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Submucosal cushioning agent

A technology of swelling agent and mucous membrane, which is applied in the field of polysaccharides with pseudoplastic fluidity as its material, and can solve problems such as high viscosity and difficulty in injection

Inactive Publication Date: 2014-07-30
CHUGAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In general, clinically, an injection needle for an endoscope can be used with an outer diameter of more than 21G (as the value increases, the actual size of the outer diameter becomes smaller) and an effective length of the needle tube is usually more than 1000mm, but this The viscosity of the local injection for endoscope is too high, and it is difficult to inject into the submucosa with a standard injection needle for endoscope with a needle diameter of 21G and a needle length of more than 1000mm

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] The injection pressure was measured for the following injections. The method for measuring the injection pressure is as described in the "Method for Measuring the Injection Pressure of Protruding Agent" on page 6 above. Among them, the injection needles for endoscopes were measured using the following two types. It was also confirmed that it is difficult to inject the injection by hand in practice.

[0076] Endoscope injection needle 1: A puncture needle for an endoscope with a needle diameter of 23G and an effective length of the needle tube of 1600 mm (Top endoscope puncture needle for upper gastrointestinal high-flow type, manufactured by Top)

[0077] Endoscope injection needle 2: Endoscope puncture needle with a needle diameter of 23G and an effective length of the needle tube of 1650 mm (disposable injection needle DNM NM-400L-0423, manufactured by OLYMPUS)

[0078] (Preparation example of injection)

[0079] Xanthan gum (KELTROL, CGT, manufactured by CP Kelco) (hereina...

Embodiment 2

[0089] Xanthan gum performance

[0090] Xanthan gum (KELTROL, CGT, manufactured by CP Kelco) (hereinafter referred to as "XG") was dissolved in water for injection to prepare a 1w / v% aqueous solution. The 1 w / v% XG aqueous solution was diluted with water for injection to prepare 0.2 to 1 w / v% (concentration described in Table 3) aqueous solution. Each aqueous solution was enclosed in a vial, and the liquid after autoclaving at 121°C for 20 minutes was used as each injection. In addition, 1w / v% sodium hyaluronate (hereinafter, sodium hyaluronate abbreviated as "HA") injection (Artz intra-articular injection 25mg, manufactured by Seikagaku Kogyo) was diluted with 0.9% sodium chloride aqueous solution to prepare 0.2~ A solution of 1 w / v% (concentration described in Table 3) was used as each comparative solution. The viscosity (cP) and injection pressure (kgf) were measured for each injection and each comparative liquid. The injection pressure (kgf) was measured according to the m...

Embodiment 3

[0096] Comparison experiment of mucosal eminence

[0097] Xanthan gum (KELTROL, CGT, CP Kelco) (hereinafter referred to as "XG") was dissolved in phosphate buffered saline (pH 7.4, osmotic pressure ratio of 1) (hereinafter referred to as "PBS") to prepare 1w / v% XG in PBS. Dilute the 1w / v% XG PBS solution with PBS to prepare 0.5w / v% XG and 0.25w / v% XG PBS solutions. The XG PBS solution of each concentration was sealed in a vial, and the liquid after autoclaving at 121°C for 20 minutes was used as each injection. The pH, osmotic pressure ratio, viscosity (cP) and injection pressure (kgf) were measured for each injection and 0.4w / v% solution (MucoUp, manufactured by Seikagaku Kogyo). The injection pressure (kgf) was measured according to the method described in "Method for Measuring the Injection Pressure of Heave Agent" on page 6 above. Among them, as an injection needle for an endoscope, a puncture needle for an endoscope (disposable injection needle DNM NM-400L-0423, manufactu...

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Abstract

In order to improve the resection efficiency, operability, and safety of endoscopic mucosal resection operations, a method has conventionally been employed wherein a cushioning agent such as physiological saline is injected into the layer below the area designated for resection, causing the lesion to lift and protrude (hereafter simply referred to as "protrusion"), after which the lesion is removed. It is difficult to accurately remove the intended area using conventional cushioning agents because applying pressure to the protrusion tends to cause deformation thereof, the degree of protrusion is low, and the cushioning agent diffuses immediately after injection into the peripheral tissue, thereby causing the protrusion to disappear. The present invention solves these problems by employing a polysaccharide having a pseudoplastic viscosity such as xantham gum, carrageenan, gellan gum, guar gum, locust bean gum, sacran, or the like as a cushioning agent.

Description

Technical field [0001] The present invention relates to a material (protruding agent) injected into the submucosa in order to swell the mucosal tissue when the mucosal tissue such as the digestive tract is excised under an endoscope. It relates to the use of xanthan gum and other polysaccharides with pseudoplastic fluidity as Its material. Background technique [0002] Clinically, laparotomy is not performed but a method of endoscopic removal of lesions such as polyps or small tumors formed on the gastrointestinal mucosa such as the stomach or intestines (endoscopic mucosal resection). At this time, the mucosal lesions are not clearly protruding, and the mucosal surface is easy to slide. Therefore, when performing endoscopic examinations while remotely removing the lesions, there are corresponding technical difficulties and there are also lesions. The residual and / or bleeding, perforation and other serious events. [0003] In the past, in order to improve the resection efficiency...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/00
CPCA61L31/042A61L31/14A61L31/145A61L2400/06C08L5/00
Inventor 西冈步
Owner CHUGAI PHARMA CO LTD
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