The invention features improved bone screws, a delivery manifold for delivering a flowable medium to a bone screw, and washers for use with the bone screw to provide compressive fixation. The invention also features methods of treatment using the bone screws, washers, and/or delivery manifold, and k
The invention features improved bone screws, a delivery manifold for delivering a flowable medium to a bone screw, and washers for use with the bone screw to provide compressive fixation. The invention also features methods of treatment using the bone screws, washers, and/or delivery manifold, and kits that include the same.
대표청구항▼
1. A bone screw having a length from about 60 millimeters (mm) to 200 mm and comprising: i) a cylindrical screw body comprising a shaft that defines a longitudinal axis, ii) a screw head at the proximal end of said screw body, and iii) a tip at the distal end of said screw body, said bone screw furt
1. A bone screw having a length from about 60 millimeters (mm) to 200 mm and comprising: i) a cylindrical screw body comprising a shaft that defines a longitudinal axis, ii) a screw head at the proximal end of said screw body, and iii) a tip at the distal end of said screw body, said bone screw further comprising: a) an interior channel extending longitudinally through said screw head and through at least a portion of the shaft of said screw body, wherein said interior channel has a diameter of about 3 to 5 mm;b) a first threaded portion on the exterior of said screw head extending from about the proximal end of said screw head along at least a portion of the screw head;c) a second threaded portion on the exterior of said screw body adjacent to the screw head that extends in a direction along the screw body away from said screw head and having one or more delivery channels;d) a third threaded portion on the exterior of said screw body adjacent to the tip that extends along a distal portion of the screw body and having one or more delivery channels;e) a non-threaded portion between the second and third threaded portions on the exterior of said screw body and having one or more delivery channels; andf) at least first and second helical grooves extending along the exterior of said screw body, wherein:i) said first helical groove is substantially anti-parallel to said second helical groove and said helical grooves extend continuously through said second threaded portion, said non-threaded portion, and at least a portion of said third threaded portion,ii) said delivery channels are coincident with said helical grooves,iii) each of said delivery channels within the helical grooves of said non-threaded portion is separated by a distance of about 18 to 24 mm along said helical groove, andiv) each of said delivery channels of said third threaded portion is separated by a distance of about 5 to 7 mm along said helical groove. 2. The bone screw of claim 1, wherein said bone screw comprises one or more, or all, of the following characteristics: a) each of said delivery channels has a diameter of about 0.5 to 2 mm;b) said screw head has a length of about 4 to 7 mm and said first threaded portion has a length of about 2 to 4 mm and an exterior diameter of about 6 to 10 mm;c) said second threaded portion comprises about 2 to 4 thread revolutions, 1 to 4 delivery channels and a length of about 5 to 8 mm;d) said third threaded portion comprises about 10 to 20 thread revolutions, 8 to 12 delivery channels and a length of about 25 to 40 mm;e) said non-threaded portion has a length of about 16 to 86 mm;f) the ratio of said delivery channels in said third threaded portion to said non-threaded portion is at least 1.25:1;g) said bone screw has a length of about 60 to 130 mm;h) said first threaded portion comprises about 1 to 5 thread revolutions;i) said delivery channels are not within about 5 mm of the proximal end and distal end of said bone screw; and/orj) each of said delivery channels within the helical grooves of said non-threaded portion is separated by a distance of about 18 to 24 mm along said helical groove. 3. The bone screw of claim 1, wherein said bone screw comprises one or more, or all, of the following characteristics: a) said interior channel has a diameter of about 3.9 mm;b) said screw head has a length of about 5.3 mm and said first threaded portion has a length of about 3.2 mm and an exterior diameter of 8.3 mm;c) said second threaded portion comprises about 3 thread revolutions, about 2 delivery channels and a length of about 6.5 mm;d) said third threaded portion comprises about 16 thread revolutions, about 10 delivery channels and a length of about 32 mm and each of said delivery channels of said third threaded portion is separated by a distance of about 6 mm along said helical grooves;e) said non-threaded portion has a length of about 16 mm to 86 mm and comprises at least one to about 24 delivery channels and each of said delivery channels of said non-threaded portion is separated by a distance of about 21 mm along said helical grooves; and/orf) each of said delivery channels has a diameter of about 1.2 mm. 4. The bone screw of claim 1, wherein: a) said delivery channels are distributed along said helical grooves to provide substantially equal distribution of a flowable medium extruded through each of said delivery channels following introduction of said flowable medium through said screw head into said interior channel;b) said bone screw is, or comprises, stainless steel alloy, titanium alloy, commercially pure titanium, cobalt chrome, or polyetheretherketone, or combinations thereof;c) each of said delivery channels is tapered along at least a portion of its radial axis or is substantially cylindrical;d) at least one edge of said helical grooves comprises a self-cutting edge; and/ore) said bone screw has a mean bending stiffness of at least 136 N/mm in a 4-point bend test. 5. The bone screw of claim 4, wherein the flowable medium comprises a bone void filler, a cement, or a pharmaceutical agent. 6. The bone screw of claim 5, wherein the cement is a self-hardening calcium phosphate composition. 7. A method of treating a patient having a bone defect, said method comprising the steps of: a) positioning the bone screw of claim 1 in proximity to said bone defect;b) attaching a bone screw manifold comprising a sheath and a sheath adapter for delivering a fluid to the bone screw, comprising:i) attaching the sheath to the screw head of the bone screw, wherein the sheath comprises a cylindrical sheath body that defines a longitudinal axis, a first attachment portion at the distal end of the sheath body, a second attachment portion at the proximal end of the sheath body, and an internal channel having a diameter of at least about 5 mm that extends continuously through the sheath body and through the first and second attachment portions to provide fluid communication through the manifold, wherein: the sheath body has a length of about 60 to 90 mm;the first attachment portion comprises a threaded region within the internal channel; andthe second attachment portion comprises a threaded region within the internal channel, and comprises a first handling portion on the exterior of at least a portion of the second attachment portion; andii) attaching the sheath adapter to the sheath, wherein the sheath adapter comprises a cylindrical sheath adapter body that defines a longitudinal axis, a third attachment portion at the proximal end of the sheath adapter body, a second handling portion adjacent to the third attachment portion, a fourth attachment portion adjacent to the second handling portion, a tapered portion at the distal end of the sheath adapter body, and an internal channel having a diameter of at least about 2 mm that extends continuously through the sheath adapter body, the third attachment portion, the second handling portion, the fourth attachment portion, and the tapered portion to provide fluid communication through the sheath adapter, wherein: the sheath adapter body has a length of about 50 to 80 mm and an external diameter that is less than the diameter of the internal channel of the sheath;the third attachment portion comprises a threaded region on an exterior portion thereof;the second handling portion comprises raised ridges on an exterior portion thereof; andthe fourth attachment portion comprises a threaded region on an exterior portion thereof; andwherein the sheath adapter body is sized and shaped for insertion into the internal channel of the sheath, the threaded region of said third attachment portion of the sheath adapter is sized and shaped to be threadingly engaged with the threaded region of the second attachment portion of the sheath, thereby reversibly joining the sheath and the sheath adapter when engaged, and, when the sheath and the sheath adapter are joined, the tapered portion of the sheath adapter extends into the first attachment portion of the sheath;c) attaching a manual pressure injection device that includes a flowable medium to said fourth attachment portion of said sheath adapter; andd) introducing the flowable medium into said interior channel of said bone screw by applying manual pressure to the injection device, whereby said flowable material is extruded through said delivery channels;wherein hardening of said flowable medium secures said bone screw, thereby treating said bone defect in said patient. 8. The method of claim 7, wherein the flowable medium is a bone void filler, a cement, or a pharmaceutical agent. 9. The method of claim 8, wherein the cement is a self-hardening calcium phosphate composition. 10. The method of claim 7, wherein the bone detect comprises a subarticular fracture or a defect of the radius, ulna, fibula, clavicle, humerus, pelvis, femur, patella, tibia, talus, Calcaneus, navicular, cuneiforms, metatarsals, metacarpals, phalanges, scapula, ankle or vertebra; or is a compression fracture. 11. The method of claim 7, further comprising, prior to step a), joining a washer to said screw head, wherein said washer is sized is sized and shaped to accept said screw head of said bone screw and to engage a bone surface. 12. The method of claim 11, wherein said washer comprises: a) a cylindrical body comprising a shaft that defines a longitudinal axis, wherein said body has a length of about 5 to 8 mm and a diameter of 7 to 10.5 mm;b) a bone engaging portion at the proximal end of the body comprising a circumferential lip with a thickness of 1 to 2 mm and a radial diameter of 10 to 15 mm; andc) a screw head engaging portion at the distal end of the body having a diameter of 6 to 9 mm, wherein the diameter of the screw head engaging portion is less than the diameter of the body. 13. A system comprising the bone screw of claim 1 wherein said system comprises one or more of a bone screw manifold, a bone screw washer, an injection device, a flowable medium, a self-hardening bone cement powder, and instructions for using said system. 14. A bone screw manifold comprising a sheath and a sheath adapter for delivering a flowable medium to a cannulated and fenestrated bone screw, wherein: a) said sheath comprises a cylindrical sheath body that defines a longitudinal axis, a first attachment portion at the distal end of said sheath body, a second attachment portion at the proximal end of said sheath body, and an internal channel having a diameter of at least about 5 mm that extends continuously through said sheath body and through said first and second attachment portions to provide fluid communication through said manifold, wherein:i) said sheath body has a length of about 60 to 90 mm;ii) said first attachment portion comprises a threaded region within said internal channel; andiii) said second attachment portion comprises a threaded region within said internal channel, and comprises a first handling portion on the exterior of at least a portion of said second attachment portion; andb) said sheath adapter comprises a cylindrical sheath adapter body that defines a longitudinal axis, a third attachment portion at the proximal end of said sheath adapter body, a second handling portion adjacent to said third attachment portion, a fourth attachment portion adjacent to said second handling portion, a tapered portion at the distal end of said sheath adapter body, and an internal channel having a diameter of at least about 2 mm that extends continuously through said sheath adapter body, said third attachment portion, said second handling portion, said fourth attachment portion, and said tapered portion to provide fluid communication through said sheath adapter, wherein:i) said sheath adapter body has a length of about 50 to 80 mm and an external diameter that is less than the diameter of the internal channel of said sheath;ii) said third attachment portion comprises a threaded region on an exterior portion thereof;iii) said second handling portion comprises raised ridges on an exterior portion thereof; andiv) said fourth attachment portion comprises a threaded region on an exterior portion thereof; andwherein the sheath adapter body is sized and shaped for insertion into the internal channel of said sheath, the threaded region of said third attachment portion of said sheath adapter is sized and shaped to be threadingly engaged with the threaded region of said second attachment portion of said sheath, thereby reversibly joining said sheath and said sheath adapter when engaged, and, when said sheath and said sheath adapter are joined, said tapered portion of said sheath adapter extends into said first attachment portion of said sheath, andwherein said manifold is capable of delivering said flowable medium to the distal tip of the cannulated and fenestrated bone screw having a length of at least about 130 mm using manual pressure. 15. The bone screw manifold of claim 14, wherein said bone screw manifold comprises one or more, or all, of the following characteristics: a) said sheath body has an external diameter of at least 8 mm;b) said first attachment portion has a length of about 5 to 8 mm, said threaded region of said first attachment portion has a length of about 2 to 4 mm and at least 3 thread revolutions, and said internal channel of said first attachment portion has an internal diameter of about 6 to 9 mm;c) said second attachment portion has a length of about 16 to 24 mm, and wherein said threaded region of said second attachment portion has a length of about 4 to 7 mm and at least 2 thread revolutions, and said internal channel of said second attachment portion has an internal diameter of about 5 to 8 mm;d) said first handling portion comprising at least five raised ridges that extend in a direction substantially parallel to the longitudinal axis of said sheath body;e) said third attachment portion has a length of about 6 to 10 mm and said threaded region of said third attachment portion has a length of about 4 to 7 mm and at least 2 thread revolutions;f) said second handling portion has a length of about 10 to 15 mm and comprises at least four raised ridges on an exterior portion thereof that extend in a direction substantially parallel to the longitudinal axis of said sheath adapter body;g) said fourth attachment portion has a length of about 6 to 9 mm and said threaded region of said fourth attachment portion has a length of about 3 to 5 mm and at least 2 thread revolutions;h) said tapered portion has a length of about 5 to 7 mm and an exterior diameter of about 2.5 to 7 mm, and said tapered portion has a chamfer at the distal end;i) said first attachment portion of said sheath is sized and shaped to be threadingly engaged with a head of the bone screw;j) said second attachment portion of said sheath is sized and shaped to be threadingly engaged with a device for injecting a flowable medium, wherein said flowable medium comprises a bone void filler, a cement, or a pharmaceutical agent;k) said bone screw manifold is, or comprises, a polymeric material;l) said sheath body has a length of about 76.2 mm and said internal channel of said sheath has a diameter of 5.8 mm; and/orm) said sheath adapter body has a length of about 67.1 mm and an external diameter of about 5.3 mm and said internal channel of said sheath adapter has a diameter of 2.5 mm. 16. A system comprising the bone screw manifold of claim 14, wherein the system comprises a bone screw and/or one or more of a bone screw washer, an injection device, a self-hardening bone cement powder, and instructions for using said system.
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