CN102325507A - 具有可膨胀和/或相互配合的隔腔、用蓖麻制成的聚氨酯泡沫和/或羟基磷灰石涂覆或未涂覆的、具有固定片或绳的硅酮植入体 - Google Patents
具有可膨胀和/或相互配合的隔腔、用蓖麻制成的聚氨酯泡沫和/或羟基磷灰石涂覆或未涂覆的、具有固定片或绳的硅酮植入体 Download PDFInfo
- Publication number
- CN102325507A CN102325507A CN200980157124.8A CN200980157124A CN102325507A CN 102325507 A CN102325507 A CN 102325507A CN 200980157124 A CN200980157124 A CN 200980157124A CN 102325507 A CN102325507 A CN 102325507A
- Authority
- CN
- China
- Prior art keywords
- implant
- separate space
- breast
- silicone
- rope
- 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.)
- Pending
Links
Images
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 and implants
-
- 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
- A61F2/0059—Cosmetic or alloplastic implants
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0034—D-shaped
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/0076—Quadric-shaped ellipsoidal or ovoid
-
- 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
-
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0006—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting angular orientation
-
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
-
- 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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0013—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting fluid pressure
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0015—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in density or specific weight
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
- A61F2250/0024—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity made from both porous and non-porous parts, e.g. adjacent parts
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
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
本发明涉及一种用于增大或再造乳房、臀部、大腿和小腿的植入体,其具有独立的可膨胀且相互作用的隔腔,这些隔腔可在生产时或手术中或手术后进行填充,该植入体还包括硅酮外膜(1),该外膜外表面或内表面涂覆有蓖麻聚氨酯泡沫(14),或者覆盖有羟基磷灰石微粒晶体(13),或者该膜内包含有纳米晶体(13),该植入体的内部空间被分成多个隔腔(3),所述隔腔内可填充有三维几何结构体,这些结构体浸没于粘性硅酮或其它的凝胶、液体、空气或气体中,其中一个腔室用于使主体(4)或乳房的下部上挺,主体(4)在主腔室中具有锥形结构以使乳房上挺。内隔腔或外隔腔分别填充并具有不同的体积。由于内隔腔室或外隔腔可相互作用,从而可通过填充阀(8)对植入体进行任何所需的调整,以使乳晕乳突区(6)、主体(4)或其它区域上挺,还可以矫正下垂、不对称、乳房或其它区域的先天性肥大。用于即时固定的突片(10)或绳(11)可确保安全、更快恢复正常活动和植入体的最终安全放置;它们还可避免植入体的移位,并可提前由医生去除。
Description
技术领域
本发明的目的在于提供一种用于乳房或人体其它部位增大或再造的新型硅酮植入体,以能显著扩展植入体的用途并提高其功效。此外,与现有类型的硅酮植入体相比,本发明提供了技术改进。
背景技术
用于乳房、臀部、大腿和小腿的增大或再造的现有植入体模型主要包括医用级硅酮弹性体膜。和其它的医用级原材料一样,其填充有盐溶液、具有不同粘性的硅胶或其它生物相容性产品。
硅酮植入体还可具有不同的表面结构,比如光滑的、具有图案的或者覆盖有不是由蓖麻(蓖麻子)制得的标准聚氨酯泡沫,且具有不同的容积和形状。
有些植入体具有填充有粘性基本一致的硅酮的内隔腔。这些植入体还具有充满通过与该植入体连接或不连接的阀注入的盐溶液的内隔腔。这允许其体积在手术中或之后显著增加,然而,这无法对医生或患者期望的乳房特定部位进行塑型或增大体积。
为缩短人体内的植入体的固定期(以避免发生移位),现有植入体可具有纹理表面或涂覆有标准聚氨酯泡沫(不是由蓖麻制得)的表面。在它们的底部还可设有多个细小的通道。
目前,全世界有很多的公司生产硅酮植入体,而它们的质量和价格大同小异。这些植入体往往具有很多局限性,这将在下文中进行讨论。
具有涂覆普通聚氨酯泡沫的膜的硅酮植入体的缺陷在于,当其由于真菌或细菌污染而发生感染时需要立即取出,否则其将因抗原-抗体机理而被身体排斥。
如果硅酮植入体未被排异,则将形成粗糙的纤维囊,这将导致乳房区域的结构发生改变而更不自然。
形成纤维囊的另一个麻烦是由于其与活组织之间的强纤维粘着力而使医生很难将其取出。
还被称作聚合硅氧烷或聚硅氧烷的硅酮是混合的有机或无机材料的聚合物,其化学式为[R2SiO]n,其中R是诸如甲基、乙基和苯基之类的有机基团。
硅酮包括具有连接至硅原子的有机侧基团的无机硅-氧骨架(...Si-O-Si-O-Si-O...)。
通过改变主链长度、侧基类型和链之间的链环,硅酮可被合成至具有多种不同的性质和组成。其稠度可以从液体变化至凝胶、橡胶或硬塑料。
由于现有的硅酮植入体为由有机-无机材料制得,其会与人体发生不良反应。这被称作排异反应,其目的在于通过在植入体周围形成粗糙的纤维膜或囊(疤)而将身体隔离,从而产生非常不自然的外观和触感。
这是硅酮植入手术后最为常见的问题之一,其将导致纤维囊收缩和乳房的硬化。这发生于围绕植入体的纤维囊开始将其推挤以设法将身体隔离时。
此外,现有的涂覆有普通聚氨酯泡沫的硅酮植入体易发生弯曲。
发明内容
为了克服上述问题,现已开发得到一种新型的硅酮植入体,以使植入体更为安全、完全符合人体结构、具有自然的外观和轻的重量。这是历经二十余载悉心研究试验的本申请的主题。
这种新颖的硅酮植入体被设计用于乳房、臀部、大腿和小腿。硅酮植入体具有内部或外部可变的隔腔,并具有光滑、带图案或涂覆有由蓖麻制成的聚氨酯泡沫的表面结构。硅酮植入体还可在内部衬设有由蓖麻制成的聚氨酯泡沫,这便于使用羟基磷灰石的微米级或纳米级晶体。
首先,本发明涉及硅酮植入体的结构方面。硅酮植入体具有一个带内部子分区的标准隔腔,并且还可以具有一个可膨胀外部隔腔。所述两个隔腔均进一步在附图中示出。
对于植入体的潜在使用者或医护人员而言,主要关心的问题是其安全性。
所述硅酮植入体在安全性方面分为三个方面:(a)植入体的内壁衬设有由蓖麻制得的聚氨酯泡沫,其可将破裂和其内容物发生泄漏的风险减少至接近为零;(b)由蓖麻制得的聚氨酯聚合物泡沫由于其杀菌(杀真菌和细菌)能力而不会有感染的风险;以及(c)由于存在所附的源自植入体底部边缘的“爪形部”而不会发生移位。
这些植入体还包括带有贯穿植入体底部的上下侧的多个孔的固定片。
可以在底部的片上设置一个或多个填充阀,使得可在以后对每个可膨胀隔腔进行填充。
本发明还涉及蓖麻聚氨酯的用途,由于该材料可更好地与人体细胞发生作用,从而将发生排异反应的情况降低至为零。这还获得了掌管北美新食品和药品发行的政府机构联邦药品管理局(FDA)的批准。
在巴西,自该生物材料在1999年获得卫生部批准以来的期间内,许多人已受益于该用于修复骨组织的刚性植入体。
这种聚合物的主要优点在于其完全的生物相容能力和其灭杀真菌和细菌的效果,这使得即使出现感染,该植入体也不会被排斥,从而避免了形成粗糙或厚的纤维囊。
该聚合物经证明具有很高的杀菌消毒能力。
制成具有不同的表面结构和密度,这种聚合物能很好地代替硅酮植入体,消除了发生过敏反应或抗原-抗体特异反应的风险。
对患者而言,由蓖麻制得的聚氨酯泡沫可以改善植入体的质量,由于其抗细菌和真菌作用,如果发生感染也只形成较薄的囊。也不再需要将植入体取出。减少了时间、与医疗和交通有关的总体成本,还减小了需要重新进行手术的可能性,从而使患者可更快地恢复其日常活动。
对医生而言,因为破裂和感染风险的减少导致手术及术后的护理更为安全,避免了压力、法律纷争和不必要的时间花费。
对于患者的亲属而言,更安全的植入体意味着更少的担心、劳动和费用。
本发明的另一个创新在于其覆盖层(覆盖植入体的膜)可涂覆有附接到其外表面的羟基磷灰石微米晶体或者嵌入于植入体的硅酮膜中的羟基磷灰石纳米晶体。这样提供了更好的生物相容性,避免了纤维囊的形成,使得乳房组织具有类似天然的较原生的结构。
评价异质移植材料的生物相容性的很多实验室研究已证明,在植入体的膜中使用羟基磷灰石比目前用于植入体中的纯硅酮具有更好的效果,因为其可形成更细的纤维囊。
为此,涂覆有羟基磷灰石的硅酮植入体推荐用作身体任何区域的内部植入体,因为植入体的膜表面不会改变植入体周围区域的结构。
对于通过改变植入体的形状和体积来修正身体的多个具有特定差异的区域的不对称性(即,当一个乳房比另一个乳房大时胸部形状和体积的不对称性),这种创新的植入体允许对体积和形状进行调整,因为其具有一个以上的独立隔腔(内部和/或外部)。然而,它们可相互作用可以填充相同器官或区域的不同部分从而对其进行塑形。
根据以上段落,这种创新的植入体可使手术过程个性化,因为每个独立的隔腔均可填充液体物质(盐水、蒸馏水等)、凝胶(粘性硅酮、蓖麻凝胶、玻璃酸、羟基磷灰石等)或气体(空气、各种气体)。并且各个隔腔可通过注射或连接到植入体的遥控阀相互配合。
从而,这些植入体更安全、灵活和全面。它们可产生看起来很自然的效果,符合医生的计划及患者的期望。
如果要进行手术后矫正,比如矫正植入体中锥体部的下垂(垂下),为增加其体积或改善下垂,该植入体具有独立且相互作用的多个空间,这些空间能被填充以能够对形状、隆起和下垂进行矫正。
在有些情况下,乳房在经过一段时间后会因为重力和胶原/弹性纤维的弱化而下垂。而且,安置任何植入体均会导致身体重量的增加,该重量主要由皮肤支撑。因此,经过一段时间,乳房会与其重量成比例地下垂。
使用传统的植入体增大乳房很难使乳房隆起,其更多地依赖体积的增加。如果皮肤松弛很小,植入体可使乳房隆起,但是如果松弛较大,就达不到这样的效果。在这种情况下,隆起乳房需要使用大(体积)的植入体,这会导致乳房与胸部比较起来不成比例。
使用这种新型的量身定制的植入体,体积和形状均可以变化,从而导致需要矫正的各个身体区域得到更为精确的调节。这将适用于这样的情况,比如乳房下垂以及小和中级的松弛,针对尤其是因为脂肪组织和腺组织之间不一致而导致的形状和体积的不对称的矫正。
通过控制对乳突-乳晕作用复合体(乳晕和乳突)作用的内部隔腔和外部作用隔腔的填充过程,该问题很容易得到解决,并防止了植入体总体积的不必要的增加。
本发明还涉及一种新颖的植入体填充系统,其可显著减小植入体的总重量,从而减小重力的影响。
所述植入体具有在工厂即已填充的主腔室,主腔室由生物相容性膜壁构成的,该生物相容性膜具有杀灭真菌和细菌的性能,该主腔室也可由医生使用具有不同形状和大小的细小三维结构体进行填充,该主内腔具有一个或多个腔室。其中可以有中央腔,其限定乳突-乳晕作用复合体以使一乳突-乳晕区域上挺,该中央腔被厚度与植入体的壁厚度不同的壁与主腔分隔开。这些三维结构体的中心可以具有其它更小的几何结构体,比如硅酮壁比植入体外层更薄的小球。这些结构体可以使用生物相容性材料进行填充,比如空气、气体、液体或比硅酮更轻的物质或其它生物相容性凝胶。该过程使溢出的风险最小化,并使植入体更轻(当填充比粘性硅酮密度更低的物质时),从而减小重力的影响,使得植入体与被植入区域的自然运动更为适应。
这种用于乳房、臀部、大腿和小腿的具有灵巧且相互配合的多个隔腔的新型硅酮植入体可解决所有可能的问题,因为其量身定制的植入体与身体细胞更好地相互配合,减少了排异的情形以及粗纤维囊的形成。
本发明还提供设置在方位基点上的用于在手术过程中即时固定植入体的新颖的突片以及位于植入体底部的用于在手术后的前几个星期内固定植入体的同心沟槽结构,比防止诸如在手术后不久可能发生的植入体移位之类的不利后果。
所述突片(具有或不具有“爪形部”)还使得术后恢复期更短,并且患者可更早地恢复其正常活动。这些突片是可以有的,并可在由医生提前取下。
附图说明
以下附图示出了主要的植入体以及其可能的变化形式:
图1示出了未充气(填)的植入体的轮廓;
图2示出了该植入体的俯视图;
图3示出了该植入体的前部;
图4示出了植入体的后(底)部;
图5示出了在重量和重力的作用下的植入体的轮廓;
图6示出了在乳房(乳突-乳晕作用复合体)前挺并且隔腔已充满时的植入体的轮廓;
图7示出了植入体腔室和隔腔的一种可能的结构变化形式;
图8示出了该植入体的结构和隔腔的另一种可能结构变化形式,其中其隔腔没有充满;
图9示出了图8中已被充满的隔腔;
图10示出了隔腔和腔室的另一种可能结构;
图11示出了图10中已被充满的隔腔;
图12示出了植入体的正剖视图,其内部衬设有聚氨酯泡沫和蓖麻微粒14和附于植入体表面结构上的羟基磷灰石晶体13。
具体实施方式
根据上述附图,这种新型的植入体包括:硅酮植入体1,填充的几何结构体2和嵌入的粘性硅凝胶和/或任何其它生物相容性材料3。所述植入体具有腔室和可变和相互作用的隔腔,后者用于使乳突-乳晕作用复合体4(锥体)前挺。用于形成乳突-乳晕作用复合体的中间腔室具有较厚的侧壁5。该植入体还包括乳突-乳晕区6。位于上方的上隔腔7,其包括位于所述植入体的上部区域后面的部分,并可以有的在所述乳突-乳晕作用复合体内有延伸的部分,进一步推挺所述的锥体。乳突-乳晕作用复合体的壁比植入体壁薄。还设填充阀8,使相互配合的隔腔室允通过该填充阀进行量身定制调整。所述植入体进一步设有使锥体上挺的下隔腔室9,它可被填充,以矫正下垂,使植入体看起来更自然。下隔腔和上隔腔可以连通。在植入体底部还设突片10和/或绳11在手术过程中用于进行更加安全的固定以确保植入体在手术过程中不会移动,必要的情况下突片10可由医生在手术前去除。
另外一个重要的因素是涂覆有由蓖麻制得的聚氨酯的植入体的成本。由于这种植入体的原材料提取自蓖麻籽,其总成本比涂覆普通聚氨酯的植入体要低15%-20%。
所述植入体可被制造成具有不同的尺寸、型号、体积、表面结构及不同的性能以满足不同的需要。
Claims (1)
1.一种具有可膨胀和/或相互配合的隔腔、用蓖麻制成的聚氨酯泡沫和/或羟基磷灰石涂覆或未涂覆的和具有固定片或绳的硅酮植入体,其特征在于,该硅酮植入体(1)用于再造乳房和/或增大乳房、臀部、大腿和小腿,并具有单个或多个可膨胀的内部或外部隔腔,在存在多个隔腔的情况下这些隔腔可相互配合,所述隔腔可在工厂生产时进行填充或由医生在手术时或手术后进行填充,该植入体具有主腔室,其可被填充有硅凝胶和/或任何其它生物相容性材料(3)和/或具有不同形状和尺寸的小填充空间的三维几何结构体(2),这些三维几何结构体可具有单个或多个分开的腔室或中心可以保持其它更小的、同样具有不同形状和尺寸的三维几何结构体,比如侧壁比覆盖植入体的硅酮层更薄的小袋(小球),所述结构体可以填满或半填充(如变形虫的样子)大量的空气、气体、液体、凝胶(比如空气或氦气、盐溶液或其它无毒生物相容性液体、生物相容性气体的混合物、羧甲酸或玻尿酸、羟基磷灰石凝胶、蓖麻油或凝胶、聚甲基丙烯酸甲酯凝胶、粘性硅酮(3)或这些物质的生物相容组合物),所述三维几何结构体被浸没于粘性硅酮或其它所述凝胶、液体、空气、气体中,上述主腔室还可被分成其它内腔室,并且每个内腔室可包含不同的生物相容性物质,所述乳房植入体的底部设有内外两组环状且同心的沟槽结构或凹孔(12),其深2mm宽5mm并填有聚乙烯网或其它的不能被吸收的物质,在四个方位基点处外沟槽被中断达30mm,有突片或附接绳布置在所述四个基点处,外部硅酮膜(层)的内部和/或外部可涂覆有a)蓖麻聚氨酯泡沫(14)或b)羟基磷灰石微粒晶体和/或c)加入该膜中的羟基磷灰石纳米晶体(13),其中该可膨胀的内外隔腔(7,9)作用于锥体4(乳晕乳突区),侧壁(5)较厚,,设有附加的绳(11),所述绳可以是吸收性的,其还可以包括“爪形部”(鱼骨形),所述绳可使用普通的医用缝合线进行固定,所述绳自植入体底部边缘上的一个或多个方位基点离心延伸,该圆形的底部具有较大的厚度,即较高的密度,其还可以有不可吸收的的突片(10),所述突片具有多个穿孔,其可以接纳位于背面的“爪形部”以锁定在底部的一个或多个基点上。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BRPI0805495 BRPI0805495A2 (pt) | 2008-12-19 | 2008-12-19 | implante de silicone com compartimentos expansìveis e/ou interativos, revestido ou não de espuma de poliuretano de ricinus communis e/ou hidroxiapatita, com abas ou cordões de fixação |
BRPI0805495-9 | 2008-12-19 | ||
PCT/BR2009/000410 WO2010069019A1 (pt) | 2008-12-19 | 2009-12-14 | Implante de silicone com compartimentos expansíveis e/ou interativos, revestido ou não de espuma de poliuretano de ricinus communis e/ou hidroxiapatita, com abas ou cordões de fixação |
Publications (1)
Publication Number | Publication Date |
---|---|
CN102325507A true CN102325507A (zh) | 2012-01-18 |
Family
ID=42268201
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN200980157124.8A Pending CN102325507A (zh) | 2008-12-19 | 2009-12-14 | 具有可膨胀和/或相互配合的隔腔、用蓖麻制成的聚氨酯泡沫和/或羟基磷灰石涂覆或未涂覆的、具有固定片或绳的硅酮植入体 |
Country Status (5)
Country | Link |
---|---|
US (1) | US20110264213A1 (zh) |
EP (1) | EP2387971A4 (zh) |
CN (1) | CN102325507A (zh) |
BR (1) | BRPI0805495A2 (zh) |
WO (1) | WO2010069019A1 (zh) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106794062A (zh) * | 2014-10-13 | 2017-05-31 | 杰克·卡努兹·百石川 | 用于矫正和预防乳晕不对称的可植入假体环 |
CN111035484A (zh) * | 2019-12-23 | 2020-04-21 | 南京市妇幼保健院 | 一种仿真义乳 |
CN111526896A (zh) * | 2017-10-06 | 2020-08-11 | 帝斯曼知识产权资产管理有限公司 | 制备骨引导性聚合物制品的方法和由此制备的骨引导性聚合物制品 |
CN111683624A (zh) * | 2017-11-13 | 2020-09-18 | 外科创新联合有限公司 | 用于医疗植入物的网状袋及其使用方法 |
Families Citing this family (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX337244B (es) * | 2008-01-31 | 2016-02-19 | Milux Holding Sa | Sistema de implante de seno. |
WO2009113745A1 (en) * | 2008-03-12 | 2009-09-17 | Jong-Soo Choi | Medical implant |
US9370414B2 (en) | 2008-10-28 | 2016-06-21 | Implite Ltd. | Reconstructive breast prostheses |
US9017403B2 (en) * | 2009-07-17 | 2015-04-28 | Peter Forsell | Breast implant system |
PL3199126T3 (pl) | 2011-03-09 | 2020-05-18 | Tepha, Inc. | Układy do mastopeksji |
EP2581193B1 (en) | 2011-10-14 | 2015-11-25 | Polytech Health&Aesthetics GmbH | Process for the manufacture of implants or intermediate products of such implants as well as implants and intermediate products obtained by such process |
US20130231743A1 (en) * | 2011-10-19 | 2013-09-05 | Hilton Becker | Hybrid breast implant |
US8932353B2 (en) * | 2011-11-04 | 2015-01-13 | Freddy Sanabria Scharf | Mammary prosthesis filled with expanded polymer microspheres |
CN105142572B (zh) * | 2013-01-30 | 2018-05-11 | 因普利特有限公司 | 人类可植入的组织扩张器 |
AU2014286999B2 (en) | 2013-07-11 | 2017-04-13 | Tepha, Inc. | Absorbable implants for plastic surgery |
US9463087B2 (en) * | 2014-03-31 | 2016-10-11 | Mentor Worldwide Llc | Directional tissue expander |
US9700405B2 (en) | 2014-03-31 | 2017-07-11 | Mentor Worldwide Llc | Directional tissue expander |
WO2016123554A1 (en) | 2015-01-29 | 2016-08-04 | Ryan A. Stanton, M.D., Inc. | Gluteal implants and implant systems |
ITUB20152200A1 (it) * | 2015-07-15 | 2017-01-15 | Solidago Ag | Protesi autoportante per interventi di chirurgia plastica e ricostruttiva |
USD836778S1 (en) | 2015-10-09 | 2018-12-25 | Tepha, Inc. | Three dimensional mastopexy implant |
GB201521474D0 (en) | 2015-12-04 | 2016-01-20 | Univ Manchester | Textured surfaces for implants |
US10548712B2 (en) | 2016-02-29 | 2020-02-04 | Biosense Webster (Israel) Ltd. | Pressure changer for a breast implant |
CA3023507A1 (en) * | 2016-05-11 | 2017-11-16 | Establishment Labs S.A. | Medical implants and methods of preparation thereof |
US10751163B2 (en) | 2017-09-01 | 2020-08-25 | Mentor Worldwide Llc | Adjustable implant |
US10751165B2 (en) | 2017-12-12 | 2020-08-25 | Mentor Worldwide Llc | Adjustable implant |
US10653517B2 (en) | 2017-11-08 | 2020-05-19 | Mentor Worldwide Llc | Adjustable implant |
USD889654S1 (en) | 2018-02-09 | 2020-07-07 | Tepha, Inc. | Three dimensional mastopexy implant |
USD889655S1 (en) | 2018-02-09 | 2020-07-07 | Tepha, Inc. | Three dimensional mastopexy implant |
ES2953544T3 (es) | 2018-02-09 | 2023-11-14 | Tepha Inc | Implante mamario de contorno completo |
USD892329S1 (en) | 2018-07-03 | 2020-08-04 | Tepha, Inc. | Three dimensional mastopexy implant |
US11779455B2 (en) | 2018-10-02 | 2023-10-10 | Tepha, Inc. | Medical devices to limit movement of breast implants |
US20200222584A1 (en) * | 2019-01-15 | 2020-07-16 | Biosense Webster (Israel) Ltd. | Breast Implant with Multiple Saline and/or Silicone Fillable Compartments |
IT201900002949A1 (it) * | 2019-02-28 | 2020-08-28 | Deco Med Srl | Dispositivo medico protesico per chirurgia plastica estetica e ricostruttiva |
AU2020392326A1 (en) | 2019-11-25 | 2022-06-23 | Tepha, Inc. | Breast implant wraps to limit movement of breast implants and related methods |
BR202021014224U2 (pt) * | 2021-07-20 | 2023-01-31 | Estefano Luiz Favaretto | Prótese mamária de silicone hibrida ou mista com superficie lisa ou microtexturizada com revestimento em poliuretano |
Family Cites Families (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3986213A (en) * | 1975-05-27 | 1976-10-19 | Medical Engineering Corporation | Gel filled medical devices |
US4650487A (en) * | 1980-10-27 | 1987-03-17 | Memorial Hospital For Cancer And Allied Diseases | Multi-lumen high profile mammary implant |
US4605412A (en) * | 1983-01-20 | 1986-08-12 | Medical Engineering Corp. | Mammary prosthesis having adjustable projection |
US4790848A (en) * | 1987-11-27 | 1988-12-13 | Dow Corning Wright | Breast prosthesis with multiple lumens |
US5092882A (en) * | 1990-05-04 | 1992-03-03 | Lynn Lawrence A | Multiple compartment breast prosthesis |
US5236454A (en) * | 1991-11-04 | 1993-08-17 | Miller Archibald S | Stacked breast implant |
US5496367A (en) * | 1993-01-13 | 1996-03-05 | Fisher; Jack | Breast implant with baffles |
FR2726173B1 (fr) * | 1994-11-02 | 1997-01-17 | Sigma Medical France | Prothese d'expansion destinee a la reconstruction mammaire |
US5824081A (en) * | 1996-09-13 | 1998-10-20 | Lipomatrix Incorporated | Hydraulic foam tissue implant |
US5961552A (en) * | 1997-08-02 | 1999-10-05 | Pmt Corporation | Internally configured prosthesis |
AU5921300A (en) * | 1999-10-22 | 2001-05-08 | Archibald S. Miller | Breast implant |
US6203570B1 (en) * | 1999-11-24 | 2001-03-20 | John L. Baeke | Breast implant with position lock |
US6755861B2 (en) * | 2001-10-16 | 2004-06-29 | Granit Medical Innovation, Inc. | Device for providing a portion of an organism with a desired shape |
DK1509256T3 (da) * | 2002-05-24 | 2009-11-23 | Angiotech Int Ag | Præparater og fremgangsmåde til coating af medicinske implantater |
AU2003902604A0 (en) * | 2003-05-26 | 2003-06-12 | Connell, Anthony Francis | A differential tissue expander implant |
US6875233B1 (en) * | 2003-06-10 | 2005-04-05 | Hinging breast implant | |
AU2004293463A1 (en) * | 2003-11-20 | 2005-06-09 | Angiotech International Ag | Implantable sensors and implantable pumps and anti-scarring agents |
US20070190108A1 (en) * | 2004-05-17 | 2007-08-16 | Arindam Datta | High performance reticulated elastomeric matrix preparation, properties, reinforcement, and use in surgical devices, tissue augmentation and/or tissue repair |
WO2007041677A2 (en) * | 2005-10-03 | 2007-04-12 | Combinatorx, Incorporated | Soft tissue implants and drug combination compositions, and use thereof |
CA2665945A1 (en) * | 2006-10-10 | 2008-04-17 | Aortech Biomaterials Pty Ltd | Soft tissue implant |
MX337244B (es) * | 2008-01-31 | 2016-02-19 | Milux Holding Sa | Sistema de implante de seno. |
MX2012000794A (es) * | 2009-07-17 | 2012-06-12 | Milux Holding Sa | Sistema de implante de mama. |
-
2008
- 2008-12-19 BR BRPI0805495 patent/BRPI0805495A2/pt not_active IP Right Cessation
-
2009
- 2009-12-14 CN CN200980157124.8A patent/CN102325507A/zh active Pending
- 2009-12-14 EP EP09832745.5A patent/EP2387971A4/en not_active Withdrawn
- 2009-12-14 WO PCT/BR2009/000410 patent/WO2010069019A1/pt active Application Filing
-
2011
- 2011-06-15 US US13/160,751 patent/US20110264213A1/en not_active Abandoned
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106794062A (zh) * | 2014-10-13 | 2017-05-31 | 杰克·卡努兹·百石川 | 用于矫正和预防乳晕不对称的可植入假体环 |
CN111526896A (zh) * | 2017-10-06 | 2020-08-11 | 帝斯曼知识产权资产管理有限公司 | 制备骨引导性聚合物制品的方法和由此制备的骨引导性聚合物制品 |
CN111526896B (zh) * | 2017-10-06 | 2022-05-10 | 帝斯曼知识产权资产管理有限公司 | 制备骨引导性聚合物制品的方法和由此制备的骨引导性聚合物制品 |
CN111683624A (zh) * | 2017-11-13 | 2020-09-18 | 外科创新联合有限公司 | 用于医疗植入物的网状袋及其使用方法 |
CN111035484A (zh) * | 2019-12-23 | 2020-04-21 | 南京市妇幼保健院 | 一种仿真义乳 |
Also Published As
Publication number | Publication date |
---|---|
US20110264213A1 (en) | 2011-10-27 |
WO2010069019A1 (pt) | 2010-06-24 |
EP2387971A1 (en) | 2011-11-23 |
EP2387971A4 (en) | 2014-01-22 |
BRPI0805495A2 (pt) | 2010-09-08 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CN102325507A (zh) | 具有可膨胀和/或相互配合的隔腔、用蓖麻制成的聚氨酯泡沫和/或羟基磷灰石涂覆或未涂覆的、具有固定片或绳的硅酮植入体 | |
AU2006306193B2 (en) | Variable cohesive gel form-stable breast implant | |
US5092882A (en) | Multiple compartment breast prosthesis | |
US8801782B2 (en) | Surgical methods for breast reconstruction or augmentation | |
US20060282164A1 (en) | Implant shell and filler apparatus | |
Becker | The expandable mammary implant | |
US20040148024A1 (en) | Soft tissue implant | |
US20220331091A1 (en) | Container device for breast prosthesis for reconstructive breast surgery | |
EP0786969B1 (en) | Appatus for establishing body pockets | |
MX2007013295A (es) | Soporte de tejido blando. | |
EP3679890A1 (en) | Breast implant | |
US20210267750A1 (en) | System and Method of Manufacturing Prostheses | |
CN110384829A (zh) | 使用化学方式制备的泡沫填充物来降低乳房植入物重量 | |
Hodgkinson | Buckled upper pole breast style 410 implant presenting as a manifestation of capsular contraction | |
KR102370662B1 (ko) | 골반 엉덩이 성형용 보형물 | |
Queen et al. | Gore-Tex for nasal augmentation: a recent series and a review of the literature | |
Capozzi | Long-term complications of polyurethane-covered breast implants | |
CN220046188U (zh) | 臀部硅凝胶假体 | |
CN219645968U (zh) | 一种新型抗菌乳房假体 | |
RU125464U1 (ru) | Тканеинженерный имплантат для замещения дефектов гортани и/или трахеи | |
CN214908653U (zh) | 一种分体式乳房植入体 | |
CN202446296U (zh) | 一种隆胸用假体 | |
CN206526312U (zh) | 一种隆胸用植入假体 | |
Mira | Anatomic asymmetric prostheses: shaping the breast | |
CN206414370U (zh) | 一种乳房植入体 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C05 | Deemed withdrawal (patent law before 1993) | ||
WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20120118 |