WO2007004214A2

WO2007004214A2 - Implant assembly

Info

Publication number: WO2007004214A2
Application number: PCT/IL2006/000752
Authority: WO
Inventors: Sergey Popov
Original assignee: Sergey Popov
Priority date: 2005-07-04
Filing date: 2006-06-28
Publication date: 2007-01-11
Also published as: WO2007004214A3

Abstract

Implant assembly 140 for supporting mammary gland 163 (see fig. 5) comprises a basket-shaped structure 152 embracing a breast lower semi-sphere for its fixation by straps 156, 157 terminating in anchoring elements 161, 162. The latter are put on the horizontal bone like clavicula 158 or a rib bone. Elements 161, 162 have widened contact surfaces dispersing the bone load on the bone external surface to avoid the mechanical deterioration of the bone in a contact zone. They are rested against a strong external cortical layer of the bone thereby distributing the load throughout the bone cross-section. In version embodiments, the implant assembly includes the damping means restricting the bone dynamic load during patient's walking or sharp movements, as well as a means for the smooth control of the distance between structure 152 and supporting bone.

Description

IMPLANT ASSEMBLY

BACKGROUND

Field of the Invention

The present invention relates to the implantable devises for plastic surgery designed for the replacement and / or correction of human anatomic structures. Specifically, it relates to the implant prostheses for the correction and reconstruction of the mammary gland including the implant supporting means.

Prior Art

The problems of the plastic surgery with applying the implantable devices are closely connected with the reliable fixation of the implants in a human organism. The quality of the implant fixation to a great extent determines the implant life, its correct function and aesthetic appearance of corrected human organ.

US Patent 4,298,997 discloses Device for inhibiting the formation of fibrous capsular contractures in silicone breast implants including a circular disc of thin silicone sheet material. This disc is adhesively attached to an annular band of Dacron felt material. The combined disc and band are surgically implanted, preferably beneath the chest muscles, with the Dacron felt band against the rib cage. A conventional breast implant having substantially the same diameter as the circular disc is then placed over the disc in register therewith and the incision closed. The arrangement reduces the incidence of problems arising from the formation of fibrous capsular contractures in silicone breast implants. However the unfastened implant installation provides its increased mobility leading to the implant migration and undesirable change the breast form as well as to enhanced growth of the connective tissue at the patient's tissue contacting with the implant.

US Patent 5,584,884 discloses Mammary prosthesis comprising a wedge shaped sheet of flexible biocompatible material having reinforced upper and lower attachment portions for attachment to bone of a patient by bone anchors, with the lower attachment portion being anchored to one or more ribs. The lower attachment portion includes a support member less flexible than the sheet material having the suture receiving openings for receiving bone anchor sutures. The disadvantage of the present prosthesis is that it creates the frontal outer restricting wall, which changes the natural form of the mammary gland and its tactile perception, restricts the natural hypertrophy of the mammary gland caused with the pregnancy. Moreover, rigid fastening the implant to upper and lower ribs hinders the mobility of the shoulder and in specific cases restricts the breath freedom. Besides, the bone anchors, made as screws, do not provide reliable and durable implant fixation to the ribs, since the rib has only thin strong cortical layer and the specificity of the screw loading leads to their shaking and falling out.

Thus, the one of the disadvantages of the known implant prostheses is the limited capability of their reliable and uniform fixation in patient's tissues leading to the disturbing the natural appearance of corrected anatomic structures and reducing the implant life. The absence of the means preventing the soft tissue stretch and female breast sagging under gravity also relates to the disadvantages of the known implants.

SUMMARY

The general objective of the present invention is providing the correct long-term function of the implant and the aesthetic appearance of corrected anatomic structures by means of the implant reliable fixation in the human organism.

Another objective is providing an improved female breast implant, which supports the breast tissue without disturbing the natural breast forms and tactile perceptions.

Another objective is providing an improved female breast implant, which supports the female breast eliminating the breast skin stretch and breast sagging under gravity.

Another objective is providing an improved female breast implant, which supports the female breast without the hindrance to the natural breast hypertrophy caused with a pregnancy.

Another objective is providing an improved female breast implant, which supports the breast without the restriction of any natural body mobility and respiration.

Another objective is providing the surgical procedures utilizing the above new and improved surgically implanted prosthesis.

The above noted objectives of the present invention are accomplished with an implant assembly for the replacement and / or correction of anatomic structures, provided with a fixation means designed for the implant fixation within the patient's body and made as anchoring elements arranged on the implant walls and serving for fastening the implant to the patient's body. The fixation means has at least one bone anchoring element engaging the implant with the bone structures and capable of withstanding an implant load. There is also a preventing means preventing the damage of the bone structure for a long time and including an operating contact surface of the bone anchoring element to be contacted with an external surface of the bone structure and transmitting the implant load to the bone structure external surface. The mentioned operating contact surface is adapted to girth the bone structure and due to this is capable of substantially uniform distribution of the implant load throughout the bone structure external surface and has sufficient size to decrease a specific pressure onto the bone structure external surface up to permissible level eliminating weakening the bone structure in its contact zone with the bone anchoring element for a long time. As a result, the implant load in the form of decreased specific pressure is transmitted onto the widened external surface of the most strong cortical bone layer, thereby providing the reliability and durability of the implant fixation.

The bone anchoring element is made in the form of a relatively rigid hook adapted for putting on the bone structure for coupling to it by gravity. The rigid hook has floating connection with the implant and its operating contact surface is substantially congruent with the bone structure external surface to provide the uniform distribution of the implant load throughout the bone carrying surface.

In version embodiment, the bone anchoring element is made in the form of a band sufficiently wide to decrease the specific pressure onto the bone external surface up to permissible level and sufficiently elastic to fit its operating contact surface to the bone external surface and provide the uniform distribution of the implant load throughout said bone external surface.

In another version, the bone anchoring element includes a bearing plate having the operating contact surface substantially congruent to the bone carrying surface, and at least one pin fastened to the bearing plate by its distal end, passing through the bone structure and having a proximal end going out of the bone structure proximal segment and provided with a means for its connecting to the implant.

In another version, the bone anchoring element is made in the form of a grasping anchoring element adapted to seizing and holding the bone structure at least at two its diametrically opposed portions. Specifically, the grasping anchoring element is adapted to fixing the implant to a rib by compressing the rib upper and lower surfaces.

In version embodiment, the bone anchoring element includes a fastening means preventing the spontaneous disconnection of the bone anchoring element from the bone structure. Specifically, the fastening means is made as holes in the bone anchoring element allowing its fixation to the bone structure by screws. In another embodiment, the fastening means presents a member of the bone anchoring element having a porous structure, contacting with the bone and allowing the ingrowth of surrounding tissues therein, thereby enhancing the fixation reliability of the implant.

The preventing means of the implant assembly includes a shock absorbing means restricting a dynamic loading of the fixation means and simulating the elastic properties inherent in the breast tissues under natural conditions. The shock absorbing means includes at least one springy element mounted between the implant and the bone anchoring element. In version embodiment, the fixation means includes at least one strap provided with the bone anchoring element and allowing the fixation of the implant to the bone structure and the springy element presents a constituent of the strap. The springy elements may be made in the form of a metal spring located in a flexible sheath to protect the metal spring from immediate contact with surrounding patient tissue. In another embodiment, the implant coήiponents are made of material having the springy properties, fulfilling the part of the shock absorbing means and having the design strength eliminating their residual deformation under the dynamic loading.

The fixation means is provided with an adjusting means allowing the control of the distance between the implant and the bone structure to obtain the needed final implant position. The adjusting means includes at least one connecting member connecting the implant and the bone anchoring element and capable of changing and fixing its length thereby allowing the control of the distance between the implant and the bone anchoring element. The connecting element is made in the form of a toothed flexible band passing through a toothed holder allowing setting i/ι fixing the length of the toothed flexible band.

In version, the anchoring elements are made as straps fastened to the implant and adapted for the fixation to a fixation base. The patient's bone can be used as the fixation base and in this case the straps have bone anchoring elements made in the form of rigid hooks adapted for putting on the substantially horizontal bone structure disposed above the mammary gland, like the clavicular or rib bones, for coupling to the bones by gravity.

In version embodiment, the fixation means includes more than one bone anchoring elements and their connections with the implant are disposed at certain distance from one another thereby providing the distribution of the implant load among the spaced external surfaces of the bone structures and stabilizing the position of the implant in the human organism. This embodiment provides for the capability of using several bone anchoring elements of various length allowing the implant fixation to different bones thereby decreasing the implant load transmitted to each one bone.

The implant presents a breast prosthesis made as a flexible container filled with fluid and designed for a female breast correction surgery, specifically for the augmentation mammoplasty or the mammary gland replacement. The fixation means is fastened to the prosthesis through a base element disposed at the upper part prosthesis and the bone anchoring element is adapted to the fixation of the prosthesis to the bone structure disposed above the prosthesis. In another embodiment, the base element is made in the form of a plate fastened to a prosthesis rear wall, and the bone anchoring element is adapted to fixing the prosthesis to ribs located approximately at the level of the prosthesis. In another embodiment, the flexible container at least partly is made of composite material including the reinforcing filaments, whose disposition in the container walls relative to the fixation means provides the relatively uniform support of the various container portions by the fixation means, thereby reducing to minimum the stress concentration in the container walls.

In version embodiment, the prosthesis designed for the augmentation mammoplasty and to be implanted between a mammary gland and a pectoral major muscle is fastened to a mammary gland by gland anchoring links having link implant ends connected to the prosthesis and link anchoring ends connected to the mammary gland. The links are flexible, peripherally arranged throughout the perimeter of the prosthesis, contacting with the mammary gland surface with some overlapping, and at least the link anchoring ends are made of a mesh-like material adapted for the fixation to the mammary gland by ingrowing the mammary gland tissue therein. As a result, the good aesthetic appearance and tactile continuity at the boundary between the prosthesis and mammary gland are achieved.

In version embodiment, the implant assembly designed for the form correction of a female breast has an implant serving as an internal brassiere. It includes a breast forming means, which embraces a mammary gland at least on the side of its lower surface and serves as a supporting bed for the mammary gland, and a fixation means designed for the fixation of the breast forming means to patient's bone structures and releasing the skin and surrounding soft tissues from a gravity action thereby eliminating the main reason of their stretch and a female breast sagging in the natural conditions. The fixation means is made as straps having implant ends fastened to the elements of the breast forming means and anchor ends provided with bone anchoring elements allowing the fixation of the straps and thereby the breast forming means to patient's bones. The breast forming means is made of a bio-compatible and non-biodegradable material whose structure permits the mammary gland tissue ingrowth therein without slitting the biologic tissue. In version embodiments, the breast forming means comprises lateral and top portions restricting the mammary gland deformation thereby maintaining the aesthetic form of the female breast. The bone anchoring elements are made in the form of rigid hooks adapted for putting on the substantially horizontal bone structure disposed above the mammary gland, like the clavicular or rib bones, for coupling to the bones by gravity. This implant assembly supports the breast tissue without disturbing the natural breast forms and tactile perceptions, eliminates the breast skin stretch under gravity, and does not hinder the natural breast hypertrophy caused with a pregnancy. It also does not restrict any natural body mobility and respiration.

In the combination version, the implant assembly includes a breast prosthesis designed for augmentation mammoplasty and fastened to the rear portion of the breast forming means so that the breast forming means has sufficient place for containing the mammary gland. This provides the new property of the augmentation mammoplasty preventing sagging the augmented female breast.

The surgical procedures utilizing the above new implant assembly for the female breast correction and preventing the breast sagging over the woman life include: performing an surgical access at least to a lower hemisphere of the mammary gland; performing at least one anchoring passage in the patient tissues from the mammary gland to the bone structure; emplacing the breast forming means in such a way to embrace the mammary gland at least on the side of its lower hemisphere and to provide functioning the breast forming means as a supporting bed of the mammary gland; dragging the bone anchoring element to the bone structure through the anchoring passage; fixing the bone anchoring element and thereby the breast forming -means to the bone structure in order to release a breast skin and surrounding soft tissues from a gravity action and thereby to eliminate the main reason of their stretch and a female breast sagging taking place under natural conditions. Therewith, the access to a lower hemisphere of the mammary gland is performed by an inframammary incision and subsequent at least partial separating the mammary gland lower hemisphere from surrounding tissues on the lower, lateral and anterior sides.

In the version of the breast forming means including an anterior top portion, the method includes separating said mammary gland anterior top part from surrounding tissues.

In the method version, a clavicula is used as the bone structure and the anchoring passage communicates the mammary gland area with a clavicula zone.

In the method version, a rib is used as the bone structure and the anchoring passage communicates the mammary gland area with a rib zone.

In the method version, a breast bone is used as the bone structure and the anchoring passage communicates the mammary gland area with a breast bone zone.

In the version of the fixation means including several bone anchoring elements, the method provides for performing the anchoring passage for each of the bone anchoring elements thereby allowing the fixation of the implant to the bone structure in its sites spaced from one another. Specifically, the bone anchoring elements may be fixed to different bone structures thereby decreasing the load of the bone structures and preventing their fracture.

In the version of the fixation means including two straps, the method provides for performing two anchoring passages for the straps disposed substantially laterally on the both sides of the mammary gland.

In the version of the fixation means including the bone anchoring element made in the form of rigid hook, its fixation to the bone structure consists in its putting on the bone structure to couple with the bone structure under gravity.

In the version of the fixation means including adjusting means, the method provides for the adjustment of the distance between the breast forming means and the bone structure to obtain the needed final breast position.

In the version of the implant assembly including a breast prosthesis designed for augmentation mammoplasty and fastened to the rear portion of the breast forming means, the method provides for emplacing the breast forming means along with the breast prosthesis in such a way to place the breast prosthesis rear of the mammary gland.

BRIEF DESCRIPNION OF THE DRAWINGS

Figs. 1 to 3 show the implant assembly in the form of a breast prosthesis for the augmentation mammoplasty or the mammary gland replacement including the flexible container filled with fluid and provided with two bone anchoring elements in the form of a rigid hooks. Figs. 4, 5 show the implant assembly in the non-implanted and implanted positions respectively serving as an internal brassiere and including the breast forming means embracing the breast on lower and lateral sides and suspended by two straps on the clavicula.

Figs. 6, 7 show the breast forming means in the non-implanted position designed to embrace the mammary gland on its lower and lateral sides und provided with two bone anchoring elements in the form of rigid hooks disposed at substantial distance from one another. Fig. 8 shows the mesh, which presents the material of the breast forming means shown in figs. 6, 7.

Fig. 9 shows the breast forming means in the implanted position fixed to a rib. Fig. 10 shows the breast forming means fixed to two different bones by two bone anchoring elements made in the form of a band sufficiently elastic to fit their operating contact surfaces to the bone external surfaces.

Fig.11 shows the fragment of a member of the bone anchoring elements of fig. 10 having a porous up to mesh-like structure, contacting with the bone and allowing the ingrowth of surrounding tissues therein.

Figs. 12 to 15 show the breast forming means in the non-implanted (figs. 12 to 14) and implanted (fig. 15) positions provided with the shock absorbing means in the form of a metal spring elements and the adjustable means.

Figs. 16 to 19 show the breast forming means, including a top portion providing additional restrictions of the mammary gland deformation, and provided with shock absorbing means and bone anchoring elements in the form of rigid hooks.

Figs. 20 to 23 show the breast forming means provided with the bone anchoring element in the form of a bearing plate congruent to the bone carrying surface and connected to the breast forming means by pins passing through the bone structure. Figs. 24 to 26 show the implant assembly including a breast prosthesis designed for augmentation mammoplasty and fastened to the rear portion of the breast forming means while the mammary gland is contained in the anterior portion of the breast forming means. Figs. 27, 28 and 29 show the implant assembly for the augmentation mammoplasty in the non- implanted and implanted positions respectively including the gland anchoring links connecting the implant to the mammary gland.

Figs. 30, 31 and 32 show the implant assembly for the augmentation mammoplasty in the non- implanted and implanted positions respectively including the gland anchoring links connecting the implant to the mammary gland and the tissue anchoring links connecting the implant to surrounding soft tissues.

DETAILED DESCRIPTION OF THE INVENTION The detailed description of the present invention is offered with references made to the enclosed drawings in figs. 1 to 32.

Implant assembly 40, shown in figs. 1 to 3, is designed for the mammary gland replacement. It includes implant-expander 41 implanted instead of the removed mammary gland into the tissue pouch formed between hypoderm and pectoral major muscle. Implant 41 is made as a flexible container 42 presenting a highly expandable shell made of an inert elastomer and serving as a patient's tissue expander. Container 42 is inflated with an inflating fluid 43, specifically with a saline, up to the achievement of the desirable dimensions shown in fig.2 and approximated to the size of natural mammary gland. Subsequently, implant-expander 41 can be replaced with the constant mammary gland prosthesis or retained in the inflated state as the constant mammary gland prosthesis. Implant assembly 40 comprises the fixation means for the implant fixation to patient's bone structures. The fixation means includes two bone anchoring elements 44, 45 providing the engagement of implant 41 with the bone structure in the form of rib 46 and capable of withstanding the implant load, caused with the implant and partly breast weights. Bone anchoring elements 44, 45 are made in the form of a relatively rigid hooks adapted for putting on rib 46 for coupling to it by gravity. Implant assembly 40 has the preventing means preventing the damage of the bone structure for a long time and including operating contact surfaces 47 of bone anchoring elements 44, 45 to be contacted with the external surface of rib 46 and transmitting the implant load to it. The rib external surface has proximal segment 48 facing implant 41 and diametrically opposed distal segment 49, and operating contact surfaces 47 of bone anchoring elements 44, 45 are adapted to interacting with distal segment 49 which is loaded with the implant load and operates as a bone carrying surface. Bone anchoring elements 44, 45 are made as girthing anchoring elements adapted to girth rib 46 by operating contact surface 47 which is substantially congruent with the rib external surface to provide the uniform distribution of the implant load throughout rib carrying surface 49. Due to this, operating contact surfaces 47 of bone anchoring elements 44, 45 are capable of substantially uniform distribution of the implant load throughout the rib external surface and have sufficient size to decrease a specific pressure onto the rib external surface up to permissible level eliminating weakening rib 46 in its contact zone with bone anchoring elements 44, 45 for a long time. Bone anchoring elements 44, 45 are disposed higher than implant 41 , loaded with substantially vertically directed forces and their operating contact surfaces 47 transmit the forces mainly to the upper portion of rib 46. Bone anchoring elements 44, 45 and their connections with implant 41 are disposed at certain distance from one another thereby providing the distribution of the implant load among the rib spaced surfaces and stabilizing the position of the implant in the human organism. As a result, the implant load in the form of decreased specific pressure is transmitted onto the widened external surface of the most strong cortical bone layer, thereby providing the reliability and durability of the implant fixation.

Implant 41 is provided with base element 50 to which bone anchoring elements 44, 45 are fastened. Base element 50 is disposed at the upper part of prosthesis 41 and therefore bone anchoring elements 44, 45 are adapted to the fixation of the implant to rib 46 disposed above it. Base element 50 provides the relatively uniform support of the various portions of container 43 by the fixation means, thereby reducing to minimum the stress concentration in the container material.

In version embodiment (not shown), the base element is made in the form of a plate fastened to a rear wall of the prosthesis, and the bone anchoring element is adapted to fixing the prosthesis to ribs located approximately at the level of the prosthesis.

In another version embodiment (not shown), the flexible container at least partly is made of composite material including the reinforcing filaments, whose disposition in the container walls relative to the fixation means provides the relatively uniform support of the various container portions by the fixation means, thereby reducing to minimum the stress concentration in the container walls.

Figs. 4, 5 show implant assembly 140 in the non-implanted and implanted positions respectively serving as an internal brassiere and including breast forming means 151 embracing mammary gland 163 on the side of its lower and lateral surfaces and serving as a supporting bed for the mammary gland. Breast forming means 151 has a bed-like form including lower portion 152, whose main function is the mammary gland support, and lateral portions 153 restricting the side deformation of the mammary gland and thereby maintaining the breast aesthetic form. The breast forming means is made of a bio-compatible and non-biodegradable material, for example the material applied in the hernia surgery for the body wall reinforcement. The breast forming means structure is capable of full ingrowing the surrounding tissues therein and simultaneously eliminating the tissue slitting. Specifically, it presents a net-like or mesh-like form including reinforcing strings 154 and thinner filling threads 155 with the cell size sufficiently small to prevent the tissue slitting. Implant assembly 140 comprises the fixation means in the form of straps 156, 157 designed for the fixation of breast forming means 151 to patient's bone structures, specifically to clavicula 158. Straps 156, 157 have strap implant ends 159, 160 fastened to breast forming means 151 and strap anchoring ends provided with bone anchoring elements 161 , 162 made in the form of rigid hooks adapted for putting on the substantially horizontal bone structure disposed above the mammary gland like clavicula 158 or a rib bone for coupling to them by gravity. Straps 156, 157 release the skin and surrounding soft tissues from a gravity action thereby eliminating the main reason of their stretch and female breast sagging under the natural conditions. Implant assembly 140 does not restrict the breast top portion allowing the certain breast natural deformation for example caused with an age changes. The design and operation of the bone anchoring elements in the form of rigid hooks 161 , 162 mainly are identical to above described rigid hooks 44, 45. The special feature of rigid hooks 161 , 162 consists in their floating connection with breast forming means 151 provided by relatively flexible intermediate elements in the form of straps 156, 157 and improving the uniform distribution of the implant load throughout the bone carrying surface.

Figs. 6 to 9 show implant assembly 240 including breast forming means 251 in the non- implanted (figs. 6, 7) and implanted (fig. 9) positions designed to operate as an internal brassier. Breast forming means 251 includes lower portion 252 embracing the mammary gland on its lower side and lateral portions 253 restricting the side deformation of the female breast. The fixation means include two spaced bone anchoring elements in the form of rigid hooks 261 , 262 adapted to fixing breast forming means 251 to rib 246 located approximately at the level of mammary gland 263. Rigid hooks 261 , 262 are mainly identical to one 161, 162 shown in figs. 4, 5. Fig.8 shows the close-up view of fragment 264 of breast forming means 251 , which presents the mesh material of the breast forming means shown in fig. 6 and capable of full ingrowing the surrounding tissues therein and simultaneously eliminating the tissue slitting. The operation of breast forming means 251 is mainly identical to one 151 shown in figs. 4, 5.

Fig. 10 shows implant assembly 340 including breast forming means 351 fixed to clavicula 367 and rib 368 by two bone anchoring elements 365, 366. The latter are made in the form of a band sufficiently wide to decrease the specific pressure onto the bone external surface up to permissible level and sufficiently elastic to fit their operating contact surfaces to the bone carrying surfaces and provide the uniform distribution of the implant load throughout the bone carrying surface. Bone anchoring elements 365, 366 have the fastening means preventing the spontaneous disconnection of the bone anchoring elements from the bone structure or substantial displacement relative it. The fastening means include sewing ends 370, 371 of the bone anchoring elements to breast forming means 351 to form the loops eliminating the disconnection of the bone anchoring elements from the ribs. Moreover, the bone anchoring elements have members with a porous structure at the portion contacting with the bones, allowing the ingrowth of adjacent bone tissues therein and thereby preventing sliding the bone anchoring elements 365, 366 relative to bones 367, 368. Fig.11 shows the close-up view of the mentioned porous member fragment 369 of the bone anchoring elements.

In version embodiment (not shown), the fastening means is made as holes in the bone anchoring element allowing the fixation of the bone anchoring element to the bone structure by screws.

Figs. 12 to 15 show implant assembly 440 including breast forming means 451 in the non- implanted (figs. 12 to 14) and implanted (fig. 15) positions. The fixation means include strap 456 provided with bone anchoring element 465 made as a flexible band girthing clavicula 458 and thereby fixing breast forming means 451 to clavicula 458. The fixation means is provided with an adjusting means allowing the control and adjustment of the distance between breast forming means 451 and clavicula 458 to obtain the needed final position of the breast forming means. The adjusting means includes the connecting member in the form of flexible strap 456 with toothed flexible band end 472 passing through toothed holder 473 and allowing setting and fixing the length of connecting member 456 to obtain the needed final position of the breast forming means. The adjusting means simultaneously fulfils the role of the fastening means imparting the form of a loop to bone anchoring element 465 and thereby preventing its disconnection from clavicula 458. Implant assembly 440 is provided with the preventing means made as a shock absorbing means restricting the dynamic loading of the fixation means and simulating the elastic properties inherent in the breast tissues under natural conditions. The shock absorbing means includes several metal springy elements 474 mounted between breast forming means 451 and bone anchoring element 465 and disposed at the lower end of strap 456. Metal spring elements 474 are housed in flexible sheath 475 to protect them from immediate contact with surrounding patient tissue. The shock absorbing means allows to decrease the maximal load of the fixation means components and thereby to enhance their reliability.

Figs. 16 to 19 show implant assembly 540 with breast forming means 551, including top portion 576 providing additional restrictions of the mammary gland deformation and maintaining the breast aesthetic appearance. Top portion 576 is provided with adjustable fasteners 578 allowing fitting the top portion dimensions to the breast size. Implant assembly 540 comprises the shock absorbing means including springy element 574 housed in flexible sheath 475 and mounted between strap 556 and the bone anchoring element in the form of rigid hook 562 put on clavicula 558. Implant assembly 540 also has the adjusting means including toothed flexible end 572 of flexible strap 556 passing through toothed holder 573 and allowing setting and fixing the length of strap 556 to obtain the needed final position of the breast forming means. Therewith, strap 556 is flexible and housed in flexible sheath 577. The designation and operation of these shock absorbing and adjusting means are identical to one shown above in figs. 13 to 15.

In version embodiment (not shown), the shock absorbing means is made as a springy portion of the fixation means, specifically as a resilient portion of the strap.

In another version embodiment (not shown), the shock absorbing means is made as the components of the implant made of material having the springy properties. Therewith, the design strength of these components is sufficient to eliminate their residual deformation under dynamic loading.

Figs. 20 to 23 show implant assembly 640 with breast forming means 651 provided with the bone anchoring element including bearing plate 679. The latter has operating contact surface 647, substantially congruent to bone carrying surface 649 of clavicula 658, and two pins 680 fastened to bearing plate 679 by their distal end. Pins 680 pass through the clavicula bone and have proximal ends going out of the distal segment of the clavicula bone and provided with the means in the form of lower plate 681 for their connecting to the breast forming means through strap 656. Therewith, pins 680 fulfill the role of the fastening means preventing the disconnection of the bone anchoring element from clavicula 658. Otherwise implant assembly 640 mainly is identical to one shown above.

In version embodiment (not shown), the bone anchoring element is made in the form of a grasping anchoring element adapted to seizing and holding the bone structure at least at two its diametrically opposed portions. Specifically, the grasping anchoring element is made in the form of a seizure adapted to fixing the implant to a rib by compressing the rib upper and lower surfaces. In principle, such anchoring element operates as the above rigid hook provided with the fastening means.

Figs. 24 to 26 show implant assembly 740 including breast prosthesis 782 designed for augmentation mammoplasty and fastened to rear portion 783 of breast forming means 751 while mammary gland 763 is contained in anterior portion 784 of breast forming means 751. Thus, the breast forming means serves for supporting both the mammary gland and breast prosthesis providing the new property of the augmentation mammoplasty preventing sagging the augmented female breast.

Implant assembly 840 applied for the augmentation mammoplasty is shown in. figs. 27, 28 and 29 in the non-implanted and implanted positions respectively. Implant assemblies 840 and 740 have many identical features and parts and the designations of their identical parts have the same two last numerals. Therefore, the description of implant assembly 840 mainly is restricted with its distinctive features. Specifically, implant assembly 840 includes implant-prosthesis 882 implanted into tissue pouch 885 between mammary gland 863 and pectoral major muscle 886. Implant assembly 840 has an implant fixation means including straps 856, 857 identical to straps 156, 157 of implant assembly 140 and designed for the implant fixation to patient's bones 846. Moreover, the fixation means includes flexible gland anchoring links 887 having the link implant ends connected to implant 882 and link anchoring ends adapted for the fixation to mammary gland 863. Anchoring links 887 are peripherally arranged throughout the implant perimeter, contacting with the mammary gland surface with some overlapping and capable of connecting implant 882 to mammary gland 863 providing the tactile continuity at the boundary between implant 882 and mammary gland 863. The gland anchoring links are made of a mesh-like material allowing ingrowing the mammary gland tissue into the gland anchoring links. The combination of straps 856, 857 fastening implant 882 to patient's bones 846 and gland anchoring links 887 fastening implant 882 to mammary gland 863 allows to provide the improved appearance of the female breast and restrict the breast skin stretch and the breast sagging under gravity.

Implant assembly 940 applied for the augmentation mammoplasty is shown in figs. 30, 31 and 32 in the non-implanted and implanted positions respectively. It includes gland anchoring links 987 connecting implant 982 to mammary gland 963 identically to gland anchoring links 887 of above implant assembly 840. Additionally, implant assembly 940 comprises tissue anchoring links 988 fastened to implant 982, contacting with the surrounding soft tissues, specifically with pectoral major muscle 986, and capable of connecting implant 982 to surrounding soft tissues, specifically to pectoral major muscle 986. Therewith, to certain extent, tissue anchoring links 988 fulfill the part of above straps 856, 857 fastening the implant and mammary gland to patient's body. Anchoring links 987 and 988 are alternately arranged throughout the implant perimeter. The design of anchoring links 987 and 988 and their mode of connecting to biologic tissues are the same. The combination of anchoring links 987 and 988 provides the improved appearance of the female breast and also restricts the breast skin stretch and the breast sagging under gravity.

The method of the female breast correction by using the implant assembly, designed to serve as an internal brassier, may be described with the references made to fig. 5. The method provides for: performing an surgical access to a lower hemisphere of mammary gland 163 including its lateral portions; performing the anchoring passages in the patient tissues from mammary gland163 to the zone of clavicula 158; emplacing breast forming means 151 in such a way to embrace mammary gland163 on the side of its lower hemisphere including its lower, lateral and anterior sides to provide functioning breast forming means 151 as a supporting bed of mammary gland 163; dragging straps 156, 157 and bone anchoring elements 161, 162 in the form of rigid hooks through the anchoring passages; putting the bone anchoring elements 161 , 162 on clavicula 158 to fix straps 156, 157 and thereby breast forming means 151 to clavicula 158 in order to release a breast skin and surrounding soft tissues from a gravity action and thereby to eliminate the main reason of their stretch and a female breast sagging taking place under natural conditions. Therewith, putting the bone anchoring elements on the clavicula leads to fastening them to the clavicula under gravity. The mentioned access to the mammary gland lower hemisphere is performed by an inframammary incision and subsequent at least partial separating the mammary gland lower hemisphere from surrounding tissues on the lower and lateral sides. In version embodiment, if the implant comprises the anterior top portion, the method includes separating the mammary gland anterior top part from surrounding tissues. In another versions, the method provides for performing the anchoring passages from the mammary gland area to a rib, or breast bone zone, or simultaneously to different bone structures. The latter may by explained by means of fig.10, where breast forming means 351 is fixed to rib 368 and clavicula 365, thereby decreasing the load of the bone structures and preventing their fracture. If the implant assembly is provided with the adjusting means (see figs. 12 to 15) to adjust the distance between breast forming means 451 and patient's bone structure 458, the method provides for the adjustment of the indicated distance to obtain the needed final breast position.

In version embodiment of the implant assembly comprising the breast prosthesis for augmentation mammoplasty, fastened to the rear portion of the breast forming means (see figs. 24 to 26), the method provides for emplacing breast forming means 751 along with breast prosthesis 782 in such a way to place the breast prosthesis rear of mammary gland 763.

Claims

1. An implant assembly for breast plastic surgery, having:

* an implant,

* a fixation means for the implant fixation to patient's bone structures,

**said fixation means having at least one bone anchoring element providing the engagement of said implant with said bone structures and capable of withstanding an implant load,

** a preventing means preventing the damage of said bone structure for a long time and including an operating contact surface of said bone anchoring element to be contacted with an external surface of said bone structure and transmitting said implant load to said bone structure external surface.

2. The implant assembly of claim 1 , wherein said operating contact surface of bone anchoring element is capable of substantially uniform distribution of said implant load throughout said bone structure external surface and having sufficient size to decrease a specific pressure onto said bone structure external surface up to permissible level eliminating weakening said bone structure in its contact zone with said bone anchoring element for a long time.

3. The implant assembly of claim 2, wherein said bone structure external surface has a proximal segment facing said implant and a diametrically opposed distal segment, and said operating contact surface of bone anchoring element is adapted to interacting with said distal segment which is loaded with said implant load and operates as a bone carrying surface.

4. The implant assembly of claim 3, wherein said bone anchoring element is made as a girthing anchoring element adapted to girth a bone of said bone structure by said operating contact surface of bone anchoring element so that said implant load is applied mainly to said bone carrying surface.

5. The implant assembly of claim 4, wherein said bone anchoring element is made in the form of a relatively rigid hook adapted for putting on said bone structure for coupling to it by gravity, when said bone carrying surface mainly is an upper external surface of said bone structure.

6. The implant assembly of claim 5, wherein said rigid hook has floating connection with implant and its said operating contact surface is substantially congruent with said bone structure external surface to provide the uniform distribution of said implant load throughout said bone carrying surface.

7. The implant assembly of claim 4, wherein said bone anchoring element is made in the form of a band sufficiently wide to decrease the specific pressure onto said bone structure external surface up to permissible level and sufficiently elastic to fit its said operating contact surface to said bone carrying surface and provide the uniform distribution of said implant load throughout said bone carrying surface.

8. The implant assembly of claim 4, wherein said bone anchoring element includes a bearing plate having said operating contact surface substantially congruent to said bone carrying surface, and at least one pin fastened to said bearing plate by its distal end, passing through said bone structure and having a proximal end going out of said bone structure distal segment and provided with a means for its connecting to said implant.

9. The implant assembly of claim 4, wherein said bone anchoring element is made in the form of a grasping anchoring element adapted to seizing and holding said bone structure at least at two its diametrically opposed portions.

10. The implant assembly of claim 9, wherein said grasping anchoring element is made in the form of a seizure adapted to fixing said implant to a rib by compressing the rib upper and lower surfaces.

11. The implant assembly of claim 1 , wherein said bone anchoring element includes a fastening means preventing the spontaneous disconnection of said bone anchoring element from said bone structure.

12. The implant assembly of claim 11 , wherein said fastening means is made as holes in said bone anchoring element allowing the fixation of said bone anchoring element to said bone structure by screws.

13. The implant assembly of claim 11 , wherein said bone anchoring element has a member with a porous structure at the portion contacting with the bone allowing the ingrowth of surrounding tissues therein, thereby enhancing the fixation reliability of said implant.

14. The implant assembly of claim 1, wherein said preventing means includes a shock absorbing means restricting a dynamic loading of said fixation means and simulating the elastic properties inherent in the breast tissues under natural conditions.

15. The implant assembly of claim 14, wherein said shock absorbing means including at least one springy element mounted between said implant and said bone anchoring element.

16. The implant assembly of claim 15, wherein said fixation means includes at least one strap provided with said bone anchoring element and allowing the fixation of said implant to said bone structure and said springy element presents a constituent of said strap.

17. The implant assembly of claim 15, wherein said springy elements is made in the form of a metal spring located in a flexible sheath to protect said metal spring from immediate contact with surrounding patient tissue.

18. The implant assembly of claim 14, wherein the components of said implant are made of material having the springy properties, fulfilling the part of said shock absorbing means and having the design strength eliminating their residual deformation under said dynamic loading.

19. The implant assembly of claim 1 , wherein said fixation means is provided with an adjusting means allowing the control and adjustment of the distance between said implant and said bone structure to obtain the needed final implant position.

20. The implant assembly of claim 19, wherein said adjusting means includes at least one connecting member connecting said implant and said bone anchoring element and capable of changing and fixing its length thereby allowing the control of the distance between said implant and said bone anchoring element.

21. The implant assembly of claim 20, wherein said connecting element is made in the form of a toothed flexible band passing through a toothed holder allowing setting and fixing the length of said toothed flexible band.

22. The implant assembly of claim 1 , wherein said fixation means comprises at least one intermediate element made as a strap having a strap implant end connected to said implant and a strap anchoring end to which said bone anchoring element is fastened.

23. The implant assembly of claim 1 , wherein there are more than one said bone anchoring elements and their connections with said implant are disposed at certain distance from one another thereby providing the distribution of said implant load among the spaced external surfaces of said bone structures and stabilizing the position of said implant in the human organism.

24. The implant assembly of claim 1 , wherein said bone anchoring element is disposed higher than said implant, loaded with substantially vertically directed forces and said operating contact surface of bone anchoring element transmits the forces mainly to upper portion of said bone structure external surface.

25. The implant assembly of claim 1 , wherein said implant presents a breast prosthesis made as a flexible container filled with fluid and designed for a female breast correction surgery, specifically for the augmentation mammoplasty or the mammary gland replacement, and said fixation means is fastened to said prosthesis.

26. The implant assembly of claim 25, wherein said prosthesis is provided with a base element to which said fixation means is fastened.

27. The implant assembly of claim 26, wherein said base element is disposed at the upper part of said prosthesis and said bone anchoring element is adapted to the fixation of said prosthesis to said bone structure disposed above said prosthesis.

28. The implant assembly of claim 26, wherein said base element is made in the form of a plate fastened to a rear wall of said prosthesis, and said bone anchoring element is adapted to fixing said prosthesis to ribs located approximately at the level of said prosthesis.

29. The implant assembly of claim 25, wherein said prosthesis is designed for the augmentation mammoplasty, to be implanted between a mammary gland and a pectoral major muscle, and fastened to said mammary gland by gland anchoring links having link implant ends connected to said prosthesis and link anchoring ends connected to said mammary gland to provide the tactile continuity at the boundary between said prosthesis and said mammary gland.

30. The implant assembly of claim 29, wherein said gland anchoring links are flexible, peripherally arranged throughout the perimeter of said prosthesis, contacting with said mammary gland surface with some overlapping, and at least said link anchoring ends are made of a mesh- like material adapted for the fixation to said mammary gland by ingrowing the mammary gland tissue therein.

31. The implant assembly of claim 25, wherein said flexible container at least partly is made of composite material including the reinforcing filaments, whose disposition in container walls relative to said fixation means provides the relatively uniform support of the various container portions by said fixation means, thereby reducing to minimum the stress concentration in the container walls.

32. The implant assembly of claim 1 , wherein said implant is made as an internal brassiere including a breast forming means, which embraces a mammary gland at least on the side of its lower surface and serves as a supporting bed for said mammary gland.

33. The implant assembly of claim 32, wherein said breast forming means includes a lower portion, whose main function is the mammary gland support, and lateral portions restricting the side deformation of said mammary gland and thereby maintaining the aesthetic form of the female breast.

34. The implant assembly of claim 33, wherein said breast forming means includes a top portion providing additional restrictions of the mammary gland deformation, thereby maintaining the aesthetic form of the female breast.

35. The implant assembly of claim 32, wherein said breast forming means is made of a biocompatible and non-biodegradable material whose structure is capable of full ingrowing of surrounding patient's tissues therein and simultaneously eliminating the tissue slitting.

36. The implant assembly of claim 35, wherein said breast forming means is made of a mesh-like material.

37. The implant assembly of claim 32, including a breast prosthesis designed for augmentation mammoplasty, fastened to the rear portion of said breast forming means so that said breast forming means has sufficient place for containing said mammary gland.

38. An implant assembly in the form of an internal brassiere for the form correction of a female breast and preventing the breast sagging, including

* a breast forming means, which embraces a mammary gland at least on its lower side and serves at least as a supporting bed of said mammary gland;

* a fixation means designed for the fixation of said breast forming means to patient's bone structure and releasing the breast skin and surrounding soft tissues from a gravity action thereby eliminating the main reason of their stretch and a female breast sagging taking place under natural conditions, **said fixation means having at least one bone anchoring element providing the engagement of said implant with said bone structures and capable of withstanding an implant load caused with the weight of the mammary gland,

39. The implant assembly of claim 38, wherein said operating contact surface of bone anchoring element is capable of substantially uniform distribution of said implant load throughout said bone structure external surface and having sufficient size to decrease a specific pressure onto said bone structure external surface up to permissible level eliminating weakening said bone structure in its contact zone with said bone anchoring element for a long time.

40. The implant assembly of claim 39, wherein said bone structure external surface has a proximal segment facing said implant and a diametrically opposed distal segment, and said operating contact surface of bone anchoring element is adapted to interacting with said distal segment which is loaded with said implant load and operates as a bone carrying surface.

41. The implant assembly of claim 40, wherein said bone anchoring element is made as a girthing anchoring element adapted to girth a bone of said bone structure by said operating contact surface of bone anchoring element so that said implant load is applied mainly to said bone carrying surface.

42. The implant assembly of claim 41 , wherein said bone anchoring element is made in the form of a relatively rigid hook adapted for putting on said bone structure for coupling to it by gravity, when said bone carrying surface mainly is an upper external surface of said bone structure.

43. The implant assembly of claim 38, wherein said preventing means includes a shock absorbing means restricting a dynamic loading of said fixation means and simulating the elastic properties inherent in the breast tissues under natural conditions.

44. The implant assembly of claim 43, wherein said shock absorbing means includes at least one springy element mounted between said implant and said bone anchoring element.

45. The implant assembly of claim 43, wherein the components of said implant are made of material having the springy properties, fulfilling the part of said shock absorbing means and having the design strength eliminating their residual deformation under said dynamic loading.

46. The implant assembly of claim 38, wherein said fixation means is provided with an adjusting means allowing the control and adjustment of the distance between said implant and said bone structure to obtain the needed final implant position.

47. The implant assembly of claim 38, wherein there are more than one said bone anchoring elements and their connections with said implant are disposed at certain distance from one another thereby providing the distribution of said implant load among the spaced surfaces of said bone structures and stabilizing the position of said implant in the human organism.

48. The implant assembly of claim 38, wherein said breast forming means includes a lower portion, whose main function is the mammary gland support, and lateral portions restricting the side deformation of the mammary gland and thereby maintaining the aesthetic form of the female breast.

49. The implant assembly of claim 48, wherein said breast forming means includes a top portion providing additional restrictions of the mammary gland deformation and thereby maintaining the aesthetic form of the female breast.

50. The implant assembly of claim 38, wherein said breast forming means is made of a biocompatible and non-biodegradable material whose structure is capable of full ingrowing of surrounding patient's tissues therein and simultaneously eliminating the tissue slitting.

51. The implant assembly of claim 50, wherein said breast forming means is made of a mesh-like material.

52. The implant assembly of claim 38, including a breast prosthesis designed for augmentation mammoplasty, fastened to the rear portion of said breast forming means so that said breast forming means has sufficient place for containing said mammary gland.

53. An implant assembly including

* a breast forming means for a mammary gland support,

** a breast prosthesis designed for augmentation mammoplasty and fastened to the rear portion of said breast forming means, * a fixation means designed for the fixation of said breast forming means and said breast prosthesis to patient's bone structure and releasing the breast skin and surrounding soft tissues from a gravity action thereby eliminating the main reason of their stretch and a female breast sagging taking place under natural conditions.

54. The implant assembly of claim 53, wherein said breast forming means embraces a mammary gland on its lower side to support said mammary gland and on its lateral sides to restrict the side deformation of said mammary gland and maintain the aesthetic form of the female breast.

55. The implant assembly of claim 53, wherein said fixation means has at least one bone anchoring element including an operating contact surface to be contacted with an external surface of said bone structure and transmitting an implant load to said bone structure external surface.

56. An implant assembly including

* a prosthesis designed for the augmentation mammoplasty, to be implanted between a mammary gland and a pectoral major muscle, and fastened to said mammary gland by gland anchoring links having link implant ends connected to said prosthesis and link anchoring ends connected to said mammary gland to provide the tactile continuity at the boundary between said prosthesis and said mammary gland,

** a fixation means designed for the fixation of said breast prosthesis and said mammary gland to a patient's bone structure and releasing the breast skin and surrounding soft tissues from a gravity action thereby eliminating the main reason of their stretch and a female breast sagging taking place under natural conditions. ^■—^«—

57. The implant assembly of claim 56, wherein said gland anchoring links are flexible, peripherally arranged throughout the perimeter of said prosthesis, contacting with said mammary gland surface with some overlapping, and at least said link anchoring ends are made of a mesh- like material adapted for the fixation to said mammary gland by ingrowing the mammary gland tissue therein.

58. The implant assembly of claim 56, wherein said fixation means has at least one bone anchoring element fastened to said breast prosthesis and including an operating contact surface to be contacted with an external surface of said bone structure and transmitting an implant load to said bone structure external surface.

59. A method of the female breast correction and preventing the breast sagging over the woman life by using an implant assembly, designed to serve as an internal brassier, wherein

* said implant assembly includes

** a breast forming means, which embraces a mammary gland at least on the side of its lower surface and serves as a supporting bed for the mammary gland and having a bed-like form, including lower as well as lateral portions restricting the side deformation of the mammary gland and thereby maintaining the aesthetic form of the female breast,

** a fixation means having at least one bone anchoring element designed for the fixation of said breast forming means to patient's bone structures, therewith said bone anchoring element has an operating contact surface to be contacted with an external surface of said bone structure, transmitting an implant load to said bone structure external surface, capable of substantially uniform distribution of said implant load throughout said bone structure external surface and having sufficient size to decrease a specific pressure onto said bone structure external surface up to permissible level eliminating weakening said bone structure in its contact zone with said bone anchoring element for a long time,

* and said method of the female breast correction and preventing the breast sagging provides for:

** performing a surgical access at least to a lower hemisphere of said mammary gland,

** performing at least one anchoring passage in the patient tissues from said mammary gland to said bone structure,

** emplacing said breast forming means in such a way to embrace a mammary gland at least on the side of its lower hemisphere and to provide functioning said breast forming means as a supporting bed of said mammary gland,

** dragging said bone anchoring element to said bone structure through said anchoring passage,

** fixing said bone anchoring element and thereby said breast forming means to said bone structure in order to release a breast skin and surrounding soft tissues from a gravity action and thereby to eliminate the main reason of their stretch and a female breast sagging taking place under natural conditions.

60. The method of claim 59, wherein said access to a lower hemisphere of a mammary gland is performed by an inframammary incision and subsequent at least partial separating the mammary gland lower hemisphere from surrounding tissues on the lower, lateral and anterior sides.

61. The method of claim 60, wherein said breast forming means also includes an anterior top portion designed to embrace said mammary gland at its anterior top part and the method includes separating said mammary gland anterior top part from surrounding tissues.

62. The method of claim 59, wherein a clavicula is used as said bone structure and said anchoring passage communicates said mammary gland area with a clavicula zone.

63. The method of claim 59, wherein a rib is used as said bone structure and said anchoring passage communicates said mammary gland area with a rib zone.

64. The method of claim 59, wherein a breast bone is used as said bone structure and said anchoring passage communicates said mammary gland area with a breast bone zone.

65. The method of claim 59, wherein said fixation means includes several said bone anchoring elements and the method provides for performing said anchoring passage for each of said bone anchoring elements thereby allowing the fixation of said implant to said bone structure in its sites spaced from one another.

66. The method of claim 65, wherein said anchoring elements are fixed to different bone structures thereby decreasing the load of said bone structures and preventing their fracture.

67. The method of claim 65, wherein said fixation means includes two straps and the method provides for performing two passages for said straps disposed. substantially laterally on the both sides of said mammary gland.

68. The method of claim 60, wherein said bone anchoring element is made in the form of rigid hooks and its fixation to said bone structure consists in its putting on said bone structure to couple with said bone structure under gravity.

69. The method of claim 60, wherein said bone anchoring element is provided with an adjusting means allowing the adjustment of a distance between said breast forming means and said patient's bone structure and the method provides for the adjustment of said distance to obtain the needed final breast position.

70. The method of claim 59, including an augmentation mammaplasty, wherein

* said implant assembly comprises a breast prosthesis designed for augmentation mammoplasty, fastened to the rear portion of said breast forming means,

* and said method provides for:

** em placing said breast forming means along with said breast prosthesis in such a way to place said breast prosthesis rear of said mammary gland.