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WO2007004213A2 - Ensemble d'implant - Google Patents

Ensemble d'implant Download PDF

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Publication number
WO2007004213A2
WO2007004213A2 PCT/IL2006/000751 IL2006000751W WO2007004213A2 WO 2007004213 A2 WO2007004213 A2 WO 2007004213A2 IL 2006000751 W IL2006000751 W IL 2006000751W WO 2007004213 A2 WO2007004213 A2 WO 2007004213A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
tissue
assembly
interstice
preparation
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/IL2006/000751
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English (en)
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WO2007004213A3 (fr
Inventor
Sergey Popov
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Individual
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2007004213A2 publication Critical patent/WO2007004213A2/fr
Publication of WO2007004213A3 publication Critical patent/WO2007004213A3/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
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the present invention relates to the implantable devises for plastic surgery designed for the replacement and / or correction of human anatomiG structures. Specifically, it relates to the implant prostheses for the correction and reconstruction of the mammary gland including the means inhibiting the genesis and overgrowth of fibrous capsular contracture as well as implant supporting means.
  • the plastic implants made preponderantly of silicones are as a rule not harmful to health and generally heal into the human organism.
  • these plastic implants after their insertion into the organism, produce the cells of the connective tissue forming a scar fibrous capsule around the implant.
  • the genesis and overgrowth of the scar tissue forming a fibrous capsule around the implant is the most common and troublesome problem of the present implant prosthetics. This is referred to as capsular contracture.
  • the fibrous capsule then tends to shrink.
  • the capsule shrinkage forms the ball-shaped implant appearance and as a result its originally existing deformability and/or elasticity are lost. Eventually, this leads to the need for the surgery intervention to prevent the further complication caused with the scar tissue overgrowth.
  • the known means for inhibiting the overgrowth and shrinkage of the capsular contracture provide for the introduction of specific medicine into the interstice between the implant surface and surrounding patient's tissue prior to insertion of the implant into the organism.
  • US Patent 4713073 discloses Plastic implant for constructing or reconstructing the female breast, wherein the surface of the implant is covered over with heparin.
  • the latter is- a potent inhibitor of connective tissue re-formation and thus prevents an excessive connective tissue reformation and/or undue capsule formation over some time after the implant insertion.
  • the disadvantage of the present heparin application is the restricted quantity of inserted heparin which is sufficient for only relative short period of time. After heparin is ended, the problems of the capsular contracture resume again.
  • US Patent 5,344,451 discloses Synthetic reconstructive implant device suitable for implanting in a human.
  • the device includes a sealed prosthesis envelope having a predetermined shape when filled with a biocompatible viscoelastic material.
  • the envelope is formed from an elastic polymer having a microporous structure.
  • the device includes a bioactive substance admixed in the polymer for elution from the microporous structure of the envelope after implantation.
  • the elution of the bioactive substance provides its entering the interstice between the envelope surface and the tissue proximate the envelope upon implant to inhibit the capsular contracture/
  • the disadvantage of the present bioactive substance application is the restricted quantity of the bioactive substance contained in the envelope pores, which is sufficient for only relative short period of time. After the bioactive substance is ended, the problems of the capsular contracture resume again.
  • 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 impiant 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 impiant.
  • 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 disadvantages of the known implant prostheses is the limited capabilities of their anti-contracture means, as well as impossibility of their uniform fixation in the patient's tissue pouch with maintaining the natural appearance and tactile perception and the capsular contracture inhibition.
  • the general objective of the present invention is the extension of the implant service life by inhibiting the genesis and growth of a capsular contracture around the implant substantially over the implant service life.
  • Another objective is providing the implant properties allowing maintaining substantially uninterrupted and practically endless action of anti-contracture means preventing the genesis and growth of a capsular contracture around the implant substantially over the implant service life.
  • Another objective is providing the speedy healing an internal dissected tissue surface of a body cavity obtained by a surgery method to emplace an implant therein.
  • Another objective is providing the implant fixation means restricting the scar tissue overgrowth and facilitating the maintenance of the female breast natural appearance.
  • Another objective is maintaining the good aesthetic appearance and tactile properties initially provided with the implant over the extended service life of the implant.
  • Another objective is avoiding the health damages, inconveniences or unpleasant sensations of patient caused with the implant over the implant service life.
  • Another objective is eliminating the need for the operative intervention in connection with the problems of the capsular contracture.
  • 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, having an implant and a capsule inhibition means designed for extending the implant service life by inhibiting the genesis and growth of a capsule around the implant substantially over the implant service life.
  • the most part of the implant external surface is non-ingrown, i. e. incapable of ingrowing the patient's biologic tissue therein, and there is an implant interstice between the implant non- ingrown surface and the opposite biologic tissue.
  • the capsule inhibition means includes a communication means allowing the communication of the implant interstice with the subjects disposed beyond the implant interstice.
  • the communication means includes a preparation delivery means allowing introducing a preparation into the implant interstice.
  • the preparation delivery means is implanted subdermally and includes an injection port through which the preparation is delivered into the implant interstice.
  • the injection port comprises a receiving chamber, which has a flow communication with the implant interstice and a diaphragm forming one of the walls of the receiving chamber and presenting a self-occluding diaphragm adapted to regular repeated punctures by a hypodermic needle to introduce the preparation through the diaphragm into the receiving chamber.
  • the preparation delivery means has also an inlet means, through which the preparation gets from the receiving chamber into the implant interstice.
  • the inlet means has at least one inlet communicating the receiving chamber with the implant interstice.
  • the injection port includes a needle stop means eliminating the through puncture of a port wall located oppositely to the diaphragm.
  • a protecting means preventing the occlusion of the inlet by its overgrowing with patient's biologic tissue.
  • the protecting means is made as a valve disposed in the inlet.
  • the above implant assembly allows regular repeated injection of the inhibiting preparation into the implant interstice thereby inhibiting the genesis and growth of the capsular contracture around the implant substantially over the implant service life.
  • the implant service life is considerably extended.
  • the substantially uninterrupted action of the inhibiting preparation prevents the overgrowth of rough scar tissue thereby maintaining the good aesthetic appearance and tactile properties initially provided with the implant, eliminating the health damages, inconveniences or unpleasant sensations of patient caused with the implant, and preventing the need for the operative intervention in connection with the problems of the capsular contracture.
  • the present invention allows injecting the inhibiting preparation as time passes after emplacing the implant thereby providing the speedy healing of an internal dissected tissue surface of an implant pouch due to the absence of the inhibiting preparation.
  • the injection port is disposed on the implant in a common tissue pouch of patient's body.
  • the injection port can be inseparably connected to the implant and the inlet is disposed in a housing of the injection port.
  • the inlet is disposed at certain distance from the injection port thereby allowing the optimum dispensing the preparation into the implant interstice.
  • the injection port has a port base and is detachably installed on the implant so that the port base is disposed adjacent to the implant non-grown surface.
  • the port base is made in the form of an elastic plate whose edges protrude beyond the injection port, and this elastic plate faces the implant by one of plate sides and the patient's tissue by another plate side and serves as a stabilizer of the position of the injection port.
  • the inlet exits into a gap between the elastic plate and implant.
  • the injection port is located in a separated port tissue pouch, the receiving chamber and the inlet are communicated through a flexible tube, and the flexible tube end is located in a tissue pouch of the implant.
  • the tube iniet end is detachabiy fastened to the implant by a mounting means
  • the orifice end of flexible tube is not fastened to the implant and is provided with a tube base plate wherein the inlet is disposed.
  • the preparation deiivery means includes a preparation accumulator receiving the preparation from the injection port, as well as a pump means designed for the preparation delivery from the preparation accumulator into the implant interstice for the extended period of time.
  • the pump means is installed subdermaliy and driven by patient by external pressing on skin above the pump means.
  • the preparation accumulator allows substantial extension of the time lapses between the needed inhibiting preparation injection into the implant interstice.
  • the capsule inhibition means presents an epithelioid cells capable of taking roots on the patient's tissue and forming a lining on the inner surface of the tissue pouch wherein the implant is placed, and the ceil iining is capable of preventing the capsuie genesis and growth.
  • the communication means includes a drainage means for removing the cell secrets from the implant interstice into an anatomic cavity, for example an abdominal cavity, capable of resorbing the cell secrets.
  • the use of the cell lining allows preventing the capsule contracture genesis without using the inhibiting preparations.
  • the implant is made as a flexible container designed for female breast correction surgery and serving as a patient's tissue expander having highly expandable envelope made of an inert elastomer.
  • Such expander is used for the mammary gland replacement and comprises a shell, which is inflated with an inflating fluid up to the achievement of the dimensions of a natural mammary gland.
  • the implant is 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 anchoring elements are made as small islands arranged over the whole implant external surface having an ingrown surface, for example a textured surface, capable of ingrowing the patient's tissue therein.
  • the relative small overall ingrowing surface and the absence of the connections between the anchoring elements restrict the scar tissue overgrowth and facilitate the maintenance of the female breast natural appearance.
  • the mentioned small islands embrace the whole implant surface thereby providing the reliable fixation of the implant in the patient's body.
  • 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 mammary gland is used as the fixation base, the straps are flexible and their anchor ends are made of a mesh-like material adapted for the fixation to the mammary gland by growing on to the mammary gland surface to provide the tactile continuity at the boundary between said implant and mammary gland. This provides the good aesthetic appearance and tactile properties of the female breast.
  • the method of inhibiting the capsule genesis and overgrowth provides for the regular repeated injection of biologically active preparations, specifically a capsule inhibition medicine, into the implant interstice through the injection port to inhibit the genesis and overgrowth of the capsule and thereby to extent the service life of the implant and avoid the need for the operative intervention.
  • the preparations After passing the port, the preparations immediately enter the implant interstice and therefore the needed frequency of the preparation injections is determined with the duration of the biologic action of the injected dose.
  • the preparation delivery means comprises the preparation accumulator and the pump means, and the method includes the preparation injection into the preparation accumulator through the injection port and subsequent regular repeated delivery of the needed preparation doses into the implant interstice by patient by external pressing on skin above the pump means.
  • the needed frequency of the preparation injections is also determined with the voiume of the preparation accumulator.
  • the implant assembly designed for the form correction of a female breast has an impiant 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 nonbiodegradable 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 femaie 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.
  • Figs. 1 , 2 show the subdermal unfastened port, which along with the mammary implant is disposed in the common tissue pouch.
  • Fig. 3 shows the implant assembly for the mammary gland replacement in the implanted position including the implant-expander implanted into femaie breast along with the unfastened injection port and inflated with a saline.
  • Fig. 4 shows the implant assembly for the mammary gland replacement including the mammary giand prosthesis provided with an injection port fastened to the prosthesis.
  • Fig. 5 shows a close-up view of the injection port fastened to the prosthesis.
  • Fig. 6 shows the implant assembly in the implanted position for the mammary gland replacement including the mammary gland prosthesis provided with an injection port fastened to the prosthesis.
  • Figs. 7, 8 show the implant assembly provided with the distant injection port and having the small textured islands arranged throughout the implant outer surface to fix the implant in the tissue pouch.
  • Fig. 9 shows the close-up view of fastening the preparation delivery means with the distant injection port to the implant.
  • Fig. 10 shows the implant assembly with the preparation delivery means including the preparation accumulator and a manual pump.
  • Figs. 11, 12 show the distant unfastened injection port to be disposed in the tissue pouch separated from the implant tissue pouch and having an elongated tube for the communication with the implant interstice.
  • Fig. 13 shows the implant assembly in the implanted position applied for the augmentation mammoplasty including the distant unfastened injection port and the plastic implant located behind the pectoral major muscle.
  • Figs. 14, 15 and 17 show the implant assembly in the non-implanted and implanted positions, respectively, designed for the augmentation mammoplasty with applying a cell lining of the implant tissue pouch and including the breast supporting straps fastened to patient's bones as well as the drainage means for removing the human secrets from the implant interstice.
  • Fig. 16 shows the close-up view of the drainage means fragment including the catcher of the human secrets disposed in the implant tissue pouch.
  • Figs. 18, 19 and 20 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. 21, 22 and 23 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.
  • Figs. 24, 26 show the implant assembly in the non- implanted and implanted positions respectively serving as an internal brassier and including the breast forming means enclosing the breast on lower and lateral sides and suspended by two straps on the clavicula.
  • Fig. 25 shows the implant assembly in non-implanted position to be applied as an internal brassier and including the breast forming means enclosing the breast on ail sides and suspended by one strap on the clavicula.
  • Implant assembly 30 shown in fig. 3 in the implanted position, is designed for the mammary gland replacement. It includes implant-expander 31 implanted instead of the removed mammary gland into tissue pouch 32 formed between hypoderm 33 and pectorai major muscle 34.
  • Implant 31 is made as a flexible container 36 presenting a highly expandable shell made of an inert elastomer and serving as a patient's tissue expander.
  • Container 36 is inflated with an inflating fluid 37, specifically with a saiine, through the thickened portion 38 of shell 36, fulfilling the part of a diaphragm, by a needle up to the achievement of the desirable dimensions shown in fig.3 and approximate to natural mammary gland.
  • implant-expander 31 can be replaced with the constant mammary gland prosthesis or retained in the inflated state as the constant mammary gland prosthesis.
  • Implant 31 has external surface 39 disposed adjacent to surface 40 of patient's biologic tissues.
  • Implant external surface 39 is a non-ingrown, for example smooth surface incapable of ingrowing the patient's biologic tissue therein. It means that surface 40 of patient's biologic tissues is a free surface, which is not ingrown into implant 31 and presents a potential zone of the genesis and overgrowth of capsule around implant 31.
  • Implant interstice 41 is formed between surfaces 39 and 40.
  • Implant assembly 30 includes a communication means allowing the communication of implant interstice 41 with the subjects disposed beyond the implant interstice.
  • the communication means is made as a preparation delivery means 42 allowing introducing an inhibiting preparation into implant interstice 41 to inhibit the capsule genesis and overgrowth around implant 31.
  • the preparation group including heparin, steroids, anti-inflammatory preparations can be used as the mentioned inhibiting preparations.
  • the close-up views of preparation delivery means 42 are shown in figs. 1 , 2.
  • Preparation delivery means 42 is fully implanted subdermally and presents the injection port through which the preparation is delivered into implant interstice 41.
  • the injection port includes receiving chamber 43 and diaphragm 44 forming one of the walls of receiving chamber 43 and presenting a self-occluding diaphragm adapted to repeated punctures by a hypodermic needle injecting the inhibiting preparation into receiving chamber 43.
  • the latter has a flow communication with implant interstice 41 through an inlet means, providing getting the inhibiting preparation from receiving chamber 43 into implant interstice 41.
  • the inlet means comprises inlets 45 disposed in housing 47 of the injection port and communicating receiving chamber 43 with implant interstice 41.
  • the injection port includes a needle stop means eliminating the through puncture of port wall 50 located oppositely to diaphragm 44. This means presents a material of wall 50, which is sufficiently hard to eliminate its puncture by the hypodermic needle.
  • Injection port 42 is disposed on implant 31 in the common tissue pouch 32 without fastening to implant 31.
  • Injection port 42 has a port base made in the form of elastic flange 51 whose edges protrude beyond the injection port.
  • Elastic flange 51 is disposed adjacent to implant non-ingrown surface 39 facing implant 31 by one of flange sides and tissue surface 40 by another flange side and serves as a stabilizer of the position of injection port 42 relative to implant 31.
  • the external surface of elastic flange 51 is provided with several projections 48 piercing hypoderm 33 and thereby additionally facilitating - the stabilization of the injection port position. Therewith, inlets 45 exits into gap 46 between elastic flange 51 and implant 31.
  • Elastic flange 51 fulfils a part of a protecting means preventing the occlusion of inlets 45 with overgrowing biologic tissue.
  • Elastic flange 51 includes also auxiliary openings 49 made as the simplest vaives in the form of the incisions in elastic flange 51 easing the contact of the inhibiting preparation with surface 40 of patient's biologic tissues located above diaphragm 44 and elastic flange 51.
  • the disposition of elastic flange 51 on the outer side of injection port 42 aliows some deepening injection port 42 into the pliant material of implant 31. Along with the pointed edges of elastic flange 51 this prevents worsening the appearance and tactile properties of female breast 35.
  • the unfastened preparation delivery means like injection port 42 can be implanted simultaneously with the implant emplacement or added to already emplaced prostheses.
  • the method of inhibiting a capsule genesis and overgrowth around implant assembly 30 provides for the regular repeated injection of biologically active preparations into implant interstice 41 through injection port 42 to inhibit the genesis and overgrowth of the capsule and thereby to extent the service life of implant 31 and avoid the need for the operative intervention.
  • the preparations are injected into injection port 42 by a hypodermic needle and after passing the injection port the preparations enter implant interstice 41 and therefore the needed frequency of the preparation injections is determined with the duration of the biologic action of the injected dose.
  • implant assembly 30 allows injecting the inhibiting preparation as time passes after emplacing implant 31 thereby providing the speedy healing of an internal dissected tissue surface 40 due to the absence of the inhibiting preparation in the early days after the implantation.
  • Implant assembly 130 shown in figs. 4, 6 in the non-implanted and implanted position respectively, has many parts and features identical to implant assembly 30 and the designations of their identical parts have the same two last numerals.
  • implant assembly 130 includes implant 131 in the form of the constant mammary gland prosthesis (not expander) and its preparation delivery means 142 is made as injection port 147 fastened to prosthesis 131.
  • the close-up view of preparation delivery means 142 in the form of injection port 147 is shown in fig. 5.
  • Injection port 147 is placed into socket 152 made in implant 131 and there is an engagement means allowing fastening injection port 147 to implant 131.
  • the engagement means includes engaging circular projection 153 on injection port 147 and engaging circular recess 154 in socket 152 of implant 131.
  • engaging circular projection 153 and engaging circular recess 154 provide the detachable fastening of injection port 147 to implant 131 allowing the replacement of injection port 147, when its diaphragm 144 is failed after a certain length of time.
  • the advantage of injection port 147 fastened to prosthesis 131 is the reliable stabilization of its position relative to prosthesis 131 without the application of special stabilizing means identical to projections 48. shown in figs. 2, 3. In this case, the role of elastic flange 151 is reduced to protecting inlet 145. Using the implant assembly in the form of an integral unit eases the surgical operations. Otherwise the features and advantages of implant assemblies 30 and 130 are practically identical.
  • Implant assembly 230 applied for the augmentation mammoplasty is shown in figs.7, 8 in the non-implanted position.
  • Implant assemblies 230, 130 and 30 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 230 mainiy is restricted with its distinctive features.
  • implant assembly 230 includes implant-prosthesis 231 provided with a fixation means designed for the implant fixation within the tissue pouch.
  • the fixation means are made as islands 252 arranged throughout the whole implant external surface and having an ingrown surface, for example a textured surface, capable of ingrowing the patient's tissue therein.
  • Implant assembly 230 comprises preparation delivery means 242 including injection port 247 to be located in a separated tissue pouch.
  • Injection port 247 has receiving chamber 243 communicated with inlets 245 through flexible tube 255. The latter is connected with inlet end 256 comprising iniets 245 to be located in the tissue pouch of impiant 231.
  • inlet end 256 is provided with inlet end base 257 made in the form of flexible plate fastened to implant 231 by welding strips 258 thereby providing the invariance of the inlet position relative to impiant 231 independently of the human organs mobility and growth.
  • the disposition of iniets 245 in the interspace zones between welding strips 258 allows the uniform dispensing the preparation in the implant interstice.
  • the edges of flexible plate 257 located in the zones of inlets 245 adjacently to implant 231 are functioned as the valves ensuring the free exit of the inhibiting preparation into the implant interstice but eliminating the tissue ingrowth into inlet 245.
  • the inlet end like one 256 is detachably fastened to implant 231 by a mounting means presenting for example magnetic elements disposed in implant 231 and in the inlet end base plate like one 257.
  • the substantial distance between injection port 247 and inlet end 256 allows providing the reliable delivery of the inhibiting preparation in the condition when there is a substantial distance between the implant and patient's skin.
  • Injection port 247 is provided with a base in the form of flexible flanges 251 stabilizing the injection port position in its tissue pouch. Otherwise the design and operation of implant assembly 230 is identical to implant assemblies 30, 130.
  • Implant assembly 330 shown in fig. 10, comprises implant 331 and preparation delivery means 342.
  • the latter has many features and parts identical to one 142 shown in figs. 4 to 6 and having the same two last numerals in the designations of the identical parts.
  • preparation delivery means 342 has the distinctive features including preparation accumulator 360 designed for receiving the inhibiting preparation from injection port 347, and pump means 361 made as a bellows and designed for the regular repeated delivery of the needed preparation doses from preparation accumulator 360 into the implant interstice by means of patient's external control.
  • Preparation accumulator 360 and pump means 361 are installed into implant 331.
  • Preparation accumulator 360 presents a preparation container with flexible shell 362 filled with the inhibiting preparation delivered from receiving chamber 343 through connective channel 363.
  • Squeezing pump means 361 by patient 1 effort applying to injection port 347 leads to forcing the preparation from volume 364 of pump means 361 to the implant interstice through delivering channel 365 and inlet 345. In such a manner the inhibiting preparation is repeatedly delivered into the implant interstice.
  • the bellows of pump means 361 straightens out creating a vacuum in volume 364. This vacuum squeezes resilient pipe 366 thereby unclosing openings 367, through which the inhibiting preparation enters volume 364 from preparation accumulator 360.
  • Preparation accumulator 360 is used as a long-term preparation repository allowing substantial extension of the time lapses between the preparation injections through injection port 347. Thus, the needed frequency of the preparation injections is also determined with the volume of preparation accumulator 360.
  • Implant assembly 430 applied for the augmentation mammoplasty is shown in fig. 13 in the impianted position.
  • Implant assemblies 430, 230 and 30 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 430 mainly is restricted with its distinctive features.
  • implant assembly 430 includes impiant-prosthesis 431 implanted into tissue pouch 432 behind pectoral major muscle 434 and provided with the fixation means designed for the implant fixation within tissue pouch 432.
  • the fixation means are made as islands 452 identical to fixation islands 252 shown in figs. 7, 8.
  • the implant surface 439 disposed between islands 452 is non-ingrown, for example smooth surface incapable of ingrowing the patient's tissue therein.
  • Implant assembly 430 comprises preparation delivery means 442 shown also in figs. 11 , 12 and including injection port 447 located in separated port tissue pouch 469.
  • Injection port 447 has receiving chamber 443 and inlet 445 communicated through flexible tube 455.
  • the latter has inlet end 456 with inlet 445 located in tissue pouch 432 of implant 431. Therewith, inlet end 456 is not fastened to implant 431 and provided with inlet end base 457 made in the form of elastic plate.
  • the latter is disposed adjacent to implant non-ingrown surface 439 facing implant 431 by one of plate sides and tissue surface 440 by another plate side and serves as a stabilizer of the position of inlet end 456 relative to implant 431.
  • Elastic plate 457 is provided with projections 448, which enter the tissue of pectoral major muscle 434 additionally enhancing the stabilization of the inlet end position.
  • inlet 445 exits into gap 446 between elastic plate 457 and implant 431. Due to this elastic plate 457 also fulfils a part of a protecting means preventing the occlusion of inlet 445 with overgrowing biologic tissue.
  • the inhibiting preparation gets from inlet 445 into gap 446 and further goes out from under the edges of elastic plate 457 thereby facilitating the uniform distribution of the inhibiting preparation throughout interstice 441.
  • the substantial distance between injection port 447 and inlet end 456 allows the reliable delivery of the inhibiting preparation in the condition when there is a substantial distance between the implant and patient's skin.
  • the unfastened preparation delivery means like one 442 can be implanted simultaneously with the implant emplacement or added to already emplaced prostheses. Otherwise the design and operation of implant assembly 430 is identical to implant assemblies 30, 230.
  • the genesis and overgrowth of the scar tissue, forming a fibrous capsule around the implant, can be eliminated by means of a cell lining formed on the walls of the implant tissue pouch around the implant.
  • This is possible due to the known properties of the certain cells, specifically epithelial celis, to take roots on the biologic tissue and cease the growth of the scar tissue.
  • the method of forming such cell lining includes a preliminary obtaining a cell culture taken from patient by means of biopsy, a cultivation of the needed quantity of the cells, a surgical formation of an initial cavity, i. e. an implant tissue pouch, in the anatomic region to be corrected, and introducing the cells into the implant interstice between the tissue pouch and the implant.
  • the cells are introduced into the initial cavity simultaneously with emplacing the implant by the previous cultivation of the cells on the implant surface or coating the cells on to the implant surface to provide the transfer of the cells onto the free surface of the tissue pouch and subsequent taking roots thereon after emplacing the implant into the initial cavity.
  • the cells in the form of a ceil suspension are injected into the implant interstice after emplacing the implant.
  • the cell suspension is injected through a cell delivery means made in the form of a catheter installed through skin so thai a catheter distal end is disposed in the implant interstice and a catheter proximal end is disposed externally and includes a catheter hub provided with a connection means in the form of a luer-connector allowing the cell injection into the implant interstice by a syringe.
  • the cell suspension is injected through the delivery means made in the form of a port means installed fully subdermally and having an injection port, and the cell suspension is injected by means of a hypodermic needle connected to a syringe.
  • the use of the secreting cells giving off a secret into the implant interstice demands a regular repeated removal of the cell secret from the implant interstice through a drainage means of the implant assembly.
  • the cell secret is removed into an anatomic cavity, for example an abdominal cavity, capable of resorbing the secret, and the method provides for forming a communication between the implant interstice and the anatomic cavity.
  • the drainage means is made as a port means communicated with the implant interstice and adapted for regular repeated removal of a secret excess by a hypodermal needle, therewith the port means is disposed subdermally in zone suitable for the repeated punctures.
  • the cell secrets are used as a correcting structure similar to the implant, and the method provides for introducing an auxiliary implant into the initial cavity to prevent the contact between the walls of the initial cavity at least up to covering the initial cavity wails by the DCis. Then, the auxiliary implant can be removed and the tissue pouch is gradually filled with the cell secret up to the achievement of the breast desirable size. After this the achieved breast size is maintained by regular repeated removal of the secret excess with a hypodermal needle through the subdermal port means communicated with the impiant interstice. In the method version embodiment, the auxiliary implant is not removed and is retained in the tissue pouch filled with the cell secret as a constant component of the corrected breast.
  • the application of the cell lining in the implant surgery is illustrated by the example of the following implant assembly 530.
  • Implant assembly 530 applied for the augmentation mammopiasty is shown in figs. 14,15 and 17 in the non-implanted and implanted positions respectively.
  • Implant assemblies 530 and 430 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 530 mainly is restricted with its distinctive features.
  • implant assembly 530 includes implant- prosthesis 531 implanted into tissue pouch 532 and having the capsule inhibition means in the form of the epithelioid cells capable of taking roots and forming a lining on internal tissue surface 540 of implant tissue pouch 532. This cell lining is capable of preventing the genesis and growth of the capsule.
  • the cells can be introduced into implant interstice 541 by one of the above noted methods: the cells are introduced simultaneously with emplacing the implant due to the cell previous cultivating on or coating on to the implant surface; after emplacing implant
  • the cell suspension is injected through a catheter installed through skin so that a catheter distal end is disposed in impiant interstice 541 and a catheter proximal end is disposed externally allowing the cell suspension injection into the implant interstice by a syringe; after emplacing implant 531 the cell suspension is injected into the implant interstice by a syringe through the port means installed subdermally and communicated with the implant interstice.
  • the noted catheter and port means for the cell suspension injection (not shown) relate to communication means 542 of implant assembly 530.
  • communication means 542 includes a drainage means for removing the cell secrets from implant interstice 541 into abdominal cavity 570, which is capable of resorbing the cell secrets.
  • the close-up view of the drainage means fragment is shown in fig. 16.
  • the cell secret passes from implant tissue pouch
  • the drainage means is made in the form of a drainage port installed subdermally, communicated with implant tissue pouch 532 and allowing removing the cell secrets by a hypodermal needle.
  • the noted drainage port also can serve for the initial ceil suspension injection into the implant interstice.
  • Implant assembly 530 includes the implant fixation means made as straps 573, 574 having the strap implant ends connected to implant 531 and the strap anchoring ends provided with bone anchoring elements 575, 576.
  • the latter are made as rigid hooks adapted for putting on the substantially horizontal bone structure, specifically on rib bone 572, for anchoring to the bone by gravity.
  • bone anchoring elements 575, 576 have openings 577, 578 for fastening to ribs 572 with screws 583.
  • Straps 573, 574 provide the partial support of the breast tissue restricting the breast skin stretch under gravity and the breast sagging, and does not hinder the natural breast hypertrophy caused with a pregnancy. It also does not restrict any natural body mobility and respiration.
  • the capsule inhibition means is made as a layer of an argentiferous material covering the implant non-ingrown surface and capable of emitting the argentums ions, which diffuse into an adjacent patient's tissue thereby inhibiting the capsuie growth around the implant.
  • This argentiferous layer can present a silver metal layer.
  • the implant assembly includes the controlling means designed for the control of - the diffusion speed of the argentums ions into the patient's tissue operating on the modei of electroerosion.
  • the implant assembly comprises two spaced different metal elements one of which is the noted argentiferous layer, and these elements immersed in conductive medium of a human body are subjected to induction electric field creating the voltage difference across the metal elements determining the argentums diffusion speed.
  • the simple electric connection of the different metal elements causes the enhanced argentums diffusion.
  • Implant assembly 630 applied for the augmentation mammoplasty is shown in figs. 18,19 and 20 in the non-implanted and implanted positions respectively.
  • Implant assemblies 630 and 430, 530 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 630 mainly is restricted with its distinctive features.
  • implant assembly 630 includes implant- prosthesis 631 implanted into tissue pouch 632 between mammary gland 668 and pectorai major muscle 634.
  • Implant assembly 630 has an implant fixation means including straps 673, 674 identical to straps 573, 574 of implant assembly 530 and designed for the implant fixation to patient's bones 672.
  • the fixation means includes flexible gland anchoring links 684 links having the link implant ends connected to implant 631 and link anchoring ends adapted for the fixation to mammary gland 668.
  • Anchoring links 684 are peripherally arranged throughout the implant perimeter, contacting with the mammary gland surface with some overlapping and capable of connecting implant 631 to mammary gland 668 providing the tactile continuity at the boundary between implant 631 and mammary gland 668.
  • the gland anchoring links are made of a mesh-like material allowing ingrowing the mammary gland tissue into the gland anchoring links.
  • straps 673, 674 fastening impiant 631 to patient's bones 672 and gland anchoring links 684 fastening implant 631 to mammary gland 632 allows to provide the improved appearance of the female breast and restrict the breast skin stretch and the breast sagging under gravity.
  • Implant assembly 730 applied for the augmentation mammoplasty is shown in figs. 21 , 22 and 23 in the non-implanted and implanted positions respectively. It includes gland anchoring links 784 connecting implant 731 to mammary gland 768 identically to gland anchoring links 684 of above implant assembly 630. Additionally, implant assembly 730 comprises tissue anchoring links 785 fastened to implant 731 , contacting with the surrounding soft tissues, specifically with pectoral major muscle 734, and capable of connecting implant 731 to surrounding soft tissues, specifically to pectoral major muscle 734. Therewith, to certain extent, tissue anchoring links 785 fulfill the part of above straps 673, 674 fastening the implant and mammary giand to patient's body.
  • Anchoring links 784 and 785 are alternately arranged throughout the implant perimeter. The design of anchoring links 784 and 785 and their mode of connecting to biologic tissues are the same. The combination of anchoring links 784 and 785 provides the improved appearance of the female breast and also restricts the breast skin stretch and the breast sagging under gravity.
  • Figs. 24, 26 show implant assembly 830 in the non-implanted and implanted positions respectively serving as an internal brassier and including breast forming means 886 embracing the mammary gland on the side of its lower and lateral surfaces and serving as a supporting bed for the mammary gland.
  • Breast forming means 886 has a bed-like form including lower portion 887, whose main function is the mammary giand support, and lateral portions 888 restricting the side deformation of the mammary gland and thereby maintaining the breast aesthetic form.
  • the breast forming means is made of a bio-compatibie 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- ⁇ ke form including reinforcing strings 891 and thinner filling threads 892 with the cell size sufficiently small to prevent the tissue slitting.
  • Implant assembly 830 comprises the fixation means in the form of straps 873, 874 designed for the fixation of breast forming means 886 to patient's bone structures, specifically to clavicula 890.
  • Straps 873, 874 have strap implant ends 889, 890 fastened to breast forming means 886 and strap anchoring ends provided with bone anchoring elements 875, 876 made in the form of rigid hooks adapted for putting on the substantially horizontal bone structure disposed above the mammary gland like clavicula 890 or a rib bone for coupling to them by gravity. Straps 873, 874 release 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. Implant assembly 830 does not restrict the breast top portion allowing the certain breast natural deformation for example caused with an age changes.
  • Fig. 25 shows implant assembly 930 in non-implanted position to be applied as an internal brassier and including breast forming means 986 enclosing the breast on all sides. Specifically, it includes lower 987, lateral 988 and top 993 portions, restricting the mammary gland deformation and thereby maintaining the aesthetic form of the female breast. This is permissible in the conditions eliminating the breast substantial natural deformation.
  • the schematically shown structure of breast forming means 986 as well as its material is identical to one of breast forming means of implant assembly 830.
  • the fixation means is made as single strap 994 having strap implant end 995 fastened to breast forming means 986 and strap anchoring end provided with bone anchoring element 996 made in the form of rigid hook adapted for putting on the clavicula.

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 ensemble d'implant pour le remplacement ou la correction d'une glande mammaire (voir fig. 13), cet ensemble comprenant un implant (431) pourvu d'un port (443) pour l'injection répétée d'une préparation dans une poche tissulaire afin d'inhiber la naissance d'une contracture capsulaire autour de l'implant. On utilise à cet effet un accumulateur de préparation sous-dermique qui permet de réduire considérablement le nombre d'injections. Selon un autre mode de mise en oeuvre, une lignée cellulaire épithéliale se forme autour de l'implant pour prévenir l'apparition des capsules. L'invention concerne également un dispositif de fixation permettant de fixer l'implant sur la glande mammaire en créant sur leur délimitation commune une continuité. Selon un autre mode de mise en oeuvre, le dispositif de fixation est conçu comme un soutien-gorge interne soutenant la poitrine par rapport au os de la patiente, ce qui empêche l'étirement de la peau des seins et l'affaissement de la poitrine sous gravité et permet à la poitrine de conserver une belle esthétique sur une longue durée.
PCT/IL2006/000751 2005-07-04 2006-06-28 Ensemble d'implant Ceased WO2007004213A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL16952105 2005-07-04
IL169521 2005-07-04

Publications (2)

Publication Number Publication Date
WO2007004213A2 true WO2007004213A2 (fr) 2007-01-11
WO2007004213A3 WO2007004213A3 (fr) 2007-05-31

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009095259A1 (fr) * 2008-01-31 2009-08-06 Milux Holding Sa Système 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
WO2011006901A1 (fr) 2009-07-17 2011-01-20 Milux Holding S.A. Système d'implant mammaire
AU2014277775B2 (en) * 2008-01-31 2016-03-31 Implantica Patent Ltd. Breast implant system
WO2016092538A1 (fr) * 2014-12-07 2016-06-16 Implite Ltd. Implants mammaires
US9713524B2 (en) 2013-01-30 2017-07-25 Implite Ltd. Human implantable tissue expanders
US9724189B2 (en) 2009-07-17 2017-08-08 Peter Forsell Breast implant system
IT201900014196A1 (it) * 2019-08-08 2021-02-08 Gardelli Manuela dispositivo medico del tipo retrattore autostatico atraumatico per chirurgia ricostruttiva del seno

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ES2570077B1 (es) * 2014-10-13 2017-03-03 Jack KANOUZI BASCHOUR Anillo protésico implantacional para la corrección y prevención de la asimetría areolar mamaria

Family Cites Families (2)

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Publication number Priority date Publication date Assignee Title
US6206930B1 (en) * 1998-08-10 2001-03-27 Charlotte-Mecklenburg Hospital Authority Absorbable tissue expander
IL150151A (en) * 2002-06-11 2010-11-30 Mim Minimally Invasive Mastopexy Ltd Breast lift system

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009050706A3 (fr) * 2007-10-16 2010-10-21 Orbix Medical Ltd. Système et procédé pour la remise en forme de tissus mous
AU2009210202B2 (en) * 2008-01-31 2014-09-18 Implantica Patent Ltd. Breast implant system
EP4046597A1 (fr) * 2008-01-31 2022-08-24 Implantica Patent Ltd Système d'implant mammaire
CN101965164A (zh) * 2008-01-31 2011-02-02 米卢克斯控股股份有限公司 乳房植入物系统
US8398710B2 (en) 2008-01-31 2013-03-19 Milux Holding Sa Breast implant system
EP2689747A1 (fr) * 2008-01-31 2014-01-29 Milux Holding SA Système d'implant mammaire
EP3354232A1 (fr) * 2008-01-31 2018-08-01 Milux Holding SA Système d'implant mammaire
CN101965164B (zh) * 2008-01-31 2014-12-24 米卢克斯控股股份有限公司 乳房植入物系统
AU2020256446B2 (en) * 2008-01-31 2022-03-31 Implantica Patent Ltd Breast Implant System
AU2014277775B2 (en) * 2008-01-31 2016-03-31 Implantica Patent Ltd. Breast implant system
WO2009095259A1 (fr) * 2008-01-31 2009-08-06 Milux Holding Sa Système d'implant mammaire
AU2022204709B2 (en) * 2008-01-31 2024-10-24 Implantica Patent Ltd Breast Implant System
US10537420B2 (en) 2008-01-31 2020-01-21 Peter Forsell Breast implant system
US9017403B2 (en) 2009-07-17 2015-04-28 Peter Forsell Breast implant system
US9724189B2 (en) 2009-07-17 2017-08-08 Peter Forsell Breast implant system
WO2011006901A1 (fr) 2009-07-17 2011-01-20 Milux Holding S.A. Système d'implant mammaire
US9713524B2 (en) 2013-01-30 2017-07-25 Implite Ltd. Human implantable tissue expanders
WO2016092538A1 (fr) * 2014-12-07 2016-06-16 Implite Ltd. Implants mammaires
WO2021024285A1 (fr) 2019-08-08 2021-02-11 Deco Med Srl Dispositif médical, de type écarteur à crémaillère non traumatique, pour chirurgie reconstructrice du sein
IT201900014196A1 (it) * 2019-08-08 2021-02-08 Gardelli Manuela dispositivo medico del tipo retrattore autostatico atraumatico per chirurgia ricostruttiva del seno

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