Irrigation system and method of use

Abstract

The therapeutic delivery system includes a fluid delivery system connected to a first fluid reservoir and a second fluid reservoir. The system directs a first fluid from the first fluid reservoir to a treatment site and a second fluid from the second fluid reservoir to the treatment site. A control unit controls the fluid delivery system according to a therapeutic process comprising a flow of the first fluid and the second fluid, the therapeutic process including multiple phases. A first phase includes controlled delivery of the first fluid from the first fluid reservoir to the treatment site. A second phase of the multiple phases includes controlled delivery of the second fluid from the second fluid reservoir to the treatment site, and the control unit automatically activates a transition from at least the first phase to the second phase. Related devices, systems, kits, and methods are also provided.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority under 35 U.S.C. §119(e) to (1) U.S. Provisional Patent Application No. 63 / 486,186, filed February 21, 2023, (2) U.S. Provisional Patent Application No. 63 / 493,577, filed March 31, 2023, (3) U.S. Provisional Patent Application No. 63 / 519,923, filed August 16, 2023, (4) U.S. Provisional Patent Application No. 63 / 596,130, filed November 3, 2023, and (5) U.S. Provisional Patent Application No. 63 / 613,533, filed December 21, 2023. The disclosures of the patent applications are incorporated herein by reference in their entireties.

[0002] The present disclosure relates generally to methods, systems, and devices for irrigation and cleaning of biological tissue. In particular, the description relates to devices and methods for the automated delivery of multiple types of medications, such as antibiotics, into a surgical site. [Background technology]

[0003] Prosthetic joint arthroplasty can lead to periprosthetic joint infections, which can be associated with serious complications. Periprosthetic joint infection treatment protocols typically involve surgery to eradicate the infection and administration of systemic antibiotics. Local antibiotic irrigation can increase antibiotic concentrations at the infected site compared to systemic administration, while maintaining safe systemic levels. Improved treatment techniques based on standardized antibiotic delivery protocols can form the basis for the successful management of prosthetic joint infections. For example, the combination of a device, fluid delivery control unit, and negative pressure waste removal can provide increased control of fluid placement and removal, superior cleanliness, and maintenance of proper joint structure, leading to superior treatment of patient infections with increased efficiency and success rates. Summary of the Invention [Means for solving the problem]

[0004] For purposes of summary, certain aspects, advantages, and novel features are described herein. It is to be understood that not all such advantages may be achieved in accordance with any one particular implementation. Thus, the disclosed subject matter may be embodied or practiced in a manner that achieves or optimizes one advantage or group of advantages without achieving all advantages as may be taught or suggested herein.

[0005] According to some implementations of the disclosed subject matter, articles, devices, systems, and methods of manufacture are provided for automated control of fluid delivery to a treatment site.

[0006] In one aspect, a therapy delivery system is provided, including a fluid delivery system connected to a first fluid reservoir and a second fluid reservoir, the fluid delivery system configured to direct a first fluid from the first fluid reservoir to a treatment site and a second fluid from the second fluid reservoir to the treatment site. A control unit is configured to control the fluid delivery system according to a therapy process including flow of the first fluid and the second fluid. The therapy process includes multiple phases. A first phase of the multiple phases includes controlled delivery of the first fluid from the first fluid reservoir to the treatment site. A second phase of the multiple phases includes controlled delivery of the second fluid from the second fluid reservoir to the treatment site. The control unit automatically activates a transition from at least the first phase to the second phase of the multiple phases.

[0007] The treatment delivery system can include a first load cell configured to detect a combined weight of a first weight of the first fluid in the first fluid reservoir and a second weight of the second fluid in the second fluid reservoir. A control unit processes the combined weight and monitors the status of the fluid delivery. The first load cell can be arranged in a vertical plane of the system and configured to be horizontally contacted by a cantilevered hanger component. The first fluid reservoir can be held by a mounting feature at a first end region of the cantilevered hanger component, and the first load cell can be contacted by a protrusion at a second end region of the cantilevered hanger component. The system can further include a collection fluid canister configured to collect fluid removed from the treatment site. A second load cell can be included configured to detect a waste weight of the waste fluid canister and any waste in the canister. A control unit can process the waste weight and monitor the status of fluid removal. The second load cell can be arranged in a vertical plane of the system and configured to be horizontally contacted by a second cantilevered hanger component. The canister can be held by a mounting feature at a first end region of the second cantilevered hanger component, and the second load cell can be contacted by a second protrusion at a second end region of the second cantilevered hanger component.

[0008] The fluid delivery system may further include a first pinch valve and a second pinch valve. The first pinch valve may be fluidly connected to a first fluid reservoir and configured to receive a first fluid delivery line, and the second pinch valve may be fluidly connected to a second fluid reservoir and configured to receive a second fluid delivery line. The first pinch valve may be controlled by a control unit to be open during the first phase and to be closed during the second phase. The second pinch valve may be controlled by the control unit to be closed during the first phase and to be open during the second phase. The first pinch valve may have a first inner dimension when in the open configuration, and the second pinch valve may have a second inner dimension when in the open configuration. The first inner dimension may be smaller than the second inner dimension. The first fluid delivery line can have a smaller outer dimension than the second fluid delivery line, the smaller outer dimension being sized to be received within the first inner dimension of the first pinch valve. The second fluid delivery line can have an outer dimension that prevents it from being received within the first inner dimension of the first pinch valve.

[0009] The control unit can include a pump configured to generate a set vacuum pressure within the system and a valve configured to control vacuum relief. The pump can be powered off during at least a first phase. The pump can be configured to operate at a substantially constant voltage for a first period of time and at a substantially constant torque for a second period of time to generate the set vacuum pressure. The system can further include a leak alarm configured to generate an alert indicating a pressure leak, determined in response to the control unit detecting that the vacuum pressure at the treatment site is below a discrete threshold.

[0010] The multiple phases may include a third phase for maintaining a volume of the first fluid or the second fluid at a portion of the treatment site for a period of time. The multiple phases may include a fourth phase automatically initiated by the control unit following the first phase for removing the first fluid from the treatment site and following the second phase for removing the second fluid from the treatment site. The system may include a collection fluid canister configured to collect fluid removed from the treatment site during the fourth phase of the multiple phases. The system may include a collection fluid canister fill sensor configured to generate a collection fluid canister fill alert during the fourth phase of the multiple phases, indicating that the fill level of the collection fluid canister exceeds a fill threshold. The control unit may stop the removal of either the first fluid or the second fluid from the treatment site in response to the collection fluid canister fill alert. The system may include an empty fluid reservoir alarm configured to generate an alert indicating that the weight of the first fluid delivered or the weight of the second fluid delivered falls below a minimum threshold corresponding to the respective phase of the multiple phases. The system can include a low battery alarm configured to generate an alert indicating a charge level of a battery of the control unit. The battery charge level can be determined in response to the control unit detecting that the battery charge level is below a minimum charge level adequate for powering automatic transitions between multiple phases. The system can include an incorrect assembly alarm configured to generate an alert indicating incorrect assembly of the therapy delivery system. The incorrect assembly can be determined in response to the control unit detecting a missing or incorrectly coupled component of the therapy delivery system that interferes with automatic transitions between multiple phases. The system can include a motion alarm configured to generate an alert indicating excessive motion that pauses fluid delivery and affects weight sensor readings during fluid delivery. The system can include a user interface configured to receive user input having a selection of an action to initiate a sequence comprising multiple phases.The first fluid can include tobramycin sulfate and the second fluid can include vancomycin hydrochloride.

[0011] In an interrelated aspect, provided is a method including controlling, by a control unit, fluid flow of a treatment solution from a fluid reservoir to a treatment site through a fluid delivery line fluid during a fluid delivery phase; activating, by the control unit, a transition from the fluid delivery phase to a fluid immersion phase, during which the treatment solution is maintained at the treatment site; and triggering, by the control unit, removal of the treatment solution from the treatment site to a collection canister during a fluid removal phase.

[0012] The control unit may include a pump configured to generate a set vacuum pressure at the treatment site and a valve configured to control vacuum relief. The pump may be configured to operate at a substantially constant voltage for a first time period and a substantially constant torque for a second time period to generate the set vacuum pressure. The method may further include generating an alert indicating a pressure leak via a leak alarm, the alert being determined in response to the control unit detecting that the vacuum pressure of the system is below a respective threshold. The fluid delivery phase, the soaking phase, and the fluid removal phase may be repeated sequentially for a period of time. The treatment solution may include a first treatment solution stored in a first fluid reservoir and a second treatment solution stored in a second fluid reservoir. The method may include generating a collection fluid canister fill alert indicating that the fill level of the collection fluid canister is above a fill threshold. The method may include generating an alert indicating that the weight of the fluid reservoir is below a minimum threshold before the fluid delivery phase. The method can include generating an alert indicating that a battery charge level of the control unit is below a minimum charge level adequate to power automatic transitions between treatment phases. The method can include detecting, by the control unit, missing or incorrectly coupled components of the treatment delivery system, generating an alert indicating incorrect assembly of the treatment delivery system, and preventing automatic transitions between treatment phases. The method can include generating an alert indicating excessive movement affecting weight sensor readings during fluid delivery.

[0013] In an interrelated aspect, provided is a non-transitory storage medium storing instructions that, when executed by at least one processor, cause the at least one processor to perform operations including controlling fluid flow of a treatment solution from a fluid reservoir to a treatment site through a fluid delivery line during a fluid delivery phase; activating a transition from the fluid delivery phase to a fluid immersion phase, during which the treatment solution is maintained at the treatment site; and controlling removal of the treatment solution from the treatment site to a collection canister during a fluid removal phase.

[0014] In a related aspect, provided is a kit for treating a localized infection in a human patient, including an irrigation and irrigation device configured to locally irrigate and irrigate a treatment site of the localized infection with at least one antibiotic and at least one dose of the at least one antibiotic. The irrigation and irrigation device includes a fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution, and a control unit configured to control the fluid delivery system according to a treatment process. The kit includes instructions for using the irrigation and irrigation device to administer the at least one dose of the at least one antibiotic to treat the localized infection. The treatment process locally administers a total amount of the at least one antibiotic that exceeds the maximum recommended daily systemic dose of the at least one antibiotic over a 24-hour period.

[0015] The at least one antibiotic can be vancomycin and / or tobramycin. The treatment process can locally administer a total amount of vancomycin that exceeds the maximum recommended daily systemic dose for vancomycin in a 24-hour period, or locally administer a total amount of tobramycin that exceeds the maximum recommended daily systemic dose for tobramycin in a 24-hour period. The first fluid reservoir can contain a first fluid containing vancomycin, and the second fluid reservoir can contain a second fluid containing tobramycin. The fluid delivery system can be configured to direct the first fluid from the first fluid reservoir to the treatment site and the second fluid from the second fluid reservoir to the treatment site. The treatment process can include multiple phases. A first phase of the multiple phases can be controlled delivery of the first fluid from the first fluid reservoir to the treatment site, and a second phase of the multiple phases can be controlled delivery of the second fluid from the second fluid reservoir to the treatment site. The control unit may automatically activate a transition from at least a first phase to a second phase of the plurality of phases.

[0016] The kit may further include a collection fluid canister configured to collect fluid removed from the treatment site. The irrigation and cleaning device may further include a first load cell configured to detect a combined weight of a first weight of the first fluid in the first fluid reservoir and a second weight of the second fluid in the second fluid reservoir. A control unit may process the combined weight and monitor the status of fluid delivery. The first load cell may be arranged in a vertical plane of the fluid delivery system and configured to be horizontally contacted by a cantilevered hanger component. The first fluid reservoir may be held by a mounting feature at a first end region of the cantilevered hanger component, and the first load cell may be contacted by a protrusion at a second end region of the cantilevered hanger component. The irrigation and cleaning device may further include a second load cell configured to detect a waste weight of the waste fluid canister and any waste within the canister. A control unit may process the waste weight and monitor the status of fluid removal. A second load cell may be arranged in the vertical plane of the system and configured to be contacted horizontally by a second cantilevered hanger component.

[0017] The fluid delivery system may further include a first pinch valve and a second pinch valve. The irrigation and flushing device may further include a first fluid delivery line and a second fluid delivery line. The first pinch valve may be configured to receive a first fluid delivery line fluidly connected to a first fluid reservoir, and the second pinch valve may be configured to receive a second fluid delivery line fluidly connected to a second fluid reservoir. The first pinch valve may be controlled by the control unit to be open during the first phase and to be closed during the second phase. The second pinch valve may be controlled by the control unit to be closed during the first phase and to be open during the second phase. The first pinch valve has a first inner dimension when in the open configuration, and the second pinch valve has a second inner dimension when in the open configuration. The first inner dimension may be smaller than the second inner dimension. The first fluid delivery line can have a smaller outer dimension than the second fluid delivery line, the smaller outer dimension being sized to be received within the first inner dimension of the first pinch valve. The second fluid delivery line can have an outer dimension that is prevented from being received within the first inner dimension of the first pinch valve.

[0018] The control unit can include a pump configured to generate a set vacuum pressure in the system and a valve configured to control vacuum relief. The pump can be powered off during at least a first phase. The pump can be configured to operate at a substantially constant voltage for a first period of time and at a substantially constant torque for a second period of time to generate the set vacuum pressure.

[0019] In a related implementation, a kit for managing localized pain in a human patient is provided, including at least one therapeutic agent, the therapeutic agent being an anesthetic or an analgesic, and an irrigation device configured to locally irrigate a treatment site for localized pain with at least one dose of the at least one therapeutic agent. The irrigation device includes a fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution, and a control unit configured to control the fluid delivery system according to a treatment process. The kit further includes instructions for administering the at least one dose of the at least one therapeutic agent using the irrigation device to treat the localized pain. The at least one therapeutic agent can be lidocaine. The irrigation device can be configured to locally administer a total amount of lidocaine equal to or exceeding the total daily dose allowed for systemic administration of lidocaine in a 24-hour period. The at least one therapeutic agent can be lidocaine and at least one antibacterial agent.

[0020] In a related implementation, a kit for administering localized antifungal therapy in a human patient is provided, the kit including at least one antifungal agent and an irrigation device configured to locally irrigate a treatment site for a localized fungal infection with at least one dose of the at least one antifungal agent. The irrigation device includes a fluid delivery system configured to connect to a fluid reservoir containing at least one dose in solution, and a control unit configured to control the fluid delivery system according to a treatment process. The kit further includes instructions for using the irrigation device to administer the at least one dose of the at least one antifungal agent to provide sustained localized antifungal therapy to the patient over at least a 24-hour period. The at least one antifungal agent can be fluconazole. The irrigation device can be configured to locally administer a total amount of fluconazole over a 24-hour period equal to or exceeding the total daily dose permitted for systemic administration of fluconazole. The kit can further include at least two antibacterial agents. The at least one antifungal agent can be fluconazole, and the at least two antibacterial agents are vancomycin and tobramycin.

[0021] Implementations of the present subject matter can include, but are not limited to, methods consistent with the description provided herein, as well as articles comprising tangibly embodied machine-readable media operable to cause one or more machines (e.g., computers, etc.) to perform operations that implement one or more of the described features. Similarly, computer systems are also described, which may include one or more processors and one or more memories coupled to the one or more processors. The memory may include a non-transitory computer-readable or machine-readable storage medium, which may include, encode, store, or the like, one or more programs that cause the one or more processors to perform one or more of the operations described herein. Computer-implemented methods consistent with one or more implementations of the present subject matter can be implemented by one or more data processors resident within a single computing system or multiple computing systems. Such multiple computing systems may be connected, for example, via one or more connections, including connections via a network (e.g., the Internet, a wireless wide area network, a local area network, a wide area network, a wired network, or the like), via a direct connection between one or more of the multiple computing systems, etc., and may exchange data and / or commands or other instructions or the like.

[0022] Details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims. While certain features of the presently disclosed subject matter are described for illustrative purposes in connection with a web application user interface, it should be readily understood that such features are not intended to be limiting. The claims following this disclosure are intended to define the scope of the protected subject matter. [Brief explanation of the drawings]

[0023] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate certain aspects of the subject matter disclosed herein and, together with the description, serve to explain some of the principles associated with the disclosed implementations as described below.

[0024] [Figure 1A] FIG. 1A shows an example of a therapeutic delivery system.

[0025] [Figure 1B] 1B-1D show detailed views of the therapeutic delivery system of FIG. 1A. [Figure 1C] 1B-1D show detailed views of the therapeutic delivery system of FIG. 1A. [Figure 1D] 1B-1D show detailed views of the therapeutic delivery system of FIG. 1A.

[0026] [Figure 2A] 2A-2F illustrate block diagrams of components of a therapy delivery system that perform distinct functions, according to some example implementations. [Figure 2B] 2A-2F illustrate block diagrams of components of a therapy delivery system that perform distinct functions, according to some example implementations. [Figure 2C] 2A-2F illustrate block diagrams of components of a therapy delivery system that perform distinct functions, according to some example implementations. [Figure 2D] 2A-2F illustrate block diagrams of components of a therapy delivery system that perform distinct functions, according to some example implementations. [Figure 2E] 2A-2F illustrate block diagrams of components of a therapy delivery system that perform distinct functions, according to some example implementations. [Figure 2F] 2A-2F illustrate block diagrams of components of a therapy delivery system that perform distinct functions, according to some example implementations.

[0027] [Figure 3A] 3A and 3B show exploded views of an example of a therapy delivery system, according to some example implementations. [Figure 3B] 3A and 3B show exploded views of an example of a therapy delivery system, according to some example implementations.

[0028] [Figure 4] FIG. 4 shows a schematic diagram of an example fluid delivery system of a therapy delivery system, according to some example implementations.

[0029] [Figure 5] 5A-5C show examples of user interfaces for controlling and monitoring processes performed by a therapy delivery system, according to some example implementations.

[0030] [Figure 6] FIG. 6 illustrates an example of a process performed by a therapy delivery system, according to some example implementations.

[0031] [Figure 7] FIG. 7 depicts an example of a parameter time-varying diagram corresponding to a process performed by a therapy delivery system, according to some example implementations.

[0032] [Figure 8] FIG. 8 illustrates a block diagram illustrating an example of a computing system, according to some example implementations.

[0033] Where practical, like reference numerals refer to like structures, features, or elements. DETAILED DESCRIPTION OF THE INVENTION

[0034] Detailed Description The disclosed subject matter relates to a therapy delivery system that can manage the delivery and removal of fluids to a treatment site. The therapy delivery system includes a control unit and can control a therapy process that includes the flow of multiple fluids during multiple phases. The therapy delivery system can deliver a first volume of a first fluid during a first phase, and after removing the first fluid, the therapy delivery system can deliver a second fluid during a second phase. The control unit can automatically activate the transition from one phase to another while verifying parameters corresponding to the individual phases to ensure correct functionality of the applied therapy and enable optimized therapy.

[0035] Among the advantages of the proposed solution described herein, the therapy delivery system described herein can execute a (24-hour) cycle of processes according to clinical protocols without user interaction. The therapy delivery system can seamlessly switch between different therapy phases and deliver set fluid volumes of selected fluid types stored in separate reservoirs according to clinical protocols. The therapy delivery system allows for monitoring of irrigation flushing performance with high accuracy.

[0036] The therapy delivery system can deliver irrigation irrigants, such as antibiotic irrigation irrigants, using precise fluid flow control driven by gravity (i.e., a fixed head height between the irrigation irrigant and the treatment site) and either active or residual vacuum assistance (i.e., the pump is turned on or off), a combination of discrete logic components integrated on a processor, load cells (weight sensors), pneumatic solenoid valves, and pinch valves. One load cell sensor in the therapy delivery system outputs a signal reflecting the combined fluid level / weight of the fluid reservoir (e.g., solution bag). Another load cell sensor in the therapy delivery system measures the weight of the canister and monitors the fluid being removed from the treatment site for potential blockages or a full waste collection canister. A control circuit monitors the differential weight (e.g., a change in fluid level) and opens or closes a pinch valve on the fluid delivery line to dispense a preset fluid volume. Another advantage of the proposed solution described herein is that the use of a load cell sensor allows for the identification of critical conditions (i.e., risk mitigation of potential therapy hazards). For example, the first load cell sensor can detect a rapid decrease in differential weight, indicating a leak in the reservoir and fluid delivery line connection, or can detect that the device is incorrectly assembled by not sensing weight, indicating that the user has forgotten to hang the fluid reservoir on the control unit or that the fluid reservoir is empty. The second load cell sensor can measure the weight of the canister and monitor fluid being removed from the treatment site for potential blockages or full canisters. This second load cell sensor can detect insufficient differential weight, indicating a fluid delivery blockage, an empty bag, kinked tubing, or other fluid delivery issues that can be identified by the treatment delivery system during fluid removal. The control unit can achieve a vacuum pressure (e.g., 0 mmHg to -125 mmHg, preferably about -25 mmHg) to assist the gravity-driven fluid delivery process. The pump does not need to be actively pumping during fluid delivery using this system. For example, the pump can be turned off and the residual vacuum, in combination with gravity due to the head height of the reservoir bag, can deliver fluid to the patient.However, it should be understood that the system can also be configured to achieve fluid delivery using active pumping, such that the pump remains active while fluid is being delivered to the treatment site. The control unit monitors load cell readings that are outside of acceptable tolerances, for example, due to movement of the system and / or solution bags or any excessive movement of the system that may affect the load cell readings and would compromise the accuracy of fluid delivery. Other advantages of the therapy delivery system are discussed with reference to Figures 1-8.

[0037] 1A-1D show an example of a therapy delivery system 100 that can provide controlled, localized delivery of fluid into a treatment site 102. Generally, the therapy delivery system 100 can include a (portable) disposable device to allow adjustment of the distance between the therapy delivery system 100 and a patient treatment site 102, such as a patient suffering from an infection treatable with localized fluid irrigation. The therapy delivery system can also be designed to be mounted on an accessory pole unit with a fixed distance between the therapy delivery system 100 and the patient treatment site 102 so that the head height remains consistent throughout the treatment. In the example illustrated in FIG. 1A, the therapy delivery system 100 provides irrigation to a treatment site 102 (e.g., a joint cavity or bone compartment) that includes an irrigation-able volume. The therapy delivery system 100 can include a fluid delivery system 104A, a fluid collection system 104B, and a control system 106. The fluid delivery system 104A can include one or more fluid reservoirs 108A, B that are held by corresponding mounting features 114A, B. The fluid collection system 104B can include one or more collection fluid canisters 109 that are held by corresponding mounting features 114B.

[0038] The control system 106 may include a vacuum pressure source (e.g., pump 226, described with reference to FIGS. 2D and 3A) configured to generate vacuum pressure within the treatment system such that a residual vacuum pressure, due to the head height of the reservoir 108, in combination with gravity, draws fluid from the fluid reservoir 108 through the fluid delivery lines 110A, 110B, 110C toward the treatment site 102. The vacuum pressure source is also configured to draw fluid through the vacuum lines 113A, 113B toward the fluid collection system 104B away from the treatment site 102. The control system 106 controls the fluid through the fluid delivery lines 110A, 110B, 110C and the vacuum lines 113A, 113B according to a treatment protocol. The treatment site 102 may include a connection mechanism 116, such as a sealable connection with a catheter and / or cannula, that conducts fluid transepidermally to an irrigation and cleansing device deployed within the area to be treated (e.g., infected tissue and / or infected joint, such as the hip, knee, shoulder, wrist, ankle, etc.). Although not shown, one or more other medical devices may assist, coordinate with, and / or operate in parallel with the treatment delivery system 100 to provide treatment for the patient (including the treatment site 102).

[0039] As a route of administration, irrigation refers to the administration of irrigant to a treatment site, such as an open wound or body cavity, by immersion or washing. Irrigation is bidirectional in that irrigant delivered to the treatment site is also removed from the treatment site via suction. Delivery of fluid to a treatment site may be referred to herein as instillation.

[0040] Some therapeutic agents, such as certain antibiotics, are generally administered systemically (e.g., intravenously), which carries a high risk of systemic toxicity. The use of repeated doses of antibiotics delivered via catheter to the periprosthetic tissue or joint cavity following aggressive dissection and one-stage prosthesis replacement as local instillation of antibiotics in solution for the treatment of periprosthetic joint infections (PJIs) has been reported. Local instillation is a one-way delivery of antibiotics to the treatment site, in which the instilled antibiotic is not aspirated or washed away from the treatment site. The instilled dose is therefore absorbed into the tissues and bloodstream, such that systemic toxicity considerations also limit the local dose and concentration that can be safely administered by instillation. Whiteside et al. reported that instillation of very high concentrations of vancomycin (50,000–100,000 μg / mL) into joint cavities once or twice daily resulted in serum concentrations exceeding safety limits in several patients, necessitating a reduction in the instilled dose and concentration (see Clin Orthop Relat Res (2011) 469:26–33). While peak and trough vancomycin concentrations in the joint cavity exceeded serum concentrations and persistently exceeded the minimum inhibitory concentration (MIC) of vancomycin for common vancomycin-susceptible bacterial species, sustained local concentrations were limited by exceeding safe systemic concentrations and were not maintained at or above the minimum biofilm eradication concentration (MBEC) of vancomycin for several common PJI bacterial species (greater than 4,000 μg / mL). Similarly, the maximum daily dose provided by this instillation method was 1,000 mg.

[0041] Described herein are systems for delivering one or more doses of at least one therapeutic agent as an irrigant (e.g., at least one therapeutic agent in solution) to a treatment site (e.g., periprosthetic tissue, a joint cavity, etc.) via irrigation (e.g., instillation and subsequent aspiration) to treat a condition at the treatment site (e.g., a localized bacterial or fungal infection or localized pain, etc.). The systems described herein can control treatment according to a treatment process. For example, the treatment process may locally administer a total amount of at least one therapeutic agent in a 24-hour period that equals or exceeds the maximum recommended daily systemic dose for that therapeutic agent. The total daily dosage of the therapeutic agent irrigant can substantially exceed the maximum recommended daily systemic dose of the therapeutic agent without the toxicity risks associated with systemic administration.

[0042] In some implementations, the antibiotic vancomycin can be administered locally as an irrigant using the systems described herein at a total dose of greater than 3,000 mg / day, e.g., greater than 3,000 mg / day, about 4,000 mg / day, about 5,000 mg / day, about 6,000 mg / day, about 7,000 mg / day, about 7,500 mg / day, or up to about 40,000 mg / day in a 24-hour period, to treat localized infections. As another example, the antibiotic tobramycin can be administered locally as an irrigant using the systems described herein at a total dose of greater than 100 mg / day, up to about 1,000 mg / day, or up to about 1,250 mg / day in a 24-hour period, to treat localized infections.

[0043] As another example, a treatment process may involve locally administering at least one therapeutic agent to treat a localized fungal infection, the therapeutic agent being an antifungal agent administered to locally irrigate the treatment site, providing the patient with sustained, localized antifungal therapy over at least a 24-hour period. The antifungal agent may be fluconazole, administered locally in a total amount equal to or exceeding the total daily dose permitted for systemic administration of fluconazole over a 24-hour period. The maximum recommended daily systemic dose for fluconazole is 400 mg / day. Fluconazole may be administered in combination with at least one antibacterial agent, such as vancomycin and / or tobramycin.

[0044] As another example, the treatment process may involve the local administration of at least one therapeutic agent, which is an anesthetic or analgesic, administered to locally irrigate the treatment site and treat localized pain. The anesthetic can be lidocaine, administered locally in a total amount equal to or exceeding the total daily amount allowed for systemic administration of lidocaine in a 24-hour period. The maximum recommended daily system dose for lidocaine is 300 mg / day. Lidocaine can be administered in combination with another therapeutic agent, such as at least one antibacterial agent, as described elsewhere herein.

[0045] The therapy delivery system 100 can be used to deliver therapy to any of a variety of treatment sites, such as an infected joint cavity. While a treatment site is referred to herein as a joint cavity or another site, it should be understood that the type of treatment site or biological tissue being treated by controlled fluid irrigation can vary, including periprosthetic tissue, joint cavities, bone compartments, and fractures of any number of bones, including bones of the hip, knee, shoulder, wrist, ankle, etc. Treatment sites can be traumatic wounds, infected tissue, surgical incisions, surgical sites, wound areas, including osteomyelitis, septic arthritis, breast implant infections, fracture-related infections, and / or infected joints. Examples of treatments include dissection, antibiotic administration, and periprosthetic joint infection treatment protocols, such as implant preservation (DAIR) and revision total joint arthroplasty. While the present application may be described in the context of a particular treatment site (e.g., an infected joint) and its connections to that site, it should be understood that other treatment sites are contemplated, and the manner in which the system connects to those various sites may also vary.

[0046] Although the therapeutic solution delivered using the systems described herein is described as an antibiotic, other fluids are contemplated as well, including any of a variety of irrigation and irrigation fluids, such as saline, including irrigation and irrigation fluids having one or more therapeutic capabilities containing any of a variety of antimicrobial agents, including antibiotics, antivirals, antifungals, antiparasitics, and the like. Examples of antibiotics include aminoglycosides, glycopeptides, cyclic lipopeptides, amikacin, cefazolin, cefepime, ampicillin, ciprofloxacin, azithromycin, doxycycline, clindamycin, vancomycin, tobramycin, gentamicin, daptomycin, and combinations thereof. The therapeutic solution delivered using the systems described herein may include an antifungal agent, either alone or in combination with an antibiotic or combination of antibiotics. Examples of antifungal agents include azole derivatives (e.g., fluconazole, isavuconazole, posaconazole), amphotericin B, echinocandins (e.g., anidulafungin, caspofungin, micafungin). Therapeutic solutions delivered using the systems described herein can include pain medications, alone or in combination with an antibiotic or combination of antibiotics. Examples of pain medications include opioids, analgesics, anesthetics, and the like. Several classes of anesthetics and analgesics are suitable for topical wound irrigation, including aminoamides (e.g., lidocaine, bupivacaine, levobupivacaine, mepivacaine, ropivacaine, prilocaine), aminoesters (e.g., benzocaine, chloroprocaine, procaine, tetracaine), NSAIDs (e.g., ketorolac, celecoxib, diclofenac, fenoprofen, indomethacin), and corticosteroids (e.g., prednisone, methylprednisolone, dexamethasone, triamcinolone, betamethasone, beclomethasone, flunisolide, fluticasone). Therapeutic solutions delivered using the systems described herein can include antibiotic combinations, e.g., tobramycin sulfate and vancomycin HCl, and anesthetic agents such as lidocaine.The fluid being delivered using the treatment systems described herein can include a combination of antibiotic and antifungal drugs, such as fluconazole.

[0047] Referring to the exemplary context of treating an infected joint, an exemplary treatment protocol may include localized delivery of a first fluid from a first fluid reservoir to the treatment site, removal of the first fluid reservoir from the treatment site after a set soak time corresponding to the first fluid soak period, localized delivery of a second fluid from a second fluid reservoir to the treatment site, and collection of the second fluid from the treatment site into a collection fluid canister after a set soak time corresponding to the second fluid soak period.

[0048] 1A-1D, the therapy delivery system 100 can be mounted to a support assembly 111. The support assembly 111 can include a pole 111A, a base 111B, a leg 111C including lockable wheels 111D, and a power cord 111E. In some implementations, the height of the pole is fixed to ensure proper flow rate and fluid delivery performance. The height of the pole can be adjustable to allow elevation optimization of the therapy delivery system 100, particularly the height of the fluid reservoirs 108A, 108B relative to the height of the treatment site 102, and to allow fluid flow from the fluid reservoirs 108A, 108B to the treatment site 102. Alternatively, the height of the pole can be fixed to ensure consistent performance of the therapy delivery system. The lockable wheels 111D of the support assembly 111 can be configured to allow the therapy delivery system 100 to be moved in a more convenient manner from one location to the next. For example, the lockable wheels 111D can be set such that, in a released mode, the therapy delivery system 100 can be displaced to adjust the location of the therapy delivery system 100 relative to the patient and to adjust the distance between the therapy delivery system 100 and the patient (e.g., the site to be treated). The lockable wheels 111D of the support assembly 111 can be configured to allow the therapy delivery system 100 to be fixed in a particular location (setting the lockable wheels 111D in a locked state and preventing movement). In some implementations, the pole can conduct a portion of the power cord to the therapy delivery system 100 to allow for (re)charging of a battery included in the control system 106. In some implementations, the system need not incorporate a support assembly with a pole, and may be fully portable for use across different treatment settings, such as with a user using a handle or other handheld feature on the system to carry the device.

[0049] 1A-1D, fluid delivery system 104A includes two or more fluid reservoirs 108A, 108B. Fluid delivery system 104A includes fluid delivery lines 110A, 110B (tubing), pinch valves 120A, 120B, spikes, connectors, and manual clamps. Fluid delivery lines 110A, 110B can be loaded into normally closed pinch valves 120A, 120B from control system 106, which can be controlled to open and allow flow of a set fluid type from fluid delivery lines 110A, 110B through fluid delivery line 110C.

[0050] Fluid delivery system 104A includes fluid delivery lines 110A, 110B (tubing) for directing fluid from selected fluid reservoirs 108A, 108B through fluid delivery line 110C to treatment site 102 during individual phases of treatment. Fluid delivery lines 110A, 110B, which transmit fluid from multiple fluid reservoirs 108A, 108B to treatment site 102, which may incorporate spacer 107, are loaded into control system 106 through entry port 112A, which, when properly attached to pinch valves 120A, 120B, can provide unobstructed access to fluid delivery lines 110A, 110B. Pinch valves 120A, 120B (best shown in FIGS. 1C and 1D) can be covered by openable doors 112B (shown in FIG. 1B).

[0051] The openable door 112B can be opened to allow access to the pinch valves 120A, 120B and to allow the fluid delivery lines 110A, 110B to be loaded into the pinch valves 120A, 120B. When closed, the openable door 112B allows the fluid delivery lines 110A, 110B to extend from outside the door 112B to the locations of the pinch valves 120A, 120B without interrupting flow through the fluid delivery lines 110A, 110B when the door 112B is hinged in a closed position. In some implementations, the openable door 112B does not close until the fluid delivery lines 110A, 110B are properly disposed within the pinch valves 120A, 120B. If the fluid delivery lines 110A, 110B are incorrectly loaded into the pinch valves 120A, 120B, closure of the door 112B is prevented. The fluid delivery system 104A can include at least two mechanical safety features: 1) the pinch valves 120A, 120B are sized to match the individual fluid delivery lines 110A, 110B so that a particular pinch valve 120A or 120B cannot receive a mismatched fluid delivery line 110B or 110A (and thus deliver the wrong fluid during a particular phase); and 2) the openable door 112B cannot be closed if not properly positioned.

[0052] The fluid delivery system 104A can include additional safety features. For example, the pinch valves 120A, 120B can include one or more features that ensure proper connection with the fluid delivery lines 110A, 110B. For example, the number of pinch valves 120A, 120B can match the number of fluid reservoirs 108A, 108B and the number of fluid delivery lines 110A, 110B. Each pinch valve 120A, 120B can have an identifier (e.g., color code, symbol marking, numeric identifier, bar code) in or near its entry port to enable proper matching of the fluid delivery lines 110A, 110B such that a first fluid delivery line 110A for fluid flow from a first fluid reservoir 108A is connected to the first pinch valve 120A and a second fluid delivery line 110B for fluid flow from a second fluid reservoir 108B is connected to the second pinch valve 120B. In some implementations, the vacuum lines 113A, 113B for directing fluid from fluid reservoirs 108A, 108B storing different types of fluids can have different geometries (circular cross-section, oval cross-section) and / or different sizes to match the geometries and sizes of the respective pinch valves 120A, 120B. 1A and 1B illustrate two pinch valves 120A, 120B connecting to vacuum lines 113A, 113B directing fluid from two fluid reservoirs 108A, 108B, therapy delivery system 100 can include more than two pinch valves 120A, 120B to allow controlled flow from more than two fluid reservoirs (e.g., two primary and two backup fluid reservoirs, or for controlled flow from more than two fluid reservoirs storing fluids with different compositions and concentrations). Further details about fluid delivery system 104A are described with reference to FIG.

[0053] The fluid delivery system 104A can deliver fluid to the treatment site 102 in a controlled manner using a control system 106. The control system 106 can generate a vacuum and induce negative pressure at the treatment site 102 to optimize, with precision, the gravity-assisted delivery of a particular fluid (e.g., cleaning fluid, antibacterial fluid, antibiotic irrigant, antifungal, or any other type of pharmacological fluid, including analgesics or local anesthetics) from a particular fluid reservoir 108A or 108B (e.g., solution bag) into the treatment site (e.g., periprosthetic space) 102 selectively and sequentially through fluid delivery lines 110A, 110B (e.g., fluid delivery lines) opened by individual pinch valves 120A, 120B. A desired set vacuum pressure within the system can be achieved prior to initiation of treatment solution delivery during a "pre-delivery cycle" using a pump or the like. When the vacuum pump is turned on, it can achieve and maintain a system vacuum pressure for fluid removal from the treatment site. The vacuum pump and relief valve can achieve a secondary vacuum pressure prior to fluid delivery before being turned off. The residual vacuum pressure maintained in the system, even after the pump is no longer running, is utilized during the delivery cycle, assisted by gravity-driven fluid delivery (i.e., reservoir head height), to draw treatment solution toward and / or remove fluid from the treatment site. For example, the pump can be turned on during the pre-delivery cycle, allowing vacuum pressure to be generated within the system to a desired set point. The pump can then be turned off, and the treatment site can be exposed to vacuum pressure within the system, causing fluid flow to and / or from the treatment site through the system. The head height of the source container, along with the residual vacuum maintained in the system, delivers and / or removes treatment solution to and from the treatment site. The head height of the source container can vary, but may be at least 12 inches above the patient wound dressing, assuming the patient is in a supine position. Delivery can be controlled by a control unit based on load cell readings and through activation of pinch valves, as opposed to the vacuum pump itself precisely controlling fluid flow and delivery to the patient.In other implementations, vacuum pressure can be actively maintained within the system during the delivery cycle.

[0054] Each fluid reservoir 108A, 108B has a specific volume and can store a specific fluid type to be delivered during a separate treatment phase. The first fluid reservoir 108A can store a first fluid, which can include an antibiotic such as tobramycin sulfate. The first fluid can be delivered from the first fluid reservoir 108A to the treatment site 102 according to a separate fluid delivery protocol that defines the volume of the first fluid to be delivered, the duration of the fluid delivery, and a pre-delivery vacuum, which can be performed at a set pressure (e.g., -125 mmHg) for a set vacuum time period (e.g., approximately 30 minutes). The volume of the first fluid to be delivered to the treatment site 102 can be set within a range of 6 mL to 500 mL, such as 50 mL. In some implementations, approximately 80 mg of tobramycin sulfate in 50 mL of 0.9% sodium chloride is delivered within approximately 30 to 60 seconds and allowed to soak for a total of two hours in a single 24-hour period. The delivery of the first fluid volume can be controlled with an accuracy of ± about 5 ml to 10 ml. In some implementations, the delivery of the first fluid is followed by a soaking protocol, allowing the treatment site 102 to be soaked in the delivered fluid. The duration of the first fluid soaking protocol can be 1 to 3 hours, such as about 2 hours. The first fluid can be removed from the treatment site 102 by the fluid collection system 104B before the second fluid is delivered to the treatment site 102. The duration of the first fluid removal from the treatment site 102 can be about 30 minutes.

[0055] The second fluid reservoir 108B can store a second fluid, which may include an antibiotic such as vancomycin hydrochloride. The volume of the second fluid to be delivered to the treatment site 102 over a time period can be set within a range of 500 mL to 1,500 mL, such as 1,200 mL. The total volume of the second fluid delivered can vary depending on the length of the time period and the total time for first fluid delivery, soaking, and removal. For example, in a 24-hour time period, if the first fluid delivery, soaking, and removal were 2 hours, the time period for second fluid delivery can be approximately 22 hours. In some implementations, 3,000 mg vancomycin hydrochloride in 1,200 mL of 0.9% sodium chloride is delivered in approximately 50 mL increments within approximately 30 to 60 seconds and allowed to soak for a total of approximately 30 minutes. The number of 50 mL deliveries can be approximately 20 to 23 times in a single 24-hour period, for a total volume of approximately 1,000 to 1,200 mL of the second fluid. The delivery of the second fluid volume can be controlled with an accuracy of approximately ±5 mL. The delivery of the second fluid is then followed by a soaking protocol, allowing the treatment site 102 to be soaked in the delivered fluid. The duration of the second fluid soaking protocol can be 15 to 45 minutes, such as approximately 30 minutes. The second fluid can be removed from the treatment site 102 by the fluid collection system 104B. The duration of the second fluid removal from the treatment site 102 can be approximately 30 minutes. In some implementations, multiple cycles of second fluid delivery, soaking, and removal are repeated before the first fluid is subsequently delivered to the treatment site 102. For example, the treatment protocol can be repeated over multiple days (e.g., 7 days), during which a first fluid can be delivered once and allowed to soak the treatment area 102, and after removal of the first fluid, multiple cycles of second fluid delivery, soaking, and removal can be repeated to complete the 24-hour treatment protocol. On day 1, for example, the treatment area 102 and system can be primed, and a vacuum can be established in the system, such as by a pump. Following a seal check and confirmation in the system, the first fluid can be delivered and allowed to soak as described above.After removal of the first fluid, a second fluid is delivered, allowed to soak, and then removed, and can be repeated multiple times (e.g., 20-23 times) for the remainder of the first day. At the start of the second day (e.g., 24 hours after initiation of treatment), the canister and / or one or more reservoir bags can be changed and sealed. A pre-treatment vacuum cycle can begin prior to initiation of first fluid delivery and soaking. After removal of the first fluid, a second fluid is delivered, allowed to soak, and then removed, and can be repeated multiple times (e.g., 20-23 times) for the remainder of the second day. This daily protocol can be repeated for periods of up to about 7 days, up to about 10 days, up to about 14 days, or for as long as treatment is desired.

[0056] The fluid collection system 104B may include vacuum lines 113A, 113B (tubing) to direct fluid from the treatment site 102 to the collection fluid canister 109. The control system 106 may generate a vacuum through vacuum line 113B within the collection fluid canister 109 to remove fluid from the treatment site 102 into the collection fluid canister 109 through vacuum line 113A. For example, a pump may be activated by the control system 106 to create a vacuum within at least the collection fluid canister 109. The collection fluid canister 109 may include a single-use canister with a known volume (e.g., 2,000 mL), such as, for example, a Bemis Mfg. 2000-cc Hi-Flow Canister - Model No. 494410. The collection fluid canister 109 collects antibiotic solution or other fluids (e.g., wound exudate) that accumulate during vacuum-induced evacuation of fluid from the treatment site 102. The collection fluid canister 109 can include a hydrophobic bacterial filter and an overfill float valve. The collection fluid canister 109 can include a single-use canister that can be replaced at set times (e.g., daily) between treatments and upon completion of treatment. A large-volume collection fluid canister 109 (e.g., approximately 2 L volume) may only need to be emptied following a full 24-hour cycle of a treatment protocol. The canister 109 material is preferably translucent or transparent to allow a user to assess the level of content within the canister 109 during use. The canister 109 material is also preferably capable of retaining vacuum at maximum vacuum levels without deformation or restricting flow.

[0057] The control system 106 can control irrigation (e.g., therapeutic fluid delivery and fluid removal) of multiple fluids (e.g., antibiotic solutions) according to a set protocol, including multiple phases, for delivery of a particular fluid type in a particular direction for a set time duration, as described with reference to Figures 6 and 7. The settings of the control system 106 can be predetermined for a particular treatment type (e.g., administration of vancomycin and tobramycin during a two-stage revision total joint arthroplasty procedure) according to one or more patient and / or treatment site characteristics (e.g., treated volume, treated location, wound type, geometry, size). In other words, the set protocol of the control system 106 for controlling fluid delivery to the patient can be preprogrammed at the time of manufacture and does not need to be programmed by the user at the time of use. A single actuation of a button on the system to initiate a treatment, for example, can be sufficient to initiate the set protocol, which, in the case of multiple treatment solutions, seamlessly switches between fluid sources (e.g., antibiotic solution bags) as the set protocol cycles through the sequential delivery and removal of the treatment solutions. In some implementations, the settings of the control system can be updated by the user (eg, number of fluid solutions to be administered to the patient, treatment option A, B, or C, etc.).

[0058] The control system 106 can enable removable attachment of multiple fluid reservoirs 108A, 108B, which can be attached to or supported by attachment features (e.g., hangers) 114A of the therapy delivery system 100. The control system 106 can enable removable attachment of a collection fluid canister 109, which can be attached to or supported by attachment features (e.g., rings) 114B of the therapy delivery system 100. The attachment features 114A, 114B can be configured to match the geometry and / or shape of at least a portion of the fluid reservoirs 108A, 108B and the collection fluid canister 109, respectively, for secured, removable attachment, ensuring that the fluid reservoirs 108A, 108B and the collection fluid canister 109 are secured in place, even during displacement (position adjustment) of the therapy delivery system 100.

[0059] The control system 106 can maintain a vacuum pressure level (e.g., −125 mmHg + / −10% or −112.5 mmHg to 137.5 mmHg) at specific intermittent periods corresponding to distinct treatment phases, deliver fluid to the treatment site 102, allow fluid to bathe the treatment site, and remove fluid from the treatment site 102 into a collection fluid canister 109. The control system 106 can control fluid flow and vacuum pressure through the use of discrete logic components, processors / firmware, pressure sensors, solenoid pinch valves, vacuum pumps, and pneumatic solenoid valves 228, as described in detail with reference to FIGS. 2A-2F . As illustrated in FIG. 1B , the control system 106 can include a user interface 118. The user interface 118 can receive user input to initiate a predetermined treatment cycle. In some implementations, the user interface 118 can receive user input for an authorized user to select a treatment type and treatment initiation. In some implementations, the user interface 118 can receive a single user input to initiate therapy. The user interface 118 can be configured to include security features to prevent unauthorized users from adjusting therapy modes or device settings. In some implementations, the user interface 118 can be configured to generate an alert in response to the control system 106 detecting that one or more detected parameters are outside of set thresholds to assist the user in ensuring correct therapy execution. Further details regarding alarms generated by the user interface 118 are described with reference to FIGS. 5 and 6.

[0060] Fluid can be delivered to and removed from the treatment site 102 through the connection mechanism 116. The connection mechanism 116 can include one or more fluid connection ports to allow attachment of a fluid delivery line 110C for delivery to the treatment site 102 and a vacuum line 113A for collection of fluid from the treatment site 102, allowing for irrigation of the treatment site 102 during corresponding treatment phases. In some implementations, the connection mechanism 116 can include a medical device acting as a delivery component, such as an intramedullary stem, spacer, and / or any of various components configured to distribute a therapeutic solution within the treatment site 102, including the joint space and the surrounding intramedullary canal. The delivery component can distribute the therapeutic solution using pressure, such as a constant pressure or a controlled pulsatile pressure, such as pulsed lavage delivery.

[0061] 2A illustrates an example block diagram 200A of a therapy delivery system 100 and illustrates connections between several components of the therapy delivery system 100, as described with reference to FIGS. 1A-1D. The control system 106 can control fluid flow from fluid reservoirs 108A, 108B to the control system 106 through fluid delivery lines 110A, 110B and from the control system 106 to the treatment site 102 through fluid delivery line 110C. The fluid delivery lines 110A, 110B can be routed through their respective pinch valves 120A, 120B of the control system 106 to provide fluid connection between the fluid reservoirs 108A, 108B and the control system 106.

[0062] The control system 106 can control fluid removal from the treatment site 102 to the collection fluid canister 109 through vacuum lines 113A, 113B. As shown in FIG. 2A , the control system 106 is connected to the fluid reservoirs 108A, 108B through fluid delivery lines 110A, 110B and to the collection fluid canister 109 through vacuum line 113B (for fluid delivery). The control system 106 is also connected directly to the fluid reservoirs 108A, 108B through mounting feature 114A and directly to the collection fluid canister 109 through mounting feature 114B (to monitor the weight of the fluid reservoirs 108A, 108B and collection fluid canister 109, respectively, throughout treatment to allow verification of treatment progress). In some implementations, the control system 106 can include a pressure sensor to monitor pressure through one or more of the fluid delivery lines 110A, 110B, 110C and one or more of the vacuum lines 113A, 113B. The pressure sensor, which can be located within the control unit on a PCB, can also be fluidly connected to the treatment site. The pressure sensor can measure the pressure of a closed system, which includes the treatment site, based on its fluid communication with the treatment site. The pressure sensor can be configured to generate a control signal that can be used by the control system 106 to regulate fluid flow to or from the treatment site 102.

[0063] The collection fluid canister 109 can include a designated inlet (patient) port 119 that is fluidly connected to the bandage kit 202 and one designated outlet (vacuum) port 121 that is fluidly connected to the control system 106. The ports 119, 121 of the collection fluid canister 109 can include fitted caps that can be used to close the ports when they are not in use (e.g., for disposal of the collection fluid canister 109). In some implementations, the ports can be customized to mate only with vacuum line tubing connectors or control unit line tubing connectors to ensure proper assembly of the system.

[0064] The bandaging kit 202 can be fluidly connected to both the collection fluid canister 109 and the treatment site 102. The bandaging kit 202 can include a sterile single-use kit including an adhesive film drape, high tensile strength foam, and tubing for fluid connection with the collection fluid canister 109 that is attached to the control system 106. For example, the bandaging kit 202 can be configured to allow the control system 106 to remove fluid from the treatment site and discard it through the bandaging kit 202 into the collection fluid canister 109 by application of a vacuum. For example, the canister 109 can simply be a canister, or a pump 226 can be activated and a vacuum can be generated within the canister 109 via a vacuum line 113B that is coupled to port 121. The vacuum within the canister 109 can be applied to the treatment site 102 via a vacuum line 113A coupled to a port 119 on a first end and a bandaging kit 202 at a second end. The bandaging kit 202 can include a commercial bandaging kit adapted for negative pressure wound therapy to aid and promote healing of the treatment site 102.

[0065] The treatment site 102 can include a connection mechanism 116, such as a catheter and / or cannula, that conducts fluid transepidermally to an irrigation and flushing device deployed within the area to be treated (e.g., infected tissue and / or infected joint, such as the hip, knee, shoulder, wrist, ankle, etc.). In some implementations, the intra-articular end of the intramedullary stem can have a variable diameter and fit within a standard coupler receptacle of the connection mechanism 116. The connection component or spacer coupler of the connection mechanism 116 can include two parts: one that connects to the fluid delivery line 110 and the other that connects to the dressing kit 202. Accessories 204, such as paste, gauze, alcohol swabs, and the like, that aid in the application of the dressing kit 202 to the patient can be provided with the system to improve the seal reliability of the dressing kit 202.

[0066] 2B illustrates an example block diagram 200B of some of the components of the control system 106. The example block diagram 200B of the control system 106 includes at least one load cell 206, a filter 208, a load cell controller 210, a microcontroller (MCU) 212, a filter 214, and at least one pinch valve 120A, 120B. If the system is used to deliver more than one treatment solution, more than one pinch valve can be incorporated. A first pinch valve 120A can be engaged and configured to control the delivery of a first treatment solution through the first delivery line 110A, and a second pinch valve 120B can be engaged and configured to control the delivery of a second treatment solution through the second delivery line 110B. The pinch valves 120A, 120B can selectively control the delivery of the individual treatment solutions toward the treatment site. The system also preferably includes two load cells, a first load cell 206A configured to engage components on the fluid delivery side of the system (see FIG. 2C) and a second load cell 206B configured to engage components on the waste removal side of the system (see FIG. 2F), which are described in further detail herein.

[0067] The load cell 206 can be a weight sensor configured to measure the weight of a component acting on the load cell 206. For example, the load cell 206 can include a strain gauge arranged to abut against the load cell 206 to monitor the mechanical load of a fluid reservoir containing a treatment solution. The strain gauge can be electronically connected to a sensor and capable of measuring the force acting on the load cell 206. The sensor of the load cell 206 can output a signal that reflects the fluid level / weight of the corresponding fluid reservoir. The load cell 206 is described in further detail below with respect to FIGS. 3A and 3B.

[0068] The filter 208 may include a bandpass filter with a frequency corresponding to the measurement frequency of the load cell, allowing noise removal from the load cell output signal that reflects the fluid level such that the transmitted fluid level decreases or increases linearly during normal (non-spill and non-blocking) operation of the treatment system.

[0069] The load cell controller 210 can control the load cell signal detection and filter frequency. For example, to extend battery life, the load cell can operate at a 1-5 second duty cycle. The duty cycle can be adjusted to increase the frequency of data collection during treatment, or even extend battery life.

[0070] The microcontroller (MCU) 212 can host software that provides the logic, which defines system functionality during therapy. The MCU 212 can include control circuitry configured to monitor differential weight (e.g., fluid level changes). The weight can be used as an input by the MCU 212 to control transitions from one phase of therapy to another (e.g., by closing a pinch valve and opening another pinch valve), determine whether a vacuum interruption exists, and / or determine whether the fluid reservoirs 108A, 108B are empty. The MCU 212 can, in turn, be connected to the load cell controller 210. The MCU 212 can include a filter 214. The filter 214 can include a soft filter configured to provide signal noise reduction using knowledge obtained from a preset fluid level fluctuation protocol corresponding to a particular therapy type.

[0071] The pinch valves 120A, 120B can be configured to open and close individual fluid delivery lines, thereby controlling the delivery of set volumes of particular fluids during particular phases of treatment. For example, one pinch valve 120A, 120B can be controlled by a digital output generated by the MCU 212 to open and allow a particular fluid to flow to the treatment site for a set period of time during a particular phase of treatment, after which the pinch valve 120A, 120B can be controlled by a digital output generated by the MCU 212 to close, and another pinch valve 120A, 120B can be controlled by a digital output generated by the MCU 212 to open and allow a different fluid to flow to the treatment site during a different phase of treatment.

[0072] 2C illustrates an example block diagram 200C of the control system 106, illustrating connections between several components of the control system 106, as described with reference to FIGS. 1A and 1B, for monitoring fluid delivery during different phases of treatment. The example block diagram 200C of the control system 106 illustrates monitoring of the fluid delivery system 104A and the fluid collection system 104B. The example block diagram 200C of the control system 106 includes a load cell 206A, a filter 208, a load cell controller 210, an MCU 212, and a soft filter 214, as described with reference to FIG. 2B.

[0073] 2D and 2E illustrate block diagrams 200D and 200E of an example of controlling a fluid delivery and fluid removal system during treatment using control system 106. The fluid control example illustrated in FIG. 2D includes a pressure sensor 218, a filter 220, an analog-to-digital converter (ADC) 222, an MCU 212, a pulse width modulator 224, and a pump 226.

[0074] The pressure sensor 218 can be configured to send a control signal to the MCU 212 of the control unit (e.g., the control system 106 described with reference to FIGS. 1A-1D ) to adjust the pressure at the treatment site 102 through the bandaging kit 202. The pressure sensor 218 can be included within the control unit and monitor the pressure of the vacuum-assisted fluid delivery to the treatment site 102 and the fluid removed during the fluid removal phase of the treatment. The pressure sensor 218 can be configured to generate an output, which can be filtered by a filter 220, that includes a pressure signal. The filtered analog pressure signal can be converted to a digital signal by an ADC 222. The ADC 222 can send a control signal to the MCU 212 of the control unit to adjust the fluid flow by modifying pump settings.

[0075] The MCU 212 can be configured to control the vacuum level delivery during fluid removal. For example, the MCU 212 can be configured to adjust the vacuum level to vary the flow rate of the collected fluid by controlling the pump 226 based on a signal received from the pressure sensor 218. In some implementations, the control signal generated by the MCU 212 can be formatted by the pulse width modulator 224 into discrete portions with set pulse widths to effectively control the pump 226.

[0076] The pump 226 can be configured to apply vacuum pressure onto the treatment site, draw fluid into the treatment site, and remove waste fluid from the treatment site during a fluid removal phase of treatment. The pump 226 can include an electronically controlled peristaltic pump, a Venturi pump, a centrifugal pump, a diaphragm vacuum pump, or any other type of suitable pump. The pump can be a reusable durable pump. Alternatively, the pump 226, along with one or more other components of the system, can be disposable. The entire control system 106 can be completely disposable and can become inoperable after a period of sustained use (e.g., 15 days).

[0077] The pump 226 can be configured to function at a predetermined set point (e.g., a set pressure) that defines the volumetric flow rate of fluid being removed. The pump 226 can be configured to operate according to multiple settings. For example, at start-up, the pump 226 can run at a constant voltage (which effectively corresponds to a constant speed). For example, the MCU 212 can monitor the voltage and turn the pump 226 on or off based on a fixed voltage threshold. As the pressure (detected by the pressure sensor 218 in the fluid delivery line or fluid collection line) increases and reaches a pressure threshold, the MCU 212 can trigger the pump 226 to run at a constant torque. The constant torque phase of the pump 226 is defined by a constant current and can slowly approach stall as the pressure detected by the pressure sensor 218 approaches a maximum absolute pressure (e.g., 125 mmHg). The selected current set point of the pump 226 can be adjusted to reduce pump noise at a set speed.

[0078] 2E includes a pressure sensor 218, a filter 220, an analog-to-digital converter (ADC) 222, an MCU 212, a pulse-width modulator 224, and a valve 228. The valve 228 can include a pneumatic valve (e.g., a check valve) and a (three-way universal) pneumatic solenoid valve. The valve 228 can control the vacuum pressure response in response to a digital signal generated by the MCU 212 in response to processing the pressure detected by the pressure sensor 218. For example, the valve 228, including a pneumatic solenoid valve, can serve to relieve vacuum pressure (e.g., vent to atmosphere) as needed during removal of fluid from the treatment site.

[0079] 2F illustrates a block diagram 200F of an exemplary system for monitoring a collection fluid canister and illustrates connections between several components of the fluid delivery system 104, as described with reference to FIGS. 1A and 1B. The exemplary system for monitoring a collection fluid canister 109 includes a load cell 206B, a filter 232, a load cell controller 210, and an MCU 212. As will be described in more detail below, the load cell 206B is configured to be contacted by a portion of a component that supports the weight of the fluid collection canister 109.

[0080] Load cell 206B (similar to load cell 206A described with reference to FIGS. 2B and 2C) can generate an output signal reflecting the fluid level / weight of collection fluid canister 109, which stores the fluid being removed. Filter 232 (similar to filter 208 described with reference to FIGS. 2B and 2C) can be configured to remove noise from the output signal of load cell 206B. Load cell controller 234 (similar to load cell controller 210 described with reference to FIGS. 2B and 2C) can control the load cell signal detection and filter frequency. MCU 212 can host software that provides the logic defining the monitoring of the fill level of the collection fluid canister during fluid removal from the treatment site. MCU 212 can include control circuitry configured to monitor differential weight (e.g., changes in fluid level). MCU 212, in turn, can be connected to load cell controller 210. The therapy delivery system can include a unique load cell and a unique load cell controller on each "side" of the system, including a fluid delivery side and a fluid removal side.

[0081] 3A and 3B show exploded views 300A, 300B of an example of a therapy delivery system 100 according to some exemplary implementations. Figures 3A and 3B illustrate components of therapy delivery system 100, as described with reference to Figures 1A and 1B, relative to their assembled position. The housing 302 of therapy delivery system 100 can include multiple sections, such as side housing sections 302A, 302B, a top section 302C, and a bottom section 302D. The housing 302 of therapy delivery system 100 can be configured to support mounting features 114A, 114B, which allow for attachment of a fluid reservoir.

[0082] Each side housing portion 302A, 302B may include an opening 302E that is dimensioned to receive the respective post 304A, 304B of the load cell 206A, 206B (see FIGS. 3A-3B). A first opening 302E extends through the side housing portion 302A to receive the post 304A of the load cell 206A. A second opening 302E extends through the side housing portion 302B to receive the post 304B of the load cell 206B. The posts 304A, 304B are, in this implementation, aligned vertically or in the vertical plane of the system so that forces can be applied to the posts 304A, 304B by the protrusions 124A, 124B horizontally or in the horizontal plane to the load cells 206A, 206B, as will be described in further detail below.

[0083] 3A-3B, the fluid reservoirs 108A, 108B can be held by an attachment feature 114A on the fluid delivery side of the system, and the fluid collection canister 109 can be held by a separate attachment feature 114B on the waste collection side of the system. The attachment feature 114A on the fluid delivery side can have any of a variety of shapes, such as a hook, a ring, or other feature. Preferably, the attachment feature 114A is a hook configured to suspend one or more fluid reservoirs 108A, 108B, similar to a hook for an IV bag system. Thus, the fluid reservoirs 108A, 108B can each be a flexible bag having a corresponding attachment at an upper end configured to be received by the attachment feature 114A. The attachment feature 114A can be configured to hold more than one fluid reservoir, for example, at least a 50 mL solution container and a 1,200 mL solution container. The canister 109 can be a container having a cylindrical shape, and the mounting feature 114B can be a ring sized to receive the outer dimensions of the cylinder. The mounting feature 114B can be configured to hold a container sized to contain at least 2,000 mL. For example, the inner diameter of the upper end of the mounting feature 114B can be at least approximately 6 inches to rest against the edge of the canister 109 and prevent the canister 109 from sliding through the inner diameter of the mounting feature 114B. The mounting features 114A, 114B can each protrude a distance away from the centrally located control system 106 such that their respective containers can hang freely in a vertical orientation relative to the mounting features 114A, 114B without contacting any other part of the system.

[0084] The mounting features 114A, 114B can be at end regions of respective protruding hanger beams 122A, 122B. The hanger beams 122A, 122B can each have a protrusion 124A, 124B on an end opposite the mounting feature 114A, 114B. The protrusions 124A, 124B are arranged to engage the load cells 206A, 206B. For example, as the weight of the fluid reservoirs 108A, 108B, hanging from the mounting feature 114A, urges the mounting feature 114A downward, the protrusion 124A of the hanger beam 122A is urged horizontally against the post 304A of the load cell 206A. Similarly, as the weight of the fluid collection canister 109, resting within the ring of the mounting feature 114B, urges the mounting feature 114B downward, the protrusion 124B of the hanger beam 122B urges horizontally against the post 304B of the load cell 206B. The load cells 206A, 206B can have a vertical orientation or be positioned in the vertical plane of the system so as to be vertically contacted by the protrusions 124A, 124B of the respective hanger beams 122A, 122B, respectively, creating a cantilever engagement. The cantilever engagement between each of the mounting features 114A, 114B and their respective load cells 206A, 206B is such that the hanger beams 122A, 122B pivot and a force (generated by the weight of the fluid reservoir and fluid collection canister) is applied vertically to the respective mounting features 114A, 114B of the hanger beams 122A, 122B such that each of the load cells 206A, 206B is engaged horizontally by the protrusions 124A, 124B of the hanger beams 122A, 122B.

[0085] The configuration of the load cells 206A, 206B relative to their respective bags / canisters can vary, as can the axial orientation of the reported forces. The orientation can be as described above, where the load cells 206A, 206B are in a vertical plane and the force applied to them is in a horizontal plane. The load cells 206A, 206B can also be in a horizontal plane and the force applied to them is in a vertical plane. The load cells 206A, 206B may be positioned above their respective bags / canisters and measure the weight of the bag / canister due to the applied tension, or may be positioned below their respective bags / canisters and measure the weight of the bag / canister due to the applied compression.

[0086] The interior of the therapy delivery system can include a battery 306 (e.g., a rechargeable battery) to power the electronic components and electrical connections 308. The interior of the therapy delivery system is designed to mate with a pump enclosure 310 configured to provide noise reduction during operation of the pump 226. One or more valves, such as a pneumatic solenoid valve 228, configured to regulate pressure during a corresponding therapy phase can be located inside the housing 302A, as shown in the enlarged section of FIG. 3B, and a pressure sensor 218 can be located inside the housing 302A and coupled to the control system 106 to regulate fluid flow to or from the therapy site.

[0087] 4 shows a schematic diagram 400 of fluid delivery system 104A including fluid delivery lines 110A, 110B, 110C, vacuum line 113A connectors 402A, 402B, cap 404, clamp 406, fluid delivery line connector 408, and fluid delivery line and latches 412A, 412B. Connectors 402A, 402B may include spike / barb connectors. Connectors 402A, 402B may include different sized fittings for connecting to fluid delivery lines with different diameters. For example, spike / barb connector 402A may fit 1 / 16 inch inner diameter silicone tubing or equivalent, and spike / barb connector 402B may fit 1 / 8 inch inner diameter silicone tubing or equivalent. Cap 404 may include a spike cap. Fluid delivery lines 110A, 110B and vacuum lines 113A, 113B can include tubing of different sizes. For example, fluid delivery line 110A can include tubing having a 1 / 16 inch inner diameter and a 1 / 8 inch outer diameter. Fluid delivery line 110B can include tubing having a 1 / 8 inch inner diameter and a 1 / 4 inch outer diameter. Multi-fluid delivery line connector 408 can include a Y-connector. Multi-fluid delivery line connector 408 can include 1 / 16 inch barbs, 1 / 8 inch barbs, and a 3 / 16 inch tubing port. Fluid delivery line 110C can include tubing of different sizes. For example, fluid delivery line 110C can include tubing having a 3 / 32 inch inner diameter, a 3 / 16 inch outer diameter, and a length of 72 inches. Vacuum line 113A can include tubing having a 3 / 32 inch inner diameter, a 3 / 16 inch outer diameter, and a length of 36 inches. Clamp 406 can be released by the user once the system is assembled and properly set up for treatment. Lock 412A can include a male luer lock. Lock 412A can include a tubing port fitting 3 / 16 OD tubing. Lock 412B can include a female luer lock. Lock 412B can include a tubing port fitting 3 / 16 OD tubing.

[0088] As discussed above, the system can include two normally closed pinch valves 120A, 120B that open for fluid delivery to the treatment site 102 and are activated to return to closed when fluid delivery is stopped. The first pinch valve 120A is sized to receive the outer diameter of the first fluid delivery line 110A when in the open configuration, and the second pinch valve 120B is sized to receive the outer diameter of the second fluid delivery line 110B when in the open configuration. The inner dimensions of the pinch valve 120A can be sized differently from the inner dimensions of the pinch valve 120B when in the open configuration. Similarly, the outer diameter of the first fluid delivery line 110A can be different from the outer diameter of the second fluid delivery line 110B. This arrangement assists the user during placement of the fluid delivery lines into their respective pinch valves. As an example, fluid delivery line 110A can have an outer diameter of 1 / 8 inch, and fluid delivery line 110B can have a larger outer diameter of approximately 1 / 4 inch. Pinch valve 120A can be sized smaller than the inner dimensions of pinch valve 120B and configured to receive an outer diameter of a fluid delivery line that is approximately 1 / 8 inch or less, such that fluid delivery line 110B cannot be practically disposed within pinch valve 120A. Pinch valves 120A, 120B can incorporate mechanisms positioned therein that are configured to pinch-close the fluid delivery line, and mechanisms for unclipsing or opening the valves while the fluid delivery line is still loaded or attached. Thus, even when pinch valves 120A, 120B are in an open configuration and not actively pinching-close the fluid delivery line, the fluid delivery line can be affixed within the inner dimensions of their respective pinch valves 120A, 120B. The first fluid reservoir 108A can contain a first fluid (antibiotic) connected to a first fluid delivery line 110A, which is sized to engage with the first pinch valve 120A during a first treatment phase.The second fluid reservoir 108B can contain a second fluid (antibiotic) that is different from the first fluid and is connected to the second fluid delivery line 110B, which is sized to engage the second pinch valve 120B during the second treatment phase so that the first and second fluids can be delivered sequentially without mixing within the fluid delivery line 110C, which directs the fluids to the treatment site 102. Each valve can be controlled to either open, allowing flow through the respective fluid delivery line, or pinch closed to prevent flow through the fluid delivery line. The first pinch valve 120A can be opened while the second pinch valve 120B is closed, allowing flow only through the fluid delivery line 110A. The first pinch valve 120A can be closed while the second pinch valve 120B is opened, allowing flow only through the fluid delivery line 110B.

[0089] 5A-C show examples of different displays 500A, 500B, 500C on the graphical user interface 118 for controlling and monitoring processes performed by the therapy delivery system 100, according to some exemplary implementations. The example graphical user interface displays 500A, 500B, 500C correspond to predetermined settings of the control unit control system 106, described with reference to FIGS. 1A-1D and 2A-2F, and can facilitate automated and controlled therapy delivery. The graphical user interface 118 can include different outputs and inputs, such as buttons, to manage automated and controlled therapy delivery. While the term "button" is used, it should be understood that alternative inputs are also contemplated, including sliders, dials, switches, keyboards, or other inputs, including touchscreen virtual buttons.

[0090] FIG. 5A illustrates an example of a graphical user interface with an initial display 500A that allows for receiving user input related to treatment selection and initiation. The example graphical user interface with the initial display 500A includes a power button 502, a battery charge level indicator 504, an alert sound mode indicator 506, a treatment mode 508, a start button 510, a stop button 512, a mute button, and a skip button 514. In response to receiving user input to power off the control system 106, the power button 502 is held, and then a vacuum is generated to remove any fluid that may be left within the treatment site. The treatment mode 508 can include multiple phases 508A, 508B, 508C that can be displayed in the order of scheduled execution. The battery charge level indicator 504 can have an icon (e.g., a schematic battery) that is colored or shaded over time. In some implementations, the battery indicator is green when the battery is full, flashing green when the battery is charging, and red when the battery is low (e.g., <20% capacity). The amount of color or shading of the shape (e.g., full) can be proportional to the battery charge level. For example, when the battery is full, the entire battery charge level indicator 504 may be filled in. As the battery charge level decreases, the amount of filling decreases. When the battery charge level decreases below an acceptable limit, the battery charge level indicator 504 can include a visual alert of very low battery life. The battery charge level visual alert can include a periodic flashing of a light and a change in the display color of the battery icon from green to red.

[0091] 5B illustrates an example of a graphical user interface display 500B that provides alerts that allow a user to modify at least a portion of a therapy delivery system (e.g., therapy delivery system 100 described with reference to FIGS. 1A and 1B) to ensure correct delivery of therapy. The example graphical user interface 500B includes a battery charge level indicator 504, a start button 510, a stop button 512, a skip button 514, an alert icon 516, a mute button, and a display 518 for providing text alerts. The alert icon 516 can include visual indicators, such as the application of a static or flashing color or highlight, that can be modified to indicate when the value of the pressure, the volume of fluid stored in the reservoir, and / or the flow rate is outside of a set range.

[0092] 5B, a leak alarm is indicated on display 518. A leak alarm can be indicated by an alert icon 516 and / or a text alert indicator provided on display 518 if the system is not reaching the target vacuum pressure setting and a significant vacuum pressure leak is detected within the system. Alert icon 516 may include a flashing red highlight to indicate that a leak has been detected, and display 518 can provide instructions for the user to correct the detected error that triggered the alert. As another example, alert icon 516 and display 518 can display an alert if a fluid reservoir (e.g., an antibiotic solution bag) does not have a weight within a set range (e.g., not installed or empty) or if a collection fluid canister does not have a weight within a set range (e.g., not installed or full). As another example, the alert icon 516 and display 518 may display an alert if the battery charge level falls below a set threshold, a vacuum interruption is detected by a pressure sensor, one or more parts of the therapy delivery system are incorrectly assembled, and / or movement of the system (i.e., the control unit device) exceeds a set threshold during the fluid delivery phase.

[0093] 5C illustrates an example of a graphical user interface display 500C that provides updates related to the progress of a treatment. The example graphical user interface 500C includes a battery charge level indicator 504, a start button 510, a stop button 512, a skip button 514, and a display 518 for providing text alerts. The display 518 can include text describing the phase or mode of treatment (e.g., "Vacuum in progress"). The display 518 can indicate the phase of treatment being performed by the system that matches a highlight that is added to the display of treatment phases 508A, 508B, 508C.

[0094] The buttons or inputs of the graphical user interface can vary, and the above are only examples of some combinations of inputs. In some implementations, the user interface can include a power button, a mute button, a start button, a stop button, and a skip button. The power button can be used to power on and off the control unit of the system. As an example, the power button can be pressed once for a relatively short period of time to turn on the control unit, and the power button can be pressed and held for a longer period of time to turn off the control unit. The mute button can be used to temporarily or permanently silence the alerts and / or alarms of the system. For example, the mute button can temporarily mute an audible indicator associated with an active alarm, such as a medium priority alarm, but will resume or turn back on if the condition persists, even if muted. The mute button can silence an alarm for a reasonable period of time, such as 30 minutes, if the condition remains active after the user presses the mute button. The start button can be used to initiate a therapy process. The Start button is used to initiate therapy and, after resolving the issue, can be used to deactivate alarms and continue a therapy that has already begun. The Skip button can be used in combination with the Start button to select the desired therapy process. The Skip button can be used to scroll through different processes, and the Start button can be used to select the desired process. For example, the day of therapy can be selected using the Start and Skip buttons. The first cycle is initiated, Day 0, to initiate a seal verification test for proper assembly. Subsequent cycles are initiated, Days 1-6, to initiate a pre-treatment vacuum cycle if properly assembled. The Skip button can also be used to skip certain phases of a cycle, such as the tobramycin soak cycle. The Stop button can be used to end the therapy process.The system need not include a stop button on the user interface, but instead may include a reset button, which may cause the control unit to return to a home screen, such as a therapy start screen.

[0095] FIG. 6 depicts a flowchart illustrating an example of a process 600 performed by a therapy delivery system (e.g., therapy delivery system 100 described with reference to FIGS. 1A-1D, 2A-2F, 3A, and 3B) according to some exemplary implementations. The exemplary process 600 can include local irrigation for the treatment of chronic periprosthetic joint infection in a skeletally mature patient undergoing a two-stage revision arthroplasty procedure, in which multiple (antibiotic) fluids (e.g., vancomycin HCl and tobramycin sulfate) are delivered during separate phases of treatment of the infection. For example, during the first phase of treatment, the infected prosthesis can be surgically removed and dissected, and a temporary spacer can be implanted. A combination therapy can be administered via the temporary spacer over a seven-day cycle, alternating tobramycin and vancomycin. During the second stage of treatment, the temporary spacer is removed, dissected, and a permanent prosthesis is implanted, followed by systemic administration of postoperative fluids (antibiotics) according to exemplary process 600. The combination treatment can also be performed without removing the infected prosthesis.

[0096] The treatment delivery system can be coupled to the treatment site as described elsewhere herein, and a user can initiate a treatment cycle, such as by pressing "Start." The pump turns on and generates vacuum pressure at the wound site during a "retraction cycle" until a set vacuum pressure is achieved. The treatment delivery system then performs a series of status checks and verifications during a "seal verification" cycle before initiating the treatment phase. Upon completion of the "seal verification" cycle, the system transitions to a "pre-treatment vacuum cycle" to verify that the set vacuum pressure achieved during the "seal verification" cycle can be maintained.

[0097] A user can assemble the system components (e.g., hangers, solution bags, canisters, tubing, etc.) and make appropriate connections between the system components and the treatment site. The therapy delivery system can be powered on using a power button or by plugging the device into a wall outlet. In response to powering on the therapy delivery system, the status of the therapy delivery system is verified. At 602, the status of the therapy delivery system is verified before a therapy phase is initiated and during each therapy phase. Verifying the status of the therapy delivery system can include measuring system parameters using multiple sensors, such as pressure and weight sensors, as described with reference to FIGS. 1A-1D, 2A-2F, and 3A-3B. Each system parameter is compared to a respective safety range and / or threshold. Verifying the status of the therapy delivery system can be adjusted based on the type of therapy (e.g., infection therapy type) the therapy delivery system is configured to perform.

[0098] At 604, an alert / alarm is generated if one or more system parameters are outside of a particular safety range. The alert / alarm can include a visual and / or an audio alert. The visual alert can be displayed by a graphical user interface, as described with reference to FIG. 5B. The alert can include a leak alarm, a vacuum cutoff alarm, a full collection fluid canister alarm, an empty bag alarm, a fluid delivery cutoff alarm, a low battery alarm, an incorrect assembly alert, and / or an excessive motion alert.

[0099] A leak alarm may appear when the system does not reach the target vacuum pressure setting or when a significant vacuum pressure leak is detected within the system, potentially compromising therapy benefit. A leak alarm can be activated (e.g., transitions from off to on) if (i) the device does not achieve a setpoint vacuum pressure of 125 mmHg ± 10% (112.5 to 137.5 mmHg) at the treatment site within a set time period (e.g., 2.5 minutes), or (ii) after a set time period, the vacuum pressure falls below a pressure threshold (e.g., -112.5 mmHg) for longer than a set time period (e.g., 60 seconds) during the fluid removal phase.

[0100] A vacuum interruption alarm may appear when the vacuum line has an interruption (e.g., an interruption in the vacuum line, a kink, a crimp, >50% blocked tubing). A vacuum interruption alarm can be activated (e.g., transitions from off to on) if the fluid volume removed at the end of a fluid removal phase is below a set fluid volume threshold. For example, if the fluid volume collected in the collection fluid canister is below a set fluid volume threshold (e.g., less than 25 cc of fluid) at the completion of a single fluid removal phase of a set duration (e.g., 30 minutes).

[0101] A full canister alarm may appear during the fluid removal phase when the fluid volume collected in the collection fluid canister exceeds a threshold (e.g., above 90% of the collection fluid canister capacity). The vacuum shutoff alarm and full canister alarm may activate a user command alert (e.g., fluid delivery shutoff) that includes a text description of the recommended user action.

[0102] An empty bag alarm can be triggered if the weight of any of the fluid reservoirs falls below a minimum weight and prevent the therapy delivery system from being powered to perform therapy. An empty bag alarm can be activated during therapy if the fluid volume (derived from the measured fluid weight detected by a separate load cell) in a fluid reservoir (e.g., antibiotic solution bag) is not sufficient to complete the fluid delivery phase (e.g., below a minimum fluid volume threshold). The empty bag alarm can activate a user instruction alert (e.g., replace the empty bag with a full bag) that includes a text description of the recommended user action.

[0103] A fluid delivery blockage alarm may appear (e.g., transition from off to on) when the therapy delivery system delivers less than a set fluid volume threshold (e.g., 45 mL) into the treatment site within a set time period (e.g., 5 minutes) from the start of fluid delivery activation. For example, a fluid delivery alarm can be activated if delivery of a particular fluid (e.g., vancomycin hydrochloride solution) results in less than a set volume (e.g., 30 mL) during its corresponding phase within a set time period (e.g., 5 minutes before the end of the corresponding fluid delivery phase).

[0104] A low battery alarm may appear when the charge level (life) of the therapy delivery system's battery falls below a minimum charge level threshold (e.g., 20% battery capacity) recommended for completing therapy and the therapy delivery system is not connected to an external power source (e.g., not plugged into a wall power source). An incorrect assembly alert can alert the user if any of the fluid reservoirs (e.g., antibiotic bags) are incorrectly attached to the therapy delivery system prior to the initiation of any therapy phase, ensuring the correct delivery of a particular fluid type during a particular therapy phase. An incorrect assembly alert can be activated (e.g., transitions from off to on) if (i) during a "seal check," the device measures a collection fluid canister weight outside of a weight range (e.g., above 1.5 kg) or (ii) during a "pre-delivery cycle," the device does not measure a fluid reservoir weight. In some implementations, the first fluid reservoir weight does not intersect with the second fluid reservoir weight, ensuring that the two fluid types can be automatically determined and differentiated.

[0105] An excessive motion alert can alert the user if the system (i.e., control unit) motion exceeds the motion threshold required for accurate dosing during treatment. The dosage is determined based on the weight of the individual fluid reservoirs or collection fluid canisters, which is determined by a load cell based on its interaction with the mounting features supporting the individual fluid reservoirs or collection fluid canisters, such that system motion (e.g., during transport of the system) can correct user interaction with the load cell that leads to dosage estimation errors. The excessive motion alert can be used to stabilize the fluid delivery system for fluid delivery. The control unit can automatically pause prior to or during the fluid delivery phase if an excessive motion alert is generated by a measurement of the differential antibiotic solution weight (e.g., ±20%) exceeding a set tolerance threshold prior to or during the fluid delivery phase. The excessive motion alert can control the function of the control unit during the instillation procedure and maintain accuracy during transport. However, the system need not incorporate an excessive motion alert.

[0106] At 606, if the system parameters are within a safe range (no alert is generated), an initial display is generated, as described with reference to Figure 5A. The initial display can be generated to be displayed by the control unit's graphical user interface and to allow for receipt of user input.

[0107] At 608, user input is received. User input can include selecting an activation of a start selector (e.g., a start button) to initiate an automated treatment delivery, including multiple phases. The system automatically transitions to the treatment phase after an initial "start" is pressed and all system checks pass. The treatment phase can include, in an alternating fashion, fluid delivery of multiple fluids to the treatment site, controlled fluid soak phases, and removal of fluids from the treatment site prior to delivery of the next fluid.

[0108] At 610, delivery of a first fluid to a treatment site is controlled by the system. Delivery of the first fluid can be provided by vacuum pressure within the system and assisted by gravity due to the head height of a reservoir container holding the first fluid. The treatment delivery system can include a start-up protocol followed by a time period for verifying vacuum pressure within the system and a pre-delivery period before automatically initiating delivery of the first fluid to the treatment site after achieving a set vacuum pressure. Delivery of the first fluid can occur from a first fluid reservoir (e.g., a first antibiotic solution bag) to the treatment site through a fluid delivery line loaded into and extending through a first pinch valve controlled by the system. Delivery of the first fluid to the treatment site can be controlled by a control unit of the system, which selectively activates (opens) the first pinch valve to allow the first fluid to flow from the first fluid reservoir to the treatment site. As discussed elsewhere herein, the system can further incorporate a second fluid reservoir of a second fluid for delivery to the treatment site through a second fluid delivery line extending through the second pinch valve. The first fluid is delivered to the treatment site through the first fluid delivery line, while flow of the second fluid through the second fluid delivery line is blocked by the second pinch valve remaining closed. During delivery of the first fluid, the control circuit can monitor the differential weight (e.g., fluid level change) of the first fluid reservoir and select timing to open and close the first pinch valve on the first fluid delivery line, thereby dispensing a fixed volume of the first fluid. The first fluid can include an antibiotic, such as tobramycin sulfate, from the first reservoir bag. The volume of the first fluid to be delivered to the treatment site can be set within a range of 6 mL to 500 mL depending on the time period of the treatment, such as 50 mL for a single 2-hour treatment cycle or up to about 500 mL for multiple treatment cycles over the course of about 7 days. Delivery of the first fluid volume can be controlled with an accuracy of ± about 5 mL. In some implementations, about 50 mL tobramycin sulfate is delivered within about 30 seconds.

[0109] After the first fluid delivery phase is completed, a soaking protocol follows, allowing the treatment site to soak in the delivered first fluid. The vacuum pressure within the system can be deactivated and vented to ambient pressure during soaking. At 612, the soaking protocol for the first fluid at the treatment site is implemented. The control unit of the treatment delivery system can be configured to allow the delivered fluid to soak the treatment site (e.g., the peri-prosthetic space) for a predetermined dwell time. In some implementations, the soaking protocol is activated after delivery of each fluid and before delivery of the subsequent fluid. The duration of the soaking phase can be set depending on the fluid type of the delivered fluid. For example, the duration of the soaking phase can be set to approximately 2 hours after delivery of the tobramycin sulfate solution and approximately 30 minutes after delivery of the vancomycin hydrochloride solution.

[0110] At 614, fluid (e.g., including the first fluid and any other fluids, such as wound exudate from the treatment site) is removed from the treatment site. The control unit of the treatment delivery system can remove fluid from the treatment site by applying a vacuum through the bandaging kit and discard the collected fluid into a collection fluid reservoir (e.g., a canister), as described with reference to FIG. 2A. For example, vacuum pressure is generated within the system by activating a pump until a set vacuum pressure is achieved and maintained. The control unit can maintain a vacuum pressure level, such as, for example, -125 mmHg ±10% (-112.5 to 127.5 mmHg), for a set intermittent period to remove fluid from the site of infection through the bandaging kit into the collection fluid canister. The vacuum pressure level can be controlled by the control unit using a pressure sensor, a vacuum pump, and a pneumatic solenoid valve, as described with reference to FIGS. 2A-2F. The sensor can generate an output as a voltage that reflects the level of vacuum applied by the therapy delivery system. A control unit can monitor the sensor voltage and turn the pump on or off based on a fixed voltage threshold. A pneumatic solenoid valve can be activated by the control unit to regulate the vacuum pressure by relieving (i.e., venting to atmosphere) the vacuum pressure as needed and maintaining the vacuum pressure within a set pressure range. The duration of the fluid removal phase can be set depending on the type of fluid collected at the treatment site. For example, the duration of the fluid removal phase can be set to approximately 30 minutes.

[0111] At 616, delivery of a second fluid to the treatment site is controlled by the system. Delivery of the second fluid can be provided by vacuum pressure within the system, which may be assisted by gravity, due to the head height of a reservoir container holding the second fluid. The treatment delivery system achieves and maintains a set vacuum pressure during a pre-delivery period before automatically triggering delivery of the second fluid to the treatment site. Delivery of the second fluid can occur from a second fluid reservoir (e.g., a second antibiotic solution bag) into a fluid delivery line loaded into and extending through a second pinch valve controlled by the system. Delivery of the second fluid to the treatment site can be controlled by a control unit of the system, which selectively activates (opens) the second pinch valve to allow the second fluid to flow from the second fluid reservoir to the treatment site while maintaining the first pinch valve in a closed configuration to block flow of the first fluid through the fluid delivery line. During delivery of the second fluid, the control circuit monitors the differential weight of the second fluid reservoir (e.g., a change in fluid level) and selects the timing to open or close a second pinch valve on the second fluid delivery line, thereby dispensing a fixed volume of the second fluid. The second fluid can include an antibiotic, such as vancomycin hydrochloride. The volume of the second fluid to be delivered to the treatment site can vary. The volume of the second fluid to be delivered can be set within a range of 500 mL to 1,500 mL, such as 1,200 mL. As discussed elsewhere herein, the second fluid can be delivered in smaller volumes that are allowed to soak and then removed before the next volume is delivered to the treatment site. Each volume delivered per soaking cycle can be only 50 mL before being removed, but can be cycled repeatedly (e.g., approximately 22 times) over the course of a single 24-hour cycle so that the total volume is approximately 1,100 mL. The delivery of the second fluid volume can be controlled with an accuracy of about ±5 mL. In some implementations, about 50 mL of vancomycin hydrochloride is delivered within about 30 seconds.

[0112] After delivery of the second fluid to the treatment site, a soaking protocol at the treatment site is performed similar to that described at 612, followed by removal of the second fluid (which may include exudate and other fluids in addition to the second fluid from the reservoir being delivered for treatment) from the treatment site similar to that described at 614.

[0113] At 618, the treatment data is displayed, as described with reference to FIG. 5C. The displayed treatment data may include real-time updates of the treatment during the treatment, such as the name of the treatment phase being performed. The treatment data displayed upon completion of the treatment may include a treatment description, including the delivered and removed fluid volumes of each fluid type. The treatment data displayed upon completion of the treatment may optionally include one or more recommendations, such as a recommendation to charge the battery and / or empty the collection fluid canister.

[0114] Exemplary process 600, or portions of process 600, can be repeated over multiple (e.g., greater than 150) cycles for controlled fluid delivery of multiple (two or more) fluids, which can flood the treatment area and be removed, preventing fusion of the different fluids. Exemplary process 600, or portions of process 600, can be repeated over the course of a week. A single completed cycle following a single user input can include at least steps 610+612+614+616+612+614. As discussed above, a second fluid can be repeatedly delivered, flooded, and removed before the first fluid is delivered again, including, for example, steps 610+612+614+[x(616+612+614)]. The system can be pre-configured to run multiple complete cycles following a single user input over an approximately 24-hour period, or until the reservoir is empty and / or the collection canister is full.

[0115] The system may also include other alarms and alerts, such as an excessive fluid loss alarm, a therapy inactivity alarm, and / or a system error alarm, which may be a medium-priority alarm. The excessive fluid loss alarm is activated (i.e., transitions from off to on) if more than 200 CC of fluid enters the canister during a therapy vacuum cycle within a single therapy vacuum cycle. This alarm ensures that the user is aware that the total volume of fluid collected in the canister has reached a certain level. The therapy inactivity alarm is activated when the control unit is powered on and therapy remains inactive for more than a selected period, such as more than 15 minutes. As examples, the therapy day selection screen may be displayed for more than a threshold period after the device is powered on, or the cycle reset screen may be displayed for more than a threshold period after a reset. The system error alarm is activated any time the system pressure sensor measures a pressure above a threshold, e.g., less than -162.5 mmHg. The system error alarm is activated if there is a software malfunction or corrupted software.

[0116] 7 depicts an example of a parameter diagram 700 corresponding to a process performed by a therapy delivery system (e.g., therapy delivery system 100 described with reference to FIGS. 1A-1D ) according to some example implementations. The example parameter diagram 700 can include parameters determined by a control unit during distinct phases 702A, 702B, 702C, 702D, 702E of therapy using multiple fluid types, as described with reference to FIG.

[0117] During a first phase 702A of treatment, a first fluid type is delivered to the treatment site for a first fluid delivery period 704A. A first fluid volume 706A at the treatment site increases with a certain accuracy (e.g., 5 mL) from zero to a set delivery first fluid volume threshold 708A. The first fluid volume 706A at the treatment site during the first phase 702A of treatment can be derived based on fluctuations in the weight of the first fluid reservoir as measured by a first load cell. The first fluid volume 706A can be delivered to the treatment site at a flow rate of the first fluid 710A, which can be approximately constant. The flow rate of the first fluid 710A can be monitored to remain within a set flow rate range 712A.

[0118] During the second phase 702B of the treatment, the first fluid is immersed into the treatment area for a set first time period or first immersion period 704B such that the first fluid volume 706B delivered to the treatment area during the first immersion period 704B remains constant.

[0119] During the third phase 702C of treatment, a first fluid is removed from the treatment site and delivered to a collection fluid canister during a fluid collection cycle 704C. The fluid volume at the treatment site 706C decreases as the volume of fluid 706E collected in the collection fluid canister increases from zero to a set collection volume threshold (e.g., a first fluid volume threshold 708B) with a certain accuracy (e.g., 5 mL). The volume of fluid 706E collected in the collection fluid canister can be derived based on the fluctuation in the weight of the collection fluid canister as measured by a separate load cell. The collected fluid 706E can be removed from the treatment site at a flow rate of collected fluid 710B, which can be approximately constant. The flow rate of collected fluid 710B can be monitored to remain within a set flow rate threshold 712B. In some implementations, the therapy delivery system can automatically transition between therapy phases, for example, in response to determining that a parameter (e.g., fluid volume) reaches a corresponding threshold, such as the first fluid volume threshold 708B to be delivered.

[0120] During the fourth phase 702D of treatment, a second fluid type is delivered to the treatment site during a second fluid delivery cycle 704D. The second fluid volume 706D at the treatment site increases with a certain accuracy (e.g., 5 mL) from zero to a set delivered second fluid volume threshold 708C. The second fluid volume 706D at the treatment site during the second phase 702B of treatment can be derived based on fluctuations in the weight of the second fluid reservoir as measured by the first load cell. The second fluid volume 706D can be delivered to the treatment site at a flow rate of the second fluid 710C, which can be approximately constant. The flow rate of the second fluid 710C can be monitored to remain within the set flow rate threshold 712C.

[0121] During the fifth phase 702E of treatment, the second fluid is immersed in the treatment area for a set second time period or second immersion period 704E such that the second fluid volume 706E in the treatment area remains constant during the second immersion period 704E. After the fifth phase 702E, the second fluid is removed from the treatment site and delivered to a collection fluid canister for a further fluid collection period (not shown).

[0122] 8 depicts a block diagram illustrating an example of a computing system 800 consistent with implementations of the present subject matter. The exemplary computing system 800 may be integrated within a control unit of a therapy delivery system, as described with reference to FIGS. 1A-1D, 2A-2F, and 3A and 3B, and may perform the processes described with reference to FIG.

[0123] As shown in FIG. 8 , computing system 800 may include a processor 810, a memory 820, a storage device 830, and an input / output device 840. The processor 810, the memory 820, the storage device 830, and the input / output device 840 may be interconnected via a system bus 850. The processor 810 is capable of processing instructions for execution within the computing system 800. Such executed instructions may be implemented, for example, by one or more components of a therapy delivery system. In some exemplary implementations, the processor 810 may be a single-threaded processor. Alternatively, the processor 810 may be a multi-threaded processor. The processor 810 is capable of processing instructions stored in the memory 820 and / or on the storage device 830 and presenting graphical information for a user interface provided via the input / output device 840.

[0124] Memory 820 is a computer-readable medium, such as a volatile or non-volatile medium, that stores information within computing system 800. Memory 820 may store data structures, for example, representing a configuration object database. Storage device 830 may provide persistent storage for computing system 800. Storage device 830 may be a floppy disk device, a hard disk device, an optical disk device, or a tape device, or other suitable persistent storage means. Input / output device 840 provides input / output operations for computing system 800. In some example implementations, input / output device 840 includes a keyboard and / or a pointing device. In various implementations, input / output device 840 includes a display unit for displaying a graphical user interface.

[0125] According to some example implementations, the input / output devices 840 may provide input / output operations for network devices. For example, the input / output devices 840 may include an Ethernet port or other networking port and communicate with one or more wired and / or wireless networks (e.g., a local area network (LAN), a wide area network (WAN), the Internet).

[0126] In some example implementations, computing system 800 can be used to execute various interactive computer software applications that can be used for organizing, analyzing, and / or storing data in various formats. Alternatively, computing system 800 can be specifically configured to execute software applications. These applications can implement various fullness-detection functionalities, such as planning functionality (e.g., generating, managing, editing spreadsheet documents, word processing documents, and / or any other objects, etc.), computing functionality, communication functionality, etc. Applications can include various add-in functionalities or can be stand-alone computing products and / or functionality. Upon activation within an application, functionality can be used to generate a user interface, which is provided via input / output devices 840. The user interface can be generated by computing system 800 and presented to a user (e.g., on a computer screen monitor, etc.).

[0127] One or more aspects or features of the subject matter described herein can be implemented in digital electronic circuitry, integrated circuits, specifically configured application-specific integrated circuits (ASICs), field-programmable gate array (FPGA) computer hardware, firmware, software, and / or combinations thereof. These various aspects or features may include implementation in one or more computer programs executable and / or interpretable on a programmable system including at least one programmable processor, which may be special-purpose or general-purpose, coupled to receive data and instructions from, and transmit data and instructions to, a storage system, at least one input device, and at least one output device. The programmable system or computing system may include clients and servers. Clients and servers are remote from each other and typically interact through a communication network. The relationship of client and server arises by means of computer programs running on separate computers and having a client-server relationship to each other.

[0128] These computer programs, which may also be referred to as programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor and may be implemented in a high-level procedural and / or object-oriented programming language and / or in an assembly / machine language. As used herein, the term “machine-readable medium” refers to any computer program product, apparatus, and / or device used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal, such as, for example, a magnetic disk, an optical disk, a memory, and a programmable logic device (PLD). The term “machine-readable signal” refers to any signal used to provide machine instructions and / or data to a programmable processor. A machine-readable medium may non-transitory store such machine instructions, such as, for example, a non-transitory solid-state memory or a magnetic hard drive or any equivalent storage medium. Alternatively, or in addition, a machine-readable medium may store such machine instructions in a transient manner, such as, for example, a processor cache or other random access memory associated with one or more physical processor cores.

[0129] To provide for user interaction, one or more aspects or features of the subject matter described herein can be implemented on a computer having, for example, a display device, such as a cathode ray tube (CRT) or liquid crystal display (LCD) or light-emitting diode (LED) monitor, for displaying information to a user, and a keyboard and pointing device, such as a mouse or trackball, by which the user can provide input to the computer. Other types of devices can be used to provide for user interaction as well. For example, feedback provided to the user can be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback, and input from the user may be received in any form, including acoustic, speech, or tactile input. Other possible input devices include touchscreens or other touch-sensitive devices, such as single- or multi-point resistive or capacitive trackpads, voice recognition hardware and software, optical scanning devices, optical pointers, digital image capture devices and associated interpretation software, and the like.

[0130] In the above description and claims, phrases such as "at least one of" or "one or more of" may appear and be followed by a conjunctive list of elements or features. The term "and / or" may also appear in lists of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to mean any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A alone, B alone, or A and B together," respectively. A similar interpretation is also intended with respect to lists containing three or more items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together," respectively. Use of the term "based on" above and in the claims is intended to mean "based at least in part on," so that unrecited features or elements are also permissible.

[0131] As used herein, a "user interface" (also referred to as an interactive user interface, graphical user interface, or user interface or UI) may refer to a network-based interface that includes data fields and / or other control elements for receiving input signals or providing electronic information and / or for providing information to a user in response to any received input signals. Control elements may include dials, buttons, icons, selectable areas, or other perceptible indicia presented via the UI that, when interacted with (e.g., clicked, touched, selected, etc.), initiates an exchange of data for the device to present the UI. The UI may be implemented, in whole or in part, using technologies such as Hypertext Markup Language (HTML), FLASH®, JAVA®, .NET®, web services, or Rich Site Summary (RSS). In some implementations, the UI may be included within a stand-alone client (e.g., thick client, fat client) configured to communicate (e.g., send or receive data) according to one or more of the described aspects. The communication may be to or from the medical device or a server in communication therewith.

[0132] As used herein, the terms "determine" or "determining" encompass a wide variety of actions. For example, "determining" may include calculating, computing, processing, deriving, generating, obtaining, looking up (e.g., looking up a table, database, or another data structure), ascertaining, and the like, through hardware elements without user intervention. Also, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), and the like, through hardware elements without user intervention. "Determining" may include resolving, selecting, choosing, establishing, and the like, through hardware elements without user intervention.

[0133] As used herein, the terms "provide" or "providing" encompass a wide variety of actions. For example, "providing" may include storing a value within a storage device location for subsequent retrieval, transmitting a value directly to a receptacle via at least one wired or wireless communication medium, transmitting or storing a reference to a value, and the like. "Providing" may also include encoding, decoding, encrypting, decrypting, verifying, verifying, and the like via a hardware element.

[0134] As used herein, the term "message" encompasses a wide variety of formats for communicating (e.g., transmitting or receiving) information. A message may include a machine-readable aggregation of information, such as an XML document, a fixed-field message, a comma-separated message, or the like. A message may, in some implementations, include a signal utilized to convey one or more representations of information. Although listed in the singular, it should be understood that a message may be broken down, transmitted, stored, received, etc., into multiple parts.

[0135] As used herein, the terms "correspond" or "corresponding" encompass a structural, functional, quantitative, and / or qualitative correlation or relationship between two or more objects, data sets, information, and / or equivalents; preferably, the correspondence or relationship may be used to transform one or more of the two or more objects, data sets, information, and / or equivalents so that they appear identical or equivalent. Correspondence may be assessed using one or more of thresholds, value ranges, fuzzy logic, pattern matching, machine learning assessment models, or combinations thereof.

[0136] In some implementations, generated or detected data may be transferred to a “remote” device or location, where “remote” means a location or device other than the location or device where the program is executed. For example, a remote location may be another location within the same city (e.g., an office, a laboratory, etc.), another location within a different city, another location within a different state, another location within a different country, etc. Thus, when one item is described as being “remote” from another, what is meant is that the two items may be in the same room but separated, or at least in different rooms or different buildings, and may be at least 1 mile, 10 miles, or at least 100 miles apart. “Communicating” information refers to transmitting data, which represents information as electrical signals, over a suitable communications channel (e.g., a private or public network). “Transferring” an item refers to any means of moving the item from one location to the next, whether by physically or otherwise (if possible) transporting the item, and at least in the case of data, includes physically transporting a medium carrying the data or communicating the data. Examples of communication media include wireless or infrared transmission channels and network connections to other computers or networked devices, and the Internet (including email transmissions and information stored on websites and the like).

[0137] The implementations described in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the subject matter described. While some variations have been described in detail above, other modifications or additions are possible. In particular, additional features and / or variations may be provided in addition to those described herein. For example, the implementations described above may be directed to various combinations and subcombinations of the disclosed features and / or combinations and subcombinations of several additional features disclosed above. In addition, the logic flow depicted in the accompanying figures and / or described herein does not necessarily require the particular order or sequential order shown to achieve desirable results. Other implementations may be within the scope of the following claims.

Claims

1. 1. A therapeutic delivery system comprising: a fluid delivery system connected to a first fluid reservoir and a second fluid reservoir, the fluid delivery system configured to direct a first fluid from the first fluid reservoir to a treatment site and a second fluid from the second fluid reservoir to the treatment site; a control unit configured to control the fluid delivery system according to a treatment process comprising a flow of the first fluid and the second fluid, the treatment process comprising a plurality of phases, a first phase of the plurality of phases comprising controlled delivery of the first fluid from the first fluid reservoir to the treatment site, and a second phase of the plurality of phases comprising controlled delivery of the second fluid from the second fluid reservoir to the treatment site, the control unit automatically activating a transition from at least the first phase to the second phase of the plurality of phases; A therapeutic delivery system comprising:

2. 10. The therapy delivery system of claim 1, further comprising a first load cell configured to detect a combined weight of a first weight of the first fluid in the first fluid reservoir and a second weight of the second fluid in the second fluid reservoir, wherein the control unit processes the combined weight and monitors a status of fluid delivery.

3. 3. The therapy delivery system of claim 2, wherein the first load cell is arranged in a vertical plane of the system and configured to be contacted horizontally by a cantilevered hanger component.

4. 4. The therapy delivery system of claim 3, wherein the first fluid reservoir is held by a mounting feature at a first end region of the cantilevered hanger component and the first load cell is contacted by a protrusion at a second end region of the cantilevered hanger component.

5. 5. The therapy delivery system of claim 4, further comprising a collection fluid canister configured to collect fluid removed from the treatment site.

6. 6. The therapy delivery system of claim 5, further comprising a second load cell configured to detect a waste weight of the waste fluid canister and any waste in the canister, and wherein the control unit processes the waste weight and monitors a status of fluid removal.

7. 7. The therapy delivery system of claim 6, wherein the second load cell is aligned in a vertical plane of the system and configured to be contacted horizontally by a second cantilevered hanger component.

8. 8. The therapy delivery system of claim 7, wherein the canister is held by a mounting feature at a first end region of the second cantilevered hanger component and the second load cell is contacted by a second protrusion at a second end region of the second cantilevered hanger component.

9. 10. The therapy delivery system of claim 1, further comprising a first pinch valve and a second pinch valve, the first pinch valve configured to receive a first fluid delivery line fluidly connected to the first fluid reservoir, and the second pinch valve configured to receive a second fluid delivery line fluidly connected to the second fluid reservoir.

10. 10. The therapy delivery system of claim 9, wherein the first pinch valve is controlled by the control unit to be open during the first phase and controlled by the control unit to be closed during the second phase, and the second pinch valve is controlled by the control unit to be closed during the first phase and controlled by the control unit to be open during the second phase.

11. 10. The therapy delivery system of claim 9, wherein the first pinch valve has a first inner dimension when in an open configuration and the second pinch valve has a second inner dimension when in an open configuration, the first inner dimension being smaller than the second inner dimension.

12. 10. The therapy delivery system of claim 9, wherein the first fluid delivery line has a smaller outer dimension than the second fluid delivery line, the smaller outer dimension being dimensioned to be received within a first inner dimension of the first pinch valve.

13. 13. The therapy delivery system of claim 12, wherein the second fluid delivery line has an outer dimension that is prevented from being received within a first inner dimension of the first pinch valve.

14. The control unit a pump configured to generate a set vacuum pressure within the system; a valve configured to control vacuum relief; and 10. The therapeutic delivery system of claim 1, comprising:

15. 15. The therapy delivery system of claim 14, wherein the pump is powered off during at least the first phase.

16. 15. The therapy delivery system of claim 14, wherein the pump is configured to operate at a substantially constant voltage for a first period of time and at a substantially constant torque for a second period of time to generate a set vacuum pressure.

17. 10. The therapy delivery system of claim 1, further comprising a leak alarm, the leak alarm configured to generate an alert indicating a pressure leak determined in response to the control unit detecting that vacuum pressure at the treatment site falls below a discrete threshold.

18. 10. The therapy delivery system of claim 1, wherein the plurality of phases comprises a third phase for maintaining a volume of the first fluid or the second fluid in a portion of the treatment site for a period of time.

19. 10. The therapy delivery system of claim 1, wherein the plurality of phases comprises a fourth phase, the fourth phase being automatically initiated by the control unit to remove the first fluid from the treatment site following the first phase and to remove the second fluid from the treatment site following the second phase.

20. 20. The therapy delivery system of claim 19, further comprising a collection fluid canister configured to collect fluid removed from the treatment site during a fourth phase of the plurality of phases.

21. 21. The therapy delivery system of claim 20, further comprising a collection fluid canister fill sensor configured to generate a collection fluid canister fill alert indicating that a fill level of the collection fluid canister exceeds a fill threshold during a fourth phase of the plurality of phases, and wherein the control unit stops removal of either the first fluid or the second fluid from the treatment site in response to the collection fluid canister fill alert.

22. 10. The therapy delivery system of claim 1, further comprising an empty fluid reservoir alarm, the empty fluid reservoir alarm configured to generate an alert indicating that a weight of the first fluid delivered or a weight of the second fluid delivered falls below a minimum threshold value corresponding to a respective phase of the plurality of phases.

23. 10. The therapy delivery system of claim 1, further comprising a low battery alarm configured to generate an alert indicating a charge level of a battery of the control unit, the charge level of the battery being determined in response to the control unit detecting that the charge level of the battery is below a minimum charge level adequate for powering automatic transitions between the plurality of phases.

24. 10. The therapy delivery system of claim 1, further comprising an improper assembly alarm configured to generate an alert indicating improper assembly of the therapy delivery system, the improper assembly being determined in response to the control unit detecting a missing or improperly coupled component of the therapy delivery system that interferes with automatic transitioning between the plurality of phases.

25. 10. The therapy delivery system of claim 1, further comprising a motion alarm configured to pause fluid delivery and generate an alert indicating excessive motion affecting weight sensor readings during fluid delivery.

26. The therapy delivery system of claim 1 , further comprising a user interface, the user interface configured to receive user input comprising a selection of an action for initiating the sequence comprising the multiple phases.

27. 10. The therapeutic delivery system of claim 1, wherein the first fluid comprises tobramycin sulfate and the second fluid comprises vancomycin hydrochloride.

28. 1. A method, comprising: controlling, by a control unit, fluid flow of the treatment solution from the fluid reservoir through the fluid delivery line fluid to the treatment site during a fluid delivery phase; activating, by the control unit, a transition from the fluid delivery phase to a fluid immersion phase, during which the treatment solution is maintained at the treatment site; and triggering, by the control unit, removal of the treatment solution from the treatment site to a collection canister during a fluid removal phase; A method comprising:

29. The control unit a pump configured to generate a set vacuum pressure at the treatment site; a valve configured to control vacuum relief; and 29. The method of claim 28, comprising:

30. 30. The method of claim 29, wherein the pump is configured to operate at a substantially constant voltage for a first period of time and at a substantially constant torque for a second period of time to generate the set vacuum pressure.

31. 30. The method of claim 28, further comprising generating an alert by a leak alarm indicating a pressure leak determined in response to the control unit detecting that the vacuum pressure of the system falls below a respective threshold.

32. 30. The method of claim 28, wherein the fluid delivery phase, the soaking phase, and the fluid removal phase are repeated sequentially for a period of time.

33. 30. The method of claim 28, wherein the treatment solution comprises a first treatment solution stored in a first fluid reservoir and a second treatment solution stored in a second fluid reservoir.

34. 30. The method of claim 28, further comprising generating a collection fluid canister fill alert indicating that the fill level of the collection fluid canister exceeds a fill threshold.

35. 30. The method of claim 28, further comprising generating an alert prior to the fluid delivery phase indicating that the weight of the fluid reservoir is below a minimum threshold.

36. 30. The method of claim 28, further comprising generating an alert indicating that the charge level of the battery of the control unit is below a minimum charge level adequate to power automatic transitions between treatment phases.

37. detecting, by the control unit, a missing or miscoupled component of the therapy delivery system; generating an alert indicating incorrect assembly of the therapeutic delivery system; Preventing automatic transitions between treatment phases 30. The method of claim 28, further comprising:

38. 30. The method of claim 28, further comprising generating an alert during fluid delivery indicating excessive movement affecting the weight sensor reading.

39. A non-transitory storage medium storing instructions that, when executed by at least one processor, cause the at least one processor to perform operations, the operations including: controlling fluid flow of the treatment solution from the fluid reservoir through the fluid delivery line to the treatment site during a fluid delivery phase; activating a transition from the fluid delivery phase to a fluid immersion phase, during which the treatment solution is maintained at the treatment site; and controlling removal of the treatment solution from the treatment site to a collection canister during a fluid removal phase; A non-transitory storage medium comprising:

40. 1. A kit for treating a localized infection in a human patient, said kit comprising: at least one antibiotic; 1. An irrigation and irrigation device configured to locally irrigate and irrigate a treatment site for a localized infection with at least one dose of said at least one antibiotic, said irrigation and irrigation device comprising: a fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution; a control unit configured to control the fluid delivery system according to a treatment process; an irrigation and cleaning device comprising: instructions for administering at least one dose of the at least one antibiotic to treat the localized infection using the irrigation and flushing device; wherein the treatment process comprises locally administering, in a 24-hour period, a total amount of the at least one antibiotic that exceeds a maximum recommended daily systemic dose of the at least one antibiotic.

41. 41. The kit of claim 40, wherein the at least one antibiotic is vancomycin.

42. 41. The kit of claim 40, wherein the at least one antibiotic is tobramycin.

43. 41. The kit of claim 40, wherein the at least one antibiotic comprises vancomycin and tobramycin.

44. 44. The kit of claim 43, wherein the treatment process locally administers a total amount of vancomycin that exceeds the maximum recommended daily systemic dose for vancomycin in a 24-hour period.

45. 45. The kit of claim 44, wherein the treatment process locally administers a total amount of tobramycin in a 24-hour period that exceeds the maximum recommended daily systemic dose for tobramycin.

46. 46. ​​The kit of claim 45, wherein a first fluid reservoir contains a first fluid containing the vancomycin and a second fluid reservoir contains a second fluid containing the tobramycin.

47. 47. The kit of claim 46, wherein the fluid delivery system is configured to direct the first fluid from the first fluid reservoir to the treatment site and the second fluid from the second fluid reservoir to the treatment site.

48. 48. The kit of claim 47, wherein the treatment process comprises a plurality of phases, a first phase of the plurality of phases comprising controlled delivery of the first fluid from the first fluid reservoir to the treatment site, and a second phase of the plurality of phases comprising controlled delivery of the second fluid from the second fluid reservoir to the treatment site, and wherein the control unit automatically activates a transition from at least the first phase to the second phase of the plurality of phases.

49. 49. The kit of claim 48, further comprising a collection fluid canister configured to collect fluid removed from the treatment site.

50. 50. The kit of claim 49, wherein the irrigation flushing device further comprises a first load cell configured to detect a combined weight of a first weight of the first fluid in the first fluid reservoir and a second weight of the second fluid in the second fluid reservoir, and wherein the control unit processes the combined weight and monitors a status of fluid delivery.

51. 51. The kit of claim 50, wherein the first load cell is aligned in a vertical plane of the fluid delivery system and configured to be contacted horizontally by a cantilevered hanger component.

52. 52. The kit of claim 51, wherein the first fluid reservoir is held by a mounting feature at a first end region of the cantilevered hanger component and the first load cell is contacted by a protrusion at a second end region of the cantilevered hanger component.

53. 53. The kit of claim 52, wherein the irrigation cleaning device further comprises a second load cell configured to detect a waste weight of the waste fluid canister and any waste within the canister, and wherein the control unit processes the waste weight and monitors a status of fluid removal.

54. 54. The kit of claim 53, wherein the second load cell is aligned in a vertical plane of the system and configured to be contacted horizontally by a second cantilevered hanger component.

55. 41. The kit of claim 40, wherein the fluid delivery system further comprises a first pinch valve and a second pinch valve, and the irrigation and flushing device further comprises a first fluid delivery line and a second fluid delivery line.

56. 56. The kit of claim 55, wherein the first pinch valve is configured to receive the first fluid delivery line fluidly connected to the first fluid reservoir, and the second pinch valve is configured to receive the second fluid delivery line fluidly connected to the second fluid reservoir.

57. 57. The kit of claim 56, wherein the first pinch valve is controlled by the control unit to be open during the first phase and controlled by the control unit to be closed during the second phase, and the second pinch valve is controlled by the control unit to be closed during the first phase and controlled by the control unit to be open during the second phase.

58. 57. The kit of claim 56, wherein the first pinch valve has a first inner dimension when in an open configuration and the second pinch valve has a second inner dimension when in an open configuration, the first inner dimension being smaller than the second inner dimension.

59. 57. The kit of claim 56, wherein the first fluid delivery line has a smaller outer dimension than the second fluid delivery line, the smaller outer dimension being dimensioned to be received within a first inner dimension of the first pinch valve.

60. 60. The kit of claim 59, wherein the second fluid delivery line has an outer dimension that is prevented from being received within the first inner dimension of the first pinch valve.

61. The control unit a pump configured to generate a set vacuum pressure within the system; a valve configured to control vacuum relief; and 41. The kit of claim 40, comprising:

62. 62. The kit of claim 61, wherein the pump is powered off during at least the first phase.

63. 63. The kit of claim 62, wherein the pump is configured to operate at a substantially constant voltage for a first period of time and at a substantially constant torque for a second period of time to generate a set vacuum pressure.

64. 1. A kit for managing localized pain in a human patient, said kit comprising: at least one therapeutic agent, wherein the at least one therapeutic agent is an anesthetic or an analgesic; 1. An irrigation and irrigation device configured to locally irrigate and irrigate a treatment site for localized pain with at least one dose of said at least one therapeutic agent, said irrigation and irrigation device comprising: a fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution; a control unit configured to control the fluid delivery system according to a treatment process; an irrigation and cleaning device comprising: instructions for administering at least one dose of the at least one therapeutic agent using the irrigation and flushing device to treat the localized pain; A kit comprising:

65. 65. The kit of claim 64, wherein the at least one therapeutic agent is lidocaine.

66. 66. The kit of claim 65, wherein the irrigation device is configured to locally administer a total amount of lidocaine in a 24-hour period that is equal to or exceeds the total daily amount allowed for systemic administration of lidocaine.

67. 65. The kit of claim 64, wherein the at least one therapeutic agent comprises lidocaine and at least one antibacterial agent.

68. 1. A kit for administering localized antifungal therapy in a human patient, said kit comprising: at least one antifungal agent; and 1. An irrigation and irrigation device configured to topically irrigate and irrigate a treatment site for a localized fungal infection with at least one dose of said at least one antifungal agent, said irrigation and irrigation device comprising: a fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution; a control unit configured to control the fluid delivery system according to a treatment process; an irrigation and cleaning device comprising: instructions for administering said at least one dose of said at least one antifungal agent using said irrigation and cleansing device to provide said patient with sustained, localized antifungal therapy over at least a 24 hour period; A kit comprising:

69. 69. The kit of claim 68, wherein the at least one antifungal agent is fluconazole.

70. 70. The kit of claim 69, wherein the irrigation device is configured to locally administer a total amount of fluconazole in the 24-hour period that is equal to or exceeds the total daily amount permitted for systemic administration of fluconazole.

71. 69. The kit of claim 68, further comprising at least two antimicrobial agents.

72. 72. The kit of claim 71, wherein the at least one antifungal agent is fluconazole and the at least two antibacterial agents are vancomycin and tobramycin.

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