TWI439258B - 可變黏膠之形穩性胸部植入物 - Google Patents
可變黏膠之形穩性胸部植入物 Download PDFInfo
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- 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
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Description
本發明概言之係關於一醫用假體,且更具體而言係關於一可用於增大或再造胸部之可變黏膠之形穩性植入物。該植入物可為一乳房假體或一軟組織膨脹體。
當前,需要可植入醫用假體之胸部增大或再造程序在整形及再造性外科手術領域中已相當常見。經常選用於此等程序的永久型假體包括用聚矽氧凝膠填充的或在手術中用生理鹽水溶液填充的圓形聚矽氧殼體、或包層。
近年來,用於此等程序之假體已經在外科手術植入後保持胸部外形方面引起人們關注。在手術後追踪期間-在癒合期間-外科醫生經常會觀察到不期望的患者胸部外形變化,尤其是皮膚特徵及/或軟組織變形(即業內熟練的技術人員通常熟知之假體起皺、突球或成扇形)。該等不良影響通常發生於假體的上極及下極處、沿假體殼體的周邊或在基部,即最接近乳房下襞的下側部分,且當接受者改變其解剖學位置時此情況更加明顯。此外,對於處於直立位的患者,已知該等不穩定的假體會在上極處萎陷或打褶及在下極處突球,進一步增加胸部外形畸形的風險。為消除該等臨床問題,人們已推薦各種醫用假體,但胸部外形之不利變化依然存在。
如美國專利第6,605,116號中闡述,可植入乳房的假體一般而言具有一抵靠患者胸廓放置的相對較平的後側面及一向前突出的半球狀前側面。通常期望,周邊區域(前側面與後側面相連處)具有一相對小的曲率半徑,尤其在該假體的上極或上側部分(即當患者站立時最高的假體部分)。在假體上極中前側面與後側面之間的漸變部分較宜有相對較窄的曲率半徑,因為在如此情況下當植入假體時乳房組織與植入物之間可有相對平滑的漸變。但小的半徑有時會與皺褶的出現有關(該等皺褶在相對較小半徑的區域中自假體的周邊向內部延伸)。此情況有時稱為成扇形效應。當假體係用液體或凝膠填充且患者為直立位因而使填充材料的重量向下牽引至假體上時,往往會發生成扇形。皺褶經常會出現在假體的前側面處及圍繞假體周邊處。此在美觀上是不受歡迎的,因為該等皺褶有時可能會透過患者的外覆皮膚而被看得清清楚楚。
美國專利第5,480,430號係關於一可經外科手術植入皮下的液體填充的胸部假體,其具有適於在液體填充物移動期間抗變形或起皺的防皺彈性外殼體。該外殼體或包層具有上側部分及下側部分。該殼體上側部分之壁相對於該殼體下側部分之壁的厚度大為增厚的。該殼體可形成一具有一內部空腔的包層,其中填充有一生物相容性液體,例如鹽水。該殼體增厚的上側部分可防止胸部假體在液體移位期間(例如當胸部假體接受者改變其解剖學位置時)形成褶皺。該有差別地增厚的殼體具有一後基底部分,其尚可經增強以進一步穩定該假體。
美國專利申請案第US 2002/0143396 A1號(美國專利第6,605,116號)係關於增大半徑的乳房假體及軟組織膨脹體。該假體經構造以便該殼體在前側面與後側面相連的區域中之平均厚度大於(例如至少兩倍於)該殼體在前側面區域中的平均厚度。其發明人認為,此增強可沿該假體上部周邊減輕或消除原本在重力向下牽引至一經填充的假體上時可能會發生的不期望成扇形效應。
具有不同密度的植入物亦係業內已知者。舉例而言,Inamed's Style 510 Dual Gel胸部植入物包含兩種不同的黏膠劑。該植入物的後部係由標準黏膠製成,而前側係由高黏膠製成。此構造可提供優良的突起及支持,強化了植入物的乳頭/乳暈區。
迄今,不同密度的填充物僅被用於提供前側的突起。如本文所述,可將不同密度的黏膠填充物特別在周邊附近及在下側及後側區域用於穩定植入物,保持其形狀並減少或消除殼體的起皺、突球、成扇形或其他形變。
本發明之一目標係提供一可變黏膠之形穩性植入物,其具有保持外形特徵以維持形狀及減少或消除植入後可能出現於該等假體的上極或下極處、沿殼體的周邊或在基部的殼體起皺、突球、成扇形或形變之不希望效應。
本發明之另一目標係提供一種當接受者改變其解剖學位置時將保持其外形的假體。
現在可通過參照較佳實施例而明瞭本發明之該等及其他目標。
現在將詳細地參照本發明較佳實施例。然而,本發明可以許多種不同形式實施,而不應將其理解為僅限於本文所述實施例。另外,且如業內熟練的技術人員應瞭解,本發明可具體表現為一方法、系統或製程。
本發明植入物可用於增大或再造胸部。該可變黏膠之形穩性植入物(具有可維持形狀的保持外形特徵)之特徵在於凝膠填充劑之黏結性變化。該凝膠填充材料之可變的黏結性可由任一方式(即化學品、加工等等)加以改變。業內熟練的技術人員應瞭解,控制凝膠的化學配方可達成更強的機械性能。舉例而言,當形成更多交聯時,可產生更硬的凝膠,得到一形狀更穩定的植入物。
應注意,但本發明並不限於單個的殼體或包層。儘管使用黏膠可使對分開的腔的需求最小化,該假體可在其殼體內具有一單腔或多個腔。本發明可在具有平滑的或有紋理的外部殼體的植入物中使用。該殼體可為圓形、橢圓形、新月形或其他適宜形狀。其可由矽氧橡膠、各種形式之聚矽氧的層合板、聚矽氧共聚物、聚胺酯、及呈各種組合形式的各種其他彈性體。該凝膠黏結性可隨該假體之增加的體積或尺寸而增強。
儘管圖1至圖5中提供了本發明實例,一業內熟練的技術人員應理解,凝膠形狀及聚結組態可有變化而不背離本發明之範圍。
如圖1中所示,本發明假體之一實施例包括一圓形可植入殼體或包層及一位於植入物周邊或外緣處的具有較高程度黏結性之凝膠填充劑。
圖2中顯示本發明假體之另一實施例,其包括一圓形可植入殼體或包層及一位於植入物下側部分的具有較高程度黏結性之凝膠填充劑,該填充劑具有一朝向該植入物上側方向漸減的梯度。
現在參照圖3,其顯示本發明假體之另一實施例,其包括一解剖學外形的可植入殼體或包層及一凝膠填充劑,其中該凝膠係經形成而使黏結性在該植入物基部(即後側部分)處較大、朝向該植入物之尖端或最突出處(即前側部分)漸減。
圖4顯示本發明假體之又一實施例,其包括一解剖學外形的殼體或包層及一凝膠填充劑,其中該凝膠係經形成而使黏結性在植入物的下側方向較大、在水平層中朝向該植入物的上側方向漸減。
圖5顯示本發明假體之再一實施例,其包括一解剖學外形的殼體或包層及一凝膠填充劑,其中該凝膠係經形成而使黏結性在植入物的下側方向較大、在傾斜層中朝向該植入物的上側方向漸減。
業內熟練的技術人員將易知,可在本發明及本文提供的具體實例中實施各種修改及改變而不背離本發明之精神或範圍。因此,本發明意欲涵蓋屬於任一權利要求及其等效內容之範圍的本發明修改及改變。
所包括附圖旨在提供對本發明之進一步理解,其併入並構成本說明書之一部分,該等附圖顯示本發明之實施例並與本說明一起用於解釋本發明之原理。在該等圖中,凝膠黏結性(交聯)程度藉由陰影指示,即越暗的陰影指示越高的黏結性。在該等附圖中:圖1為根據一本發明態樣製造的一圓形胸部假體之前視圖;圖2為根據本發明另一態樣製造的一圓形胸部假體的前視圖;圖3為根據本發明又一態樣製造的一解剖學外形的胸部假體剖面側視圖;圖4為根據本發明製造的另一解剖學外形的胸部假體剖面側視圖;及圖5為根據本發明製造的又一解剖學外形的胸部假體剖面側視圖。
Claims (8)
- 一種形穩性胸部植入物,其包括:一彈性殼體,其適用於植入人體胸部;及複數種包含於該彈性殼體內之黏膠填充劑,其具有至少兩種不同程度之凝膠黏結性,且形成該植入物之後側部份及前側部份,其中該植入物之後側部份界定一基部而該植入物之前側部份界定一尖端;其中該凝膠黏結性自該植入物之後側部份朝向該植入物之前側部份呈垂直層之梯度漸減。
- 如請求項1之形穩性植入物,其中該凝膠黏結性在該植入物的後側部份最大。
- 如請求項1之形穩性植入物,其中該植入物為乳房植入物。
- 如請求項1之形穩性植入物,其中該植入物為軟組織膨脹體。
- 如請求項1之形穩性植入物,其中該彈性殼體係有紋理的。
- 如請求項1之形穩性植入物,其中該植入物具有解剖學外形。
- 如請求項1之形穩性植入物,其進一步包含至少一個內腔。
- 如請求項1之形穩性植入物,其中該不同程度之凝膠黏結性係藉由該黏膠填充劑不同程度之化學交聯所界定。
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US73055905P | 2005-10-26 | 2005-10-26 |
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TW200726451A TW200726451A (en) | 2007-07-16 |
TWI439258B true TWI439258B (zh) | 2014-06-01 |
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US (3) | US8070808B2 (zh) |
EP (2) | EP2286761B1 (zh) |
JP (1) | JP5102216B2 (zh) |
AR (1) | AR058497A1 (zh) |
AU (1) | AU2006306193B2 (zh) |
BR (1) | BRPI0617789A2 (zh) |
CA (1) | CA2626399A1 (zh) |
DK (1) | DK1940317T3 (zh) |
ES (2) | ES2421934T3 (zh) |
TW (1) | TWI439258B (zh) |
WO (1) | WO2007050693A1 (zh) |
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DE2819968A1 (de) * | 1978-05-08 | 1979-11-15 | Hans B Bauerfeind | Brustprothese |
US4470160A (en) * | 1980-11-21 | 1984-09-11 | Cavon Joseph F | Cast gel implantable prosthesis |
US4298998A (en) * | 1980-12-08 | 1981-11-10 | Naficy Sadeque S | Breast prosthesis with biologically absorbable outer container |
DE3440960A1 (de) * | 1984-10-13 | 1986-04-24 | S + G Implants GmbH, 2400 Lübeck | Prothese als ersatzfuer eine amputierte brust |
US4701230A (en) * | 1985-07-18 | 1987-10-20 | Nearly Me | Method for manufacturing a breast prosthesis |
US4790848A (en) * | 1987-11-27 | 1988-12-13 | Dow Corning Wright | Breast prosthesis with multiple lumens |
US5480430A (en) * | 1993-06-04 | 1996-01-02 | Mcghan Medical Corporation | Shape-retaining shell for a fluid filled prosthesis |
WO1996000048A1 (en) * | 1994-06-23 | 1996-01-04 | Janice Marie Thielbar | Custom formed natural fit artificial breast appliance |
US5545217A (en) * | 1995-04-20 | 1996-08-13 | C.M. Offray & Son, Inc. | Breast implant |
DE29607969U1 (de) * | 1996-05-02 | 1996-06-20 | "Amoena" Medizin-Orthopädie-Technik GmbH, 83064 Raubling | Brustprothese |
US5824081A (en) | 1996-09-13 | 1998-10-20 | Lipomatrix Incorporated | Hydraulic foam tissue implant |
US5902335A (en) * | 1997-10-01 | 1999-05-11 | Capital Marketing Technologies, Inc. | Multiple section breast prosthesis |
CN2389638Y (zh) * | 1999-09-07 | 2000-08-02 | 曹孟君 | 聚丙烯酰胺水凝胶乳房假体 |
US6605116B2 (en) | 2001-04-03 | 2003-08-12 | Mentor Corporation | Reinforced radius mammary prostheses and soft tissue expanders |
ES2190339B1 (es) * | 2001-05-07 | 2004-11-01 | Ricardo Gonzalez De Vicente | Protesis para mama. |
-
2006
- 2006-10-25 ES ES10181933T patent/ES2421934T3/es active Active
- 2006-10-25 EP EP10181933.2A patent/EP2286761B1/en not_active Not-in-force
- 2006-10-25 CA CA002626399A patent/CA2626399A1/en not_active Abandoned
- 2006-10-25 BR BRPI0617789-1A patent/BRPI0617789A2/pt not_active IP Right Cessation
- 2006-10-25 JP JP2008537913A patent/JP5102216B2/ja active Active
- 2006-10-25 DK DK06817372.3T patent/DK1940317T3/da active
- 2006-10-25 EP EP06817372A patent/EP1940317B1/en not_active Not-in-force
- 2006-10-25 US US11/586,134 patent/US8070808B2/en active Active
- 2006-10-25 ES ES06817372T patent/ES2389378T3/es active Active
- 2006-10-25 WO PCT/US2006/041642 patent/WO2007050693A1/en active Application Filing
- 2006-10-25 AU AU2006306193A patent/AU2006306193B2/en not_active Ceased
- 2006-10-26 AR ARP060104684 patent/AR058497A1/es not_active Application Discontinuation
- 2006-10-26 TW TW95139583A patent/TWI439258B/zh not_active IP Right Cessation
-
2011
- 2011-11-03 US US13/288,596 patent/US20120143328A1/en not_active Abandoned
-
2013
- 2013-09-13 US US14/027,005 patent/US8858630B2/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
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EP2286761B1 (en) | 2013-07-03 |
US20120143328A1 (en) | 2012-06-07 |
JP5102216B2 (ja) | 2012-12-19 |
US20070135916A1 (en) | 2007-06-14 |
EP1940317B1 (en) | 2012-06-13 |
US8858630B2 (en) | 2014-10-14 |
TW200726451A (en) | 2007-07-16 |
AR058497A1 (es) | 2008-02-06 |
AU2006306193B2 (en) | 2013-07-04 |
EP1940317A1 (en) | 2008-07-09 |
AU2006306193A1 (en) | 2007-05-03 |
ES2389378T3 (es) | 2012-10-25 |
DK1940317T3 (da) | 2012-08-20 |
BRPI0617789A2 (pt) | 2011-08-09 |
EP2286761A1 (en) | 2011-02-23 |
US8070808B2 (en) | 2011-12-06 |
US20140012377A1 (en) | 2014-01-09 |
WO2007050693A1 (en) | 2007-05-03 |
JP2009513261A (ja) | 2009-04-02 |
ES2421934T3 (es) | 2013-09-06 |
CA2626399A1 (en) | 2007-05-03 |
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