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Mucosal tissue dressing and method of use

a technology of mucosal tissue and dressing, which is applied in the direction of bandages, dermatological disorders, drug compositions, etc., can solve the problems of nausea, post-operative bleeding, and children's general inability to eat solid food, and achieve the effect of reducing or eliminating pain

Inactive Publication Date: 2010-06-17
ACCLARENT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for reducing pain after surgical procedures related to mucosal tissue, such as tonsillectomy and adenoidectomy. The invention includes a biodegradable film or covering that serves as a mechanical barrier to reduce pain caused by friction between solid food and healing tissue in the first few days after surgery. The invention also includes a method of treating healthy tissue proximate an injury site to increase the adhesion between such tissue and a tissue dressing. The tissue dressing may contain different therapeutic substances to locally reduce pain, facilitate healing, and / or otherwise treat mucosal tissue. The tissue dressing may be applied to areas other than a tonsil bed, such as a nasal septum, for various functions like treating sleep apnea or covering or plugging cerebrospinal fluid leaks.

Problems solved by technology

Both tonsillectomy and adenoidectomy are associated with considerable post-operative pain that may often last as long as two weeks.
Due to this post-operative pain, which is most severe when trying to swallow food, children typically cannot eat solid food for at least two days after surgery and often for as long as six days after surgery.
In addition to post-operative pain, children also commonly suffer from post-operative bleeding, nausea, and / or bad breath after tonsillectomy / adenoidectomy.
Although tonsillectomy and adenoidectomy are performed less commonly on adults, the procedures cause similar post-surgical pain and discomfort in adult patients.
Generally, surgical procedures on mucosal tissue, such as tonsillectomy and adenoidectomy, present several post-operative challenges.
Mucosal tissue is typically very delicate and difficult to bandage.
Damaged mucosal tissue can produce significant patient discomfort.
However, even using the Coblation Tonsillectomy procedure or other less invasive procedures, post-operative pain and bleeding are still significant for many children and adult patients, often preventing them from eating food for days after their surgeries.
To date, no satisfactory post-operative treatments have been developed to alleviate this pain and to allow patients to comfortably eat after tonsillectomy and adenoidectomy procedures.

Method used

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  • Mucosal tissue dressing and method of use
  • Mucosal tissue dressing and method of use
  • Mucosal tissue dressing and method of use

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0119]In this example, dressings were made from films composed of modified cellulose.

[0120]Method—all the raw materials are prepared into solutions in certain concentrations respectively; then the solutions are coated on a PTFE sheet individually or in mixture with single or double layers to make different films.

[0121]1. Raw Materials

[0122]Polypropylene glycol (PPG), Alfa Aesar Cat# 40811, Lot#K28Q011, used as received.

[0123]DI water was prepared on site by DI water generation system.

[0124]The following raw materials are prepared into solutions for use:

[0125]Ethanol, Aldrich Cat# 493546-1 L, Lot# 06862EH

[0126]Ethyl cellulose (EC), Spectrum Cat# ET110, Lot# UT0371

[0127]Methyl cellulose (MC), Aldrich Cat# M0555-100G, Lot# 037K00611

[0128]Hydroxypropyl methyl cellulose (HPMC), Aldrich Cat# H3785-100G, Lot# 086K0115.

[0129]2. Solution Preparation

[0130]Ethyl Cellulose Solution Preparation

[0131]Composition: 20 wt % ethyl cellulose (EC) in USP grade ethanol.

[0132]Example: 37.5 g EC in 150 g ...

example 2

[0210]Film Adhesion Strength Test

[0211]For the evaluation of the adhesion strength of oral wound dressing film samples, An apparatus was set up, which can be used to evaluate the film samples for their adhesion performances. Two types of adhesion strength, i.e., lift-off strength and peel-off strength, can be measured through the use of the apparatus.

[0212]1. Lift-off Adhesion Strength Test Setup and Procedures

[0213]By measuring the vertical detaching force and time, the lift-off adhesion strength of the film adhering to fresh pork steak can be tested. The test apparatus 1600 is set up as shown in FIG. 16. Tests are performed at room temperature, 23 deg. C. The procedures are described below:

[0214]1) Cut a sample film 1610 in a certain size, e.g., 15×15 mm2;

[0215]2) Use superglue to fix a fresh, boneless pork steak 1620 to the bottom of a dish;

[0216]3) Use Scotch tape to fix the string at the center of sample (for single-layer film) or sample protective layer (for double-layer film)...

example 3

[0232]In this example, films were tested for properties desirable in a dressing. The set time, or the time it takes for a hydrogel to form, was measured for each of the adhesion films. Carboxymethyl cellulose performed better than hydroxypropyl methyl cellulose, which in turn performed better than methyl cellulose. All adhesion films and the barrier film displayed good flexibility and lack of swelling. All adhesion films and the barrier film remained intact in artificial saliva. In degradation testing, after 5 days the carboxymethyl cellulose film was 70% degraded, the hydroxypropyl methyl cellulose film was 40% degraded, the methyl cellulose film was 25% degraded, and the barrier films was 15% degraded. All degradation values are given by weight.

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Abstract

A method and apparatus for reducing or eliminating pain after surgical procedures related to mucosal tissue, including tonsillectomy, adenoidectomy, or other pharyngeal operations. Certain embodiments provide a biodegradable film or covering that serves as a mechanical barrier to reduce pain caused, for example, by friction between solid food and healing tissue in the first few days after surgery. Some embodiments include a method for increasing the adhesion between tissue and the film or covering.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation-in-part of U.S. application Ser. No. 12 / 341,315, filed Dec. 22, 2008, which is herein incorporated by reference in its entirety.BACKGROUND OF THE INVENTION[0002]Tonsillectomy and adenoidectomy are two of the most common surgical procedures performed on children. Both tonsillectomy and adenoidectomy are associated with considerable post-operative pain that may often last as long as two weeks. Due to this post-operative pain, which is most severe when trying to swallow food, children typically cannot eat solid food for at least two days after surgery and often for as long as six days after surgery. In addition to post-operative pain, children also commonly suffer from post-operative bleeding, nausea, and / or bad breath after tonsillectomy / adenoidectomy. Although tonsillectomy and adenoidectomy are performed less commonly on adults, the procedures cause similar post-surgical pain and discomfort in adult pati...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61F13/02A61B18/18
CPCA61L15/42Y10T156/10A61L15/58A61L15/64A61L26/0061A61L26/0066A61L26/009A61L2300/402A61L2300/406A61L2300/41A61L2300/608A61F13/00017A61F2013/00357A61L26/0023A61L15/44A61P17/00A61K9/006A61F13/01017
Inventor MAKOWER, JOSHUACHANG, JOHN Y.MUNI, KETAN P.CARLYLE, WENDALEVINE, HOWARDFACTEAU, WILLIAM M.
Owner ACCLARENT INC
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