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US 2019/0159904 A1Published application
Spacer device for treating a joiny of the human body
OwnerAugusto Magagnoliinventor
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OwnerAugusto Magagnoliinventor
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An implantable modular spacer device to treat an infected articular seat includes a stem element, a head or ball element, and coupling elements between the stem element and the head that include a plurality of elongated teeth, placed at pre-established distances from each other, and a plurality of housing seats for the teeth. An implantable spacer device to treat a bone seat or joint seat or for the two-step treatment of infections of joint prostheses includes a joint component adapted to be inserted in an articular zone of the patient and having an external surface, a stem component adapted to be implanted in a bone or in a residual bone bed of a preceding joint prosthesis, and adjustable connection elements, wherein at least part of the external surface of the first portion of the stem component and at least part of the external surface of the joint component define a contact surface with the bone tissue or adapted for coupling with the bone tissue. The connection elements are placed between the joint component and the stem component to adjust the distance thereof, and the contact surface in the joint component and/or in the stem component has a plurality of recesses or housing a filling material that includes a pharmaceutical or medical substance, wherein the plurality of recesses affects or is substantially placed along the entire contact surface or in proximity thereto.
Spacer device, implantable in the human body for the treatment of an infected bone seat or joint seat or for the two-step treatment of the infections of the joint prosthesis, comprising a joint component (2), a stem component (3) and connection means (4) of adjustable type, wherein said joint component (2) is during use adapted to be inserted in an articular zone of the patient and wherein said stem component (3) is during use adapted to be implanted in a bone or in a residual bone bed of a preceding joint prosthesis, wherein said joint component (2) has an external surface (E) and wherein said stem component (3) comprises a first portion (11) having a substantially elongated shape, wherein at least part of the external surface of the first portion (11) of said stem component (3) and/or at least part of the external surface (E) of said joint component (2) define a contact surface with the bone tissue and/or adapted for coupling with the bone tissue, characterized in that said connection means (4) are placed between said joint component (2) and said stem component (3) in order to adjust the distance (G) thereof, in that said contact surface present in said joint component (2) and/or in said stem component (3) comprises a plurality of recesses (14, 24) for housing at least one filling material (M) comprising at least one pharmaceutical or medical substance, wherein said plurality of recesses (14, 24) affects or is placed substantially along the entire contact surface or in proximity thereto, and in that each recess of said plurality of recesses (14, 24) has a planar surface extension and a depth, wherein said surface extension is greater than the depth.
Spacer device according to any one of the preceding claims, wherein said joint component (2) comprises a first cavity (8) which is extended from said base (6), determining an opening (10) in the latter, possibly circular, wherein said first cavity (8) is adapted to house a shank (13) of said stem component (3).
Spacer device according to any one of the preceding claims, wherein said first portion (11) comprises two substantially flattened faces (11A, 11B) and two substantially curved faces (11C, 11D), wherein said two substantially flattened faces (11A, 11B) are positioned on opposite sides with respect to a longitudinal symmetry plane (S) of said stem component (3), wherein said plurality of recesses (24) is placed at least along said substantially flattened faces (11A, 11B).
Spacer device according to the preceding claim, wherein in plan or side view, each substantially flattened face (11A, 11B) has a substantially trapezoidal shape, with two longitudinal sides (L1, L2) substantially corresponding to the length of each of said substantially flattened faces (11A, 11B), which converge towards a first base (B1), placed at a distal end (D) of the stem component (3), and a second base (B2), of size greater than said first base (B1), wherein said side (L1) has a size or length less than said side (L2), such that said base (B2) is tilted.
Device according to any one of the preceding claims, wherein said joint component (2) comprises said recesses (14), wherein said recesses (14) have a first size or width less than a second size or height, and/or wherein said recesses have a substantially oval or polygonal shape with rounded edges and rounded corners, and/or wherein said first size or width of said recesses (14) is placed at the opening (10) of the cavity (8) while the second size or height of said recesses (14) is placed in a manner substantially perpendicular to the opening (10), and/or wherein said plurality of recesses (14) is radially positioned around the opening (10) of the joint component (2).
Spacer device according to any one of the preceding claims, wherein said plurality of recesses (14) is positioned at said lateral wall (7) of said joint component (2), and/or wherein each recess (14a) of said plurality of recesses (14) is positioned offset height-wise with respect to the adjacent recesses (14b), and/or wherein recesses (14a) are positioned at the same height (H1), with respect to said base (6) of the joint component (2) and wherein recesses (14b), placed at a height (H2) with respect to said base (6), are staggered with said recesses (14a), wherein (H2) is greater than or equal to (H1).
Spacer device according to any one of the preceding claims, wherein each recess (14, 24) has a perimeter wall (15, 25), which is respectively extended towards the interior of said joint component (2) or of said stem component (3), and a base wall (16, 26) which forms a base of each recess (14, 24) and determines the planar surface extension or the opening of each recess (14, 24).
Spacer device according to any one of the preceding claims, wherein said stem component (3) and/or its faces (11A, 11B) comprise said plurality of recesses (24), wherein said recesses (24) are adjacent to each other and have a substantially trapezoidal or polygonal shape with rounded edges and/or corners, and/or wherein said recesses (24) have a first size or width less than a second size or height, and/or wherein said base wall (26) of each recess (24) is placed parallel to the symmetry plane (S) of said stem component (3).
Spacer device according to any one of the preceding claims, wherein said recesses (24) occupy substantially the entire area of each face (11A, 11B) and are delimited by sections or ribs (27) that are projecting with respect to the base wall (26).
Spacer device according to the preceding claim, wherein said sections or ribs (27) have a width that is less than both the width and the length of said recesses (24).
Spacer device according to any one of the preceding claims, wherein said connection means (4) comprise a thread and a nut screw, possibly with rounded profile, wherein said first cavity (8) has an internal lateral wall (9) which has a thread or nut screw and wherein said shank (13) comprises a thread corresponding to that of the thread or nut screw of said first cavity (8).
Spacer device according to any one of the preceding claims, wherein said spacer device and/or said filling material (M) is made of a biologically compatible material, possibly porous, admixed and/or admixable with one or more pharmaceutical products, active and/or therapeutic principles, adapted to be released during use in the tissues of the patient adjacent to the device, wherein said biologically compatible material is selected from among metals, metallic alloys, organic metals, ceramic, glass, plastic, thermoplastic polymers, acrylic resins, acrylic alloys and copolymers, polyvinylchloride, polystyrene, polyethylene, ultra-high molecular weight polyethylene (UHMWPE), high or low density polyethylene, etcetera, polypropylene, polypropylene thermoformable via injection molding or by molding with blowing, polymethylmethacrylate or a polymethylmethacrylate-based bone cement, a ceramic cement, such as the calcium sulfate known as plaster or CaSO4 and/or wherein said filling material (M) is of hardening or solidifiable type.
Method for obtaining a spacer device, implantable in the human body for the treatment of an infected bone seat or joint seat or for the two-step treatment of the infections of the joints prosthesis, according to any one of the preceding claims, comprising the following steps:
Method according to any one of the claims from 15 to 17, wherein said step of housing, in at least some of said recesses (14, 24), the filling material (M) comprising at least one pharmaceutical or medical substance, comprises the steps of housing, in at least one first recess, said filling material (M) comprising a first pharmaceutical or medical substance and of housing in at least one second recess said filling material (M) comprising a second pharmaceutical or medical substance, wherein said at least one first recess is different or separate from said at least one second recess and wherein said first pharmaceutical or medical substance is different from said second pharmaceutical or medical substance.
Kit for making a spacer device according to any one of the claims from 1 to 14, comprising at least two stem components (3) having sizes or dimensions different from each other, at least two joint components (2) having sizes or dimensions different from each other, at least one filling material (M).
Dependencies are inferred from the claim text.