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密封技術

Vascutek 使用独特的已获得专利的改良性牛膠注入技术,於全球已有逾 15 年的臨床經驗。這些產品經 Vascutek 的 100% 多孔性測試。

1983-gelatin-sealant-chinese

除了密封的主要功能外,此注入技術亦具備多項其他重要功能。與其他密封劑不同,其於 14 天內 透過非酶糖基化機制水解,不會引起長期的炎症反應2。此降級的資料讓未受損傷的組織融入移植的 母體3,4

凝膠密封技術的其他优点

低凝血活性/肝素結合*

凝膠已被證實有低凝血活性4,5。在測試狀況下,与非注入性聚酯6 及骨膠原密封聚酯相比7,密封的聚酯吸引較少的血小板。其亦可被動地吸收肝素*(以簡單的浸泡技術),於物料表面提供短期高局部集中性。這在關鍵的手術後期提供更多的主動凝血抵抗性,於低流量情況尤其适用8

肝素與 Vascutek 獨特凝膠的結合已取得 CE dossier 的批准15

抗生素結合*

Vascutek 凝膠已被證實是離子結合抗生素 利福平(Rifampicin)* 的理想密封劑9。此技術可減少手術後的移植感染10狀況。簡單的結合程序於高風險個案中10,11特別有用,包括更換受感染的移植物12, 利福平凝膠的組合可承受動脈壓力及流量13。与銀及骨膠原涂层移植物14相比,Vascutek Rifampicin* 結合移植物在阻止細菌感染方面已被证实更为有效。


利福平* 與 Vascutek 凝膠結合已取得 CE dossier 的批准15,并发表于 35 本相关刊物且擁有 10 年經驗。 刊物按要求提供。


註:* 這些肝素及利福平的應用並未獲 FDA 批准於美國使用或 TPD 批准於加拿大使用

參考資料(點按以放大) 

1. US Patent No: 4,747,848

2. Vohra R, et al.
Sealed Versus Unsealed Knitted Dacron® Prosthesis: A Comparison of the Acute Phase Protein Response.
Annals of Vasc Surg. (1987) I: 548-551

3. Jonas R A, et al.
Unsatisfactory Clinical Experience with a Collagen-Sealed Knitted Dacron® Extracardiac Conduit.
Journal of Cardiac Surgery. (1987), Vol 2, No 2, 257-264

4. Harasaki H. et al.
Blood-Blood Pump Surface Interaction.
Ch 9 Biocompatible Polymers, Metals and Composites, ed. M. Szycher, Technomic (1983)

5. Gloviczki P. et al.
Experimental Evaluation of Bleeding Complications, Thrombogenicity and Neointimal Characteristics of Prosthetic Patch Materials Used for Carotid Angioplasty.
Cardiovascular Surgery (1996), Vol. 4, No 6, 746-752

6. Drury J.K. et al.
Experimental and Clinical Experience with a Gelatin Impregnated Dacron® Prosthesis.
Ann. Vasc Surg (1987);5; 542-547

7. Safepharm Report on Thrombogenicity (Data available on request)

8. Data on file at Vascutek Ltd.

9. Ashton T. et al.
Antibiotic Loading of Vascular Grafts
16th Annual Meeting of the Society for Biomaterials, May 1990, Charleston, USA

10. Strachan C.J.L. et al.
The Clinical Use of an Antibiotic-Bonded Graft.
Eur J Vasc Surg (1991), 5, 627-632

11. Strachan C.J.L. et al.
Prosthetic Graft Infection.
Critical Ischaemia (1993), Vol 2. No 3, 5-16

12. Naylor A R et al.
Treatment of Major Aortic Graft Infection: Preliminary Experience with Total Graft Excision and In Situ Replacement with a Rifampicin Bonded Prosthesis.
Eur J Vasc Endovasc Surg. (1995), 9, 252-256

13. Braithwaite B.D. et al.
Early Results of a Randomized Trial of Rifampicin-Bonded Dacron Grafts for Extra-Anataomic Vascular Reconstruction

British Journal of Surgery 1998; 85; 1378-1381

14. Goëau-Brissonnière, Olivier et al.
Comparison of the Resistance to Infection of Rifampicin Bonded Gelatin-Sealed and Silver/Collagen-Coated Polyester Prostheses.

Journal of Vascular Surgery 2002; vol 35, No 6; 1260-1263

15. Rinsing of Gelatin Sealed Prostheses with Rifampicin and/or Heparin BSI EQ# 10020927

所有臨床文件可按要求提供。

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