WO2012131222A2

WO2012131222A2 - Implantable medical device for the correction of breast ptosis

Info

Publication number: WO2012131222A2
Application number: PCT/FR2012/050578
Authority: WO
Inventors: Edouard Pelissier; Bernard RICBOURG
Original assignee: Edouard Pelissier; Ricbourg Bernard
Priority date: 2011-03-22
Filing date: 2012-03-19
Publication date: 2012-10-04
Also published as: FR2972916A1; EP2709538A2; WO2012131222A3

Abstract

The invention relates to an implantable medical device for the treatment of ptosis, particularly breast ptosis. The device comprises a suspension wire provided with a distal end portion and a proximal end portion. The device is characterised in that the distal end portion of the suspension wire comprises a wire shaft on which is mounted a part bearing at least one projection, advantageously an anchoring hook.

Description

I MPLANTABLE MEDICAL DEVICE FOR THE CORRECTION OF MAMMARY SWEET AND METHOD OF CORRECTION OF PTOSIS

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. On the basis of this definition, 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. A second degree, average ptosis, in which the nipple is moved five to ten centimeters down. And a third degree, of great ptosis, in which the nipple looks down and is lowered from ten to twenty centimeters.

Lalardrie and Jouglard (Plastic breast surgery, Masson,

1974) define ptosis by the fall of the inferior pole of the breast with respect to the inframammary groove, the degree of ptosis being determined by the distance between a horizontal plane passing through the sub-mammary groove and a plane tangent to the most inclined point. of the lower pole of the breast, on a woman standing. The ptosis is moderate when this distance is between one and two centimeters and the ptosis is important when this distance is between four and ten 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. In the minor ptosis, the nipple is at the level of the under-mammary sulcus. For a moderate ptosis, 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. In type I, 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. In type II, 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. In type III, ptosis is secondary, moderate to severe and the skin has lost all supportive elements, cutaneoglandular connections are non-existent, excess skin is important and hypoplasia is secondary and important, the general consistency of the breast is bad. Vrebos proposes a general scheme of treatment as follows, according to the following parameters:

a: distance between the nipple and the sternal fork

b: distant existing between a horizontal plane passing through the under mammary groove and a plane tangent to the most sloping point of the lower pole of the breast

c: distance between the nipple and the median line

d: skin condition

Type of treatment Type I Type II Type III

Ptôse Limited Ptôse Limited

a: <19-20 cm to: <19-20 cm Counter

Simple insertion of

b: <1.5 cm b: <1.5 cm prosthesis indication

c: normal c: normal absolute d: excellent condition d: excellent condition

Isolated remodeling of the Plasty

Simple cutaneous surgery Plasty breast

breast breast

Associated remodeling

to Autogenous Possible Possible Possible Tissue Use

Associated remodeling

Implantation of Possible Breast Supports Possible Breast Indication in an Absolute Time

Associated remodeling

to the implementation of Preferred to

Preferred to the operation

prostheses the operation in a specified

in a time

two-stage breast

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. And 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.

Brink, Plast Reconstration

Surg 1993, 91, pp. 657-662) classifies mammary ptosis according to their clinical form and distinguishes four clinical forms, represented in figures 2 to 5: ptosis glandular (figure 2), true ptosis (figure 3) this ptosis being effected by rotation of the gland around its base, pseudo ptosis (Figure 4), with excessive sequence III, parenchyma poor distribution (Figure 5) described as a hypoplasia of the lower pole of the breast with a submarine furrow high inserted, which predispose to ptosis.

Laurence 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:

- Areolar mastopexy (Figure 6) possibly associated with internal mastopexy, for the stages in which the nipple is two cm above one cm below the sub-mammary groove;

isolar mastopexy associated with a vertical incision (Figure 7), when the nipple is at the level of the under-mammary sulcus and up to two cm below this furrow,

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.

For conventional treatment of mammary ptosis, 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. In case of ptosis associated with breast hypertrophy, the corrective procedure includes both glandular excision and cutaneous excision. 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.

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).

The establishment of a support net also involves invasive surgery (see for example De Bruijn, Aesth Plast Surg 2008 32: 757-765). Such nets are marketed under the Breform brand. For this establishment of internal threads, reference may be made, for example to the documents US5584884, US6210439, WO2004096098, WO2009001293.

Is also invasive the establishment of devices creating a hammock of internal suspension of the gland, hammock fixed to the ribs, according to the techniques described by the documents US20060030939, US2008027273, WO2007004214.

Surgical treatment of mammary ptosis, according to conventional techniques thus generates many disadvantages. First there is a risk of scarring, especially when taking estrogen or pigmented skin. 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.

The documents WO 2008042992, WO200911802, WO201051506

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.

The placement of the suspension elements as described in WO 201051506 has many disadvantages. In particular, 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.

For these purposes, 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.

The term "distal" is used with reference to that part of the suspension wire intended to be placed inside the mass of the breast. The term "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:

it comprises at least two parts each carrying at least one projection advantageously forming mooring hook, these two parts being separated by an intermediate piece, relative to the wire axis;

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. The establishment of 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. Advantageously, 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.

In some implementations, 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. Advantageously, 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 .

In some embodiments, 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.

Advantageously, the parts carrying the projections advantageously forming docking hooks comprise a tubular sleeve provided with a passage hole of the wire axis.

In some embodiments, the passage hole is substantially smooth and of a diameter substantially equal to the outer diameter of the wire axis.

In other embodiments, 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.

In one embodiment, the fixing means comprise a plate provided with a through hole of the proximal end portion of the suspension wire. Advantageously, 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.

In another implementation, 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. Advantageously, 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. .

In another implementation, the fixing means comprise a clip provided with at least one receiving orifice of the proximal end of the suspension son. Advantageously, 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. Advantageously, the trocar is curved. Advantageously, 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.

These dimensions are suitable for the treatment of moderate breast ptosis without hypotrophy or hypertrophy.

Other objects and advantages of the invention will emerge during the description of currently preferred embodiments, a description which will be made with reference to the accompanying drawings, in which:

- Figure 1 illustrates the classification of ptosis according to

Regnault;

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;

- Figures 24 to 26 are schematic views of a fastening device of the proximal end portion of a suspension wire, according to another embodiment;

Figures 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;

- Figures 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;

- Figure 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.

In the present description, for simplicity, 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. As will become apparent from the description, 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.

Referring first to Figures 9 to 14.

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. .

By "axis of the suspension wire" is meant here the main axis of slenderness of the suspension wire. In some embodiments, 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.

In other embodiments, 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, however, 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. In the case of a pre-curved 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.

In one implementation, 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.

In the embodiments shown, 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.

In one implementation, 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.

In the embodiments shown, 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. In some implementations, the hook pieces have their projections substantially disposed in the same orientation. In other implementations, 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. For example, 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.

In the embodiments shown, 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. For example, the suspension wire is subjected to a chemical or physical vapor phase treatment or else a plasma deposit. As a variant or in combination, at least part of the intermediate pieces is provided with a surface treatment increasing its bio-accounting, for example a plasma deposit.

In the embodiment shown in FIG. 9, 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.

In some implementations, 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.

In an implementation, after threading pieces 104 on the wired axis 105, at least a portion of the parts 104 are secured to the wire axis, by gluing, for example using a silicone glue, or welding . In another implementation, the parts 104 remain free to rotate relative to the wire axis 105 and are not secured to the wire axis 105. Similarly, the spacers 110 may be welded or not to the axis Wired 105 and 104,110 pieces can be simply butted or fixed together. The absence of 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. Advantageously, 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.

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.

Reference is now made to FIGS. 15 to 18.

In Figures 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.

In one embodiment, 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. In some implementations, 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.

In the embodiment shown, the slots 151 are substantially identical and arranged in four rows and four columns. Depending on the number of wires to be fixed, the plate 150 may comprise more than four columns of holes and / or more than four rows of holes. In one implementation, 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 surgeon then adjusts the tension by pulling on the suspension threads 101. He holds the suspension threads 101 by a small clip (not shown) placed on the proximal end of these threads 101, then he places staples 154 together suspension wire 101, the lattice of the plate 150 and the wall of the body. After which it returns the proximal end portion 113 of the thread 101 to itself and places additional staples 155.

Referring now to Figures 19 to 23 which illustrate a second embodiment of the attachment of the proximal end portions of the suspension son.

In this second embodiment, 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. Advantageously, 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.

In the embodiment shown in Figure 19, during installation, the suspension wire 101 is secured to the suspension tongue 160 by a ligature.

In another embodiment shown in FIG. 20, 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.

In the package, the 450 disposable needle and thumbtack

161 are supplied integral with each other to simplify handling.

Referring now to Figures 24 to 26 which illustrate another method of attachment of the proximal end of the son of suspension.

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.

During placement, after attachment of the staple 190, 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.

Advantageously, an ancillary instrument 470 makes it possible to hold the staple 190 to position it.

In one embodiment, 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 for placing the suspension threads in the mass of the breast will now be described with reference to FIGS. 27 to 30.

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 placement technique is now described with reference to Figures 31-34.

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.

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.

In the embodiment shown in Figures 21 to 23, 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.

Reference is now made to Figures 35-38.

In these figures 35 to 38 is shown 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.

The establishment of two suspension son 101 with proximal attachment to a plate 150, to obtain an arrangement as shown in Figure 33 is simple.

With the patient in a semi-sitting position, 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. To do this, one hand firmly empties the breast 20, the other hand guides the trocar 401, so that the anchoring zone is well located in the thickness of the gland and not in the fatty tissue. The trocar 401 is removed by holding the pusher 402 in place. It should not especially push on the pusher 402 during removal of the trocar 401. Indeed, the pusher 402 holds the device in place during removal of the trocar 401. 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.

Several variants, not shown, can be implemented. In a first variant, a compression spring can be placed between the proximal end portion and the distal end portion of a suspension wire.

Between two pieces 104 carrying the projections 108, a compression spring can be placed engenued in a tube of flexible material.

The device according to the invention offers many advantages.

In particular, several fasteners of the proximal portion of the suspension son are possible.

Where there is concern that adhesion to bone tissue is sufficient, because of the rib structure, which has a thin cortex and friable spongy tissue, or where it is necessary to attach more than two suspension wires, In place of several pins 161 would require several scars and could compromise the aesthetic result, the proximity of large vessels and lung may expose to serious complications in case of technical error. In these cases, the proximal end of the suspension son is advantageously fixed with a plate 150 as described above.

The implementation of the device according to the invention is carried out:

without introduction of bulky equipment,

with very limited risk of injury to the large axillary vessels or the lung, the entire procedure taking place in a plane between the breast and the pectoralis major muscle, away from the vascular elements and the lung; without a visible scar in the breast or anterior aspect of the thorax, the procedure being entirely axillary.

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.

Introduction using a trocar is done without a low incision. The introduction of the trocar takes place by a small incision, and no dissection is performed. A trocar of curved shape facilitates the positioning of the device, despite the proximity of the bone reliefs.

Although the invention has been described in detail with reference to the treatment of mammary ptosis, other applications of a device according to the invention are conceivable, in particular the treatment of sagging soft tissues of the buttocks, arms, by the neck.

The lattice fixation plate 150 may find application in other types of tissue suspensions, including genital or rectal prolapse.

Claims

Implantable medical device for the treatment of ptosis, in particular mammary ptosis, this device comprising a suspension wire (101) provided with a distal end portion (102) and a proximal end portion (113), characterized in that the suspension wire (101) comprises, in its distal end portion (102), a wire axis (105) to which is attached a piece (104) carrying at least one projection (108), and more particularly a hook mooring (109).

2. Device according to claim 1, characterized in that it comprises at least two parts (104) each carrying at least one projection, and more particularly a mooring hook (109), these two parts (104) being separated by an intermediate piece (110), relative to the wire axis (105).

3. Device according to claim 1 or 2, characterized in that the suspension wire (101) carries a mooring net (111).

4. Device according to claim 3 when dependent on claim 2, characterized in that the mooring net (111) is disposed around at least one intermediate piece (110).

5. Device according to any one of claims 3 or 4, characterized in that the net (111) is a lattice made of a material selected from the group comprising polypropylenes, polyesters, polyglactin polyester blends.

6. Device according to any one of claims 1 to 5, characterized in that the wire axis (105) is made of a material selected from the group consisting of polyurethanes, silicones, polyesters, polypropylenes, metals and metal alloys.

7. Device according to any one of claims 1 to 6, characterized in that it comprises several parts (104) each carrying at least two mooring hooks (109), these hooks (109) having a radial extension relative to to the slenderness of the wired axis (105).

8. Device according to claim 7, characterized in that a portion of the hooks (109) have a longitudinal extension relative to the axis of slenderness of the suspension wire (101).

9. Device according to claims 7 or 8, characterized in that the mooring hooks (109) are arranged on at least a length of the distal end portion of the suspension wire (101) in a predetermined pattern.

10. Device according to claim 9, characterized in that the hooks (109) are arranged helically.

11. Apparatus according to claim 9, characterized in that the hooks (109) are arranged in alignment with each other, when the suspension wire (101) is viewed perpendicular to its slenderness.

12. Device according to any one of claims 7 to 11, characterized in that a portion of the hooks (109) have a longitudinal extension oriented towards the distal end of the suspension wire (101), the other hooks (109). having a longitudinal extension oriented towards the proximal end of the suspension wire (101) or a substantially zero longitudinal extension.

13. Device according to any one of the preceding claims, characterized in that the parts (104) carrying the mooring hooks (109) comprise a tubular sleeve (106) provided with a hole (107) for passage of the wired axis (105).

14. Device according to claim 13, characterized in that the hole (107) of passage is substantially smooth and of a diameter substantially equal to the outer diameter of the wire axis (105).

15. Device according to claim 13, characterized in that the hole (107) for passage of the wire axis (105) is provided with a groove complementary to a projection disposed on the wire axis (105).

16. Device according to claim 15, characterized in that the groove of the tubular sleeve and the projection of the wire axis are substantially longitudinal.

17. Device according to claim 15, characterized in that the groove of the tubular sleeve and the projection of the wire axis are helical.

18. Device according to any one of the preceding claims, characterized in that the parts (104) and the intermediate pieces (110) are made of a material chosen from nylons, polyethylenesterephthalates, polypropylenes, silicones, polyurethanes expanded polytetrafluoroethylene.

19. Device according to any one of the preceding claims, characterized in that it comprises means for fixing the body of the proximal end portion (113) of the suspension wire (101).

20. Device according to claim 19, characterized in that the fixing means comprise a plate (150) provided with holes (151) for passage of the proximal end portion (113) of the suspension wire (101).

21. Device according to claim 20, characterized in that the plate (150) for fixing is a lattice.

22. Device according to claim 21, characterized in that the mesh is made of a polymeric material selected from the group comprising polypropylenes, polyurethanes, silicones, polyesters.

23. Device according to claims 21 or 22, characterized in that the slots (151) of the lattice are arranged in at least two rows.

24. Device according to any one of claims 20 to 21, characterized in that the proximal end portion (113) of the suspension wire (101) forms a ribbon of substantially rectangular cross section.

25. Device according to claim 19, characterized in that the fastening means comprise a tongue (160) of suspension and a pin (161) fixing.

26. Device according to claim 25, characterized in that the tongue (160) is provided with at least two holes (162) for passage of the tip (163) of the pin (161) attachment.

27. Device according to claim 25 or 26, characterized in that the tongue (160) of attachment forms a ribbon of substantially rectangular cross section.

28. Device according to any one of claims 25 to 27, characterized in that the proximal end portion (113) of the suspension wire (101) is assembled or integral with the tongue (160) suspension.

29. Device according to any one of claims 25 to 28, characterized in that the attachment pin (161) comprises a head (165) flattened provided with receiving means of the end portion of an ancillary (450) such as a needle, the tip (163) of the pin (161) attachment being provided with notches (170) transverse and a throat (171) longitudinal.

30. Device according to claim 19, characterized in that the fixing means comprise a clip (190) provided with at least one orifice (193) for receiving the proximal end portion (113) of the suspension son (101).

31. Device according to claim 30, characterized in that the clip (190) is provided with at least two holes (193) for receiving the proximal end portion (113) of the suspension wires (101), at least one these orifices (193) having an opening in the form of a keyhole.

32. Device according to any one of the preceding claims, characterized in that it comprises an ancillary (40) for placing at least one suspension wire (101), this ancillary device (40) comprising a trocar (401). ) and a pusher (402).

33. Device according to claim 32, characterized in that the trocar (401) is curved.

34. Device according to claim 31 or 32, characterized in that trocar (401) has a beveled end (403).

35. Device according to any one of the preceding claims, characterized in that the proximal end portion (113) of the suspension wire (101) has a total length of the order of 60 to 80 mm, the cross section of the part distal end (102) of the suspension wire (101) being of the order of 2 millimeters.

36. Device according to any one of the preceding claims, characterized in that the proximal end portion (113) of the suspension wire (101) is ribbon-shaped with a width of the order of 4 millimeters and a length of the order of 145 mm.

37. Device according to claims 35 or 36, characterized in that the suspension wire comprises a substantially smooth intermediate portion and of circular section, disposed between the distal end portion (102) provided with hooks (109) and the proximal end portion ( 113).

38. Device according to claim 37, characterized in that the intermediate portion extends over a length of about 20 mm.

39. Device according to any one of the preceding claims, characterized in that the parts (104) bearing the projections (108) have a longitudinal dimension of the order of 10 mm.

40. Device according to any one of claims 32 to 39, characterized in that the outer diameter of the pusher (402) is of the order of 5 mm, the inner diameter of the pusher (402) being of the order of 4 mm, the inner diameter of the trocar (401) being substantially equal, with the functional clearance close, to the outer diameter of the pusher (402), the outer diameter of the trocar (401) being of the order of 7 mm.

41. Device according to any one of the preceding claims, characterized in that the projections (108) form an angle of between 15 and 50 degrees with respect to the axis of slenderness of the suspension wire (101), and preferably between 30 and 50 degrees and more preferably of the order of 38 degrees.