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Methods and compositions comprising biodegradable cyanoacrylates

A cyanoacrylate, biodegradable technology for non-polymeric organic compound adhesives, tissue regeneration, surgical adhesives, etc., which can solve problems such as lack of long-term integrity

Pending Publication Date: 2019-09-20
FEMASYS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is well known that lower alkyl cyanoacrylates tend to form brittle polymers that lack long-term integrity due to cracking

Method used

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  • Methods and compositions comprising biodegradable cyanoacrylates
  • Methods and compositions comprising biodegradable cyanoacrylates
  • Methods and compositions comprising biodegradable cyanoacrylates

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0160] Example 1: Biodegradable Cyanoacrylate Compositions at 52 Weeks in a Rabbit Fallopian Tube Implantation Study

[0161] This study involved the surgical delivery of the biodegradable cyanoacrylate compositions disclosed herein. A biodegradable cyanoacrylate composition is prepared, for example, by premixing all components, namely 0.42 g methoxypropyl cyanoacrylate (MPCA) and 0.18 g methoxyisopropyl cyanoacrylate (MIPCA ) to form cyanoacrylate component, stabilizer component (0.0004g SO 2 With 0.003g BHA (butylated hydroxyanisole)), a polymerization inhibitor, thereby forming a biodegradable cyanoacrylate composition. Sufficient quantities of the biodegradable cyanoacrylate composition were prepared and delivered into screened rabbit oviducts using a modified PICC-NATE catheter to simulate use in humans and test in situ polymerization in oviducts in vivo. The effects on animals during the presence and degradation of the biodegradable cyanoacrylate composition in the ovi...

Embodiment 2

[0164] Example 2: Cytotoxicity ISO 10993-5 Test

[0165] Determination of the potential biological response of mammalian cell cultures (mouse fibroblast L929) in response to exposure to extracts of a test article (test article) of a polymeric biodegradable cyanoacrylate composition as used in Example 1 sex. Test articles were extracted for 24±2 hours at 37±1° C. in minimal essential medium (MEM) with 10% fetal calf serum (referred to as complete MEM). Negative and positive controls were prepared similarly. In sextuplicate, the maintenance medium of L929 cells grown in 96-well plates was replaced with 100% (pure) extracts of test articles and controls, and cells were incubated at 37±1° C. for 24 to 26 hours. Cell viability after exposure to the extract was measured via the ability of the cells to take up the vital dye Neutral Red (NR). The dye is added to cells for active incorporation into living cells. The number of viable cells is correlated with the color intensity dete...

Embodiment 3

[0169] Example 3: Hysterectomy Preoperative Testing

[0170] Implantation of biodegradable cyanoacrylate compositions in human subjects was carried out under all appropriate protocols for human experiments. Human females undergoing hysterectomy are pretreated by providing a biodegradable cyanoacrylate composition to the cornea of ​​at least the fallopian tube using the devices disclosed herein. Use the following biodegradable cyanoacrylate compositions.

[0171] Biodegradable cyanoacrylate composition 100% by weight MCPA (cyanoacrylate component), BHA5000ppm (polymerization inhibitor component) and 2260SO 2 (stabilizer component).

[0172] Biodegradable cyanoacrylate composition 50% by weight MCPA and 50% by weight MIPCA (cyanoacrylate component), BHA 5000ppm (polymerization inhibitor component) and 2260SO 2 (stabilizer component).

[0173] Biodegradable cyanoacrylate composition 70% by weight MCPA and 30% by weight MIPCA (cyanoacrylate component), BHA 5000ppm (polymerizat...

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Abstract

Disclosed herein are methods of making and using cyanoacrylate compositions comprising one or more cyanoacrylates, a high level of at least one stabilizing agent and at least one free-radical polymerization inhibitor. Methods disclosed comprise making such compositions and using such compositions, for example, for occluding conduits such as fallopian tubes.

Description

[0001] related application [0002] This application claims priority and benefit from the filing date of US Provisional Patent Application Serial No. 62 / 456,916, filed February 9, 2017, which is hereby incorporated in its entirety. technical field [0003] The present disclosure relates to compositions and methods comprising cyanoacrylates for medical and veterinary use. Background technique [0004] Cyanoacrylates have been used as tissue adhesives in the medical and research fields. Cyanoacrylates known in the art are generally formulated for their intended use and may contain additives. Cyanoacrylates can be represented by the formula: [0005] [0006] wherein R is an alkyl group or other suitable substituent forming the ester component of the molecule. Such cyanoacrylates are disclosed in the following US Patent Nos.: 3,527,224; 3,591,676; 3,667,472; 3,995,641; 4,035,334; and 4,650,826, and the preparation of such compounds is known in the art. Typically, when us...

Claims

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Application Information

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IPC IPC(8): A61L24/00C09J4/00A61B17/00
CPCC09J4/00A61B17/12186A61L24/001A61L24/0042A61L24/043A61L24/06A61L2430/36C08F222/327C08L35/04A61B17/00491A61B2017/00513C08F222/32
Inventor K·李-谢普谢克
Owner FEMASYS INC
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