Method and device for smoothing a balloon of a balloon catheter

Abstract

Method for producing a balloon (1) of a balloon catheter, characterized in that the balloon (1) is smoothed by a tempered, smooth surface sliding along the balloon (1).

Description

[0001] The invention relates to a method for manufacturing a balloon catheter.

[0002] Methods for manufacturing balloon catheters are generally known. For example, European Patent EP 0 891 201 B1 discloses a manufacturing method for a balloon catheter, wherein the balloon of the balloon catheter has different coefficients of friction. European Patent EP 0 730 879 B1 discloses a method for manufacturing a balloon catheter, wherein the balloon is manufactured in such a way that it can be folded up to a particularly small size.

[0003] US Patent 5,163,989 A discloses a shape and method for manufacturing small-diameter balloons suitable for dilation catheters, such as those used in angioplasty procedures.

[0004] US 7 147 817 B1 discloses medical devices, in particular intracorporeal devices for therapeutic or diagnostic purposes, such as balloon catheters and vascular grafts.

[0005] However, a disadvantage of the known manufacturing methods is that the subsequent folding of the balloon is very complex and, moreover, the folding of the balloon cannot be exact, i.e., with inaccurate fold edges.

[0006] The object of the present invention was therefore to provide a manufacturing process in which the subsequent folding of the balloon can be carried out more easily and precisely than in the manufacturing processes known to date.

[0007] The problem is solved by a method for manufacturing a balloon of a balloon catheter, wherein the balloon is smoothed. Smoothing the balloon advantageously simplifies subsequent folding, as no creases in the balloon interfere with the folding process. Furthermore, a smoothed balloon can be folded much more precisely, since the fold edges are not affected by creases. Particularly when balloon catheters are used multiple times, as described in application DE 10 2007 021 144 A1 with the internal file number PY0011, filed on May 3, 2007, with the German Patent and Trademark Office, smoothing the balloon is important for the subsequent flawless treatment of new patients. The aforementioned patent application is hereby introduced as a reference and forms part of the disclosure.The inventive method according to the main claim and the embodiments according to the dependent claims are therefore applicable both to new, unused balloon catheters and to balloon catheters that have already been used.

[0008] Regarding the folding of the balloon, reference is made to application DE 10 2007 021 117 A1 with the internal file number PY0012, filed on May 3, 2007, with the German Patent and Trademark Office. The patent application is hereby introduced as a reference and forms part of the disclosure.

[0009] Creases are defined as any kinks and / or folds in the balloon material that may have occurred during the manufacturing process, previous use of the balloon catheter, or during reprocessing. For example, creases or folds can be caused by the machinery used during balloon production. A previously used balloon may exhibit creases such as imprints from a stent or vessel wall, or may have acquired creases during cleaning or reprocessing.

[0010] Preferably, the balloon is smoothed by an ironing process and / or a pressing process and / or a steaming process. In an ironing process, the balloon is preferably inflated to a defined diameter. A tempered, smooth surface then glides along the balloon, advantageously smoothing out creases. Naturally, the tempered, smooth surface can also be used on the uninflated balloon to smooth out creases. In a steaming process, the balloon is preferably heated with steam and expanded slightly beyond a defined diameter. The heating of the balloon material and the slight overstretching of the balloon smooth out creases.

[0011] The defined diameter of a balloon is the diameter of the balloon at a specified overpressure. This defined diameter depends on the size of the balloon, which may have different defined diameters depending on the application. Typically, the manufacturer of the balloon catheter specifies a defined overpressure to be applied to the balloon and / or a defined balloon diameter. Naturally, the balloon can also be expanded beyond the defined diameter without being damaged. For the method according to the invention, the balloon can, for example, be expanded slightly below, above, or even to its nominal diameter. All three variations are possible without damaging the balloon. Which variation is chosen for the balloon essentially depends on the method used to flatten the balloon.However, each of the three variants can be described as a fixed diameter of the balloon.

[0012] Preferably, during a compression process, the balloon is inserted into a temperature-controlled mold sleeve. The temperature-controlled mold sleeve is slightly smaller than or equal to the specified diameter of the inflated balloon. The temperature-controlled mold sleeve is preferably heated. It is understood that parts other than the balloon of the balloon catheter may also be inserted into the temperature-controlled mold sleeve, since the balloon is essentially permanently and irreversibly connected to the balloon catheter. However, in the following, only the balloon will be referred to.

[0013] Preferably, the balloon is inflated or expanded within the temperature-controlled mold sleeve to at least the specified diameter. Preferably, the balloon surface is pressed against the inside of the temperature-controlled mold sleeve. During the pressing process, the specified diameter of the balloon is therefore selected such that at least partial areas of the balloon surface are pressed against the temperature-controlled mold sleeve. Particularly preferably, however, the specified diameter of the balloon is selected such that substantially the entire balloon surface is pressed against the temperature-controlled mold sleeve. The expansion of the balloon to the specified diameter can be achieved with gas and / or liquid, in both cases referred to as balloon inflation. The temperature-controlled mold sleeve preferably has very smooth inner surfaces without any material protrusions or depressions.During the pressing process, the balloon surface is pressed against the smooth inner surfaces of the heated mold sleeve and heated. The heating of the balloon material by the heated mold sleeve, combined with the pressure exerted by pressing the balloon against the inside of the sleeve, smooths out any creases in the balloon.

[0014] Preferably, the temperature-controlled mold sleeve has a temperature that is matched to the balloon material. Furthermore, preferably, the balloon is pressed against the temperature-controlled mold sleeve for a defined time, the defined time depending on the balloon material. The temperature used for the pressing process and / or the defined time can, for example, be indicated by the balloon manufacturer on the balloon catheter.

[0015] Preferably, the inflated balloon is moved within the temperature-controlled mold sleeve about its longitudinal axis and / or along its longitudinal axis. The longitudinal axis of the balloon is defined as the axis through the balloon's principal plane of extension. When moving about the longitudinal axis, the balloon rotates. When moving along the longitudinal axis, the balloon is pushed forward and / or backward within the temperature-controlled mold sleeve. Naturally, both movements can also occur essentially simultaneously. Moving the balloon within the temperature-controlled mold sleeve ensures that essentially all areas of the balloon's surface are pressed against the mold sleeve and thus smoothed, even if the balloon's diameter is smaller than the diameter of the mold sleeve. Of course, the balloon can also be smoothed without movement within the mold sleeve and without movement of the mold sleeve itself.

[0016] Another aspect of the invention is the use of a device for flattening the balloon of a balloon catheter, wherein the device comprises a temperature-controlled mold sleeve. Devices with temperature-controlled mold sleeves are known. For example, Fortimedix offers a device with temperature-controlled sleeves for creating a positive seal with a crimped stent. However, the use of this device for flattening the balloon is novel.

[0017] Other possible designs for a device to smooth a balloon include, for example, providing temperature-controlled depressions, the temperature of which is advantageously adjustable by a regulator. The depressions can have different diameters, so that different types of balloons with different diameters can be smoothed in them.

[0018] Preferably, the tempered mold sleeve has a diameter that is only slightly smaller than or equal to the specified diameter of the inflated balloon.

[0019] Preferably, during use of the device, the balloon is inflated to at least the specified diameter or subjected to the specified pressure and pressed against the tempered mold sleeve, thereby smoothing out the creases in the balloon surface.

[0020] Preferably, when using the device, the temperature and / or size of the heated molding sleeve is adjusted depending on the balloon to be smoothed. For example, the heated molding sleeve can be made smaller or larger to adapt to the specified diameter of different balloon types. Furthermore, the temperature of the heated molding sleeve can be set so that optimal smoothing of the balloon surface is achieved without damaging the balloon surface with heat.

[0021] Preferably, the entire tempered mold sleeve or just the inner surface of the tempered mold sleeve is particularly smooth and / or highly thermally conductive for use in smoothing the balloon, and / or the tempered mold sleeve exhibits high biocompatibility. Due to the good thermal conductivity, the heat from the tempered mold sleeve can be transferred to the balloon material particularly efficiently. The high biocompatibility advantageously does not reduce the biocompatibility of the balloon, allowing it to be used for treatment on a living organism even after smoothing (page 4).

[0022] Preferably, the balloon is movably arranged within the temperature-controlled mold sleeve during the smoothing process, and / or the temperature-controlled mold sleeve moves around the balloon. For example, it is conceivable that both the temperature-controlled mold sleeve and the balloon can move within the mold sleeve. For instance, the balloon can be pushed forward and / or backward along its longitudinal axis within the mold sleeve, and the mold sleeve rotates around the longitudinal axis of the balloon.

[0023] Another aspect of the invention is a balloon catheter, wherein the balloon of the balloon catheter has been smoothed according to the described method. The balloon catheter can be a new, unused balloon catheter or a previously used balloon catheter. Preferably, the previously used balloon catheter has already been used in the treatment of a first patient and is reprocessed for use in a second patient. The described smoothing process can be part of this reprocessing process. With both a new and a previously used balloon catheter, smoothing the balloon allows for more precise folding of the balloon, thereby improving balloon dilation and the attachment of a stent to the balloon.

[0024] Preferably, the balloon of the balloon catheter is folded and has a crimped stent. A balloon catheter with a stent is used for stent implantation. Of course, the balloon can also be used without a stent. In this case, the arrangement of the balloon's folds is preferably fixed by a first sleeve and a second sleeve. Embodiments of the first and second sleeves are described in application DE 10 2007 021 117 A1, internal file number PY0012, filed on May 3, 2007, with the German Patent and Trademark Office.

[0025] Another aspect of the invention is a method for preparing a balloon for treatment on a living being. In this method, the balloon is smoothed and folded according to the described procedure. The folding of the smoothed balloon, or the arrangement of the folds, is then fixed.

[0026] Preferably, a stent and / or sleeves are attached to the smoothed and folded balloon. The sleeves are preferably the first and second sleeves already mentioned. The sleeves and / or the stent advantageously fix the balloon's folds in such a way as to prevent unwanted dilation and / or changes in the arrangement of the balloon's folds.

[0027] The invention is explained below with reference to figures, whereby the explanations are merely exemplary and do not restrict the general inventive concept. Fig. Figure 1 schematically represents a temperature-controlled mold sleeve. Fig. Figure 2 schematically depicts the temperature-controlled mold sleeve and a balloon in a top view. Fig. Figure 3 schematically depicts the tempered mold sleeve with balloon in a side view. Fig. Figure 4 schematically represents a possible embodiment of a device for smoothing the balloon.

[0028] In the Fig. Figure 1 schematically depicts a temperature-controlled forming sleeve 2. The temperature-controlled forming sleeve 2 has an inner diameter 5. Preferably, the inner diameter 5 is slightly smaller than or equal to a defined diameter 6 (outer diameter) of a balloon 1. Furthermore, preferably, the length of the temperature-controlled forming sleeve 2 corresponds at least to the length of the balloon 1. Reference numeral 3 denotes the inner surface of the temperature-controlled forming sleeve 2. Preferably, the temperature-controlled forming sleeve 2 is located in a first device for creating a positive fit between a balloon and a crimped stent. Preferably, the first device has a plurality of temperature-controlled forming sleeves 2, so that a plurality of balloons 1 can be flattened within the temperature-controlled forming sleeves 2. The temperature-controlled forming sleeve 2 is preferably designed to be variable in its diameter 5 and / or its length and / or its temperature.The variable design of the temperature-controlled mold sleeve 2 allows it to be used for different types of balloons. For example, the balloon material and / or the defined diameter 6 of two balloons 1 may differ between different balloon types.

[0029] In the Fig. Figure 2 schematically shows a top view of the temperature-controlled mold sleeve 2 with a balloon 1 located inside it. The balloon 1 is preferably the balloon 1 of a balloon catheter. The balloon 1 is expanded to a defined diameter 6 within the temperature-controlled mold sleeve 2, so that the balloon 1 presses against the inner surfaces 3 of the temperature-controlled mold sleeve 2. The outer surface of the temperature-controlled mold sleeve 2 is shown with dashed lines for orientation. The pressure with which the balloon 1 is pressed against the inner surfaces 3 of the temperature-controlled mold sleeve 2, combined with the heat from the side 5 of the temperature-controlled mold sleeve 2, smooths the surface of the balloon 1.

[0030] In the Fig. Figure 3 schematically shows a side view of the tempered mold sleeve 2 with a balloon 1 located inside the tempered mold sleeve 2. The balloon 1 is essentially completely enclosed by the tempered mold sleeve 2. The balloon 1, expanded to a defined diameter 6, is located in the lower part of the Fig. Figure 3 is shown schematically in dashed lines. The balloon 1 can move within the temperature-controlled mold 2 in the direction of its longitudinal axis 4 or rotate around the longitudinal axis 4, as indicated by the circular arrow. Naturally, the temperature-controlled mold 2 can also be moved within the first device, either in the direction of the longitudinal axis 4 or around the longitudinal axis 4 of the balloon.

[0031] The Fig.Figure 4 schematically illustrates an embodiment of a second device 7 for smoothing the balloon, wherein a plurality of temperature-controlled forming sleeves 2 are provided within the second device 7. The second device 7 differs, for example, in the temperature control of the temperature-controlled sleeves 2 from the first device for creating a positive fit between a balloon and a crimped stent. In the second device 7, the temperature-controlled forming sleeves 2 are preferably heated by heating elements 8, with a controller 9 determining and regulating the temperature of the temperature-controlled forming sleeve 2. The heating elements 8 are preferably heating coils, with the heating coils preferably extending around the temperature-controlled forming sleeves 2. Of course, heating the entire second device 7 by one or more heating elements is also possible. Preferably, the temperature-controlled forming sleeves 2 were produced by depressions in a metal block.Naturally, the recesses can also be provided in a heat-resistant plastic block, thus creating the temperature-controlled mold sleeves 2 within a single plastic block. The temperature of the temperature-controlled mold sleeves 2 can also be adjusted via the regulator 9, making the device 7 adaptable to different balloon types. Reference number list 1 balloon 2 tempered mold sleeves 3 Inside tempered mold sleeve 4 Longitudinal axis 5 diameter tempered mold sleeve 6 fixed diameter balloon 7 second device 8 heating elements 9 controllers

Claims

[1] Method for manufacturing a balloon (1) of a balloon catheter, characterized by , that the balloon (1) is smoothed, whereby a tempered, smooth surface slides along the balloon (1). [2] Method according to claim 1 characterized by , that the balloon (1) is smoothed by an ironing process. [3] Use of a device for smoothing a balloon (1) of a balloon catheter with a tempered mold sleeve (2), wherein the tempered mold sleeve is slightly smaller than or equal to the specified diameter of the inflated balloon. [4] Use of a device according to claim 3, characterized by , that the balloon (1) is inflated at least to the specified diameter (6) and is pressed with the balloon surface against the tempered mold sleeve (2), thereby smoothing out wrinkles in the balloon surface. [5] Use of a device according to one of the preceding claims 3 or 4, characterized by, that the temperature and / or the size of the tempered mold sleeve (2) is adjusted depending on the balloon (1). [6] Use of a device according to any one of the preceding claims 3 to 5, characterized by that the entire tempered mold sleeve (2) or only the inside (3) of the tempered mold sleeve (2) is particularly smooth and / or has particularly high thermal conductivity and / or exhibits particularly high biocompatibility. [7] Use of a device according to any one of the preceding claims 3 to 6, characterized by , that the tempered mold sleeve (2) is movably arranged in the device and / or the balloon (1) is moved in the tempered mold sleeve (2). [8] Balloon catheter with a balloon (1), characterized by , that the balloon (1) was manufactured according to the method of claims 1 to 2. [9] Balloon catheter according to claim 8, characterized by , that the balloon (1) is folded or the balloon (1) is folded and has a crimped stent.

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