An assembly for the preparation of a medical device having a coating comprising hydrogen peroxide

A hydrogen peroxide, medical device technology, applied in the field of hydrophilic coating, medical use, can solve the problem of hydrogen peroxide stability, etc.

Active Publication Date: 2006-03-29
COLOPLAST AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Said US patent does not address the stability of hydrogen peroxide present in hydrophilic coatings

Method used

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  • An assembly for the preparation of a medical device having a coating comprising hydrogen peroxide
  • An assembly for the preparation of a medical device having a coating comprising hydrogen peroxide
  • An assembly for the preparation of a medical device having a coating comprising hydrogen peroxide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0205] Example 1 - Preparation of Catheter Coated with Polyvinylpyrrolidone

[0206]A urinary catheter with a hydrophilic coating of polyvinylpyrrolidone can be prepared as follows:

[0207] a) Prepare first and second solutions of high molecular weight polyvinylpyrrolidone (PVP) (for example, Plasdone K-90) dissolved in N-methylpyrrolidone (NMP), ethanol and Citrofol A1 including photoinitiator in solvent / plasticizer mixtures. The PVP content of the solution is in the range of 1-8% (w / w). The first and second solutions may be the same.

[0208] b) Soak the polyurethane raw catheter in the first solution and let it dry at room temperature for 10-120 seconds.

[0209] c) Soak the resulting catheter in a second solution of PVP.

[0210] d) Further drying the catheter at higher temperature (eg, at 70-80°C).

[0211] e) crosslinking the PVP by exposing the coated conduit to UV light in the wavelength range of 200nm-300nm for 1 / 2-15 minutes.

[0212] f) Place the cross-linked...

Embodiment 2

[0214] Example 2 - Preparation of Catheters Comprising Hydrogen Peroxide

[0215] The preparation of a sterile catheter with a hydrophilic coating comprises the following steps:

[0216] a) Prepare first and second solutions of high molecular weight polyvinylpyrrolidone (PVP) (for example, Plasdone K-90) dissolved in N-methylpyrrolidone (NMP), ethanol and Citrofol A1 including photoinitiator in solvent / plasticizer mixtures. The PVP content of the solution is in the range of 1-8% (w / w). The first and second solutions may be the same.

[0217] b) Soak the polyurethane raw catheter in the first solution and let it dry at room temperature for 10-120 seconds.

[0218] c) Soak the resulting catheter in a second solution of PVP.

[0219] d) Further drying the catheter at higher temperature (eg, at 70-80°C).

[0220] e) crosslinking the PVP by exposing the coated conduit to UV light in the wavelength range of 200nm-300nm for 1 / 2-15 minutes.

[0221] f1) Place the cross-linked co...

Embodiment 3

[0226] Example 3 - Preparation of Catheter Assembly

[0227] The catheter assembly shown in Figure 2 can be prepared as follows:

[0228] A dry urinary catheter (1) coated with polyvinylpyrrolidone (PVP) was prepared as described in Example 1. The catheter is placed in the first chamber (4) of the packaging device (3), which chamber is sealed by welding. Prepare a formulation containing aqueous hydrogen peroxide, DETAPMP, and an osmolarity-enhancing formulation (e.g., Na 2 SO 4 or NaNO 3 ) of liquid expansion medium (for example, as shown in Example 2) and loaded into the second chamber formed by the outer rigid container (5), which is installed as an integral part of the packaging device (3) . As shown in Figure 2 (b), the container (5) is installed to be able to rotate about 90 degrees relative to the end wall (8), so that the end wall (8) of the container (5) is provided towards the chamber (4) The liquid outlet and inlet of the rigid end wall (9) of the rigid end wal...

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Abstract

The present invention provides an assembly for the preparation of a medical device having a porous coating comprising hydrogen peroxide. Particularly interesting medical devices are catheters (such as urinary catheters), endoscopes, laryngoscopes, tubes for feeding, tubes for drainage, guide wires, condoms, urisheaths, barrier coatings e.g. for gloves, stents and other implants, extra corporeal blood conduits, membranes e.g. for dialysis, blood filters, devices for circulatory assistance, dressings for wound care, and ostomy bags. The coating is in particular a hydrophilic coating formed from cross-linked polyvinylpyrrolidone. In one embodiment, the assembly holds a dry catheter element in one compartment of a package and an aqueous hydrogen peroxide solution in another compartment. The solution may also comprise stabilizers, e.g. chelators, and osmolality increasing agents. The catheter for insertion in the urethra is useful for the treatment, alleviation or prophylaxis of microbial infections such as urinary tract infections (UTI).

Description

field of invention [0001] The present invention relates to components useful for providing a medical device having a coating of a porous polymer composition, e.g. a hydrophilic coating, on at least a portion of its surface, wherein the coating comprises a liquid, e.g. A liquid expansion medium comprising hydrogen peroxide. [0002] The invention also relates to the medical device itself, in particular the expansion medium containing hydrogen peroxide, and the medical use of said components and medical devices. Background of the invention [0003] In many medical applications, polymer compositions constitute at least a part of medical devices, such as hydrophilic coatings, hydrogels, stents, adhesives, etc., which can be used in close contact with the human body. Medical devices can also be used to introduce, cover, or fill body cavities. Examples of body cavities or openings may be naturally occurring cavities such as the urethra, mouth, ear, nose, eyes, rectum, or artific...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M25/00A61L29/12A61L29/16A61L29/08A61L31/12
Inventor B·R·尼尔森S·克里斯蒂安森B·K·布鲁恩M·西登纽斯
Owner COLOPLAST AS
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