• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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  • 优先权
    • 专利摘要:
    systems, implants and mastopexy kits and methods to elevate the lower pole of the female breast and minimally invasive to implant a device to elevate the patient's breast and nipple-areola complex. it is an implant to keep the breast in an elevated and aesthetically attractive position, the implant including a support for the lower pole with edges that are fixed on the chest wall or on a previously installed upper suspension rod. the implant is loaded into an insertion device. the insertion device is inserted, through a small incision, into a subcutaneous pouch formed in the lower half of the breast. the support for the lower pole can be in several structures and, in one embodiment, includes an adaptable unitary mesh with several members or bands that connect along the breast parenchyma and the chest wall.
    公开号:BR112013020638B1
    申请号:R112013020638-1
    申请日:2012-03-07
    公开日:2020-09-08
    发明作者:Arikha Moses；Emily Stires；Anthony Natale
    申请人:Tepha, Inc.；
    IPC主号:
    专利说明:

    [0001] [0001] The present application claims priority to the United States application for serial number 61 / 451,103, filed on March 9, 2011, and to the United States application for serial number 61 / 604,242, filed on February 28 2012, both of which are incorporated herein by reference. FIELD OF THE INVENTION
    [0002] [0002] In general terms, the present invention relates to systems and methods for mastopexy or breast lift. BACKGROUND OF THE INVENTION
    [0003] [0003] Breast ptosis implies the descending displacement or decay of the mammary parenchyma accompanied by the descending displacement of the nipple-areola complex (NAC) in relation to the inframammary fold (IMF). Breast ptosis occurs in patients with normal breast size, relatively small breast size (hypoplasia) or with large breast size (hypertrophy). The combination of ptosis and hypoplasia can develop in the breast after delivery as the relative enlargement of the breasts during pregnancy and lactation recedes, leaving behind a stretched skin membrane that contains the involute parenchyma. Hypertrophic breasts usually include a degree of breast ptosis in addition to the marked size.
    [0004] [0004] Breast ptosis is categorized according to the position of the NAC in relation to the MFI and the lower pole of the breast tissue. Grade 1 ptosis is considered mild, with the nipple just below the IMF, but still above the lower pole. Grade 2 ptosis is considered moderate, with the lower nipple of the IMF, but with some tissue from the lower pole below the nipple. Severe grade 3 ptosis has the nipple well below the IMF and no lower pole tissue below it. Pseudoptosis, seen with postpartum breast atrophy, includes ptosis of the lower pole with the nipple positioned on or above the IMF.
    [0005] [0005] Mastopexy is a surgical procedure performed to correct breast ptosis. Its objectives are to restore the normal contour of the mammary mound and to reposition the NAC. To do so, the excess breast skin is removed or contracted, the parenchymal volume is increased or decreased as necessary and the NAC is repositioned. The choice of technique is based on the desired final breast size and the degree of ptosis. In case of minimal ptosis and breast hypoplasia, breast augmentation is sometimes used instead of mastopexy, even if this implies the use of a silicone implant. Breast augmentation involves placing a breast implant under the breast parenchyma, usually through an incision in the inframammary fold. The implant forces the parenchyma up and out, giving a less ptotic and wider appearance. The projection is much more pronounced when the implants are placed in the subglandular position compared to submuscular positioning.
    [0006] [0006] When greater correction of ptosis is necessary, traditional mastopexy employs the repositioning of the NAC and / or the resection of the skin. Various types of skin incisions can be adopted, each leaving its own characteristic healing pattern after healing. Skin incisions include the Wise or anchor pattern, the circumareolar incision and the periareolar incision.
    [0007] [0007] As it is a voluntary and aesthetic procedure, avoiding or minimizing skin incisions adds to the challenge of mastopexy surgery. Traditionally, mastopexy surgery is accompanied by considerable healing. The extensive scars of mastopexy in the Wise pattern, for example, may be necessary if major repositioning and resection are performed, but they represent a significant disadvantage to the procedure. Although endoscopic techniques have been developed for mastopexy procedures, open surgery is necessary in many cases to move the nipple, remove excess tissue or redesign the breast mound. Although it is possible to avoid scars "at anchor" of the Wise pattern, other techniques of open mastopexy still generate visible scars on the breast.
    [0008] [0008] The growing or periareolar incision causes less noticeable scarring; however, severe areola stretching or tissue necrosis is not a rare problem, as all newly elevated parenchymal weight is supported by sutures around the areola.
    [0009] [0009] In traditional mastopexy procedures, the contracted skin membrane serves as the main support for the raised breast. It is possible to use breast implants to fill the breast contour superiorly, a procedure called mastopexy with enlargement. The augmented mastopexy procedure has a higher risk of disease incidence and twice the number of scars.
    [0010] [0010] The repositioning of the breast flap can also be used to fill the upper contour of the breast; however, this type of repositioning of the mammary mound is a significantly more invasive and complex procedure, which involves transposing a mass of tissue from the lower pole, raising it and fixing it in a deeper and higher tissue plane.
    [0011] [0011] Regardless of the type of mastopexy procedure adopted, it is standard for the procedure that the contracted skin remains as the main support to keep the breast mound elevated. As the skin of the lower pole stretches over time, as it did in the first place, ptosis can recur or pseudoptosis ("tissue fall") occurs. The placement of a breast implant leads to more weight on the skin of the lower pole, possibly leading to a faster expansion of the skin and a recurrence of ptosis.
    [0012] [0012] In order to maintain the upright configuration of the raised breast and avoid the post-operative sequelae of recurrent ptosis or pseudoptosis, or "tissue fall", certain authors advocate the use of permanent prostheses, such as a polypropylene mesh or lining of silicone, to reinforce the lower pole (see, for example, the Orbix breast lift kit, manufactured by Orbix Medical, Tel Aviv, Israel) or to wrap the entire parenchyma (see, for example, the Breform ™ device, manufactured by Aspide Medical , St. Etienne, France). Concerns about leaving foreign bodies permanently in the breast limit the widespread adoption of these techniques to some extent. A permanent foreign body, according to the literature, is prone to infection and can facilitate a chronic inflammatory reaction. In addition, chronic foreign body reactions are usually associated with tissue hardening and capsular contracture in the same way as breast implants. In addition, a permanent foreign body can interfere with the examination of breast cancer and distort tissue plans if an oncological procedure is necessary.
    [0013] [0013] Several permanent sheets, such as polypropylene or polyester meshes, have been arranged around the parenchyma (see, for example, the Breform ™ device, manufactured by Aspide Medical, St. Etienne, France), but they lack an element of anchorage that removes the skin load from the lower pole, thus submitting the covered breast not only to the possible chronic inflammatory response, but also to the same ptotic forces as before the surgery. Permanent silicone sheets have also been used to support the lower pole, which is then suspended by screws in the rib cage, placing the full load force on one or two fixation points just above the nipple. In addition, several minimally invasive mastopexy procedures are described in United States Patent No. 7,670,372, in the name of Orbix, and in Patent Publication No. 2008/0027273, in the name of Gutterman.
    [0014] [0014] More recently, allograft or xenograft products have been proposed as suitable to provide extra support to breast tissue or breast implants during post-mastectomy reconstruction. For example, acellular cadaveric dermal matrix or cross-linked bovine or ovine dermal matrix or collagen has been proposed. The acellular cadaveric dermal matrix has been used extensively in procedures to extend the skin flap or reposition the breast during reconstruction procedures. Depending on the level of processing involved in the formation of these structures, they gradually degrade and sometimes resorb, with reported evidence that they are replaced by tissue. If the degradation occurs too quickly, however, these tissue matrices are not replaced by the scar tissue and the patient may experience new ptosis and "tissue fall". And if they do not resorption or resorption very slowly, there is evidence in the literature that they cause abundant seroma formation and infections compared to flaps of natural tissue. As with synthetic mesh, these devices require fully open procedures and do not mitigate healing.
    [0015] [0015] Another challenge for mastopexy surgeons is the aesthetics in development of the upper pole. While traditional mastopexy techniques focused on elevating the ptotic NAC and the lower pole, there is now also a demand for a more stout look from the upper pole. The corpulence of the upper pole, generally observed after breast augmentation surgery with silicone and preformed implants, has become the paradigm that some women aspire to when they think of breast surgery. This aesthetics can motivate a mastopexy patient to aspire for a heavier upper pole together with an elevated lower pole, a contracted lower skin membrane and a repositioned NAC.
    [0016] [0016] The need persists in the area, therefore, for mastopexy systems and methods that enable the creation or restoration of an elevated breast shape in a more lasting way, as well as that prevent postoperative pseudoptosis or recurrent ptosis without compromising the safety or aesthetic quality of the surgical result. Desirably, this solution would avoid the possible complications that haunt the standard mastopexy procedure, the placement of mesh and / or permanent breast implants, while providing lasting support for the reshaped breast. For example, it would be desirable to employ frames and resorbable supports that promote the growth of soft tissue or a resorbable matrix that is elastic enough to allow a dynamic natural appearance to the breast through smaller incisions so that, once positioned, it offers good balance between healing, internal tissue growth and final resorption. There is still a need in the area for mastopexy techniques that provide a more stout contour to the upper pole in order to satisfy aesthetic demands. And, as already mentioned, avoiding or minimizing scarring remains a desirable goal. SUMMARY OF THE INVENTION
    [0017] [0017] In this document, in the embodiments, systems for mastopexy are revealed, which comprise an introduction device, a suspension rod and a support for the lower pole, in which the introduction device inserts the suspension rod in the breast, in which the suspension rod provides the projection of the upper pole, in addition to connections with the support for the lower pole, and where the support for the lower pole provides the elevation of the upper pole of the breast.
    [0018] [0018] In certain embodiments, a method for preventing recurrence of ptosis is revealed. This method involves removing part of the parenchymal load from the skin membrane. In certain embodiments, the suspension rod is made of biodegradable material. In certain embodiments, the support for the lower pole is made of biodegradable material. In certain embodiments, the support for the lower pole is made of mesh material. In certain embodiments, the support for the lower pole is an adaptable unitary mesh or sheet. In this document, kits are also revealed that comprise the aforementioned mastopexy system.
    [0019] [0019] In the embodiments of this document, methods for raising the lower pole of the female breast are also revealed, which include providing an introduction device, a suspension rod and a support for the lower pole; insert the insertion device in the female breast in order to define a channel in the upper pole of it; implant the suspension rod in the channel, thus exerting force on the upper pole to project it; position the support for the lower pole under at least part of the lower pole; and connect the support for the lower pole to the suspension rod with enough tension to raise the lower pole.
    [0020] [0020] In the embodiments of this document, methods are also revealed to form a subcutaneous space between the skin and the parenchyma around the lower pole of the breast; insert a support in the lower pole of the breast; and elevate the lower pole of the breast using the support and connecting the handles of the support to a suspension pole of the upper pole and / or to attachment points in the soft or hard tissue.
    [0021] [0021] Implants for mastopexy are also revealed in the embodiments of this document, which comprise a central body region and several loops extending from it. The implant can be inserted into a subcutaneous pouch at the bottom of the breast and fixed at various points in the soft, hard supportive tissue around the parenchyma.
    [0022] [0022] In certain embodiments, an implant for mastopexy comprises a unitary and flexible bioabsorbable mesh. The mesh includes a substantially 2D configuration, in the form of a central region and several distinct handles or extension members that extend to parts thereof, and further comprises a second 3D configuration when implanted in order to hold the breast. When implanted, the central region covers at least part of the lower pole of the breast and at least two of the extension members extend superiorly around the NAC away from it. In addition, at least two extension members extend inferiorly towards the MFI. The implant raises the lower pole of the breast when attached to the supporting tissue.
    [0023] [0023] In certain embodiments, an implant for mastopexy comprises a sheet or mesh with several regions or sections. A first region, or upper region, is arranged above a second region, or lower region. The region is sized to substantially expand part of the lower pole of the breast and not cover the NAC. The upper region comprises several upper connecting edges to attach to the patient's supporting tissue in the vicinity of the upper side of the breast. The lower region comprises several lower connecting edges to attach to the supporting tissue in the vicinity of the IMF in order to secure the breast in the second position when attached to the supporting tissue. The upper region can be in a wide variety of shapes, including elliptical, oval or other types of shape. The lower region may comprise a similar or different shape, as well as a similar or different size, of the upper region.
    [0024] [0024] In the embodiments of this document, a method and tools for elevating the lower pole of the breast are also revealed, which comprise forming at least one incision, preferably in the lateral, medial, inframammary and / or periareolar areas of the breast; forming a subcutaneous pouch with a dissection or subcision tool; Insert and implant the support for the lower pole using the insertion device so that the handles of the support for the lower pole are positioned over the breast parenchyma, unrolled and anchored at various points to raise the lower pole of the breast and remove the load from the breast. skin membrane to prevent recurrence of ptosis.
    [0025] [0025] In the embodiments of this document, a system for mastopexy is also revealed, comprising an introduction tool that contains a support for the lower pole with several pre-loaded handles.
    [0026] [0026] In the embodiments of this document, a system for mastopexy is also revealed, comprising a support for the lower pole with several handles involving an introduction tool. BRIEF DESCRIPTION OF THE FIGURES
    [0027] [0027] Fig. 1A illustrates an embodiment of an insertion device.
    [0028] [0028] Figs. 1B-1D illustrate several suspension rods.
    [0029] [0029] Figs. 2A-2D schematically illustrate the passage of an insertion device according to an embodiment.
    [0030] [0030] Figs. 3A-3C schematically illustrate the placement of a suspension rod according to an embodiment.
    [0031] [0031] Figs. 4A-4E schematically illustrate the positioning of a support for the lower pole according to an embodiment.
    [0032] [0032] Fig. 4F illustrates a support for the lower pole, changing from a contracted configuration to an expanded shape.
    [0033] [0033] Figs. 5A-5B illustrate supports for the lower pole with several handles.
    [0034] [0034] Figs. 6A-6B illustrate supports for the lower pole with elliptical shapes.
    [0035] [0035] Figs. 7A-7C schematically illustrate various supports for the lower pole implanted in the breast to raise the lower pole and the NAC.
    [0036] [0036] Figs. 8A-8C illustrate various supports for the lower pole in the form of a canoe.
    [0037] [0037] Figs. 9A-9F schematically illustrate a procedure for raising the lower pole and the NAC.
    [0038] [0038] Figs. 10A-10E schematically illustrate a procedure for forming a subcutaneous pouch to accommodate a support for the lower pole. DETAILED DESCRIPTION
    [0039] [0039] Before describing the present invention in detail, it should be understood that it is not limited to the variations specifically outlined in this document, it being possible to make several changes or modifications to the described invention and substitutions by equivalents without diverting the scope or essence of the invention. As those skilled in the art will realize by reading this disclosure, each of the different embodiments described and illustrated in this document has distinct components and features that can be easily isolated or combined with the features of the other various embodiments without departing from the scope or essence of the present invention. In addition, it is possible to make several modifications in order to adapt a specific situation, material, composition of matter, process, acts or process steps to the objectives, scope or essence of the present invention. All such changes are considered to be within the scope of the Claims defined in this document.
    [0040] [0040] The methods reported here can be performed in any order of the narrated events that is logically possible, as well as in the narrated order of events. Furthermore, when a range of values is given, it will be understood that each value interposed between the upper and lower limits of that range and any other value declared or interposed in that range is covered by the invention. In addition, it is contemplated that any optional feature of the inventive variations described may be presented and claimed independently or in combination with any one or more of the features described in this document.
    [0041] [0041] All existing study material mentioned in this document (for example, publications, patents, patent applications and devices) is incorporated by reference to this document in its entirety, except where it differs from the present invention (in which case the which is the one provided here will prevail).
    [0042] [0042] This document reveals products, systems and methods for performing mastopexy surgery on a female breast. As used in this document, the term “mastopexy” refers to a procedure that modifies and / or repositiones part of the female breast, usually with the aim of enhancing the aesthetics of the breast, which may include the upward repositioning of a part lower breast and / or the upward repositioning of the nipple-areola complex (NAC). As an option, mastopexy may include configuring the breast in an aesthetically desirable manner, for example, by enlarging the projection of the upper pole of the breast or the central subareolar mound of the breast. For greater advantage, the systems and methods revealed in this document make use of minimally invasive technologies in order to perform a mastopexy with less healing compared to traditional open surgical procedures.
    [0043] [0043] MASTOPEXY SYSTEM
    [0044] [0044] A system for performing mastopexy according to the present disclosure comprises an insertion device and a support for the lower pole. In another embodiment, the system comprises an introduction device, a suspension rod and a support for the lower pole. In another embodiment, the suspension rod and the introducing device are the same item. A method for performing mastopexy according to the present invention includes the steps of forming a channel to position the suspension rod by manipulating the suspension rod through the fabric; position the suspension rod using the insertion device, if these are two different items; and connect the support for the lower pole to the suspension rod with sufficient tension to support the lower pole and project the upper pole of the breast. In certain embodiments, the systems shown in this document may come in kits, with the different components distributed for ready access by the surgeon. Kits can be prepared with disposable or reusable components, and the delivery device access tube can be pre-loaded with certain components. Kits can be prepared for sterilization or pre-sterilized.
    [0045] [0045] As illustrated in Fig. 1A, an insertion device 100 comprises, in certain embodiments, an access tube 103 with an internal passage through which it is possible to pass other components. For example, a dissector 115 can be passed through the access tube, which will allow the surgeon to dissect a space under the skin or inside the breast tissue for the subsequent passage of the suspension rod, as described below. In certain embodiments, dissector 115 is configured for blunt dissection. In others, dissector 115 comprises an electrocautery or other mechanism for hemostasis. In still other embodiments, the dissector 115 comprises a liposuction component for use in the dissection itself or as an auxiliary device to other dissection mechanisms. Dissector 115 may comprise a special tip 101 to facilitate dissection, which tip 101 may comprise electrocautery devices or other hemostatic devices. In certain embodiments, dissector 115 may be a rigid device with a pre-selected shape. In other embodiments, the dissector 115 can be flexible or deformable, so that it can be configured by the surgeon in a desirable format.
    [0046] [0046] The dissector 115 can cooperate with a suspension rod 111 to be inserted on or beside the dissector 115 once the dissection has been completed. The positioning of the suspension rod 111 on the dissector can be accomplished by a combination of advancing the suspension rod 111 forward (using, for example, a propellant or plunger (not shown) and / or retracting the access tube 103 and the dissector 115).
    [0047] [0047] In one embodiment, the suspension rod 111 is positioned inside the access tube 103, around the dissector 115, throughout the dissection process, to be positioned using the insertion device 110 after completing the dissection. In another embodiment, the dissector 115 is used inside the access tube 103 to form the submammary or inframammary pocket, after which the dissector 115 is collected and the suspension rod 111 is positioned. In other embodiments, the suspension rod 111 on the dissector 115 after collecting the access tube 103, with the dissector 115 acting as a guide wire for the positioning of the suspension rod 111.
    [0048] [0048] Although we have described the introduction process by unseen dissection, the introduction device 110 can also optionally include visualization technologies, for example, endoscopic visualization or a luminous tip whose position is possible to be monitored while using the input device 100.
    [0049] [0049] In certain embodiments, the insertion device 100 is advanced through a single incision (positioned medially or laterally, or in some other way at the surgeon's discretion), leaving the suspension rod 111 behind after dissecting a suitable pouch . In other embodiments, the insertion device 100 is inserted through an incision to dissect the pouch by blunt dissection or electrocautery, when a pointed tip 101 is then used to punch from the inside of the breast to form a second cut on the opposite side of this. For example, if a medial access incision was used, a lateral or axillary cut is formed, or vice versa. This technique makes it possible to form a second access site for better handling of the suspension rod 111 or for its attachment to the chest wall, breast tissue or other bone or soft tissue or for its connection with the support for the lower pole, as described -will below.
    [0050] [0050] If two incisions are used (ie, a proximal incision and a distal cut, as described above), it is possible to pass a retrograde gripper (not shown) through the second incision to grasp the suspension rod 111 or to grasp a suture or pulling thread 109 attached to it and pulling it to the right place inside the dissected pouch.
    [0051] [0051] In certain embodiments, a suture or pull thread 109 attached to the suspension rod 111 is used to secure it, the suture or pull thread 109 being used to connect the distal end of the suspension rod 111 to the surrounding tissues or to a fixing anchor (not shown) that has already been positioned on the fabrics. In other embodiments, the pulling suture or thread 109 is used to connect the distal end of the suspension rod 111 to the support mechanism for the lower pole which is positioned as described below.
    [0052] [0052] Also for fixation, a distal fixation frame 105 and a proximal fixation frame 113 can be included. As shown in Fig. 1A, the fixing frames 105 and 113 can be configured in the form of holes or other openings through which sutures, clamps or other anchoring mechanisms can be arranged, to allow the connection of the suspension rod 111 with fabrics soft tissues, hard tissues, fixation anchors (not shown) and / or the support mechanism for the lower pole, for example, using sutures that are inserted by the surgeon intraoperatively. Figs. 1B to 1D illustrate non-limiting examples of suspension rods. Fig. 1B shows a rod 111 that includes a groove or slot 122 for attachment. The slit may receive a suture, tongue, flap or other structure to interconnect with an anchor or support for the lower pole. Fig. 1D illustrates a rod 111 comprising a recess or chamfer 132 for receiving an anchor, base or tab device for fixing. A wide variety of structures can be incorporated by retaining, securing and connecting to the supporting fabric, anchors and devices for the lower pole.
    [0053] [0053] In other embodiments, the fixing frames 105 and 113 can be configured in the form of fittings, hooks, anchors, fasteners, tacks or the like to allow direct or indirect connection with soft tissues, hard fabrics, sustained fixing anchors on the fabric and / or the support mechanism for the lower pole. In one embodiment, for example, one or both of the fixing frames 105 and 113 can be configured in the form of an arrowhead or flange that can snap with a matching anchor in the support mechanism for the lower pole. A variety of attachment frames for attachment to fabrics or other components of the mastopexy system are within the scope of the present invention and can be inferred by those skilled in the art.
    [0054] [0054] As shown in Fig. 1A, the insertion device 100 can be provided with a handle 117, which can be held by the surgeon during the insertion process. The handle 117 can be any structure incorporated or attached to the proximal end of the delivery device 100 that provides the surgeon with a firm surface to hold and handle the delivery device 100. Although the handle 117 shown in Fig. 1A is in the form of two wings Perpendicular to the axis of the access tube 103, the handle 117 can be formulated in the form of a one-sided structure (for example, like a pistol grip) or any other structure that allows it to be gripped and manipulated firmly. For example, the handle may comprise various protrusions and recesses that support the surgeon's hand to grasp the proximal end of the insertion device 100. Various types of handle 117 for the insertion device 100 are within the scope of the present invention. and can be inferred by practitioners versed in the technique.
    [0055] [0055] As shown in Figs. from 2A to 2D, an insertion device 205 is inserted in the breast 200 to position a suspension rod 311, as shown in Figs. from 3A to 3C. Referring to Fig. 2A, a female breast 200 is illustrated with an access incision 201 made through the skin in the parasternal region. In other embodiments, the access incision 201 can be formed in the lateral aspect of the breast 203, in the periareolar skin 207, as shown in Fig. 2A, in the armpit (not shown) or in the inframammary fold under the breast (not shown). The curvature of the delivery device 205 is suitable for use through access incisions in the superolateral or superomedial skin of the breast, although, in other embodiments, the delivery device 205 can be configured for use through an incision in other areas of the breast skin. . For exemplary purposes, the system and method for mastopexy with a parasternal access incision 201 will be described and illustrated, although it is clear that other access incisions can also be used.
    [0056] [0056] As shown in Fig. 2B, the insertion device 205 penetrates the access incision 201 laterally directed. Figs. 2C and 2D illustrate the path of the introduction device 205 as it makes its way under the breast tissue, just above the pectoral fascia, or within the breast tissue. The path 209 of the path and its inframammary or subglandular positioning is determined by the surgeon based on pre and intraoperative evaluations of the patient. As these figures illustrate, the introduction device 205 follows the path 209 determined by the surgeon by blunt dissection, electrocauterization, cutting dissection, balloon dissection, or some combination of these or other tissue destitution techniques (guided, for example, by palpation, indirect visualization or direct visualization) to form a pocket along the path 209 that will house the suspension rod, as shown in more detail below. In the embodiment shown in Fig. 2B, the introduction device 205 acts as a guide for the introduction of the suspension rod, as will be described below.
    [0057] [0057] It is clear that the introduction device 205 may include other features, for example, a visualization device (not shown) to provide the direct generation of images of ongoing procedures. In certain embodiments, the delivery device 205 may include other trackers, such as an externally visible light, or an electromagnetic tag, or the like, which allows the position of the tip of the delivery device 205 to be determined by visualization or positioning identification technologies . In certain embodiments, the delivery device 205 may include a balloon or other dissection mechanism to allow dissection of the pouch or tissue pathway to the suspension rod.
    [0058] [0058] In certain embodiments, the percutaneous access incision 201 may be in the form of a cut by a needle, followed by the introduction of a guidewire to position the insertion device 205. In an exemplary embodiment, the device introduction 205 can be conducted along a predetermined path 209 with the aid of balloon dissection or hydrodissection. In an exemplary embodiment, the dissection process can be observed directly, for example, through a fibro-optical viewing scope.
    [0059] [0059] In certain embodiments the suspension rod 311 can be made of various biodegradable materials. As an option, the suspension rod 311 can include one or more pharmacologically active agents capable of inducing local or systemic effects. As used in this document, the term “biodegradable” refers to a material that, when inserted into the body of a human or animal, is hydrolytically labile, oxidatively labile, susceptible to enzymatic activity or the like (collectively, “actions biodegradants ”), in which such biodegradable actions lead to partial or complete decomposition of the material within the human body. Materials, for example, polymers, which are biodegradable have varying resorption times after decomposition, depending on local and systemic factors within the body and depending on the characteristics of the decomposed product such as its size and chemical composition.
    [0060] [0060] The materials for use in these systems and methods are, desirably, biocompatible. As used herein, the term "biocompatible" refers to a material that is compatible with living tissue or a living system so that it can be used on the body of a human or animal. A biocompatible material, for example, a biocompatible polymer, does not cause significant or unacceptable physiological damage to the body. For example, biocompatible material may be non-toxic, or otherwise non-injurious to living tissue or system, or it may not cause significant immune or inflammatory responses on the part of the host.
    [0061] [0061] Various biodegradable materials can be used, either as simple agents or in combinations, to manufacture the suspension rod 211. When selecting polymeric materials for the suspension rod 211, one can take into account the glass transition temperature ( Tg), as well as the compatibility of the material with pharmacological agents that can optionally be added to them. In certain embodiments, a polymer readily manufactured in the desired shape will be selected for the suspension rod 211. For example, polymers with sufficient differential between their melting temperature and their decomposition temperature can be molded or extruded in tubular or cylindrical shapes.
    [0062] [0062] Various biodegradable polymers suitable for use according to these systems and methods are familiar to those skilled in the art. Processing and coating methods for these polymers are similarly familiar. For example, polymers such as those mentioned below can be used: polylactic acid, polyglycolic acid and copolymers and mixtures thereof such as poly (L-lactide) (PLLA), poly (D, L-lactide) (PLA), polyglycolic acid or polyglycolide (PGA), poly (L-lactide-co-D, L-lactide) (PLLA / PLA), poly (L-lactide-co-glycolide) (PLLA / PGA), poly (D, L-lactide-co -glycolide) (PLA / PGA), poly (trimethylene glycolide-co-carbonate) (PGA / PTMC), poly (D, L-lactide-co-caprolactone) (PLA / PCL) and poly (glyco-lide-co -caprolactone) (PGA / PCL); polyhydroxyalkanoates, poly (oxa) esters, polyethylene oxide (PEO), polydioxanone (PDS), polypropylene fumarate, poly (ethyl glutamate-co-glutamic acid), poly (tert-butyloxy-carbonylmethyl glutamate), polycaprolactone (PCL), polycaprolactone co-butylacrylate, polyhydroxybutyrate (PH BT) and polyhydroxybutyrate copolymers, poly (phosphazene), poly (phosphate ester), poly (amino acid), polidepsipeptides, maleic anhydride copolymers (polycarbonates, polyiminocarbons) of 97.5% dimethyl trimethylene) - co- (2.5% trimethylene carbonate)], poly (orthoesters), tyrosine-derived polyarylates, tyrosine-derived polycarbonates, tyrosine-derived polyiminocarbonates, polyphosphonates derived from tyrosine, polyethylene oxide, polyethylene glycol (PEG), polyalkylene oxides (PAO), hydroxypropylmethylcellulose, polysaccharides such as hyaluronic acid, chitosan and reneged cellulose, and proteins such as gelatin and collagen, and mixtures and copolymers of these, among others, b on how PEG derivatives or mixtures of any of the aforementioned Desirably, polymeric materials that have good strength retention are selected for these systems and methods, such as polydioxanone, silk-based polymers and copolymers, poly-4-hydroxybutyrates and their similar. Suitable biocompatible polymers can be used separately or in mixtures with other biocompatible materials.
    [0063] [0063] Desirably, the material selected for the suspension rod will be adaptable (either before or after the introduction into the body) in a format that allows the projection of the upper pole. In addition, the material selected for the suspension rod will desirably have sufficient strength and durability to maintain the projection of the upper pole. Without attaching to the theory, it is expected, in certain embodiments, that the presence of an inflammatory response and collagen deposition in the short term, all attributable to a stimulating effect that accompanies the suspension rod's biodegradability process, provides greater corpulence and long-term support.
    [0064] [0064] The suspension rod 311 can be in the form of a cylindrical structure, like a ribbon, or in any other shape that flexes in response to the weight exerted by the support for the lower pole, as will be described below, at the same time in which imposes the desired shape on the upper pole of the breast. In certain embodiments, the suspension rod 311 comprises more than one shape, for example, a central flat part and cylindrical or tapered side parts, and the suspension rod 311 can comprise more than one material with specific properties.
    [0065] [0065] As shown in Fig. 3A, the suspension rod 311 can be passed through a hollow passage inside the introduction device 305, as shown. Alternatively, it is possible to use the introduction device 305 as a guide wire, with the suspension rod 311 around it (not shown). As shown in Figs. from 3A to 3C, a single access incision 301 can be used to insert the inserter. In these figures, the access incision 301 is illustrated in the mid or parasternal aspect of the breast. It is understood that the access incision 301 can be positioned on the lateral aspect of the breast, on the chest wall, in the armpit or in other regions (inframammary fold, periareolar etc.) familiar to those skilled in the art. An additional access incision (not shown) can be used at any of these locations to assist in the placement or positioning of the 311 suspension rod.
    [0066] [0066] After positioning the suspension rod 311 in place, as shown in Fig. 3B, the introduction device 305 is removed along its entry path. Fig. 3C illustrates the suspension rod 311 in place within the breast. In patients where greater corpulence of the upper pole is desired, the suspension rod 311 can be positioned so that it protrudes anteriorly instead of under the breast tissue in the pectoral fascia. Normally, the positioning of the 311 suspension rod is determined by the surgeon who plans and performs the procedure. To obtain the anterior projection of the suspension rod 311, dissection through the breast tissue may be necessary when the suspension rod is initially implanted.
    [0067] [0067] SUPPORT FOR THE LOWER POLE
    [0068] [0068] Figs. 4A to 4E schematically illustrate certain steps in a procedure for placing a support for the lower pole 413 along with other stages of mastopexy. As shown in Fig. 4A, in certain embodiments, a periareolar incision 415 is made, thus allowing access to the lower pole of the breast. Through this incision, dissection is performed, for example, with an electrocautery device 403 to produce a subcutaneous dissection area 409. Fig. 4A illustrates, in one embodiment, the extent of subcutaneous dissection 409 in an anterior view, and the Fig. 4B illustrates, in one embodiment, the extent of subcutaneous dissection 409 in a side view. However, as will be discussed in more detail in this document, another dissection can be performed to create different pouch shapes, including deep pouches and channels to accommodate extension members, bands, ribbons and elongated straps from the support to the lower pole. In certain embodiments, dissection can be performed to extend the pouch or canal to the chest wall (that is, proximal or posterior to the breast parenchyma). In certain embodiments, dissection can be performed to extend ascending channels radially towards the medial and lateral chest wall.
    [0069] [0069] Fig. 4B also schematically illustrates the positioning of a suspension rod 411 to cause greater anterior projection, although other positions for the suspension rod 411 are also in accordance with this disclosure (ie, a more flat position with less previous projection). The level of anterior projection for the suspension rod 411 can be determined at the time of surgery according to the patient's aesthetic desires, as discussed preoperatively. Although the embodiment shown illustrates the suspension rod 411 in a subcutaneous position, it can also be positioned within or below the breast parenchyma, as described above.
    [0070] [0070] As shown in Figs. 4C and 4D, a support for the lower pole 413 'can be positioned within the breast so that it occupies part or all of the subcutaneous dissection area illustrated in Figs. 4A and 4B above. Figs. 4C and 4D also illustrate that the support for the lower pole can be inserted, or repositioned, or fixed through the periareolar, medial or lateral incisions (for example, 401 and 415). In certain embodiments, a positioning tool 417 can insert the support for the lower pole 413 'into the dissected area through the lateral or medial incisions and, in addition, it can pass the support for the lower pole 413 to its expanded shape 413' ' , as schematically illustrates Fig. 4E. In one embodiment, the support for the lower pole 413 is flexible and capable of being rolled cylindrically within a hollow positioning tool 417. In one embodiment, the support for the lower pole 413 is wrapped around the outer surface of the positioning tool .
    [0071] [0071] The expansion of the support for the lower pole 413 occurs in part by retracting the positioning tool 417 and leaving the support for the lower pole 413 behind. In certain embodiments, where the periareolar incision is used in the introduction of the positioning tool 417, only part (for example, a side part) of the support for the lower pole 413 can be positioned using the tool, with a part of the support for the lower pole 413 (for example, the medial part) remaining outside the incision and requiring subsequent manual positioning.
    [0072] [0072] In another practice, the incision used to position the suspension rod 411 can be used to position the support for the lower pole 413 after subcutaneous dissection 409 within the lower pole. The positioning tool 417 can access the entire subcutaneous dissection 409 through the initial incision 401 and implant the support for the lower pole 413 from the distal to the proximal side within the subcutaneous dissection space 409. This practice minimizes the exposure of the support to the lower pole 413 to the skin itself, potentially decreasing the risk of contamination. In these practices, in which two incisions are used to position the suspension rod 411, the two incisions can be used to more accurately position the support for the lower pole 413.
    [0073] [0073] It is understood that, in certain embodiments, the access incision can be positioned on the lateral aspect of the breast, on the chest wall, in the armpit or in other regions (inframammary fold, periareolar etc.) familiar to those skilled in the art. An additional access incision (not shown) can be used at any of these locations to assist in the placement or positioning of the support for the lower pole. In certain embodiments, the positioning tool is inserted through the lateral incision 401, following all the way through the lower pole and positioned by manual guidance using forceps or the like through a second medial incision (not shown) in the breast. In certain embodiments, the distal positioning of the support for the lower pole 413 can be accompanied by fixation, either on the patient's hard or soft tissues or on the suspension rod 411, or both. In certain embodiments, the suspension rod 411 is manufactured with a proximal and / or distal fixing frame that includes a region for connecting, fixing or seating the support for the lower pole 413. For example, several frame structures are illustrated on the rods represented in Figs. 1A to 1D, described above.
    [0074] [0074] In certain embodiments, the suspension rod 411 is equipped with a suture, clamp, fastener or other connection mechanism at each of its ends to allow the fixation of the support for the lower pole on it. In embodiments where two incisions are used to position the suspension rod 411, these incisions can be used to facilitate the connection of the suspension rod 411 with the support for the lower pole 413, for example, allowing the binding of a suture to connect these two components together. In addition, in certain embodiments, two or more parts of the support for the lower pole can be attached to the soft or hard tissue by means of a clamp, suture or anchor through the two medial and lateral incisions.
    [0075] [0075] In certain embodiments, the distal positioning of the support for the lower pole 413 is accompanied by fixation, either on the patient's hard or soft tissues or on the suspension rod 411, or both. In certain embodiments, the suspension rod 411 is manufactured with a proximal and / or distal fixing frame that includes a region for connecting, fixing or seating the support for the lower pole 413. In certain embodiments, the suspension rod 411 is equipped with a suture, clamp, fastener or other connection mechanism at each of its ends to allow the fixation of the support for the lower pole in it. In embodiments where two incisions are used to position the suspension rod 411, these incisions can be used to facilitate the connection of the suspension rod 411 in the support to the lower pole 413, for example, allowing the suture to be attached to connect these two components to each other.
    [0076] [0076] As an option, it is possible to insert a light source in the subcutaneous dissection 409 together with another suitable optical device to allow direct visualization of the connection of the suspension rod 411 with the support for the lower pole 413.
    [0077] [0077] In certain embodiments, the support for the lower pole can be self-expanding or self-configuring. For example, the support for the lower pole can be made of materials with format memory or other plastic or metallic materials that maintain a predetermined shape when releasing a coercive force. In certain embodiments, the support for the lower pole 413 can be inserted, positioned and expanded without a positioning tool 417, using standard surgical instruments. In certain embodiments, the support for the lower pole 413 is in increasing shape. In other embodiments, the support for the lower pole 413 is rectangular or in any other shape. The support for the lower pole 413 can expand only through the central region of the lower pole in order to establish support over a relatively small area within the breast, or it can occupy a wider area from the medial breast to the lateral breast. In one embodiment, the support for the lower pole 413 acts as an “inner bra”, raising and shaping the breast in an aesthetically desirable way.
    [0078] [0078] Fig. 4F illustrates a support for the lower pole in increasing shape, going from a first discrete profile, or rolled-up configuration, to an expanded shape. More specifically, the support for the lower pole 413 'is illustrated in a rolled or contracted configuration. The support for the lower pole 413 ’’ illustrates an intermediate configuration. The support for the lower pole 413 ’’ ’illustrates an expanded final shape or configuration. The support for the lower pole 413 of Fig. 4F is illustrated with the environment removed for clarity. In addition, it is understood that the formats and configurations may differ from the embodiment illustrated in Fig. 4F. Formats can vary widely and the invention is limited only to that described in the appended Claims.
    [0079] [0079] Fig. 5A illustrates another type of support for the lower pole 500 to raise or hold the breast tissue. The support 500 is illustrated in an unwound condition, for example, in an intermediate condition after manufacture, still prior to loading in the input device as described above.
    [0080] [0080] The support 500 is illustrated in an approximately X format. Four loops or bands 510a, 510b, 510c and 510d extend from a central body part. Although four handles or bands 510 are illustrated on the holder 500 of Fig. 5A, the number of handles may vary and, in certain embodiments, the holder may include 2, 3, 4, 5 or more handles and the same number of attachment points on the fabric. The support 500 is illustrated with a vertical symmetry axis 516. Each side of the vertical symmetry axis 516 comprises a diagonally inclined descending leg 510c, 510d and an upward concave arm 510a, 510b extending from the body. The body serves to support the lower pole when expanded and, preferably, its size is such that it shapes the breast uniformly and aesthetically. The area of the central body region varies, for example, between 1 and 15 cm2.
    [0081] [0081] The halves separated by the horizontal axis 520, in turn, differ. The larger upper half has longer handles 510a and 510b than the lower handles 510c and 510d. As will be described in more detail below, the longer straps serve to cover a larger volume of the breast above than below. The 510c and 510d legs are shorter than the arms.
    [0082] [0082] Exemplary lengths of the legs vary from about 1 to 15 cm and, preferably, are about 10 cm. Exemplary arm lengths range from about 3 to 30 cm and are preferably about 16 cm.
    [0083] [0083] In some embodiments, the ratio of the length of the legs to the arms is 2: 1.
    [0084] [0084] The width of the legs varies from about 0.25 to 5 cm and, preferably, is about 0.5 cm. The width of the arms also varies from about 0.25 to 5 cm and is preferably about 0.5 cm. In some embodiments, the bands are of constant width. In other embodiments, the width of the bands varies. The bands can comprise straight, tapered edges or that culminate in a point.
    [0085] [0085] It should be understood that, although the format of the bands and loops can vary widely, by "band" or "loop" it is intended to exclude the shape of a suture. The bands and handles of the support for the lower pole have an aspect ratio different from that of a suture. For example, an aspect ratio (width / thickness) ranging from 5/1 to 500/1. In addition, in certain embodiments, the band and handles can be integral with the cup of the support. The support can be a unitary structure.
    [0086] [0086] In certain embodiments, the support 500 and the handles 510 are flexible, adaptable and thin. The support 500 can be made of various materials and can comprise materials as described in this document in relation to other embodiments of the invention. In one embodiment, support 500 comprises a two-dimensional polymeric structure of poly-4-hydrobutyrate (P4HB). An example of suitable mesh is TephaFlex ™, manufactured by Tepha inc., Lexington, MA. However, the present invention is not limited to that. The support may comprise other materials and is limited only to that described in the appended Claims.
    [0087] [0087] Without attaching to the theory, the straps, bands or tapes serve to more evenly distribute the loads of force along the support to the lower pole (and along the various points of attachment) in order to decrease the load and failure at any attachment point. In addition, the tapes do not strangle the fabric, as sutures may do in certain circumstances. These are advantages over standard breast lift devices, which use sutures to support loads.
    [0088] [0088] Furthermore, on the support 500 shown in Fig. 5A, the suspension arms 510a and 510b are shown with a curvature. More specifically, the arms or handles are illustrated as upwardly concave from the vertical axis of symmetry 516. However, the curvature and shape of the arms can vary widely. The limbs, whether arms or legs, can be straight or curved.
    [0089] [0089] Fig. 5B illustrates another support 504 for raising breast tissue. Support 504 is illustrated in an unexpanded or unrolled condition, with the environment removed for clarity. The support 504 is similar to the support 500 described above, except that the arms 510e and 510f are descendingly convex with respect to the vertical symmetry axis 518.
    [0090] [0090] The length of the arms varies from about 5 to 30 cm and, preferably, is about 18 cm. The length and width of the legs may be similar to those described with reference to the support 500 of Fig. 5A.
    [0091] [0091] Fig. 6A illustrates another support for the lower pole. Support 600 includes an upper region 620 of elliptical shape and a lower region 630 of similar shape to the upper region, albeit of different size. The bieliptic (or bioval) support 600 shown in Fig. 6A includes four ends 610a, 610b, 610c and 610d. The ends or edges of the two ellipses can be used as an anchor point to fix the support to the chest wall or other supporting tissue, as described in more detail below.
    [0092] [0092] The upper ellipse 620 is illustrated with a footprint similar to or slightly larger than that of the lower ellipse 630. However, the shapes can vary widely. The shapes can be substantially different from that shown in Fig. 6B, where the upper ellipse 640 is much larger than the lower ellipse 650. The figures are given by way of example only, and the upper area of the breast support device 600 may be larger , equal to or less than the bottom.
    [0093] [0093] In addition, the formats themselves may be different or similar. For example, the upper ellipse can be stacked or combined in some other way with a lower crescent shape, half-moon, semicircular, rectangular or any other shape contemplated in this document. In addition, one or more of the regions may comprise one or more loops or bands as described above with reference to Figs. 5A and 5B.
    [0094] [0094] The specific dimensions of the support may vary. Exemplary non-limiting lengths (Cprincipal) for the major ellipse 620 along its long or main axis vary from 16 to 36 cm, perhaps, about 25 cm. The larger ellipse 620 may have a height (Ama) that varies from 4 to 12 cm and, in one embodiment, about 7 cm.
    [0095] [0095] Preferably, the smaller ellipse 630 is centered in relation to the upper ellipse and has a long axis that varies from 12 to 25 cm, perhaps, about 17 cm. The smaller ellipse 630 can have a height (Ame) that varies from 2 to 10 cm and, in one embodiment, about 5 cm. In addition, the top crescent can be about 2 times the width of the bottom shape.
    [0096] [0096] The support materials illustrated in Figs. 6A and 6B may be similar to the materials and compositions of the mesh and supports described in this document.
    [0097] [0097] Figs. 7A, 7B and 7C illustrate various tissue supports 700, 730 and 760, respectively, implanted in the breast 702 of a patient 706, serving to raise the lower pole of the breast and the NAC 704 to a desired position. The breast skin is not illustrated for clarity in representing the positioning and shape of the supports. As will be discussed in more detail below, the supports are positioned in a subcutaneous pouch through one or more incisions.
    [0098] [0098] With reference to Fig. 7A, the support 700 includes a central body part 703 and four handles, including two upper handles 714 and two lower handles 708 extending from the body part. The lower straps 708 are manipulated from below and attached to the supporting tissue in the chest wall. It is possible to use 712 sutures to secure the straps to the chest wall.
    [0099] [0099] The upper loops 714 are manipulated through the breast parenchyma and fixed to the chest wall at points 716. The support 700 fixes the lower pole of the breast parenchyma in a desired position.
    [0100] [00100] With reference to Fig. 7B, a support 730 is illustrated in an expanded condition and includes substantially the same features as those described with reference to support 700 of Fig. 7A, except that the upper arm members 732 are different from the handles upper arms 714. More specifically, the upper arm members 732 shown in Fig. 7B have a convex curvature with respect to the axis of vertical symmetry. The 732 arm members bend slightly outward.
    [0101] [00101] Without being tied to theory, this difference in shape on the handles is desirable in certain cases and to adjust or produce certain survey formats. The convex curvature tends to place forces on a more upper part of the breast, thus providing a different appearance or shape. By adjusting the level of curvature, you can adjust the shape or lift.
    [0102] [00102] With reference to Fig. 7C, support 760 is shown in an expanded condition and includes a minor elliptical region 762, attached to the chest wall, and a major elliptical region 764, which surrounds the breast parenchyma and attaches to its edges 766 or corners, thus constituting a sling to support the breast 702 in the raised position.
    [0103] [00103] Fig. 8A illustrates another support 800 in 3D format. More specifically, the support 800 shown in Fig. 8A includes a canoe body with walls 802 and 806 and a cavity 804 formed between them. Cavity 804 serves to accommodate the breast parenchyma when expanded.
    [0104] [00104] An exemplary non-limiting length is about 22 cm, and with a flexibility or elasticity to extend 10% to the length. Exemplary non-limiting curves for the two radii illustrated in Fig. 8A are about 5.5 cm and 4.5 cm with 50% to 100% extensibility.
    [0105] [00105] The support may comprise a unitary sheet or mesh made of polymer, such as that described in this document, which is cut and folded to form the 3D structure or shape. An exemplary pore size is preferably about 1 mm.
    [0106] [00106] Support 800 attaches to the patient's chest wall or other supporting tissue at two points to support the breast's soft tissue. The ends 808 and 810 are fixed in points on the patient's chest wall. In certain embodiments, a suture, hook, tack or other anchoring mechanism attaches to the edges to anchor or fix them to the supporting fabric.
    [0107] [00107] Fig. 8B illustrates, for example, a support 830 with rings 832 for attaching to the supporting fabric or other fixation device, as the case may be. Fig. 8C illustrates, for example, a support 850 with sutures 856 for attaching to the supporting tissue or other fixation device, as the case may be. However, the invention is not limited to this, being possible to incorporate a wide variety of means to connect the ends, edges, loops or supports to the supporting fabric. In addition, "sustaining tissue" is intended to include, among others, the tissue of the chest wall, including subglandular, fascial, bone, cartilage and muscle tissues.
    [0108] [00108] When connected with the supporting tissue and / or with a suspension rod as described above, the support for the lower pole is positioned to exert sufficient lifting force to the breast to mitigate pre-diagnosed ptosis in such a way as to mitigate also the force on the incision sites and the skin of the lower pole. In one embodiment, the support for the lower pole is temporarily fixed on the supporting fabric and / or on the suspension rod, with the tension on the system being adjusted intraoperatively. It may be desirable to adjust the patient's position to a sitting or upright position in order to optimize the tension on the system and the subsequent correction of breast ptosis.
    [0109] [00109] The support for the lower pole (for example, without restriction to support 413, 500, 600, 700, 800 etc.) can be configured in the form of a sheet, a solid sheet or a discontinuous layer, such as a mesh. Non-limiting examples of support include a mesh, a set of strips, a fabric, a woven structure, a knitted structure, a braided structure, a porous frame, a nanowire, an electrofoil or a blown structure.
    [0110] [00110] In certain embodiments, the support for the lower pole can be made of the same materials (for example, biodegradable polymeric materials) described as usable on the suspension rod. Suitable tissue derived products include allograft, autograft, xenograft, collagen and the like. Also included are compositions in which two or more synthetic and animal-based materials are used to form a composite structure to convey ideal strength resorption and retention characteristics.
    [0111] [00111] In certain embodiments, the support for the lower pole is made of biocompatible metals. In certain embodiments, the support for the lower pole is made of a composite of materials among those described above.
    [0112] [00112] In certain embodiments, the support for the lower pole is made of biodegradable and / or resorbable materials. Preferably, these materials would be selected so as to provide adequate tensile strength to support the breast and prolong the time during which the corrected lift remains stable, as well as so that the corrected position is stabilized by the formation of a layer of collagen or healing tissue concomitant with the loss of strength of the support for the lower pole.
    [0113] [00113] Preferred materials include poly-4-hydroxybutyrate and polydioxanone, silk-based fibers and other biodegradable polymers. Other materials that may be suitable if properly structured include allograft or xenograft or biodegradable polymers with shorter force retention times. Similarly, the preferred materials for the suspension rod are biodegradable materials with extended force retention times, as described above. In certain embodiments, the components of the mastopexy system disclosed in this document are substantially biodegradable and / or resorbable in order to produce a lasting breast lift without leaving permanent foreign bodies in the breast region. This biodegradable / resorbable system would provide sufficient and long-lasting tensile strength to allow the repositioned breast tissues to remain in place during tissue remodeling and collagen deposition around the resorbent implant, with the breast's raised long-lasting shape being maintained by the tissue newly generated fibrous fiber.
    [0114] [00114] MASTOPEXY PROCEDURE
    [0115] [00115] Figs. 9A to 9F illustrate steps in a mastopexy procedure. More specifically, Figs. 9A to 9F illustrate the implantation of tissue support 900 in the breast. The support raises the lower pole of the breast from a first position 902 'to a desired position 902' '.
    [0116] [00116] First, and with reference to Fig. 9A, one or more upper incisions 910a, 910b are formed in the lateral and medial parts of the breast and lower incisions 910c, 910d are formed proximally to the inframammary fold, slightly below the bottom edge of NAC 912. In addition, a 908 crescent shaped skin part is removed from above NAC 912.
    [0117] [00117] Fig. 9B illustrates the step of forming a subcutaneous pocket 920 using a dissector tool 922 inserted through the incision in the NAC. The dissection is performed to form a preferably triangular pouch in the superficial and lower half of the breast, with one side of the triangle being tangent to the lower part of the NAC 912. The pouch 920 serves to accommodate the support 900.
    [0118] [00118] In certain embodiments, the pouch may be defined or characterized by comprising several regions, including an anterior region, or main region, arranged more anteriorly, as well as several deep regions that extend to points on the chest wall or in close proximity to it is. In certain embodiments, two regions or deeper pockets are formed above the NAC in the same subcutaneous plane as the main region to position the upper loops 904. Similarly, in certain embodiments, two regions or deeper pockets are formed preferably below the NAC to position the lower handles 906.
    [0119] [00119] Fig. 9C illustrates an introduction device 930 penetrating the subcutaneous pocket through the lateral incision 910a and being conducted, through the side of the bag tangent to the NAC, to the medial incision 910b. The direction is indicated by reference number F1 in Fig. 9C. The input device was preloaded with the support for the lower pole 900. The support for the lower pole 900 illustrated in Figs. 9A to 9F includes four suspension arms (each pre-tied with two suture lines, and one suture at the end of each upper "arm"). The support for the lower pole is folded (preferably in the middle) and then rolled up and inserted into the input device. Suture lines 940 can protrude beyond the distal end of the delivery device.
    [0120] [00120] Fig. 9D illustrates the expansion of the support for the lower pole 900. The expansion can be performed by retracting the introduction device 930 with a force T1 while holding the suture lines 940 and exerting tension or sutures 940 in the direction indicated by T2. The insertion device 930 is removed horizontally, expanding the support for the lower pole 900 within the subcutaneous pouch 920.
    [0121] [00121] Fig. 9E illustrates the manipulation or positioning of the support for the lower pole. More specifically, by holding the suture lines, loops 904 and 906 can be manipulated in order to optimize the positioning of the support for the lower pole. The option of sitting the patient to better align the positioning of the breast is also feasible. The straps are arranged through the deep pockets. If desired, it is possible to form new small incisions to provide better access to manipulate the support.
    [0122] [00122] Fig. 9F illustrates the breast lifted from a first position 902 'to the desired position 902' '. The breast can be manipulated from the first position to the desired position by adjusting it directly with the hand or manipulating the handles or parts of the support for the lower pole. With the breast already in the desired position, the straps are fixed. Examples of fastening techniques are described above and include, for example, nailing the loops to the supporting fabric, suturing the loops to the supporting fabric, or attaching the loops to anchors attached to the sustaining fabric.
    [0123] [00123] In some embodiments, it is also possible to use a periareolar incision to correctly position the support inferiorly around the lower pole of the breast parenchyma. An inframammary incision is formed and the wired subcision is used to expand the lower point of the triangular bag so that it is more quadrangular. In addition, wired subcision or electrocautery can be used once again to deeply dissect the breast at two points on the lower chest wall and medial at the two initial fixation points. Absorbable tacks can be used to fix the "legs" of the support in the same plane of the chest wall where the "arms" are fixed.
    [0124] [00124] Although the method described above with reference to Figs. 9A to 9F describes the implantation of a type of support for the lower pole, it should be understood that the invention is not limited to that, and other types of support for the lower pole can be implanted according to the methods of the present invention.
    [0125] [00125] In addition, the dissecting step can be performed in a variety of ways, including, but not limited to, blunt dissection, electrocauterization or wired subcision.
    [0126] [00126] Electrocauterization or blind dissection can be performed through the various incisions described above. The instrument is inserted through the incision and the pouch is formed by applying force or energy or a combination of both.
    [0127] [00127] Figs. 10A to 10E illustrate an example of wired subcision. With reference to Fig. 10A, several incisions are formed as described above. Preferably, two medial and two lateral incisions are formed. Next, as shown in Figs. from 10B to 10D, several contiguous pockets 1010, 1012 and 1014 are formed. Preferably, the pockets are triangular and formed in sequence with a thread and needle member 1020. The needle is manipulated from under the skin to form a triangular pouch and then recessed, thus separating the skin from the fabric to form the respective pouch.
    [0128] [00128] Fig. 10E illustrates an example of contiguous triangular pouch 1022 to accommodate various types of lower pole support described above.
    [0129] [00129] EQUIVALENTS
    [0130] [00130] Although specific embodiments of the present invention have been discussed, the above specification is illustrative and not restrictive. Many variations of the invention will be apparent to those skilled in the art when analyzing this specification. Unless otherwise stated, all numbers expressing quantities or properties of components or methods used in the specification and in the Claims must be interpreted in such a way that they are modified, in all cases, by the term "about". Therefore, unless otherwise indicated, the numerical parameters defined in this document are approximations that may vary depending on the desired properties whose achievement is desired by the present invention.
    [0131] [00131] Although the present invention has been illustrated and described particularly with reference to its preferred embodiments, those skilled in the art will realize that it is possible to make various changes in form and details to the present invention without thereby deviating from its scope, revealed in the appended Claims .
    权利要求:
    Claims (15)
    [0001]
    Mastopexy implant, in which the implant is to protect a patient's breast in a raised position, characterized by the fact that the implant comprises: a flexible, self-configuring lower pole support (413, 500, 600, 700, 800) formed from biodegradable polymer comprising an upper region (620) and a lower region (630) dimensioned to cover part of a lower breast pole and not cover a nipple-areola complex (NAC) (704, 912) of the breast; and wherein the upper region comprises a plurality of upper fixation end parts (766) for fixing to the patient's support tissue in the vicinity of an upper side of the breast and said lower region comprises a plurality of fixing end lower parts for attach to the support tissue in the vicinity of an inframammary fold (IMF).
    [0002]
    Mastopexy implant according to Claim 1, characterized in that the upper region defines a plurality of upper loops (714, 904), each upper loop ending in one of said pluralities of upper parts of the fixation end.
    [0003]
    Mastopexy implant according to Claim 2, characterized in that the mastopexy implant comprises two lower loops (708, 906) and two upper loops (714, 904).
    [0004]
    Mastopexy implant according to Claim 2 or 3, characterized in that each of said upper loops (714, 904) comprises a length of at least 10 cm and / or each of said upper loops comprises a width of at least 1 cm.
    [0005]
    Mastopexy implant according to any one of the preceding Claims, characterized in that the lower region (630) comprises a plurality of lower loops (708, 906), and each lower loop ends in one of said pluralities of lower parts of the end of fixation.
    [0006]
    Mastopexy implant according to Claim 5, characterized in that each of said lower loops (708, 906) comprises a length of at least 5 cm and / or wherein each of said lower loops comprises a width of 0, 5 cm.
    [0007]
    Mastopexy implant according to any one of the preceding Claims, characterized in that the support of the lower pole (500) comprises a sheet with a vertical axis of symmetry (516, 518), so that each side of the vertical axis of symmetry is identical.
    [0008]
    Mastopexy implant according to Claim 7, characterized in that the plurality of upper loops (714, 904) are two upper loops and, optionally, in which the upper loops are curved, concave or convex.
    [0009]
    Mastopexy implant, according to one of the preceding Claims, characterized in that at least one of the upper region (620) and the lower region (630) has a shape selected from the group consisting of a rectangle, ellipse, crescent, arc, square, teardrop, circle and triangle and, optionally, where the upper region (620) is elliptical in shape and even more optionally, where the lower region (630) is smaller than the upper region.
    [0010]
    Mastopexy implant, according to Claim 1, characterized in that the upper parts of the fixation end taper.
    [0011]
    Mastopexy implant, according to Claim 10, characterized in that the upper parts of the fixation end taper in points.
    [0012]
    Mastopexy implant, according to Claim 1, characterized in that the support of the lower pole comprises a leaf.
    [0013]
    Mastopexy implant according to Claim 12, characterized in that the sheet has a uniform thickness.
    [0014]
    Mastopexy implant according to Claim 12 or 13, characterized in that the sheet is bioabsorbable.
    [0015]
    Mastopexy implant according to any one of Claims 12 to 14, characterized in that the sheet comprises a mesh material.
    类似技术:
    公开号 | 公开日 | 专利标题
    BR112013020638B1|2020-09-08|MASTOPEXY IMPLANT
    US10595985B2|2020-03-24|Minimally invasive breast lift method with a superior tissue support and an inferior anchor
    US7875074B2|2011-01-25|Naturally contoured, preformed, three dimensional mesh device for breast implant support
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    同族专利:
    公开号 | 公开日
    US20190216595A1|2019-07-18|
    EP3636222A1|2020-04-15|
    ES2684949T3|2018-10-05|
    US20170143475A1|2017-05-25|
    BR122019027590B1|2020-09-15|
    US20200360129A1|2020-11-19|
    US10258460B2|2019-04-16|
    US9277986B2|2016-03-08|
    ES2769324T3|2020-06-25|
    US8858629B2|2014-10-14|
    EP2683329A4|2014-08-27|
    CA2829201A1|2012-09-13|
    BR112013020638A2|2016-10-25|
    WO2012122215A2|2012-09-13|
    CA2829201C|2019-03-12|
    EP3199126A1|2017-08-02|
    EP3199126B1|2019-11-06|
    PL3199126T3|2020-05-18|
    US10765507B2|2020-09-08|
    US20140222146A1|2014-08-07|
    EP2683329A2|2014-01-15|
    US20150351891A1|2015-12-10|
    WO2012122215A3|2013-01-03|
    US20120283826A1|2012-11-08|
    EP2683329B1|2018-05-30|
    US9585744B2|2017-03-07|
    PT3199126T|2020-01-28|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2020-07-21| B09A| Decision: intention to grant|
    2020-09-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 07/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161451103P| true| 2011-03-09|2011-03-09|
    US61/451,103|2011-03-09|
    US201261604242P| true| 2012-02-28|2012-02-28|
    US61/604,242|2012-02-28|
    PCT/US2012/027975|WO2012122215A2|2011-03-09|2012-03-07|Systems and methods for mastopexy|BR122019027590-4A| BR122019027590B1|2011-03-09|2012-03-07|MASTOPEXY IMPLANT|
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