Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06166—Sutures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
• • 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
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00792—Plastic surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00796—Breast surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
  • A61B2017/0404—Buttons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B2017/0496—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06166—Sutures
  • A61B2017/06171—Sutures helically or spirally coiled
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06166—Sutures
  • A61B2017/06176—Sutures with protrusions, e.g. barbs

Definitions

• the invention relates to an implantable medical device for the correction of moderate breast ptosis, as well as to a method for correcting moderate breast ptosis.
• the objective of the treatment of breast ptosis is to obtain a harmonious breast, rather than normal or ideal, that is to say, adapted to the best morphology of the patient (volume, shape, projection) respecting the established criteria (lengths and distances of the different segments, base of implantation) which are fundamental elements of stability.
• Conical in shape the breast should have a stable anterior projection in segments II and III and, from the front, a homogeneous glandular distribution.
• This targeted result takes into account physiological changes (normal variation in glandular volume during menstrual periods, pregnancy and breastfeeding) and pathological changes (volume change and rapid change in weight, involution of the glandular parenchyma by adipose invasion or sclerotic degeneration of stroma collagen) which will break the harmony of the breast, acting on the elasticity of the skin, the consistency and glandular compactness, and considerably weakening the elements of fixity of the breast, themselves very fragile.
• the mammary ptosis a consequence of conjugated phenomena, physiological or pathological, causes a displacement of the breast which is carried out below (cutaneous distension) and outside (thoracic convexity).
• Dufourmental and Mouly (Plastic Surgery, Flammarion, 1959, pp. 327-370) define the ptosis by moving the nipple upwards and outwards from its normal position, the normal position of the nipple, for a woman standing up at the intersection of a horizontal line passing through the middle of the arm and a vertical down to two across the finger outside the sternoclavicular joint.
• Dufourmental et al differentiate three degrees of mammary ptosis. A first degree, of small ptosis, in which the nipple is lowered from one to five centimeters.
• Regnault Breast ptosis, definition and treatment, Clin Plast Surg, 1976, pp. 193-203 proposes a classification of ptosis according to the position of the nipple with respect to the sub-mammary groove and a tangent plane passing at the most breast in a woman while standing.
• Figure 1 shows the classification of ptosis according to Regnault: from left to right a normal breast, minor ptosis, moderate ptosis, major ptosis, pseudo-ptosis and poor distribution of the parenchyma.
• the nipple is at the level of the under-mammary sulcus.
• the nipple is below the mammary groove and above the plane passing through the most sloping point of the breast.
• the major ptosis is related to a nipple placed below the under mammary groove and below the plane passing through the most sloping point of the breast.
• the pseudo ptosis is defined by Regnault by a breast whose nipple is above the under mammary groove with a hypoplastic gland below the groove.
• Vrebos (Classification and Operative Tactics in the Treatment of the Small Breast Pose, Acta Chir Belg, 1976, 5: 485: 504) proposes a classification to guide surgical treatment, a classification that distinguishes three types of breasts, small and ptose.
• the ptosis is primitive, mild or moderate, the skin retaining its qualities and cutaneoglandular connections, with little cutaneous excess; the hypoplasia is primitive, moderate or important and the overall consistency of the breast is good.
• ptosis is secondary, the skin losing its tonicity, the cutaneous glandular connections remaining normal, the cutaneous surplus is moderate; Hypoplasia is secondary, moderate or important and the overall consistency of the breast is relatively good.
• Vrebos proposes a general scheme of treatment as follows, according to the following parameters:
• time Bostwick (1984) describes three stages of ptosis as a function of the position of the nipple relative to the sub-mammary groove.
• Vandenbussche (Breast Ptosis: Classification and Summary of Surgical Indications, Ann Chir Plast Esthet, 1992, 37: 218-226) classifies mammary ptosis into four groups.
• the first group includes early or primary ptosis, including ptosis by skin elasticity disorder and primary morphological ptosis.
• the second group is that of ptosis secondary to hypertrophy or hyperplasia of the breast.
• the third group is ptosis acquired by tissue fusion.
• the fourth group is that of primary or secondary asymmetric ptosis.
• Ptosis correction techniques are classified into five categories: dermopexy nipple refocusing with or without associated prosthesis; insertion of isolated prosthesis, isolated reduction of the cutaneous sac, cutaneous glandular reduction, glandular resection with nipple graft.
• Kirwan (Augmentation on the ptotic breast: simultaneous perialveolar mastopexy and breast augmentation, Aestht Sur 1999, 19, 34-39) proposes a classification of ptosis, using the principles developed by Bostwick, and proposes a graduation of surgical techniques, with or without prosthesis. For treatments without prosthesis, Kirwan distinguishes:
• Isolar mastopexy associated with a vertical or classic mastopexy with vertical and horizontal ( Figure 8) when the nipple is more than two cm below the furrow.
• the mammary ptosis is most often defined by a collapse of the gland and a distension of the skin that surrounds it. Ptosis may exist immediately, but often occurs after significant weight loss or after a pregnancy with breastfeeding. This is the case, for example, of ptosis with post-pregnancy atrophy of the upper quadrants, in young women after two deliveries.
• the ptosis can be isolated, it is called pure ptosis.
• Ptosis may be associated with some breast hypertrophy, or breast hypoplasia or hypotrophy.
• the evaluation of the degree of ptosis is carried out by measuring the sterno-areolar distance (segment I + segment II), by the location of the areola with respect to the submammary groove (segment III) and by the relation between segment II and segment III. Indeed, if the segment III is short and although the segment II is unwound, it will be possible to resorb a significant portion of the sterno-areolar distance by the artifice of the periareolar pathway. On the other hand, the longer the segment III, the longer the scar will be, the postoperative areolar-sub-mammary distance being fixed and stable.
• Surgical treatment of the ptosis is intended to place the areola and nipple in "good" position, refocus and ascend the gland and remove excess skin, if any.
• the corrective procedure includes both glandular excision and cutaneous excision.
• the procedure In the case of ptosis associated with breast hypotrophy, the procedure generally involves the placement of a prosthesis and a resection of skin to tighten the skin envelope of the breast.
• the present invention relates to an implantable medical device and a method for the correction of mammary ptosis, and more particularly of moderate mammary ptosis, primary or secondary, glandular or true, without hypertrophy nor hypotrophy, ie the ordinary ptosis the relatively young woman with normal size breasts, not yet involved, who simply tend to go down naturally, without any other component to correct.
• mammary ptosis The surgical treatment of mammary ptosis, according to conventional techniques, is invasive (isolar mastopexy, areolar mastopexy associated with a vertical incision, areolar mastopexy associated with a vertical incision or classic mastopexy with vertical and horizontal incisions, see Figures 6 to 8).
• Surgical treatment of mammary ptosis thus generates many disadvantages.
• the evolution of the scars can be unfavorable with the occurrence of hypertrophic scars, even keloids, appearance and evolution difficult to predict, and requiring often long treatments. Alterations of sensitivity, particularly nipple, are observed.
• the risks of relapse are also important.
• Traditional surgery for breast ptosis is invasive, with extensive dissection and risk of fibrotic reaction.
• US20080027486, US20080097526 disclose the use of notched threads placed in the ptose breast, these son being placed with a trocar and put under tension before fixation.
• suspension elements as described in WO 201051506 has many disadvantages.
• the suspending elements are not satisfactorily fixed, their attachment close to the skin to soft tissues causing risks of stalling, with driving and wrinkling of the skin.
• This disadvantage is also present for the prosthesis described in EP1532942.
• the invention aims to overcome the disadvantages of devices and methods for treating ptosis known in the prior art.
• a first object of the invention is to provide a device for returning the breasts to the position they were a few years ago, compared to the anatomical landmarks that define the ideal position, associated with youth.
• a second objective of the invention is to provide a device and a minimally invasive method for the treatment of breast ptosis, particularly moderate ptosis, and more particularly moderate ptosis without hypertrophy or hypotrophy.
• a third objective of the invention is to provide a minimally invasive surgical technique for the treatment of mammary ptosis, this technique limiting bleeding, reducing postoperative pain, limiting the risks of adhesion and infectious risks, reducing the durations hospitalization, compared to open-air techniques.
• a fourth object of the invention is to provide a device and a method for treating breast ptosis, the attachment of the device being reliable and durable.
• a fifth object of the invention is to provide a device and a method for treating breast ptosis without significant side effects, particularly without significant impact on breast tenderness.
• a sixth object of the invention is to provide a device and a method of treating breast ptosis limiting pain and discomfort of patients and reducing convalescence time compared to conventional techniques.
• a seventh objective of the invention is to provide a device and a method for treating breast ptosis adapted to moderate breast ptosis, without hypotrophy or hypertrophy (sizes B to D), in particular for patients 27 to 45 years old. , without removal of the gland or removal of the areola, without scars in T or L conventional mastopexies, this technique can be implemented with short hospitalization times of the order of a few hours, and without general anesthesia , at least for some patients.
• the invention relates, according to a first object, to an implantable medical device for the treatment of ptosis, in particular mammary ptosis, this device comprising a suspension wire provided with a distal end portion and a proximal end portion, the suspension wire comprising, in its distal end portion, a wire axis on which is reported a piece carrying at least one projection, advantageously forming docking hook.
• distal is used with reference to that part of the suspension wire intended to be placed inside the mass of the breast.
• proximal is used with reference to that portion of the suspension wire for attachment to bone or muscle.
• the device has the following characters, possibly combined, according to various embodiments:
• the suspension wire carries a mooring net, in particular arranged around at least one intermediate piece, the net being advantageously a mesh made of a material chosen from the group comprising polypropylenes, polyesters, polyester polyglactin mixtures.
• a mooring net allows, in the long term, a fixation by strong adhesion with tissues, by tissue colonization;
• the wired axis is made of a material selected from the group consisting of polyurethanes, silicones, polyesters, polypropylenes, metals and metal alloys.
• the device comprises several parts each carrying at least two projections, advantageously forming docking hooks, these hooks having a radial extension relative to the slenderness of the wire axis.
• a portion of the hooks have a longitudinal extension relative to the axis of slenderness of the suspension wire.
• the mooring hooks have different provisions following the embodiments.
• they are arranged, over at least a length of the distal end of the suspension wire, in a predetermined pattern, for example helically, or in alignment with each other, when the suspension wire is seen perpendicular to its slenderness .
• a portion of the hooks have a longitudinal extension oriented toward the distal end of the suspension wire, the other hooks having a longitudinal extension oriented towards the proximal end of the suspension wire or a substantially zero longitudinal extension.
• the parts carrying the projections advantageously forming docking hooks comprise a tubular sleeve provided with a passage hole of the wire axis.
• the passage hole is substantially smooth and of a diameter substantially equal to the outer diameter of the wire axis.
• the passage hole of the wire axis is provided with a groove complementary to a projection disposed on the wire axis.
• the throat of the tubular sleeve and the projection of the wire axis are substantially longitudinal or are curved, especially helical.
• the device comprises means for fixing the body of the proximal end portion of the suspension wire.
• the fixing means comprise a plate provided with a through hole of the proximal end portion of the suspension wire.
• the fixing plate is a lattice, in particular made of a polymer material chosen from the group comprising polypropylenes, polyurethanes, silicones and polyesters.
• the proximal end of the suspension wire forms advantageously a ribbon of substantially rectangular cross-section.
• the fixing means comprise a suspension tongue and a fixing pin.
• the attachment tongue is provided with at least two holes for passing the tip of the attachment pin.
• the fixing tongue forms a ribbon of substantially rectangular cross-section, the proximal end portion of the suspension wire being assembled or integral with the suspension tongue.
• the attachment pin advantageously comprises a flattened head provided with means for receiving the end portion of an ancillary such as a needle, the tip of the fixation pin being provided with transverse catches to ensure a solid anchoring in the bone tissue and a groove along the longitudinal axis to prevent axial rotation. .
• the fixing means comprise a clip provided with at least one receiving orifice of the proximal end of the suspension son.
• the clip is provided with at least two receiving orifices of the proximal end of the suspension son, at least one of these holes having a keyhole-shaped opening.
• the device comprises an ancillary installation of at least one suspension wire, the ancillary comprising a trocar and a pusher.
• the ancillary comprising a trocar and a pusher.
• the trocar is curved.
• the trocar has a beveled end.
• the dimensions of a device are for example the following: the distal end portion of the suspension wire has a total length of between about 60 and 80 mm, the cross section of the distal end portion of the suspension wire being of the order of 2 millimeters;
• the proximal end of the suspension wire is ribbon-shaped with a width of the order of 4 millimeters and a length of the order of 145 mm;
• the suspension wire has a substantially smooth intermediate portion and of circular section, disposed between the distal end portion and the proximal end portion, this intermediate portion extending over a length of about 20 mm;
• the parts carrying mooring hooks have a longitudinal dimension of the order of 10 mm;
• the outside diameter of the pusher is of the order of 5 mm, the internal diameter of the pusher being of the order of 4 mm, the inside diameter of the trocar being substantially equal, with the functional clearance close, to the outside diameter of the pusher; outer diameter of the trocar being of the order of 7 mm; the hooks form an angle of between 15 and 50 degrees with respect to the axis of slenderness of the suspension wire, and preferably between 30 and 50 degrees and more preferably of the order of 38 degrees.
• Figures 2 to 5 represent, according to Brink, the glandular ptosis (Figure 2), the true ptosis ( Figure 3), the pseudo ptosis (Figure 4), and poor distribution of the parenchyma (Figure 5);
• Figures 6 to 8 show the usual scars during areolar mastopexy (Figure 6), isolar mastopexy associated with a vertical incision ( Figure 7), and isolar mastopexy associated with a vertical incision and incision. horizontal ( Figure 8);
• Figure 9 is a perspective view of a distal end portion of a suspension wire
• Fig. 10 is a perspective view of an element of the distal end portion of a suspension wire
• Figure 11 is a side view of the element shown in Figure 10;
• Figure 12 is a top view of the element shown in Figures 10 and 11;
• Figure 13 is a view below the element shown in Figures 10 to 12;
• Figure 14 is a sectional view along the plane XIV-XIV of Figure 13;
• Fig. 15 is a plan view of a suspension wire
• Figure 16 is a detail view of the suspension wire shown in Figure 15;
• FIG. 17 is a view of a plate for fixing a suspension wire, the proximal end portion of a suspension wire being threaded through the orifices of the plate;
• Figure 18 is a view similar to Figure 17, the proximal end portion of a suspension wire being secured to the fixing plate;
• Fig. 19 is a detail view of a fastener tab, in another embodiment
• Figure 20 is a view similar to Figure 19, the proximal end portion of a suspension wire being placed against or integral with the fastening tab;
• Figure 21 is a sectional view of a device for securing the end portion of a suspension wire to the fixing plate shown in Figure 19;
• Figure 22 is a schematic view of the end portion of an ancillary mounting of the securing device shown in Figure 21;
• Figure 23 is a bottom view of the securing device shown in Figure 21, after its mounting on the fixing plate;
• FIGS. 24 to 26 are schematic views of a fastening device of the proximal end portion of a suspension wire, according to another embodiment
• FIGS 27 to 29 illustrate the passage of a suspension wire, as shown in Figures 15 and 16 in an ancillary;
• FIG. 30 is a perspective view of an angled trocar according to one embodiment
• Figures 31 to 33 are front views of three steps of implementation of a device according to the invention.
• Figure 34 is a dissection plane of a breast provided with a device as shown in Figure 33;
• FIG. 35 to 38 are schematic views illustrating the establishment of a breast prosthesis
• Figure 35 shows a breast prosthesis provided with an integrated suspension tab
• Fig. 36 shows the fastening tab of the prosthesis shown in Fig. 35, this tab being threaded through a fixing plate;
• FIG. 37 represents the prosthesis according to FIG. 35, placed in premuscular manner with attachment to the superficial surface of the pectoralis major muscle via the plate;
• FIG. 38 shows the prosthesis according to Figure 35, placed in retromuscular fixation with the deep face of the pectoralis major muscle, through the fixing plate;
• FIG. 40 shows the placement of a retromuscular prosthesis and a suspension device in a ptose breast schematized in FIG. 39.
• the term “wire” is used to designate a slender element, without the cross section of this wire is constant over the entire length of this wire.
• the term “suspension wire” will thus be used to designate an element whose cross section, at its proximal end, is in the form of a ribbon, in certain embodiments (see for example FIG. 15) and whose distal end carries hooks.
• the device comprises an anchoring system 10, placed in the glandular tissue 201 of the breast 20, a fastening system 30 of the anchoring system 10 and an ancillary instrumentation 40 for easy placement of the device.
• the anchoring system 10 comprises a suspension wire 101, a distal end portion 102 of which is shown in FIG. 9.
• the suspension wire 101 is provided with anchoring elements 103, that is to say notches, reliefs, projections, having a radial extension and, where appropriate, longitudinal with respect to the axis of the suspension wire. .
• axis of the suspension wire is meant here the main axis of slenderness of the suspension wire.
• the suspension wire extends substantially parallel to a straight line, when the wire is placed on a table, without applying stress. This straight line is then parallel to the axis of slenderness of the suspension wire.
• the suspension wire is pre-curved, during its manufacture, this pre-curvature being close to that desired for the wire during its placement in the body.
• the pre-curved suspension wire retains an elasticity allowing it to be placed in a right trocar or in a trocar whose curvature is different from that of the suspension wire.
• the term "suspension wire axis" refers to the axis of slenderness of the wire placed in a right trocar.
• the curvature of the suspension wire is for example obtained by the use of a shape memory material forming the wire axis or molded in the polymeric material forming the wire axis.
• the shape memory material belongs, for example, to the family of nickel titanium alloys or else to shape memory polymers.
• the notches are made of material with the suspension wire. In another implementation, the notches are formed by machining the suspension wire, using cutting tools. In another implementation, the notches are derived from a thermophysical treatment of the suspension wire.
• the notches are formed by parts 104 advantageously mounted on a wire axis 105.
• These parts 104 comprise a tubular sleeve 106, the opening 107 of the tubular sleeve 106 allowing the passage of the wire axis 105.
• Projections 108 extend from the tubular sleeve 106, these projections 108 having a radial extension and a longitudinal extension relative to the wire axis 105 and thus advantageously forming anchoring elements or mooring hook 109.
• Each piece 104 thus forms a hook for anchoring the distal end portion 102 in the breast 20.
• Each piece 104 may comprise one, two or more projections 108.
• the projections 108 are of identical shapes and dimensions. In other implementations, the protrusions 108 are not shapes and / or are not of identical dimensions. In some implementations, the protrusions 108 are not equidistant. In some particular implementations, the projections 108 are arranged in a pattern, for example helically around the tubular sleeve 106.
• the projections 108 are of identical shape and dimensions, are equidistant and extend from the same cross section of the pieces 104, these projections 108 being three in number (FIG. 9) or four ( Figures 10 to 12).
• the distal end portion 102 of the suspension wire 101 carries several pieces 104.
• the hook pieces have their projections substantially disposed in the same orientation.
• the wired axis 105 is provided with an external thread and each workpiece 104 is provided with an internal thread, so as to provide a predefined orientation of the projections 108 along the distal end portion 102 suspension wire 101.
• the projections of at least a portion of the parts 104 are arranged in a single or double helix.
• Pieces 104 forming a hook are, in some implementations, in greater density on a portion of the length of the suspension wire 101, for example in the vicinity of the distal end of the wire.
• the projections 108 of the pieces 104 have any angular orientation with respect to each other, as shown in FIG. 9, and the pieces 104 are separated from one another by an intermediate or intermediate piece. 110.
• At least a portion of the spacers 110 may be provided with a surface treatment providing drug diffusion, for example analgesic or limiting microbial infection.
• a surface treatment providing drug diffusion, for example analgesic or limiting microbial infection.
• the suspension wire is subjected to a chemical or physical vapor phase treatment or else a plasma deposit.
• at least part of the intermediate pieces is provided with a surface treatment increasing its bio-accounting, for example a plasma deposit.
• At least one intermediate part 110 carries a trellis 111.
• This trellis 111 is advantageously made of polypropylene, of polyester, or of a polyglactin / polyester mixture, in particular 60% polyglactin 40% polyester. The presence of this lattice promotes the attachment of suspension wire by tissue colonization to increase the adhesion of tissues and sustain the suspension.
• Pieces 104 and spacer pieces 110 may be made of nylon, polyethylene terephthalate, polypropylene, silicone, polyurethane, or expanded polytetrafluoroethylene. In other embodiments, the parts 104 and / or the spacers 110 may be made of metal.
• the wired axis 105 is advantageously made of a flexible polymer material, that is to say able to be bent elastically by a manual action.
• the section of the wired axis 105 and its constituent material are advantageously chosen such that the wired axis 105 can withstand a load corresponding to a mass of about three hundred to six hundred grams, without significant creep at this level of charge and for temperatures between thirty degrees C below zero and fifty degrees above zero, and no significant creep at this level of charge and for temperatures between 35 and 41 degrees C.
• the wired axis 105 is polypropylene, polyurethane, polyester, or silicone.
• the pieces 104 form anchoring elements and are, in one embodiment, strung like beads on the wire axis 105. This implementation makes it possible to adapt the number and the arrangement of the pieces 104 at the distal end portion 102 of the suspension wire 101, depending on the desired snap effect and breast size 20.
• the parts 104 are secured to the wire axis, by gluing, for example using a silicone glue, or welding .
• the parts 104 remain free to rotate relative to the wire axis 105 and are not secured to the wire axis 105.
• the spacers 110 may be welded or not to the axis Wired 105 and 104,110 pieces can be simply butted or fixed together.
• connection of the parts 104, 110 between them and the absence of connection of the parts 104, 110 to the wire axis 105 facilitate, where appropriate, the removal of the suspension wire 101 or some elements of the suspension wire 101 during the installation of the device or during a subsequent intervention.
• the protrusions 108 extend obliquely to the axis of the suspension wire 101, so as to exert an effect of attachment and tensile strength when they are in place in the glandular tissue of the breast 20.
• the projections 108 form an angle of the order of 38 ° with the axis 112 of the sleeve 106, in the embodiments shown.
• the constituent material of the protrusions 108 and / or their dimensions are advantageously chosen such that the projections 108 flex at least in part, and fold towards the axis of the suspension wire 101 when the device is placed in a trocar 401 or a cannula d 'introduction.
• this deflection of the projections 108 is largely or completely elastic and the protrusions 108 return to their original shape and unfold to hang the glandular tissue, when the sheath that forms the trocar 401 is removed.
• suspension wire 101 All the materials used for the production of the suspension wire 101 are advantageously well tolerated and radiolucent so as not to hinder the interpretation of the mammograms.
• FIGS 17 and 18 is shown a plate 150, pierced with slots 151, plate for allowing the attachment of the proximal end portion 113 of the suspension wire 101.
• this plate 150 is a polypropylene or polyester net, the slots 151 being heat-treated to avoid barbs and tearing, the lateral edges of the plate 150 being also thermo-treated to avoid snagging. to the tissues of the body.
• the slots 151 are arranged in a single row or column. In some implementations, the slots 151 are of different shapes and / or sizes from each other.
• the slots 151 are substantially identical and arranged in four rows and four columns.
• the plate 150 may comprise more than four columns of holes and / or more than four rows of holes.
• the plate 150 is formed by cutting a band.
• the proximal end portion 113 of the suspension son 101 is threaded through the slots 151. After the suspension device has been placed in the breast, the surgeon passes this proximal end portion 113 into the slots 151, and then secures the plate 150. in place, for example by means of staple 152, placed at each of the corners 153 of the plate 150.
• the plate 150 is advantageously attached to the aponeurosis of the pectoralis major, on its superficial surface, or to the costal grill, under the deep surface of the muscle.
• the fastening system comprises two parts: a suspension tongue 160 and a fixing pin 161.
• the suspension tongue 160 is advantageously made of a material with a certain degree of elasticity, in order to dampen jolts related to certain movements, such as running or jumping, which could weaken the suspension wire 101 it was attached directly to the bug.
• the suspension tongue 160 also facilitates the positioning of the attachment point.
• this tongue 160 is made of an elastic material, such as silicone or polyurethane.
• the suspension tongue 160 has a form of flattened strip pierced with orifices 162 for the placement of the tip 163 of the attachment pin 161, orifices 162 separated by gaps 164 without perforation. Marks of different colors may facilitate the identification of the orifice 162 in which the tip 163 of the pin 161 will be placed during attachment.
• the suspension wire 101 is secured to the suspension tongue 160 by a ligature.
• the suspension wire 101 is cast in the mass in the suspension tongue 160, in the manufacture
• the attachment pin 161 comprises a head 165 and a tip 163.
• the head 165 of the pin 161 has a flattened top face 166, barely rounded gently sloping, not to protrude under the skin. Its underside 167 is hollowed out of a gutter 168 for receiving the suspension tongue 160, to avoid crushing when it is fixed.
• the upper face 166 has at its center a short female thread 169 intended to accommodate the corresponding male part 451 of the needle 450.
• the tip 163 of the attachment pin 161 has transverse notches 170 to ensure a solid anchorage in the bone tissue and a groove 171 along the longitudinal axis to prevent axial rotation.
• the fixing pin 161 is advantageously made of biocompatible, osteointegrable, well tolerated and solid metal, such as titanium or titanium alloy, for example titanium vanadium alloy (TA6V), or titanium zirconium molybdenum alloy.
• the attachment pin 161 is manufactured in one piece to avoid any point of least resistance at the junction between head 165 and tip 163.
• the needle 450 is a piece of cylindrical metal barely larger than that of the head 165 of the pin 161.
• the needle 450 has an end 452 which draws a recess matching the head 165 of the push pin 161.
• This end 452 carries at its center a male thread 453 intended to be assembled with the female thread 169 of the head 165 of the pin 161, so as to facilitate the handling of the pin 161 held by the needle 450.
• a metal clip 190 is fixed to the side by two or three peaks 191 of the same type as the pushpin 161.
• the staple 190 comprises a rack 192 pierced with holes 193 for receiving the suspension son 101.
• the orifices 193 of the rack 192 are in keyhole.
• the suspension son 101 is passed through the orifices 193; when the position is correct, the suspension wire 101 is slid into the narrow portion of the keyhole to lock the position and the suspension wire 101 is fixed by a knot.
• an ancillary instrument 470 makes it possible to hold the staple 190 to position it.
• the staple 190 is provided with oblique peaks 194.
• the hammer strokes are applied to the needle 471, which is secured to the staple by a small screw 472.
• the staple 190 is held by the needle 471 during positioning and during attachment to the hammer, then the needle 471 is disengaged by unscrewing.
• the small screw 472 can be replaced by a simple magnetic stud.
• the ancillary equipment 40 allowing the establishment of suspension son comprises two elements: a hollow trocar 401 and a pusher 402 hollow for the introduction of the anchoring system.
• the trocar 401 hollow is a tubular metal sheath, in which is placed the anchoring system for introduction into the breast.
• Trocar light 401 is adapted to the size of the anchoring system 10, so that it passes smoothly in the trocar 401.
• the trocar 401 is provided with a sharpened bevel end 403, allowing the introduction of the trocar 401 into the glandular tissue which is resistant.
• the other end 404 of the trocar carries a handle 405 which facilitates handling.
• the trocar 401 may have a rectilinear shape or be provided with a certain curvature to facilitate manipulations.
• the trocar 401 is made of metal alloy, for example stainless steel, sufficiently strong so that the trocar 401 does not bend, while the thickness of its wall must be as thin as possible to minimize tissue damage and allow a good grip of the anchoring projections 108.
• the anchoring system is introduced into the trocar 401 so as to be flush with the end 403 without exceeding it.
• the pusher 402 is a hollow core metal rod that allows the passage of the suspension wire 101 without friction.
• the shape of the pusher 402 is adapted to that of the trocar 401.
• the pusher 402 may be rectilinear or with the same curvature as the trocar 401.
• the pusher 402 has the same length as the trocar 401 and is provided with a manipulation button .
• the pusher 402 is threaded onto the suspension wire 101 so that on the manipulator button side, the pusher 402 protrudes out of the trocar 401 by a length equal to the length of the anchoring element.
• the surgeon After analyzing the morphology, the disorder to be corrected and determining the degree of ascension sought, the surgeon marks on the skin the anatomical landmarks and in particular the most suitable fixation point.
• a short incision (of the order of 8 to 10 mm) is made at the reference point with regard to the bone relief selected (clavicle or second rib for example).
• the incision must be a little offset with respect to the future location of the fixing means (plate 150, pin 161, clip 190), so that the fixing means 150, 161, 190 is not directly under the skin scar, but under healthy skin.
• the trocar 401 provided with the anchoring system is introduced through the skin incision, towards the glandular center of the breast 20.
• the trocar 401 is manipulated so as to travel away from the cutaneous plane, in the premuscular plane, or retromuscularly or even passing in the muscle pectoralis major.
• the trocar 401 When the trocar 401 is positioned in the gland, it is withdrawn while the pusher 402 is held in place, until it is completely covered by the trocar 401. At this stage the protrusions 108 of the anchoring system are out of the trocar 401 and the trocar 401 / pusher 402 assembly is removed. Moderate traction on the suspension wire 101 then ensures anchoring in the gland.
• the surgeon evaluates the ideal positioning of the breast 20 by manipulation of the suspension wire 101.
• the proximal end portion of the suspension wire 101 is then secured to the suspension tongue 160 by a ligature, in the embodiment of FIG. 19.
• the orifice of the suspension tongue 160 to be fixed by the pin 161 is determined.
• the tip 163 of the pin 161 held by the needle 450 is inserted into this hole 162 marked by its color, then the pin 161 is fixed to the bone by a few strokes of a small hammer on the needle 450.
• the needle 450 is then separated from the bug 161 by unscrewing it. The skin is sutured as much as possible offset from the stink bug.
• a mammary enlargement prosthesis 50 advantageously monobloc, provided with a tongue 51 suspension which can be secured to a plate 52 similar to that described with reference to the embodiment of Figures 17 and 18 .
• the width of the tongue 51 is for example two centimeters and the plate 52 has for example dimensions of 8x5 cm.
• FIG. 37 represents the placement of the prosthesis 50 in the prepectorium, with fixation of the plate 52 to the pectoralis major 21.
• Figure 38 shows the placement of the retropectoral prosthesis 50 with fixation to the deep side of the pectoralis major 21.
• Figures 39 and 40 which show the combination of a retromuscular prosthesis 55 and suspension son 101 in the gland. This association is adapted to the treatment of ptosis in the young woman during sexual activity who, after two deliveries, is affected by a breast ptosis with post-pregnancy atrophy of the upper quadrants.
• the prosthesis 55 compensates for atrophy and the suspension son 101 compensates for ptosis.
• an incision 60 is made in the axillary hollow 61, behind the edge of the tendon of the pectoralis major muscle (FIG. 31).
• Dissection is performed in the avascular plane between the fascia of the pectoralis major muscle and the fascia superficialis; the assistant lifting the wall strongly with the aid of a spacer 62 (FIGS. 32 and 34).
• the dissection is extended towards the median line, beyond the mid-clavicular line and cephalic, to the inferior border of the clavicle.
• the two anchoring threads 101 are then put in place.
• the two suspension son 101 are then placed in the breast 20, one in each half of the breast, advantageously symmetrically. A slight manual pull is performed to control the mooring of the protrusions 108 in the gland, as for shoeing a fish.
• the proximal ends of the suspension threads 101 are threaded into the slits 151 of the plate 150.
• the plate 150 is then attached to the fascia of the pectoralis major 21 muscle by four fascia or four stitches, at four angles 153 of the the plate 150.
• the tension of the suspension son 101 is adjusted to obtain the desired correction, the aid releasing the tension of the spacer 62 during this maneuver.
• a small clamp is placed on the proximal end of the suspension wire (s), which extends beyond the plate (150) to hold it in position.
• the threads are attached to the plate 150 by staples or stitches taking thread, staple and fascia.
• the end portion (s) of the suspension wire (s) protruding from the plate (150) are (are) folded onto the plate (150) one or two staples or sutures are carried over. The excess yarn is then cut if necessary.
• a compression spring can be placed between the proximal end portion and the distal end portion of a suspension wire.
• a compression spring can be placed engenued in a tube of flexible material.
• the device according to the invention offers many advantages.
• the proximal end of the suspension son is advantageously fixed with a plate 150 as described above.
• the device allows to fix several son of suspension according to the needs.
• the plate 150 can be fixed both on the costal grill in the deep face of the pectoralis major, and in the aponeurosis of the pectoralis major, between the muscle and the subcutaneous plane. Adhesive fixation can also be used for small breast masses.
• the strength of the assembly is acquired by the gradual integration of the plate 150 with the tissues, which can take about a month. Meanwhile the wearing of the bra is advantageously permanent.
• the device performs a kind of internal bracing of the breast, without any excision glandular or cutaneous, with minimal scars and little or no visible.
• a trocar of curved shape facilitates the positioning of the device, despite the proximity of the bone reliefs.
• the lattice fixation plate 150 may find application in other types of tissue suspensions, including genital or rectal prolapse.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Veterinary Medicine (AREA)
• General Health & Medical Sciences (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
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• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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• 2011
  • 2011-03-22 FR FR1152368A patent/FR2972916A1/fr not_active Withdrawn
• 2012
  • 2012-03-19 EP EP12714813.8A patent/EP2709538A2/de not_active Withdrawn
  • 2012-03-19 WO PCT/FR2012/050578 patent/WO2012131222A2/fr not_active Ceased

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