Systems and devices for the treatment of localized infections in and around diarthrodial joints and methods of use

Abstract

The system includes a cannula having a tubular portion with a lumen extending from a proximal opening to a distal opening. A distal flange surrounds the distal opening and has an outer diameter greater than the outer diameter of the tubular portion near the distal end region of the cannula. An open-cell sponge is included having a first portion shaped for implantation into the wound space and a second portion sized and shaped to extend through each of the distal opening, lumen, and proximal opening of the tubular portion. The sponge has sufficient tensile strength to prevent tearing of the sponge into the distal opening and through the lumen of the tubular portion during retraction of the first portion in the proximal direction. Related devices, systems, kits, and methods are also provided.

Description

[Technical Field]

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

[0002] The present disclosure relates generally to methods, systems, and devices for irrigation of biological tissue. In particular, the description relates to methods, systems, and devices for irrigation of localized infections in and around diarthrodial joints, including infected autogenous joints, and for dissection, antibiotic administration, and implant preservation of infected prosthetic joints. [Background technology]

[0003] Joint infections, including septic arthritis and periprosthetic joint infection (PJI), are rare but devastating conditions that can be associated with serious complications. Successful management of joint infections involves surgical intervention and systemic antibiotics in the majority of cases. A critical part of the surgical procedure is the reduction of bacterial bioburden. Bioburden reduction is accomplished through irrigation and dissection of infected soft tissues. Infected implants can be replaced or preserved at the time of treatment, depending on the clinical presentation. Replacing the implant is more invasive and increases patient morbidity compared with implant preservation, but reduces bacterial bioburden and improves outcomes compared with implant preservation. In chronic cases, the infection is well advanced, and the implant is typically replaced in a one- or two-stage revision arthroplasty. In acute cases, cases of PJI in medically fragile patients, and cases of PJI involving prostheses that are usually difficult to remove, the most common surgical treatment is to preserve the implant, known as irrigation and dissection (I&D) or dissection, antibiotics, and implant preservation (DAIR).

[0004] Conventional systems and devices are not optimized for controlled delivery of local antibiotics during I&D, DAIR, and Double DAIR procedures, due in part to the lack of medical devices to maximize the effectiveness of irrigation and minimize the risks associated with exposure of the joint during local antibiotic therapy.

[0005] In light of the foregoing, there exists a need for improved devices, systems, and methods relating to controlling the introduction and removal of fluid into and from the diarthrodial joint space. Summary of the Invention [Means for solving the problem]

[0006] In one implementation, a system is provided that includes a cannula and an open-cell sponge. The cannula includes a tubular portion having a lumen extending from a proximal opening at a proximal end region of the cannula to a distal opening at a distal end region of the cannula, the lumen having a first cross-sectional area at the proximal opening and a second, larger cross-sectional area at the distal opening. A distal flange is on the distal end region of the cannula, surrounds the distal opening, and has an outer diameter that exceeds the outer diameter of the tubular portion near the distal end region of the cannula. The open-cell sponge has a first portion shaped for implantation within a wound space and located distal to the distal opening of the tubular portion, and a second portion sized and shaped to extend through each of the distal opening, the lumen, and the proximal opening of the tubular portion. The sponge has sufficient tensile strength to prevent the open-cell sponge from tearing during pullback through the lumen of the tubular portion into the distal opening in the proximal direction of the first portion.

[0007] Upon implantation of the system within a patient, a first portion of the sponge can be positioned within the wound space and a second portion can be positioned within the lumen of the cannula such that a proximal end region of the second portion is positioned at an extradermal location. The distal flange can be flexible and configured to be compressed to a reduced outer diameter after removal of the sponge from the cannula for removal from the wound space through an opening in the patient's skin. A proximal flange can be on the proximal end region of the cannula, surround the proximal opening, and have an outer diameter that exceeds the outer diameter of the tubular portion near the proximal end region of the cannula.

[0008] The system may further include a connecting line configured for bidirectional or unidirectional fluid flow to the wound space. The system may further include a therapy delivery system fluidly coupled to the connecting line and configured to control fluid flow to the wound space. The therapy delivery system may provide instillation and / or suction of the wound space. The therapy delivery system may be manually or electronically controlled. The therapy delivery system may include a fluid delivery system and a control unit. The fluid delivery system may include a vacuum source. The cannula and open-cell sponge may provide fluid communication between the vacuum source and the wound space for fluid removal.

[0009] Instilling the wound space can include delivering a therapeutic fluid to the wound space. The therapeutic fluid can include at least one therapeutic agent. The at least one therapeutic agent can be an antibiotic, an analgesic, an antifungal, or a combination thereof. The wound space can be a joint cavity.

[0010] In a related aspect, provided is a treatment support system including a fluid delivery system for directing fluid to and / or from a treatment site, a portion of the fluid delivery system configured to prevent migration of the fluid delivery system from the treatment site, and a portion of the fluid delivery system configured to collapse to a minimal cross-section for minimally invasive transepidermal deployment to or removal from the treatment site.

[0011] The therapeutic support system may further include an inflatable structure configured to fill the opening at the treatment site during treatment. The inflatable structure may include a balloon or bladder inflatable with gas and / or liquid. The fluid delivery system may include a catheter or tubing. The catheter or tubing may include an external attachment feature for removably attaching the catheter or tubing to a portion of the treatment site during treatment. The external attachment feature may be a magnet, suture, adhesive, resorbable material, hook, and / or ring. The therapeutic support system may further include a cannula that is flared or funnel-shaped at a distal end at the treatment site. The cannula may include a flared internal channel, the cross-sectional area of ​​which is greater at the distal end than at the proximal end of the cannula. The cannula may be a flexible biocompatible polymer.

[0012] The portion of the fluid delivery system configured to prevent migration can be a porous component formed from compressible open-cell foam. The porous component can have a distal end, a proximal end, and a central section, with the distal end, proximal end, and central section each having a cross-sectional area. The porous component can be positioned with at least a portion of the central section compressed within the internal channel of the cannula and at least the distal end positioned within the treatment site. The cross-sectional areas of the distal end and the proximal end can exceed the cross-sectional area of ​​the portion of the central section compressed within the internal channel of the cannula. The porous component can be removable from the treatment site and the cannula by proximally withdrawing the proximal component through the cannula. The cross-sectional area of ​​the distal end can be compressed by the cannula as the porous component is withdrawn. The cannula can be flexible so that the cross-sectional area of ​​the interior channel of the cannula can be reduced by compressing, folding, or other manipulation to facilitate removal of the distal end of the cannula from the treatment site. The system can further include an insertion tool including a plurality of sequentially sized slidable segments. The fluid delivery system can be a biocompatible material.

[0013] In a related implementation, a therapeutic support system is provided that includes a fluid delivery system for directing fluid to and / or from a treatment site, a portion of the fluid delivery system configured to direct fluid while mechanically stabilizing the treatment site during articulation of the treatment site, and a portion of the fluid delivery system configured to expand from a first collapsed configuration to a second expanded, stable configuration during treatment and return to the collapsed configuration for removal from the treatment site. The portion of the fluid delivery system configured to expand can be an open-cell sponge, mesh, and / or lattice. The mesh can include one or more flexible, biocompatible materials, such as polyester, polypropylene, silicone, silk, nylon, and / or nickel-titanium alloy. The mesh can include a helically wound braided tube. The mesh can include a sleeve shaped to conform to the anatomy of a portion of the treatment site. The system can further include a spacer configured to move with an inner surface of the treatment site. The expansion from the first collapsed configuration to the second expanded, stable configuration can occur when the fluid delivery system reaches a temperature at or near the patient's body temperature.

[0014] In a related implementation, provided is a therapeutic support system having a fluid delivery system for directing fluid to and / or from a treatment site comprising a portion of a joint and an attachment feature attached to the fluid delivery system. The attachment feature is configured to prevent migration, kinking, or clogging of the fluid delivery system. The fluid delivery system can further include a catheter or tubing. The system can further include a mesh with a sleeve shaped to conform to the anatomy of a portion of the treatment site and direct flow thereto. The attachment feature can include a spacer configured to allow fluid flow and protect a spared implant during therapy. The spacer can be configured to deliver fluid to and from the treatment site while mechanically stabilizing the treatment site during articulation of the treatment site.

[0015] In a related implementation, provided is a treatment support system including a fluid delivery system for directing fluid to and / or from a treatment site and an irrigation and irrigation device for use at the treatment site. The irrigation and irrigation device includes a flexible cannula having a lumen with a proximal opening and a distal opening, and a porous component including an open-cell foam having a proximal end portion and a distal end portion. The irrigation and irrigation device has an assembled configuration in which the distal end portion of the porous component is positioned distal to the distal opening of the lumen of the flexible cannula, and the proximal end portion of the porous component extends through the lumen such that at least a portion of the proximal end portion is proximal to the proximal opening. The distal end portion of the porous component is dimensioned to be pulled back through the lumen of the flexible cannula.

[0016] The flexible cannula can be a biocompatible elastomer such as silicone. The flexible cannula can be collapsible. The irrigation and cleaning device can be configured to be implanted at the treatment site in the assembled configuration. The flexible cannula can be removable from the treatment site after removal of the porous component from the flexible cannula. The flexible cannula can facilitate removal of the porous component from the treatment site. The system can further include an external vacuum source. The flexible cannula and the porous component can provide fluid communication between the external vacuum source and the treatment site for fluid removal from the treatment site. The foam can have high tensile strength to prevent tearing of the porous component during its removal through the cannula. In the assembled configuration, the distal end portion of the porous component can have a cross-sectional area that is larger than the cross-sectional area of ​​the distal opening. The distal end portion can be compressible to a smaller cross-sectional area that is smaller than the cross-sectional area of ​​the distal opening of the flexible cannula.

[0017] In a related implementation, a kit for treating a localized infection in a human patient is provided, the kit including at least one therapeutic agent, the therapeutic agent being an antibiotic, and an irrigation and irrigation device configured to locally irrigate and irrigate a treatment site of the localized infection with at least one dose of the at least one therapeutic agent. The irrigation and irrigation device includes a porous component configured to be positioned through an opening in the patient's skin such that at least a portion of the porous component is positioned within the infected site and at least a portion of the porous component is positioned external to the skin. The porous component includes an open-cell foam or sponge. The irrigation and irrigation device also includes at least one connecting line for delivering and removing a therapeutic fluid to and from the infected site through the porous component. The kit further includes instructions for administering at least one dose of the at least one therapeutic agent to treat the localized infection and for removing the porous component from the treatment site in a minimally invasive manner through the opening in the skin after administration. The porous component can have sufficient tensile strength to prevent tearing during removal of the porous component from the treatment site through a minimally invasive opening after treatment. The antibiotic can include aminoglycosides, glycopeptides, cyclic lipopeptides, amikacin, cefazolin, cefepime, ampicillin, ciprofloxacin, azithromycin, doxycycline, clindamycin, vancomycin, tobramycin, gentamicin, and daptomycin. The antibiotic can be a combination of vancomycin and tobramycin. The at least one dose is administered according to a treatment process in a control unit configured to control a fluid delivery system, and the fluid delivery system can be configured to connect to a fluid reservoir containing the at least one dose in solution.

[0018] In a related implementation, a kit for managing localized pain in a human patient is provided, including at least one therapeutic agent, the therapeutic agent being an anesthetic or an analgesic, and an irrigation and irrigation device configured to locally irrigate and irrigate a treatment site for localized pain with at least one dose of the at least one therapeutic agent. The irrigation and irrigation device includes a porous component configured to be positioned through an opening in the patient's skin such that at least a portion of the porous component is positioned within the treatment site and at least a portion of the porous component is positioned external to the skin. The porous component includes an open-cell foam or sponge. The irrigation and irrigation device includes at least one connecting line for delivering and removing a therapeutic fluid to and from the treatment site through the porous component. The kit includes instructions for administering at least one dose of the at least one therapeutic agent to treat localized pain and, after administration, removing the porous component from the treatment site in a minimally invasive manner through the opening in the skin. The anesthetic agent can be lidocaine. The at least one therapeutic agent can include lidocaine and at least one antibacterial agent. The at least one dose is administered according to a treatment process of a control unit configured to control a fluid delivery system, the fluid delivery system can be configured to connect to a fluid reservoir containing the at least one dose in solution.

[0019] In a related implementation, a kit for administering localized antifungal therapy in a human patient is provided, the kit including at least one therapeutic agent, the therapeutic agent being an antifungal agent, and an irrigation and irrigation device configured to locally irrigate and irrigate a treatment site of a localized fungal infection with at least one dose of the at least one therapeutic agent. The irrigation and irrigation device includes a porous component configured to be positioned through an opening in the patient's skin such that at least a portion of the porous component is positioned within the treatment site and at least a portion of the porous component is positioned external to the skin. The porous component includes an open-cell foam or sponge. The irrigation and irrigation device includes at least one connecting line for delivering and removing a therapeutic fluid to and from the treatment site through the porous component. The kit further includes instructions for administering at least one dose of the at least one therapeutic agent to treat the fungal infection and, following administration, removing the porous component from the treatment site in a minimally invasive manner through the opening in the skin. The antifungal agent can be fluconazole. The at least one therapeutic agent can include fluconazole and at least one antibacterial agent. The at least one dose can be administered according to a treatment process of a control unit configured to control a fluid delivery system. The fluid delivery system can be configured to connect to a fluid reservoir containing the at least one dose in solution.

[0020] 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 presently disclosed subject matter are described for illustrative purposes, it should be readily understood that such features are not intended to be limiting. The claims following this disclosure are intended to define the scope of the protected subject matter. [Brief explanation of the drawings]

[0021] These and other aspects will now be described in detail with reference to the following drawings. Generally, the figures are not drawn to scale in absolute terms or comparatively and are intended to be illustrative. Also, the relative placement of features and elements may be modified for purposes of illustrative accuracy. It should be understood that devices described herein may include features that are not necessarily depicted in each figure.

[0022] [Figure 1] FIG. 1 shows, in a schematic diagram, a therapeutic system fluidly coupled to a therapeutic delivery system.

[0023] [Figure 2A] FIG. 2A illustrates an example of a treatment system that includes a cannula for placement and removal of an irrigation and flushing device.

[0024] [Figure 2B] FIG. 2B shows the treatment system of FIG. 2A, with the distal end of the cannula positioned against the proximal end of the porous component.

[0025] [Figure 3A] FIG. 3A is an exploded view of an irrigation and cleaning device including a cannula for placement and / or removal of the porous component.

[0026] [Figure 3B] FIG. 3B is an assembled view of the irrigation and cleaning device of FIG. 3A.

[0027] [Figure 4] 4A-4C are cross-sectional views of a cannula for use with a porous component.

[0028] [Figure 5A] FIG. 5A shows a medial patellar rim approach for a knee procedure.

[0029] [Figure 5B]FIG. 5B illustrates placement of the pre-assembled irrigation and cleaning device of FIG. 3A in the knee of FIG. 5A.

[0030] [Figure 5C] FIG. 5C shows the insertion of an instillation treatment line into the irrigation and flushing device of FIG. 5B into the knee.

[0031] [Figure 5D] FIG. 5D shows the reduced patella over the top of the instillation treatment line and irrigation flushing device of FIG. 5C.

[0032] [Figure 5E] FIG. 5E shows the incision closed over the treatment system of FIG. 5D, with instillation treatment lines and vacuum lines configured for fluid connection to the treatment system.

[0033] [Figure 6A] FIG. 6A illustrates an example of a sequentially expanding cannula for placement and removal of an irrigation and cleaning device.

[0034] [Figure 6B] FIG. 6B shows the treatment system of FIG. 6A with the sequentially expanding cannula removed.

[0035] [Figure 7A] FIG. 7A shows an example of an irrigation and cleaning device having an external mesh.

[0036] [Figure 7B] FIG. 7B shows the irrigation and cleaning device of FIG. 7A following collapse toward its narrow outer diameter.

[0037] [Figure 8] FIG. 8 illustrates an example of a portion of an irrigation and cleaning device, according to some example implementations.

[0038] [Figure 9]9A and 9B show an embodiment of a sleeve for use with a treatment system in a hip joint in assembled and separated views, respectively.

[0039] [Figure 10] 10A and 10B show an embodiment of a sleeve for use with a treatment system in a knee in assembled and separated views, respectively.

[0040] [Figure 11A] FIG. 11A shows, in an exploded view, an embodiment of a treatment system for irrigation of a diarthrodial joint, which additionally incorporates a spacer.

[0041] [Figure 11B] FIG. 11B shows the treatment system of FIG. 11A in cross section.

[0042] [Figure 12A] FIG. 12A shows, in an exploded view, another embodiment of a treatment system for irrigation of a diarthrodial joint, which additionally incorporates a spacer.

[0043] [Figure 12B] FIG. 12B shows the treatment system of FIG. 12A in cross section.

[0044] [Figure 13A] FIG. 13A shows another embodiment of a treatment system for irrigation and irrigation of a diarthrodial joint that additionally incorporates a spacer for the knee and includes a separate irrigation and irrigation device.

[0045] [Figure 13B] 13B-13D are different views of the treatment system of FIG. 13A. [Figure 13C] 13B-13D are different views of the treatment system of FIG. 13A. [Figure 13D] 13B-13D are different views of the treatment system of FIG. 13A.

[0046] [Figure 14] 14A-14D show different views of the expandable spacer of the treatment system of FIG. 13A.

[0047] Where practical, like reference numerals refer to like structures, features, or elements. DETAILED DESCRIPTION OF THE INVENTION

[0048] Detailed Description The disclosed subject matter relates to surgically or minimally invasively deployed components that may improve fluid delivery to and removal from treatment sites, including localized infections in and around diarthrodial joints, during I&D (Irrigation and Dissection), DAIR (Dissection, Antibiotic Administration, and Implant Preservation), and Double DAIR procedures.

[0049] The DAIR procedure can be performed by a single surgical procedure (referred to herein as Single DAIR or DAIR) or as a planned two-stage procedure (Double DAIR). DAIR therapy often involves surgical dissection of the infected joint, including removal of any modular components (components not attached to bone) of the infected prosthesis, sterilization and reimplantation (or replacement) of the modular components, and postoperative systemic antibiotic therapy. Septic arthritis, an infection of the joint without a prosthesis, is treated in a very similar manner to the I&D procedure, involving soft tissue surgery or minimally invasive irrigation and dissection, and postoperative systemic antibiotic therapy.

[0050] Double DAIR therapy involves a second extensive soft-tissue dissection and replacement of the modular implant components 5–7 days after the first dissection and modular component sterilization. Recent reports have shown that DAIR efficacy has been improved using a Double DAIR therapy regimen. The first surgical procedure in Double DAIR therapy involves soft-tissue dissection, removal, sterilization, and reimplantation of the modular components, and implantation of antibiotic-impregnated PMMA (polymethyl methacrylate) beads adjacent to the infected implant in an attempt to improve local antibiotic delivery to the infected joint. The second surgical procedure in Double DAIR therapy involves removal of the antibiotic-impregnated beads, a second dissection, and modular component exchange (replacement of the modular components with new sterilized components). The disclosed devices and systems can improve the effectiveness of I&D, DAIR, and Double DAIR by providing local irrigation of infected joints using an antimicrobial agent in solution, complementing systemic antibiotic therapy and replacing controlled antibiotic irrigation via antibiotic beads and an implanted temporary irrigation device in Double DAIR therapy.

[0051] With the significant incidence of systemic antibiotic toxicity reported in DAIR patients, controlled local irrigation provides improved safety by allowing for the local delivery of higher concentrations of antibiotics, which can be easily and more quickly reduced or discontinued if high systemic antibiotic levels are encountered. For example, during the first phase of Double DAIR treatment, the modular components are removed and sterilized, extensive dissection is performed, and a temporary irrigation device is implanted. Combination therapy can be administered over a 7-day cycle of alternating tobramycin and vancomycin irrigation via the temporary irrigation device. During the second phase of treatment, the temporary irrigation device is removed, a second extensive dissection is performed, and the modular prosthetic components are replaced, followed by postoperative systemic antibiotic administration. Double DAIR can be further improved by eliminating the need for a second phase (i.e., a second dissection and local antibiotic delivery device removal) by designing the irrigation device to allow for minimally invasive removal without a second surgical procedure. This improvement provides the benefit of local antibiotic delivery, currently only available with Double DAIR, with the benefit of a single surgical intervention provided by I&D or Single DAIR.

[0052] The irrigation and lavage of mammalian joints described herein involves the delivery of any of a series of therapeutic fluids, allowing the fluid to dwell for a predetermined period of time, and subsequent removal of wound exudate and excess therapeutic fluid, to provide flow to and from infected joints to flush the joint and reduce bioburden as part of an antimicrobial therapy. Therapy delivery systems described herein can include tubular devices such as catheters and cannulas, porous materials such as open-cell sponges and other meshes or grids, and combinations of the two, in which the tubular device is in line with, internal to, external to, or parallel to the porous material. Such irrigation and lavage devices can be used in practice, as further described below, and can be the only devices used for local irrigation and lavage of therapeutic fluids, or can be used in conjunction with additional devices.

[0053] As an advantage of the proposed solution described herein, the treatment delivery system described herein can enable minimally invasive procedures, including I&D, DAIR, and Double DAIR procedures. For example, one or more portions of the treatment delivery system are configured to aid in the placement and removal of an irrigation and irrigation device through a small incision in the skin. The treatment delivery system described herein is configured to minimize trauma to the skin and underlying tissue, preferably eliminating the need for a surgical procedure and removal of the irrigation and irrigation device. As another advantage of the proposed solution described herein, the treatment delivery system can control fluid delivery to the treatment site according to the anatomy of the area to be treated, ensuring successful treatment. Other advantages of the treatment delivery system are discussed with reference to the figures.

[0054] While implementation of the irrigation and irrigation devices, spacers, and other components of the treatment systems described herein may be described in the context of a particular diarthrodial joint or a particular procedure, it should be understood that other diarthrodial joints or procedures are contemplated as well. For example, while the device is described as being useful in the knee joint, the device may also be configured for use in other diarthrodial joints, such as the hip, shoulder, elbow, wrist, or ankle. Also, while the device is described as being useful during a specific procedure, such as DAIR or Double DAIR, the device may also be configured for use in other procedures to treat localized infections, including wounds or traumatic bone injuries, surgical site infections, septic arthritis, breast implant infections, and fracture-related infections, with or without existing implants or hardware (e.g., fracture plates and screws). The devices described herein may be configured for use in any of a variety of procedures and treatment sites other than those specifically described herein.

[0055] The systems described herein can be used to deliver therapy to any of a variety of treatment sites, such as an infected joint cavity. While the treatment site is referred to herein as a joint cavity or another site, it should be understood that the treatment site or type of biological tissue being treated by controlled fluid irrigation can vary, including periprosthetic tissue, joint cavities, bone compartments, and fractures of any number of bones, including bones of the hip, knee, shoulder, wrist, ankle, etc. Treatment sites can be traumatic wounds, infected tissue, surgical incisions, surgical sites, wound areas, including osteomyelitis, septic arthritis, breast implant infections, fracture-related infections, and / or infected joints. Examples of treatments include periprosthetic joint infection treatment protocols, such as DAIR and revision total joint arthroplasty. While the present application may be described in the context of a particular treatment site (e.g., an infected joint) and its connection to that site, it should be understood that other treatment sites are contemplated, and the manner in which the system connects to those various sites may also vary.

[0056] Minimally invasive, as used herein, refers to surgical procedures performed using small incisions and few sutures that are less traumatic to the patient than non-minimally invasive or open surgery.

[0057] Although the fluids delivered using the therapeutic systems described herein are described as antibiotics, other fluids are contemplated as well, including any of a variety of irrigation and irrigation fluids, such as saline, including irrigation and irrigation fluids having one or more therapeutic capabilities containing any of a variety of antimicrobial agents, including antibiotics, antivirals, antifungals, antiparasitics, and the like. Examples of antibiotics include aminoglycosides, glycopeptides, cyclic lipopeptides, amikacin, cefazolin, cefepime, ampicillin, ciprofloxacin, azithromycin, doxycycline, clindamycin, vancomycin, tobramycin, gentamicin, daptomycin, and combinations thereof. Fluids delivered using the therapeutic systems described herein may include antifungals, either alone or in combination with an antibiotic or combination of antibiotics. Examples of antifungal agents include azole derivatives (e.g., fluconazole, isavuconazole, posaconazole), amphotericin B, echinocandins (e.g., anidulafungin, caspofungin, micafungin). Fluids delivered using the therapeutic systems described herein can include pain medications, alone or in combination with an antibiotic or combination of antibiotics. Examples of pain medications include opioids, analgesics, anesthetics, and the like. Several classes of anesthetics and analgesics are suitable for topical wound irrigation, including aminoamides (e.g., lidocaine, bupivacaine, levobupivacaine, mepivacaine, ropivacaine, prilocaine), aminoesters (e.g., benzocaine, chloroprocaine, procaine, tetracaine), NSAIDs (e.g., ketorolac, celecoxib, diclofenac, fenoprofen, indomethacin), and corticosteroids (e.g., prednisone, methylprednisolone, dexamethasone, triamcinolone, betamethasone, beclomethasone, flunisolide, fluticasone). Fluids delivered using the therapeutic systems described herein can include antibiotic combinations, e.g., tobramycin sulfate and vancomycin HCl, and anesthetics such as lidocaine.The fluid being delivered using the treatment systems described herein can include a combination of an antibiotic and an antifungal agent, such as fluconazole.

[0058] FIG. 1 shows an example of a treatment system 100 positioned at a treatment site 102 (e.g., the area in and around a diarthrodial joint). The treatment system 100 can be fluidly coupled to a treatment delivery system 107, as shown in FIG. 1 . The treatment system 100 can also be coupled to a syringe or another manual component for delivery and withdrawal of fluid to and from the treatment site. Generally, the treatment system 100 includes an irrigation and irrigation device 101 having a porous component 103 coupled to a distal end region of a connecting line 105, which may include a catheter or tubing. The connecting line 105 can be configured for bidirectional or unidirectional flow. The connecting line 105 delivers treatment fluid from the treatment delivery system 107 to the treatment site through the porous component 103. The porous component 103 of the irrigation and irrigation device 101 is configured to fill spaces and / or openings in the treatment site and allow fluid to exit the tubing and flow through the porous component 103 into the treatment site 102. The porous component 103 of the irrigation and irrigation device 101 is configured to be compressed to a smaller dimension for use in a minimally invasive manner during placement at and removal from the treatment site. A tool, such as a cannula, can be inserted over the connecting line 105 to minimize the cross-sectional area of ​​the porous component 103 prior to or upon completion of the irrigation and irrigation treatment as the porous component 103 is advanced / removed through the cannula. The treatment system 100 can be used for a variety of methods, including DAIR, as described elsewhere herein, or other types of healing, including wound and perioperative healing.

[0059] The treatment system 100 (e.g., the connecting line 105 of the irrigation and irrigation device 101) can be configured to fluidly couple with a treatment delivery system 107, which can provide controlled, localized delivery of fluid (e.g., antibiotics, saline, local anesthetic) into a treatment site 102 (e.g., an infected diarthrodial joint such as a knee or hip) during, for example, an I&D, DAIR, Double DAIR, or another procedure. Generally, the treatment delivery system 107 can include a device for allowing adjustment of the distance between the treatment delivery system 107 and the treatment site 102 of a patient receiving medical treatment, such as a patient afflicted with an infection treatable with fluid irrigation and irrigation during an I&D, DAIR, or Double DAIR procedure. In the example illustrated in FIG. 1 , the treatment delivery system 107 provides irrigation and irrigation to the treatment site 102, which includes an irrigable volume (e.g., a joint or bone compartment), through the irrigation and irrigation device 101. Although not shown, one or more other medical devices may assist, coordinate with and / or operate in parallel with the therapy delivery system 107 to provide therapy for the patient (including the treatment site 102).

[0060] The treatment delivery system 107 includes a fluid delivery system 104 and a control unit 106. The fluid delivery system 104 is connected to fluid reservoirs 108A, 108B. The fluid delivery system 104 includes tubing, spikes, connectors, and manual clamps. The fluid delivery system 104 can be loaded onto the control unit 106 into normally closed pinch valves that are controlled to open and allow flow of a set fluid type through the fluid lines 110A, 110B, 110C and the control unit 106. The fluid delivery system 104 includes fluid lines 110A, 110B, 110C (tubing) for directing fluid from selected fluid reservoirs 108A, 108B to the treatment site during a particular phase of treatment, and fluid lines 110D, 110E (tubing) for directing fluid from the treatment site to the collection reservoir 108C. Fluid lines 110A, 110B may be attached to the control unit 106, transmitting fluid from the multiple fluid reservoirs 108A, 108B to the control unit 106.

[0061] The control unit 106 can control irrigation (e.g., therapy fluid delivery and fluid removal) of multiple fluids (e.g., irrigation irrigants) according to a set protocol, including multiple phases for delivery of specific fluid types in specific directions for set time durations. The settings of the control unit 106 can be predetermined for specific treatment types (e.g., I&D, DAIR, and Double DAIR procedures). The control unit 106 can enable gravity / vacuum-driven delivery of fluids (e.g., irrigation irrigants) from fluid reservoirs 108A, 108B (e.g., solution bags) into the treatment site (e.g., joint cavity) 102 via fluid lines 110A, 110B, and 110C (e.g., delivery lines) with high precision. The control unit 106 can control vacuum pressure levels to remove fluid from the treatment site 102 via fluid line 110D into collection fluid reservoir 108C (e.g., a canister).

[0062] As a route of administration, irrigation refers to the administration of irrigant to a treatment site, such as an open wound or body cavity, by immersion or washing. Irrigation is bidirectional in that irrigant delivered to the treatment site is also removed from the treatment site via suction. Delivery of fluid to a treatment site may be referred to herein as instillation.

[0063] Some therapeutic agents, such as certain antibiotics, are generally administered systemically (e.g., intravenously), which carries a high risk of systemic toxicity. The use of repeated doses of antibiotics delivered via catheter to the periprosthetic tissue or joint cavity following aggressive dissection and one-stage prosthesis replacement as local instillation of antibiotics in solution for the treatment of periprosthetic joint infections (PJIs) has been reported. Local instillation is a one-way delivery of antibiotics to the treatment site, in which the instilled antibiotic is not aspirated or washed away from the treatment site. The instilled dose is therefore absorbed into the tissues and bloodstream, such that systemic toxicity considerations also limit the local dose and concentration that can be safely administered by instillation. Whiteside et al. reported that instillation of very high concentrations of vancomycin (50,000–100,000 μg / mL) into joint cavities once or twice daily resulted in serum concentrations exceeding safety limits in several patients, necessitating a reduction in the instilled dose and concentration (see Clin Orthop Relat Res (2011) 469:26–33). While peak and trough vancomycin concentrations in the joint cavity exceeded serum concentrations and persistently exceeded the minimum inhibitory concentration (MIC) of vancomycin for common vancomycin-susceptible bacterial species, sustained local concentrations were limited by exceeding safe systemic concentrations and were not maintained at or above the minimum biofilm eradication concentration (MBEC) of vancomycin for several common PJI bacterial species (greater than 4,000 μg / mL). Similarly, the maximum daily dose provided by this instillation method was 1,000 mg.

[0064] Described herein are systems for delivering one or more doses of at least one therapeutic agent as an irrigant (e.g., at least one therapeutic agent in solution) to a treatment site (e.g., periprosthetic tissue, a joint cavity, etc.) via irrigation (e.g., instillation and subsequent aspiration) to treat a condition at the treatment site (e.g., a localized bacterial or fungal infection or localized pain, etc.). The systems described herein can control treatment according to a treatment process. For example, the treatment process may locally administer a total amount of at least one therapeutic agent in a 24-hour period that equals or exceeds the maximum recommended daily systemic dose for that therapeutic agent. The total daily dosage of the therapeutic agent irrigant can substantially exceed the maximum recommended daily systemic dose of the therapeutic agent without the toxicity risks associated with systemic administration.

[0065] In some implementations, the antibiotic vancomycin can be administered locally as an irrigant using the systems described herein at a total dose of greater than 3,000 mg / day, e.g., greater than 3,000 mg / day, about 4,000 mg / day, about 5,000 mg / day, about 6,000 mg / day, about 7,000 mg / day, about 7,500 mg / day, or up to about 40,000 mg / day in a 24-hour period, to treat localized infections. As another example, the antibiotic tobramycin can be administered locally as an irrigant using the systems described herein at a total dose of greater than 100 mg / day, up to about 1,000 mg / day, or up to about 1,250 mg / day in a 24-hour period, to treat localized infections.

[0066] As another example, a treatment process may involve locally administering at least one therapeutic agent to treat a localized fungal infection, the therapeutic agent being an antifungal agent administered to locally irrigate the treatment site, providing the patient with sustained, localized antifungal therapy over at least a 24-hour period. The antifungal agent may be fluconazole, administered locally in a total amount equal to or exceeding the total daily dose permitted for systemic administration of fluconazole over a 24-hour period. The maximum recommended daily systemic dose for fluconazole is 400 mg / day. Fluconazole may be administered in combination with at least one antibacterial agent, such as vancomycin and / or tobramycin.

[0067] As another example, the treatment process may involve the local administration of at least one therapeutic agent, which is an anesthetic or analgesic, administered to locally irrigate the treatment site and treat localized pain. The anesthetic can be lidocaine, administered locally in a total amount equal to or exceeding the total daily amount allowed for systemic administration of lidocaine in a 24-hour period. The maximum recommended daily system dose for lidocaine is 300 mg / day. Lidocaine can be administered in combination with another therapeutic agent, such as at least one antibacterial agent, as described elsewhere herein.

[0068] The control unit 106 can maintain a vacuum pressure level (e.g., about −5 mmHg to about −200 mmHg, preferably about −125 mmHg + / −10% or −112.5 mmHg to 137.5 mmHg) at a specific intermittent period to remove fluid from the treatment site 102 into a collection fluid reservoir 108C (e.g., a canister) through the connection mechanism 116. The connection mechanism 116 can include one or more fluid connection ports to allow bidirectional flow to / from openings in the treatment site 102, and can allow attachment of fluid lines 110C, 110D for delivery and collection of fluid to and from a single irrigation and irrigation device that allows irrigation and irrigation of the treatment site 102 during the corresponding treatment phase. Alternatively, one or more one-way flow irrigation and flushing devices dedicated to inflow and one or more separate one-way flow irrigation and flushing devices dedicated to outflow may be used, with the inflow device fluidly coupled to fluid line 110C and the outflow device fluidly coupled to fluid line 110D. The control unit 106 can control fluid flow and vacuum pressure through the use of discrete logic components, firmware, pressure sensors, vacuum pumps, and solenoid pneumatic valves.

[0069] 2A and 2B illustrate an example of a treatment system 200 including an irrigation and irrigation device 202 configured to be positioned within a treatment site 102, such as a diarthrodial joint 203, having an implant 205 in place within one or more bones 207A, 207B, and a delivery / removal cannula 204. The irrigation and irrigation device 202 includes a porous component 103 and a connecting line 105. The porous component 103 can be coupled to a distal end region of the connecting line 105 and to the flared end of the delivery cannula 204. The connecting line 105 can include one or more of a catheter or tubing. The porous component 103 is shown colinear with the connecting line 105. The porous component 103 in the version of FIGS. 2A-2B has a tubular structure with a lumen extending therethrough that is sized to receive the outer diameter of the connecting line 105. The porous element 103 need not have this alignment with the connecting lines 105 and can be placed anywhere within the treatment site 102. Figures 3A-3B show another implementation in which the porous element is not co-linear with the connecting lines. The porous element 103 is positioned within the treatment site, and the connecting lines are simply located adjacent to the porous element 103. The connecting lines 105 in the implementation of Figures 2A-2B are bidirectional, such that inflow and outflow occur through a single lumen in a single line. The connecting lines 105 can also be unidirectional, such that flow into and out of the site occurs through different lumens in different lines (see also Figures 5E, 9A-9B, and 10A-10B). In still further implementations, connecting lines 105 for fluid removal need not be incorporated at all. Rather, a vacuum is applied on the skin surface, and fluid can be removed through openings in the skin. Porous element 103 can be positioned such that it is completely subcutaneous and in fluid communication with transepidermal connecting line 105, as shown in Figures 2A-2B. Porous element 103 can also be positioned such that a portion is subcutaneous and another portion extends outside the skin to apply a vacuum onto the skin surface via connecting line 105 (see Figures 5B-5D).

[0070] The bandaging kit can be in fluid communication with the treatment site via the porous component. For example, the bandaging kit can include a sterile single-use kit including an adhesive film drape, tubing for fluid connection to a collection canister, and the porous component. Fluid can be removed from the treatment site and disposed of in the canister by applying a vacuum through the bandaging kit. The bandaging kit can include a commercial bandaging kit adapted for negative pressure wound therapy.

[0071] 2A-2B, irrigation and flushing device 202 is configured to be positioned at a treatment site (e.g., knee joint, hip joint, and the like) for delivery of fluid into the joint through connecting line 105 and through porous component 103 during a treatment regimen for the joint. Connecting line 105 may include one or more distal openings (not shown) arranged inside or in fluid communication with porous component 103 such that fluid delivered through the lumen of connecting line 105 is dispersed through porous component 103 and into the treatment site, including joint 203.

[0072] The porous component 103 of the irrigation and irrigation device 202 can be a compressible material so that its cross-sectional area can be reduced to a smaller cross-sectional area suitable for minimally invasive insertion through a small opening in the irrigation and irrigation device 202, and once in place within the joint, can be expanded or allowed to return toward its original cross-sectional area to fill the space to deliver fluid therapy. Upon completion of the treatment regimen, the porous component 103 can again be compressed and removed from the joint in a minimally invasive manner. The porous component 103 need not be inserted in a minimally invasive manner, but instead can be positioned while the treatment site is open, as described with respect to FIGS. 5A-5E.

[0073] As explained above, one or more connecting lines 105 can be configured for unidirectional or bidirectional flow, such that fluid is delivered to and from the joint along the same flow path, including both the connecting line 105 and the porous component 103. In one preferred implementation, two or more connecting lines 105 can be configured for unidirectional flow, such that fluid is delivered to the porous component 103 and joint through one connecting line 105 and removed from the joint and the porous component 103 through a different connecting line 105. The unidirectional connecting lines 105 can include one line for flow into the site and another line for flow out of the site. The bidirectional connecting line 105 can accommodate inflow to and out of the treatment site. In yet a further implementation, the connecting line 105 is not used, and fluid transport out of the treatment site relies on a vacuum applied to the skin. Alternatively, any combination of connecting line 105 and porous component 103 can be configured to provide fluid flow into and out of the joint, including configurations in which only connecting line 105 is used for flow in one or both directions, and other configurations in which only porous component 103 is used within the joint for flow in one or both directions and is in fluid communication with connecting line 105 outside the skin.

[0074] The porous component 103 can be an open-cell foam or sponge or any type of biocompatible compressible material, including polyester, polyurethane, polyethylene, silicone, or other biocompatible material, or combinations thereof, that can be in fluid communication with the connection line 105 and allow for irrigation and irrigation of the joint 203. For example, the porous component 103 can include an open-cell sponge, fluid-conductive channels, or openings to allow for irrigation and irrigation of the joint 203. In some implementations, at least a portion of the connection line 105 includes uniformly distributed openings that allow fluid to be transmitted to the porous component 103. In some implementations, the distal end of the connection line 105, which is surrounded by the porous component 103, includes one or more openings that allow fluid to be transmitted to the porous component 103 and allow for irrigation and irrigation of the joint 203.

[0075] The porous component 103 can have an open proximal end 209A and a closed distal end 209B. The open proximal end 209A of the porous component 103 can be sized to receive the distal end of the connecting line 105 (see FIGS. 2A and 2B). The closed distal end 209B of the porous component 103 can prevent the connecting line 105 from extending beyond the distal end 209B of the porous component 103. The porous component 103 can have internal dimensions that match the external dimensions of the connecting line 105 and allow stable positioning of the porous component 103 relative to the joint 203 during treatment.

[0076] 2A and 2B, the treatment system 200 may additionally include a cannula 204 to aid in the insertion and removal of the irrigation and irrigation device 202. The cannula 204 may be placed diametrically across the connecting line 105 and porous component 103 of the irrigation and irrigation device 202, which are positioned under the skin during the initial surgical procedure to install the irrigation and irrigation device 202. The cannula 204 may be introduced through a small incision 212 in the skin during irrigation and irrigation device removal to facilitate removal of the irrigation and irrigation device. The cannula 204 is preferably removed during the instillation treatment cycle between insertion and removal.

[0077] The outer diameter of the cannula 204 increases toward its distal end, forming a flared or funnel-shaped feature in the distal end region 206B of the cannula 204. Similarly, the inner diameter of the cannula 204 can increase in the distal end region 206B of the cannula 204, which may have a cylindrical or flared outer diameter. The flared or funnel-shaped feature in the distal end region 206B gradually compresses the outer dimension of the porous structure 103 as the porous structure 103 is withdrawn into the distal end region 206B of the cannula 204 (e.g., upon removal of the porous structure 103 through the skin puncture 212). In some implementations, the cannula 204 can include a first proximal end 206A with a generally cylindrical first outer diameter and a second distal end 206B with a second outer diameter, the first outer diameter being smaller than the second outer diameter. The proximal end 206A of the expanded cannula can be sized to fit within a minimally invasive opening 212 through the skin, such as a surgical puncture wound approximately 6 mm in diameter. The distal end 206B of the expanded cannula can be sized with a maximum inner diameter large enough to accommodate the cross-sectional area of ​​the compressible porous component 103 (e.g., a sponge or sponge-coated catheter) of the irrigation and cleaning device 202. For example, the distal end 206B of the expanded cannula 204 can have an outer diameter of approximately 10 mm or more less than the maximum stretched diameter of the skin to prevent skin tearing at the puncture 212. The length of the taper from the larger to the smaller outer diameter of the expanded cannula 204 can be long enough to facilitate gradual decompression of the porous component 103 from the larger to the smaller diameter as the porous component 103 is pulled through the expanded cannula 204.

[0078] 2A-2B, cannula 204 can include proximal opening 208A and distal opening 208B. Cannula 204 can be used to remove irrigation and cleaning device 202 from treatment site 102. Cannula 204 can be inserted during surgery such that a portion of cannula 204 is positioned within an open wound at the treatment site and a portion of cannula 204 is positioned outside the treatment site. Cannula 204 can be inserted by pushing proximal end 206A through a stab incision near the open wound, and can be pushed through the stab incision until distal end 206B is positioned adjacent porous component 103, which is positioned within the open wound. Because portions of the surgical procedure are open, larger components, such as the expanded distal end 206B, can be placed in an open surgical procedure, and smaller components, such as the proximal end 206B, can be removed through a puncture in a minimally invasive manner. Alternatively, the expanded cannula 204 can be inserted percutaneously, while the expanded distal end 206B is constrained to a smaller outer diameter, such as within an outer sheath. The outer sheath can be removed from the expanded cannula 204, allowing the expanded region to expand only after it is positioned subcutaneously within the treatment site.

[0079] The distal end 206B of the cannula 204 can be positioned within the treatment site 102 so that the distal opening 208B of the cannula 204 is adjacent to or overlaps the proximal end 209A of the porous component 103 of the irrigation and cleaning device 202 (see FIG. 2A). The proximal end 206A of the cannula 204 can remain outside the patient's skin. The taper at the distal end 206B of the cannula 204 compresses the porous component 103 of the irrigation and cleaning device 202 as the cannula 204 is withdrawn into the distal opening 208B and pulled back through the cannula 204 toward the proximal end 206A (see FIG. 2B). The distal end 206B of the cannula 204 can taper from an outer diameter at the distal opening 208B to an outer diameter at the proximal-most end of the taper over a length of about 5 mm to about 20 mm. The distal end 206B of the cannula 204 is expanded to taper linearly from a larger diameter to a smaller diameter or to follow a trumpet or exponential shape, with the greatest reduction in diameter occurring closest to the larger diameter end, allowing the irrigation and cleaning device 202 to be rapidly compressed initially upon entering the expanded cannula 204.

[0080] In some implementations, the expanded cannula 204, the distal end 206B of the cannula 204, or a portion thereof may be adjustable to facilitate placement and removal of the cannula 204 in a minimally invasive manner by reducing the diameter of the distal end 206B during placement or removal of the expanded cannula 204, and expanding the diameter of the distal end 206B during its use and removing the irrigation and flushing device 202.

[0081] The features of the expanded cannula 204, according to the corresponding maximum extension dimension, can facilitate a reduction in the cross-sectional area of ​​the porous component 103 of the irrigation and irrigation device 202 prior to removal through a minimal skin incision, minimizing trauma to the skin and underlying tissue and preferably eliminating the need for a surgical procedure to remove the irrigation and irrigation device 202. The expanded cannula 204 can be constructed from one or more biocompatible materials, such as stainless steel, titanium, or a polymer (e.g., polyetheretherketone (PEEK), polyethylene, or polyurethane), or a composite of materials in which the inner surface is constructed from a low-friction material (e.g., Teflon® or ultra-high molecular weight polyethylene (UHMWPE)).

[0082] The expanded cannula 204 can include one or more external features that can be used by a surgeon to temporarily anchor the expanded cannula 204 within the tissue at the treatment site during DAIR treatment so that the system can remain secured in place for extended periods (e.g., days / weeks). The external features of the expanded cannula 204 can include attachment features 210 such as roughened surfaces, porous surfaces, hooks, rings, flanges, and other attachment points, as well as a separate (open or releasable) ring located across the proximal end of the irrigation and irrigation device 202 that maintains the position of the irrigation and irrigation device 202 in its intended location.

[0083] The porous component 103 interfaces with the flexible cannula 104, allowing fluid communication through the skin and soft tissue for fluid removal from the joint. In some implementations, the expanded cannula 204 is positioned only during insertion and / or removal of the porous component 103 and is not in place during cycles between insertion and removal during fluid delivery to and / or fluid removal from the treatment site. In other implementations, the expanded cannula 204 can be inserted during an instillation procedure and left in place until the system is removed from the patient. The porous component 103 and flexible cannula 104 can remain in place within the patient during therapy and be removed along with the other components in a minimally invasive procedure at the conclusion of therapy. Implementation of the irrigation and flushing device 202 and the surgical procedures for deploying and removing the irrigation and flushing device 202 are described in further detail below.

[0084] 3A-3B illustrate an implementation of an irrigation and irrigation device 202 including a porous component 103 and a cannula 204, each designed to remain in place during treatment. The porous component 103 is for positioning at least partially within a treatment site, such as a surgical site, wound site, or other location. The cannula 204 is configured to maintain an opening through the skin and provide access to the porous component 103, such as for removal from the treatment site following treatment without requiring an additional surgical procedure. The treatment site 102 can be a joint (e.g., knee, hip, shoulder, ankle, elbow, wrist, etc.) having implants in place within one or more bones for delivery of fluid into and out of the joint during a treatment regimen for the joint. As discussed herein, fluid can be delivered to and removed from the treatment site through more than one lumen or connecting line in a unidirectional manner, or through a single connecting line in a bidirectional manner. 3A-3B illustrate an implementation in which two or more connecting lines are configured for unidirectional flow such that fluid is delivered to the porous component 103 and joint of the irrigation and cleaning device 202 through a first connecting line and removed from the joint and porous component 103 through a second, different connecting line. The fluid delivery lines are positioned adjacent to the porous component 103.

[0085] The porous component 103 can be a compressible material, such as a foam, sponge, or other type of biocompatible compressible material, that is in fluid communication with the connecting line and can allow fluid transmission to or throughout the treatment site. The porous component 103 can be an open-cell sponge with fluid-conducting channels or can include openings that allow fluid to be transmitted through and withdrawn from the porous component. Fluid delivered through the connecting line can be dispersed into the treatment site through the porous component 103. Fluid can also be drawn from the treatment site through the porous component 103.

[0086] 3A-3B, the porous component 103 can have a distal end region 222 and a proximal end region 224. The distal end region 222 is sized and shaped to be positioned within the treatment site. The proximal end region 224 is sized and shaped to extend through the cannula 204, which is designed to be positioned percutaneously such that at least a portion of the proximal end region 224 of the porous component 103 is located outside the skin during use. A portion of the proximal end region 224 of the porous component 103 is positioned outside the patient, while the distal end region 222 of the porous component 103 is positioned within the surgical site or wound to draw suction / fluid therethrough. The porous component 103 is preferably open-celled so that a vacuum can be applied to a first region (e.g., the proximal end region 224) and transmitted through the porous component 103 to a second region (e.g., the distal end region 222) spaced a distance away from the first region. The open cells of the porous component 103 can be formed by a reticulation process. The porous component 103 preferably has high tensile strength so that the proximal end region 224, located outside the patient, can be pulled by a user after a treatment regimen without tearing or breaking, and the distal end region 222 of the porous component 103, located inside the patient, can be withdrawn through the cannula 204 and out of the treatment site. The tensile strength of the porous component is sufficient to prevent tearing of the porous component 103 even when one end of the porous component material is pulled, causing the porous component to stretch and elongate. Applying a tensile force on the material of the porous component, causing it to extend along its longitudinal axis, stretches the material but avoids fracturing it into separate pieces. The porous component 103 thus remains a unitary body during removal.

[0087] In a preferred embodiment, the porous component 103 has a higher tensile strength than known polyester-based polyurethane foams, such as ROCF-V, VAC VeraFlo Dressing, and polyether-based polyurethane (ROCF-G VAC GranuFoam Dressing) have been tested under both wet and dry conditions (see Lessing et al., Wounds (2011); 23(10):309-319). ROCF-G had a tensile strength of 95.44±5.17 kPa under dry conditions and 75.26±5.27 kPa under wet conditions. ROCF-V had a tensile strength of 156.67±7.36 kPa under dry conditions and 117.48±9.08 kPa under wet conditions. These materials, including ROCF-V, which are described as having a higher tensile strength, have a tensile strength that is too low to be reliably withdrawn from the treatment site through a small opening, such as cannula 204, without tearing.

[0088] In particular, the tensile strength of the porous component material in a wet condition is high enough to prevent one end of the material from tearing as it is pulled, pulling the porous component 103 back out of the treatment site, but not so high that it resists compression to the smaller outer dimensions the material is sized to slide through a minimally invasive opening. The porous component 103 can be formed from a reticulated polyester-based polyurethane foam. The foam can have a nominal density of about 2-2.5 lbs / ft³, a pore size of about 50-60 pores per inch (ppi), and a tear strength of greater than about 5 lbf / in, such as about 6-7 lbf / in. The tensile strength of the porous component 103 along the axis between the proximal and distal end regions (tested on a 15 mm thick sample under dry conditions according to ASTM D3574 Test E) is preferably greater than about 27 psi, e.g., at least about 28 psi, at least about 30 psi, at least about 35 psi, at least about 40 psi, at least about 45 psi, at least about 50 psi, up to about 52 psi.

[0089] The cannula 204 can be molded from a soft and flexible material, such as a biocompatible material, including silicone, polyimide, polytetrafluoroethylene (PTFE), polyurethane, polyethylene, polypropylene, polyethylene terephthalate, and nylon, that is configured to conform to the soft tissue at the wound site.

[0090] 3A-3B and also 4A-4C, cannula 204 can be generally spool-shaped with a single flange at one end of the cylindrical spool or two flanges, one at each end of the cylindrical spool. Cannula 204 can include a tubular central region 225 having a lumen 230. The inner lumen 230 of central region 225 can have an inner diameter sized to allow distal end region 222 of porous component 103 to be pulled through lumen 230. However, the outer diameter of central cannula 225 is small enough to ensure that cannula 225 can span the skin without stretching the skin puncture too much.

[0091] Central region 225 can extend between a first flange 227 on the proximal end region of the tubular element and a second flange 229 on the distal end region of the tubular element. Proximal flange 227 surrounds a proximal opening 208A into a lumen 230 of cannula 204. Distal flange 229 surrounds a distal opening 208B into a lumen 230 of cannula 204. Flanges 227, 229 can have any of a variety of shapes, but generally can be relatively flat and substantially conform to the surrounding surface of the puncture.

[0092] As described above, cannula 204 is positioned within the skin when implanting porous component 103 and can remain in place until porous component 103 is removed from the patient. Flanges 227, 229 protect the skin at the wound site, and lumen 230 through central region 225 allows porous component 103 to be accessed externally from the skin for non-surgical removal from the treatment site, even days after treatment. Proximal flange 227 of cannula 204 is arranged to seat on the outer surface of the skin surrounding skin puncture 212 (see FIG. 5B ). Distal flange 229 of cannula 204 is arranged to engage the inner surface of the soft tissue surrounding skin puncture 212. Central region 225 has a length sufficient to substantially span the thickness of the skin and soft tissue at the location of skin puncture 212 between proximal flange 227 and distal flange 229. The length of the central region 225 can be between about 1 mm and 10 mm.

[0093] Flanges 227, 229, which surround the outer diameter of central region 225, create a localized increase in the outer dimension of cannula 204 and aid in positioning and securing cannula 204 during use. Distal flange 229 can have an outer diameter of about 10 mm to about 20 mm and a thickness of about 1 mm. Distal flange 229 is preferably sufficiently flexible to be easily deformed for percutaneous insertion and removal without causing trauma to puncture site 212. Proximal flange 227 can have an outer diameter of about 10 mm to about 20 mm and a thickness of about 1 mm to about 3 mm. Proximal flange 227, which is designed to remain outside the wound site, can be more rigid than distal flange 229. The distal flange 229, which may be referred to herein as the wound flange or intradermal flange, can have a larger outer diameter compared to the proximal flange 227, which may be referred to herein as the skin flange. The increased outer diameter helps prevent inadvertent removal of the distal flange 229 through the skin puncture 212. The distal flange 229 can also be the same size as the outer diameter of the proximal flange 227.

[0094] Flanges 227, 229 can lie in a plane that is angled relative to the longitudinal axis A of central region 225 (see FIGS. 4A-4C). The angle of flanges 227, 229 relative to central region 225 is non-perpendicular such that the lower surface of proximal flange 227 and the upper surface of distal flange 229 can be substantially flush with the outer and inner surfaces of the skin, respectively.

[0095] In some implementations, cannula 204 has only distal flange 229 and not proximal flange 227 (see FIG. 4B). In this implementation, central region 225 can be longer than the thickness of the skin extending therethrough. A surgeon may trim the excess length on the proximal end after inserting cannula 204 through skin puncture 212. Thus, the length of central region 225 can be tailored to the treatment site and / or patient being treated at the time of its use.

[0096] If present, the proximal flange 227 can be connected to the outflow line directly, such as by a removable connector (e.g., a Luer or Morse taper connection). A direct connection can reduce vacuum leaks and the need for occlusive dressings associated with standard wound therapy vacuum connections.

[0097] 4A-4C, the length of the central region 225 between the flanges 227, 229 can vary depending on the treatment area and size of the patient. In some implementations, the length of the central region 225 between the flanges is about 1 mm to about 3 cm. The outer and / or inner diameters of the central region 225 of the cannula 204 can vary along the length of the cannula 204, e.g., can be flared toward its distal end, as described elsewhere herein. The outer diameter of the central region 225 can be larger at the distal end compared to the outer diameter of the central region 225 at the proximal end. The inner diameter of the central region 225 at the distal end, including the size of the distal opening 208B, can be greater than the inner diameter of the central region 225 at the proximal end, including the size of the proximal opening 208A.

[0098] The lumen 230 extending through the central region 225 of the cannula 204 is preferably free of any obstructions, allowing the porous component 103 to be received therein with low resistance. The inner diameter of the cannula 204 lumen 230 can be about 5 mm to about 15 mm. The inner diameter is less than the maximum cross-sectional area of ​​the portion of the porous component 103 being removed therethrough, so that it moderately compresses the porous component 103 and reduces the size of the puncture opening, but does not cause too much compressive force that could overcome the high tensile strength of the material of the porous component 103 and tear the porous component 103, or prevent the distal end region 222 of the porous component 103 from being removed through the lumen 230 during removal. For wound sites such as the knee, the cross-sectional area of ​​the porous component 103 inside the knee joint may be larger, so that the inner diameter of the cannula 204 lumen 230 is larger. The inner diameter of the lumen 230 of the cannula 204 is preferably sized so that the outer diameter of the central region 225 is about 15 mm or less. The outer diameter of the cannula 204, as it extends through the skin, is preferably slightly larger than the incision / puncture it extends through. For example, the incision may be about 8 mm, and the outer diameter of the cannula 204, as it spans the incision, may be about 8.25 mm. Generally, minimally invasive wounds in the skin are less than about 15 mm.

[0099] The lumen 230 of the cannula 204 flares toward the distal end to better accommodate the larger cross-sectional area of ​​the distal end region 222 of the porous component 103, while still serving to compress the distal end region 222 of the porous component 103 to a smaller cross-sectional area for removal through the cannula 204 during removal from the patient. During removal, the porous component 103 is pulled by grasping the proximal end region 224 outside the proximal opening 208A and withdrawing the distal end region 222 through the lumen 230. Once the porous component 103 is removed through the cannula 204, the cannula 204 is then removed. The distal flange 229 of the cannula 204 can be sufficiently flexible to deform to a smaller dimension as the cannula 204 is withdrawn through the skin puncture. The presence of proximal end region 224 of porous component 103 within central region 225 helps maintain patency of lumen 230 and keeps cannula 204 in place within skin puncture 212. Once porous component 103 is withdrawn from cannula 204, cannula 204 is more easily removed from skin puncture 212.

[0100] The shape of the porous component 103 can vary depending on the anatomy being treated. Generally, at least a portion of the porous component 103 is elongated and extends outside the treatment site external to the patient. The proximal end region 224 of the porous component 103 can form an extradermal portion that is generally elongated in shape and sized to extend through the lumen 230 of the central region 225 of the cannula 204 without being subjected to excessive compression by the central region 225. The distal end region 224 of the porous component 103, which forms the portion positioned within the treatment site, can have any of a variety of shapes depending on the needs of the anatomy in which it is used. As an example, the distal end region 222 of the porous component 103, which remains within the knee joint during knee replacement, can incorporate at least two portions sized to extend across the two condyles of the knee. The two portions are preferably spaced apart from each other, providing a Y-shape to the porous component 103, as shown in FIGS. 3A-3B, to prevent the porous component 103 from becoming entrapped by the patella during wound closure. The shape of the portions located within the treatment site can be designed to avoid material being entrapped within the treatment space in a manner that would hinder its removal through the cannula 204. The porous component 103 of FIGS. 3A-3B has a first portion 231 separated by a distance from a second portion 232, which includes a distal end region 222. The first portion 231 and second portion 232 can contact the knee condyles on either side of the patella. The proximal end region 224 of the porous component 103 of FIGS. 3A-3B is elongated to extend from within the distal opening 208B through the lumen 230 and out the proximal opening 208A of the cannula 204.

[0101] A porous component 103 for use in a shoulder joint may have a conical, rectangular, or prismatic shape. A porous component 103 for use in a fracture site may have a more planar shape and be placed over the bone within the wound. A porous component 103 for use in a mastectomy site may have, for example, a bulbous or generally hemispherical shape.

[0102] It should be understood that a cannula (e.g., cannula 204 of FIGS. 2A-2B or cannula 204 of FIGS. 3A-3B, 4A-4C) need not be perfectly cylindrical or have a circular cross-sectional shape. Thus, while a "diameter" of a cannula is described herein, whether an inner diameter or an outer diameter, it should be understood that the cannula may have a different diameter depending on where the diameter is measured. For example, a cannula can have a non-circular elongated cross-sectional shape, such as an oval or another elongated shape, having a diameter through its center along its minor axis dimension that is less than the diameter through its center along its major axis dimension. The porous structures described herein may also have non-circular cross-sectional shapes. However, generally, the porous structure has a larger cross-sectional area at rest compared to the cross-sectional area when the porous structure is compressed or stretched, such as in response to advancing the porous structure through or withdrawing it from the lumen of a cannula.

[0103] 5A-5E illustrate one method of using the irrigation and cleaning device 202 of FIGS. 3A-3B. FIG. 5A illustrates an existing prosthesis 205 visible through an open incision 211 in a surgical site 213. While the knee joint is used as an example of the method, other joints and implanted device sites are also contemplated herein, including the hip, ankle, shoulder, elbow, wrist, spine, etc., or the radius, ulna, humerus, tibia, femur, pelvis, skull, etc. The method illustrates a medial patellar rim approach, but other approaches are also contemplated, depending on the surgical site being treated. A stab incision 212 can be made, such as with a scalpel, trocar, or other similar tool, to provide access to the suprapatellar space in the knee (FIG. 5B). The stab incision 212 can be oriented such that the tool making the stab incision 212 enters the knee joint from the medial side of the surgical site 213 distal to the open incision 211 and exits the knee joint proximal to the incision 211. A grasping tool, such as forceps, can be inserted through the stab incision 212 from the exterior surface of the skin and hooked onto the proximal end region 224 of the porous component 103 of the pre-assembled irrigation and cleaning device 202. The proximal end region 224 of the porous component and the proximal flange 227 of the cannula 204 can be pulled through the skin of the anteromedial thigh (see FIG. 5B ). The proximal flange 227 can rest on the skin surrounding the stab incision 212, and the distal flange 229 can rest within the wound and / or against the interior of the skin surrounding the stab incision 212. In implementing the knee joint, the patella P is moved away from the condyles. The proximal end region 224 of the porous component 103 extends upward through the lumen 230 of the cannula 204, and the distal end region 222 of the porous component 103 spans the knee implant 205, such that the first portion 231 and the second portion 232 are against the condyle.

[0104] The system can include separate components for delivering and removing fluid to and from a site. Figure 5C illustrates an implementation of a fluid delivery line 105 that includes a catheter or tubing 235 having a trocar tip 237 at a proximal end and multiple outlets 239 on a distal outflow end 240. The distal outflow end 240, with multiple outlets 239, allows fluid to flow from a fluid source through the tubing 235, exit the line 105, and into a treatment site.

[0105] The fluid delivery line 105 is inserted by pushing a trocar tip 237 on the proximal end of the line 105 through soft tissue, such as from the medial side of the wound site 213 to the exterior of the skin outside the anteromedial aspect of the thigh. The trocar tip 237 facilitates surgical placement and can be sharp and configured to pierce through the skin. The tubing 235 can span the skin puncture site 212 so that the distal outflow end 240 remains within the treatment site and the proximal end is located outside the treatment site.

[0106] Once the tubing 235 is passed through the skin, the trocar tip 237 can be removed from the proximal end of the tubing 235. A distal outflow end 240, having multiple outlets 239, can be positioned across the porous component 103 (see FIG. 5C ). In some implementations, the porous component 103 is Y-shaped, and the distal outflow end 240 is positioned between the first and second portions 231, 232 of the distal end region 224 of the porous component 103. The fluid delivery line 105 is preferably positioned adjacent to the porous component 103 to deliver fluid to the material of the component 103, but not above the top of the porous component 103 to avoid entrapment between the porous component 103 anatomy and the line 105. The porous component 103 can be cut by the surgeon to conform its shape to the anatomy and / or fluid delivery line 105 to avoid becoming entrapped within the treatment site.

[0107] The outflow end 240 can have any of a variety of cross-sectional shapes, including circular, oval, square, rectangular, or other shapes. In some implementations, the outflow end 240 can incorporate at least one flattened surface designed to lie flush against the anatomy of the treatment site. The multiple outlets 239 on the distal outflow end 240 can be located on a lower surface of the flattened surface and / or on an upper surface spaced apart from the flattened surface.

[0108] Once the line 105 is properly positioned relative to the porous component 103, the patella can be reduced (see FIG. 5D) and the incision 211 can be closed (see FIG. 5E). The fluid delivery line 235 can be connected to a source of fluid (not shown), and a separate fluid line 105 can be connected to the irrigation and flushing device 202 at the distal end and a vacuum source at the proximal end. Fluid removal from the treatment site can be accomplished using vacuum pressure applied to the treatment site, which is transmitted through the porous component 103. In some implementations, the vacuum line 105 can be coupled to the proximal flange 227 of the cannula 204 across the proximal end region 224 of the porous component 103, which is located external to the cannula 204 and the skin (see FIGS. 5D-5E).

[0109] After a treatment protocol cycle, the fluid line 105 can be removed through the puncture. The fluid delivery line 105 can be pulled and the outflow end 240 can be removed through the skin puncture. The vacuum line 105 can be detached from the proximal flange 227, exposing the proximal end region 224 of the porous component 103. The proximal end region 224 can be grasped and pulled, removing the distal end region 222 of the porous component 103 located within the treatment site through the lumen 230 of the cannula 204. Once the porous component 103 is removed from the cannula 204, the flexible cannula 204 tends to collapse somewhat within the puncture 212. The cannula 204 can then be grasped and removed from the puncture 212. The puncture 212 can be sized to self-seal, or one or more sutures can be placed adjacent to the puncture 212 after removal of the cannula 204.

[0110] The irrigation and irrigation devices described herein, including at least a porous component, are configured to be applied to a treatment site to aid in localized therapy of the treatment site. The time period over which the irrigation and irrigation device is applied can vary from at least several hours to at least 24 hours, preferably more than one day, at least about two days, at least about three days, at least about four days, at least about five days, at least about six days, at least about seven days, or up to about ten days, before the irrigation and irrigation device is removed from the treatment site. The treatment site can also vary, as can the treatment fluid, as discussed elsewhere herein.

[0111] 6A and 6B illustrate an example of a set of sequentially expanding cannulas 302 for placement and removal of the irrigation and cleaning device 202 within the treatment site 102. The irrigation and cleaning device 202 is shown assembled in exploded views in FIGS. 6A and 6B. The irrigation and cleaning device 202 includes a porous component 103 and a connecting line 105. The porous component 103 is coupled to a distal end region of the connecting line 105, which in turn can expand the cannulas 302. The connecting line 105 may include a catheter or tubing.

[0112] The irrigation and flushing device 202 is shown with the porous component 103 fully intra-articular below the skin incision 212 and expanded to fill the space between the femur 207A and the tibia 207B / fibula 207C. The connecting line 105 is shown positioned to extend from the porous component 103 to an area outside the skin incision 212. The cannula 302 is shown positioned over the connecting line 105 such that the distal-most section of the cannula 302 is engaged with the proximal end 209A region of the porous component 103.

[0113] The sequentially expanding cannula 302 can be placed diametrically across the skin across the connection line 105 of the irrigation and irrigation device 202, at which point the irrigation and irrigation device 202 can be inserted or removed to facilitate transport of the irrigation and irrigation device 202. For example, each cannula of the set of cannulas 304A-D can be placed through the skin by sequentially introducing a successively larger cannula over each previously placed cannula during irrigation and irrigation device insertion, temporarily widening the wound by reversibly stretching it without cutting or tearing it. The sequentially expanding cannula 302 can facilitate removal of the irrigation and irrigation device through minimal puncture wounds in the skin, minimizing trauma to the skin and underlying tissue and preferably eliminating the need for a surgical procedure to remove the irrigation and irrigation device 202.

[0114] The sequentially expanding cannula 302 can include a set of two or more cannulas 304A-D. Alternatively, the cannula can be a single cannula device with a telescoping section. Each cannula in the set of cannulas 304A-D can be shaped as a cylinder. The cannulas in the set of cannulas 304A-D can have matching inner and outer diameters such that the outer diameter of a first cannula matches and fits closely diametrically with the inner diameter of a second cannula so that each cannula slides over the next smallest cannula with minimal clearance between them. The smallest cannula 304D of the set of cannulas 304A-D can be sized to cross a minimally invasive skin incision 212 (an opening through the skin, such as a surgical puncture wound) approximately 6 mm in diameter during treatment. The largest cannula 304A of the set of cannulas 304A-D can be sized with an inner diameter that is large enough to accommodate the outer diameter of the irrigation and flushing device 202. For example, the inner diameter of the largest cannula 304A in the set of cannulas 304A-D can be about 10 mm or greater in diameter.

[0115] The sequentially expanding cannula 302 can be constructed from one or more biocompatible materials, such as stainless steel, titanium, or a polymer (e.g., PEEK, polyethylene, or polyurethane), or a composite of materials in which the interior surface is constructed from a low-friction material (e.g., Teflon or UHMW). The sequentially expanding cannula 302 can include one or more external attachment features that can be used by a surgeon to temporarily secure the sequentially expanding cannula 302 to a joint during treatment, including extended periods of time. External attachment features can include roughened surfaces, porous surfaces, hooks, rings, flanges, and other attachment points, as well as a separate ring located across the proximal end of the irrigation and flushing device 202 that maintains the position of the irrigation and flushing device 202 in its intended location. The external attachment feature extends adjacent to the porous component 103 and can be attached to a portion of the implant 205 or to the joint 203.

[0116] 7A-7B show another example of an irrigation and flushing device 202 for use with a treatment system 200, according to some exemplary implementations, including a connecting line 105 having a porous component 103 and an outer mesh 402 coupled to its distal end region. The outer mesh 402, as an outer layer, surrounds the porous component 103 of the irrigation and flushing device 202 and can control the outer dimensions of the porous component 103, which match the inner dimensions of the outer mesh 402.

[0117] 2A-2B, the porous component 103 of FIGS. 4A-4B need not be coaxially arranged with the connecting line 105 as shown, but can have other arrangements as described herein, such that the connecting line 105 can be positioned so that its outlet / inlet is located near the porous component 103 and assists in fluid delivery into and / or out of the porous component 103. Similarly, the connecting line 105 can be a bidirectional connecting line configured to deliver fluid to and away from the treatment site. Unidirectional connecting lines 105 are also contemplated, in which case one lumen or line is used to transport fluid toward the treatment site and a second lumen or line is used to transport fluid from the treatment site. Also, still further, the connecting line 105 is not contemplated, in which case a vacuum can be applied to withdraw fluid from the treatment site through the skin.

[0118] 7A-7B , the outer mesh 402 can be expandable so as to be freely expanded and collapsed using a handle 405 connected to the proximal end 403A of the outer mesh 402 by a link, such as a mechanical linkage. The outer mesh 402 is configured to expand, allowing the porous component 103 to be in a radially expanded state, during delivery of therapeutic fluid into the treatment site 102 through the irrigation and irrigation device 202 and / or aspiration of fluid from the treatment site 102 for maximized fluid transfer from the connecting line 105 through the porous component 103 and the outer mesh 402 to the treatment site. The outer mesh 402 is configured to collapse toward its narrow outer dimension, compressing the porous component 103 within its lumen, during insertion and / or removal of the irrigation and irrigation device 202. The outer mesh 402 can include an elongated tubular device with multiple openings, such as a helically wound braided tube. In the expanded configuration, the openings in the outer mesh 402 are dilated to allow fluid delivery into regions of the treatment area 102, such as the space between the acetabular shell 406 and the stem 408 of the bone (hip) implant 205. In the collapsed configuration, the openings in the outer mesh 402 are reduced generally parallel to the outer dimension of the outer mesh 402 so that the outer mesh 402 may be transported through a skin incision without catching and preventing skin tears during deployment and / or removal of the irrigation and cleaning device 202. The distal end 403B of the outer mesh 402 may be closed (by a permanent mesh structure) during insertion or removal of the irrigation and cleaning device 202 or during treatment to prevent the porous component 103 from sliding outside the outer mesh 402.

[0119] The external mesh 402, connecting lines 105, and porous component 103 can vary over the length of the irrigation and irrigation device 202. In some implementations, the connecting lines 105 (e.g., flexible catheters) can be contained along the entire length of the porous component 103 and external mesh 402, extending from within the patient's body to outside the patient's body. In some implementations, the connecting lines 105 can be surrounded by the porous component 103 and further surrounded by the mesh 402 as the outermost structure in one or more selected areas of the irrigation and irrigation device 202 corresponding to important anatomical fluid delivery or aspiration locations.

[0120] The outer mesh 402 may include slidably interwoven filaments arranged to reduce the overall cross-sectional area of ​​the porous structure 103 when the proximal end of the irrigated irrigation device 202 is retracted to remove the irrigated irrigation device 202. For example, the proximal end of the connecting line 105 may be retracted to begin withdrawing the irrigated irrigation device 202 from the treatment site. In response to the application of a pulling force in the longitudinal direction of the outer mesh 402, the outer mesh 402 collapses toward its narrow outer diameter, compressing the porous component 103 within its lumen. This facilitates removal of the irrigated irrigation device 202 through minimal incisions 212 in the skin, minimizing trauma to the skin and underlying tissue, and preferably eliminating the need for a surgical procedure to remove the irrigated irrigation device 202. In some implementations, the connecting line 105 is withdrawn from the irrigation and cleaning device 202 prior to removal of the outer mesh 402 and porous structure 103 to further reduce the outer diameter of the outer mesh 402 .

[0121] The outer mesh 402 of the irrigation and cleaning device 202 can be constructed from one or more flexible biocompatible materials such as silk, nylon, or polypropylene, or a superelastic material such as a nickel-titanium alloy, which may be coated with any biocompatible material (e.g., Teflon or ultra-high molecular weight polyethylene). The outer mesh 402 can be a helically wound braided tube. In some implementations, the outer mesh 402 can resemble an expandable stent or Chinese finger trap, which is limited in its ability to open, such that when tension is applied along the longitudinal axis of the braid, the braid fiber angle is reduced, allowing the braid to elongate while decreasing its diameter. The expansion limit of the outer mesh 402 prevents the outer mesh 402 from opening before insertion or during removal. Although the external mesh 402 of the irrigated irrigation device 202 is illustrated for irrigation irrigation around the hip joint, a similar external mesh 402 of the irrigated irrigation device 202 can also be used for other treatment areas, such as the knee, shoulder, elbow, or other joint, or within one of any of a variety of anatomical spaces or traumatic wounds. The irrigated irrigation device 202 can be configured to deliver unidirectional flow through one or more irrigated irrigation devices 202 or bidirectional flow through a single irrigated irrigation device 202.

[0122] FIG. 8 shows an example of the porous structure 103 of the irrigation and irrigation device 202, according to some exemplary implementations. The porous structure 103 can be configured for delivery of therapeutic fluid and / or suction of fluid from the body. The porous structure 103 can have an elongated tubular shape that is open at the proximal end 209A, allowing for insertion of the connection line 105. The porous structure 103 can include an elastic sponge, such as an open-cell sponge, with a specific fluid permeability, allowing for fluid delivery from the connection line 105 to the treatment site. The connection line 105 can include at least one structure, such as a tubular catheter or cannula, capable of conveying fluid along the length of the irrigation and irrigation device. The connection line 105 can be temporarily or permanently attached to the lumen of the porous structure 103. For example, if the outer diameter of the connecting line 105 exceeds the inner diameter of the porous structure 103, the elastic force of the expanded porous structure 103 can maintain a temporary attachment between the connecting line 105 and the porous structure 103. A permanent attachment between the connecting line 105 and the porous structure 103 can include a biocompatible adhesive that does not deteriorate or react with moisture or bodily fluids.

[0123] At least a portion 502 of the porous structure 103 can be shaped by bending into one or more shapes, including serpentine or other shapes or planar surfaces, configured to provide increased surface area coverage and the ability to fill the space at the treatment site 102 after dissection of the infected joint cavity. The shaped portion 502 of the porous structure 103 can be releasably secured to maintain its configuration during implantation and irrigation and released at the time of removal so that it can be removed as a thin structure through a minimally invasive opening in the skin. The shaped portion 502 of the porous structure 103 can be secured by anchoring features 504, including any of magnets, sutures, hooks, adhesives, resorbable materials, or other means, to maintain the optimal configuration of the irrigation and irrigation device 202. The anchoring features 504 can be temporarily or permanently attached to the porous structure 103. The anchoring features 504 releasably attached to the porous structure 103 can be pre-fabricated for a device to be placed during an open surgical procedure, added after the porous structure 103 is inserted into the treatment site 102, or configured to be actuated to achieve a particular shape after insertion. The anchoring features 504 attached to the porous structure 103 can be stitched or otherwise attached as multiple sutures, adhesive bonds, etc. throughout the porous structure 103 or at multiple discrete locations. As shown in FIG. 8 , the shaped portion 502 of the porous structure 103 is S-shaped and is maintained in a fixed configuration by the anchoring features 504. The anchoring features 504 maintain the optimal configuration during therapy and release the shaped portion 502 of the irrigation and irrigation device 202 upon completion of therapy, thereby facilitating removal of the irrigation and irrigation device 202 through minimal incisions 212 in the skin, minimizing trauma to the skin and underlying tissue and preferably eliminating the need for a surgical procedure to remove the irrigation and irrigation device 202. The irrigation and irrigation device 202 can be used alone or in combination with an expanded cannula 204 or a sequentially expanding cannula 302, described with reference to FIGS. 2A-2B and 6A-6B, to further facilitate removal of the irrigation and irrigation device 202.The porous structure 103 does not need to be aligned coaxially with the connecting lines 105, as discussed elsewhere herein, but can simply be embedded adjacent to one or more connecting lines 105, such as with the irrigation and cleaning device 202 of Figures 3A-3B, 5A-5E.

[0124] 9A-9B and 10A-10B illustrate a sleeve 1002 that may be used in conjunction with the treatment system described above and configured to enclose the treatment site 102. FIGS. 9A-9B illustrate the sleeve 1002 for localized irrigation of the hip joint, and FIGS. 10A-10B illustrate the sleeve 1002 for localized irrigation of the knee.

[0125] 9A-9B, sleeve 1002 can include upper and lower tubular peripheries configured to be secured to the circular sections of lines 105, 806. Sleeve 1002 can be freely expanded and collapsed by adjusting the distance between connecting line 105 and fluid line 806. Note that connecting line 105 and fluid line 806 are unidirectional lines, in which fluid is delivered to the system through one line and removed from the system through a second line. Sleeve 1002 can have a fully or partially cylindrical shape (e.g., C-shaped) with its upper and lower components. Sleeve 1002 is formed from a flexible material that can be collapsed or flattened during delivery into the joint space and expanded or enlarged after positioning. 9A-9B, the upper end of the sleeve 1002 can incorporate a first component 610 configured to surround a first region of the implant that has been preserved (e.g., under the acetabular shell), and the lower end of the sleeve 1002 can incorporate a second component configured to surround a second region of the implant that has been preserved, such as around the upper end of the femur. Figures 10A-10B show a sleeve 1002 having an upper end that incorporates a first component 610 configured to surround the lower end of the femur and a second component configured to surround a second region, such as a tibial component.

[0126] The sleeve 1002 can remain extended to secure the irrigation and irrigation device 202 to the treatment site 102 during delivery of therapeutic fluid through the irrigation and irrigation device into the treatment site 102 (e.g., via any of the irrigation and irrigation devices 202 shown in FIGS. 2A-2B, 6A-6B, 7A-7B, and 8) and / or aspiration of fluid from the treatment site 102. The sleeve 1002 is configured to be removed through an opening in one of the circular sections of the line 105, 806 and collapsed for removal from the treatment site prior to removal of the irrigation and irrigation device 202. For example, a ripcord can be formed, using sutures or the like, that can cause the mesh to disintegrate from the tubular portion of the device (e.g., the porous component 203) in response to pulling.

[0127] The sleeve 1002 can include a flexible substrate or mesh shaped to accommodate the joint anatomy during treatment and prevent irrigation and irrigation line disruption, such as migration, kinking, and / or clogging. The flexible substrate can be a woven fabric constructed from a biocompatible material, such as polyester (PET), polypropylene, UHMWPE, nylon, PTFE, ePTFE, PEEK, aromatic polyester, LCP (liquid crystal polymer), elastomer, or other specialty polymer. The sleeve 1002 can be shaped to fit the treatment site (the hip joint as illustrated in FIGS. 9A-9B or the knee as illustrated in FIGS. 10A-10B) during treatment, thereby reducing the likelihood of irrigation and irrigation line disruption. For example, the dimensions of the sleeve 1002 can vary over the height of the irrigation and irrigation device 202 to conform to the underlying anatomy and the geometry of the treatment site 102 and the preserved implant.

[0128] The sleeve 1002 can be woven with a pocket 1004A to allow for easy insertion and attachment of the foam sponge / catheter structure of the irrigation and irrigation device 202. In some implementations, the lines 105, 806 can be attached to the base of the sleeve 1002 using adhesives, sutures, radio frequency welding, or other processes. The sleeve 1002 can have one or more attachment features used by the surgeon to temporarily secure the base of the sleeve 1002 to local soft tissue and further prevent irrigation and irrigation line fracture. The attachment features can include reinforced areas to facilitate passage of sutures for attachment to local bone or soft tissue and provide additional migration, kinking, and / or clogging prevention during treatment.

[0129] The devices and systems described above with respect to Figures 2A-10B are particularly useful for treating the surgical site and can be used during an initial surgical procedure, such as a DAIR procedure, to provide irrigation to the infected joint space through an expandable / compressible component, eliminating the need for an additional surgical procedure to remove the irrigation device. The devices of Figures 11A-14D provide irrigation to the infected joint space and also occupy the space between the spared implant components, protecting the surface during irrigation therapy. Thus, the devices and systems of Figures 11A-14D are particularly useful for Double DAIR procedures or procedures in which structures are removed using a separate surgical procedure.

[0130] 11A-14D illustrate a system incorporating a modular spacer designed to protect the surfaces and locking mechanisms (if present) of the preserved components from mechanical damage while allowing therapeutic fluid flow to the preserved prosthetic components and infected joint space during therapy. The spacer can be placed by the medical practitioner after removal of the modular components and dissection in the first phase of Double DAIR, thereby eliminating the need to replace or sterilize and reinsert previously infected modular components during treatment. The spacer can be removed and replaced with a final modular component that matches the preserved component during the subsequent second-phase surgery of Double DAIR.

[0131] 11A and 11B show an example of a treatment system 600 for use in a hip joint, according to some exemplary implementations, in which one or more modular components of the prosthesis are not preserved but temporarily replaced with system 600, which may be useful, for example, in Double DAIR. The hip joint prosthesis may include a femoral component and an acetabular component. The femoral component is a metal ball-shaped femoral head that replaces the upper part of the femur and is on the end of a stem or pin that is embedded within the femur. The acetabular component replaces the socket side of the joint and includes a metal acetabular shell and a polymer acetabular liner that is movable in conjunction with the femoral head. One or more components of the hip joint prosthesis are fixed to the patient's bone, and one or more components can be modular. For example, the femoral stem and acetabular shell are typically well fixed to the bone, while the femoral head can be removed from the femoral stem and the acetabular liner can be removed from the acetabular shell.

[0132] 11A shows the treatment system 600 disassembled, and FIG. 11B shows the assembled system 600 in cross section. The system 600 for a hip joint can include a spacer 602, at least a first conformable porous component 610 located on an exterior surface of the spacer 602, a femoral head 608, and an adapter 614 (which can also be a porous component). The system 600 is dimensioned to be received between an acetabular shell 406 of a hip joint prosthesis, which is placed in the patient's acetabulum, and a stem 408, which is placed in the femur.

[0133] The spacer 602 can be hemispherical, with an outer surface 604A configured to contact a porous component 610, which can be a porous component such as a foam sponge, as described elsewhere herein. The spacer 602 can have an inner surface 604B configured to contact and hemispherically contain the femoral head 608 during healing and provide joint stability. The spacer 602 and / or the femoral head 608 can incorporate a plurality of openings (defining a cage-like structure) or channels extending between the inner and outer surfaces for allowing therapy fluid flowing through the spacer 602 to contact the porous component 610 and the head 608. The spacer 602 can be in fluid communication with the preserved acetabular shell 406 via the porous component 610 adjacent the outer surface 604A of the spacer 602. The spacer 602 can be in fluid communication with the femoral head 608 adjacent the inner surface 604B.

[0134] The spacer 602, which may be hemispherical, can be constructed from a suitable biocompatible material such as stainless steel, UHMWPE, PEEK, or other low-friction material. The spacer 602 can be provided in multiple outer diameters to allow for secure fixation into preserved acetabular shells 406 of varying sizes. The spacer 602 can include features, such as spikes, on the outer surface 604A to improve fixation to the porous component 610. Alternatively, the spacer 602 can be secured to the porous component 610 using an adhesive. In an alternative implementation, the porous component 610 and adapter 614 can be replaced with a rigid solid or porous adapter specifically dimensioned to connect the spacer 602 to preserved implants of various sizes and manufacturers. The spacer 602 can be constructed for a knee (not shown) with an upper surface configured to move in conjunction with a preserved femoral component and an lower surface designed to interface with a preserved tibial component, and can include similar features that can provide fluid communication with the preserved component.

[0135] In a hip joint, as illustrated in FIGS. 11A and 11B , a porous component 610 can be placed between the modular spacer 602 and the preserved acetabular shell 406 to protect the preserved shell, provide a compressive fit, and stabilize the modular spacer 602 within the preserved acetabular shell 406 while allowing fluid communication between the modular spacer 602 and the surface of the preserved acetabular shell 406. The adaptable nature of the porous component 610 provides a universal fit between the spacer 602 of the treatment system 600 and a variety of available hip prostheses. In some implementations, the porous component 610 includes an expandable foam, allowing the porous component 610 to be customized for an improved fit. The porous component 610 can be sized and shaped to fit within the preserved acetabular shell 406 and can be used to provide therapeutic fluid to the preserved shell 406 while the spacer 602 has a secure fit within the preserved shell 406. The porous component 610 can comprise an open-cell foam or other biocompatible material that allows fluid to flow therethrough while having sufficient compressive and shear stiffness to resist loading through the hip joint during therapy. The porous component 610 can comprise an expansion material that can form a preserved hip or knee prosthesis in situ and further stabilize the foam sponge within the acetabular shell 406. In some implementations, the porous component 610 can be made from a shape-memory material that expands to its final size and shape after implantation as the temperature of the porous component 610 increases to the patient's body temperature. Biocompatible shape-memory foam can be manufactured in a variety of biocompatible materials, with one preferred material being open-cell polyurethane shape-memory foam.

[0136] As shown in FIGS. 11A and 11B , the femoral head 608 is supported by the preserved stem 408 of the hip implant 205, which is covered by an adapter 614. The adapter 614 can include a polymeric material, including polymer foam, specifically shape-memory foam. The adapter 614 can be locked or otherwise secured to the stem 408 (e.g., a Morse taper lock). The femoral head 608 can be configured (in shape and size) to move in conjunction with the inner surface 604B of the modular spacer 602. In some implementations, the femoral head 608 includes a porous structure or channels that allow therapeutic fluid flow between the single-sized spacer 602 and the adapter 614 of the preserved femoral stem 408. The adapter 614 can be constructed from a suitable material used to fit the single-sized spacer 602 and enable its stable fixation onto multiple trunnion sizes within commercially available femoral stems 408. The thickness of the adapter 614, which in one preferred implementation may be porous foam, is sufficient to allow fluid flow when compressed between the femoral head 608 and the stem 408. In another implementation, the adapter 614 may be made from memory foam that is pre-assembled to the femoral head 608 and can expand and fit onto the trunnion of the stem 408 in response to reaching body temperature.

[0137] The connecting line 105 may include a fluid delivery catheter. The connecting line 105 may be fluidly attached to the spacer 602, allowing therapy fluid to be delivered through the spacer 602. For example, the distal end of the connecting line 105 may be inserted into an opening 612 at the base of the spacer 602, such as the space between the inner and outer shells of the spacer 602. The opening 612 may have an inner diameter and shape that matches the outer diameter of the connecting line 105. The opening 612 may be configured to fit over a portion of the distal end of the connecting line 105, with a length (e.g., 10 mm) that ensures a secure connection during treatment. The opening 612 may be fluidly connected to the center of the spacer 602 so that fluid delivered by the connecting line 105 is uniformly distributed throughout the spacer 602.

[0138] The treatment system 600 provides structural support and ensures fluid delivery to the joint space that would otherwise be blocked by the modular components of conventional implants. In some implementations, one or more separate delivery catheters or optional irrigation and irrigation devices 202 can be used to deliver and / or aspirate therapy fluid. The spacer 602, which may be a separate component or integrated with the femoral head 608, along with the porous component 610 and adapter 614, is formed from a porous material that allows fluid to flow through the components of the system 600, such as by having one or more regions and / or by having one or more channels or interruptions from the interior surface through the exterior surface. The treatment system 600 can be used alone to connect directly to the fluid line 105 for delivery of fluid to the treatment site. The treatment system 600 can also be used in combination with any of the irrigation and irrigation devices 202 described herein that have a porous component 203 coupled to the connection line 205. Thus, the porous components of the treatment system 600 can further distribute fluid delivered to (and / or withdrawn from) the treatment site in and around the joint from the irrigation and flushing device 202. Connecting lines, which may be the same as those used to deliver fluid to the site, can also be incorporated to aspirate fluid from the treatment site.

[0139] The treatment system 600 is described above as incorporating a fluid connection between the connecting line 105 and the spacer 602. In an alternative implementation, the fluid connection can be made between the connecting line 105 and the porous femoral head 608 in the same manner as described for the spacer 602 herein. And even further, the femoral head 608 and spacer 602 can be integrated as a single component, such that the connecting line 105 is coupled to a region of the spacer / head component.

[0140] In an alternative implementation (not shown), the spacer 602 is not included, and the femoral head 608 moves directly in conjunction with the porous component 610. In such an implementation, the porous component 610 can be further configured to extend around the head 608, provide stability to the joint, and fill the void space around the spared implant.

[0141] 12A and 12B show an example of a treatment system 700 for use in a hip joint, according to some exemplary implementations, where one or more modular components of the prosthesis are not preserved and are temporarily replaced with system 700, which may be useful, for example, in Double DAIR. System 700 for a hip joint may include a spacer 702, at least a first porous component 610 located on an exterior surface of spacer 702, a femoral head 608, and an adapter 614. System 700 is sized to be received between an acetabular shell 406 of a hip joint prosthesis preserved in a patient's acetabulum and a stem 408 preserved in the femur.

[0142] The spacer 702 can be hemispherical with an outer surface 704A and an inner surface 704B. The outer surface 704A is movable in conjunction with the porous component 610, which can be a shape-memory sponge. As discussed above, the treatment system can be used in combination with any of the irrigation and irrigation devices 202 described herein that incorporate a porous component coupled to a fluid line. In this implementation of the treatment system, the outer surface 704A can be configured to leave a marginal section of the porous component 610 protruding from the outer circumference of the hemispherical spacer 702, allowing fluid conduction around the irrigation and irrigation device 202. The spacer 702 can have an inner surface 704B configured to contact and be movable in conjunction with the femoral head 608. The two movable outer surfaces 704A, 704B of the hemispherical spacer 702 can increase the range of joint motion and reduce the chance of dislocation. The hemispherical spacer 702 can constrain the ball head to encompass an arc of motion greater than 180 degrees, requiring the spacer and ball head to be pre-assembled or assembled in situ by the surgeon, further reducing the chance of hip dislocation. The hemispherical spacer 702 can be constructed from a suitable biocompatible material (e.g., stainless steel, UHMWPE, PEEK) or other low-friction material. The porous component 610 can be provided in multiple outer diameters and include surface features, such as spikes, to enable secure fixation into preserved acetabular shells 406 of varying sizes.

[0143] The porous component 610 can be placed between the hemispherical spacer 702 and the preserved acetabular shell 406 to protect the preserved shell, provide a compressive fit, and stabilize the hemispherical spacer 702 within the preserved acetabular shell 406 while allowing fluid communication between the joint cavity and the surface of the preserved acetabular shell 406. In some implementations, the porous component 610 comprises an expandable foam, and a foam sponge can be customized for an improved fit. The porous component 610 can be sized and shaped to fit within the preserved acetabular shell 406, allowing the spacer 702 to securely fit within the preserved shell 406 while being used to provide therapy fluid to the preserved shell 406. The porous component 610 can comprise an open-cell foam or other biocompatible material that allows fluid to flow therethrough while having sufficient compression and shear stiffness to resist loading through the hip joint during therapy. The porous component 610 can include an expansion material that can form a preserved hip or knee prosthesis in situ and further stabilize the porous component 610 within the acetabular shell 406. In some implementations, the porous component 610 can be made from a shape memory material that, after being placed by the surgeon, expands to its final size and shape after implantation as its temperature increases to body temperature.

[0144] 13A-13D show an example of a treatment system 800 for a treatment site 102 in which one or more modular components of the prosthesis are not preserved but are temporarily replaced with the system 800. FIG. 13A illustrates the treatment system 800 used in combination with an irrigation and flushing device 202, including a porous structure 103 coupled to the area of ​​a connecting line 105. An implant 205 is preserved in place within one or more bones 207A, 207B, 207C. Flexible spacers 802 are positioned between the implant components. The flexible spacers 802 are configured to fill the space at the treatment site 102 after the modular components, for example, during a removal DAIR treatment. Similar to hip prostheses, knee implants can also have modular components. Knee implants typically include at least a femoral component, a tibial component, and a modular and removable plastic spacer therebetween. In conventional implants, the plastic spacer is not porous and therefore blocks the delivery of fluid to the infected implant surface to be treated. The treatment system 800 shown in Figures 13A-13D incorporates porous components that may improve the delivery and / or removal of fluid to the joint space and implant surface.

[0145] 13B illustrates the tibial component of the implant and a spacer 802 positioned thereover. The irrigation and flushing device 202 includes a porous component 103, which may have a hook shape that conforms to the femoral portion of the implant 205, and a connecting line 105 coupled to the porous component 103. The porous component 103 can be coupled to a distal end region of the connecting line 105 or can contain the connecting line 105 therein along some or all of its length. The irrigation and flushing device 202 is configured to be positioned around a lower portion of the femoral section 207A surrounding the femoral portion of the implant 205 for delivery of fluid through the connecting line 105 and / or through the porous component 103 into the joint during a treatment regimen for the joint. For example, the porous component 103 can include fluid-conductive channels or openings to allow irrigation and flushing of the joint 203. In some implementations, at least a portion of the connecting line 105 includes uniformly distributed openings that allow fluid to be transmitted to the porous component 103 or directly into the joint space. In some implementations, the end of the connecting line 105, which is surrounded by the porous component 103, includes one or more openings that allow fluid to be transmitted to the porous component 103 and allow irrigation of the joint 203. The inner (lumen) diameter of the porous component 103 can match the outer diameter of the connecting line 105, allowing stable positioning of the porous component 103 relative to the joint 203 during treatment. The porous component 103 of the irrigation and irrigation device 202 can be a compressible material so that its cross-sectional area can be minimized during insertion of the irrigation and irrigation device 202 through a small skin incision and, once in position within the treatment site 102, can expand to fill the space to deliver fluid therapy. Upon completion of the treatment regimen, the porous component 103 can be re-compressed and removed from the joint in a minimally invasive manner, as discussed in detail above with respect to Figures 2A-5.

[0146] The flexible spacer 802 can include an upper surface 804A and a lower surface 804B. The upper surface 804A can be flat when the flexible spacer 802 is contracted, as shown in FIG. 13B. The upper surface 804A can be configured to move in conjunction with a bottom surface of the preserved femoral component of the implant 205 when expanded, as shown in FIGS. 13A, 13C, and 13D. The upper surface 804A can have a wavy shape and, when expanded, is thicker in the center than on the sides. The lower surface 804B can be flat when the flexible spacer 802 is contracted, as shown in FIG. 13B. The lower surface 804B can be designed to interface with the preserved tibial component of the implant 205 by extending over at least the periphery of the preserved tibial component of the implant 205. The flexible spacer 802 can be contracted so that its outer thickness is minimized during insertion of the spacer and, once in place within the treatment site 102, can expand and fill the space for support and for delivery of fluid therapy by the irrigation and flushing device 202. Upon completion of the treatment regimen, the flexible spacer 802 can be contracted again and removed from the joint in a minimally invasive manner.

[0147] 14A-14D show the flexible spacer 802 of FIGS. 13A-13D. The flexible spacer 802 can include an inflatable bladder 902 surrounded by a porous component 904, such as a foam sponge or any type of biocompatible compressible material, that can expand during treatment to provide support for the preserved implant 205 and stability of the joint. The inflatable bladder 902 can be used to adjust the size of the sponge inserted between the preserved hip or knee implants to accommodate varying component sizes and anatomies. The inflatable bladder 902 can be connected to a fluid line 806 to control the fluid pressure within the inflatable bladder 902 and the volume of the inflatable bladder 902 therein. The porous component 904 can be connected to another fluid line 905 for delivery of irrigation and flushing fluid to the treatment site.

[0148] FIG. 14A shows an inflated bladder 902 in cross section. FIG. 14B shows the bladder 902 in cross section prior to inflation. FIG. 14C shows the bladder without the outer porous component 904. FIG. 14D shows the outer porous component 904 covering the bladder 902 and prior to inflation. The fluid used to inflate the inflatable bladder 902 can include sterile saline solution or other biocompatible fluids (gas and / or liquid) that can be added to or withdrawn from the bladder 902 via a sealable connection 906 between the fluid (liquid or gas) source and the bladder 902. The fluid source can be a syringe. The covering of the porous component 904 on the expandable bladder 902 can be continuous or intermittent. In a permanent implementation, the porous component 904 can be applied to the bladder 902 and packaged in a compressed configuration such that when the bladder 902 can be expanded in situ, the porous component 904 can expand along with the bladder 902 at the interface between the two components. In some implementations, only a portion of the inflatable bladder 902 can be covered by the porous component 904 such that the area of ​​the inflatable bladder 902 with the porous component covering can have limited expansion or can expand to less than the exposed area of ​​the bladder 902.

[0149] 14A-14D, the bladder 902 is not included, and the function of expanding the porous component 904 is performed by making it from a biocompatible memory foam that expands as the foam reaches body temperature after implantation. In another implementation, the bladder 902 can be filled with memory foam, which causes the bladder 902 to expand as the bladder temperature rises to body temperature. In another implementation, additional fluid lines can be fluidly coupled to the porous component 904 for delivery of therapy fluid to and / or withdrawal of fluid from the body.

[0150] Treatment system 800 of Figures 12A-12D and treatment system 600 and treatment system 700 of Figures 11A-11B can be used in conjunction with an irrigation and irrigation device 202, such as the device shown in Figures 2A-10B. When irrigation and irrigation device 202 is incorporated with the system to pass fluid into the joint space, a separate tube (i.e., tube 105 of Figures 11A-11B or tube 905 of Figures 14A-14D) need not be incorporated. Instead, the treatment system can rely on fluid delivery to (and / or removal from) irrigation and irrigation device 202 through a single tube (e.g., delivery line 105). The irrigation provided to the joint space by the device of Figures 2A-10B may be sufficient to expose all pathogens within the joint to the therapeutic fluid. However, to improve fluid delivery / removal, the treatment system can incorporate one or more porous components to substitute for one or more of the modular components of the prosthesis that would otherwise block fluid delivery to and from the implant site. Combining a treatment system 800 having one or more porous modular components with the porous component of the irrigation and cleaning device 202 provides an additional level of fluid communication to the system.

[0151] One or more conduits can be used for delivery of treatment fluid to the treatment site, and one or more conduits can be used for fluid egress from the treatment site. The same conduits used for fluid removal from the treatment site can be used for delivery of treatment fluid to the treatment site. Still further, a separate conduit need not be incorporated for fluid removal from the treatment site. Instead, a vacuum can be applied to the skin surface to remove fluid from the treatment site.

[0152] In various implementations, the description is provided with reference to the figures. However, certain implementations may be practiced without one or more of these specific details, or in combination with other known methods and configurations. In the description, numerous specific details, such as specific configurations, dimensions, and processes, are set forth to provide a thorough understanding of the implementations. In other instances, well-known processes and manufacturing techniques have not been described in particular detail so as not to unnecessarily obscure the description. Throughout this specification, references to “one embodiment,” “an embodiment,” “one implementation,” “an implementation,” or the like mean that a particular feature, structure, configuration, or characteristic being described is included in at least one embodiment or implementation. Thus, appearances of the phrases “one embodiment,” “an embodiment,” “one implementation,” “an implementation,” or the like in various places throughout this specification do not necessarily refer to the same embodiment or implementation. Furthermore, particular features, structures, configurations, or characteristics may be combined in any suitable manner in one or more implementations.

[0153] The use of relative terms throughout the description may indicate relative positions or directions. For example, "distal" may refer to a first direction, away from a reference point. Similarly, "proximal" may refer to a location in a second direction, opposite the first direction. The reference point used herein may be the operator, such that the terms "proximal" and "distal" refer to the operator using the device. Regions of the device closer to the operator may be described herein as "proximal," and regions of the device further away from the operator may be described herein as "distal." Similarly, the terms "proximal" and "distal" may also be used herein to refer to a patient's anatomical location from the operator's perspective, or from the perspective of the entry point, or along the path of insertion from the entry point of the system. Thus, a proximal location may refer to a location within a patient closer to the entry point of the device along the path of insertion toward the target, and a distal location may refer to a location within a patient further away from the entry point of the device along the path of insertion toward the target. However, such terms are provided to establish a relative frame of reference and are not intended to limit the use or orientation of the device to the specific configurations described in the various implementations.

[0154] As used herein, the term "about" refers to a range of values, including the specified value, that one of ordinary skill in the art would consider reasonably similar to the specified value. In an aspect, "about" refers to within a standard deviation using measurements generally accepted in the art. In an aspect, "about" refers to a range extending to + / - 10% of the specified value. In an aspect, "about" includes the specified value.

[0155] While this specification contains many details, these should not be construed as limitations on the scope of what is or can be claimed, but rather as descriptions of features specific to particular embodiments. Certain features described herein in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Also, while features may be described above as acting in a combination and may even be initially claimed as such, one or more features from the claimed combination may, in some cases, be deleted from the combination, and the claimed combination may be directed to a subcombination or a variation of the subcombination. Similarly, although operations may be depicted in a particular order in the figures, this should not be understood as requiring such operations to be performed in the particular or sequential order shown, or that all of the illustrated operations be performed, to achieve desirable results. Only several examples and implementations are disclosed. Variations, modifications, and enhancements to the described examples and implementations, as well as other implementations, may be made based on the disclosed content.

[0156] In the above description and claims, phrases such as "at least one of" or "one or more of" may appear and be followed by a conjunctive list of elements or features. The term "and / or" may also appear in lists of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to mean any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A alone, B alone, or A and B together," respectively. A similar interpretation is also intended with respect to lists containing three or more items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together," respectively.

[0157] Use of the term "based on" above and in the claims is intended to mean "based at least in part on," such that unrecited features or elements are also permissible.

[0158] The systems disclosed herein may be packaged together in a single package. The finished package would be sterilized using a sterilization method such as ethylene oxide or radiation, labeled, and boxed. Instructions for use may also be provided in the box or through an internet link printed on the label.

[0159] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any examples or exemplary language (e.g., "such as") provided herein is intended merely to better illustrate the invention and does not impose limitations on the scope of any claims. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0160] According to some implementations of the disclosed subject matter, articles, devices, systems, and methods of manufacture are provided for controlling fluid delivery to a treatment site during dissection, antibiotic administration, and implant preservation (DAIR) and double DAIR procedures.

[0161] In one aspect, the treatment support system includes a fluid delivery system for directing fluid to and from the treatment site, a portion of the fluid delivery system configured to prevent migration of the fluid delivery system from the treatment site, and a portion of the fluid delivery system configured to collapse to a minimal cross-section for minimally invasive transepidermal deployment to or removal from the treatment site.

[0162] In some variations, one or more features disclosed herein, including the following features, can be optionally included in any workable combination. The therapeutic assistance system can further include an inflatable structure configured to fill an opening in the treatment site during treatment. The inflatable structure can include a balloon or bladder inflatable with gas and / or liquid. The fluid delivery system can include a catheter or tubing. The catheter or tubing can include external attachment features for removably attaching the catheter or tubing to a portion of the treatment site during treatment. The external attachment features can include magnets, sutures, adhesives, resorbable materials, hooks, and / or rings. The therapeutic assistance system can further include a cannula, the cannula being flared or funnel-shaped. The therapeutic assistance system can further include an insertion tool, the insertion tool including a plurality of sequentially sized slidable sections. The fluid delivery system can include a biocompatible material.

[0163] In interrelated aspects, the treatment support system includes a fluid delivery system for directing fluid to and from the treatment site, a portion of the fluid delivery system configured to deliver fluid to and from the treatment site while mechanically stabilizing the treatment site during articulation of the treatment site, and a portion of the fluid delivery system configured to expand from a first collapsed configuration to a second expanded stable configuration during treatment and return to the collapsed configuration for removal from the treatment site.

[0164] In some variations, one or more features disclosed herein, including the following features, can be optionally included in any workable combination. The portion of the fluid delivery system configured to expand can include an open-cell sponge, a mesh, and / or a lattice. The mesh can include one or more flexible biocompatible materials including polyester, polypropylene, polymer, silk, nylon, and / or a nickel-titanium alloy. The mesh can include a helically wound braided tube. The mesh can include a sleeve shaped to conform to the anatomy of a portion of the treatment site. The therapeutic support system can further include a spacer configured to move with an inner surface of the treatment site. The expansion from the first collapsed configuration to the second expanded stable configuration can occur when the fluid delivery system reaches a temperature at or near the patient's body temperature.

[0165] In interrelated aspects, the therapeutic support system includes a fluid delivery system for directing fluid to and from a treatment site including a portion of a joint, and an attachment feature attached to the fluid delivery system, the attachment feature configured to prevent migration, kinking, or clogging of the fluid delivery system.

[0166] In some variations, one or more features disclosed herein, including the following features, can be optionally included in any workable combination: The fluid delivery system can further include a catheter or tubing. The therapeutic support system can further include a mesh, including a sleeve, shaped to conform to the anatomy of a portion of the treatment site and direct flow to or from there. The attachment feature can include a spacer configured to allow fluid flow and protect a spared implant during therapy. The spacer can be configured to deliver fluid to and from the treatment site while mechanically stabilizing the treatment site during articulation of the treatment site.

[0167] P embodiment

[0168] P Embodiment 1. A therapeutic support system comprising a fluid delivery system for directing fluid to and from a treatment site, a portion of the fluid delivery system configured to prevent migration of the fluid delivery system from the treatment site, and a portion of the fluid delivery system configured to collapse to a minimal cross-section for minimally invasive transepidermal deployment to or removal from the treatment site.

[0169] P Embodiment 2. A therapeutic support system as described in P Embodiment 1, further comprising an expandable structure configured to fill the opening in the treatment area during treatment.

[0170] P Embodiment 3. A therapeutic support system as described in P Embodiment 2, wherein the inflatable structure comprises a balloon or bladder that is inflatable with gas and / or liquid.

[0171] P Embodiment 4. A therapeutic support system according to P Embodiment 1, wherein the fluid delivery system comprises a catheter or tubing.

[0172] P Embodiment 5. A therapeutic support system as described in P Embodiment 4, wherein the catheter or tubing comprises an external attachment feature for removably attaching the catheter or tubing to a portion of the treatment site during treatment.

[0173] P Embodiment 6. A therapeutic support system as described in P Embodiment 5, wherein the external attachment features comprise magnets, sutures, adhesives, resorbable materials, hooks, and / or rings.

[0174] P Embodiment 7. A therapeutic support system as described in P embodiment 1, further comprising a cannula, the cannula being flared or funnel-shaped.

[0175] P Embodiment 8. A therapeutic support system as described in P embodiment 1, further comprising an insertion tool, the insertion tool comprising a plurality of sequentially sized slidable sections.

[0176] P Embodiment 9. The therapeutic support system of P embodiment 1, wherein the fluid delivery system comprises a biocompatible material.

[0177] P Embodiment 10. A therapeutic support system comprising a fluid delivery system for directing fluid to and from a treatment site, a portion of the fluid delivery system configured to deliver fluid to and from the treatment site while mechanically stabilizing the treatment site during articulation of the treatment site, and a portion of the fluid delivery system configured to expand from a first collapsed configuration to a second expanded stable configuration during treatment and return to the collapsed configuration for removal from the treatment site.

[0178] P Embodiment 11. A therapeutic support system as described in P embodiment 10, wherein the portion of the fluid delivery system configured to expand comprises an open-cell sponge, a mesh, and / or a lattice.

[0179] P Embodiment 12. A therapeutic support system as described in P embodiment 11, wherein the mesh comprises one or more flexible biocompatible materials comprising polyester, polypropylene, polymer, silk, nylon, and / or nickel-titanium alloy.

[0180] P Embodiment 13. A therapeutic support system as described in P embodiment 11, wherein the mesh comprises a helically wound braided tube.

[0181] P Embodiment 14. A therapeutic support system as described in P embodiment 11, wherein the mesh comprises a sleeve that is shaped to conform to the anatomy of a portion of the treatment area.

[0182] P Embodiment 15. A therapeutic support system as described in P embodiment 11, further comprising a spacer configured to move with the inner surface of the treatment area.

[0183] P Embodiment 16. The therapeutic support system of P embodiment 15, wherein the expansion from the first collapsed configuration to the second expanded stable configuration occurs when the fluid delivery system reaches a temperature at or near the patient's body temperature.

[0184] P Embodiment 17. A therapeutic support system comprising: a fluid delivery system for directing fluid to and from a treatment site comprising a portion of a joint; and an attachment feature attached to the fluid delivery system, the attachment feature configured to prevent migration, kinking, or clogging of the fluid delivery system.

[0185] P Embodiment 18. A therapeutic support system according to P embodiment 17, wherein the fluid delivery system further comprises a catheter or tubing.

[0186] P embodiment 19. A therapeutic support system as described in P embodiment 18, further comprising a mesh comprising a sleeve shaped to conform to the anatomy of a portion of the treatment area and direct flow to or from there.

[0187] P Embodiment 20. A therapeutic support system as described in P embodiment 18, wherein the attachment feature comprises a spacer configured to allow fluid flow and protect the preserved implant during therapy.

[0188] P embodiment 21. A therapeutic support system as described in P embodiment 20, wherein the spacer is configured to deliver fluid to and from the treatment site while mechanically stabilizing the treatment site during articulation of the treatment site.

Claims

1. 1. A system comprising: A cannula, the cannula comprising: a tubular portion comprising a lumen extending from a proximal opening at a proximal end region of the cannula to a distal opening at a distal end region of the cannula, the lumen having a first cross-sectional area at the proximal opening and a second, larger cross-sectional area at the distal opening; a distal flange on the distal end region of the cannula surrounding the distal opening and having an outer diameter greater than the outer diameter of the tubular portion of the cannula adjacent the distal end region; a cannula comprising: An open-cell sponge, the open-cell sponge comprising: a first portion shaped for implantation within a wound space and located distal to the distal opening of the tubular portion; a second portion sized and shaped to extend through each of the distal opening, the lumen, and the proximal opening of the tubular portion; an open-cell sponge comprising: wherein the open-cell sponge has sufficient tensile strength to prevent tearing of the open-cell sponge during retraction of the first portion in a proximal direction into the distal opening and through the lumen of the tubular portion.

2. 2. The system of claim 1, wherein upon implantation of the system into a patient, a first portion of the sponge is located within the wound space and the second portion is located within the lumen of the cannula such that a proximal end region of the second portion is located at an extradermal location.

3. 3. The system of claim 2, wherein the distal flange is flexible and configured to be compressed to a reduced outer diameter for removal from the wound space through an opening in the patient's skin after removal of the sponge from the cannula.

4. The system of claim 1 , further comprising a proximal flange on the proximal end region of the cannula surrounding the proximal opening and having an outer diameter greater than an outer diameter of the tubular portion of the cannula near the proximal end region.

5. The system of claim 1 , further comprising a connecting line configured for bidirectional or unidirectional fluid flow to the wound space.

6. The system of claim 5 , further comprising a therapy delivery system fluidly coupled to the connecting line and configured to control fluid flow to the wound space.

7. The system of claim 6 , wherein the treatment delivery system provides instillation and / or suction of the wound space.

8. The system of claim 7 , wherein the therapy delivery system is manually or electronically controlled.

9. The system of claim 7 , wherein the therapy delivery system comprises a fluid delivery system and a control unit.

10. The system of claim 9 , wherein the fluid delivery system comprises a vacuum source.

11. The system of claim 10 , wherein the cannula and open-cell sponge provide fluid communication between the vacuum source and the wound space for fluid removal.

12. The system of claim 7 , wherein instilling the wound space comprises delivering a therapeutic fluid to the wound space.

13. The system of claim 12 , wherein the therapy fluid comprises at least one therapeutic agent.

14. 14. The system of claim 13, wherein the at least one therapeutic agent comprises an antibiotic, an analgesic, an antifungal, or a combination thereof.

15. The system of claim 1 , wherein the wound space comprises a joint cavity.

16. A treatment support system, comprising:

1. A therapeutic support system comprising: a fluid delivery system for directing fluid to and / or from a treatment site, a portion of the fluid delivery system configured to prevent migration of the fluid delivery system from the treatment site, and a portion of the fluid delivery system configured to collapse to a minimal cross-section for minimally invasive transepidermal deployment to or removal from the treatment site.

17. 17. The therapeutic support system of claim 16, further comprising an expandable structure configured to fill the opening in the treatment site during treatment.

18. 18. The therapeutic support system of claim 17, wherein the inflatable structure comprises a balloon or bladder inflatable with gas and / or liquid.

19. The therapeutic support system of claim 16 , wherein the fluid delivery system comprises a catheter or tubing.

20. 20. The therapeutic support system of claim 19, wherein the catheter or tubing comprises external attachment features for removably attaching the catheter or tubing to a portion of the treatment site during treatment.

21. 21. The therapeutic support system of claim 20, wherein the external attachment features comprise magnets, sutures, adhesives, resorbable materials, hooks, and / or rings.

22. 17. The therapeutic support system of claim 16, further comprising a cannula, the cannula having a flared or funnel-shaped configuration at a distal end at the treatment site.

23. 23. The therapeutic support system of claim 22, wherein the cannula comprises a flared interior channel, the cross-sectional area of ​​the flared interior channel being greater at the distal end than at the proximal end of the cannula.

24. 24. The therapeutic support system of claim 23, wherein the cannula is a flexible biocompatible polymer.

25. 23. The therapeutic support system of claim 22, wherein the portion of the fluid delivery system configured to prevent migration comprises a porous component formed from compressible open-cell foam, the porous component having a distal end, a proximal end, and a central section, the distal end, the proximal end, and the central section each having a cross-sectional area, the porous component being positioned with at least a portion of the central section compressed within the interior channel of the cannula and at least the distal end positioned within the treatment site.

26. 26. The therapeutic support system of claim 25, wherein the cross-sectional area of ​​the distal end and the cross-sectional area of ​​the proximal end are greater than the cross-sectional area of ​​the portion of the central section compressed within the interior channel of the cannula.

27. 27. The therapeutic support system of claim 26, wherein the porous component is removable from the treatment site and the cannula by withdrawing the proximal component proximally through the cannula, and the cross-sectional area of ​​the distal end is compressed by the cannula when the porous component is withdrawn.

28. 28. The therapeutic support system of claim 27, wherein the cannula is flexible such that the cross-sectional area of ​​the interior channel of the cannula can be reduced by compressing, folding, or other manipulation to facilitate removal of the distal end of the cannula from the treatment site.

29. 17. The therapeutic assistance system of claim 16, further comprising an insertion tool, the insertion tool comprising a plurality of sequentially sized slidable sections.

30. The therapeutic support system of claim 16 , wherein the fluid delivery system comprises a biocompatible material.

31. A treatment support system, comprising:

1. A therapeutic assistance system comprising: a fluid delivery system for directing fluid to and / or from a treatment site, a portion of the fluid delivery system configured to direct the fluid while mechanically stabilizing the treatment site during articulation of the treatment site, the portion of the fluid delivery system configured to expand from a first collapsed configuration to a second expanded stable configuration during treatment and return to the collapsed configuration for removal from the treatment site.

32. 32. The therapeutic support system of claim 31, wherein the portion of the fluid delivery system configured to expand comprises an open-cell sponge, a mesh, and / or a lattice.

33. 33. The therapeutic support system of claim 32, wherein the mesh comprises one or more flexible biocompatible materials comprising polyester, polypropylene, silicone, silk, nylon, and / or nickel-titanium alloy.

34. 33. The therapeutic support system of claim 32, wherein the mesh comprises a helically wound braided tube.

35. 33. The therapeutic support system of claim 32, wherein the mesh comprises a sleeve that is shaped to conform to the anatomy of a portion of the treatment area.

36. 33. The therapeutic support system of claim 32, further comprising a spacer configured to move with the inner surface of the treatment site.

37. 37. The therapeutic support system of claim 36, wherein expansion from the first collapsed configuration to the second expanded stable configuration occurs when the fluid delivery system reaches a temperature at or near a patient's body temperature.

38. A treatment support system, comprising: a fluid delivery system for directing fluid to and / or from a treatment site comprising a portion of a joint; an attachment feature attached to the fluid delivery system, the attachment feature configured to prevent migration, kinking, or clogging of the fluid delivery system; A treatment support system comprising:

39. 39. The therapeutic support system of claim 38, wherein the fluid delivery system further comprises a catheter or tubing.

40. 40. The therapeutic support system of claim 39, further comprising a mesh, the mesh comprising a sleeve shaped to conform to a portion of the anatomy of the treatment site and direct flow to or from the anatomy.

41. 40. The therapeutic support system of claim 39, wherein the attachment feature comprises a spacer configured to allow fluid flow and protect a preserved implant during therapy.

42. 42. The therapeutic support system of claim 41, wherein the spacer is configured to deliver fluid to and from the treatment site while mechanically stabilizing the treatment site during articulation of the treatment site.

43. A treatment support system, a fluid delivery system for directing fluid to and / or from the treatment site; 1. An irrigation and irrigation device for use at the treatment site, the irrigation and irrigation device comprising: a flexible cannula having a lumen with a proximal opening and a distal opening; a porous component comprising an open-cell foam having a proximal end portion and a distal end portion; an irrigation and cleaning device comprising: Equipped with the irrigation and cleaning device has an assembled configuration, in which the distal end portion of the porous component is positioned distal to the distal opening of the lumen of the flexible cannula and the proximal end portion of the porous component extends through the lumen such that at least a portion of the proximal end portion is proximal to the proximal opening; the distal end portion of the porous component is sized to be pulled back through the lumen of the flexible cannula. Treatment support system.

44. 44. The therapeutic support system of claim 43, wherein the flexible cannula is a biocompatible elastomer.

45. 45. The therapeutic support system of claim 44, wherein the biocompatible elastomer is silicone.

46. 44. The therapeutic support system of claim 43, wherein the flexible cannula is collapsible.

47. 44. The therapeutic support system of claim 43, wherein the irrigation and cleaning device, in the assembled configuration, is configured to be implanted in the treatment site.

48. 48. The therapeutic support system of claim 47, wherein the flexible cannula is removable from the treatment site after the porous component is removed from the flexible cannula.

49. 44. The therapeutic support system of claim 43, wherein the flexible cannula facilitates removal of the porous component from the treatment site.

50. 44. The therapeutic support system of claim 43, further comprising an external vacuum source, wherein the flexible cannula and the porous component provide fluid communication between the external vacuum source and the treatment site for fluid removal from the treatment site.

51. 44. The therapeutic support system of claim 43, wherein the foam has high tensile strength to prevent tearing of the porous component during removal from the cannula.

52. 44. The therapeutic support system of claim 43, wherein the distal end portion of the porous component in the assembled configuration has a cross-sectional area that is larger than a cross-sectional area of ​​the distal opening, and the distal end portion is compressible to a cross-sectional area that is smaller than a cross-sectional area of ​​the distal opening of the flexible cannula.

53. 1. A kit for treating a localized infection in a human patient, said kit comprising: at least one therapeutic agent, wherein the at least one therapeutic agent is an antibiotic; 1. An irrigation and irrigation device configured to topically irrigate and irrigate a treatment site for a localized infection with at least one dose of said at least one therapeutic agent, said irrigation and irrigation device comprising: a porous component configured to be positioned through an opening in the patient's skin such that at least a portion of the porous component is positioned within the infected site and at least a portion of the porous component is positioned external to the skin, the porous component comprising an open-cell foam or a sponge; at least one connecting line for delivery of therapeutic fluid to and removal of fluid from the infected site through the porous component; an irrigation and cleaning device comprising: instructions for administering at least one dose of said at least one therapeutic agent to treat said localized infection, and after said administration, removing said porous element from said treatment site through said opening in said skin in a minimally invasive manner; A kit comprising:

54. 54. The kit of claim 53, wherein the porous component has sufficient tensile strength to prevent tearing during removal of the porous component from the treatment site through a minimally invasive opening after treatment.

55. 54. The kit of claim 53, wherein the antibiotic is selected from the group consisting of an aminoglycoside, a glycopeptide, a cyclic lipopeptide, amikacin, cefazolin, cefepime, ampicillin, ciprofloxacin, azithromycin, doxycycline, clindamycin, vancomycin, tobramycin, gentamicin, and daptomycin.

56. 54. The kit of claim 53, wherein the antibiotic comprises a combination of vancomycin and tobramycin.

57. 54. The kit of claim 53, wherein the at least one dose is administered according to a treatment process of a control unit configured to control a fluid delivery system, the fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution.

58. 1. A kit for managing localized pain in a human patient, said kit comprising: at least one therapeutic agent, wherein the at least one therapeutic agent is an anesthetic or an analgesic; 1. An irrigation and irrigation device configured to locally irrigate and irrigate a treatment site for localized pain with at least one dose of said at least one therapeutic agent, said irrigation and irrigation device comprising: a porous component configured to be positioned through an opening in the patient's skin such that at least a portion of the porous component is positioned within the treatment site and at least a portion of the porous component is positioned external to the skin, the porous component comprising an open-cell foam or a sponge; at least one connecting line for delivery of a therapeutic fluid to and removal of a fluid from the treatment site through the porous component; an irrigation and cleaning device comprising: instructions for administering at least one dose of the at least one therapeutic agent to treat the localized pain, and after said administration, removing the porous element from the treatment site through the opening in the skin in a minimally invasive manner; A kit comprising:

59. 59. The kit of claim 58, wherein the anesthetic is lidocaine.

60. 59. The kit of claim 58, wherein the at least one therapeutic agent comprises lidocaine and at least one antibacterial agent.

61. 59. The kit of claim 58, wherein the at least one dose is administered according to a treatment process of a control unit configured to control a fluid delivery system, the fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution.

62. 1. A kit for administering localized antifungal therapy in a human patient, said kit comprising: at least one therapeutic agent, wherein the at least one therapeutic agent is an antifungal agent; 1. An irrigation and irrigation device configured to topically irrigate and irrigate a treatment site of a localized fungal infection with at least one dose of said at least one therapeutic agent, said irrigation and irrigation device comprising: a porous component configured to be positioned through an opening in the patient's skin such that at least a portion of the porous component is positioned within the treatment site and at least a portion of the porous component is positioned external to the skin, the porous component comprising an open-cell foam or a sponge; at least one connecting line for delivery of a therapeutic fluid to and removal of a fluid from the treatment site through the porous component; an irrigation and cleaning device comprising: instructions for administering at least one dose of the at least one therapeutic agent to treat the fungal infection, and after said administration, removing the porous element from the treatment site through the opening in the skin in a minimally invasive manner; A kit comprising:

63. 63. The kit of claim 62, wherein the antifungal agent is fluconazole.

64. 63. The kit of claim 62, wherein the at least one therapeutic agent comprises fluconazole and at least one antibacterial agent.

65. 63. The kit of claim 62, wherein the at least one dose is administered according to a treatment process of a control unit configured to control a fluid delivery system, the fluid delivery system configured to connect to a fluid reservoir containing the at least one dose in solution.

Images