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WO2020012295A1 - Dispositif d'espacement destiné à remplacer une prothèse mammaire ou conçu pour être implanté dans un sein du corps humain - Google Patents

Dispositif d'espacement destiné à remplacer une prothèse mammaire ou conçu pour être implanté dans un sein du corps humain Download PDF

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Publication number
WO2020012295A1
WO2020012295A1 PCT/IB2019/055637 IB2019055637W WO2020012295A1 WO 2020012295 A1 WO2020012295 A1 WO 2020012295A1 IB 2019055637 W IB2019055637 W IB 2019055637W WO 2020012295 A1 WO2020012295 A1 WO 2020012295A1
Authority
WO
WIPO (PCT)
Prior art keywords
spacer device
recesses
main body
notch
peripheral edge
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2019/055637
Other languages
English (en)
Inventor
Giovanni Faccioli
Renzo Soffiatti
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tecres SpA
Original Assignee
Tecres SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tecres SpA filed Critical Tecres SpA
Publication of WO2020012295A1 publication Critical patent/WO2020012295A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/12—Mammary prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/02—Devices for expanding tissue, e.g. skin tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0815—Implantable devices for insertion in between organs or other soft tissues
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0021—Angular shapes square
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0023—Angular shapes triangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0026—Angular shapes trapezoidal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0026—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0059—Additional features; Implant or prostheses properties not otherwise provided for temporary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/009—Additional features; Implant or prostheses properties not otherwise provided for for single use, e.g. having means for preventing re-use

Definitions

  • the present invention regards a spacer device for replacing a breast prosthesis or suitably for being inserted at a breast of the human body.
  • such spacer device which is of temporary and disposable type, is in use implanted at a surgical site placed at a breast of the human body, for example suitable for replacing an infected breast prosthesis and/or for treating an infection occurring at said surgical site.
  • Still other devices are formed of plates or beads of various material, tied to each other, but in the latter case the shape of the surgical site is not at all maintained.
  • the spacer device according to the present invention therefore sets out to overcome the drawbacks of the prior art, so as to overcome the present needs of the field.
  • the task of the present invention is to improve the state of the prior art.
  • one object of the present invention is to provide a spacer device suitable for being implanted in use at a surgical site placed at a breast of the human body, for example suitable for replacing an infected breast prosthesis and/or for treating an infection occurring at the surgical site.
  • Another object of the present invention is to provide a spacer device capable of being inserted in the human body by means of an incision of small size, with respect to the prior art.
  • a further object of the present invention is to provide a spacer device capable of at least partially re-establishing the shape of the surgical site in which it is inserted in use.
  • a spacer device according to claim 1 is provided.
  • figure 1 is a perspective view of the upper or outer part of the spacer device according to the present invention.
  • figure 2 is a top plan view of the spacer device pursuant to figure 1;
  • figure 3 is a sectional side view taken along the trace plane III-III of figure 2;
  • figure 4 is a sectional side view taken along the trace plane IV-IV of figure 2;
  • figure 5 is a sectional side view taken along the trace plane V-V of figure 2;
  • figure 6 illustrates a further version of the spacer device according to the present invention
  • figure 7 illustrates a further version of the spacer device according to the present invention.
  • figure 8 is a top plan view of the spacer device pursuant to figure 7;
  • figure 9 is a sectional side view taken along the trace plane IX-IX of figure 8;
  • figure 10 is a sectional side view taken along the trace plane X-X of figure 8;
  • figure 11 is a sectional side view taken along the trace plane XI-XI of figure 8;
  • figure 12 illustrates a further version of the spacer device of figure 7;
  • figure 13 illustrates a further version of the spacer device of figure 1.
  • reference number 1 overall indicates a spacer device according to the present invention, suitable for being implanted in use at a surgical site placed at a breast of the human body, for example suitable for replacing an infected breast prosthesis and/or for treating an infection occurring at the surgical site.
  • the spacer device l is a temporary and disposable spacer device, suitable for remaining in the human body for a limited time period, such as for example several months, for example until the infection present at the surgical site has healed and/or up until the implant of a new permanent prosthesis.
  • the spacer device 1 comprises a main body 2 provided with an outer surface 3, substantially directed towards the exterior of the human body in use, and with an inner surface 4, substantially directed towards the interior of the human body in use.
  • the main body 2 has a substantially circular plan shape or a substantially polygonal plan shape, such as square, rectangular, trapezoidal, triangular, pentagonal, hexagonal, octagonal etcetera.
  • the main body 2 has a (three-dimensional) shape that is substantially cap-like (e.g. spherical cap) or in another version of the invention, a (three- dimensional) shape that is substantially flat.
  • outer surface 3 and/or the inner surface 4 are at least slightly curved, and/or the outer surface 3 is substantially convex while the inner surface 4 is substantially concave.
  • the surface 3 and the surface 4 can be substantially flat and parallel to each other.
  • At least one of the surfaces 3, 4 (e.g. the outer surface 3) is substantially curved (e.g. convex) while the other (e.g. the inner surface 4) is substantially flat.
  • main body 2 has a substantially cap-like shape (e.g. spherical)
  • it can have a curvature having a radius comprised between 5 cm and 15 cm or between 6 cm and 10 cm or 6 cm or another curvature depending on the anatomical needs of the patient or of the surgical site.
  • the outer surface 3 and/or the inner surface 4 has a curvature with the above-indicated radius.
  • the main body 2 has an outer peripheral edge 5 with a substantially circular or polygonal, such as square, rectangular, trapezoidal, triangular, pentagonal, hexagonal, octagonal, etcetera, plan shape.
  • outer peripheral edge 5 can have a substantially rounded section, e.g. so as to avoid the presence of sharp edges that can in some manner damage the tissues surrounding the surgical implant site.
  • the main body 2 comprises a central zone C.
  • Such central zone C in a version of the invention is an apical zone of the spacer device 1 and/or substantially corresponds to the center of symmetry of the spacer device 1, and/or, considering the version illustrated in the plan view of fig. 2 or 8, to the zone adjacent to the center of the circle or to the polygon that identifies the outer peripheral edge 5.
  • the longitudinal symmetry axis of the spacer device 1 can pass through the center of symmetry C. In at least one version of the invention, such longitudinal symmetry axis coincides with the trace plane IV-IV or X-X.
  • such central zone C has a diameter or a width of about 2 cm or comprised between 2 and 4 cm.
  • the central zone C corresponds to the top zone of the main body 2, when this has a cap shape and/or to the most protruding zone of the spacer device 1 with respect to the peripheral edge 5. Otherwise, or in another version, the central zone C is that zone of the spacer device which is substantially equidistant from the peripheral edge 5.
  • the main body 2 also has a thickness W.
  • Such thickness W can be constant or not constant along the extension of the main body 2.
  • Such thickness W can have a size comprised, for example, between 3 mm and 15 mm.
  • the spacer device 1 according to the present invention, and/or the main body 2 has a notch 10.
  • Such notch 10 is suitable for facilitating the insertion of the spacer device in use according to the present invention at the assigned surgical site. Indeed, as will be better described hereinbelow, such notch allows the spacer device 1 to be inserted at the surgical site by means of an incision having very limited extension with respect to the size of the device itself. Such incision, for example, due to such specific shape of the spacer device 1, can substantially correspond to or be smaller than the curvature radius and/or half of the overall lateral size of the device itself.
  • the notch 10 is a kind of slit or through opening present in the main body 2 which determines the particular ease of insertion thereof at the surgical site.
  • this can correspond, in accordance with the shape of the main body 2, substantially to an arc of circumference and/or have an arcuate or curved progression or even a substantially longitudinal progression.
  • the width S of the notch 10 (for example indicated in figures 2, 3, 8 and 9) can be constant over the entire longitudinal extension of the notch 10 or it can vary along the same.
  • a first width S’ can be present that is greater at the central zone C (where it can have the same diameter size or width of the latter) and a second smaller width S” at the outer peripheral edge 5.
  • the width S” at the peripheral edge 5 is equal to 1.4 cm or comprised between 1.0 cm and 2.5 cm.
  • the edges of the central body 5 at the notch 10 are smoothed or rounded in order to facilitate the insertion or prevent damage to the tissues of the human body at the surgical site.
  • Said main body 2, moreover, in at least one version of the invention, comprises recesses 11
  • the recesses 11, in one version of the invention, are not through recesses.
  • Such recesses 11 are for example present at the outer surface 3 and/or at the inner surface 4 of the main body 2.
  • the recesses placed on the outer surface 3 are indicated with 1 la while those of the inner surface 4 are indicated with 1 lb.
  • the recesses l la of the outer surface 3 are offset with respect to the recesses 1 lb of the inner surface 4 (as is visible in figure 1).
  • Such recesses 11, l la, l lb can all have the same shape, or they can have different shapes with respect to each other or the recesses l la with respect to the recesses 1 lb.
  • such recesses 11, l la, l lb have a substantially circular or ovoidal shape or an elongated extension that is substantially extended in a radial manner from said central zone C of the central body 2 until it approaches the outer peripheral edge 5.
  • such recesses 11, l la, l lb can also have different shape, such as rectangular, triangular or polygonal in general, without departing from the protective scope of the present invention.
  • the recesses 11, l la, l lb do not reach the outer peripheral edge 5, which therefore has a substantially constant thickness equal to W and/or a substantially continuous shape (except for the zone corresponding to the notch 10).
  • the thickness of the spacer device 2 is smaller than W and in particular is equal to W’.
  • the recesses 11 have a recessed zone.
  • Such recessed zone in at least one version, can gradually return from the outer surface 3 and/or from the inner surface 4 of the main body 2.
  • the recessed zone can have a perimeter zone that has a greater thickness (only slightly smaller than W) and a central zone in which the thickness is smaller (equal to W’). In such central zone, the depth of the recess 11 is greater.
  • the minimum thickness W’ of the recess 11 is equal to 1.5 mm or less than or greater than 1.5 mm.
  • the outer surface 3 has a series of recesses.
  • the outer surface 3 appears smooth and not recessing.
  • the inner surface 4 has a series of recesses given by the recesses l lb while, at the recesses l la, the inner surface 4 appears smooth.
  • the notch 10 lies along a diameter or a diagonal of the spacer device 1; in particular, it substantially occupies a first half of such diameter or diagonal. In the second half of such diameter or diagonal, a recess l la can be positioned.
  • the spacer device 1 is ideally divided, by such diameter or diagonal, into two halves, la and lb, which each house two recesses 1 la (in the version illustrated in figures 1 to 5).
  • the spacer device 1 is ideally divided into two halves, la and lb, also by its longitudinal symmetry axis.
  • the recess l la that is positioned close to the notch 10 has a longitudinal axis (possibly corresponding to a radius of the spacer device 1) which forms, with the axis of the notch 10, an angle A of 60° (fig. 2).
  • the various recesses l la have longitudinal axes, which are intersected at the center of the spacer device 1, each separated by 60°.
  • Analogous spacing could also be present for the recesses 1 lb.
  • the recesses 11, l la, l lb could also be separated from each other by smaller, greater or variable distances in accordance with the requirements.
  • such recesses 11 could be through and hence constitute openings or holes that place in communication the outer surface 3 and the inner surface 4 of the main body 2.
  • the recesses 11 can have a different configuration from each other, for example they can have an ovoidal or circular or polygonal size, possibly with different dimensions from one recess to another. In this case, the thickness of the wall of the main body 2 at these through recesses 11 is equal to zero.
  • the spacer device 1 comprises a main body 2 formed by a network or lattice structure or having the shape described above but made as a kind of mesh forming through or non-through recesses with circular, square, triangular, rhomboidal, hexagonal or polygonal section, or cubic, polyhedral, tetrahedral or other shape.
  • the main body 2 is attained by a series of first band or belt elements 2a of the material that constitutes the spacer device 1, flanked parallel to each other and spaced apart by a certain distance from each other.
  • the space between a first element 2a and the first element 2a adjacent thereto constitutes the space that determines the at least one first recess 1 ld.
  • the first band elements 2a described above are arranged in a first layer, whose shape constitutes that (e.g. outer) of the spacer device 1.
  • the outer peripheral edge 5 of the spacer device is preferably continuous.
  • second band or belt elements 2b of the material that constitutes the spacer device 1 are present, flanked parallel to each other and spaced apart by a certain distance from each other.
  • the space between a second element 2b and the second element 2b adjacent thereto constitutes the space that determines the at least one second recess 11 e.
  • the second band or belt elements 2b are arranged in a second layer, below the first layer formed by the first elements 2a, whose assembly constitutes the shape (e.g. inner) of the spacer device 1. Also in this case, the outer peripheral edge 5 of the spacer device is preferably continuous.
  • the arrangement of the first elements 2a can be tilted or perpendicular with respect to that of the second elements 2b. In such a manner, a network structure is created, in which the recesses l ld determined by the first elements 2a intersect the recesses l le determined by the second elements 2b, creating central recesses 1 lc common to the first and second layer of first and second elements 2a, 2b.
  • the recesses l lc pass from the outer surface 3 to the inner surface 4 while the recesses 1 ld, 1 le only cover the outer surface 3 or the inner surface 4, respectively.
  • the recesses l le and/or the elements 2b are arranged along a longitudinal axis that forms, with the axis of the notch 10, an angle A of 60°. Since the elements 2b and/or the recesses l ld are perpendicular (in the illustrated version) to the elements 2a and/or to the recesses l ld, the latter for, with the axis of the notch 10, an angle of 30°. Such sizes can also vary depending on the respective tilt of the elements 2a and 2b and of the position of the notch 10.
  • the spacer device 1 is made of a biologically compatible plastic material, such as an acrylic resin or an acrylic polymer, such as polymethylmethacrylate or a bone cement or a polymethylmethacrylate-based bone cement.
  • a biologically compatible plastic material such as an acrylic resin or an acrylic polymer, such as polymethylmethacrylate or a bone cement or a polymethylmethacrylate-based bone cement.
  • the spacer device 1 can also be made of a thermoplastic material and/or of an elastomeric material, or of silicone or of the material with which breast prostheses are normally made, or a plastic material such as polyethylene or PEEK or another suitable and biologically compatible plastic material.
  • the spacer device can comprise at least one antibiotic, such as gentamicin sulfate, vancomycin, etcetera.
  • the spacer device moreover, can at its interior comprise a further drug, depending on the specific needs.
  • the spacer device 1 is therefore capable of releasing and/or eluting the antibiotic and/or the drug possible present at its interior.
  • the material that constitutes the spacer device 1 therefore, is porous, i.e. provided with interconnected pores, so as to allow the outflow of the antibiotic and/or of the drug towards the tissues surrounding the surgical implant site.
  • the pores present within the material (and at a surface zone) that constitutes it have a transverse size not greater than 100 micron.
  • the recesses 11, 1 la, 1 lb, 1 lc, l ld, l le in addition to having the function of lightening the weight of the spacer device 1, and hence being more comfortable and less invasive for the patient, can also be (in at least one version of the invention) suitable for housing an additional material 20, of different or equal type with respect to the material that constitutes the spacer device 1. This option is for example illustrated in figures 12 and 13.
  • the additional material is bone cement, possibly with PMMA base, comprising at least one antibiotic and/or drug.
  • the spacer device 1 only minimally performs a mechanical function, since in this zone (unlike for example what happens with spacer devices for the hip or knee) it is not necessary (or it is only minimally) to sustain weights or loads.
  • such additional material 20, which can be solidified type, can in turn contain at least one antibiotic and/or a drug, so as to assist in the treatment function of the spacer device 1.
  • the material of the spacer device could also lack antibiotics and/or drugs, since the treatment function can be completely given to the additional material 20.
  • the material of the spacer device 1 is inert.
  • the additional material 20 can be applied at the outer surface 3 and/or at the inner surface 4 of the spacer device 1 and/or outside the first layer and/or inside the second layer of the network structure formed by the first elements 2a and/or by the second elements 2b.
  • First and second layer are in contact with each other, and are possibly attained so as to form a single piece.
  • the spacer device 1 according to the present invention can be made via molding, such as injection molding or three-dimensional molding.
  • the spacer device 1 while being made of a single piece, due to the notch 10 is in use inserted within the breast of a patient, by means of a very narrow incision.
  • Such incision is for example made in the lower part of the breast itself.
  • the spacer device 1 in fact, due to the notch 10 has a substantially circular plan shape or, better yet, a C or a stylized C shape. Therefore, even if it does not have the exact shape as a breast, once inserted it is able to at least slightly recreate the camber of the breast itself, in at least some versions of the present invention.
  • a first half la of the spacer device 1 is in fact inserted within the surgical site by following a direction parallel to that of the notch 10 or better yet inserting such device by longitudinally following the notch 10.
  • One of the inner edges of the notch 10 (e.g. the left edge) is then inserted in position, placing it close to one end (e.g. the right end) of the surgical incision.
  • the spacer device 1 After having inserted the spacer device 1 up to its central zone C, it is in fact rotated, with center corresponding to the center of the device itself, according to a clockwise direction, up to the complete insertion of the entire spacer device.
  • the insertion can also occur in counter-clockwise sense, depending on the needs or on the preferences of the surgeon.
  • the surgical device 1 is maintained in position, for example by means of stitching, e.g. by passing surgical thread within two small holes 12 (visible in figure 2) suitably arranged at the ends of the notch 10, at the outer peripheral edge 5.
  • the spacer device therefore, as stated, at least partly recreates the convexity and/or the volume of the breast of the patient, thus being of assistance during the treatment period for the patient himself/herself.
  • spacer device 1 can be provided for, so as to better meet the anatomic needs of the patient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

Dispositif d'espacement temporaire, jetable, conçu pour être implanté, en utilisation, dans un site chirurgical situé au niveau d'un sein du corps humain, par exemple conçu pour remplacer une prothèse mammaire infectée et/ou pour traiter une infection se produisant au niveau du site chirurgical, et comprenant un corps principal (2) pourvu d'une surface externe (3) et d'une surface interne (4), d'une zone centrale (C) et d'un bord périphérique externe (5) lequel corps principal (2) peut avoir une forme de plan sensiblement circulaire et/ou une forme de calotte sensiblement sphérique, ledit dispositif d'espacement comprenant une encoche (10) conçue pour faciliter l'insertion dudit dispositif, en utilisation, au niveau du site chirurgical.
PCT/IB2019/055637 2018-07-10 2019-07-02 Dispositif d'espacement destiné à remplacer une prothèse mammaire ou conçu pour être implanté dans un sein du corps humain Ceased WO2020012295A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102018000007088 2018-07-10
IT201800007088 2018-07-10

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WO2020012295A1 true WO2020012295A1 (fr) 2020-01-16

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PCT/IB2019/055637 Ceased WO2020012295A1 (fr) 2018-07-10 2019-07-02 Dispositif d'espacement destiné à remplacer une prothèse mammaire ou conçu pour être implanté dans un sein du corps humain

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AR (1) AR115723A1 (fr)
WO (1) WO2020012295A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2136692A (en) * 1983-03-18 1984-09-26 Roehm Gmbh Implantable plastic moulding
US5112352A (en) * 1991-07-18 1992-05-12 Brian Novack Pectoral implant and method for implanting the same
CN2291130Y (zh) * 1997-02-28 1998-09-16 张建军 一种方便植入人体的乳房假体
US20090149953A1 (en) * 2007-12-10 2009-06-11 Schuessler David J Form stable breast implant sizer and method of use
US20110137244A1 (en) * 2009-12-08 2011-06-09 Taris Biomedical, Inc. Tissue Expander Configured for Drug Delivery
US20130289721A1 (en) * 2012-04-27 2013-10-31 Michael Klebuc Breast Implant Spacers for the Treatment of Periprosthetic Breast Implant Infections
EP2995278A1 (fr) * 2014-09-09 2016-03-16 Klinikum rechts der Isar der Technischen Universität München Implant médical/chirurgical

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2136692A (en) * 1983-03-18 1984-09-26 Roehm Gmbh Implantable plastic moulding
US5112352A (en) * 1991-07-18 1992-05-12 Brian Novack Pectoral implant and method for implanting the same
CN2291130Y (zh) * 1997-02-28 1998-09-16 张建军 一种方便植入人体的乳房假体
US20090149953A1 (en) * 2007-12-10 2009-06-11 Schuessler David J Form stable breast implant sizer and method of use
US20110137244A1 (en) * 2009-12-08 2011-06-09 Taris Biomedical, Inc. Tissue Expander Configured for Drug Delivery
US20130289721A1 (en) * 2012-04-27 2013-10-31 Michael Klebuc Breast Implant Spacers for the Treatment of Periprosthetic Breast Implant Infections
EP2995278A1 (fr) * 2014-09-09 2016-03-16 Klinikum rechts der Isar der Technischen Universität München Implant médical/chirurgical

Also Published As

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