Infection control devices and methods for total joint replacement

Abstract

This application relates to an infection control device and method for total joint replacement. An orthopedic system for delivering a therapeutic agent to bone includes an elongated rod adapted for insertion into an intramedullary canal, an inlet configured to receive the therapeutic agent, and one or more outlets configured to deliver the therapeutic agent to the bone. The elongated rod may include one or more protrusions engaging the bone, and one or more channels extending longitudinally therein, the one or more channels being fluidly coupled to the inlet. The therapeutic agent flows from the inlet through the one or more channels and then exits through the one or more outlets into the intramedullary canal. The system may be configured to allow adjustment of one or more dimensions of the system to fit the patient's anatomy.

Description

[0001] This application is a divisional application of the application filed on June 9, 2016, with application number 201680045688.2 and invention title "Total Joint Replacement Infection Control Device and Method".

[0002] Cross-referencing

[0003] This application is a PCT application of U.S. Patent Application No. 14 / 841,529, filed August 31, 2015, which is a non-provisional application of U.S. Provisional Application No. 62 / 180,986, filed June 17, 2015, and claims the benefit thereof; the entire contents of the above applications are incorporated herein by reference. Technical Field

[0004] 1. Technical Field of the Invention Total joint replacement (TJR) is a medical procedure involving the repair and replacement of joints such as the hip and knee. In these surgeries, the bones at the hip and knee joints are fitted with orthopedic implants that mimic the structure of the joint being replaced.

[0005] In some cases, infection can occur, which can be a serious complication of TJR surgery. Unless the infection is correctly diagnosed within the first 2–4 weeks after the original surgery (which is rare), the infected implant must be removed in conjunction with extensive debridement of the surrounding joint tissues and bone.

[0006] The current standard of care for infected TJRs in the United States typically involves a two-stage reimplantation procedure. In the first stage of this procedure, the infected component is surgically exposed through an incision. This is followed by debulking of scar tissue and loosening of other soft tissues, sometimes including osteotomy. This stage also includes the removal of all prosthetic components and foreign bodies, including, for example, acrylic bone cement. After extensive joint debridement of the infected soft tissue and bone, a spacer block composed of a high-dose antibiotic bone cement is temporarily placed in the joint space. The purpose of the antibiotic bone cement is to sterilize the joint environment and serve as an antibiotic delivery system. Additionally, the bone cement acts as a spacer to maintain joint space and preserve ligament length. However, the antibiotics released by the bone cement are uncontrolled and quite expensive to use. Furthermore, preparing this spacer material requires more operating room time. This increases the cost of the procedure.

[0007] After the infected implant is removed and an antibiotic-coated bone spacer is inserted, patients typically must wait 6 to 12 weeks before the second stage of surgery can be performed. This time is necessary so that medical professionals can be certain that the infection has been successfully eradicated. The second stage can only proceed after the infection has been eliminated. During the second stage, a new prosthesis is then implanted.

[0008] In other countries, such as throughout Europe, one-stage reimplantation has become common. This involves removing the infected implant as described above, followed by thorough debridement, and then immediately reimplanting a new implant. The success rate of this technique is generally lower than that of two-stage surgery. One-stage reimplantation is typically reserved for patients deemed too weak or too ill to undergo the traditional two-stage reimplantation procedure.

[0009] In some cases, both one-stage and two-stage procedures can have disadvantages. For example, as mentioned above, a two-stage reimplantation procedure requires 6 to 12 weeks between operations. This is a very difficult period for patients because they do not have a functional joint in place, and moving or walking with an antibiotic spacer is often very painful. Articulated spacers are somewhat better than static spacers, but they are still more expensive, more difficult, and more time-consuming to place in the original one-stage surgery. From a healthcare perspective, two-stage surgery also requires two separate hospitalizations. Finally, from a surgeon's perspective, a significant amount of scar tissue grows during the time span between the two surgeries. This makes the second-stage operation very difficult and time-consuming. Furthermore, a two-stage reimplantation procedure does not involve one, but two very difficult and expensive surgeries.

[0010] On the other hand, one-stage reimplantation surgical procedures require absolute identification of the infected organism. Unfortunately, achieving this absolute identification is extremely difficult in the current healthcare system. Furthermore, one-stage reimplantation procedures require the use of fully adhesive components. American surgeons generally discourage the use of fully adhesive components in revision surgeries because they require large amounts of antibiotics, which can structurally weaken the adhesive.

[0011] Furthermore, in both one-stage and two-stage reimplantation protocols, the release of antibiotics from the bone cement is completely uncontrolled. This is a significant drawback of both protocols and effectively prolongs the time between the first and second surgeries in a two-stage reimplantation procedure.

[0012] Therefore, there remains a need for a device that can be used during reimplantation surgery to deliver antibiotics or other therapeutic agents directly into the synovial joint cavity and adjacent medullary ducts in a controlled and titrable manner as a means of eliminating infection after removal of the previous orthopedic implant. Additionally, there remains a need for a device that can provide stability and maintain the physical dimensions of joint space and normal soft tissue capsule in any joint undergoing reimplantation of an orthopedic implant. Furthermore, there remains a need for a device that is easy to use, helps reduce the time required for stage-one reimplantation surgery, and reduces the overall time between the first and second stages of a two-stage reimplantation surgical protocol. At least some of these will be addressed by the devices and methods described herein.

[0013] 2. Background Technology Description Other patents disclosing devices and methods for delivering antibiotics into the intramedullary tube include: U.S. Patent Nos. 8,900,323; 8,900,322 and 8,454,706. Summary of the Invention

[0014] The present invention generally relates to medical systems, devices and methods, and more particularly to orthopedic devices for delivering therapeutic agents into intramedullary canals in joints or bones.

[0015] In one aspect of the invention, a therapeutic agent delivery system includes: a first intramedullary rod configured for placement in a first medullary duct of a first bone; a second intramedullary rod configured for placement in a second medullary duct of a second bone; and a coupling member coupled to the first intramedullary rod and the second intramedullary duct. Each of the first intramedullary rod and the second intramedullary duct includes: an elongated body having a longitudinal axis, a first end, a second end opposite the first end, and a channel extending between the first end and the second end. Each of the first intramedullary rod and the second intramedullary duct further includes a plurality of projections extending radially outward from the elongated body, wherein adjacent projections define one or more recessed regions therebetween. The plurality of projections are configured to engage the first medullary duct in a stable manner, and one or more outlet orifices are disposed in the one or more recessed regions, wherein the one or more outlet orifices are in fluid communication with the channel. The coupling member may be coupled to a first end of the first intramedullary rod and a first end of the second intramedullary rod, wherein the coupling member holds the first intramedullary rod and the second intramedullary rod together at a fixed distance. The coupling member may further include an inlet in fluid communication with channels in the first intramedullary rod and the second intramedullary rod.

[0016] In some embodiments, the coupling member may include an adjustable height manifold configured to increase or decrease the distance between the first ends of the two intramedullary rods when the adjustable height manifold is actuated. The adjustable height manifold may include a housing having a central housing channel through which it is disposed, a rotating nut coupled to the housing, and an adjustable connector disposed within the housing channel. The adjustable connector has an adjustable connector channel disposed therein. The inlet coupled to the housing may be fluidly connected to the adjustable connector channel, and the adjustable connector channel may be fluidly coupled to the channel in the first or second rod. Rotation of the nut may extend or retract the adjustable connector relative to the housing. The rotating nut may thread-engage the adjustable connector, and the adjustable connector may be slidably disposed within the housing channel, wherein rotation of the rotating nut may move the adjustable connector up and down within the housing channel without rotating the adjustable connector.

[0017] In some embodiments, the coupling member may include a wedge element, wherein the wedge element, positioned between a first end of the first intramedullary rod and a first end of the second intramedullary rod, adjusts the distance between the first ends of the two intramedullary rods.

[0018] The therapeutic agent delivery system may further include a source of the therapeutic agent for delivery into the bone marrow duct from one or more outlet orifices in one or more recessed regions of the first and second rods. The therapeutic agent may be an antibiotic, wherein the antibiotic may include vancomycin, tobramycin, or a combination thereof.

[0019] In some embodiments, the first medullary duct may be located in the femur and the first rod may be configured to be housed therein. The second medullary duct may be located in the tibia and the second rod may be configured to be housed therein.

[0020] In some embodiments, the coupling member can be releasably coupled to the first intramedullary rod and the second intramedullary rod.

[0021] In some implementations, the first rod is the same as the second rod.

[0022] In some embodiments, the first or second rod may include four fins evenly spaced around the elongated body and extending along its longitudinal axis. The first or second rod may also include a plurality of outlet holes extending axially along a line substantially parallel to its longitudinal axis.

[0023] In some embodiments, the coupling member may include a flange region, wherein a first end of the first or second rod includes a recessed region for receiving the flange region, and wherein rotation of the flange region relative to the recessed region can releasably lock the first end to the coupling member. One or more pins may be disposed in the first end of the first or second rod, and the one or more pins may protrude therefrom to engage the flange region and prevent further rotation of the first or second rod relative to the coupling member. In some embodiments, the coupling member may include a snap-fit ​​portion or a dovetail portion for engaging a corresponding dovetail portion or a corresponding snap-fit ​​portion on the first or second rod.

[0024] In some embodiments, the channel may extend from the first end of the first rod or the second rod to the second end, and the channel may extend through both the first end and the second end. The system may also include a plug disposed in the channel at the second end of the first rod or the second rod. In some embodiments, the channel may be a blind channel in the first rod or the second rod, the blind channel having a closed second end.

[0025] In some embodiments, the elongated body of the first or second rod may be tapered.

[0026] In some embodiments, the coupling member may include a housing and a first rod connector configured to engage the first end of the first intramedullary rod and a second rod connector configured to engage the first end of the second intramedullary rod. The first rod connector and the second rod connector may be mounted on opposite sides of the housing. The first rod connector may have an orientation relative to the second rod connector, wherein the orientation may remain the same during actuation of the adjustable height manifold.

[0027] In some embodiments, the coupling member may include a housing in which a concave groove is circumferentially disposed around at least a portion of the housing. The size of the concave groove may be configured to receive a conduit.

[0028] The therapeutic agent delivery system may further include a cap disposed above the first or second rod, or a sponge disposed in at least some of the one or more recessed regions of the first or second rod. The cap or the sponge may be configured to facilitate uniform delivery of the therapeutic agent therefrom into the first or second intramedullary canal.

[0029] The therapeutic agent delivery system may also include a pump configured to pump the therapeutic agent into a channel of the first or second rod.

[0030] The therapeutic agent delivery system may also include a vacuum pump configured to remove unwanted fluid from the first or second medullary duct via one or more outlet holes or channels in the first or second rod.

[0031] In some embodiments, the plurality of protrusions in the first or second rod may be spirally disposed around them, or the one or more recessed regions in the first or second rod may be spirally disposed around them.

[0032] In some embodiments, the first or second rod may have a surface area, and 50% or less of the surface area may be configured to contact the bone in the first or second medullary duct.

[0033] The therapeutic agent delivery system may also include an outlet fluidly coupled to the first rod, the second rod, or the coupling member.

[0034] In another aspect of the invention, a method for treating a joint includes: placing a first intramedullary rod in a first medullary duct of a first bone, placing a second intramedullary rod in a second medullary duct of a second bone, coupling the first intramedullary rod to the second intramedullary rod therebetween by a coupling member, and delivering a therapeutic agent to the first medullary duct and the second medullary duct.

[0035] In some embodiments, the coupling member may include an adjustable height manifold, and the method may further include actuating the adjustable height manifold to adjust the distance between a first end of the first intramedullary rod and a first end of the second intramedullary rod. Actuating the adjustable height manifold may include rotating a nut coupled to a housing of the adjustable height manifold, and rotating the nut may move an adjustable connector of the adjustable height manifold relative to the housing.

[0036] In some embodiments, the coupling member may include a wedge-shaped element with a fixed height, and the method may further include selecting a wedge-shaped element from a plurality of wedge-shaped elements having different fixed heights. Coupling the first rod to the second rod with the coupling member may include coupling the first intramedullary rod to the second intramedullary rod between them using the selected wedge-shaped element, thereby adjusting the distance between a first end of the first intramedullary rod and a first end of the second intramedullary rod.

[0037] In some embodiments, placing the first intramedullary rod in the first medullary duct or placing the second intramedullary rod in the second medullary duct may include engaging a plurality of protrusions on the first or second rod with bone lined with a corresponding first or second medullary duct.

[0038] In some embodiments, delivery of the therapeutic agent may include delivery of an antibiotic, wherein the antibiotic may include vancomycin, tobramycin, or a combination thereof.

[0039] In some embodiments, delivery of the therapeutic agent may include delivering the therapeutic agent from one or more outlet holes located in a recessed region of the first or second rod.

[0040] In some embodiments, the first bone may be the femur and the second bone may be the tibia.

[0041] In some embodiments, coupling may include engaging a flange region in the adjustable height manifold with a recessed region in the first end of the first rod or the second rod.

[0042] In some embodiments, delivery of the therapeutic agent may include pumping the therapeutic agent from the first or second rod into a corresponding first or second bone marrow duct.

[0043] The method may further include aspirating unwanted fluid from the first or second medullary tube, wherein the unwanted fluid passes through one or more holes in the first or second tube.

[0044] In some embodiments, placing the first or second rod may include placing the first or second rod in the respective medullary duct such that 50% or less of the surface area of ​​the first or second rod contacts the bone in the respective first or second medullary duct.

[0045] In another aspect of the invention, a therapeutic agent delivery system includes a femoral head configured for placement in an acetabulum and a femoral rod coupled to the femoral head, the femoral rod being configured for placement in a femoral medullary canal. The system may further include an inlet coupled to the femoral rod and a plurality of outlets in the femoral head or the femoral rod. The therapeutic agent may be introduced into the system from the inlet, and the therapeutic agent may be deliverable from the plurality of outlets into the acetabulum or the femoral medullary canal.

[0046] In some embodiments, the femoral rod may include a threaded neck region configured to thread with the femoral head, thereby allowing adjustment of the distance between the femoral head and the femoral rod.

[0047] In some embodiments, the femoral rod may include a plurality of protrusions extending axially along the longitudinal axis of the femoral rod.

[0048] In some embodiments, the femoral rod may include an elongated channel extending therethrough, the channel being fluidly coupled to the inlet and the plurality of outlets. The elongated channel may be a through-hole, wherein one end of the femoral rod includes a plug.

[0049] In some embodiments, the femoral rod may be tapered.

[0050] In some embodiments, the plurality of outlets may be disposed within the femoral head. The femoral head may include a central channel that is fluidly coupled to the plurality of outlets via a plurality of channels extending radially outward from the central channel.

[0051] The therapeutic agent delivery system may also include an outlet for removing fluid from the femoral head or the femoral rod.

[0052] The therapeutic agent delivery system may further include an acetabular cup coupled to the femoral head, wherein the therapeutic agent is delivered from the acetabular cup to the acetabulum.

[0053] In some implementations, the plurality of outlets may include a plurality of holes with different diameters.

[0054] In some embodiments, the femoral head may be at least partially hollow.

[0055] The therapeutic agent delivery system may also include a locking mechanism for locking the femoral head to the femoral rod.

[0056] In another aspect of the invention, a method for treating a joint includes placing a femoral rod in the medullary canal of the femur, coupling a femoral head to the femoral rod, placing the femoral head in the acetabulum, and delivering a therapeutic agent to the medullary canal and the acetabulum.

[0057] In some embodiments, coupling may include adjusting the distance between the femoral heads. In some embodiments, coupling may include threading the femoral head to the femoral rod.

[0058] In some embodiments, placing the femoral rod may include engaging a plurality of protrusions on the femoral rod with bone lined with the medullary canal.

[0059] In some embodiments, delivery of the therapeutic agent may include delivery of an antibiotic, wherein the antibiotic may include vancomycin, tobramycin, or a combination thereof.

[0060] In some embodiments, delivery of the therapeutic agent may include delivering the therapeutic agent from one or more outlet holes located in a recessed region of the femoral rod.

[0061] In some embodiments, delivery of the therapeutic agent may include pumping the therapeutic agent from the femoral rod into the medullary canal or from the femoral head into the acetabulum.

[0062] The method may also include aspirating unwanted fluid from the medullary duct or the acetabulum.

[0063] In some embodiments, placing the femoral rod may include placing the femoral rod in the medullary duct such that 50% or less of the surface area of ​​the femoral rod contacts the bone in the medullary duct.

[0064] In another aspect of the invention, an apparatus for delivering a therapeutic agent to a joint in a patient's body includes an implant having a plurality of outlets for delivering the therapeutic agent to the joint, wherein the joint is a shoulder joint, ankle joint, or spinal joint.

[0065] These and other embodiments are described in more detail in the following description in connection with the accompanying drawings.

[0066] Incorporation

[0067] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent or patent application is specifically and individually incorporated by reference. Attached Figure Description

[0068] The novel features of the invention are specifically set forth in the appended claims. A better understanding of the features and advantages of the invention will be obtained by referring to the following detailed description and accompanying drawings, which illustrate illustrative embodiments in which the principles of the invention are utilized, in which:

[0069] Figure 1A This is a perspective view of an exemplary therapeutic agent delivery system for the knee;

[0070] Figure 1B yes Figure 1A An exploded view of a therapeutic agent delivery system;

[0071] Figure 2A This is a perspective view of an exemplary intramedullary rod;

[0072] Figure 2B and Figure 2C This is a side view of an exemplary intramedullary rod;

[0073] Figure 3A and Figure 3B An alternative embodiment of the elongated body of the intramedullary rod is shown;

[0074] Figure 4A An exemplary embodiment of an adjustable height manifold in a collapsed configuration is shown;

[0075] Figure 4B It shows the extended structure Figure 4A Adjustable height manifold;

[0076] Figure 5 yes Figure 4A Exploded view of the adjustable height manifold;

[0077] Figure 6A yes Figure 4A A perspective view of an exemplary embodiment of the housing of an adjustable height manifold;

[0078] Figure 6B yes Figure 6A Side view of the shell;

[0079] Figure 6C yes Figure 6A Top view of the shell;

[0080] Figure 6D yes Figure 6A A bottom view of the shell;

[0081] Figure 6E yes Figure 6A Vertical cross-sectional view of the shell;

[0082] Figure 7A yes Figures 4A-4B A perspective view of an exemplary embodiment of a rotating nut for an adjustable height manifold;

[0083] Figure 7B yes Figure 7A A top view of the rotating nut;

[0084] Figure 7C yes Figure 7A Vertical cross-sectional view of the rotating nut;

[0085] Figure 8A yes Figures 4A-4B A perspective view of an exemplary embodiment of an adjustable connector for an adjustable height manifold;

[0086] Figure 8B yes Figure 8A A bottom view of the adjustable connector;

[0087] Figure 8C and Figure 8D yes Figure 8A Side view of the adjustable connector;

[0088] Figure 9 It shows Figures 4A-4B An exemplary embodiment of the manifold pin of an adjustable height manifold;

[0089] Figure 10A Is it like this? Figure 4A The top view shown is of the assembled adjustable height manifold in a collapsed structure.

[0090] Figure 10B yes Figure 10A Vertical cross-sectional view of the assembled adjustable height manifold;

[0091] Figure 11A This is a perspective view of an exemplary embodiment of a fixed-height wedge;

[0092] Figure 11B and Figure 11C yes Figure 11A Side view of a fixed-height wedge;

[0093] Figures 12A-12H An exemplary mechanism for coupling an intramedullary rod to a coupling member is illustrated;

[0094] Figures 13A-13C The illustration shows another exemplary mechanism for coupling an intramedullary rod to a coupling member;

[0095] Figures 14A-14D The illustration shows another exemplary mechanism for coupling an intramedullary rod to a coupling member;

[0096] Figure 15 This demonstrates a method for treating the knee using a therapeutic agent delivery system;

[0097] Figure 16 This demonstrates a method for treating the knee using a therapeutic agent delivery system;

[0098] Figure 17A This is a perspective view of an exemplary therapeutic agent delivery system for the hip.

[0099] Figure 17B yes Figure 17A An exploded view of a therapeutic agent delivery system;

[0100] Figure 18A This is a perspective view of an exemplary embodiment of the femoral rod;

[0101] Figure 18B yes Figure 18A Side view of the femoral shaft;

[0102] Figure 18C yes Figure 18A Lateral sectional view of the femoral shaft;

[0103] Figure 18Dyes Figure 18A A top view of the femoral shaft;

[0104] Figure 19 An exemplary embodiment of the lever plug is shown;

[0105] Figure 20A This is a side view of an exemplary embodiment of the femoral head;

[0106] Figure 20B yes Figure 20A A lateral cross-sectional view of the femoral head;

[0107] Figure 21A and Figure 21B This is a side cross-sectional view of another exemplary embodiment of the femoral head;

[0108] Figure 22 This is a side cross-sectional view of another exemplary embodiment of the femoral head;

[0109] Figure 23A and Figure 23B An exemplary mechanism for coupling the femoral head to the femoral rod is shown;

[0110] Figure 24A and Figure 24B An exemplary mechanism for locking a predetermined distance between the femoral head and the femoral rod is shown;

[0111] Figures 24C-24F The diagram illustrates the assembly process. Figure 24A and Figure 24B Methods for locking mechanisms;

[0112] Figure 25A and Figure 25B An exemplary embodiment of a therapeutic agent delivery system with an acetabular cup is shown;

[0113] Figure 26 An exemplary embodiment of a therapeutic agent delivery system for the hip is shown;

[0114] Figure 27 A method for treating the hip using a therapeutic agent delivery system is shown;

[0115] Figure 28A and 28B The illustration shows a negative pressure wound therapy using an intramedullary device;

[0116] Figure 29 An optional cap for the intramedullary rod is shown;

[0117] Figure 30 An exemplary implementation of a therapeutic agent delivery system is shown;

[0118] Figure 31A and Figure 31BAn exemplary embodiment of a therapeutic agent delivery system with an inlet and an outlet is shown;

[0119] Figure 32A and Figure 32B An exemplary construction of the internal channels of the intramedullary device is illustrated.

[0120] Figures 33A-33C Another exemplary construction of the internal channel of the intramedullary device is illustrated; and

[0121] Figures 34-36 An exemplary implementation of a therapeutic agent delivery system is shown. Detailed Implementation

[0122] Specific embodiments of the disclosed apparatus, delivery system, and method will now be described with reference to the accompanying drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the invention.

[0123] This document describes a therapeutic agent delivery system that can be used in the knee, hip, or any other joint. For example, the therapeutic agent delivery system can be used to treat the shoulder or ankle joint, or a portion of the spine. Those skilled in the art will understand that other joints can also be treated using the systems, devices, and methods disclosed herein. Optionally, in any embodiment, the therapeutic agent delivery system may include one or more intramedullary rods configured to be stably disposed within the medullary canal of the bone. The intramedullary rods may be configured to deliver a therapeutic agent into the medullary canal, joint space, or a combination thereof. Optionally, in any embodiment, the intramedullary rod is coupled to another component, such as another intramedullary rod or the femoral head, to allow the distance between the rod and the other component to be adjustable in a patient-appropriate manner, or the distance between them may be fixed.

[0124] Therapeutic agents delivered by the delivery system described herein may include any fluid. For example, therapeutic agents may include solutions of antibiotics, such as vancomycin or tobramycin, combinations thereof, or other antibiotics commonly used to treat implant-related infections. Those skilled in the art will understand that any therapeutic agent may also be delivered alone or in combination with antibiotics or other therapeutic agents. Other exemplary therapeutic agents may include saline or other fluids for flushing a joint or medullary duct being treated.

[0125] Knee treatment delivery system

[0126] Figure 1A and Figure 1B An exemplary therapeutic agent delivery system 100 for the knee is shown. Figure 1A The components of the delivery system assembled together are shown, while Figure 1BThe disassembled components of the delivery system, aligned for reassembly, are shown. The delivery system 100 includes a first intramedullary rod 110, a second intramedullary rod 120, and a coupling member 130. Each of the two intramedullary rods 110 and 120 can be configured for placement in the medullary canal of bone. For example, the first intramedullary rod 110 can be configured for placement in the medullary canal of a patient's femur, while the second intramedullary rod 120 can be configured for placement in the medullary canal of a patient's tibia. The coupling member 130, configured for placement in the joint space, enables stable coupling of the two rods while maintaining a desired distance 105 between them throughout the entire length of the therapeutic delivery system in the patient.

[0127] The first intramedullary rod 110 and the second intramedullary rod 120 can be any intramedullary rod as described herein. These two rods can be two identical rods, or they can be two different rods configured to have one or more differences in size, construction, or characteristics. For example, a delivery system may include a first intramedullary rod specifically configured for engagement of the femur and a second intramedullary rod specifically configured for engagement of the tibia. These two rods may differ in one or more dimensions such as length, diameter, or taper. Alternatively or in combination, these two rods may differ in one or more constructions or characteristics as described herein (e.g., construction of rod channels, number, shape, and size of protrusions, groove areas, and / or outlet orifices, etc.).

[0128] The coupling member 130 may include any coupling member as described herein, such as an adjustable height manifold or a fixed height wedge. In many embodiments of the delivery system 100, the coupling member 130 may be configured to allow adjustment of the distance 105 between the two rods to accommodate the patient's anatomy. The coupling member may be configured to fluidly couple to and receive a source of therapeutic agent, and to deliver the therapeutic agent to the intramedullary rod for delivery into the medullary duct.

[0129] The first rod 110 and the second rod 120 can be releasably coupled to the coupling member 130. Each of the first and second rods can be configured for coupling to a rod connector 132 of the coupling member. The first rod can be coupled to a first rod connector 132a, and the second rod can be coupled to a second rod connector 132b. Various mechanisms for connection between the rods and the coupling member are described herein, any of which can be incorporated into the coupling member 130 for coupling to either the first or the second rod. The first and second rods can be coupled to the first and second rod connectors, respectively, via the same mechanism or via different mechanisms. Thus, the first rod connector 132a and the second rod connector 132b of the coupling member can be the same or different. In a preferred embodiment, the first and second rods are identical, and therefore the coupling member accordingly includes two identical rod connectors configured for coupling to the first and second rods via the same mechanism.

[0130] Intramedullary rod

[0131] Figures 2A-2C An exemplary intramedullary rod 200 suitable for integration with a therapeutic agent delivery system for the knee is shown. Figure 2A It is a perspective view, and Figure 2B and Figure 2C This is a side view of an intramedullary rod 200. Each intramedullary rod 200 includes an elongated body 205 having a longitudinal axis 210, the elongated body having a first end 215 and a second end 220 opposite the first end. The first end or proximal end may be configured for coupling to a coupling member 130, such as an adjustable height manifold or a fixed height wedge as described herein. The second end or distal end may be disposed within the medullary duct of the bone. The elongated body 205 includes a rod channel 225 extending between the first end 215 and the second end 220, the rod channel being configured to deliver therapeutic agents through the rod and into the medullary duct. The first end 215 of the intramedullary rod 200 may be configured to couple the rod to the coupling member. As described in further detail herein, the first end may include any mechanism for connecting the rod to the coupling member (e.g., a flange region, a dovetail joint, a snap-fit, a wing nut, etc.), as described in more detail herein.

[0132] The intramedullary rod 200 may include a plurality of projections 230 projecting radially outward from the elongated body 205. The plurality of projections may include any number of projections having any suitable shape, size, or construction to stably engage the medullary duct. For example, the projections may include elongated fins extending along the longitudinal length of the elongated body, such as… Figures 2A-2CAs shown. In one exemplary embodiment, the plurality of protrusions may include four fins equidistantly spaced at approximately 90° intervals around the longitudinal axis 210 of the elongated body. The plurality of protrusions 230 and the elongated body 205 may be formed separately and then coupled together. Alternatively or in combination, the plurality of protrusions 230 may be formed by removing material from the elongated body 205, such that the plurality of protrusions and the elongated body are formed as a single component. Adjacent protrusions 230 may define one or more recessed regions 235 between them, the recessed regions being radially recessed compared to the protrusions. The recessed regions may form concave recessed regions between adjacent protrusions.

[0133] Multiple protrusions and grooves can be configured to minimize the surface area of ​​the rod in contact with the bone lined with medullary canals, thereby maximizing the area of ​​bone available for irrigation with therapeutic agents. For example, multiple protrusions and grooves can be configured such that less than 50% of the rod's surface area contacts the bone lined with medullary canals. This is not intended to be limiting, and those skilled in the art will understand that any percentage of the rod's surface area can contact the bone. Figures 2A-2C As shown, the rod may include multiple identical recessed regions defined by a plurality of elongated fins, the recessed regions being symmetrically distributed about the longitudinal axis 210 of the rod. Alternatively, as described further in detail herein, the multiple recessed regions may be asymmetrically distributed about the longitudinal axis of the rod, and / or may have different shapes or sizes.

[0134] The intramedullary rod 200 may further include a plurality of outlet holes 240 in fluid communication with the rod channel 225. The plurality of outlet holes 240 may be configured to deliver therapeutic agents delivered through the rod channel 225 to the medullary duct and adjacent tissues, including joints. The plurality of outlet holes may be disposed in a recessed region 235 to deliver therapeutic agents to bone areas not in contact with the intramedullary rod. The plurality of outlet holes may include any number of outlet holes having any suitable size, shape, or distribution. For example, the plurality of outlet holes may include a plurality of equal-sized and spaced holes extending axially along a line substantially parallel to the longitudinal axis 210 of the rod, such as... Figures 2A-2C As shown. As described in further detail herein, multiple outlet orifices can be arranged in various configurations. Multiple outlet orifices may include orifices of the same shape and / or size, or orifices of various shapes and / or sizes. Changing the orifice size allows for further fluid control of the therapeutic agent as it exits different regions of the rod.

[0135] The rod channel 225 may be a through-hole extending from the first end 215 through both the first and second ends 220 to the second end, such that the elongated body includes an open second end or distal end. The system may further include an embolus (not shown) configured to couple to the open second end of the rod to close the second end and thereby create a non-perforated channel. Alternatively, the rod channel 225 may be a non-perforated channel in which the second end of the elongated body is closed. In a configuration where the second end is open, the therapeutic agent may exit the rod channel through the second end and / or through a plurality of outlet orifices disposed along the elongated body 205 as described herein and enter the medullary duct. If the rod only includes the rod channel 225 extending through the first and second ends without a plurality of outlet orifices, the therapeutic agent may exit the rod channel only through the second end. In a configuration where the second end of the rod is closed, the therapeutic agent may exit the rod channel only through a plurality of outlet orifices and enter the medullary duct.

[0136] The intramedullary rod 200 may taper gradually to accommodate the medullary duct. For example, as shown, the elongated body 205 and / or multiple projections 230 may taper gradually from a first end 215 to a second end 220 to have a smaller radial cross-sectional area at the second end than at the first end. For example, the taper may include a gradual taper, wherein the degree of taper may preferably be in the range of about 0.1° to about 10°, more preferably about 0.5° to about 5°, even more preferably about 1° to about 10°, or about 1° to about 4°, or in the range of about 2° or about 3°. The taper can be adjusted to accommodate the medullary duct of a particular type of bone.

[0137] Figures 2A-2C Exemplary implementations may include, for example, Figure 1A and 1B The illustrated therapeutic agent delivery system for the knee includes one or both of the two intramedullary rods. Preferably, the therapeutic agent delivery system for the knee comprises two identical intramedullary rods, such as... Figures 2A-2C Exemplary implementations.

[0138] Figure 3A and Figure 3B It shows Figures 2A-2C An alternative embodiment of the elongated body 205 of the intramedullary rod 200. Figure 3A An elongated body 205 is shown, comprising one or more protrusions 231 spirally disposed around the elongated body 205 along its longitudinal length. Adjacent spiral or helical protrusions 231 define one or more recessed regions 236 between them, the one or more recessed regions 236 spirally disposed around the elongated body. Figure 3B An elongated body 205 is shown comprising a plurality of protrusions 232, which are removed by cutting or otherwise such as Figure 3AThis is created by a portion of the spirally arranged protrusion 231 shown. For example, as shown, multiple radial cuts can be made into the elongated body to define multiple protrusions 232. Multiple recessed regions 237 can be defined between the remaining portions of adjacent spiral protrusions. Figure 3B The removal or excision of a portion of the spiral protrusion 231 shown can further reduce the contact area between the rod and the bone, thereby allowing the therapeutic agent to flow more freely along the medullary duct.

[0139] exist Figure 3A In some embodiments, multiple outlet holes (not shown) may extend along a spiral or vortex line, such as along a spiral or vortex-shaped groove region 236. Figure 3B In the embodiment shown, a plurality of outlet holes 240 may be provided in the recessed region 237 such that the holes extend around a plurality of rings around the circumference of the elongated body.

[0140] Adjustable height manifold

[0141] Figure 4A and Figure 4B It shows that it is suitable for use with, for example Figure 1A-Figure 1B The adjustable height manifold 300 is incorporated into a therapeutic agent delivery system for the knee. The adjustable height manifold 300 is an example of a coupling member capable of stably coupling two intramedullary rods while maintaining a desired distance between the two rods along the entire length of use of the therapeutic agent delivery system within the patient's body. The adjustable height manifold also enables adjustment of the distance between the two rods, allowing the delivery system to be configured to optimally fit the patient's anatomy. The adjustable height manifold 300 may include a housing 315, a rotating nut 320, and an adjustable connector 325. The rotating nut 320 and the adjustable connector 325 may be coupled to the housing 315 and configured to allow the manifold height 305 to increase or decrease based on a desired set distance between the two rods for the patient. Rotating the nut 320 clockwise and counterclockwise can cause the manifold to collapse or extend by translating the adjustable connector along the longitudinal axis 310 of the manifold. Figure 4A An adjustable height manifold 300 in a collapsed configuration is shown, so the manifold height 305 is relatively short, and the manifold can therefore be adapted to patients who require a shorter set distance between the two knee joint bars. Figure 4B An adjustable height manifold 300 in an extended configuration is shown, so the manifold height 305 is relatively long, and the manifold can therefore be adapted to patients who need a longer setting distance between the two knee joint bars.

[0142] The adjustable height manifold 300 also includes a first rod connector 342 and a second rod connector 344 disposed on opposite sides of the housing. The first rod connector 342 may be configured to couple to a first end of a first intramedullary rod, while the second rod connector 344 may be configured to couple to a first end of a second intramedullary rod. The first rod connector 342 may be coupled to an adjustable connector 325, while the second rod connector 344 may be coupled to the housing 315. Each rod connector may include a coupling mechanism to couple to a corresponding connection mechanism disposed on the first end of the intramedullary rod. The first rod connector and the second rod connector may include different connection mechanisms, or they may include the same connection mechanism. In a preferred embodiment, the first rod connector and the second rod connector include the same connection mechanism and are fixedly oriented relative to each other such that the orientation remains the same during actuation of the adjustable height manifold to adjust the manifold height. The fixed orientation of the two rod connectors relative to each other allows the manifold to be properly and simultaneously coupled to each rod during implantation of the delivery system into the patient using the same actuation motion for both rods.

[0143] Figure 5 yes Figures 4A-4B An exploded view of the adjustable height manifold 300. The adjustable height manifold 300 includes a housing 315, a rotating nut 320 having a toothed outer surface and internal threads providing a gripping area for the operator's fingers, and an adjustable connector 325, wherein these three components are axially aligned along the longitudinal axis 310 of the manifold. The manifold also includes a manifold pin 330 configured to secure the coupling of the adjustable connector to the housing and control the range of motion of the adjustable connector. The adjustable connector includes a first rod connector 342 configured to couple to a first intramedullary rod. The housing includes a second rod connector 344 configured to couple to a second intramedullary rod. The housing also includes an inlet 335 coupled thereto, configured to fluidly couple to a source (not shown) of a therapeutic agent to be delivered to the patient. The housing is configured to couple to the rotating nut and slidably receive the adjustable connector. The swivel nut is configured to thread-engage the adjustable connector so that the adjustable connector extends outward from the housing along the longitudinal axis 310, or retracts inward into the housing along the longitudinal axis when the nut is rotated.

[0144] Figures 6A-6E It shows Figures 4A-4B An exemplary embodiment of the housing 315 of the adjustable height manifold 300. Figure 6A It is a perspective view. Figure 6B It is a side view. Figure 6C It is a top view. Figure 6D It is a bottom view, and Figure 6E This is a vertical cross-sectional view of shell 315. Figure 6BThe housing 315 includes an inlet 335 fluidly coupled to a source of therapeutic agent, and a housing channel 340 extending through the housing along the longitudinal axis 310 (in the cross section AA). Figure 6E (Best visible in the middle). The housing channel 340 is in fluid communication with the inlet 335, allowing therapeutic agents added to the therapeutic agent delivery system via the inlet to be delivered through the housing channel to other components of the delivery system. The inlet 335 may include a barbed outer surface to securely engage the inner surface of the tube supplying the therapeutic agent. Figure 28A (Best visible in the middle). The housing may also include a recessed groove 345, which is at least partially or completely disposed around the circumference of the housing, thereby minimizing the profile of the conduit / housing assembly. The groove may allow placement of a conduit for supplying therapeutic agents, which is coupled to the inlet 335.

[0145] The housing 315 also includes a second rod connector 344 configured for coupling to an intramedullary rod, such as any intramedullary rod described herein. A housing channel 340 extends through the rod connector 344 such that the housing channel can be fluidly coupled to a rod channel of the rod coupled to the rod connector. As described further in detail herein, the rod connector 344 may include any mechanism for connecting the coupling member to the rod (e.g., flange region, dovetail joint, snap-fit, wing nut, etc.).

[0146] The housing channel 340 can be configured with a geometry that allows an adjustable connector disposed within the channel to slide axially along the longitudinal axis 310 while preventing the adjustable connector from rotating within the channel. For example, the channel 340 may include two flat inner surfaces 347 disposed opposite each other, the flat inner surfaces 347 being configured to engage with two flat side surfaces of the adjustable connector. The channel may further include two circular side inner surfaces 349 configured to engage with two corresponding circular surfaces of the adjustable connector. For example, the circular inner surfaces 347 may include concave surfaces, while the circular side surfaces of the adjustable connector may include convex surfaces. The engagement of the flat inner surfaces of the housing channel with the flat side surfaces of the adjustable connector prevents the adjustable connector from rotating therein, thereby ensuring that the adjustable connector moves only slidably within the housing channel, rather than rotationally. Even when the rotating nut 320 is rotated, preventing rotation of the adjustable connector, including the first rod connector 342, ensures that the orientation of the second rod connector 344 remains fixed relative to the orientation of the first rod connector. The fixed orientation of the first and second rod connectors relative to each other ensures that the manifold can be easily coupled to both the first and second rods. For example, the manifold can be inserted into the space between the first and second rods and then rotated in one direction to couple to both rods. This configuration of the rod connectors facilitates implantation of the delivery system in the patient by avoiding the need to rotate one or more intramedullary rods after the rods have been inserted into the patient's medullary cavity.

[0147] The housing may further include one or more forks 355, which are disposed around the periphery of the housing channel 340 and extend longitudinally from the housing. The forks may include, for example... Figures 6A-6E The four forked teeth shown have their inner surfaces configured to engage each of the four sides of the adjustable connector to be mounted in the housing channel. Two forked teeth positioned opposite each other may be configured to have a flat inner surface 347 of the housing channel, while the remaining two forked teeth, also positioned opposite each other, may be configured to have a circular inner surface 349 of the housing channel. One or more forked teeth may further include an outwardly facing lip 357 disposed at the edge of the forked tooth. The lip 357 may be configured to engage a corresponding manifold groove in the swivel nut as described further herein, so as to securely couple the swivel nut to the housing and prevent axial movement of the swivel nut along the longitudinal axis 310 during rotation of the nut. The lip 357 may further include a chamfer 359, which is configured to facilitate coupling of the swivel nut to the housing by guiding the lip into the manifold groove of the nut.

[0148] The housing may further include a housing pin hole 360 ​​configured to receive a portion of the manifold pin. The pin hole 360 ​​may be disposed on a fork tooth 355 configured to engage a rotating nut, such that the pin hole 360 ​​can be aligned with a nut pin hole in the rotating nut that is also configured to receive the manifold pin. When fully assembled, the manifold pin may be partially disposed within the housing and partially disposed in a slot in an adjustable connector disposed within the housing channel to create a hard stop to prevent the manifold assembly from separating, as described in further detail herein. The housing pin hole 360 ​​may be sized to ensure that the manifold pin is secured within the pin hole. For example, the diameter of the housing pin hole may be substantially equal to the diameter of the portion of the manifold pin configured to be disposed within the housing, such that the pin can be press-fitted into the housing pin hole.

[0149] Figures 7A-7C It shows Figures 4A-4B An exemplary embodiment of the rotating nut 320 of the adjustable height manifold 300. Figure 7A It is a perspective view. Figure 7B It is a top view. Figure 7C This is a vertical cross-sectional view of the swivel nut 320. Figure 7B(Cross section AA). The swivel nut 320 includes a plurality of threads 362 disposed on a portion of its inner surface. The threads 362 may be configured to engage corresponding threads on a portion of the adjustable connector, such that rotation of the nut 320 about the adjustable connector may cause axial movement of the adjustable connector along the longitudinal axis of the manifold. The nut 320 may also include a manifold groove 364 circumferentially disposed around the inner surface of the nut. The manifold groove may be configured to receive one or more lips disposed on one or more forks of the housing as described herein, in order to lock the nut to the housing while still allowing the nut to rotate relative to the housing. The nut may also include a chamfer 366 disposed below the manifold groove, the chamfer 366 extending circumferentially around the inner surface of the nut. The chamfer 366 may be configured to correspond to a chamfer of the housing lip in order to guide the lip into the manifold groove. The nut may further include a nut pin hole 368 disposed on a portion of the nut below the threads 362, the nut pin hole being configured to receive a manifold pin passing through it. During manifold assembly, the manifold pin can be pushed into and completely through the body of the swivel nut to partially house the pin within the housing and partially within the adjustable connector, thus avoiding any physical obstruction to the nut's rotation. Correspondingly, when the manifold assembly is complete, the manifold pin will not pass through any part of the swivel nut, allowing the swivel nut to rotate freely. The size of the nut pin hole 368 can be configured to facilitate insertion and passage of the manifold pin into the pin hole. For example, the diameter of the nut pin hole can be larger than the diameter of the largest portion of the manifold pin, allowing the pin to easily pass through the nut pin hole.

[0150] Figures 8A-8D It shows Figures 4A-4B An exemplary embodiment of the adjustable connector 325 of the adjustable height manifold 300. Figure 8A It is a perspective view. Figure 8B It is a bottom view, and Figure 8C and Figure 8D This is a side view. The adjustable connector 325 includes an adjustable connector channel 370 extending axially along a longitudinal axis 310. The channel 370 extends through the length of the adjustable connector and is configured to be in fluid communication with a housing channel 340, such that an inlet 335 is fluidly coupled to the housing channel. The adjustable connector further includes a first rod connector 342 configured to couple to an intramedullary rod, such as any intramedullary rod described herein. The connector channel 370 extends axially through the rod connector 342 such that the channel 370 is in fluid communication with a rod channel of a rod coupled to the first rod connector 342. As described further in detail herein, the rod connector 342 may include any mechanism for connecting the coupling member to the rod (e.g., flange region, dovetail joint, snap-fit, wing nut, etc.).

[0151] The adjustable connector may further include a thread 372 configured to engage with a corresponding threaded portion of a rotating nut, such that rotation of the nut causes the adjustable connector to move vertically into or out of the housing. The adjustable connector may include two flat side surfaces 327 and two circular side surfaces 329, wherein the flat side surfaces may be configured to abut a flat inner surface of the housing channel, and wherein the circular side surfaces may be configured to abut a circular inner surface of the housing channel. As described herein, such a configuration prevents the adjustable connector from rotating when the rotating nut rotates, thereby ensuring that the orientation of the adjustable connector, and therefore the first lever connector 342, remains constant relative to the orientation of the second lever connector. Furthermore, this converts rotational actuation of the nut into linear movement of the adjustable connector.

[0152] Figure 8C A proximal flat-side surface 327a of the adjustable connector is shown, configured to face proximal to the housing inlet. The proximal flat-side surface may be configured to have an open slot 374 extending through the bottom of the adjustable connector. The open slot 374 may be fluidly coupled to the adjustable connector channel 370, such as... Figure 8B The best view in the middle Figure 8B A bottom view of the adjustable connector is shown. The open slot 374 can be configured such that when the assembled manifold is in a position such as... Figure 4A In the collapsed configuration shown, the open slot is aligned with the inlet to couple the inlet fluid to the adjustable connector channel 370. When the assembled manifold is in the position shown... Figure 4B In the extended position shown, the open bottom of the open slot 374 ensures that the inlet remains in fluid communication with the housing channel, and thus with the adjustable connector channel.

[0153] Figure 8D A distal flat side surface 327b of the adjustable connector is shown, configured to face distally relative to the inlet of the housing. The distal flat side surface includes a closing slot 376 configured to engage a portion of a manifold pin held within the housing. As described herein, the manifold pin can be coupled to the manifold assembly after the housing, swivel nut, and adjustable connector are assembled together. After full assembly, the manifold pin can be partially seated in the housing and partially seated in the closing slot 376 of the adjustable connector. The manifold pin can be configured to remain engaged in the closing slot 376 during retraction or extension of the adjustable connector. The closing slot can be configured to have a width larger than the diameter of the portion of the manifold pin seated in the slot to facilitate movement of the adjustable connector. When the assembled manifold is in a position such as Figure 4A In the collapsed configuration shown, the manifold pin can be aligned with the top of the closed slot 376. When the assembled manifold is in the position shown... Figure 4BIn the extended configuration shown, the manifold pin can be aligned with the bottom of the closing slot 376. The bottom of the closing slot 376 provides a hard stop for the extension of the adjustable connector from the housing, thereby preventing the adjustable connector from extending further. Therefore, the closing slot 376 and the manifold pin can prevent the manifold assembly from separating.

[0154] Figure 9 It shows Figures 4A-4B An exemplary embodiment of the manifold pin 330 of the adjustable height manifold 300. The manifold pin 330 may include a small-diameter portion 332 and a large-diameter portion 334. The small-diameter portion 332 may be configured to engage a closed slot in the adjustable connector, while the large-diameter portion 334 may be configured to be seated in a manifold pin bore in the housing. As described herein, the manifold pin can be coupled to the manifold assembly by inserting the pin through a nut pin bore in a rotating nut. To facilitate insertion of the manifold pin through the rotating nut, the diameter of the large-diameter portion 334 may be smaller than the diameter of the nut pin bore. To ensure that the manifold pin is secured within the housing, the diameter of the large-diameter portion 334 may be substantially equal to the diameter of the housing pin bore, such that the large-diameter portion presses into the housing pin bore. To facilitate translational movement of the adjustable connector within the housing channel, the diameter of the small-diameter portion 332 may be smaller than the width of the closed slot of the adjustable connector.

[0155] Figure 10A It is a top view, and Figure 10B Is it like this? Figure 4A The vertical cross-sectional view of the assembled adjustable height manifold 300 in the collapsed structure shown in the figure. Figure 10A(Cross section AA). The housing 315 is coupled to the rotating nut 320 via the engagement of the lip 357 with the manifold groove 364 of the nut. The adjustable connector 325 is slidably mounted in the housing channel 340 and threadedly engaged with the rotating nut 320. The large-diameter portion 334 of the manifold pin 330 is disposed in the housing pin hole 360, while the small-diameter portion 332 is disposed in the closed slot 376 of the adjustable connector. When the rotating nut is rotated clockwise or counterclockwise, the adjustable connector can slide up and down within the housing channel without rotating. The manifold pin can control the extent to which the adjustable connector can extend by providing a hard stop when the pin strikes the bottom of the closed slot 376. The housing inlet 335 can be coupled to the source of the therapeutic agent to be delivered to the patient. The inlet can be fluidly connected directly or indirectly to the housing channel 340 via the open slot 374 of the adjustable connector. When the manifold is in a collapsed configuration, the inlet can be fluidly coupled indirectly to the housing channel via the open slot 374 of the adjustable connector. When the manifold is in its extended configuration, the inlet can be directly fluidly coupled to the housing channel. The housing channel can be fluidly connected to the adjustable connector channel 370 to fluidly connect to the rod channel of the first rod, which is coupled to the first rod connector of the adjustable connector. The housing channel can also be fluidly connected to the rod channel of the second rod, which is coupled to the second rod connector of the housing. Therefore, therapeutic agents supplied via inlet 335 can be delivered to the first and second intramedullary rods coupled to the manifold.

[0156] Fixed height wedge

[0157] Figures 11A-11C A fixed-height wedge 400 suitable for integration with a therapeutic agent delivery system for the knee is shown. Figure 11A A perspective view is shown, while Figure 11B and Figure 11C A side view of wedge 400 is shown. The fixed-height wedge 400 is an example of coupling member 130, which enables the two intramedullary rods to be coupled in a stable configuration while maintaining the desired distance between the two rods over the entire length of use of the therapeutic delivery system within the patient's body. The wedge provides a relatively simple connection between the two intramedullary rods, wherein the wedge comprises a single, integral component rather than an assembly of multiple components. Although the wedge height 405 is fixed, the wedge can be provided in multiple sizes with various wedge heights, and the most suitable size can be selected for each patient based on their anatomy.

[0158] The fixed-height wedge 400 includes a first rod connector 442 configured to couple to a first intramedullary rod and a second rod connector 444 configured to couple to a second intramedullary rod. As described further herein, the first and second rod connectors may include any mechanism for connecting the rods to the coupling member (e.g., flange region, dovetail joint, snap-fit, wing nut, etc.). The wedge further includes an inlet 435 configured to couple to a source of therapeutic agent to be delivered to the patient. The inlet 435 may be fluidly connected to a wedge channel 440 extending along the longitudinal axis 410 of the wedge through both the first and second rod connectors. Thus, therapeutic agent provided through the inlet can be delivered via the wedge channel to the intramedullary rod coupled to the wedge.

[0159] The fixed-height wedge 400 may additionally include one or more of any applicable structures and features described with respect to the adjustable-height manifold 300. For example, the wedge may include a concave groove 445, similar to the concave groove 345 described with respect to the housing of the adjustable-height manifold. Similar to the concave groove 345, the concave groove 445 may be partially disposed around the circumference of the wedge to provide for placement of a pipe coupled to the inlet.

[0160] Coupling mechanism

[0161] Figures 12A-12H An exemplary mechanism for coupling an intramedullary rod 200 to a coupling member 130 is illustrated. The rod 200 may include any embodiment of an intramedullary rod as described herein, and the coupling member 130 may include any embodiment of a coupling member as described herein. The rod 200 includes a first end 215 configured to engage the coupling member, and the coupling member 130 includes a rod connector 132 configured to engage the first end of the rod. The rod connector 132 may be any rod connector (e.g., rod connectors 342, 344, 442, 444, etc.) coupled to any coupling member as described herein. Figure 12A This is a perspective view of the first end 215 of the intramedullary rod 200. Figure 12B This is a perspective view of the rod connector 132 of the coupling member 130. Figure 12C and Figure 12D This is a side view of the therapeutic agent delivery system 100 before assembly. Figure 12E It is a side view of a conveying system 100 comprising two rods 200 coupled together and a coupling member 130. Figure 12F Is it like this? Figure 12C An enlarged vertical cross-sectional view of a portion of the assembled system 100 shown. Figure 12G and Figure 12H The system 100 is assembled in different assembly steps along such Figure 12E The radial cross section of line AA shown in the figure.

[0162] like Figure 12A As shown, the first end 215 includes a protrusion 250 disposed around a portion of the periphery of the first end. The protrusion 250 defines a circular cavity 251 therein, as... Figure 12B As shown, a circular cavity 251 is configured to receive a flange region 150 of a coupling member 130. The protrusion 250 has a circumferential opening 252 configured to receive the flange region 150 through which the coupling member passes. Figure 12F As best viewed from the center, the protrusion 250 further includes a recessed lip 253 defining a recessed region 254. The recessed region 254 can receive and retain the flange region 150 to limit axial movement of the coupling member along the longitudinal axis 210 of the rod. Figure 12E and Figure 12F As shown, the flange region 150 may have a length 154 longer than the width 152. The flange region may further include two flat edges 157 extending along the length 154 of the flange region and two rounded edges 159 extending around the width 152 of the flange region. The circumferential opening 252 may have a width greater than or equal to the width 152 of the flange region 150 but less than the width of the length 154 of the flange region, such that the flange region can only enter the circumferential opening in a perpendicular orientation 151 relative to the circumferential opening 252, as... Figure 12G As shown in the image.

[0163] Figure 12C and Figure 12D A delivery system 100 prior to assembly is shown, wherein coupling member 130 is aligned for insertion into the space between two intramedullary rods 200. The flange regions 150 of the first rod connector 132a and the second rod connector 132b are vertically oriented relative to the circumferential openings 252 of the protrusions on the intramedullary rods. When aligned in this orientation, the coupling member can be pushed into the space between the two intramedullary rods such that the flange regions are inserted through the circumferential openings of each rod, and as... Figure 12E , Figure 12F and Figure 12G The image shows the area captured in the recessed region of the raised portion.

[0164] Once the flange region 150 is placed within the circular cavity 251, the flange region can rotate in the direction indicated by arrow 155, as shown. Figure 12G As shown. The flange region can be rotated until it is positioned on the horizontal orientation 153 relative to the circumferential opening 252, as shown. Figure 12HAs shown. In a horizontal orientation, since the length 154 of the flange region is greater than the size of the opening 252, the flange region can be prevented from sliding out of the circular cavity through the circumferential opening. The first end 215 may further include one or more pins 255 disposed therein, the one or more pins 255 being configured to further secure the coupling between the rod and the rod connector. For example, the first end 215 may include two pins 255, each pin spaced approximately 90° from the center angle of the circumferential opening 252. Each circular edge 159 of the flange region 150 may include a smaller diameter edge 159a and a larger diameter edge 159b, such that a notch 156 is created at the intersection of edges 159a and 159b. As described, the flange region 150 may be as follows: Figure 12G The pin 255 is inserted through opening 252 in a vertical orientation 151 and subsequently rotates within a recessed region 254 at the first end 215 in the direction indicated by arrow 155. As the flange region rotates, the pin 255 can slide against the smaller diameter edge 159a until it collides with a notch 156 created by the larger diameter edge 159b. For example, the pin can be configured to allow the flange region to rotate approximately 90° or a quarter turn before colliding with the pin. The engagement of the notch 156 with the pin 255 prevents further rotation of the rod relative to the coupling member. The pin 255 can thus provide a hard stop for the rotation of the flange region, ensuring that the final orientation of the flange region is horizontal 153, which prevents the flange region from sliding out of the circular cavity as described herein.

[0165] Figures 13A-13C Another exemplary mechanism for coupling an intramedullary rod to a coupling member 130 is illustrated. Figure 13A A perspective view of a coupling member 130 including an exemplary connecting mechanism is shown, and Figure 13B A top view of a coupling member 130 including an exemplary connecting mechanism is shown. Figure 13CA side view of a portion of a delivery system 100 comprising two rods 200 coupled together and a coupling member 130 is shown. The rods 200 may include any embodiment of an intramedullary rod as described herein, and the coupling member 130 may include any embodiment of a coupling member as described herein. The rods 200 include a first end 215 configured to engage the coupling member, and the coupling member 130 includes a rod connector 132 configured to engage the first end of the rod. The rod connector 132 may be any rod connector coupled to any of the coupling members described (e.g., rod connectors 342, 344, 442, 444, etc.). Each rod connector 132 may include one or more dovetail regions 160 configured to engage one or more corresponding dovetail regions 260 of the first end 215 of the rod 200. Each rod connector 132 may further include a snap-fit ​​162 configured to engage a corresponding snap-fit ​​(not shown) disposed on the first end 215 of the rod. The latch 162 may include a flexible rod 164, which can be centrally stretched when the coupling member 130 is slidably inserted into the rod 200. When the coupling member is pushed through the notch 166 in the rod, the coupling member can be engaged into place.

[0166] Figure 14A and Figure 14B Another exemplary mechanism for coupling the intramedullary rod 200 to the coupling member 130 is illustrated. Figure 14A The first step of assembling the rod and coupling member using an exemplary mechanism is shown, while Figure 14B The second step of assembly is shown. Rod 200 may include any embodiment of an intramedullary rod as described herein, and coupling member 130 may include any embodiment of a coupling member as described herein. Rod 200 includes a first end 215 configured to engage the coupling member, and coupling member 130 includes a rod connector 132 configured to engage the first end of the rod. Rod connector 132 may be any rod connector coupled to any of the coupling members described (e.g., rod connectors 342, 344, 442, 444, etc.). Each rod connector 132 may include one or more dovetail regions 160 configured to engage one or more corresponding dovetail regions 260 of the first end 215 of rod 200. Figure 14A A coupling member 130 is shown aligned for insertion into the space between two intramedullary rods 200, wherein the dovetail region 160 of the coupling member is aligned with the corresponding dovetail region 260 of the rod. The coupling member can be pushed into the space between the two rods such that the dovetail region 160 engages within the dovetail region 260 of the rod. Optionally, the first end 215 of each rod may include a design similar to... Figures 12A-12HThe embodiment includes a protrusion with a circumferential opening, wherein a dovetail region 260 is disposed within a circular cavity defined within the protrusion. In this configuration, the coupling member can be pushed into the space between the two rods until the dovetail region 160 abuts against a rigid stop of the protrusion of the rod. The coupling member 130 or the intramedullary rod 200 may further include one or more anti-rotation members 176 configured to hold the coupling member in place once it is coupled to the rod. Figure 14B An assembled delivery system 100 is shown, wherein each rod 200 includes an anti-rotation element 176 configured to hold the coupling member 130. Each anti-rotation element may be rotatable, allowing adjustment of its position relative to the rod and the coupling member. Figure 14A In the assembly steps shown, each anti-rotation element can be rotated such that it does not extend beyond the first end 215 of each rod, thereby allowing the dovetail region 160 of the coupling member to slide into the dovetail region 260 of the rod without any physical obstruction from the anti-rotation element. Once the coupling member is coupled to the rod, the anti-rotation element can be rotated to... Figure 14B In the position shown, the anti-rotation element extends beyond the joint between the rod and the coupling member. Therefore, the anti-rotation element prevents the coupling member from slipping out of its engagement with the intramedullary rod.

[0167] Figure 14C and Figure 14D It shows Figure 14A and Figure 14B A variation of the embodiment shown. The coupling member 130 may include a wing nut 170 rotatably fixed to the front of the coupling member, instead of an anti-rotation element. The wing nut 170 may be configured to have a length 174 greater than the width 172. The length 174 of the nut may be greater than the height 135 of the coupling member. During assembly, the coupling member 130 can be slidably inserted into the rod 200, wherein the wing nut 170, as... Figure 14A As shown, it is in a horizontal orientation 173. Subsequently, the wing nut 170 can be rotated to... Figure 14B In the vertical orientation 171 shown, the length 174 of the nut extends beyond the junction between the dovetail region 160 and the dovetail region 260. In the vertical orientation, the wing nut prevents the coupling member 130 from sliding out of the rod 200.

[0168] Instructions for use of therapeutic agent delivery systems for the knee

[0169] Figure 15The illustration depicts a method 1500 for treating a patient's knee using a therapeutic agent delivery system for the knee as described herein. In step 1505, a first intramedullary rod is placed in the medullary canal of the patient's femur. In step 1510, a second intramedullary rod is placed in the medullary canal of the patient's tibia. In step 1515, the height of an adjustable height manifold is adjusted to suit the joint space between the first and second rods. In step 1520, the adjustable height manifold is coupled to the first and second rods. The adjustable height manifold can be inserted into the joint space between the first and second rods in a specific orientation suitable for the connection mechanism used. For example, if the adjustable height manifold includes a rod connector with a flanged region as described herein, the rod connector being configured to engage the corresponding circular cavity of the rod, the adjustable height manifold can be inserted by guidance using the two circular edges of the flanged region. In step 1525, coupling between the adjustable height manifold and the first and second rods is further secured via appropriate steps for the connection mechanism used. For example, if the adjustable height manifold includes a flange region as described herein, the manifold can be rotated to securely engage the flange region into the corresponding cavity of the rod. If the adjustable height manifold and rod include a dovetail-shaped region with an anti-rotation element as described herein, the anti-rotation element can be rotated to extend over the engagement between the rod and the manifold, thereby preventing the manifold from decoupling from the rod. In step 1530, a therapeutic agent is delivered into the medullary canals of the femur and tibia, as well as the joint space.

[0170] Figure 16The illustration depicts a method 1600 for treating a patient's knee using a therapeutic agent delivery system for the knee as described herein. In step 1605, a first intramedullary rod is placed within the medullary canal of the patient's femur. In step 1610, a second intramedullary rod is placed within the medullary canal of the patient's tibia. In step 1615, a fixed-height wedge of appropriate height is selected to fit the joint space between the first and second rods. In step 1620, the fixed-height wedge is coupled to the first and second rods, wherein the fixed-height wedge can be inserted into the joint space between the first and second rods in a specific orientation suitable for the connection mechanism used. For example, if the fixed-height wedge includes a rod connector with a flanged region as described herein, the rod connector being configured to engage the corresponding circular cavity of the rod, the fixed-height wedge can be inserted by guidance using the two circular edges of the flanged region. In step 1625, coupling between the fixed-height wedge and the first and second rods is further ensured via appropriate steps for the connection mechanism used. For example, if the fixed height wedge includes a flange region as described herein, the fixed height wedge can be rotated to securely engage the flange region into the corresponding cavity of the rod. If the fixed height wedge and rod include a dovetail region with an anti-rotation element as described herein, the anti-rotation element can be rotated to extend over the engagement between the rod and the fixed height wedge to prevent the fixed height wedge from decoupling from the rod. In step 1630, the therapeutic agent is delivered to the medullary canals of the femur and tibia, as well as the joint space.

[0171] The steps of methods 1500 and 1600 are provided as examples of methods using a therapeutic agent delivery system according to embodiments. Those skilled in the art will recognize many variations and modifications of methods 1500 and 1600 based on the disclosure provided herein. For example, some steps may be added or removed. One or more steps can be performed differently from... Figure 15 and Figure 16 The steps are executed in the sequence shown in the diagram. Some steps may include sub-steps. Many steps may be repeated multiple times, as appropriate or as necessary.

[0172] Treatment delivery system for the hip

[0173] Figure 17A and 17B An exemplary therapeutic agent delivery system 500 for the hip is shown. Figure 17A It is a perspective view of the assembled delivery system, and Figure 17BThis is an exploded perspective view of the system. The delivery system 500 includes a femoral rod 510 and a femoral head 520. The femoral rod 510 can be configured for placement in the femoral medullary canal of a patient. The femoral head 520 can be configured for placement in the acetabulum of a patient. The femoral rod may include an inlet 535 configured to couple to a source of therapeutic agent to be delivered to the patient. The inlet may be fluidly coupled to a channel in the femoral rod to allow delivery of therapeutic agent within the femoral medullary canal. The femoral rod and femoral head can be configured to be removably coupled together to fluidly connect a femoral rod channel to one or more channels in the femoral head, allowing delivery of therapeutic agent into the acetabular joint space. The femoral rod and femoral head can be configured to be stably coupled to maintain a desired distance between the femoral rod and femoral head along the length of use of the therapeutic agent delivery system within the patient's body. Optionally, the femoral rod and femoral head can be connected in a manner that allows adjustment of the distance between the rod and femoral head to suit the patient's anatomy. System 500 may further include a rod plug 530 configured to couple to one end of the femoral rod.

[0174] femoral stem

[0175] Figures 18A-18D An exemplary femoral rod 600 suitable for integration with a therapeutic agent delivery system for the hip is shown. Figure 18A This is a perspective view of the femoral shaft at 600°. Figure 18B This is a side view of the femoral shaft at 600°. Figure 18C It is a bottom view of the femoral shaft at 600 degrees, and Figure 18D This is a side cross-sectional view of the femoral rod 600. The femoral rod 600 includes an elongated body 605 having a longitudinal axis 610, the elongated body having a first end 615 and a second end 620 opposite to the first end. The elongated body includes a neck region 650 disposed near the first end 615, wherein the neck region can be configured to couple to the femoral head. The second end 620 can be configured to be disposed in the femoral medullary canal. The femoral rod 600 further includes an inlet 535 configured to couple to a source of therapeutic agent. The inlet 535 is in fluid communication with a rod channel 625 extending between the first end 615 and the second end 620, such as... Figure 18D Best viewed in the middle. Rod channels can be configured to deliver therapeutic agents through a rod and into the medullary duct. Furthermore, rod channels can be configured for fluid coupling to one or more channels in the femoral head.

[0176] The elongated body 605 may have one or more structures or features similar to the previously described intramedullary rod 200. For example, the femoral rod 600 may include a plurality of projections 630 projecting radially outward from the elongated body 605. The plurality of projections may include any number of projections having any suitable shape, size, or construction to stably engage the medullary duct. For example, the projections may include elongated fins extending along the longitudinal length of the elongated body, such as... Figures 18A-18D As shown. In one exemplary embodiment, the plurality of protrusions may include four fins spaced equidistantly at approximately 90° around the longitudinal axis 610 of the elongated body. This is not intended to be limiting, and the number of fins can be any number, such as three fins spaced approximately 120 degrees apart, five fins spaced approximately 72 degrees apart, etc. The plurality of protrusions 630 and the elongated body 605 may be formed separately and then coupled together. Alternatively or in combination, the plurality of protrusions 630 may be formed by removing material from the elongated body 605, such that the plurality of protrusions and the elongated body are formed as a single component. Adjacent protrusions 630 may define one or more recessed regions 635 between them, the recessed regions being radially recessed compared to the protrusions.

[0177] Multiple protruding and recessed regions can be configured to minimize the surface area of ​​the rod in contact with the bone lined with medullary canals, thus maximizing the area of ​​bone that can be flushed with therapeutic agents. For example, multiple protruding and recessed regions can be configured such that less than 50% of the rod's surface area contacts the bone lined with medullary canals. Of course, this is not intended to be limiting, and those skilled in the art will understand that any percentage of the rod's surface area can contact the bone. Figures 18A-18D As shown, the rod may include multiple identical recessed regions defined by a plurality of elongated fins symmetrically distributed about the longitudinal axis 610 of the rod. Alternatively, the multiple recessed regions may be asymmetrically distributed about the longitudinal axis of the rod, and / or may have different shapes or sizes. For example, the elongated body 605 may include, as described above... Figure 3A and Figure 3B The described protrusions and grooves.

[0178] The femoral rod 600 may further include a plurality of outlet holes 640 in fluid communication with the rod channel 625. The plurality of outlet holes 640 may be configured to deliver therapeutic agents delivered through the rod channel 625 to the femoral medullary canal and adjacent tissues, including joints. The plurality of outlet holes may be disposed in a recessed region 635 to deliver therapeutic agents to bone areas not in contact with the femoral rod. The plurality of outlet holes may include any number of outlet holes having any suitable size, shape, or distribution. For example, the plurality of outlet holes may include a plurality of equal-sized and spaced holes extending axially along a line substantially parallel to the longitudinal axis 610 of the rod, such as... Figures 18A-18DAs shown. Alternatively, multiple outlet holes can be arranged along, as shown... Figure 3A The vortex or spiral lines shown extend, or the hole can surround, as... Figure 3A As shown, multiple rings extend around the circumference of the elongated body. Multiple outlet orifices may include orifices of the same shape and / or size, or orifices of various shapes and / or sizes. Varying the orifice size allows for further fluid control of the therapeutic agent as it exits different regions of the rod.

[0179] The rod channel 625 may be a through-hole extending from the first end 615 to the second end 620, such that the elongated body includes an open second end or distal end. The system may further include, for example... Figure 19 The plunger shown is configured to couple to the open second end of the rod to close the second end and thereby create a non-porous channel. Alternatively, the rod channel 625 can be a non-porous channel in which the second end of the elongated body is closed. In a configuration where the second end is open, the therapeutic agent can exit the rod channel and enter the medullary duct through the second end and / or through a plurality of outlet orifices disposed along the elongated body 605 as described herein. If the rod comprises only the rod channel 625 extending through the first and second ends, without the plurality of outlet orifices, the therapeutic agent can exit the rod channel only through the second end. In a configuration where the second end of the rod is closed, the therapeutic agent can exit the rod channel and enter the medullary duct only through the plurality of outlet orifices.

[0180] The neck region 650 extends along the neck axis 655 and is positioned at an angle 660 relative to the longitudinal axis 610 of the elongated body 605. The angle 660 can range from about 120° to about 160°, about 130° to about 150°, about 140° to about 150°, or about 145°. The neck region may include one or more connecting mechanisms or features for coupling to the femoral head. For example, as shown, the neck region may include a plurality of threads 670 configured for threaded engagement of complementary threads on the femoral head.

[0181] The femoral rod 600 may be tapered to accommodate the medullary duct. For example, as shown, the elongated body 605 and / or multiple projections 630 may taper gradually from a first end 615 to a second end 620 to have a smaller radial cross-sectional area at the second end than at the first end. For example, the taper may include a gradual taper, wherein the taper ranges from about 0.1° to about 10°, about 0.5° to about 5°, about 1° to about 5°, about 1° to about 4°, or about 2° or about 3°. The taper can be adjusted to accommodate the medullary duct of a particular type of bone.

[0182] Figure 19A rod plug 530 suitable for integration with any therapeutic agent delivery system as described herein is shown. The rod plug 530 may include a smaller diameter region 535 and a larger diameter region 540. The smaller diameter region may be configured for press-fitting into an open second end of an elongated body of any intramedullary rod or hip rod as described herein.

[0183] femoral head

[0184] Figure 20A and Figure 20B An exemplary embodiment of a femoral head 700 suitable for integration with a therapeutic agent delivery system for the hip is shown. Figure 20A It is a side view, and Figure 20B It is along the femoral head 700. Figure 20A The lateral cross-sectional view along line AA is shown. The femoral head 700 may include a truncated spherical shape, wherein the truncated base 715 of the femoral head is configured for coupling to the femoral rod. The femoral head 700 includes a central channel 725 extending axially along the central axis 710 of the femoral head. The central channel 725 is configured for coupling to the neck of the femoral rod and thus fluidly communicating with a hip rod channel when the femoral head is connected to the femoral rod. The femoral head further includes a plurality of outlet holes 740 fluidly coupled to the central channel 725. The outlet holes may be configured to extend radially outward from the central channel. Thus, a therapeutic agent can be supplied to the delivery system via an inlet to the femoral rod, move through the rod channel into the central channel 725 of the femoral head, and exit through the outlet holes 740 into the acetabular joint space.

[0185] The base 715 may include one or more mechanisms for coupling the femoral head to the neck region of the femoral rod. For example, as shown, a portion of the central channel 725 near the base 715 may include a plurality of threads 770 configured to threadedly engage a plurality of complementary threads at the neck of the femoral rod. The threaded connection between the femoral head and the neck of the femoral rod allows adjustment of the distance between the femoral head and the femoral rod to suit the patient's anatomy. Optionally, the femoral head may be further configured to receive one or more fixation screws near the base, wherein once the distance is properly set, the fixation screws can fix the distance between the femoral head and the femoral rod. For example, as shown... Figure 20B As shown, the base may include two fixation screw receiving areas 780, each including multiple threads 785 for engaging a fixation screw with complementary threads. The fixation screw receiving areas may extend radially outward from the central channel, such that the end of the fixation screw may be directly or indirectly coupled to the neck of the femoral rod housed within the central channel. Although Figure 20BThe diagram illustrates two fixation screw receiving areas radially offset from each other by approximately 180°. The femoral head may include any number of fixation screws distributed in any suitable configuration. For example, the femoral head may include three fixation screw receiving areas radially offset from each other by approximately 120°, or four fixation screw receiving areas radially offset from each other by approximately 90°.

[0186] Figure 21A and Figure 21B Another exemplary embodiment of a femoral head 800 suitable for integration with a therapeutic agent delivery system 500 for the hip is shown. The femoral head 800 is partially hollow to reduce material mass and the weight of the femoral head. The femoral head 800 includes a central channel 825 configured for fluid communication with a rod channel of the femoral rod as described herein. The femoral head further includes an inner shell 830 and an outer shell 835, wherein the inner shell and outer shell are thin truncated spherical shells disposed around the periphery of the femoral head. The inner shell 830 is connected to the material disposed around and defining the central channel 825. The outer shell 835 is connected to the inner shell 830 via a plurality of support struts 845 extending between the inner shell and the outer shell. The inner shell defines an inner cavity 855 between the inner shell and the material defining the central channel. The inner cavity 855 is hollow and configured to be a sealed abutment against the central channel and the inner shell, such that no fluid can enter the inner cavity during use of the delivery system. An inner shell and an outer shell define an outer cavity 850 therebetween, wherein the outer cavity 850 is fluidly coupled to a central channel 825. The outer shell includes a plurality of outlet holes 840, allowing fluid in the outer cavity 850 to exit the femoral head through the outlet holes. Thus, therapeutic agents supplied through the inlet of the femoral rod can move through the rod channel to the central channel 825 of the femoral head 800, enter the outer cavity 850, and enter the acetabular joint space through the outlet holes 840. Components of the femoral head 800 can be formed via 3D printing or laser sintering.

[0187] Figure 22Another exemplary embodiment of a femoral head 900 suitable for integration with a therapeutic agent delivery system for the hip is shown. The femoral head 900 includes a central channel 925 configured to be in fluid communication with a rod channel of the femoral rod as described herein. The femoral head further includes a plurality of hollow tubes 940 extending radially outward from and fluidly coupled to the central channel 925. The femoral head further includes a housing 935, which is a thin truncated spherical shell disposed around the periphery of the femoral head. The housing 935 is coupled to the plurality of hollow tubes 940 such that the hollow tubes 940 extend through the thickness of the housing. The hollow tubes, the housing, and the material disposed around defining the central channel together define a plurality of cavities 855, which are hollow and configured to be fluid-tight so that no fluid can enter the cavities during use of the delivery system. Thus, therapeutic agents supplied through the inlet of the femoral rod can move through the rod channel into the central channel 925 of the femoral head 900, into the plurality of hollow tubes 940, and into the acetabular joint space. The inner diameter and / or thickness of the hollow tube can be varied to control the flow of fluid within the femoral head and to adjust the amount of support provided by the hollow tube to the outer shell to protect the integrity of the outer shell.

[0188] Coupling mechanism

[0189] Figure 23A and Figure 23B An exemplary mechanism for coupling a femoral head 520 to a femoral rod 510 is shown. The femoral head 520 may include any femoral head as described herein, such as those described above. Figures 20A-22 The femoral heads 700, 800, and 900 are described herein. The femoral rod 510 may include any femoral rod described herein, such as any embodiment of the femoral rod 600 described herein. Figure 23A This is a side cross-sectional view of the femoral head 520, which is fixedly coupled to the femoral rod 510. The neck region 650 of the rod is fixedly coupled to a portion of the central channel 725 of the femoral head, such that the length 540 of the neck engaging the femoral head is fixed. For example, the neck 650 can be press-fitted into the central channel 725, such that the neck is advanced into the central channel to a predetermined length. The neck 650 may include regions of different diameters to create notches between these regions, wherein the notches can provide a stop against the surface of the femoral head when the neck 650 has been advanced into the central channel to a predetermined length. In a delivery system incorporating such a connection mechanism, the distance between the femoral head and the femoral rod is fixed. Figure 23BThis is a side cross-sectional view of the femoral head 520, which is adjustablely coupled to the femoral rod 510. For example, the neck region 650 of the rod is adjustablely coupled to a portion of the central channel 725 via an engagement of a thread 670 on the neck of the rod and a complementary thread 770 on a portion of the central channel 725. Thus, the length 540 of the neck engaging the central channel can be increased or decreased by threadedly rotating the femoral head around the femoral rod. When the femoral head is rotated to axially translate further away from the femoral rod, the length 540 decreases, and the distance between the femoral head and the femoral rod increases, allowing the delivery system to be adapted to patients requiring a longer set distance between the femur and the acetabulum. When the femoral head is rotated to axially translate closer to the femoral rod, the length 540 increases, and the distance between the femoral head and the femoral rod decreases, allowing the delivery system to be adapted to patients requiring a shorter set distance between the femur and the acetabulum. In a delivery system incorporating such a connection mechanism, the distance between the femoral head and the femoral rod can therefore be adjusted to suit the patient's anatomy.

[0190] Figure 24A and Figure 24B An exemplary mechanism is shown for locking a predetermined distance between the femoral head 520 and the femoral rod 510 in a therapeutic agent delivery system for the hip. The femoral head 520 may include any femoral head as described herein, such as those described above. Figures 20A-22 The femoral heads 700, 800, and 900 are described herein. The femoral rod 510 may include any femoral rod described herein, such as any embodiment of the femoral rod 600 described herein. Figure 24A It is a perspective view including the femoral head 520 of the exemplary mechanism, and Figure 24B This is a bottom view of the femoral head 520 including the exemplary mechanism. As described herein, the femoral head 520 may include a pair of fixation screw receiving regions 780 adjacent to the base 715 of the femoral head, which may receive a pair of fixation screws configured to engage a femoral rod neck disposed in a central channel 725 of the femoral head to fix the position of the rod neck therein. The femoral head may further include a pair of blocks 550 disposed within the fixation screw receiving regions 780 adjacent to the central channel 725. Each block may be coupled to a fixation screw 554, wherein the block may include a circular cavity to receive an end of the fixation screw, and wherein the end of the fixation screw may rotate freely within the circular cavity. Two locating pins 552 may be coupled to the block fixation screw assembly to restrict translational movement of the fixation screw relative to the blocks. Rotation of the fixation screw within the fixation screw receiving region may cause the coupled block to translate radially inward or outward. The block can be translated radially inward until it engages and pushes against the neck region of the rod located within the central channel, thereby preventing further rotation of the femoral head around the femoral rod. The block can distribute the force between the neck and the fixation screw over a wider surface for more effective neck positioning. Although Figures 24A-24F The diagram shows a pair of fixation screw receiving areas radially offset from each other by approximately 180°, but the locking mechanism can include any number of fixation screws distributed in any suitable configuration. For example, the femoral head can include three fixation screw receiving areas radially offset from each other by approximately 120°, or four fixation screw receiving areas radially offset from each other by approximately 90°.

[0191] Figures 24C-24F The diagram illustrates the assembly process. Figure 24A and Figure 24B Methods for locking mechanisms. Figure 24C The femoral head 520 and components of the locking mechanism are shown before assembly. As previously described, the femoral head may include one or more fixation screw receiving areas 780 extending radially outward from the central channel 725. Each fixation screw receiving area may be configured to receive a fixation screw 554, a block 550, and a pair of locating pins 552. Figure 24D The first step of assembling the locking mechanism is shown, wherein block 550 is coupled to femoral head 520. The femoral head may include a block receiving region 556 adjacent to the central channel 725, and the block can be inserted from the base 715 of the femoral head into the block receiving region. (As shown in...) Figure 24B Ideally, the block 550 may have a concave surface 551 at its first end and a circular notch 553 at its second end opposite the first end. Figure 24C As shown, the block can be inserted into the femoral head, with the concave surface facing radially inward toward the central channel, while the circular notch faces radially outward. Figure 24E The second step of assembling the locking mechanism is shown, wherein the fixing screw 554 is coupled to the femoral head 520. (As shown in...) Figure 24B In its most visible location, the retaining screw receiving region 780 includes retaining screw threads 785 configured to engage a threaded region of the retaining screw. The retaining screw can be threadedly engaged with the retaining screw threads in the retaining screw receiving region, allowing the retaining screw to translate radially inward within the retaining screw receiving region. (As shown in...) Figure 24D As best seen, the fixing screw may include a fixing screw head 555, the non-threaded region of the fixing screw having a smaller diameter than the threaded region of the fixing screw. Figure 24E During the steps shown, the fixing screw can be moved radially inward until the screw head is positioned within the circular notch 553 of the block 550 (as shown in...). Figure 24B (Best visible in the middle). Figure 24FThe final steps of assembling the locking mechanism are shown, wherein locating pins 552 are coupled to the femoral head. The two locating pins can be pressed into the block 550 in an interference fit. When the locating pins are fully pressed into the block, the tips of the pins can engage the retaining screw head 555, such that the pins prevent the retaining screw from separating from the block. For example, the screw head may include a circumferentially extending recess 557 around the retaining screw head 555 (as shown in...). Figure 24B and Figure 24D (Best visible in the middle). The front end of the locating pin can be configured to be used when the pin is fully pressed into the block (as in...). Figure 24B The best visible part is the concave groove, which prevents the fixing screw from separating from the block.

[0192] Optional features

[0193] Figure 25A and Figure 25B An exemplary embodiment of a therapeutic agent delivery system 500 for the hip is shown, the therapeutic agent delivery system 500 further comprising an acetabular cup 560. Figure 25A It is a perspective view of system 500, and Figure 25B This is a side cross-sectional view of system 500. The delivery system 500 may further include a separate acetabular cup 560, configured for insertion into the acetabular space of the hip joint. The femoral head 520 thus engages with the acetabular cup, rather than directly with the patient's acetabulum. The acetabular cup may include multiple grooved external structures 565 through which fluid can flow to the acetabulum.

[0194] Figure 26 An exemplary embodiment of a therapeutic agent delivery system 500 for the hip is illustrated. The therapeutic agent delivery system 500, as described herein, can be configured to function as a final implant rather than as a temporary implant intended for the first stage of a two-stage reimplantation procedure. System 500 may include a femoral rod 510, such as any femoral rod described herein, a femoral head 520, such as any femoral head described herein, and a rod plug 530. Additionally, system 500 may further include a liner 570 and an acetabular cup 560 configured for implantation between the femoral head 520 and the acetabulum in a patient. Fluid can flow through the femoral head and out of the liner and acetabular cup into the joint space and acetabulum. Optionally, instead of or in combination with the inlet 535 of the femoral rod 510, the acetabular cup 560 may include a separate inlet through which therapeutic agents can be supplied.

[0195] Instructions for use of a therapeutic agent delivery system for the hip

[0196] Figure 27The illustration depicts a method 1700 for treating a patient's hip using a therapeutic agent delivery system for the hip as described herein. In step 1705, a femoral rod is placed in the medullary canal of the patient's femur. In step 1710, the femoral head is coupled to the femoral rod. In an optional step 1715, the distance between the femoral rod and the femoral head is adjusted such that the delivery system is best suited to the patient's anatomy. For example, if the femoral head is coupled to the femoral rod via a threaded connection mechanism as described herein, the distance between the femoral rod and the femoral head can be adjusted by rotating the femoral head about the rod thread. Step 1715 may further include, for example, via... Figures 24A-24F The described fixation screw mechanism is used to lock the distance between the femoral head and the femoral rod. In step 1720, the femoral head is positioned in the patient's acetabulum. In step 1725, a therapeutic agent is delivered to the medullary duct and acetabulum via a delivery system.

[0197] The steps of method 1700 are provided as an example of a method for using a therapeutic agent delivery system according to an embodiment. Those skilled in the art will recognize many variations and modifications of method 1700 based on the disclosure provided herein. For example, some steps may be added or removed. Some steps may include sub-steps. Many steps may be repeated multiple times as appropriate or necessary. One or more steps can be performed in a manner different from... Figure 27 The sequence is as illustrated in the diagram. For example, the femoral head and femoral rod can be coupled together, and if necessary, the distance between the femoral head and rod is adjusted before the assembled device is placed in the patient's femur and acetabulum.

[0198] Additional features of therapeutic agent delivery systems

[0199] In any therapeutic agent delivery system described herein, fluid flow within the system can be modulated by altering one or more dimensions or configurations of the channels and / or outlet orifices. For example, the diameter of the channels and / or outlet orifices can be increased or decreased, or the channels can be configured to have varying diameters along the length of the component to influence fluid flow in a particular direction. The angle at the junctions between channels can also be changed to affect fluid flow within the system.

[0200] Any therapeutic agent delivery system as described herein may further include a pump operatively coupled to an inlet. The pump may be configured to pump a therapeutic agent into one or more channels of the system.

[0201] Any therapeutic agent delivery system described herein may optionally include a vacuum pump that can be coupled to the system's inlet or outlet. The vacuum pump may be configured to remove any unwanted or excess fluid from the patient's body before the therapeutic agent is introduced into the body using the delivery system.

[0202] Any therapeutic agent delivery system as described herein may optionally include a subcutaneous port that can be coupled to an inlet or outlet of the delivery system. The port may be accessed via a needle or syringe if necessary.

[0203] Figure 28A and Figure 28B The illustration depicts negative pressure wound therapy using a therapeutic agent delivery system for the knee. Negative pressure wound therapy can optionally be used in conjunction with a therapeutic agent delivery system to further improve treatment outcomes. The patient's wound is wrapped with a sponge 90 and then optionally covered with a wound dressing 85 coupled to a vacuum pump 80. The actuated vacuum pump then draws blood and nutrients to the infected area. Figure 28B As shown, the optional sponge for negative pressure wound therapy can also be configured as a sponge strip 95 arranged along the intramedullary rod 200 of the delivery system 100. The sponge strip can be trimmed to fit the space along the grooved area 235 of any intramedullary rod 200. Negative pressure wound therapy involves pulling material through the sponge and into multiple outlet holes of the rod, into the rod channel, and then out of the body through the system's inlet or outlet. While delivery systems for the knee, such as Figure 28A and Figure 28B As shown, negative pressure wound therapy can be used with any therapeutic agent delivery system as described herein, including delivery systems for joints other than the knee.

[0204] Figure 29 An optional cap 75 for the intramedullary rod 200, suitable for integration with any therapeutic delivery system described herein, is shown. The cap 75 may include a conical thin sponge configured to serve as an interface between the bone and the intramedullary rod 200 within the medullary duct. The cap may be configured to substantially cover the entire elongated body 205 of the rod and thus uniformly contact the intramedullary bone. When covered with the cap 75, therapeutic agents can be dispersed within the cap and reach the corresponding surface of the medullary duct, regardless of the shape of the intramedullary rod (e.g., the shape, size, number, or construction of the protruding and recessed areas). This exemplary configuration can also be used in conjunction with the previously described negative pressure wound therapy.

[0205] Figure 30An exemplary embodiment of a therapeutic agent delivery system 1000 is illustrated. The delivery system 1000 may include an intramedullary rod 1010, which may be any intramedullary rod as described herein, such as intramedullary rods 110, 120, or 200, or femoral rods 510 or 600. The rod 1010 may include a rod channel 1025 extending through both a first end 1015 and a second end 1020 of the rod. The rod 1010 may be configured to receive a catheter 1030 supplied with therapeutic agent through the first end 1015, rather than receiving the therapeutic agent from a coupling member coupled to the rod. The therapeutic agent may be delivered to the medullary duct via the second end 1020.

[0206] Figure 31A and Figure 31B An exemplary embodiment of a therapeutic agent delivery system with an inlet and an outlet is shown. Figure 31A An exemplary embodiment of a therapeutic agent delivery system 100 for the knee as described herein is illustrated. The delivery system 100 may include an inlet 140 configured to couple to a source of therapeutic agent. The inlet 140 may be fluidly coupled to one or more channels of a coupling member 130, and one or more channels of the coupling member may be fluidly coupled to a rod channel in a rod 200. Optionally, the system may further include an outlet 145 configured to remove therapeutic agent and / or any other fluid from the body. The rod and coupling member may include internal channels configured to guide fluid between the inlet and the rod channel and between the rod channel and the outlet. Other aspects of the system may generally take the same form as previously described. Figure 31B An exemplary embodiment of a therapeutic agent delivery system 500 for the hip as described herein is illustrated. The delivery system 500 may include an inlet 535 configured to couple to a source of therapeutic agent. The inlet 535 may be fluidly coupled to a channel of a femoral rod 510, and the rod channel may be fluidly coupled to a central channel of a femoral head 520, which is coupled to the femoral rod. Optionally, the system may further include an outlet 545 configured to remove therapeutic agent and / or any other fluid from the body. The femoral rod and femoral head may include internal channels configured to guide fluid between the inlet and the channels of the rod and femoral head, and between the outlet and the channels of the rod and femoral head. Other aspects of the system may generally take the same form as previously described.

[0207] Figure 32A and Figure 32B An exemplary construction of the internal channels of the intramedullary rod is illustrated. Figure 32A It is a cross-sectional view of the intramedullary rod 1100, which includes multiple separate internal fluid pathways, and Figure 32BThis is a cross-sectional view of an intramedullary rod 1100 including multiple separate internal fluid paths. The rod 1100 may include any intramedullary rod as described herein, such as intramedullary rods 110, 120, or 200, or femoral rods 510 or 600. The rod 1100 may include a first internal channel 1110 centrally located along the longitudinal axis of the rod, and a second internal channel 1120 surrounding the periphery of the first internal channel (the second internal channel may form a cylindrical shell shape surrounding the first internal channel). The first internal channel may be fluidly coupled to a first plurality of outlet holes 1115, each of which extends from the first internal channel through the second internal channel to an outer wall of the rod (such as a recessed region 1135 of the rod). The second internal channel may be fluidly coupled to a second plurality of outlet holes 1125, each of which extends directly from the second internal channel to the outer wall of the rod. The first and second internal channels may be fluid-tight relative to each other, and each of the first plurality of outlet holes 1115 may traverse the second internal channel 1120 via a side channel fluid-tight relative to the second internal channel. Therefore, the first and second internal channels can form two separate internal fluid pathways, each of which can be used to deliver fluid to or remove fluid from the tissue. Figure 32B As shown, the first plurality of outlet holes 1115 and the second plurality of outlet holes 1125 can be arranged linearly along the length of the rod in an alternating manner, such that every other hole is in fluid communication with a different internal fluid path.

[0208] Figures 33A-33C Another exemplary construction of the internal channel of the intramedullary rod is illustrated. Figure 33A This is a perspective view of the intramedullary rod 1200, which includes multiple separate internal fluid pathways. Figure 33B It is a vertical cross-sectional view of the intramedullary rod 1200, and Figure 33CThis is a horizontal cross-sectional view including an intramedullary rod 1200. Rod 1200 may include any intramedullary rod as described herein, such as intramedullary rods 110, 120, or 200, or femoral rods 510 or 600. Rod 1200 may include a first internal channel 1210 extending along the length of the rod, and a second internal channel 1220 adjacent to the first internal channel and also extending along the length of the rod. The first and second internal channels may be fluid-tight relative to each other, such that each channel forms a separate internal fluid path. The first internal channel may be fluidly coupled to a first plurality of outlet orifices 1215, each of the first plurality of outlet orifices extending from the first internal channel to the outer wall of the rod (such as a fluid region 1235 of the rod) without penetrating the second internal channel. The second internal channel may be fluidly coupled to a second plurality of outlet orifices 1225, each of the second plurality of outlet orifices extending from the second internal channel to the outer wall of the rod without penetrating the first internal channel. Thus, the first and second internal channels may form two separate internal fluid paths, each of which may be used to deliver fluid to or remove fluid from tissue. Figure 33A As shown, the first plurality of outlet holes 1215 and the second plurality of outlet holes 1225 can be arranged alternately along the length of the rod, such that every other hole is in fluid communication with a different internal fluid path.

[0209] Can be used as Figures 32A-33C The intramedullary rod shown includes two or more separate internal fluid pathways to simultaneously deliver fluid to and remove fluid from tissue without cross-contamination between the fluid to be delivered and the fluid to be removed. For example, the first internal channel may be fluidly coupled to an inlet configured to receive therapeutic agents from a source (such as...). Figure 31A Entrance 140 or Figure 31B The inlet 535), while the second internal channel can be fluidly coupled to an outlet (such as) configured to remove fluid from the tissue. Figure 31A Exports of 145 or Figure 31B (Exit 545). In this configuration, a first plurality of outlet orifices can deliver a therapeutic agent to the tissue, while a second plurality of outlet orifices can remove fluid from the tissue, thereby allowing simultaneous delivery of the therapeutic agent and removal of fluid from the tissue without cross-contamination between the therapeutic agent and the fluid to be removed. In another exemplary configuration, a first internal channel can be fluidly coupled to a first inlet configured to receive a first therapeutic agent, while a second internal channel can be fluidly coupled to a second inlet configured to receive a second therapeutic agent different from the first therapeutic agent. In this configuration, simultaneous delivery of two different therapeutic agents can be achieved without cross-contamination between the agents before they reach the tissue.

[0210] Figures 34-36Exemplary embodiments of therapeutic agent delivery systems applicable to various joints are shown. While the description of the therapeutic agent delivery system is primarily directed toward systems used in the knee or hip, systems incorporating similar components and features can also be used to treat any other joint. Figure 34 An exemplary embodiment of a delivery system 1200 for the shoulder is shown. Figure 35 An exemplary embodiment of a delivery system 1300 for the ankle is shown, while Figure 36 An exemplary embodiment of a delivery system 1400 for the spine is shown. In the illustrated embodiment, delivery systems 1200, 1300, and 1400 include an inlet 140 through which therapeutic agents can be supplied, and a plurality of outlet ports 240 through which therapeutic agents can be delivered to corresponding locations on the body. Any of delivery systems 1200, 1300, and 1400 may incorporate any other structures or features disclosed herein with respect to delivery systems for the knee and hip.

[0211] Components of the therapeutic agent delivery system described herein can be formed from one or more of a number of materials commonly used in orthopedic implants, including but not limited to titanium alloy Ti 6Al-4V, polyetheretherketone (PEEK), polymethyl methacrylate (PMMA), and ultra-high molecular weight polyethylene (UHMWPE). The material can be incorporated into an antibiotic-impregnated outer layer, such as an antibiotic-impregnated PMMA outer layer. The surface of the component can be polished to inhibit bone growth and biofilm formation. Alternatively, the surface of the component can be sandblasted or plasma-sprayed, incorporating one or more of a hyaluronic acid (HA) coating, a silver coating, or an antibiotic carrier coating, or passivated and irradiated to form a hydrophilic nanostructure. The delivery system described herein may include one or more machined or sintered fittings.

[0212] While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided merely by way of example. Numerous modifications, alterations, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. The following claims are intended to define the scope of the invention and therefore cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. A therapeutic agent delivery system, the system comprising: The femoral head, configured for placement in the acetabulum, comprises: A housing that forms the outer surface of the femoral head, the housing including a first plurality of outlets; An inner shell, located inside the outer shell, is connected to the outer shell via a plurality of support struts; and A central axis, which protrudes through the interior of the femoral head, is coupled to a region of the inner shell and defines a central channel. The inner cavity is located within the femoral head and is partially defined by the inner surface of the inner shell, and the outer cavity is located within the femoral head and is partially defined by the outer surface of the inner shell and the inner surface of the outer shell, wherein the inner cavity is isolated from fluid in the central channel, and wherein the outer cavity is in fluid communication with the central channel and the first plurality of outlets; A femoral rod, coupled to the femoral head for fluid communication with the central channel, the femoral rod being configured for placement within the femoral medullary canal; and The inlet, which is coupled to the femoral rod; and The second plurality of outlets located in the femoral rod, The therapeutic agent is introduced into the system from the inlet, and the therapeutic agent is deliverable into the acetabulum or the femoral spinal cord canal from the first plurality of outlets and the second plurality of outlets.

2. The system of claim 1, wherein the femoral rod includes a threaded neck region configured to thread into the femoral head, thereby allowing adjustment of the distance between the femoral head and the femoral rod.

3. The system of claim 1, wherein the femoral rod includes a plurality of protrusions extending axially along the longitudinal axis of the femoral rod.

4. The system of claim 1, wherein the femoral rod includes an elongated channel extending therethrough, the elongated channel being fluidly coupled to the inlet and the second plurality of outlets.

5. The system of claim 4, wherein the elongated channel is a through-hole, and wherein one end of the femoral rod includes a plug.

6. The system of claim 1, wherein the femoral rod is tapered.

7. The system of claim 1, wherein the central channel is fluidly coupled to the first plurality of outlet channels via a plurality of channels extending radially outward from the central channel.

8. The system of claim 1 further includes an outlet for fluid coupling to the outlet channel for removing fluid from the femoral head or the femoral rod.

9. The system of claim 1, further comprising an acetabular cup coupled to the femoral head, wherein the therapeutic agent is delivered from the acetabular cup to the acetabulum.

10. The system of claim 1, wherein the first plurality of outlets and the second plurality of outlets comprise a plurality of holes having different diameters.

11. The system of claim 1, wherein the femoral head is at least partially hollow.

12. The system of claim 1, further comprising a locking mechanism for locking the femoral head to the femoral rod.

13. The system of claim 1, wherein the second plurality of outlets are in fluid communication with the inlet.

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