Low swell tissue adhesive and sealant formulations

Inactive Publication Date: 2016-06-30
ACTAMAX SURGICAL MATERIALS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0005]The present disclosure is directed to a hydrogel tissue adhesive and sealant that has good adhesion and cohesion properties, crosslinks readily at body temperature, does not degrade

Problems solved by technology

Conventional tissue adhesives are generally not suitable for a wide range of adhesive applications.
For example, cyanoacrylate-based adhesives have been used for topical wound closure, but the release of toxic degradation products limits their use for internal applications.
Fibrin-

Method used

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  • Low swell tissue adhesive and sealant formulations

Examples

Experimental program
Comparison scheme
Effect test

examples

[0116]The present invention is further defined in the following Examples. It should be understood that these Examples, while indicating preferred embodiments of the invention, are given by way of illustration only. From the above discussion and these Examples, one skilled in the art can ascertain the essential characteristics of this invention, and without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various uses and conditions.

[0117]Reagent Preparation

[0118]Preparation of Dextrans Having Pendant Aldehyde Groups (AFD-15-177-15% and AFD-10-216-94%).

[0119]Dextran containing pendant aldehyde groups and having a weight-average molecular weight of about 10 kDa to about 15 kDa, an equivalent weight per aldehyde group of about 177, and a degree of aldehyde substitution of about 115% was prepared using a two-step procedure. In the first step, dextran having an average molecular weight of about 8.5-11.5 kDa was reacte...

examples 1-5

Low Swell Hydrogels

[0136]The purpose of these Examples was to demonstrate the low swell property of the hydrogels disclosed here.

[0137]Hydrogels were formed by mixing two aqueous solutions, the first aqueous solution containing the aldehyde-functionalized dextran (AFD-15-177-115%) and 300 ppm of FD&C Blue #1 dye, and the second aqueous solution containing a polyethylene glycol amine (P8-10-1). The two aqueous solutions were mixed using a dual barrel syringe with a 16 stage mixing tip (MEDMIX SYSTEMS AG, Rotkreuz, Switzerland). The concentrations of the aqueous solutions used are given in Table 1. The resulting mixture was injected directly into a piece of plastic tubing having an internal diameter of about 4 mm. After gelation, the hydrogel was removed from the tubing by slitting the tubing open. The resulting cylindrical hydrogel was cut into pieces having a length of approximately 10 mm and each piece was placed inside a separate piece of plastic tubing, which had an internal diam...

example 6

In Vivo Adhesion Prevention in a Rabbit Laminectomy Model

[0141]The compositions of the present disclosure were tested to determine their effectiveness in preventing the formation of deleterious fibrous tissues in a Rabbit Laminectomy study. Two low swell compositions (i.e., Examples 1 and 5) were evaluated for adhesion prevention in a rabbit dorsal laminectomy model.

[0142]Aqueous solutions of AFD-15-177-115% (10 wt % and 15 wt %) and P8-10-1 (15 wt / o) were prepared and sterilized as follows. The appropriate weight of each component was calculated and adjusted for moisture content (as measured using a Mettler Toledo HB43-S moisture analyzing balance). This amount was weighed into a glass vessel and the calculated weight of water was added. A volume of a stock solution of FD&C Blue #1 dye was added to each of the AFD-15-177-115% solutions to give a final concentration of 300 ppm. The resulting solutions were capped and placed on a shaker incubator at 170 rpm and 40° C. until the compo...

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Abstract

A hydrogel tissue adhesive formed by reacting an aldehyde-functionalized dextran containing pendant aldehyde groups with a multi-arm polyethylene glycol amine is described. The hydrogel exhibits little to no swell upon exposure to physiological conditions. The hydrogel may be useful as a tissue adhesive or sealant for medical applications that require a low swell hydrogel to inhibit complications, such as fibrosis, including scar formation or surgical adhesions.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a national stage application filed under 35 USC 371 of PCT / US2014 / 048459, filed Jul. 28, 2014, which claims the benefit of U.S. Provisional Application No. 61 / 859,458, filed Jul. 29, 2013 the contents of which are incorporated by reference herein.FIELD OF THE INVENTION[0002]The present disclosure relates to the field of medical adhesives. More specifically, the present disclosure relates to a hydrogel tissue adhesive formed by reacting an aldehyde-functionalized dextran containing pendant aldehyde groups with a multi-arm polyethylene glycol amine.BACKGROUND OF THE INVENTION[0003]Tissue adhesives have many potential medical applications, including wound closure, supplementing or replacing sutures or staples in internal surgical procedures, preventing leakage of fluids such as blood, bile, gastrointestinal fluid and cerebrospinal fluid, adhesion of synthetic onlays or inlays to the cornea, drug delivery devices, and as a...

Claims

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Application Information

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IPC IPC(8): A61L24/04A61L24/00
CPCA61L24/0031A61L24/046A61L24/043A61L2400/06C08L5/02C08L71/02
Inventor JENKINS, LAURI L.DILUCCLO, ROBERT C.
Owner ACTAMAX SURGICAL MATERIALS
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