Apparatus and method for administering a biologically active substance to a bone

Description: TECHNICAL FIELD [Detailed description of the invention]

Equipment and methods for the administration of biologically active substances to bone Background of the invention Orthopedic fasteners used to repair fractures in humans or other animals Has been used. Repairing fractures of the long bones of the body, for example the human femur Intrabone marrow nails are used for this purpose. Intramedullary nails also have a surgically damaged thigh, Of femoral elongation, such as when it is progressively separated and regenerated over a long period of time It has also been used as a tool for. Besides, it is for reconstruction surgery of the hip bone. A fracture plate is used for spinal cord fractures. In either case, infection can occur at the fracture site or bone growth Bone growth factors may be required at the fracture site to stimulate. these Cases may require additional surgery to deliver treatment to the fracture site To. Abstract of the invention The present invention is like a therapeutic agent at the fracture site of a bone through an implanted device. Resolve the need for more invasive methods by delivering bioactive substances Decide or reduce. These remedies include antibiotics, analgesics, bone-forming proteins, DN A, including, but not limited to, chemotherapeutic agents and angiogenic factors. Preferably Is made to deliver therapeutic agents to the long bones of the body using intramedullary nails. fracture And, in addition to the osteotomy site, the site of bone must be a graft site. Can be done. However, the present invention is appropriately modified, such as lumbar reconstruction screws or fracture plates. Delivered structures to the relevant site of other bones, such as the hip bone or spinal cord, To It can be used for delivery. Also for treating cartilage like the knee Similar devices can be manufactured according to the present invention. In general, the present invention is for administering a biologically active substance to a selected bone site. Regarding the equipment of. The device can be implanted inside the bone or on its surface Attached and now deliver biologically active substances directly to that part of the bone Includes delivery structures. Preferably, the delivery structure is an intramedullary nail, for reconstruction. Bone fasteners, such as screws or fracture plates. A preferred embodiment of the internal bone fastener according to the present invention is inserted into the selected bone. Includes the body of the sea urchin fastener. Cavity within the fastener body or separate delivery structure Stores the drug for delivery. Deliver therapeutic agent to preselected bone sites At least one delivery passage extending from the cavity through the fastener body for There is a (channel). Internal fasteners include intramedullary nails and reconstructive screws. The cavity inside the fastener inside the bone is a collar saturated with an applicator or therapeutic agent. Gen sponge can be included. When the sponge is compressed by an external force, the drug Is released from the sponge and flows into the delivery aisle. In addition to the sponge or it From the cavity of the fastener to the outside of the body or to the implanted reservoir, along with the doctor Reached by needle so that a person can administer a dose of therapeutic agent to that part of the bone The catheter can be extended as much as possible. The above-mentioned aspects of the present invention, including various novel details and combinations of parts of the structure. And other purposes, features and advantages are similar for the same part through different diagrams Bone biologically active substance with a reference letter The following, more specific diagrams and preferred embodiments of the equipment and methods for delivery to. It will be clear from the explanation. The figures are not necessarily intended for scale, but rather the present invention. It is emphasized to show the principle of. Specific bone fasteners representing the present invention are shown in the illustration. Therefore, it is shown only and not as a limitation of the present invention. Principle of the present invention And features can be used in a variety of and numerous aspects without departing from the scope of the invention. Can be done. Brief description of the figure FIG. 1 is a shortened cross-sectional schematic of a limb with a fractured bone. FIG. 2 is a partial cross-sectional view of the fractured bone of FIG. 1 with an intramedullary nail fixed in place. Is. FIG. 3 is a schematic cross-sectional view of a preferred embodiment of the present invention shown on an intramedullary nail. .. FIG. 4 is a schematic cross-sectional view taken along line II of FIG. FIG. 5 is a perspective view of the administration sponge system of FIG. Figure 6 shows the administration sponge system for use with the intramedullary nails of Figure 3. It is a perspective view of one aspect. Figures 7A-7B show the favors of the invention, represented by dynamized intramedullary nails. It is a schematic of a partial cross section of a better aspect. FIG. 7C shows another preferred embodiment of the invention represented by an enhanced intramedullary nail. It is a schematic of a partial cross section of. FIG. 8 shows a partial cut of a preferred embodiment of the invention represented by an intramedullary nail for bone elongation. It is a schematic diagram of a surface. FIG. 9 shows another preferred embodiment of the invention represented by an intramedullary nail for bone elongation. It is a schematic of a partial cross section of. FIG. 10 is a cross-sectional view taken along line II-II of FIG. FIG. 11 shows yet another preference of the invention, represented by an intramedullary nail for bone elongation. It is the schematic of the partial cross section of a mode. FIG. 12 is a schematic cross-sectional view of the present invention represented by an orthopedic screw. FIG. 13 shows an implant for storing a biologically active substance according to the present invention. It is a perspective view of a possible reservoir. FIG. 14 is a plan view of a preferred embodiment of the present invention represented on the fracture plate. Detailed description of preferred embodiments of the invention FIG. 1 is a schematic cross-sectional view of a limb 9 having a fractured bone 1. Bone marrow 3, 3'and bone marrow endoscopy 5, 5'are shown. As shown in the figure, fracture site 7 is bone 1 Two main parts that are offset from each other: closer to the body and farther from the body It is divided into the distal part of the body. Bone 1 reduces fractures and is an orthopedic bone Repair by fixing two bone parts to each other with fasteners Can be done. FIG. 2 shows the shortening of the fractured bone of FIG. 1, including the intramedullary nail 10 fixed in place. It is a sectional drawing. Bone cross sections are first aligned (ie reduced) and then , The intramedullary nail 10 is inserted. Over time, fracture site 7 becomes bone cell growth Heal more. Once healed, the intramedullary nail 10 can be removed from bone 1. FIG. 3 is a schematic cross-sectional view of a preferred embodiment of the present invention represented by an intramedullary nail. To. The nail has an elongated stainless steel body 20 with a hollow cavity 25. Shown As shown, the vertically arranged pattern of the passage opening 22 passes through the nail body 20 and the nail body 20 It extends into an elongated groove 24 on the outside of the. Nail body 20, delivery passage or passage (via) ) 22 and distribution passages or ditches (groove) 24 can be more easily understood from FIG. FIG. 4 is a schematic cross-sectional view taken along line II of FIG. Intramedullary nail is groove 24 Is chamfered in the length direction (fluted). The cross section of the intramedullary nail is generally Although shown to be circular, in a preferred embodiment of the invention other cuts Faces can be used. For example, an intramedullary nail has a cross section of a clover leaf. , Can incorporate 3 aisle columns and grooves instead of the 4 columns shown Wear. Returning to Figure 3, the storage member in the form of an applicator, such as sponge 30, is nailed. Shown in lumen 25 of body 20. The sponge 30 later passes through passage 22 Saturated with biologically active substances released into the bone in the direction of the groove 24. Good Furthermore, the sponge 30 is placed at or near the selected bone site. Top and bottom of sponge 30 to contain bioactive material in cavity 25 Seal 35 is installed in. Multiple spots to treat multiple bone areas The nail can be placed inside the intramedullary nail. Preferably, the sponge 30 is cut off. The surface is adapted to match the cross section of the cavity 25. The doctor uses an x-ray or fluoroscope to measure the distance along the nail to the fracture site. Place the sponge 30 near the relevant part of the bone; absolute placement of the sponge 30 Accuracy is not required. As shown, from the sponge 30 through the top of the nail, the body A catheter 34 extends to the outside of the body. The doctor goes through catheter 34 Additional bioactive substances can be administered to Ponzi 30. Top of nail body 20 The top is sealed by a lid 26 into which the tube is inserted. FIG. 5 is a perspective view of the applicator system of FIG. The appliqué The engineer system preferably uses, for example, a sponge 30 made from collagen. Including. The bottom seal 35a, the top seal 35b, and the catheter 34 are shown. ing. Preferably, the catheter 34 is a doctor's sponge 30 of the intramedullary nail. Move vertically through the part 38 of the bone, based on a known distance along the nail. Hard enough to allow sponge 30 to be placed in the vicinity. Figure 6 shows another administration sponge system for use in the intramedullary nail of Figure 3. It is a perspective view of the aspect of. The placement handle 36 is connected to the bottom seal 35a , The actuating handle 38 is connected to the upper seal 35b. Placement handle 36 Used by doctors to place a sponge near selected bone sites Is done. Preferably, the sponge is saturated with the desired biologically active substance and is medically active. A person uses the actuating handle 36 to squeeze the biologically active substance out of the sponge. Written The moving handle 38 acts as a pump and seals the sponge 30 35a, 35 Pis that compresses between b and fixes in place, or squeezes sponge 30 Tons can be activated. In response, the biologically active substance is the body of the nail It drains down the groove 24 from passage 22 of 20 to treat the site of bone. after use , Sponge 30 can be removed from the intramedullary nail. 7A-7B show the partial cross-section of the invention shown in the enhanced intramedullary nail 40. It is a schematic diagram. The enhanced nail 40 is a distal piston member 41 and a proximal cylinder. -Includes member 51. Piston member 41 includes two fixing holes 42A, 42B. The cylinder member 51 includes two fixing holes 52A and 52B. Piston member 41 is manufactured to be acceptable to the compartment or cavity 55 of the cylinder member 51. Has been done. The piston member 41 and the cylinder member 51 are connected to the piston member 4 by the tab 44. 1 is arranged in a line on top. Tab 44 is slot 53 on cylinder member 51 It is lined up in a line. The assembly is a thread 56 on the cylinder member 51 Tightened by a collar 45 with mating threads 46. One like that When arranged in a line and fixed by the collar 45, the piston member 41 is slotted. To move the distance determined by the length of the 53 with respect to the cylinder member 51. Can be done. Spring member 58 to resist pressure of piston 41 into cylinder member 51 Is located in the cavity 55. The spring member 58 is provided by the piston 41 It resists the compressive force and returns the piston to its extended position after compression. Preferably, It is known that the longitudinal movement of bone with an amplitude of about 0.25 mm stimulates bone growth. Therefore, the stroke of the piston is about 0.25 mm. Spring member 58 is a coil Although shown as a spring, the spring member 58 is an elastomeric, flat spring or base. Can be a belville washer. In a preferred embodiment of the invention, an applicator such as sponge 57 may also be used. It is also placed in the cavity 55. The sponge 57 is a passage due to the compression of the screw member 58. Tired of biologically active substances extruded from 59 through the body of cylinder member 51 It is being harmonized. The seal 43 at the top of the piston member 41 is airtight around the cavity 55. And the biologically active material is piston member 41 and cylinder member 51 It prevents it from seeping through the joint between them. Figure 7C shows another preference of the invention, represented by the enhanced intramedullary nail 40'. It is the schematic of the partial cross section of a mode. Intrabone marrow nails 40 in Figures 7A-7B 40 Unlike the passage 59'in the piston member 41 instead of the cylinder member 51 It is formed. Passage 59'connects to lumen 55 by central cannula 53 There is. Therefore, when the spring member 58 is compressed, the biologically active substance is in the central cannula. -Le 53 can be pressed down to passage 59'. In all other respects, Figure 7 The intramedullary nail 40'of C is similar to the intramedullary nail 40 in FIGS. 7A-7B. FIG. 8 shows a portion of a preferred embodiment of the invention, represented by an intramedullary nail 60 that stretches bone. It is a schematic diagram of a sectional cross section. Proximal cylinder member 66 with fixing holes 68 and passages 67 It is shown. The passage 67 extends from the lumen 65 of the cylinder member 66 to the outer surface. There is. Distal piston member 61, including fixing holes 62A, 62B and seal 63, is also It is shown. At the time of operation, the piston member 61 has a bone at a predetermined distance. A regular fixed amount is extended outward from the cylinder member 66 until it extends to .. For further details on bone elongation and, as appropriate, intramedullary nails that extend bone US Pat. No. 5, whose principle is incorporated herein by reference. , 350,379 by Aran Spievack Are listed. Once the bone has grown to a predetermined length, the bone growth factors are used in the osteotomy section. Can be added to the position to promote bone growth and bone hardening at the osteotomy site .. In addition, once bone growth has stopped, antibiotics are applied to the area of bone to prevent infection. May need to be added. As shown, the nail 60 for bone extension is empty It has a maximum extension distance D partitioned by the top of the cave 65 and the passage opening 67. Jeong The stone 61 is extended under water pressure through the catheter 34. Traditionally hydraulic liquid Saline is used as Has been used. When the piston member 61 extends the distance D, saline flows from the passage 67. Put out. At that time, the biologically active substance is added through catheter 34. Can be done. Biologically active substances also flow out of passage 67 through the surrounding bone site. Can be treated. FIG. 9 is another preferred of the present invention, represented by an intramedullary nail 70 for bone elongation. It is a schematic of the partial cross section of an aspect. For extension of this bone, such as the intramedullary nail 60 in Figure 8. The nail 70 also has a piston member 71 having fixing holes 72A and 72B and a fixing hole 78. Includes one cylinder member 76. The cavity 75 is formed in the cylinder member 76, and the cavity 75 is formed therein. Then, the piston member 71 moves vertically in the cavity 75. Liquid by catheter 34 Introduced, the seal 73 on the piston member 71 allows the fluid to escape from the cavity 75 Prevents, thereby maintaining water pressure. The intramedullary nail 70 is a vertical delivery passage or slot 77 within the cylinder member 76, Also included in the piston member 71 is a vertical flow passage or groove 74. Enough bones When the piston member 71 extends sufficiently within the cylinder member 76, the cavity 75 Liquid can flow out of slot 77 into groove 74. in this way, The biologically active substance is therapeutically applied to the site of the bone in contact with the groove 74 in the piston member 71. Can be applied. FIG. 10 is a cross-sectional view of an intramedullary nail 70 for bone elongation taken along line II-II of FIG. Is. The piston member 71 in the cylinder member 76 is shown. Groove 74 and Slots 77 are arranged in a straight line. FIG. 11 shows yet another preference of the present invention, represented by an intramedullary nail 80 for bone elongation. It is a schematic diagram of the member cross section of a further aspect. As shown in intramedullary nails 60 and 70 in Figures 8 and 9. , This bone extension nail 80 has fixing holes 82A, 82B Includes a piston member 81 with a piston member and a cylinder member 86 with a fixing hole 88. cavity 85 is formed in the cylinder member 86, and the piston member 81 is vertically in the cavity 85. Moving. Seal 83 on the piston member prevents liquid from escaping from cavity 85 Stop, thereby maintaining water pressure. The intramedullary nail 80 includes a conduit 87 attached to the outside of the cylinder member 86. Organism The catheter 34 supplying the bioactive substance is connected to the conduit 87 at the connector 89. Touch. Biologically active material from catheter 34 drains down conduit 87 to bone It is excreted at the relevant part of. The principle of the present invention can be applied to devices other than intramedullary nails. Especially in the lumbar region Reconstructive screws for use in surgery are bioactive substances at the relevant site of the bone in the lumbar region. Can be modified by the present invention to deliver. FIG. 12 is a schematic cross-sectional view of the present invention represented by the orthopedic screw 90. Out of orthopedics The medical screw 90 includes a screw body 92 that forms a lumen 95 when intubated. .. The passage 94 extends from the lumen 95 to the outside of the screw body 92. Sponge 30 Such a dosing system can be placed with respect to passage 94 within lumen 95. Before As noted, the sponge 30 utilizes distance measurements obtained by x-ray or fluoroscope. To be placed. Once placed, catheter 34 the biologically active substance Can be applied to sponge 30 through. Then pass the biologically active substance 94 Through it, it can be exuded or extruded into the selected bone site. Sports The engine 30 limits the dispersion of the biologically active substance to a specific area of the lumen 95. Can include top and bottom seals 35 for the purpose. The aforementioned aspect of the present invention is for transporting a biologically active substance to the site of bone. The Teter 34 can be used. Biologically active substances Catheter through an external outlet on the body or from an implantable reservoir Can be introduced in. FIG. 13 shows implantable for storing biologically active material according to the present invention. It is a perspective view of a capable reservoir. Reservoir 100 is a reservoir book that partitions the inner storage capacity Includes body 102 and silastic doorway 104. The doctor puts the needle in the doorway 10 By penetrating 4, the drug can be administered to the reservoir 100 with a syringe and a needle. Wear. By applying pressure to the doorway 104, the liquid from the reservoir 100 It can also be extruded through the catheter 34 under pressure. Imp like this Landable Reservoir 100 can be purchased on the market, for example from CR Bard. Wear. The present invention is adequately suitable for internal bone fasteners such as intramedullary nails and orthopedic screws. However, the device representing the present invention does not necessarily have to be placed inside the bone. FIG. 14 is an elevational view of a preferred embodiment of the present invention, represented on a fracture plate. Fracture plate 110 includes a plate body 112 having a fixing hole 114 through which it passes. Fracture plate 110 Is preferably used with spinal cord fractures, where fracture plates 110 are fixed holes 11 It is fixed to the spinal cord by 4. Fracture plate 110 is woven with biologically active substances Formed from biologically absorbable substances such as polyglycolic acid (PGA) Includes groove 116. When the fracture plate 110 is placed, the groove 116 is in contact with the fracture site. Placed by touch. Over time, biologically absorbable substances will be present in that part of the bone. Releases the active substance at the position. Is the fracture plate 110, in some cases, an injection of a biologically active substance, or the site of the plate? Can include conduits 115A, 115B for drainage To. Vessels 115A, 115B are preferably made from metals such as stainless steel And glued to the fracture plate 110 by welding or other means .. Each conduit 115A, 115B is connected to a plastic injection or drainage catheter Includes connectors 117A, 117B for Preferably, one conduit 11 Although 5A is used for infusion and the other conduit 115B is used for drainage , Both conduits 115A and 115B can be used for both infusion and drainage. The augmentation method is also biologically active from the groove 116 or other region of the fracture plate 110. It can be used with the fracture plate 110 to promote the release of material. Example For example, augmentation expands one or more solid holes 114, and makes it a PGA-like delivery. Achieved by wrapping solid hole 114 with bioactive material embedded in a mixture it can. Similar substances Although the present invention has been specifically shown and described with respect to its preferred embodiments, To the trader, without departing from the spirit and scope of the invention as defined in the appended claims. It will be appreciated that various changes in form and detail can be made. For example Similar devices can be manufactured for the treatment of cartilage in the knee or other parts of the body. To. These and all other similar devices are covered by the claims below. Is intended.