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Reinforced absorbable multi-layered fabric for hemostatic applications

一种吸收性、织物的技术，应用在吸收性多层止血器领域，能够解决没有描述出或提出具有止血功能等问题

Active Publication Date: 2013-01-23
ETHICON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, none of the above references describe or suggest such a nonwoven double layer fabric with hemostatic function

Method used

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  • Reinforced absorbable multi-layered fabric for hemostatic applications

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0022] Double layer matrix of example 1-PGLA

[0023] Poly(glycolide-lactide) copolymer (PGLA, 90 mol / 10 mol) was melt spun into PGLA copolymer fibers. The multifilament yarns from PGLA copolymer fibers were consolidated, crimped, and cut into staple fibers having a length of 2.0 inches. The staple fibers were carded to produce a nonwoven batt, which was then pressed to a thickness of about 1.0 mm and a density of about 60 mg / cc. A second nonwoven batt was prepared by a similar procedure, which was then pressed to a thickness of about 1.0 mm and a density of about 120 mg / cc. Two nonwovens with densities of 60 mg / cc and 120 mg / cc were then needle punched into each other to fix the nonwoven bilayer matrix.

example 2

[0024] Example 2 Double layer matrix for hemostasis in spleen model

[0025] A mild to moderate bleeding model was prepared by making an incision 15 mm long and 3 mm deep in the pig spleen. The bilayer matrix as described in Example 1 was then applied to the surgical site and packed for two minutes. The haemostatic effect was checked within 30 seconds after two minutes of tamponade. If no self-bleeding was observed within 30 seconds, the time to hemostasis was recorded. If self-bleeding is observed, pack for an additional 30 seconds until hemostasis is achieved or until the test period reaches ten minutes (this is defined as hemostatic failure). Three test samples measuring 2.5 x 4.0 cm were cut from the bilayer matrix prepared according to Example 1, and all three test samples achieved hemostasis within 5.62 ± 0.76 minutes (Table 1).

[0026] Table 1. Hemostasis of PGLA bilayer matrix in spleen model

[0027] Sample serial number

example 3

[0029] In vitro tests were used to characterize the mechanical properties of the bilayer matrices prepared according to Example 1. Cut the bilayer matrix into strips (approximately 3 / 8 inch wide by 2 inches long). The tensile strength of the bilayer matrix was then evaluated using an Instron tensile tester under dry and wet conditions. Under wet conditions, strips were placed in conical tubes containing PBS buffer at pH 7.4 at 37°C. The tensile strength of the strips was then measured at 90 minutes, 4 days, 7 days, 11 days and 14 days. The measured values ​​of the tensile strength of the tapes of the bilayer matrix are shown in Table 2.

[0030] Table 2. Tensile Strength of Bilayer Substrates in Dry and Wet Conditions

[0031]

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PUM

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Abstract

The present invention is directed to a synthetic fabric comprising a multi-layered nonwoven fabric made from staples of a polyglycolide / polylactide copolymer, each layer having a different density. The multi-layer fabric can be used as a reinforced absorbable hemostat medical device.

Description

technical field [0001] The present invention relates to a reinforced absorbent multilayer hemostat useful as a construction for use as a medical device. Background technique [0002] In surgery, control of bleeding is vital and critical to improve surgical outcomes and shorten the duration of surgery in the operating room. A variety of hemostatic materials, including oxidized cellulose-based materials, have been used as dressings in a variety of surgical procedures, including neurosurgery, abdominal surgery, cardiovascular surgery, thoracic surgery, head and neck surgery, pelvic surgery, and skin and subcutaneous tissue surgery. [0003] The use of multiple layers of fabrics in connection with medical procedures is generally accepted. For example, multilayer fabrics are used as general purpose pads, wound dressings, surgical meshes (including hernia repair meshes, anti-adhesion meshes, and tissue reinforcement meshes), defect closure devices, and hemostats. [0004] U.S. P...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61F13/00
CPCA61L2400/04D04H1/46A61L2300/418B32B2262/0276D04H1/44A61L15/44A61B2017/00526D04H1/55D04H1/498B32B2305/18A61L31/00A61L15/62B32B2535/00A61B17/06166A61B17/064A61L15/26B32B5/26A61B2017/00004A61L27/00B32B7/08D04H1/74D04H1/435D04H1/4374B32B5/022B32B5/06B32B2307/72B32B2307/732Y10T428/24967Y10T428/24992C08L67/04
Inventor O.莫罗耶-奥拉比西D.S.谢蒂R.W.范霍尔滕D.钟
Owner ETHICON INC
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