Reprocessed catheter system with one stent

Abstract

Device for smoothing the surface of a balloon (9) of a balloon catheter (2), in particular of a previously used and optionally cleaned balloon catheter (2), characterized in that the device has a temperature-controlled sleeve, wherein the diameter of the temperature-controlled sleeve is slightly smaller than or equal to a specified diameter of the balloon (9), wherein the balloon (9) can be expanded in the device to at least the specified diameter and the surface of the balloon (9) is pressed against the temperature-controlled sleeve in the device, thereby smoothing the surface of the balloon (9), and the sleeve has a diameter that is minimally larger than the balloon with a folding fixation.

Description

[0001] The invention relates to a catheter system with a stent.

[0002] Catheter systems are generally known. German patent application DE 195 32 288 A1 discloses a balloon catheter that can be reused for vascular dilation in one patient and subsequently for stent implantation in the same patient. German patent application DE 102 09 993 A1 describes a device for reprocessing balloon catheters. In this process, the catheters are flushed; however, they are not tested, sterilized, or folded, nor are any parts of them. The catheter systems used, as well as the device for reprocessing previously used catheter systems, have the disadvantage that the catheter systems already used, as described in patent application DE 102 09 993 A1, cannot be reused for another patient.Without sterilization and testing of the previously used catheter, the catheter system cannot be used on another person. Furthermore, according to German patent DE 102 09 993 A1, flushed catheters could no longer be used for all types of treatment. For example, a stent can only be attached to a precisely folded balloon catheter. Therefore, with a catheter that has only been flushed but without a precisely folded balloon, a stent could no longer be securely attached to the balloon, thus preventing stent implantation that meets current safety standards.

[0003] The object of the present invention was therefore to further develop previously used catheter systems and reprocessing methods in such a way that, when treating different patients with a previously used catheter system, essentially all treatment types (such as stent implantation) can be performed just as with a new catheter system. Furthermore, the use of a previously used catheter system should be essentially as safe for a patient as the use of a new, unused catheter system.

[0004] The problem is solved with a catheter system containing a stent, wherein at least one part of the catheter system is reprocessed. A reprocessed part is understood to be a part of a catheter system that has already been used in the treatment of a first patient and subsequently reprocessed. After reprocessing, this reprocessed part is to be used in the treatment of a second patient. Reprocessing the part advantageously ensures that, even after its use in a first patient, there are no higher risks for a subsequent second patient than would be the case with treatment using a new, unused part. Furthermore, the catheter system according to the invention makes essentially all treatment types possible, since the catheter system, like new, unused catheter systems, also contains a stent.Furthermore, the use of at least one reprocessed component in the catheter system significantly reduces material consumption, as only damaged parts need to be replaced or repaired, or components remaining in the body (such as the stent) need to be replaced. This advantageously means that the entire catheter system does not always have to be discarded after use.

[0005] Preferably, the catheter system comprises at least one balloon catheter and / or a guide catheter. In the case of a balloon catheter, one balloon of the balloon catheter is preferably smoothed. The smoothing is preferably achieved by inserting the balloon into a temperature-controlled sleeve. The sleeve preferably has a diameter that is substantially less than or equal to a defined diameter of the inflated balloon. When the balloon is inflated to at least the defined diameter, the balloon surface comes into contact with the temperature-controlled sleeve, thereby smoothing out wrinkles or creases in the balloon surface, similar to an ironing process. For details regarding the smoothing of the balloon with a temperature-controlled sleeve or shaped sleeve, reference is made to the description in patent application DE 10 2007 021 116 A1, internal file number PY0013, filed on May 3, 2007, with the German Patent and Trademark Office.The aforementioned application shall be considered part of this disclosure. Alternatively, the balloon can also be smoothed by ironing, without the use of a heated sleeve. Smoothing the balloon is particularly important for previously used balloon catheters, as the balloon will have material imprints in the form of creases from a previous treatment on a first patient. These creases arise, for example, from the attachment of a stent to the balloon for stent implantation in the first patient. However, these creases prevent the balloon from being folded precisely, which is necessary for the subsequent proper dilation of the balloon in a second patient. Furthermore, poor folding makes it difficult or impossible to attach a stent to the balloon.

[0006] Balloon wrinkling refers to any changes in the balloon's shape and / or diameter. For example, material imprints from a stent on the balloon can be considered wrinkling. Similarly, vessel imprints within the balloon, such as those resulting from balloon dilation in a heavily calcified vessel, which leave a negative impression of the calcification on the balloon, should also be considered wrinkling.

[0007] 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 reprocessing 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 depends primarily on the reprocessing method.However, each of the three variants can be described as a fixed diameter of the balloon.

[0008] The balloon catheter preferably comprises at least one balloon and / or a guidewire channel and / or another channel and / or a pump and / or an integrated guide element and / or a guide element and / or a connector. The catheter system preferably also includes a sheath. The balloon is preferably a balloon of the type used in balloon catheters for vessel dilation or stent dilation. Preferably, the stent is crimped onto the balloon. The balloon preferably has markers, particularly radiopaque markers. This makes the balloon visible on X-rays during treatment, for example, during stenosis treatment. The precise placement of the balloon and the stent can thus be advantageously verified. The guide element is preferably guided through the at least one guidewire channel during use of the catheter system.Preferably, the guide element is a thin wire, such as that used in over-the-wire or rapid-exchange catheters. Gas or liquid is preferably guided through the additional channel, with the balloon being inflated or expanded by the gas or liquid. An integrated guide element is present, for example, in a fixed-wire balloon, since in this catheter system the guide element is integrated into the balloon. The pump is preferably connected to the port, and actuation of the pump generates pressure to inflate the balloon. The sheath can preferably be inserted into a blood vessel. A catheter system most preferably consists only of pre-processed components. The more frequently the pre-processed components can be used on different patients, the lower the material consumption, since the components do not have to be discarded even after multiple uses.It is understood that only individual components of the catheter system, or even only individual components of the balloon catheter or the guide catheter, may be reprocessed, while other components can be replaced with new ones for treatment on a second patient. For example, a balloon catheter may be reprocessed, but the guide element of the used balloon catheter may be replaced with a new, unused guide element. In another case, for example, the connector of a balloon catheter may be replaced, while the other components of the balloon catheter remain reprocessed.

[0009] Particularly preferably, at least one part of the catheter system has a manufacturer identification mark. Particularly preferably, the processed parts of the catheter system have this mark.

[0010] Preferably, the identifier includes information about the reprocessing. For example, the identifier preferably indicates how often a part has already been reprocessed, which reprocessing method was used, the part's defect tolerances, and / or when and / or where the last reprocessing took place. Of course, other information not directly related to the reprocessing is also conceivable. For example, the identifier could include information about the expiration date, the place of manufacture, or the part's date of manufacture. Preferably, the identifier can transmit the information stored in it to a receiving unit via at least one transmission channel. The receiving unit is preferably located on equipment used for the reprocessing process. Advantageously, the identifier thus assumes transponder functions.

[0011] The equipment used for the reprocessing procedure includes, for example, rinsing devices, drying units, measuring stations, sterilization devices, crimping devices, folding devices and / or tempering devices.

[0012] Preferably, at least one part of the reprocessed catheter system has defined minimum material thicknesses and / or material types and / or component sizes and / or component shapes and / or connections. These properties make the part preferably connectable to the devices used in the reprocessing process and / or enable it to withstand mechanical stresses that occur during the reprocessing process as well as through repeated use. For example, the additional channel is divided into a proximal and a distal shaft, with the transition from the proximal to the distal shaft preferably being reinforced. The balloon tip is also preferably reinforced in the area of ​​the guide element exit point.The part is thus advantageously adapted to the reprocessing procedure and multiple uses, so that the probability of damage can be reduced and the prerequisite for repairing or reprocessing the part is met.

[0013] Another object of the present invention is a balloon catheter for use in the catheter system according to the invention. The balloon of the balloon catheter is folded and / or tempered, as described in the following reprocessing method. It is understood that, in the case of a previously used balloon catheter, the balloon was first cleaned, inspected, and smoothed before folding and / or tempering. Tempering and folding advantageously prepare the balloon for reuse in a second patient. Folding allows a stent to be attached to the previously used balloon of the balloon catheter, so that the balloon catheter can also be used for stent implantation in the subsequent second patient. Tempering fixes the fold of the balloon, preventing it from immediately unfolding even after the removal of a protective covering, the so-called fold fixation.Furthermore, small creases caused by folding can be advantageously smoothed out by tempering.

[0014] Another aspect of the invention is a reprocessing method for catheter systems, wherein the balloon catheter and / or the guide catheter is subjected to a plurality of measurements during the reprocessing process. Preferably, each balloon catheter and / or each guide catheter is subjected to a plurality of measurements. Of course, it is also possible that some measurements are only performed on a random sample basis. Particularly preferably, previously used catheter systems are subjected to a plurality of measurements during the reprocessing process. The measurements advantageously allow the condition of the reprocessed component to be determined. This makes it possible to ensure the proper use of a reprocessed component. A defective component can preferably be identified, sorted out, or repaired during the reprocessing process.Simultaneously, the reprocessed part can be classified based on its condition and any defects. This classification determines, for example, the intended use of the part after reprocessing. For instance, depending on the part's condition, use on humans may be ruled out, while use on animals may still be permitted. Of course, unused catheter systems can also be subjected to multiple measurements. This ensures a higher degree of certainty regarding proper treatment with the tested catheter system.

[0015] Preferably, the catheter system is cleaned before, during, and / or after the reprocessing procedure. Particularly with a previously used catheter system, cleaning creates the necessary conditions for testing or measuring the catheter system and thus for its reuse. For example, a detailed optical inspection of a catheter system can only be performed once it has been cleaned of blood and / or contrast medium. A device and a method for cleaning previously used catheter systems are described in German Patent Application DE 102 09 993 A1, for example, in column 3 et seq. Patent Application DE 102 09 993 A1 is hereby incorporated by reference and shall be considered part of this disclosure.

[0016] Preferably, the crimp strength, compliance, expansion pressure, deflation time, inflation time, leak tightness, and / or particle-free status of a guide catheter and / or a balloon catheter are tested during the reprocessing procedure. Furthermore, bioburden measurement, cytotoxicity measurement, chest pressure measurement, hemocompatibility measurement, detection of chemical and biological particles, pyrogen measurement, and / or coating verification are preferably performed. Preferably, the guide catheter and / or the balloon catheter is sterilized and packaged at the end of the reprocessing procedure. The measurement methods described above advantageously ensure consistent quality of the reprocessed part of a catheter system.Particularly advantageous are the testing and measurement procedures, which can rule out potential risks to patients from a reprocessed component. For example, pathogens with which the component was contaminated during treatment on a patient can be identified and destroyed in the subsequent reprocessing procedure. Furthermore, the tests and measurements can determine whether the connections of the catheter system are leak-proof, preventing unintentional fluid leakage from the catheter system during treatment. To determine the inflation time, the time required for a balloon to inflate substantially to the specified diameter is preferably measured. The deflation time is preferably determined by measuring the time until the balloon has collapsed substantially completely after the inflation described above.Sterilization of the catheter system is preferably carried out by gas, for example by ethylene oxide, and / or by autoclaving, and / or by radiation, for example by radioactive radiation. The sterilization method used depends primarily on the material properties of the catheter system to be sterilized. Before sterilization, the processed component is preferably dried, for example by infrared drying. It goes without saying that optical measurements are also performed. For example, the guidewire can be examined microscopically, with particular attention paid to the coil on the guidewire for damage and / or contamination. Naturally, all measurements can also be performed on at least one component of an unused catheter system, thereby advantageously ensuring the flawless quality of the catheter systems.

[0017] Another aspect of the present invention is a reprocessing method for a balloon catheter, wherein the balloon is smoothed during reprocessing. Whether the balloon has already been used or is new and unused, smoothing the balloon simplifies and improves its folding, as previously described. This allows new, unused balloons to be folded more precisely and fixed in their fold. This improves the quality of the balloon catheters, for example, by improving balloon dilation.

[0018] Preferably, the balloon catheter is subjected to a first and / or a second tempering process. Particularly preferably, the balloon is smoothed in the first tempering process, with the smoothing being carried out using the tempered sleeve as already described. More preferably, after smoothing, the balloon is folded, and the folds of the balloon are then arranged in a specific configuration. Preferably, the second tempering process follows. In the second tempering process, the balloon is inserted into a tempered sleeve, with or without a fold fixation device. If a fold fixation device is used, the tempered sleeve preferably has a diameter that is slightly larger than the balloon with the fold fixation device. When the balloon is then expanded by pressure, the folds of the balloon are fixed, and minor creases, such as those caused by the folding or the arrangement of the folds, are smoothed out.In the case where no folding fixation is used, the sleeve preferably has a diameter that essentially corresponds to the diameter of the folded balloon. Preferably, the balloon is expanded under pressure, whereby the fold of the balloon is pressed against the sleeve and thus fixed. Regarding the folding, positioning, and fixing of the balloon's folds, reference is made to patent application DE 10 2007 021 117 A1, internal file number PY0012, filed on May 3, 2007, with the German Patent and Trademark Office. This application is hereby introduced as a reference and is thus part of the disclosure.

[0019] Preferably, the preparation process includes a first and / or a second crimping process to attach the stent to the balloon. Preferably, the preparation process involves the first crimping process followed by the second. The first crimping process preferably reduces the diameter of the stent so that it is slidably attached to the balloon. For this purpose, the stent is preferably compressed using a crimping device. Before the second crimping process, the stent is readjusted on the balloon. In the second crimping process, the diameter of the stent is then reduced so that it is firmly attached to the balloon and essentially no longer slidable.

[0020] Another object of the present invention is a catheter system which has been processed according to the described processing method.

[0021] The prepared catheter system can be used to insert a stent into the body of a living being. For example, the stent can be inserted into the body of a human or an animal. Preferably, the stent is inserted into a hollow organ. A hollow organ for stent insertion could be, for example, a coronary artery, a carotid artery, a leg artery, a cerebral artery, a renal artery, a bile duct, a lacrimal duct, the esophagus or another part of the gastrointestinal tract, or even the cervix.

[0022] Another aspect of the present invention is a device for smoothing a balloon surface, wherein the device comprises a temperature-controlled sleeve. The balloon is inserted into the sleeve within the device, the sleeve having a diameter that is at least less than or equal to the specified diameter of the balloon. Subsequently, when the balloon is expanded to at least the specified diameter, the balloon surface is advantageously smoothed because the balloon surface is pressed against the temperature-controlled sleeve. Such a device is manufactured, for example, by Fortimedix for creating a positive fit between a balloon and a stent after a crimping process, wherein, in the device used to date, the sleeves are adapted in diameter to the folded balloon with the stent.

[0023] Another aspect of the invention is a storage device for, for example, used catheter systems. In this storage device, the used catheter systems can be placed in a substantially unfolded state, with a water vapor-saturated atmosphere prevailing inside the device and / or the catheter systems being substantially covered with liquid. The water vapor-saturated atmosphere advantageously prevents contrast medium or blood, with which the catheter system came into contact during treatment, from drying out. It is also conceivable, however, that the storage device be designed in such a way that initial reprocessing steps are carried out automatically. For example, the storage device could include a rinsing tray in which the catheter systems can be placed in a solution and pre-cleaned, for example, by ultrasound waves.The reprocessing device is preferably designed to be portable, so that the catheter systems can be transported within the device, for example, to the reprocessing procedure. Advantageously, the storage device allows preparation for reprocessing to begin immediately after use of the catheter systems. Of course, the storage device is also suitable for other items. However, it is preferably suitable for items that are to be reprocessed and / or where the drying out of substances is to be prevented. Regarding the design of the storage device, reference is made to patent application DE 10 2007 021 118 A1, internal file number PY0014, filed on May 3, 2007, with the German Patent and Trademark Office. The patent application is introduced by reference and is thus part of this disclosure.

[0024] The invention is described below by way of example using a single figure. This description does not limit the general concept of the invention. The single figure schematically depicts a catheter system.

[0025] The figure schematically depicts a catheter system 1, which in the exemplary embodiment comprises a balloon catheter 2 and a guide catheter 7. In the exemplary embodiment, the balloon catheter 2 includes a balloon 9, a guide wire channel 4, a further channel 5, and a connection 6. A guide element 3, for example a guide wire, is preferably guided in the guide wire channel 4. The connection 6 is preferably a Luer-lock connection and preferably not made of polycarbonate. The balloon catheter 2 can preferably be connected to a pump via the connection 6, whereby pressure can be generated by the pump to inflate the balloon 9. In particular, areas 8 and 10 of the balloon catheter 2 are subject to special stresses due to repeated use and the reprocessing procedure. Therefore, these areas 8 and 10 are preferably reinforced by, for example, having metal mesh or double adhesive seams.The catheter system 1 further comprises a sheath 11. Preferably, the sheath 11 is inserted into the femoral artery 12 of a patient, so that blood cannot flow freely from the previously opened femoral artery 12. The balloon catheter 2 is preferably guided into the guiding catheter 7, so that injury to the femoral artery 12 by the balloon catheter 2 can be essentially ruled out. Reference symbol list 1 catheter system 2 balloon catheters 3 Guide element 4 guide wire channel 5 more channels 6 connection 7 guide catheters Area 8 9 Balloon Area 10 11 Lock 12 Leg artery

Claims

[1] Device for smoothing the surface of a balloon (9) of a balloon catheter (2), in particular a balloon catheter (2) that has already been used and possibly cleaned, characterized by , that the device has a tempered sleeve, wherein the diameter of the tempered sleeve is slightly less than or equal to a specified diameter of the balloon (9), wherein the balloon (9) is expandable in the device to at least the specified diameter and the surface of the balloon (9) is pressed against the tempered sleeve in the device, thereby smoothing the surface of the balloon (9), and the sleeve has a diameter that is minimally larger than the balloon with a folding fixation.

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