CN104837441A - 乳房假体 - Google Patents

乳房假体 Download PDF

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Publication number
CN104837441A
CN104837441A CN201380064358.4A CN201380064358A CN104837441A CN 104837441 A CN104837441 A CN 104837441A CN 201380064358 A CN201380064358 A CN 201380064358A CN 104837441 A CN104837441 A CN 104837441A
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Prior art keywords
prosthese
clad
breast prosthesis
implant
breast
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F·梅奥·马丁
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/12Mammary prostheses and implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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

呈解剖形态乳房假体有可能在植入位置在移转,这将影响美观。植入本发明,将解决该问题。这得益于乳房假体的布置、硅胶带(5-8)包盖正面(2)及或背面(3)的布置,所述硅胶带充分固定至所述包裹物,并在硅胶带的自由端设有供缝合点通过的相应小孔(7-9),使得这些缝合点允许假体固定至使用者的肉体组织,例如,乳房组织、胸大肌、胸大肌筋膜等,而假体保持固定。所述假体还包括一个放射性材料制成的标记(10),使得可通过常规放射学或其他装置检查假体的位置。

Description

乳房假体
说明
发明目的
本发明涉及一种乳房假体,尤指呈解剖形态的乳房假体,它具备特殊构设和结构,能解除假体中期和长期出现的移转问题。
通过适合用简单缝合点而固定的装置将假体固定至患者身体可实现这一点。
因此,本发明属于外科领域,具体而言,属于乳房整形手术领域,如隆乳和因任何类型的健康问题或其它问题移除乳腺后的乳房再造。
发明背景
呈解剖形态的乳房假体可以填充硅凝胶或生理盐水。在一些情况下,可以使用硅凝胶和盐水混合的填充物。围绕填充物的表面,不管其如何,都称为包盖。包盖通过添加硅层,并让其变干而制成。各制造商有他们自己制作包盖的方法,即便标准是这些解剖假体的最终表面要具有纹理。有的制造商将聚氨酯包盖加入至纹理中。解剖假体在乳房切除手术后为再造乳房而用作扩胸目的的,包盖的背面上有一个设有金属部件的阀件,使包盖能外部调整位置,并可通过经皮注射而连续填充。
光滑的解剖假体不能商业化,因为它们的表面没有粘性,无论怎样它们都会移动或转动。如果采用了纹理化的解剖乳房假体,纹理本身的细孔发挥粘合作用,能防止部分但非所有情况下的假体转动。细孔越深,纹理越明显,理论粘性度越大,但是,在中期和长期也将有更多的问题,比如血清肿延迟不愈以及包膜挛缩。
因此,理想的解剖假体当具有微纹理,但是,它们转动更为频繁,尽管它们包膜挛缩和血清肿延迟不愈发生率很小。
运用完全为解剖假体而定制的解剖手术技术,能使短期和中期转动更少。
在许多情况下,尽管外科医生实施为假体定制的解剖,但还是存在病人的内在因素,例如组织弹性,或身体锻炼,从而导致胸袋随时间变形,因此引起假体转动。
另一方面,事实上,解剖假体通常会转动,导致世界各地许多外科医生不太使用它们,尽管事实上,较之用其它圆形假体,使用这种假体进行手术的,美观效果更加自然。
也没有真正的统计数据表明,假体转动的占多少百分比或平均转动程度,因为制造厂家没有对解剖假体加入任何便于从病人的外部检测中期和长期假设中的转动的装置。
解剖假体的所有转动问题通过一种新的外科手术解决,但这种转动并非受外部操纵而解决。
在大多数的情况下,外部操纵不能解决转动的问题,而病人还得重新进行外科手术。
转动轻微的,即便反复出现,都可以容忍,因这变形很小,患者愿意接受轻微的变形,从而避免再次动手术。
因此,在呈解剖形态的乳房假体领域中,目前存在两个问题:
-假体的转动
-缺少从外部通过放射检查或类似方法检查所述假体的位置是否正确或者反而言之是否发生了转动的装置。
发明描述
本发明提出的乳房假体可以完全令人满意的方式从上述两个方面解决前文提出的问题。
为此,从呈解剖形态的乳房假体的经典结构而定义的假体,其特点侧重于假体包盖采用新的结构,作为一种借助于简单缝合点将所述假体固定于患者体内最佳位置的机构,防止在中期和长期出现的转动。
更具体而言,所述结构由与包盖相同的材料制成的带子,即,固体硅胶,而包盖便是用存在固有阻力和伸长属性的硅胶而制成的。
这种长方形的构造物充分固定至假体(例如通过一种类似的密封装置封闭后部的填充孔位),设有远端孔口,供用于固定至病人合适组织的缝合点通过。优选情况下,假体设有四条固定带或构造物,两个在其正面,两个在其背面,长度为约2厘米,宽度6至8毫米。
根据发明的另一种特征,并且为了能够在假体植入后从外部检查假体的位置,所述假体包括了一个设有用生物相容材料(例如钛)制成的不透射线基座的标记,基座位于所述触觉标记之上,而传统假体设在下极,使得能用常规放射学或任何其它合适的类似装置在任何时候确定假体的位置。
附图说明
为了补充后面的说明,且便于更好地理解本发明的特点,按照发明的优选实用实施例,所述说明配有一组附图,组成一个整体,下文采用说明性的和非限制性的方式描述:
图1和图2示出了呈传统解剖形态的乳房假体的相应原理描述,第一个采用正面视图,第二采用侧面或横向视图。
图3示出根据本发明的目的制成的乳房假体之正视图。
图4示出了图3相同假体的后视图。
图5示出了图3和4假体的剖面图。
优选示例性实施方式
根据描述的附图,可以观察到在图3和5的描述中,本发明提出的乳房假体如何通过呈解剖形态的主体(2)而构成,对于同一患者而言在形式和尺寸上匹配图1和2的乳房假体,即,通过一个包裹物或密闭盖,在其内部容纳硅胶和/或盐水填充物,在后部为密封于后部的硅胶填充物设有一个孔口(11),构成正面(2)和背面(3)。
根据本发明,假体的所述主体(1)包括在其正面由与包盖相同材料制成的两根条带(5),也即固体硅胶,条带位于一个较低的层级上,采用与假体假设垂直轴和内侧轴的一种简单对称布置,如在图3中观察到的,条带于其一端(6)通过一个密封装置固定在假体的正壁(2),且包括便于缝合点通过的两个孔口(7),对应于其另一端。
在假体的背面(3),重复所述结构,即设有另两根条带(8)固定至包盖的后壁(3),并在其一端设有相应的孔口(9),供缝合点通过。
如前所述,条带(5、8)基本为长方形,长度约为2cm,宽6至8mm,具有较好的触感和阻力。
固定条带(5、8)的组织可以是乳房组织、胸大肌、胸大肌筋膜、前直肌的筋膜或肋间肌肉筋膜。具体采用哪种组织取决于假体植入的空间,乳腺下平面、筋膜下平面、胸大肌后平面或双平面,及植入入路,例如乳晕或乳房下或甚至腋下的入路。
最后,作为对所描述的结构的补充,本发明提出的乳房假体可以包括一个标记(10),设有用生物相容材料制成的不透射线的基座,优选情况下位于假体在下极所设的触觉标记之上,允许在任何时间通过常规放射学、乳房X光检查或扫描仪或超声等手段了解所述假体的位置。

Claims (4)

1.乳房假体,属于呈解剖形态的类型,基于硅盖和硅胶填充物和/或生理食盐水组成,其正面/背面的至少之一包括互补的构造物,采用与包盖(2-3)相同材料制成的条带的形式(5-8),条带牢固地接合到包盖,
其特征在于,所述条带在其一端设有一个为将固定假体固定至患者身体的组织而供缝合点通过的孔口。
2.根据权利要求1的乳房假体,其特征在于,设有四条固定条带,两根(5)位于包盖正面(2),两根(8)位于所述包盖的背面(3),所有条带(5-8)位于所述假体的下半部分。
3.根据前述权利要求中的乳房假体,其特征在于,所述固定条带(5-8)具备一个明显的矩形轮廓,长度为2厘米,宽度6至8毫米,并且通过生物粘合剂被固定至假体的所述包盖(2-3)。
4.根据权利要求1的乳房假体,其特征在于,包括一由不透射线的生物相容材料(例如钛)制成的第二标记,对应于这些假体下极包括的触觉标记。
CN201380064358.4A 2012-11-16 2013-11-11 乳房假体 Pending CN104837441A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ES201231778A ES2409691B1 (es) 2012-11-16 2012-11-16 Implante mamario
ESP201231778 2012-11-16
PCT/ES2013/070782 WO2014076339A1 (es) 2012-11-16 2013-11-11 Implante mamario

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CN104837441A true CN104837441A (zh) 2015-08-12

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US (1) US9750600B2 (zh)
EP (1) EP2921137A4 (zh)
CN (1) CN104837441A (zh)
BR (1) BR112015011082A2 (zh)
CO (1) CO7350629A2 (zh)
ES (1) ES2409691B1 (zh)
WO (1) WO2014076339A1 (zh)

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US10864661B2 (en) 2012-12-13 2020-12-15 Allergan, Inc. Device and method for making a variable surface breast implant
US10898607B2 (en) 2009-03-27 2021-01-26 Allergan, Inc. Bioerodible matrix for tissue involvement
US11202853B2 (en) 2010-05-11 2021-12-21 Allergan, Inc. Porogen compositions, methods of making and uses

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US10898607B2 (en) 2009-03-27 2021-01-26 Allergan, Inc. Bioerodible matrix for tissue involvement
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US10864661B2 (en) 2012-12-13 2020-12-15 Allergan, Inc. Device and method for making a variable surface breast implant

Also Published As

Publication number Publication date
WO2014076339A1 (es) 2014-05-22
ES2409691B1 (es) 2013-11-21
US9750600B2 (en) 2017-09-05
US20150313708A1 (en) 2015-11-05
EP2921137A4 (en) 2016-07-06
EP2921137A1 (en) 2015-09-23
CO7350629A2 (es) 2015-08-10
BR112015011082A2 (pt) 2017-07-11
ES2409691A1 (es) 2013-06-27

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Application publication date: 20150812