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DE-102009024245-B4 - Method for manufacturing a patient interface with gel filling as well as patient interface with gel filling

DE102009024245B4DE 102009024245 B4DE102009024245 B4DE 102009024245B4DE-102009024245-B4

Abstract

Method for manufacturing a gel-filled patient interface, comprising the following steps: In a first step, the production of a closed gel shell (3), wherein a shell blank is closed by a plug and a firm connection between the shell blank and the plug is established by using a bonding agent, wherein the closed shell is made of a uniform material and is intended for placement on an external surface of a patient's body and Subsequently, in a second step, an opening of the closed gel shell (3) is caused by an injection of an injectable medium and liquid gel is injected into the gel shell (3) by means of the injectable medium.

Inventors

  • Martin Eifler
  • Arnold Frerichs
  • Henry Hahn
  • Martin Bechtel
  • Matthias Pulla
  • Joachim Gardein

Assignees

  • Löwenstein Medical Technology S.A.

Dates

Publication Date
20260513
Application Date
20090604
Priority Date
20080605

Claims (7)

  1. A method for manufacturing a gel-filled patient interface, comprising the following steps: In a first step, the production of a closed gel shell (3), wherein a shell blank is closed by a plug and a firm connection between the shell blank and the plug is established by using a bonding agent. is produced, wherein the closed shell is made of a uniform material and is intended for placement on an external surface of a patient's body, and subsequently, in a second step, an opening of the closed gel shell (3) is caused by an injection of an injectable medium and liquid gel is injected into the gel shell (3) by the injectable medium.
  2. Procedure according to Claim 1 characterized by the fact that the uniform material is silicone.
  3. Procedure according to Claim 1 characterized in that the bonding agent is liquid silicone.
  4. Procedure according to Claim 1 characterized in that the connecting agent is activated by the application of energy.
  5. Method according to one of the preceding claims characterized in that the gel filling has a cross-section of less than 5 mm.
  6. Method according to one of the preceding claims characterized in that the gel shell has a wall thickness of about 0.5 mm and preferably of less than 0.3 mm.
  7. Patient interface with a gel filling manufactured according to the procedure according to Claim 1 , characterized in that a gel shell (3) formed from a flexible material at least partially defines a cavity (9), wherein the gel shell (3) has a closed opening (10) through which the gel in liquid form was filled into the cavity (9).

Description

The invention relates to a method for producing a gel-filled patient interface, comprising the following steps: In a first step, the production of a closed gel shell (3), wherein a shell blank is closed by a plug and a firm connection between the shell blank and the plug is established by using a connecting agent, wherein the closed shell is made of a uniform material and is intended for placement on an external surface of a patient's body, and subsequently, in a second step, an opening of the closed gel shell (3) is caused by an injection of an injection agent and liquid gel is filled into the gel shell (3) by means of the injection agent. The invention further relates to a patient interface with a gel filling manufactured according to the method according to claim 1. A gel ball for a state-of-the-art ventilation mask, as in the EP 0 799 076 B1 The device described is made of a polyurethane (PU) gel enclosed in a protective PU film. An additional silicone shell lies between the patient's face and the PU gel body. The wall thicknesses of the PU film and the silicone shell are essentially constant. The hardness of the gel filling is below Shore 10. The material properties and hardness of polyurethanes are not equally suitable for all users. Polyurethanes (PU) are formed through a condensation and adduction reaction between isocyanates and polyols. Numerous additives are used in PU production. In partially cured polyurethanes, monomers such as isocyanates can remain. Exposure to isocyanates and additives can lead to both allergic and irritant contact dermatitis. This causes some patients to reject PU materials. In the US 2007 / 02 21 227 A1 A method for manufacturing a patient interface is described. The patient interface has a gel filling arranged in a cavity within a gel shell made of a flexible material. Comparable methods for manufacturing a patient interface, as well as gel-filled patient interfaces, are also used in the DE 10 2005 033 649 A1 , the DE 20 2007 019 573 U1 as well as the EP 1 946 901 A1 described. The present invention aims to improve the wearing comfort of a patient interface and patient compliance, and to enable cost-effective manufacturing. The problem is solved by the features of claim 1. A further object of the present invention is to design a patient interface of the type mentioned in the introduction in such a way that improved wearing comfort is achieved with cost-effective manufacturing. This problem is solved by the features of claim 7. The gel filling can have a wide variety of properties, including gel materials such as polyurethane or silicone gel, or the natural gel agarose, as well as foams, gas mixtures, and liquids such as saline solution, which is often used in medicine. Ultimately, it can also be the same material from which the gel shell is made, especially if it is foamed. Thanks to the integrated design according to the invention, the thickness of the gel shell walls can be very precisely adjusted to the requirements, in order to give certain areas of the gel shell more or less rigidity as needed. The invention is suitable for any patient interface that rests against the body. The invention can therefore be used in particular with the following types of patient interfaces: nasal, oral, and full-face masks, nasal pillows or nasal prongs, in emergency, home, and hospital ventilation, CPAP, APAP, and bilevel ventilation, as well as with medical orthoses, prostheses, and support devices. To manufacture the patient interface according to the invention, it is proposed to produce the gel shell from an elastic plastic, preferably a silicone, with at least one cavity using a molding process, and then to fill this cavity with the intended gel. The filling should preferably be carried out through at least one opening provided for this purpose, which is preferably not located in the areas of the gel shell that come into contact with the skin. Filling is particularly preferably carried out by injecting the filling material, with the casing preferably being pierced in the thicker areas. The at least one opening is, particularly when filling with liquid or gaseous filling materials, sealed after filling, for example, The container is tightly sealed with a plug, by welding, or by gluing. Gaseous fillers, in particular, can be pressurized, so that the pressure can influence and determine the properties of the gel body. An alternative manufacturing process involves first closing a shell blank with a plug and creating a firm connection between the shell blank and the plug by using a connecting agent, wherein the closed shell is made of a uniform material, preferably silicone. An alternative manufacturing method results from specifying the geometry of the casing blank in the manufacturing process by at least one metal core, and removing the metal core after the casing blank has been manufactured through an opening in the casing blank, the length of which is less than half the circumferenc