Irrigation system and methods of use

Abstract

A treatment delivery system having a fluid delivery system for directing at least a first fluid from a first fluid reservoir to a treatment site; and a control unit programmed to control the fluid delivery system according to a treatment process. The treatment process of the control unit automatically activates transitions between phases in treatment that are activated without user intervention or input. Related devices, systems, kits, and methods are provided.

Description

VIAEFS Atty. Docket No.: 061016-508001 WODate of Filing: August 20, 2025 Customer No. 64046IRRIGATION SYSTEM AND METHODS OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application Ser. No. 63 / 685,599, filed August 21, 2024. The disclosure of the patent application is incorporated by reference herein in its entirety.TECHNICAL FIELD

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

[0003] Artificial joint arthroplasty can lead to periprosthetic joint infection, which can be associated with severe complications. The periprosthetic joint infection treatment protocol typically includes surgery and administration of systemic antibiotics to eradicate the infection. Local irrigation of antibiotics can increase antibiotic concentrations at the infected site compared to systemic administration while maintaining safe systemic levels. Improved treatment techniques based on a standardized antibiotic delivery protocol can form the basis of successfully managing prosthetic joint infections. For example, a combination of devices, fluid delivery control unit, and negative pressure waste removal can provide an increased control of the placement and removal of the fluids, superior cleansing, maintenance of proper joint structures, leading to a superior treatment of the patient’s infection with increased efficiency and success rate.

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

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

[0006] Implementations of the current subject matter can include, but are not limited to, methods consistent with the descriptions provided herein as well as articles that comprise aAtty. Docket No.: 061016-508001 WO tangibly embodied machine-readable medium operable to cause one or more machines (e.g., computers, etc.) to result in operations implementing one or more of the described features. Similarly, computer systems are also described that can include one or more processors and one or more memories coupled to the one or more processors. A memory, which can include a non-transitory computer-readable or machine-readable storage medium, can include, encode, store, or the like one or more programs that cause 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 current subject matter can be implemented by one or more data processors residing in a single computing system or multiple computing systems. Such multiple computing systems can be connected and can exchange data and / or commands or other instructions or the like via one or more connections, including, for example, to a connection over 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.

[0007] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the 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 currently disclosed subject matter are described for illustrative purposes in relation to web application user interfaces, it should be readily understood that such features are not intended to be limiting. The claims that follow this disclosure are intended to define the scope of the protected subject matter.SUMMARY

[0008] For purposes of summarizing, certain aspects, advantages, and features have been described herein. It is to be understood that not all such advantages can be achieved in accordance with any one particular implementation. Thus, the disclosed subject matter can be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages without achieving all advantages as can be taught or suggested herein.

[0009] In an aspect, provided is a treatment delivery system including a fluid delivery system for directing a first fluid from a first fluid reservoir to a treatment site and for directing a second fluid from a second fluid reservoir to the treatment site; and a control unit programmed to control the fluid delivery system according to a treatment process including a flow of the first fluid and the second fluid. The treatment process has a plurality of phases. AAtty. Docket No.: 061016-508001 WO first phase of the plurality of phases includes a controlled delivery of the first fluid from the first fluid reservoir to the treatment site, maintaining the first fluid at the treatment site for a first period of time, and removing a first site fluid from the treatment site, the first site fluid comprising at least some of the first fluid. A second phase of the plurality of phases includes a controlled delivery of the second fluid from the second fluid reservoir to the treatment site, maintaining the second fluid at the treatment site for a second period of time, and removing a second site fluid from the treatment site, the second site fluid comprising at least some of the second fluid. A third phase of the plurality of phases includes repeating the second phase with the second fluid at least once. The treatment process of the control unit automatically activates a first transition from at least the first phase to the second phase and a second transition from the second phase to the third phase. Each of the first and second transitions is activated without user intervention or input.

[0010] In some implementations, before commencing the first phase, the system can perform one or more of (i) verifying a presence of a sufficient weight of the first fluid to perform the treatment process, (ii) verifying a presence of a sufficient weight of the second fluid to perform the treatment process, (iii) verifying a presence of a sufficient weight of any fluid for instillation, and (iv) removing an initial site fluid from the treatment site via application of negative pressure over a predetermined period of time.

[0011] The treatment delivery system can further include a first load cell configured to detect a combined weight including a first weight of the first fluid and the first fluid reservoir and a second weight of the second fluid and the second fluid reservoir. The control unit can process the combined weight measured at a first point in time and at a second point in time later than the first point, in order to monitor a status of fluid delivery. The first load cell can be arranged within a vertical plane of the system and can be configured to be contacted horizontally by a cantilevered hanger component. The first fluid reservoir can be held by an attachment 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.

[0012] The treatment delivery system can further include a waste fluid canister configured to collect a fluid removed from the treatment site. A second load cell can be included that is configured to detect a waste weight of the waste fluid canister and any waste within the waste fluid canister. The control unit can process the waste weight to monitor a status of fluid removal. The second load cell can be arranged within the vertical plane of the system andAtty. Docket No.: 061016-508001 WO can be configured to be contacted horizontally by a second cantilevered hanger component. The waste fluid canister can be held by an attachment 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.

[0013] The fluid delivery system can further include at least one pinch valve controlled by the control unit to open and close according to the treatment process. The fluid delivery system can include a first pinch valve and a second pinch valve, wherein the first pinch valve is configured to receive a first fluid delivery line fluidly connected to the first fluid reservoir and the second pinch valve is configured to receive a second fluid delivery line fluidly connected to the second fluid reservoir. The first pinch valve can be 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. The second pinch valve can be 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.

[0014] 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 can be different 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 can be sized to be received within the first inner dimension of the first pinch valve. The second fluid delivery line can have an outer dimension prevented from being received within the first inner dimension of the first pinch valve.

[0015] The control unit can further include at least one pump configured to generate a set vacuum pressure within the system; and a valve configured to control a vacuum relief. The pump can be powered off during at least the first phase. The pump can be configured to run at approximately constant voltage during a first period of time and at an approximately constant torque during a second period of time to generate set vacuum pressure.

[0016] The treatment delivery system can further include a leak alarm configured to generate an alert indicating a pressure leak determined in response to the control unit detecting a vacuum pressure at the treatment site being below a respective threshold.

[0017] The treatment delivery system can further include a waste fluid canister fill sensor can be included that is configured to generate a waste fluid canister fill alert indicating a fill level of the waste fluid canister being above a fill threshold. The control unit can stopAtty. Docket No.: 061016-508001 WO removal of any of the first fluid and the second fluid from the treatment site in response to the collecting fluid canister fill alert.

[0018] The treatment delivery system can further include an empty fluid reservoir alarm configured to generate an alert indicating that a weight of the first fluid delivered from the first fluid reservoir or a weight of the second fluid delivered from the second fluid reservoir is below a minimum threshold corresponding to a respective phase of the plurality of phases. A low battery alarm can be included that is configured to generate an alert indicating a charge level of the battery of the control unit. The charge level of the battery is determined in response to the control unit detecting the charge level of the battery being below a minimum charge level adequate for powering automatic transition between the plurality of phases. An incorrect assembly alarm can be included that is configured to generate an alert indicating an incorrect assembly of the treatment delivery system. The incorrect assembly is determined in response to the control unit detecting a missing or incorrectly coupled component of the treatment delivery system that prevents an automatic transition between the plurality of phases. A motion alarm can be included that is configured to pause fluid delivery and generate an alert indicating an excessive motion that affects a weight sensor reading during fluid delivery.

[0019] The treatment delivery system can further include a user interface configured to receive a user input comprising a selection of an operation for initiating a sequence comprising the plurality of phases.

[0020] The first fluid delivered by the treatment delivery system can be tobramycin antibiotic fluid. The second fluid delivered by the treatment delivery system can be vancomycin antibiotic fluid.

[0021] The treatment delivery system can further include at least a fourth phase including repeating one of the first phase and the second phase and a third transition from the third phase to the fourth phase. The third transition can be activated without user intervention or input. The third phase can repeat the first phase and the fourth phase can repeat the second phase. The third phase can repeat the second phase at least once and the fourth phase can repeat the first phase. The third phase can include repetitively performing the second phase for a plurality of second-phase repetitions before the fourth phase. The third transition from the third phase to the fourth phase can include automatically transitioning between the plurality of second-phase repetitions without user intervention or input.Atty. Docket No.: 061016-508001 WO

[0022] In an interrelated implementation, provided is a treatment delivery system including a fluid delivery system having a vacuum pump; a first fluid reservoir hanger for suspending at a head height a first fluid reservoir containing a first fluid; and a fluid delivery line configured to be placed in fluid communication with the first fluid reservoir and in fluid communication with a treatment site. The treatment delivery system also includes a control unit programmed to control the fluid delivery system according to a treatment process having a plurality of phases. A first phase of the plurality of phases includes the vacuum pump turned on to deliver a first volume of the first fluid from the first fluid reservoir to the treatment site due to vacuum generated by the vacuum pump. A second phase of the plurality of phases can include the vacuum pump turned off to deliver a second volume of the first fluid from the first fluid reservoir to the treatment site due to one or both of a residual vacuum within the fluid delivery system and gravity provided by the head height. The treatment process of the control unit automatically activates a first transition from at least the first phase to the second phase. The first volume of the first fluid can be about 25 mL to about 50 mL. The residual vacuum within the fluid delivery system can be decaying residual vacuum.

[0023] In an interrelated implementation, provided is a treatment delivery system including a fluid delivery system for directing a first fluid from a first fluid reservoir to a treatment site through a first fluid delivery line formed of a first material; a control unit programmed to control the fluid delivery system according to a treatment process; and a first pinch valve sized to receive the first fluid delivery line. The first pinch valve is normally closed to compress the first fluid delivery line preventing fluid flow through the first fluid delivery line. The first pinch valve is opened by a combination of a solenoid activated by the control unit to open according to the treatment process and a spring-like mechanical force against the first pinch valve supplied by the first material of the first fluid delivery line.DESCRIPTION OF DRAWINGS

[0024] The accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations as provided below.

[0025] FIG. 1A shows an example of a treatment delivery system.Atty. Docket No.: 061016-508001 WO

[0026] FIGs. IB- ID show detailed views of the treatment delivery system of FIG. 1A.

[0027] FIGs. 2A-2F illustrate block diagrams of components of the treatment delivery system performing respective functions, in accordance with some example implementations.

[0028] FIGs. 3 A and 3B show exploded views of the example of the treatment delivery system, in accordance with some example implementations.

[0029] FIG. 4A shows a diagram of an example fluid delivery system of the treatment delivery system, in accordance with some example implementations.

[0030] FIG. 4B shows a close-up of an example fluid delivery system including a flow control segment within the lines;

[0031] FIGs. 5A-5C show examples of user interfaces to control and monitor processes performed by the treatment delivery system, in accordance with some example implementations .

[0032] FIG. 6 shows an example of a process performed by the treatment delivery system, in accordance with some example implementations.

[0033] FIG. 7 depicts an example of a parameter time variation diagram corresponding to the process performed by the treatment delivery system, in accordance with some example implementations .

[0034] FIG. 8 illustrates a block diagram illustrating an example of a computing system, in accordance with some example implementations.

[0035] When practical, similar reference numbers denote similar structures, features, or elements.DETAILED DESCRIPTION

[0036] The disclosed subject matter relates to a treatment delivery system that can administer the delivery and removal of fluid to a treatment site. The treatment delivery system can include a control unit to control a treatment process including flow of multiple fluids during multiple phases. The treatment delivery system can deliver a first volume of a first fluid during a first phase and, after first fluid removal, the treatment delivery system can deliver a second fluid during a second phase. The control unit can automatically activate a transition from one phase to another phase without user intervention or input, while verifyingAtty. Docket No.: 061016-508001 WO parameters corresponding to respective phases to ensure correct functionality of the applied treatment to enable an optimized treatment.

[0037] As an advantage of the proposed solution described herein, the treatment delivery system described herein can execute a (24-hour) cycle of processes in accordance with a clinical protocol without user interaction or input. The clinical protocol or treatment process is predetermined and preprogrammed into the control unit so as to be non-adjustable by a user aside from turning off or pausing or resetting the system. The control unit can be programmed to control the fluid delivery system according to the treatment process that automatically activates transitions in phases of fluid delivery, fluid soak, and / or fluid removal without user intervention or input. The treatment delivery system can switch seamlessly between different phases of the treatment to deliver a set fluid volume of selected fluid types stored in separate reservoirs, according to the clinical protocol. The treatment delivery system enables monitoring of irrigation performance with high accuracy.

[0038] The treatment delivery system can deliver irrigants, such as an antibiotic irrigants, with precise fluid flow control, driven by gravity (i.e., fixed head height between irrigant and treatment site) and either active vacuum assist using one or more pumps or residual vacuum assist (i.e., pump turned on or off), combined discrete logic components incorporated onto a processor, load cells (weight sensors), a pneumatic solenoid valve, and pinch valve(s). If multiple pumps are used, the second pump can serve simply as a back-up to the first in case of failure, can operate in parallel or in series to the first pump at all times to enhance pumping and vacuum generation, or can operate only intermittently, when additional or quicker fluid removal and / or vacuum generation is required or called for and the system is programmed to automatically call on the addition pump for activation for prescribed period(s) of time. One load cell sensor of the treatment delivery system outputs a signal that reflects the combined fluid level / weight of the fluid reservoirs (e.g., solution bags) and can be used to sense changes in weight over time, corresponding to the loss of fluid from one or both of the fluid reservoirs. Although loss of weight of the reservoir(s) usually relates to the delivery of fluid to the patient during a fluid instillation phase, loss of weight during a different phase, or an increased loss of weight beyond what is expected for a particular prescribed delivery of fluid, can be interpreted as either a leak or failure of the system to block / close the instillation line(s), which can be programmed to trigger an audible and / or visual alarm state. Another load cell sensor of the treatment delivery system outputs a signal that reflects the combined weight of the waste fluid and weight of the waste canister. Thus, one load cell sensorAtty. Docket No.: 061016-508001 WO monitors fluid delivery during instillation and a separate load cell sensor monitors fluid removal during evacuation. The two load cell sensors aid in monitoring fluid instillation and fluid removed from the treatment site for potential blockages or a full waste collection canister, etc. A control circuit monitors the differential weight (e.g., change in fluid level over a pre-determined time) to open or close a pinch valve on the fluid delivery line to dispense a preset fluid volume. As another advantage of the proposed solution described herein, the use of load cell sensors enables identification of critical conditions (i.e., risk mitigation of potential treatment hazards). For example, the first load cell sensor can detect a rapid reduction in differential weight within a time period that indicates a reservoir-to-fluid delivery line connection leak, or it can detect the device is incorrectly assembled by sensing no or insufficient weight (when compared to a predetermined threshold value) within a time period that indicates a user has failed to hang a fluid reservoir on the control unit or that the fluid reservoirs are empty or has insufficient fluid to support the therapy. Instillation of fluid is preferably based on both weight and time. The treatment delivery system will not start instilling fluid unless it detects a weight greater than a pre-determined threshold weight within a time period indicating the reservoirs are sufficiently full for an entire one-day cycle. The treatment delivery system tracks instillation of fluid for a particular change in weight within a time limit. If the particular change in weight to be instilled has not been instilled by the time limit, the system may continue to try instilling, cease attempting to instill, and / or trigger an alarm. The second load cell sensor can detect the weight of the canister to monitor fluid removed from the treatment site for potential blockages or full canisters. This second load cell sensor can detect an insufficient differential weight within a time period during fluid removal that indicates fluid delivery blockage, empty bag, tubing kink, or other fluid delivery issues can be identified by the treatment delivery system.

[0039] The control unit can achieve a vacuum pressure (e.g., 0 mmHg to -125 mmHg, preferably about -25 mmHg) that assists the gravity-driven fluid delivery process using at least one pump. The pump(s) can, but need not be actively pumping during fluid delivery with the system. For example, the pump(s) can be off and residual vacuum in combination with gravity due to a head height of the reservoir bags can cause fluid to be delivered to the patient. The residual vacuum can be decaying residual vacuum within the system after turning off the pump(s). However, it should be appreciated that the system can be configured to achieve fluid delivery using continuous active pumping so that the pump(s) remains in an active state while fluid is being delivered to the treatment site. The control unit monitors loadAtty. Docket No.: 061016-508001 WO cell readings that are outside a window of acceptable tolerances that would impair the accuracy of the fluid delivery, for example, due to movement of the system and / or the solution bags, or any excessive motion of the system can impact the load cell readings.

[0040] As an example, the treatment delivery system can include a fluid delivery system and a control unit programmed to control the fluid delivery system according to a treatment process. The fluid delivery system can direct a first fluid from a first fluid reservoir to the treatment site and can direct a second fluid from a second fluid reservoir to the treatment site. The treatment process of the control unit includes a flow of the first fluid and the second fluid according to a plurality of phases. For example, a first phase of the plurality of phases can include a controlled delivery of the first fluid from the first fluid reservoir to the treatment site, maintaining the first fluid at the treatment site for a period of time, and removing a first site fluid from the treatment site, the first site fluid including at least some of the first fluid. A second phase of the plurality of phases can include a controlled delivery of the second fluid from the second fluid reservoir to the treatment site, maintaining the second fluid at the treatment site for a period of time, and removing a second site fluid from the treatment site, the second site fluid including at least some of the second fluid. The plurality of phases can include a third phase that involves repeating one of the first and second phases. The plurality of phases can include at least a fourth phase including repeating one of the first phase and the second phase. The treatment process automatically activates a first transition from at least the first phase to the second phase, a second transition from the second phase to the third phase, and a third transition from the third phase to the fourth phase. Each of the first, second, and third transitions are activated without user intervention or input.

[0041] As another example, the treatment delivery system can include a fluid delivery system and a control unit. The fluid delivery system can include at least one vacuum pump; a first fluid reservoir hanger for suspending at a head height a first fluid reservoir containing a first fluid; and a fluid delivery line configured to be placed in fluid communication with the first fluid reservoir and in fluid communication with a treatment site. The control unit can be programmed to control the fluid delivery system according to a treatment process comprising a plurality of phases. A first phase of the plurality of phases can include the vacuum pump(s) turned on to deliver a first volume of the first fluid from the first fluid reservoir to the treatment site due to vacuum generated by the vacuum pump(s). A second phase of the plurality of phases can include the vacuum pump(s) turned off to deliver a second volume of the first fluid from the first fluid reservoir to the treatment site due to one or both of a residualAtty. Docket No.: 061016-508001 WO vacuum within the fluid delivery system and gravity provided by the head height. The treatment process of the control unit can automatically activate a first transition from at least the first phase to the second phase. The first volume of the first fluid can be about 25 mL to about 50 mL. The residual vacuum within the fluid delivery system can be decaying residual vacuum.

[0042] As another example, the treatment delivery system can include a fluid delivery system for directing a first fluid from a first fluid reservoir to a treatment site through a first fluid delivery line formed of a first material; a control unit programmed to control the fluid delivery system according to a treatment process; and a first pinch valve sized to receive the first fluid delivery line. The first pinch valve can be normally closed to compress the first fluid delivery line preventing fluid flow through the first fluid delivery line. The first pinch valve can be opened by a combination of a solenoid activated by the control unit to open according to the treatment process and a spring-like mechanical force against the first pinch valve supplied by the first material of the first fluid delivery line.

[0043] As mentioned, the system can incorporate at least one pump to perform fluid instillation. In some implementations, the fluid delivery system for directing fluid from the reservoir to a treatment site through a fluid delivery line includes one vacuum pump to achieve a vacuum pressure that assists the gravity-driven fluid delivery process. In other implementations, the fluid delivery system for directing fluid from the reservoir to a treatment site through a fluid delivery line includes two pumps in series to achieve a vacuum pressure that assists the gravity-driven fluid delivery process. The two pumps can be used simultaneously, alternately, or both. For example, the two pumps can be used simultaneously during a first phase, such as to draw vacuum to a desired vacuum within the system quickly, and only one of the two pumps can be used during a second phase, such as to manage pressure within the system once the desired vacuum is achieved with the two pumps during the first phase. The two pumps can provide core component redundance to the system as well. For example, if one of the two pumps malfunctions, the system can return to using a single pump for performing instillation and / or can automatically switch to the backup pump to substitute for the failed pump upon detecting the pump’s failure.

[0044] Other advantages of the treatment delivery system are discussed with reference to FIGs. 1-8.Atty. Docket No.: 061016-508001 WO

[0045] FIGs. 1A -ID show an example of a treatment delivery system 100 that can provide controlled local delivery of fluids into a treatment site 102. In general, the treatment delivery system 100 can include a (portable) disposable device for enabling adjustment of a distance between the treatment delivery system 100 and a treatment site 102 of a patient, such as a patient suffering from an infection treatable with local fluid irrigation. The treatment delivery system can also be designed to mount to an accessory pole unit with a fixed distance between the treatment delivery system 100 and a treatment site 102 of a patient, such that the head height remains consistent throughout treatment. In the example illustrated in FIG. 1A, the treatment delivery system 100 provides irrigation to a treatment site 102 including an irrigable volume (e.g., joint space or bone segment). The treatment 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 held by corresponding attachment features 114A, B. The fluid collection system 104B can include one or more collection fluid canisters 109 held by corresponding attachment features 114B.

[0046] The control system 106 can include a vacuum pressure source (e.g., at least one pump 226 described with reference to FIG. 2D and FIG. 3A) configured to create vacuum pressure within the treatment system. The vacuum pressure source can be actively pumping to manage vacuum pressure within the system during instillation phase, soak phase, or evacuation phase. The vacuum pressure source can actively pump during instillation of a fluid to the treatment site. The vacuum pressure source can actively pump during just a portion of the instillation of the fluid, measured by weight or passage of a predetermined time period, after which, the remainder of the instillation is performed without active pumping, under residual vacuum. The vacuum pressure source can actively pump before instillation of fluid begins and shut off during instillation to thereby rely on residual vacuum pressure in combination with gravity due to a head height of the reservoirs 108 to draw fluid from the fluid reservoirs 108 towards the treatment site 102 through fluid delivery lines 110A, HOB, HOC. The residual vacuum pressure can be decaying over time. The vacuum pressure source can actively pump before instillation of fluid begins and remain active during instillation, but at a lower level or only at certain times during instillation. The vacuum pressure source can also be actively pumping to manage vacuum pressure within the system during a soak phase after instillation of the fluid. The vacuum pressure source can actively pump at low levels if an amount of fluid exits the treatment site during the soak phase, for example, to ensure fluid within the treatment site is replenished. The vacuum pressure sourceAtty. Docket No.: 061016-508001 WO is also configured to draw fluid away from the treatment site 102 toward the fluid collection system 104B through vacuum lines 113A, 113B. The control system 106 controls fluid through the fluid delivery lines 110A, HOB, HOC, and vacuum lines 113A, 113B according to a treatment protocol. The treatment site 102 can include a connection mechanism 116 such as a sealable connection with a catheter and / or cannulas that conduct the fluid transcutaneously to irrigation devices deployed within treated area (e.g., infected tissue and / or infected joints, such as hip, knee, shoulder, wrist, ankle). Although not shown, one or more other medical devices may be assisting and working in coordination and / or parallel with the treatment delivery system 100 to provide treatment for the patient (including the treatment site 102).

[0047] As a route of administration, irrigation means to administer, such as by bathing or flushing, an irrigant to a treatment site, such as an open wound or a body cavity. Irrigation is bi-directional in that the irrigant that is delivered to the treatment site is also removed from the treatment site via aspiration. Delivery of a fluid to the treatment site may be referred to herein as instillation.

[0048] Some therapeutics, such as certain antibiotics, are commonly administered systemically (e.g., intravenously), which has high risk of systemic toxicity. Local instillation of an antibiotic in solution for the treatment of periprosthetic joint infection (PJI) has been reported using repeated doses of antibiotics delivered via catheter to the periprosthetic tissue or joint space following aggressive debridement and one-stage exchange of the prosthesis. Local instillation is a unidirectional delivery of the antibiotic to the treatment site in which none of the instilled antibiotic is aspirated or flushed from the treatment site. Instillation doses, therefore, are absorbed in the tissue and bloodstream such that systemic toxicity considerations also limit the local dose and concentration that may be safely administered by instillation. Whiteside et al. reported that instillation of very high concentrations of vancomycin (50,000-100,000 pg / mL) once or twice daily into the joint space resulted in serum concentrations exceeding safe limits in multiple patients, which required a reduction in the instilled dose and concentration (see Clin Orthop RelatRes (2011) 469:26-33). Although the peak and trough concentrations of vancomycin in the joint space exceeded serum concentrations and were sustained above minimum inhibitory concentration (MIC) of vancomycin for common organisms susceptible to vancomycin, the sustained local concentration was limited by exceeding safe systemic concentrations and was not maintained at or above minimum biofilm eradication concentration (MB EC) of vancomycin (greater thanAtty. Docket No.: 061016-508001 WO4,000 pg / mL) for multiple common PJI organisms. Similarly, the maximum daily dose provided by this instillation method was 1,000 mg.

[0049] Described herein are systems that deliver via irrigation (e.g., instillation and subsequent aspiration) one or more doses of at least one therapeutic as an irrigant (e.g., at least one therapeutic in solution) to a treatment site (e.g., periprosthetic tissue, joint space, etc.) to treat a condition (e.g., localized bacterial or fungal infection, or localized pain, etc.) at the treatment site. The systems described herein can control the treatment according to a treatment process. For example, the treatment process may locally administer in a 24-hour period a total amount of the at least one therapeutic that equals or exceeds a maximum recommended daily systemic dose for that therapeutic. The total daily dosage of the therapeutic irrigant can substantially exceed the maximum recommended daily systemic dose of the therapeutic without the toxicity risks associated with systemic administration.

[0050] In some implementations, the antibiotic vancomycin can be administered locally as an irrigant using the systems described herein at a total dose that exceeds 3,000 mg / day in a 24-hour period to treat a localized infection, for example, over 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 up to about 40,000 mg / day. As another example, the antibiotic tobramycin can be administered locally as an irrigant using the systems at a total dose that exceeds 100 mg / day in a 24-hour period up to about 1,000 mg / day, up to about 1,250 mg / day to treat a localized infection.

[0051] As another example, the treatment process may locally administer at least one therapeutic that is an antifungal agent that is administered to locally irrigate a treatment site that is a localized fungal infection to provide the patient continuous localized antifungal therapy for at least a 24-hour period. The antifungal can be fluconazole locally administered in a 24-hour period a total amount that equals or exceeds a total daily amount permitted for systemic administration of fluconazole. The maximum recommended daily systemic dose for fluconazole is 400 mg / day. The fluconazole can be administered in combination with at least one antimicrobial agents, such as vancomycin and / or tobramycin.

[0052] As another example, the treatment process may locally administer at least one therapeutic that is an anesthetic or an analgesic that is administered to locally irrigate a treatment site to treat localized pain. The anesthetic can be lidocaine locally administered in a 24-hour period a total amount that equals or exceeds a total daily amount permitted forAtty. Docket No.: 061016-508001 WO system administration of lidocaine. The maximum recommended daily system dose for lidocaine is 300 mg / day. The lidocaine can be administered in combination with another therapeutic as described elsewhere herein, such as with at least one antimicrobial agent.

[0053] The treatment delivery system 100 can be used for delivering treatment to any of a variety of treatment sites, such as an infected joint space. Where treatment sites are referred to herein as a joint space or another site, it should be appreciated that the treatment site or type of biological tissue being treated by controlled fluid irrigation can vary, including periprosthetic tissue, joint space, bone segment, bone fracture, of any number of bones, including bones of the hip, knee, shoulder, wrist, ankle, etc. The treatment site can be a wound area, including traumatic wounds, infected tissue, surgical incision, surgical site, osteomyelitis, septic arthritis, breast implant infection, fracture-related infection, and / or infected joints. Examples of treatments include periprosthetic joint infection treatment protocols, such as debridement, antibiotics and implant retention (DAIR) and exchange arthroplasty. Although the application may be described in the context of a particular treatment site (e.g., infected joints) and connection with that site, it should be appreciated that other treatment sites are considered and the way in which the system connects with those various sites may vary.

[0054] Where the treatment solutions being delivered using the systems described herein are described as an antibiotic, other fluids are considered as well, including any of a variety of irrigation fluids such as saline including irrigation fluids having one or more therapeutic capabilities including any of a variety of antimicrobials, 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 treatment solutions being delivered using the systems described herein can include antifungals, alone or in combination with the antibiotic or combination of antibiotics. Examples of antifungals include azole derivatives (e.g., fluconazole, isavuconazole, Posaconazole), amphotericin B, echinocandins (e.g., anidulafungin, caspofungin, micafungin). The treatment solutions being delivered using the systems described herein can include pain medications, alone or in combination with the antibiotic or combination of antibiotics. Examples of pain medications include opioids, analgesics, anesthetics, and the like. Several classes of anesthetic and analgesics are appropriate for local irrigation of wounds, including: amino amides (e.g., lidocaine,Atty. Docket No.: 061016-508001 WO bupivacaine, levobupivacaine, mepivacaine, ropivacaine, prilocaine), amino esters (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). The treatment solutions being delivered using the systems described herein can include a combination of antibiotics, for example, tobramycin sulfate and vancomycin HC1, and an anesthetic, such as lidocaine. The fluid being delivered using the treatment systems described herein can include a combination of antibiotics and an antifungal, such as fluconazole.

[0055] Referring to the example context of treating an infected joint, an example treatment protocol can 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 soaking 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 to a collection fluid canister after a set soaking time corresponding to the second fluid soak period.

[0056] Again with regard to FIG. 1A-1D, the treatment delivery system 100 can be attached to a support assembly 111. The support assembly 111 can include a pole 111A, a base 11 IB, legs 111C including lockable wheels HID, and a power cord 11 IE. 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 enable elevation optimization of the treatment delivery system 100 and, in particular, the height of the fluid reservoir(s) 108A, 108B, relative to a height of the treatment site 102 to enable flow of the fluid from the fluid reservoir(s) 108A, 108B to the treatment site 102. Alternatively, the height of the pole can be fixed to ensure consistent performance of the treatment delivery system. The treatment delivery system 100 can be designed to provide a minimum head height to provide gravity- driven instillation of fluid from the reservoirs (e.g., about 12 inches), a maximum head height to remove fluid under vacuum, and accessibility of device components for standard user tasks.

[0057] The lockable wheels HID of the support assembly 111 can be configured to enable the treatment delivery system 100 to be moved from one location to the next in a more convenient manner. For example, the lockable wheels HID can be set in a release mode to enable the treatment delivery system 100 to be displaced to adjust a location of the treatmentAtty. Docket No.: 061016-508001 WO delivery system 100 relative to the patient and to adjust a distance between the treatment delivery system 100 and the patient (e.g., treated site). The lockable wheels HID of the support assembly 111 can be configured to enable the treatment delivery system 100 to be fixed at a particular location (setting the lockable wheels HID in a locked state to prevent motion). The pole 111A can incorporate a handle or other user feature to aid in manipulating the pole 111A on its wheels HID. In some implementations, the pole can conduct a portion of the power cord to the treatment delivery system 100 to enable (re)charge of the 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 care settings such as a user carrying the device with a handle or other hand-held feature on the system.

[0058] Again with respect to FIGs. 1A-1D, the fluid delivery system 104A includes two or more fluid reservoir(s) 108A, 108B. The fluid delivery system 104A includes fluid delivery lines 110A, HOB (tubing), pinch valve(s) 120A, 120B, spike(s), connectors, and manual clamp(s). The fluid delivery lines 110A, HOB can be loaded on the control system 106 into normally closed pinch valve(s) 120A, 120B, which can be controlled to open and enable flow of set fluid types from the fluid delivery lines 110A, HOB, through the fluid delivery line HOC. The fluid delivery system need not incorporate two pinch valves, but rather a single pinch valve configured to control different fluids through different fluid lines without significant mixing. In some implementations, the fluid delivery system includes a single pinch valve designed to control fluid through two fluid delivery lines. The single pinch valve can be a solenoid valve where one of the fluid delivery lines is normally open while the other of the fluid delivery lines is normally closed. Alternatively, the single pinch valve can be structured in such a way that both fluid delivery lines are normally closed, and each can be selectively activated to open to deliver the desired fluid for the desired weight change or period of time. Such a valve could be structured with a rotating structure that closes both lines in a first position, opens the first line while keeping the second line closed in a second potion, and closes the first line while opening the second line in the third position.

[0059] The fluid delivery system 104A includes fluid delivery lines 110A, HOB (tubes) for directing fluid from a selected fluid reservoir 108A, 108B during a respective phase of the treatment, through the fluid delivery line HOC to the treatment site 102 fluid delivery line. The fluid delivery lines 110A, HOB that transmit fluid from multiple fluid reservoir(s) 108A, 108B to the treatment site 102, which can incorporate a spacer 107 positioned within a jointAtty. Docket No.: 061016-508001 WO space, can be loaded into the control system 106 through an entry port 112A, providing unobstructed access to fluid delivery lines 110A, HOB, if correctly attached to the pinch valves 120A, 120B. The pinch valves 120A, 120B (best shown in FIGs. 1C and ID) can be covered by an openable door 112B (shown in FIG. IB).

[0060] The openable door 112B can be opened to enable access to the pinch valves 120A, 120B to enable loading of the fluid delivery lines 110A, HOB within the pinch valves 120A, 120B. The openable door 112B, when closed allows the fluid delivery lines 110A, HOB to extend from outside the door 112B to the location of the pinch valves 120A, 120B without disrupting flow through the fluid delivery lines 110A, HOB when the door 112B is hinged to the closed position. In some implementations, the openable door 112B does not close until the fluid delivery lines 110A, HOB are installed properly in the pinch valves 120A, 120B. If the fluid delivery lines 110A, HOB are incorrectly loaded in the pinch valves 120A, 120B the closure of the door 112B is prevented. The fluid delivery system 104A can include at least two mechanical safety features: 1) pinch valves 120A, 120B size-matched with respective fluid delivery lines 110A, HOB such that a particular pinch valve 120A or 120B cannot receive a non-matching fluid delivery line HOB or 110A (and therefore, deliver an incorrect fluid during a particular phase); and 2) The openable door 112B cannot close if not installed properly.

[0061] The fluid delivery system 104A can include additional safety features. The fluid delivery lines 110A, HOB can have an identifier (e.g., color code, marking, numerical identifier, barcode, etc.) providing information about the fluid being delivered through them. The pinch valves 120A, 120B can include one or more features that ensure a correct connection with the fluid delivery lines 110A, HOB. For example, the number of the pinch valves 120A, 120B can match the number of fluid reservoir(s) 108A, 108B and the number of the fluid delivery lines 110A, HOB. Each of the pinch valves 120A, 120B can have an identifier (e.g., color code, symbol marking, numerical identifier, barcode) within or near the entry ports to enable correct matching of the fluid delivery lines 110A, HOB, such that a first fluid delivery line 110A for fluid flow from the first fluid reservoir 108A is connected to a first pinch valve 120A and a second fluid delivery line HOB for fluid flow from the second fluid reservoir 108B is connected to a second pinch valve 120B. In some implementations, the fluid delivery lines 110A, HOB for directing fluid from fluid reservoir(s) 108A, 108B storing different types of fluids can have different geometries (circular cross-section, oval cross-section) and / or different sizes that match the geometry and size of respective pinchAtty. Docket No.: 061016-508001 WO valves 120A, 120B. Even though FIGs. 1A and IB illustrate two pinch valves 120A, 120B connecting to the fluid delivery lines 110A, HOB that direct fluid from two fluid reservoirs 108A, 108B, the treatment delivery system 100 can include just one pinch valve or more than two pinch valves 120A, 120B to enable controlled flow from more than two fluid reservoirs (e.g., two main fluid reservoirs and two back-up fluid reservoirs or for controlled flow from more than two fluid reservoirs storing fluids with different compositions and concentrations).

[0062] Each fluid delivery line 110A, HOB can include a flow control segment 415 along its length that is designed to be received within the respective pinch valves 120A, 120B (see FIG. 4B). The flow control segment 415 can be size-matched to the pinch valve opening to accept or prevent insertion of the flow control segment 415 of the fluid delivery line into the pinch valve. The flow control segment 415 of the fluid delivery lines can be formed by a separate segment of tubing that is connected to the remainder of the delivery line by two inline connectors. These inline connectors can be gripped by a user during loading of the flow control segment 415 into the pinch valve openings. The inline connectors on either end of the flow control segment 415 can be gripped and used to gently stretch, lengthwise, the flow control segment 415 tubing so that it can be firmly inserted into the slot of the pinch valve. More details about the fluid delivery system 104A are described with reference to FIGs. 4A-4B.

[0063] The fluid delivery system 104A can deliver fluid to the treatment site 102 in a controlled manner, using the control system 106. The control system 106 can generate vacuum to induce a negative pressure at the treatment site 102 to optimize gravity-assisted delivery of a particular fluid (e.g., cleansing fluid, antimicrobial fluid, antibiotic irrigants, antifungals, or any other type of pharmacological fluid, including analgesics, or local anesthetics), with high precision, from a particular fluid reservoir 108A or 108B (e.g., solution bag) into the treatment site (e.g., periprosthetic space) 102 via fluid delivery lines 110A, HOB (e.g., fluid delivery lines) that are selectively and sequentially opened, such as by respective pinch valves 120A, 120B. A desired set vacuum pressure within the system can be achieved prior to the initiation of treatment solution delivery during a “pre-delivery period,” such as with at least one pump. The vacuum pump(s) when turned on, can achieve and maintain vacuum pressure of the system for fluid instillation to the treatment site and fluid removal from the treatment site. The vacuum pump(s) and relief valve can achieve a secondary vacuum pressure, before turning off, in advance of fluid delivery. Residual vacuum pressure within the system even after the pump is no longer running can be leveragedAtty. Docket No.: 061016-508001 WO during the delivery period(s) and aided by gravity-driven fluid delivery (z.e., head height of reservoirs) to draw treatment solutions toward the treatment site and / or remove fluid from the treatment site. For example, the pump(s) can be turned on during the pre-delivery period to generate vacuum pressure within the system to a desired set-point. The pump(s) can then be turned off and the treatment site exposed to the residual vacuum pressure within the system to cause flow of liquids through the system to and / or from the treatment site. The head height of the source container together with the residual vacuum within the system delivers and / or removes the treatment solutions to and from the treatment site. The residual vacuum can be decaying over time. The pump(s) may be activated or at a low setting at least once during the soak phase and need not be completely turned off for the duration. The head height of the source containers can vary, but assuming a patient in the supine position may be at least 12 inches above the patient wound dressing. The delivery can be controlled by the control unit based on the load cell readings and also via activation of the pinch valves as opposed to the vacuum pump itself precisely controlling fluid flow and delivery to a patient. The system can rely on gravity and residual vacuum in the system for driving instillation of fluid to the patient. In other implementations, the vacuum pressure can be actively maintained within the system during the delivery period(s) with at least one pump. For example, to assist the gravity-driven instillation of a fluid, such as to overcome back-pressure, an unprimed line, or minimum head height, etc., the controller can maintain a low vacuum pressure during instillation. The instill pressure setpoint can vary, for example, about 0 mmHg to about -125 mmHg. The amount of fluid instilled before the pump is automatically turned off or turned down can also vary. The pump can be turned off or turned down by the controller after all or some fluid has been instilled, for example, after about 25 - 50 mL of the fluid has been instilled. Similarly, the timing to vent to atmospheric pressure after the pump is turned off / down can vary. This timing can keep instill flowing while avoiding significant removal of fluid via the patient suction line during an instillation or soak. Once the fluid has been instilled to the treatment site and a soak phase of the fluid begins, the pump may remain off or may remain active, but at a low setting (e.g., target vacuum of about -25 mm Hg to about -35 mmHg). The system can detect entry of fluid into the suction line (e.g., about 10-15 mL) and turn off a pump that is at a low setting to prevent further fluid exiting the treatment site during soak phase. Thus, even during soak periods, the pump may remain active for at least some time during soak and may be automatically switched off for at least some time during soak based on the detection of fluid in the line, passage of a predetermined period of time, etc.Atty. Docket No.: 061016-508001 WO

[0064] In some implementations, a pressure process applies a control loop to the vacuum pump to apply negative pressure to the treatment site. A pressure setpoint is provided along with a tolerance. The control loop first applies vacuum until the most negative (highest vacuum) of the tolerance allowed is reached. When the pressure eventually leaks to the lower limit of the tolerance (lowest vacuum, most positive pressure), the vacuum pump turns on again until the highest vacuum is reached, and repeats. An exception to this is on vacuum relief, which opens the relief valve for a set amount of time after atmospheric pressure is reached. The control loop logic is different depending on the setpoint. If the process is controlling to a vacuum pressure (negative relative to atmospheric pressure), then it follows a pattern similar to the following. The pump applies vacuum and a pressure sample is taken and compared to a maximum setpoint. If the sample is not greater than or is equal to the maximum setpoint, the vacuum pump continues generating a vacuum. If the sample is greater than or equal to the maximum setpoint, the vacuum pump shuts off. Pressure samples are taken and compared to the maximum setpoint. The vacuum pump remains off if the pressure is greater than or equal to the maximum setpoint. Once the pressure is less than the maximum setpoint, the vacuum pump turns on again to start generating a vacuum.

[0065] If the process is attempting to relieve pressure to atmosphere and maintain it at atmosphere, the control loop behavior can be different. For that process, the pressure sample is compared to zero pressure. If the pressure sample is not at zero, the system continues relieving pressure. Once the pressure sample is at zero, the relief valve can be held open for a period (e.g., 2.5 minutes) and another pressure sample taken. If the pressure is above the maximum setpoint for relief, the relief valve is held open for a period (e.g., 2.5 minutes) and another pressure sample taken. If the pressure is not above the maximum setpoint for relief, but is below the minimum, the relief valve is held open for a period and pressure sample taken again. The process can be repeated to confirm the pressure sample is at zero and inside the control band for atmospheric pressure.

[0066] In other implementations, the pressure process applies a Proportional-Integral- Derivative (PID) control loop to the vacuum pump to apply negative pressure to the treatment site to evacuate fluid from the treatment site to a canister as discussed throughout. A pressure setpoint can be provided along with a tolerance to provide control. To improve performance, the PID controller can use two sets of gains and settings, one for the vacuum setpoint (e.g., - 140 mmHg) and one for the instill setpoint (e.g., -25 mmHg). The zero offset taken after initial pressure relief can be clipped to theoretical bounds for total error in the pressure.Atty. Docket No.: 061016-508001 WOPressure measurements used by the application can be relative to this zero offset point. Clipping the zero offset can protect the application in different scenarios, such as the relief valve failing to relieve pressure or a large negative pressure incorrectly used as the zero offset point. The control loop can handle any non-linearity in the vacuum pump drive (e.g., only turning on at minimum 45% duty cycle) by output on the positive scale 0-100% and that is mapped to 45-100% for the pump drive. The control loop can control with 0-100% of the pump’s usable range. This method of control can increase sensitivity of the control loop and performance. However, the controller can work without this method as well. The control output (or effort) can be logged and passed to the pressure monitoring process.

[0067] The system need not be symmetric in that it does not proportionally apply vacuum and relieve vacuum and can be limited in its negative action. The system can have an overdamped response to avoid excessive overshoot and / or steady state error.

[0068] There can be a provision where if the controller wants to apply a negative control output below a threshold, the relief valve is opened until the setpoint is passed. The controller is reset and then it is updated to evacuate air to reach the setpoint (e.g., on-the-fly setpoint change from -140 mmHg to -25 mmHg). Negative control action can be improved to opening the relief valve for a proportion of a fixed time (e.g., if the maximum time is 1 second and the controller outputs -25%, then the relief valve is opened for 250 ms and then closed). The pressure sensed by the control loop can be at the control unit’s circuit board or at the treatment site.

[0069] If the process attempts to relieve pressure to atmosphere and maintain it at atmosphere, the control loop behavior can be different. The relief valve can be held open for a fixed time, referred to as the Soak Pressure Setpoint Open Time (SPSOT). For that process, the pressure sample is compared to zero pressure. If the pressure sample is not at zero, the system continues relieving pressure. Once the pressure sample is at zero, the relief valve can be held open for SPSOT and another pressure sample taken. If the pressure is above the maximum, the relief valve is held open for SPSOT and another pressure sample taken. If the pressure is not above the maximum, but rather is below the minimum, the relief valve is held open for SPSOT and pressure sample taken again. The process can be repeated to confirm the pressure sample is at zero and inside the control band.

[0070] Again with respect to FIGs. 1A-1D, each of the fluid reservoirs 108A, 108B can have a particular volume and store a particular fluid type that is delivered during a respectiveAtty. Docket No.: 061016-508001 WO treatment phase. The first fluid reservoir 108A can store a first fluid that can include an antibiotic, such as tobramycin sulfate. The first fluid can be delivered from first fluid reservoir 108 A to the treatment site 102 according to a respective fluid delivery protocol defining a volume of the first fluid to be delivered, a duration of fluid delivery, and predelivery vacuum that can be performed for a set vacuum time period (e.g., approximately 30 minutes) at a set pressure (e.g., -125 mmHg). The volume of first fluid to be delivered to the treatment site 102 can be set in a range between 6 mL and 500 mL, such as, 50 mL. In some implementations, approximately 80 mg of tobramycin sulfate in 50 mL of 0.9% sodium chloride are delivered in about 30 to 60 seconds and allowed to soak for a total of 2 hours in a single 24-hour period. The delivery of the first fluid volume can be controlled with an accuracy of ± approximately 5 mL to 10 mL. In some implementations, the delivery of first fluid is followed by a soaking protocol to enable the treatment site 102 to soak the delivered fluid. The duration of the first fluid soaking protocol can vary, and in some implementation is between 1 and 3 hours, such as approximately 2 hours. The first fluid can be removed from the treatment site 102, by the fluid collection system 104B, before a second fluid is delivered to the treatment site 102. The duration of the first fluid removal from the treatment site 102 can be approximately 30 minutes.

[0071] The second fluid reservoir 108B can store a second fluid that can include an antibiotic, such as vancomycin hydrochloride. The volume of second fluid to be delivered to the treatment site 102 over at time period can be set in a range between 500 mL and 1500 mL, such as, 1200 mL. In some implementations, approximately 125 mg of vancomycin hydrochloride in 50 mL of 0.9% sodium chloride are delivered in about 30 to 60 seconds and allowed to soak for 30-minutes before being removed under vacuum over a period of 30- minutes and repeated for 20-23 times before the treatment protocol is reset for the next 24- hour period. The total volume of the second fluid delivered can vary depending on the length of the time period as well as the total time for first fluid delivery, soak, and removal. For example, in a 24-hour time period where the first fluid delivery, soak, and removal was 2 hours, the time period of delivery of the second fluid can be approximately 22 hours. In some implementations, approximately 50 mL increments of 3000 mg vancomycin hydrochloride in 1200 mL of 0.9% sodium chloride are delivered in about 30 to 60 seconds and allowed to soak for a total of about 30 minutes. The number of 50 mL increments delivered can be about 20-23 in a single 24-hour period for a total of about 1000-1200 mL volume of the second fluid. The delivery of the second fluid volume can be controlled with an accuracy of ±Atty. Docket No.: 061016-508001 WO approximately 5 mL. The delivery of second fluid is followed by a soaking protocol to enable the treatment site 102 to soak the delivered fluid. The duration of the second fluid soaking protocol can be between 15 and 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) and during each day, the first fluid can be delivered once to soak the treatment area 102 and after the removal of the first fluid, multiple cycles of second fluid delivery, soaking, and removal can be repeated to complete a 24-hour treatment protocol. On day 1, for example, the treatment site 102 and system can be prepped and a vacuum within the system established, such as by a pump. Following seal checks and confirmations within the system, the first fluid can be delivered and allowed to soak as described above. After removal of the first fluid, the second fluid can be delivered, allowed to soak, and subsequently removed. The delivery, soak, and removal of the second fluid can be performed once, or twice, or a plurality of times (e.g., 20-23 times) the remainder of day 1. At the start of day 2 (e.g., about 24 hours after initiation of treatment), the canister and / or one or more reservoir bags can be changed and seal confirmed. A pre-treatment vacuum cycle can commence prior to initiation of the first fluid delivery and soak. After removal of the first fluid, the second fluid can be delivered, allowed to soak, and subsequently removed a plurality of times (e.g., 20-23 times) the remainder of day 2. This daily protocol can be repeated for a period of up to about 7 days, up to about 10 days, up to about 14 days, or however long the treatment is desired.

[0072] The therapeutic protocol can be a series of irrigation cycles performed within a single day, each irrigation cycle of which including a fluid instillation period, a soak period, and a fluid removal period. The protocol can begin with an irrigation cycle of a first fluid, such as tobramycin, followed by an irrigation cycle of a second fluid, such as vancomycin. The irrigation cycle of the first fluid and the irrigation cycle(s) of the second fluid can be performed in a single 24-hour period or a daily protocol. The daily protocol is performed including transitions from one phase to another phase without user intervention or input. The daily protocol can be repeated the following 24-hour period, beginning again with the first fluid irrigation cycle, which can begin at approximately the same time every day, for any number of days. The irrigation cycles of the second fluid in a given 24-hour period can varyAtty. Docket No.: 061016-508001 WO due to variations in temporary delays such as handling of alarms, changes in the first fluid start time due to, for example, delays in receipt of therapeutic fluids from the pharmacy. The irrigation cycle of the first fluid can include preferably 1 irrigation cycle, although more than one irrigation cycle is considered, including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, or more irrigation cycles in a single 24-hour period. The irrigation cycle of the second fluid can include 1 irrigation cycle, preferably more than one irrigation cycle, including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, or more irrigation cycles in a single 24-hour period. For example, the first fluid irrigation cycle can be performed followed by a single second fluid irrigation cycle before repeating the following day. Alternatively, the first fluid irrigation cycle can be performed and repeated one or more times before the second fluid irrigation cycle is performed in the single 24-hour period before repeating the following day. Any of a variety of irrigation cycle combinations between the first and second fluids are considered herein depending upon the desired treatment protocol for a particular drug or drug combination. The irrigation cycles can vary depending on the therapeutics being delivered. A single drug may be delivered over a single 24-hour period before initiating a treatment protocol that involves alternating between different drugs. As another example, tobramycin may be most effective when administered according to a once daily irrigation cycle followed by an irrigation cycle of vancomycin, which may be most effective when delivered and maintained for a majority of that same day. As such, each day the tobramycin irrigation cycle can be performed and is followed by one, two, three, or more irrigation cycles of vancomycin and then repeated the next day. The order of drug delivery can also vary and need not be exactly as described with the single irrigation cycle of the first fluid being performed before the multiple irrigation cycles of the second fluid. Other therapeutic agents or combinations of therapeutic agents may benefit from a different administration protocol, such as a treatment protocol that alternates between two drug irrigation cycles once, twice, three times, or more in a single 24-hour period. In still further implementations, a first therapeutic irrigation cycle can be performed once or repeated so as to be performed once, twice, three times, or more in a single 24-hour period before a second therapeutic irrigation cycle is initiated. The second therapeutic irrigation cycle can be performed once, twice, three times, or more in the single 24-hour period before returning to the first therapeutic irrigation cycle. The transitions between these irrigation cycles being performed automatically without user intervention or input in that 24-hour period. The therapeutic protocols described herein are used as anAtty. Docket No.: 061016-508001 WO example of what the treatment protocol can be and are not intended to be limiting as the only protocols considered.

[0073] The fluid collection system 104B can include vacuum lines 113A, 113B (tubes) for directing fluid from the treatment site 102 to a collection fluid canister 109 The control system 106 can generate a vacuum in the collection fluid canister 109 through the vacuum line 113B to remove the fluid from the treatment site 102 into the collection fluid canister 109 through the vacuum line 113A. For example, a pump can be activated by the control system 106 to create a vacuum within at least the collection fluid canister 109. The collection fluid canister 109 can include a single-use canister with a known volume (e.g., 2000 mL), such as, for example, Bemis Mfg. 2000-cc Hi-Flow Canister - Model No. 494410 or Model No. 495410. The collection fluid canister 109 collects antibiotic solution or other fluids (e.g., wound exudate) accumulated during vacuum-induced drainage 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) during the treatment and at the completion of the treatment. The large volume collection fluid canister 109 (e.g., about 2L volume) may need only be emptied following a full 24-hour cycle of a treatment protocol. The material of the canister 109 is preferably translucent or transparent for a user to assess the level of the contents within the canister 109 during use. The material of the canister 109 is also preferably capable of retaining a vacuum without deforming or restricting flow at maximum vacuum level. The canister 109 can incorporate a patient port to patient suction line, a vacuum port to vacuum tube of control unit, and other features, such as a pour spout on its self-sealing lid. The ports can incorporate fitted caps to close off the ports when not in use.

[0074] The control system 106 can control the 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 in a particular direction a particular fluid type for a set time duration, as described with reference to FIGs. 6 and 7. The settings of the control system 106 can be predetermined for a particular treatment type (e.g., the administration of vancomycin and tobramycin during a two-stage exchange arthroplasty procedure) according to one or more patient characteristics 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 to control the fluid delivery to a patient can be pre-programmed at a point of manufacturing and need not be programmed by a user at the time of use. A singleAtty. Docket No.: 061016-508001 WO actuation of a button on the system to initiate a treatment, for example, may be sufficient to initiate the set protocol, which in the case of multiple treatment solutions switches seamlessly between fluid sources (e.g., antibiotic solution bags) as the set protocol cycles through sequential deliveries and removals of the treatment solutions. In some implementations, the settings of the control system can be updated by the user (e.g., number of fluid solutions administered to the patient, treatment option A, B, or C, etc.).

[0075] The control system 106 can enable removable attachment of multiple fluid reservoir(s) 108A, 108B that can be attached to or supported by an attachment feature (e.g., hanger) 114A of the treatment delivery system 100. The control system 106 can enable removable attachment of the collection fluid canister 109 that can be attached to or supported by an attachment feature (e.g., ring) 114B of the treatment delivery system 100. The attachment features 114A, 114B can be configured to match a geometry and / or shape of at least a portion the fluid reservoir(s) 108A, 108B, and collection fluid canister 109, respectively, for secured removable attachment to ensure that the fluid reservoir(s) 108A, 108B, and collection fluid canister 109 are secured in position even during displacement (position adjustment) of the treatment delivery system 100.

[0076] The control system 106 can maintain vacuum pressure levels (e.g., -125 mmHg + / - 10% or -112.5 mmHg to -137.5 mmHg) at particular, intermittent periods corresponding to respective treatment phases, to deliver fluid to the treatment site 102, to allow the fluid to soak at the treatment site, and to remove the fluid from the treatment site 102 into the collection fluid canister 109. The control system 106 can control fluid flow and vacuum pressure by using discrete logic components, processor / firmware, a pressure sensor, solenoid pinch valves, a vacuum pump, and a pneumatic solenoid valve 228, as described in detail with reference to FIGs. 2A-2F. As illustrated in FIG. IB, the control system 106 can include a user interface 118. The user interface 118 can receive a user input for initiating a predetermined treatment cycle. In some implementations, the user interface 118 can receive a user input for an authorized user to select a treatment type and initiation of the treatment. In some implementations, the user interface 118 can receive a single user input to initiate treatment. The user interface 118 can be configured to include security features to prevent an unauthorized user from adjusting a therapy mode 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 is outside a setAtty. Docket No.: 061016-508001 WO threshold to assist the user to ensure correct treatment execution. More details about the alarms generated by the user interface 118 are described with reference to FIGs. 5 and 6.

[0077] The fluid can be delivered to and removed from the treatment site 102, through a connection mechanism 116. The connection mechanism 116 can include one or more fluid connection ports to enable attachment of the fluid delivery lines HOC for delivery to the treatment site 102 and vacuum lines 113A for collection of the fluids from the treatment site 102 to allow irrigation of the treatment site 102 during corresponding treatment phases. In some implementations, the connection mechanism 116 can include a medical device that acts as a delivery component, such as an intramedullary stem, spacer, and / or any of a variety of components configured to distribute the treatment solution into the treatment site 102 including joint space and a surrounding intramedullary canal. The delivery component can, using pressure, such as steady pressure or a controlled pulsating pressure, such as a pulsatile lavage delivery, distribute the treatment solution.

[0078] FIG. 2A illustrates an example block diagram 200A of the treatment delivery system 100 illustrating the connections between some components of the treatment delivery system 100, described with reference to FIGs. 1A- ID. The control system 106 can control fluid flow from the fluid reservoirs 108A, 108B through the fluid delivery lines 110A, HOB to the control system 106 and from the control system 106 through the fluid delivery line HOC to the treatment site 102. The fluid delivery lines 110A, HOB can be routed through their respective pinch valves 120A, 120B of the control system 106 to provide a fluid connection between the fluid reservoirs 108A, 108B and the control system 106.

[0079] The control system 106 can control fluid removal from the treatment site 102 to the collection fluid canister 109 through the vacuum line 113A, 113B. As illustrated in FIG. 2A, the control system 106 is connected to the fluid reservoirs 108A, 108B through the fluid delivery lines 110A, HOB and to the collection fluid canister 109 through the vacuum lines 113B (for fluid delivery). The control system 106 is also connected directly to the fluid reservoirs 108A, 108B through attachment feature 114A and directly to collection fluid canister 109 through attachment feature 114B (for monitoring the weight of the fluid reservoirs 108A, 108B) and of the collection fluid canister 109, respectively, throughout the treatment to enable 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, HOB, HOC, and one or more of the vacuum lines 113A, 113B. The pressure sensor, which can be located within the control unit on the PCB, can also be fluidlyAtty. Docket No.: 061016-508001 WO connected to the treatment site. The pressure sensor can measure pressure of the closed system, which includes the treatment site based on its being in 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 adjust fluid flow to or from the treatment site 102.

[0080] The collection fluid canister 109 can include a designated inlet (patient) port 119 fluidly connected to the dressing kit 202 and one designated outlet (vacuum) port 121 fluidly connected to the control system 106. The ports 119, 121 of the collection fluid canister 109 can include fitted caps available to close off the ports when the ports are not in use (e.g., disposal of the collection fluid canister 109). In some implementations, the ports can be customized to fit with only a vacuum line tube connector or a control unity line tube connector to ensure appropriate assembly of the system.

[0081] The dressing kit 202 can be in fluid connection with both the collection fluid canister 109 and the treatment site 102. The dressing kit 202 can include a sterile, single-use kit, including an adhesive film drape, a high tensile strength foam, and tubing for fluid connection with the collection fluid canister 109 attached to the control system 106. For example, dressing kit 202 can be configured to enable the control system 106 to remove fluid from the treatment site and to deposit it in the collection fluid canister 109 by the application of vacuum, through the dressing kit 202. For example, the canister 109 can be a canister or the pump 226 can be activated to generate a vacuum within the canister 109 via vacuum line 113B coupled at port 121. The vacuum within the canister 109 can be applied to the treatment site 102 via the vacuum line 113A coupled at port 119 on a first end and the dressing kit 202 at a second end. The dressing kit 202 can include a commercial dressing kit indicated for negative pressure wound therapy to aid and promote healing of the treatment site 102.

[0082] The treatment site 102 can include a connection mechanism 116, such as a catheter and / or cannula that conducts the fluid transcutaneously to irrigation devices deployed within the treated area (e.g., infected tissue and / or infected joints, such as hip, knee, shoulder, wrist, ankle). In some implementations, an intra- articular end of the intramedullary stem can have a variable diameter to fit in 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 connecting to the fluid delivery lines 110 and the other connecting to the dressing kit 202. Accessories 204 that assist in the application of the dressing kit 202 to a patient, for example, paste, gauze, alcohol swab sticks, and the like, can be provided with the system to improve seal reliability of the dressing kit 202.Atty. Docket No.: 061016-508001 WO

[0083] FIG. 2B illustrates an example block diagram 200B of a portion 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(s) 120A, 120B. Where the system is used to deliver more than a single treatment solution, one or more pinch valves can be incorporated. In some implementations, a single pinch valve is engaged with and configured to control delivery of a first treatment solution through a first delivery line 110a and delivery of a second treatment solution through a second delivery line 110b without significant mixing of the first and second treatment solutions. In other implementations, a first pinch valve 120A is engaged with and configured to control delivery of a first treatment solution through a first delivery line 110A and a second pinch valve 120B is engaged with and configured to control delivery of a second treatment solution through a second delivery line HOB. The pinch valves 120A, 120B can selectively control delivery of the respective treatment solutions through respective delivery lines toward the treatment site.

[0084] The system also preferably includes two load cells, a first load cell 206A configured to engage a component on the fluid delivery side of the system (see FIG. 2C) and a second load cell 206B configured to engage a component on the waste removal side of the system (see FIG. 2F), which are described in more detail herein. The load cell 206 can be a weight sensor configured to measure a weight of a component acting on the load cell 206. For example, the load cell 206 can include strain gauge to monitor the mechanical load of a fluid reservoir containing a treatment solution that is arranged to abut against the load cell 206. The strain gauges can be electronically connected to a sensor capable of measuring the forces 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 cells 206 are described in more detail below regarding FIGs. 3 A and 3B.

[0085] The filter 208 can include a band-pass filter with a frequency corresponding to the measurement frequency of the load cell to enable noise removal from the load cell output signal that reflects the fluid level, such that the transmitted fluid level is linearly decreasing or increasing during normal (leakage free and blockage free) operation of the treatment system.

[0086] The load cell controller 210 can control a load cell signal detection and filter frequency. For example, to extend battery lifetime, the load cell can operate on a 1-5 second duty cycle. The duty cycle can be adjusted to increase frequency of data collection during treatment or to further extend battery life. The control system can incorporate a single loadAtty. Docket No.: 061016-508001 WO cell controller 210 that receives information from the first load cell 206 A on the fluid delivery side of the system during instillation and receives information from the second load cell 206B on the waste removal side of the system during evacuation. In this implementation, signals from one load cell are being processed during instillation and signals from the other load cell are being processed during evacuation. The control system can also incorporate dedicated load cell controllers 210 for each load cells 206 A, 206B so that signals from each load cells 206A, 206B are being received and processed simultaneously, which may be advantageous to track that no unexpected weight losses are experienced in either the waste or instillation sides of the system during instillation or fluid removal, respectively, which may indicate the presence of an unintentional fluid leak if that were to happen.

[0087] The microcontroller (MCU) 212 can host the software that provides the logic which defines the system functionality during the treatment. The MCU 212 can include a control circuit configured to monitor the differential weight (e.g., change in fluid level). The weight can be used as an input, by the MCU 212 to control transition from one phase of the treatment to another (e.g., by closing a pinch valve and opening another pinch valve), to tell if there is a blockage of vacuum, and / or to determine if a fluid reservoir 108A, 108B is empty. The MCU 212 can serially 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 the knowledge obtained from set fluid level variation protocols corresponding to particular treatment types.

[0088] The pinch valve(s) 120A, 120B can be configured to open or close a respective fluid delivery line, thereby controlling delivery of a set volume of a particular fluid during a particular phase of the treatment. For example, the pinch valve(s) 120A, 120B can be controlled by a digital output generated by the MCU 212 to open and allow a particular fluid during a particular phase of the treatment to flow to the treatment site for a set period of time, after which the pinch valve(s) 120A, 120B can be controlled by the digital output generated by the MCU 212 to close and another pinch valve(s) 120A, 120B can be controlled by a digital output generated by the MCU 212 to open to allow another fluid during another phase of the treatment to flow to the treatment site.

[0089] As mentioned above, the treatment delivery system 100 can include a single pinch valve 120 designed to control fluid through each of the fluid delivery lines 110A, HOB where one of the fluid delivery lines 110A is open while the other fluid delivery line HOB is closed and vice-versa.Atty. Docket No.: 061016-508001 WO

[0090] FIG. 2C illustrates an example block diagram 200C of the control system 106, illustrating the connections between some components of the control system 106, described with reference to FIGs. 1A and IB to monitor fluid delivery during different phases of the treatment. The example block diagram 200C of the control system 106 illustrates monitoring of the fluid delivery system 104A and fluid collection system 104B. The example block diagram 200C of the control system 106 includes a load cell 206A, the filter 208, the load cell controller 210, the MCU 212, and the soft filter 214, as described with reference to FIG. 2B.

[0091] FIGs. 2D and 2E illustrate block diagrams 200D and 200E of examples of controlling, using the control system 106, the fluid delivery and the fluid removal systems during a treatment. The example of fluid control, illustrated in FIG. 2D, includes a pressure sensor 218, a filter 220, an analog to digital converter (ADC) 222, the MCU 212, a pulse width modulator 224, and at least one pump 226.

[0092] The pressure sensor 218 can be configured to send a control signal to the MCU 212 of the control unit (e.g., control system 106 described with reference to FIGs. 1A-1D) to adjust pressure at the treatment site 102 through the dressing kit 202. The pressure sensor 218 can be included in the control unit to monitor pressure of the vacuum-assisted fluid delivery to the treatment site 102 and the removed fluid during the fluid removal phase of the treatment. The pressure sensor 218 can be configured to generate an output including a pressure signal that can be filtered by the filter 220. The filtered analog pressure signal can be converted to a digital signal by the ADC 222. The ADC 222 can send a control signal to the MCU 212 of the control unit to adjust fluid flow by modifying a pump setting.

[0093] 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 for varying the flow rate of the collected fluid by controlling the at least one pump 226, based on signals 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 parts with a set pulse width to effectively control the pump 226.

[0094] The pump 226 can be configured to apply a vacuum pressure on the treatment site to draw fluid into the treatment site and to remove waste fluid from the treatment site during the fluid removal phase of the treatment. The pump 226 can include an electronically controlled peristaltic pump, 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,Atty. Docket No.: 061016-508001 WO the pump 226 along with one or more other components of the system can be disposable. The entire control system 106 can be fully disposable and can be inoperable after a period of continuous use (e.g., 15 days).

[0095] As mentioned above, the fluid delivery system for directing fluid from the reservoir to a treatment site through a fluid delivery line can include two pumps 226 in series to achieve a vacuum pressure that assists the gravity-driven fluid delivery process. The two pumps 226 can be used simultaneously during a first phase to draw vacuum to a desired vacuum within the system quickly, and only one of the two pumps 226 can be used during a second phase to manage pressure within the system once the desired vacuum is achieved with the two pumps during the first phase.

[0096] The pump 226 can be configured to function at a pre-determined set point (e.g., set pressure) defining the volumetric flow rate of the removed fluid. The pump 226 can be configured to run according to a plurality of settings. For example, at start-up, the pump(s) 226 can run at a constant voltage (effectively corresponds to constant velocity). For example, the MCU 212 can monitor the voltage and turns the pump 226 on or off based on fixed voltage thresholds. As pressure (detected, at the fluid delivery line or fluid collection line, by the pressure sensor 218) increases and reaches a pressure threshold, MCU 212 can trigger the pump 226 to run at a constant torque. The constant torque phase of the pump 226 can be defined by constant current to 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 decrease the pump noise at a set speed. In other implementations, the system incorporates a PID controller and need not run at a constant torque. The PID control loop to the pump 226 can use two sets of gains and settings, one for the vacuum setpoint and one for the instill setpoint as described elsewhere herein.

[0097] The example of fluid collection system 104B, illustrated in FIG. 2E, includes a pressure sensor 218, a filter 220, an analog to digital converter (ADC) 222, the MCU 212, a pulse width modulator 224, and a valve 228. The valve 228 can include pneumatic valves (e.g., check valves), and (3-way universal) pneumatic solenoid valve(s). The valve 228 can control vacuum pressure 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 (e.g., exhaust to atmosphere) vacuum pressure as needed during the removal of the fluid from the treatment site.Atty. Docket No.: 061016-508001 WO

[0098] FIG. 2F illustrates a block diagram 200F of an example system for monitoring of a collection fluid canister illustrating the connections between some components of the fluid delivery system 104, described with reference to FIGs. 1A and IB. The example system for monitoring of a collection fluid canister 109 includes a load cell 206B, a filter 232, a load cell controller 210, and the MCU 212. As will be described in more detail below, the load cell 206B is configured to be contacted by a portion of the component supporting the weight of the fluid collection canister 109. As discussed above, the load cell controller 210 can be the same load cell controller 210 that communicates with load cell 206A or a dedicated load cell controller 210 for load cell 206B.

[0099] The load cell 206B (similar to load cell 206 A described with reference to FIGs. 2B and 2C) can generate an output a signal that reflects the fluid level / weight of the collection fluid canister 109 storing removed fluid. The filter 232 (same as or similar to filter 208 described with reference to FIGs. 2B and 2C) can be configured to remove noise from the output signal of the load cell 206B. The load cell controller 234 (same as or similar to load cell controller 210 described with reference to FIGs. 2B and 2C) can control a load cell signal detection and filter frequency. The MCU 212 can host the software that provides the logic which defines monitoring of the fill level of the collection fluid canister during fluid removal from the treatment site. The MCU 212 can include a control circuit configured to monitor the differential weight (e.g., change in fluid level). The MCU 212 can serially connected to the load cell controller 210. The treatment delivery system can include unique load cell and unique load cell controllers on each “side” of the system including the fluid delivery side and the fluid removal side.

[0100] FIGs. 3 A and 3B show exploded views 300A, 300B of the example of the treatment delivery system 100, in accordance with some example implementations. FIGs. 3A and 3B illustrate the components of the treatment delivery system 100, described with reference to FIGs. 1A and IB with respect to their assembly position. The housing 302 of the treatment delivery system 100 can include multiple portions, such as side housing portions 302A, 302B, a top portion 302C and a bottom portion 302D. The housing 302 of the treatment delivery system 100 can be configured to support the attachment features 114A, 114B that enable attachment of the fluid reservoir(s).

[0101] The side housing portions 302A, 302B each can include an opening 302E sized to receive respective posts 304A, 304B of the load cells 206A, 206B (see FIGs. 3A-3B). A first opening 302E extends through side housing portion 302A and receives post 304A of load cellAtty. Docket No.: 061016-508001 WO206A. A second opening 302E extends through side housing portion 302B and receives post 304B of load cell 206B. The posts 304A, 304B in this implementation are arranged vertically or within a vertical plane of the system so that a force can be applied against the posts 304A, 304B by protrusions 124A, 124B horizontally or in a horizontal plane relative to the load cells 206 A, 206B, which will be described in more detail below.

[0102] Still with respect to FIGs. 3A-3B, the fluid reservoir(s) 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, ring, or other feature. Preferably, the attachment feature 114A is a hook configured to hang one or more fluid reservoirs 108 A, 108B similar to a hook for an IV bag system. Thus, each of the fluid reservoirs 108A, 108B can be a soft bag having a corresponding attachment at an upper end that is configured to be received by the attachment feature 114A. The attachment feature 114A can be configured to hold more than a single fluid reservoir, for example, at least a 50 mL solution container and a 1200 mL solution container. The canister 109 can be a container having a cylindrical shape and the attachment feature 114B can be a ring sized to receive the outer dimension of the cylinder. The attachment feature 114B can be configured to hold a container sized to contain at least 2000 mL. For example, the inner diameter of the upper end of the attachment feature 114B can be sized relative to an outer diameter of a lip of the canister 109 (e.g., at least about 6 inches) to rest against the lip of the canister 109 and prevent the canister 109 from sliding through the inner diameter of the attachment feature 114B. The attachment features 114A, 114B can each project 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 attachment features 114A, 144B without the fluid containers coming into contact with any other portion of the system.

[0103] The assembled canister can be held by its attachment feature 114B and can be installed within the attachment feature 114B, such as from above and lowering the canister down through the inner diameter of the attachment feature 114B. The canister can be oriented relative to a central axis of the attachment feature 114B turning the canister to align one or more features on the lid aided by one or more indicia on the attachment feature 114B. It is preferable to keep the head height of the system fixed during the entire treatment protocol, even during replacement of a canister that is filled with fluid. As such, the pole canAtty. Docket No.: 061016-508001 WO be maintained at the same height during canister replacement. Insertion of an empty canister is generally easy due to the light-weight materials of the canister even at the head height of the pole. However, removal of a full canister from the attachment feature 114B can be more challenging for some because the full canister is lifted vertically back out through and above the attachment feature 114B. The height of the attachment feature 114B for the canister can be positioned lower than a height of the attachment feature 114A for the reservoirs for user ease and comfort. Generally, the height of the attachment feature 114B for the canister can be limited to an overall height relative to the ground that enables users to lift the canister vertically above the attachment feature 114B without undue difficulty or the need for assistance, such as with a step. The height of the attachment features 114A, 114B for usability considers height relative to the treatment site, which is important for both instillation performance and vacuum removal, and height relative to the ground, which is important for usability.

[0104] The attachment features 114A, 114B each can be at an end region of respective protruding hanger beams 122A, 122B. The hanger beams 122A, 122B can each have protrusions 124A, 124B on an opposite end from the attachment features 114A, 114B. The protrusions 124A, 124B are arranged to engage the load cells 206 A, 206B. For example, as the weight of the fluid reservoirs 108A, 108B hanging from the attachment feature 114A urges the attachment feature 114A in a downward direction, the protrusion 124A of the hanger beam 122A is urged horizontally against the post 304A of the load cell 206A. Fluid reservoir 108A, which is sized to contain one type of fluid, is hung from the same attachment feature 114A as the fluid reservoir 108B, which is sized to contain a second type of fluid. Thus, two fluid reservoir types are hung from a single attachment feature 114A that engages a single load cell 206A. Similarly, as the weight of the fluid collection canister 109 resting within the ring of the attachment feature 114B urges the attachment feature 114B in a downward direction, the protrusion 124B of the hanger beam 122B is urged horizontally against the post 304B of the load cell 206B. Each of the load cells 206A, 206B can have a vertical orientation or are positioned within a vertical plane of the system so as to be contacted perpendicularly by the protrusions 124A, 124B of the respective hanger beams 122A, 122B creating the cantilever engagement. The cantilever engagement between each of the attachment features 114A, 114B and their respective load cells 206A, 206B is the pivoting of the hanger beams 122A, 122B where the force (generated by the weight of the fluid reservoirs and fluid collection canister) is being applied in a vertical direction against theAtty. Docket No.: 061016-508001 WO respective attachment features 114A, 114B of the hanger beams 122A, 122B such that each of the load cells 206 A, 206B is engaged in a horizontal direction by the protrusions 124A, 124B of the hanger beams 122A, 122B.

[0105] The configuration of the load cells 206A, 206B relative to their respective bags / canisters can vary as can the axis orientation of the reporting forces. The orientation can be as described above in which the load cells 206A, 206B are within a vertical plane and the force applied to them is within the horizontal plane. The load cells 206A, 206B can be within a horizontal plane and the force applied to them can be within the vertical plane. The load cells 206A, 206B may be positioned above their respective bags / canister to measure the weight of the bags / canister due to a tension force applied or may be positioned below their respective bags / canister to measure the weight of the bags / canister due to a compression force applied.

[0106] The interior of the treatment delivery system can include a battery 306 (e.g., rechargeable battery) to power the electronic components and an electrical connection 308. The interior of the treatment delivery system is designed to fit a pump enclosure 310 configured to provide noise reduction during operation of the pump(s) 226. One or more valves such as a pneumatic solenoid valve 228 configured to regulate pressure during a corresponding treatment phase can be located inside the housing 302. As illustrated in magnified section of FIG. 3B, the pressure sensor 218 can be located inside in the housing 302 and coupled to the control system 106 to adjust fluid flow to or from the treatment site.

[0107] FIGs. 4A-4B shows a schematic diagram 400 of the fluid delivery system 104A including fluid delivery lines 110A, HOB, HOC, vacuum line 113A connectors 402A, 402B, a cap 404, a clamp 406, a fluid delivery line connector 408, fluid delivery line and locks 412A, 412B. The connectors 402A, 402B can include spike to barb connectors. The connectors 402A, 402B can include fits of different dimensions to connect to fluid delivery lines with different diameters. For example, the spike-to-barb connector 402A can fit 1 / 16 inch inner diameter silicone tubing or equivalent and the spike-to-barb connector 402B can fit 1 / 8 inch inner diameter silicone tubing or equivalent. The cap 404 can include a spike cap. The fluid delivery lines 110A, HOB and vacuum lines 113A, 113B can include tubing of different dimensions. For example, fluid delivery line 110A can include a tube having 1 / 16 inch internal diameter and 1 / 8 inch outer diameter. The fluid delivery line HOB can include a tube having 1 / 8 inch internal diameter and 1 / 4 inch outer diameter. The multi fluid delivery line connector 408 can include a Y-connector. The multi fluid delivery line connector 408 canAtty. Docket No.: 061016-508001 WO include a 1 / 16 inch barb, 1 / 8 inch barb, and 3 / 16 inch tubing port. The fluid delivery lines HOC can include tubing of different dimensions. For example, fluid delivery line HOC can include a tube having 3 / 32 inch internal diameter and 3 / 16 inch outer diameter and 72 inch length. The vacuum line 113A can include a tube having 3 / 32 inch internal diameter and 3 / 16 inch outer diameter and 36 inch length. The clamp 406 can be released by a user once the system is assembled and set up properly for treatment. The lock 412A can include a male luer lock. The lock 412A can include a tubing port fitting 3 / 16 outer diameter tubing. The lock 412B can include a female luer lock. The lock 412B can include a tubing port fitting 3 / 16 outer diameter tubing.

[0108] As discussed above, the system can include two normally closed pinch valves 120A, 120B that are activated to open for fluid delivery to the treatment site 102 and return to close when fluid delivery is stopped. A first pinch valve 120A, when in the open configuration, is sized to receive the outer diameter of the first fluid delivery line 110A, and a second pinch valve 120B, when in the open configuration, is sized to receive the outer diameter of the second fluid delivery line HOB. The inner dimension of pinch valve 120A can be sized differently than the inner dimension of 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 HOB. This arrangement aids a user during installation of the fluid delivery lines into their respective pinch valves. As an example, the fluid delivery line 110A can be 1 / 8 inch outer diameter and the fluid delivery line HOB can be larger at about 1 / 4 inch outer diameter. The pinch valve 120A can be sized smaller than the inner dimension of pinch valve 120B and configured to receive an outer diameter of a fluid delivery line that is no greater than about 1 / 8 inch so that the fluid delivery line HOB cannot be practically installed within the pinch valve 120A. The pinch valves 120A, 120B can incorporate a mechanism configured to pinch closed the fluid delivery lines positioned within them and a mechanism to unpinch or open the valve while still loaded or attached with the fluid delivery lines. Thus, even when the pinch valves 120A, 120B are in the open configuration and not actively pinching the fluid delivery lines closed, the fluid delivery lines can be affixed within the inner dimension of their respective pinch valves 120A, 120B. The first fluid reservoir 108 A can contain a first fluid (antibiotic) that is connected to a first fluid delivery line 110A sized to engage with a 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 a second fluid delivery line HOB sized to engage withAtty. Docket No.: 061016-508001 WO a second pinch valve 120B during a second treatment phase. The first and second fluid can be sequentially delivered without mixing in the fluid delivery line HOC that guides the fluid to the treatment site 102. Each of the valves can be controlled to either open allowing flow through a respective fluid delivery line or close pinching off 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 HOB.

[0109] The entirety of each fluid delivery line 110A, HOB need not be a different dimension and can instead include a flow control segment 415 along its length that is designed in size and / or shape to be received within the respective pinch valves 120A, 120B (see FIGs. 4A-4B). The flow control segment 415 can be size-matched to the pinch valve slot so as to be received (or prevented from being received) within the pinch valve slot. The flow control segment 415 of the fluid delivery lines can be formed by a separate segment of tubing that is connected to the remainder of the delivery line by two inline connectors. These inline connectors can be gripped by a user during loading of the flow control segment 415 into the pinch valves. The inline connectors on either end of the flow control segment 415 of the fluid delivery line can be gripped and used to gently stretch, lengthwise, the flow control segment 415 tubing so that it can be firmly inserted into the slot of the pinch valve.

[0110] The pinch valves 120A, 120B can be solenoid valves configured to regulate flow through the fluid delivery lines 110A, HOB. The pinch valves 120A, 120B can be normally closed and actuated to open. In the normally closed valve, flow is prevented and when power is applied, a solenoid actuator opens the pinch elements to release the tube allowing the material to open up and fluid flow proceed through the lumen. A spring-loaded plunger positioned above the tubing can be actuated to move away from the compressed tubing. The pinch valves 120A, 120B operate by having a peak power to initiate opening and a holding power to maintain the open position. The solenoid provides an actuation force to close the pinch valves 120A, 120B. An opposing mechanical force to aid in opening the pinch valves 120A, 120B can be supplied by the tubing material and dimensions, as well as the pressure conditions of the system. The material and dimensions of the tubing forming the fluid delivery lines are selected to provide an opposing force on the pinch valves 120A, 120B to ensure the plunger returns to the fully open position for fluid flow through the tubing. In some implementations, the Shore A durometer is 45-60. The shore durometer of the tubingAtty. Docket No.: 061016-508001 WO material tends to reshape upon opening the pinch valve and removal of the plunger away from the fluid delivery lines 110A, HOB and to assist in valve actuation. Thus, the combination of the solenoid’s actuation force and the opposing mechanical force provided by the tubing enables repeated opening and closing of fluid flow through the system for the full treatment protocol without deformation under continuous pressure over time.

[0111] This interaction between the tubing and the pinch valves 120A, 120B can be performed multiple times each day for the multiple days of a full treatment protocol. Each valve 120A, 120B may close against a location along the tubing of its corresponding fluid delivery line 110A, HOB a minimum of 1 time per day and for some daily protocols between 20 - 25 times per day. Each valve 120A, 120B may close against the location along the tubing of its corresponding fluid delivery line 110A, HOB that number of times per day for a total of at least 3 days, at least 5 days, at least 7 days, at least 10 days, up to about 14 days and in number of days in between so that the fluid delivery lines 110A, HOB may be compressed within its respective pinch valve 120A, 120B at least about 3 up to about 250 times or more for a full treatment protocol. Each time the delivery lines 110A, HOB are compressed by its respective pinch valve, the lumen of the delivery lines 110A, HOB preferably return to their fully patent size upon opening of the pinch valve to allow full fluid delivery through the lines 110A, HOB. The tubing used to form the fluid delivery lines 110A, HOB is preferably capable of reliable performance (i.e., being repeatedly compressed to shut off fluid flow and returning to patency after compression to enable fluid flow) over the treatment period. The material of the tubing can have a Shore A durometer that is capable of being repeatedly compressed and returning to patency in a manner that aids in opening the pinch valves 120A, 120B without significant deformation or degradation of the cross- sectional shape of the tubing that could negatively impact fluid flow through the line or valve operation. The entirety of the delivery lines 110A, HOB need not be uniform and can instead of a particular size and / or shape along just a segment of its length, such as the flow control segment 451 that is intended to be received within the slot of the pinch valves.

[0112] The fluid delivery system need not incorporate two pinch valves, but rather a single pinch valve configured to control different fluids through different fluid lines without significant mixing. In some implementations, the fluid delivery system includes a single pinch valve designed to control fluid through two fluid delivery lines. The single pinch valve can be a solenoid valve where one of the fluid delivery lines is normally open while the other of the fluid delivery lines is normally closed. Alternatively, the single pinch valve can beAtty. Docket No.: 061016-508001 WO structured in such a way that both fluid delivery lines are normally closed, and each can be selectively activated to open to deliver the desired fluid for the desired weight change or period of time. Such a valve could be structured with a rotating structure that closes both lines in a first position, opens the first line while keeping the second line closed in a second potion, and closes the first line while opening the second line in the third position.

[0113] The logic of the valve control prevents simultaneous open states of both pinch valves 120A, 120B or, if a single pinch valve 120 is used, prevent simultaneous open states through the fluid delivery lines. The valve control logic avoids mixing and crosscontamination of the different fluids from the fluid reservoirs within the fluid delivery line HOC. In some implementations, the circuitry incorporates a switch so that only one of the two valves is powered at a time or only one slot is opened at a time so that fluid is sequentially delivered rather than simultaneously delivered through the delivery lines 110A, HOB. The selective activation can be controlled by software and / or by hardware.

[0114] FIGs. 5A-5C show examples of different displays 500A, 500B, 500C on the graphical user interfaces 118 to control and monitor processes performed by the treatment delivery system 100, in accordance with some example implementations. The examples of graphical user interface displays 500A, 500B, 500C can correspond to predetermined settings of a control unit control system 106 described with reference to FIGs. 1A-1D and FIGs. 2A- 2F) to promote automatic and controlled treatment delivery. The graphical user interface 118 can include different outputs and inputs such as buttons to manage automatic and controlled treatment delivery. Where the term “button” is used it should be appreciated that alternative inputs are considered including sliders, dials, switches, keyboards, or other inputs including touchscreen virtual buttons.

[0115] FIG. 5A illustrates an example of a graphical user interface with an initial display 500A that enables receipt of a user input related to selection and initiation of a treatment. The example of a graphical user interface with an 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 a user input to power off the control system 106, the power button 502 is held, and then a vacuum occurs to remove any fluid that might be left in the treatment site. The treatment mode 508 can include multiple phases 508A, 508B, 508C that can be displayed in an order of scheduled execution. The modes can be identified by colored LED’s indicating current mode of operation. The battery charge level indicator 504 can have an icon (e.g., aAtty. Docket No.: 061016-508001 WO schematic representation of a 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 the shape that is colored or shaded (e.g., the fill amount) 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. As the battery charge level decreases, the amount of fill lessens. When the battery charge level decreases below acceptable limits, the battery charge level indicator 504 can include a visual alert of the critically low battery lifetime. The visual alert of the battery charge level can include periodic flashes of light and change display color of battery icon from green to red.

[0116] FIG. 5B illustrates an example of a graphical user interface display 500B providing an alert that enables a user to modify at least a portion of the treatment delivery system (e.g., treatment delivery system 100 described with reference to FIGs. 1A and B) to ensure correct delivery of the treatment. The example of a graphical user interface 500B includes the battery charge level indicator 504, the start button 510, the stop button 512, the skip button 514, an alert icon 516, a mute button, and a display 518 for providing textual alerts. The alert icon 516 can include visual indicator, such as a static or flashing color or an applied highlighting that can be modified to indicate when a value of pressure, fluid volume stored in a reservoir, and / or flow rate is outside of a set range.

[0117] In the illustrated example of FIG. 5B a leak alarm is shown on a display 518. The leak alarm can be shown by the alert icon 516 and / or the textual alert indicator provided on the display 518, if the system has not reached the target vacuum pressure setting, a significant vacuum pressure leak has been detected in the system. The alert icon 516 may include a red flashing highlight indicating that a leak is detected and the display 518 can provide an instruction for a user to correct the detected error that triggered the alert. As another example, the alert icon 516 and the display 518 can display an alert if a fluid reservoir (e.g., an antibiotic solution bags) does not have a weight within a set range (e.g., is not installed or is empty) or a collecting fluid canister does not have a weight within a set range (e.g., is not attached or is full). As another example, the alert icon 516 and the display 518 can display an alert if battery charge level is below a set threshold, a vacuum blockage is detected by the pressure sensor(s), one or more portions of the treatment delivery system are incorrectly assembled, and / or movement of the system (i.e., control unit device) is above a set threshold during fluid delivery phase(s).Atty. Docket No.: 061016-508001 WO

[0118] FIG. 5C illustrates an example of a graphical user interface display 500C that provides updates related to a progression of a treatment. The example of a graphical user interface 500C includes the battery charge level indicator 504, the start button 510, the stop button 512, the skip button 514, and a display 518 for providing textual alerts. The display 518 can include a text describing a phase or mode of the treatment (e.g., “vacuum in progress”). The display 518 can match a highlight added to the display of treatment phases 508A, 508B, 508C to indicate the phase of the treatment that is being performed by the system.

[0119] The buttons or inputs of the graphical user interface can vary and the above are just examples of some combinations of inputs. The user interface can include in some implementations one or more of a power button 502, a mute button, a start button 510, a stop button 512, a skip button 514, and / or a reset button. The power button 502 can be used to power on and power off the control unit of the system. As an example, the power button 502 can be pressed once for a relatively short time to turn the control unit on and the power button 502 can be pressed and held for a longer time to turn the control unit off. The mute button can be used to silence, temporarily or permanently, an alert and / or alarm of the system. For example, the mute button can temporarily mute the audible indicator associated with an active alarm, such as a medium priority alarm that will resume or turn back on if the state remains even if muted. The mute button can silence the alarm for a reasonable period, such as after 30 minutes if the state remains active after a user presses the mute button. The start button 510 can be used to initiate a treatment process. The start button 510 can be used to start the therapy and used to deactivate alarms after resolving an issue to continue a therapy already initiated.

[0120] The skip button 514 can be used in combination with the start button 510 to select a desired treatment process. The skip button 514 can be used to scroll through different processes and the start button 510 can be used to select a desired process. For example, a day of treatment can be selected using the start button 510 and skip button 514. Day zero, the first cycle initiated starts a seal confirmation test, if assembled properly. Days one through six, the subsequent cycles initiated starting the pre-treatment vacuum cycle, if assembled properly. The skip button 514 can also be used to skip a particular phase of a cycle, such as a tobramycin soak cycle. For example, vancomycin instillation may occur for about 22 hours for every 24 hour period. During that period it may be desirable for a patient to stop vancomycin instillation to take a break from the system, such as for a patient who is mobileAtty. Docket No.: 061016-508001 WO and requires bathroom breaks. The stop button 512 can be used to terminate a treatment process, such as the vancomycin instillation, to take a break. Upon return of the patient to the system, the control logic allows the portion of the therapy where the patient left off to be selected by skipping over the default Day 0 or Day 1-6 therapy choices with the skip button 514. In some implementations of the system, Day 0 therapy initiates a tobramycin delivery / soak first followed by a vacuum period and Day 1-6 therapy initiates a preprogrammed 30-minute vacuum followed by an instillation of the desired therapeutic fluid. The skip button 514 allows a user to skip a portion of the selected default phase upon pressing the start button 510 (e.g., tobramycin delivery) so that a later phase (e.g., vancomycin instillation) may start. The system need not include a stop button 512 on the user interface and instead can include a reset button. The reset button can cause the control unit to revert back to a home screen, such as a start therapy screen.

[0121] The system preferably includes no pause button. The system is designed to deliver therapeutics, such as antibiotics, into a joint space. Allowing a user, such as a patient, to pause one or more functions of the system can inadvertently and dangerously prolong certain phases of the dwell period of the therapeutic, which can have negative impact on treatment outcomes. For example, the system can be used to deliver two antibiotics in alternating fashion, such as tobramycin and vancomycin. Tobramycin may be delivered to the joint space once daily and soaked before being subsequently aspirated away from the joint space before vancomycin is repeatedly delivered to, soaked and then removed from the joint space for the remainder of that day. A user who pauses the system during a dwell phase of tobramycin may inadvertently expose the joint space to the drug for too long resulting in a dose outside a desired range, which can contribute to side effects and / or drug resistance and / or fluid edema. The system control process is therefore designed to avoid inadvertent dwell periods of the therapeutics outside the desired parameters. In addition, any time the system automatically pauses or shuts off, the system preferably will automatically trigger an evacuation of fluid for a predetermined period of time, to ensure the joint space of the patient is not filled with delivered fluid for longer periods than desired, or for periods outside the desired repetitive treatment regimen, whether that fluid is a therapeutic agent or not (e.g., saline).

[0122] FIG. 6 depicts a flowchart illustrating an example of a process 600 performed by a treatment delivery system (e.g., treatment delivery system 100 described with reference to FIGs. 1A — ID, 2A-2F, 3A and 3B), in accordance with some example implementations. TheAtty. Docket No.: 061016-508001 WO example process 600 can include local irrigation for treatment of chronic periprosthetic joint infection in skeletally mature patients undergoing a two-stage revision arthroplasty procedure, where multiple (antibiotic) fluids (e.g., vancomycin HC1 and tobramycin sulfate) are delivered during separate phases of the treatment of the infection. For example, during a first stage of the treatment, the infected prosthesis can be removed surgically, debrided, and the temporary spacer implanted. The combination treatment can be performed over a seven- day period alternating tobramycin and vancomycin via the temporary spacer. During a second stage of the treatment, the temporary spacer is explanted, debrided, and a permanent prosthesis implanted followed by systemic administration of postoperative fluids (antibiotics), according to the example process 600. The combination treatment can also be performed without removing the infected prosthesis.

[0123] 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 at least one pump turns on to generate a vacuum pressure at a wound site during a ‘Drawdown Period’ until a set vacuum pressure is achieved. The treatment delivery system then performs a series of checks and confirmations of the status before initiation of treatment phases during the ‘Seal Confirmation” period. Upon completion of a ‘Seal Confirmation’ period, the system transitions to a ‘Pre-Treatment Vacuum Cycle,’ to confirm the set vacuum pressure achieved during the ‘Seal Confirmation’ period can be maintained.

[0124] The user can assemble the system components (e.g., hangers, solution bags, canister, tubing, etc.) and makes the appropriate connections between the system components and the treatment site. The upper end of the pole can be received within a corresponding slot in a lower end region of the control unit and the hangers for the infusion bags and the canister can be received within corresponding slots in an upper end region of the control unit.

[0125] The treatment delivery system can be powered on with a power button 502 or by plugging the device into a wall outlet. Upon powering up the treatment delivery system, the status of the treatment delivery system is verified. At 602, a status of the treatment delivery system is verified before the treatment phases are initiated and during each of the treatment phases. Verifying the status of the treatment delivery system can include measurement of 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 of the system parameters is compared to a respective safety range and / or threshold. Verifying the status of the treatmentAtty. Docket No.: 061016-508001 WO delivery system can be adjusted based on a treatment type (e.g., infection therapy type) for which the treatment delivery system was configured to execute.

[0126] The treatment delivery system can include a fluid delivery system and a control unit. The control unit is programmed to control the fluid delivery system according to a treatment process including a flow of a first fluid from a first fluid reservoir and a flow of a second fluid from a second fluid reservoir. The treatment process includes a plurality of phases. One of the plurality of phases can be a first phase that includes a controlled delivery of the first fluid to the treatment site, maintaining the first fluid for a first period of time at the treatment site, and removing fluid from the treatment site, including at least some of the first fluid. Another of the plurality of phases can be a second phase that includes a controlled delivery of the second fluid to the treatment site, maintaining the second fluid for a first period of time at the treatment site, and removing fluid from the treatment site, including at least some of the second fluid. Another of the plurality of phases can be a third phase that includes repeating, for example, the second phase with the second fluid at least once. The treatment process of the control unit automatically activates a first transition from at least the first phase to the second phase and a second transition from the second phase to the third phase. Each of the transitions can be activated without user intervention or input. Before commencing the first phase, the system can perform one or more verifications. For example, the system can perform one or more verifications that sufficient fluid is present for an entire one-day cycle of a treatment protocol. Sufficiency of fluid can be assess by verifying weight of one or more fluids and their respective containers. One verification that the system performs can be to verify a presence of a sufficient weight of the first fluid to perform the treatment process. Another verification that the system performs can be to verify a presence of a sufficient weight of the second fluid to perform the treatment process. The system can perform verification of a presence of a sufficient weight of any fluid for instillation before commencing the first phase. A sufficient weight indicates there is a minimum volume of the treatment fluid present to be delivered to the patient according to the treatment protocol to last an entire one-day cycle. For example, for tobramycin delivery, sufficient weight detected for a single day treatment can be the weight of the volume of the tobramycin solution, which is delivered once during the 24-hour period, and the weight of the bag within which the solution is held. For vancomycin delivery, sufficient weight detected for a single day treatment can be the weight of volume of the vancomycin solution, which is delivered in smaller increments repeated 20-23 times during the 24-hour period, and the weight of the bagAtty. Docket No.: 061016-508001 WO within which the solution is held. It should be appreciated that a sufficient weight may vary depending on the treatment protocol and the treatment fluid. Another verification that the system performs can include removing an initial site fluid from the treatment site, such as by application of negative pressure over a predetermined period of time before commencing the first phase of treatment.

[0127] At 604, if one or more system parameters is outside a respective safety range, an alarm is generated. The alarm can include a visual and / or audio alarm. The visual alarm can be displayed by a graphical user interface (GUI), as described with reference to FIG. 5B. The alarms can include a leak alarm, a vacuum blockage alarm, a full collecting fluid canister alarm, an empty bag alarm, a fluid delivery blockage alarm, a low battery alarm. The alerts can include an incorrect assembly alert, and / or an excessive motion alert. Other alarms can include an excess patient fluid loss alarm, a system error alarm, a system malfunction alarm, a therapy inactive alarm. The alarms and alerts can be physiological alarms or technical alarms (see Table 1 below). Some alarms are recoverable, such as a system error alarm, whereas others are irrecoverable, such as system malfunction alarm. The alarms and alerts can be color-coded on the GUI to indicate what sort of priority the alerts and alarms have. For example, low priority alerts can be indicated by a yellow light (e.g., incorrect assembly alert for canister, incorrect assembly alert for bag(s)) and medium priority alarms indicated by an orange light (e.g., seal confirmation failure alarm, leak alarm, full canister alarm, empty bag alarm, low battery alarm, system error alarm, system malfunction alarm, treatment inactive alarm).

[0128] Table 1Atty. Docket No.: 061016-508001 WO

[0129] The leak alarm can appear when the system has not reached the target vacuum pressure setting or a significant vacuum pressure leak has been detected in the system, potentially compromising therapeutic benefits. The leak alarm can be activated (e.g., transitions from OFF to ON) if (i) device does not achieve set point vacuum pressure of -125 mmHg ± 10% (-112.5 to -137.5 mmHg) at treatment site in a set time period (e.g., 2.5 minutes) or (ii) after the set time period, vacuum pressure falls below a pressure threshold (e.g., -112.5 mmHg) for longer than a set time (e.g., 60 seconds) during a fluid removal phase.

[0130] The vacuum blockage alarm can appear when the vacuum line has a blockage (e.g., blockage in vacuum line, kink, crimped, >50% blocked tubing). The vacuum blockage alarm can be activated (e.g., transitions from OFF to ON) at the end of a fluid removal phase, if the removed fluid volume is below a set fluid volume threshold. For example, if the fluid volume collected in the collecting fluid canister at completion of a single fluid removal phase of a set duration (e.g., 30 minutes) is below a set fluid volume threshold (e.g., less than 25cc fluid).

[0131] The full canister alarm can appear when the fluid volume collected in the collecting fluid canister during the fluid removal phase exceeds a threshold (e.g., greater than 90% of collecting fluid canister capacity). The vacuum blockage alarm and the full canister alarm can activate a user instruction alert (e.g., fluid delivery blockage) including a textual description of recommended user action.

[0132] The empty bag alarm can be triggered if a weight of the fluid reservoirs is below a minimum weight, preventing the treatment delivery system from being powered to execute the treatment. The system will attempt to instill if the load cell detects something having sufficient weight suspended from its attachment. If the detected weight of the fluid reservoirsAtty. Docket No.: 061016-508001 WO(bags and fluid) is below a predetermined threshold weight (e.g., 20-35 grams) indicating the reservoirs are not sufficiently full to last an entire one-day cycle, instillation with not commence and / or the empty bag alarm will be triggered. The empty bag alarm can be activated during the treatment, if the fluid volume (derived from the measured fluid weight detected by the respective load cell on the fluid delivery side) in a fluid reservoir (e.g., antibiotic solution bag) is not sufficient (e.g., is below a minimum fluid volume threshold) to complete a fluid delivery phase. The empty bag alarm can activate a user instruction alert (e.g., replace empty bag with full bag) including a textual description of recommended user action.

[0133] The fluid delivery blockage alarm can appear when the treatment delivery system delivers less than a set fluid volume threshold (e.g., 45mL) into the treatment site in a set time period (e.g., 5 minutes) from the start of fluid delivery activation (e.g., transition from OFF to ON). For example, the fluid delivery alarm can be activated if the delivery of a particular fluid (e.g., vancomycin hydrochloride solution) during its corresponding phase results in less than a set volume (e.g., 30 mL) in a set time period (e.g., 5 minutes before the end of the corresponding fluid delivery phase).

[0134] The low battery alarm can appear when the charge level (lifetime) of a battery of the treatment delivery system is below a minimum charge level threshold (e.g., 20% battery capacity) recommended to complete the treatment and the treatment delivery system is not connected to an external power source (e.g., plugged into wall power). The incorrect assembly alert can alert a user if any of the fluid reservoirs (e.g., antibiotic bags) is incorrectly attached to the treatment delivery system prior to initiation of any treatment phase, to ensure correct delivery of a particular fluid type during a particular treatment phase. The incorrect assembly alert can activate (e.g., transition from OFF to ON) if (i) during a ‘seal confirmation,’ the device measures the collection fluid canister weight outside a weight range (e.g., greater than 1.5kg), (ii) during a ‘pre-delivery period,’ 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 to ensure that the two fluid types can be automatically determined and differentiated.

[0135] The excessive motion alert can notify a user if the system (i.e., Control Unit) motion exceeds a motion threshold required for accurate dosage during treatment. The motion can be detected by incorporating an accelerometer into the pole unit that suspends the bags, or monitoring excessive noise from the load cells, or some other method of detecting undesiredAtty. Docket No.: 061016-508001 WO motion of the reservoirs that could impact load cell readings. The dosage is determined based on weight of the respective fluid reservoir or collection fluid canister, which are determined by the load cells based on an interaction with the attachment features supporting the respective fluid reservoir or collection fluid canister, such that system motion (e.g., during transportation of the system) can modify the interaction with the load cell, leading 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 a fluid delivery phase, if an excessive motion alert is generated by a measurement of a differential antibiotic solution weight (e.g., ± 20%) exceeding a set tolerance threshold prior to, or during a fluid delivery phase. The excessive motion alert can be a control function of the control unit during instillation to maintain accuracy during transportation.

[0136] Detection of excessive motion by the system need not immediately result in notifying the user with an excessive motion alert. For example, the system can automatically pause a function (e.g., the instillation, if instilling) or prevent a function (e.g., instillation initiation, upon detecting movement or noise above an acceptable motion threshold for a predetermined period. If the movement or noise decreases to an acceptable motion level within the predetermined period, the system can be programmed to automatically resume the paused or prevented function and consider the suspended time in its calculations. If the movement or noise does not decrease and remains above the acceptable motion threshold for the predetermined period, the system can trigger an excessive motion alert to notify a user.

[0137] The system includes priority logic when multiple alerts and / or multiple alarms are triggered. If two or more alarm conditions are present, the highest priority alarm condition will be displayed, and lower priority alarm conditions will not be displayed. If the two or more alarm conditions are of equal priority, the most recent alarm condition will display and the less recent alarm condition will not display. Each alarm condition is independently resolved. As an example, the higher priority alarm condition is displayed, and the lower priority alarm condition is not displayed. A user resolves the higher priority alarm condition removing it from being displayed and the lower priority alarm condition (or the next highest priority alarm condition) gets displayed. Alarm conditions take priority over alert conditions and will be displayed first.

[0138] At 606, if the system parameters are within safety ranges (no alarm or alert is generated), an initial display is generated, as described with reference to FIG. 5A. The initialAtty. Docket No.: 061016-508001 WO display can be generated to be displayed by a graphical user interface of a control unit to enable receipt of a user input.

[0139] At 608, a user input is received. The user input can include a selection of an activation of a start selector (e.g., start button) to initiate an automatic treatment delivery including multiple phases. The system automatically transitions into the treatment phases after the initial “start” is pressed and all system checks are passed. The treatment phases can include fluid delivery of multiple fluids in alternating fashion to a treatment site, controlled fluid soaking phases, and removal of fluid from the treatment site prior to delivery of the next fluid.

[0140] At 610, delivery of first fluid to a treatment site is controlled by the system. The delivery of the first fluid can be provided by active and / or residual vacuum pressure within the system and assisted by gravity due to head height of the reservoir container holding the first fluid as described above. The treatment delivery system following the start-up protocol can include time period to confirm the vacuum pressure within the system and a pre-delivery period after achieving the set vacuum pressure before automatically initiating delivery of first fluid to the treatment site. The delivery of the first fluid can be from the first fluid reservoir (e.g., first antibiotic solution bag), through the fluid delivery line loaded in and extending through a first pinch valve controlled by the system, to the treatment site. The delivery of the first fluid to the treatment site can be controlled by a control unit of the system that selectively activates (opens) the first pinch valve (aided by an opposing mechanical force provided by the tubing of the delivery line) 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 that extends through a second pinch valve or through another slot of the same pinch valve. The first fluid is delivered through the first fluid delivery line to the treatment site 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, a control circuit can monitor the differential weight (e.g., change in fluid level) of the first fluid reservoir to select a timing to open or close the first pinch valve on the first fluid delivery line, thereby dispensing a fixed volume of first fluid. The first fluid can include an antibiotic, such as tobramycin sulfate, from the first reservoir bag. The volume of first fluid to be delivered to the treatment site can be set in a range between 6 mL and 500 mL depending on the time period of the treatment, such as, 50 mL for a single 2-hour treatmentAtty. Docket No.: 061016-508001 WO period or up to about 500 mL for multiple treatment periods over course of about 7 days. The delivery of the first fluid volume can be controlled with an accuracy of ± approximately 5mL. In some implementations, approximately 50 mL tobramycin sulfate are delivered in about 30 seconds.

[0141] The delivery of the first fluid can be provided by the residual vacuum in combination with gravity due to head height. Alternatively, the delivery of the first fluid can include application of a low vacuum pressure (e.g., 0 mmHg to -125 mmHg or about -25 to about -45 mmHg instill pressure setpoint) to assist the gravity-driven instillation. The pump can shut off (or turn down) after an amount of the first fluid has been instilled. The amount of the first fluid before shut-off of the pump can be a portion of the fluid to be instilled (e.g., 25- 50 mL) or all of the fluid to be instilled. The low vacuum pressure during instillation can help to overcome back-pressure, an unprimed line, minimum head height, and the like.

[0142] After completion of the delivery phase of first fluid a soaking protocol follows that enables the treatment site to soak in the delivered first fluid. The vacuum pressure within the system can be deactivated and vented to atmospheric pressure during soaking. At 612, a soaking protocol of the first fluid at the treatment site is performed. The control unit of the treatment delivery system can be configured to allow the delivered fluids to soak the treatment site (e.g., periprosthetic space) for a predetermined dwell time. In some implementations, the soaking protocol is activated after delivery of each fluid and before the delivery of the following 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 be approximately 2 hours after delivery of tobramycin sulfate solution and approximately 30 minutes after delivery of vancomycin hydrochloride solution. The pump need not remain off during the soaking protocol and may be active at a lower level or active for short periods as described elsewhere herein.

[0143] 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 the fluid from the treatment site and deposit the collected fluid in a collecting fluid reservoir (e.g., canister) by the application of vacuum, through a dressing kit, as described with reference to FIG. 2A. For example, vacuum pressure is generated within the system by activating the at least one pump until a set vacuum pressure is achieved and maintained. The control unit can maintain vacuum pressure levels, such as, for example, -125 mmHg ± 10% (-112.5 to -137.5 mmHg) for set, intermittent periods toAtty. Docket No.: 061016-508001 WO remove the fluid from the site of infection into the collecting fluid canister, through the dressing kit. The vacuum pressure level can be controlled by the control unit using a pressure sensor, at least one vacuum pump, and a pneumatic solenoid valve, as described with reference to FIGs. 2A-2F. A sensor can generate an output as a voltage to reflect the vacuum level applied by the treatment delivery system. The control unit can monitor the sensor’s voltage and turn the pump on or off based on fixed voltage thresholds. The pneumatic solenoid valve can be activated by the control unit to adjust vacuum pressure by relieving (i.e., exhausting to atmosphere) vacuum pressure, as needed to maintain the vacuum pressure within a set pressure range. The duration of the fluid removal phase can be set depending on the fluid type collected at the treatment site. For example, the duration of the fluid removal phase can be set to be approximately 30 minutes.

[0144] At 616, delivery of second fluid to the treatment site is controlled by the system. The delivery of the second fluid can be provided by active and / or residual vacuum pressure within the system that can be assisted by gravity due to head height of the reservoir container holding the second fluid and optionally by the at least one vacuum pump running at a low level or intermittently activated during delivery. The treatment delivery system achieves and maintains a set vacuum pressure during a pre-delivery period before automatically initiating delivery of the second fluid to the treatment site. The delivery of the second fluid can be from the second fluid reservoir (e.g., second antibiotic solution bag) into the fluid delivery line loaded in and extending through the second pinch valve controlled by the system. The delivery of the second fluid to the treatment site can be controlled by the control unit of the system that selectively activates (opens) the second pinch valve (aided by an opposing mechanical force provided by the tubing of the delivery line) to allow the second fluid to flow from the second fluid reservoir to the treatment site while blocking the flow of the first fluid through the fluid delivery line, by maintaining the first pinch valve in a closed configuration. It should be appreciated the system may instead include a single pinch valve that is capable of controlling flow through one of the fluid lines while flow through the other fluid line is prevented to avoid significant mixing between the two fluids in the flow lines. During delivery of the second fluid, a control circuit can monitor the differential weight (e.g., change in fluid level) of the second fluid reservoir to select a timing to open or close the second pinch valve on the second fluid delivery line, thereby dispensing a fixed volume of second fluid. The second fluid can include an antibiotic, such as vancomycin hydrochloride. The volume of second fluid to be delivered to the treatment site can vary. The volume of theAtty. Docket No.: 061016-508001 WO second fluid to be delivered can be set in a range between 500 mL and 1500 mL, such as, 1200 mL. As discussed elsewhere herein, the second fluid can be delivered in smaller volumes that are allowed to soak and are removed prior to the next volume being delivered to the treatment site. Each volume delivered for each soak period before being removed can be just 50 mL, but can be cycled repeatedly over the course of a single 24-hour period (e.g., about 22 times) such that the total volume is about 1100 mL. The delivery of the second fluid volume can be controlled with an accuracy of ± approximately 5mL. In some implementations, approximately 50 mL vancomycin hydrochloride are delivered in about 30 seconds.

[0145] The delivery of the second fluid can be provided by the residual vacuum in combination with gravity due to head height. Alternatively, the delivery of the second fluid can include application of a low vacuum pressure (e.g., 0 mmHg to -125 mmHg or about -25 to about -45 mmHg instill pressure setpoint) to assist the gravity-driven instillation. The pump can shut off (or turn down) after an amount of the second fluid has been instilled. The amount of the second fluid before shut-off of the pump can be a portion of the second fluid to be instilled (e.g., 25-50 mL) or all of the second fluid to be instilled. The low vacuum pressure during instillation can help to overcome back-pressure, an unprimed line, minimum head height, and the like.

[0146] After, completion of the delivery phase of second fluid to the treatment site, the soaking protocol at the treatment site is performed, similar to what is described at 612 and subsequently, the second fluid (which may include exudate and other fluids in addition to the second fluid from the reservoir that is being delivered for treatment) is removed from the treatment site, similar to what is described at 614.

[0147] At 618, treatment data is displayed, as described with reference to EIG. 5C. The displayed treatment data can include real time updated of the treatment during the treatment, such as the name of the treatment phase being performed. The displayed treatment data at a completion of treatment can include a treatment summary, including delivered fluid volumes of each fluid type, and volume of removed fluid. The displayed treatment data at a completion of treatment can optionally include, one or more recommendations, such as a recommendation to charge a battery and / or empty the collecting fluid canister.

[0148] The example process 600 or portions of the process 600 can be repeated over multiple (e.g., over 150) cycles for controlled fluid delivery of multiple (two or more) fluids,Atty. Docket No.: 061016-508001 WO that can soak the treatment area, and can be removed to prevent merging of different fluids. The example process 600 or portions of the process 600 can be repeated over the course of one week. A single completed cycle following a single user input being received can include at least steps 610+612+614+616+612+614. As discussed above, the second fluid can be repeatedly delivered, allowed to soak, and removed before the first fluid is delivered again, for example, including steps 610+612+614+[x(616+612+614). The system can be pre-set to run a plurality of complete cycles following the single user input over a period of about 24 hours or until a reservoir empties and / or a collection canister fills.

[0149] The system can include other alarms and alerts, such as an Excess Fluid Loss alarm, a Therapy Inactive alarm, System Malfunction, and / or a System Error alarm, which may be medium priority alarms. The Excess Fluid Loss alarm is activated (i.e., transition from OFF to ON) during a Treatment Vacuum Cycle if greater than, for example, 200 cc of fluid enters the canister within a single Treatment Vacuum Cycle. This alarm ensures a user is aware of the total volume of fluid being collected in the canister is reaching a certain level. The Therapy Inactive alarm is activated if the control unit is powered on and the treatment remains inactive for more than a selected period, such as more than 15 minutes. As an example, a treatment day select screen is on for longer than the threshold period after the device is powered on or cycle reset screen is on for longer than the threshold period after a reset. The System Error alarm is activated at any time if the system pressure sensor measured a pressure above a threshold value, for example, less than -162.5 mmHg. The System Error alarm is activated if there is a software failure or corrupted software. As discussed above, The system includes priority logic when multiple alerts and / or multiple alarms are triggered. If two or more alarm conditions are present, the highest priority alarm condition will be displayed, and lower priority alarm conditions will not be displayed. If the two or more alarm conditions are of equal priority, the most recent alarm condition will display and the less recent alarm condition will not display. Each alarm condition is independently resolved. As an example, the higher priority alarm condition is displayed, and the lower priority alarm condition is not displayed. A user resolves the higher priority alarm condition removing it from being displayed and the lower priority alarm condition (or the next highest priority alarm condition) gets displayed. Alarm conditions take priority over alert conditions and will be displayed first.

[0150] FIG. 7 depicts an example of a parameter diagram 700 corresponding to the process performed by the treatment delivery system (e.g., treatment delivery system 100 describedAtty. Docket No.: 061016-508001 WO with reference to FIGs. 1A-1D), in accordance with some example implementations. The example parameter diagram 700 can include the parameters determined by the control unit during separate phases 702A, 702B, 702C, 702D, 702E of the treatment using multiple fluid types, as described with reference to FIG. 6.

[0151] During a first phase 702A of the treatment, a first fluid type is delivered to a treatment site during a first fluid delivery period 704A. The first fluid volume 706A at the treatment site increases from zero to a set delivered first fluid volume threshold 708 A with a particular accuracy (e.g., 5mL). The first fluid volume 706A at the treatment site, during the first phase 702A of the treatment can be derived based on the variation of the weight of the first fluid reservoir, as measured by a first load cell. The first fluid volume 706A can be delivered at the treatment site at a flow rate of 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. The flow rate is preferably monitored indirectly by assessing a minimum flow rate / volume dispersed after a period of time (e.g., 2.5 minutes) during an instillation and a minimum volume removed over a period of time (e.g., 30 minutes) in the canister.Volume and weight are monitored via load cell measurements. The flow rate can also be monitored directly, such as using a flowmeter or similar device.

[0152] During a second phase 702B of the treatment, the first fluid is allowed to soak into the treatment area for a set first time period or a first soak period 704B, such that the delivered first fluid volume 706B at the treatment area during the first soak period 704B remains constant.

[0153] During a third phase 702C of the treatment, the first fluid is removed from the treatment site and delivered to a collecting fluid canister during a fluid collection period 704C. The fluid volume at the treatment site 706C decreases as the volume of the collected fluid 706E at the collecting fluid canister increases from zero to a set collected volume threshold (e.g., the delivered first fluid volume threshold 708B) with a particular accuracy (e.g., 5mL). The volume of the collected fluid 706E at the collecting fluid canister can be derived based on the variation of the weight of the collecting fluid canister, as measured by a respective load cell. The collected fluid 706E can be removed from the treatment site at a flow rate of collected fluid 710B, which can be an approximately constant. The flow rate of the collected fluid 710B can be monitored to remain within a set flow rate threshold 712B. As mentioned above, the flow rate is preferably monitored indirectly by assessing a minimum flow rate / volume dispersed after a period of time (e.g., 2.5 minutes) during an instillationAtty. Docket No.: 061016-508001 WO and a minimum volume removed over a period of time (e.g., 30 minutes) in the canister where volume and weight are monitored via load cell measurements. Absolute weight and differential weight are measured during fluid removal. Absolute weight over a high threshold (e.g., greater than about 75%-85% volume of the canister) can trigger a full canister alarm and differential weight measured during fluid removal can trigger a leak alarm, for example, if volume change is less than a certain volume (e.g., 20-30 mL) or more than a certain volume (e.g., 150-250 mL). In some implementations, the treatment delivery system can automatically transition between treatment phases, for example, in response to determining that a parameter (e.g., fluid volume) reached a corresponding threshold such as a delivered first fluid volume threshold 708B.

[0154] During a fourth phase 702D of the treatment, a second fluid type is delivered to the treatment site during a second fluid delivery period 704D. The second fluid volume 706D at the treatment site increases from zero to a set delivered second fluid volume threshold 708C with a particular accuracy (e.g., 5mL). The second fluid volume 706D at the treatment site, during the second phase 702B of the treatment can be derived based on the variation of the weight of the second fluid reservoir, as measured by the first load cell. The second fluid volume 706D can be delivered at the treatment site at 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 a set flow rate threshold 712C. Where monitoring of flow rate is described herein it should be appreciated that the flow rate can be monitored indirectly by monitoring the volume / weights of the reservoir bags and canister via load cell readings, as discussed elsewhere herein.

[0155] During a fifth phase 702E of the treatment, the second fluid is allowed to soak into the treatment area for a set second time period or second soak period 704E, such that the second fluid volume 706E at the treatment area during the second soak period 704E remains constant. After the fifth phase 702E, the second fluid is removed from the treatment site and delivered to the collecting fluid canister during a further fluid collection period (not shown).

[0156] The systems described herein incorporate logic to control transitions between phases of the treatments. As an example, instillation of a fluid will not begin until certain conditions have been met (e.g., vacuum setpoint is reached, load cell readings indicate sufficient weight and no excessive noise or instability, and the like). Generally, instillation of fluid is based on change in weight of fluid reservoirs and time elapsed. The system tracks instillation of fluid by assessing a change in weight of the reservoirs (e.g., 50 g) within a timeAtty. Docket No.: 061016-508001 WO limit after initiation (e.g., 2.5 minutes). If the change in weight for the instillation is achieved within the time limit, then instillation ceases. If the change in weight for the instillation remains less than a predetermined weight change and the time limit has not been reached, the system will continue instillation. If the change in weight for the instillation is less than a predetermined weight change and the time limit has been reached, then instillation may cease and an alarm may get triggered. Alternatively, the system may continue attempting instillation to the predetermined weight once the alarm has been triggered or shut off instillation and display an alarm. The cause may be an empty reservoir, a failure of the load cell, failure of a pinch valve, a blockage, a leak, or the fluid delivery line is installed improperly into the pinch valve, etc. In order for the system to automatically transition from instillation of a fluid to a controlled fluid soak phase, the system detects a change in weight of the reservoirs over a time period and the system logic blocks the automatic transition to the next phase without certain conditions being met, such as the prescribed weight loss (corresponding to the delivery of fluid) within the maximum time-period permitted for fluid instillation. Similarly, for the system to automatically transition from fluid removal phase to instillation phase of the next fluid, certain conditions must also be met, such as application of vacuum within a range of desired negative pressure during the fluid removal phase for a predetermined period of time. The conditions are typically based on one or more of weight, time, and pressure.

[0157] FIG. 8 depicts a block diagram illustrating an example of computing system 800 consistent with implementations of the current subject matter. The example computing system 800 can be integrated in the control unit of a treatment delivery system, as described with reference to FIGs. 1A-1D, 2A-2F, and 3A and 3B, to execute the process described with reference to FIG. 6.

[0158] As shown in FIG. 8, the computing system 800 can include a processor 810, a memory 820, a storage device 830, and input / output devices 840. The processor 810, the memory 820, the storage device 830, and the input / output devices 840 can 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 can be implemented by one or more components of, for example, the treatment delivery system. In some example implementations, the processor 810 can be a single-threaded processor. Alternatively, the processor 810 can be a multi-threaded processor. The processor 810 is capable of processingAtty. Docket No.: 061016-508001 WO instructions stored in the memory 820 and / or on the storage device 830 to present graphical information for a user interface provided via the input / output device 840.

[0159] The memory 820 is a computer readable medium such as volatile or non-volatile that stores information within the computing system 800. The memory 820 can store data structures representing configuration object databases, for example. The storage device 830 is capable of providing persistent storage for the computing system 800. The storage device 830 can be a floppy disk device, a hard disk device, an optical disk device, or a tape device, or other suitable persistent storage means. The input / output device 840 provides input / output operations for the computing system 800. In some example implementations, the input / output device 840 includes a keyboard and / or pointing device. In various implementations, the input / output device 840 includes a display unit for displaying graphical user interfaces.

[0160] The memory 820 can be accessible by a user including a manufacturer, for example, to obtain data from the system from a past therapy regimen, a past day, a past week up to the full duration of the therapy. In a system that is durable instead of disposable, information may be stored for retrieval from multiple therapy treatments over days, weeks, a past month, past several months, or longer. The data log can include patient-relevant data, including data regarding administered treatments, device history logs, and any other data the system collects to assist in determining whether the system is performing properly and according to manufactured settings. The system can incorporate a port for uploading software that can optionally be used for data logging for reading data recorded during use of the system.

[0161] According to some example implementations, the input / output device 840 can provide input / output operations for a network device. For example, the input / output device 840 can include Ethernet ports or other networking ports to communicate with one or more wired and / or wireless networks (e.g., a local area network (LAN), a wide area network (WAN), the Internet).

[0162] In some example implementations, the computing system 800 can be used to execute various interactive computer software applications that can be used for organization, analysis and / or storage of data in various formats. Alternatively, the computing system 800 can be specifically configured to execute software applications. These applications can perform various fullness detection functionalities, e.g., planning functionalities (e.g., generating, managing, editing of spreadsheet documents, word processing documents, and / or any other objects, etc.), computing functionalities, communications functionalities, etc. TheAtty. Docket No.: 061016-508001 WO applications can include various add-in functionalities or can be standalone computing products and / or functionalities. Upon activation within the applications, the functionalities can be used to generate the user interface provided via the input / output device 840. The user interface can be generated and presented to a user by the computing system 800 (e.g., on a computer screen monitor, etc.).

[0163] One or more aspects or features of the subject matter described herein can be realized in specifically configured digital electronic circuitry, integrated circuitry, applicationspecific integrated circuit (ASIC), field programmable gate arrays (FPGAs) computer hardware, firmware, software, and / or combinations thereof. These various aspects or features can include implementation in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which can be special or general purpose, coupled to receive data and instructions from, and to 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. A client and server are remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0164] These computer programs, which can also be referred to as programs, software, software applications, applications, components, or code, include machine instructions for a programmable processor, and can be implemented in a high-level procedural and / or object- oriented programming language, and / or in assembly / machine language. As used herein, the term “machine-readable medium” refers to any computer program product, apparatus and / or device, such as for example magnetic discs, optical disks, memory, and Programmable Logic Devices (PLDs), 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. The term “machine-readable signal” refers to any signal used to provide machine instructions and / or data to a programmable processor. The machine-readable medium can store such machine instructions non-transitorily, such as for example as would a non-transient solid-state memory or a magnetic hard drive or any equivalent storage medium. The machine-readable medium can alternatively or additionally store such machine instructions in a transient manner, such as for example, as would a processor cache or other random access memory associated with one or more physical processor cores.Atty. Docket No.: 061016-508001 WO

[0165] To provide for interaction with a user, one or more aspects or features of the subject matter described herein can be implemented on a computer having a display device, such as for example a cathode ray tube (CRT) or a liquid crystal display (LCD) or a light emitting diode (LED) monitor for displaying information to the user and a keyboard and a pointing device, such as for example a mouse or a trackball, by which the user may provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well. For example, feedback provided to the user can be any form of sensory feedback, such as for example 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 touch screens or other touch- sensitive devices such as single or multipoint resistive or capacitive track pads, voice recognition hardware and software, optical scanners, optical pointers, digital image capture devices and associated interpretation software, and the like.

[0166] In the descriptions above and in the claims, phrases such as “at least one of’ or “one or more of’ may occur followed by a conjunctive list of elements or features. The term “and / or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited 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 each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including 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 each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

[0167] As used herein a “user interface” (also referred to as an interactive user interface, a graphical user interface or a user interface or UI) may refer to a network-based interface including data fields and / or other control elements for receiving input signals or providing electronic information and / or for providing information to the user in response to any received input signals. Control elements may include dials, buttons, icons, selectable areas, or other perceivable indicia presented via the UI that, when interacted with (e.g., clicked, touched, selected, etc.), initiates an exchange of data for the device presenting the UI. A UIAtty. Docket No.: 061016-508001 WO may be implemented in whole or in part using technologies such as hyper-text mark-up language (HTML), FLASH™, JAVA™, .NET™, web services, or rich site summary (RSS). In some implementations, a UI may be included in a stand-alone client (for example, thick client, fat client) configured to communicate (e.g., send or receive data) in accordance with one or more of the aspects described. The communication may be to or from a medical device or server in communication therewith.

[0168] 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 in a table, a database or another data structure), ascertaining and the like via a hardware element without user intervention. Also, “determining” may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like via a hardware element without user intervention. “Determining” may include resolving, selecting, choosing, establishing, and the like via a hardware element without user intervention.

[0169] As used herein, the terms “provide” or “providing” encompass a wide variety of actions. For example, “providing” may include storing a value in a location of a storage device for subsequent retrieval, transmitting a value directly to the 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, validating, verifying, and the like via a hardware element.

[0170] 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, fixed field message, comma separated message, or the like. A message may, in some implementations, include a signal utilized to transmit one or more representations of the information. While recited in the singular, it will be understood that a message may be composed, transmitted, stored, received, etc. in multiple parts.

[0171] As user herein, the terms “correspond” or “corresponding” encompasses a structural, functional, quantitative and / or qualitative correlation or relationship between two or more objects, data sets, information and / or the like, preferably where the correspondence or relationship may be used to translate one or more of the two or more objects, data sets, information and / or the like so to appear to be the same or equal. Correspondence may beAtty. Docket No.: 061016-508001 WO assessed using one or more of a threshold, a value range, fuzzy logic, pattern matching, a machine learning assessment model, or combinations thereof.

[0172] In some implementations, data generated or detected can be forwarded to a “remote” device or location, where “remote,” means a location or device other than the location or device at which the program is executed. For example, a remote location could be another location (e.g., office, lab, etc.) in the same city, another location in a different city, another location in a different state, another location in a different country, etc. As such, when one item is indicated as being “remote” from another, what is meant is that the two items can be in the same room but separated, or at least in different rooms or different buildings, and can be at least one mile, ten miles, or at least one hundred miles apart. “Communicating” information references transmitting the data representing that information as electrical signals over a suitable communication channel (e.g., a private or public network). “Forwarding” an item refers to any means of getting that item from one location to the next, whether by physically transporting that item or otherwise (where that is possible) and includes, at least in the case of data, physically transporting a medium carrying the data or communicating the data. Examples of communicating media include radio or infra-red transmission channels as well as a network connection to another computer or networked device, and the internet or including email transmissions and information recorded on websites and the like.

[0173] The implementations set forth 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 described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and sub-combinations of the disclosed features and / or combinations and subcombinations of several further features disclosed above. In addition, the logic flows depicted in the accompanying figures and / or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. Other implementations can be within the scope of the following claims.

Claims

Atty. Docket No.: 061016-508001 WOWHAT IS CLAIMED IS:

1. A treatment delivery system comprising: a fluid delivery system for directing a first fluid from a first fluid reservoir to a treatment site and for directing a second fluid from a second fluid reservoir to the treatment site; and a control unit programmed 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, wherein a first phase of the plurality of phases comprises a controlled delivery of the first fluid from the first fluid reservoir to the treatment site, maintaining the first fluid at the treatment site for a first period of time, and removing a first site fluid from the treatment site, said first site fluid comprising at least some of the first fluid, a second phase of the plurality of phases comprises a controlled delivery of the second fluid from the second fluid reservoir to the treatment site, maintaining the second fluid at the treatment site for a second period of time, and removing a second site fluid from the treatment site, said second site fluid comprising at least some of the second fluid, and a third phase of the plurality of phases comprises repeating the second phase with the second fluid at least once, wherein the treatment process of the control unit automatically activates a first transition from at least the first phase to the second phase and a second transition from the second phase to the third phase, wherein each of said first transition and the second transition is activated without user intervention or input, wherein, before commencing the first phase, the system performs one or more of (i) verifying a presence of a sufficient weight of the first fluid to perform the treatment process, (ii) verifying a presence of a sufficient weight of the second fluid to perform the treatment process, (iii) verifying a presence of a sufficient weight of any fluid for instillation, and (iv) removing an initial site fluid from the treatment site via application of negative pressure over a predetermined period of time.Atty. Docket No.: 061016-508001 WO2. The treatment delivery system of claim 1, further comprising: a first load cell configured to detect a combined weight comprising a first weight of the first fluid and the first fluid reservoir and a second weight of the second fluid and the second fluid reservoir, wherein the control unit processes the combined weight measured at a first point in time and at a second point in time later than the first point, in order to monitor a status of fluid delivery.

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

4. The treatment delivery system of claim 2 or claim 3, wherein the first fluid reservoir is held by an attachment 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. The treatment delivery system of any one of claims 1-4, further comprising a waste fluid canister configured to collect a fluid removed from the treatment site.

6. The treatment 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 within the waste fluid canister, wherein the control unit processes the waste weight to monitor a status of fluid removal.

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

8. The treatment delivery system of claim 6 or claim 7, wherein the waste fluid canister is held by an attachment 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. The treatment delivery system of any one of claims 1-8, wherein the fluid delivery system further comprises at least one pinch valve controlled by the control unit to open and close according to the treatment process.Atty. Docket No.: 061016-508001 WO10. The treatment delivery system of claim 9, wherein the at least one pinch valve of the fluid delivery system comprises a first pinch valve and a second pinch valve, wherein the first pinch valve is configured to receive a first fluid delivery line fluidly connected to the first fluid reservoir and the second pinch valve is configured to receive a second fluid delivery line fluidly connected to the second fluid reservoir.

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

12. The treatment delivery system of claim 10, wherein the first pinch valve has a first inner dimension when in an open configuration and wherein the second pinch valve has a second inner dimension when in an open configuration, wherein the first inner dimension is different than the second inner dimension.

13. The treatment delivery system of claim 12, wherein the first fluid delivery line has a smaller outer dimension than the second fluid delivery line, the smaller outer dimension sized to be received within the first inner dimension of the first pinch valve.

14. The treatment delivery system of claim 12, wherein the second fluid delivery line has an outer dimension prevented from being received within the first inner dimension of the first pinch valve.

15. The treatment delivery system of any one of claims 1-14, wherein the control unit comprises: a pump configured to generate a set vacuum pressure within the system; and a valve configured to control a vacuum relief.

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

17. The treatment delivery system of claim 15, wherein the pump is configured to run at approximately constant voltage during a first period of time and at an approximately constant torque during a second period of time to generate set vacuum pressure.Atty. Docket No.: 061016-508001 WO18. The treatment delivery system of any one of claims 15-17, further comprising: a leak alarm configured to generate an alert indicating a pressure leak determined in response to the control unit detecting a vacuum pressure at the treatment site being below a respective threshold.

19. The treatment delivery system of any one of claims 5-18, further comprising: a waste fluid canister fill sensor configured to generate a waste fluid canister fill alert indicating a fill level of the waste fluid canister being above a fill threshold, wherein the control unit stops removal of any of the first fluid and the second fluid from the treatment site in response to the waste fluid canister fill alert.

20. The treatment delivery system of any one of claims 1-19, further comprising: an empty fluid reservoir alarm configured to generate an alert indicating that a weight of the first fluid delivered from a first fluid reservoir or a weight of the second fluid delivered from a second fluid reservoir is below a minimum threshold corresponding to a respective phase of the plurality of phases.

21. The treatment delivery system of any one of claims 1-20, further comprising: a low battery alarm configured to generate an alert indicating a charge level of a battery of the control unit, wherein the charge level of the battery is determined in response to the control unit detecting the charge level of the battery being below a minimum charge level adequate for powering automatic transition between the plurality of phases.

22. The treatment delivery system of any one of claims 1-21, further comprising: an incorrect assembly alarm configured to generate an alert indicating an incorrect assembly of the treatment delivery system, wherein the incorrect assembly is determined in response to the control unit detecting a missing or incorrectly coupled component of the treatment delivery system that prevents an automatic transition between the plurality of phases.

23. The treatment delivery system of any one of claims 1-22, further comprising: a motion alarm configured to pause fluid delivery and generate an alert indicating an excessive motion that affects a weight sensor reading during fluid delivery.Atty. Docket No.: 061016-508001 WO24. The treatment delivery system of any one of claims 1-23, further comprising a user interface configured to receive a user input comprising a selection of an operation for initiating a sequence comprising the plurality of phases.

25. The treatment delivery system of any one of claims 1-24, wherein the first fluid comprises tobramycin antibiotic fluid and the second fluid comprises vancomycin antibiotic fluid.

26. The treatment delivery system of any one of claims 1-25, further comprising at least a fourth phase comprising repeating one of the first phase and the second phase and a third transition from the third phase to the fourth phase, wherein the third transition is activated without user intervention or input.

27. The treatment delivery system of claim 26, wherein the third phase repeats the first phase and the fourth phase repeats the second phase.

28. The treatment delivery system of claim 26, wherein the third phase comprises repeating the second phase at least once and the fourth phase comprises repeating the first phase.

29. The treatment delivery system of claim 28, wherein the third phase comprises repetitively performing the second phase for a plurality of second-phase repetitions before the fourth phase, and further wherein said third transition from the third phase to the fourth phase comprises automatically transitioning between said plurality of second-phase repetitions without user intervention or input.

30. A treatment delivery system comprising: a fluid delivery system comprising: a vacuum pump; a first fluid reservoir hanger for suspending at a head height a first fluid reservoir containing a first fluid; and a fluid delivery line configured to be placed in fluid communication with the first fluid reservoir and in fluid communication with a treatment site; andAtty. Docket No.: 061016-508001 WO a control unit programmed to control the fluid delivery system according to a treatment process, the treatment process comprising a plurality of phases, wherein a first phase of the plurality of phases comprises the vacuum pump turned on to deliver a first volume of the first fluid from the first fluid reservoir to the treatment site due to vacuum generated by the vacuum pump; and a second phase of the plurality of phases comprises the vacuum pump turned off to deliver a second volume of the first fluid from the first fluid reservoir to the treatment site due to one or both of a residual vacuum within the fluid delivery system and gravity provided by the head height, wherein the treatment process of the control unit automatically activates a first transition from at least the first phase to the second phase.

31. The treatment delivery system of claim 30, wherein the first volume of the first fluid is about 25 mL to about 50 mL.

32. The treatment delivery system of claim 30 or claim 31, wherein the residual vacuum within the fluid delivery system is decaying residual vacuum.

33. A treatment delivery system comprising: a fluid delivery system for directing a first fluid from a first fluid reservoir to a treatment site through a first fluid delivery line formed of a first material; a control unit programmed to control the fluid delivery system according to a treatment process; and a first pinch valve sized to receive the first fluid delivery line, wherein the first pinch valve is normally closed to compress the first fluid delivery line preventing fluid flow through the first fluid delivery line, and wherein the first pinch valve is opened by a combination of a solenoid activated by the control unit to open according to the treatment process and a spring-like mechanical force against the first pinch valve supplied by the first material of the first fluid delivery line.

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