US20100042213A1 - Drug delivery implants - Google Patents
Drug delivery implants Download PDFInfo
- Publication number
- US20100042213A1 US20100042213A1 US12/540,676 US54067609A US2010042213A1 US 20100042213 A1 US20100042213 A1 US 20100042213A1 US 54067609 A US54067609 A US 54067609A US 2010042213 A1 US2010042213 A1 US 2010042213A1
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- reservoir
- implant
- therapeutic agent
- channels
- porous
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
- A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
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- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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- A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7061—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- Orthopaedic implants include short-term implants, long-term implants, and non-permanent implants.
- Short-term implants include implants for the treatment of infection.
- Long-term implants include total implants for total hip, knee, shoulder, and elbow joints.
- Non-permanent implants include trauma products such as nails, plates, and external fixation devices.
- antibiotic cements typically provide useful local antibiotic levels for a duration of less than one week.
- the treatment time is frequently 6 to 8 weeks. However, beyond one week, the antibiotic cement implants provide no useful amount of antibiotics.
- infections can be caused by a great number of bacteria, viruses, yeast, etc.
- the effectiveness of various antibiotics depends greatly upon what in particular has caused the infection.
- the cause of that infection must be known.
- the results of cell cultures give this information and indicate which antibiotic and dose will most effectively treat the infection.
- the samples for culturing are usually collected during surgery.
- the results of the culture are not known until several days after the surgery. Since the type of antibiotic cement used in current temporary implants must be chosen at or before the time of surgery, the information gained from the cultures cannot be applied to the antibiotics used at the infection site.
- one key to a patient recovering from joint surgery with full range of motion in that joint is to encourage movement of that joint. This helps to prevent the formation of scar tissue and stiffening of tissue around the joint.
- the current options for temporary implants allow limited range of motion and weight bearing at best.
- bone ingrowth into a porous material is sometimes required to provide stability or fixation of an implant to the bone.
- porous coatings on total joint components fusion devices (i.e., spinal fusion devices), and bone augmentation components (i.e., tibial wedges).
- External fixation devices typically include several pins fixed in the bone and extending through the skin to a rigid plate, ring, rod, or similar stabilizing device. These devices carry the added risk of infection due to their extending through the skin. Bacteria can travel along the pins directly to the soft tissue and bone.
- an orthopaedic implant which includes a reservoir and a plurality of channels leading from the reservoir to deliver at least one therapeutic agent locally to bone or surrounding soft tissue.
- the present invention provides an orthopaedic implant which includes a reservoir and a plurality of channels leading from the reservoir to deliver at least one therapeutic agent locally to bone or surrounding soft tissue.
- the porous surface is configured for receiving at least one of bone and tissue ingrowth therein and includes a first side attached to the exterior surface and a second side opposing the first side.
- the porous surface includes a plurality of through-holes running from the first side to the second side.
- the plurality of surface channels communicate and cooperate with the plurality of through-holes to provide the therapeutic agent from the plurality of surface channels to the first side of the porous surface and to the second side of the porous surface.
- An advantage of the present invention is that it provides an orthopaedic implant that allows for the delivery of drugs directly to the bone.
- Yet another advantage of the present invention is that the implant according to the present invention allows for the delivery of the correct dose of antibiotics, continuously for any length of time required.
- Yet another advantage of the present invention is that is provides an orthopaedic implant which can deliver a therapeutic agent locally to bone or surrounding soft tissue as long as the implant remains implanted in a corporeal body.
- Yet another advantage of the present invention is that it provides a long-term implant which would allow drugs to be delivered directly to the bone and surrounding tissue (or to any specific location).
- Yet another advantage of the present invention is that, with regard to enhancing bone ingrowth and combating resorbtion, it provides that bone growth stimulators can be injected intraoperatively or postoperatively to enhance or speed bone ingrowth into porous material (i.e., porous coatings on total joint components; fusion devices, i.e., spinal fusion devices; bone augmentation components, i.e., tibial wedges); these drugs could also be injected months to years post-operatively, using an implant according to the present invention, to combat bone resorbtion due to such causes as stress-shielding, osteolysis, or bone metabolic disorders.
- porous material i.e., porous coatings on total joint components
- fusion devices i.e., spinal fusion devices
- bone augmentation components i.e., tibial wedges
- Yet another advantage of the present invention is that, with regard to oncology, the present invention provides an implant that would similarly allow for delivery of drugs to some or all tissue surrounding the implant.
- Yet another advantage of the present invention is that it would allow antibiotics to be delivered to the bone surrounding the nail of the present invention as a preventative or to treat an infection if one develops.
- Yet another advantage of the present invention is that it provides a non-permanent implant, such as a nail according to the present invention, which can provide localized delivery of oncological drugs in the region of tumors which may improve results in slowing/halting tumor growth; this ability for localized delivery provided by the present invention may also lessen the need/dose of systemic drugs, resulting in fewer side effects.
- Yet another advantage of the present invention is that it provides an external fixation device that would allow antibiotics or other anti-infective agents to be provided to the bone and soft tissue surrounding the pins.
- FIG. 2 is a schematic representation of a sectional view of a short-term femoral hip implant system according to the present invention
- FIG. 4 is a schematic representation of a top view of a short-term femoral knee implant according to the present invention.
- FIG. 5 is a schematic representation of a sectional view of the short-term femoral knee implant taken along line 5 - 5 in FIG. 4 ;
- FIG. 17 is a schematic representation of a sectional view of an orthopaedic nail according to the present invention.
- FIG. 21 is a schematic representation of a sectional view of an orthopaedic implant of FIG. 20 without the therapeutic agent cartridge inserted therein;
- FIG. 22 is a schematic representation of a side view of an orthopaedic implant that is entirely porous
- FIG. 25 is a schematic representation of a sectional view of an orthopaedic implant that is partially porous and includes a reservoir and drug delivery channels according to the present invention
- FIG. 1 shows two reservoirs 38 and a plurality of channels 40 running from each reservoir 38 .
- the implant according to the present invention i.e., implant 232
- the reservoirs 38 of FIG. 1 can optionally hold different therapeutic agents 36 at the same time; stated another way, each reservoir 38 can hold a different therapeutic agent 36 , or each reservoir 38 can hold at least two therapeutic agents 36 .
- the implant according to the present invention is configured for delivering a plurality of therapeutic agents to the corporeal body via the reservoir and the plurality of channels; examples of such implants include implant 32 ( FIG. 1 ) and implant 232 ( FIG. 3 ). Further, implant 32 may be formed such that no seal or seal cap is formed over any of channels 40 prior to release of any therapeutic agent 36 .
- FIG. 1 shows that both the stem and the femoral head include reservoirs 38 and a plurality of channels 40 running from the respective reservoirs 38 to the exterior surface 46 of the implant 32 .
- channels 40 can be formed as holes or apertures in body 44 .
- therapeutic agent 36 is inserted in reservoirs 38 prior to and/or after implantation of implant in body 34 .
- Therapeutic agent 36 can then migrate into channels 40 and travel via channels 40 to exterior surface 46 (channels 40 forming holes in exterior surface 46 ).
- Therapeutic agent 36 exits channels 40 and contacts treatment site 42 , which can be for example bone or tissue.
- FIG. 8 shows a sectional view of a short-term tibial knee implant 632 according to the present invention. Structural features in FIG. 8 corresponding to similar features in prior figures have reference characters raised by a multiple of 100.
- the body 644 of implant 632 is the tibial knee implant 632 .
- Body 644 includes a tibial tray (the generally horizontal piece in FIG. 8 ) and an optional stem (the generally vertical piece below the horizontal piece in FIG. 8 ). Both the lower portion and the stem define drug reservoirs 638 and drug delivery channels/holes 640 communicating the respective reservoir 638 with exterior surface 646 to deliver the therapeutic agent(s) to the treatment site(s) 642 .
- the therapeutic agent can move from the reservoir 638 to the treatment site 642 via channels 640 .
- a device such as a port could be used to allow for post-operative injections of antibiotics into the implant. (See FIG. 2 ). This would allow for the delivery of multiple antibiotics throughout treatment. Reservoirs and/or channels in the implant would allow the antibiotics from these injections to be delivered over a time-period from hours to weeks. ( FIGS. 1-8 ). Injection intervals of approximately a week would likely be well-accepted clinically. The drugs could be delivered to all bone and soft tissue surrounding the implant or only to specific locations. Variations of this concept would allow for a range of joint mobility from no motion at the joint to the mobility typical of a permanent total joint. These short-term implants can be held in the bone with a loose press-fit or with antibiotic or standard bone cement. In the case of bone cement, cement restrictors would also be included in the technology to prevent cement from sealing over the drug delivery holes.
- the present invention further provides a long-term implant which would allow drugs to be delivered directly to the bone and surrounding tissue (or to any specific location).
- a device such as a port could be used to allow for post-operative injections of drugs into the long-term implant. (See FIG. 14 ). This would allow for the delivery of any number of drugs throughout treatment and allow for the refilling of drugs to provide proper drug dosing throughout treatment. Reservoirs and/or channels in the long-term implant according to the present invention would allow the drugs from these injections to be delivered over a time period from hours to weeks. (See FIGS. 9-16 ). The drugs could be delivered to all bone and soft tissue surrounding the implant or only to specific locations.
- FIGS. 9 and 10 show a long-term femoral hip prosthetic implant system 730 according to the present invention. Structural features in FIGS. 9 and 10 corresponding to similar features in prior figures have reference characters raised by multiples of 100.
- System 730 includes a long-term femoral hip prosthetic implant 732 and a porous surface 754 attached to the exterior surface 746 . Similar to the short-term implants discussed above, implant has a body 744 defining a drug reservoir 738 and a plurality of drug delivery channels 740 running from the reservoir 738 to the exterior surface 746 so as to deliver a therapeutic agent(s) to a treatment site in the corporeal body. Porous surface 754 is configured for receiving bone and/or tissue ingrowth therein.
- the lower portion also includes at least one drug delivery channel 840 leading from reservoir to a treatment site.
- the therapeutic agent can move from the reservoir 838 to the treatment site via channels 840 .
- FIG. 13 shows a long-term femoral knee implant system 930 according to the present invention. Structural features in FIG. 13 corresponding to similar features in prior figures have reference characters raised by multiples of 100.
- System 930 includes a prosthetic implant 932 similar to the implant 832 of FIG. 12 but with a plurality of ingrowth porous surfaces 954 attached to the body 944 of implant 932 . Each porous surface 954 is configured for receiving bone and/or tissue ingrowth therein.
- a drug delivery channel 940 leading from the drug reservoir is shown in FIG. 13 .
- the reservoir of FIG. 13 can be situated just under exterior surface 946 as reservoir 838 is shown in FIG. 12 .
- implant body 1044 may or may not define an additional internal reservoir.
- the therapeutic agent can move from the reservoir of implant 1032 to the treatment site via the drug delivery channels. If implant 1032 does not have an internal reservoir, then the therapeutic agent moves to the treatment site via the drug delivery channels from external reservoir 1062 via catheter 1060 , injection port 1058 , and attachment element 1050 .
- FIGS. 15 and 16 show a long-term femoral hip implant system 1130 according to the present invention. Structural features in FIGS. 15 and 16 corresponding to similar features in prior figures have reference characters raised by multiples of 100.
- FIG. 15 shows long-term femoral hip implant system 1130 including a long-term femoral hip prosthetic implant 1132 and an ingrowth porous surface 1154 .
- FIG. 16 shows a first porous surface 1154 on the top (as oriented in FIG. 16 ) of the implant body 1144 or substrate 1144 (in each of the figures, the body 1144 can also be referred to as a substrate) and a second porous surface 1154 on the bottom (as oriented in FIG. 16 ) of the body 1144 .
- Porous surfaces 1154 are configured for receiving bone and/or tissue ingrowth therein, as shown by arrow 1156 . While FIG. 16 shows some space between porous surfaces 1154 and body 1144 , it is understood that this space is for illustrative purposes and that porous surfaces 1154 can be flush with body 1144 but for any adhesive that may be used to attach surfaces 1154 with exterior surface 1146 of body 1144 .
- Each porous surface 1154 includes a first side 1164 attached to exterior surface 1146 of body 1144 and a second side 1166 opposing said first side 1164 .
- Each porous surface 1154 includes a through-hole 1168 running from first side 1164 to second side 1166 .
- FIG. 16 shows a reservoir 1138 and connecting channels 1140 in broken lines; for, it is understood that such a reservoir 1138 and connecting channels 1140 (connecting reservoir 1138 with channels 1170 and/or 1172 ) may not be visible in this section, or, alternatively, that such a reservoir 1138 and connecting channels 1140 can be optional (stated another way, the implant 1132 would not contain such an interior reservoir 1138 and connecting channels 1140 leading from the reservoir 1138 to the surface channels 1170 or the sub-surface channels 1172 ).
- FIG. 16 shows that exterior surface 1146 of body 1144 can define a surface channel 1170 which is in communication with and cooperates with channel 1140 and through-hole 1168 of porous surface 1154 to provide the therapeutic agent 1136 from the reservoir 1138 to the treatment site 1142 .
- FIG. 16 shows a plurality of such surface channels 1170 , each of which can optionally be connected to reservoir 1138 via a respective connecting channel 1140 , as discussed above. If implant 1132 has reservoir 1138 and connecting channels 1140 , then upon filling reservoir 1138 with the therapeutic agent (either initially or as a refill), the therapeutic agent can move from reservoir 1138 to the treatment site via the channels 1140 and 1170 .
- surface channels 1170 can be filled with the therapeutic agent (either initially and/or as a refill) and the therapeutic agent moves via surface channels 1170 , through through-holes 1168 , to the treatment site 1142 .
- the therapeutic agent can also be provided to the bone and/or tissue growing into porous surface 1154 .
- FIG. 16 shows that channels 1140 running from reservoir 1138 can connect to the sub-surface channels 1172 .
- Sub-surface channels 1172 and through-holes 1168 in porous surface 1154 are aligned with and cooperate with one another to provide the therapeutic agent 1136 from the reservoir 1138 to the treatment site 1142 .
- Holes 1174 (which can also be considered as channels of the present invention, like channels 40 ) are also provided in body 1144 leading from subsurface channels 1172 to exterior surface 1146 . These holes 1174 can be considered to be part of the respective channels 1140 and 1172 .
- the plurality of surface channels 1170 are configured for receiving, holding, delivering, and being refilled with the therapeutic agent 1136 after implant 1132 has been implanted in corporeal body 1134 .
- Orthopaedic implant 1132 is a prosthesis.
- implant 1132 can be formed as a nail ( FIG. 17 ), a plate ( FIG. 18 ), or an external fixation device with an implantable pin ( FIG. 19 ).
- Porous surface 1154 is attached to exterior surface 1146 .
- Porous surface 1154 is configured for receiving at least one of bone and tissue ingrowth therein, as shown by arrow 1156 .
- porous surface 1154 includes a first side 1164 attached to exterior surface 1146 and a second side 1166 opposing first side 1164 .
- Porous surface 1154 includes a plurality of through-holes 1168 running from first side 1164 to second side 1166 .
- the plurality of surface channels 1170 communicate and cooperate with the plurality of through-holes 1168 to provide the therapeutic agent 1136 from the plurality of surface channels 1170 , then to first side 1164 of porous surface 1154 , and then to second side 1166 of porous surface 1154 .
- Surface channels 1170 can be filled with the therapeutic agent (either initially and/or as a refill) and the therapeutic agent 1136 moves via surface channels 1170 , through through-holes 1168 , to the treatment site 1142 .
- Nails are temporary, intramedullary devices. They are typically used to treat traumatic fracture. The risk of infection can be high especially in the case of open fractures.
- the present invention would allow antibiotics to be delivered to the bone surrounding the nail as a preventative or to treat an infection if one develops.
- the drug delivery portion of plate is similar to that for orthopaedic nails according to the present invention.
- Plate allows drugs to be delivered directly to the bone and surrounding tissue (or to any specific location).
- a device such as a port could be used to allow for post-operative injections of drugs into plate. This would allow for the delivery any number of drugs throughout treatment.
- Reservoirs 1338 and/or channels 1340 in the plate implant 1332 allow the drugs from these injections to be delivered over a time-period from hours to weeks. The drugs could be delivered to all bone and soft tissue surrounding the plate implant 1332 or only to specific locations.
- Sheath 1478 serves to prevent drugs from exiting that portion of the external fixation device 1432 which is outside of the skin 1434 .
- drug reservoir 1480 is attached to sheath 1478 .
- Drug reservoir 1480 is shaped to allow attachment of the external fixation device 1432 to external fixation rods and/or plates (not shown).
- the therapeutic agent moves from drug reservoir 1480 to the inner spatial area 1484 of pin 1476 , through channels/holes 1440 in pin wall 1482 , and to the treatment site.
- the therapeutic agent can move from the reservoir 1480 to the treatment site 1442 via inner spatial area 1484 and channel(s) 1440 .
- the replaceable cartridge may be optionally formed relative to the implant.
- the cartridge may be considered a distinct device relative to the implant but which can be directly attached to the implant, as shown in FIG. 20 .
- the cartridge may be considered a portion of the implant which can be detached from the implant body.
- the cartridge may be a second replaceable implant located within the patient body away from the first implant (i.e., the femoral hip implant) but connected to the first implant, such as via a catheter.
- the cartridge may be a device that is situated external to the patient body, while the implant (i.e., the femoral hip implant) is implanted in the patient body.
- FIG. 22 does not include in addition thereto a drug reservoir or drug delivery channels.
- the therapeutic agent is delivered via the pores 1690 of implant 1632 to the treatment site, which can be within or outside of the pores 1690 .
- FIG. 23 shows a drug reservoir 1638 and drug delivery channels 1640 embedded in or defined by the body 1644 of the implant 1632 .
- the therapeutic agent can move from the reservoir 1638 to the treatment site via channels 1640 .
- FIGS. 24-26 each shows a femoral hip prosthetic implant 1732 in which a portion of the body 1744 of the implant 1732 is porous to facilitate leaching of therapeutic agents therefrom.
- the therapeutic agent can move from the reservoir 1838 (and thus also from spongy element 1892 ) to the treatment site via channels 1840 .
- the material of the sponge-like element 1892 can be a number of possibilities. For example, if the sponge 1892 is to remain in reservoir 1838 for a long time, then a Polyvinyl Alcohol (PVA) or Ivalon sponge, for example, can be used.
- the sponge 1892 is to last a shorter amount of time, then a collagen based material (i.e., Instat, by Johnson and Johnson, for example) or a gelatin sponge (i.e., Gelfoam, by Pfizer, for example), for example, can be used.
- a collagen based material i.e., Instat, by Johnson and Johnson, for example
- a gelatin sponge i.e., Gelfoam, by Pfizer, for example
- therapeutic agents can be introduced into the delivery channels/paths and/or implant reservoir of the implant of the present invention by one or more of the following ways:
- orthopaedic implants of the present invention can be applied in conjunction with any currently available designs, including porous coatings, and can also be used in conjunction with cemented implants.
- the present invention further provides a method of using an orthopaedic implant system, such as system 30 .
- the method includes the steps of: implanting an orthopaedic implant 32 at a selected location within a corporeal body 34 , implant 32 including a reservoir 38 and a plurality of channels 40 ; receiving at least one therapeutic agent 36 in reservoir 38 ; conveying at least one therapeutic agent 36 from reservoir 38 to a treatment site 42 relative to corporeal body 34 via channels 40 ; and delivering at least one therapeutic agent 42 to corporeal body 34 .
- the implant according to the present invention is a prosthesis, a nail, a plate, or an external fixation device with an implanted pin.
- Implant 32 includes a body 44 which is implanted at the selected location, body 44 defining reservoir 38 and channels 40 and including an exterior surface 46 , channels 40 fluidly communicating reservoir 38 with exterior surface 46 and thereby conveying therapeutic agent 36 from reservoir 38 to exterior surface 46 .
- the method can include attaching a porous surface 1154 to exterior surface 1146 , porous surface 1154 receiving bone and/or tissue ingrowth 1156 therein, porous surface 1154 including a first side 1164 attached to exterior surface 1146 and a second side 1166 opposing first side 1164 , porous surface 1154 including a through-hole 1168 running from first side 1164 to second side 1166 , through-hole 1168 communicating at least one therapeutic agent 1136 from first side 1164 to second side 1166 and thereby communicating at least one therapeutic agent 1136 to treatment site 1142 .
- Exterior surface 1146 can define a surface channel 1170 , surface channel 1170 being in communication with and cooperating with at least one channel 1140 and at least one through-hole 1168 and thereby providing at least one therapeutic agent 1136 from reservoir 1138 to treatment site 1142 .
- At least one channel 40 can be a sub-surface channel 1172 , sub-surface channel 1172 and through-hole 1168 being aligned with and cooperating with one another and thereby providing at least one therapeutic agent 1136 from reservoir 1138 to treatment site 1142 .
- the method can include implanting a second reservoir 1994 , a pump 1995 , and/or a port 1996 in corporeal body 1934 remote from implant 1932 , connecting second reservoir 1994 , pump 1995 , and/or port 1996 to reservoir 1938 of implant 1932 by at least one catheter 1998 implanted in corporeal body 1934 , and delivering at least one therapeutic agent 1936 to treatment site 1942 via implant 1932 , catheter 1998 , and second reservoir 1994 , pump 1995 , and/or port 1996 .
- the method can include inserting a cartridge 1586 into reservoir 1538 , cartridge 1586 containing at least one therapeutic agent 1536 and releasing at least one therapeutic agent 1536 into reservoir 1538 and/or at least one channel 1540 such that at least one therapeutic agent 1536 moves away from reservoir 1538 in at least one channel 1540 , removing cartridge 1586 from reservoir 1538 after implant 1532 has been implanted in corporeal body 1534 , and replacing cartridge 1586 with another cartridge 1586 after implant 1532 has been implanted in corporeal body 1534 .
- the method can include providing a spongy element 1892 , reservoir 1838 containing spongy element 1892 .
- Body 1644 , 1744 of implant 1632 , 1732 can be partially or completely porous.
- External fixation device 1432 can include implantable pin 1476 , a sheath 1478 coupled with pin 1476 , and reservoir 1480 coupled with sheath 1478 , pin 1476 defining a plurality of channels 1440 .
- Implant may include only one reservoir.
- the method can include refilling reservoir 38 with at least one therapeutic agent 36 after implant 32 has been implanted in corporeal body 34 .
- the method can include delivering a plurality of therapeutic agents 36 to corporeal body 34 via reservoir 38 and channels 40 of implant 32 .
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Abstract
Description
- This is a non-provisional application based upon U.S. provisional patent application Ser. No. 61/088,379, entitled “DRUG DELIVERY IMPLANTS”, filed Aug. 13, 2008, which is incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates to implants, and, more particularly, to orthopaedic implants.
- 2. Description of the Related Art
- Orthopaedic implants include short-term implants, long-term implants, and non-permanent implants. Short-term implants include implants for the treatment of infection. Long-term implants include total implants for total hip, knee, shoulder, and elbow joints. Non-permanent implants include trauma products such as nails, plates, and external fixation devices.
- Regarding short-term implants, when tissue, especially bone, surrounding an orthopaedic implant becomes infected, that implant must typically be removed, the infection must be eliminated, and a new implant (revision implant) is then implanted. The span of time between implant removal and revision implantation can be from several weeks (about 4 weeks) to a few months (approximately 3 months). During this time surgeons currently have two basic options: create temporary implants during surgery with antibiotic bone cement (created with or without the aid of a mold) or use a preformed antibiotic bone cement temporary implant (e.g. Exactech's InterSpace™ Hip and Knee). In either case, antibiotic bone cement is used to deliver antibiotics directly to the site of the infection in the bone. The patient also typically receives IV antibiotics. The shortcomings of such implants are the limited duration in which they deliver a clinically relevant dose of antibiotics, the lack of ability to change antibiotic type or dose during the 4-12 week treatment time, and the limited patient mobility, range of motion, and weight bearing that they allow.
- Further, antibiotic cements typically provide useful local antibiotic levels for a duration of less than one week. The treatment time is frequently 6 to 8 weeks. However, beyond one week, the antibiotic cement implants provide no useful amount of antibiotics.
- Further, infections can be caused by a great number of bacteria, viruses, yeast, etc. The effectiveness of various antibiotics depends greatly upon what in particular has caused the infection. Thus, in order to treat an infection most effectively, the cause of that infection must be known. The results of cell cultures give this information and indicate which antibiotic and dose will most effectively treat the infection. The samples for culturing are usually collected during surgery. The results of the culture are not known until several days after the surgery. Since the type of antibiotic cement used in current temporary implants must be chosen at or before the time of surgery, the information gained from the cultures cannot be applied to the antibiotics used at the infection site.
- Further, one key to a patient recovering from joint surgery with full range of motion in that joint is to encourage movement of that joint. This helps to prevent the formation of scar tissue and stiffening of tissue around the joint. The current options for temporary implants allow limited range of motion and weight bearing at best.
- Regarding long-term implants, with regard to bone ingrowth, bone ingrowth into a porous material is sometimes required to provide stability or fixation of an implant to the bone. Examples of this include porous coatings on total joint components, fusion devices (i.e., spinal fusion devices), and bone augmentation components (i.e., tibial wedges).
- With regard to resorbtion, resorbtion can occur in the region surrounding a total joint implant for a number of reasons and can lead to implant loosening and subsequent revision surgery. Some causes of resorbtion include:
-
- Stress shielding—Bone tissue requires loading to remain strong and healthy. If an implant does not properly transfer loads to the surrounding bone, regions of bone can resorb.
- Lysis due to wear particles—Osteolysis and resorbtion are frequently caused by the body's reaction to wear particles created by the bearing of one total joint component on another.
- Osteoporosis or other bone disorders—bone metabolic disorders can also cause the resorbtion of bone.
- With regard to oncology, localized delivery of oncological drugs in the region of tumors may improve results in slowing/halting tumor growth. The ability for localized delivery may also lessen the need/dose of systemic drugs, resulting in fewer side effects.
- Regarding non-permanent implants (i.e., trauma implants), such non-permanent implants include nails, plates, and external fixation devices. Nails are temporary, intramedullary devices. They are typically used to treat traumatic fracture. The risk of infection can be high especially in the case of open fractures. With regard to oncology, nails can be used to treat fractures associated with bone tumors. They can also be used to help prevent a fracture where cancer has weakened bone. Plates treat many of the same indications as nails; however plates are applied to the outside of the bone. External fixation devices are a temporary implant that is used to stabilize a fracture. These can be used for days to months. External fixation devices typically include several pins fixed in the bone and extending through the skin to a rigid plate, ring, rod, or similar stabilizing device. These devices carry the added risk of infection due to their extending through the skin. Bacteria can travel along the pins directly to the soft tissue and bone.
- What is needed in the art is an orthopaedic implant which includes a reservoir and a plurality of channels leading from the reservoir to deliver at least one therapeutic agent locally to bone or surrounding soft tissue.
- The present invention provides an orthopaedic implant which includes a reservoir and a plurality of channels leading from the reservoir to deliver at least one therapeutic agent locally to bone or surrounding soft tissue.
- The invention in one form is directed to an orthopaedic implant system, including an orthopaedic implant implantable at a selected location within a corporeal body and configured for delivering at least one therapeutic agent to the corporeal body. The implant includes a reservoir and a plurality of channels. The reservoir is configured for receiving the at least one therapeutic agent. The plurality of channels are configured for conveying the at least one therapeutic agent from the reservoir to a treatment site relative to the corporeal body.
- The invention in another form is directed to a method of using an orthopaedic implant system, the method including the steps of: implanting an orthopaedic implant at a selected location within a corporeal body, the implant including a reservoir and a plurality of channels; receiving at least one therapeutic agent in the reservoir; conveying the at least one therapeutic agent from the reservoir to a treatment site relative to the corporeal body via the plurality of channels; and delivering the at least one therapeutic agent to the corporeal body.
- The invention in yet another form is directed to an orthopaedic implant system including an orthopaedic implant and a porous surface. The orthopaedic implant includes a body implantable at a selected location within a corporeal body and which is configured for delivering a therapeutic agent to the corporeal body. The body includes an exterior surface defining a plurality of surface channels and having an absence of a therapeutic agent reservoir. The plurality of surface channels are configured for receiving, holding, delivering, and being refilled with the therapeutic agent after the implant has been implanted in the corporeal body. The porous surface is attached to the exterior surface. The porous surface is configured for receiving at least one of bone and tissue ingrowth therein and includes a first side attached to the exterior surface and a second side opposing the first side. The porous surface includes a plurality of through-holes running from the first side to the second side. The plurality of surface channels communicate and cooperate with the plurality of through-holes to provide the therapeutic agent from the plurality of surface channels to the first side of the porous surface and to the second side of the porous surface.
- An advantage of the present invention is that it provides an orthopaedic implant that allows for the delivery of drugs directly to the bone.
- Another advantage of the present invention is that it provides a temporary or short-term implant that would allow for the delivery of antibiotics directly to the bone and surrounding tissue.
- Yet another advantage of the present invention is that it would allow for post-operative injections of antibiotics into the implant, thereby allowing for the delivery of multiple antibiotics throughout treatment.
- Yet another advantage of the present invention is that the implant according to the present invention allows for the delivery of the correct dose of antibiotics, continuously for any length of time required.
- Yet another advantage of the present invention is that is provides an orthopaedic implant which can deliver a therapeutic agent locally to bone or surrounding soft tissue as long as the implant remains implanted in a corporeal body.
- Yet another advantage of the present invention is that it provides a long-term implant which would allow drugs to be delivered directly to the bone and surrounding tissue (or to any specific location).
- Yet another advantage of the present invention is that, with regard to enhancing bone ingrowth and combating resorbtion, it provides that bone growth stimulators can be injected intraoperatively or postoperatively to enhance or speed bone ingrowth into porous material (i.e., porous coatings on total joint components; fusion devices, i.e., spinal fusion devices; bone augmentation components, i.e., tibial wedges); these drugs could also be injected months to years post-operatively, using an implant according to the present invention, to combat bone resorbtion due to such causes as stress-shielding, osteolysis, or bone metabolic disorders.
- Yet another advantage of the present invention is that, with regard to oncology, the present invention provides an implant that would similarly allow for delivery of drugs to some or all tissue surrounding the implant.
- Yet another advantage of the present invention is that it would allow antibiotics to be delivered to the bone surrounding the nail of the present invention as a preventative or to treat an infection if one develops.
- Yet another advantage of the present invention is that it provides a non-permanent implant, such as a nail according to the present invention, which can provide the delivery of bone growth stimulators directly to the region of bone fracture(s); such delivery of bone growth stimulators can be advantageous in difficult cases such as non-unions, bony defects, and osteotomies.
- Yet another advantage of the present invention is that it provides a non-permanent implant, such as a nail according to the present invention, which can provide localized delivery of oncological drugs in the region of tumors which may improve results in slowing/halting tumor growth; this ability for localized delivery provided by the present invention may also lessen the need/dose of systemic drugs, resulting in fewer side effects.
- Yet another advantage of the present invention is that it provides an external fixation device that would allow antibiotics or other anti-infective agents to be provided to the bone and soft tissue surrounding the pins.
- The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 is a schematic representation of a sectional view of a short-term femoral hip implant according to the present invention; -
FIG. 2 is a schematic representation of a sectional view of a short-term femoral hip implant system according to the present invention; -
FIG. 3 is a schematic representation of a sectional view of a short-term acetabular cup implant according to the present invention; -
FIG. 4 is a schematic representation of a top view of a short-term femoral knee implant according to the present invention; -
FIG. 5 is a schematic representation of a sectional view of the short-term femoral knee implant taken along line 5-5 inFIG. 4 ; -
FIG. 6 is a schematic representation of a top view of a short-term femoral knee implant according to the present invention; -
FIG. 7 is a schematic representation of a front view of short-term femoral knee implant; -
FIG. 8 is a schematic representation of a sectional view of a short-term tibial knee implant; -
FIG. 9 is a schematic representation of a side view of a long-term femoral hip implant system according to the present invention; -
FIG. 10 is a schematic representation of a sectional view of the long-term femoral hip implant ofFIG. 9 ; -
FIG. 11 is a schematic representation of a top view of a long-term femoral knee implant according to the present invention; -
FIG. 12 is a schematic representation of a sectional view of the long-term femoral knee implant taken along line 12-12 inFIG. 11 ; -
FIG. 13 is a schematic representation of a top view of a long-term femoral knee implant system according to the present invention; -
FIG. 14 is a schematic representation of a side view of a long-term femoral knee implant system according to the present invention, the long-term femoral implant being attached to a femur; -
FIG. 15 is a schematic representation of a side view of a long-term femoral hip implant system according to the present invention; -
FIG. 16 is a schematic representation of a sectional view of the long-term femoral hip implant system ofFIG. 15 taken along line 16-16; -
FIG. 17 is a schematic representation of a sectional view of an orthopaedic nail according to the present invention; -
FIG. 18 is a schematic representation of a sectional view of an orthopaedic plate according to the present invention; -
FIG. 19 is a schematic representation of a sectional view of an external fixation device according to the present invention; -
FIG. 20 is a schematic representation of a sectional view of an orthopaedic implant system including a therapeutic agent cartridge; -
FIG. 21 is a schematic representation of a sectional view of an orthopaedic implant ofFIG. 20 without the therapeutic agent cartridge inserted therein; -
FIG. 22 is a schematic representation of a side view of an orthopaedic implant that is entirely porous; -
FIG. 23 is a schematic representation of a side view of an orthopaedic implant that is entirely porous and includes a reservoir and drug delivery channels according to the present invention; -
FIG. 24 is a schematic representation of a sectional view of an orthopaedic implant that is partially porous; -
FIG. 25 is a schematic representation of a sectional view of an orthopaedic implant that is partially porous and includes a reservoir and drug delivery channels according to the present invention; -
FIG. 26 is a schematic representation of a sectional view of an orthopaedic implant that is partially porous and includes a reservoir and drug delivery channels according to the present invention; -
FIG. 27 is a schematic representation of a sectional view of an orthopaedic implant system according to the present invention including a sponge-like material; -
FIG. 28 is a schematic representation of an orthopaedic implant system according to the present invention; and -
FIG. 29 is a schematic representation of an orthopaedic implant system according to the present invention. - Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
- Referring now to the drawings, and more particularly to
FIG. 1 , there is shown anorthopaedic implant system 30 according to the present invention which generally includes anorthopaedic implant 32 implantable at a selected location within acorporeal body 34 and configured for delivering at least onetherapeutic agent 36 to thecorporeal body 34. Theimplant 32 includes at least onereservoir 38 and a plurality ofchannels 40. Thereservoir 38 is configured for receiving at least onetherapeutic agent 36 and can be configured for being refilled with the therapeutic 36 agent after theimplant 32 has been implanted in thecorporeal body 34.Channels 40 form pathways for thetherapeutic agent 36 to move from thereservoir 38 to atreatment site 42 relative to thecorporeal body 34. Each pathway formed by achannel 40 is an interior space formed by the walls ofchannel 40.Channel 40 can, for example, have a circular, square, or some other cross-sectional shape. Thus,channels 40 are configured for conveying at least onetherapeutic agent 36 fromreservoir 38 totreatment site 42 relative tocorporeal body 34. -
FIG. 1 shows tworeservoirs 38 and a plurality ofchannels 40 running from eachreservoir 38. The implant according to the present invention (i.e., implant 232) may include only one reservoir (i.e., reservoir 238). Thereservoirs 38 ofFIG. 1 can optionally hold differenttherapeutic agents 36 at the same time; stated another way, eachreservoir 38 can hold a differenttherapeutic agent 36, or eachreservoir 38 can hold at least twotherapeutic agents 36. Thus, the implant according to the present invention is configured for delivering a plurality of therapeutic agents to the corporeal body via the reservoir and the plurality of channels; examples of such implants include implant 32 (FIG. 1 ) and implant 232 (FIG. 3 ). Further,implant 32 may be formed such that no seal or seal cap is formed over any ofchannels 40 prior to release of anytherapeutic agent 36. - A corporeal body herein means the physical body of a human being or of an animal (i.e., a veterinary patient). Thus, a corporeal body is one of flesh and bones. The corporeal body can be alive or dead. The corporeal body can also be referred to as a patient body herein, which includes both human and veterinary “patients”, alive or dead. Therapeutic agents can also be referred to herein as drugs or medicinal agents. Therapeutic agents can be formed, for example, as a liquid, a solid, a capsule, or a bead.
- Further,
FIG. 1 shows that implant 32 includes abody 44 implantable at the selected location.Body 44 definesreservoir 38 andchannels 40 and includes anexterior surface 46. The reservoir of the present invention can be a cavity or an enclosed pocket (closed but for channels extending to the surface of the body of the implant) formed by the body of the implant. The reservoir can be formed by the core (i.e., the central interior portion) of the body, rather than in the exterior surface of the body. The reservoir can occupy a substantial portion of the core but yet still have elongate channels running from the reservoir to the exterior surface.Reservoir 38 is a cavity inbody 44.Reservoir 38 is not a through-hole throughbody 44.Channels 40 fluidly communicatereservoir 38 withexterior surface 46 and thereby forms the pathways for the at least onetherapeutic agent 36 to move fromreservoir 38 toexterior surface 46. That is,channels 40 fluidly communicatereservoir 38 withexterior surface 46 and thereby convey at least onetherapeutic agent 36 fromreservoir 38 toexterior surface 46.FIG. 1 shows thebody 44 of theimplant 32 being theimplant 32 itself. - Further,
FIG. 1 shows that implant 32 is formed as a hip prosthesis and thatcorporeal body 34 is formed as a hip. More specifically,FIG. 1 shows a sectional view of a short-term femoral hip implant 32 (which is one type of orthopaedic implant) which forms part of the upper femur (or, thighbone) and is thus load-bearing. Thebody 44 of thefemoral hip prosthesis 32 ofFIG. 1 (thebody 44 and thefemoral hip prosthesis 32 being coextensive relative to one another and thus being the same structural member inFIG. 1 ) includes a stem (the downward extending portion ofimplant 32 inFIG. 1 ) which can be inserted into the upper femur of abody 34 and a femoral head (the ball portion ofimplant 32 inFIG. 1 ) which is received by and mates with an acetabulum (i.e., the patient's natural acetabulum, or a prosthetic acetabular cup).FIG. 1 shows that both the stem and the femoral head includereservoirs 38 and a plurality ofchannels 40 running from therespective reservoirs 38 to theexterior surface 46 of theimplant 32. Depending upon the size ofreservoir 38 relative toexterior surface 46 and/or the nearness ofreservoir 38 toexterior surface 46,channels 40 can be formed as holes or apertures inbody 44. In use,therapeutic agent 36 is inserted inreservoirs 38 prior to and/or after implantation of implant inbody 34.Therapeutic agent 36 can then migrate intochannels 40 and travel viachannels 40 to exterior surface 46 (channels 40 forming holes in exterior surface 46).Therapeutic agent 36exits channels 40 andcontacts treatment site 42, which can be for example bone or tissue. - The orthopaedic implant of the present invention can be a prosthesis, a nail, a plate, or an external fixation device formed as an implantable pin.
FIGS. 1-16 and 20-27 shows orthopaedic implants which are prostheses. A prosthesis is an implant that substitutes for or supplements a missing or defective part of the corporeal body.FIG. 17 shows an orthopaedic implant which is a nail.FIG. 18 shows an orthopaedic implant which is a plate.FIG. 19 shows an orthopaedic implant which is an external fixation device with an implantable pin. -
FIG. 2 shows another embodiment of the orthopaedic implant according to the present invention. Structural features inFIG. 2 corresponding to similar features inFIG. 1 have reference characters raised by a multiple of 100. Short-termorthopaedic implant system 130 includes a short-term prosthetic implant 132 and anattachment feature 150.Body 144 definesreservoir 138 andchannels 140 running fromreservoir 138 toexterior surface 146.Attachment feature 150 is for attaching a port (not shown inFIG. 2 ) thereto. Theattachment feature 150 can be a tubular element. Theattachment feature 150 and the port can be used to refill thereservoir 138 with a therapeutic agent. Upon fillingreservoir 138 with the therapeutic agent (either initially and/or as a refill) viaattachment feature 150, the therapeutic agent can move from thereservoir 138 to the treatment site viachannels 140. -
FIG. 3 shows another embodiment of the orthopaedic implant according to the present invention. Structural features inFIG. 3 corresponding to similar features in prior figures have reference characters raised by a multiple of 100.FIG. 3 shows a sectional view of another short-term hip implant 232.Prosthetic implant 232 is formed as an acetabular cup, which receives a femoral head. Thebody 244 of theacetabular cup 232 is theacetabular cup 232 inFIG. 3 .Body 244 definesreservoir 238 and a plurality ofchannels 240 running fromreservoir 238 toexterior surface 246. Upon fillingreservoir 238 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent moves from thereservoir 238 to the treatment site viachannels 240. -
FIGS. 4-8 show additional embodiments of orthopaedic implants according to the present invention. More specifically,FIGS. 4-8 show short-term orthopaedic implants formed as prosthetic knee implants, both femoral and tibial prosthetic knee implants. Structural features inFIGS. 4-7 corresponding to similar features in prior figures have reference characters raised by a multiple of 100.FIGS. 4 and 5 show that thebody 344 ofimplant 332 is thefemoral knee implant 332.Body 344 includes a lower portion (the generally U-shaped piece inFIG. 5 ) and an optional stem (the vertical, upstanding piece atop the lower portion inFIG. 5 ). Both the lower portion and the stem includedrug reservoirs 338 and drug delivery channels/holes 340 communicating therespective reservoir 338 withexterior surface 346 to deliver the therapeutic agent(s) in thereservoirs 338 to the treatment site(s) 342.FIG. 6 shows a top view offemoral knee implant 432 similar to theimplant 332 shown inFIG. 5 .Channels 440 are shown as exit holes inexterior surface 446 of the lower portion. The circle inFIG. 6 represents an optional,upstanding stem 452.FIG. 7 shows a front view of short-termfemoral knee implant 532 marked with lettering which is more radiopaque than theimplant body 544 so that the letters are visible on an X-ray or fluoroscope, as shown inFIG. 7 . Upon filling the reservoirs forFIGS. 5 and 6 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from these reservoirs to the treatment site viachannels -
FIG. 8 shows a sectional view of a short-termtibial knee implant 632 according to the present invention. Structural features inFIG. 8 corresponding to similar features in prior figures have reference characters raised by a multiple of 100. Thebody 644 ofimplant 632 is thetibial knee implant 632.Body 644 includes a tibial tray (the generally horizontal piece inFIG. 8 ) and an optional stem (the generally vertical piece below the horizontal piece inFIG. 8 ). Both the lower portion and the stem definedrug reservoirs 638 and drug delivery channels/holes 640 communicating therespective reservoir 638 withexterior surface 646 to deliver the therapeutic agent(s) to the treatment site(s) 642. Upon fillingreservoir 638 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 638 to thetreatment site 642 viachannels 640. - The implants according to the present invention shown in
FIGS. 1-8 are thus short-term implants that can be used, for example, to treat infections within a corporeal body. Such short-term or temporary implants allow for the delivery of therapeutic agents, such as antibiotics, directly to the bone of a corporeal body and to surrounding tissue. - A device such as a port could be used to allow for post-operative injections of antibiotics into the implant. (See
FIG. 2 ). This would allow for the delivery of multiple antibiotics throughout treatment. Reservoirs and/or channels in the implant would allow the antibiotics from these injections to be delivered over a time-period from hours to weeks. (FIGS. 1-8 ). Injection intervals of approximately a week would likely be well-accepted clinically. The drugs could be delivered to all bone and soft tissue surrounding the implant or only to specific locations. Variations of this concept would allow for a range of joint mobility from no motion at the joint to the mobility typical of a permanent total joint. These short-term implants can be held in the bone with a loose press-fit or with antibiotic or standard bone cement. In the case of bone cement, cement restrictors would also be included in the technology to prevent cement from sealing over the drug delivery holes. - Antibiotic cements typically provide useful local antibiotic levels for a duration of less than one week. The treatment time is frequently six to eight weeks. However, beyond one week, the antibiotic cement implants provide no useful amount of antibiotics. The implant according to the present invention, by contrast, allows the delivery of the correct dose of antibiotics continuously for any length of time required. Through a feature such as a port attached to the implant of the present invention, the implant reservoir can be refilled as often as necessary to provide the proper drug dosing.
- The implant of the present invention allows for any number of antibiotics to be used at any time during treatment. An initial antibiotic can be used at the time of surgery. If the cell cultures indicate that a different antibiotic or dose would be more effective, that change in treatment regimen can be made in accordance with the present invention.
- A short-term femoral hip implant, as discussed above, can include a stem and a separate head or could be a one-piece construction. Multiple sizes of stem and head size could be accommodated. A separate acetabular component could be provided, as discussed above. The femoral head could mate with a short-term acetabular component or with the patient's acetabulum. (See
FIGS. 1-3 ). According to the present invention, drugs can be delivered to the acetabulum through the head of the femoral component if an acetabular component is not used (SeeFIG. 1 ) or through the acetabular component if one is used (SeeFIG. 3 ). - A short term knee implant can include a one-piece tibial component (combining the two pieces of a standard total knee replacement) and a one- or two-piece femoral component (the two-piece design would combine the condyles and stem). The present invention provides multiple sizes of tibia components and of stem and condyles (either combined as one piece or separate). (See
FIGS. 4-8 ). Similar components are provided for shoulder, elbow, and other joints, according to the present invention. - Since the implants of
FIGS. 1-8 are designed for short-term use, the short-term implants of the present invention can include markings which are both visible on the implant surface by the naked eye and visible by X-ray, as indicated above. These markings would clearly indicate that the implants are intended for short-term use only. (SeeFIG. 7 ). - The present invention provides an orthopaedic implant system (whether short-term, long-term, or non-permanent implants) which provide for continuously delivering drugs to a point near the implant or to the entire region surrounding the implant for extended periods of time. The implants according to the present invention shown in
FIGS. 9-16 are long-term implants. Such implants can be used, for example, as total hip, knee, shoulder, and elbow joints within a patient body. The long-term implants of the present invention have a basic similarity with the short-term implants described above. Thus, structural features inFIGS. 9-16 corresponding to similar features in prior figures have reference characters raised by multiples of 100. Thus, similar to the short-term implants described above, the present invention further provides a long-term implant which would allow drugs to be delivered directly to the bone and surrounding tissue (or to any specific location). A device such as a port could be used to allow for post-operative injections of drugs into the long-term implant. (SeeFIG. 14 ). This would allow for the delivery of any number of drugs throughout treatment and allow for the refilling of drugs to provide proper drug dosing throughout treatment. Reservoirs and/or channels in the long-term implant according to the present invention would allow the drugs from these injections to be delivered over a time period from hours to weeks. (SeeFIGS. 9-16 ). The drugs could be delivered to all bone and soft tissue surrounding the implant or only to specific locations. -
FIGS. 9 and 10 show a long-term femoral hipprosthetic implant system 730 according to the present invention. Structural features inFIGS. 9 and 10 corresponding to similar features in prior figures have reference characters raised by multiples of 100.System 730 includes a long-term femoral hipprosthetic implant 732 and aporous surface 754 attached to theexterior surface 746. Similar to the short-term implants discussed above, implant has abody 744 defining adrug reservoir 738 and a plurality ofdrug delivery channels 740 running from thereservoir 738 to theexterior surface 746 so as to deliver a therapeutic agent(s) to a treatment site in the corporeal body.Porous surface 754 is configured for receiving bone and/or tissue ingrowth therein. Such ingrowth is shown byarrow 756 inFIG. 9 . Theporous surface 754 can be variously referred to as a porous member, a porous pad, or a scaffold.Drug delivery channels 740 can be routed by or throughbody 744 so as to avoid the ingrowth region. Stated another way,channels 740 can be routed by or throughbody 744 so as to avoid releasing therapeutic agents intoporous surface 754. By contrast,channels 740 can be routed by or throughbody 744 so as to release drugs through the ingrowthporous surface 754.FIG. 9 showschannels 740 which avoid releasing drugs intoporous surface 754. Upon fillingreservoir 738 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 738 to the treatment site viachannels 740. -
FIGS. 11 and 12 show a long-term femoral knee implant according to the present invention. Structural features inFIGS. 11 and 12 corresponding to similar features in prior figures have reference characters raised by multiples of 100. Thebody 844 ofimplant 832 is thefemoral knee implant 832.Body 844 includes a lower portion (the generally U-shaped piece inFIG. 12 ) and an optional stem (the vertical, upstanding piece atop the lower portion inFIG. 12 ). Both the lower portion and the stem includedrug reservoirs 838. The stem further includes drug delivery channels/holes 840 communicating therespective reservoir 838 withexterior surface 846 to deliver the therapeutic agent(s) to the treatment site(s) 846. The lower portion also includes at least onedrug delivery channel 840 leading from reservoir to a treatment site. Upon fillingreservoir 838 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 838 to the treatment site viachannels 840. -
FIG. 13 shows a long-term femoralknee implant system 930 according to the present invention. Structural features inFIG. 13 corresponding to similar features in prior figures have reference characters raised by multiples of 100.System 930 includes aprosthetic implant 932 similar to theimplant 832 ofFIG. 12 but with a plurality of ingrowthporous surfaces 954 attached to thebody 944 ofimplant 932. Eachporous surface 954 is configured for receiving bone and/or tissue ingrowth therein. Further, while the reservoir cannot be seen inFIG. 13 , adrug delivery channel 940 leading from the drug reservoir is shown inFIG. 13 . The reservoir ofFIG. 13 can be situated just underexterior surface 946 asreservoir 838 is shown inFIG. 12 .Channel 940 routes around (and thereby avoids)ingrowth pads 954. Upon filling the reservoir ofimplant 932 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from the reservoir ofimplant 932 to the treatment site viachannels 940. -
FIG. 14 shows a long-term femoralknee implant system 1030 according to the present invention. Structural features inFIG. 14 corresponding to similar features in prior figures have reference characters raised by multiples of 100.System 1030 includes aprosthetic implant 1032 similar to theimplant 832 ofFIG. 12 .Implant 1032 is attached to afemur 1035. Thesystem 1030 further includes an attachment feature or element 1050 (such as a tubular element) for aninjection port 1058, aninjection port 1058, acatheter 1060, and areservoir 1062 remote to theimplant 1032. The injection port is provided for additional refilling of drugs into theimplant 1032, which includes at least one channel for routing the therapeutic agent to the treatment site. Since anexternal reservoir 1062 is attached toimplant 1032,implant body 1044 may or may not define an additional internal reservoir. Upon filling the internal reservoir ofimplant 1032 with the therapeutic agent (either initially and/or as a refill) viaattachment element 1050,injection port 1058,catheter 1060, andexternal reservoir 1062, the therapeutic agent can move from the reservoir ofimplant 1032 to the treatment site via the drug delivery channels. Ifimplant 1032 does not have an internal reservoir, then the therapeutic agent moves to the treatment site via the drug delivery channels fromexternal reservoir 1062 viacatheter 1060,injection port 1058, andattachment element 1050. -
FIGS. 15 and 16 show a long-term femoralhip implant system 1130 according to the present invention. Structural features inFIGS. 15 and 16 corresponding to similar features in prior figures have reference characters raised by multiples of 100.FIG. 15 shows long-term femoralhip implant system 1130 including a long-term femoralhip prosthetic implant 1132 and an ingrowthporous surface 1154.FIG. 16 shows a firstporous surface 1154 on the top (as oriented inFIG. 16 ) of theimplant body 1144 or substrate 1144 (in each of the figures, thebody 1144 can also be referred to as a substrate) and a secondporous surface 1154 on the bottom (as oriented inFIG. 16 ) of thebody 1144.Porous surfaces 1154 are configured for receiving bone and/or tissue ingrowth therein, as shown byarrow 1156. WhileFIG. 16 shows some space betweenporous surfaces 1154 andbody 1144, it is understood that this space is for illustrative purposes and thatporous surfaces 1154 can be flush withbody 1144 but for any adhesive that may be used to attachsurfaces 1154 withexterior surface 1146 ofbody 1144. Eachporous surface 1154 includes afirst side 1164 attached toexterior surface 1146 ofbody 1144 and asecond side 1166 opposing saidfirst side 1164. Eachporous surface 1154 includes a through-hole 1168 running fromfirst side 1164 tosecond side 1166. Through-hole 1168 is configured for communicating thetherapeutic agent 1136 fromfirst side 1164 tosecond side 1166 and thereby for communicating thetherapeutic agent 1136 to thetreatment site 1142. The through-holes 1168 inporous surfaces 1154 lead to surface channels 1170 andsub-surface channels 1172, respectively.Channels 1170 and 1172 can function essentially the same aschannels 40 in that they are drug delivery channels.FIG. 16 shows areservoir 1138 and connectingchannels 1140 in broken lines; for, it is understood that such areservoir 1138 and connecting channels 1140 (connectingreservoir 1138 with channels 1170 and/or 1172) may not be visible in this section, or, alternatively, that such areservoir 1138 and connectingchannels 1140 can be optional (stated another way, theimplant 1132 would not contain such aninterior reservoir 1138 and connectingchannels 1140 leading from thereservoir 1138 to the surface channels 1170 or the sub-surface channels 1172). - Further,
FIG. 16 shows thatexterior surface 1146 ofbody 1144 can define a surface channel 1170 which is in communication with and cooperates withchannel 1140 and through-hole 1168 ofporous surface 1154 to provide thetherapeutic agent 1136 from thereservoir 1138 to thetreatment site 1142.FIG. 16 shows a plurality of such surface channels 1170, each of which can optionally be connected toreservoir 1138 via a respective connectingchannel 1140, as discussed above. Ifimplant 1132 hasreservoir 1138 and connectingchannels 1140, then upon fillingreservoir 1138 with the therapeutic agent (either initially or as a refill), the therapeutic agent can move fromreservoir 1138 to the treatment site via thechannels 1140 and 1170. Ifimplant 1132 does not havereservoir 1138 and connectingchannels 1140, then surface channels 1170 can be filled with the therapeutic agent (either initially and/or as a refill) and the therapeutic agent moves via surface channels 1170, through through-holes 1168, to thetreatment site 1142. The therapeutic agent can also be provided to the bone and/or tissue growing intoporous surface 1154. - Further,
FIG. 16 shows thatchannels 1140 running fromreservoir 1138 can connect to thesub-surface channels 1172.Sub-surface channels 1172 and through-holes 1168 inporous surface 1154 are aligned with and cooperate with one another to provide thetherapeutic agent 1136 from thereservoir 1138 to thetreatment site 1142. Holes 1174 (which can also be considered as channels of the present invention, like channels 40) are also provided inbody 1144 leading fromsubsurface channels 1172 toexterior surface 1146. Theseholes 1174 can be considered to be part of therespective channels -
FIGS. 15 and 16 thus also show anorthopaedic implant system 1130 including anorthopaedic implant 1132 and aporous surface 1154. Theorthopaedic implant 1132 includes abody 1144 implantable at a selected location within acorporeal body 1134 and configured for delivering atherapeutic agent 1136 tocorporeal body 1134.Body 1144 ofimplant 1132 includes anexterior surface 1146 defining a plurality of surface channels 1170 and, as discussed above, can have an absence of atherapeutic agent reservoir 1138. The broken lines of thereservoir 1138 inFIG. 16 , as stated above, indicates that thereservoir 1138 is optional. The plurality of surface channels 1170 are configured for receiving, holding, delivering, and being refilled with thetherapeutic agent 1136 afterimplant 1132 has been implanted incorporeal body 1134.Orthopaedic implant 1132 is a prosthesis. Alternatively,implant 1132 can be formed as a nail (FIG. 17 ), a plate (FIG. 18 ), or an external fixation device with an implantable pin (FIG. 19 ).Porous surface 1154 is attached toexterior surface 1146.Porous surface 1154 is configured for receiving at least one of bone and tissue ingrowth therein, as shown byarrow 1156. As discussed above,porous surface 1154 includes afirst side 1164 attached toexterior surface 1146 and asecond side 1166 opposingfirst side 1164.Porous surface 1154 includes a plurality of through-holes 1168 running fromfirst side 1164 tosecond side 1166. The plurality of surface channels 1170 communicate and cooperate with the plurality of through-holes 1168 to provide thetherapeutic agent 1136 from the plurality of surface channels 1170, then tofirst side 1164 ofporous surface 1154, and then tosecond side 1166 ofporous surface 1154. Surface channels 1170 can be filled with the therapeutic agent (either initially and/or as a refill) and thetherapeutic agent 1136 moves via surface channels 1170, through through-holes 1168, to thetreatment site 1142. - Thus, the present invention could be applied to long-term implants with any type of porous coating or surface or to cemented implants. Drugs could be delivered through the porous coatings or be routed to regions without porous coatings (as disclosed above), depending on the requirements. (See
FIGS. 9 , 10, 13, 15, and 16). For delivery through the porous coatings, channels can be created on the surface of the implant substrate (the solid material of the implant to which the porous surface is attached - seeFIG. 14 ) or below the surface, as disclosed above relative toFIGS. 15 and 16 . For surface channels, holes can be drilled through the porous surface to the surface channels to create a path through which the drugs can be delivered. For sub-surface channels, holes must be drilled from the surface of the substrate (the body of the implant) to the sub-surface channels to create paths for drugs to be delivered. (SeeFIG. 16 ). This drilling can occur prior to attaching the porous coating/surface or after the porous coating/surface is attached. If this drilling occurs after the porous coating/surface is attached, the holes will be created through the porous coating/surface and the substrate/body surface. (SeeFIG. 16 ). - Cement restrictors can also be used according to the present invention to prevent cement from sealing over the drug delivery holes. The present invention can be applied to all types of total joint implants, such as total hip components, total knee components, total shoulder components, and total elbow components.
- With regard to enhancing bone ingrowth and combating resorbtion, bone growth stimulators can be injected intraoperatively or postoperatively to enhance or speed bone ingrowth into porous material (i.e., porous coatings or pads or surfaces on total joint components, on fusion devices (i.e., spinal fusion devices), or on bone augmentation components (i.e., tibial wedges)). These drugs could also be injected months to years post-operatively, using a long-term implant according to the present invention, to combat bone resorbtion due to such causes as stress-shielding, osteolysis, or bone metabolic disorders.
- With regard to oncology, the implant of the present invention would similarly allow for delivery of drugs to some or all tissue surrounding the implant. The implants of the present invention may be cemented. The present invention provides a way to route the drugs around the regions of cement and provides a way for preventing the cement from sealing over the drug delivery holes.
- The implants according to the present invention shown in
FIGS. 17-19 are non-permanent implants. Such implants can be trauma products, such as nails, plates, and external fixation devices. The non-permanent implants of the present invention are not necessarily limited to these devices. The non-permanent implants of the present invention have a basic similarity with the short-term and long-term implants described above. Thus, structural features inFIGS. 17-19 corresponding to similar features inFIG. 1 have reference characters raised by multiples of 100. Thus, similar to the short-term and long-term implants described above, the present invention further provides a non-permanent implant which would allow drugs to be delivered directly to the bone and surrounding tissue (or to any specific location). Reservoirs and/or channels in the non-permanent implant according to the present invention would allow the drugs to be delivered to the treatment site and could be refilled. A nail according to the present invention is shown inFIG. 17 . A plate according to the present invention is shown inFIG. 18 . An external fixation device according to the present invention is shown in 19. - Nails are temporary, intramedullary devices. They are typically used to treat traumatic fracture. The risk of infection can be high especially in the case of open fractures. The present invention would allow antibiotics to be delivered to the bone surrounding the nail as a preventative or to treat an infection if one develops.
- With regard to bone growth, in the case of fractures, there are instances in which the delivery of bone growth stimulators directly to the region of the fracture(s) would be beneficial. This is especially true in difficult cases such as non-unions, bony defects, and osteotomies. The nail according to the present invention would allow for such delivery bone growth stimulators directly to the region of the fracture(s).
- With regard to oncology, nails can be used to treat fractures associated with bone tumors. They can also be used to help prevent a fracture where cancer has weakened bone. The nail according to the present invention provides for localized delivery of oncological drugs in the region of tumors which may improve results in slowing/halting tumor growth. This ability for localized delivery provided by the nail according to the present invention may also lessen the need/dose of systemic drugs, resulting in fewer side effects.
-
FIG. 17 shows anorthopaedic nail 1232 implantable in the corporeal body. Structural features inFIG. 17 corresponding to similar features in prior figures have reference characters raised by multiples of 100.Nail 1232 includes abody 1244 defining areservoir 1238 and adrug delivery channel 1240 leading fromdrug reservoir 1238 toexterior surface 1246 ofnail 1232. The present invention thus provides anorthopaedic nail 1232 with a drug delivery portion, which is similar to that, for instance, for long-term implants, such as a femoral hip implant (such as a hip stem). This design allows drugs to be delivered directly to all areas of the bone or to any specific location. (FIG. 17 ). A device such as a port could be used to allow for post-operative injections of drugs into thenail 1232. This would allow for the delivery of any number of drugs throughout treatment.Reservoirs 1238 and/orchannels 1240 in thenail 1232 would allow the drugs from these injections to be delivered over a time period from hours to weeks. Thus, upon fillingreservoir 1238 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 1238 to the treatment site viachannels 1240. The drugs could be delivered to all bone tissue surrounding the implant or only to specific locations. All types of nails could utilize this technology, including antegrade and retrograde versions of femoral, tibial, and humeral nails. - Orthopaedic plates treat many of the same indications as nails; however, plates are applied to the outside of the bone. Plates offer the same opportunities for delivering drugs locally. Since nails are intramedullary, they can be used to deliver drugs, according to the present invention, primarily to the bone tissue. Since plates are applied to the outside of the bone, they can be used to deliver drugs, according to the present invention, to both bone and soft tissues. Examples of potential soft tissue treatments benefited by localized drug delivery include the enhancement of soft tissue ingrowth or healing, the prevention of infection by the delivery of antibiotics, and the treatment of nearby soft tissue tumors with localized delivery of oncological drugs.
-
FIG. 18 shows anorthopaedic plate 1332 that is implantable in a corporeal body. Structural features inFIG. 18 corresponding to similar features in prior figures have reference characters raised by multiples of 100.Plate 1332 includes abody 1344 defining areservoir 1338 and adrug delivery channel 1340 leading fromdrug reservoir 1338 toexterior surface 1346 ofplate 1332. Upon fillingreservoir 1338 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 1338 to the treatment site viachannels 1340. - Thus, the drug delivery portion of plate is similar to that for orthopaedic nails according to the present invention. Plate allows drugs to be delivered directly to the bone and surrounding tissue (or to any specific location). A device such as a port could be used to allow for post-operative injections of drugs into plate. This would allow for the delivery any number of drugs throughout treatment.
Reservoirs 1338 and/orchannels 1340 in theplate implant 1332 allow the drugs from these injections to be delivered over a time-period from hours to weeks. The drugs could be delivered to all bone and soft tissue surrounding theplate implant 1332 or only to specific locations. - External fixation devices are temporary implants that are used to stabilize a fracture. These external fixation devices can be used for days to months. External fixation devices typically include several pins fixed in the bone and extending through the skin to a rigid plate, ring, rod, or similar stabilizing device. These devices carry the added risk of infection considering that the pins extend through the skin. Bacteria can travel along the pins directly to the soft tissue and bone. The present invention can be applied to external fixation devices. Thus, antibiotics or other anti-infective agents can be provided to the bone and soft tissue surrounding the pins. (
FIG. 19 ). An external reservoir could be used to supply/pump antibiotics to the bone and soft tissue. -
FIG. 19 , for instance, shows anexternal fixation device 1432 according to the present invention which is a trauma device. Structural features inFIG. 19 corresponding to similar features in prior figures have reference characters raised by multiples of 100.External fixation device 1432 includes animplantable pin 1476, asheath 1478 coupled withpin 1476, and areservoir 1480 coupled withsheath 1478,pin 1476 defining a plurality ofchannels 1440. More specifically,pin 1476 includes awall 1482 defining an innerspatial area 1484 and a plurality ofdrug delivery channels 1440 or holes 1440. Connected to the outer circumference of thepin 1476 issheath 1478, which can be coaxial withpin 1476.Sheath 1478 serves to prevent drugs from exiting that portion of theexternal fixation device 1432 which is outside of theskin 1434. To the right (as oriented on the page ofFIG. 19 ) of the wall ofskin 1434 is space that is external to the corporeal body. Further,drug reservoir 1480 is attached tosheath 1478.Drug reservoir 1480 is shaped to allow attachment of theexternal fixation device 1432 to external fixation rods and/or plates (not shown). The therapeutic agent moves fromdrug reservoir 1480 to the innerspatial area 1484 ofpin 1476, through channels/holes 1440 inpin wall 1482, and to the treatment site. Thus, upon fillingreservoir 1480 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 1480 to thetreatment site 1442 via innerspatial area 1484 and channel(s) 1440. - Shortcomings of temporary bone cement implants used to treat infections are discussed above. An additional shortcoming includes the difficulty of delivering adequate quantities of therapeutic agents through such implants to bone due to lack of blood flow.
FIGS. 20-27 provide orthopaedic drug delivery implants which address this shortcoming. More specifically,FIGS. 20-21 provide therapeutic agent delivery via a removable and replaceable cartridge. Further,FIGS. 22-26 provide therapeutic agent delivery via leaching through an implant that is partially or totally porous. Further,FIG. 27 provides a modified reservoir design. The designs shown inFIGS. 20-27 can be used in short-term, long-term, or non-permanent orthopaedic implants. Structural features inFIGS. 20-27 corresponding to similar features in prior figures have reference characters raised by multiples of 100. -
FIGS. 20 and 21 show anorthopaedic implant system 1530 including anorthopaedic implant 1532 and acartridge 1586. More specifically,FIG. 20 shows cartridge 1586 inserted inimplant 1532.FIG. 21 , however, showsimplant 1532 withcartridge 1586 removed.Implant 1532 is formed as, for example, a short-term femoralhip prosthetic implant 1532.Implant 1532 is implanted incorporeal body 1534.Implant 1532 is defined by itsbody 1544.Body 1544 defines areservoir 1538 and a plurality ofchannels 1540 running from thereservoir 1538 to theexterior surface 1546 ofbody 1544.Cartridge 1586 is inserted into and thus received byreservoir 1538, which serves as a housing forcartridge 1586. Thus,reservoir 1538, as a housing forcartridge 1586, may be shaped to matingly accommodate and connect tocartridge 1586.Reservoir 1538 can be generally cup-shaped and thus be open to exterior surface 1546 (and thusreservoir 1538 can essentially be a blind hole in exterior surface 1546) so as to receivecartridge 1586.Cartridge 1586 contains at least onetherapeutic agent 1536, which is shown in broken lines inFIG. 20 .Cartridge 1586 is configured for releasing the therapeutic agent 1536 (shown as a circle in cartridge 1586) intoreservoir 1538 and/or at least onechannel 1540 such that thetherapeutic agent 1536 moves away fromreservoir 1538 in at least onechannel 1540 and thus toexterior surface 1546 ofbody 1544.Cartridge 1586 is removable fromreservoir 1538 and is replaceable with anothercartridge 1586 afterimplant 1532 has been implanted in the corporeal body. Thefirst cartridge 1586 is replaced when it is empty of the therapeutic agent (or when it has otherwise released the desired amount of therapeutic agent from the first cartridge 1586). Thesecond cartridge 1586, which replaces the emptyfirst cartridge 1586, is full (or has the desired amount of therapeutic agent therein) of therapeutic agent when it is inserted intoreservoir 1538 and thereby replacesfirst cartridge 1586. Thus, the refilling ofreservoir 1538 insystem 1530 occurs by replacingfirst cartridge 1586 with asecond cartridge 1586. - Thus,
system 1530 can haveimplant body 1544 and a replaceable portion orcartridge 1586. (FIGS. 20-21 ).Replaceable cartridge 1586, as stated, contains therapeutics. Upon implantation, the surgeon can decide with what therapeutics to fillcartridge 1586. Over time,cartridge 1586 can be replaced with anew cartridge 1586 filled with the same therapeutic as before or a different therapeutic. Ideally, cartridge replacement would occur as a minor outpatient procedure. - The replaceable cartridge may be optionally formed relative to the implant. As a first option, the cartridge may be considered a distinct device relative to the implant but which can be directly attached to the implant, as shown in
FIG. 20 . As a second option, the cartridge may be considered a portion of the implant which can be detached from the implant body. As a third option, the cartridge may be a second replaceable implant located within the patient body away from the first implant (i.e., the femoral hip implant) but connected to the first implant, such as via a catheter. As a fourth option, the cartridge may be a device that is situated external to the patient body, while the implant (i.e., the femoral hip implant) is implanted in the patient body. -
FIGS. 22-26 show implants that are partially or totally porous to facilitate therapeutic agent delivery via leaching through the respective implant. In much the same manner of powder metallurgy bearings that are self-lubricating, therapeutic agents may be delivered to the patient body from an implant that is partially or totally porous. (FIGS. 22-26 ). Therapeutics will leach from the porous portions of the implant to the body. Such implants may also contain drug delivery channels, reservoirs, and the various ways of recharging therapeutics as previously discussed herein.FIGS. 22 and 23 each shows a femoralhip prosthetic implant 1632 in which theentire body 1644 of theimplant 1632 is porous to facilitate leaching of therapeutic agents therefrom. Pores are labeled as 1690. Theimplant 1632 ofFIG. 22 , however, does not include in addition thereto a drug reservoir or drug delivery channels. Thus, the therapeutic agent is delivered via thepores 1690 ofimplant 1632 to the treatment site, which can be within or outside of thepores 1690. By contrast,FIG. 23 shows adrug reservoir 1638 anddrug delivery channels 1640 embedded in or defined by thebody 1644 of theimplant 1632. Thus, upon fillingreservoir 1638 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 1638 to the treatment site viachannels 1640.FIGS. 24-26 each shows a femoralhip prosthetic implant 1732 in which a portion of thebody 1744 of theimplant 1732 is porous to facilitate leaching of therapeutic agents therefrom. The porous portion ofbody 1744 is labeled as 1790. Theimplant 1732 ofFIG. 24 , however, does not include in addition thereto a drug reservoir or drug delivery channels. Thus, the therapeutic agent can be delivered via theporous portion 1790 to the treatment site, which can be within or outside of theporous portion 1790. By contrast, theimplants 1732 ofFIGS. 25 and 26 do include in addition thereto adrug reservoir 1738 anddrug delivery channels 1740.FIG. 25 shows thereservoir 1738 embedded in or defined by theporous portion 1790 of thebody 1744 of theimplant 1732 anddrug delivery channels 1740 at least partially embedded in or defined by theporous portion 1790 of thebody 1744 of theimplant 1732. Thus, upon fillingreservoir 1738 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 1738 to the treatment site (which can be either within or outside of the porous portion 1790) viachannels 1740.FIG. 26 shows that thereservoir 1738 is not located in theporous portion 1790 and shows thedrug delivery channels 1740 at least in part leading to theporous portion 1790. Thus, upon fillingreservoir 1738 with the therapeutic agent (either initially and/or as a refill), the therapeutic agent can move from thereservoir 1738 to the treatment site (which can be either within or outside of the porous portion 1790) viachannels 1740. -
FIG. 27 shows anorthopaedic implant system 1830 with a femoralhip prosthetic implant 1832 and a sponge-like or spongy material orelement 1892. Similar to the implants discussed above, thebody 1844 of theimplant 1832 defines adrug reservoir 1838 anddrug delivery channels 1840 leading from thereservoir 1838 to theexterior surface 1846 of thebody 1844. Thereservoir 1838 contains or houses thespongy element 1892. The purpose of this material is to control dispersion of the therapeutic agents from thereservoir 1838 into thedrug delivery channels 1840, to keep bone and tissue from growing into and filling thereservoir 1838, and/or to stiffen theimplant 1832. Upon fillingreservoir 1838 with the therapeutic agent (either initially and/or as a refill) and having positioned sponge-like material 1892 inreservoir 1838, the therapeutic agent can move from the reservoir 1838 (and thus also from spongy element 1892) to the treatment site viachannels 1840. Depending upon the outcome desired, the material of the sponge-like element 1892 can be a number of possibilities. For example, if thesponge 1892 is to remain inreservoir 1838 for a long time, then a Polyvinyl Alcohol (PVA) or Ivalon sponge, for example, can be used. On the other hand, if thesponge 1892 is to last a shorter amount of time, then a collagen based material (i.e., Instat, by Johnson and Johnson, for example) or a gelatin sponge (i.e., Gelfoam, by Pfizer, for example), for example, can be used. These examples of thesponge 1892 are provided by way of example, and not by way of limitation. - Any of the devices according to the present invention described above can include a single or multiple attachment features (such as connections for catheters or ports) and a single or multiple sets of reservoirs and/or channels. The same therapeutic agent can be used in all reservoirs/channels, or several therapeutic agents can be used at one time. Separate reservoirs/channels allow each of the therapeutic agents to be delivered to a specific location on the implant, if desired.
- Any of the internal (implanted) devices according to the present invention described above can include an internal reservoir (contained within the implant) in conjunction with delivery channels/paths to allow for short- and/or long-term delivery of the therapeutic agents. If an internal reservoir does not exist, the implant can contain delivery channels/paths to allow for the dispersion of the therapeutic agent.
- According to the present invention, therapeutic agents can be introduced into the delivery channels/paths and/or implant reservoir of the implant of the present invention by one or more of the following ways:
-
- a. Direct interface between a delivery vessel (such as a hypodermic syringe).
- b. Direct attachment of a drug pump, external reservoir (external to the implant, but can be located internally or externally to the patient), and/or port to the implant; that is, a drug pump, external reservoir, and/or port can be attached directly to the implant. A catheter can be, but is not necessarily, located between the drug pump, external reservoir, and/or port and the implant. The therapeutic agent is then introduced into one of these intermediary devices by, for example, a hypodermic syringe. The therapeutic agent is then transferred to the implant delivery channels/paths and/or implant reservoir.
- c. A drug pump, reservoir, and/or port can be implanted in the body in another location remote to the implant and/or can be connected to the implant by, for example, a delivery tube or catheter.
FIG. 28 shows schematically this option for an orthopaedic implant system. According tosystem 1930, areservoir 1994, apump 1995, and aport 1996 are implanted under the skin of apatient body 1934 remote fromimplant 1932 and are shown connected via an implantedcatheter 1998 to thereservoir 1938 of theimplant 1932. Thereservoir 1994,pump 1995, andport 1996 are thereby configured for delivering the therapeutic agent (shown byarrow 1936, which also shows the direction of travel of the therapeutic agent) from thereservoir 1994 to thetreatment site 1942 via theimplant 1932. Stated another way, thepump 1995 andport 1996 can cooperate with thereservoir 1938 to deliver thetherapeutic agent 1936 via thecatheter 1998 to thereservoir 1938 defined by the body of theimplant 1932. The body ofimplant 1932 can define channels, either sub-surface or surface channels, running fromreservoir 1938 to the exterior surface ofimplant 1932. Theimplant 1932 is an orthopaedic implant, such as a prosthesis, a nail, a plate, or an implanted pin of an external fixation device. - d. A drug pump, reservoir, and/or port can be located external to the body and connected to the implant by, for example, a delivery tube or catheter. The main difference between the example of this subparagraph and the example of subparagraph c of this paragraph is that the catheter runs from one location inside the body to another location inside the body in the example of subparagraph c of this paragraph, while the catheter runs from outside of the body to the implant inside the body in the example of this subparagraph.
FIG. 29 shows schematically this option for an orthopaedic implant system. According tosystem 2030, areservoir 2094, apump 2095, and aport 2096 are not implanted under the skin of apatient body 2034 but are shown connected to thereservoir 2038 of theimplant 2032 by a transcutaneous (passing, entering, or made by penetration through the skin)catheter 2098. Thereservoir 2094,pump 2095, andport 2096 are thereby configured for delivering the therapeutic agent (shown byarrow 2036, which also shows the direction of travel of the therapeutic agent) from thereservoir 2094 to thetreatment site 2042 via theimplant 2032. Stated another way, thepump 2095 andport 2096 can cooperate with thereservoir 2094 to deliver thetherapeutic agent 2036 via thecatheter 2098 to thereservoir 2038 defined by the body of theimplant 2032. The body ofimplant 2032 can define channels, either sub-surface or surface channels, running fromreservoir 2038 to the exterior surface ofimplant 2032. Theimplant 2032 is an orthopaedic implant, such as a prosthesis, a nail, a plate, or an implanted pin of an external fixation device. - e. A catheter runs from outside the body to the implant inside the body but would not include a pump, a reservoir, or a port being attached to the outside end of the catheter (the outside end being the end opposite the end which is attached to the implant).
- The orthopaedic implants of the present invention can be applied in conjunction with any currently available designs, including porous coatings, and can also be used in conjunction with cemented implants.
- The present invention further provides a method of using an orthopaedic implant system, such as
system 30. The method includes the steps of: implanting anorthopaedic implant 32 at a selected location within acorporeal body 34,implant 32 including areservoir 38 and a plurality ofchannels 40; receiving at least onetherapeutic agent 36 inreservoir 38; conveying at least onetherapeutic agent 36 fromreservoir 38 to atreatment site 42 relative tocorporeal body 34 viachannels 40; and delivering at least onetherapeutic agent 42 tocorporeal body 34. As discussed above, the implant according to the present invention is a prosthesis, a nail, a plate, or an external fixation device with an implanted pin.Implant 32 includes abody 44 which is implanted at the selected location,body 44 definingreservoir 38 andchannels 40 and including anexterior surface 46,channels 40 fluidly communicatingreservoir 38 withexterior surface 46 and thereby conveyingtherapeutic agent 36 fromreservoir 38 toexterior surface 46. The method can include attaching aporous surface 1154 toexterior surface 1146,porous surface 1154 receiving bone and/ortissue ingrowth 1156 therein,porous surface 1154 including afirst side 1164 attached toexterior surface 1146 and asecond side 1166 opposingfirst side 1164,porous surface 1154 including a through-hole 1168 running fromfirst side 1164 tosecond side 1166, through-hole 1168 communicating at least onetherapeutic agent 1136 fromfirst side 1164 tosecond side 1166 and thereby communicating at least onetherapeutic agent 1136 totreatment site 1142.Exterior surface 1146 can define a surface channel 1170, surface channel 1170 being in communication with and cooperating with at least onechannel 1140 and at least one through-hole 1168 and thereby providing at least onetherapeutic agent 1136 fromreservoir 1138 totreatment site 1142. At least onechannel 40 can be asub-surface channel 1172,sub-surface channel 1172 and through-hole 1168 being aligned with and cooperating with one another and thereby providing at least onetherapeutic agent 1136 fromreservoir 1138 totreatment site 1142. The method can include implanting asecond reservoir 1994, apump 1995, and/or aport 1996 incorporeal body 1934 remote fromimplant 1932, connectingsecond reservoir 1994,pump 1995, and/orport 1996 toreservoir 1938 ofimplant 1932 by at least onecatheter 1998 implanted incorporeal body 1934, and delivering at least onetherapeutic agent 1936 totreatment site 1942 viaimplant 1932,catheter 1998, andsecond reservoir 1994,pump 1995, and/orport 1996. The method can include providing asecond reservoir 2094, apump 2095, and/or aport 2096 which is not implanted incorporeal body 2034, connectingsecond reservoir 2094,pump 2095, and/orport 2096 toreservoir 2038 ofimplant 2032 by at least onetranscutaneous catheter 2098, and delivering at least onetherapeutic agent 2036 totreatment site 2042 viaimplant 2032,catheter 2098, andsecond reservoir 2094,pump 2095, and/orport 2096. The method can include inserting acartridge 1586 intoreservoir 1538,cartridge 1586 containing at least onetherapeutic agent 1536 and releasing at least onetherapeutic agent 1536 intoreservoir 1538 and/or at least onechannel 1540 such that at least onetherapeutic agent 1536 moves away fromreservoir 1538 in at least onechannel 1540, removingcartridge 1586 fromreservoir 1538 afterimplant 1532 has been implanted incorporeal body 1534, and replacingcartridge 1586 with anothercartridge 1586 afterimplant 1532 has been implanted incorporeal body 1534. The method can include providing aspongy element 1892,reservoir 1838 containingspongy element 1892.Body implant External fixation device 1432 can includeimplantable pin 1476, asheath 1478 coupled withpin 1476, andreservoir 1480 coupled withsheath 1478,pin 1476 defining a plurality ofchannels 1440. Implant may include only one reservoir. The method can include refillingreservoir 38 with at least onetherapeutic agent 36 afterimplant 32 has been implanted incorporeal body 34. The method can include delivering a plurality oftherapeutic agents 36 tocorporeal body 34 viareservoir 38 andchannels 40 ofimplant 32. - While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
Claims (32)
Priority Applications (10)
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US12/549,748 US9616205B2 (en) | 2008-08-13 | 2009-08-28 | Drug delivery implants |
JP2011525237A JP5658154B2 (en) | 2008-08-29 | 2009-08-28 | Drug delivery implants |
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ES09810665.1T ES2613943T3 (en) | 2008-08-29 | 2009-08-28 | Implants for drug administration |
PCT/US2009/055380 WO2010025378A2 (en) | 2008-08-13 | 2009-08-28 | Drug delivery implants |
US14/505,144 US9561354B2 (en) | 2008-08-13 | 2014-10-02 | Drug delivery implants |
US15/413,493 US10357298B2 (en) | 2008-08-13 | 2017-01-24 | Drug delivery implants |
US15/700,788 US10349993B2 (en) | 2008-08-13 | 2017-09-11 | Drug delivery implants |
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Also Published As
Publication number | Publication date |
---|---|
WO2010025378A2 (en) | 2010-03-04 |
WO2010019781A1 (en) | 2010-02-18 |
WO2010025378A3 (en) | 2010-06-03 |
US20150038941A1 (en) | 2015-02-05 |
US9561354B2 (en) | 2017-02-07 |
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