 without the need to change the familiar typical workflow. In addition to this, to prevent the cleaning spike from falling off, the cleaning port 230 may include a feature, marking, or engraving that instructs the user to fully insert the cleaning spike 307 into the cleaning port 230. The marking / engraving can visually indicate to the user that the cleaning spike is properly inserted when the cleaning spike is aligned with the engraving, i.e., "spike to the line".

[0054] Figures 7 through 10 illustrate examples of an interface device 700 according to aspects of the present disclosure. In some examples, the interface device 700 described below may share features with the interface device 200 described above, may include features that replace the features described above, and / or may be similar to the interface device 200 described above. In addition to this, the aspects described throughout the present disclosure can be used with the features described below with respect to Figures 7 through 10.

[0055] The interface device 700 may include, for example, a grippable surface or a tactile surface 702. The tactile surface 702 may include a series of radially spaced recesses, which, for example, enable the user to easily grip the interface device 700 even when wearing gloves. Further, for example, when the gloves of a technician or a doctor are wet, or when otherwise covered with a material that may reduce the coefficient of friction between the user's gloves and the interface device 700, the tactile surface 702 can provide an extra grip. Although a series of recesses or valleys are shown in FIG. 7, it should be noted that any surface irregularities or patterns that can improve the user's grip on the interface device 700 may be provided. Some exemplary alternatives include ribs, grooves, dots, and / or a roughened surface.

[0056] The interface device 700 may further include a container interface receiving portion 705. The container receiving portion 705 may include a radially inner wall having a thread 704 configured to threadedly engage with the threaded container engagement provision 104 of the solution container 100 (FIGS. 1, 2A through 2E). In some examples, the interface receiving portion 705 of the interface device 700 may include a child lock type or anti-unlocking lock within the thread. For example, the anti-unlocking lock may require a twisting operation and a second operation by another technician or user. For example, the second operation may be the application of squeezing and / or pressing to a button or buttons, which, in combination with the twisting operation, causes the threads of the solution container 100 to engage and enables removal. In the foregoing example, when the second operation is not performed, the interface device 700 can simply rotate the solution container (i.e., without engaging the thread 704) and / or lock it from rotation. This feature can prevent accidental or unintentional removal of the interface device 700 from the solution container 100.

[0057] As shown in the exemplary cross-sectional views of the interface device 700 of FIGS. 8 to 10, the container interface receiving portion 705 may have a spike interface 708 therein. The spike interface 708 may extend, for example, from the inner wall 722 of the interface device 700. The spike interface 708 may taper to a reduced cross-sectional point and / or may have a pointed tip (e.g., as shown in FIGS. 8 to 10). The point or pointed tip may be dimensioned or otherwise configured to pierce the membrane or pierceable section of the solution container when the interface device 700 (e.g., as shown in FIGS. 2A to 2D) is screwed into or otherwise attached to the solution container. The spike interface 708 may include one or more fluid conduits configured to provide fluid communication to the solution container 100 when the interface device 700 is attached to the container interface 102 (FIG. 1) of the solution container 100. The spike interface 708 may include a fluid passage 707 for supplying fluid (e.g., a cleaning solution contained in the solution container) to one or more fluid conduits 306 of a cleaning device (e.g., the device 300 of FIGS. 2A to 2D). The arrows 706 in FIGS. 9 and 10 represent an example of the fluid path of the cleaning solution supplied from the container 100 (FIGS. 1 to 2E), through the interface device 700, to the cleaning devices 300, 314, 415 (FIGS. 2A to 2E).

[0058] The spike interface 708 may further include a vent passage 709. The vent passage can supply air or gas to the solution container 100, for example, to equalize the pressure in the solution container 100 when the cleaning solution is removed from the container 100 through the fluid passage 707. In one example implementation, the vent passage may include, for example, a one-way valve or multiple vents 711 having a membrane such as a hydrophobic membrane 712 (FIG. 10). As shown in the example of FIG. 7, the multiple vents 711 may include, for example, a first vent 711a, a second vent 711b, and / or a third vent 711c, which may be semi-circular and along the outer contour of the upper surface (710 or 71) of the interface device 700. Although three vent openings are shown in FIG. 7, it should be noted that the number or shape of the vent openings may be provided without departing from the scope of the present disclosure. In one example implementation, the hydrophobic membrane 712 allows air to move freely into and / or out of the solution container 100 while preventing the liquid solution from passing therethrough, thus enabling the pressure in the solution container to equalize when the solution is removed from the solution container 100 by the cleaning device. In some examples, the vent passage may have, for example, a filter or other membrane, and the filter or other membrane may be a sterile filter or membrane at the opening of the hydrophobic membrane to prevent contaminants from entering the solution container. The arrows 710, 766 in FIG. 9 show an example of the fluid air / gas flow through the vent passage 709 and the hydrophobic membrane 712 (for example, when the interface device 700 is attached to the solution container 100).

[0059] The interface device 700 may further include an end face 723, which can provide, for example, a surface transition from the thread 704 of the interface device 700 to an unthreaded radial surface and / or a blind wall 725. The end face 723 and / or the blind wall can provide a mechanical stop point when the interface device 700 engages the solution container 100 in a threaded manner. The mechanical stop point provided by the end face 723 and / or the blind wall 725 has the additional advantage of indicating to the user that the interface device 700 is properly attached to the solution container 100 and that the spike interface 708 has completely penetrated the membrane or pierceable section of the solution container 100. In some examples, the end face 723 may include, for example, additional feedback mechanisms or devices. For example, the blind wall may have an elastic or semi-elastic secondary wall or other protrusion (not shown) that provides a tactile or audible "click" when the interface device 700 is fully engaged with the solution container 100.

[0060] By engaging any one or a combination of the thread 704, the spike interface 708, and / or the blind wall 725 or the end face 723, a seal can be formed between the solution container 100 and the interface device 700, ensuring that the cleaning solution does not leak from the interface and / or the container. For example, to attach the interface device 700 to the solution container, the user can align the receiving portion 705 with the container interface 102 of the solution container 100, and while gripping the grippable surface or the tactile surface 702 of the solution container 100 and the interface device 700, press and twist the interface device 700 against the container interface 102. When the threaded container engagement provision 104 and the receiving thread 704 are threadedly engaged, and the spike interface 708 pierces the membrane or the pierceable portion 108 of the solution container 100, the user can continue to twist the interface device with respect to the solution container 100. Also, when the container interface 102 reaches the bottom with respect to the end face 723 and / or the blind wall 725 of the interface device 700, the user can continue to twist the interface device until resistance is felt. The increase in resistance felt by the user when the container interface 102 reaches the bottom with respect to the end face 723 and / or the blind wall 725 of the interface device 700 indicates that the interface device 700 is fully attached and a seal with the solution container 100 is established.

[0061] As an alternative to the foregoing aspect, the user may align the spike interface 708 with the membrane or pierceable portion 108 of the solution container and use the spike interface 708 to pierce the membrane or pierceable portion 108 before the threaded container engagement provision 104 and the receiving thread 704 are threadedly engaged. After the membrane or pierceable portion 108 is pierced by the spike interface 708, the user may engage the threaded container engagement provision 104 and the receiving thread 704, and twist the interface device 700 relative to the solution container 100 until resistance is felt when the container interface 102 reaches the bottom against the end face 723 and / or the blind wall 725 of the interface device 700. Similar to the above aspect, the increase in resistance felt by the user when the container interface 102 reaches the bottom against the end face 723 and / or the blind wall 725 of the interface device 700 indicates that the interface device 700 is fully attached and a seal with the solution container 100 has been established.

[0062] In one example that can be used in the foregoing example, and similar to the aspect described above with respect to the interface device 200, the interface device 700 may include, for example, a protective seal 780. The protective seal can further prevent contamination of the spike interface 708 and / or protect the user from accidentally contacting and being injured by the spike interface 708. In one example, the protective seal 780 can be removable before attaching the interface device 700 to the solution container 100 and / or can be configured to break or pierce when the user attaches the interface device 700 to the solution container 100 using the method described above, and can be a polymer film or foil. In another example, the spike interface 708 may be covered with a spike sheath (not shown) until activation or use. As another alternative, the interface device 700 may incorporate a retractable spike interface 708 that is simply exposed when the interface device 700 is screwed into the solution container 100. In the foregoing example, the spike interface 708 remains hidden when the interface device 700 is not in use. When the interface device 700 is screwed into the container interface 102 of the solution container 100, the spike interface 708 is simply exposed. In the foregoing example, the interface device 700 may include a split polymer material 781 that covers the spike interface 708, and when the interface device 700 is screwed into the container interface 102 of the solution container 100, the polymer material splits to expose the spike interface 708. The foregoing split polymer material may be an elastic material configured to retain its original shape, and thus is configured to cover the spike interface 708 again when the interface device 700 is removed from the container interface 102. In one example, the split polymer material 781 may be, for example, silicon or other material that maintains or returns to its original shape while providing the flexibility necessary for the spike interface 708 to pierce the material. In one example, the split polymer material 781 may be formed of, for example, semi-rigid silicone.The foregoing examples provide improved safety to the user both before the interface device 700 is attached and after the interface device 700 is removed.

[0063] Either the protective seal 780 or the split polymer material 781 may be coated or treated with, and / or include, an antibacterial agent, for example. This can further reduce the likelihood of contamination of the solution or solution pathway and help maintain the sterility of the cleaning solution.

[0064] Although not shown in FIGS. 7-10, in one example aspect of the present disclosure, the interface device 700 may include a check valve or one-way valve (e.g., similar to the one-way valve 299 of FIG. 6). The check valve or one-way valve may include any known valve, membrane, or combination thereof. The check valve can, for example, allow flow only in the direction of arrow 706, thereby preventing potential contaminants in the cleaning device 300 and / or one or more fluid conduits (e.g., 306, 350, and / or 450 in FIGS. 2A and 2E) from being drawn back into the solution container 100 due to a pressure differential by the pump between the cleaning device 300 and the solution container 100. Since the check valve is incorporated into the interface device 700, the risk of contamination of the cleaning solution is further reduced and / or completely eliminated.

[0065] As shown in FIG. 10, the interface device 700 may further include a cleaning port 730. The cleaning port 730 may have, for example, a channel or fluid path 731 that is in fluid communication with the fluid passage 707. As shown in FIG. 10, the fluid passage may have, for example, a cleaning port seal 734. The cleaning port seal 734 may be, for example, a foil or film seal and / or may be formed as part of the interface device 700, and may be configured to be broken by the sharp tip 811 of the cleaning spike 807 of the cleaning device (e.g., the cleaning devices 300 and / or 315 or 415 of FIGS. 2A-2E) or otherwise have an opening formed therein. The inner diameter of the channel or fluid path 731 may be dimensioned, for example, to be slightly smaller than or equal to at least a portion of the cleaning spike, thus forming a sealing fit with the cleaning spike 807. In addition, the cleaning port 730 and / or the region surrounding the channel or fluid path 731 may be formed of, for example, a flexible or semi-flexible material. Any one or combination of the foregoing features may allow a liquid-impermeable seal to be formed between the interface device 700 and the cleaning spike 807 when the cleaning spike 807 is pushed into the cleaning port 730. When preparing the cleaning device 300 for use, the user may push the cleaning spike 807 into the cleaning port 730. This may break the cleaning port seal 734 or otherwise open the fluid path between the cleaning spike 807 and the fluid passage 707 of the interface device 700. Thus, when the cleaning spike 807 is attached to the interface device 700 and the solution container 100 is connected to the interface device 700, the cleaning solution can be pumped from the solution container 100 to the cleaning device (e.g., 300 and / or 315 or 415).

[0066] In addition to preventing contamination of the interface device 700, the cleaning port seal 734 can further provide improved usability and efficiency, and can reduce waste or accidents of the cleaning fluid. Typically, technicians and medical staff are accustomed to suspending fluid on an IV pole and then directly attaching the cleaning spike 807 of the cleaning device 800 (300) to the bag containing the solution. Thus, if the cleaning port seal 734 is absent and the technician suspends the solution container 100, to which the interface device 700 has already been attached, on the IV pole, the cleaning fluid will flow out of the solution container 100 through the channel or fluid path 731. The cleaning port seal 734 enables the technician to use the solution container 100 together with the interface device 700 without the need to change the familiar typical workflow.

[0067] In addition to this, to prevent the cleaning spike from falling off, the cleaning port 730 may include features, markings, or imprints that instruct the user to fully insert the cleaning spike 807 into the cleaning port 730. The marking / imprint can visually indicate to the user that the cleaning spike is properly inserted when the cleaning spike is aligned with the imprint, i.e., "spike to the line".

[0068] This specification uses examples to disclose aspects of the invention, including preferred embodiments. It also uses examples to enable any person skilled in the art to carry out those aspects, including the manufacture and use of any device or system and the execution of any incorporated method. The patentable scope of these aspects is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are intended to be included in the claims if they have structural elements that do not differ from the literal language of the claims or if they include equivalent structural elements with insubstantial differences from the literal language of the claims. Aspects from the various described embodiments and other known equivalents for such aspects may be combined and matched by those skilled in the art to construct additional embodiments and techniques in accordance with the principles of this application.

[0069] [IV. Example Implementation] The following implementation sections include the example implementation of the aspects described in this specification.

[0070] 1. An interface device that can be used with a solution container and an infusion device, a receiving portion configured to provide a sealed connection with the container interface of the solution container, and including a receiving portion further including a spike interface therein, the spike interface including a first fluid path that provides fluid communication between the solution container and the infusion device via the interface device. The interface device. 2. The interface device according to implementation section 1, wherein the spike interface has a tip configured to pierce a part of the solution container, and the first fluid path is configured to provide fluid communication with the solution container when the solution container is pierced. 3. The interface device according to implementation section 2, wherein the spike interface includes a second fluid path, and the second fluid path is configured to provide the solution container with fluid communication to the atmosphere outside the solution container via a vent when the solution container is pierced by the spike interface. 4. The interface device according to implementation section 3, wherein the vent further includes at least one of a one-way valve, a membrane, or a sterile filter. 5. The interface device according to implementation section 2, wherein the interface device is configured to be attached to the container interface of the solution container. 6. The interface device according to implementation section 5, wherein the receiving portion further includes an engaging thread configured to engage threadedly with the threaded container engagement provision of the container interface. When the interface device is rotated relative to the solution container, the spike interface pierces the solution container at the container interface by a screw engagement between the engagement thread and the threaded container engagement provision, interface device. 7. The interface device according to embodiment item 6, further comprising an infusion port configured to interface with the solution container and provide fluid communication from the solution container to the infusion device connector, interface device. 8. The interface device according to embodiment item 7, wherein the infusion device connector is an infusion device spike, and the infusion device connector is configured to provide fluid communication from the solution container to the infusion device connector and the infusion device when the infusion device spike is pushed into the infusion port, interface device. 9. The interface device according to embodiment item 8, wherein the infusion port further includes an infusion port seal, and the infusion port seal is configured to be pierced by the infusion device spike when the infusion device spike is pushed into the infusion port, interface device. 10. A cleaning device and an interface device, the cleaning device comprising a nozzle and a pump in fluid communication with the nozzle, the pump supplying a pressurized flow of cleaning solution supplied from the solution container, cleaning device and interface device, The interface device is a receiving portion configured to provide a sealed connection with the container interface of the solution container, the receiving portion further including a spike interface therein, The spike interface includes a first fluid path providing fluid communication between the solution container and the cleaning device via the interface device, cleaning device and interface device. 11. In the cleaning device and the interface device according to Embodiment 10, the spike interface has a tip configured to puncture a part of the solution container, and the first fluid path is configured to be in fluid communication with the solution container when the solution container is punctured. The cleaning device and the interface device. 12. In the cleaning device and the interface device according to Embodiment 11, the spike interface includes a second fluid path, and the second fluid path is configured to provide fluid communication to the atmosphere outside the solution container through a vent when the solution container is punctured by the spike interface. The cleaning device and the interface device. 13. In the cleaning device and the interface device according to Embodiment 12, the vent further includes at least one of a one-way valve, a membrane, or a sterile filter. The cleaning device and the interface device. 14. In the cleaning device and the interface device according to Embodiment 11, the interface device is configured to be attached to the container interface of the solution container. The cleaning device and the interface device. 15. In the cleaning device and the interface device according to Embodiment 14, the receiving portion further includes an engaging thread configured to engage threadedly with the threaded container engagement provision of the container interface. When the interface device is rotated relative to the solution container, due to the threaded engagement between the engaging thread and the threaded container engagement provision, the spike interface punctures the solution container at the container interface. The cleaning device and the interface device. 16. In the cleaning device and the interface device according to Embodiment 15, further provided with a cleaning port configured to interface with the solution container and provide fluid communication from the solution container to the cleaning device connector. The cleaning device and the interface device. 17. In the cleaning device and the interface device according to embodiment item 16, the cleaning device connector is a cleaning spike, and the cleaning device connector is configured to provide fluid communication from the solution container to the cleaning device connector and the cleaning device when the cleaning spike is pushed into the cleaning port. The cleaning device and the interface device. 18. In the cleaning device and the interface device according to embodiment item 17, the cleaning port further includes a cleaning port seal, and the cleaning port seal is configured to be punctured by the cleaning spike when the cleaning spike is pushed into the cleaning port. The cleaning device and the interface device. 19. A method for providing a fluid path from a solution container to an infusion device, The step of connecting the receiving portion of the interface device to the solution container by puncturing a part of the solution container with the spike interface of the interface device, and establishing a fluid connection between the solution container and the infusion device through the interface device by puncturing a part of the solution container with the spike interface. The method. 20. In the method according to embodiment item 19, the receiving portion further has an engaging thread, and the solution container further has a threaded container engaging provision, The method further includes threadedly engaging the engaging thread of the receiving portion with the threaded container engaging provision to provide a seal interface between the interface device and the solution container. The method.

Claims

1. An interface device that can be used with a solution container and an infusion device, a receiving portion configured to provide a sealed connection with the container interface of the solution container, the receiving portion further including a spike interface therein, the spike interface including a first fluid path that provides fluid communication between the solution container and the infusion device via the interface device, the interface device.

2. The spike interface has a tip portion configured to pierce a part of the solution container, and the first fluid path is configured to provide fluid communication with the solution container when the solution container is pierced, the interface device according to Claim 1.

3. The spike interface includes a second fluid path, and the second fluid path is configured to provide the solution container with fluid communication to the atmosphere outside the solution container via a vent when the solution container is pierced by the spike interface, the interface device according to Claim 2.

4. The vent further includes at least one of a one-way valve, a membrane, or a sterile filter, the interface device according to Claim 3.

5. The interface device is configured to be attached to the container interface of the solution container, the interface device according to Claim 2.

6. The receiving portion further includes an engaging thread configured to engage threadedly with a threaded container engagement provision of the container interface, when the interface device is rotated relative to the solution container, by the threaded engagement between the engaging thread and the threaded container engagement provision, the spike interface pierces the solution container at the container interface, the interface device according to Claim 5.

7. Furthermore, it includes an infusion port configured to interface with the solution container and provide fluid communication from the solution container to an infusion device connector, the interface device according to Claim 6.

8. The perfusion device connector is a perfusion device spike, and the perfusion device connector is configured to provide fluid communication from the solution container to the perfusion device connector and the perfusion device when the perfusion device spike is pushed into the perfusion port. The interface device according to claim 7.

9. The perfusion port further includes a perfusion port seal, and the perfusion port seal is configured to be punctured by the perfusion device spike when the perfusion device spike is pushed into the perfusion port. The interface device according to claim 8.

10. A cleaning device and an interface device, the cleaning device includes a nozzle and a pump in fluid communication with the nozzle, and the pump supplies a pressurized flow of a cleaning solution supplied from a solution container. A cleaning device and an interface device, The interface device is A receiving portion configured to provide a sealed connection with the container interface of the solution container, and includes a receiving portion further including a spike interface therein. The spike interface includes a first fluid path that provides fluid communication between the solution container and the cleaning device via the interface device. A cleaning device and an interface device.

11. The spike interface has a tip configured to puncture a portion of the solution container, and the first fluid path is configured to be in fluid communication with the solution container when the solution container is punctured. The cleaning device and interface device according to claim 10.

12. The spike interface includes a second fluid path, and the second fluid path is configured to provide fluid communication from the solution container to the atmosphere outside the solution container via a vent when the solution container is punctured by the spike interface. The cleaning device and interface device according to claim 11.

13. The vent further includes at least one of a one-way valve, a membrane, or a sterile filter. The cleaning device and interface device according to claim 12.

14. The interface device is configured to be attached to the container interface of the solution container, the cleaning device and interface device according to claim 11.

15. The receiving portion further includes an engaging thread configured to engage in a threaded manner with a threaded container engagement provision of the container interface, When the interface device is rotated relative to the solution container, the spike interface punctures the solution container at the container interface by a threaded engagement between the engaging thread and the threaded container engagement provision, the cleaning device and interface device according to claim 14.

16. The cleaning device and interface device according to claim 15 further comprising a cleaning port configured to interface with the solution container and provide fluid communication from the solution container to a cleaning device connector.

17. The cleaning device connector is a cleaning spike, and the cleaning device connector is configured to provide fluid communication from the solution container to the cleaning device connector and the cleaning device when the cleaning spike is pushed into the cleaning port, the cleaning device and interface device according to claim 16.

18. The cleaning port further includes a cleaning port seal configured to be punctured by the cleaning spike when the cleaning spike is pushed into the cleaning port, the cleaning device and interface device according to claim 17.

19. A method of providing a fluid path from a solution container to an infusion device, The step of connecting the receiving portion of the interface device to the solution container by puncturing a portion of the solution container with a spike interface of the interface device, and establishing a fluid connection between the solution container and the infusion device via the interface device by puncturing a portion of the solution container with the spike interface, a method.

20. The receiving portion further has an engaging thread, and the solution container further has a threaded container engagement provision, The method further comprises threadedly engaging the engagement thread of the receiving portion with the threaded container engagement provision to provide a seal interface between the interface device and the solution container, the method according to claim 19.

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