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WO2007004214A2 - Assemblage d'implant - Google Patents

Assemblage d'implant Download PDF

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Publication number
WO2007004214A2
WO2007004214A2 PCT/IL2006/000752 IL2006000752W WO2007004214A2 WO 2007004214 A2 WO2007004214 A2 WO 2007004214A2 IL 2006000752 W IL2006000752 W IL 2006000752W WO 2007004214 A2 WO2007004214 A2 WO 2007004214A2
Authority
WO
WIPO (PCT)
Prior art keywords
bone
implant
breast
mammary gland
implant assembly
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IL2006/000752
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English (en)
Other versions
WO2007004214A3 (fr
Inventor
Sergey Popov
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2007004214A2 publication Critical patent/WO2007004214A2/fr
Publication of WO2007004214A3 publication Critical patent/WO2007004214A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00792—Plastic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00796—Breast surgery

Definitions

  • 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.
  • 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.
  • rigid fastening the implant to upper and lower ribs hinders the mobility of the shoulder and in specific cases restricts the breath freedom.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the grasping anchoring element is adapted to fixing the implant to a rib by compressing the rib upper and lower surfaces.
  • the bone anchoring element includes a fastening means preventing the spontaneous disconnection of the bone anchoring element from the bone structure.
  • the fastening means is made as holes in the bone anchoring element allowing its fixation to the bone structure by screws.
  • 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.
  • 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.
  • the implant co ⁇ iponents 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/ ⁇ fixing the length of the toothed flexible band.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • the method includes separating said mammary gland anterior top part from surrounding tissues.
  • a clavicula is used as the bone structure and the anchoring passage communicates the mammary gland area with a clavicula zone.
  • a rib is used as the bone structure and the anchoring passage communicates the mammary gland area with a rib zone.
  • a breast bone is used as the bone structure and the anchoring passage communicates the mammary gland area with a breast bone zone.
  • 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.
  • the bone anchoring elements may be fixed to different bone structures thereby decreasing the load of the bone structures and preventing their fracture.
  • the method provides for performing two anchoring passages for the straps disposed substantially laterally on the both sides of the mammary gland.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • rigid hooks 161 , 162 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.
  • 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.
  • 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.
  • the shock absorbing means is made as a springy portion of the fixation means, specifically as a resilient portion of the strap.
  • 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.
  • pins 680 fulfill the role of the fastening means preventing the disconnection of the bone anchoring element from clavicula 658.
  • implant assembly 640 mainly is identical to one shown above.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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
  • the method includes separating the mammary gland anterior top part from surrounding tissues.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un assemblage d'implant (140) destiné à servir de support à une glande mammaire (163) (voir figure 5). Cet assemblage comprend une structure en forme de panier (152) entourant une hémisphère inférieure de sein, laquelle structure (152) est fixée par des bandoulières (156, 157) se terminant par des éléments d'ancrage (161, 162). Les éléments d'ancrage (161, 162) sont placés sur un os horizontal comme la clavicule (158) ou une cote. Les éléments (161, 162) présentent des surfaces de contact élargies qui distribuent la charge osseuse sur la surface extérieure osseuse pour éviter la détérioration mécanique de l'os dans une zone de contact. Ces éléments reposent contre une couche corticale extérieure forte de l'os, ce qui distribue la charge sur toute la section osseuse. Dans d'autres modes de réalisation de l'invention, l'assemblage d'implant comprend un moyen d'amortissement qui restreint la charge dynamique osseuse lors de la marche ou de mouvements brusques du patient, ainsi qu'un moyen destiné à une commande sans à-coup de la distance séparant la structure (152) de l'os de support.
PCT/IL2006/000752 2005-07-04 2006-06-28 Assemblage d'implant Ceased WO2007004214A2 (fr)

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Application Number Priority Date Filing Date Title
IL16952105 2005-07-04
IL169521 2005-07-04
IL17116205 2005-09-29
IL171162 2005-09-29

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WO2009039371A1 (fr) * 2007-09-19 2009-03-26 Ethicon, Inc. Dispositif de support préformé et procédé et appareil pour le fabriquer
WO2009039373A1 (fr) * 2007-09-19 2009-03-26 Ethicon, Inc. Dispositif à mailles tridimensionnel, préformé, de forme naturelle, pour un support d'implant mammaire
WO2009050706A3 (fr) * 2007-10-16 2010-10-21 Orbix Medical Ltd. Système et procédé pour la remise en forme de tissus mous
US20110022171A1 (en) * 2009-07-21 2011-01-27 Kinetic Concept, Inc. Graft Materials for Surgical Breast Procedures
US8101116B2 (en) 2007-09-19 2012-01-24 Ethicon, Inc. Preformed support device and method and apparatus for manufacturing the same
CN101480360B (zh) * 2009-01-22 2012-08-29 广东冠昊生物科技股份有限公司 一种乳房假体支撑装置
WO2012131222A2 (fr) 2011-03-22 2012-10-04 Edouard Pelissier Dispositif medical implantable pour la correction de la ptôse mammaire et procede de correction de la ptôse mammaire
US20140100655A1 (en) * 2012-10-04 2014-04-10 Lifecell Corporation Surgical template and delivery device
FR3023158A1 (fr) * 2014-07-07 2016-01-08 Souheil Baccache Fixation de prothese mammaire par des languettes
EP3056167A1 (fr) * 2015-02-11 2016-08-17 Novus Scientific AB Dispositif de support d'implant mammaire à grande surface arrière
EP3085337A1 (fr) * 2015-04-24 2016-10-26 Sofradim Production Prothèse pour supporter une structure mammaire
WO2016186803A1 (fr) * 2015-05-15 2016-11-24 Lifecell Corporation Matrices de tissu pour chirurgie plastique
ITUB20152200A1 (it) * 2015-07-15 2017-01-15 Solidago Ag Protesi autoportante per interventi di chirurgia plastica e ricostruttiva
US9549812B2 (en) 2012-01-13 2017-01-24 Lifecell Corporation Breast prostheses, methods of manufacturing breast prostheses, and methods of treatment using breast prostheses
EP3199126A1 (fr) * 2011-03-09 2017-08-02 Tepha, Inc. Systèmes pour mastopexie
US10039633B2 (en) 2012-06-21 2018-08-07 Lifecell Corporation Implantable prosthesis having acellular tissue attachments
IT201800003509A1 (it) * 2018-03-13 2019-09-13 Compagnone Daniele Rivestimento in rete o membrana a base di materiale biologico o biosintetico per protesi, con sistema di fissaggio alla protesi stessa, e relativo procedimento di realizzazione.
CN110327136A (zh) * 2019-07-25 2019-10-15 徐军利 一种人工韧带和包含该韧带的假体固定装置
WO2019175911A3 (fr) * 2018-03-13 2019-11-07 CARA, Nello Revêtement de maille ou de membrane basé sur un matériau biologique ou biosynthétique pour prothèse, comprenant un système de fixation pour une fixation à ladite prothèse, et son procédé de fabrication correspondant
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WO2022055966A1 (fr) 2020-09-09 2022-03-17 Tepha, Inc. Implants et systèmes pour mastopexie sans cicatrice
US11298220B2 (en) 2019-05-03 2022-04-12 Lifecell Corporation Breast treatment device
WO2022164779A1 (fr) 2021-01-26 2022-08-04 Tepha, Inc. Système de suspension mammaire à invasion minimale
US11439490B2 (en) 2013-07-11 2022-09-13 Tepha, Inc. Absorbable implants for plastic surgery
US11642216B2 (en) 2018-09-07 2023-05-09 Musculoskeletal Transplant Foundation Soft tissue repair grafts and processes for preparing and using same
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EP3335669A3 (fr) * 2007-09-19 2018-09-12 Ethicon, Inc. Dispositif de support préformé et procédé et son appareil de fabrication
US7875074B2 (en) 2007-09-19 2011-01-25 Ethicon, Inc. Naturally contoured, preformed, three dimensional mesh device for breast implant support
WO2009039373A1 (fr) * 2007-09-19 2009-03-26 Ethicon, Inc. Dispositif à mailles tridimensionnel, préformé, de forme naturelle, pour un support d'implant mammaire
US8101116B2 (en) 2007-09-19 2012-01-24 Ethicon, Inc. Preformed support device and method and apparatus for manufacturing the same
WO2009050706A3 (fr) * 2007-10-16 2010-10-21 Orbix Medical Ltd. Système et procédé pour la remise en forme de tissus mous
CN101480360B (zh) * 2009-01-22 2012-08-29 广东冠昊生物科技股份有限公司 一种乳房假体支撑装置
US8986377B2 (en) * 2009-07-21 2015-03-24 Lifecell Corporation Graft materials for surgical breast procedures
US10835370B2 (en) 2009-07-21 2020-11-17 Lifecell Corporation Graft materials for surgical breast procedures
US10449034B2 (en) 2009-07-21 2019-10-22 Lifecell Corporation Graft materials for surgical breast procedures
US20110022171A1 (en) * 2009-07-21 2011-01-27 Kinetic Concept, Inc. Graft Materials for Surgical Breast Procedures
US11179235B2 (en) 2009-07-21 2021-11-23 Lifecell Corporation Graft materials for surgical breast procedures
US11744696B2 (en) 2011-03-09 2023-09-05 Tepha, Inc. Implants and methods for mastopexy
EP3636222A1 (fr) * 2011-03-09 2020-04-15 Tepha, Inc. Systèmes pour mastopexie
US10765507B2 (en) 2011-03-09 2020-09-08 Tepha, Inc. Methods for mastopexy
EP3199126A1 (fr) * 2011-03-09 2017-08-02 Tepha, Inc. Systèmes pour mastopexie
WO2012131222A2 (fr) 2011-03-22 2012-10-04 Edouard Pelissier Dispositif medical implantable pour la correction de la ptôse mammaire et procede de correction de la ptôse mammaire
US10004590B2 (en) 2012-01-13 2018-06-26 Lifecell Corporation Breast prostheses, methods of manufacturing breast prostheses, and methods of treatment using breast prostheses
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US10039633B2 (en) 2012-06-21 2018-08-07 Lifecell Corporation Implantable prosthesis having acellular tissue attachments
US9956072B2 (en) 2012-10-04 2018-05-01 Lifecell Corporation Surgical template and delivery device
US20140100655A1 (en) * 2012-10-04 2014-04-10 Lifecell Corporation Surgical template and delivery device
US11439490B2 (en) 2013-07-11 2022-09-13 Tepha, Inc. Absorbable implants for plastic surgery
US12285325B2 (en) 2013-07-11 2025-04-29 Tepha, Inc. Absorbable implants for plastic surgery
WO2016005667A1 (fr) * 2014-07-07 2016-01-14 Baccache Souheil Fixation des prothèses mammaires anatomiques par des languettes crantées
FR3023158A1 (fr) * 2014-07-07 2016-01-08 Souheil Baccache Fixation de prothese mammaire par des languettes
EP3056168A1 (fr) 2015-02-11 2016-08-17 Novus Scientific AB Dispositif de support d'implant mammaire à grande surface arrière
EP3056167A1 (fr) * 2015-02-11 2016-08-17 Novus Scientific AB Dispositif de support d'implant mammaire à grande surface arrière
AU2016201622B2 (en) * 2015-04-24 2020-12-03 Sofradim Production Prosthesis for supporting a breast structure
US9931198B2 (en) 2015-04-24 2018-04-03 Sofradim Production Prosthesis for supporting a breast structure
US10660741B2 (en) 2015-04-24 2020-05-26 Sofradim Production Prosthesis for supporting a breast structure
EP3085337A1 (fr) * 2015-04-24 2016-10-26 Sofradim Production Prothèse pour supporter une structure mammaire
US12161547B2 (en) 2015-04-24 2024-12-10 Sofradim Production Prosthesis for supporting a breast structure
US11439498B2 (en) 2015-04-24 2022-09-13 Sofradim Production Prosthesis for supporting a breast structure
WO2016186803A1 (fr) * 2015-05-15 2016-11-24 Lifecell Corporation Matrices de tissu pour chirurgie plastique
US10307237B2 (en) 2015-05-15 2019-06-04 Lifecell Corporation Tissue matrices and methods of treatment
ITUB20152200A1 (it) * 2015-07-15 2017-01-15 Solidago Ag Protesi autoportante per interventi di chirurgia plastica e ricostruttiva
EP3117800A1 (fr) * 2015-07-15 2017-01-18 Solidago AG Prothèse autoportante destinée à la chirurgie plastique et reconstructive
US10842612B2 (en) 2015-08-21 2020-11-24 Lifecell Corporation Breast treatment device
US10537665B2 (en) 2015-09-11 2020-01-21 Lifecell Corporation Perforated tissue matrix
US11383007B2 (en) 2015-09-11 2022-07-12 Lifecell Corporation Perforated tissue matrix
USD985773S1 (en) 2015-10-09 2023-05-09 Tepha, Inc. Three dimensional mastopexy implant
USD927689S1 (en) 2015-10-09 2021-08-10 Tepha, Inc. Three dimensional mastopexy implant
US11045579B2 (en) 2016-08-31 2021-06-29 Lifecell Corporation Breast treatment device
US10869745B2 (en) 2016-10-06 2020-12-22 Lifecell Corporation Tissue matrix with preformed openings or pilot openings
US11672636B2 (en) 2017-05-02 2023-06-13 Sofradim Production Prosthesis for inguinal hernia repair
US10675137B2 (en) 2017-05-02 2020-06-09 Sofradim Production Prosthesis for inguinal hernia repair
USD889655S1 (en) 2018-02-09 2020-07-07 Tepha, Inc. Three dimensional mastopexy implant
USD889654S1 (en) 2018-02-09 2020-07-07 Tepha, Inc. Three dimensional mastopexy implant
EP4529887A3 (fr) * 2018-02-09 2025-06-25 Tepha, Inc. Implant mammaire à contour complet
US11903816B2 (en) 2018-02-09 2024-02-20 Tepha, Inc. Full contour breast implant
US11154393B2 (en) 2018-02-09 2021-10-26 Tepha, Inc. Full contour breast implant
USD976407S1 (en) 2018-02-09 2023-01-24 Tepha, Inc. Three dimensional mastopexy implant
US11833027B2 (en) 2018-02-09 2023-12-05 Tepha, Inc. Full contour breast implant
EP4230178A1 (fr) * 2018-02-09 2023-08-23 Tepha, Inc. Implant mammaire à contour complet
US12004942B2 (en) 2018-03-13 2024-06-11 Flavio NANNI Mesh or membrane covering based on biological or biosynthetic material for prosthesis, provided with fixing system for fixing to the same prosthesis, and corresponding manufacturing process thereof
WO2019175911A3 (fr) * 2018-03-13 2019-11-07 CARA, Nello Revêtement de maille ou de membrane basé sur un matériau biologique ou biosynthétique pour prothèse, comprenant un système de fixation pour une fixation à ladite prothèse, et son procédé de fabrication correspondant
IT201800003509A1 (it) * 2018-03-13 2019-09-13 Compagnone Daniele Rivestimento in rete o membrana a base di materiale biologico o biosintetico per protesi, con sistema di fissaggio alla protesi stessa, e relativo procedimento di realizzazione.
US12186449B2 (en) 2018-05-03 2025-01-07 Collplant Ltd. Dermal fillers and applications thereof
USD892329S1 (en) 2018-07-03 2020-08-04 Tepha, Inc. Three dimensional mastopexy implant
USD977102S1 (en) 2018-07-03 2023-01-31 Tepha, Inc. Three dimensional mastopexy implant
USD1040347S1 (en) 2018-07-03 2024-08-27 Tepha, Inc. Three dimensional mastopexy implant
US11642216B2 (en) 2018-09-07 2023-05-09 Musculoskeletal Transplant Foundation Soft tissue repair grafts and processes for preparing and using same
US11779455B2 (en) 2018-10-02 2023-10-10 Tepha, Inc. Medical devices to limit movement of breast implants
US11298220B2 (en) 2019-05-03 2022-04-12 Lifecell Corporation Breast treatment device
CN110327136A (zh) * 2019-07-25 2019-10-15 徐军利 一种人工韧带和包含该韧带的假体固定装置
US11766321B2 (en) 2019-11-25 2023-09-26 Tepha, Inc. Breast implant wraps to limit movement of breast implants and related methods
US12064330B2 (en) 2020-04-28 2024-08-20 Covidien Lp Implantable prothesis for minimally invasive hernia repair
WO2022055966A1 (fr) 2020-09-09 2022-03-17 Tepha, Inc. Implants et systèmes pour mastopexie sans cicatrice
EP4647040A2 (fr) 2020-09-09 2025-11-12 Tepha, Inc. Implants et systèmes pour mastopexie sans cicatrice
WO2022164779A1 (fr) 2021-01-26 2022-08-04 Tepha, Inc. Système de suspension mammaire à invasion minimale

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